Certain Dental and Orthodontic Scanners and Software, Inv. 337-TA-1144

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In the Matter of

CERTAIN DENTAL AND ORTHODONTIC
SCANNERS AND SOFTWARE

Investigation No. 337-TA-1144

Publication 5300 March 2022

U.S. International Trade Commission

Washington, DC 20436

U.S. International Trade Commission
COMMISSIONERS
Jason E. Kearns, Chair
Randolph J. Stayin, Vice Chair
David S. Johanson, Commissioner
Rhonda K. Schmidtlein, Commissioner
Amy A. Karpel, Commissioner
Address all communications to
Secretary to the Commission
United States International Trade Commission
Washington, DC 20436

U.S. International Trade Commission
Washington, DC 20436
www.usitc.gov
Publication 5300 	March 2022
In the Matter of
Investigation No. 337-TA-1144
CERTAIN DENTAL AND ORTHODONTIC
SCANNERS AND SOFTWARE

1
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN DENTAL AND
ORTHODONTIC SCANNERS AND
SOFTWARE
Investigation No. 337-TA-1144
NOTICE OF THE COMMISSION’S FINAL DETERMINATION FINDING NO
VIOLATION OF SECTION 337; TERMINATION OF THE INVESTIGATION
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
SUMMARY: Notice is hereby given that the U.S. International Trade Commission has found
no violation of section 337 of the Tariff Act of 1930, as amended. The investigation is hereby
terminated.
FOR FURTHER INFORMATION CONTACT: Robert Needham, Office of the General
Counsel, U.S. International Trade Commission, 500 E Street, S.W., Washington, D.C. 20436,
telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this
investigation are or will be available for inspection during official business hours (8:45 a.m. to
5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street,
S.W., Washington, D.C. 20436, telephone (202) 205-2000. General information concerning the
Commission may also be obtained by accessing its Internet server (http://www.usitc.gov). The
public record for this investigation may be viewed on the Commission’s electronic docket
(EDIS) at http://edis.usitc.gov. Hearing-impaired persons are advised that information on this
matter can be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on
March 5, 2019. 84 FR 7933-34 (March 5, 2019) based on a complaint filed on behalf of Align
Technology, Inc. of San Jose, California (“Align”). The complaint alleges violations of section
337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United
States, the sale for importation, or the sale within the United States after importation of certain
dental and orthodontic scanners and software by reason of infringement of one or more claims of
U.S. Patent Nos. 9,299,192 (“the ’192 patent”); 7,077,647 (“the ’647 patent”); 7,156,661
(“the ’661 patent”); 9,848,958 (“the ’958 patent”); and 8,102,538 (“the ’538 patent”). Id. The
complaint further alleges that a domestic industry exists. Id. The Commission’s notice of
investigation named as respondents 3Shape A/S of Copenhagen, Denmark; 3Shape, Inc. of
Warren, New Jersey; and 3Shape Trios A/S of Copenhagen, Denmark (together, “3Shape”). Id.
The Office of Unfair Import Investigations is not participating in the investigation. Id.

2
The Commission subsequently terminated the investigation with respect to the ’958
patent based on Align’s withdrawal of those complaint allegations. Order No. 17 (Jul. 2, 2019),
not reviewed Notice (Jul. 23, 2019). On October 8, 2019, Align stated that it would no longer
pursue a violation with respect to claims 4 and 20 of the ’647 patent, claims 1 and 19 of the ’661
patent, and claims 1, 3-5, and 22 of the ’192 patent. On October 21, 2019, Align stated that it
would no longer pursue a violation with respect to claim 2 of the ’647 patent. Accordingly, at
the time of the Final ID, Align asserted claims 1 and 18 of the ’647 patent, claims 2 and 20 of
the ’661 patent, claims 1 and 2 of the ’538 patent, and claims 2, 28, and 29 of the ’192 patent.
On April 30, 2020, the ALJ issued the Final ID finding a violation of section 337 with
respect to the ’647 and ’661 patents, and no violation with respect to the ’538 and ’192 patents.
Specifically, the ALJ found that claims 1 and 18 of the ’538 patent are not infringed and that
claims 2, 28, and 29 of the ’192 patent are invalid. The ALJ found that Align satisfied the
remaining requirements for a violation with respect to the ’538 and ’192 patents.
On May 12, 2020, 3Shape and Align each filed a petition for review of the Final ID. On
May 20, 2020, the parties responded to each other’s petitions. The Commission also received
four comments on the public interest.
On January 31, 2020, the Commission determined to review the Final ID in part.
Specifically, the Commission determined to review the following issues: (1) the findings
regarding importation and induced infringement; (2) the construction of limitation 1.5/18.5 of the
‘647 patent (“individually matching [match] each of the dental objects in the subsequent digital
model with a dental object in the initial digital model to determine corresponding dental objects,
the matching comprising [including instructions to]”) in the asserted claims of the ’647 patent,
and the application of that construction regarding infringement, invalidity, and the technical
prong of the domestic industry; (3) the findings regarding whether the asserted claims of the ’647
and ’661 patents are directed to patentable subject matter; (4) the construction of the limitation
“wherein the device is configured for maintaining a spatial disposition with respect to the portion
that is substantially fixed during operation of the optical scanner and imaging means” in the
asserted claims of the ’538 patent, and the application of that construction regarding
infringement, invalidity, and the technical prong of the domestic industry requirement; (5) the
findings regarding whether Okamato anticipates the asserted claims of the ’538 patent; (6) the
findings regarding whether Paley-Kriveshko anticipates or renders obvious the asserted claims of
the ’192 patent; and (7) the findings regarding the satisfaction of the economic prong of the
domestic industry requirement.
Having examined the record of this investigation, including the Final ID, the petitions,
responses, and other submissions from the parties, the Commission has determined that Align
has failed to show a violation of section 337. Specifically, the Commission has determined to:
(1) modify the Final ID’s findings on importation; (2) reverse the Final ID’s finding that Align
showed induced infringement for the ’647 and ’661 patents; (3) modify the Final ID’s
interpretation of the limitation “to determine corresponding dental objects” in the asserted claims
of the ’647 patent, but find that the modification does not affect the application of the
construction to infringement, the domestic industry, or invalidity; (4) take no position on the
Final ID’s finding that the asserted claims of the ’647 and ’661 patents are directed to patentable

3
subject matter; (5) modify the ALJ’s construction of “wherein the device is configured for
maintaining a spatial disposition with respect to the portion that is substantially fixed during
operation of the optical scanner and the imaging means” of the asserted claims of the ’538
patent, and find that, under the modified construction, Align established infringement and the
technical prong of the domestic industry requirement but that the asserted claims are invalid; (6)
reverse the Final ID’s finding that the asserted claims of the ’538 patent are not anticipated by
Okamoto; (7) reverse the Final ID’s finding that the asserted claims of the ’192 patent are not
anticipated by Paley-Kriveshko, and affirm the Final ID’s finding that the asserted claims are
invalid as obvious under modified reasoning; and (8) take no position on whether Align satisfied
the economic prong of the domestic industry requirement.
Accordingly, the Commission finds no violation of section 337. Specifically, the
Commission finds that Align failed to establish a violation with respect to the asserted claims of
the ’647 and ’661 patents because Align failed to show infringement; that Align failed to
establish a violation with respect to the asserted claims of the ’538 patent because Align failed to
show infringement and because the claims are invalid; and that Align failed to establish a
violation with respect to the asserted claims of the ’192 patent because the claims are invalid.
The Commission’s determinations are explained more fully in the accompanying Opinion. All
other findings in the ID under review that are consistent with the Commission’s determinations
are affirmed. The investigation is hereby terminated.
The Commission vote for these determinations took place on November 17, 2020.
The authority for the Commission’s determination is contained in section 337 of the
Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of
Practice and Procedure (19 CFR part 210).
By order of the Commission.
Lisa R. Barton
Secretary to the Commission
Issued: 	November 17, 2020

CERTAIN DENTAL AND ORTHODONTIC SCANNERS
AND SOFTWARE
Inv. No. 337-TA-1144
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached NOTICE has been served upon the
following parties as indicated, on November 17, 2020.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainant Align Technology, Inc.:
Blair M. Jacobs, Esq.
PAUL HASTINGS LLP
2050 M Street NW
Washington, DC 20036
Email: blairjacobs@paulhastings.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download
On Behalf of Respondents 3Shape A/S, 3Shape Trios A/S, and
3Shape Inc.:
Goutam Patnaik, Esq.
TROUTMAN PEPPER HAMILTON SANDERS LLP
2000 K Street NW
Suite 600
Washington, DC 20006
Email: Goutam.Patnaik@Troutman.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download

PUBLIC VERSION
1
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN DENTAL AND
ORTHODONTIC SCANNERS AND
SOFTWARE
Investigation No. 337-TA-1144
COMMISSION OPINION
Table of Contents
I. 	BACKGROUND ................................................................................................................................. 2
A. 	Procedural History.......................................................................................................................... 2
B. 	The Asserted Patents ...................................................................................................................... 4
C. 	The Accused Products .................................................................................................................... 5
D. 	The Domestic Industry Products ................................................................................................... 6
II. 	STANDARD OF REVIEW ............................................................................................................ 6
III. 	ANALYSIS ...................................................................................................................................... 6
A. 	Importation...................................................................................................................................... 6
B. 	Induced Infringement ..................................................................................................................... 8
C. 	The Construction of Limitation 1.5/18.5 of the ’647 patent..................................................... 13
D. 	The Construction of the “Spatial Disposition . . .” Limitation of the ’538 Patent .................. 15
E. 	Anticipation by Okamoto of the Asserted Claims of the ’538 Patent....................................... 19
F. 	Anticipation and Obviousness by Paley-Kriveshko of the
Asserted Claims of the ’192 Patent .............................................................................................. 21
G. 	Patentable Subject Matter and the Economic Prong............................................................. 25
IV. 	CONCLUSION ............................................................................................................................. 25

PUBLIC VERSION
2
The Commission has determined that there has been no violation of section 337 of the
Tariff Act of 1930, as amended, 19 U.S.C. § 1337, with respect to U.S. Patent Nos. 9,299,192
(“the ’192 patent”); 7,077,647 (“the ’647 patent”); 7,156,661 (“the ’661 patent”); and 8,102,538
(“the ’538 patent”) on review of the final initial determination (“ID”) of the presiding
administrative law judge (“ALJ”). This opinion sets forth the Commission’s reasoning in
support of that determination.
I. 	BACKGROUND
A. 	Procedural History
On March 5, 2019, the Commission instituted this investigation based on a complaint
filed on behalf of Align Technology, Inc. of San Jose, California (“Align”). 84 Fed. Reg. 7933-
34 (March 5, 2019). The complaint alleged violations of section 337 based upon the importation
into the United States, the sale for importation, and the sale within the United States after
importation of certain dental and orthodontic scanners and software by reason of infringement of
one or more claims of the ’192, ’647, ’661, and ’538 patents, as well as U.S. Patent No.
9,848,958 (“the ’958 patent”). The Commission’s notice of investigation named as respondents
3Shape A/S of Copenhagen, Denmark; 3Shape, Inc. of Warren, New Jersey; and 3Shape Trios
A/S of Copenhagen, Denmark (together, “3Shape”). Id. The Office of Unfair Import
Investigations did not participate in this investigation. Id.
The Commission subsequently terminated the investigation with respect to the ’958
patent based on Align’s withdrawal of those allegations. Order No. 17 (Jul. 2, 2019), unreviewed
Notice (Jul. 23, 2019). At the time of the ID, Align asserted claims 1 and 18 of the ’647 patent,
claims 2 and 20 of the ’661 patent, claims 1 and 2 of the ’538 patent, and claims 2, 28, and 29 of
the ’192 patent.

PUBLIC VERSION
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On April 30, 2020, the ALJ issued the ID finding a violation of section 337 with respect
to the asserted claims of the ’647 and ’661 patents, and no violation with respect to the ’538
and ’192 patents. Specifically, the ALJ found that claims 1 and 18 of the ’538 patent are not
infringed and that claims 2, 28, and 29 of the ’192 patent are invalid. The ALJ found that Align
satisfied the remaining requirements for a violation with respect to the ’538 and ’192 patents.
On May 12, 2020, 3Shape and Align each filed a petition for review of the ID. On May
20, 2020, the parties responded to each other’s petitions. On July 28, 2020, the Commission
determined to review: (1) the findings regarding importation and induced infringement; (2) the
construction of limitation 1.5/18.5 in the asserted claims of the ’647 patent (“individually
matching [match] each of the dental objects in the subsequent digital model with a dental object
in the initial digital model to determine corresponding dental objects, the matching comprising
[including instructions to]”), and the application of that construction regarding infringement,
invalidity, and the technical prong of the domestic industry; (3) the findings regarding whether
the asserted claims of the ’647 and ’661 patents are directed to patentable subject matter; (4) the
construction of the limitation “wherein the device is configured for maintaining a spatial
disposition with respect to the portion that is substantially fixed during operation of the optical
scanner and imaging means” in the asserted claims of the ’538 patent, and the application of that
construction regarding infringement, invalidity, and the technical prong of the domestic industry
requirement; (5) the findings regarding whether Okamato anticipates the asserted claims of the
’538 patent; (6) the findings regarding whether Paley-Kriveshko anticipates or renders obvious
the asserted claims of the ’192 patent; and (7) the findings regarding the satisfaction of the
economic prong of the domestic industry requirement. Notice, 85 Fed. Reg. 46713-14 (Aug. 3,
2020).

PUBLIC VERSION
4
The Commission requested briefing on certain issues under review and on remedy, the
public interest, and bonding. On August 11, 2020, the Commission received initial submissions
from Align and 3Shape.1 On August 18, 2020, the Commission received reply submissions from
Align and 3Shape.2 The Commission received no submissions from third parties.
B. 	The Asserted Patents
The technology at issue in this investigation relates to imaging and software for
orthodontia and dentistry. U.S. Patent No. 7,077,647 is entitled “Systems and Methods for
Treatment Analysis by Teeth Matching.” It was filed on August 22, 2002. Align asserted claims
1 and 18, which are independent claims for a method and a computer readable medium
containing code for using a first digital dental model to create planned dental positions, and then
comparing a subsequent digital dental model after treatment and calculating differences between
the planned and actual positions of the teeth.
U.S. Patent No. 7,156,661 is a continuation-in-part of the ’647 patent and is also entitled
“Systems and Methods for Treatment Analysis by Teeth Matching.” It claims priority to
the ’647 patent application’s filing date of August 22, 2002. Align asserted claims 2 and 20,
which are claims for a method and a computer readable medium containing code for using
1 Complainant Align Technology, Inc.’s Written Submission in Response to the Issues Identified
in the Notice of Commission Determination to Review in Part a Final Initial Determination
Finding a Violation of Section 337 (Aug. 11, 2020) (“Align Init. Sub.”) and Respondents 3Shape
A/S, 3Shape TRIOS A/S, and 3Shape Inc.’s Written Submission in Response to Commission’s
Determination to Review in Part the Initial Determination (Aug. 11, 2020) (“3Shape Init. Sub.”),
respectively.
2 Complainant Align Technology, Inc.’s Reply to Respondents Response to the Issues Identified
in the Notice of Commission Determination to Review in Part a Final Initial Determination
Finding a Violation of Section 337 (Aug. 18, 2020) (“Align Rep. Sub.”) and Respondents
3Shape A/S, 3Shape TRIOS A/S, and 3Shape Inc.’s Response to Align Technology, Inc.’s
Written Submission to the Commission Determination to Review in Part the Initial
Determination (“3Shape Rep. Sub.”), respectively.

PUBLIC VERSION
5
matched regions to compare the positions of teeth in an initial and a subsequent dental model.
U.S. Patent No. 8,102,538 is entitled “Method and Apparatus for Colour Imaging a
Three-Dimensional Structure,” and claims priority to two provisional applications, both of which
were filed on June 17, 2004 and a nonprovisional application filed on June 17, 2005. Align
asserted claims 1 and 2 of the ’538 patent, which cover a device with an optical scanner for
obtaining depth data and an imaging device obtaining color data with respect to a two-
dimensional array in order to produce a three-dimensional color model.
U.S. Patent No. 9,299,192 is entitled “Method and Systems for Creating and Interacting
with Three Dimensional Virtual Models,” and claims priority to a provisional application filed
on July 19, 2010. Align asserted claims 2, 28, and 29 of the ’192 patent, which cover a method
and system for allowing a user to select and replace a portion of a first virtual model with a
second portion of a second virtual model.
C. 	The Accused Products
The accused products for each patent are as follows:
’647 Patent: TRIOS Intraoral Scanner with TRIOS Patient Monitoring (“TPM”)
(additionally with Ortho System)
’661 Patent: TRIOS Intraoral Scanner with Patient Monitoring or Ortho System
Compare Model Sets (“CMS”)
’538 Patent: TRIOS Intraoral Scanner
‘192 Patent: TRIOS Intraoral Scanner with TRIM tool, and the TRIOS
Application’s implant workflow, post and core workflow, and
preparation workflow
Final ID at xxiii. The specific accused TRIOS Intraoral Scanners are all versions of the TRIOS 3
and TRIOS 4 scanners. Id. at xxiv. The TRIOS scanners are physical devices, whereas TPM,
Ortho System, CMS, the TRIM tool, and the TRIOS application are software that can be used
with the TRIOS scanners.

PUBLIC VERSION
6
D. 	The Domestic Industry Products
The asserted domestic industry products for each patent are as follows:
’647 Patent: iTero Element Intraoral scanner with Progress Assessment
’661 Patent: iTero Element Intraoral scanner with TimeLapse
’538 Patent: iTero Element Intraoral scanner
’192 Patent: Align’s Eraser software on iTero
Final ID at xxiii. The iTero Element Intraoral scanner (“iTero”) is a physical device, and
Progress Assessment, TimeLapse, and Eraser are all software that can be used with the iTero. Id.
at 26-31.
II. 	STANDARD OF REVIEW
With respect to the issues under review, “the Commission may affirm, reverse, modify,
set aside or remand for further proceedings, in whole or in part, the initial determination of the
administrative law judge.” 19 C.F.R. § 210.45(c). The Commission also “may take no position
on specific issues or portions of the initial determination,” and “may make any finding or
conclusions that in its judgment are proper based on the record in the proceeding.” Id.
III. 	ANALYSIS
The Commission’s findings, conclusions, and supporting analysis follow. The
Commission affirms and adopts the ID’s findings, conclusions, and supporting analysis that are
not inconsistent with the Commission’s opinion.
A. 	Importation
1. 	Overview
A violation of section 337 based on patent infringement requires a showing of
“importation into the United States, the sale for importation, or the sale for importation within
the United States after importation . . . of articles that infringe a valid and enforceable United

PUBLIC VERSION
7
States patent.” 19 U.S.C. § 1337(a)(1)(B)(i). Here, the ID found that 3Shape imported the
TRIOS 3 scanner, the TRIOS 4 scanner, the Ortho System software, the TPM software, and the
TRIM tool. ID at 7-12. The Commission determined to review the ID’s findings on importation.
Notice, 85 Fed. Reg. 46713-14 (Aug. 3, 2020).
2. 	Analysis
The Commission finds that 3Shape has imported the TRIOS 3 scanner, the TRIOS 4
scanner, the Ortho System software, and the TRIM tool, but that Align has not proven that
3Shape imported the TPM software. As an initial matter, the Commission notes that 3Shape
stipulated that it imported the TRIOS 3 and 4 scanners. CX-2164C (Joint Stipulation Regarding
Importation of TRIOS 3 and TRIOS 4 Products). 3Shape also admitted that it has imported the
Ortho System software and the TRIM tool software by [ 	]
[ 	]. 3Shape Pet. at 7 (admitting that
3Shape has imported the Ortho System software); id. at 7 n.7 (admitting that 3Shape has
imported the TRIM tool). 3Shape contends, however, that the importation requirement is not
satisfied with respect to the Ortho System software because 3Shape subsequently [ 	]
[ 	]. Id. at 7-8. The
Commission disagrees. The “importation” language recited in section 337(a) in reference to an
accused article is satisfied by proof of a single act of importation. See, e.g., Certain Trolley
Wheel Assemblies, Inv. No. 337-TA-161, USITC Pub. 1605, Comm’n Op. at 7-8 (1984) (finding
that the importation of a single infringing trolley wheel was sufficient for the importation
requirement).
The Commission, however, finds that Align failed to show that 3Shape has imported the
TPM software. The ID acknowledged that there is “no direct evidence” that the TPM software
has been imported. ID at 10. While the ID found that the importation requirement is satisfied

PUBLIC VERSION
8
through circumstantial evidence, the ID relied solely on the testimony of 3Shape witnesses who
stated at times that [ 	]
[ 	]. ID at 11-12 (citing Tr. 643:3-5 and 10-21;
662:24-663:4, 1169:11-25, 1175:24-1176:7, 1178:1-1179:7). But regardless of the ID’s views
on the credibility of 3Shape’s testimony, that testimony is not affirmative evidence that the TPM
software is imported. Accordingly, neither the ID nor Align identified any affirmative evidence
showing that the TPM software was imported.
Align has the burden to establish that the importation requirement is satisfied. 19 C.F.R.
§ 210.37(a) (“The proponent of any factual proposition shall be required to sustain the burden of
proof with respect thereto.”). Here, by failing to present any evidence that the TPM software is
imported, Align failed to meet that burden with respect to the TPM software. Although the ID
stated that 3Shape failed to corroborate its witness testimony and “failed to disprove Align’s
theory and evidence,” ID at 11, 3Shape did not bear the burden of proof.
Accordingly, the Commission finds that Align established that 3Shape has imported the
TRIOS 3, TRIOS 4, the Ortho System software, and the TRIM tool, but failed to establish that
3Shape has imported the TPM software.
B. 	Induced Infringement
1. 	Overview
The ID found that Align showed that 3Shape induced infringement with respect to the
’647, ’661, and ’192 patents, but failed to show that 3Shape induced infringement with respect to
the ’538 patent. ID at 246-57. The ID relied on 3Shape’s provision of manuals and training
materials, but did not explain how those manuals and materials induced infringement of the ’647
and ’661 patents. Id. at 246-52. The ID also relied on evidence that Patterson Dental, an entity
that resells 3Shape products, instructs end users on how to infringe the ’647 patent, but did not

PUBLIC VERSION
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tie that instruction to 3Shape. Id. at 249-50. The Commission determined to review the ID’s
findings on induced infringement. Notice, 85 Fed. Reg. 46713-14 (Aug. 3, 2020).
2. 	Analysis
The Commission finds that Align failed to show that 3Shape induced infringement of the
asserted claims of the ’647 or ’661 patents. To establish induced infringement, the patent owner
must show evidence of the accused infringer’s “intent to encourage infringement,” such as
through evidence that the accused infringer recommended, encouraged, or promoted an
infringing use of its product. Takeda Pharms U.S.A., Inc. v. West-ward Pharm. Corp., 785 F.3d
625, 631 (Fed. Cir. 2015);3 see also Certain Vision-Based Driver Assistance System Cameras,
Components Thereof, and Products Containing the Same, Inv. No. 337-TA-907, USITC Pub.
4866, Comm’n Op. at 23 (Dec. 1, 2015) (“complainant must show an affirmative act that
encourages another’s direct infringement”); Certain Electronic Imaging Devices, Inv. No. 337-
TA-850, USITC Pub. 4846, Comm’n Op. at 11-12 (Apr. 21, 2014) (finding that the complainant
must have evidence that a respondent specifically intended that others infringe the patent to
establish induced infringement). Here, the Commission finds that the evidence supplied by
Align and relied upon in the ID fails to establish that 3Shape recommended, encouraged, or
promoted that its products be used to infringe the asserted claims of the ’647 or ’661 patents.
The ID first relied upon 3Shape’s provision of manuals and training. ID at 248-49, 251-
52. Align’s post-hearing briefing argued that 3Shape induces infringement based on the
provision of manuals and training materials, but failed to explain how those manuals and training
3 See also ePlus, Inc. v. Lawson Software, Inc., 789 F.3d 1349, 1360 (Fed. Cir. 2015) (“A seller
does not induce infringement of a method claim by merely selling an apparatus capable of
performing the method . . . . Inducement requires such steps as ‘encourage[ing],’
‘recommend[ing],’ or ‘promot[ing]’ an infringing use.”) (internal citations omitted).

PUBLIC VERSION
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materials encourage or instruct users on how to the infringe the ’647 or ’661 patents.
Complainant Align Technology, Inc.’s Post-Hearing Br. (Dec. 3, 2019) at 26-27, 48-49.
Furthermore, none of the evidence cited by Align or in the ID explains how these manuals and
training materials encourage or instruct users to infringe the specific asserted claims of the ’647
or ’661 patents. Id.4 The relevant issue is not whether 3Shape provided manuals and training,
which is not disputed, but rather whether those manuals and training recommended, encouraged,
or promoted others to infringe the asserted claims of the ’647 and ’661 patents. See Vita-Mix
Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1328-29 (Fed. Cir. 2009) (holding that the patentee
failed to show induced infringement based on manuals that did not encourage customers to
infringe). Because Align failed to explain how the manuals and training materials
recommended, encouraged, or promoted such infringement, and finding no such evidence in the
record, the Commission concludes that this evidence of manuals and training alone fails to
establish that 3Shape induced infringement of the asserted claims of the ’647 and ’661 patents.
The ID also relied on a 3Shape user manual stating that the TPM software is intended to
track a patient’s treatment plan as evidence of infringement of the ’647 patent. ID at 249.5 	But
neither the ID nor Align explain why that language recommends, encourages, or promotes the
infringement of the asserted claims of the ’647 patent. Id.; Align Post-Hearing Br. at 27. For
4 [ 	]
[ 	]
[ 	]
[ 	]
[ 	]
[ 	]
[ 	]
[ 	]
5 Citing CX-0923.0003 (a TPM manual stating that TPM can be used to track an orthodontic
treatment plan).

PUBLIC VERSION
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example, neither the ID nor Align explain what it means to track a treatment plan, or why such
tracking would result in the infringement of the asserted claims of the ’647 patent. Because there
is no evidence as to why the tracking of a treatment plan would result in infringement, the
Commission finds that this evidence fails to establish that 3Shape induced infringement of ’647
patent.
The ID further relied on evidence that a reseller of 3Shape products, Patterson Dental,
induces end users to infringe the asserted claims by demonstrating how to make a Virtual Setup
file in Ortho System and import that file into the TPM software, ID at 249-50.6 The Virtual
Setup file is required to infringe under Align’s infringement theory for the ’647 patent. Id. at 39-
43, 54-55. But 3Shape is not liable for the acts of third parties such as Patterson Dental.
Microsoft Corp. v. DataTern, Inc., 755 F.3d 899, 905 (Fed. Cir. 2014) (holding that Microsoft is
not liable for induced infringement based on third-party documentation encouraging
infringement). Here, neither the ID nor Align cite any evidence that 3Shape recommended or
encouraged Patterson Dental to demonstrate such functionality to end users. Id.; Align Post-
Hearing Br. at 27. And even if 3Shape’s products are capable of being used in an infringing
manner, that is not sufficient to establish induced infringement unless 3Shape encouraged such
direct infringement. See Microsoft, 755 F.3d at 905 (“Nothing in the record suggests that
Microsoft encouraged the acts accused of direct infringement, and simply selling a product
capable of being used in an infringing manner is not sufficient”). 	Because there is no evidence
that 3Shape recommended, encouraged, or promoted the actions of Patterson Dental or end users
to infringe the asserted claims of the ’647 patent, the Commission finds that this evidence fails to
establish that 3Shape induced infringement of ’647 patent.
6 Citing CX-0026 (Lake Decl.). at 3(i)(iii) (describing general steps of the demonstration).

PUBLIC VERSION
12
The ID additionally relied on evidence that, [ 	]
[ 	]
[ 	]
[ 	]. ID at 249-50. Under the ALJ’s
direct infringement findings, direct infringement of claims 1 and 18 of the ’647 patent requires
that an end user load a Virtual Setup file from Ortho System into the TPM software in order to
satisfy the limitations relating to “planned positions” for the set of dental objects. ID at 39-44,
54-57. Here, the evidence shows [ 	]
[ 	]
[ 	]. Tr. 821:14-826:25. The evidence also shows that the
restriction could be circumvented [ 	]
[ 	]
[ 	]. Id. Align also failed to present any evidence
that 3Shape encouraged or taught its customers to circumvent these restrictions. The
Commission finds that 3Shape’s imperfect attempt to prevent infringement does not constitute
evidence that 3Shape recommended, encouraged, or promoted end users to directly infringe the
asserted claims of the ’647 patent.
Accordingly, the Commission finds that Align failed to show that 3Shape induced
infringement of the asserted claims of the ’647 and ’616 patents. As discussed above, the alleged
evidence of inducement chiefly consists of: (1) unexplained manuals and training; (2) an
unexplained statement that TPM is intended to track a treatment plan; (3) evidence that a third
party encourages infringement; and (4) evidence that 3Shape (imperfectly) attempted to preclude
infringement. Moreover, Align’s arguments and the ID’s findings with respect to the

PUBLIC VERSION
13
inducement of the ’661 patent are conclusory. 	Align Post-Hearing Br. at 48-49; ID at 251-52.
The Commission finds, therefore, that this evidence does not demonstrate that 3Shape
recommended, encouraged, or promoted others to infringe the asserted claims of the ’647 and
’661 patents, and further finds that Align failed to carry its burden on induced infringement for
the ’647 and ’661 patents.
C. 	The Construction of Limitation 1.5/18.5 of the ’647 patent
1. 	Overview
The fifth limitation of claims 1 and 18 (“Limitation 1.5/18.5”) of the ’647 patent recites
the following:
Limitation 1.5 	Limitation 18.5
individually matching each of the dental
objects in the subsequent digital model with a
dental object in the initial digital model to
determine corresponding dental objects, the
matching comprising;
individually match each of the dental objects in
the subsequent digital model with a dental
object in the initial digital model to determine
corresponding dental objects, including
instructions to;
(emphasis added). Additional substeps in claims 1 and 18 further describe the above-mentioned
“matching.” Those substeps require:
• 	“identify[ing] one or more reference points on each set of corresponding dental
objects in the initial and subsequent digital models;”
• 	“approximately match[ing] each set of corresponding dental objects by
approximately aligning corresponding reference points on corresponding dental
objects”; and
• 	“match[ing] each set of corresponding dental objects more closely by iteratively
minimizing error between corresponding reference points on corresponding dental
objects.”
The ID found that the language “to determine corresponding dental objects” is a mere
intended result of three substeps. ID at 46-47. The ID then concluded that there was no need for
Align to show that the accused products practiced the limitation “to determine corresponding
dental objects.”

PUBLIC VERSION
14
2. 	Analysis
The Commission has determined to vacate the ALJ’s finding that Align need not show
the limitation “to determine corresponding dental objects” because it is an intended result.
Literal infringement requires that “the patentee must show that the accused device contains every
limitation in the asserted claims.” 	Riles v. Shell Exploration and Prod. Co., 298 F.3d 1302,
1308 (Fed. Cir. 2002). Accordingly, Align is required to show every limitation of claims 1 and
18, including the fifth limitation, in order to establish infringement.
The Federal Circuit has found that certain claim language is not limiting if the language
merely expresses “the intended result of a process step positively recited.” Hoffer v. Microsoft
Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005). That exception, however, does not apply if the
claim language “is more than the intended result of a process step” but rather is “a part of the
process itself.” Id. at 1330. Here, the Commission finds that the “to determine corresponding
dental objects” language is a part of the claimed process because it is recited as a part of a step,
and therefore is a limitation that must be shown. See Aristocrat Techs. Australia Pty Ltd. v. Int’l
Game Tech., 709 F.3d 1348, 1362 (Fed. Cir. 2013) (holding that “a patentee must prove that each
and every step of the method or process was performed”).
But while the Commission finds that the “to determine corresponding dental objects” is a
limitation that must be shown, the Commission also finds that the limitation will necessarily be
shown if each of the substeps is shown. The substeps require “individually matching each of the
dental objects in the subsequent digital model with a dental object in the initial digital model,”
which necessarily determines which dental objects “correspond” to each other between the initial
and subsequent models.
Accordingly, while the Commission disagrees with the ID’s reasoning that the “to
determine corresponding dental objects” is an intended result, the Commission ultimately agrees

PUBLIC VERSION
15
with the ID’s conclusion that the limitation can be met by a showing of “individually matching
each of the dental objects in the subsequent digital model with a dental object in the initial digital
model” by performing the three substeps. The Commission’s modification of this reasoning
therefore does not affect the ALJ’s application of this limitation to infringement, invalidity, or
the domestic industry requirement, so the Commission affirms those findings under the modified
reasoning set forth above.
D. 	The Construction of the “Spatial Disposition . . .” Limitation of the ’538
Patent
1. 	Overview
The asserted claims of the ’538 patent recite “[a] device for determining the surface
topology and associated color of at least a portion of a three dimensional structure,” where the
device comprises an “optical scanner” and “imaging means,” and “wherein the device is
configured for maintaining a spatial disposition with respect to the portion that is substantially
fixed during operation of the optical scanner and the imaging means.” The ID construed the
latter “spatial disposition” limitation to require that “operation by the optical scanner and the
imaging means is at least substantially or effectively simultaneous such that movement (i.e., a
change in spatial disposition) can be ignored and depth data and color data correspond to the
same reference array,” and that “substantially or effectively simultaneous” means “concurrently
or separated by a small duration of time.” Order 36, Appx. A at 36.
The ID acknowledged that the term’s plain and ordinary meaning requires that the device
experience little to no movement with respect to the scanned object during the operation of the
“optical scanner” and “imaging means,” but found that the patentee acted as a lexicographer to
arrive at the above construction. Id. at 65. Specifically, the ALJ relied on the following passage
in the specification:

PUBLIC VERSION
16
wherein the device is adapted for maintaining a spatial disposition
with respect to said portion that is substantially fixed during
operation of said scanning means and said imaging means. In
other words, operation of the scanning means and the imaging
means is substantially or effectively simultaneous in practical
terms, and thus the actual time interval that may exist between
operation of the two means is so short that the amplitude of any
mechanical vibration of the device or movement of the oral
cavity will be so small as can be ignored.
’538 patent at 4:61-5:3 (emphasis added). The Commission determined to review the ALJ’s
construction and its application.
2. 	Written Submissions
The Commission sought written submissions on whether the term “wherein the device is
configured for maintaining a spatial disposition with respect to the portion that is substantially
fixed during operation of the optical scanner and the imaging means” should be construed to
mean “the operation of the optical scanner and imaging means is substantially or effectively
simultaneous.” That construction deletes the portion of the ALJ’s construction about the reason
why the operation must be simultaneous. The parties were also asked to explain how the
construction would affect its application on infringement, the domestic industry, and invalidity.
Align contends that the Commission’s proposed construction is not appropriate and
argues that the Commission should adopt the ALJ’s construction. Align Init. Sub. at 1-5. Align
argues that the ALJ’s construction closely tracks the “in other words” language in the
specification and is consistent with the specification’s recitation of preferred time intervals. Id.
at 2. Align also argues that 3Shape never challenged that portion of the construction before the
ALJ. Id. at 5.
3Shape argues that the Commission’s proposed construction is not appropriate because
there should not be any timing requirement. 3Shape Init. Sub. at 1-6. 3Shape argues that the
“maintaining a spatial disposition” limitation is readily understandable on its face and does not

PUBLIC VERSION
17
need construction. Id. at 1. Although 3Shape acknowledges that the specification describes
operating the optical scanner and imaging means substantially simultaneously as a preferred
embodiment for “maintaining a spatial disposition,” 3Shape argues that the substantially
simultaneous time interval is not required by the claims. 3Shape Rep. Sub. at 1.
3. 	Analysis
a. 	Claim Construction
The Commission has determined that the term “wherein the device is configured for
maintaining a spatial disposition with respect to the portion that is substantially fixed during
operation of the optical scanner and the imaging means” needs no construction. The
Commission finds that the meaning of the term is readily understood from the plain language of
the claim, and that the patentee did not act as a lexicographer to change that meaning.
Patent claims are “generally given their ordinary and customary meaning” because “it is
unjust to the public, as well as an evasion of the law, to construe [them] in a manner different
from the plain import of [their] terms.” Philips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir.
2005) (en banc) (internal citations omitted). Here, as the ID found, there is no dispute that the
plain and ordinary meaning of the above limitation relating to maintaining a substantially fixed
spatial disposition is readily understood. As the ALJ acknowledged, the plain and ordinary
meaning simply means that the device does not substantially move with respect to the scanned
object while the optical scanner and imaging means are operating. Order No. 36 (Oct. 1, 2019),
Appx. A at 65.
The ID found, and Align argues, that the inventor acted as a lexicographer to require that
maintaining a substantially fixed spatial disposition must be accomplished by operating the
optical scanner and imaging means substantially simultaneously. To act as a lexicographer,
however, the patentee must “clearly set forth a definition of the disputed claim term other than its

PUBLIC VERSION
18
plain and ordinary meaning.” Thorner v. Sony Comput. Ent’mt Am. LLC, 669 F.3d 1362, 1365
(Fed. Cir. 2012). Here, as discussed above, the ID and Align base their lexicography reasoning
on the specification’s use of a sentence beginning with “[i]n other words” that describes the
simultaneous operation of the scanning means and imaging means. The Commission finds that,
while that sentence describes an embodiment that uses the simultaneous operation of the optical
scanner and imaging means to accomplish the maintenance of a substantially fixed spatial
disposition, the specification does not clearly define the limitation to require simultaneous
operation. Accordingly, the Commission finds no basis that the patentee acted as a lexicographer
to modify the plain and ordinary meaning of the claim.
Moreover, other portions of the specification show that the substantially simultaneous
operation of the means in a short interval is merely a preferred embodiment for maintaining a
substantially fixed spatial disposition between the device and the scanned portion of the object.
For example, the specification states that “[t]he present invention is directed to a method”
requiring “(c) ensuring that a spatial disposition with respect to said portion during steps (a) and
(b) is substantially fixed,” and that “[p]referably, in step (c), a minimum time interval is allowed
between acquisition of said depth and acquisition of said image data.” ’538 patent 8:56-9:3.
Elsewhere, the specification states that “the present invention” operates the two means “typically
within a short time interval.” Id. at 3:58-60. If the patentee believed that it had clearly defined
the maintenance of a spatial disposition as requiring the substantially simultaneous operation of
means in a short time interval, there would be no need to refer to the time interval at all, let alone
as a preferred or typical embodiment.
In conclusion, the Commission finds that the term “wherein the device is configured for
maintaining a spatial disposition with respect to the portion that is substantially fixed during

PUBLIC VERSION
19
operation of the optical scanner and the imaging means” is easily understood and should be
given its plain and ordinary meaning. The specification does not clearly define the spatial
disposition limitation to require a particular timing or speed, whether it be a substantially
simultaneous operation or a short time interval, and the Commission declines to read such a
limitation from the specification into the claim.7 Align chose to recite a limitation requiring a
substantially fixed spatial disposition and chose not to recite a limitation requiring substantially
simultaneous operation or a short time interval, and 3Shape, the Commission, and the public
should be able to rely upon those choices.
b. 	Infringement and Technical Prong of the Domestic Industry
Requirement
The Commission finds that Align showed that the accused products and domestic
industry products satisfy the “maintaining spatial disposition” limitation under the plain and
ordinary meaning of the term. The Commission’s construction is broader than the ID’s, and
permits any method of maintaining a spatial disposition, including the substantially simultaneous
time interval required in the ALJ’s construction. Accordingly, the accused products and
domestic industry products satisfy this limitation for the same reasons set forth in the ID—[ 	]
[ 	]
[ 	]
[ 	]. ID at 149-52, 166-67.
E. 	Anticipation by Okamoto of the Asserted Claims of the ’538 Patent
The Commission’s claim construction of the “maintaining spatial disposition” limitation,
7 See, e.g., SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004)
(“Though understanding the claim language may be aided by the explanations contained in the
written descriptions, it is important not to import into a claim limitations that are not part of the
claim.”).

PUBLIC VERSION
20
however, does affect whether the asserted claims are invalid as anticipated.
1. 	Overview
The ID found that Japanese Unexamined Patent Application Publication No. 2001-82935
(“Okamoto”) (RX-0180) disclosed every limitation of the asserted claims except for the
limitation “wherein the device is configured for maintaining a spatial disposition with respect to
the portion that is substantially fixed during operation of the optical scanner and the imaging
means.” ID at 170-84. The ID found that its construction of that limitation required that the
optical scanner and imaging means operate “at least substantially or effectively simultaneous
such that movement (i.e., a change in spatial disposition) can be ignored and depth data and color
data correspond to the same reference array,” but found that there was no evidence that Okamoto
disclosed such a requirement. Id. at 183-84. The ID, however, stated that whether Okamoto
anticipated the claims was a “close question.” Id. at 169.
2. 	Analysis
As noted above, the Commission has determined to modify the ID’s construction of the
“maintaining spatial disposition” limitation. Under the Commission’s plain and ordinary
construction of the term, the Commission finds that 3Shape showed that Okamoto teaches this
limitation by clear and convincing evidence.
Okamoto describes a confocal microscope and three-dimensional measurement device
that measures a sample on a sample stage. See generally Okamoto. As the ALJ found, and
Align did not dispute, Okamoto describes a confocal optical scanner for obtaining depth data and
an imaging means photo receptor for obtaining color data. ID at 171-72. The disclosed scanner
has a scanning lens and sample stage, whereby the sample stage may be “driven in the Z
direction” to change “the relative position” between the lens and the sample. Id. at [0018].
Okamoto explains that the device functions by measuring the depth data [i.e., “height data”] and

PUBLIC VERSION
21
color data from the scanned object with the sample stage at an initial level, and then lowers the
sample stage by one level and repeats the process. Id. at [0039]-[0040]. Because the optical
scanner and photo receptor are located on a fixed location on the microscope and the scanned
object is located on a fixed sample stage level during the scanning operation, the positional
difference between the scanned object and the scanning sensors does not change during the
scanning operation. Accordingly, Okamoto describes a device that “maintain[s] a spatial
disposition . . . that is substantially fixed” between the scanning sensors and scanned item
“during operation of the optical scanner and the imaging means,” and thereby satisfies the
limitation. Because the ID found that Okamoto satisfied every other limitation of claims 1 and 2
of the ’538 patent, the Commission finds that Okamoto anticipates those claims.
F. 	Anticipation and Obviousness by Paley-Kriveshko of the Asserted Claims of
the ’192 Patent
1. 	Overview
The ID found that 3Shape failed to show that the asserted claims of the ’192 patent are
anticipated by U.S. Patent Application Publication No. US 2007/0172112 (RX-0226) (“Paley”),
which incorporates by reference U.S. Patent Application Publication No. US 2007/0236494 (RX-
0227) (“Kriveshko”) (together, “Paley-Kriveshko”). ID at 225-28. The ID found that Align only
challenged whether Paley-Kriveshko disclosed the limitation “replacing at least said identified
portion of the first virtual model with a corresponding portion of the second virtual model,” and
therefore waived a challenge to all other limitations. Id. at 221-22. Although the ID found that
Paley-Kriveshko discloses combining two models into a single representation, the ID found that
Paley-Kriveshko fails to satisfy the disputed limitation because the limitation’s recitation of
“replacing” requires deletion or removal, and Paley-Kriveshko does not expressly disclose
deletion or removal. Id. at 225-26.

PUBLIC VERSION
22
The ID concluded, however, that 3Shape showed that Paley-Kriveshko renders the
asserted claims obvious. The ID found that 3Shape showed that it would be trivial to adapt the
combining step of Paley-Kriveshko to delete and replace a portion of the virtual model. Id. at
225-26. Although the ID noted that 3Shape failed to provide a clear motivation to make that
modification, the ID found that the Paley-Kriveshko reference provided that motivation by
repeatedly stating that its purpose is to fix scans that contain incomplete, inaccurate, or
insufficient data without having to complete an entirely new scan of the whole area. Id. at 237.
2. 	Written Submissions
The parties were asked to provide submissions on whether the record supports finding a
motivation to modify Paley-Kriveshko to include deletion. Align argues that there is simply no
evidence that a person of ordinary skill would have modified Paley-Kriveshko to include
deletion—the ALJ struck all of 3Shape’s relevant expert testimony, so 3Shape’s only evidence
was mere attorney argument that adding deletion was trivial. Align Init. Sub. at 12-14. Align
also argues that Paley-Kriveshko already provided accurate models, so there is no reason to
modify Paley-Kriveshko to include deletion. Id. at 15-17. Additionally, Align contends that
3Shape’s pre-hearing brief relied solely upon its expert for the motivation to combine, so once
that expert testimony was stricken, 3Shape was left with no evidence and cannot change theories
now. Align Rep. Sub. at 3-7.
3Shape contends that there is motivation to modify Paley-Kriveshko to allow for
deleting. 3Shape argues that Paley-Kriveshko discloses a desire for error-free models, and a
person of ordinary skill in the art would have found it obvious to delete inaccurate scan data to
achieve that goal. 3Shape Init. Sub. at 10-13. 3Shape also argues that its expert showed that
deletion is a well-known concept. Id. at 13-15.

PUBLIC VERSION
23
3. 	Analysis
The Commission has determined to reverse the ID’s finding that Paley-Kriveshko does
not anticipate the asserted claims of the ’192 patent and to find that 3Shape showed by clear and
convincing evidence that Paley-Kriveshko anticipates those claims. The ID finds, and Align
does not dispute, that Paley-Kriveshko taught every limitation of the asserted claims except the
limitation “replacing at least said identified portion of the first virtual model with a
corresponding portion of the second virtual model.” ID at 221-22. The ID concluded that Paley-
Kriveshko did not satisfy that limitation because Paley-Kriveshko does not disclose deletion. Id.
at 226-28.
Nothing in the asserted claims, however, requires deletion. The claim text requires
“replacing,” not deleting. Moreover, unasserted dependent claim 5 recites that the above
limitation further comprises “causing the computer system to at least one of delete, remove, or
replace said identified portion of the first virtual model” (emphasis added), which demonstrates
that “deleting” is not the same thing as “replacing.” Accordingly, there is no basis to conclude
that the asserted claims of the ’192 patent require deletion.
After removing the ID’s requirement for deletion, the ID’s findings demonstrate that
Paley-Kriveshko replaces a portion of the first virtual model. The ID found that Paley-
Kriveshko describes “a process for identifying a portion of a first virtual model having
incomplete, inaccurate, or insufficient data,” “a process of rescanning the corresponding
structure thereby generating a second virtual model,” and “the creation of a single modified
virtual model” using both the first and second virtual model. ID at 227. The ID also found that
Paley-Kriveshko discloses updating a “void” of omitted or missing scan data with new data. Id.
at 228 n. 97. In our view, these findings demonstrate that a portion of the first virtual model is
replaced with a corresponding portion of the second virtual model, as required by the claim

PUBLIC VERSION
24
limitation.
The ID’s findings are consistent with the teachings of Paley-Kriveshko. Paley describes
that it can detect “omitted or missing scan data,” as well as “regions of incomplete scan data,
inaccurate scan data, insufficient scan detail . . . and the like.” RX-0226 at [0059]. Paley then
explains that a user can select such areas to “permit a user to return to data acquisition, e.g., the
scanning mode of FIG. 4 where a void or deviation is detected,” which allows “a user to select a
specific point on the surface of the digital model . . . where the continuous scan is to be
reacquired from the subject.” Id. at [0060]. Paley also explains that its general process is to
capture incremental data, derive three-dimensional data from the incremental data, and register
the incremental data into a single common coordinate system with the remaining old data. Id. at
[0006]. In other words, Paley-Kriveshko teaches allowing the user to replace a portion of a
virtual model containing bad or missing data with new data, thereby satisfying the limitation
“replacing at least said identified portion of the first virtual model with a corresponding portion
of the second virtual model.”8 Because the ID found that Paley-Kriveshko discloses all other
limitations of the asserted claims, the Commission finds that Paley-Kriveshko anticipates the
asserted claims of the ’192 patent.
The Commission also affirms the ID’s finding of obviousness under modified reasoning.
The Federal Circuit has held that “it is well settled that ‘a disclosure that anticipates under § 102
also renders the claim invalid under § 103, for ‘anticipation is the epitome of obviousness.’”
Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1373 (Fed. Cir. 2019). Accordingly, because the
8 Even under the ID’s view that “replacing” requires “deleting,” the ID stated that the
overwriting of old data would necessarily result in its deletion. ID at 227 n.96. The above
citations demonstrate that Paley-Kriveshko discloses such overwriting.

PUBLIC VERSION
25
Commission finds that the asserted claims are anticipated, they are also rendered obvious.9
G. 	Patentable Subject Matter and the Economic Prong
As discussed above, the Commission has already found that Align failed to establish a
violation of section 337 based on the dispositive issues of patent invalidity and the failure to
show induced infringement. That final determination of no violation is unchanged regardless of
whether Align satisfied the economic prong of the domestic industry requirement or whether
3Shape established that the asserted claims of the ’647 and ’661 patents are directed to
patentable subject matter. 	Accordingly, the Commission has determined to take no position on
whether Align satisfied the economic prong of the domestic industry requirement and on whether
the asserted claims of the ’647 and ’661 patents are directed to patentable subject matter.10 See
Beloit Corp. v. Valmet Oy, 742 F.2d 1421, 1423 (Fed. Cir. 1984) (holding that the Commission
need not address every issue when certain issues are case-dispositive).
IV. 	CONCLUSION
For the reasons set forth herein, the Commission determines that Align failed to establish
a violation of section 337 by 3Shape with respect to any asserted claim. Specifically, the
Commission finds that the asserted claims of the ’647 and ’661 patents are not infringed, that the
asserted claims of the ’538 patent are invalid and not infringed, and the asserted claims of the
’192 patent are invalid. The Commission also determined to take no position on whether the
9 Align waived its arguments relating to secondary considerations of non-obviousness. ID at
238.
10 Chair Kearns finds that information on how investments in the United States with respect to
the article at issue compare on a quantitative basis to investments outside the United States – as
reflected in measures such as relative dollar amounts invested in plant, equipment, capital,
employment, or the percentage of the article’s value that is added in the United States – is
particularly important to his evaluation of whether U.S. investments are significant under section
337(a)(3).

PUBLIC VERSION
26
asserted claims of the ’647 and ’661 patents are directed to patentable subject matter and whether
Align satisfied the economic prong of the domestic industry requirement. Accordingly, the
investigation is terminated with a finding of no violation of section 337.
By order of the Commission.
Lisa R. Barton
Secretary to the Commission
Issued: 	December 3, 2020

CERTAIN DENTAL AND ORTHODONTIC SCANNERS
AND SOFTWARE
Inv. No. 337-TA-1144
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached OPINION, COMMISSION has
been served upon the following parties as indicated, on December 3, 2020.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainant Align Technology, Inc.:
Blair M. Jacobs, Esq.
PAUL HASTINGS LLP
2050 M Street NW
Washington, DC 20036
Email: blairjacobs@paulhastings.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download
On Behalf of Respondents 3Shape A/S, 3Shape Trios A/S, and
3Shape Inc.:
Goutam Patnaik, Esq.
TROUTMAN PEPPER HAMILTON SANDERS LLP
2000 K Street NW
Suite 600
Washington, DC 20006
Email: Goutam.Patnaik@Troutman.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download

1
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN DENTAL AND
ORTHODONTIC SCANNERS AND
SOFTWARE
Investigation No. 337-TA-1144
NOTICE OF A COMMISSION DETERMINATION TO REVIEW IN PART A FINAL
INITIAL DETERMINATION FINDING A VIOLATION OF SECTION 337; REQUEST
FOR WRITTEN SUBMISSIONS ON THE ISSUES UNDER REVIEW AND ON
REMEDY, THE PUBLIC INTEREST, AND BONDING; EXTENSION OF THE
TARGET DATE
AGENCY: 	U.S. International Trade Commission.
ACTION: 	Notice.
SUMMARY: Notice is hereby given that the U.S. International Trade Commission
(“Commission”) has determined to review in part a final initial determination (“ID”) of the
presiding administrative law judge (“ALJ”). The Commission requests written submissions from
the parties on the issues under review and submissions from the parties, interested government
agencies, and interested persons on the issues of remedy, the public interest, and bonding, under
the schedule set forth below. The target date is extended to September 28, 2020.
FOR FURTHER INFORMATION CONTACT: Robert Needham, Esq., Office of the
General Counsel, U.S. International Trade Commission, 500 E Street S.W., Washington, D.C.
20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection
with this investigation may be viewed on the Commission’s electronic docket (EDIS) at
https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. General
information concerning the Commission may also be obtained by accessing its Internet server at
https://www.usitc.gov. Hearing-impaired persons are advised that information on this matter can
be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.

2
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on
March 5, 2019. 84 FR 7933-34 (March 5, 2019) based on a complaint filed on behalf of Align
Technology, Inc. of San Jose, California (“Align”). The complaint alleges violations of section
337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United
States, the sale for importation, or the sale within the United States after importation of certain
dental and orthodontic scanners and software by reason of infringement of one or more claims of
U.S. Patent Nos. 9,299,192 (“the ’192 patent”); 7,077,647 (“the ’647 patent”); 7,156,661
(“the ’661 patent”); 9,848,958 (“the ’958 patent”); and 8,102,538 (“the ’538 patent”). Id. The
complaint further alleges that a domestic industry exists. Id. The Commission’s notice of
investigation named as respondents 3Shape A/S of Copenhagen, Denmark; 3Shape, Inc. of
Warren, New Jersey; and 3Shape Trios A/S of Copenhagen, Denmark (together, “3Shape”). Id.
The Office of Unfair Import Investigations (“OUII”) is not participating in the investigation. Id.
The Commission subsequently terminated the investigation with respect to the ’958
patent based on Align’s withdrawal of those allegations. Order No. 17 (Jul. 2, 2019), not
reviewed Notice (Jul. 23, 2019). On October 8, 2019, Align stated that it would no longer pursue
a violation with respect to claims 4 and 20 of the ’647 patent, claims 1 and 19 of the ’661 patent,
and claims 1, 3-5, and 22 of the ’192 patent. On October 21, 2019, Align stated that it would no
longer pursue a violation with respect to claim 2 of the ’647 patent. Accordingly, at the time of
the Final ID, Align asserted claims 1 and 18 of the ’647 patent, claims 2 and 20 of the ’661
patent, claims 1 and 2 of the ’538 patent, and claims 2, 28, and 29 of the ’192 patent.
On April 30, 2020, the ALJ issued the Final ID finding a violation of section 337 with
respect to the ’647 and ’661 patents, and no violation with respect to the ’538 and ’192 patents.
Specifically, the ALJ found that claims 1 and 18 of the ’538 patent are not infringed and that
claims 2, 28, and 29 of the ’192 patent are invalid. The ALJ found that Align satisfied the
remaining requirements for a violation with respect to the ’538 and ’192 patents.
On May 12, 2020, 3Shape and Align each filed a petition for review of the Final ID. On
May 20, 2020, the parties responded to each other’s petitions. The Commission also received
four comments on the public interest.
Having reviewed the record of the investigation, including the final ID and the parties’
petitions and responses, the Commission has determined to review the ID in part. Specifically,
the Commission has determined to review: (1) the findings regarding importation and induced
infringement; (2) the construction of limitation 1.5/18.5 of the ‘647 patent (“individually
matching [match] each of the dental objects in the subsequent digital model with a dental object
in the initial digital model to determine corresponding dental objects, the matching comprising
[including instructions to]”) in the asserted claims of the ’647 patent, and the application of that
construction regarding infringement, invalidity, and the technical prong of the domestic industry;
(3) the findings regarding whether the asserted claims of the ’647 and ’661 patents are directed to
patentable subject matter; (4) the construction of the limitation “wherein the device is configured
for maintaining a spatial disposition with respect to the portion that is substantially fixed during
operation of the optical scanner and imaging means” in the asserted claims of the ’538 patent,
and the application of that construction regarding infringement, invalidity, and the technical
prong of the domestic industry requirement; (5) the findings regarding whether Okamato

3
anticipates the asserted claims of the ’538 patent; (6) the findings regarding whether Paley-
Kriveshko anticipates or renders obvious the asserted claims of the ’192 patent; and (7) the
findings regarding the satisfaction of the economic prong of the domestic industry requirement.
In connection with its review, the Commission requests responses to the following
questions. The parties are requested to brief their positions with reference to the applicable law
and the existing evidentiary record.
(1) Please explain whether it is proper to construe the limitation “wherein the device is
configured for maintaining a spatial disposition with respect to the portion that is
substantially fixed during operation of the optical scanner and imaging means” to
mean “the operation of the optical scanner and imaging means is substantially or
effectively simultaneous.” Please note that this proposed construction removes the
following requirement of the ALJ’s construction: “such that movement (i.e., a
change in spatial disposition) can be ignored and depth data and color data
correspond to the same reference array.” Additionally, please explain how the above
construction would impact findings on infringement, invalidity, and the domestic
industry requirement.
(2) Please explain, with citations to the record, whether there is a motivation to modify
Paley-Kriveshko in a way that renders invalid as obvious the asserted claims of the
’192 patent.
(3) What information, if any, is contained in the record concerning Align’s employee
headcount and salary and compensation expenditures outside the United States
pertaining to Align’s DI Products? 	What information, if any, is contained in the
record concerning the value added in the United States to Align’s DI Products?
(4) Please explain, with citations to the record, whether Align’s investments in plant and
equipment under a sales-based allocation are significant.
The parties are invited to brief only the discrete issues requested above. The parties are not to
brief other issues on review, which are adequately presented in the parties’ existing filings.
In connection with the final disposition of this investigation, the statute authorizes
issuance of, inter alia, (1) an exclusion order that could result in the exclusion of the subject
articles from entry into the United States; and/or (2) cease and desist orders that could result in
the respondents being required to cease and desist from engaging in unfair acts in the importation
and sale of such articles. Accordingly, the Commission is interested in receiving written
submissions that address the form of remedy, if any, that should be ordered. If a party seeks
exclusion of an article from entry into the United States for purposes other than entry for
consumption, the party should so indicate and provide information establishing that activities
involving other types of entry either are adversely affecting it or likely to do so. For background,
see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360,
USITC Pub. No. 2843, Comm’n Op. at 7-10 (Dec. 1994).

4
The statute requires the Commission to consider the effects of that remedy upon the
public interest. The public interest factors the Commission will consider include the effect that
an exclusion order would have on: (1) the public health and welfare, (2) competitive conditions
in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with
those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore
interested in receiving written submissions that address the aforementioned public interest
factors in the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade Representative, as
delegated by the President, has 60 days to approve, disapprove, or take no action on the
Commission’s determination. See Presidential Memorandum of July 21, 2005, 70 FR 43251
(July 26, 2005). During this period, the subject articles would be entitled to enter the United
States under bond, in an amount determined by the Commission and prescribed by the Secretary
of the Treasury. The Commission is therefore interested in receiving submissions concerning the
amount of the bond that should be imposed if a remedy is ordered.
WRITTEN SUBMISSIONS: The parties to the investigation are requested to file written
submissions on the issues identified in this notice. Parties to the investigation, interested
government agencies, and any other interested parties are encouraged to file written submissions
on the issues of remedy, the public interest, and bonding. Such submissions should address the
recommended determination by the ALJ on remedy and bonding.
In its initial submission, Complainant is also requested to identify the remedy sought and
to submit proposed remedial orders for the Commission’s consideration. Complainant is further
requested to state the dates that the Asserted Patents expire, the HTSUS subheadings under
which the accused products are imported, and to supply the identification information for all
known importers of the products at issue in this investigation. The initial written submissions
and proposed remedial orders must be filed no later than close of business on August 11, 2020.
Reply submissions must be filed no later than the close of business on August 18, 2020. No
further submissions on these issues will be permitted unless otherwise ordered by the
Commission. Initial submissions are limited to 40 pages. Reply submissions are limited to 20
pages. No further submissions on any of these issues will be permitted unless otherwise ordered
by the Commission.
Persons filing written submissions must file the original document electronically on or
before the deadlines stated above. The Commission’s paper filing requirements in 19 CFR
210.4(f) are currently waived. 85 FR 15798 (March 19, 2020). Submissions should refer to the
investigation number (Inv. No. 337-TA-1144) in a prominent place on the cover page and/or the
first page. (See Handbook for Electronic Filing Procedures,
https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). Persons with questions
regarding filing should contact the Secretary, (202) 205-2000.
Any person desiring to submit a document to the Commission in confidence must request
confidential treatment. All such requests should be directed to the Secretary to the Commission
and must include a full statement of the reasons why the Commission should grant such

5
treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission
is properly sought will be treated accordingly. A redacted non-confidential version of the
document must also be filed simultaneously with any confidential filing. All information,
including confidential business information and documents for which confidential treatment is
properly sought, submitted to the Commission for purposes of this investigation may be
disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel
(a) for developing or maintaining the records of this or a related proceeding, or (b) in internal
investigations, audits, reviews, and evaluations relating to the programs, personnel, and
operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government
employees and contract personnel, solely for cybersecurity purposes. All contract personnel will
sign appropriate nondisclosure agreements. All nonconfidential written submissions will be
available for public inspection on EDIS.
The target date is extended to September 28, 2020.
The Commission vote for this determination took place on July 28, 2020.
The authority for the Commission’s determination is contained in section 337 of the
Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission’s Rules of
Practice and Procedure (19 CFR Part 210).
By order of the Commission.
Lisa R. Barton
Secretary to the Commission
Issued: July 28, 2020

CERTAIN DENTAL AND ORTHODONTIC SCANNERS
AND SOFTWARE
Inv. No. 337-TA-1144
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached NOTICE has been served upon the
following parties as indicated, on July 28, 2020.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainant Align Technology, Inc.:
Blair M. Jacobs, Esq.
PAUL HASTINGS LLP
2050 M Street NW
Washington, DC 20036
Email: blairjacobs@paulhastings.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download
On Behalf of Respondents 3Shape A/S, 3Shape Trios A/S, and
3Shape Inc.:
Goutam Patnaik, Esq.
TROUTMAN PEPPER HAMILTON SANDERS LLP
2000 K Street NW
Suite 600
Washington, DC 20006
Email: Goutam.Patnaik@Troutman.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN DENTAL AND
ORTHODONTIC SCANNERS AND
SOFTWARE
Inv. No. 337-TA-1144
INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
RECOMMENDED DETERMINATION ON REMEDY AND BOND
Administrative Law Judge MaryJoan McNamara
(April 30, 2020)
Appearances:
For the Complainant Align Technology, Inc.:
Blair M. Jacobs, Esq., Christina A. Ondrick, Esq., Elizabeth Bernard, Esq., John S. Holley,
Esq., Stuart McCommas, Esq., and Mark Consilvio, Esq. of Paul Hastings LLP, Washington,
DC.
Thomas A. Counts, Esq. of Paul Hastings LLP, San Francisco, CA.
Raymond W. Stockstill of Paul Hastings LLP, Costa Mesa, CA.
For the Respondents 3Shape A/S, 3Shape Trios A/S, and 3Shape, Inc.:
Goutam Patnaik, Esq., Tuhin Ganguly, Esq. David J. Shaw, Esq., Arvind Iyengar, Esq., and
Gerar M. Mazarakis, Esq. of Pepper Hamilton LLP, Washington, DC.
William D. Belanger, Esq. Gregory D. Len, Esq., Frank D. Liu, Esq., Brittanee L. Friedman,
Esq., and L. Andrew Tseng, Esq. of Pepper Hamilton LLP, Boston, MA.
S. Lloyd Smith, Esq., Kimberly E. Coghill, Esq., and Bryan J. Cannon, Esq. of Buchanan
Ingersoll & Rooney PC, Alexandria, VA.
Public Version

SELECTED SUMMARY FINDINGS
Pursuant to the Notice of Investigation, 84 Fed. Reg. 7933, dated March 5, 2019, this is
the Initial Determination (“ID”) of the Investigation in the Matter of Certain Dental and
Orthodontic Scanners and Software, United States International Trade Commission Investigation
No. 337-TA-1144. See 19 C.F.R. § 210.42(a).
It is a finding of this ID that Complainant Align Technology, Inc. (“Align” or
“Complainant”) has proven by a preponderance of evidence that Respondents 3Shape A/S,
3Shape Trios A/S, and 3Shape, Inc. (collectively, “3Shape” or “Respondents,” and with Align,
the “Parties”) have violated subsection (b) of Section 337 of the Tariff Act of 1930, in the
importation into the United States, the sale for importation, or the sale within the United States
after importation of certain dental and orthodontic scanners and software
It is a finding of this ID that 3Shape has infringed asserted claims 1 and 18 of U.S. Patent
No. 7,077,647 (“the ’647 patent”). It is a finding of this ID that the asserted claims of the ’647
patent are valid.
It is a finding of this ID that 3Shape has infringed asserted claims 2 and 20 of U.S. Patent
No. 7,156,661 (“the ’661 patent”). It is a finding of this ID that the asserted claims of the ’661
patent are valid.
It is a finding of this ID that 3Shape has not infringed asserted claims 1 and 18 of U.S.
Patent No. 8,102,538 (“the ’538 patent”). It is a finding of this ID that the asserted claims of the
’538 patent are valid.
It is a finding of this ID that 3Shape has infringed asserted claims 2, 28, and 29 of U.S.
Patent No. 9,299,192 (“the ’192 patent”). It is a finding of this ID that asserted claims 2, 28, and
29 of the ’192 patent are invalid.
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It is a finding of this ID that one or more of Align’s domestic industry products have
satisfied the technical industry prong of the domestic industry requirement for the ’647, ’661,
’538, and ’192 patents. It is a finding of this ID that Align has satisfied the economic prong of
the domestic industry requirement under Section 337(a)(3)(A) and (B).
The ID contains a recommendation that the Commission issue a Limited Exclusion Order
and a Cease and Desisting Order against the infringing Respondents. A bond has not been
recommended for the Presidential Review Period.
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iv
TABLE OF CONTENTS
I. 	SUMMARY OF FINDINGS ............................................................................................ 1
II. 	BACKGROUND ............................................................................................................... 1
A. 	Institution and Selected Procedural History ........................................................... 1
B. 	The Parties .............................................................................................................. 5
1. 	Complainant Align Technology, Inc........................................................... 5
2. 	Respondents 3Shape A/S, 3Shape Trios A/S, and 3Shape, Inc. ................. 6
III. 	JURISDICTION, IMPORTATION, AND STANDING ............................................... 6
A. 	The Commission Has Jurisdiction .......................................................................... 6
1. 	Subject Matter Jurisdiction ......................................................................... 7
2. 	Personal Jurisdiction ................................................................................... 7
3. 	Importation .................................................................................................. 7
a) 	Importation Satisfied for Ortho System Software .......................... 8
b) 	Importation Satisfied for TPM Software ...................................... 10
c) 	Importation Satisfied for Ortho System and TPM Software
Under Suprema ............................................................................. 12
4. 	In Rem Jurisdiction ................................................................................... 17
B. 	Align Has Standing in the Commission ................................................................ 19
IV. 	THE ASSERTED PATENTS......................................................................................... 20
A. 	Overview of the Technology ................................................................................ 20
B. 	Overview of U.S. Patent Nos. 7,077,647 (“the ’647 Patent”) and 7,156,661 (“the
’661 Patent”) ......................................................................................................... 20
C. 	Overview of U.S. Patent No. 8,102,538 (“the ’538 Patent”) ................................ 22
D. 	Overview of U.S. Patent No. 9,229,192 (“the ’192 Patent”) ................................ 23
V. 	THE PRODUCTS AT ISSUE ........................................................................................ 24
A. 	3Shape’s Accused Products .................................................................................. 24
B. 	Align’s Domestic Industry Products ..................................................................... 26
1. 	iTero with Progress Assessment, iTero with TimeLapse, and Invisalign
with Treat .................................................................................................. 26
2. 	iTero Element Scanner .............................................................................. 29
3. 	iTero Eraser ............................................................................................... 31
VI. 	PERSON OF ORDINARY SKILL IN THE ART ....................................................... 32
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v
A. 	Definition of a Person of Ordinary Skill in the Art .............................................. 32
VII. 	U.S. PATENT NO. 7,077,647 ......................................................................................... 32
A. 	Infringement .......................................................................................................... 32
1. 	Infringement Overview ............................................................................. 32
2. 	Direct Infringement: Legal Standards ...................................................... 35
a) 	Literal Infringement ...................................................................... 35
b) 	Infringement Under Doctrine of Equivalents ............................... 35
3. 	The 647 Accused Products Practice Claims 1 and 18 of the ’647 Patent . 36
a) 	Claims 1 and 18 ............................................................................ 36
i. 	[1.1] / [18.1]: “A method for determining progress of
a dental treatment, the method comprising” / “A
computer readable medium containing code for
matching computer models of dental objects to
determine progress of a dental treatment, the
computer readable medium comprising instructions
to”...................................................................................... 36
ii. 	[1.2] / [18.2]: “providing an initial digital model of a
set of dental objects” / “receive an initial digital
model of a set of dental objects”; [1.3] / [18.3]:
“determining planned positions for the set of dental
objects” / “determine planned positions for a [sic] the
set of dental objects” ......................................................... 39
iii. 	[1.4] / [18.4]: “providing a subsequent digital model
of the set of dental objects in their moved positions
after at least some of them have been moved by the
dental treatment” / “receive a subsequent digital
model of the set of dental objects, wherein at least
some of the dental objects have new positions in the
subsequent model, relative to their positions in the
initial model” .................................................................... 44
iv. 	[1.5] / [18.5]: “individually matching each of the
dental objects in the subsequent digital model with a
dental object in the initial digital model to determine
corresponding dental objects, the matching
comprising” / “individually match each of the dental
objects in the subsequent digital model with a dental
object in the initial digital model to determine
corresponding dental objects, including instructions
to”...................................................................................... 45
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vi
v. 	[1.6] / [18.6]: “identifying one or more reference
points on each set of corresponding dental objects in
the initial and subsequent digital models” / “identify
one or more reference points on each set of
corresponding dental objects in the initial and
subsequent digital models”; [1.7] / [18.7]:
“approximately matching each set of corresponding
dental objects by approximately aligning
corresponding reference points on corresponding
dental objects” / “approximately match each set of
corresponding dental objects by approximately
aligning corresponding reference points on
corresponding dental objects” ........................................... 47
vi. 	[1.8] / [18.8]: “matching each set of corresponding
dental objects more closely by iteratively minimizing
error between corresponding reference points on
corresponding dental objects” / “match each set of
corresponding dental objects more closely by
iteratively minimizing error between corresponding
reference points on corresponding dental objects” ........... 50
vii. 	[1.9] / [18.9]: “matching the subsequent digital
model as a whole with the initial digital model” /
“match the subsequent digital model with the initial
digital model”.................................................................... 51
viii. 	[1.10] / [18.10]: “calculating one or more positional
differences between the moved and planned positions
of at least some of the corresponding dental objects” /
“calculate one or more positional differences between
the moved and planned positions of the
corresponding dental objects” ........................................... 54
B. 	Technical Prong of Domestic Industry ................................................................. 58
1. 	Legal Standard .......................................................................................... 58
2. 	The 647 DI Products Practice Claims 1 and 18 of the ’647 Patent........... 59
a) 	Claims 1 and 18 ............................................................................ 59
i. 	[1.1] / [18.1]: “A method for determining progress of
a dental treatment, the method comprising” / “A
computer readable medium containing code for
matching computer models of dental objects to
determine progress of a dental treatment, the
computer readable medium comprising instructions
to”...................................................................................... 59
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vii
ii. 	[1.2] / [18.2]: “providing an initial digital model of a
set of dental objects” / “receive an initial digital
model of a set of dental objects”; [1.3] / [18.3]:
“determining planned positions for the set of dental
objects” / “determine planned positions for a [sic] the
set of dental objects” ......................................................... 60
iii. 	[1.4] / [18.4]: “providing a subsequent digital model
of the set of dental objects in their moved positions
after at least some of them have been moved by the
dental treatment” / “receive a subsequent digital
model of the set of dental objects, wherein at least
some of the dental objects have new positions in the
subsequent model, relative to their positions in the
initial model” .................................................................... 61
iv. 	[1.5] / [18.5]: “individually matching each of the
dental objects in the subsequent digital model with a
dental object in the initial digital model to determine
corresponding dental objects, the matching
comprising” / “individually match each of the dental
objects in the subsequent digital model with a dental
object in the initial digital model to determine
corresponding dental objects, including instructions
to”...................................................................................... 62
v. 	[1.6] / [18.6]: “identifying one or more reference
points on each set of corresponding dental objects in
the initial and subsequent digital models” / “identify
one or more reference points on each set of
corresponding dental objects in the initial and
subsequent digital models”; [1.7] / [18.7]:
“approximately matching each set of corresponding
dental objects by approximately aligning
corresponding reference points on corresponding
dental objects” / “approximately match each set of
corresponding dental objects by approximately
aligning corresponding reference points on
corresponding dental objects” ........................................... 64
vi. 	[1.8] / [18.8]: “matching each set of corresponding
dental objects more closely by iteratively minimizing
error between corresponding reference points on
corresponding dental objects” / “match each set of
corresponding dental objects more closely by
iteratively minimizing error between corresponding
reference points on corresponding dental objects” ........... 65
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viii
vii. 	[1.9] / [18.9]: “matching the subsequent digital
model as a whole with the initial digital model” /
“match the subsequent digital model with the initial
digital model”.................................................................... 67
viii. 	[1.10] / [18.10]: “calculating one or more positional
differences between the moved and planned positions
of at least some of the corresponding dental objects” /
“calculate one or more positional differences between
the moved and planned positions of the
corresponding dental objects” ........................................... 68
C. 	Invalidity ............................................................................................................... 69
1. 	Invalidity Overview .................................................................................. 69
2. 	Legal Standards ......................................................................................... 70
a) 	Obviousness .................................................................................. 70
b) 	Written Description....................................................................... 72
c) 	Indefiniteness ................................................................................ 73
d) 	Patent Eligibility ........................................................................... 74
3. 	Rubbert WO (RX-0237) Alone or in Combination with Rusinkiewicz
(RX-2276) Do Not Render Obvious Claims 1 and 18 of the ’647 Patent 75
a) 	[1.5] / [18.5]: “individually matching each of the dental
objects in the subsequent digital model with a dental object
in the initial digital model to determine corresponding dental
objects, the matching comprising” / “individually match each
of the dental objects in the subsequent digital model with a
dental object in the initial digital model to determine
corresponding dental objects, including instructions to” .............. 75
b) 	[1.6] / [18.6]: “identifying one or more reference points on
each set of corresponding dental objects in the initial and
subsequent digital models” / “identify one or more reference
points on each set of corresponding dental objects in the
initial and subsequent digital models” .......................................... 77
c) 	[1.7] / [18.7]: “approximately matching each set of
corresponding dental objects by approximately aligning
corresponding reference points on corresponding dental
objects” / “approximately match each set of corresponding
dental objects by approximately aligning corresponding
reference points on corresponding dental objects” ....................... 79
d) 	[1.8] / [18.8]: “matching each set of corresponding dental
objects more closely by iteratively minimizing error between
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ix
corresponding reference points on corresponding dental
objects” / “match each set of corresponding dental objects
more closely by iteratively minimizing error between
corresponding reference points on corresponding dental
objects” ......................................................................................... 80
e) 	[1.9] / [18.9]: “matching the subsequent digital model as a
whole with the initial digital model” / “match the subsequent
digital model with the initial digital model” ................................. 81
f) 	[1.10] / [18.10]: “calculating one or more positional
differences between the moved and planned positions of at
least some of the corresponding dental objects” / “calculate
one or more positional differences between the moved and
planned positions of the corresponding dental objects” ............... 82
g) 	3Shape Failed to Present Any Evidence of Motivation to
Combine or Reasonable Expectation of Success .......................... 83
4. 	Claims 1 and 18 of the ’647 Patent Are Not Indefinite and Do Not Lack
Written Description................................................................................... 86
5. 	The ’647 and ’661 Patents Claim Patent Eligible Subject Matter ............ 89
a) 	Alice Step 1: The ’647 and ’661 Patents Claim a Specific
Technological Improvement ......................................................... 89
b) 	Alice Step 2: The ’647 and ’661 Patents Claim an Inventive
Concept ......................................................................................... 93
VIII. 	U.S. PATENT NO. 7,156,661 ......................................................................................... 94
A. 	Infringement .......................................................................................................... 94
1. 	Infringement Overview ............................................................................. 94
2. 	The 661 Accused Products Practice Claims 2 and 20 of the ’661 Patent . 96
a) 	Claims 1 and 19 ............................................................................ 96
i. 	[1.1] / [19.1]: “A method for matching computer
models of a jaw, the method comprising” / “A
tangible computer readable medium containing code
for matching computer models of a jaw, the tangible
computer readable medium comprising instructions
to”...................................................................................... 96
ii. 	[1.2] / [19.2]: “loading a first computer model of a
jaw having teeth in initial positions” / “load a first
computer model of a jaw having teeth in initial
positions”; [1.3] / [19.3]: “loading a second
computer model of the jaw, wherein positions of at
least some of the teeth in the second computer model
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x
are different than the initial positions” / “load a
second computer model of the jaw, wherein positions
of at least some of the teeth in the second computer
model are different than the initial positions”................... 97
iii. 	[1.4] / [19.4]: “identifying at least one reference
point on a region of the first computer model, the
region comprising a portion of the jaw other than the
teeth” / “identify at least one reference point on a
region of the first computer model, the region
comprising a portion of the model other than the
teeth”; [1.5] / [19.5]: “identifying a corresponding
reference point on a corresponding region of the
second computer model for each point identified on
the first model” / “identify a corresponding reference
point on a corresponding region of the second
computer model for each point identified on the first
model” ............................................................................... 98
iv. 	[1.6] / [19.6]: “matching the region of the first
computer model with the corresponding region of the
second computer model, using the identified
reference points” / “ma[t]ch the region of the first
computer model with the corresponding region of the
second computer model, using the identified
reference points” ............................................................. 101
v. 	[1.7] / [19.7]: “matching the first and second
computer models as a whole, using the matched
regions” / “match the first and second computer
models as a whole, using the matched regions” ............. 104
vi. 	[1.8] / [18.8]: “calculating positional differences
between the teeth in their initial positions and the
teeth in their positions in the second computer model,
using the matched regions as non-moving reference
regions” / “calculate positional differences between
the teeth in their initial positions and the teeth in their
positions in the second computer model, using the
matched regions as non-moving reference regions” ....... 107
b) 	Claims 2 and 20 .......................................................................... 109
i. 	[2.1] / [20.1]: “The method of claim 1, further
comprising: displaying the positional differences
between the teeth in the first and second models.” /
“The medium of claim 19, further comprising
instructions to: display the positional differences
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xi
between the teeth in the first and second models.” ......... 109
B. 	Technical Prong of Domestic Industry ............................................................... 110
1. 	The 661 DI Products Practice Claims 2 and 20 of the ’661 Patent......... 110
a) 	Claims 1 and 19 .......................................................................... 110
i. 	[1.1] / [19.1]: “A method for matching computer
models of a jaw, the method comprising” / “A
tangible computer readable medium containing code
for matching computer models of a jaw, the tangible
computer readable medium comprising instructions
to”.................................................................................... 110
ii. 	[1.2] / [19.2]: “loading a first computer model of a
jaw having teeth in initial positions” / “load a first
computer model of a jaw having teeth in initial
positions”; [1.3] / [19.3]: “loading a second
computer model of the jaw, wherein positions of at
least some of the teeth in the second computer model
are different than the initial positions” / “load a
second computer model of the jaw, wherein positions
of at least some of the teeth in the second computer
model are different than the initial positions”................. 111
iii. 	[1.4] / [19.4]: “identifying at least one reference
point on a region of the first computer model, the
region comprising a portion of the jaw other than the
teeth” / “identify at least one reference point on a
region of the first computer model, the region
comprising a portion of the model other than the
teeth”; [1.5] / [19.5]: “identifying a corresponding
reference point on a corresponding region of the
second computer model for each point identified on
the first model” / “identify a corresponding reference
point on a corresponding region of the second
computer model for each point identified on the first
model” ............................................................................. 112
iv. 	[1.6] / [19.6]: “matching the region of the first
computer model with the corresponding region of the
second computer model, using the identified
reference points” / “ma[t]ch the region of the first
computer model with the corresponding region of the
second computer model, using the identified
reference points” ............................................................. 114
v. 	[1.7] / [19.7]: “matching the first and second
computer models as a whole, using the matched
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regions” / “match the first and second computer
models as a whole, using the matched regions” ............. 115
vi. 	[1.8] / [18.8]: “calculating positional differences
between the teeth in their initial positions and the
teeth in their positions in the second computer model,
using the matched regions as non-moving reference
regions” / “calculate positional differences between
the teeth in their initial positions and the teeth in their
positions in the second computer model, using the
matched regions as non-moving reference regions” ....... 116
b) 	Claims 2 and 20 .......................................................................... 117
i. 	[2.1] / [20.1]: “The method of claim 1, further
comprising: displaying the positional differences
between the teeth in the first and second models.” /
“The medium of claim 19, further comprising
instructions to: display the positional differences
between the teeth in the first and second models.” ......... 117
C. 	Invalidity ............................................................................................................. 118
1. 	Invalidity Overview ................................................................................ 118
2. 	Obviousness ............................................................................................ 119
a) 	Claims 1 and 19 .......................................................................... 119
i. 	[1.1] / [19.1]: “A method for matching computer
models of a jaw, the method comprising” / “A
tangible computer readable medium containing code
for matching computer models of a jaw, the tangible
computer readable medium comprising instructions
to”.................................................................................... 119
ii. 	[1.2] / [19.2]: “loading a first computer model of a
jaw having teeth in initial positions” / “load a first
computer model of a jaw having teeth in initial
positions”; [1.3] / [19.3]: “loading a second
computer model of the jaw, wherein positions of at
least some of the teeth in the second computer model
are different than the initial positions” / “load a
second computer model of the jaw, wherein positions
of at least some of the teeth in the second computer
model are different than the initial positions”................. 119
iii. 	[1.4] / [19.4]: “identifying at least one reference
point on a region of the first computer model, the
region comprising a portion of the jaw other than the
teeth” / “identify at least one reference point on a
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region of the first computer model, the region
comprising a portion of the model other than the
teeth”; [1.5] / [19.5]: “identifying a corresponding
reference point on a corresponding region of the
second computer model for each point identified on
the first model” / “identify a corresponding reference
point on a corresponding region of the second
computer model for each point identified on the first
model” ............................................................................. 121
iv. 	[1.6] / [19.6]: “matching the region of the first
computer model with the corresponding region of the
second computer model, using the identified
reference points” / “ma[t]ch the region of the first
computer model with the corresponding region of the
second computer model, using the identified
reference points” ............................................................. 122
v. 	[1.7] / [19.7]: “matching the first and second
computer models as a whole, using the matched
regions” / “match the first and second computer
models as a whole, using the matched regions” ............. 123
vi. 	[1.8] / [18.8]: “calculating positional differences
between the teeth in their initial positions and the
teeth in their positions in the second computer model,
using the matched regions as non-moving reference
regions” / “calculate positional differences between
the teeth in their initial positions and the teeth in their
positions in the second computer model, using the
matched regions as non-moving reference regions” ....... 125
b) 	Claims 2 and 20 .......................................................................... 126
i. 	[2.1] / [20.1]: “The method of claim 1, further
comprising: displaying the positional differences
between the teeth in the first and second models.” /
“The medium of claim 19, further comprising
instructions to: display the positional differences
between the teeth in the first and second models.” ......... 126
3. 	3Shape Failed to Present Any Evidence of Motivation to Combine or
Reasonable Expectation of Success ........................................................ 127
IX. 	U.S. PATENT NO. 8,102,538 ....................................................................................... 129
A. 	Infringement ........................................................................................................ 129
1. 	Infringement Overview ........................................................................... 129
2. 	The Accused Products Do Not Practice Claims 1 and 2 of the ’538
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xiv
Patent Literally or Under the Doctrine of Equivalents ........................... 131
a) 	[1.1]: “A device for determining the surface topology and
associated color of at least a portion of a three dimensional
structure, comprising:” ................................................................ 131
b) 	[1.2]: “optical scanner configured for providing depth data
of the portion corresponding to a two-dimensional reference
array substantially orthogonal to a depth direction;” .................. 133
i. 	Align Failed to Prove Literal Infringement of
“Optical Scanner” ........................................................... 133
ii. 	Align Failed to Prove Infringement of “Optical
Scanner” Under the Doctrine of Equivalents .................. 142
iii. 	Align Proved Infringement of the Remainder of
Element [1.2]: “configured for…” ................................. 144
c) 	[1.3]: “imaging means configured for providing two-
dimensional color image data of the portion associated with
the reference array;” .................................................................... 147
d) 	[1.4]: “wherein the device is configured for maintaining a
spatial disposition with respect to the portion that is
substantially fixed during operation of the optical scanner
and the imaging means.” ............................................................. 149
e) 	[2]: “The device according to claim 1, wherein the operation
of the optical scanner is based on confocal imaging
techniques.” ................................................................................. 153
f) 	The TRIOS 3 Mono Does Not Infringe ...................................... 155
B. 	Technical Prong of Domestic Industry ............................................................... 157
a) 	[1.1]: “A device for determining the surface topology and
associated color of at least a portion of a three dimensional
structure, comprising:” ................................................................ 158
b) 	[1.2]: “optical scanner configured for providing depth data
of the portion corresponding to a two-dimensional reference
array substantially orthogonal to a depth direction;” .................. 159
c) 	[1.3]: “imaging means configured for providing two-
dimensional color image data of the portion associated with
the reference array;” .................................................................... 164
d) 	[1.4]: “wherein the device is configured for maintaining a
spatial disposition with respect to the portion that is
substantially fixed during operation of the optical scanner
and the imaging means.” ............................................................. 166
e) 	[2]: “The device according to claim 1, wherein the operation
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of the optical scanner is based on confocal imaging
techniques.” ................................................................................. 167
C. 	Invalidity ............................................................................................................. 168
1. 	Invalidity Overview ................................................................................ 168
2. 	Legal Standards ....................................................................................... 169
a) 	Anticipation................................................................................. 169
3. 	Okamoto Does Not Anticipate Claims 1 and 2 of the ’538 Patent ......... 170
a) 	[1.1] (Preamble): “A device for determining the surface
topology and associated color of at least a portion of a three
dimensional structure, comprising:” ........................................... 174
b) 	[1.2]: “optical scanner configured for providing depth data
of the portion corresponding to a two-dimensional reference
array substantially orthogonal to a depth direction;” .................. 175
c) 	[1.3]: “imaging means configured for providing two-
dimensional color image data of the portion associated with
the reference array;” .................................................................... 180
d) 	[1.4]: “wherein the device is configured for maintaining a
spatial disposition with respect to the portion that is
substantially fixed during operation of the optical scanner
and the imaging means.” ............................................................. 182
e) 	[2]: “The device according to claim 1, wherein the operation
of the optical scanner is based on confocal imaging
techniques.” ................................................................................. 184
4. 	Xu Does Not Anticipate Claims 1 and 2 of the ’538 Patent ................... 184
5. 	Neither Okamoto Nor Xu Alone or in Combination of Okamoto and
Cha, Render the Asserted Claims Obvious ............................................. 187
6. 	3Shape’s Invalidity Arguments Based on Babayoff Fail for Lack of
Evidence .................................................................................................. 189
X. 	U.S. PATENT NO. 9,299,192 ....................................................................................... 195
A. 	Infringement ........................................................................................................ 195
1. 	Infringement Overview ........................................................................... 195
2. 	The 192 Accused Products Practice Practice Claims 2, 28, and 29 of the
’192 Patent .............................................................................................. 197
a) 	Claims 1 and 28 .......................................................................... 197
i. 	[1.1] / [28.1]: “A method for generating a modified
virtual model of a physical structure, comprising” /
“A system to generate a modified virtual model of a
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physical structure, comprising” ...................................... 197
ii. 	[1.2] / [28.2]: “displaying an image of a first virtual
model on a display operatively connected to a
computer system, wherein the first virtual model is
generated from first 3D scan data of the physical
structure, and wherein said first virtual model fails to
properly represent a first physical part of the physical
structure” / “a display to display images of said
modified virtual model; and a computer system
operatively connected to the display and comprising a
program that, when executed by the computer
system, causes the computer system to, display an
image of a first virtual model generated from first 3D
scan data of the physical structure on the display,
wherein said first virtual model fails to properly
represent a first physical part of the physical
structure” ......................................................................... 198
iii. 	[1.3] / [28.3]: “receiving user input identifying at
least a portion of the first virtual model that is desired
to be modified, wherein the user input is generated by
user interaction with the image on the display” /
“receive user input identifying at least a portion of
the first virtual model that is desired to be modified,
the user input generated by user interaction with the
image of the first virtual model on the display” ............. 200
iv. 	[1.4] / [28.4]: “receiving a second virtual model of
the physical structure with the computer system, the
second virtual model generated from second 3D scan
data of the physical structure” / “receive a second
virtual model of the physical structure, the second
virtual model generated from second 3D scan data of
the physical structure”..................................................... 202
v. 	[1.5] / [28.5]: “modifying the first virtual model with
the computer system by replacing at least said
identified portion of the first virtual model with a
corresponding portion of the second virtual model,
thereby generating the modified virtual model” /
“modify the first virtual model by replacing at least
said identified portion of the first virtual model with a
corresponding portion of the second virtual model,
thereby providing the modified virtual model” .............. 204
b) 	Claim 2 ........................................................................................ 207
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i. 	“The method according to claim 1, wherein said
physical structure comprises any one of an intra-oral
cavity of a patient or a physical dental model
representative of said intra-oral cavity.” ......................... 207
c) 	Claim 29 ...................................................................................... 207
i. 	“The system according to claim 28, wherein the at
least said identified portion of the first virtual model
and the corresponding portion of the second virtual
model are each representative of a physical portion of
the physical structure, the first virtual model
providing a deficient representation of the physical
portion and the second virtual model providing an
adequate representation of the physical portion.” ........... 207
B. 	Technical Prong of Domestic Industry ............................................................... 208
1. 	The 192 DI Product Practice Claims 2, 28, and 29 of the ’192 Patent ... 208
a) 	Claims 1 and 28 .......................................................................... 208
i. 	[1.1] / [28.1]: “A method for generating a modified
virtual model of a physical structure, comprising” /
“A system to generate a modified virtual model of a
physical structure, comprising” ...................................... 208
ii. 	[1.2] / [28.2]: “displaying an image of a first virtual
model on a display operatively connected to a
computer system, wherein the first virtual model is
generated from first 3D scan data of the physical
structure, and wherein said first virtual model fails to
properly represent a first physical part of the physical
structure” / “a display to display images of said
modified virtual model; and a computer system
operatively connected to the display and comprising a
program that, when executed by the computer
system, causes the computer system to, display an
image of a first virtual model generated from first 3D
scan data of the physical structure on the display,
wherein said first virtual model fails to properly
represent a first physical part of the physical
structure” ......................................................................... 210
iii. 	[1.3] / [28.3]: “receiving user input identifying at
least a portion of the first virtual model that is desired
to be modified, wherein the user input is generated by
user interaction with the image on the display” /
“receive user input identifying at least a portion of
the first virtual model that is desired to be modified,
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xviii
the user input generated by user interaction with the
image of the first virtual model on the display” ............. 211
iv. 	[1.4] / [28.4]: “receiving a second virtual model of
the physical structure with the computer system, the
second virtual model generated from second 3D scan
data of the physical structure” / “receive a second
virtual model of the physical structure, the second
virtual model generated from second 3D scan data of
the physical structure”..................................................... 212
v. 	[1.5] / [28.5]: “modifying the first virtual model with
the computer system by replacing at least said
identified portion of the first virtual model with a
corresponding portion of the second virtual model,
thereby generating the modified virtual model” /
“modify the first virtual model by replacing at least
said identified portion of the first virtual model with a
corresponding portion of the second virtual model,
thereby providing the modified virtual model” .............. 213
b) 	Claim 2 ........................................................................................ 216
i. 	“The method according to claim 1, wherein said
physical structure comprises any one of an intra-oral
cavity of a patient or a physical dental model
representative of said intra-oral cavity.” ......................... 216
c) 	Claim 29 ...................................................................................... 216
i. 	“The system according to claim 28, wherein the at
least said identified portion of the first virtual model
and the corresponding portion of the second virtual
model are each representative of a physical portion of
the physical structure, the first virtual model
providing a deficient representation of the physical
portion and the second virtual model providing an
adequate representation of the physical portion.” ........... 216
C. 	Invalidity ............................................................................................................. 217
1. 	Invalidity Overview ................................................................................ 217
2. 	Legal Standard ........................................................................................ 218
a) 	Enablement ................................................................................. 218
3. 	Overview of the Prior Art ....................................................................... 219
a) 	Paley............................................................................................ 219
b) 	Kriveshko .................................................................................... 220
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xix
c) 	Rubbert ........................................................................................ 220
4. 	Anticipation............................................................................................. 221
a) 	The Asserted Claims Are Not Anticipated by Paley-
Kriveshko .................................................................................... 221
b) 	The Asserted Claims Are Not Anticipated by Rubbert .............. 229
5. 	Obviousness ............................................................................................ 235
a) 	The Asserted Claims are Obvious Under Paley-Kriveshko ........ 235
i. 	Secondary Considerations ............................................... 238
b) 	The Asserted Claims are Not Obvious Under Rubbert ............... 238
6. 	Enablement ............................................................................................. 239
7. 	Patent Eligibility ..................................................................................... 241
XI. 	INDIRECT INFRINGEMENT ................................................................................... 242
A. 	Legal Standard .................................................................................................... 242
1. 	Induced Infringement .............................................................................. 242
2. 	Contributory Infringement ...................................................................... 244
B. 	3Shape Indirectly Infringed the ’647, ’661, and ’192 Patents ............................ 246
1. 	’647 Patent .............................................................................................. 246
2. 	’661 Patent .............................................................................................. 251
3. 	’538 Patent .............................................................................................. 252
4. 	’192 Patent .............................................................................................. 255
XII. 	DOMESTIC INDUSTRY REQUIREMENT: ECONOMIC PRONG ................... 257
A. 	Legal Standard .................................................................................................... 257
B. 	Align’s Investments in Plant and Equipment Are Significant Under Section 337
(a)(3)(A) .............................................................................................................. 261
C. 	Align’s Investments in Employment of Labor and Capital Are Significant Under
Section 337(a)(3)(B) ........................................................................................... 269
XIII. 	REMEDY AND BOND................................................................................................. 276
A. 	Legal Standard .................................................................................................... 276
B. 	A Limited Exclusion Order Is Warranted ........................................................... 276
C. 	A Cease and Desist Order Is Warranted ............................................................. 279
D. 	A Bond During the Presidential Review Period Is Not Warranted .................... 281
XIV. 	WAIVER OR WITHDRAWAL OF 3SHAPES’ DEFENSES .................................. 285
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XV. 	CONCLUSIONS OF FACT OR LAW: THIS INITIAL DETERMINATION
FINDS A SECTION 337 VIOLATION BASED UPON INFRINGEMENT OF U.S.
PATENT NO. 7,188,751 ............................................................................................... 285
XVI. 	CONCLUSION AND ORDER .................................................................................... 286
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ABBREVIATIONS
The following shorthand references to the parties, related U.S. agencies, and related proceedings
are used in this Initial Determination:
Complainant or
Align Complainant Align Technology, Inc.
Respondents or
3Shape
Respondents 3Shape A/S, 3Shape Trios A/S, and 3Shape, Inc.,
collectively
CBP 	U.S. Customs and Border Protection
USPTO or PTO 	U.S. Patent and Trademark Office
PTAB 	Patent Trial and Appeal Board
1090 Investigation Certain Intraoral Scanners and Related Hardware and Software,
Inv. No. 337-TA-1090
1091 Investigation Certain Color Intraoral Scanners and Related Hardware and
Software, Inv. No. 337-TA-1091
The following abbreviations for pleadings, exhibits, briefs, transcripts, and Orders are used in
this Initial Determination:
Compl. 	Complaint
Resp.
Response of Respondents to the Notice of Investigation and
Complaint Under Section 337 of the Tariff Act of 1930, as
Amended
CX 	Complainant’s exhibit
CDX 	Complainant’s demonstrative exhibit
CPX 	Complainant’s physical exhibit
CPBr. 	Complainant’s Pre-Hearing Brief
CBr. 	Complainant’s Initial Post-Hearing Brief
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CRBr. 	Complainant’s Post-Hearing Reply Brief
CPSt. 	Complainant’s Pre-Hearing Statement
JX 	Joint exhibit
RX 	Respondents’ exhibit
RDX 	Respondents’ demonstrative exhibit
RPX 	Respondents’ physical exhibit
RPBr. 	Respondents’ Pre-Hearing Brief
RBr. 	Respondents’ Initial Post-Hearing Brief
RRBr. 	Respondents’ Post-Hearing Reply Brief
RPSt. 	Respondents’ Pre-Hearing Statement
Tr. 	Evidentiary hearing transcript
Dep. Tr. 	Deposition transcript
COMBr. 	Complainant’s Opening Markman Brief
ROMBr. 	Respondents’ Opening Markman Brief
CSMBr. 	Complainant’s Supplemental Markman Brief
RSMBr. 	Respondents’ Supplemental Markman Brief
Joint CC Chart Joint Post-Hearing Final Claim Construction Chart (Doc. ID No.
685923 (Aug. 21, 2019))
Markman Order 	Order No. 36 (Oct. 1, 2019)
The following shorthand references to certain products and patents at issue are used in this Initial
Determination:
’647 patent 	U.S. Patent No. 7,077,647
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’661 patent 	U.S. Patent No. 7,156,661
’538 patent 	U.S. Patent No. 8,102,538
’192 patent 	U.S. Patent No. 9,299,192
647 Accused
Products
TRIOS Intraoral scanner with TRIOS Patient Monitoring
(additionally with Ortho System)
661 Accused
Products
TRIOS Intraoral scanner with Patient Monitoring or Ortho System
Compare Model Sets
538 Accused
Products TRIOS Intraoral scanner
192 Accused
Products
TRIOS Intraoral scanner with TRIM tool, and the TRIOS
Application’s implant workflow, post and core workflow, and pre-
preparation workflow
647 DI Products 	iTero Element Intraoral scanner with Progress Assessment
661 DI Products 	iTero Element Intraoral scanner with TimeLapse
538 DI Products 	iTero Element Intraoral scanner
192 DI Product 	Align’s Eraser software on iTero
Asserted Patents 	’647 patent, ’661 patent, ’538 patent, and ’192 patent, collectively
Accused Products TRIOS, TRIOS with TRIM, TRIOS with TPM, TRIOS with Ortho
System with Virtual Setup and CMS
CMS 	TRIOS with Ortho System and Compare Model Sets software
DI Products
iTero, iTero with Outcome Simulator with Progress Assessment,
iTero with TimeLapse, iTero with Eraser, and/or Align’s Invisalign
System (including Treat)
Eraser 	Align’s Eraser software on iTero
Invisalign System 	Align’s clear aligner treatment process (including Treat)
iTero
Align’s iTero Element scanner, including the Element, Element 2,
and Element Flex, and related software (including the Progress
Assessment, TimeLapse and Eraser tools)
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Progress Assessment 	Align’s Progress Assessment software on iTero
TimeLapse Align’s TimeLapse software on iTero TRIM TRIOS with TRIM
tool software workflows
TPM 	TRIOS with TRIOS Patient Monitoring software
TRIM TRIOS with TRIM tool software workflows for placing crowns and
bridges
TRIOS 	All versions of 3Shape’s TRIOS 3 or TRIOS 4 scanners
Virtual Setup 	TRIOS with Ortho System and Virtual Setup software
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I. SUMMARY OF FINDINGS

Public Version

A summary of this decision’s finding is provided below.

Table No. 1: Summary of Findings

Products Patent Claims Determination
647 Accused ’647 patent 1 and 18 Infringement of valid
Products claims
661 Accused 661 patent 2 and 20 Infringement of valid
Products claims
538 Accused °538 patent 1 and 2 No infringement of
Products valid claims
192 Accused ’192 patent 2, 28, and 29 Infringement of
Products invalid claims
647 DI Products ’647 patent 1 and 18 Satisfied
661 DI Products °661 patent 2 and 20 Satisfied
538 DI Products °538 patent 1 and 2 Satisfied
192 DI Products ’192 patent 2, 28, and 29 Satisfied

Il. BACKGROUND

A. Institution and Selected Procedural History

On December 10, 2018, Align Technology, Inc. filed a complaint (“Complaint”) under

Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337, alleging infringement of

claims 1-13 and 18-21 of the ’647 patent, claims 1-9 and 19-26 of the 661 patent, claims 1 and 2

of the ’538 patent, claims 1-32 of the ’192 patent, and claims 1-20 of U.S. Patent No. 9,848,958

(“the ?958 patent”). (Doc. ID No. 663673 (Comp!.) at 4 2, 72, 77, 82, 87 (Dec. 10, 2018).).

The Commission instituted this Investigation pursuant to subsection (b) of Section 337 of

Page 1 of 287

Page 2 of 287
the Tariff Act of 1930, as amended, on March 5, 2019. 84 Fed. Reg. 7933 (Mar. 5, 2019). The
Notice of Investigation (“NOI”) names as complainant: Align Technology, Inc. of San Jose,
California (“Complainant”). Id. The NOI names as respondents: 3Shape A/S of Copenhagen,
Denmark; 3Shape Trios A/S of Copenhagen, Denmark; and 3Shape, Inc. of Warren, New Jersey.
Id. The Office of Unfair Import Investigations is not a party in this Investigation. Id.
On April 2, 2019, 3Shape filed a response to the Complaint and NOI (“Response”).
(Doc. ID No. 672037 (Resp.) (Apr. 2, 2019).). In its Response, 3Shape identified 10 affirmative
defenses (“3Shape’s Affirmative Defenses”). (Resp. at 22-26.).
On April 22, 2019, the Parties filed a joint motion setting certain dates by which to
reduce the number of asserted claims in the Investigation. (Doc. ID No. 673766 (Apr. 22, 2019);
see also Order No. 6 (Apr. 23, 2019).). The Parties agreed that Align would begin reducing the
number of asserted claims to 45 or less by May 13, 2019, and then reduce the number of
asserted claims again to 30 or fewer by June 20, 2019. (Doc. ID No. 673766 (Apr. 22, 2019).).
The Parties also agreed that a third and final reduction of the number of asserted claims should
occur on or before August 9, 2019. (Id.).
On June 20, 2019, Align filed an unopposed motion for partial termination of this
Investigation against 3Shape with respect to the asserted claims of the ’958 patent, which was
granted. (Motion Docket No. 1144-009 (June 20, 2019); Order No. 17 (July 2, 2019).).
Subsequently, Align filed notices indicating that it would no longer be asserting certain asserted
claims.1 (Doc. ID No. 690717 (Oct. 8, 2019); Doc. ID No. 691640 (Oct. 21, 2019).). As a
result, the remaining claims of Asserted Patents that are the subject of this decision are claims 1
1 3Shape also filed notices regarding dropped prior art references. (Doc. ID No. 690724 (Oct. 8, 2019);
Doc. ID No. 691640 (Oct. 18, 2019).).
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and 18 of the 647 patent, claims 2 and 20 of the ’661 patent, claims 1 and 2 of the ’538 patent,
and claims 2, 28 and 29 of the 7192 patent. (Doc. ID No. 691640 (Oct. 21, 2019); CBr. at 9, 37,
55, 77.).

A Markman hearing was held on August 8, 2019. (See Doc. ID No. 684877 (Aug. 9,
2019).). On October 1, 2019, a Markman Order issued that construed the claim terms in dispute.
(Order No. 36 (“Markman Order’) (Oct. 1, 2019).).

Align initially filed five (5) motions in limine (“MILs”). (Motion Docket Nos. 1144-044
(Sept. 16, 2019), 1144-045 (Sept. 16, 2019), 1144-046 (Sept. 16, 2019), 1144-047 (Sept. 16,
2019), 1144-048 (Sept. 16, 2019).). Align withdrew its MIL Nos. 3 (Motion Docket No. 1144-
046) and 4 (Motion Docket No. 1144-047). (Doc. ID No. 691797 (Oct. 21, 2019); Order No. 38
(Oct. 16, 2019).).

3Shape initially filed four (4) MILs. (Motion Docket Nos. 1144-043 (Sept. 16, 2019),
1144-049 (Sept. 16, 2019), 1144-050 (Sept. 16, 2019), 1144-051 (Sept. 16, 2019).). 3Shape
withdrew its MIL No. 4 (Motion Docket No. 1144-051). (Doc. ID No. 688910 (Sept. 23,
2019).).

Align’s and 3Shape’s MILs, and the rulings on these motions, are summarized in Table
Nos. 2 and 3 below.

Table No. 2: Align’s MILs

MIL No. Issue Ruling
MIL No. 1 MIL to Preclude Denied in-part, granted in-part. (Oct.
(Motion Docket No Undisclosed and Unreliable | 10, 2019 Teleconference Tr. (“10/10/19
1144-044) ’ | Expert Testimony Teleconf. Tr.”’) at 29:18-32:9.).
Regarding Invalidity
MIL No. 2 MIL to Preclude Arguments | Denied in-part, granted in-part.
and Evidence Regarding (10/10/19 Teleconf. Tr. at 42:5-43:4,

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MIL No. Issue Ruling
(Motion Docket No. | 3Shape’s Untimely Non- 47:14-52:25.).
1144-045) Infringement and Domestic
Industry Theories Regarding
the 538 Patent
MIL No. 5 MIL to Preclude Opinions Granted. (10/10/19 Teleconf. Tr. at
(Motion Docket No Regarding Prosecution 56:6-57:13.).
1144-048) ’ | History Estoppel
Table No. 3: 3Shape’s MILs
MIL No. Issue Ruling
MIL No. 1 MIL to Exclude Align’s Resolved by the Parties. (Oct. 17, 2019
. Improper Designations of Teleconference Tr. (“10/17/19 Teleconf.
MaLot3)? ee Personal Deposition Tr.”) at 6:4-7:11.).
Testimony
MIL No. 2 MIL to Exclude Having considered 3Shape’s motion,
. Designations of Testimony | 3Shape’s MIL No. 2, Motion Docket
M4050) cket No. Outside the Scope of No. 1144-050, is hereby denied.
Witness’ 30(b)(6) Topics
MIL No. 3 MIL to Exclude Align’s Having considered 3Shape’s motion,
. Improper Counter- 3Shape’s MIL No. 3, Motion Docket
Motion Docket No. ot . .. . ,
“ 44-049) one Designation of Deposition No. 1144-049, is hereby denied.
Testimony from Align’s
Own Foreign Witnesses

The evidentiary hearing (“Hearing”) was held on October 24-25, 28-30, 2019. (See Doc.

ID No. 671056 at Ex. 1 (Mar. 22, 2019); Order No. 4 (Mar. 25, 2019).). During and immediately

after the Hearing, Align filed four (4) motions to strike (“MTSs”) evidence presented during the

? This MIL was partially withdrawn. (Doc. ID No. 688761 (Sept. 20, 2019).).

3 This MIL was partially withdrawn. (Doc. ID No. 688761 (Sept. 20, 2019).).

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Hearing. Align’s MTSs, and rulings on these motions, are summarized in Table No. 4 below.

Table No. 4: Align’s Motions to Strike

Motion Issue Ruling
Motion Docket No. | Motion to Strike Dr. Saber’s | Denied. (Order No. 46 (Dec. 18,
1144-058 Provision Testimony 2019).).
Regarding a Rejected Claim
Construction

Motion Docket No. | Motion to Strike Testimony | Denied. (Order No. 46 (Dec. 18,

1144-059 Concerning Invalidity 2019).).

Theories for U.S. Patent No.

8,102,538
Motion Docket No. | Motion to Strike Dr. Saber’s | Granted. (Order No. 46 (Dec. 18,
1144-061 Provisional Testimony 2019).).

Offering Previously

Undisclosed Validity

Opinions and Analysis
Motion Docket No. | Motion to Strike Testimony | Denied. (Order No. 46 (Dec. 18,
1144-062 Regarding Non- 2019).).

Infringement of Claim 2 of

USS. Patent No. 8,102,538

B. The Parties
1. Complainant Align Technology, Inc.

Align is a publicly traded corporation organized and existing under the laws of the State
of Delaware, with its principal place of business located at 2820 Orchard Parkway, San Jose,
California 95134. (See, e.g., Compl. at § 14; CPBr. at 1-2.).

Align described itself and its products as follows:

Align was founded in 1997 when two visionary business students ambitiously set

out to create the pioneering invisible aligner dental market, leading to the

introduction of the Invisalign System. Created as an alternative to braces,

Invisalign uses a series of clear aligners that patients swap out every two weeks to
straighten their teeth. For more than 18 years, Align has been in the business of

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researching, designing, developing, and selling innovative scanners and image
processing devices for the dental and orthodontic industries. 	In 2011, Align
acquired Cadent Holdings Inc. and its pioneering iTero intraoral scanner. Today
Align offers an integrated digital platform of digital dentistry solutions.
(Id. at 2; see also Compl. at ¶¶ 3-6, 15-17.).
2. 	Respondents 3Shape A/S, 3Shape Trios A/S, and 3Shape, Inc.
3Shape A/S and 3Shape Trios A/S are Danish corporations with their principal place of
business at Holmens Kanal 7, 1060 Copenhagen K, Denmark. (Resp. at ¶¶ 18, 20.). 3Shape A/S
and 3Shape Trios A/S are “sister” corporations that are wholly-owned subsidiaries of 3Shape
Holdings A/S. (Id. at ¶ 20.).
3Shape A/S develops and sells 3Shape’s unaccused lab scanner products. (See, e.g.,
RPBr. at 2.). 3Shape A/S also develops and sells and/or licenses Ortho System. (Id.).
Additionally, 3Shape A/S developed TPM. (Id.). 3Shape Trios A/S develops and sells 3Shape’s
Trios 3/4 scanners and the Trios App software and ScanSuite Trios software. (Id.).
3Shape, Inc. is a Delaware corporation with a principal place of business at 10
Independence Boulevard, Suite 150, Warren, New Jersey 07059. (Resp. at ¶ 19.).
3Shape Inc. is 3Shape’s regional support entity for North America. (RPBr. at 2.).
3Shape Inc. supports 3Shape’s U.S. distributors, or “resellers,” by providing marketing and sales
support and training. (Id.).
III. 	JURISDICTION, IMPORTATION, AND STANDING
A. 	The Commission Has Jurisdiction
To have the authority to decide a case, a court or agency must have both subject matter
jurisdiction and jurisdiction over either the parties or the property involved. See Certain Steel
Rod Treating Apparatus and Components Thereof, Inv. No. 337-TA-97, Comm’n Opinion, 215
U.S.P.Q. 229, 231 (U.S.I.T.C. 1981). For the reasons discussed below, the facts support a
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finding that the Commission has jurisdiction over this Investigation.
1. 	Subject Matter Jurisdiction
The Commission has subject matter jurisdiction over this Investigation because Align
alleged that 3Shape has violated 19 U.S.C. §1337(a)(1)(B). See Amgen v. U. S. Int’l Trade
Comm’n, 902 F.2d 1532, 1536 (Fed. Cir. 1990). 3Shape did not contest that the Commission has
subject matter jurisdiction. (See RPBr. at 8.).
2. 	Personal Jurisdiction
3Shape did not dispute that the Commission has personal jurisdiction over 3Shape. (See
RPBr. at 8.). Moreover, 3Shape appeared and responded to the Complaint and NOI, and fully
participated in this Investigation, which included participating in discovery and the Hearing, and
by filing motions. Thus, the Commission has personal jurisdiction over 3Shape. See, e.g.,
Certain Windshield Wiper Devices and Components Thereof (“Wiper Devices”), Inv. No. 337-
TA-881, Initial Determination at 5 (May 8, 2014) (unreviewed in relevant-part) (Doc. ID No.
534255).
3. 	Importation
As described in detail below in Section V.A., the Accused Products in this case include
TRIOS 3 scanners, TRIOS 4 scanners, TRIM software, Patient Monitoring (“TPM”) software,
and Ortho System software which includes CMS and Virtual Setup.
3Shape did not dispute, and in fact stipulated to, the importation of TRIOS 3 and TRIOS
4 scanners. (RPBr. at 8 (citing (CX-2164C (Joint Stipulation Regarding Importation of TRIOS 3
and TRIOS 4 Products) Doc. ID No. 686112 at ¶ 1 and Appendix A (August 21, 2019))
(“Importation Stipulation”)).). However, 3Shape argued that the importation requirement was
not satisfied for the Ortho System software because since February or March of 2018, the Ortho
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System was not pre-loaded onto the TRIOS 3 and TRIOS 4 scanners when the scanners were
imported. (RPBr. at 8-13; RRBr. at 1-8.).
3Shape also argued that the importation requirement has not been satisfied for the TPM
software because TPM was never imported as pre-installed software on a TRIOS 3 or TRIOS 4
scanner. (RPBr. at 9; RRBr. at 6-7.). However, 3Shape did not advance any arguments in its
Pre-Hearing Brief or Post-Hearing Reply Brief to oppose Align’s importation allegations with
respect to the TRIM tool. Therefore, the only Accused Products for which the importation
requirement was contested were the Ortho System and TPM software. For the reasons described
below, I find that 3Shape’s arguments with respect to the Ortho System and TPM software are
misplaced. Moreover, 3Shape has waived arguments with respect to the importation of the
TRIM tool software pursuant to Ground Rules 7.2 and 10.1.
a) 	Importation Satisfied for Ortho System Software
Despite 3Shape’s arguments, Align has proven factually, and it is a finding that the
importation requirement has been satisfied for the Ortho System. 3Shape stipulated that the
Ortho software was used at least once in the United States between December 10, 2018, and
October 31, 2019. (Accused Product Stipulation at ¶ 3.). 3Shape also stipulated that at least one
non-basic TRIOS 3 accused scanner exists in the United States with a license to the Ortho
System software. (Id. at ¶ 4.).
Align also presented evidence in its original Complaint in the form of a Declaration by
Dr. John Dovgan4 in which he attested to his purchase and use in the United States in October
4 In his Declaration dated November 13, 2017, Dr. John Dovgan identified himself as a cosmetic dentist
in Phoenix, AZ, who purchased a “3Shape TRIOS 3 Wired Pod with pen-grip scanner” and “a Dell
Alienware laptop loaded with certain Dental System software including the TRIOS, Ortho Analyzer,
Implant Studio Planner, Planning Model Builder, and Appliance Designer software.” (Dovgan
Declaration at ¶¶ 1-2.).
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2017 of a TRIOS 3 scanner with the Ortho System functionality as part of the system. (Compl.
at ¶ 96; CX-0020C (Declaration of Dr. John Dovgan) at ¶¶ 1-3 and 7 (“Dovgan Declaration”).).
While Dr. Doygan’s Declaration does not specify whether the TRIOS 3 scanner was imported
with the Ortho System software pre-installed, his Declaration suggests that the TRIOS 3 scanner
was enabled with the Ortho System. (See id. at ¶¶ 1-3 and 7.). In view of Mr. Mikael Petersen’s
Declaration that “all TRIOS scanners” using Ortho System software that were imported to the
U.S. prior to February or March of 2018 had the Ortho System pre-installed prior to importation,
the TRIOS 3 scanner of the Dovgan Declaration appears to be at least one example of a scanner
which had Ortho System capability installed prior to importation into the United States.5
The Stipulations, together with Hearing testimony, and the Dovgan Declaration, together
support a finding that not only was it
importation, but that at least one TRIOS scanner was
imported into the U.S. with the Ortho System pre-installed.
3Shape attempted to undermine Align’s evidence supporting importation of scanners with
pre-installed Ortho Software prior to February or March 2018, by eliciting testimony from its
expert Mr. Petersen, about the current supply chain for TRIOS 3 scanners at the Ortho System as
of the date of the hearing. (Tr. (Petersen) at 1134:13-15, 1138:12-24, 1141:10-16, 1141:17-
1142:7.). However, none of that testimony proved that the supply chain prior to February or
March 2018 did not pre-install the Ortho System on TRIOS scanners prior to U.S. importation.
5 When he testified during the Hearing in this Investigation on October 29, 2019, Mr. Mikael Petersen
held the position of Senior Vice President at 3Shape A/S. (Tr. at 1131-1:16.). 3Shape identified Mr.
Petersen as a fact witness expected to testify regarding 3Shape’s supply chain for the accused products.
(RPSt. at 2.).
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Moreover, 3Shape did not submit any evidence, such as documentation or internal directives,
other than single witness testimony to support its claim that the Ortho software was no longer
uploaded to the scanners prior to U.S. importation. (Tr. (Petersen) at 1179:9-1182:9.). 3Shape’s
evidence was both insufficient and unsatisfactory. Therefore, Align successfully demonstrated,
given the weight of the evidence, at least one instance of the importation of a TRIOS 3 scanner
with the Ortho System pre-installed. For that reason, the importation requirement has been met
for the Ortho System.
b) 	Importation Satisfied for TPM Software
With respect to the TPM software, Align also proved factually, and it is a finding, that the
importation requirement has been satisfied. Indeed, no direct evidence in the form of exhibits
was presented by either party which explicitly showed that TPM was pre-installed on a TRIOS 3
or TRIOS 4 scanner, and then imported to the U.S. However, the circumstantial evidence that
Align presented is sufficient to support that conclusion.
3Shape stipulated that, in addition to the TRIOS 3 scanners, TRIOS 4 scanners, TRIM
tool software, and Ortho System software, the TPM software was used at least once in the United
States between December 10, 2018, and October 31, 2019. (Accused Product Stipulation at ¶
3.). 3Shape also stipulated that at least one non-basic TRIOS 3 accused scanner exists in the
United States with a license to the Ortho System software. (Id. at ¶ 4.). Align also established
during cross-examination of Mr. Petersen that
. (Tr. (Petersen) at 1167:19-1169:6.).
Although both Mr. Petersen and Dr. Rune Fisker6 both testified that
6 When he testified during the Hearing on October 28, 2019, Mr. Rune Fisker, Ph.D. was 3Shape’s Senior
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, their testimony has been given little weight because they
contradicted themselves and each other. (See Tr. (Petersen) at 1175:24-1176:7, 1178:1-1179:7;
Tr. (Fisker) at 643:3-5, 10-21, 662:24-663:4.). Neither witness provided testimony supported by
documentation let alone clear testimony either alone or together. For example, notwithstanding
his seeming certainty during the Hearing, during his May 2019 deposition, Mr. Petersen was not
certain whether the TPM software was part of the Dental Desktop software that was uploaded
onto the TRIOS 3 and TRIOS 4 scanners. He stated that he would need to consult with Dr.
Fisker to verify the information. (Tr. (Petersen) at 1169:11-25.). However, Dr. Fisker testified
during his July 2019 deposition that he would need to verify with Mr. Petersen whether the TPM
was a part of the Dental Desktop software that was pre-loaded onto the scanners prior to
importation. (Tr. (Fisker) at 643:10-21; id. Tr. (Fisker) at 643:3-5, 662:24-663:4.).
Dr. Fisker’s and Mr. Petersen’s testimony suggests that neither witness knew the answer
to a straightforward issue. Apparently, each was identified has having knowledge about the
components of the TRIOS 3 and TRIOS 4 scanners, yet neither had categorical knowledge. 	At
the time of their depositions, neither party seemed to know the answer. That changed during the
Hearing, when they testified that TPM was not
, all while pointing to each other as
having enlightened the other person. 3Shape did not provide any documentation, in the form of
waybills, invoices, or other information, to support their witnesses’ uncorroborated testimony.
3Shape failed to disprove Align’s theory and evidence supporting the importation of
Vice President of Product Strategy. Mr. Fisker was 3Shape’s corporate witness who testified about the
Parties’ interactions; 3Shape’s equitable defenses; 3Shape’s products; and related issues. (CPSt. at 6;
RPSt. at 2; Tr. (Fisker) at 637-38.).
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scanners with pre-installed TPM Software. 3Shape’s evidence was largely circumstantial and
unsupported. It was less persuasive than Align’s. 3Shape failed to present internal documents or
testimony that TPM is not pre-loaded before U.S. importation. (Tr. (Petersen) at 1170:7-22,
1179:9-1182:9.). On direct examination, Dr. Fisker testified that TPM was “announced” in
2016, but not “commercially released” until 2019, 	as the reason
for the delay. (Tr. (Fisker) at 638:23-639:5.). Yet, 3Shape failed to support even this testimony
with documentation or exhibits to show when TPM entered the market. Part of this timeframe is
before 2018 during the time in which Mr. Petersen testified that essentially all software was
installed in Poland before being imported into the United States. 3Shape undermined its own
evidence with other confusing or contradictory evidence.
Therefore, based upon the more substantial, albeit circumstantial, evidence, Align
successfully demonstrated at least one instance of the importation of a TRIOS 3 or TRIOS 4
scanner with the TPM software pre-installed. The importation requirement has been met for the
TPM System.
c) 	Importation Satisfied for Ortho System and TPM Software
Under Suprema
Align’s alternative theory for the importation of the Ortho System and TPM software
relies upon post-importation infringement as the Federal Circuit explained in Suprema, Inc. v.
Int’l Trade Comm’n, 796 F.3d 1338, 1352 (Fed. Cir. 2015) (en banc) (“Suprema”). In Suprema,
the Federal Circuit held that for the purpose of satisfying the importation requirement, “articles
that infringe” include “goods that were used by an importer to directly infringe post-importation
as a result of the seller’s inducement.” Suprema, 796 F.3d at 1352. The Federal Circuit has
upheld the Commission’s application of Suprema in a subsequent case. See Comcast Corp. v.
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Int’l Trade Comm’n, 951 F.3d 1301, 1308 (Fed. Cir. Mar. 2, 2020). The Commission has
interpreted Suprema to have “repudiated a time-of-importation requirement.” See Certain
Beverage Dispensing Systems and Components Thereof, Inv. No. 337-TA-1130, Comm’n Op. at
15 (Mar. 26, 2020). In other words, as the Federal Circuit has held, so long as the imported
articles are combined and used post-importation to infringe the claims of a U.S. patent, the
imported articles still meet the importation requirement even if they do not infringe the patent
claims at the time of importation.
Importation is a separate inquiry from infringement, and the two inquiries, while related,
should not be conflated. With respect to the Ortho System and TPM software, Align argued that
even if 3Shape could establish that the TRIOS 3 and TRIOS 4 scanners were not imported with
pre-installed Ortho System or TPM software, the fact that the imported scanner was later
combined with the separately imported Ortho System or TPM software satisfied the importation
requirement under Suprema. (CPBr. at 12-16; CBr. at 3-7.).
Align presented evidence that 3Shape imports and has imported the accused TRIOS 3
and TRIOS 4 scanners at least once into the United States, consistent with Section 337(a)(1)(B).
First, Align submitted photographic and written evidence that 3Shape imports TRIOS 3 with its
initial Complaint as supported by Dr. Dovgan’s Declaration. (Compl. at ¶ 96; CX-0020C.). Dr.
Dovgan attested that he purchased a “3Shape TRIOS 3 Wired Pod with pen-grip scanner” and “a
Dell Alienware laptop loaded with certain Dental System software including the TRIOS, Ortho
Analyzer, Implant Studio Planner, Planning Model Builder, and Appliance Designer software”
on October 17, 2017, and the corresponding software licenses on October 23, 2017. (Dovgan
Declaration at ¶¶ 2-3.).
Second, 3Shape stipulated to both importing and using TRIOS 3 or TRIOS 4 type
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scanners, both Accused Products, between December 2018 and at least June 2019. (Importation
Stipulation at ¶¶ 1-4; Accused Product Stipulation at ¶¶ 1-3.). Therefore, to the extent that
3Shape’s attempted to dispute later the importation of the TRIOS 3 and TRIOS 4 scanners, these
arguments are precluded by its own stipulations.
Align also presented evidence that the accused TRIOS 3 and TRIOS 4 scanners are
combined with allegedly infringing Ortho System and TPM and software in the U.S. after the
scanners have been imported. For example, the TRIOS 3 scanner that Dr. Dovgan purchased in
2017 was at some point combined with the Ortho System software. (Dovgan Declaration at ¶¶ 2-
3.). He was not exactly clear when, but he did used the software in combination with the
hardware. Moreover, 3Shape stipulated to “using” the accused Ortho System and the TPM
software in the U.S. between December 10, 2018 and October 31, 2019, and to the existence of
“TRIOS 3 accused scanner…in the United States with a license to the Ortho System software.
(Accused Product Stipulation at ¶¶ 1-4.).
Align presented evidence that 3Shape induced the resellers and/or end users to combine
the accused TRIOS 3 or TRIOS 4 scanners with the allegedly infringing software systems by
importing the USB dongle, which had the license key for accused hardware scanners to gain
access to the accused Ortho System or TPM software. (Dovgan Declaration at 16 and ¶ 7; Tr.
(Fisker) at 643:10-645:9; Tr. (Petersen) at 1153:10-15, 1165:9-11.). Therefore, under Suprema,
the importation requirement is satisfied for the accused TRIOS 3 and TRIOS 4 scanners and the
accused TRIM, TPM, and Ortho System software because the hardware and software elements
are imported separately, but later combined to infringe the Asserted Patents.
In response, 3Shape argued that the importation requirement is not satisfied because since
at least April 2018, 3Shape and/or its downstream users in the U.S. download the accused Ortho
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System and TPM software into the United States through the internet. (RRBr. at 2-5.). 3Shape’s
theory that the importation requirement is not satisfied relies upon the Federal Circuit’s holding
in ClearCorrect Operating LLC v. Int’l Trade Comm’n, 810 F.3d 1283, 1286 (Fed. Cir. 2015)
(“ClearCorrect”). ClearCorrect holds that for the purposes of Section 337, “articles” do not
include “electronically transmitted digital data.” However, ClearCorrect is distinguishable from
the facts in this Investigation in at least one critical aspect. ClearCorrect contemplates an
importation scenario in which accused products are only “digital models” made by a process
which allegedly infringed a patented process. ClearCorrect, 810 F.3d at 1287. As the panel in
ClearCorrect noted: “The only purported ‘article’ found to have been imported was digital data
that was transferred electronically, i.e., not digital data on a physical medium such as a compact
disk or thumb drive” (emphasis added). Id. at 1290.
ClearCorrect’s “digital model” distinction does not apply here. In this case, the Accused
Products to which 3Shape and Align stipulated include TRIOS 3 and TRIOS 4 scanner hardware.
(Importation Stipulation at ¶ 4.). The Federal Circuit’s comment that distinguishes “digital data
that was transferred electronically” from “digital data on a physical medium such as a . . . thumb
drive,” it is also relevant here. Both of 3Shape’s experts, Mr. Petersen and Mr. Fisker, seemed to
agree (notwithstanding the lack of clarity in other parts of their testimony) that a thumb drive
(USB “dongle”), that contains the data to enable access to the accused Ortho System or TPM
software, is imported with the accused TRIOS 3 and TRIOS 4 scanners. (Tr. (Fisker) at 643:10-
645:9; Tr. (Petersen) at 1153:10-15, 1165:9-11.). ClearCorrect should not control in this case
because it would lead to the consequence cautioned against by the en banc decision in Suprema:
it would provide “an open invitation to various foreign entities … to circumvent Section 337 by
importing articles in a state requiring post-importation combination or modification before direct
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infringement could be shown.” Suprema, 796 F.3d at 1352.
Finally, the testimony of 3Shape’s two experts, Mr. Fisker and Mr. Petersen, is ultimately
inconclusive solely on the issue of importation of the accused TPM software because both
witnesses seemed to defer to each other on the facts. Neither of them knew the facts.
Although Mr. Petersen testified on re-direct examination during the Hearing that TPM
software is not loaded onto the TRIOS 3 or TRIOS 4 scanners before importation Mr. Petersen
undermined his own testimony by his own subsequent testimony during re-cross-examination
that he would need to defer to Mr. Fisker to verify the facts with respect to when and how
3Shape’s TPM software is downloaded now. (See Tr. (Petersen) at 1175:24-1176:7, 1178:1-
1179:7.). Similarly, although Mr. Fisker testified during direct examination during the Hearing
that TPM software is not currently loaded onto the TRIOS 3 or TRIOS 4 scanners prior to
importation, he too undermined his own testimony during cross-examination because he said he
learned this information from Mr. Petersen who, in turn, testified he relied upon Mr. Fisker’s
testimony. (Tr. (Fisker) at 643:10-21; id. Tr. (Fisker) at 643:3-5, 662:24-663:4.). Indeed, Mr.
Fisker even testified that he was “surprised” to learn that Mr. Petersen implicated him as the
proper source for such information during his May 2019 deposition. (See Tr. (Fisker) at 667:11-
22.).
In other words, neither Mr. Petersen nor Mr. Fisker seemed to know during their
depositions in May 2019 and July 2019, respectively, whether TPM software was pre-loaded
onto the TRIOS 3 or TRIOS 4 scanners prior to their importation into the United States.
Moreover, both witnesses then testified during the Hearing that they learned from each other that
TPM software was not pre-loaded prior to U.S. importation. This makes their testimony on the
issue of whether TPM is imported separately from a TRIOS 3 or TRIOS 4 scanner inconclusive
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and unreliable.
Accordingly, the weight of the evidence supports a finding that the Accused Products in
this Investigation have been imported into the United States. 3Shape’s Ortho System and TPM
software that 3Shape imports are “articles that infringe” under Suprema.
4. 	In Rem Jurisdiction
Section 337(a)(1)(B) applies to the “[t]he importation into the United States, the sale for
importation, or sale within the United States after importation” of articles that infringe a valid
and enforceable United States patent.” 19 U.S.C. § 1337(a)(1)(B). A single instance of
importation is sufficient to satisfy the importation requirement of Section 337. Certain Optical
Disc Drives, Components Thereof, and Prods. Containing the Same, Inv. No. 337-TA-897,
Order No. 101 at 3 (Sept. 22, 2014) (citations omitted) (EDIS Doc. 543438); Certain Wiper
Devices, Inv. No. 337-TA-881, Init. Det. at 5 (in rem jurisdiction exists when importation
requirement is satisfied).
In rem jurisdiction is contested in this case. Align argued that the importation
requirement is satisfied because the accused TRIOS 3 and TRIOS 4 scanners have been imported
with the accused TRIM, TPM, and/or Ortho software pre-loaded. (CPBr. at ix, 1, and 9-14; CBr.
at ix, and 1-3.). Align argued as an alternative theory of importation that the accused TRIOS 3
and TRIOS 4 scanners have been imported and then combined with the accused TRIM, TPM,
and/or Ortho software after importation to form an infringing product, which was then sold in the
United States. (CBr. at 2-7.).
Align also established certain facts during the Hearing during the cross-examination of
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one of 3Shape’s witnesses, Mr. Mikael Petersen,7 that support a finding that in rem jurisdiction is
satisfied for the Ortho System Software.
Mr. Petersen testified that prior to February or March 2018, “all TRIOS scanners” which
used Ortho System software were imported to the U.S. with the Ortho System pre-installed. (Tr.
(Petersen) at 1162:7-21, 1163:7-14.). Mr. Petersen also testified that as of April 2018, some four
(4) months after Align initiated the 1091 Investigation8 and (8) months before Align filed its
Complaint in this Investigation, the Ortho System software was
. (Tr. (Petersen) at 1165:17-23, 1166:14-
16.). Mr. Petersen also testified that 3Shape’s co-Chief Executive Officer (“CEO”), Mr. Nikolaj
Deichmann, instructed him in December 2017 as a legal matter to change the importation
process for U.S. bound scanners and software. Mr. Deichmann’s instruction occurred
approximately one (1) month after Align sued 3Shape in the 1091 Investigation. (Tr. (Petersen)
at 1166:17-1167:14.). According to Mr. Petersen, as of September 2018, everywhere in the
world, except the U.S., where 3Shape sells TRIOS scanners with the Ortho System Software, the
Ortho System software 	into the
destination country. (Tr. (Petersen) at 1166:7-13.). 3Shape did not offer documentation that
reflected the change to which Mr. Petersen testified.
7 When he testified during the Hearing on October 29, 2019, Mr. Mikael Petersen was 3Shape’s Senior
Vice President of Supply Chain, Group IT and Facilities. Mr. Petersen was 3Shape’s corporate witness
who testified about 3Shape’s supply chain for the Accused Products, importation, and related issues.
(CPSt. at 9; RPSt. at 2; Tr. (Petersen) at 1131.).
8 There are two (2) previous Investigations involving Align and 3Shape that are relevant to the present
Investigation. See Certain Intraoral Scanners & Related Hardware and Software, Inv. No. 337-TA-
1090, Initial Determination (Apr. 26, 2019) (the “1090 Investigation”); Certain Intraoral Scanners &
Related Hardware & Software, Inv. No. 337-TA-1091, Initial Determination (Mar. 1, 2019) (the “1091
Investigation”).
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3Shape’s attempts to rebut that there is in rem jurisdiction by attempting to apply
ClearCorrect are unpersuasive and unsupported. Moreover, 3Shape stipulated that a variety of
TRIOS 3 and TRIOS 4 scanners have been imported to the U.S. (See Importation Stipulation at
¶ 1, App. A.). As noted above, 3Shape stipulated that each accused product, including the Ortho
and TPM software, was used at least once in the U.S. between December 10, 2018 and October
31, 2019. (Accused Product Stipulation at ¶ 3.). 3Shape also failed to support the expert
testimony of Mr. Petersen with documented evidence that the importation process had been
changed to import the scanners to the U.S. without pre-installed Ortho software. (Tr. (Petersen)
at 1180:9-1182:9.).
Thus, the weight of the evidence supports a finding that the Commission has in rem
jurisdiction over the Accused Products.
B. 	Align Has Standing in the Commission
Jurisdiction also requires standing. See SiRF Technology, Inc. v. Int’l Trade Comm’n,
601 F.3d 1319, 1326 (Fed. Cir. 2010) (standing to bring an infringement suit is the same under
Commission Rules as it would be in a Federal District Court case); Certain Optical Disc Drives,
Components Thereof and Prods. Containing Same, Inv. No. 337-TA897, Opinion Remanding the
Investigation at 4 (Jan. 7, 2015). Commission Rule 210.12 requires that intellectual property-
based complaints filed by a private complainant “include a showing that at least one complainant
is the exclusive license of the subject intellectual property.” 19 C.F.R. § 210.12(a)(7).
Align has standing to bring suit for infringement under Section 337 because Align
Technology, Inc. owns by assignment the full right, title and interest in the Asserted Patents.
(See CX-2165; CX-2166; CX-2167; CX-2168; CX-2169; CX-2170; CX-2294; JX-0001-JX-
0004.). See SiRF Tech., 601 F.3d at 1327-28 (finding that “[t]he recording of an assignment with
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the PTO . . . creates a presumption of validity as to the assignment and places the burden to rebut
such a showing on one challenging the assignment”).
IV. 	THE ASSERTED PATENTS
A. 	Overview of the Technology
The technology claimed in the Asserted Patents generally relates to analyzing an
orthodontic treatment by using digital models of teeth; the modification of virtual models created
by using scanning systems; and a system that generates color three-dimensional (3D) models of
an object. (Doc. ID No. 679910 (Joint Technology Stipulation) at 1 (July 1, 2019).).
B. 	Overview of U.S. Patent Nos. 7,077,647 (“the ’647 Patent”) and 7,156,661
(“the ’661 Patent”)
The ’647 patent, titled “Systems and Methods for Treatment Analysis by Teeth
Matching,” was filed on August 22, 2002, as U.S. Patent Application Serial No. 10/225,889 (“the
’889 application”). (JX-0001 at (21), (22), (54).). The ’889 application issued as the ’647 patent
on July 18, 2006, and names Woncheol Choi, Jihua Cheng, and Eric Kuo as the inventors, and
Align Technology, Inc. as the assignee. (Id. at (10), (45), (75).).
The ’661 patent, also titled “Systems and Methods for Treatment Analysis by Teeth
Matching,” was filed on August 12, 2003, as U.S. Patent Application Serial No. 10/640,439 (“the
’439 application”). (JX-0002 at (21), (22), (54).). The ’439 application issued as the ’661 patent
on January 2, 2007, and like the ’647 patent, names Woncheol Choi, Jihua Cheng, and Eric Kuo
as the inventors. (Id. at (10), (45), (75).). The ’661 claims priority to the ’889 application, which
issued as the ’647 patent.9 (Id. at (63).).
The’647 and ’661 patents describe matching computer models of two (2) sets of teeth.
9 The ’439 application is a continuation-in-part of the ’889 application. (JX-0002 at (63).).
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(See, e.g., JX-001 at Abstract; JX-0002 at Abstract.). The ’661 patent is a continuation-in-part of
the ’647 patent, and thus shares portions of the same specification. (JX-0002 at (63).). The
claimed inventions generally relate to the field of orthodontics and more specifically to systems
and methods for the measurement of teeth movements. (JX-0001 at 1:7-9; JX-0002 at 1:13-15.).
Methods for digitizing plaster models of teeth of a patient were well-known and described in the
patent and medical literature. (JX-0001 at 1:44-2:3.).
The ’647 and ’661 patents teach that one advantage of the digital model are that they
provide more accurate measurements. (JX-0001 at 2:4-5; JX-0002 at 2:9-11.). The patents
disclose that, traditionally, in the prior art, dentists depended upon manual measurement to
measure dental features and orthodontic properties. (JX-0001 at 2:5-7; JX-0002 at 1:34.). In
prior art, dentists used a ruler on teeth impressions or on X-ray images. The process they used
was a manual process, and the dental measurements were two-dimensional only. (JX-0001 at
2:7-10; JX-0002 at 1:34-37.). Thus, according to the ’647 and ’661 patents, the prior art
measurements were incomplete and imprecise, because, for example, the rotation of a tooth is
difficult to measure. (JX-0001 at 2:10-11; JX-0002 at 1:38-39.).
Contrary to the teachings in the prior art, the digital models disclosed in the ’647 and
’661 patents describe the performance of precise measurement and movement analysis. (JX-
0001 at 2:11-15; JX-0002 at 2:10-11.). Specifically, using three-dimensional rigid body analysis,
the patents teach that accurate and complete movement of a tooth or the entire jaw can be
calculated. (JX-0001 at 2:11-13; JX-0002 at 2:11-15.). In order to accurately compare two (2)
digital models (for example, a digital model of a patient’s tooth, teeth and/or jaw), accurate
matching of the two models is necessary before measuring positional differences. The ’647 and
’661 patents provide methods and systems to match two (2) digital models to measure positional
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and shape differences in a patient’s dentition.
C. 	Overview of U.S. Patent No. 8,102,538 (“the ’538 Patent”)
The ’538 patent, titled “Method and Apparatus for Colour Imaging a Three-Dimensional
Structure,” was filed on April 29, 2010, as U.S. Patent Application Serial No. 12/770,379 (“the
’379 application”). (JX-0003 at (21), (22), (54).). The ’379 application issued as the ’538 patent
on January 24, 2012, and names Noam Babayoff as the sole inventor, and Align Technology,
Inc.’s predecessor, Cadent Ltd. (“Cadent”), as the assignee. (Id. at (10), (45), (75); Compl. at
¶¶ 7, 16; CX-2167.0002 (assignment from Cadent Ltd. to Align Technology, Inc.).).
The ’538 patent “relates to optical scanners, particularly for providing a digital
representation of three-dimensional objects including color.” (Id. at 1:18-20.). Finding particular
application in the surveying of teeth in the intraoral cavity, the ’538 patent notes that “[m]any
methods have been developed for obtaining the three-dimensional location of surface points of
an object,” but that those methods generate a “three-dimensional surface model that is inherently
monochromatic, i.e., no color information is obtained in the imaging process.” (Id. at 1:20-21,
1:25-45.).
Below is a diagram that illustrates the electromagnetic spectrum, which includes
ultraviolet, visible, and infrared light.
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Figure 1: Electromagnetic Spectrum
(Join Tech. Stip. at 2 (citing https://www.khanacademy.org/science/biology/photosynthesis-in-
plants/the-light-dependent-reactions-of-photosynthesis/a/light-and-photosyntheic-pigments).).
As the ’538 patent noted, the human eye can detect light that has a wavelength in the
range of about 400nm (violet) to 700nm (red). (Id.). Two ways of capturing 2D color images
include: (i) illuminating an object with white light and capturing the light from the object with a
color image sensor (e.g., an array of sensor elements sensitive to different regions of the visible
spectrum, such as red, green, and blue); and (ii) illuminating an object with a sequence of
different illuminations and capturing the light from the object with a monochromatic image
sensor at different times. (Id.).
D. 	Overview of U.S. Patent No. 9,229,192 (“the ’192 Patent”)
The ’192 patent, titled “Methods and Systems for Creating and Interacting with Three
Dimensional Virtual Models,” was filed on March 29, 2016, as U.S. Patent Application Serial
No. 13/574,723 (“the ’723 application”). (JX-0004 at (21), (22), (54).). The ’723 application
issued as the ’192 patent on March 29, 2016, and names Avi Kopelman as the sole inventor, and
Align Technology, Inc. as the assignee. (Id. at (10), (45), (75).).
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The ’192 patent is directed to a method and system that displays a first virtual model
generated from 3D scan data of a physical structure (e.g., a patient’s tooth, teeth or jaw), where
the first virtual model fails to properly represent a first physical part of the physical structure.
(Joint Tech. Stip. at 3.). To remedy this failure of representation, the ’192 patent noted that the
method and system receives user input identifying a portion of the first virtual model the user
desires to modify, receives a second virtual model also generated from 3D scan data (i.e., by
rescanning at least a portion of the physical structure), and finally modifies the first virtual model
by replacing at least the identified portion the user desires to modify with a corresponding
portion of the second virtual model, resulting in a modified virtual model. (Id. at 3-4.).
V. 	THE PRODUCTS AT ISSUE
A. 	3Shape’s Accused Products
Align and 3Shape stipulated that the Accused Products in this case are “Trios 3 and Trios
4 intraoral scanners and certain software, specifically 3Shape’s Trim Tool, Ortho System, and
Patient Monitoring.” (See Joint Stipulation Regarding Accused 3Shape Products, Doc. ID No.
692907 at ¶ 1 (October 31, 2019)) (“Accused Product Stipulation”). The Accused Product
Stipulation does not specifically mention the Compare Model Sets (“CMS”) software, the
“Virtual Setup” tool, the “lab scanner” hardware, or the Dental System software.
Both Align and 3Shape characterized the CMS software as a part of the accused Ortho
System. (CPBr. at ix; CBr. at ix; RPBr. at xii; RRBr. at viii.). Therefore, CMS is also an
accused product.
With respect to the Virtual Setup tool, Align clarified in both its Pre-Hearing Brief and
Post-Hearing Brief that the accused Ortho System software includes the Virtual Setup tool
(CPBr. at ix, x, and 9-11; CBr. at ix, x, 10.). However, 3Shape claimed that the Virtual Setup
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tool was “unaccused.” (RPBr. at 21; RRBr. at 11.). That argument is unavailing.
Based upon the list of “Defined Terms” and arguments included in Align’s Pre-Hearing
Brief, 3Shape was well aware when the Accused Product Stipulation was filed on October 31,
2019, that Align interpreted the Virtual Setup tool to be part of the “Ortho System” software. As
such, 3Shape had the opportunity to clarify or disclaim “Virtual Setup” from consideration as an
accused product. However, 3Shape failed to do so. 3Shape failed to support its claim with any
detailed contentions explaining why Virtual Setup is not an accused product. Align interpreted
the accused “Ortho System” software to include the “Virtual Setup” tool in its Pre-Hearing and
Post-Hearing briefs. 3Shape did not advance any detailed arguments to the contrary aside from
merely characterizing the tool as “unaccused. Since Align and 3Shape stipulated to the “Ortho
System” being an accused product, the Virtual Setup tool is an accused product in this case.
With respect to the “lab scanner” hardware, Align included the 3Shape “lab scanner” in
the Complaint, to the extent that the “lab scanner” used the accused Dental System software.
(Compl. at ¶¶ 1, 33, 95.). More specifically, Align initially accused the Dental System software
of infringing the ’958 patent. (Id. at ¶ 1.). However, Align indicated in its Pre-Hearing Brief
that the ’958 patent was no longer being asserted in the litigation. (CPBr. at 1.). Moreover,
Align did not include the “lab scanner” or the Dental System software in the list of Accused
Products in its Pre-Hearing Brief or Post-Hearing Brief. (CPBr. at ix; CBr. at ix.). 3Shape has
consistently described the “lab scanner” as “unaccused.” (Resp. at 7; RPBr. at 2, 9; RRBr. at 2.).
Therefore, the “lab scanner” is not an accused product in this case.
The Dental System software (“Dental Desktop”), while not an accused product in this
case, is accused only to the extent that it includes the Patient Monitoring (“TPM”) software.
Align accused TPM of infringing the ’641 and ’647 patents. (CPBr. at 9.). Indeed, both Align
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and 3Shape stipulated that TPM is an accused product. (Accused Product Stipulation at ¶ 1.).
However, Align also argued that “TPM source code 	.” (See
CBr. at 13 (Footnote 11) and 25.). 3Shape seemed to acknowledge the argument advanced by
Align, but 3Shape denied the validity the argument. (RRBr. at 22.). Further, neither Align nor
3Shape associated the Dental Desktop software separately or individually with their respective
definitions of the term “Accused Products” used in their Pre-Hearing, Post-Hearing, or Post-
Hearing Reply Briefs. As such, Dental Desktop is not wholly an accused product in this case,
except to the extent that it incorporates the accused TPM software.
Therefore, the full array of Accused Products in this case includes TRIOS 3 scanners,
TRIOS 4 scanners, TRIM software, TPM software, and Ortho System software which includes
CMS and Virtual Setup.
B. 	Align’s Domestic Industry Products
Align relied upon the following Domestic Industry (“DI”) Products: iTero, iTero with
Outcome Simulator with Progress Assessment, iTero with TimeLapse, iTero with Eraser, and
Align’s Invisalign System (including Treat). (See, e.g., CBr. at ix.).
1. 	iTero with Progress Assessment, iTero with TimeLapse, and
Invisalign with Treat
Align’s iTero intraoral scanning system comes with two (2) features, one is called
Progress Assessment and one is called TimeLapse. (See CX-2125C (Badler Expert Rpt.) at ¶¶
129-144.).10
10 When he testified during the Hearing on October 25, 2019, Dr. Norman Badler was a Professor at the
University of Pennsylvania in the Department of Computer and Information Science. (CPSt. at Ex. 1.).
Align identified Dr. Badler as an expert to testify with respect to the technical background of the ’192
patent, the ’647 patent, the ’661 patent; the interpretation of claims in those patents; the design,
manufacture, structure, function, and operation of the Accused Products and any article or method
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Align argued that: (i) its iTero system with Progress Assessment and Invisalign Treat
practice claims 1 and 18 of the ’647 patent; while (ii) its iTero system with TimeLapse practices
claims 2 and 20 of the ’661 patent. (CPBr. at 7; CBr. at 28-37.). Progress Assessment (a feature
of Outcome Simulator) and TimeLapse are software tools for the iTero Element Intraoral
scanner, and Treat is the software for the Invisalign System. (See, e.g., CPBr. at 7.).
With Progress Assessment in Figure 2, below, a practitioner can track the progress of an
Invisalign treatment plan by comparing a patient’s current dentition to the treatment plan and
seeing color-coded changes in movement as compared to the plan. (See, e.g., CX-1839; CX-
1798C; CX-1801C; CX-1237C; CX-1789C.). With TimeLapse in Figure 3, below, a practitioner
can compare historical scans to a current scan to see changes in tooth wear, tooth movement and
changes in gingiva over time. (See, e.g., CX-1967C; CX-1956C; CX-1582C.).
asserted to be protected by the Asserted Patents. Additionally, Dr. Badler was identified as a person of
ordinary skill in the who was called to testify to the scope of the prior art and issues in connection with
infringement, validity, enforceability and/or the technical prong of the domestic industry requirement.
(Id. at 3.).
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Figure 2: iTero Progress Assessment
(CX-1789C.0005.).
Figure 3: iTero TimeLapse
(CX-1967C.0050.).
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Invisalign’s Treat feature also tracks the progress of an Invisalign treatment plan by
comparing a patient’s current dentition to the treatment plan and by comparing changes in the
movement as compared to the plan. (CX-1784C; CX-1789C.).
2. 	iTero Element Scanner
The iTero Element family, depicted below in Figure 4, consists of the iTero Element,
iTero Element 2, iTero Element Flex, and iTero Element 5D.11 Each member of the iTero
family generates color three-dimensional models of the dentition that may be used in conjunction
with the production of dental devices (e.g., aligners, braces, appliances, etc.) and accessories.
(Id.). 3Shape did not dispute that the iTero Element is representative product for purposes of this
investigation. (Tr. (Robert Louis Stevenson)12 at 946:10-950:6; CX-0311; CX-1853.0003
(depicting stand and monitor differences for Element and Element 2, and Flex as the portable
version); CDX-0014C.0058.). Align uses and sells the iTero in the United States. (Tr. (Zelko
Relic)13 at 211:14-20, 356:18-357:15.).
11 Align represented that Element 5D is currently sold outside the United States but that Align is in the
process of obtaining Food and Drug Administration (“FDA”) approval for sale in the United States. (CX-
2274C (Saphier Dep. Tr. (May 30, 2019)) at 14:25-15:3.).
12 When he testified during the Hearing on October 28-29, 31, 2019, Dr Robert Louis Stevenson was the
Associate Chair, Director of the Undergraduate Studies Department of Electrical Engineering at
University of Notre Dame, as well as a Professor in the Department of Electrical Engineering at the
University of Notre Dame. (CPSt. at Ex. 3.). Align identified Dr. Stevenson as an expert to testify with
respect to the technical background of the ’538 patent; the interpretation of the asserted claims in the
Asserted Patents; the design, manufacture, structure, function, and operation of the Accused Products and
any article or method asserted to be protected by the Asserted Patents. Align identified Dr. Stevenson as
a person of ordinary skill in the art who Align called to testify with respect to the scope of the prior art,
and to issues related to infringement, validity, enforceability and/or the technical prong of the domestic
industry requirement; and any other technical matters at issue. (Id. at 11-12.).
13 When he testified during the Hearing on October 28, 2019, Mr. Zelko Relic was Align’s Chief
Technology Officer (“CTO”) and senior vice president of global research and development. (Tr. (Relic)
at 194:23-195:1.). Align identified Mr. Relic as a fact witness to testify on Align’s background and
business and Align’s interactions with 3Shape. Mr. Relic was also called to provide rebuttal to 3Shape’s
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The iTero includes a
.
(Tr. (Stevenson) at 947:10-950:6; Tr. (Ofer Saphier)14 at 256:5-257:20, 258:14-22, 260:1-16;
CDX-0014C.0061.). The
. (Tr. (Stevenson) at 948:5-12; Tr. (Saphier) at 265:18-266:25,
269:24-270:15; CDX-0014C.0062.). To calculate depth, the iTero
. (Tr. (Stevenson) at
948:13-951:2; Tr. (Saphier) at 259:14-19; CDX-0014C.0063-64.). The encoder in the iTero
provides the
. (Tr. (Stevenson) at 950:20-951:21; Tr. (Saphier) at
260:17-261:6, 260:24-270:15; CX-1238C.0020.).
The
. (Tr. (Saphier) at 270:16-272:19; Tr. (Stevenson) at 948:5-951:24.). To calculate color
for each point in the surface topology, the iTero
. (Tr. (Stevenson) at 949:3-952:11; Tr. (Saphier) at 270:16-
25; CDX-0014C.0063, .0065.).
The 	. (Tr. (Stevenson) at 952:12-23; CDX-
equitable defenses, Align’s domestic industry in the Asserted Patents. He was called to testify to the
non-obviousness of Align’s iTero Element, Invisalign System, and its digital ecosystem. Finally, Mr.
Relic was called to testify on remedy and bond and related issues. (CPSt. at 10.).
14 When Mr. Ofer Saphier provided his deposition and hearing testimonies on May 30, 2019 and October
24, 2019, respectively, he was an employee of Align Technology, Inc. (Tr. (Saphier) at 254:24-25; CX-
2274C (Saphier Dep. Tr. (May 30, 2019)) at 16:5-8.).
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0014C.0066.). The
. (Tr. (Stevenson) at 952:24-953:10; CDX-0014C.0067.).
Figure 4: iTero Product Family
3. 	iTero Eraser
Align’s Eraser tool is error-correction software. It allows the user to “correct” the initial
scan of the patient’s teeth by removing unwanted “artifacts” (i.e. saliva, debris, collapsed
gingiva, or margin line) which appear in the scan. (CX-2125C (Badler Expert Rpt.) at ¶ 805.).
After the virtual model from the scan has been created, the user reviews the scan for accuracy.
(Id. at ¶ 807.). If the user notices any unwanted detail included by the scan in the initial model,
the user can select the area of that detail in the initial model. (Id. at ¶¶ 805-807.). After the area
with the undesired detail has been marked by the user, another scan of the patient’s teeth is
conducted in order to produce a second model. (Id.). In the second model, the selected defective
areas in the initial model are then filled in with hopefully more accurate information from the
second scan. (Id.).
This error correction process is iterative and can be repeated until the user is satisfied
with the final model. (Id. at ¶ 806.). Such correction provides an enhanced model more accurate
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than the model produced by the initial scan. (Id. at ¶ 796.).
VI. 	PERSON OF ORDINARY SKILL IN THE ART15
A. 	Definition of a Person of Ordinary Skill in the Art
The Parties stipulated to the following definitions of a personal of ordinary skill in the art.
(Doc. ID No. 692583 (Joint POSITA Stipulation) (Oct. 29, 2019).).
For the ’647, ’661, and ’192 patents, the Parties agreed that a personal of ordinary skill in
the art “would have had at least a bachelor's degree in electrical engineering, computer science,
applied mathematics, or an equivalent field, as well as at least one or two years of industry
experience in three-dimensional modeling, or at least five years of comparable industry
experience in three-dimensional modeling, or an equivalent combination of academic study and
work experience.” (Id.).
For the ’538 patent, the Parties agreed that a person of ordinary skill in the art “would
have (1) at least a bachelor’s degree in electrical engineering, computer science, applied
mathematics, or an equivalent field, as well as at least one or two years of industry experience in
optical scanning, (2) at least five years of comparable industry experience in optical scanning, or
(3) an equivalent combination of academic study and work experience.” (Id.).
VII. 	U.S. PATENT NO. 7,077,647
A. 	Infringement
1. 	Infringement Overview
Align accused 3Shape of directly infringing claims 1 and 18 of the ’647 patent, both
literally and under the doctrine of equivalents (“DOE”). (CPBr. at 27-37; CBr. at 9-25.). Align
15 The legal standard for the level of ordinary skill in the art can be found in the Markman Order. (See
Markman Order at 19-20.).
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also accused 3Shape of indirectly infringing claims 1 and 18 of the ’647 patent by inducing
infringement and contributing to the infringement of these asserted claims.

Specifically, Align asserted that 3Shape’s TRIOS intraoral scanner with TPM" and
Ortho System software including Virtual Setup and CMS"’ practice claims 1 and 18 of the ’648
patent. (CPBr. at 9; CBr. at 9, 25.).

As shown in Table No. 5 below, the elements recited in claim 1 drawn to a “method for
determining progress of a dental treatment” are almost identical to the elements recited in claim
18, which are drawn to a “computer readable medium containing code for matching computer
models of dental objects to determine progress of a dental treatment.” Thus, the claim elements

are addressed together in Section VII.A.3. below (e.g., elements [1.1] / [18.1], [1.2] / [18.2],

etc.).
Table No. 5: Comparison of Claims 1 and 18 of the ’647 Patent
Cl. 1 Element Cl. 18 Element
[1.1] | A method for determining progress [18.1] | A computer readable medium
of a dental treatment, the method containing code for matching
comprising: computer models of dental objects

to determine progress of a dental
treatment, the computer readable
medium comprising instructions to:

[1.2] | providing an initial digital model of | [18.2] | receive an initial digital model of a

a set of dental objects; set of dental objects;
[1.3] | determining planned positions for [18.3] | determine planned positions for a
the set of dental objects; [sic] the set of dental objects;

16 TPM is an acronym and stands for 3Shape’s TRIOS Patent Monitoring software.
17 CMS is an acronym and stands for the Compare Model Sets tool offered by 3Shape’s Ortho System

software. (See, e.g., CX-0827C.0123-.0127.). Virtual Setup is also a tool offered by 3Shape’s Ortho
System software. (/d. at .0128-.0132.).

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Cl. 1 Element Cl. 18 Element

[1.4] | providing a subsequent digital [18.4] | receive a subsequent digital model
model of the set of dental objects in of the set of dental objects, wherein
their moved positions after at least at least some of the dental objects
some of them have been moved by have new positions in the
the dental treatment; subsequent model, relative to their

positions in the initial model;

[1.5] | individually matching each of the [18.5] | individually match each of the
dental objects in the subsequent dental objects in the subsequent
digital model with a dental object in digital model with a dental object in
the initial digital model to determine the initial digital model to determine
corresponding dental objects, the corresponding dental objects,
matching comprising; including instructions to;

[1.6] | identifying one or more reference [18.6] | identify one or more reference
points on each set of corresponding points on each set of corresponding
dental objects in the initial and dental objects in the initial and
subsequent digital models: subsequent digital models;

[1.7] | approximately matching each set of | [18.7] | approximately match each set of
corresponding dental objects by corresponding dental objects by
approximately aligning approximately aligning
corresponding reference points on corresponding reference points on
corresponding dental objects; corresponding dental objects;

[1.8] | and matching each set of [18.8] | and match each set of corresponding
corresponding dental objects more dental objects more closely by
closely by iteratively minimizing iteratively minimizing error between
error between corresponding corresponding reference points on
reference points on corresponding corresponding dental objects;
dental objects;

[1.9] | matching the subsequent digital [18.9] | match the subsequent digital model
model as a whole with the initial with the initial digital model;
digital model;

[1.10] | and calculating one or more [18.10] | and calculate one or more positional

positional differences between the
moved and planned positions of at
least some of the corresponding
dental objects.

differences between the moved and
planned positions of the
corresponding dental objects.

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For the reasons discussed in Section VII.A.3 below, Align has met its burden and proven
by a preponderance of evidence that the 647 Accused Products practice claims 1 and 18.
2. 	Direct Infringement: Legal Standards
a) 	Literal Infringement
“Determination of infringement is a two-step process which consists of determining the
scope of the asserted claim (claim construction) and then comparing the accused product . . . to
the claim as construed.” Certain Sucralose, Sweeteners Containing Sucralose, and Related
Intermediate Compounds Thereof, Inv. No. 337-TA-604, Comm’n Opinion at 36 (U.S.I.T.C.,
April 28, 2009) (citing Litton Sys., Inc. v. Honeywell, Inc., 140 F.3d 1449, 1454 (Fed. Cir.
1998)).
An accused device literally infringes a patent claim if it contains each limitation recited in
the claim exactly. Litton, 140 F.3d at 1454. Each patent claim element or limitation is
considered material and essential. London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538
(Fed. Cir. 1991). In a Section 337 investigation, the complainant bears the burden of proving
infringement of the asserted patent claims by a preponderance of the evidence. Enercon GmbH
v. Int’l Trade Comm’n, 151 F.3d 1376, 1384 (Fed. Cir. 1998). If any claim limitation is absent,
there is no literal infringement of that claim as a matter of law. Bayer AG v. Elan Pharm.
Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000).
b) 	Infringement Under Doctrine of Equivalents
Where literal infringement is not found, infringement can still be found under the
doctrine of equivalents. The Supreme Court has described the essential inquiry of the doctrine of
equivalents analysis in terms of whether the accused product or process contains elements
identical or equivalent to each claimed element of the patented invention. Warner-Jenkinson
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Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 40 (1997). According to the Federal
Circuit:
Infringement under the doctrine of equivalents may be found when the accused
device contains an “insubstantial” change from the claimed invention. 	Whether
equivalency exists may be determined based on the “insubstantial differences” test
or based on the “triple identity” test, namely, whether the element of the accused
device “performs substantially the same function in substantially the same way to
obtain the same result.” The essential inquiry is whether “the accused products or
process contain elements identical or equivalent to each claimed element of the
patented invention[.]”
TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1376-77 (Fed. Cir. 2008)
(citations omitted).
3. 	The 647 Accused Products Practice Claims 1 and 18 of the ’647 Patent
a) 	Claims 1 and 18
i. 	[1.1] / [18.1]: “A method for determining progress of a dental
treatment, the method comprising” / “A computer readable
medium containing code for matching computer models of
dental objects to determine progress of a dental treatment, the
computer readable medium comprising instructions to”18
Align’s expert, Dr. Badler, testified that the accused TPM is used to track an orthodontic
treatment to see if a patient is on track with the treatment plan. (Tr. (Badler) at 381:14-24,
385:9-386:1; CX-0923.0003; CX-2125C (Badler Expert Rpt.) at ¶¶ 149-53; CDX-0011C.0010.).
3Shape’s witness, Dr. Rune Fisker,19 testified during the Hearing that a user of TPM can create a
digital orthodontic treatment plan using a scan of the patient’s mouth and compare that treatment
18 The Parties agreed that the terms “dental object / dental objects” mean “tooth” / “teeth,” respectively.
(Markman Order, App. A. at 42.).
19 When he testified during the Hearing on October 28, 2019, Dr. Rune Fisker was the Senior Vice
President of 3Shape A/S. (Tr. (Fisker) at 637:17-18, 637:25:638:3.). 3Shape identified Dr. Fisker as a
fact witness to testify about 3Shape’s interactions with Align, the market for intraoral scanners and
3Shape’s design and development of its Trios intraoral scanners, and 3Shape’s Patient Monitoring
software. (RPSt. at 2.).
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plan to a current scan to make any necessary adjustments to the plan if the patient is off track.
Q. Now, a user of 3Shape’s Patient Monitoring can obtain a digital treatment plan
using an initial digital set-up and compare that to actual scans of a patient’s
dentition using a DCM or STL file importation process. That’s correct, isn’t it, sir?
A. Yes.
Q. And if the patient is not on track with regard to an intended treatment plan, a
user can make adjustments to the treatment plan to put them back on track using
Patient Monitoring. That’s correct, isn’t it, sir?
A. In theory, yes.
(Tr. (Fisker) at 661:2-20, 688:6-689:5.).
Evidence adduced in this Investigation indicates that 3Shape either loads the software on
the TRIOS Intraoral scanner hardware or transmits the software to users to load onto the
hardware. (Tr. (Badler) at 410:25-411:24; CX-0923.0003, .0032.). Thus, TPM comprises
instructions and code stored on a computer. Moreover, 3Shape’s resellers confirmed that they
sell and use TPM in the United States. (CX-0025 (Charlie Mozeko Decl.);20 CX-0026 (Richard
Lake Decl.).).21 Therefore, there is a computer readable medium in the United States with
accused instructions for TPM.
3Shape argued that Mr. Mozeko’s and Mr. Lake’s “declarations should be given little to
no weight because the declarants lack sufficient knowledge and expertise on the Asserted Patents
20 Mr. Charlie Mozeko, the Products Manager for Great Lakes Dental Technologies, Ltd. (“Great Lakes”),
provided a declaration at Align’s request. (CX-0025 (Mozeko Decl.) at ¶ 1.). Based on his personal
knowledge, Mr. Mozeko affirmed that “Great Lakes offers more than 4,000 products and services,
including products developed and manufactured by 3Shape[.]” (Id. at ¶ 4.).
21 Mr. Richard Lake, the Senior Cateory manager of Patterson Dental Holdings, Inc. (“Patterson”),
provided a declaration at Align’s request. (CX-0026 (Lake Decl.) at ¶ 1.). Mr. Lake averred that he is
“responsible for overseeing Patterson’ marketing efforts in connection with a portfolio of products that
include 3Shape products[.]” (Id.). He also affirmed that based on his personal knowledge, “Patterson
through its wholly-owned subsidiary Patterson Dental Supply Inc is a reseller of 3Shape products in the
United States.” (Id. at ¶ 3.).
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and Accused Products.” (RRBr. at 8.). Specifically, 3Shape based this argument, inter alia, on
the fact that Mr. Lake and Mr. Mozeko did not personally prepare the declarations and they
relied on others to provide information regarding 3Shape’s products. (Id. (citations omitted).).
3Shape’s contention is unavailing. Both declarants testified that although they did not draft the
declarations, they reviewed the declarations, and confirmed with the assistance of knowledgeable
people that the information contained in the declarations were true.
Q. And it’s probably fair to say that you personally did not draft this Declaration;
is that right?
A. I did not draft the Declaration.
Q. Does that affect the truth of the information that you attested to based on your
personal knowledge?
A. I would say that I didn’t draft the Declaration, but I reviewed the Declaration
and I was satisfied in signing it.
Q. Satisfied that the information inside of the Declaration is true?
A. Correct.
(RX-2420C (Lake Dep. Tr.) at 15:9-21.).
Q. 	Mr. Mozeko, counsel asked you about the fact that you had not personally
drafted the declaration. Do you recall that?
A. Yes.
Q. You did take the opportunity to verify the information in the declaration and to
make sure that it was all accurate from your perspective before you signed and
submitted it; right?
A. 	I verified that part with some of our technical people and they indicated that
was correct.
Q. And you mentioned technical support people. They are people who you trust
with having knowledge --
A. Yes.
Q. -- to provide those types of statements. Fair enough, sir?
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A. Yes.
(Tr. (Mozeko) at 764:2-17.).
Accordingly, for the reasons discussed above, Align has proven by a preponderance of
evidence that the 647 Accused Products meet preambles [1.1] and [18.1] of claims 1 and 18,
respectively, of the ’647 patent.
ii. 	[1.2] / [18.2]: “providing an initial digital model of a set of
dental objects” / “receive an initial digital model of a set of
dental objects”; [1.3] / [18.3]: “determining planned positions
for the set of dental objects” / “determine planned positions
for a [sic] the set of dental objects”22
3Shape’s witnesses and resellers acknowledged during the Hearing that TPM provides
the claimed initial digital model of a set of teeth. (Tr. (Fisker) at 649:18-23, 652:18-653:25,
660:22-661:20; Tr. (Alen Bogdanic)23 at 818:22-819:3, 822:9-823:19; Tr. (John Mellor)24 at
1745:17-20, 1749:10-1750:1.). Documentary evidence and testimony elicited during the Hearing
together confirm that TPM loads TRIOS scans and treatment plans from Virtual Setup through
Dental Desktop in the form of both STL and DCM files that provide models of a treatment plan
22 The Parties agreed that the terms “dental object” and “dental objects” mean “tooth” and “teeth,”
respectively. (Markman Order, App. A at 42.). The Parties also agreed that the term “planned positions”
means “target positions.” (Id.).
23 When he testified during the Hearing on October 28, 2019, Mr. Alen Bogdanic was an employee of
3Shape A/S and held the position of project manager of the TPM product. (Tr. (Bogdanic) at 809:22-
810:6.). 3Shape identified Mr. Bogdanic as a fact witness to testify about 3Shape’s design and
development of its Patient Monitoring software and the structure, function, and operation of that software.
(RPSt. at 3.).
24 When he testified during the Hearing on October 31, 2019, Dr. John P. Mellor, Ph.D. was the
Department Head of Computer Science and Software Engineering at the Rose-Hulman Institute of
Technology. (RPSt. at Ex. C.). 3Shape identified Dr. Mellor as an expert to testify about 3Shape’s non-
infringement of the asserted claims of the ’647 and ’661 patents and the technical prong with respect to
those patents. (Id. at 5.).
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or target positions for comparison.25 (Tr. (Badler) at 386:2-387:2, 388:2-389:16; see also CX-
0772C; CX-0906C.0001; CX-0908C.0001; CX-0915C.0001; CX-0923.0001-.0005; CX-2220C
(Fisker Dep. Tr.) at 40:11-41:1, 46:18-47:5, 51:15-24, 80:2-81:2, 83:7-22, 102:2-8, 116:1-8,
122:9-16, 139:11-24, 143:20-144:17; CX-2229C (Bardur Isleifsson Dep. Tr.)26 at 28:19-22,
31:14-20; CX-2233C (Marat Khaitov Dep. Tr.)27 at 45:4-47:19, 50:1-6.).
The described functionality for loading a single model is also confirmed in the source
code in 	. (Tr. (Badler) at 388:19-24; CPX-0208C;
CX-2229C (Isleifsson Dep. Tr.) at 24:3-29:17, 54:1-12.). The evidence also indicates that a user
of TPM has imported a “Virtual Setup” file into TPM for comparison. (See CX-0026 (Lake
Decl.) at ¶ 3(i), (iii).). 3Shape’s expert, Dr. Mellor, conceded that he no longer offered the
opinion that TPM is not configured to load virtual models created by the Virtual Setup tool in
Ortho System. (Tr. (Mellor) at 1747:23-1750:14.).
Dr. Badler explained that TPM then determines planned or target positions from the
treatment plan as shown in the source code in 	, which confirms loading the
25 Dr. Badler explained that an STL file is “a common format for exchanging 3-D models[.]” (Tr.
(Badler) at 388:2-6; see also CX-2220C (Fisker Dep. Tr.) at 47:23-24 (“Q. STL files . . . contain 3D
mesh data, right? A. Yes.”).). It is referred to “stereolithographic format” or “simple triangle list.” (Id.).
3Shape’s fact witness, Dr. Fisker, confirmed that DCM files also “contain 3D mesh data.” (CX-2220C
(Fisker Dep. Tr.) at 47:14-15.).
26 When he provided his deposition testimony on June 12, 2019, Mr. Bardur Isleifsson was an employee
of 3Shape A/S and held the position of a software developer. (CX-2229C (Isleifsson Dep. Tr.) at 8:15-
9:3.). Mr. Isleifsson confirmed that Alen Bogdanic was his project manager. (Id. at 9:23-24.). His job
responsibilities included writing software for TPM, reviewing software, and writing specifications. (Id. at
9:7-12.).
27 When he provided his deposition testimony on June 13, 2019, Mr. Marat Khaitov was an employee of
3Shape A/S and 3Shape Ukraine. (CX-2233C (Khaitov Dep. Tr.) at 9:14-16.). Specifically, Mr. Khaitov
was the software architect for the Ortho System. (Id. at 9:21-22.). His job responsibilities included, inter
alia, “maintaining software specifications” and “[d]ecisions on technologies used by [the] Ortho System.”
(Id. at 9:23-10:4.).
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models from an active patient. (Tr. (Badler) at 389:12-392:15; CPX-0127C.). He testified that
once loaded, the TPM source code at 	loads the models, and the upper and lower
jaws are identified, linked, and ordered. (Tr. (Badler) at 389:12-392:15; Tr. (Mellor) at 1706:21-
1707:9; CPX-0202C.).
Dr. Badler also testified that following this initial processing, the code performs
segmentation of individual teeth. (Tr. (Badler) at 389:12-392:15; CDX-0011C.0022; CPX-
0044C; CX-0923.0006-.0009; CX-2229C (Isleifsson Dep. Tr.) at 55:25-56:18.). He explained
that segmentation of the model enables the software to identify and compare each tooth
individually. (Tr. (Badler) at 389:17-391:24, 817:1-8; CX-0923.0006-.0009; CX-2220C (Fisker
Dep. Tr.) at 67:15-68:3; CX-2229C (Isleifsson Dep. Tr.) at 55:4-56:18.). 3Shape’s expert, Dr.
Mellor, testified that TPM’s segmentation establishes individual teeth so “you know what tooth
you are talking about.” (Tr. (Mellor) at 1706:1-13.). Moreover, 3Shape’s software
specifications demonstrate that
that are then used in subsequent
processing in TPM, e.g., an array of determined positions for teeth. (Tr. (Badler) at 390:17-
391:21; Tr. (Mellor) at 1752:2-1753:13; CX-0887C.0008-.0014; CX-0912C.0008-.0014; see also
CX-2229C (Isleifsson Dep. Tr.) at 56:6-18, 59:7-23.).
Dr. Mellor appears to have misunderstood Dr. Badler’s testimony with respect to the
claimed “providing an initial digital model” and “determining planned positions” elements.
During the Hearing, Dr. Mellor characterized Dr. Badler’s infringement theory as “alleging that
loading a model with teeth in planned position and then determining tooth number via
segmentation meets those two limitations.” (Tr. (Mellor) at 1702:16-19 (emphasis added).).
Based on that understanding, Dr. Mellor opined that “[i]f you load an initial model and the teeth
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are in planned position, they can’t be in planned positions because the next claim element
requires determining planned positions from the teeth that you just loaded in the initial model. If
they were in planned positions, then there wouldn’t be anything to do for that second step.”
(Id. at 1702:20-1703:1 (emphases added).).
Dr. Mellor’s testimony is not an accurate characterization of Dr. Badler’s testimony. Dr.
Badler did not testify that the teeth in the “initial digital model” created by the 647 Accused
Products are already in the planned or target positions. Rather, he explained that Patient
Monitoring (TPM) loads a virtual model, i.e., initial digital model, created in the Ortho
Analyzer’s virtual setup tool.
Q. All right. So now moving to claim element 1.2. Have you formed an opinion
as to whether claim element 1.2 is satisfied by Patient Monitoring?
A. Yes, the parties agree that dental objects can be construed as teeth, and I will
often use that construction. So the very first step in the exemplary embodiment is
illustrated in the flowchart from [Fig.3 of] the patent, is, in fact, met by Patient
Monitoring, because it loads a virtual model created in Ortho Analyzer’s virtual
setup tool that I just mentioned. And therefore it provides an initial digital model
of the set of dental objects.
(Tr. (Badler) at 386:2-14.).
Dr Badler testified that the TRIOS Intraoral scanner working in conjunction with the
Ortho System provides options through Virtual Setup to simulate orthodontic treatment by
moving teeth in a patient’s TRIOS scan, thus providing target positions for the teeth and an
initial digital model or an original treatment case for comparison. (Tr. (Badler) at 383:13-23;
CX-0772C.0012-.0014; CX-0827C.0127-.0142, .0155-.0156; CX-2233C (Marat Khaitov Dep.
Tr.) at 31:23-32:1, 32:24-33:1; CX-2125C (Badler Expert Rpt.) at ¶¶ 116-122, 161-162.).
Additionally, the evidence discussed above establishes that when using Ortho System and
Virtual Setup, a user can modify an initial digital model from a patient before treatment to create
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and simulate the planned or target positions and then load the initial digital model file with the
target positions into TPM for comparison. (See, e.g., supra; see also Tr. (Badler) at 383:13-23;
Tr. (Fisker) at 661:2-20; Tr. (Bogdanic) at 822:9-823:15; (Tr. (Mellor) at 1746:15-1747:21,
1749:10-1750:1; CX-0827C.0127-.0142; CX-2125C (Badler Expert Rpt.) at ¶¶ 116-22, 161-62.).
Evidence presented during the Hearing also demonstrates that 3Shape’s resellers perform exactly
these steps and load Virtual Setup files into TPM. (CX-0026 (Lake Decl.) at ¶ 3(i)-(j); CX-
2040C.). Accordingly, the 647 Accused Products literally meet these claim elements.
Dr. Badler testified that if the 647 Accused Products do not literally satisfy these
limitations, they do under the doctrine of equivalents because any differences between the claim
elements and TPM are insubstantial. (Tr. (Badler) at 386:2-387:2, 389:12-392:9.). However, as
3Shape pointed out, Dr. Badler did not address the prosecution history of the ’647 patent.
(RRBr. at 13 (citing JX-0005.0112, .0116-.0018).). During prosecution, the applicant amended
at least claim 1 to include “determining planned positions for the set of dental objects” (JX-
0005.0112), which was a narrowing amendment. With respect to such instances, the Federal
Circuit explained that:
A narrowing amendment made for a substantial reason relating to patentability
gives rise to a presumption that the patentee has surrendered all subject matter
between the original claim limitation and the amended claim limitation. 	If the
narrowing amendment was the addition of a new claim limitation, as in the case
before us, equivalents are presumptively not available with respect to that
limitation.
A patentee may rebut the presumption of surrender by showing that at the time of
the amendment one skilled in the art could not reasonably be expected to have
drafted a claim that would have literally encompassed the alleged equivalent. The
Supreme Court identified three ways in which the patentee may overcome the
presumption. The patentee may show that the alleged equivalent would have been
unforeseeable at the time of the amendment, that the rationale underlying the
amendment bore no more than a tangential relation to the equivalent in question, or
that there was “some other reason” that the patentee could not reasonably have been
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expected to have described the alleged equivalent.
Biagro W. Sales, Inc. v. GrowMore, Inc., 423 F.3d 1296, 1305 (Fed. Cir. 2005) (emphases
added) (citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 741 (2002);
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359 (Fed. Cir. 2003) (en
banc); Honeywell Int’l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1141 (Fed. Cir. 2004).
Because Align failed to rebut the presumption raised by the narrowing amendment by
any of the means the Supreme Court and the Federal Circuit identified, Align has not shown that
the 647 Accused Products meet these claim elements under DOE.
Nevertheless, Align has proven by a preponderance of evidence that the 647 Accused
Products literally practice elements [1.2] / [18.2] and [1.3] / [18.3] of claims 1 and 18,
respectively, of the ’647 patent.
iii. 	[1.4] / [18.4]: “providing a subsequent digital model of the set
of dental objects in their moved positions after at least some of
them have been moved by the dental treatment” / “receive a
subsequent digital model of the set of dental objects, wherein
at least some of the dental objects have new positions in the
subsequent model, relative to their positions in the initial
model”
Align presented evidence that demonstrates that TPM provides a subsequent digital
model of the set of teeth in their positions moved by dental treatment because it can compare the
scan of a current visit with a previously created treatment plan. (Tr. (Badler) at 392:16-393:24;
CX-0923.0003, .0011, .0017; CX-2125C (Badler Expert Rpt.) at ¶¶ 166-71.). The source code in
, confirms this functionality for loading a single
model. (Tr. (Badler) at 392:16-393:24; CPX-0208C; CX-2229C (Isleifsson Dep. Tr.) at 24:3-
29:17, 54:1-12.). As Dr. Badler explained, tracking an orthodontic treatment requires providing
or loading a model taken at a later time, when the patient’s teeth are at a different position. (Tr.
(Badler) at 392:16-393:24; CX-0923.0003.). Thus, TPM presents a visual representation of the
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changes between a plan and a scan taken at a subsequent visit, showing changes in tooth
movement. (See CX-2220C (Fisker Dep. Tr.) at 39:25-41:1, 46:18-48:24.).
3Shape appears to have conceded that TPM meets these claim elements because Dr.
Mellor did not address these limitations during the Hearing. (See Tr. (Mellor) at 1701:10-
1704:25; see also RRBr. at 13.).
For the reasons discussed above, Align has proven by a preponderance of evidence that
the 647 Accused Products practice elements [1.4] and [18.4] of claims 1 and 18, respectively, of
the ’647 patent.
iv. 	[1.5] / [18.5]: “individually matching each of the dental
objects in the subsequent digital model with a dental object in
the initial digital model to determine corresponding dental
objects, the matching comprising” / “individually match each
of the dental objects in the subsequent digital model with a
dental object in the initial digital model to determine
corresponding dental objects, including instructions to”28
Evidence adduced in this Investigation establishes that TPM “individually match[es]”
under the adopted construction. TPM first segments the model into individual teeth models as
discussed above with respect to claim elements [1.3] /[18.3]. (See Section VII.A.3.ii, supra.).
Subsequently, TPM individually matches tooth-by-tooth, through the execution of the three
claimed sub-steps by the Automatic Alignment process, to determine for each tooth the relative
position of a tooth in one model to the corresponding tooth in the other model using reference
points. (Tr. (Badler) at 394:4-395:22; CX-2125C (Badler Expert Rpt.) at ¶¶ 172-79; see also
CX-0887C.0014; CX-0912C.0014.).
28 The terms “individually matching / match each of the dental objects” were construed to mean “for each
of the teeth in the subsequent digital model, using the identified reference points to determine the position
of a tooth in the subsequent digital model relative to the corresponding tooth in the initial digital model.”
(Markman Order, App. A at 19.).
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Specifically, Dr. Badler explained that as an initial step in the TPM workflow,
segmentation is used to identify the teeth of each model. (Tr. (Badler) at 389:12-392:15; CX-
0887C.0011; CX-0923.0006-.0009.). Dr. Badler testified that performing segmentation enables
TPM to determine each tooth individually and to align and compare each tooth individually
going forward in the process, which was confirmed by 3Shape’s witnesses. (Tr. (Badler) at
389:12-392:15, 394:4-22; CPX-0044C; CX-0887C.0008-0014; CX-2220C (Fisker Dep. Tr.) at
67:15-68:3 (“Q. And the segmentation identifies each individual tooth in the 3D model, right?
A. It segments each tooth, yes. Q. Okay. Performing this segmentation process on each 3D
model enables Patient Monitoring to compare each tooth individually, right? A. Yes.”); CX-
2229C (Isleifsson Dep. Tr.) at 41:1-20, 55:4-56:5 (“Q. And the segmentation step identifies each
individual tooth in the 3D model, right? A. Correct. Q. Performing the segmentation process
on each 3D model enables Patient Monitoring to identify and compare each tooth individually,
right? THE WITNESS: Correct.”).).
3Shape’s non-infringement theories primarily rely upon the claim language “to determine
corresponding dental objects,” recited in claim elements [1.5] / [18.5]. Dr. Mellor opined that
TPM does not meet these elements because in TPM, “segmentation is the mechanism for
determining the correspondences between teeth,” and “does not perform the three substeps in the
process of determining correspondences.” (Tr. (Mellor) at 1706:1-13.).
However, as Align pointed out, the plain claim language of claim element [1.5] states
“individually matching . . . to determine corresponding dental objects” is “the matching,
comprising” the three following sub-steps.29 (JX-0001 at cl. 1.). Thus, by the express language,
29 Claim element [18.5] states “individually match . . . to determine corresponding dental objects,
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the “determining corresponding” teeth is accomplished through the claimed matching process, as
Dr. Badler testified. (Tr. (Badler) at 405:24-406:11, 520:5-521:18, 527:8-12.). There is no
separate “process of determining correspondences” as asserted by Dr. Mellor, because claim
elements [1.5] and [18.5] do not positively recite any “determining” step. Rather, the “to
determine corresponding” teeth language describes the intended result of the three sub-steps.
For the foregoing reasons, Align has proven by a preponderance of evidence that the 647
Accused Products practice elements [1.5] and [18.5] of claims 1 and 18, respectively, of the ’647
patent.
v. 	[1.6] / [18.6]: “identifying one or more reference points on
each set of corresponding dental objects in the initial and
subsequent digital models” / “identify one or more reference
points on each set of corresponding dental objects in the initial
and subsequent digital models”30; [1.7] / [18.7]:
“approximately matching each set of corresponding dental
objects by approximately aligning corresponding reference
points on corresponding dental objects” / “approximately
match each set of corresponding dental objects by
approximately aligning corresponding reference points on
corresponding dental objects”31
TPM default Automatic Alignment satisfies the referenced claim elements under the
adopted constructions of “reference points” and “approximately matching / match each set of
corresponding dental objects.” (See Tr. (Badler) at 395:23-400:20; CX-0923.0010-.0011; CX-
including instructions to” perform the following sub-steps. (JX-0001 at cl. 1.).
30 The term “reference points” was construed to mean “points used to determine the position of a digital
model, or part thereof, relative to another digital model, or part thereof.” (Markman Order, App. A at 22-
23.).
31 The Parties agreed that the phrases “approximately matching / match each set of corresponding dental
objects” mean “initially aligning / align each set of corresponding teeth.” (Markman Order, App. A at
42.).
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2125C (Badler Expert Rpt.) at ¶¶ 180-92.). Automatic Alignment
. The Parties’ experts agreed that TPM
. (Tr. (Badler) at 396:19-397:6; Tr. (Mellor) at 1707:18-
1709:9.). Thus, there is no dispute that TPM identifies “points used to determine the position of
a digital model or part thereof relative to another digital model or part thereof.” (See Tr.
(Bogdanic) at 817:1-818:15; CPX-0117C; CPX-0194C; CX-2229C (Isleifsson Dep. Tr.) at
72:21-75:3, 80:8-25, 75:11-76:25, 79:8-82:18, 84:15-85:18, 90:4-20, 91:14-92:23, 97:11-101:5.).
Mr. Isleifsson testified during his deposition that TPM
. (CX-2229C (Isleifsson Dep. Tr.) at 74:2-75:3.).
TPM’s project manager, Mr. Bogdanic, also confirmed that the accused product’s
. (Tr. (Bogdanic) at
817:1-818:15; see also Tr. (Fisker) at 656:11-17.). Moreover, Dr. Badler showed this
functionality in 3Shape’s source code through operation of
. (Tr. (Badler) at 399:23-400:14; CPX-0194C.). Dr. Mellor acknowledged that TPM
Automatic Alignment performs an initial alignment using
. (Tr. (Mellor) at 1756:9-1757:9.).
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Nevertheless, Dr. Mellor testified that the “identifying” reference points element is not
satisfied because “all three of the substeps use the same reference point language and [TPM
uses] different reference points.” (Tr. (Mellor) at 1707:18-1709:3, 1754:9-20.). In other words,
3Shape argued that the sub-steps require the use of the same reference points. However, no
claim construction supports 3Shape’s position and the claim language does not recite such a
requirement. As Align pointed out, there is no antecedent basis for “reference points” in the
claimed steps. (JX-0001 at 10:8-18.). Nor is there any claim language that requires the same
reference points must be used. (Id.).
Moreover, as Dr. Mellor acknowledged, the plain claim language states identifying “one
or more” reference points and does not limit the identified reference points to one set of
reference points. (Id.; Tr. (Mellor) at 1754:1-8.). Dr. Mellor also agreed that Figure 4,
describing an embodiment of the patent, illustrates a process that uses different reference points
for the approximate alignment and the iterative process. (Tr. (Mellor) at 1754:21-1755:23; JX-
0001 at 5:45-6:14, Fig. 4.). This is consistent with Dr. Badler’s testimony that it is highly
unlikely that the same reference points would be used for the sub-steps because one of ordinary
skill in the art would recognize the need for more reference points to do the alignment. (Tr.
(Badler) at 404:15-19.). Therefore, nothing prevents the same points from being used in both
steps. As Mr. Isleifsson explained, the
.32 (CX-2229C (Isleifsson Dep. Tr.) at 75:11-76:14, 80:11-81:18,
82:13-18.).
Accordingly, Align has proven by a preponderance of evidence that the 647 Accused
32 	(See, e.g., Tr. (Badler) at 401:11-15; see also CX-
2229C (Isleifsson Dep. Tr.) at 86:5-25; CDX-0011C.0034; CX-0948).).
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Products practice elements [1.6] / [18.6] and [1.7] / [18.7] of claims 1 and 18, respectively, of the
’647 patent.
vi. 	[1.8] / [18.8]: “matching each set of corresponding dental
objects more closely by iteratively minimizing error between
corresponding reference points on corresponding dental
objects” / “match each set of corresponding dental objects
more closely by iteratively minimizing error between
corresponding reference points on corresponding dental
objects”33
TPM Automatic Alignment practices these claim elements under the adopted
construction of “iteratively minimizing error.” TPM uses 3Shape’s
to more closely match each set of teeth in the two models.
(Tr. (Badler) at 400:21-404:23; CPX-0194C at line 51; CX-2229C (Isleifsson Dep. Tr.) at 75:11-
76:25, 79:8-82:18, 84:15-85:18, 86:5-25, 87:11-22, 88:14-92:4, 93:4-16, 97:11-101:5; CX-
2125C (Badler Expert Rpt.) at ¶¶ 193-98.). As Dr. Badler generally explained,
. (Tr. (Badler) at 402:5-403:23.).
to align the whole as discussed further below for claim element 1.9. (Id.).
Following the
, i.e., “reference points.” (Tr. (Badler) at 403:25-404:23; CPX-0194C at
line 51; CX-2229C (Isleifsson Dep. Tr.) at 75:11-76:25, 84:15-18, 87:5-10 (“Q.
33 The term “iteratively minimizing error” was construed to mean “repeating a process to minimize the
error until the error is less than a termination criterion or a maximum number of iterations has been
reached.” (Markman Order, App. A at 28.).
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). According to 3Shape’s corporate witness, Mr. Isleifsson, the
aligns two sets of data. (CX-2229C (Isleifsson Dep. Tr.) at 86:5-90:15.). The
first step in
. (Id.).
. (Id.).
more closely aligned corresponding teeth. (Id.). Dr. Badler confirmed this
operation in the 	source code during the Hearing, which
after the
. (Tr.
(Badler) at 403:25-404:10; CPX-0194C.). Dr. Mellor did not dispute that TPM Automatic
Alignment uses 	. (See Tr. (Mellor) at 1709:5-17, 1758:4-
1759:9.).
For the foregoing reasons, Align has proven by a preponderance of evidence that the 647
Accused Products practice elements [1.8] and [18.8] of claims 1 and 18, respectively, of the ’647
patent.
vii. 	[1.9] / [18.9]: “matching the subsequent digital model as a
whole with the initial digital model” / “match the subsequent
digital model with the initial digital model”34
TPM Automatic Alignment practices these claim elements under the adopted
construction for “determining the position of the subsequent digital model as a whole relative to
34 The phrase “matching the subsequent digital model as a whole with the initial digital model” was
construed to mean “determining the position of the subsequent digital model as a whole relative to the
initial digital model.” (Markman Order, App. A at 32.).
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the initial digital model.” (Tr. (Badler) at 406:12-408:11; CX-2125C (Badler Expert Rpt.) at
¶¶ 199-205.). As discussed above, Automatic Alignment performs
. As Dr. Badler demonstrated in the
source code during the Hearing and in his demonstrative
exhibit (CDX-0011C.0037), the separate and final step of the
.
Figure 5: Dr. Badler’s Demonstrative Showing Matching
(CDX-0011C.0037; Tr. (Badler) at 406:12-408:11; CPX-0194C at line 66.).
In this step, TPM Automatic Alignment
. (Tr. (Badler) at 406:12-408:11; CPX-0194C at line 66; see also, e.g., JX-0001 at 7:51-55
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). TPM can then match the models as a
whole because
. (Tr. (Badler) at
406:12-407:14; see also JX-0001 at Fig. 3, (208), 5:33-44.). 3Shape’s corporate representative,
Mr. Isleifsson,
. (CX-2229C (Isleifsson Dep. Tr.) at 87:1-4
; Tr (Mellor) at 1759:10-13.).
Nevertheless, Dr. Mellor contended during the Hearing that “Align is pointing to the
exact same code to satisfy this third sub-element or substep and the next claim element.” (Tr.
(Mellor) at 1709:5-1709:23.). However, Dr. Badler found that claim elements [1.8] / [18.8]
, and claim elements [1.9] / [18.9],
. (Tr. (Badler) at 400:20-404:19,
406:12-408:11, 411:3-24; CPX-0194C at lines 40-68.). 3Shape provided no contrary testimony
or evidence to disputing Dr. Badler’s testimony that TPM
. (CPX-0194C at lines 40-68.). Because claim elements
[1.8] / [18.8] only require a repeated process or steps to “more closely” match each set of teeth
models using reference points,
, is a separate step of
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determining the position of one model as a whole relative to the other.
TPM also meets these claim elements by
, as shown in the Measurements view. (See JX-0001 at
Fig. 3 (208), 5:33-44.). TPM’s Compare Scan and Measurements tool superimposes the two
models in their entirety as shown in the TPM user guide, where the primary and secondary 3D
models are overlaid and thus are placed in the same coordinate system and matched as a whole.
(CX-0923.0017-.0026.). Because the tools can be used to display and measure the differences
between two (2) scans to calculate changes in both tooth surface and movement, the evidence
presented during the Hearing demonstrates that the models must be positioned in the same
coordinate system to enable the calculations and display the differences, thereby confirming that
the whole models have been matched. (CX-2229C (Isleifsson Dep. Tr.) at 95:6-97:10 (in TPM,
models are placed in the same coordinate system for comparison following alignment
, 102:24-104:6 (
.).
For the reasons explained above, Align has proven by a preponderance of evidence that
the 647 Accused Products practice elements [1.9] and [18.9] of claims 1 and 18, respectively, of
the ’647 patent.
viii. 	[1.10] / [18.10]: “calculating one or more positional
differences between the moved and planned positions of at
least some of the corresponding dental objects” / “calculate
one or more positional differences between the moved and
planned positions of the corresponding dental objects”
As discussed above in Section VII.A.3.ii for claim elements [1.2] / [18.2] and [1.3] /
[18.3], the evidence demonstrates that TPM loads models of a treatment plan, i.e., planned or
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target positions, and a subsequent patient model of moved teeth for comparison. (See also Tr.
(Bogdanic) at 823:16-19; CX-2125 (Badler Expert Rpt.) at ¶¶ 206-13.). After a Virtual Setup
model is imported into TPM, it can be compared to the subsequent model. (Tr. (Fisker) at
688:14-23; see also CX-0881C.). For example, TPM’s Scan Comparison tool calculates
movements of teeth, as shown in the
and thus calculates positional differences between teeth in the two
models. (Tr. (Badler) at 408:13-410:19; CX-0923.0023; see also CPX-0061C; CX-0885C; CX-
0901C.0003-.0011; CX-0905C.0001-.0007; CX-0912C.0014; CX-2220C (Fisker Dep. Tr.) at
49:16-50:21; CX-2229C (Isleifsson Dep. Tr.) at 122:9-139:9; CX-2265C (Katrina Rindom Dep.
Tr.)35 at 92:18-25.). The Tooth Comparison tool measures positional differences on individual
teeth by 	.
(Tr. (Bogdanic) at 820:8-821:9; CX-0887C.0014; CX-0895C; CX-0912C.0014; CX-0920C; CX-
0923.0021-.0022; CX-2229C (Isleifsson Dep. Tr.) at 143:3-147:5.).
3Shape’s witnesses confirmed TPM’s calculation of positional differences between
corresponding teeth in the moved and planned models. Dr. Fisker testified that TPM determines
changes to individual teeth and that the comparison of two models in TPM calculates movements
in the teeth from the first model to the second model, showing that distance measure in a
difference map. (Tr. (Fisker) at 655:8-24; CX-2220C (Fisker Dep. Tr.) at 49:16-50:21, 75:8-25.)
He clarified that the distance map allows a user to calculate positional differences in millimeters.
35 When she gave her deposition testimony on May 10, 2019, Ms. Katrina Rindom held the position of
Global Academy Program Manager at 3Shape. (CX-2265C (Rindom Dep. Tr.) at 11:16-17, 12:10-11.).
As Global Academy Program Manager, Ms. Rindom’s overall responsibilities included “production of
training material packages and online training setting the didactic direction for academy.” (Id. at 12:10-
14.).
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(Tr. (Fisker) at 655:25-656:3.). Additionally, Mr. Bogdanic confirmed that TPM performs
measurements, including determining the differences in distance between a virtual model and a
current scan of a patient’s dentition and tooth movement. (Tr. (Bogdanic) at 819:4-20, 820:20-
821:9.). Mr. Bogdanic also confirmed that the Scan Comparison tool presents in millimeters the
differences between teeth in the models.
Q. And the Scan Comparison tool would show a user in millimeters the differences
between one scan and another scan and, for example, you could use that to show
the differences between teeth in an actual model and a virtual model. Fair enough?
A. Yeah. So it would show any change.
(Id. at 831:16-21.).
3Shape’s expert, Dr. Mellor, testified that TPM does not meet these claim limitations
because the Scan Comparison code
(Tr. (Mellor) at 1711:1-
19.). As an initial matter, the claim elements do not require 	.
(See JX-0001 at cls. 1, 18.). Nor does the claim language prevent a global comparison and
calculation of differences of the entire jaw, as this will necessarily include “at least some of the
corresponding” teeth. (See id.).
Moreover, Dr. Mellor’s position is not only contradicted by 3Shape’s own witnesses
(e.g., Tr. (Bogdanic) at 831:16-21), but also by documentation that explicitly states that the Scan
Comparison tool can be used to measure the difference between any two scans on a timeline,
along with changes in tooth movement (e.g., CX-0923.0023 (“The Scan comparison tool can be
used to measure the difference between any two scans on the timeline along with changes in both
tooth surface and tooth movement.”)). The Scan Comparison tool clearly allows a user to
determine the distance between two models by individual teeth, as it displays the differences by
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teeth, not just mesh with no discernible teeth. (See, e.g., CX-0923.0023.). 3Shape’s source code
corporate representative, Mr. Isleifsson, confirmed that the
. (CX-2229C (Isleifsson Dep. Tr.) at 123:6-124:13, 133:6-135:6, 138:13-
142:23.). Therefore, the calculations of positional differences are necessarily done for sets of
teeth in millimeters.
Dr. Mellor also opined that TPM is just “calculating point-to-point differences” and thus
does not meet these claim elements. (Tr. (Mellor) at 1711:7-24.). Pointing to Figures 9A and 9B
of the ’647 patent, Dr. Mellor testified that the patent discusses “shape differences” and
“positional differences” differently, and claimed “the shape difference is defined as the distance
between the sampled point on one tooth and its projection on the other tooth.” (Id. at 1713:4-17;
JX-0001 at 7:63-67.). However, Dr. Mellor selectively described only a portion of the passage
and failed to acknowledge that in the next sentence, it states that “[f]or displaying the difference
in teeth position variance[,] a color-coded model and a transparent tooth model are used in these
exemplary figures.” (JX-0001 at 8:1-3 (emphasis added); see also id. at 7:59-62.). Thus, there is
no support for Dr. Mellor’s opinion that the “shape differences” discussed in the ’647 patent for
Figures 9A and 9B are different than positional variances or differences. Like TPM, the ’647
patent discloses an embodiment calculating deviation between two models in millimeters, which
is sufficient to meet claim elements [1.10] / [18.10]. (See JX-0001 at Figs. 9A and 9B.)
Accordingly, Align has proven by a preponderance of evidence that the 647 Accused
Products practice elements [1.10] and [18.10] of claims 1 and 18, respectively, of the ’647
patent.
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B. 	Technical Prong of Domestic Industry
1. 	Legal Standard
A complainant in a patent-based Section 337 investigation must demonstrate that it is
practicing or exploiting the patents at issue. See 19 U.S.C. § 1337(a)(2) and (3); Certain
Microsphere Adhesives, Process for Making Same, and Prods. Containing Same, Including Self-
Stick Repositionable Notes, Inv. No. 337-TA-366, Comm’n Op. at 8, Pub. No. 2949 (U.S.I.T.C.
Jan. 16, 1996) (“Microsphere Adhesives”). “In order to satisfy the technical prong of the
domestic industry requirement, it is sufficient to show that the domestic industry practices any
claim of that patent, not necessarily an asserted claim of that patent.” Certain Ammonium
Octamolybdate Isomers (“Certain Isomers”), Inv. No. 337-TA-477, Comm’n Op. at 55
(U.S.I.T.C. Jan. 5, 2004).
The test for claim coverage for the purposes of the technical prong of the domestic
industry requirement is the same as that for infringement. Certain Doxorubicin and
Preparations Containing Same, Inv. No. 337-TA-300, Initial Determination at 109, 1990 WL
710463 (U.S.I.T.C. May 21, 1990), aff’d, Views of the Commission at 22 (October 31, 1990)
(“Doxorubicin”). “First, the claims of the patent are construed. Second, the complainant’s
article or process is examined to determine whether it falls within the scope of the claims.” Id.
The technical prong of the domestic industry can be satisfied either literally or under the doctrine
of equivalents. Certain Dynamic Sequential Gradient Devices and Component Parts Thereof,
Inv. No. 337-TA-335, Initial Determination at 44, Pub. No. 2575 (U.S.I.T.C. Nov. 1992).
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2. 	The 647 DI Products Practice Claims 1 and 18 of the ’647 Patent
a) 	Claims 1 and 18
i. 	[1.1] / [18.1]: “A method for determining progress of a dental
treatment, the method comprising” / “A computer readable
medium containing code for matching computer models of
dental objects to determine progress of a dental treatment, the
computer readable medium comprising instructions to”
Align’s documentation explains that a practitioner can “track progress” of a treatment by
using the Progress Assessment feature of the iTero Intraoral scanner with Outcome Simulator to
compare a patient’s current dentition with the treatment plan. (Tr. (Badler) at 415:12-416:11;
CX-1237C; CX-1782C; CX-1789C; CX-1790C; CX-1798C; CX-1800C; CX-1839.0037-.0048;
CX-2266C (Roman Roschin Dep. Tr.)36 at 27:22-28:17; CX-2125C (Badler Expert Rpt.) at
¶¶ 413-19.). The Treat software of the Invisalign System
and is intended to be used by Align technicians to create virtual treatment plans that include
using a progress tracking tool to compare progress scans and active treatment. (CX-1783C; CX-
1784C; CX-1786C; CX-1792C.). These are methods for determining progress of a dental
treatment.
For the reasons explained above, Align has proven by a preponderance of evidence that
the 647 DI Products meet preambles [1.1] and [18.1] of claims 1 and 18, respectively, of the ’647
patent.
36 When he gave his deposition testimony on July 11, 2019, Mr. Roman Roschin was the Senior Director
of software development for the Moscow branch of Align Technology. (CX-2266C (Roschin Dep. Tr. at
8:25-9:5.). His job responsibilities included “organiz[ing] the process of, . . . project execution as it
relates to implementation of the software.” (Id. at 9:9-14.). Mr. Roschin confirmed that he and his team
worked on the source code for Align’s Outcome Simulator, Treat, and Progress Assessment software
tools. (Id. at 10:11-11:2.). Align identified Mr. Roschin as a fact witness to provide testimony about the
background and business of Align, domestic industry of the Asserted Patents, and related issues. (CPSt.
at 10.).
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ii. 	[1.2] / [18.2]: “providing an initial digital model of a set of
dental objects” / “receive an initial digital model of a set of
dental objects”; [1.3] / [18.3]: “determining planned positions
for the set of dental objects” / “determine planned positions
for a [sic] the set of dental objects”
Align presented evidence that Progress Assessment and Treat can load a simulated model
of the patient’s dentition to practice “providing an initial digital model of a set of teeth.” (Tr.
(Badler) at 416:12-417:15; CX-1784C; CX-1839.0037-.0048; CX-2266C (Roschin Dep. Tr.) at
29:2-36:12; CX-2125C (Badler Expert Rpt.) at ¶¶ 420-24.). Historical files or any stage of
treatment plans, or several treatment plans, may be provided. (CX-2266C (Roschin Dep. Tr.) at
29:2-36:12.). This is shown in the source code
. (Tr. (Badler) at 416:12-24; CPX-0332C.).
. (Tr. (Badler) at 417:16-418:6; CPX-0315C;
CX-2125C (Badler Expert Rpt.) at ¶¶ 425-30; CDX-0011C.0055 (showing the code at line 33).).
The software 	. (Tr.
(Badler) at 417:20-418:11; CX-2266C (Roschin Dep. Tr.) at 36:13-38:5, 38:21-25, 40:17-43:14
( 	).).
The iTero Intraoral scanner with Outcome Simulator that includes the Progress
Assessment feature and Invisalign System including Treat also provide an initial digital model of
a set of teeth as both provide for the simulation of the movement of teeth to their final positions
and set up of a prescribed final position of a patient’s teeth. (Tr. (Badler) at 412:16-414:12; CX-
1784C; CX-1839.0037-.0048; CX-2266C:11 (Roschin Dep. Tr.) at 8-14, 23:2-11 (Progress
Assessment is a part of Outcome Simulator and 	functionality is found in Treat),
115:15-23.). In this manner, Outcome Simulator on the iTero and Treat in the Invisalign System
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also determines planned positions under 3Shape’s interpretation of the claim elements because
the features provide an alignment plan or simulated outcome for a patient that constitutes
planned or target positions for teeth that is loaded in Progress Assessment or the progress
tracking tool of Treat. (CX-1397C; CX-1784C; CX-1839.0026-.0036; CX-2266C (Roschin Dep.
Tr.) at 27:22-30:6, 107:25-110:9.).
Accordingly, Align has proven by a preponderance of evidence that the 647 DI Products
practice elements [1.2] / [18.2] and [1.3] / [18.3] of claims 1 and 18, respectively, of the ’647
patent.
iii. 	[1.4] / [18.4]: “providing a subsequent digital model of the set
of dental objects in their moved positions after at least some of
them have been moved by the dental treatment” / “receive a
subsequent digital model of the set of dental objects, wherein
at least some of the dental objects have new positions in the
subsequent model, relative to their positions in the initial
model”
Align offered testimonial and documentary evidence that Progress Assessment and Treat
provide a subsequent digital model of the set of teeth in their positions moved by the dental
treatment as they load and compare a current scan to a treatment plan. (Tr. (Badler) at 418:12-
419:12; CX-2266C (Roschin Dep. Tr.) at 28:1-29:23; CX-2125C (Badler Expert Rpt.) at ¶¶ 431-
35.). This is shown in the source code 	. (Tr. (Badler) at 418:12-419:12; CPX-
0299C.). For Progress Assessment, the user can “perform a complete scan of the patient’s
current dentition just as [was done] at the beginning of the treatment process” using the iTero
scan functionality. (CX-1839.0037.). The Invisalign System including Treat provides a new
scan or achieved positions and thus provides a subsequent digital model of the set of teeth after
at least some of them have been moved by treatment. (CX-1784C.0009.).
3Shape’s expert, Dr. Mellor, did not provide an analysis of these claim elements during
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the Hearing. (Tr. (Mellor) at 1716:10-1717:11.)
For the reasons discussed above, Align has proven by a preponderance of evidence that
the 647 DI Products practice elements [1.4] and [18.4] of claims 1 and 18, respectively, of the
’647 patent.
iv. 	[1.5] / [18.5]: “individually matching each of the dental
objects in the subsequent digital model with a dental object in
the initial digital model to determine corresponding dental
objects, the matching comprising” / “individually match each
of the dental objects in the subsequent digital model with a
dental object in the initial digital model to determine
corresponding dental objects, including instructions to”
Align elicited testimony and presented documentary/source code evidence that Progress
Assessment and Treat “individually match” to determine corresponding teeth. (Tr. (Badler) at
419:3-421:14; CX-2125C (Badler Expert Rpt.) at ¶¶ 436-42.). In the source code for Progress
Assessment and Treat,
. (CX-2266C (Roschin Dep. Tr.) at 39:24-46:11.).
. (Id.).
. (Id. at 41:23-42:9; CPX-0326C.). Subsequently, the software
. (CX-2266C (Roschin Dep. Tr.) at 42:1-20.).
, CPX-0329C), the
. (CX-2266C
(Roschin Dep. Tr.) at 40:17-42:20.). The 	. (Id. at 42:1-
43:14.).
. (Tr. (Badler) at 420:4-15; CPX-0276C; CX-2266C (Roschin Dep. Tr.)
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at 45:13-46:11.). The
. (CPX-0276C; CX-1839.0037; CX-2266C (Roschin Dep. Tr.) at 46:13-
56:16.). The 	. (CX-2266C (Roschin
Dep. Tr.) at 48:20-59:1.). This is confirmed in the documentation and source code that show
. (Tr. (Badler) at 420:21-421:6; CPX-0280C; CPX-0286C;
CPX-0317C; CX-1791C.0004; CDX-0011C.0059.).
As discussed in Sections VII.B.2.a.v-viii below for the following steps, Progress
Assessment and Treat’s
Specifically,
as discussed in Section
VII.B.2(a)(vi) below. (CX-2266C (Roschin Dep. Tr.) at 55:24-57:8
).
For the foregoing reasons, Align has proven by a preponderance of evidence that the 647
DI Products practice elements [1.5] and [18.5] of claims 1 and 18, respectively, of the ’647
patent.
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v. 	[1.6] / [18.6]: “identifying one or more reference points on
each set of corresponding dental objects in the initial and
subsequent digital models” / “identify one or more reference
points on each set of corresponding dental objects in the initial
and subsequent digital models”; [1.7] / [18.7]: “approximately
matching each set of corresponding dental objects by
approximately aligning corresponding reference points on
corresponding dental objects” / “approximately match each set
of corresponding dental objects by approximately aligning
corresponding reference points on corresponding dental
objects”
Both documentary and testimonial adduced in this Investigation demonstrate that
Progress Assessment and Treat meet these claim elements. (Tr. (Badler) at 421:15-423:4; CX-
2125C (Badler Expert Rpt.) at ¶¶ 443-53.). The
. (See, e.g., CX-2266C (Roschin Dep. Tr.) at 37:21-76:23.).
. (See, e.g., id. at 52:1-53:25.).
. (See, e.g., Tr. (Badler) at 420:4-422:5; CPX-
0276C; CX-1817C; CX-1965C; CX-2266C (Roschin Dep. Tr.) at 44:2-58:19.). As discussed
above,
. (CX-2266C (Roschin Dep. Tr.) at 44:2-51:10.). As
discussed in detail below in Sections VII.B.2.a.v-viii, Progress Assessment and Treat also
. (Tr. (Badler) at
421:15-422:9; CX-2266C (Roschin Dep. Tr.) at 59:2-76:23.).
Progress Assessment and Treat then
. (Tr. (Badler) at 422:10-423:4;
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CPX-0275C; CX-2266C (Roschin Dep. Tr.) at 51:5-59:1; CX-2125 (Badler Expert Rpt.) at
¶¶ 449-53.). The
. (CPX-
0275C; CX-2266C (Roschin Dep. Tr.) at 51:5-59:1; CDX-0011C.0061 (showing the code).).
The
as discussed below in Sections VII.B.2.a.v-viii. (CX-2266C (Roschin Dep. Tr.) at
56:24-57:19.).
Accordingly, Align has proven by a preponderance of evidence that the 647 DI Products
practice elements [1.6] / [18.6] and [1.7] / [18.7] of claims 1 and 18, respectively, of the ’647
patent.
vi. 	[1.8] / [18.8]: “matching each set of corresponding dental
objects more closely by iteratively minimizing error between
corresponding reference points on corresponding dental
objects” / “match each set of corresponding dental objects
more closely by iteratively minimizing error between
corresponding reference points on corresponding dental
objects”
Align offered evidence that Progress Assessment and Treat practice these claim elements.
(Tr. (Badler) at 423:5-424:10; CX-2125C (Badler Expert Rpt.) at ¶¶ 454-58.). Progress
Assessment and Treat
. (CX-2266C (Roschin Dep. Tr.) at 58:20-76:23.).
. (Id.; CPX-0303C; CDX-0011C.0062 (showing the code).). 	,
as discussed above in Section VII.A.3.a.vi, generally is
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. (CX-2266C (Roschin Dep. Tr.) at
69:14-77:1.). Progress Assessment and Treat
. (Tr. (Badler) at 423:10-23;
CX-2266C (Roschin Dep. Tr.) at 58:20-69:13.).
. (Tr. (Badler) at 423:10-23; CX-2266C (Roschin
Dep. Tr.) at 58:20-69:13.).
Dr. Mellor disagreed with Dr. Badler’s opinion regarding claim elements [1.6] / [18.6],
[1.7] / [18.7], and [1.8] / [18.8], because in Dr. Mellor’s opinion, the claims require the same
“reference points” to be used and that the process determines “correspondences.” (Tr. (Mellor)
at 1717:8-1719:10.). However, as discussed above in Section VII.B.2.a.vi, the claims do not
require that the same reference points be used in the initial alignment and the more closely
aligning steps. (See, e.g., Tr. (Badler) at 424:7-10.).
Moreover, this
. (Tr. (Badler) at 423:10-424:19; CX-2266C
(Roschin Dep. Tr.) at 58:20-77:1.). As a result, the above three sub-steps (claim elements [1.6] /
[18.6], [1.7] / [18.7], and [1.8] / [18.8])
. (Tr. (Badler) at 423:10-
424:19.).
For the reasons explained above, Align has proven by a preponderance of evidence that
the 647 DI Products practice elements [1.8] and [18.8] of claims 1 and 18, respectively, of the
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’647 patent.
vii. 	[1.9] / [18.9]: “matching the subsequent digital model as a
whole with the initial digital model” / “match the subsequent
digital model with the initial digital model”
Align presented testimony and evidence that Progress Assessment and Treat practice the
referenced claim elements. (Tr. (Badler) at 424:20-425:6; CX-2125C (Badler Expert Rpt.) at ¶¶
459-65.). Progress Assessment and Treat
. (Tr. (Badler) at 424:20-425:6; CPX-0280C at line 255 (
function); CX-1791C.0004-.0005; CX-2266C (Roschin Dep. Tr.) at 77:10-85:18
).). This is
illustrated in the source code
. (CX-2266C (Roschin Dep. Tr.) at 77:10-85:1.). The
. (Tr. (Badler) at
424:20-425:6; CX-1791C.0004.).
. (CX-2266C (Roschin Dep. Tr.) at 77:25-85:18, 122:10-124:24.).
Progress Assessment also
. (See, e.g., CX-1789C; CX-1839.0046; see also CX-2266C (Roschin Dep. Tr.) at
119:13-122:7
; CPX-
0332C.). Treat also has 	.
(CX-1784C.0011; CPX-0332C.).
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3Shape did not dispute that Progress Assessment and Treat practice these elements,
because Dr. Mellor did discuss these elements during the Hearing. (Tr. (Mellor) at 1718:9-
1719:15.). 3Shape has waived any argument on this issue pursuant to Ground Rule 10.2.
For the reasons discussed above, Align has proven by a preponderance of evidence that
the 647 DI Products practice elements [1.9] and [18.9] of claims 1 and 18, respectively, of the
’647 patent.
viii. 	[1.10] / [18.10]: “calculating one or more positional
differences between the moved and planned positions of at
least some of the corresponding dental objects” / “calculate
one or more positional differences between the moved and
planned positions of the corresponding dental objects”
As discussed above in Section VII.B.2.a.ii, Progress Assessment and Treat load models
of a treatment plan and a subsequent patient model of moved teeth for comparison. Progress
Assessment practices these claim elements by providing a report panel showing its calculations
of specific movements per tooth. (Tr. (Badler) at 425:7-24; CX-1789C; CX-1839.0043-.0048;
CX-2125C (Badler Expert Rpt.) at ¶¶ 466-70.). Treat also has a teeth table view report that
shows achieved movements per tooth. (CX-1784C; CX-1791C; CPX-0294C; CPX-0320C;
CPX-0332C.).
. (CPX-0294C; CPX-
0320C; CX-2266C (Roschin Dep. Tr.) at 117:6-119:11; CDX-0011C.0065 (showing code).).
Dr. Mellor did not dispute that the described functionality exists in Progress Assessment
and Treat, but again claimed that the calculation of point-to-point distances between teeth are not
“positional” differences. (Tr. (Mellor) at 1719:9-1720:9.). As discussed above, Dr. Mellor is
incorrect. Measuring tooth movement satisfies the claim elements.
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Accordingly, Align has proven by a preponderance of evidence that the 647 DI Products
practice elements [1.10] and [18.10] of claims 1 and 18, respectively, of the ’647 patent.
C. 	Invalidity
1. 	Invalidity Overview
3Shape alleged that asserted claims 1 and 18 of the ’647 patent are obvious in view of
Rubbert WO (RX-2037),37 alone or in combination with Rusinkiewicz (CX-0948).38 (RBr. at
15.). In its Pre-Hearing Brief, Align only disputed that Rubbert WO, alone or in combination
with Rusinkiewicz, teach elements [1.5] / [18.5], [1.6] / [18.6], [1.7] / [18.7], [1.8] / [18.8], [1.9]
/ [18.9], or [1.10] / [18.10]. (CPBr. at 45-52.). Thus, any argument on elements [1.1] / [18.1],
[1.2] / [18.2], [1.3] / [18.3], and [1.4] / [18.4] is waived under Ground Rule 7.2.
For the reasons discussed below in Section VII.C.3, 3Shape failed to meet its burden that
either prior art reference discloses by clear and convincing evidence elements [1.5] / [18.5], [1.6]
/ [18.6], [1.7] / [18.7], [1.8] / [18.8], [1.9] / [18.9], or [1.10] / [18.10] of the ’647 patent. 3Shape
also failed to present clear and convincing evidence that a person of ordinary skill in the art at the
time of invention would have been motivated to, or had a reason to, combine Rubbert WO with
“ICP” or Rusinkiewicz and would have a reasonable expectation of success.
3Shape also asserted that the language “to determine corresponding dental objects”
recited in claims 1 and 18 is indefinite and/or lacks written description support in the
specification of the ’647 patent. (RBr. at 14.). As discussed below in Section VII.C.4, the
specification and plain claim language explains how the steps (i.e., claim elements [1.6] / [18.6],
37 International Publication No. WO 01/80761 A2.
38 Szymon Rusinkiewicz & Marc Levoy, Efficient Variants of the ICP Algorithm, Stanford University
(article not dated).
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[1.7] / [18.7], [1.8] / [18.8]) result in the determination of corresponding dental objects through
the positioning and repositioning of the same teeth from two models.
Additionally, 3Shape contended that the asserted claims of the ’647 and ’661 patents are
directed to patent-ineligible subject matter. (RBr. at 6.). For the reasons discussed below in
Section VII.C.5, the asserted claims of the ’647 and ’661 patents are directed to non-abstract
solutions to a problem specific to virtual dentistry and orthodontics. Moreover, the claims are
not directed to simply invoking a generic computer for the performance of well-known
techniques.
2. 	Legal Standards
a) 	Obviousness
Under 35 U.S.C. § 103(a), a patent is valid unless “the differences between the subject
matter sought to be patented and the prior art are such that the subject matter as a whole would
have been obvious at the time the invention was made” to a person having ordinary skill in the
art. 35 U.S.C. § 103(a). The ultimate question of obviousness is a question of law, but “it is well
understood that there are factual issues underlying the ultimate obviousness decision.”
Richardson-Vicks, 122 F.3d 1476, 1479 (Fed. Cir. 1997) (citing Graham v. John Deere Co. of
Kansas City, 383 U.S. 1, 17 (1966)).
After claim construction, “[t]he second step in an obviousness inquiry is to determine
whether the claimed invention would have been obvious as a legal matter, based on underlying
factual inquiries including: (1) the scope and content of the prior art, (2) the level of ordinary
skill in the art, (3) the differences between the claimed invention and the prior art, and (4)
secondary considerations of non-obviousness.” Smiths Indus. Med. Sys., Inc. v. Vital Signs, Inc.,
183 F.3d 1347, 1354 (Fed. Cir. 1999) (citing Graham, 383 U.S. at 17).
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The existence of secondary considerations of non-obviousness does not control the
obviousness determination; a court must consider “the totality of the evidence” before reaching a
decision on obviousness. Richardson-Vicks, 122 F.3d at 1483.
The Supreme Court clarified the obviousness inquiry in KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398 (2007). The Supreme Court said:
When a work is available in one field of endeavor, design incentives and other
market forces can prompt variations of it, either in the same field or a different one.
If a person of ordinary skill can implement a predictable variation, § 103 likely bars
its patentability. For the same reason, if a technique has been used to improve one
device, and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill. Sakraida and Anderson’s-Black Rock
are illustrative–a court must ask whether the improvement is more than the
predictable use of prior art elements according to their established functions.
Following these principles may be more difficult in other cases than it is here
because the claimed subject matter may involve more than the simple substitution
of one known element for another or the mere application of a known technique to
a piece of prior art ready for the improvement. 	Often, it will be necessary for a
court to look to interrelated teachings of multiple patents; the effects of demands
known to the design community or present in the marketplace; and the background
knowledge possessed by a person having ordinary skill in the art, all in order to
determine whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue. To facilitate review, this analysis should
be made explicit.
* * *
The obviousness analysis cannot be confined by a formalistic conception of the
words teaching, suggestion, and motivation, or by overemphasis on the importance
of published articles and the explicit content of issued patents. 	The diversity of
inventive pursuits and of modern technology counsels against limiting the analysis
in this way. 	In many fields it may be that there is little discussion of obvious
techniques or combinations, and it often may be the case that market demand, rather
than scientific literature, will drive design trends. 	Granting patent protection to
advances that would occur in the ordinary course without real innovation retards
progress and may, in the case of patents combining previously known elements,
deprive prior inventions of their value or utility.
KSR, 550 U.S. at 417-19.
The Federal Circuit has since held that when a patent challenger contends that a patent is
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invalid for obviousness based on a combination of several prior art references, “the burden falls
on the patent challenger to show by clear and convincing evidence that a person of ordinary skill
in the art would have had reason to attempt to make the composition or device, or carry out the
claimed process, and would have had a reasonable expectation of success in doing so.”
PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007) (citations
omitted).
The TSM39 test, flexibly applied, merely assures that the obviousness test proceeds
on the basis of evidence--teachings, suggestions (a tellingly broad term), or
motivations (an equally broad term)--that arise before the time of invention as the
statute requires. 	As KSR requires, those teachings, suggestions, or motivations
need not always be written references but may be found within the knowledge and
creativity of ordinarily skilled artisans.
Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed. Cir. 2008).
b) 	Written Description
Patents are presumed valid. 35 U.S.C. § 282. The first paragraph of Section 112 states:
“The specification shall contain a written description of the invention, and of the manner and
process of making and using it, in such full, clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains, or with which it is most nearly connected, to make
and use the same. . . .” 35 U.S.C. § 112. To comply, a patent applicant must “convey with
reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in
possession of the [claimed] invention.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64
(Fed. Cir. 1991) (emphasis omitted). “The form and presentation of the description can vary
with the nature of the invention[.]” In re Skvorecz, 580 F.3d 1262, 1269 (Fed. Cir. 2009).
39 TSM is an acronym that stands for teaching, suggestion, motivation.
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“[T]he applicant [for a patent] may employ ‘such descriptive means as words, structures, figures,
diagrams, formulas, etc., that fully set forth the claimed invention.”’ Id. (citing In re Alton, 76
F.3d 1168, 1172 (Fed. Cir. 1996)). The adequacy of the description depends on content, rather
than length. In re Hayes Microcomputer Prods., Inc. Patent Litig., 982 F.2d 1527, 1534 (Fed.
Cir. 1992). “Specifically, the level of detail required to satisfy the written description
requirement varies depending on the nature and scope of the claims and on the complexity and
predictability of the relevant technology.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
1352 (Fed. Cir. 2010) (en banc).
Compliance with the written description requirement is a question of fact, and in order to
overcome the presumption of validity a party must set forth clear and convincing evidence.
Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1347 (Fed. Cir. 2011). The
Federal Circuit has also held with respect to the written description requirement that “[a] claim
will not be invalidated on section 112 grounds simply because the embodiments of the
specification do not contain examples explicitly covering the full scope of the claim language.”
Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006) (quoting LizardTech, Inc.
v. Earth Resource Mapping, PTY, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005)).
c) 	Indefiniteness
A patent specification must “conclude with one or more claims particularly pointing out
and distinctly claiming the subject matter which the applicant regards as [the] invention.”
35 U.S.C. § 112, ¶ 2. Previously, the Federal Circuit held that a patent claim is not indefinite “so
long as the claim is amenable to construction, and the claim, as construed, is not insolubly
ambiguous.” Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2124 (2014). More
recently, the U.S. Supreme Court determined that this standard lacks precision. Id. at 2130.
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Instead, the Supreme Court held:
[W]e read § 112, ¶ 2 to require that a patent’s claims, viewed in light of the
specification and prosecution history, inform those skilled in the art about the scope
of the invention with reasonable certainty. 	The definiteness requirement, so
understood, 	mandates 	clarity, 	while 	recognizing 	that 	absolute 	precision 	is
unattainable. 	The standard we adopt accords with opinions of this Court stating
that “the certainty which the law requires in patents is not greater than is reasonable,
having regard to their subject-matter.”
Id. at 2129 (citations omitted).
A party seeking to invalidate a patent claim must do so by clear and convincing evidence.
See, e.g., Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008) (citing
Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1375 (Fed. Cir. 1986)).
d) 	Patent Eligibility
Section 101 of the Patent Act states: “Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35
U.S.C. § 101. In Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014), the Supreme
Court explained that, the application of section 101 requires courts to “distinguish between
patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that integrate the
building blocks into something more.” Id. at 2354 (quoting Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 132 S.Ct. 1289, 1294 (2012)). To make this distinction, courts must first
“determine whether the claims at issue are directed to a patent-ineligible concepts,” such as the
“laws of nature, natural phenomena, and abstract ideas.” Id. at 2355 (citing Mayo, 132 S.Ct. at
1296-1297)). If so, courts must examine the elements of the claim to determine whether it
contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Id.
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“[T]he prohibition against patenting abstract ideas cannot be circumvented by attempting
to limit the use of the idea to a particular technological environment.” Id. at 2358 (quoting Bilski
v. Kappos, 561 U.S. 593, 610-611 (2010)). In other words, “transformation into a patent-eligible
application requires ‘more than simply stat[ing] the [abstract idea] while adding the words ‘apply
it.’” Id. at 2357 (alteration in original) (citing Mayo, 132 S.Ct. at 1294).
However, “[a]t some level, ‘all inventions . . . embody, use, reflect, rest upon, or apply
laws of nature, natural phenomena, or abstract ideas.’ Thus, an invention is not rendered
ineligible for patent simply because it involves an abstract concept.” Id. at 2354 (quoting Mayo,
132 S.Ct. at 1293-94; citing Diamond v. Diehr, 450 U.S. 175, 187 (1981)). “‘[A]pplication[s]’
of such concepts ‘to a new and useful end’ . . . remain eligible for patent protection.” Id.
(quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972).
3. 	Rubbert WO (RX-0237) Alone or in Combination with Rusinkiewicz
(RX-2276) Do Not Render Obvious Claims 1 and 18 of the ’647 Patent
a) 	[1.5] / [18.5]: “individually matching each of the dental objects
in the subsequent digital model with a dental object in the
initial digital model to determine corresponding dental objects,
the matching comprising” / “individually match each of the
dental objects in the subsequent digital model with a dental
object in the initial digital model to determine corresponding
dental objects, including instructions to”
3Shape contended that Rubbert WO teaches the “individually matching” element recited
in claim elements [1.5] / [18.5] in the disclosures at RX-0237.102:31-103:2. (RBr. at 18.).
Specifically, 3Shape argued that the following description in Rubbert WO discloses
“individually matching each of the teeth in two models.” (Id.).
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(Id. (citing RX-0237.102:31-103:2) (emphasis added by 3Shape); Tr. (Parris Egbert)40 at
1087:10-24).).
3Shape also asserted that Rubbert WO discloses matching a subsequent model with a
model with teeth in their expected or target positions. (Id.).
(Id. (citing RX-0237.103:3-11 (emphasis added by 3Shape).).
However, as Align contended, these disclosures upon which 3Shape relied do not
disclose matching tooth-by-tooth, but rather, describe selecting a point on one tooth and
superimposing two teeth, not each set of corresponding teeth in a computer model of a patient’s
jaw. (CRBr. at 12-13.). 3Shape’ expert, Dr. Parris Egbert, opined during the Hearing that
Rubbert WO describes “select[ing] a point on one tooth, and then match[ing] the corresponding
tooth to that tooth that you’ve selected.” (Tr. (Egbert) at 1083:12-18 (emphasis added).).
Additionally, 3Shape argued that Rubbert WO teaches individually matching each of the
teeth in the current and original models to precisely measure tooth erosion.
40 When he testified during the Hearing on October 29, 2019, Dr. Parris Egbert, Ph.D. was a Professor in
the Computer Science Department at Brigham Young University. (RPSt., Ex. A at 2.). 3Shape identified
Dr. Egbert as an expert to testify about the invalidity of the ’647 and ’661 patents. (RPSt. at 4.).
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(Id. (citing RX-0237.81:30-82:5 (emphasis added by 3Shape).).
However, as Align pointed out, 3Shape’s “template” argument based on the disclosure
found at RX-0237.81:30-82:5 is waived and abandoned under Ground Rule 7.2 because 3Shape
did not raise this argument its Pre-Hearing Brief. (See Ground Rule 7.2.). See also Certain
Graphic Systems, Components Thereof, & Consumer Products Containing the Same, Inv. No.
337-TA-1044, ID at 126-27 (U.S.I.T.C. Oct. 17, 2019).
Accordingly, 3Shape has failed to meet its burden of proving that Rubbert WO teaches
these claim elements by clear and convincing evidence.
b) 	[1.6] / [18.6]: “identifying one or more reference points on
each set of corresponding dental objects in the initial and
subsequent digital models” / “identify one or more reference
points on each set of corresponding dental objects in the initial
and subsequent digital models”
3Shape asserted that Rubbert WO, alone or in combination with Rusinkiewicz, renders
obvious these claim elements. (RBr. at 19-20.). 3Shape relied on the same disclosure of Rubbert
WO at RX-0237.102:31-32 for “individually matching.” (Id. at 20 (citing RX-0237.102:31-
32).). However, as discussed above with respect to claim elements [1.5] / [18.5], Rubbert WO
fails to disclose “individually matching” because the reference only discloses superimposing two
teeth, and not each set of corresponding teeth in the jaw. For the same reasons, Rubbert WO
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fails to disclose the “identifying” reference points elements. (See RX-0237.102:30-103:1.).
Moreover, Dr. Egbert only provided conclusory testimony during the Hearing that “Rubbert
states that he does that.” (Tr. (Egbert) at 1089:16-1090:12.).
In an attempt to remedy this lack of disclosure of the claimed “identifying” reference
points in Rubbert WO, 3Shape relied upon generic ICP disclosed in Rusinkiewicz. (RBr. at 20.).
However, Rusinkiewicz generally examines several variants of ICP and does not disclose
identifying references points on each set of corresponding teeth of a computer model of a
patient’s jaw, as Dr. Egbert confirmed. (CX-00948.0001.).
Q. Now, you would agree with me that the ICP paper Rusinkiewicz that you relied
on itself doesn’t give any examples in use in the field of dentistry; correct?
A. 	I believe that’s correct. 	He talks about applications of ICP. 	I don’t think he
mentions dentistry.
(Tr. (Egbert) at 1104:1-5.).
Dr. Egbert again provided only conclusory testimony regarding ICP, stating that the ICP
algorithm consists of six steps, one of which is the “selection of some of the points.” He then
concluded that this disclosure meets the “identifying” reference points element.
Q. And where in Rusinkiewicz is the identifying step of -- substep of claim 1?
A. If you look at the bottom figure there, there’s a – there’s six steps that are done.
In that first step, that is when the selection of some of the points is performed. And
that meets the claim element of identifying one or more reference points on each
set of the corresponding teeth in the initial and subsequent digital models.
(Tr. (Egbert) at 1090:4-12.).
However, in his conclusory testimony, Dr. Egbert failed to identify any disclosure in
Rusinkiewicz that identifies points on corresponding sets of teeth. (Id.). Because the only record
evidence of implementation of ICP is Rusinkiewicz, 3Shape failed to present sufficient evidence
that “ICP,” as a purported “well-known” algorithm, identifies references points on each set of
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corresponding teeth on a computer model of a patient’s dentition.
For the reasons explained above, 3Shape has failed to meet its burden of proving by clear
and convincing evidence that Rubbert WO teaches the referenced claim elements.
c) 	[1.7] / [18.7]: “approximately matching each set of
corresponding dental objects by approximately aligning
corresponding reference points on corresponding dental
objects” / “approximately match each set of corresponding
dental objects by approximately aligning corresponding
reference points on corresponding dental objects”
3Shape contended that Rubbert WO, alone or in combination with Rusinkiewicz, renders
obvious these claim elements. (RBr. at 22.). 3Shape first argued that Rubbert WO alone renders
these claim elements obvious because a person of ordinary skill in the art in 2002 would know to
use “ICP” to match 3D models. (Id.). However, as explained above in Section VII.C.3(a),
Rubbert WO does not disclose “individually matching,” there is no evidence supporting the use
of ICP to match 3D models of teeth, and Rubbert WO does not disclose an “initial alignment”
because it discloses only one single superimposition.
To remedy the lack of disclosure, Dr. Egbert relied upon ICP disclosed in Rusinkiewicz.
(Tr. (Egbert) at 1090:21-24.). Dr. Egbert testified that in Rusinkiewicz, ICP performs an “initial
guess” to approximately match two objects – i.e., an initial alignment. (Id. at 1090:21-1091:11
(“He says that you start with the two 3D models, you then perform an initial guess . . . .”).).
However, as Align pointed out, Rusinkiewicz explicitly states that “[i]n this paper, we assume
that a rough initial alignment is always available.” (CX-0948.0001 (emphasis added); see also
id. (“ICP starts with two meshes and an initial guess for their relative rigid body transform”)
(emphasis added).). Thus, because Rusinkiewicz does not clearly and convincingly disclose an
“initial alignment,” the prior art reference fails to teach the claimed “initial alignment” using
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corresponding reference points on each set of corresponding teeth as disclosed in the ’647 patent
For these reasons, 3Shape has failed to meet its burden of proving that Rubbert WO
teaches these claim elements by clear and convincing evidence.
d) 	[1.8] / [18.8]: “matching each set of corresponding dental
objects more closely by iteratively minimizing error between
corresponding reference points on corresponding dental
objects” / “match each set of corresponding dental objects
more closely by iteratively minimizing error between
corresponding reference points on corresponding dental
objects”
3Shape contended that Rubbert WO, alone or in combination with Rusinkiewicz, renders
obvious these claim elements. (RBr. at 22.). For the reasons discussed above for claim elements
[1.5] / [18.5], [1.6] / [18.6], and [1.7] / [18.7], neither Rubbert WO nor Rusinkiewicz discloses
the preceding claim elements, that is, “individually matching,” “identifying” reference points on
each set of teeth, and “initially aligning.” As a result, Rubbert WO, “ICP,” and Rusinkiewicz
also fail to disclose the “matching each set” of teeth more closely claim element.
Moreover, as discussed above, ICP does not disclose a matching of sets of teeth in two
models using reference points. Dr. Egbert did not even provide any testimony or opinion that
Rusinkiewicz or ICP disclose matching two sets of teeth closer together.
Q. And what art did you use to address the next substep, which is “matching each
set of corresponding dental objects more closely by iteratively minimizing error
between corresponding reference points on corresponding dental objects”?
A. I used Rusinkiewicz for that disclosure.
Q. Moving to slide 60. How did Rusinkiewicz inform your analysis with respect
to this matching substep of claim 1?
A. Once you have the models aligned initially with a rough match, then the next
step that you do in Rusinkiewicz, and this is shown in step number 6, in the top box
there, the next thing you do, then, is to iteratively match the two objects closer
together using the error metric that we talked about.
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Q. And can you explain a little more about the error metric?
A. Yeah. So when you do the initial match, you get the two objects fairly close
together but probably not as accurate as you want. 	The next step, then, is to
iteratively just slightly move them to bring them closer together. And again, you
do that either until the error that you get -- and the error you compute by looking at
the differences between the two models. You continue the process either until that
error is small enough or you reach some number of iterations and you want to stop
at that point.
(Tr. (Egbert) at 1091:22-1092:23.).
3Shape cannot remedy the lack of disclosure of “teeth” with Dr. Egbert’s testimony
because his testimony is conclusory hindsight unsupported by the evidence. 41 Additionally,
3Shape did not provide any explanation why one of skill in the art would look to ICP or
Rusinkiewicz for more closely aligning when Rubbert WO does not disclose or suggest any
additional alignment beyond a single generic superimposition or use of any algorithm.
For the foregoing reasons, 3Shape has failed to meet its burden of proving that Rubbert
WO teaches these claim elements by clear and convincing evidence.
e) 	[1.9] / [18.9]: “matching the subsequent digital model as a
whole with the initial digital model” / “match the subsequent
digital model with the initial digital model”
3Shape asserted that Rubbert WO teaches the referenced claim elements. (RBr. at 23.).
Rubbert WO on its face discloses superimposition of two teeth but does not disclose the two-step
matching process of the claim. It is improper for 3Shape to rely on the same “superimposition”
step for two matching steps in the claimed process. See, e.g., Lantech, Inc. v. Keip Machine Co.,
32 F.3d 542, 546 (Fed. Cir. 1994) (“When claiming a combination where more than one of a
certain element, here a conveyor [means], is included in the combination, the term ‘at least two’
sets forth the minimum number of a particular element required. This interpretation gives full
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effect to the recitation of two distinct elements in the claimed structure. Therefore, properly
interpreted, all claims at issue require two or more conveyor structures, not one.”).
Moreover, Dr. Egbert supported this proposition by conceding that the mere disclosure of
“superimposing” using a single point on a tooth would not necessarily provide any sort of precise
matching or alignment of the teeth. (Tr. (Egbert) at 1103:13-17 (“Q. Now, you would agree
with me that this superimposition disclosed by Rubbert using a single point on a tooth would not
provide any sort of precise matching or alignment of the teeth? A. It may or may not.”).).
Accordingly, 3Shape has failed to meet its burden of proving by clear and convincing
evidence that Rubbert WO teaches the referenced claim elements.
f) 	[1.10] / [18.10]: “calculating one or more positional differences
between the moved and planned positions of at least some of
the corresponding dental objects” / “calculate one or more
positional differences between the moved and planned
positions of the corresponding dental objects”
3Shape relied solely on Rubbert WO for the referenced claim limitations. (RBr. at 27.).
However, Rubbert WO does not disclose or teach the claimed “calculating . . . positional
differences.” (RX-0237.102:30-103:1 (disclosing a single superimposition of one tooth using a
single point).). 3Shape’s expert, Dr. Egbert, merely provided conclusory testimony that Rubbert
WO discloses the “calculating . . . positional differences” element based on the reference’s
modest disclosure that “the differences can be quantified with precision.”
Q. How did Rubbert inform your analysis with respect to the calculating step of
claim 1?
A. So Rubbert discloses being able to take the two models, match them together
and then compute differences between them. 	He says, “the differences can be
quantified with precision,” and he talks about one of the features of his system, the
measurement marker feature, allows the user to quantify precisely the amount of
movement.
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(Tr. (Egbert) at 1094:1-8.).
The Rubbert disclosure is insufficient, however, because it fails to provide any
description of how any differences can be quantified. (RX-0237.102:30-103:1.). Dr. Egbert’s
reference to the “measurement marker feature” fails to meet the claimed “calculating . . .
positional differences,” because Dr. Egbert acknowledged during the Hearing that the mere
disclosure of “superimposing” by Rubbert WO using a single point on a tooth would not
guarantee any sort of precise matching or alignment of the teeth. (Tr. (Egbert) at 1103:13-17.).
For the reasons discussed above, 3Shape has failed to meet its burden of proving by clear
and convincing evidence that Rubbert WO teaches these claim elements by clear and convincing
evidence.
g) 	3Shape Failed to Present Any Evidence of Motivation to
Combine or Reasonable Expectation of Success
3Shape failed to present clear and convincing evidence that a person of ordinary skill in
the art at the time of invention would have been motivated to, or had a reason to, combine
Rubbert WO with “ICP” or Rusinkiewicz and would have had a reasonable expectation of
success. The entirety of Dr. Egbert’s testimony regarding motivation to combine during the
Hearing consisted of one brief answer.
Q. And Dr. Egbert, why, if at all, would one of ordinary skill in the art have been
moved to combine Rubbert and Rusinkiewicz in the way you’ve just described?
A. 	Rubbert describes the system, then, for taking the two computer models and
matching them together and then allowing the orthodontist to monitor the
movements and see how things have changed, either tooth by tooth or as a whole.
Rubbert doesn’t go into a lot of detail as to exactly how you do that. At the time of
Rubbert, the technique that was typically used to do this operation is ICP. And so
it would be obvious for a person to use the ICP technique for doing those matching
steps.
(Tr. (Egbert) at 1094:9-21.).
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Dr. Egbert’s testimony on its face fails to meet the clear and convincing standard because
it does not include any analysis with facts that a combination would have a “reasonable
expectation of success.” See, e.g., In re Stepan, 868 F.3d 1342, 1345-46 (Fed. Cir. 2017) (“An
obviousness determination requires finding both ‘that a skilled artisan would have been
motivated to combine the teachings of the prior art . . . and that the skilled artisan would have
had a reasonable expectation of success in doing so.’”) (citation omitted); PharmaStem, 491 F.3d
1342 at 1360.
Moreover, Rubbert WO’s disclosure consists of a few lines that at best describes
selecting a point on one tooth and superimposing two teeth, not each set of corresponding teeth
in a jaw. (RX-0237.102:30-103:1.). In an attempt to backfill this disclosure, 3Shape argued that:
(i) “a POSITA at the time would have known to use ICP to match 3D models” (RBr. at 20); or
(ii) “a POSITA would have been motivated to combine Rubbert WO with Rusinkiewicz” (id. at
21).
3Shape’s contentions are not supported by the evidence. During the Hearing, Dr. Egbert
acknowledged that he was not aware of any evidence that ICP was being used in applications
related to dentistry or orthodontics in 2002.
Q. And you are not aware of any evidence that ICP was being used in applications
related to dentistry in 2002; correct, sir?
A. I’m not aware of them. It would be the obvious thing to do, because ICP was a
well-known technique at the time, used for matching any 3D models.
Q. Okay. Sir, but my question was, you are not aware of any evidence that ICP
was being used in applications related to dentistry in 2002; correct?
A. I -- I don’t believe I’m aware of any.
Q. And you don’t know if ICP was being used in orthodontics -- orthodontics in
August 2002; right?
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A. Again, I’m not aware of specifics, but it would be the logical thing to use.
Q. 	Sir, my question again was, you don’t know if ICP was being used in
orthodontics in August 2002; correct?
A. And I think I answered that, yeah. I’m not aware of any specific, but ICP would
be the logical thing to use for an orthodontics application of 3D models.
(Tr. (Egbert) at 1104:11-1105:4.).
Dr. Egbert also conceded that none of the references 3Shape identified in either the field
of orthodontics or dentistry mention the use of ICP. (Id. at 1104:6-10 (“Q. Now, in fact, none of
the references that you’ve presented for your opinion today in the field of orthodontics or
dentistry cite the use of ICP; isn’t that correct, sir? A. None of them cite ICP specifically.”).).
Additionally, 3Shape’s assertion fails because motivation to combine arguments “cannot
be sustained by mere conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S.
at 418 (citations omitted). 3Shape failed to identify any factual underpinning in Rubbert WO’s
disclosure to support a conclusion that it would have been obvious to modify Rubbert WO with
ICP. Indeed, Dr. Egbert testified that “Rubbert doesn’t go into a lot of details as to exactly how
you do that.” (Tr. (Egbert) at 1094:9-21.). Thus, 3Shape’s arbitrary selection of ICP from the
vast field of alignment techniques constitutes impermissible hindsight bias. Absent hindsight,
there is no suggestion or motivation to combine Rubbert WO with ICP. See, e.g., In re Rouffet,
149 F.3d 1350, 1358 (Fed. Cir. 1998) (noting that “the suggestion to combine requirement is a
safeguard against the use of hindsight combinations to negate patentability”).
Moreover, it is not sufficient that ICP simply existed and was known at the time.
Although 3Shape argued that “ICP was the dominant technique typically used to match 3D
objects at the time of the patent” (RBr. at 21), it failed to “identify a reason that would have
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prompted a person of ordinary skill in the relevant field to combine the elements in a way the
claimed new invention does . . . because inventions in most, if not all, instances rely upon
building blocks long since uncovered, and claimed discoveries almost of necessity will be
combinations of what, in some sense, is already known.” KSR, 550 U.S. at 418-19 (emphasis
added). Neither 3Shape nor Dr. Egbert provided an explanation of how one of ordinary skill in
the art would have a reasonable expectation of success in combining Rubbert WO with ICP or
Rusinkiewicz, especially where Rubbert WO does not provide detail in its disclosures for
matching a single tooth to another that amounts to a disclosure that it can be done. See
Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1335 (Fed. Cir. 2013).
For the reasons explained, 3Shape’s arguments, which rely upon conclusory and
hindsight testimony, are inadequate to support its claim of obviousness. See, e.g., KSR, 550 U.S.
at 418.
4. 	Claims 1 and 18 of the ’647 Patent Are Not Indefinite and Do Not
Lack Written Description
3Shape contended in two (2) conclusory paragraphs that the language “to determine
corresponding dental objects” of the ’647 patent is indefinite and/or lacks written description
support. (RBr. at 14-15.). 3Shape relied solely on similarly conclusory testimony of its expert,
Dr. Egbert, to support this position.
Q. Dr. Egbert is, which portion of claim 1 is indefinite, in your opinion?
A. The portion where it states, “individually matching each of the dental objects in
the subsequent digital model with a dental object in the initial digital model to
determine corresponding dental objects.”
Q. And why, in your opinion, is that portion of claim 1, which also appears in claim
18, indefinite?
A. That’s correct. If you look at the wording in that portion of claim 1, it says that
you need to ‘individually match each of the teeth in the subsequent digital model
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with a tooth in the initial digital model.’ And so the idea is you have to match two
teeth together. The next part of the phrase, though, states the reason you do that is
to determine corresponding dental objects. In order to do the matching, you have
to have already determined those corresponding dental objects. 	You can’t do a
match if you haven’t determined that two things correspond. And so the language
in the claim states that you do the match in order to determine the corresponding
dental objects, but you can’t do the match without having those corresponding
dental objects.
Q. And Dr. Egbert, in your opinion, does claim 1 -- does this portion of claim 1
find written description support in the ’647 patent?
A. No. I could not find any.
Q. 	And same question with respect to claim 18 of the ’647 patent. 	Does the
“individually match each of the dental objects in the subsequent digital model with
a dental object in the initial digital model to determine corresponding dental
objects” step, including the substeps, find written description support in the ’647
patent?
A. I could not find any.
(Tr. (Egbert) at 1098:5-1099:14.).
However, when the claim language is read correctly, in light of the specification,
3Shape’s contention is unavailing. As an initial matter, from a legal perspective, the patent’s
requirement of “to determine corresponding dental objects” is an intended result. This is clear
from the plain language “individually matching . . . to determine corresponding dental objects
. . . the matching comprising.” (JX-0001 at 10:4-18.).
Moreover, by the plain language of the claims, “to determine corresponding dental
objects” is accomplished through the three sub-steps of the “individually matching . . . the
matching comprising” claim element. (JX-0001 at 10:4-18; Tr. (Badler) at 405:24-406:11,
424:11-19.). Specifically, the patent specification describes an approximate positioning of the
teeth and then an iterative process that involves positioning and repositioning teeth until the
distance is minimized after which the process has found the corresponding teeth and matched
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them more closely through the three sub-steps. (See, e.g., JX-0001 at 5:62-6:14, Figs. 3-4; Tr.
(Badler) at 405:24-406:11, 424:11-19.). This is consistent with the adoped claim construction of
“individually matching,” which was construed to mean “for each of the teeth in the subsequent
digital model, using the identified reference points to determine the position of a tooth in the
subsequent digital model relative to the corresponding tooth in the initial digital model.”
(Markman Order, App. A. at 19.).
The specification and plain claim language thus plainly explain how the steps result in the
determination of corresponding dental objects through the positioning and repositioning of the
same teeth from two models. (See JX-0001 at 5:6-7:62.). See also Blue Calypso, LLC v.
Groupon, Inc., 815 F.3d 1331, 1345 (Fed. Cir. 2016) (finding the exact terms appearing in the
claim “need not be used in haec verba” for written description support); Cordis Corp. v.
Medtronic Ave, Inc., 339 F. 3d 1352, 1364-65 (Fed. Cir. 2003) (same).
3Shape’s assertion rests on an interpretation of the claims that “each sub-step requires
that the corresponding dental objects are already determined.” (RBr. at 14.). However, no such
requirement exists in the claims and 3Shape did not seek a claim construction consistent with
this position. (See id. at 14-15.). Instead, 3Shape misquoted the claim language. (Id. at 15.).
For example, the claim language does not state that the “corresponding dental objects” “are
determined by: (i) identifying corresponding dental objects.” (Id.; JX-0001 at 10:8-10.). The
plain language is “identifying one or more reference points on each set of corresponding dental
objects in the initial and subsequent models.” (JX-0001 at 10:8-10.). This is easily understood,
because as detailed in the specification, the process is done for each tooth on two models of the
teeth of a patient. (Id. at 5:6-6:14.). The process therefore places points on corresponding teeth
as the models are two models of the same patient’s teeth and the claims require that the
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references points are identified on each set of teeth. (JX-0001 at 10:8-10.).
3Shape’s expert, Dr. Egbert, provided only conclusory opinions to support this position.
However, conclusory testimony by an expert is not clear and convincing evidence of invalidity.
WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1339, n.8 (Fed. Cir. 2016). For example, Dr. Egbert
failed to address Dr. Badler’s testimony regarding his understanding of the “to determine
corresponding dental objects” claim language and did not address any of the portions of the
patent specification or any of the Figures and embodiments described therein. Rather than
examining the language of the patent, Dr. Egbert stated that “I could not find any” written
description support. (Tr. (Egbert) at 1099:4-7.). This conclusory testimony is insufficient to
meet 3Shape’s burden to prove indefiniteness or failure of written description. WBIP, 829 F.3d
at 1339, n.8; Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1155 (Fed. Cir. 2004).
For the foregoing reasons, 3Shape has failed to prove by clear and convincing evidence
that asserted claims 1 and 18 of the ’647 patent are invalid.
5. 	The ’647 and ’661 Patents Claim Patent Eligible Subject Matter
a) 	Alice Step 1: The ’647 and ’661 Patents Claim a Specific
Technological Improvement
As explained in the specification of the ’647 and ’661 patents, the asserted claims of the
’647 and ’661 patents are directed to non-abstract solutions to a problem specific to virtual
dentistry and orthodontics. Prior art conventional methods of orthodontics and teeth movement
involved manual processes. (JX-0001 at 2:4-11; JX-0002 at 1:32-47.). Traditionally,
practitioners relied on using rulers on 2D x-ray images of a patient over time and the manual 2D
measurements were not precise and were incomplete. (JX-0001 at 2:4-11.). Although 3D digital
scans of a patient’s jaw were known (see id. at 1:44-65), there is no evidence of any known
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methods of matching and comparing 3D digital scans and treatment plan models of a patient’s
jaw to calculate positional differences as claimed in the ’647 and ’661 patent claims. (See, e.g.,
id. at 2:4-26.).
One of the named inventors on the ’647 and ’661 patents, Dr. Eric Kuo,42 testified that at
the time of the invention, Align faced the novel problem of patients going off track from aligner
treatment and was trying to figure out how to get a patient back on track.
Q. Was there a particular problem that you were trying to address when you came
up with the idea that led to the filing of this patent application?
A. Yes. So when we were looking at the progress results of how treatments were
going, one of the things we learned was that sometimes the appliances, the aligners,
they weren’t fitting on the patient’s teeth as well as the doctor would like. And at
the time initially, the manufacturing lead time was pretty long, and the cost to make
these aligners was pretty expensive. So the doctors would have a whole bunch of
these trays sitting in the office that they couldn’t use because the cases were going
off track. So we were trying to come up with a way to get the patient to get back
on track to the rest of the aligners that were already manufactured and sitting in the
doctor's office.
(Tr. (Kuo) at 69:7-23.).
Dr. Kuo explained that as a practitioner, he understood that in order to solve this problem,
a doctor would need to scan the patient and then find a way to match the scan to a treatment
stage to figure out what teeth are not on track. (Id. at 69:24-70:13.). He testified that at the time,
42 When he testified during the Hearing on October 24, 2019, Dr. Eric Kuo was an orthodontist as well as
an orthodontic consultant. (Tr. (Kuo) at 65:13-14.). From 1999 until March of 2013, Dr. Kuo was an
Align full-time employee. (Id. at 67:5-7.). He was hired initially as an associate clinical director. In that
role, Dr. Kuo “primarily focused on supervising technicians in the manufacturing operations.” (Id. at
67:10-11.). Dr. Kuo’s last role at Align was Vice President of clinical technology. (Id. at 67:18-19.).
Align identified Dr Kuo as a fact witness to testify about Align’s background and business; domestic
industry in the Asserted Patents; background and development of the technology disclosed in the ’661
and ’647 patents; validity of the Asserted Patents, including nonobviousness and secondary
considerations of the ’661 and ’647 patents; standing and ownership of the Asserted Patents; Align’s
iTero Element and Invisalign System; and related issues. (CPSt. at 8.).
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the known way for measuring teeth movement was the manual method that yielded limited and
imprecise results. (Id. at 70:14-71:10; JX-0001 at 2:4-26.).
Dr. Kuo testified that while different ways to match scans existed, those that existed to
match did not meet his need for a tool that match teeth quickly and accurately. (Tr. (Kuo) at
71:11-72:18, 84:11-17.). Dr. Kuo stated that the 2D traditional solution was “problematic”
because of the need for precision and accuracy and “you will end up with trays that don’t fit.”
(Id. at 72:19-73:8.).
Beyond providing known orthodontic knowledge to others, Dr. Kuo recognized and
anticipated a new problem specific to clear aligners and worked iteratively with the other
inventors to come up with the exact solution to solve the unique problem. (Tr. (Kuo) at 68:16-
76:5, 84:8-15.). The ’647 and ’661 patents claim a specific solution for precise calculation of
positional differences and tracking of a treatment plan of teeth, that is, a two-step matching
process and calculation process using reference points on individual teeth or non-tooth, non-
moving regions of the computer model. (See JX-0001 at 9:63-10:23; JX-0002 at 13:8-30.). The
weight of the evidence reflected that in prior art and conventional techniques, 3D “matching,”
calculations and tracking were not performed at all. As the evidence reflected, to the extent that
there was matching, the process was performed manually by practitioners and resulted in
incomplete and inaccurate results. (Tr. (Kuo) at 72:19-73:8; JX-0001 at 2:4-11; JX-0002 at 2:41-
44.). Using the specific matching steps and calculation steps described in the patents, the
inventions provide improved solutions. (See JX-0001 at 2:53-58, 6:41-60, 10:59-67.).
As a result, the inventions here are not abstract, specific methods and improvements to
solve problems in existing technological processes and computer technology and do not simply
invoke the use of a generic computer. Alice at 2355, 2357. 3Shape is mistaken that any
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improvement lies only in the use of a computer to perform 3D calculations. 3Shape did not
present evidence to support its contention that the patents are directed to well-known and
conventional techniques. 3Shape presented only attorney argument. (RBr. at 6-7.).
Specifically, 3Shape did not offer evidence that the two-step matching and calculation
process of the claimed inventions was well-known or conventional. To the contrary, traditional
orthodontic measurements were performed manually and the inventors did not simply take the
traditional method using a ruler and invoke a computer. (See Section IV.A.).
The claims here are analogous to the claims that were held to be patent eligible in McRO,
Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016). In McRO, the court
found claims directed to a process for lip-synching animated characters that used specific rules to
automate a previously subjective manual process patent eligible. Id. at 1313-16. The Federal
Circuit found that “[w]hen looked at as a whole, claim 1 is directed to patentable, technological
improvement over the existing, manual 3-D animation techniques.” Id. at 1316; see also
Koninklijke KPN N.V. v. Gemalto M2M GmbH, 942 F.3d 1143, 1151 (Fed. Cir. 2019) (finding
patent eligible claims that recite a specific implementation of an existing tool that improved the
functionality of the technological process); Thales Visionix, Inc. v. United States, 850 F.3d 1343,
1348 (Fed. Cir. 2017); Diamond v. Diehr, 450 U.S. 175, 187 (1981).
The cases 3Shape cited are inapposite. 3Shape relied solely on cases where, unlike the
claims here, the “improvement” recited by the claims was at such a level of result-oriented
generality that the claims amounted to mere implementation of an abstract idea on a computer,
not to a specific solution and method that improves the relevant technology, or involved
processes were there was evidence that the claims could be performed by a human. See, e.g.,
Intellectual Ventures I LLC v. Symantic Corp., 838 F.3d 1307, 1313-18 (Fed. Cir. 2016) (claims
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directed to human practicable concepts as confirmed by specification); SAP Am., Inc. v.
InvestPic, LLC, 898 F.3d 1161, 1167 (Fed. Cir. 2018) (claims directed to merely performing
certain statistical analysis of information); Elec. Power Grp. v. Alstom S.A., 830 F.3d 1350,
1353-54 (Fed. Cir. 2016) (claims directed generally to analyzing and displaying information
without any new source or techniques); see also Koninklijke, 942 F.3d at 1151-53 (distinguishing
cases).
In its Post-Hearing Brief, 3Shape repeatedly argued that the concepts in the claims
amount to no more than the use of a generic computer to apply “conventional 3D modelling
techniques” to assess movement of teeth and do not claim improvements over known orthodontic
procedures or dentistry software. (RBr. at 6, 7, 9, 11, 12.). However, the evidence presented
during the Hearing establishes that the claims are specific methods and solutions that are
technological improvements in known orthodontic practices and dentistry software. (See Section
IV (regarding description of patents.). 3Shape did not cite to evidence to support its conclusory
attorney argument for the position they advance here. (RBr. at 6, 7, 9, 11, 12.).
Because the inventions here are non-abstract, specific methods and improvements to
solve problems in existing technological processes and computer technology, 3Shape’s argument
under Alice Step 1 fails.
b) 	Alice Step 2: The ’647 and ’661 Patents Claim an Inventive
Concept
As explained for Step 1, the claims are not directed to simply invoking a generic
computer for the performance of well-known techniques. To the contrary, evidence presented
during the Hearing demonstrates that the claims provide a specific method and solution that is a
technological improvement to known orthodontics and dentistry procedures and software. (See
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Section IV, supra.). 3Shape’s position disregards the specific teeth matching or non-tooth region
matching and measurement recitations of the claims.
Because the claims capture an improvement to conventional practice and are directed to a
technological improvement not attributable to a computer, but to the inventive concept of the
specific claimed process of matching and calculating, 3Shape’s argument under Alice Step 2 also
fails.
VIII. 	U.S. PATENT NO. 7,156,661
A. 	Infringement
1. 	Infringement Overview
Align accused 3Shape of directly infringing claims 2 and 20 of the ’661 patent,43 both
literally and under DOE. (CPBr. at 58-70; CBr. at 37-55.). Align also accused 3Shape of
indirectly infringing claims 2 and 20 of the ’661 patent by inducing infringement and
contributing to the infringement of these asserted claims.44 (CBr. at 47-49.).
Claims 2 and 20 depend from independent claims 1 and 19, respectively. Thus, an
analysis of each of the elements of claims 1 and 19 are provided in Section VIII.A.2(a) below.
Moreover, as shown in Table Nos. 6 and 7 below, the elements recited in claim 1 drawn to a
“method for matching computer models of a jaw” are nearly identical to the elements recited in
claim 19, which are drawn to a “tangible computer readable medium containing code for
matching computer models of a jaw.” Thus, the claim elements are addressed together in
43 In its Pre-Hearing Brief, Align alleged that the 661 Accused Products infringe both literally and under
DOE. (CPBr. at 58-70.). However, Align did not raise DOE against the asserted claims of the ’661
patent in its Initial Post-Hearing. Thus, Align has waived any argument on this issue under Ground Rule
10.2.
44 Indirect infringement for all Asserted Patents is addressed in Section XI.B, infra.
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Section VIII.A.2(a) below (e.g., elements [1.1] / [19.1], [1.2] / [19.2], etc.). The additional

elements contained in dependent claims 2 and 20 are also substantially similar and like claims 1

and 19, are addressed together in Section VIII.A.2(b) below.

Table No. 6: Comparison of Claims 1 and 19 of the ’661 Patent

computer models as a whole, using

Cl. 1 Element Cl. 19 Element

[1.1] | A method for matching computer [19.1] | A tangible computer readable
models of a jaw, the method medium containing code for
comprising: matching computer models of a jaw,

the tangible computer readable
medium comprising instructions to:

[1.2] | loading a first computer model of a [19.2] | load a first computer model of a jaw
jaw having teeth in initial positions; having teeth in initial positions;

[1.3] | loading a second computer model of | [19.3] | load a second computer model of the
the jaw, wherein positions of at least jaw, wherein positions of at least
some of the teeth in the second some of the teeth in the second
computer model are different than computer model are different than
the initial positions; the initial positions;

[1.4] | identifying at least one reference [19.4] | identify at least one reference point
point on a region of the first on a region of the first computer
computer model, the region model, the region comprising a
comprising a portion of the jaw portion of the model other than the
other than the teeth; teeth;

[1.5] | identifying a corresponding [19.5] | identify a corresponding reference
reference point on a corresponding point on a corresponding region of
region of the second computer the second computer model for each
model for each point identified on point identified on the first model;
the first model;

[1.6] | matching the region of the first [19.6] | ma[t]ch the region of the first
computer model with the computer model with the
corresponding region of the second corresponding region of the second
computer model, using the identified computer model, using the identified
reference points; reference points;

[1.7] | matching the first and second [19.7] | match the first and second computer

models as a whole, using the

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comprising: displaying the
positional differences between the
teeth in the first and second models.

Cl. 1 Element Cl. 19 Element
the matched regions; matched regions;

[1.8] | and calculating positional [19.8] | and calculate positional differences
differences between the teeth in their between the teeth in their initial
initial positions and the teeth in their positions and the teeth in their
positions in the second computer positions in the second computer
model, using the matched regions as model, using the matched regions as
non-moving reference regions. non-moving reference regions.

Table No. 7: Comparison of Claims 2 and 20 of the ’661 Patent
Cl. 2 Element Cl. 20 Element
[2.1] | The method of claim 1, further [20.1] | The medium of claim 19, further

comprising instructions to: display
the positional differences between
the teeth in the first and second
models.

For the reasons discussed in Section VIII.A.2(b) below, Align has met its burden and

proven that the 661 Accused Products practice claims 2 and 20.

2. The 661 Accused Products Practice Claims 2 and 20 of the ’661 Patent

a) Claims 1 and 19

i = [1.1] / [19.1]: “A method for matching computer models of a
jaw, the method comprising” / “A tangible computer readable
medium containing code for matching computer models of a
jan, the tangible computer readable medium comprising

instructions to”

Align presented evidence that TPM and CMS perform methods for matching computer

models of a jaw. (CX-0827C.0123-.0127; CX-0923; CX-2125C (Badler Expert Rpt.) at J 284-

88.). The user guides for TPM and CMS enable a user to compare intraoral scans or models of a

patient over time or to compare a current scan to a treatment plan. ((CX-0827C.0123-.0127; CX-

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0923; Tr. (Badler) at 430:14-432:6.).
3Shape did not dispute that the 661 Accused Products meet the preambles of these claim
elements in its Post-Hearing Reply Brief. (RRBr. at 27.). Thus, 3Shape has waived any
argument on this issue under Ground Rule 10.1.
For these reasons, Align has proven by a preponderance of evidence that the 661 Accused
Products meet preambles [1.1] and [19.1] of claims 1 and 19, respectively, of the ’661 patent.
ii. 	[1.2] / [19.2]: “loading a first computer model of a jaw having
teeth in initial positions” / “load a first computer model of a
jaw having teeth in initial positions”; [1.3] / [19.3]: “loading a
second computer model of the jaw, wherein positions of at
least some of the teeth in the second computer model are
different than the initial positions” / “load a second computer
model of the jaw, wherein positions of at least some of the
teeth in the second computer model are different than the
initial positions”
Evidence adduced in this Investigation establishes that both TPM and CMS allow a user
to select a patient and to load computer models of a patient’s jaw from the list of TRIOS scans or
models created over time and over different visits, including a treatment plan. (Tr. (Badler) at
432:7-434:3; CX-0827C.0123-.0127; CX-0923.0003-.0005; CPX-0208C; CX-2220C (Fisker
Dep. Tr.) at 40:17-41:1, 48:10-24; CX-2229C (Isleifsson Dep. Tr.) at 24:14-26:19; CX-2233C
(Khaitov Dep. Tr.) at 77:24-81:9; CX-2261C (Tommy Poulsen Dep. Tr.)45 at 153:14-155:15.).
The source code for TPM in 	, as discussed above in Section VII.A.3(a),
and
for CMS confirm the model scans that occur during different visits that comprise a treatment
45 When he was deposed on June 7, 2019, Mr. Tommy Paulsen was a Director at 3Shape. (CX-2261C
(Poulsen Dep. Tr.) at 14:17-15:3.). Prior to becoming a Director, Mr. Poulsen was, inter alia, a software
developer, project manager, group manager, and department manager at 3Shape. (Id. at 13:16-18, 14:17-
15:3.).
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plan. (CPX-0208C; CPX-0235C; CPX-0248C.).
In its Post-Hearing Reply Brief, 3Shape did not contest that the 661 Accused Products
meet these claim elements. (RRBr. at 27.). Because 3Shape did not address the issues on which
it has the burden of proof until its Reply Brief, 3Shape has waived any argument on this issue
pursuant to Ground Rule 10.1.
Accordingly, Align has proven by a preponderance of evidence that the 661 Accused
Products practice elements [1.2] / [19.2] and [1.3] / [19.3] of claims 1 and 19, respectively, of the
’661 patent.
iii. 	[1.4] / [19.4]: “identifying at least one reference point on a
region of the first computer model, the region comprising a
portion of the jaw other than the teeth” / “identify at least one
reference point on a region of the first computer model, the
region comprising a portion of the model other than the
teeth”46; [1.5] / [19.5]: “identifying a corresponding reference
point on a corresponding region of the second computer model
for each point identified on the first model” / “identify a
corresponding reference point on a corresponding region of
the second computer model for each point identified on the
first model”
TPM 3-Point Alignment allows a user to align initially a region of a model by manually
selecting three (3) corresponding points on an area on each scan, such as the preferred, non-
moving or immovable rugae region.47 (Tr. (Badler) at 434:25-436:20; Tr. (Bogdanic) at 812:22-
813:4, 814:1-8; Tr. (Mellor) at 1761:11-1762:20, 1763:17-24; CPX-0165C; CX-0884C; CX-
46 The term “reference point” was construed to mean “a point used to determine the position of a
computer model, or part thereof, relative to another computer model, or part thereof.” (Markman Order,
App. A at 7.). The term “region(s)” was construed to mean “area.” (Id. at 11.). The Parties agreed that
the phrases “comprising a portion of the jaw / model other than the teeth” mean “including at least a non-
tooth portion of the jaw.” (Markman Order, App. A at 19.).
47 Dr. Badler described the rugae as part of the jaw, other than the teeth, and are “like a fingerprint almost
on the roof of the mouth.” (Tr. (Badler) at 434:19-24; see also e.g., CDX-0011C.0088.).
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0891C.0001; CX-0917C.0001; CX-0923.0012; CX-2220C (Fisker Dep. Tr.) at 69:18-70:25; CX-
2229C (Isleifsson Dep. Tr.) at 61:23-65:16; CX-2230C (Isleifsson Dep. Tr.) at 223:20-224:12;
CDX-0011C.0081.).
The user can also select a region to optimize the initial alignment to align the jaw as a
whole, which 	, as discussed below in Section VIII.A.2(a)(v). (Tr. (Badler) at
814:13-20, 1763:25-1764:12; CX-0923.0013.). TPM allows the user to choose three
corresponding points anywhere on the primary and secondary jaw models. (CX-0923.0011-
.0014; Tr. (Badler) at 435:17-436:8, 813:5-12, 1762:24-1763:1; CX-2220C (Fisker Dep. Tr.) at
69:18-70:25.). The user manual explains that the points should be placed on areas of the jaw that
did not undergo changes during the time interval between scans, thus instructing the user to place
the points on non-moving regions or areas of the jaw model, such as the rugae area. (CX-
0923.0012, .0014; Tr. (Badler) at 434:25-435:16.).
3Shape’s corporate witnesses acknowledged that the user can place three (3) points
anywhere on the computer models of the jaws, including portions of the jaw such as the gingiva
or rugae. This is also supported by 3Shape’s technical documents. (CX-2229C (Isleifsson Dep.
Tr.) at 63:2-64:13; CX-2220C (Fisker Dep. Tr.) at 69:18-70:25; see also Tr. (Badler) at 435:17-
436:8; CX-0891C.0001; CX-0917C.0001.). 3Shape’s source code confirms this in
. (Tr. (Badler) at 436:9-20; CPX-0165C; CX-2230C (Isleifsson Dep.
Tr.) at 223:5-224:12.). As Dr. Badler testified, placing points on the rugae meets the adopted
construction of “reference points” because, as discussed below in Section VIII.A.2(a)(v), the
reference points will be used initially to position or match the regions or rugae of the two
computer models and the construction of “area” for region, as the rugae is an area on the
computer model and additionally satisfies the remainder of the claim language, which only
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requires the “region” to be a non-tooth portion on the model. (Tr. (Badler) at 434:4-436:20,
509:2-15, 512:13-513:13; see also JX-0002 at 13:16-18 (“identifying at least one reference point
on a region of the first computer model, the region comprising a portion of the jaw other than
the teeth”) (emphasis added).)
CMS also offers multiple model alignment methods, including Surface 1-Point and
Surface 3-Point. (Tr. (Badler) at 436:21-438:16, 1765:15-1766:16; CX-0767C; CX-
0827C.0123-.0127; CX-2233C (Khaitov Dep. Tr.) at 81:14-86:2; CX-2261C (Poulsen Dep. Tr.)
at 110:9-116:1.). For both methods, the user can identify corresponding points on each model
for alignment and optionally select the surface for a better alignment as a whole. (TR. (Badler)
at 436:21-438:16, 1765:15-1766:16; CX-0827C.0123-.0127; CX-2233C (Khaitov Dep. Tr.) at
89:18-90:4.). 3Shape’s documentation indicates that the placement of the corresponding points
can be on non-tooth areas of the models, including the rugae.
Figure 6: 3Shape Ortho Analyzer Manual
(CX-0775.0036-.0038.)
Thus, if the user selects three (3) points on the rugae region using the Surface 3-Point
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alignment method, for example, the rugae region is 	. (Tr.
(Mellor) at 1766:21-1767:1; CX-2233C (Khaitov Dep. Tr.) at 128:21-129:1.). 3Shape’s
corporate witness, Mr. Khaitov, confirmed that a user can select points on the rugae of each of
the computer models for the reason that it may be immovable and a good reference region, and
the resulting alignment may be more precise. (CX-2233C (Khaitov Dep. Tr.) at 87:2-88:3; see
also Tr. (Badler) at 436:21-438:16; Tr. (Mellor) at 1767:2-12.). This is shown in the source code
in
. (Tr. (Badler) at 438:3-10; CPX-0152C; CPX-
0153C; CPX-0154C; CX-2233C (Khaitov Dep. Tr.) at 84:5-85:16.).
For the reasons discussed above, Align has proven by a preponderance of evidence that
the 661 Accused Products practice elements [1.4] / [19.4] and [1.5] / [19.5] of claims 1 and 19,
respectively, of the ’661 patent.
iv. 	[1.6] / [19.6]: “matching the region of the first computer
model with the corresponding region of the second computer
model, using the identified reference points” / “ma[t]ch the
region of the first computer model with the corresponding
region of the second computer model, using the identified
reference points”48
TPM determines the position or matches the region or area of the first computer model
relative to the second computer model using the identified points by
, as an example. (Tr. (Badler) at 438:17-441:25; CX-2125C (Badler Expert Rpt.) at ¶¶ 335-
49.). In 3-Point Alignment, the points are chosen in an area that will be matched or aligned
. (Tr. (Bogdanic) at 814:13-
48 The terms “matching / match . . . using the identified reference points” was construed to mean “using
the identified reference points to determine the position of a region of the first computer model relative to
the corresponding region of the second computer model.” (Markman Order, App. A at 14.).
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816:2; Tr. (Mellor) at 1763:17-24; CX-2230 (Khaitov Dep. Tr.) at 228:1-231:21; CPX-0165C;
CX-0891C.0001; CX-0917C.0001.). As discussed below in Section VILA.2(a)(v),
OO or alignment of the jaw as a whole. (CX-2229C (Isleifsson Dep.
Tr.) at 87:1-15.).

Moreover, for example, the points are used to match the Po
ee
— . (Tr. Badler) at 439:8-441:23; Tr. (Mellor) at 1763:2-24;
CX-2230C (Isleifsson Dep. Tr.) at 223:20-227:25.). Thus, using the three (3) points, the
ees
a). The
[NNN 4. De. Baer demonstrated ths during the
Hearing and confirmed this in the sourcecode).

4” The
. See, e.g., CX-2230C son Dep. Tr.) at 226:6-12.).

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Page 103 of 287
Figure 7: 3-Point Alignment
(CDX-0011C.0094; see also Tr. (Badler) at 439:8-441:25; CPX-0165C starting at line 107; CX-
2230C (Isleifsson Dep. Tr.) at 223:20-227:25; CDX-0011C.0087-0093.).
Dr. Mellor conceded during the Hearing that the alignment using the three (3) points in
each model is an “initial” alignment and if the user puts the points on the rugae regions, it is the
rugae regions that are brought into more close proximity as part of the process. (Tr. Mellor) at
1763:2-24.).
CMS also matches the region or the area of the first and second computer models using
the identified points by aligning the corresponding points on the rugae. (Tr. (Badler) at 442:1-
18.). Mr. Khaitov confirmed that when Surface 1-Point or Surface 3-Point alignment methods
are used, 3Shape’s software will
. (CX-2233C (Khaitov Dep. Tr.) at 81:14-83-11.). After the point(s) are
identified, the user will draw a surface area that is going to define some additional region that
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will refine the matching. (Id.). For example, if the user selects three (3) points in the rugae
region, the rugae regions are matched 	. (Id. at 89:18-
90:4, 128:21-129:1; Tr. (Mellor) at 1767:17-1768:18; CX-0767C.). This is supported by the
same code identified for claim elements [1.4] and [1.5]. (Tr. (Badler) at 442:13-18; CPX-0152C;
CPX-0153C; CPX-0154C.).
Accordingly, Align has proven by a preponderance of evidence that the 661 Accused
Products practice elements [1.6] and [19.6] of claims 1 and 19, respectively, of the ’661 patent.
v. 	[1.7] / [19.7]: “matching the first and second computer
models as a whole, using the matched regions” / “match the
first and second computer models as a whole, using the
matched regions”
As discussed above, TPM uses the reference points initially to match a region. (Tr.
(Badler) at 438:17-441:25; Tr. (Mellor) at 1763:17-24; CX-2125C (Badler Expert Rpt.) at
¶¶ 350-61.). TPM first matches a non-tooth region, e.g., rugae, using the points, and then the
software performs 	to better align the jaw in its entirety. (Tr. (Badler)
at 442:19-444:24; Tr. (Mellor) at 1763:25-1764:12; CX-2229C (Isleifsson Dep. Tr.) at 66:23-
67:12; CX-2230C (Isleifsson Dep. Tr.) at 223:5-244:21.).
.50 (CX-2230C (Isleifsson
Dep. Tr.) at 228:1-18; Tr. (Mellor) at 1763:25-1764:12; CX-0891C.0001; CX-0917C.0001; CX-
2229C (Isleifsson Dep. Tr.) at 113:1-6; CX-2230C (Isleifsson Dep. Tr.) at 238:24-241:6.).
, because it needs an “initial guess” to better align
the jaw in its entirety. (Tr. (Badler) at 444:1-9, 445:21-24; Tr. (Mellor) at 1764:13-15; CX-
50 The term “optimization” is used here in the context of optimizing alignment of the selected points.
(See, e.g., Tr. (Mellor) at 1764:5-12.).
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2229C (Isleifsson Dep. Tr.) at 88:14-19; CX-2230C (Isleifsson Dep. Tr.) at 258:17-259:2; CX-
0948.0001
that
aligns or positions the models as a whole. (Tr. (Badler) at 443:10-13; Tr. (Bogdanic) at 814:23-
815:8, 830:8-19.).
Additionally, as discussed above in Section VII.A.3(a)(vii) for the ’647 patent for claim
element [1.9] / [18.9], TPM also has a Measurements view that shows the two (2) computer
models of the patient’s jaw overlaid and positioned as a whole in the same coordinate system.
(Tr. (Badler) at 444:10-24; CX-0923.0019-.0026; CX-2229C (Isleifsson Dep. Tr.) at 95:6-97:10,
103:24-104:12; CDX-0011C.0098.). In Measurements view, for example, TPM has a Scan
Comparison tool that can be used to measure the difference between two (2) scans to calculate
changes and tooth movement. (CX-0923.0023.). This Scan Comparison tool demonstrates that
the models are matched as a whole, using the matched regions, because the regions are matched
in the first step and if using the non-movable regions, such as the rugae, it will result in better
alignment and thus better calculation and display of changes or differences. (Tr. (Bogdanic) at
813:13-25; CX-2229C (Isleifsson Dep. Tr.) at 72:9-24.).
CMS also matches the first and second computer models as a whole, using the matched
regions. In this manner, CMS functions the same as TPM. (Tr. (Badler) at 444:25-446:16.).
After the points are used 	, the user defines a surface area matching so that
a finer alignment based on a user-selected area can then be performed. This area matching will
then align the models as a whole. (CX-2233C (Khaitov Dep. Tr.) at 81:14-83:11, 128:21-129:1;
CX-2261C (Poulsen Dep. Tr.) at 110:9-116:1; Tr. (Mellor) at 1768:19-1769:20.). The models
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are matched using the matched regions because as explained above,
. Additionally, 3Shape’s corporate witness verified that
and thus CMS uses the
matched regions for matching as a whole. (CX-2261C (Poulsen Dep. Tr.) at 113:22-115:7; CX-
0775.0038 (3Shape’s training guide showing how to use the initially matched rugae region for
optimization).).
Additionally, the models in CMS can be overlaid such that they are shown in the same
coordinate system as shown in the alignment code and thus are matched as a whole. (CX-2233C
(Khaitov Dep. Tr.) at 90:19-91:16.). This permits the user to visualize the model separately or
overlay them on top of each other. (Id. at 91:12-92:22.). 3Shape’s witness, Mr. Poulsen,
confirmed that a user can superimpose one model over the other model as well as compare the
upper and lower jaw of a second model. (CX-2261C (Poulsen Dep. Tr.) at 150:15-152:6.). The
regions are also used to match before the models are overlaid, and as discussed for claim
elements [1.4] and [1.5], selecting points on the rugae region of each of the computer models and
using those matched regions results in a more precise alignment and display. (CX-2233C
(Khaitov Dep. Tr.) at 87:2-88:3; Tr. (Badler) at 436:21-438:16.).
For the foregoing reasons, Align has proven by a preponderance of evidence that the 661
Accused Products practice elements [1.7] and [19.7] of claims 1 and 19, respectively, of the ’661
patent.
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vi. 	[1.8] / [18.8]: “calculating positional differences between the
teeth in their initial positions and the teeth in their positions in
the second computer model, using the matched regions as
non-moving reference regions” / “calculate positional
differences between the teeth in their initial positions and the
teeth in their positions in the second computer model, using
the matched regions as non-moving reference regions”
As discussed in Section VII.A.3(a)(viii) for the ’647 patent claim element [1.10], in the
Measurements view, a user can compare and perform measurements between two (2) selected
scans using various tools, such as Scan Comparison. (CX-0923.0016-.0026; CX-2125C (Badler
Expert Rpt.) at ¶¶ 362-72.). TPM’s Scan Comparison tool calculates movements of teeth, as
shown in 	distance between two points. (Tr.
(Badler) at 446:17-447:9; CPX-0061C; CX-2229C (Isleifsson Dep. Tr.) at 122:9-139:9.). Mr.
Bogdanic confirmed during the Hearing that the Scan Comparison tool shows in millimeters the
differences between teeth in the models. (Tr. (Bogdanic) at 831:16-21.). The changes are
calculated using the non-moving regions as a reference region because as discussed above, the
non–moving regions, e.g., rugae or gingiva areas, allow for more accurate alignment and better
results for calculating positional differences or changes. (Tr. (Badler) at 447:10-16.). TPM also
displays the changes in movement with different colors for user calculations, with the non-
moving regions as references as they are colored differently. (CX-0923.0016-.0026.). The user
is encouraged to select the region on which to place the points (i.e., the “matched region”) as a
non-moving reference region for better alignment and thus better calculations. (Tr. (Badler) at
446:17-447:16; CX-0923.0012.).
Similarly, CMS can be used to compare scans over time to determine differences in
movement between the two (2) models. (Tr. (Badler) at 447:20-448:14.). This is shown
expressly by the difference map in the Ortho System manual. (See CX-0827C.0123-.0127.).
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Once the models are matched, the user can see a map that shows the differences between the
teeth on the first model and the teeth on the second model. (Id.). The models are overlaid and
values indicate whether the tooth has moved inside or backwards, or forward or outside. (CX-
2233C (Isleifsson Dep. Tr.) at 90:5-96:2.). The matching and resulting calculation are done
using non-moving reference regions because, as discussed above, a user may select points on the
rugae, which 	. 3Shape’s witness, Mr. Isleifsson verified that a user can
choose the rugae precisely because it may be immovable and that the alignment and any
resulting calculation performed is more precise if the user selected the immovable part. (Id. at
87:3-89:1.)
As discussed above in Section VII.A.3(a) with respect to claim 1 of the ’647 patent, Dr.
Mellor’s analysis is incorrect that 3Shape’s TPM and CMS products only calculate “shape”
differences and not positional differences. Dr. Mellor acknowledged that Scan Comparison is
identified in the TPM manual as measuring tooth movement and that Mr. Bogdanic confirmed it
shows in millimeters the differences between teeth in the models. (Tr. (Mellor) at 1760:10-
1761:6; CX-2233C (Isleifsson Dep. Tr.) at 90:5-96:2.).
Moreover, as with Figures 9A and 9B discussed above in Section VII.A.3(a), Dr.
Mellor’s own testimony belies his position. Dr. Mellor pointed to Figure 10F of the ’661 patent
as showing “positional differences” as ostensibly opposed to “shape differences” in Figures 9A
and 9B. (Tr. (Mellor) at 1730:5-22.). But, Figure 10F clearly shows “move” and “deviation”
calculations—“positional” differences under Dr. Mellor’s own definition. (See JX-0002 at Fig.
10F.). The patent specification confirms and clearly states that Figure 10F shows “an exemplary
data analysis of teeth positional variances.” (Id. at 10:58-61.). The patent specification also
defines “deviation” as “the distance between the sampled point on one tooth and its projection
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point on the other tooth.” (Id. at 9:8-10.). This is a calculation performed by TPM and CMS.
Accordingly, Align has proven by a preponderance of evidence that the 661 Accused
Products practice elements [1.8] and [19.8] of claims 1 and 19, respectively, of the ’661 patent.
b) 	Claims 2 and 20
i. 	[2.1] / [20.1]: “The method of claim 1, further comprising:
displaying the positional differences between the teeth in the
first and second models.” / “The medium of claim 19, further
comprising instructions to: display the positional differences
between the teeth in the first and second models.”
Claim 2 depends from claim 1, which is directed to a method for matching computer
models of a jaw. As discussed above for claim elements [1.7] and [1.8] of the ’661 patent, TPM
and CMS display the positional differences between the teeth in the models by displaying a
difference map and highlighting changes on the computer screen. (Tr. (Badler) at 448:15-
449:22; CX-0827C.0123-.0127; CX-0923.).
Dr. Mellor did not provide testimony during the Hearing to dispute that TPM and CMS
meet this claim element. (Tr. (Mellor) at 1731:13-19.).
Claim 20 depends from claim 19, which is directed to a computer readable medium
containing code for matching computer models of a jaw. TPM and CMS are software tools for
the TRIOS Intraoral scanner hardware that enable a user to compare intraoral scans and
treatment plans to monitor a patient’s state and track changes as discussed above. 3Shape either
loads the software on hardware or transmits the software to users to load onto hardware. (See,
e.g., Tr. (Badler) at 449:23-450:14; CX-0827C.0008-.0016; CX-0923.0003, .0032.). Thus, TPM
and CMS are code stored on a computer.
Dr. Mellor did not provide testimony or opinion to dispute that TPM and CMS include
instructions on a computer readable medium. (Tr. (Mellor) at 1731:21-1732:6.).
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For the foregoing reasons, Align has proven by a preponderance of evidence that the 661
Accused Products practice the additional elements [2.1] and [20.1] recited in claims 2 and 20,
respectively, of the ’661 patent.
B. 	Technical Prong of Domestic Industry
1. 	The 661 DI Products Practice Claims 2 and 20 of the ’661 Patent
a) 	Claims 1 and 19
i. 	[1.1] / [19.1]: “A method for matching computer models of a
jaw, the method comprising” / “A tangible computer readable
medium containing code for matching computer models of a
jaw, the tangible computer readable medium comprising
instructions to”
iTero TimeLapse allows for comparison of a patient’s jaw scans over time. (Tr. (Badler)
at 451:5-453:5; CX-2251C (Mikhail Minchenkov Dep. Tr.)51 at 85:13-18; CX-2125C (Badler
Expert Rpt.) at ¶¶ 547-50.). As discussed in the iTero Element manual, two (2) models of a jaw
from the same patient may be selected by the user: “Once two scans are selected, the option
‘Compare Selected’ will become enabled and pressing it will launch the Comparison Tool.”
(CX-1967C.0049-.0050.). For example, an historical scan can be compared to the current scan
of the same patient. (CX-1956C.0005-.0007.). After analyzing the two (2) selected scans,
TimeLapse “will provide a color map in the areas where significant change exists between the 2
scans.” (Id.; see also CX-1581C; CX-1582C; CX-1952C.0028-.0029; CX-1955C.0013-.0015;
CX-1957C; CX-1958C; CX-1969C; CX-1823C; CX-1829C; CX-1830C; CX-1831C.). These
51 When he was deposed on July 12, 2019, Mr. Mikhail Minchenkov was a senior manager at Align
Technology. (CX-2251C (Minchenkov Dep. Tr.) at 14:15-20.). Mr. Minchenkov had been employed by
Align for 10 years. His role as senior manager included leading the algorithmic team, the application
team, and the back‐ end infrastructure team. (Id. at 18:13-18.). Align identified Mr. Minchenkov as a
fact witness to testify about the background and business of Align; the domestic industry with respect to
the Asserted Patents; and related issues. (CPSt. at 9.).
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functionalities are methods for matching computer models of a jaw. (CX-2251C (Minchenkov
Dep. Tr.) at 88:7-19.).
Accordingly, Align has proven by a preponderance of evidence that the 661 DI Products
preambles [1.1] and [19.1] of claims 1 and 19, respectively, of the ’661 patent.
ii. 	[1.2] / [19.2]: “loading a first computer model of a jaw having
teeth in initial positions” / “load a first computer model of a
jaw having teeth in initial positions”; [1.3] / [19.3]: “loading a
second computer model of the jaw, wherein positions of at
least some of the teeth in the second computer model are
different than the initial positions” / “load a second computer
model of the jaw, wherein positions of at least some of the
teeth in the second computer model are different than the
initial positions”
3Shape did not dispute that TimeLapse meets claim elements [1.2] / [19.2] and [1.3] /
[19.3] of the ’661 patent. (RPBr. at 53.). Moreover, Dr. Mellor did not address these claim
elements in his testimony during the Hearing. (Tr. (Mellor) at 1732:12-1734:22.).
TimeLapse allows a user to select two (2) models of a jaw from the same patient to
compare the two models, including comparing a historical scan to the current scan of the same
patient. (Tr. (Badler) at 454:1-23; CX-1967C.0049-.0050; CX-2251C (Minchenkov Dep. Tr.) at
88:21-99:21; CX-2125C (Badler Expert Rpt.) at ¶¶ 551-59.). The source code
. (CPX-0268C; CX-2251C (Minchenkov Dep. Tr.) at 88:21-
99:21.). When the teeth have moved, the earlier model will show the teeth in historical positions,
while the later model will show teeth in different positions. (CX-1967C.0049-.0050; see also id.
at .0034-.0048; CPX-0268C; CPX-0269C; CX-2251C (Minchenkov Dep. Tr.) at 88:21-99:21.)
For the foregoing reasons, Align has proven by a preponderance of evidence that the 661
DI Products practice elements [1.2 / [19.2] and [1.3] / [19.3] of claims 1 and 19, respectively, of
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the ’661 patent.
iii. 	[1.4] / [19.4]: “identifying at least one reference point on a
region of the first computer model, the region comprising a
portion of the jaw other than the teeth” / “identify at least one
reference point on a region of the first computer model, the
region comprising a portion of the model other than the
teeth”; [1.5] / [19.5]: “identifying a corresponding reference
point on a corresponding region of the second computer model
for each point identified on the first model” / “identify a
corresponding reference point on a corresponding region of
the second computer model for each point identified on the
first model”
TimeLapse practices these “identifying” claim elements under the adopted construction
of “reference point” and “region.” (Tr. (Badler) at 455:25-458:14; CX-2125C (Badler Expert
Rpt.) at ¶¶ 560-74.). TimeLapse 	. (Tr. (Badler) at
455:25-456:16; CPX-0298C; CX-2251C (Minchenkov Dep. Tr.) at 99:23-105:2.). TimeLapse
. (Tr. (Badler) at 456:17-458:14; CPX-0309C; CX-
2251C (Minchenkov Dep. Tr.) at 105:3-115:18.).
TimeLapse’s
(CX-2251C (Minchenkov Dep. Tr.) at 99:23-105:2.). This is shown in the source
code in 	. (Id.; CPX-0298C.). TimeLapse
. (CX-2251C (Minchenkov Dep. Tr.) at 105:3-110:15; CPX-0309C at line 57.).
The
. (Tr. (Badler) at 457:17-458:14; CX-2251C (Minchenkov
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Dep. Tr.) at 105:3-110:15; CPX-0309C.). In addition, the
. (CX-2251C
(Minchenkov Dep. Tr.) at 99:23-105:2, 119:13-122:5.).
Thus,
. (See id.).
In other words, because the
. (Tr. (Badler) at 455:25-456:10.). There is
. (See CX-2251C (Minchenkov Dep. Tr.) at 155:6-20.).
Dr. Mellor did not provide any testimony to dispute this functionality of TimeLapse
during the Hearing. He merely testified that TimeLapse does not “subdivide” the second model
into regions. (Tr. (Mellor) at 1732:12-1733:18.). However, there is no such requirement in the
claim language for identifying or subdividing regions, only that the points are identified on
corresponding regions. (JX-0002 at 13:16-21.). Dr. Badler’s testimony with respect to how
TimeLapse identifies reference points on corresponding regions thus is unrebutted.
For the reasons discussed above, Align has proven by a preponderance of evidence that
the 661 DI Products practice elements [1.4] / [19.4] and [1.5] / [19.5] of claims 1 and 19,
respectively, of the ’661 patent.
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iv. 	[1.6] / [19.6]: “matching the region of the first computer
model with the corresponding region of the second computer
model, using the identified reference points” / “ma[t]ch the
region of the first computer model with the corresponding
region of the second computer model, using the identified
reference points”
TimeLapse matches the region or portion of the first and second computer models using
the identified reference points. (Tr. (Badler) at 458:15-459:18; CX-2125C (Badler Expert Rpt.)
at ¶¶ 575-81.). As discussed above in Section VIII.B.1(a)(i), TimeLapse
. (See CX-2251C (Minchenkov Dep. Tr.) at 99:23-110:15.).
The
. (CPX-0323C; CX-2251C (Minchenkov Dep. Tr.) at
106:11-110:15.).
. (CPX-0324C ( 	at lines 77-93);
CX-2251C (Minchenkov Dep. Tr.) at 106:11-110:15.). The
. (Id. at 111:4-115:18.). The
. (Id.; CPX-0309C at line 283.). The
. (Tr. (Badler) at 458:15-459:14; CPX-0309C at line 71, 283.). Thus,
. (CX-2251C (Minchenkov
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Dep. Tr.) at 105:3-115:18.).
Accordingly, Align has proven by a preponderance of evidence that the 661 DI Products
practice elements [1.6] and [19.6] of claims 1 and 19, respectively, of the ’661 patent.
v. 	[1.7] / [19.7]: “matching the first and second computer
models as a whole, using the matched regions” / “match the
first and second computer models as a whole, using the
matched regions”
TimeLapse next matches the first and second computer models as a whole, using the
matched regions. (Tr. (Badler) at 459:19-460:13; CX-2251C (Minchenkov Dep. Tr.) at 115:19-
119:12; CX-2125C (Badler Expert Rpt.) at ¶¶ 582-88.). The
. (Tr. (Badler) at 459:19-460:13; CX-2251C (Minchenkov Dep. Tr.) at 115:19-
119:12.).
Specifically,
. (Tr. (Badler) at 459:19-460:13; CX-2251C (Minchenkov Dep.
Tr.) at 115:19-119:12.). There is
. (CX-
2251C (Minchenkov Dep. Tr.) at 117:1-119:12; CPX-0309C at lines 11, 160-72.). TimeLapse
. (CX-2251C (Minchenkov
Dep. Tr.) at 115:19-119:12; CPX-0309C.). Dr. Badler confirmed that this is illustrated in
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. (Tr. (Badler) at 459:19-460:15.).
Moreover, the
. (CX-2251C
(Minchenkov Dep. Tr.) at 115:9-116:25.).
For these reasons, Align has proven by a preponderance of evidence that the 661 DI
Products practice elements [1.7] and [19.7] of claims 1 and 19, respectively, of the ’661 patent.
vi. 	[1.8] / [18.8]: “calculating positional differences between the
teeth in their initial positions and the teeth in their positions in
the second computer model, using the matched regions as
non-moving reference regions” / “calculate positional
differences between the teeth in their initial positions and the
teeth in their positions in the second computer model, using
the matched regions as non-moving reference regions”
TimeLapse calculates positional differences between the two (2) models, using the
matched regions as non-moving reference regions. (Tr. (Badler) at 460:19-462:8; CX-
1967C.0049-.0050; CX-2251C (Minchenkov Dep. Tr.) at 115:9-116:25, 121:16-122:5; CX-
2125C (Badler Expert Rpt.) at ¶¶ 589-97.). TimeLapse can show tooth movement, gingival
recession, and tooth wear. (CX-1967C.0049-.0050; CX-1798C; CX-1839.). To show these
changes to the user, TimeLapse must calculate positional differences between the models. This
is supported by the source code that
. (CPX-0306C; see also CX-
1829C; CX-1582C.).
The
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. (Tr. (Badler) at 460:19-462:18; CX-2251C (Minchenkov Dep. Tr.) at 115:9-
116:25, 121:16-122:5.). This improves the accuracy of positional differences computed by the
application. (Tr. (Badler) at 460:19-462:18; CPX-0306C; CX-2251C (Minchenkov Dep. Tr.) at
121:16-122:5.). In TimeLapse,
. (CPX-0309C; CX-2251C (Minchenkov Dep. Tr.) at 115:9-116:25,
121:16-122:5.). Thus, TimeLapse
. (Tr. (Badler)
at 461:21-462:5; CPX-0309C at line 231.). This is illustrated and supported in
. (CPX-0306C at line 34.).
Accordingly, Align has proven by a preponderance of evidence that the 661 DI Products
practice elements [1.8] and [19.8] of claims 1 and 19, respectively, of the ’661 patent.
b) 	Claims 2 and 20
i. 	[2.1] / [20.1]: “The method of claim 1, further comprising:
displaying the positional differences between the teeth in the
first and second models.” / “The medium of claim 19, further
comprising instructions to: display the positional differences
between the teeth in the first and second models.”
Claim 2 depends from claim 1, which is directed to a method for matching computer
models of a jaw. TimeLapse displays the positional differences between the teeth by displaying
and highlighting changes on a computer screen. (See, e.g., Tr. (Badler) at 462:9-25; CX-
1967C.0050.). This is shown and supported in
(CPX-0270C.).
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Claim 20 depends from claim 19, which is directed to a computer readable medium
containing code for matching computer models of a jaw comprising the claimed instructions.
TimeLapse is a software tool for the iTero Element scanner hardware that enables a user to
compare intraoral scans to monitor that patient’s state and track changes. (CX-1967C.0003-
.0007.). The software is loaded onto the computer and TimeLapse is thus code stored on a
computer. (Tr. (Badler) at 463:1-13.). Additionally, TimeLapse includes instructions to display
the positional differences between the teeth in the first and second models, as discussed for claim
19.
For the foregoing reasons, Align has proven by a preponderance of evidence that the 661
DI Products practice the additional elements [2.1] and [20.1] recited in claims 2 and 20,
respectively, of the ’661 patent.
C. 	Invalidity
1. 	Invalidity Overview
3Shape alleged that the claims 2 and 20 are invalid as obvious the combination of
Commer (RX-0240)52 with Ashmore (RX-0239).53 (RBr. at 30-41; Tr. (Egbert) at 1077:16-
1079:5.). For the reasons discussed below, 3Shape failed to demonstrate by clear and convincing
evidence that Commer and Ashmore disclose all the elements of the asserted claims.
Furthermore, 3Shape has not presented clear and convincing evidence that a person of ordinary
52 P. Commer, C. Bourauel, K. Maier, & A. Jager, Construction and testing of a computer-based intraoral
laser scanner for determining tooth positions, Medical Engineering & Physics 22 (2000) 625-635
(received Oct. 5, 2000; accepted Nov. 22, 2000).
53 Jennifer L Ashmore, DDS, MSD, Brenda F. Kurland, MS, EdM, Gregory J, King, DMD, DMSc,
Timothy T. Wheeler, DMD, PhD, Joseph Ghafari, DMD, & Douglas S. Ramsay, DMD, PhD, MSD, A 3-
Dimensional Analysis of Molar Movement During Headgear Treatment, Am J Orthod Dentofacial Orthop
2002;121:18-30 (2002).
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skill in the art at the time of invention would have been motivated to combine Commer with
Ashmore and would have had any reasonable expectation of success.
2. 	Obviousness
a) 	Claims 1 and 1954
i. 	[1.1] / [19.1]: “A method for matching computer models of a
jaw, the method comprising” / “A tangible computer readable
medium containing code for matching computer models of a
jaw, the tangible computer readable medium comprising
instructions to”
3Shape relied upon Commer as prior art for the preamble. (RBr at 31; Tr. (Egbert) at
1078:1-20.). However, Commer does not teach or suggest the claimed “method for matching
computer models of a jaw.” 3Shape’s expert, Dr. Egbert, acknowledged that “[Commer] uses
those pallet regions as he does the matching.” (Tr. (Egbert) at 1120:2-9.). He conceded that “a
pallet by itself is not a jaw.” (Id. at 1107:4-7; see also id. at 1108:16-19.).
Accordingly, 3Shape has failed to meet its burden of proving by clear and convincing
evidence that Commer teaches the preambles of claims 1 and 19.
ii. 	[1.2] / [19.2]: “loading a first computer model of a jaw having
teeth in initial positions” / “load a first computer model of a
jaw having teeth in initial positions”; [1.3] / [19.3]: “loading a
second computer model of the jaw, wherein positions of at
least some of the teeth in the second computer model are
different than the initial positions” / “load a second computer
model of the jaw, wherein positions of at least some of the
teeth in the second computer model are different than the
initial positions”
3Shape relied upon Commer for these limitations. (RBr. at 31-33; Tr. (Egbert) at 1078:1-
20.). As Align pointed out, Commer does not teach or suggest the first and second “computer
54 3Shape did not separately address the elements of claim 19 in its Initial Post-Hearing Brief. (RBr. at
31-40.).
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model of a jaw” as recited in the claim elements. To the contrary, Commer discloses separate
models for the palate and molars for its method for determining molar movement. In particular,
Commer discloses that “the data sets have been segmented into separate clouds of the palate, the
moved molar and two further molars.” (RX-0240.0008 (emphasis added).). A point cloud is a
type of computer model, which Dr. Egbert acknowledged. (Tr. (Egbert) at 1106:7-9.). Thus,
these are separate computer models.
Dr. Egbert also confirmed that Commer creates separate models for the palate and
molars. (Id. at 1043:16-1044:11 (“[s]o once the two scans of teeth have been entered into the
computer, the next thing that Commer does is separates the pallet points from the other points”);
see also id. at 1107:16-24 (“Q. . . . Now, I want to take a look at a passage from Commer. As
you can see, we have highlighted here, it states, ‘surfaces have been generated from the point
clouds and the data sets have been segmented into separate clouds of the palate, the moved polar
and two further molars.’ Did I read that correct, sir? A. I believe so.”).). In other words, prior
to any matching, Commer discloses creating separate models that are less than a jaw from the
data sets, in particular, a palate model and separate molar models. (See, e.g., RX-0240.0008.).
Dr. Egbert confirmed this during cross-examination. (Tr. (Egbert) at 1107:1-12, 1107:25-
1108:15.). Furthermore, Dr. Egbert testified that “[Commer] uses those pallet regions as he
does the matching.” (Id. at 1120:2-9 (emphasis added).).
3Shape’s reliance on Figure 5 in Commer is misplaced because it appears that this figure
is not relevant to Commer’s disclosure for determining molar movement. (Compare RX-
0240.0005-6 (discussing acquisition of data) with RX-0240.0008-9 (the method for determining
tooth movements); see also id. at .0010 (Figure 8 illustrating the separate palate and molar
models).). In fact, Dr. Egbert conceded on cross-examination that he was “not sure what figure 5
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is” (Tr. (Egbert) at 1125:14-19) and that “Figure 8 does show what happens when you apply
[Commer’s] three steps” for determining molar movement (id. at 1125:20-23). (See also id. at
1125:24-1126:13.).
Because a model of a palate as disclosed in Commer is not a model of a jaw, 3Shape has
failed to meet its burden of proving by clear and convincing evidence that Commer teaches these
elements of claims 1 and 19.
iii. 	[1.4] / [19.4]: “identifying at least one reference point on a
region of the first computer model, the region comprising a
portion of the jaw other than the teeth” / “identify at least one
reference point on a region of the first computer model, the
region comprising a portion of the model other than the
teeth”; [1.5] / [19.5]: “identifying a corresponding reference
point on a corresponding region of the second computer model
for each point identified on the first model” / “identify a
corresponding reference point on a corresponding region of
the second computer model for each point identified on the
first model”
3Shape relied upon Ashmore for these limitations. (RBr. at 33-35; Tr. (Egbert) at
1078:1-20.). Ashmore does not teach or suggest the “identifying . . . on . . . [first/second]
computer model” as recited in the claim elements. Rather, Ashmore discloses identifying points
on plaster models prior to acquiring a digital model. In particular, Ashmore discloses that points
were identified on a plaster cast models and “[t]he points were [then] marked with a 0.3-mm
graphite pencil” prior to digitizing the points. (RX-0239.0003.). 3Shape appears to have
disregarded this disclosure, and argued that “Ashmore’s computer identifies reference points on
non-tooth regions of the computer model during the digitization step.” (RBr. at 34 (emphasis
added).). 3Shape’s argument is unsupported because Ashmore does not disclose an
identification step of reference points occurring on a computer model. (See generally, RX-
0239.0001-11.).
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3Shape attempted to overcome this deficiency of Ashmore by advancing a new argument
it did not raise in its Pre-Hearing Brief. (RPBr at 59-60; RBr. at 33-35.). In its Initial Post-
Hearing Brief, 3Shape contended that these claim elements are met because “Ashmore further
confirms that the digitized points are identified and present on the first computer model, e.g., the
T1 computer model.” (RBr. at 35.). 3Shape’s argument is waived under Ground Rule 7.2. (See
also Certain Graphic Systems, ID at 126-27.).
Because identifying points on a plaster model as disclosed in Ashmore is not identifying
points on a computer model, 3Shape has failed to meet its burden of proving by clear and
convincing evidence that Ashmore teaches these elements of claims 1 and 19.
iv. 	[1.6] / [19.6]: “matching the region of the first computer
model with the corresponding region of the second computer
model, using the identified reference points” / “ma[t]ch the
region of the first computer model with the corresponding
region of the second computer model, using the identified
reference points”
3Shape relied upon Ashmore for this limitation. (RBr. at 35-36; Tr. (Egbert) at 1078:1-
20.). The Commer-Ashmore combination does not teach or suggest the “matching the region of
the first computer model [of a jaw] with the corresponding region of the second computer model,
using the identified reference points” as required by the asserted claims.
As discussed above for claim elements [1.2] / [19.2] and [1.3] / [19.3], Commer does not
disclose a computer model of a jaw. Therefore, to the extent one of ordinary skill in the art
would have “exchange[d] Commer’s matching step with Ashmore’s matching step” as 3Shape
asserted (RBr. at 35-36), this matching step in the combination would have occurred on a first
and second model of a palate—not the jaw—as disclosed in Commer. (See, e.g., RX-
0240.0008.).
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Accordingly, 3Shape has failed to meet its burden of proving by clear and convincing
evidence that Ashmore teaches these elements of claims 1 and 19.
v. 	[1.7] / [19.7]: “matching the first and second computer
models as a whole, using the matched regions” / “match the
first and second computer models as a whole, using the
matched regions”
3Shape relied upon Commer for this claim element. (RBr. at 36-37; Tr. (Egbert) at
1078:1-20.). Commer does not teach or suggest the second “matching the first and second
computer models [of a jaw] as a whole, using the matched regions” as required by the asserted
claims. 3Shape identified Commer’s “final matching procedure” for this claim element. (RBr.
at 36.). However, Commer does not disclose or suggest any matching of a first and second
computer models as a whole. Rather Commer’s final matching procedure merely operates on
each individual molar.
For instance, Commer discloses that “[f]inal matching procedures of all transformed teeth
of cast 2 to the corresponding teeth of cast 1 deliver the movement parameters (X, Y, Z, ɸ, θ , Ψ)
from the function minimization for each individual molar.” (RX-0240.0008-9 (emphases
added).). Commer also states that “[t]he result [of the final matching procedure] is shown in Fig.
8c” (id. at 0008), and Figure 8 describes that 8c is the “matching of the moved molar and the
reference teeth” (id. at 0010) (emphases added). In other words, Commer’s final matching
procedure is applied to each of the tooth models, i.e., three molars, for “deliver[ing] the [tooth]
movement parameters” and, thus, only uses points in those tooth models and does not result in
the superimposition of the whole jaw models as shown in Figure 8c. (RX-0240.0008-10.). Dr.
Egbert acknowledged this on cross-examination, testifying that “a molar [i.e., tooth] is not a jaw”
(Tr. (Egbert) at 1107:8-15) and that “a model of three molars [is not] an entire jaw” (id. at
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1109:2-4.). Dr. Egbert also testified that in “figure 8, the entire jaw is not shown there.” (Id. at
1110:3-13.).
Additionally, Commer does not disclose or suggest any matching of a first and second
computer models as a whole, using the matched regions. As discussed directly above, Commer’s
final matching is applied to each of the tooth models to obtain the tooth movement parameters.
(See, e.g., RX-0240.0008-9.). Specifically, Commer discloses that these parameters are obtained
“from the function minimization for each individual molar.” (Id.). Commer provides that this
function minimization (i.e., surface-surface matching) “defines the distance between the point
clouds by the sum of the distances of each individual point in cloud one and two.” (RX-
0240.0008.). The final matching step as disclosed by Commer thus obtains the movement
parameters for each individual molar by using only those points in the transformed individual
molar of cast 2 to the corresponding individual molar of cast 1. (RX-0240.0008.). Dr. Egbert
conceded this on cross-examination, agreeing that for this limitation “the region has to be more
than—has to comprise the portion of the jaw other than the teeth.” (Tr. (Egbert) at 1111:20-
1112:12.). Because Commer’s final matching step only involves matching of the teeth models, it
cannot disclose or suggest this limitation for this additional reason.
Because any matching individual molar teeth disclosed in Commer is not the claimed
matching the first and second computer model of a jaw as a whole, 3Shape has failed to meet its
burden of proving by clear and convincing evidence that Commer teaches these claim elements.
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vi. 	[1.8] / [18.8]: “calculating positional differences between the
teeth in their initial positions and the teeth in their positions in
the second computer model, using the matched regions as
non-moving reference regions” / “calculate positional
differences between the teeth in their initial positions and the
teeth in their positions in the second computer model, using
the matched regions as non-moving reference regions”
3Shape relied upon Commer for this claim element. (RBr. at 37-38; Tr. (Egbert) at
1078:1-20.). Commer does not teach or suggest “calculating positional differences between the
teeth in their initial positions and the teeth in their positions in the second computer model, using
the matched regions as non-moving reference regions” as required by the asserted claims.
3Shape asserted that “Commer teaches this element by describing a method that calculates
translational and rotational ‘movement parameters’ – i.e., positional differences – of the moved
teeth after the ‘final’ matching step.” (RBr. at 37 (emphases added).).
3Shape mischaracterized Commer’s disclosure to support its argument.55 Contrary to
3Shape’s assertion, Commer discloses that “[f]inal matching procedures of all transformed teeth
of cast 2 to the corresponding teeth of cast 1 deliver the movement parameters (X, Y, Z, ɸ, θ, Ψ)
from the function minimization for each individual molar.” (RX-0240.0008-9 (emphases
added).). In other words, the final matching step in Commer delivers the tooth movement
parameters for each individual molar. Thus, 3Shape is mapping a single prior art element in
Commer to two claim elements, i.e., claim elements [1.7] / [19.7] and [1.8] / [19.8]. (Compare
RBr. at 36 with RBr. at 37.).
Moreover, Commer determines movement parameters by using only the points on a
55 3Shape either mischaracterized Commer or erroneously attempted to use Commer to support its
position when it does not. Commer should not have been used as prior art. This is the type of miscasting
that is occurring far too frequently. There is line between “colorable” advocacy and that which is not.
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tooth, which are not the claimed “matched regions.” (See, e.g., RX-0240.0008-9.). Dr. Egbert
acknowledged on cross-examination that “the [matched] region has to be more than—has to
comprise the portion of the jaw other than the teeth.” (Tr. (Egbert) at 1111:20-1112:12.).
Because 3Shape relied upon the same disclosure of Commer for two (2) distinct
limitations and because Commer fails to disclose or suggest “calculating positional differences . .
. using the matched regions as non-moving reference regions,” 3Shape has failed to meet its
burden of proving by clear and convincing evidence that Commer teaches these claim elements.
b) 	Claims 2 and 20
i. 	[2.1] / [20.1]: “The method of claim 1, further comprising:
displaying the positional differences between the teeth in the
first and second models.” / “The medium of claim 19, further
comprising instructions to: display the positional differences
between the teeth in the first and second models.”
3Shape relied upon Commer for these claims. (RBr. at 38-39, 40-41; Tr. (Egbert) at
1078:23-1079:5.). Commer does not teach or suggest the “display[ing] the positional differences
between the teeth in the first and second models.” Commer merely discloses a figure illustrating
the different stages in aligning point clouds—e.g., an initial model in white and a later model in
black. (RX-0240.0010.).
3Shape appears to have relied upon Commer for the specific “computer readable
medium” limitation. (RBr. at 40-41; Tr. (Egbert) at 1079:18-1080:4.). Commer does not contain
any discussion of a computer readable medium and also is devoid of discussion of code or
storing code for matching computer models. (RX-0240.0008.). To the extent that 3Shape relied
upon Ashmore, Ashmore also does not contain a discussion of a computer readable medium,
code or storing code for matching computer models. (RX-0239.0002-4.). Dr. Egbert failed to
explain how Commer or Ashmore discloses or suggests a computer readable medium for storing
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code for matching computer models. (See, e.g., Tr. (Egbert) at 1079:25-1080:10.).
Accordingly, 3Shape has failed to meet its burden of proving by clear and convincing
evidence that either Commer or Ashmore teaches these claim elements.
3. 	3Shape Failed to Present Any Evidence of Motivation to Combine or
Reasonable Expectation of Success
3Shape failed to present clear and convincing evidence that a person of ordinary skill in
the art at the time of invention would have been motivated to, or had a reason to, combine
Commer with Ashmore and would have a reasonable expectation of success. 3Shape argued that
one of ordinary skill in the art would have combined Commer with Ashmore because “a
POSITA would have recognized that the Ashmore modification results in a more accurate
matching” and by “us[ing] a select number (e.g., eight) of reference points on a specifically
stable region [would] improve processing speed and reduce processing burden.” (RBr. at 40.).
3Shape’s rationale for combining Ashmore with Commer ignores that Ashmore expressly
teaches away from using its disclosed methodology for matching two models. In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994) (“A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be discouraged from following the path set out
in the reference, or would be led in a direction divergent from the path that was taken by the
applicant . . . [or] if it suggests that the line of development flowing from the reference’s
disclosure is unlikely to be productive of the result sought by the applicant.”) (emphases
added).).
Here, Ashmore expressly discloses that its methodology is undesirable for application in
orthodontics because of poor results in measuring molar movements. (RX-0239.0001; see also
Tr. (Egbert) at 1112:21-1113:5.). For example, Ashmore states “[t]he reliability of the method
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for computing rotation of maxillary molars was poor.” (RX-0239.0006 (emphases added); see
also Tr. (Egbert) at 1113:6-16, 1113:21-1114:11.). In particular, “the large standard deviations
for rotations (7°- 11°) indicate an unacceptably large measurement error.” (RX-0239.0006
(emphasis added); see also (Tr. (Egbert) at 1113:6-1115:2.).
Moreover, one of ordinary skill in the art would not have been motivated to incorporate
Ashmore’s methodology into Commer’s for measuring molar displacement where the
combination of Ashmore would make Commer “inoperable for its intended purpose.” Plas-Pak
Indus., Inc. v. Sulzer Mixpac AG, 600 F. App’x 755, 758 (Fed. Cir. 2015) (emphasis added). As
Commer discloses, precision and accuracy in the measurement of molar displacement is an
indisputably important factor in orthodontics. (RX-0240.0009 (stating that the error should
ideally be zero).). Commer states that “[a]n error [in measurement] of up to 10% should be
adequate” for orthodontic application where the tooth movement can range up to “several 10
degrees for rotations.” (RX-0240.0009; Tr. (Egbert) at 1116:20-1117:7.). Despite these
disclosures in Commer, Dr. Egbert testified that he was “not sure exactly what that accuracy
needs to be,” or what the reliability needs to be, for measuring rotation in the field orthodontics.
(Tr. (Egbert) at 1118:22-1119:8.).
3Shape offered the combination of Commer and Ashmore “to exchange Commer’s
matching step, which uses all points of the segmented palate point cloud, with Ashmore’s
matching step, which uses the digitized reference points on the palatal rugae.” (RBr. at 39-40.).
However, as Align noted, 3Shape did not provide provide any weighting or balancing of
benefits, both lost and gained, for this alleged combination. See, e.g., Winner Int’l Royalty Corp.
v. Wang, 202 F.3d 1340, 1349 at n.8 (Fed. Cir. 2000). Furthermore, 3Shape violated the
“longstanding principle that the prior art must be considered for all its teachings, not selectively”
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because 3Shape neither considered the intended purpose of Commer nor the express criticisms in
Ashmore. See, e.g., Merck & Cie v. Gnosis S.p.A., 808 F.3d 829, 834-35 (Fed. Cir. 2015).
3Shape merely relied upon the unsubstantiated testimony of its expert that he has not
“experimented with putting [Commer and Ashmore]” together (Tr. (Egbert) at 1116:10-19), he
had not “writt[en] any software program that involve superimposing two or more digital models”
(id. at 1105:17-20), and he does not have any experience with applying techniques in computer
graphics to dentistry or orthodontics (id. at 1105:17-20). Thus, 3Shape did not offer any credible
evidence to support 3Shape’s conclusory contention that Commer combined with Ashmore
would improve both its efficiency and accuracy.
For the reasons discussed above, 3Shape has failed to prove by clear and convincing
evidence that asserted claims 2 and 20 of the ’661 patent are invalid.
IX. 	U.S. PATENT NO. 8,102,538
A. 	Infringement
1. 	Infringement Overview
Align has failed to prove by a preponderance of the evidence that the 538 Accused
Products satisfy the limitations of claims 1 and 2 of the ’538 patent.
Specifically, the 538 Accused Products lack the claimed “optical scanner” that is separate
and distinct from the claimed “imaging means.” The ’538 patent teaches the use of an optical
scanner to capture depth data and a distinct imaging means to capture color data. (JX-0003 (’538
patent) at 25:11-14 (“any suitable means for providing 3D scanning can be used so long as the
3D scan and the color 2D scan correspond substantially to the same object or portion thereof
being scanned, and the same frames of references are maintained.”).).
The 538 Accused Products operate not by separating these functionalities, but instead by
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combining them, such a single mechanism is used to capture a cohesive set of pixel information

used to calculate both the color and depth contours of a scanned object. Specifically, the 538

Accused Products:

. In other words, the 538 Accused Products

possess only the claimed “imaging means.” There is no separate “optical scanner” for capturing

only depth data.
Table No. 8: Claims 1 and 2 of the ’538 Patent
Cl. 1 Element aoe
(1.1 A device for determining the surface topology and associated
(preamble) color of at least a portion of a three dimensional structure, Y
comprising:
optical scanner configured for providing depth data of the
[1.2] portion corresponding to a two-dimensional reference array N
substantially orthogonal to a depth direction;
1.3] imaging means configured for providing two-dimensional color y
. image data of the portion associated with the reference array;
wherein the device is configured for maintaining a spatial
[1.4] disposition with respect to the portion that is substantially fixed N
during operation of the optical scanner and the imaging means.
Cl. 2 Element
The device according to claim 1, wherein the operation of the
[2] Z P Y
optical scanner is based on confocal imaging techniques.

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2. 	The Accused Products Do Not Practice Claims 1 and 2 of the ’538
Patent Literally or Under the Doctrine of Equivalents
a) 	[1.1]: “A device for determining the surface topology and
associated color of at least a portion of a three dimensional
structure, comprising:”
As shown below in Figure 8, the 538 Accused Products56 are devices for “determining
the surface topology and associated color of at least a portion of a three dimensional structure.”
(Tr. (Stevenson)57 at 863:1-864:13; CDX-0014C.0028-29.). Dr. Stevenson testified, and
3Shape’s engineer, Mr. Kristian Hansen,58 verified, that the TRIOS scanner
in order to render a 3D model of a 3D object (e.g., teeth, gums, etc.). (Tr.
(Stevenson) at 860:5-23; Tr. (Hansen) at 1238:19-23; CDX-0014C.0026; CX-0351C.0002.).
3Shape’s expert, Dr. James Zavislan,59 corroborated that the TRIOS scanners “are devices for
56 The Accused TRIOS scanners include all versions of the TRIOS 3 and TRIOS 4 currently for sale in
the United States. (Tr. (Stevenson) at 846:12-24; Joint Stipulation Regarding Representativeness of the
TRIOS 3 Products (“Trios 3 Rep. Product Stip.”) (Doc ID No. 691981 (Oct. 23, 2019)); CX-2164C; CX-
0387C; CX-0388C; CX-0389C; CX-0391C; CX-0392C; CX-0975C.).
57 When he testified during the Hearing on October 28, 2019, Dr. Robert Stevenson was an Associate
Chair of the Department of Electrical Engineering at the University of Notre Dame. (CPSt. at Ex. 3.).
Align identified Dr. Stevenson as an expert witness to testify to “the technical background of the ’538
Patent; the interpretation of claims in those patents; the design, manufacture, structure, function, and
operation of the accused products and any article or method asserted to be protected by the asserted
patents; the knowledge of a person of ordinary skill in the art; the scope of the prior art; other issues in
connection with infringement, validity, enforceability and/or the technical prong of the domestic industry
requirement; and any other technical issues that may arise.” (CPSt. at 11.). Align indicated that Dr.
Stevenson “may also be called to rebut the testimony of Respondents’ expert or fact witness, should any
be presented, regarding the same.” (CPSt. at 12.).
58 When he testified during the Hearing on October 30, 2019, Mr. Kristian Hansen was a project manager
at 3Shape A/S. (Tr. (Hansen) at 1183:25-1184:4.). 3-Shape identified Mr. Hansen as a fact witness to
testify “regarding 3Shape’s design and development of its Trios intraoral scanners and the structure,
function, and operation of those products.” (RPSt. at 2.).
59 When he testified during the Hearing on October 31, 2019, Dr. James Zavislan was an Associate
Professor of Optics at the University of Rochester Institute of Optics, having worked in that position since
2002. (Tr. (Zavislan) at 1614:3-13.). Prior to his career as a professor, Dr. Zavislan earned his Ph.D.
from the University of Rochester in 1988 and worked for five years at IBM Almaden Research Center.
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determining the surface topology and an associated color of at least a portion of a three-
dimensional structure.” (Tr. (Zavislan) at 1681:7-11.). Certain 3Shape documents confirm that
the TRIOS meets the preamble of claim 1. (CX-0318C.0001, 3; CX-0333C; CX-0386C.0003;
CX-0388C.0003, 5; CX-0397C.0002; CX-0810C.0011; CX-0815C.0035.).
Figure 8: Align’s Depiction of the 538 Accused Products Determining “Surface Topology”
and Associated Color of Scanned Object
(CDX-0014C.0026 (introduced during the testimony of Dr. Stevenson).).
In its Reply Post-Hearing Brief, 3Shape contended that the 538 Accused Products fail to
satisfy the preamble of claim 1 because they do not determine “surface topology.” (RRBr. at 59-
60.). However, 3Shape did not raise or address this argument in its Pre-Hearing Brief and thus
(Id. at 1613:1-25.). He also co-founded a medical imaging company called Lucid and led the optical
development on the VivaScope 1000 system, which performed in vivo measurement of skin and oral
tissues for cancer diagnoses. (Id.). 3-Shape identified Dr. Zavislan as an expert witness to testify
“regarding the invalidity of Align’s U.S. Patent No. 8,102,538 (the ‘’538 patent’).” (RPSt. at 5.).
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waived the argument pursuant to Ground Rule 7.2. (RPBr. at 103-104.).
Accordingly, Align has proven by a preponderance of evidence that the 538 Accused
Products practice element [1.1] of the ’538 patent.
b) 	[1.2]: “optical scanner configured for providing depth data of
the portion corresponding to a two-dimensional reference
array substantially orthogonal to a depth direction;”
i. 	Align Failed to Prove Literal Infringement of “Optical
Scanner”
The Parties’ disputed whether the 538 Accused Products possess the claimed “optical
scanner” required by asserted claims 1 and 2. According to Align, referencing the contested
Markman construction of this term, each 538 Accused Product is “a device that uses light
projection to capture data other than color image data,” literally or under the doctrine of
equivalents. (CBr. at 80-89; Markman Order, App. A at 42.). 3Shape challenged this
description and argued that the 538 Accused Products cannot possess an “optical scanner”
because the 	that Align identified as purportedly part of the
“optical scanner” enables the scanner to capture precisely what the claim construction says an
“optical scanner” cannot capture: color image data. (RRBr. at 51 (citing Tr. (Mike van der
Poel)60 at 1584:7-1585:18, 1609:22-1610:6, 1610:10-24; (Tr. (Zavislan) at 1634:21-1635:4,
1635:14-1636:7, 1656:7-15, 1658:18-1659:7, 1659:12-1660:16) (emphasis added).).
However, the 538 Accused Products do not contain an “optical scanner,” literally or
under the doctrine of equivalents. What Align identifies as the “optical scanner” captures color
60 When he testified during the Hearing on October 31, 2019, Mr. Mike van der Poel held the position of
Scanner Manager and Director of New Business Ventures with 3Shape. (Tr. (Poel) at 1577:5-20; CX-
2276 at 10:25-11:9.). 3Shape identified Mr. Van der Poel as a fact witness who was called to testify
regarding 3Shape’s design and development of its TRIOS intraoral scanners and the structure, function,
and operation of those products. (RPSt. at 3.).
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image data in violation of the claim construction for that term.

“oe 9: oe oe of the Accused TRIOS Scanner Showing

(CDX-0014C.0019 (introduced during Dr. Stevenson’s testimony).).
To obtain depth and color information for a portion of an object, the 538 Accused

Products perform subscans, as shown below in Figure 10. (CX-0558C.0005-6; Tr. (Hansen) at

1185:9-1188:9). A subscan consists of lll
oo . (CX-0386C.0008 (“A 3D image (scan) is obtained by
>: cx-0558¢-.0009

(“a single subscean| Tr. (van der Poel) at 1602:11-15.). The
538 Accused Products generate a subscan by using: (1) re

LLL ana

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2)
Po that comprise the subscan. (RX-0569C.0008; Tr. (Zavislan) at 1631:22-

1632:10.).

Figure 10: Align’s Depiction of 538 Accused Products Performing Multiple Subscans and,
for Each Scan

(CDX-0014C.0022 (introduced during the testimony of Dr. Stevenson).).

The 2D subscans capture data that are then used to determine the 3D depth and color of

the resulting 3D model. (RRBr. at 50.). For 3D depth data, Po

6! The image sensor consists of a set of red, green, and blue color filters arranged in front of the
photosensors in the image sensor. -0430C at 51:5-52:25: Tr. (van der Poel) at 1591:20-1592:16,

1631:9-18.). The

. (RX-0430C at 63:14-64:17; Tr. (van der Poel) at

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are used.
, as shown below in Figure 11. (CX-1204C.0010, 21.).
To determine depth for a single point,
. (Tr. (Stevenson) at 851:13-852:6, 856:23-859:4; RPBr. at
94; CDX-0014C.0022-23.).
. (Tr. (Stevenson) at 848:3-17; CDX-
0014C.0019.). The images each 	.
. (Tr. (Stevenson) at 856:23-858:18; CDX-0014C.0023.). The 538
Accused Products use 	to calculate depth
measurements. (CBr. at 79.).
Figure 11: Align’s Depiction of Depth Processing in the 538 Accused Products
(CDX-0014C.0023 (introduced during the testimony of Dr. Stevenson).).
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To collect color data, the image sensor includes pixels fitted with red, green, and blue
filters. (Tr. (Stevenson) at 848:3-17.). As shown below in Figure 12, the 538 Accused Products
calculate color using the red, green, and blue pixels
. (Tr. (Stevenson) at 859:4-860:4; CDX-0014C.0025.). The
color values of those particular red, green, and blue pixels 	. (Tr. (Stevenson) at
858:19-859:4; CDX-0014C.0024.). The color is then associated with the depth
. (Tr. (Stevenson) at 859:4-860:4; CDX-
0014C.0025.). The 538 Accused Products then stitch together information from multiple
subscans to create a 3D model. (Tr. (Stevenson) at 860:5-23; CDX-0014C.0026.).
Figure 12: Align’s Depiction of Color Processing in the 538 Accused Products
(CDX-0014C.0024 (introduced during the testimony of Dr. Stevenson).).
3Shape contended, as shown above in Figure 12, that the color image sensor in the 538
Accused Products captures all the light reflected from the scanned object, using red, green, and
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blue pixels of the color image sensor. (Tr. (Stevenson) at 983:17-984:2, 995:9-16; Tr. (van der
Poel) at 1584:7-1585:18; Tr. (Zavislan) at 1635:14-1636:7, 1658:18-1659:7.). Yet, as explained

also, iii. tnstead, Dr. Stevenson

and Dr. Zavislan agreed, as shown above in Figure 12, that the 538 Accused Products derive

performed.™ (Tr. (Stevenson) at 849:18-850:4, 851:13-852:6, 858:13-18, 865:3-867:15, 987:4-
8; CDX-0014C.0032-36; Tr. (Zavislan) at 1660:1-16; CX-0668C; CX-0978C.0006; CX-

1204C.0009; Tr. (Hansen) at 1241:24-1242:7; Tr. (van der Poel) at 1603:17-23.).

Moreover, iii
LLL. stevenson) at
859:4-860:4; CDX-0014C.0025.). To Align, the

demonstrates the independence of depth and color data in the 538 Accused Products. (CBr. at
82-83.).

Against this backdrop, Align asserted that its expert, Dr. Stevenson, “testified that the

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TRIOS provides depth data by
(CBr. at 80 (emphasis added).). This attempted sleight
of hand is a mischaracterization of the record. Dr. Stevenson actually testified that the “optical
scanner” of the TRIOS
. His exacts words were: “it is an optical
scanner configured to
(Tr. (Stevenson) at 865:25-866:2 (emphasis added).).
Align’s mischaracterization of Dr. Stevenson’s testimony, together with its distortive
wordsmithing illustrates how Align’s infringement position flies in the face of the Markman
Order without formally challenging the claim construction that was adopted. The Markman
Order clearly explains that “the ‘optical scanner’ does not capture color image data.” Moreover,
the Markman Order also explains that the adopted construction of “optical scanner” “effectively
restores the depth and color data independence touted by the patentee and used by the patentee to
overcome Mueller,” a prior art reference that the patentee distinguished during prosecution of a
related patent. (Markman Order, App. A at 54.).
In line with the Markman Order, Dr. Stevenson did not testify that the purported “optical
scanner” of the TRIOS captures “data other than color image data.” He could not have testified
in this way without deviating from either the facts or the Markman Order. Nevertheless, in direct
contravention of the Markman Order, and without the support of either expert, Align insisted on
mapping the “optical scanner” limitation onto functionality that explicitly captures color image
data and, thus, cannot be an “optical scanner.”
Align also stated wrongly that its infringement theory is in line with “[t]he rationale
behind the court’s claim construction.” (CBr. at 82 (“The function of the claimed ‘optical
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scanner’ is to 	Order No. 36 at 46 (citing JX-
0003 at 12:21-23.). This is
).). In so doing, Align made a critical error. Align ignored the express
language of the adopted claim construction, which targets what data are captured by the “optical
scanner:” “a device that uses light projection to capture data other than color image data.”
(Markman Order, App. A at 42.).
Within the 538 Accused Products, the purported “optical scanner” clearly
, as Dr. Stevenson acknowledged. Therefore, the Accused Products cannot satisfy the
claim construction contrary to Align’s unsuccessful attempt at revisionism. (Tr. (Stevenson) at
983:13-984:2 (conceding that the output of the pixels of a color image sensor would constitute
color image data).). As 3Shape explained:
constitute color image data. … The fact that
only the 	derive depth does not change the fact that the
captured image data is color image data.” (RRBr. at 51-52 (citing Tr. (van der Poel) at 1592:17-
21; Tr. (Zavislan) at 1660:1-16).).
Align also tried to suggest that the ’538 patent discloses embodiments that operate like
the 538 Accused Products. (CBr. at 82.). Align argued:
For example, the ’538 patent discloses a color CCD for capturing red, green, and
blue reflected from white illumination and using the red channel to determine
depth. … Thus, this embodiment illustrates the dual use of [white light] image
data—for both depth data and 2D color image data.
(Id.).
Align’s diversionary tack is unavailing for two (2) reasons. First, the time for claim
construction passed months ago. The Markman Order states that: “the ‘optical scanner’ does not
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capture color image data” and that the adopted construction of “optical scanner” “effectively
restores the depth and color data independence touted by the patentee[.]” (Markman Order, App.
A at 54.). To the extent that Align tried to use embodiments disclosed in the specification of the
’538 patent to reargue claim construction, it is too late. Moreover, Align has not addressed the
relevance of these embodiments in light of the prior art, Mueller and, in particular, the patentee’s
comments during prosecution with respect to how the claimed invention overcame Mueller.
(Markman Order, App. A at 54.).
Second, it appears that none of the embodiments from the ’538 patent to which Align
cited describes deriving depth data from a color image sensor capturing white illumination. (Tr.
(Zavislan) at 1686:19-22.). Where the ’538 patent describes the use of white light illumination
and a color image sensor, the ’538 patent does so in the context of capturing a 2D color image.
(See JX-0003 (’538 patent) at 23:43-46 (“According to a second technique for providing the
aforesaid 2D color image ….”).). Passages in the ’538 patent that Align cited describe the use of
a color CCD in conjunction with monochromatic (not white light) illuminations. (See JX-0003
at 24:13-17 (referring to the sixth embodiment, described at 23:6-42, which describes the use of
red, blue, or green illuminating radiations for obtaining depth data).). Align also cited to
embodiments that use different monochromatic illuminations and a monochromatic image
sensor. (See JX-0003 (’538 patent) at 16:37-23:42 (using different colored illuminations and a
monochrome image sensor), 19:44-48 (generating monochromatic data from a monochromatic
illumination).). Yet, missing from the specification is an embodiment that functions like the 538
Accused Products.
Thus, based upon the explanations and distinctions provided above, Align’s bald attempt
to read “optical scanner” on the 538 Accused Products fails because Align’s argument is not
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supported by the operation of the 538 Accused Products, by the constructions in the Markman
Order, or the intrinsic evidence. Align should not have asserted this argument. It involved
testimony mischaracterization and an unfortunate twisting of the Markman Order, not to mention
the patent specification.
ii. 	Align Failed to Prove Infringement of “Optical Scanner”
Under the Doctrine of Equivalents
Align also failed to prove by a preponderance of the evidence that the 538 Accused
Products possess an “optical scanner” under the doctrine of equivalents. Align recognized that
the patentee’s previously discussed amendment over Mueller led to the narrowing claim
construction that thwarted Align’s attempt to prove literal infringement, as explained above.
(CBr. at 87.). Align nevertheless argued that “’the rationale underlying the … amendment
[bears] no more than a tangential relationship to the equivalent in question.’” (Id. (citing Festo
Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 344 F.3d 1359, 1369–70 (Fed. Cir.
2003).). According to Align, “[i]n allowing the claims, the Examiner stated that Mueller
disclosed ‘using the color information from a series of two dimensional color images to derive
the three dimensional location in space of the surface points which produced the color images.’”
(Id. (citing CX-2178.0239).). By contrast, the 538 Accused Products purportedly “associate two
independent sets of data, the exact limitation that was added to overcome Mueller.” (Id.).
Align’s argument here is unavailing because it selectively focuses on the language of the
claim amendment while ignoring the patentee’s justification for the amendment. As the patentee
explained in making the amendment, “depth data is obtained independently of the colour data,
and the two sets of data are combined by conformally mapping or associating the colour data
with the depth data for a given two-dimensional array of points.” (CX-2178 at 170-72 (emphasis
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added).). As shown below in Figure 13, and as discussed at length above, the 538 Accused

Products do not capture or obtain depth data independently of color data. Instead, the 538

couse Prt collin

(NNN. te one a, anc NN

(SUNN, on te other hand. They then ill
PY The underlying data comes from a cohesive source — the

subscans.

(CDX-0014C.0025 (introduced during the testimony of Dr. Stevenson).).

In other words, the 538 Accused Products determine depth data directly from, not

independent of, captured color image data. (Tr. (van der Poel) at 1592:17-21, 1610:2-6, 1656:7-

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15, 1658:18-1659:7.). Indeed, “[t]he Trios 3/4 captures
[.]” (RRBr. at 51-52 (citing Tr. (van der Poel)
at 1592:17-21; Tr. (Zavislan) at 1660:1-16).). Consequently, the operation of the 538 Accused
Products is a substantial departure from the claimed “optical scanner,” which is explicitly
forbidden from capturing color image data. (Order No. 36, Appx A at 54.).
Pursuant to patent prosecution principles, Align is barred from using the doctrine of
equivalents to recapture subject matter the patentee disavowed during prosecution. Augme
Technologies, Inc. v. Yahoo! Inc., 755 F.3d 1326, 1335 (Fed. Cir. 2014) (DOE cannot
“encompass a structural feature that is the opposite of, or inconsistent with, the recited
limitation”). Notwithstanding Align’s assertions to the contrary, using 2D color scans to derive
3D depth and color topology is the same concept the patentee disclaimed during prosecution.
(CX-2178. at 238 (“Mueller discloses using the color information from a series of two
dimensional color images to drive the three dimensional location in space of the surface points
which produced the color images”).). Align cannot now, in the throes of litigation, reclaim claim
scope that it previously abandoned.
Based on the analysis above, Align has failed to prove that the 538 Accused Products
satisfy the “optical scanner” limitation of claims 1 and 2 under the doctrine of equivalents.
iii. 	Align Proved Infringement of the Remainder of Element [1.2]:
“configured for…”
According to Align, the 538 Accused Products are “configured for providing depth data
of the portion corresponding to a two-dimensional reference array substantially orthogonal to a
depth direction.” (CBr. at 84.). Dr. Stevenson’s testimony and supporting documentary
evidence prove that, as shown below in Figure 14, the 538 Accused Products provide depth data
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such that depth direction is defined by the
. (Tr. (Stevenson) at 931:8-933:17; CX-0722C; CX-0723C; CX-0978C.0006;
CDX-0014C.0037-39, 41; CX-0464C; CX-0978C.0016; CX-2279C:21:10-15; CX-
2276C:155:25-156:14.). The supporting documents together with Dr. Stevenson’s testimony are
consistent with the language of the ’538 patent, which states that the image sensor may define a
two-dimensional (X-Y) “frame of reference.” (JX-0003 (’538 patent) at 10:55-57, 12:65-13:1
(“Detection optics 60 comprises an image sensor, typically a CCD…, and which typically
defines the X-Y frame of reference.”), 15:30-65, 21:48-50 (“the depth scan is obtained by
displacing the objective [lens] 166 along the Z-direction in a continuous or stepped motion”).).
Dr. David Schaafsma,63 3Shape’s invalidity expert, and Dr. van der Poel, a 3Shape technical
employee, agreed that the claimed two-dimensional reference array can reside at the image
sensor. (Tr. (Schaafsma) at 1348:8-11; Tr. (van der Poel) at 1594:17-1595:4.).
63 When he testified during the Hearing on October 31, 2019, Dr. David Schaafsma was the President of
California Optical Engineering, Inc. (RPSt. at Ex. E.). 3Shape identified Dr. Shaafsma as an expert
called to testify with respect to the invalidity of the ’538 patent.
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Figure 14: Align’s Depiction of How the 538 Accused Products Satisfy the “Configured
For …” Language of Claim Element [1.2] of the ’538 Patent
(CDX-0014C.0037, 39 (introduced during the testimony of Dr. Stevenson).).
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In its Reply Post-Hearing Brief, 3Shape did not dispute Align’s assertion that the 538
Accused Products satisfy the “configured for …” portion of limitation [1.2]. (RRBr. at 50-60.).
Thus, 3Shape has waived any such argument for all purposes pursuant to Ground Rule 10.1.
Accordingly, based upon the evidence and the analysis provided, Align has proven by a
preponderance of evidence that the 538 Accused Products practice the “configured for …”
portion of limitation [1.2] of the ’538 patent, but not the “optical scanner” portion of that
limitation.
c) 	[1.3]: “imaging means configured for providing two-
dimensional color image data of the portion associated with the
reference array;”
Align has proven that the 538 Accused Products possess the claimed “imaging means.”
(Tr. (Stevenson) at 938:15-939:14; CDX-0014C.0042.). The 538 Accused Products provide
two-dimensional color image data via the 	, as
explained above in Section IX.A.2(b)(i). (Tr. (Stevenson) at 938:15-939:14, 940:6-22; CX-
0722C; CX-0723C; CX-0978C.0006.). Dr. Stevenson testified that, as shown below in Figure
15, the 538 Accused Products include
for providing 2D color image
data. (Tr. (Stevenson) at 939:15-940:22; see also CX-0427C; CX-0428C; CX-0430C; CX-
0431C; CX-0547C; CX-0722C; CX-0723C; CX-0978C.0006; CDX-0014C.0043.). The 538
Accused Products also include a color image sensor 	that detects the intensity of
the white illumination reflecting from the scanned object. (Tr. (Stevenson) at 849:7-17, 940:6-
22; CX-0382C.0001; CX-0460C; CX-0462C; CX-0723C; CX-0863C; CX-0976C.0012; CX-
0978C.0006; CDX-0014C.0044.). The “imaging means” provide two-dimensional color image
data by using information collected by the sensor’s red, green, and blue pixels and, in particular,
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by using only the
. (Tr. (Stevenson) at 851:13-852:6, 856:15-21, 939:7-11.).
Figure 15: Align’s Depiction of “Imaging Means” of Claim Element [1.3] of the ’538 Patent
(CDX-0014C.0044 (introduced during the testimony of Dr. Stevenson).).
Based upon the evidence presented and corresponding testimony, there is no dispute that
the 538 Accused Products include the structure recited in element [1.3].
However, in its Reply Post-Hearing Brief, 3Shape made a tortured argument about how
the claimed “reference array” in element [1.2] (for the “optical scanner”) must, but does not,
match the claimed “reference array” in element [1.3] (for the “imaging means”). (RRBr. at 58-
59.). 3Shape claimed that, while the 538 Accused Products calculate depth data using
, the Accused Products calculate color image data for each
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. (Id.). This argument is suspect on its face64 and akin in
archery to an assertion that, within a single target, the yellow bull’s eye, on the one hand, and
surrounding rings, on the other hand, are not part of the same frame of reference for an archer.
Moreover, pursuant to Ground Rule 7.2, 3Shape waived the argument by not raising it in its Pre-
Hearing Brief. (See RPBr. at 110-111).
Accordingly, based on the analysis provided, Align has proven by a preponderance of
evidence that the 538 Accused Products practice element [1.3] of the ’538 patent.
d) 	[1.4]: “wherein the device is configured for maintaining a
spatial disposition with respect to the portion that is
substantially fixed during operation of the optical scanner and
the imaging means.”
The 538 Accused Products satisfy this claim element. (Tr. (Stevenson) at 940:23-943:16;
CX-0395C.0001; CX-0979C.0002; CX-2279C (van der Poel Dep. Tr.) at 105:10-22; CDX-
0014C.0046-47.). In those Accused Products, the operation of the optical scanner and imaging
means “is at least substantially or effectively simultaneous such that movement (i.e., a change in
spatial disposition) can be ignored and depth data and color data correspond to the same
reference array.” (Markman Order, App. A at 64-65; Tr. (Stevenson) at 942:17-943:16; CDX-
0014C.0048-49.). This is because, as Dr. Stevenson testified, the 538 Accused Products
64 Element [1.2] requires “providing depth data of the portion corresponding to a two-dimensional
reference array.” (JX-0003 (’538 patent), cl. 1.). Element [1.3] requires “providing two-dimensional
color image data of the portion associated with the reference array.” (Id.). According to the ’538 patent,
the purpose of the reference array is “associating said color data with said depth data.” (Id. at 5:14-15.).
Based on the description above with respect to how the 538 Accused Products operate, the two-
dimensional image sensor in general, and the 	generated by
the image sensor in particular, clearly serve to match the color and depth data within a (X-Y) “frame of
reference” delineated by the 	. Elements [1.2] and [1.3] merely require that depth data and
color data “correspond[] to” or “associate[] with” the required reference array. (Id., cl. 1.). In the 538
Accused Products, that matching occurs at the level of a 	. Claim 1 does not require that
the matching of color or depth occur on a pixel-by-pixel basis. (Id.).
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complete a subscan in 	. (Tr. (Stevenson) at 940:23-941:25; CX-
0352C.0002; CX-0395C.0001; CX-0979C.0001; CDX-0014C.0046.).
That level of speed is consistent with the teachings of the patent, in which 50
milliseconds is offered as an example of a time interval for “acquisition of said depth data and
said color image data such that substantially no significant relative movement between said
device and said portion occurs,” as shown below in Figure 16. (JX-0003 (’538 patent at 5:7-12;
see also Tr. (Stevenson) at 845:4-846:1; CDX-0014C.0015.). Additional proof was provided by
3Shape’s corporate representative, Dr. Mike van der Poel, 65 who stated that the 538 Accused
Products 	(CX-2279 (van der Poel
Dep. Tr.) at 105:10-22, 106:5-7, 123:11-125:24.).
65 Mr. Mike van der Poel gave his deposition testimony on June 12, 2019. (CX-2279.). As recently as
May 24, 2018, he held the position of Scanner Manager and Director of New Business Ventures with
3Shape. (CX-2276 at 10:25-11:9.).
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Figure 16 Align’s Depiction of the Speed At Which the 538 Accused Products Perform
Subscans (Capable of Performing a Subscan 	)
(CDX-0014C.0046 (introduced during the testimony of Dr. Stevenson).).
Moreover, as explained above, the 538 Accused Products function such that there is little
risk of movement causing a mismatch of depth and color data. That is so for
. (Tr. (Stevenson) at 859:4-860:4 (color is
calculated using the
, 943:3-10; CX-0722C; CX-0723C; CDX-0014C.0025,
.0049.). A 3D color topology is created by processing myriad 2D images within a subscan and,
from those images, choosing and assembling only the 	(including their
). (Tr. (Stevenson) at 859:4-860:23; CDX-
0014C.0025-26.). That is why movement of a 538 Accused Product during a subscan can cause
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distortions in the spatial disposition of the reference array, making it difficult to assemble a
.66 (See id.). However, within a
given 2D image, color and depth data are captured simultaneously such that, within that 2D
image, spatial disposition of the reference array necessarily remains fixed. (See Tr. (Stevenson)
at 859:4-860:4, 943:3-10; CX-0722C; CX-0723C; CDX-0014C.0025, .0049.).
This operational detail relates to why the 538 Accused Products do not satisfy element
[1.4] of the ’538 patent. By using a single mechanism to capture color and depth data within a
given 2D image, the 538 Accused Products distinguish themselves from the distinct depth and
color collection mechanisms described and claimed in the ’538 patent.
As discussed in detail above, the ’538 patent teaches the use of an optical scanner to
capture depth data and a distinct imaging means to capture color data. (JX-0003 (’538 patent) at
25:11-14 (“any suitable means for providing 3D scanning can be used so long as the 3D scan and
the color 2D scan correspond substantially to the same object or portion thereof being scanned,
and the same frames of references are maintained.”).). As the Markman Order explained:
“[s]pecifying that the ‘optical scanner’ does not capture color image data effectively restores the
depth and color data independence touted by the patentee and used by the patentee to overcome
Mueller.” (Markman Order, App. A at 54.). The Abstract of the ’538 patent echoes the
consequences of this arrangement, explaining that “[a] processor combines the color data and
depth data for each point in the array, thereby providing a three-dimensional color virtual model
of the surface of the structure.” (JXM-0003 (’538 patent) at Abstract.).
66 Indeed, the 538 Accused Products “include a motion detection algorithm, which stops the addition of a
captured subscan if the user moves the scanner too fast over the dentition. (Tr. (Stevenson) at 942:17-
943:3; CX-0351C.0002; CDX-0014C.0048.).
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Against this backdrop, 3Shape contended that the 538 Accused Products cannot satisfy
the optical scanner and imaging means limitations required by elements [1.2] and [1.3] and
reiterated in the wherein clause of element [1.4]. (RRBr. at 59 (citing JX-0003 (’538 patent) at
cl. 1 (emphasis added)).). In particular, 3Shape asserted that “[b]ecause Align failed to show that
Trios includes the claimed ‘optical scanner’ and the ‘imaging means,’ Align likewise cannot
show that Trios meets the wherein clause of claim 1.” (Id.).
3Shape is partially correct. Align has proven that the 538 Accused Products possess
“imaging means,” but Align has also failed to prove that these Products possess an “optical
scanner.” Likewise, here, Align has proven by a preponderance of the evidence that the 538
Accused Products satisfy all of element [1.4] except the existence of an distinct “optical
scanner.” For this reason, and this reason only, Align has not proven by a preponderance of
evidence that the 538 Accused Products practice element [1.4] of the ’538 patent.
e) 	[2]: “The device according to claim 1, wherein the operation of
the optical scanner is based on confocal imaging techniques.”
Claim 2 is a dependent claim that adds the following limitation to claim 1: “wherein the
operation of the optical scanner is based on confocal imaging techniques.” (JX-0003 (’538
patent), cl. 2.). The Markman Order construed “confocal imaging techniques” as “‘imaging
techniques characterized by illumination and detection paths with conjugate focal planes.”
(Markman Order, App. A at 69.). Measuring the “illumination path” from the
found in the 538 Accused Products, as shown below in Figure 17, Align asserted that “the
optical scanner of the TRIOS is based on confocal imaging techniques[.]” (CBr. at 91.).
Measuring the “illumination path” from the 	source in the 538 Accused
Products, 3Shape asserts that these Products do not possess conjugate illumination and detection
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paths. (RRBr. at 60-61.). As explained below, Align has the stronger argument on this issue.
Figure 17: Align’s Depiction of Confocal Imaging in the 538 Accused Products
(CDX-0014C.0053 (introduced during the testimony of Dr. Stevenson).).
3Shape reads the claim limitation too narrowly. The Markman construction requires
“illumination and detection paths with conjugate focal planes,” not that the illumination source is
necessarily in a plane conjugate to the plane of the image detector. (Markman Order, App. A at
69.). The Parties’ experts agreed that, within the 538 Accused Products, “the
is optically conjugate to the 	[.]” (RRBr. at 60; Tr. (Stevenson) at 944:5-
946:16; Tr. (Zavislan) at 1608:6-13, 1630:16-20, 1682:23-1683:1.). Even documentary evidence
that 3Shape provided and together with its witnesses confirmed this. (CX-0722; CX-0723C;
CDX-0014C.0053-55; CX-2279C (van der Poel Dep. Tr.) at 94:6-12, 106:21-107:1; CX-2287C
(1090 Investigation Hearing Tr.) at 187:3-15.). Indeed, 3Shape’s
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(See, e.g., CX-0557C.0025.).
According to 3Shape, “Align’s interpretation would fail to give the term ‘confocal
imaging techniques’ any meaning, as there are multiple conjugate relationships in any optical
system.” (RRBr. at 61 (citing Tr. (Zavislan) at 1690:24-1691:2).). However, 3Shape failed to
flesh out this statement in any meaningful way by, for example, identifying all of the “planes” in
the illumination and detection paths of the 538 Accused Products and determining the number of
possible combinations of illumination and detection planes that exhibit a conjugate
relationship.67 Without more, conclusory statements cannot pass muster here.
Thus, Align has proven by a preponderance of the evidence that the 538 Accused
Products possess “confocal imaging techniques” as defined as “imaging techniques characterized
by illumination and detection paths with conjugate focal planes.” However, the 538 Accused
Products do not satisfy claim 2 of the ’538 patent because they do not satisfy claim 1 from which
claim 2 depends. In particular, the 538 Accused Products lack the required “optical scanner.”
f) 	The TRIOS 3 Mono Does Not Infringe
According to 3Shape, with the 538 Accused Products, the Trios 3 Mono does not infringe
because it does not provide color data and cannot generate a color 3D virtual model. (RRBr. at
61 (citing Tr. (Hansen) at 1208:9-14); JX-0003 (’538 patent), cls. 1, 2.). Align argued that the
Trios 3 Mono infringes because it can be upgraded to a Trios 3 Color Scanner and is “reasonably
capable” of generating a 3D color model without “significant alteration.” 68 (CBr. at 77-78
67 Align also pointed out: “The fallacy in Respondents’ position regarding non-infringement is exposed
by their position on domestic industry, where Respondents do not dispute and have never disputed that
the microlens array of the iTero, rather than the laser (i.e., the light source), is one of the conjugate focal
planes.” (CBr. at 92.). Whether the iTero satisfies claims 1 and 2 of the ’538 patent is addressed below.
68 3Shape argued that Align waived this argument by not raising it in its Pre-Hearing Brief. (RRBr. at 61-
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(citing Ericsson, Inc. v. D-Link Sys., 773 F.3 1201, 1217 (Fed. Cir. 2014).). According to Align,
“TRIOS ‘mono’ differs [from the other 538 Accused Products] only in that
(CBr. at 77 (citing CX-2279C (van der Poel Dep.
Tr. (6/12/2019)) at 60:21-62:4, 63:3-64:19; Tr. (Stevenson) at 945:17-946:4; CDX-0014C.0057;
CX-2276C (van der Poel Dep. Tr. (5/24/2018)) at 49:7-51:1).).
Align’s argument fails here for the same reasons it failed in the 1091 Investigation. In
the 1091 Investigation, Judge Cheney found in his Initial Determination on Violation that “Trios
3 Mono scanners are configured with different software that 	and is
‘only capable of outputting monochromatic data.’” Or, in the Commission’s words, the
Commission affirmed that “the Trios monochromatic scanners can be modified at a 3Shape
factory to add color scanning functionality[.]” (Certain Color Intraoral Scanners and Related
Hardware and Software, 337-TA-1091, Commission Op. at 42 (Nov. 22, 2019) (citing
underlying Initial Determination at 58-59 (“1091 Investigation”).). Judge Cheney concluded that
“[b]ecause modifications are required to enable to color functionality, [the Trios monochromatic
scanners] cannot be found to infringe.” (Id.). The Commission adopted that finding without
substantive review. (Id. at 2.).
The same reasoning applies here. 3Shape offers a color upgrade program for the Trios 3
Mono scanners, which activates the scanners’ latent color functionality. (CX-2279C (van der
Poel Dep. Tr. (6/12/2019)) at 60:21-62:4, 63:3-64:19; CX-1173C.0004; CX-0810C.0025; CX-
0333C.0027; CX-0388C.0005; CX-0398C.0103-106.). However, upgrading the Trios 3 Mono to
include color requires sending the Trios 3 Mono back to 3Shape, where the scanner receives a
62.). That is plainly wrong, because the argument appeared in a footnote in Align’s Pre-Hearing Brief.
(CPBr. at 105 n. 40.).
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. (Tr. (Hansen) at 1208:9-21; CX-2276C (van der Poel Dep. Tr.
(5/24/2018)) at 163:11-22.). Thus, from a user’s perspective, the Trios 3 Mono is not
“reasonably capable” of generating a 3D color model. Contrary to Align’s position, a
“significant alteration” is required to convert the Trios 3 Mono into a color scanner. See
Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1217 (Fed. Cir. 2014) (system “reasonably
capable” of infringing “if a user followed the accused infringer’s own instructions” to make
necessary modification); Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316 (Fed. Cir.
2001) (“[T]hat a device is capable of being modified to operate in an infringing manner is not
sufficient, by itself, to support a finding of infringement.”). This makes sense from a business
perspective because 3Shape presumably would not want customers who paid for a monochrome
scanner to be able to modify that scanner unilaterally and receive the benefits of a color scanner.
For the reasons described above, and based upon the weight of the evidence, the TRIOS 3
Mono scanners do not infringe claims 1 and 2 of the ’538 patent.
B. 	Technical Prong of Domestic Industry
It is undisputed that Align’s iTero Element (“iTero”) is representative of all the 538 DI
Products, including the iTero Element, the iTero Element 2, and the iTero Element Flex. (Tr.
(Stevenson) at 946:10-950:6; CX-0311; CX-1853.0003 (depicting stand and monitor differences
for Element and Element 2, and Flex as the portable version); CDX-0014C.0058.). All of these
intraoral scanners work identically in that they all practice the asserted claims. (Id.). Align uses
and sells the iTero in the United States. (Tr. (Relic) at 211:14-20; Tr. (Kling) at 356:18-357:15.).
During the Hearing, 3Shape’s expert, Dr. Zavislan, did not present testimony or evidence
regarding the iTero.
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Figure 18: Align’s DI Products
a) 	[1.1]: “A device for determining the surface topology and
associated color of at least a portion of a three dimensional
structure, comprising:”
The iTero is “[a] device for determining the surface topology and associated color of at
least a portion of a three dimensional structure.” Dr. Stevenson testified that the iTero is a device
that determines the surface topology (i.e., the three-dimensional outer surface of an object) and
associated color (i.e., corresponding visible color for each location on the surface) of at least a
portion of a three-dimensional structure (where the three-dimensional is a patient’s dentition or
tooth). (Tr. (Stevenson) at 956:21-958:21; CX-1238C.0004; CX-1410.0003; CX-1409.0032; CX-
1731C.0001; CDX-0014C.0069.). Align’s technical documents support a finding that the iTero
Element takes multiple subscans in order to produce a surface topology of a dentition. (See, e.g.,
CX-1866.0003.). 3Shape did not dispute that the iTero meets the preamble. (RPBr. at 110-111.).
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Figure 19: Topology in iTero Element Wand
In its Reply Post-Hearing Brief, 3Shape did not dispute Align’s assertion that the iTero
satisfies the element [1.1] of the ’538 patent. (RRBr. at 63-64.). Thus, 3Shape has waived any
such argument pursuant to Ground Rule 10.1.
Accordingly, based upon the weight of the evidence and as explained in the analysis,
Align has proven by a preponderance of evidence that the iTero practices element [1.1] of the
’538 patent.
b) 	[1.2]: “optical scanner configured for providing depth data of
the portion corresponding to a two-dimensional reference
array substantially orthogonal to a depth direction;”
The iTero includes an “optical scanner” that “uses light projection to capture data other
than color image data.” (Tr. (Stevenson) at 958:23-959:13; Tr. (Saphier) at 256:5-257:20,
258:14-22, 260:1-16; CX-1236C.0004, 7, 9; CX-1242C.0008; CX-1238C.0016, 0019; CX-
1304C; CX-1361.0005; CX-1386C.0005; CX-1683C.0016; CX-1866C.0016; CDX-
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0014C.0071.) The iTero does indeed 	for light projection
(i.e., a pattern of red spots) onto the tooth. (Tr. (Stevenson) at 949:19-950:3; CDX-0014C.0063-
64.). The pattern of spots is
. (Tr. (Stevenson) at 948:13-951:2.). The
iTero provides depth data by capturing 	.
(Tr. (Stevenson) at 949:19-950:19, 959:19-25; CDX-0014C.0072.). None of that data is used for
generating color. (Tr. (Stevenson) at 959:19-25; Tr. (Saphier) at 269:24-270:15; CX-1236C;
CX-1238C.0019; CX-1683C.0021, 22, CX-1865C.0159; CDX-0014C.0072.). The iTero thus
“captures data other than color image data.”42 (Tr. (Stevenson) at 948:5-951:24, 959:19-25; Tr.
(Saphier) at 269:24-270:15; CX-1238C.0016, 0019; CX-1683C.0016; CX-1732.0016; CDX-
0014C.0072; see also JX-0003 at 12:21-23.). In addition, and for the same reasons discussed
above in the context of the 538 Accused Products, the
at a certain point in time, which provides depth data that is not used for color.
(Tr. (Stevenson) at 950:20-951:24, 960:1-11; Tr. (Saphier) at 260:17-261:7; CX-2273C:96:1-
97:16; CX-1865C.0159; CDX-0014C.0072.).
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Figure 20: Depth Processing in iTero Element Wand
The iTero Element “provid[es] depth data of the portion corresponding to a two-
dimensional reference array substantially orthogonal to a depth direction.” Dr. Stevenson
testified that the image sensor of the iTero provides a two-dimensional reference array that is
substantially orthogonal to the optical axis and hence the depth direction. (Tr. (Stevenson) at
960:12-17, 961:3-962:1; CX-1236C.0014; CX-1238C.0016, 19; CX-1242C.0007; CDX-
0014C.0073-74; see also JX-0003 at 12:60-13:7.). In addition to the documentary evidence, Dr.
Stevenson testified that the iTero provides depth data for the portion of the object being scanned
that corresponds to the reference array. (Tr. (Stevenson) at 961:3-962:1; CX-1236C; CX-
1238C.0019; CX-1242C; CX-1732C.0007; CDX-0014C.0073.). Mr. Ofer Saphier, the technical
director of algorithms at Align, also testified that the image sensor provides a two-dimensional
reference array that is perpendicular to the depth direction (i.e., along the optical axis or z-
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direction). (Tr. (Saphier)69 at 261:7-21, 267:16-268:5, 268:11-269:11, 287:14-288:10; CX-
2273C at 60:8-25, 96:22-98:17, 112:4-8, 140:15-141:2; see also CX-2202C at 59:2-11, 109:4-
110:10.).
3Shape disputed that Dr. Stevenson identified a proper “reference array.” (Tr.
(Stevenson) at 960:12-17.). This is because the data the image sensor on the iTero collects is
before it functions as the “reference.” (Tr. (Saphier) at
278:19-21.). Specifically, Align’s director of algorithms, Mr. Saphier, testified that the
(Tr. (Saphier) at 278:19-
279:23.).
. (RX-0440C at 906; Tr. (Saphier) at
278:19-281:9.). A
. (CPBr. at 118, 122-123; Tr.
(Saphier) at 281:7-9, 281:18-282:3.). In other words, 3Shape argued that
as claim 1 of the ’538 patent requires.
3Shape’s position shows a fundamental misreading of claim 1. The “optical scanner”
limitation in claim 1 requires “depth data of the portion corresponding to a two-dimensional
reference array substantially orthogonal to a depth direction[.]” (JX-0003 (’538 patent), cl. 1.).
3Shape seeks to rewrite the claim language to require “depth data of the portion embodying a
69 When he testified during the Hearing on October 24, 2019, Mr. Ofer Saphier was Director of
Algorithms at Align. (Tr. (Saphier) at 255:5-10.). Align identified Mr. Saphier as a fact witness who
Align called to testify on Align’s background and business, Cadent’s background and business, and the
domestic industry in the Asserted Patents. Align also called Mr. Saphier to testify with respect to the
validity of the Asserted Patent, including the topics of non-obviousness and secondary considerations, as
they apply to Align’s iTero Element and Invisalign System. (CPSt. at 11.).
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two-dimensional reference array substantially orthogonal to a depth direction[.]” By using
“corresponding to … a reference array” in reference to the data collected by the “optical
scanner,” claim 1 provides the scope for an intraoral scanner, such as the iTero, to collect depth
data and manipulate or translate it in a predictable way such that it matches the same “reference
array” used by the “imaging means.”70
Align argued, in the alternative, that the iTero satisfies the “optical scanner” requirement
under the doctrine of equivalents. (CBr. at 98.). It was not necessary that Align provide an
alternative argument. The iTero literally satisfies the “optical scanner” limitation.
Also, for the sake of clarity, a comparison of the “optical scanner” in the 538 Accused
Products and the iTero is warranted. As explained above in the context of infringement, the
Accused Products lack an “optical scanner” that captures “data other than color image data”
because, in the 538 Accused Products, depth and color data are captured at the exact same time
on the same scans. By contrast, in the iTero, depth and color data are captured at different time
on different scans, as shown below in Figure 21, below.
70 This is true given the broad treatment of “reference array” herein in the context of infringement and
invalidity. Specially, the claimed “reference array” is not confined to the face of an image sensor or, for
that matter, to a plane immediately above the surface of a scanner object.
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Figure 21: Data Extraction in iTero Element Wand
Accordingly, based upon the weight of the evidence as explained in the analysis, Align
has proven by a preponderance of evidence that the iTero practices element [1.2] of the ’538
patent.
c) 	[1.3]: “imaging means configured for providing two-
dimensional color image data of the portion associated with the
reference array;”
The iTero includes “imaging means configured for providing two-dimensional color
image data of the portion associated with the reference array.” (Tr. (Stevenson) at 962:17-
967:17; CX-1236C.0014; CX-1238C.0020; CDX-0014C.0076.). Dr. Stevenson explained that
the iTero includes “white illumination, optics, and a color image sensor (e.g., a color CCD) for
detecting intensity of the white illuminating radiation after reflection from the portion.” (Tr.
(Stevenson) at 966:6-967:17; CDX-0014C.0077-78.). Specifically, the iTero includes
. (Tr. (Stevenson) at 966:6-16; 270:16-25; CX-1236C.0014;
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CX-1238C.0020; CX-1330C; CDX-0014C.0077.). The iTero also has optics (e.g., the
) and a color image sensor.
(Tr. (Stevenson) at 966:17-967:10; CX-1236C.0014; CX-1238C.0020; CX-1242C.0007, 11; CX-
1683C.0022, 26; CX-1724C; CDX-0014C.0078.).
Dr. Stevenson testified that the iTero provides two-dimensional color image data of the
portion associated with the reference array (i.e., the same array are used for providing depth
data). (Tr. (Stevenson) at 962:23-963:5.) The two-dimensional color image data is derived from
certain red, blue, and green pixels in the two images collected at the end of the subscan. (Tr.
(Stevenson) at 951:25-952:11, 962:22-963:19, 964:7-25, 965:25-966:5.)
Figure 22: Color Processing in iTero Element Wand
In its Reply Post-Hearing Brief, 3Shape did not dispute Align’s assertion that the iTero
satisfies the element [1.3] of the ’538 patent. (RRBr. at 63-64.). Thus, 3Shape has waived any
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such argument for all purposes pursuant to Ground Rule 10.1.
Accordingly, based upon the weight of the evidence, as explained in the analysis
provided, Align has proven by a preponderance of evidence that the iTero practices element [1.3]
of the ’538 patent.
d) 	[1.4]: “wherein the device is configured for maintaining a
spatial disposition with respect to the portion that is
substantially fixed during operation of the optical scanner and
the imaging means.”
The iTero “is configured for maintaining a spatial disposition with respect to the portion
that is substantially fixed during operation of the optical scanner and the imaging means.” Dr.
Stevenson testified that the “operation by the optical scanner and the imaging means” of the
iTero Element “is at least substantially or effectively simultaneous,” because each subscan
occurs 	. (Tr. (Stevenson) at 967:18-968:20; Tr. (Saphier) 271:12-23,
272:9-272:19; CX-1236C.0014; CX-1238C.0012; CX-1242C.0008; CX-1410.0003; CX-
1666C.0012; CX-1683C.0025; CX-1731C.0016; CDX-0014C.0080.). The depth data and color
data correspond to the same reference array because both depth data and color data are collected
by the image sensor during a subscan. (Tr. (Stevenson) at 969:25-970:9; CX-1238C.0016, 19;
CDX-0014C.0083.). The iTero operates such that movement (i.e., a change in spatial
disposition) can be ignored. (Tr. (Stevenson) at 968:21-970:9; CX-1238C.0016, 19; CX-
1730C.0004; CX-1732C.0016; CX-1743C.0004; CX-1863C.0003; CX-1865C.0033; CDX-
0014C.0081-83.). The iTero includes
and, similar to the 538 Accused Products,
. (Tr. (Stevenson) at 952:14-23; 968:21-
969:24; Tr. (Saphier) at 272:23-273:12; CX-1362.0017; CX-1863C.0003; CDX-0014C.0081-
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82.).
Figure 23: iTero Depth and Color
In its Reply Post-Hearing Brief, 3Shape did not dispute Align’s assertion that the iTero
satisfies the element [1.4] of the ’538 patent. (RRBr. at 63-64.). Thus, 3Shape has waived any
such argument for all purposes pursuant to Ground Rule 10.1.
Based upon the weight of the evidence, as explained in the analysis provided, Align has
proven by a preponderance of evidence that the iTero practices element [1.4], and the entirety of
claim 1, of the ’538 patent.
e) 	[2]: “The device according to claim 1, wherein the operation of
the optical scanner is based on confocal imaging techniques.”
The “operation of the optical scanner is based on confocal imaging techniques.” (Tr.
(Stevenson) at 971:12-972:1; CX-1360C.0004; CX-1387C; CDX-0014C.0087, .0089.). The
iTero uses “imaging techniques characterized by illumination and detection paths with conjugate
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focal planes.” (Tr. (Stevenson) at 971:12-23; CX-1236C.0003; CX-1866C.0009; CDX-
0014C.0087.) The
. (Id.; Tr. (Saphier) at 256:5-257:20.).
Align’s technical documents confirm that the iTero uses confocal imaging techniques. (See, e.g.,
CX-1236C.0003; CX-1238C.0016, .0019; CX-1250C.0006-13; CX-1684C.0006-13; CX-
1866C.).
In its Reply Post-Hearing Brief, 3Shape did not dispute Align’s assertion that the iTero
satisfies claim 2 of the ’538 patent. (RRBr. at 63-64.). Thus, 3Shape has waived any such
argument pursuant to Ground Rule 10.1.
As explained in the analysis, Align has proven by a preponderance of evidence that the
iTero practices claim 2 of the ’538 patent.
C. 	Invalidity
1. 	Invalidity Overview
3Shape raised an inordinate number of invalidity grounds for claims 1 and 2 of the ’538
patent. This is reflected in Table No. 9, below. This was unnecessary and risked wasting
precious resources of all involved. It may have been prudent for 3Shape to raise most, if not all,
of these invalidity grounds in its Pre-Hearing Brief filed on August 30, 2019, prior to the
issuance of the Markman Order, which settled the Parties’ claim construction disputes.
However, once the Markman Order issued on October 1, 2019, 3Shape should have dropped
most of its invalidity grounds for the asserted claims of the ’538 patent. This is clear from
Align’s cross examination of 3Shape’s expert, Dr. Schaafsma, which laid bare the gaps in
3Shape’s invalidity arguments.
As suggested in Table No. 9, below and the analysis that follows, it should be evident
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that most of 3Shape’s invalidity grounds suffer from one or more conspicuous shortcomings.
Nevertheless, 3Shape nearly proved by clear and convincing evidence that Okamoto anticipates
claims 1 and 2 of the ’538 patent. Consequently, the bulk of the invalidity analysis below
pertains to this single ground for invalidity.
Table No. 9: Invalidity Grounds Raised by 3Shape for the ’538 Patent
Invalidity Ground 	Reference(s) 	Outcome
Anticipation 	Okamoto Unsuccessful
(close question)
Anticipation 	Xu 	Unsuccessful
Obviousness 	Okamoto 	Unsuccessful
Obviousness
Okamoto and “Nontranslational three
dimensional profilometry by chromatic
confocal microscopy with dynamic
configurable micromirror scanning,”
Appl. Opt. 39:2605-2613 (Cha)
Unsuccessful
Obviousness 	Xu 	Unsuccessful
Obviousness WIPO Publication No. WO 00/08415
(Babayoff) and Okamoto Unsuccessful
Obviousness Babayoff, Okamoto, and U.S. Patent
No. 6,594,539 (Geng) Unsuccessful
Obviousness 	Babayoff and Xu 	Unsuccessful
Obviousness 	Babayoff, Xu, and Geng 	Unsuccessful
2. 	Legal Standards
a) 	Anticipation
A determination that a patent is invalid as being anticipated under 35 U.S.C. § 102
requires a finding, based upon clear and convincing evidence, that each and every limitation is
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found either expressly or inherently in a single prior art reference. See, e.g., Celeritas Techs. Inc.
v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). Anticipation is a question of fact,
including whether a limitation, or element, is inherent in the prior art. In re Gleave, 560 F.3d
1331, 1334-35 (Fed. Cir. 2009). The limitations must be arranged or combined the same way as
in the claimed invention, although an identity of terminology is not required. Id. at 1334 (noting,
“the reference need not satisfy an ipsissimis verbis test”); MPEP § 2131.
In addition, a prior art reference’s disclosure must enable one of ordinary skill in the art
to practice the claimed invention “without undue experimentation.” Gleave, 560 F.3d at 1334-
35. A prior art reference that allegedly anticipates the claims of a patent is presumed enabled;
however, a patentee may present evidence of non-enablement to overcome this presumption.
Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1382 (Fed. Cir. 2006). “[W]hether a
prior art reference is enabling is a question of law based upon underlying factual findings.”
Gleave, 560 F.3d at 1335.
3. 	Okamoto Does Not Anticipate Claims 1 and 2 of the ’538 Patent
Okamoto is a Japanese patent application filed on September 10, 1999 and published on
March 30, 2001. (RX-0180cv (Okamoto) at Cover.). Okamoto’s publication date is more than
one year before the claimed June 17, 2004 priority date of the ’538 patent, and thus qualifies as
prior art under 35 U.S.C. § 102(b). Okamoto was cited (but not discussed) by the examiner
during the prosecution of the ’538 patent. (JX-0003 (’538 patent) at 2 (citing JP 2001-82935);
JX-0007 (’538 patent prosecution history).). Yet, if the examiner had focused on Okamoto, he
likely would have appreciated that the ’538 patent and Okamoto bear striking similarities. An
overview of these similarities is set forth below. For this overview, Figure 24 below provides a
comparison of the essential requirements of claim 1 of the ’538 patent in bullet-pointed fashion
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with Okamoto.
Figure 24: 3Shape’s Depiction of the Requirements of Claim 1 of the ’538 Patent
(RDX-0001.0027 (introduced during the testimony of Dr. Schaafsma).).
Device for surface topology and associated color of 3D structure. Both Okamoto and the
’538 patent attempt to solve the problem of providing color 3D scans. Okamoto distinguished
prior art approaches that used shading and color gradation to display depth contour and how it
was “not necessarily easy on eyes.” (RX-0180 (Okamoto) ¶¶ 5-6.). The ’538 patent states that
the problem of “conformally mapping the two-dimensional color information onto the three
dimensional surface model is difficult and it is common for mismatching of the color with three-
dimensional points to occur.” (JX-0003 (’538 patent) at 1:50-54.).
Optical scanner for providing depth data and separate imaging means for proving 2D
color data. Okamoto and the ’538 patent propose similar solutions. Okamoto teaches “using a
photo receptor” to “obtain[] 3-dimensional surface shape … based on the light reception
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information” and a separate “color filming means that obtains color of the measurement target
object[.]” (RX-0180 (Okamoto) at ¶ 8.). The ’538 patent teaches “a scanner for providing depth
data for points along a two-dimensional array substantially orthogonal to the depth direction, and
an image acquisition means for providing color data for each of the points of the array, while the
spatial disposition of the device with respect to the structure is maintained substantially
unchanged.” (JX-0003 (’538 patent) at Abstract.).
Figure 25: Abstract and Figure 1 of Okamoto Showing the Scanned Object (W), Photo
Receptor (19) for Obtaining Depth Data, and Color CCD (24) for Obtaining Color Data
(RX-0180 (Okamoto) at Cover (highlighting added for emphasis).).
Maintaining special disposition such that depth and color data correspond. Okamoto and
the ’538 patent both appear to coordinate the matching of depth and color information using a X-
Y reference plane. Okamoto teaches depth scanning “in XY direction … vertical to optical axis
direction” and using color information “for each pixel” to color the “3-dimensional display of
surface shape[.]” (RX-0180 (Okamoto) at Abstract at ¶ 8.). The ’538 patent teaches
“combin[ing] the color data and depth data for each point” in a “two-dimensional array
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substantially orthogonal to the depth direction.” (JX-0003 (’538 patent) at Abstract.).
It is clear that claims 1 and 2 of the ’538 patent reflect a desire by the patentee to obtain broad
claim scope coverage. As explained below, that breadth almost reads on Okamoto.
Perhaps appreciating the precariousness of its position, Align attempted to distinguish
Okamoto not based on claim limitations, but instead based on unclaimed and thus irrelevant
differences between the systems taught in Okamoto and the ’538 patent, on the other hand.
For example, Align asserted that Okamoto lacks a “reference array” because it uses pixel-
by-pixel raster scanning to obtain depth data instead of using an image sensor with a X-Y planar
surface. (CRBr. at 51-52.). However, Align’s argument adds a requirement for “reference
array” that is not found in the Markman Order or otherwise supported by the ’538 patent.
Discussed and rejected below are this and other examples of Align’s artificial attempts to narrow
the broad asserted claims of the ’538 patent to escape invalidity and Okamoto.
Nevertheless, Align raised one persuasive point of novelty that sets claims 1 and 2 apart
from Okamoto. That point pertains to the speed at which depth and color data are collected.
Situated in a patent pertaining to intraoral scanners, claims 1 and 2 require that “operation by the
optical scanner and the imaging means is at least substantially or effectively simultaneous such
that movement (i.e., a change in spatial disposition) can be ignored and depth data and color data
correspond to the same reference array.” (Markman Order at 64-65.). There is nothing in
Okamoto, a patent application directed to microscopes, about the speed of the disclosed “optical
scanner” and “imaging means.” Moreover, the Parties’ experts disagreed over the speed at
which the optical system disclosed in Okamoto would operate from the perspective of one of
ordinary skill in the art. On balance, this is not the type of clear and convincing evidence
required for anticipation. Thus, Okamoto does not anticipate claims 1 and 2 of the ’538 patent.
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a) 	[1.1] (Preamble): “A device for determining the surface
topology and associated color of at least a portion of a three
dimensional structure, comprising:”
Okamoto determines a surface topology and associated color for a scanned object. The
system obtains 3D surface shape information for a portion of the object using a confocal optical
system and associated color of that portion using a non-confocal optical system. (See, e.g., RX-
0180 at ¶¶ 8, 9, 12, 15, 21, 28-30, 46, Fig. 1 at ref. nos. 1 and 2; Tr. (Schaafsma) at 1287:15-
1288:24, 1303:11-13, 1332:5-13.). The 3D surface shape information and 2D color information
are then combined to create a color 3D model that is displayed on a screen. (Id. at ¶¶ 8, 33; Tr.
(Schaafsma) at 1277:25-1278:7.).
Align contended that Okamoto does not disclose “a device for determining the surface
topology…of at least a portion of a three-dimensional structure” because the object is scanned
from a single perspective. (CBr. at 50-51; Tr. (Stevenson) at 1791:16-1792:3.). It appears that,
in Align’s view, the “surface topology” in the preamble of claims 1 and 2 of the ’538 patent
requires scanning an object from multiple perspectives. (Id.).
Yet, the ’538 patent does not support Align’s interpretation. Instead, the ’538 patent
contemplates a 3D representation of an object generated from a depth scan from a single
perspective, noting that “[t]he 2D color image is taken at substantially the same angle and
orientation with respect to the structure as the case when the 3D scan was taken.” (JX-0003
(’538 patent) at 3:61-63.). Reflecting this understanding, claim 1 states that the “device is
configured to maintain a spatial disposition with respect to the portion that is substantially fixed
during operation of the optical scanner and the imaging means.” (JX-0003, cl. 1; see also Tr.
(Stevenson) at 1004:20-25.). Align’s interpretation that “surface topology” is obtained from
multiple perspectives is also inconsistent with the Markman Order. That Order rejected a
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limitation, requested by Align, that the claimed device be “movable.” (Markman Order at 68-
69.).
Finally, Align attempted to draw a distinction between “surface shape information” in
Okamoto and “surface topology” in the ’538 patent. (CRBr. at 50-51.). Align likens this
distinction to a contrast, drawn within the context of the ’538 patent, between “depth data” and
“surface topology.” (Id.). Yet, this comparison in inapt and actually cuts against Align’s
argument.
Okamoto teaches the display of “surface shape information,” and the ’538 patent teaches
the display of “surface topology,” making these respective concepts comparable. (RX-0180
(Okamoto) at Abstract; JX-0003 (’538 patent) at 16:19-33, Fig. 4B.). Also, Align’s suggestion,
based on extrinsic evidence, that a scan from a single perspective does not generate a 3D
representation is directly contradicted by the intrinsic evidence and, thus, unavailing. (CRBr. at
50-51); see Vitronics Corp. v. Conceptronic, Inc., 90 F. 3d 1576, 1584 (Fed. Cir. 1996) (extrinsic
evidence cannot be used to contradict the claims of specification).
Based upon the evidence and the analysis provided, 3Shape has proven by clear and
convincing evidence that Okamoto discloses element [1.1] of the ’538 patent.
b) 	[1.2]: “optical scanner configured for providing depth data of
the portion corresponding to a two-dimensional reference
array substantially orthogonal to a depth direction;”
Okamoto teaches a confocal optical system configured to provide depth data of a portion
of an object. (Tr. (Schaafsma) at 1286:20-1290:1, 1302:10-1303:2,1303:9-13, 1303:25-1304:13;
RX-0180 at ¶¶ 16-24, Fig. 1, ref. no. 1.).
As shown below in Figure 26, the confocal optical system includes a laser beam as a light
source 10, which is deflected in the X- and Y-direction to different X-Y positions within a plane
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orthogonal to the depth direction. (See, e.g., RX-0180 at ¶¶ 2-4, 8, 15-24, Fig. 1, ref. no. 1; Tr.
(Schaafsma) at 1286:29-1290:1, 1303:3-8.). The laser beam is focused to a focal point by
objective lens 17. (RX-0180 at ¶¶ 17, 19.). Laser light is reflected from the surface of the object
back through objective lens 17 and a spatial filter (pinhole, labeled “PH”) to photo detector 19.
(RX-0180 at ¶ 20.). The photo detector measures the intensity of the laser light reflected back to
the photo detector.71 (Id.)
As the confocal optical system scans the object, the focal point of objective lens 17 is
displaced relative to the sample along the optical axis direction (Z or height direction) by either:
(1) moving the object relative to the objective lens 17 (e.g., by driving the sample stage 30 in the
Z direction): or (2) moving the objective lens relative to the object (e.g., by driving the objective
lens in the Z-direction along the optical axis). (RX-0180 at ¶¶ 12, 18-19; Tr. (Schaafsma) at
1304:15-20.). The intensity of the laser light reflected back to the photo detector is measured as
the focal point of the objective lens is displaced in the Z-direction relative to the sample, and the
surface of the object is detected when the measured intensity peaks for a given pixel. (RX-0180
at ¶ 22, Fig. 2.). Surface height (Z) information of the pixel is derived from the optical
characteristics at which the maximum intensity occurs. (RX-0180 at ¶¶ 20-24, Figs. 2, 5; Tr.
(Schaafsma) at 1286:20-1290:1.).
71 Importantly, in compliance with the claim construction, Okamoto’s confocal “optical scanner” captures
data “other than color image data.” (Markman Order, App. A at 42.). Separately, Okamoto uses a non-
confocal optical system to capture color, which uses a white light source to illuminate the scanned object
and a CCD to capture color data. (RX-0180 at Fig. 1 ref no. 2 at ¶¶ 28-31; Tr. (Schaafsma) at 1286:20-
1290:14.).
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Figure 26: 3Shape’s Depiction of Okamoto Satisfying the Optical Scanner Limitation
(RDX-0001.0028 (introduced during the testimony of Dr. Schaafsma).).
Align contended that Okamoto’s confocal optical system does not include the claimed
“reference array” because it uses a photodetector that takes measurements point-by-point along
an X-Y plane instead of using a 2D image sensor. (CRBr. at 51.). According to Align, in
contrast to the image sensor disclosed in the ’538 patent, “Okamoto’s photodiode indisputably is
not a 2D reference array.” (Id.; see also JX-0003 (’538 patent) at 12:54-13:2 (“[d]etection optics
60 comprises an image sensor, typically a CCD, …, and which typically defines the X-Y frame
of reference.”), 13:31-33 (“The X-Y plane of entity E is substantially parallel to the sensing face
of the image sensing means of the detection optics 60, typically a CCD.”).).
Yet, Align’s position improperly limits “reference array” to a physical instantiation in the
form of an image sensor. As an initial matter, the Parties did not identify “reference array” as a
disputed claim term during claim construction. (Joint Claim Construction Chart at 3-5.).
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Moreover, nothing in the ’538 patent, including the passages that Align cited above, necessarily
ties the “reference array” to a specific location or to a particular part of an optical system, such as
an image sensor. 3Shape is correct that at least one part of the specification refers to a reference
array at the object being scanned: “an array range of X-Y points (according to a known frame of
reference) along the surface of the object.” (JX-0003 at 12:60-13:1; see also Tr. (Schaafsma) at
1348:8-1349:16.).
During cross-examination, Dr. Schaafsma aptly captured the breadth of the ’538 patent’s
“reference array” and how the term is defined not by location but function:
Q. And you told me it could be the CCD; right?
A. I believe I recall that I did tell you it could be the CCD. I think the ’538 patent
has a number of statements about where it could be.
Q. And you told me it could be a raster scan; right?
A. I think I probably told you that as well, yes.
Q. You told me it could be any number of things; right?
A. I think -- and I think I told you that, because I think that a person of skill in the
art would understand what the function of that was, the two-dimensional
reference array, was to scan the physical geometry of the surface and come up
with measurement of actual physical characteristics of the object being
scanned.
Q. And so it was your opinion that the point of having the 2D reference array is so
you can overlap two things; right?
A. Well, I think that's in the construction that’s been applied to the claim language.
I think that the function of having a 2D -- of having this reference array, which
I think the definition for which is somewhat ambiguous in the ’538 patent, or
at least there are different interpretations at different locations in that patent. I
think that the purpose is really what a person of skill in the art would come
back to. And the purpose is to be able to align these two sets of data so that
they're looking at the same part of the structure.
Q. So a reference array could be any number of things is what you said, sir?
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A. 	I think there are a number of interpretations for it, but I don’t think that the
actual location is as important as the function that has been ascribed to it.
(Tr. (Schaafsma) at 1348:8-1349:16.).
Against this backdrop, there is little doubt that the Okamoto uses a “reference array” to
match depth and color data. It is axiomatic that each pixel for which depth and color are
matched in Okamoto is part of the X-Y plane that is identified in Okamoto. Specifically, the
laser light source in Okamoto’s confocal scanning system is used to measure the object’s depth
in the Z-direction at different X-Y locations along a X-Y plane. (RX-0180 at ¶ 24; Tr.
(Schaafsma) at 1346:4-11.). This X-Y plane constitutes a “reference array” in terms of
organizing measured depth (Z) values for an array of X-Y points in the same way that depth Z
values are organized at different X-Y points in the ’538 patent. (See RX-0180 at ¶¶ 4, 24; JX-
0003 (’538 patent) at 3:28-32; 3:50-52.)
The depth data in Okamoto corresponds to “a two-dimensional reference array
substantially orthogonal to a depth direction” because depth is measured with respect to the X-Y
plane. (Tr. (Schaafsma) at 1303:9-1304:13, 1338:18-1339:2, 1343:2-15, 1346:4-11.). The laser
beam is deflected along an X-Y plane, with each position on this X-Y plane corresponding to the
object’s depth. (RX-0180 at ¶¶ 4, 24; Tr. (Schaafsma) at 1286:20-1288:6.). This X-Y plane is
substantially orthogonal to a depth direction, as depth is measured along the Z direction (optical
axis direction) orthogonal to the X-Y plane. (Tr. (Schaafsma) at 1286:20-1290:1, 1303:9-
1304:20; RX-0180 at ¶ 23.)
Based upon the evidence and the analysis of the evidence, 3Shape has proven by clear
and convincing evidence that Okamoto discloses element [1.2] of the ’538 patent.
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c) 	[1.3]: “imaging means configured for providing two-
dimensional color image data of the portion associated with the
reference array;”
Okamoto discloses the claimed function: “providing two-dimensional color image data
of the portion associated with the reference array.” As reflected below in Figure 27, Okamoto’s
non-confocal optical system captures 2D color image data by illuminating the object with white
light and capturing the light reflected from the object with a color CCD. (See RX-0180 at ¶¶ 28-
33; Tr. (Schaafsma) at 1288:15-1289:13, 1304:21-1307:5; Tr. (Stevenson) at 1820:4-9; RDX-
0001.29.). On a pixel-by-pixel basis, the CCD 24 collects the 2D color image data that
corresponds to the depth information collected for each X-Y point on the measured sample W,
and as such, the 2D color image data is “of the portion associated with the reference array.” (RX-
0180 at ¶¶ 30, 35, 39 (“The received light quantity data, the color data and the height data (Z
direction location) for each picture in the X-Y scanning range are respectively stored in light
memory 51, the color memory 52, and the height memory 53 (step 103)”); Tr. (Schaafsma) at
1288:15-1289:13, 1306:7-22.).
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Figure 27: 3Shape’s Depiction of Okamoto Satisfying the Imaging Means Limitation
(RDX-0001.0029 (introduced during the testimony of Dr. Schaafsma).).
Okamoto’s non-confocal optical system discloses the claimed structure. The Okamoto
non-confocal system has “a white light source 20, optics (e.g., lenses 16 and 17), and a color
CCD 24 that detects the white light reflected from the sample. (RX-0180 at ¶¶ 28-30; Tr.
(Schaafsma) at 1304:21-1306:22.). This system shares the same objective lens 17 as used in the
confocal optical system addressed above because both systems share the same optical axis. (RX-
0180 at ¶ 28.)
Align contended that Okamoto does not disclose the claimed “imaging means” because
Okamoto does not disclose the claimed “two-dimensional reference array.” (CRBr. at 53-54.).
However, as discussed above, Okamoto discloses the claimed “two-dimensional reference array”
because it uses an X-Y plane where each point or pixel in that X-Y plane has both depth and
color information. (RX-0180 at ¶¶ 31, 39; Tr. (Schaafsma) at 1288:15-1289:13.).
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Based upon the evidence and as explained in the analysis, 3Shape has proven by clear
and convincing evidence that Okamoto discloses element [1.3] of the ’538 patent.
d) 	[1.4]: “wherein the device is configured for maintaining a
spatial disposition with respect to the portion that is
substantially fixed during operation of the optical scanner and
the imaging means.”
Okamoto does not disclose this element. The element pertains to a specific problem
identified in (and supposedly solved by) the ’538 patent:
Associating 	color 	information 	with 	three-dimensional 	objects 	is 	not
straightforward, particularly when the position information is obtained by using a
three dimensional scanning method, while the color information is obtained by
using a two dimensional scanning method. The problem of conformally mapping
the two dimensional color information onto the three dimensional surface model is
difficult and it is common for mismatching of the color with three-dimensional
points to occur. 	Essentially, where two-dimensional color detectors are used for
obtaining the color information, it is difficult to accurately associate color
information from the detectors with the correct points on the three dimensional
surface model, particularly where relative movement between the object and the
device occurs between the acquisition of the three-dimensional topological data and
acquisition of the two-dimensional image data.
(JX-0003 (’538 patent) at 1:45-55.).
The ’538 patent purports to solve this problem as follows:
operation of the scanning means and the imaging means is substantially or
effectively simultaneous in practical terms, and thus the actual time interval that
may exist between operation of the two means is so short that the amplitude of any
mechanical vibration of the device or movement of the oral cavity will be so small
as can be ignored.
(Id. at 4:61-5:3.).
The Markman Order construed element [1.4] to require: “operation by the optical
scanner and the imaging means is at least substantially or effectively simultaneous such that
movement (i.e., a change in spatial disposition) can be ignored and depth data and color data
correspond to the same reference array.” (Markman Order at 64-65.).
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In Okamoto, at each focal position along the optical axis (Z direction), the confocal
optical system performs a raster scan across the X-Y plane to collect height data (depth data),
either before or after the capture of 2D color image data by the non-confocal optical system.
(RX-0180 at ¶¶ 38-40, Fig. 4; Tr. (Schaafsma) at 1288:15-1290:14; 1307:8-1309:2, 1365:25-
1366:14; RDX-0001.31). Figure 4 of Okamoto shows that “the color data, and the height data (Z
direction location) for each picture element in the XY scanning range” are received in their
respective memories in the same step. (RX-0180, ¶ 39; Tr. (Schaafsma) at 1365:25-1367:6.).
Yet there is limited evidence that this process is performed in real-time such that the
operation of the optical scanner and imaging means is effectively simultaneous and movement
can be ignore to “ensure[] that the [depth and color] data come from the same points on the
surface of the structure” (i.e., correspond to the same XY reference frame). (Tr. (Schaafsma) at
1308:1-13; RX-0180 at ¶¶ 31, 38-40.). Dr. Schaafsma did testify that the confocal optical system
in Okamoto can scan “very fast,” at several frames per second. (Tr. (Schaafsma) at 1361:11-
1362:7.). However, the speed of the 3D scan alone does not address the simultaneity of the
optical scanner and imaging means, or the luxury of ignoring movement, which is what the
asserted claims require.
There is also evidence that the system in Okamoto would not operate at a sufficiently fast
speed to satisfy the asserted claims. Dr. Stevenson testified that, although Dr. Schaafsma
“implied that these things could be built to go fast,” “[t]hat’s not really my experience.” (Tr.
(Stevenson) at 1795:20-25.). Dr. Stevenson explained that “the raster scan is mirrors moving
and stages moving,” which is “generally a slow operation.” (Id.). Documentary evidence and
testimony from other witnesses during the Hearing support Dr. Stevenson’s testimony. (See CX-
1894 ¶ 0007 (3Shape’s patent stating raster scanners are unsuitable for use in a handheld
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intraoral device); Tr. (Noam Babayoff)72 at 97:13-20 (microscope scanners were too slow), 99:6-
100:7; RX-0182.003 (raster scan as “relatively slow”).).
Based upon the evidence and the analysis provided, 3Shape has not by clear and proven
by convincing evidence that the microscope system disclosed in Okamoto even contemplated,
much less satisfied, the sort of speed requirements required by the asserted claims.
For this reason alone, Okamoto does not disclose element [1.4] of the ’538 patent and
does not anticipate claims 1 or 2 of the ’538 patent.
e) 	[2]: “The device according to claim 1, wherein the operation of
the optical scanner is based on confocal imaging techniques.”
Okamoto satisfies this additional limitation found in claim 2. The optical system in
Okamoto is based upon confocal imaging techniques because the laser light source is conjugate
to the pinhole detector (PH). (RX-0180 at ¶¶ 16-20 (“Focused laser beam goes through pin hole
of pinhole plate PH placed at the focal position of the image forming 18 and enters into 1st photo
receptor 19”), Fig. 1; Tr. (Schaafsma) at 1328:16-1329:11.). In its Pre and Post-Hearing Briefs,
Align did not dispute that this limitation is met by Okamoto. Therefore, Align has waived any
such argument pursuant to Ground Rules 7.2 and 10.1. (CPBr. at 128; CRBr. at 57.)
4. 	Xu Does Not Anticipate Claims 1 and 2 of the ’538 Patent
Xu is U.S. Patent No. 5,912,735, which issued on June 15, 1999, more than one year
before the claimed June 17, 2004 priority date of the ’538 patent. Xu therefore qualifies as prior
art under 35 U.S.C. § 102(b).
Xu is like Okamoto in certain respects. Xu discloses an imaging device that uses a
72 Mr. Noam Babayoff was the former Vice President of R & D and Operations of Cadent, which was
later acquired by Align. (Tr. (Babayoff) at 91:16-18, 93:17-20, 94:1-3.). Align identified Mr. Babayoff
as a fact witness to testify about the technology disclosed in the ’538 patent; the Cadent/Align products;
the history of Cadent and related issues. (CPSt. at 2.).
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conventional white light system to obtain color of an examined sample and a laser confocal
microscope system for performing raster scans to provide 3D data about the sample. (RX-0166
at 2:21-56, 3:40-46.).
However, unlike Okamoto, Xu is not directed to the problem of providing color 3D
imagery. Instead, purporting to “analyze defects on semiconductor wafers, or other objects
having surface defects,” Xu teaches an “imaging system capable of simultaneously [but
separately] producing white light and laser confocal images” without the imaging distortions
found in prior art solutions. (Id. at 3:26-36.). The system can “produce a complete XY-scanned
laser image, in a single plane of focus, at video rates” and display the resulting 2D image “on a
high resolution monitor, also in real time,” allowing the operator to “scan through different levels
of focus in real time, as with a conventional microscope.” (Id. at 6:5-12.).
However, Xu does not disclose the generation of a 3D topography at “video rates.”
Instead, “[t]o obtain a three dimensional image, the following process takes place:
the optics head works with the fine z-stage control (not shown) to develop an
expanded depth-of-field image. The sample height is stepped over a pre-selected
vertical interval (typically 12 nm or some multiple thereof) using the fine z-stage
control. After each complete raster scan at a particular sample height, the height of
the sample is changed using the fine z-stage control, and a new raster scan
performed, as described above, to obtain a map of light intensity in the focal plane
of objective lens 14 (at the new sample height) by measuring the light intensity at
each XY location of the raster scan.
(Id. at 9:28-38.).
Xu also does not disclose the combination of depth data and color data to produce a 3D
color scan of an object. Instead, “the microscope image is displayed on a computer display
(simultaneously with the laser image, if desired), either in a separate window on computer
display (not shown), using appropriate software, or on a separate video monitor display (not
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shown).” (Id. at 10:7-12.).
Against this backdrop, Xu fails to disclose at least two elements of claims 1 and 2. First,
Xu lacks express disclosure a device capable of “determining the surface topology and
associated color” of a portion of a 3D structure, as required by the preamble. Dr. Schaafsma
failed to provide any testimony on the preamble (element [1.1]), perhaps because he could not
identify a disclosure that color and 3D information are associated in any way.73 (Tr.
(Schaafsma) at 1352:24-1353:17.).
Second, Xu lacks an express disclosure that “operation by the optical scanner and the
imaging means is at least substantially or effectively simultaneous,” as required by element [1.4].
While, as explained above, the system disclosed in Xu can perform a single X-Y raster scan
simultaneous with the collection of color information, there is no indication in Xu that the
plethora of raster scans required to generate 3D topology is performed with sufficient haste “such
that movement (i.e., a change in spatial disposition) can be ignored and depth data and color data
correspond to the same reference array.” (Markman Order at 64-65.).
Dr. Schaafsma failed to provide any testimony on this important concept within element
[1.4]. Instead, he focused on the simultaneity of color acquisition and a single raster scan:
Q. 	Dr. Schaafsma, can you explain why you consider Xu to anticipate or render
obvious the wherein clause of claim 1?
A. 	Yeah. 	As I’ve just described, if we’re intending to take data simultaneously
from the same portion of the sample, then this is a system that does exactly that.
Literally the two imaging systems can be on at the same time and taking the data at
the same time.
Q. And in your opinion, Dr. Schaafsma, is that data of the color imaging system
73 Pursuant to Ground Rule 7.2, 3Shape waived argument that Xu discloses the preamble because their
Pre-Hearing Brief merely contends that Xu discloses one system for color and another for 3D information
with no mention of surface topology or associated color. (RPBr. at 122.).
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and the depth -- the optical scanning system in Xu taken of a same reference array?
A. Well, as I’ve said, I think that the function of the reference array discussion isto
say that there's a particular portion of the surface of the sample that we’re looking
at, and we want to make sure we’re looking at the same portion or same area
between those two exposures, the two different images. 	And this -- this system
basically does that.
(Tr. (Schaafsma) at 1318:1-18.).
Dr. Schaafsma’s discussion of a “reference array” is particularly telling. “[T]his system
basically does that” is not clear and convincing evidence of disclosure in Xu. Moreover, on
cross examination, Dr. Schaafsma undermined his tepid identification of a “reference array” in
Xu by acknowledging that Xu lacked disclosure of the underlying reason why a “reference
array” exists in the first place in the ’538 patent: to relate depth and color data. (Tr. (Schaafsma)
at 1354:24-1353:17 (“I don't recall an express disclosure or anything like that in Xu, but I would
-- I would go back and look again.”); see also RX-0166 at 10:7-11.).
Based on the weight of the evidence, 3Shape has not proven by clear and convincing
evidence that the system disclosed in Xu even contemplated, much less satisfied, the surface
topology and speed requirements required by the asserted claims. For these reasons, Xu does not
disclose elements [1.1] and [1.4] of the ’538 patent and does not anticipate claim 1 or 2 of the
’538 patent.
5. 	Neither Okamoto Nor Xu Alone or in Combination of Okamoto and
Cha, Render the Asserted Claims Obvious
According to 3Shape, replacing Okamoto’s or Xu’s raster confocal scanning system with
a faster confocal scanning technique (such as the one found in Cha) would have been obvious in
light of the knowledge of a person of ordinary skill in the art. (RBr. at 74-76 (citing Tr.
(Schaafsma) at 1330:10-1332:2, 1361:15-1363:4, 1365:2-1366:1).).
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3Shape made a similar argument in its combination of Okamoto with Cha. (Id.). Cha is
prior art under 35 U.S.C. § 102(b). (See RX-2276.). Cha describes using a confocal microscope
where scanning is performed by a digital micromirror device (DMD). (See RX-0743.) A DMD
can be used to create an array of light beams that are directed in different directions using
electronic signals. (Id.)
3Shape argued that a person of ordinary skill in the art would have understood that
instead of using a relatively “slow” raster scanning technique to obtain depth data, as disclosed in
Okamoto or Xu, he or she could have used a staring confocal optical scanner. (RBr. at 74-76
(citing Tr. (Schaafsma) at 1330:10-24).). Such a scanner would generate parallel beams to
illuminate a portion of an entire of an object. (Id.). According to 3Shape, replacing Okamoto’s
or Xu’s raster scanning confocal system with a staring scanner would also require the use of a
CCD image sensor to detect the illumination beams reflecting back from the object. (Id. (citing
Tr. (Schaafsma) at 1365:5-24).).
3Shape’s alleged motivation to modify Okamoto or Xu in this way falls short. 3Shape
frames the obviousness inquiry as whether a person of ordinary skill in the art could modify
Okamoto or Xu to get a faster microscope. (RBr. at 74-76.). However, that is not the proper
inquiry. See Broadcom Corp. v. Emulex Corp., 732 F.3d 1325 (Fed. Cir. 2013) (stating that “[a]n
invention is not obvious just “because all of the elements that comprise the invention were
known in the prior art”;[] rather a finding of obviousness at the time of invention requires a
“plausible rational[e] [sic] as to why the prior art references would have worked together”).
3Shape improperly assumes that a person in the art of the invention would seek to modify
microscope technology in Okamoto or Xu to create scanning technology. (CX-2277C at 275:21-
276:1 (3Shape’s engineer testifying that a microscope is not a 3D scanner).).
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3Shape did not present clear and convincing evidence of such motivation. Instead, Dr.
Schaafsma testified to likelihood of success, not motivation.
Q. Dr. Schaafsma, in your opinion, would it have been obvious to one of ordinary
skill in the art to replace the optical scanner of Xu with a staring confocal system?
A. I believe that, yes, that a person of skill in the art would know that that had been
done.
* * *
Q. 	And the same question for Okamoto. 	Would it have been obvious to one of
ordinary skill in the art to have replaced the optical scanner of Okamoto with a
staring confocal system?
A. I think that, yes, a person of skill in the art would know that that could be done
and had been done.
(Tr. (Schaafsma) at 1330:5-1331:15.).
In short, 3Shape has failed to prove by clear and convincing evidence “that a skilled
artisan would have been motivated to combine the teachings of the prior art references to achieve
the claimed invention[.]” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359,
1367–68 (Fed. Cir. 2016).
Consequently, 3Shape has failed to prove that the asserted claims are rendered obvious
by Okamoto or Xu alone, or by the former in combination with Cha.
6. 	3Shape’s Invalidity Arguments Based on Babayoff Fail for Lack of
Evidence
3Shape’s invalidity arguments based upon Okamoto and Xu have been addressed above.
As shown below in Figure 28, what remains are 3Shape’s invalidity arguments based on
Babayoff. Babayoff is a named inventor on the ’538 patent. In addition to the grounds listed in
Figure 28 (combinations of Babayoff and another reference), it appears that 3Shape argued that
the asserted claims were obvious based on Babayoff alone. (RBr. at 76.).
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Figure 28: Align’s Depiction of 3Shape’s Grounds for Invalidity
(CDX-0015.0005 (introduced during the testimony of Dr. Stevenson).).
Babayoff is prior art under 35 U.S.C. § 102(b). It describes a method and confocal
apparatus for non-contact imaging of 3D objects, including teeth, by “confocal focusing an array
of light beams,” to determine the surface topology of the scanned 3D structure. (See, e.g., RX-
0338 at Abstract, 3.). Babayoff essentially discloses the monochrome 3D scanner of the ’538
patent. The ’538 patent states that Babayoff describes an embodiment of the “optical scanner.”
(JX-0003 at 25:7-11.).
Babayoff determines the surface topology of a 3D structure by illuminating the surface
with an array of incident light beams. (Id. at 3:3-4:14.) These arrays of incident light beams are
formed by a laser beam passed through a grating or a microlens array. (Id. at 8:26-9:2.). The
light beams are then passed through telecentric confocal optics connected to a motor which
changes the relative location of the focal plane of the optics along the Z-axis (i.e., the plane at
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which the light beams are focused can be scanned along the Z-direction). (Id. at 9:18-24, 11:10-
13.)
When the array of incident light beams impinge on the surface of the scanned 3D
structure, a corresponding array of illumination spots form on the surface of the scanned object at
spatially separate X-Y positions. (See id. at 5:1-21, 9:18-24, 11:10-13.). These illumination
spots are in-focus if the surface of the 3D structure is coincident with the focal plane, or out-of-
focus if the surface of the 3D structure is not coincident with the focal plane. (Id.). Whether the
illumination spot is in-focus is determined by measuring the intensity of light returned from each
spot as the focal plane is shifted along the Z-direction. Where the intensity is maximum
corresponds to the in-focus position. (Id. at 4:18-29.)
The intensity of each returned light beam is measured by passing it through a
corresponding pinhole in pinhole array 66. (Id. at 10:29-11:5.). The pinhole acts as a spatial
filter to exclude out-of-focus light from the image sensor, allowing the pixels in the image sensor
to measure intensity differences in the returned light as the focal plane moves in the Z-direction.
(Id.). This is well-known and conventional in confocal scanning. (Tr. (Schaafsma) at 1277:3-
1278:18.)
The surface topology of the scanned 3D structure is obtained from the maximum
measured intensities because “[t]he SSP for each illuminated spot will be different for different
spots” – i.e., the in-focus position of each illuminated spot is independent from other spots. (Id.
at 5:1-6.). This is also a part of conventional confocal scanning systems. (Tr. (Schaafsma) at
1369:18-1371:2.)
In addition to Babayoff, 3Shape makes prior art combinations based on Geng ’539. Geng
’539, or U.S. Patent No. 6,594,539, is prior art under 35 U.S.C. § 102(a) and § 102(e). Geng
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’539 describes an intra-oral imaging system that produces both 3D and color 2D images of dental
structures. (See, e.g., RX-0168 at 3:23-32.).
According to 3Shape, “[i]f a POSITA would not have been motivated to combine the
white light imaging systems of Okamoto or Xu with Babayoff’s intraoral confocal scanning
system because Okamoto and Xu are directed to microscopes, Geng ’539 provides additional
motivation.” (RBr. at 84.). 3Shape continued: “Geng ’539 would motivate a POSITA to
incorporate a 3D scanner and a 2D color imaging system into a hand-held device for intraoral
use, and teaches that such a combination was feasible and within the level of ordinary skill.” (Id.
(citing Tr. (Schaafsma) at 1326:13-1327:8).). From 3Shape’s perspective, Geng ’539 is a
bridging or mapping reference of sorts.
Yet the substantive value of Geng ’539 is far from clear and convincing. Geng does not
explain why a person of ordinary skill in the art would have looked to combine the 3D scanner
technology of Babayoff with microscope references such as Okamoto and Xu. Geng is directed
to a “mechanical structure and optical design [that] are very simple and reliable” because there is
“no scanning mechanism or moving parts” such as a translating lens. (RX-0168 at 5:63-64; Tr.
(Schaafsma) at 1356:12-25.). Thus, Geng ’539 does not direct a person of ordinary skill in the
art toward microscopes with scanning mechanisms (i.e., x-y raster scanner and z-stage scanner).
Even 3Shape acknowledged that the asserted claims of the ’538 patent do not require what Geng
’539 appears to offer in terms of “a hand-held device, a movable device, a processor, or the
ability to scan teeth.” (RBr. at 84.). Thus, the obviousness combination of Babayoff with
Okamoto or Xu, for which Geng ’539 supposedly created a motivation, also need not disclose
these unclaimed features. (Tr. (Stevenson) at 1804:11-1805:1; see also Order No. 36, Appx. A at
68.).
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Setting aside Geng ’539, it is clear that Babayoff alone cannot render the asserted claims
obvious. Dr. Schaafsma testified that Babayoff does not teach a device “for determining surface
topology and associated color,” the “imaging means” feature, and the “spatial disposition” clause
of claim 1. (Tr. (Schaafsma) at 1319:21-1321:1.).
While 3Shape attempted to manufacture a disclosure of color scanning in Babayoff, no
such disclosure exists. During the Hearing, Mr. Noam Babayoff74 himself testified that the
Babayoff reference was monochromatic. (Tr. (Babayoff) at 115:2-117:20, 121:19-123:10). His
testimony is consistent with the express teachings of the ’538 patent that the Babayoff reference
is monochromatic and does not capture color data. (JX-0003 at 1:40-45). While the Babayoff
patent does disclose using light of three different wavelengths, nothing in Babayoff indicates that
these wavelengths refer to red, green, and blue illuminations used for color imaging. Instead,
these “different wavelengths” are used to reduce measurement time by focusing different
wavelengths simultaneously to different planes. (Tr. (Babayoff) at 121:10-123:10; RX-0028 at
14:3-20; RX-0155 at 1:63-2:39.). Indeed, a set of three narrow-band wavelengths will not
produce a color image. (Tr. (Babayoff) at 116:17-117:20.).
3Shape fares no better with combinations of Babayoff with Okamoto or Xu. 3Shape
failed to provide clear and convincing evidence of a motivation to make either of these
combinations. “Whether a skilled artisan would be motivated to make a combination includes
whether he would select particular references in order to combine their elements.” WBIP, LLC v.
Kohler Co., 829 F.3d 1317, 1337 (Fed. Cir. 2016).
As Judge Cheney found in the 1091 Investigation, Babayoff and Okamoto (referred to as
74 When he testified during the Hearing on October 24, 2019, Mr. Noam Babayoff was a named inventor
of the ’538 patent. He testified with respect to the ’538 patent and its technology.
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Yoichi therein) are from different fields and “seemingly dissimilar inventions.” (See 1091
Investigation, Initial Determination at 96.). Okamoto and Xu, which emerged from the field of
microscopy, and Babayoff, which emerged from commercial intraoral scanning, are directed to
different problems, different applications, and have different design configurations.
As Mr. Babayoff explained during the Hearing, raster scanning microscopes (such as
those disclosed in Okamoto and Xu) were slow and not suitable for intraoral scanners. (Tr.
(Babayoff) at 97:13-20; see also Tr. (Stevenson) at 1795:20-25 (expert testimony describing
raster scan as “slow operation”).). Indeed, when filing its own patent on a color intraoral scanner
in 2015, 3Shape denigrated the same x-y raster scanning technique as used by Okamoto and Xu.
(CX-1894 at ¶0007.).
Against this backdrop, 3Shape has failed to explain why a person of ordinary skill in the
art seeking to add color imaging to the monochromatic 3D scanning of Babayoff would turn for
support to prior art microscopes with known flaws. “Known disadvantages in old devices which
would naturally discourage search for new inventions may be taken into account in determining
obviousness.” United States v. Adams, 383 U.S. 39, 52 (1966). 3Shape’s engineer and intraoral
scanner developer, Dr. van der Poel, testified that one would not look to a microscope to design
an intraoral scanner. (CX-2277C at 275:12-276:2.).
3Shape has provided nothing more than cursory expert opinion in support of its argument
that a personal of ordinary skill in the art would have a reasonable expectation of success in
actually making the obviousness combinations. (Tr. (Schaafsma) at 1323:8-1326:12; see also
RDX-0001.41); ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1327
(Fed. Cir. 2012) (affirming non-obviousness when expert’s opinions were “conclusory and
factually unsupported” because he “failed to explain how specific references could be combined,
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which combination(s) of elements in specific references would yield a predictable result, or how
any specific combination would operate or read on the asserted claims” and therefore his opinion
was “insufficient”). With respect to the Xu combination, Dr. Schaafsma merely stated that
changing out scanning and imaging systems was an “idea…available to a person at the time.”
(Tr. (Schaafsma) at 1326:5-12; see also RX-0116 at Fig. 1; RDX-0001.41.). Dr. Schaafsma
provide similarly cursory testimony on the Okamoto combination. (Id. (Schaafsma) at 1324:5-
20; see also RX-0180 at Fig. 1; RDX-0001.41.). Cursory testimony is not clear and convincing
evidence.
The shortcomings in 3Shape’s obviousness combinations are also compounded by the
fact that the Okamoto and Xu references, standing alone, are missing claim elements that 3Shape
contended are present in those references.
X. 	U.S. PATENT NO. 9,299,192
A. 	Infringement
1. 	Infringement Overview
Align accused 3Shape of directly infringing claims 2, 28, and 29 of the ’192 patent, both
literally and under the doctrine of equivalents.75 (CPBr. at 82-89; CBr. at 55-68.). Align also
accused 3Shape of indirectly infringing claims 2, 28, and 29 of the ’192 patent by inducing
infringement of these asserted claims.
Claims 2 and 29 depend from independent claim 1 and 28, respectively. Thus, in
addition to addressing the asserted claims, an analysis of each of the elements of unasserted
claim 1 is provided in Section X.A.2 below. Moreover, as shown in Table No. 10 below, the
75 DOE was not reached because the 192 Accused Products have been found to infringe literally the
asserted claims of the ’192 patent.
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elements recited in claim 1 drawn to a “method for generating a modified virtual model of a

physical structure” are nearly identical to the elements recited in claim 28, which are drawn to a

“system to generate a modified virtual model of a physical structure.” Thus, the claim elements

are addressed together in Section X.A.2(a) below (e.g., elements [1.1] / [28.1], [1.2] / [28.2],

etc.).
Table No. 10: Comparison of Claims 1 and 28 of the ’192 Patent

Cl. 1 Element Cl. 28 Element

[1.1] | A method for generating a modified | [28.1] | A system to generate a modified
virtual model of a physical structure, virtual model of a physical structure,
comprising: comprising:

[1.2] | (A) displaying an image of a first [28.2] | a display to display images of said
virtual model on a display modified virtual model; and a
operatively connected to a computer computer system operatively
system, wherein the first virtual connected to the display and
model is generated from first 3D comprising a program that, when
scan data of the physical structure, executed by the computer system,
and wherein said first virtual model causes the computer system to,
fails to properly represent a first display an image of a first virtual
physical part of the physical model generated from first 3D scan
structure; data of the physical structure on the

display, wherein said first virtual
model fails to properly represent a
first physical part of the physical
structure,

[1.3] | (B) receiving user input identifying [28.3] | receive user input identifying at
at least a portion of the first virtual least a portion of the first virtual
model that is desired to be modified, model that is desired to be modified,
wherein the user input is generated the user input generated by user
by user interaction with the image interaction with the image of the
on the display; first virtual model on the display,

[1.4] | (C) receiving a second virtual model | [28.4] | receive a second virtual model of the
of the physical structure with the physical structure, the second virtual
computer system, the second virtual model generated from second 3D
model generated from second 3D scan data of the physical structure,
scan data of the physical structure; and

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Cl. 1 Element Cl. 28 Element

and

[1.5] | (D) modifying the first virtual model | [28.5] | modify the first virtual model by

with the computer system by replacing at least said identified
replacing at least said identified portion of the first virtual model
portion of the first virtual model with a corresponding portion of the
with a corresponding portion of the second virtual model, thereby
second virtual model, thereby providing the modified virtual
generating the modified virtual model.

model.

For the reasons discussed in Sections X.A.2(a-c) below, Align has met its burden and
proven that the 192 Accused Products practice claims 2, 28, and 29.

2. The 192 Accused Products Practice Practice Claims 2, 28, and 29 of
the ’192 Patent

a) Claims 1 and 287
i. = [1.1] / [28.1]: “A method for generating a modified virtual
model of a physical structure, comprising” / “A system to
generate a modified virtual model of a physical structure,
comprising”””
There is no dispute that the 192 Accused Products meet preambles [1.1] and [28.1]. (Tr.
(Badler) at 484:12-485:2; CX-2125C (Badler Expert Rpt.) at {J 684-95.). Dr. Badler confirmed

that a user of the TRIM tool identifies and removes an inaccuracy in the first virtual model and

then “replace[s] that portion . . . by rescanning” in order to end up with “a unified or modified
whole virtual model.” (Tr. (Badler) at 467:9-22; see also id. at 484:12-485:2, 489:17-490:15.).

3Shape’s technical documents describe deleting the marked area from the model and, after

76 3Shape did not separately address the elements recited in claim 28.

” The Parties agreed that the term “virtual model” should be given its plain and ordinary meaning, which
is “3D virtual representation.” (Markman Order, App. A at 6.).

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trimming, the user can “continue scanning on the rest of the model.” (CX-1093.0001-2; see also
CX-1106C.0027 (user manual); CX-0417:1:47-2:27 (3Shape training video); CDX-
0011C.0208.).
As Dr. Eli Saber explained,78 the TRIM tool “provides the user the ability to trim away
and replace certain sections from a virtual model of a patient’s teeth.” (Tr. (Saber) at 1485:9-
12.). Moreover, he testified that “when you go back and rescan, you can obtain an updated
virtual model that represents what you are doing.” (Id. at 1488:13-22.). In short, the user is
“creat[ing] a new virtual model for that area.” (Id. at 1496:16-1497:2.).
For these reasons, Align has proven by a preponderance of evidence that the 192 Accused
Products meet preambles [1.1] and [28.1] of claims 1 and 28, respectively, of the ’192 patent.
ii. 	[1.2] / [28.2]: “displaying an image of a first virtual model on
a display operatively connected to a computer system, wherein
the first virtual model is generated from first 3D scan data of
the physical structure, and wherein said first virtual model
fails to properly represent a first physical part of the physical
structure” / “a display to display images of said modified
virtual model; and a computer system operatively connected to
the display and comprising a program that, when executed by
the computer system, causes the computer system to, display
an image of a first virtual model generated from first 3D scan
data of the physical structure on the display, wherein said first
virtual model fails to properly represent a first physical part of
the physical structure”
The Parties agreed that the claimed “virtual model” means a “3D virtual representation.”
(Markman Order, App. A at 6.). Evidence adduced in this Investigation establishes that TRIOS
78 When he testified during the Hearing on October 30, 2019, Dr. Eli Saber was a Professor in Department
of Electrical and Microelectronic Engineering at the Kate Gleason College of Engineering. (RPSt. at Ex.
D.). 3Shape identified Dr. Saber as an expert to testify about the invalidity of the ’192 patent, 3Shape’s
non-infringement of the asserted claims of the ’192 patent, and Align’s failure to satisfy the technical
prong with respect to the ’192 patent. (RPSt. at 4.).
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displays an image of the first virtual model. (Tr. (Badler) at 478:17-480:8, 485:3-487:22; Tr.
(Kristian Hansen)79 at 1216:6-1217:8, 1219:17-1220:9; Tr. (Saber) at 1452:14-21; CX-2225C
(Hansen Dep. Tr.) at 147:4-8, 150:16-21, 151:14-20, 165:12-166:2, 184:18-22; CX-1093.0001;
CX-0417 (TRIOS video) at 2:22; CDX-0011C.0206, .0210.). Dr. Badler, one of Align’s experts,
explained that
(Tr. (Badler) at 481:25-482:1.). Mr. Hansen, a 3Shape fact
witness, confirmed that
(Tr. (Hansen) at 1221:12-16.). He also testified that an
“image of the model [is] displayed on the computer screen connected to the TRIOS scanner.”
(CX-2225C (Hansen Dep. Tr.) at 147:4-8; CDX-0011C.0219.).
As Dr. Badler and Mr. Hansen both testified, the first virtual model is generated from
first 3D scan data of the physical structure. (Tr. (Badler) at 486:3-25; CX-2225C (Hansen Dep.
Tr.) at 150:1-7; CDX-011.0222.). Mr. Hansen confirmed that the TRIOS application software is
“responsible for receiving scanner data and constructing three-dimensional models.” (Tr.
(Hansen) at 1184:10-16.). According to a 3Shape document, this 3D scan data “is obtained by
and these images are
transformed “into 3D surface information.” (CX-1095C.0008; see also CX-2225C (Hansen Dep.
Tr.) at 64:1-7; CX-0953C.0009-10 (§ 1.4.1), 5-6 (§ 1.1), 15 (Fig. 1.12).). Each
has 	, which provides the 	orientation in 3D space as determined by
79 When he testified during the Hearing on October 29-30, 2019, Mr. Kristian Hansen was employed by
3Shape TRIOS AS a project manager of the TRIOS application software. (Tr. (Hansen) at 1183:25-
1184:4.). 3Shape identified Mr. Hansen as a fact witness to testify about 3Shape’s design and
development of its TRIOS intraoral scanners and the structure, function, and operation of those products.
(RPSt. at 2.).
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the scanner’s geometry. (CX-2225C (Hansen Dep. Tr.) at 32:25-33:16; Tr. (Badler) at 481:13-
482:5 (discussing 	), 487:23-488:13 (same); Tr. (Hansen) at 1242:17-
1243:10 (the package sent to the computer contains gyroscope information); CX-0953C.0013-14
at § 1.5.3; CPX-0168.0002-3.)
The first virtual model generated from this 3D scan data may have some area that the user
does not like, and the user can erase that area using the TRIM tool. (CX-2225C (Hansen Dep.
Tr.) at 150:16-151:20.). For example, if there is “blood,” “saliva,” or “too much soft tissue
obstructing [the doctor’s] work,” then you remove those portions of the model with the TRIM
tool. (Id.; see also Tr. (Badler) at 484:12-22, 659:1-4; CX-2125C (Badler Expert Rpt.) at ¶¶ 670-
71; CX-0417C (TRIOS video) at 2:22-2:31.). Blood, saliva, and too much soft tissue on the
model are examples of the first virtual model failing to properly represent a first physical part
(tooth or margin line) of the physical structure (jaw), as claimed. (JX-0004 at 5:45-51; 8:57-63;
12:9-15; 14:44-48; 20:42-49.).
Accordingly, Align has proven by a preponderance of evidence that the 192 Accused
Products practice elements [1.2] and [28.2] of claims 1 and 28, respectively, of the ’192 patent.
iii. 	[1.3] / [28.3]: “receiving user input identifying at least a
portion of the first virtual model that is desired to be modified,
wherein the user input is generated by user interaction with
the image on the display” / “receive user input identifying at
least a portion of the first virtual model that is desired to be
modified, the user input generated by user interaction with the
image of the first virtual model on the display”80
The Parties agreed that “identifying at least a portion of the first virtual model that is
80 The Parties agreed that the phrase “identifying at least a portion of the first virtual model that is desired
to be modified” means “identifying at least a portion on the first virtual model that is desired to be
replaced.” (Markman Order, App. A at 6.).
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desired to be modified” means “identifying at least a portion on the first virtual model that is
desired to be replaced.” Dr. Fisker, 3Shape’s expert, confirmed there are instances where the
first 3D model has “an unwanted area such as blood or collapsed gingiva” and the “TRIM tool
allows the user to delete the area from the first model.” (Tr. (Fisker) at 658:23-659:7; see also
CX-2220C (Fisker Dep. Tr.) at 230:15-233:20.). Other witnesses confirmed this, testifying that
the user identifies a portion on the first virtual model that is desired to be replaced using the
TRIM tool. (Tr. (Badler) at 478:17-480:8, 485:3-487:22; Tr. (Hansen) at 1216:6-1217:8,
1219:17-1220:9; Tr. (Saber) at 1452:14-21; CX-2225C (Hansen Dep. Tr.) at 147:4-8, 150:16-21,
151:14-20, 165:12-166:2, 184:18-22; CX-1093.0001; CX-0417 (TRIOS video) at 2:22; CDX-
0011C.0206, .0210.).
As Dr. Badler, Align’s expert, explained, when the user invokes the TRIM tool the user
“work[s] on the screen to indicate some area of that model . . . that we’d like to rescan” and the
“inaccurate portion is removed.” (Tr. (Badler) at 467:3-22; see also id. at 468:20-25, 470:19-
471:9, 479:9-480:8.). Dr. Badler and Mr. Hansen confirmed that the
file allows the user to manually mark and delete a part of
the model on the screen using the TRIM tool. (Tr. (Badler) at 483:11-16; Tr. (Hansen) at
1217:9-12.). Mr. Hansen also testified “when the user uses the TRIM tool, they
on the displayed model by using their finger. (Tr. (Hansen) at 1246:1-12; see also id.
at 1193:25-1194:3; CX-2225C (Hansen Dep. Tr.) at 165:12-166:2.). Dr. Badler’s and Mr.
Hansen’s factual testimonies are confirmed in 3Shape’s technical documentation, which requires
the ability to “draw on the scan,” and when the user stops drawing, “then the marked area must
be deleted from the scan.” (CX-1093.0001; CDX-0011C.0225.).
Accordingly, Align has proven by a preponderance of evidence that the 192 Accused
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Products practice elements [1.3] and [28.3] of claims 1 and 28, respectively, of the ’192 patent.
iv. 	[1.4] / [28.4]: “receiving a second virtual model of the
physical structure with the computer system, the second virtual
model generated from second 3D scan data of the physical
structure” / “receive a second virtual model of the physical
structure, the second virtual model generated from second 3D
scan data of the physical structure”81
Align presented supported, compelling evidence that the ’192 Accused Products infringe
claim elements [1.4] / [28.4]. (Tr. (Badler) at 487:23-489:16; CX-2125C (Badler Expert Rpt.) at
¶ 725-42.). The term “second virtual model” was construed to mean “second 3D virtual
representation.” (Markman Order, App. A at 1.). Both experts, Dr. Badler, Dr. Saber3 together
with 3Shape’s fact witness, Mr. Hansen all agreed that point clouds are “virtual models.” Dr.
Badler testified that output of the scanner is 	(Tr. (Badler) at 488:2-10.). As
Dr. Badler explained, the
(Id.). Simply put, “the second virtual model is generated from new 3D scan data
in the same manner that the first model was generated from scan data.” (Tr. (Badler) at 489:3-
7.).
Mr. Hansen confirmed that the TRIOS uses 3D scan data to construct a “virtual
representation” (i.e., a second virtual model) that is later added to a combined model. (Tr.
(Hansen) at 1184:10-16.). He testified that from the 3D scan data, the TRIOS constructs a three-
dimensional point cloud that is
(Id. at 1184:21-1185:8.).
Dr. Saber also testified that a three-dimensional point cloud is “a virtual representation.”
81 The term “second virtual model” was construed to mean “second 3D virtual representation.”
(Markman Order, App. A at 1.).
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(Tr. (Saber) at 1493:17-19; see also id. at 1491:13-1492:4.). He described it as “3D digitized
data.” (Id. at 1495:17-20.). As Dr. Saber expressed, when the user rescans, they “create a new
virtual model for that area.” (Id. at 1496:16-1497:2; CX-0558C.0006; CDX-0025.0010.).
The original model and the newly created virtual model are generated from a different
data scans, i.e., the original scan and the rescan, respectively. Dr. Saber testified that during
rescanning the scanner is adding
. (Tr. (Saber) at 1507:5-1508:6.). Mr. Hansen confirmed that the 192 Accused
Products obtain “at least a second 3D representation by scanning at least a modified part of the
object after modification.” (CX-2225C (Hansen Dep. Tr.) at 184:23-185:5.). Dr. Fisker echoed
this testimony, stating that the TRIOS will “obtain a second 3D representation by rescanning the
object after modification.” (Tr. (Fisker) at 660:1-8.).
Additionally, Dr. Fisker confirmed that a 	obtained by
rescanning “can be interpreted as a model.” (Tr. (Fisker) at 659:12-21.). Dr. Fisker agreed
during his deposition that “of course you can interpret 	as a second model.” (CX-
2220C (Fisker Dep. Tr.) at 233:8-234:12.). This is because the newly acquired sub scans are “a
different model than the initial model.” (Id.). Dr. Badler confirmed these facts by referring to
the following 3Shape source code files:
(Tr. (Badler) at 488:11-13.). Dr.
Saber failed to opine on this source code.
Mr. Mozeko, a witness who testified on behalf of a 3Shape reseller, Great Lakes,
confirmed through his technical team that the TRIM tool and TRIOS allow a user to “rescan[]
the deleted area on the jaw to receive a second virtual model.” (CX-0025 at ¶ 4(u)(i)(4); Tr.
(Mozeko) at 752:15-753:5; 760:22-761:7; see also CX-0026 ¶ 3(i)(i).)
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In sum, the TRIM tool allows the user to avoid “rescanning the entire object” exactly like
the ’192 patent’s disclosure. (Tr. (Fisker) at 657:13-658:1; JX-0004 at 2:15-24, 15:13-16, 16:37-
42, 25:3-12, 27:24-29, 29:8-15.). 3Shape’s documentation confirms that the user is “only
allowed to scan within a certain distance from the marked preparation,” which allows the user to
avoid rescanning the entire object. (CX-0356C.).
For the reasons discussed above, Align has proven by a preponderance of evidence that
the 192 Accused Products practice elements [1.4] and [28.4] of claims 1 and 28 respectively, of
the ’192 patent.82
v. 	[1.5] / [28.5]: “modifying the first virtual model with the
computer system by replacing at least said identified portion of
the first virtual model with a corresponding portion of the
second virtual model, thereby generating the modified virtual
model” / “modify the first virtual model by replacing at least
said identified portion of the first virtual model with a
corresponding portion of the second virtual model, thereby
providing the modified virtual model”
Evidence proffered in this Investigation demonstrates that the 192 Accused Products
practice these claim elements. (Tr. (Badler) at 489:17-490:23; CX-2125C (Badler Expert Rpt.)
at ¶¶ 743-51.). Dr. Badler testified that infringement of claim element [1.5] is “evidenced both
by Mr. Hansen’s testimony that TRIOS allows you to align first and second 3D representations,
and that the first representation is modified with data from the second representation, and that’s
exactly what the workflow produces.” (Tr. (Badler) at 489:21-490:2; CX-2225C (Hansen Dep.
Tr.) at 184:23-185:5.).
For the volumetric scanning technique, “when the user is done using the TRIM tool, the
82 Dr. Badler testified that “[t]o the extent that claim element 1.4 is not literally infringed, it's infringed
under DOE, [because the accused products] provide[] substantially the same function in the same way
with the same result of allowing the acquisition of new scan data to correct inaccurate scan data, therefore
provide better scan quality.” (Tr. (Badler) at 391:25-392:9.).
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changes are
(Tr. (Hansen) at 1219:17-1220:1.). Consistent with Mr. Hansen’s testimony, Dr. Badler
confirmed that “the
” and when the user does local rescanning of the area to be
re-built, “that creates 	” that “can then be 	” (Tr.
(Badler) at 470:19-471:9; see also id. at 560:17-562:6.). Dr. Badler explained that both the
only need to be modified locally because “the unmodified parts of the first
model” are retained “when the modified model is generated.” (Tr. (Badler) at 471:10-21.).
Dr. Badler’s analysis is supported by the pertinent source code. For example, Dr. Balder
commented that with respect to
meaning that the code
(Tr. (Badler) at 471:22-472:13; CPX-0088C at line 247.). He also expressed
that
(Tr. (Badler) at 472:14-473:3; CPX-0088C
at line 362.).
With respect to the surface scanning technique, Mr. Hansen confirmed that “when the
user begins scanning again with the surface scanning mode, the TRIOS
. . . .” (Tr. (Hansen) at 1246:13-17; see also id. at 1251:5-8,
1506:19-1508:6; CX-0351C.0002.). He explained that rescanning “only affect[s]
” (Tr. (Hansen) at 1246:22-1247:4; see also id. at 1251:12-22,
1261:1-6; CX-0351C.0002.). In other words, the model updating occurs locally and the model
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remains unchanged in areas where no new sub scans are coming in. (Id.).
Dr. Fisker confirmed that after using the TRIM tool, the user has a first model without the
undesirable portion. (CX-2222C (Fisker Dep. Tr.) at 289:4-17.). Subsequently, the user
“need[s] to fill that in” to have “an accurate scan” so the user performs a second 3D scan to
obtain the second 3D virtual representation. (Id. at 289:4-24.). The end result, as detailed
extensively above, is a modified virtual model that is generated from different data scans (e.g.,
the first scanning session and the rescanning session). (CX-0352C.0014 (“new scan data must be
appended to the model” and the “[p]ost processed scan should contain scan data from both first
and second scanning”); CX-0351.0009 (upon rescanning “[t]he model must continue being built
from the location where you previously stopped” and the “3D mod[e]l must be built up in real
time”).)
Great Lakes’ Mr. Mozeko confirmed that the TRIM tool and TRIOS allow a user to
“modify[] the initial model with the second model obtained during the rescanning to provide a
modified virtual model.” (CX-0025 ¶ 4(u)(i)(5); Tr. (Mozeko) at 752:15-753:5, 760:22-761:7
(The “information was given to [him] by [Great Lakes’s] technical support people.”).).
For the foregoing reasons, Align has proven by a preponderance of evidence that the 192
Accused Products literally practice elements [1.5] and [28.5] of claims 1 and 28, respectively, of
the ’192 patent.83
83 Dr. Badler testified that “to the extent claim element 1.5 is not infringed literally, it’s infringed under
DOE. Again, [the ’192 Accused Products] perform[] substantially the same function of modifying the first
virtual model by stitching the first virtual model together with the selected modified portion and the
second virtual model generated from the same scanning system that results in a modified virtual model.”
(Tr. (Badler) at 490:3-15; CX-2225C (Hansen Dep. Tr.) at 184:23-185:5; CX-0417 (TRIOS video) at
2:22; CX-1093C.0002 (“start to scan the trimmed area” and “must be able to continue scanning on [the]
rest of the model.”); CX-0025 ¶ 4(u)(i)(5) (“modifying the initial model with the second model obtained
during the rescanning to provide a modified virtual model.”); CX-2222C (Fisker Dep. Tr.) at 268:3-9,
280:8-12; 281:14-23; CX-0558.0006; CDX-0011C.0234.).
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b) 	Claim 2
i. 	“The method according to claim 1, wherein said physical
structure comprises any one of an intra-oral cavity of a patient
or a physical dental model representative of said intra-oral
cavity.”
Align presented evidence that the 192 Accused Products practice the additional limitation
recited in claim 2, which 3Shape did not separately dispute. (Tr. (Badler) at 490:24-491:7; CX-
2125C (Badler Expert Rpt.) at ¶¶ 752-53; RRBr. at 42.). Thus, there is no dispute that the
TRIOS is an intraoral scanner for scanning physical structures such as a patient’s intraoral
cavity. (Tr. (Avi Kopelman)84 at 155:2-4; Tr. (Badler) at 490:24-491:7 (Tr. (Fisker) at 651:5-13,
654:12-24, 685:3-17; Tr. (Hansen) at 1209:25-1210:4.).
Accordingly, Align has proven by a preponderance of evidence that the 192 Accused
Products practice the additional limitation recited in claim 2 of the ’192 patent.
c) 	Claim 29
i. 	“The system according to claim 28, wherein the at least said
identified portion of the first virtual model and the
corresponding portion of the second virtual model are each
representative of a physical portion of the physical structure,
the first virtual model providing a deficient representation of
the physical portion and the second virtual model providing an
adequate representation of the physical portion.”
The ’192 Accused Products infringe the additional limitations recited in claim 29, which
84 When he testified during the Hearing on October 24, 2019, Mr. Avi Kopelman was a Vice President
and Chief Scientist for Align. (Tr. at 126:14-18.). Align identified Mr. Kopelman as a fact witness
expected to testify on the background and business of Align; background and business of Cadent; Align’s
interactions with 3Shape; equitable defenses; domestic industry in the Asserted Patents; the background
and development of the technology in asserted ’538 and ’192 patents; Align’s domestic industry products;
validity of asserted patents including non-obviousness and secondary considerations; standing and
ownership of Asserted Patents; Align’s iTero Element and Eraser Tool; and related issues. (CPSt. at 7-
8.).
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3Shape did not separtely contest. (Tr. (Badler) at 491:22-493:5; CX-2125C (Badler Expert Rpt.)
at ¶¶ 781-83; RRBr. at 42; see also Tr. (Saber) at 1471:20-1472:2.). 3Shape teachs TRIOS users
that when the first virtual model is deficient because it is distorted by blood or saliva, the
distorted portion can be replaced by the second virtual model, which is adequate because it more
accurately represents the patient’s dentition. (CX-0417C (TRIOS video) at 2:00-2:31; CX-
0413C (TRIO video) at 2:50-4:50; CX-0416C (TRIOS video); Tr. (Badler) at 491:22-492:21.).
For the foregoing reasons, Align has proven by a preponderance of evidence that the 192
Accused Products practice the additional limitation recited in claim 29 of the ’192 patent.
B. 	Technical Prong of Domestic Industry
1. 	The 192 DI Product Practice Claims 2, 28, and 29 of the ’192 Patent
a) 	Claims 1 and 28
i. 	[1.1] / [28.1]: “A method for generating a modified virtual
model of a physical structure, comprising” / “A system to
generate a modified virtual model of a physical structure,
comprising”85
Align presented evidence that the 192 DI Product practices preambles [1.1] and [28.1].
(Tr. (Kopelman) at 138:24-139:17, 140:17-142:7; Tr. (Badler) at 497:1-10, 501:18-23; CX-
1809C; CDX-0005.0011; CDX-0011C.0252-54; CX-2125C (Badler Expert Rpt.) at ¶¶ 792-
813.). As Dr. Badler explained, the iTero Element’s Eraser tool receives user input on a touch
screen to identify at least a portion of a first virtual model, or 3D virtual representation, that
requires modification. (Tr. (Badler) at 495:8-496:4, 498:12-499:2; CDX-0011C.0241-49; CX-
1809C; CX-1909; Eraser_actor.cpp; eraser_region_logic.cpp.).
The
85 The Parties agreed that the term “virtual model” should be given its plain and ordinary meaning, which
is “3D virtual representation.” (Markman Order, App. A at 6.).
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. (Tr. (Badler) at 495:8-496:4, 498:12-499:2; CDX-0011C.0245-50.).
. (Tr. (Badler) at 495:8-496:4, 498:12-499:2; CDX-0011C.0245-50;
.). Dr.
Badler explained that the new scan data is: (i)
. (Tr.
(Badler) at 495:19-496:4 (
), 499:3-500:6; CX-2251C
(Minchenkov Dep. Tr.) at 135:21-139:4, 145:16-146:5; CDX-0011C.0247, .0250.).
After rescanning in Scan Mode,
. (Tr. (Badler) at 496:5-25 (
), 499:3-500:6; CX-2251C (Minchenkov Dep. Tr.)
at 126:25-129:21, 135:21-139:4, 145:16-146:5; CDX-0011C.0248, .0251.). View Mode
. (Tr. (Badler) at 496:5-
25; CDX-0011C.0251; CX-2251C (Minchenkov Dep. Tr.) at 135:21-139:4, 150:5-151:14; CX-
1909.0292, .0293, .0308.).
. (Tr. (Badler) at 496:5-25, 499:12-500:6; CDX-
0011C.0248, .0251-52; CX-2251C (Minchenkov Dep. Tr.) at 138:17-139:11.). As Dr. Badler
testified, the 	is a “modified virtual model” 	from the
first and second virtual models, as Dr. Badler explained. (Tr. (Badler) at 496:5-25, 499:12-
500:6, 500:24-501:23; CDX-0011C.0248, .0251-52.).
For these reasons, Align has proven by a preponderance of evidence that the 192 DI
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Product meets preambles [1.1] and [28.1] of claims 1 and 28, respectively, of the ’192 patent.
ii. 	[1.2] / [28.2]: “displaying an image of a first virtual model on
a display operatively connected to a computer system, wherein
the first virtual model is generated from first 3D scan data of
the physical structure, and wherein said first virtual model
fails to properly represent a first physical part of the physical
structure” / “a display to display images of said modified
virtual model; and a computer system operatively connected to
the display and comprising a program that, when executed by
the computer system, causes the computer system to, display
an image of a first virtual model generated from first 3D scan
data of the physical structure on the display, wherein said first
virtual model fails to properly represent a first physical part of
the physical structure”
Align offered evidence in this Investigation that the 192 DI Product practices claim
element 1.2. (Tr. (Badler) at 497:11-498:11; CDX-0011C.0255-59; CX-2125C (Badler Expert
Rpt.) at ¶¶ 814–25; see also Section X.B.1(a)(I), supra, regarding preambles [1.1] / [28.1].).
After the user scans the jaw, a “ 	.” (CX-
1351.0087.). Dr. Badler explained that the Eraser tool allows the user to “correct mistakes in the
scanned model, such as blood or saliva on the margin line.” (Tr. (Badler) at 493:21-494:1,
497:11-498:11, 495:6-7 ( 	); CX-
1909.0086 (showing moisture and artifacts on the margin line).). 3Shape’s expert, Dr. Saber,
testified that “the iTero Element and its Eraser tool [will] display an image of the model” that is
“generated from three-dimensional scan data of patient’s teeth.” (Tr. (Saber) at 1501:4-15.).
Align’s and 3Shape’s experts agreed that the Eraser tool allows the user to erase a portion of the
model and update it by rescanning. (Tr. (Saber) at 1501:12-21.; Tr. (Badler) at 498:3-11; CDX-
0011C.0256.).
Accordingly, Align has proven by a preponderance of evidence that the 192 DI Product
practices elements [1.2] and [28.2] of claims 1 and 28, respectively, of the ’192 patent.
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iii. 	[1.3] / [28.3]: “receiving user input identifying at least a
portion of the first virtual model that is desired to be modified,
wherein the user input is generated by user interaction with
the image on the display” / “receive user input identifying at
least a portion of the first virtual model that is desired to be
modified, the user input generated by user interaction with the
image of the first virtual model on the display”86
The ’192 DI Product practices claim elements [1.3] and [28.3]. (Tr. (Badler) at 495:8-15,
498:12-499:2; CDX-0011C.0260-62; CX-2125C (Badler Expert Rpt.) at ¶¶ 826-36; see also
Sections X.B.1(a)(i-ii), supra, regarding claim elements [1.1] / [28.1], [1.2] / [28.2].). The
iTero’s touch screen allows the user to “select the area to erase on the screen.” (CX-1909.0099,
.0027, .0085, .0094.). In View Mode, the user activates the Eraser tool by pressing on the
“Eraser” button and then marking a region on the model using the touch screen. (CX-
1351C.0088; CX-1814C.0001.). The “marked area becomes a hole.” (CX-1814C.0001; see also
CX-1351C.0088; Tr. (Badler) at 498:21-499:2.). Dr. Badler explained that
performs the erasing functionality. (Tr. (Badler) at 495:8-9.). Moreover, he testified that
(Id. at 494:22-495:18.).
Accordingly, Align has proven by a preponderance of evidence that the 192 DI Product
practices elements [1.3] and [28.3] of claims 1 and 28, respectively, of the ’192 patent.
86 The Parties agreed that the phrase “identifying at least a portion of the first virtual model that is desired
to be modified” means “identifying at least a portion on the first virtual model that is desired to be
replaced.” (Markman Order, App. A at 6.).
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iv. 	[1.4] / [28.4]: “receiving a second virtual model of the
physical structure with the computer system, the second virtual
model generated from second 3D scan data of the physical
structure” / “receive a second virtual model of the physical
structure, the second virtual model generated from second 3D
scan data of the physical structure”87
Evidence adduced in this Investigation demonstrate that the 192 DI Product practices
claim elements [1.4] / [28.4] literally, or in the alternative, under the doctrine of equivalents. (Tr.
(Badler) at 499:3-500:23; CDX-0011C.0263-67; CX-2125C (Badler Expert Rpt.) at ¶¶ 837–58;
see also Sections X.B.1(a)(i-iii), supra, for claim elements [1.1] / [28.1] – [1.3] / [28.3].). As Dr.
Badler explained, when rescanning, “the scan only appears in the erased area.” (Tr. (Badler) at
495:19-496:4 (citing
), 499:12-21; CX-1351C.0064 at step 24.). He testified
that 	(Tr.
(Badler) at 499:12-21.). In other words, the
(Id. at 499:22-500:6 (discussing CDX-
0011C.0265).). Dr. Badler explained that the Eraser tool is “more than just an eraser, it’s
selective,” i.e., “it allows a user to define what will be replaced” by “creating a second model in
the relevant areas to be replaced, the initial model is updated.” (Id. at 500:24-501:10; CX-1809;
CX-1952C.0019.). When the second model is created, the software
(CX-1351C.0064.).
For the reasons discussed above, Align has proven by a preponderance of evidence that
the 192 DI Product practices elements [1.4] and [28.4] of claims 1 and 28 respectively, of the
87 The term “second virtual model” was construed to mean “second 3D virtual representation.”
(Markman Order, App. A at 1.).
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’192 patent.88
v. 	[1.5] / [28.5]: “modifying the first virtual model with the
computer system by replacing at least said identified portion of
the first virtual model with a corresponding portion of the
second virtual model, thereby generating the modified virtual
model” / “modify the first virtual model by replacing at least
said identified portion of the first virtual model with a
corresponding portion of the second virtual model, thereby
providing the modified virtual model”
Evidence adduced in this Investigation indicates that the 192 DI Product practices claim
elements [1.5] / [28.5]. (Tr. (Badler) at 494:22-496:25, 500:24-502:5; CDX-0011C.0249-51,
.0268-70; CX-2125C (Badler Expert Rpt.) at ¶¶ 859-78; see also Sections X.B.1(a)(i-iv)
regarding claim elements [1.1] / [28.1] –[1.4] / [28.4].).
Without reviewing Align’s code or Align products, 3Shape’s expert, Dr. Saber, opined
that “the original model is discarded and a new model is created.” (Tr. (Saber) at 1476:3-9, 20-
24.). However, there is no support in the patent or in the record evidence for Dr. Saber’s
opinion. During the Hearing, Dr. Saber referred to Mr. Minchenkov’s deposition at page 135,
line 21 to page 136, line 1 and page 150, line 17 to page 151, line 14, to support this position.
(Tr. (Saber) at 1476:10-23.). In context, Dr. Saber’s first cite reflects that Mr. Minchenkov
described a “cancel eraser” function in the View Mode, which is equivalent to an undo. (CX-
2251C (Minchenkov Dep. Tr.) at 134:19-136:14 (the “cancel eraser functionality is available
before you go to [Scan Mode]” and once the user has identified the surface area to be deleted
they go back to “Scan Mode”); CX-1351C.0088 at steps 11-13 (describing the cancel easer
functionality); CX-1769C.0005 (“the user can Cancel his selection of marked scans, or choose
88 3Shape argued that the 192 DI Product also practices the claim element under the doctrine of
equivalents. (Tr. (Badler) at 500:15-23; CDX-0011C.0267.).
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Apply to delete the marked scans”) (emphasis added).). Dr. Saber disregarded Mr.
Minchenkov’s testimony and evidence with respect to the deleted, erased area after the user re-
scans the erased area in Scan Mode and then re-enters View Mode. (CX-1769C.0006 (“the
selected sections will be deleted from the model”).).
When read in context, Dr. Saber’s second cite described that the original model with an
error is “essentially discarded” after the user creates a modified model with the good parts from
the first and second models. (CX-2251C (Minchenkov Dep. Tr.) at 150:5-151:5.). The source
code and technical documents confirm that the
. (CX-2251C (Minchenkov Dep. Tr.) at 150:1-151:14; CX-
1769C.0006.). Mr. Minchenkov testified that upon re-entering View Mode after rescanning,
. (CX-2251C (Minchenkov Dep. Tr.) at 150:1-20.). In other words, upon re-
entering View Mode, iTero
. (Id. at 135:21-139:4, 150:5-151:14.).
Dr. Badler discussed the Align software with Mr. Minchekov; he reviewed Mr.
Minchenkov’s deposition testimony; and he examined the relevant Align source code. (Tr.
(Badler) at 494:22-496:22; 497:1-10; CX-2125C (Badler Expert Rpt.) at ¶¶ 860-78.). Dr. Badler
also reviewed Align’s technical documentation and analyzed the 192 DI Products. This lead to
Dr. Badler’s opinion and conclusion that with respect to Align’s Eraser tool, “the first and
second models [are] combined.” (Tr. (Badler) at 496:23-25.). Dr. Badler’s opinions are
consistent with a straightforward and accurate reading of Mr. Minchenkov’s testimony. (Id. at
493:6-504:2; CDX-0011C.0249-51, 268-270; CX-2125C (Badler Expert Rpt.) at ¶¶ 860-78.).
Specifically, after scanning to capture the second model, the user returns to View Mode
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where thei. ccx-t815C.). Dr. Badte
cline tht iTeo ill

___.. (Tr. (Badler) at 494:22-496:25, 499:12-502:5; CDX-0011C.0249-51, .0268-270;

see also CX-2251C (Minchenkov Dep. Tr.) at 126:25-129:21, 135:21-139:11, 150:5-151:14;
CX-1909.0292, 0293, .0308.). As Dr. Badler testified, ©

___ (Ir. adler) at 496:5-22.). He also explained that:

(d.).

In sum, the “first and second models are combined” to generate a modified virtual model.
(Ud. at 496:23-25; 501:2-23; CDX-0011C.0268-69.).

For the foregoing reasons, Align has proven by a preponderance of evidence that the 192
DI Product literally practices elements [1.5] and [28.5] of claims 1 and 28, respectively, of the

”192 patent. *?

8° Dr. Badler opined that “[t]o the extent claim element 1.5 is not met literally, it’s met under DOE,
because it provides substantially the same function in the same way with the same result of generating a
modified virtual model. (Tr. (Badler) at 502:2-5; CDX-0011C.0270.).

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b) 	Claim 2
i. 	“The method according to claim 1, wherein said physical
structure comprises any one of an intra-oral cavity of a patient
or a physical dental model representative of said intra-oral
cavity.”
Align presented evidence that the 192 DI Product practices the additional limitation
recited in claim 2, which 3Shape did not contest. (Tr. (Badler) at 502:6-16; CDX-0011C.0271;
CX-2125C (Badler Expert Rpt.) at ¶¶ 879-80; RRBr. at 45.). Thus, there is no dispute that the
iTero Element is an intraoral scanner for scanning an intra-oral cavity of a patient.
Accordingly, Align has proven by a preponderance of evidence that the 192 DI Product
practices claim 2 of the ’192 patent.
c) 	Claim 29
i. 	“The system according to claim 28, wherein the at least said
identified portion of the first virtual model and the
corresponding portion of the second virtual model are each
representative of a physical portion of the physical structure,
the first virtual model providing a deficient representation of
the physical portion and the second virtual model providing an
adequate representation of the physical portion.”
Align offered evidence that the 192 DI Product practices claim 29. (Tr. (Badler) at
503:3-504:2; CDX-0011C.0273-74; CX-2125C (Badler Expert Rpt.) at ¶¶ 919-38.). Dr. Badler
confirmed that when the first virtual model is deficient, the distorted portion can be replaced by
the second virtual model, which is adequate because it more accurately represents the patient’s
dentition. (Tr. (Badler) at 503:3-504:2; CDX-0011C.0273-74; CX-2125C (Badler Expert Rpt.)
at ¶¶ 919-38.).
Accordingly, Align has proven by a preponderance of evidence that the 192 DI Product
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literally practices claim 29 of the ’192 patent.90
C. 	Invalidity
1. 	Invalidity Overview
3 Shape argued that the asserted claims of the ’192 patent (claims 2, 28, and 29) are
invalid as anticipated, obvious, not enabled, and directed to patent ineligible subject matter.
(RBr. at 41; Joint Chart of Subst. Legal Issues (Doc. ID No. 697190) at 4 (Dec. 13, 2019).).
Specifically, 3Shape argued that the asserted claims of the ’192 patent were anticipated by Paley
(RX-0226) (which incorporates Kriveshko (RX-0227) by reference, hereinafter “Paley-
Kriveshko”), and Rubbert (RX-0229). (RBr. at 44-53.). 3Shape argued that the asserted claims
of the ’192 patent were obvious in view of Paley-Kriveshko or Rubbert individually. (Id. at 54.).
Based upon the analysis that follows:
1) 	3Shape has not proven by clear and convincing evidence that the asserted claims of
the ’192 patent are anticipated in light of the references Paley-Kriveshko or Rubbert.
2) 	3Shape has proven by clear and convincing evidence that the asserted claims of the
’192 patent are obvious in view of Paley-Kriveshko.
3) 	3Shape has not proven by clear and convincing evidence that the asserted claims of
90 Dr. Badler opined that “[t]o the extent this claim element is not literally infringed by Accused Product
when used as intended the Accused Product infringes under the doctrine of equivalents. (CX-2125C
(Badler Expert Rpt.) at ¶¶ 782; see also Tr. (Badler) at 491:22-493:5.). “[A]ny differences between this
claim limitation and the Accused Product are insubstantial changes from that which is claimed. . . . The
TRIOS permits the user to trim away unwanted portions of a virtual model and then fill
in that trimmed away portion of the model with newly acquired new scan data or 3D images.
Additionally, the Accused Product performs substantially the same function (receiving updated scan data
to correct for scan data that is defective because it represents a tooth that is obscured by blood salvia
debris or some other foreign object) in substantially the same way (replacing a deficient representation
from the first virtual model with an adequate representation from the second virtual model) to achieve
substantially the same result (generating a modified virtual model) and therefore are equivalent.” (CX-
2125C (Badler Expert Rpt.) at ¶ 782.).
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the ’192 patent are obvious in view of Rubbert.
4) 	3Shape has not proven by clear and convincing evidence that the asserted claims of
the ’192 patent are not enabled, or that they are directed to ineligible subject matter.
Notably, Align did not elicit expert testimony during the Hearing on the invalidity of the
’192 patent. Align’s arguments, to the extent that Align made them, were attorney arguments.
To the extent Align’s critical arguments of 3Shape’s evidence were accurate, they were
considered. For the rest, Align’s arguments suffered from a failure of proof. 3Shape’s evidence
and, therefore, 3Shape’s ability to meet its burden of proof is largely the basis for the invalidity
findings in the sections below.
2. 	Legal Standard
a) 	Enablement
To satisfy the enablement requirement a patent specification must “contain a written
description of the invention . . . to enable any person skilled in the art . . . to make and use the
same.” 35 U.S.C. §112, ¶1. The specification must enable a person of ordinary skill in the art to
practice the claimed invention without undue experimentation. Transocean Offshore Deepwater
Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296, 1305 (Fed. Cir. 2010). Although
a specification need not disclose minor details that are well known in the art, this is “merely a
rule of supplementation, not a substitute for a basic enabling disclosure.” Auto. Tech. Int’l Inc., v.
BMW of N. Am., 501 F.3d 1274, 1283 (Fed. Cir. 2007) (quoting Genentech, Inc. v. Novo Nordisk,
A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997)). “It is the specification, not the knowledge of one
skilled in the art, that must supply the novel aspects of an invention in order to constitute
adequate enablement.” Auto. Tech., 501 F.3d at 1283.
Enablement is a question of law with underlying questions of fact regarding undue
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experimentation. Transocean, 617 F.3d at 1305. The factors weighed by a court in determining
whether a disclosure requires undue experimentation include: (1) the quantity of experimentation
necessary, (2) the amount of direction provided, (3) the presence of working examples, (4) the
nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7)
the predictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737
(Fed. Cir. 1988). Undue experimentation is “a matter of degree” and “not merely quantitative,
since a considerable amount of experimentation is permissible, if it is merely routine, or if the
specification in question provides a reasonable amount of guidance with respect to the direction
in which the experimentation should proceed.” PPG Indus., Inc, v. Guardian Indus. Corp., 75
F.3d 1558, 1564 (Fed. Cir. 1996); Northpoint Tech, Ltd. v. MDS Am, Inc., 413 F.3d 1301, 1318
(Fed. Cir. 2005).
3. 	Overview of the Prior Art
a) 	Paley
Paley was filed on September 3, 2007, and published July 27, 2007. (RX-0226.). Paley
is prior art to the ’192 patent under 35 U.S.C. §102(b).91 See Blue Calypso, LLC v. Groupon,
Inc., 815 F.3d 1331, 1353 (Fed. Cir. 2016) (“[a]n invention is unpatentable by reason of
anticipation if it was patented or described in a printed publication in this or a foreign country or
in public use or on sale in this country, more than one year prior to the date of application for
patent in the United States” (citing pre-AIA §102(b)). Paley relates to “continuous scanning in
which incremental three-dimensional data is acquired and assembled into a full three-
91 In passing the Leahy–Smith America Invents Act (“AIA”), Congress amended § 102, and 103. See Pub.
L. No. 112-29, § 3(b-c), 125 Stat. 284, 285–87 (2011). However, because the application that led to
the ’192 patent was filed before March 16, 2013, the pre-AIA § 102(b) and § 103 applies. See id. §
3(n)(1), 125 Stat. at 293.
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dimensional model.” (RX-0226 at ¶ 5.). Paley discloses a three-dimensional intraoral scanning
system that uses “visual feedback techniques to assist in acquiring and analyzing three-
dimensional data.” (Id. at ¶¶ 12, 21.). Errors in a three-dimensional digital model, such as
“regions of incomplete scan data, inaccurate scan data, [and/or] insufficient scan detail” can be
visually identified and then corrected. (Id. at ¶¶ 59-60.). To correct errors, the user can “return
to data acquisition . . . to acquire additional data where a void or deviation is detected.” (Id. at ¶
60.). Paley expressly incorporates Kriveshko by reference on the topic of reacquiring scanning
data to supplement the original three-dimensional model of Paley. (Id. at ¶¶ 60, 73, 77.).
b) 	Kriveshko
Kriveshko was filed on January 20, 2006 and published on October 11, 2007. (RX-
0227.). Kriveshko is prior art to the ’192 patent under 35 U.S.C. §102(b). Kriveshko relates to
the acquisition of three-dimensional intraoral scan data and subsequent incorporation of that data
into an existing three-dimensional model. (Id. at ¶¶ 9, 59.). Kriveshko discloses “recover” and
“landing” modes to facilitate corrections in a three-dimensional model. (Id. at ¶ 59.). In the
“recover” mode, the system “test fit[s] new scan data to previously acquired scan data, and
provid[es] visual feedback to a user to assist in navigating back to a scan location on the subject
where the re-acquisition is being attempted.” (Id.). In the “landing mode” a user may attempt to
initiate a new scan in connection with an existing three-dimensional model; the user is able to
“select a point on the original three-dimensional model for re-acquisition of a scan.” (Id. at ¶¶ 59,
97.)
c) 	Rubbert
Rubbert was filed on March 27, 2003 and published on November 13, 2003. (RX-0229.).
Rubbert is prior art to the ’192 patent under 35 U.S.C. § 102(b). Rubbert discloses an apparatus
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and method of verifying and displaying the location of a dental appliance within a three-
dimensional model of teeth. (Id. at Abstract; 1:10-16.). Rubbert describes scanning a patient’s
dentition to generate a three-dimensional virtual model, which can be used to monitor the
progress of orthodontic treatment. (Id. at 1:22-24, 2:8-21, 6:1-13.). This virtual model contains
tooth scan data, as well as scan data of orthodontic brackets bonded to the teeth. (Id. at 21:20-
21; Fig. 7). Under Rubbert, an operator may delete scan data near a bracket model. (Id. at
14:32-15:1, 29:12-30:10.). Tooth scan data from a pre-existing second virtual model of the
patient’s dentition can be registered to the current virtual model, producing an updated virtual
model including the tooth underlying the bracket in the original model. (See id.).
4. 	Anticipation
a) 	The Asserted Claims Are Not Anticipated by Paley-Kriveshko
3Shape argued that Paley-Kriveshko anticipates claims 2, 28, and 29 of the ’192 patent.
(RBr. at 44-50.).92 Align disagreed. (CRBr. at 35-39.). 3Shape mapped the Paley disclosure
onto the elements of the asserted claims of the ’192 patent. (RBr. at 44-50.).93 In response,
Align challenged the application of Paley-Kriveshko to the limitation of “replacing at least said
identified portion of the first virtual model with a corresponding portion of the second virtual
model,” that the independent claims 1 and 28 recite. (CRBr. at 37-39.).
Claim 1 is representative of how the “replacing at least …” limitation is used in claim 28,
92 The Parties stipulated that a person of ordinary skill in the art for the ’192 patent “would have had at
least a bachelor's degree in electrical engineering, computer science, applied mathematics, or an
equivalent field, as well as at least one or two years of industry experience in three-dimensional modeling,
or at least five years of comparable industry experience in three-dimensional modeling, or an equivalent
combination of academic study and work experience.” (Joint Stip. Regarding Person of Ordinary Skill in
the Art (Doc. ID No. 692583) at ¶ 2 (Oct. 23, 2019).).
93 While not asserted, the Parties’ anticipation and obviousness arguments are mainly directed to claim 1
of the ’192 patent. Asserted claim 2 of the ’192 patent depends from claim 1.
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and recites:
A method for generating a modified virtual model of a physical
structure, comprising:
(A) displaying an image of a first virtual model on a display
operatively connected to a computer system, wherein the first virtual
model is generated from first 3D scan data of the physical structure,
and wherein said first virtual model fails to properly represent a first
physical part of the physical structure;
(B) receiving user input identifying at least a portion of the first
virtual model that is desired to be modified, wherein the user input
is generated by user interaction with the image on the display;
(C) receiving a second virtual model of the physical structure with
the computer system, the second virtual model generated from
second 3D scan data of the physical structure; and
(D) modifying the first virtual model with the computer system by
replacing at least said identified portion of the first virtual model
with a corresponding portion of the second virtual model, thereby
generating the modified virtual model.
(JX-0004 (’192 patent), cl. 1 (emphasis added).).
Align did not contest the remaining aspects of 3Shape’s anticipation argument for Paley-
Kriveshko, thereby waiving unraised challenges on this issue for all purposes pursuant to Ground
Rules 10.1 and 10.2. (CRBr. at 35-39; Ground Rules 10.1 and 10.2, Order No. 2 (Mar. 14,
2019).).
3Shape argued that Paley discloses the display of an image of a first virtual model
generated from three-dimensional scan data, as visualized below:
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Figure 29: Figure 5 of Paley
(RBr. at 44-45 (citing RX-0226 at Fig. 5, ¶¶ 28-29, 30, 32, 58, 70, 74.).
3Shape identified Paley’s teachings that the display of a first virtual model “may include
gross errors in the digital model, such as a region with omitted data, fuzziness, incomplete scan
data, or inaccurate scan data.” (Id. (citing RX-0226 at ¶ 59).). Nonetheless, 3Shape asserted that
Paley discloses that these gross errors are portions of the virtual model, which corresponds to
limitation 1[a] of the ’192 patent. (Id.)
3Shape argued that Paley teaches a “system that receives user input identifying a portion
on the first virtual model (such as a void or a region with inaccurate scan data) that is desired to
be replaced.” (Id. at 45-46 (citing RX-0226 at Fig. 5, ¶ 60).). 3Shape argued this disclosure
corresponds to limitation 1[b] of the ’192 patent. (Id.). 3Shape next pointed to a disclosed
rescanning mode called “landing mode” that represents limitation 1[c] of the ’192 patent. (Id. at
46-47.). 3Shape asserted that landing mode allows for the reacquisition of scanning data to
correct the identified error in the virtual model. 3Shape also asserted that Paley expressly
incorporates “Kriveshko by reference specifically when talking about how to reacquire
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continuous scan data from the subject to update a void or deviation.” (Id.).94 According to
3Shape, Kriveshko discloses that in landing mode, “supplemental 3D scan data of the physical
structure is acquired and then assembled into a supplemental 3D virtual model,” which
corresponds to the “second virtual model” of limitation 1[c] of the ‘192 patent. (Id. at 46-47
(citing RX-0227 at ¶¶ 74, 97.).
3Shape argued that the “supplemental 3D virtual model” of Kriveshko is “then registered
with or fit to the original 3D virtual model” that Paley teaches. (Id. at 47-48 (citing RX-0227 at
¶¶ 74, 86, 97).). 3Shape pointed to the testimony of its expert, Dr. Eli Saber, to demonstrate that
a person of ordinary skill in the art would understand Kriveshko to describe claim limitation
1[d]. (Id. at 48 (citing Tr. (Saber) at 1402:22-1403:17).).95 Dr. Saber testified that considering
the “replacing at least …” limitation, 3Shape asserted that “replacing” in 1[d] “simply requires
that new data replace the original data [of the first virtual model] – not the deletion or removal of
that original data.” (Id. at 48 (citing Tr. (Saber) at 1427:20-1428:12).). 3Shape argued that Dr.
Saber provided unrebutted testimony that Paley (incorporating Kriveshko) “discloses both
overwriting inaccurate or deficient data and replacing a void with new data” and therefore
teaches claim 1 of the ’192 patent. (Id. at 48-49 (citing Tr. (Saber) at 1402:18-1403:17, 1427:22-
24, 1428:10-12, 1443:10-15; RX-0226 at Fig. 5, ¶ 60).).
94 In relevant part, Paley recites that “where the continuous scan is to be reacquired from the subject, as
described for example in commonly-owned U.S. application Ser. No. 11/337,182 filed on Jan. 20, 2006
[Kriveshko], the entire content of which is incorporate herein by reference.” (RX-0226 at ¶ 60.). Align
did not dispute that Paley expressly incorporates Kriveshko, nor did it contest the consideration of Paley
and Kriveshko together in an anticipation analysis.
95 When he testified during the Hearing on October 30, 2019, Dr. Eli Saber was a professor at the
Electrical and Microelectronic Engineering Department of the Rochester Institute of Technology. (Tr.
(Saber) at 1377:17-23.). 3Shape identified Dr. Saber as an expert witness expected to testify regarding
the invalidity of the ’192 patent, non-infringement of the asserted claims of the ’192 patent, and the
technical prong of the domestic industry requirement for the ’192 patent. (RPSt. at 4.).
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3Shape argued that these disclosures collectively anticipate claim 1 of the ’192 patent,
and that asserted claims 2, 28, and 29 were likewise anticipated. (Id. at 44-50.). 3Shape asserted
that Paley-Kriveshko teaches an intraoral scanner used to scan a patient’s dentition, or a model
thereof, disclosing claim 2. (Id. at 49 (citing RX-0226 at ¶ 30, Fig. 5).). For claim 28, 3Shape
stated the claim relates to an apparatus (i.e. a system) that is fully disclosed for the reasons
discussed in its claim 1 analysis. (Id. (citing JX-0004 at cl. 28).). Regarding claim 29, 3Shape
argued that Paley-Kriveshko discloses “that a supplemental virtual model may replace an
inaccurate (‘deficient’) region on its virtual teeth model.” (Id.). 3Shape asserted that the
supplemental model of Paley-Kriveshko is generated with corrections to replace deviations in a
first virtual model, corresponding to the teachings of claim 29. (Id. at 49-50 (citing RX-0226 at
¶¶ 59-60; Tr. (Saber) at 1405:1-17).). Thus, 3Shape argued that Paley-Kriveshko anticipates all
asserted claims. (Id. at 49-50.).
Align focused its criticism on Paley-Kriveshko by contending that it does not expressly
disclose “replacing at least said identified portion of the first virtual model with a corresponding
portion of the second virtual model.” (CRBr. at 37.). Because this “replacing at least …”
limitation is not expressly disclosed, Align argued that 3Shape is limited to an inherent
anticipation argument with Paley-Kriveshko. (Id. (citing Finnigan Corp. v. Int’l Trade Comm’n,
180 F.3d 1354, 1365 (Fed. Cir. 1999).). Align asserted that because Paley-Kriveshko does not
necessarily disclose this “replacing at least …” limitation, there can be no anticipation. (Id. at
37-38 (citing United States Water Servs. v. Novozymes A/S, 843 F.3d 1345, 1350 (Fed. Cir.
2016).). 3Shape did not make an “inherency” argument.
According to Align, replacing a portion of the first virtual model is distinguishable from
modifying, or adding data to, said first virtual model. (CRBr. at 37-39.). Align argued that
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3Shape’s own expert acknowledged that “replacement is different from adding,” and that
Kriveshko frequently recites examples of “adding” reacquisition data to the original three-
dimensional model. (Id. at 38-39 (citing Tr. (Saber) at 1427:14-16; RX-0227 at ¶ 23).). Align
asserted that 3Shape’s expert further testified that “replacing” a portion of a three-dimensional
model with new data involves a deletion or removal step. (Id. at 38-39 (citing Tr. (Saber) at
1427:9-13, 1427:20-1428:12).).
Align contended that under Paley-Kriveshko, updating a void in an original three-
dimensional model does not involve replacing data as described in claim limitation 1[d]. (Id. at
39.). Align argued that a void arises from “omitted or missing scan data” according to Paley.
(Id. (citing RX-0226 at ¶ 59, Fig. 5).).
Align asserted that a user would be unable to identify unscanned data on the first virtual
model for replacement. Moreover, a user would not be able to delete “non-existent data” when
performing the claimed replacement of a void. (Id.). Align argued that the “replacing” of claim
limitation 1[d] was not necessarily present in Paley-Kriveshko, and therefore the claim was not
anticipated. Because this limitation is present in each of the asserted claims, Align argued that
none of the asserted claims were anticipated by Paley-Kriveshko. (Id. at 37-39.).
Align’s argument that “replacing is different from adding” is persuasive. (See CRBr. at
38.). The recited limitation of “replacing at least said identified portion of the first virtual model
with a corresponding portion of the second virtual model” in claim 1 describes something
different than the mere addition of data from the second virtual model to the corresponding
portion of the first virtual model. (See JX-0004 at cl. 1.). The term “replacing” conveys that the
portion of the original virtual model identified as having incomplete, inaccurate, or insufficient
data is ultimately discarded or deleted as a result of the method of claim 1 of the ’192 patent.
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This is consistent with the testimony that 3Shape’s expert, Dr. Saber gave, when he stated that
the replaced portion of the first virtual model would be “overwritten.” (See Tr. (Saber) at
1427:20-1428:12.).96 In short, the process of claim 1 produces a modified virtual model with the
previously identified erroneous data substituted with the corrected data for the relevant portion.
(See JX-0004 at cl. 1.).
Paley-Kriveshko does not uniformly require the deletion of old model data. Paley-
Kriveshko clearly describes a process for identifying a portion of a first virtual model having
incomplete, inaccurate, or insufficient data. (See RX-0226 at ¶¶ 59-60.). Paley-Kriveshko also
discloses a process of rescanning the corresponding physical structure thereby generating a
second virtual model. (See RX-0227 at ¶¶ 74, 86.). Paley-Kriveshko recites that all or some of
the second virtual model may then be “registered to the original three-dimensional model,”
thereby producing a modified virtual model. (Id.). Paley-Kriveshko describes the registration
process generally: “a scanning process can be divided into abstract steps of incremental data
capture, incremental derivation of three-dimensional data, and registration of the incremental
data to a common coordinate system. The final registration step brings the incremental data
together into a single three-dimensional model of a scan subject.” (RX-0226 at ¶ 6; RX-0227 at
¶ 5.). Thus, the disclosed “registration” of Paley-Kriveshko describes the creation of a single
modified virtual model, without explicitly teaching that data from the original three-dimensional
96 3Shape and its expert argued that “overwriting” original virtual model data was distinguishable from
the “deletion or removal” of the same. RBr. at 48 (citing Tr. (Saber) at 1427:20-1428:12).). Claim 1 does
not recite a discrete data deletion or removal step. Nevertheless, the claim term “replacing” does convey
that the older, erroneous model data is not present in the final modified virtual model. (See JX-0004 at cl.
1.). 3Shape did not offer a compelling argument why overwriting old model data would not result in its
deletion or removal.
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model is deleted.97
Kriveshko identifies one scenario in which multiple models are combined to produce a
single modified virtual model with overlapping portions:
In one embodiment multiple scans of an object, including scans taken at different
times, may be interpreted as a single scan. For example, in a dental application, a
tooth surface may be scanned before and after a surface preparation for dental
prosthetic. By starting the second, post-preparation scan, by reacquiring a scan of
an unprepared tooth surface, the pre-scan and post-scan structure of the prepared
surface may be combined into a single surface representation that encloses a space
to be filled by the dental prosthetic.
(RX-0227 at ¶ 99.).
Here, Paley-Kriveshko describes a situation where the modified virtual model contains
both old and new data, thereby undermining 3Shape’s position that the references teach the
replacement of data. 3Shape relied on Dr. Saber’s expert testimony that a person of ordinary
skill in the art “would have understood that [Kriveshko] describes the same material as claim
1(d) of the ’192 patent,” but then Dr. Saber failed to provide explicit support in either reference
for his argument or opinion. (RBr. at 47-48 (citing Tr. (Saber) at 1402:22-1403:17).). Paley-
Kriveshko does not directly instruct that old model data is deleted in the modified virtual model.
Therefore, it does not teach the limitation of “replacing at least said identified portion of the first
virtual model with a corresponding portion of the second virtual model.” (See JX-0004 at cl. 1.).
As described previously, this limitation is present in each of claims 2, 28, and 29. If claim 1 is
not met, neither are claims 2, 28 ad 29.
Based upon the analysis provided above, it is a finding here that 3Shape has not proven
97 The same is true when a “void” in a model is updated under Paley-Kriveshko. Paley-Kriveshko
describes a “void” as a region of omitted or missing scan data. (See RX-0226 at ¶¶ 59-60; Fig. 5.).
3Shape did not \ demonstrate persuasively that updating a void under Paley-Kriveshko requires the
deletion or removal of data from the original three-dimensional model.
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clear and convincing evidence that Paley-Kriveshko anticipates asserted claims 2, 28, and 29 of
the ’192 patent.
b) 	The Asserted Claims Are Not Anticipated by Rubbert
3Shape argued that Rubbert anticipates the asserted claims of the ’192 patent. (RBr. at
50-53.). Align disagreed. (CRBr. at 39-43.). 3Shape asserted that Rubbert discloses “a method
for generating a modified virtual model of a tooth.” (RBr. at 50 (citing RX-0229 at Abstract, 1:7-
16, 19:21-20:31, 29:28-30:29; Tr. (Saber) at 1411:2-16).). 3Shape described the process of
Rubbert as:
(i) displaying a first virtual model (i.e., showing the patient’s teeth
in the current state after some treatment has occurred);
(ii) deleting a portion of the first virtual model to create a void;
(iii) receiving a second virtual model of the tooth from the patient’s
record prior to treatment; and
(iv) combining the current first virtual model (with the void) and the
retrieved second virtual model to construct a new virtual model by
filling the void in.
(Id. (citing RX-0229 at Figs. 16-19; 14:30-15:1; 17:30-18:3, 19:21-20:31, 29:28-31:3).).
With respect to claim 1, 3Shape argued that Rubbert discloses “intraoral scanning to
create a 3D virtual image of a patient’s dentition, which is then displayed on a display
operatively connected to a computer system.” (Id. (citing RX-0229 at 10:4-11).). According to
3Shape, Rubbert teaches that this virtual tooth model may contain incomplete or inaccurate
three-dimensional surface information. (Id. at 50-51 (citing RX-0229 at 3:9-4:18).). 3Shape
contended that the virtual tooth model of Rubbert discloses claim limitation 1[a] of the ’192
patent. (Id. (citing Tr. (Saber) at 1411:2-7).).
3Shape argued that Rubbert teaches “(i) a user interface including a keyboard and a
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mouse for performing tooth registration and (ii) that the first step of the tooth registration process
includes deleting scan data that is in close vicinity to the registered bracket model to provide a
virtual tooth model with a data void.” (Id. at 51 (citing RX-0229 at 14:30-15:1; 30:9-11).).
According to 3Shape, this teaches the limitations in claim 1[b]. (Id. (citing Tr. (Saber) at
1411:24-1412:3).).
For limitation 1[c], 3Shape identified Rubbert’s disclosure of a library of patient records,
including prior information relating to the three-dimensional tooth models of existing patients.
(Id. (citing RX-0229 at 17:30-18:3; 30:16-25).). 3Shape argued that these patient records
represent the second virtual model of claim 1[c]. (Id. (citing Tr. (Saber) at 1411:1-16).). 3Shape
contended that the ’192 patent does not require that the claimed second virtual model be
generated after the first virtual model, and that the ’192 patent is not directed to a specific order
of steps. (Id. at 51-52 (citing JX-0004 at 29:38-41).).
For limitation 1[d], 3Shape noted that Rubbert teaches that the virtual tooth model
retrieved from the patient’s records is “registered” to the new virtual tooth model containing a
void. (Id. at 52 (citing JX-0004 at 30:25-31:3).). 3Shape argued that registering the two models
generates a modified virtual tooth model that fills in the void using data from the patient’s
records. (Id. (citing JX-0004 at Figs. 16-18, 8:30-9:16, 17:4-18:24, 27:22-28:30, 30:25:31:3).).
3Shape relied upon its expert to show that a person of ordinary skill in the art would understand
these teachings of Rubbert to disclose claim limitation 1[d]. (Id. (citing Tr. (Saber) at 1411:1-
16).). According to 3Shape, Rubbert consistently discloses that the patient’s teeth which are
scanned and rescanned corresponds to the “physical structure” of claim 1 of the ’192 patent. (Id.
(citing Tr. (Saber) at 1434:15-25).).
3Shape argued that these disclosures collectively anticipate claim 1 of the ’192 patent,
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and that asserted claims 2, 28, and 29 were likewise anticipated. (Id. at 52.). For claim 2,
3Shape identified Rubbert’s disclosure that an intraoral scanner is used to generate a virtual
model of a patient’s dentition. (Id. at 53 (citing RX-0229 at 10:4-10).). 3Shape asserted that
claim 28 recites apparatus claims that largely overlap with the method recited in claim 1 and
described above. (Id. (citing RX-0229 at Figs. 1B, cl. 1, 10:3-25, 31:6-34:24.). Regarding claim
29, 3Shape contended that Rubbert disclosed a virtual model of a patient’s teeth generated “after
some orthodontic treatment has occurred,” which represents the “first virtual model providing a
deficient representation of the physical portion” of claim 29. (Id. (citing RX-0229 at 3:9-19,
4:11-18, 21:31-22:4); see also Tr. (Saber) at 1413:2-16 (describing the undesirable bracket
assembly as “deficient” because it obscures the underlying tooth portion).). For these reasons,
3Shape asserted that the asserted claims were anticipated by Rubbert.
Align responded with two (2) challenges to 3Shape’s interpretation of Rubbert’s
disclosures. (CRBr. at 41-43.). First, Align argued that Rubbert discloses scanning a different
“physical structure” between the first and second virtual models, in contrast to claim 1 of the
’192 patent. (Id. at 41.). Align contended that under Rubbert, the first virtual model corresponds
to a patient’s teeth “with brackets bonded to them,” while the second virtual model corresponds
to the patient’s teeth before brackets had been applied. (Id. (citing RX-0229 at 19:21-26, 19:32-
33, 20:26-27, 21:18-21).). Align asserted that 3Shape’s expert, Dr. Saber, admitted that “the
physical structures being scanned to generate the first and second virtual models are ‘different
physical structures.’” (Id. (citing Tr. (Saber) at 1436:5-22).). Align argued that because Rubbert
teaches the scanning of separate physical structures, the reference does not anticipate the ’192
patent.
Second, Align argued that Rubbert does not disclose the user identification of a portion
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on the first virtual model to be replaced. (Id. at 42.). Align contended that the keyboard and
mouse in Rubbert was not disclosed in connection to the replacement of data in a first virtual
model. (Id.). According to Align, 3Shape relies on Rubbert’s keyboard and mouse in
connection with the tooth registration process for “a model of a patient’s tooth with a virtual
model of a bracket.” (Id. (citing RBr. at 51; RX-0229 at 23:11-34; 28:31-29:6; Figs. 14, 15).).
Furthermore, Align argued that Rubbert’s tooth registration process does not disclose user
identification of a portion of any model for replacement. (Id.). Align asserted that Rubbert is
“silent on whether the user is involved in the ‘tooth registration’ process.” (Id.). Align argued
that the keyboard and mouse allow a user to select the second virtual model (i.e. the pre-
treatment scan data), while software “finds the best fit between the two models.” (Id. (citing
RX-0229 at 16:13-21; 30:16-29.). Align contended that Rubbert fails to disclose the user
identification of a virtual model portion to be replaced, and therefore it does not anticipate. (Id.).
For these reasons, Align argued that Rubbert did not anticipate claim 1 of the ’192 patent.
(Id. at 41-43.). Align contended that independent claim 28 is valid because 3Shape’s analysis for
the claim relies on its flawed analysis of claim 1. (Id. at 43.). Likewise, Align asserted that
dependent claims 2 and 29 are valid because of their dependence from claims 1 and 28,
respectively. (Id.).
Align’s argument that Rubbert describes scanning two (2) separate physical structures is
persuasive. Independent claims 1 and 28 of the ’192 patent are directed to a “modified virtual
model of a physical structure,” a “first virtual model . . . generated from first 3D scan of the
physical structure,” and a “second virtual model generated from second 3D scan data of the
physical structure.” (JX-0004 at cls. 1, 28.). Thus, the asserted claims of the ’192 patent
describe first and second virtual models of the same physical structure.
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In contrast, Rubbert discloses a first virtual model showing a patient’s teeth after some
treatment has occurred (i.e. with one or more brackets bonded to the surface of the patient’s
teeth), and a second virtual model of a patient’s teeth prior to any treatment. (RX-0229 at Figs.
16-19; 14:30-15:1; 17:30-18:3, 19:21-20:31, 29:28-31:3.). Three-dimensional data from the
second virtual model is registered to the first virtual model, producing a modified virtual tooth
model. (RX-0229 at 30:25-30.). Thus, Rubbert discloses a method of generating a modified
virtual tooth model that combines scan data from one model of brackets bonded to a patient’s
teeth, and one model of teeth without brackets.
While 3Shape’s expert, Dr. Saber, opined that the underlying teeth are the scanned
physical structure in both virtual models of Rubbert, this position does not withstand scrutiny.
3Shape’s expert previously conceded that the first and second virtual models of Rubbert
“potentially” relate to different physical structures.
Q. So you understand that in figure 6, the user will obtain some scan data and then
generate a 3D model; right?
A. Yes.
Q. And you understand that at this point in time, there’s actually no brackets on
the patient's teeth; right?
A. Yes.
Q. And so it’s actually a different physical structure that’s being scanned. True?
A. Potentially, yes.
(Tr. (Saber) at 1436:9-22; CX-2138C (Saber Dep. Tr.) at 408:20-409:5.).98
3Shape also argued that the brackets around the teeth in Rubbert were analogous to the
“saliva as discussed in the ’192 patent itself.” (RBr. at 52.). These comparisons are not
98 Dr. Saber’s deposition was taken pursuant to Commission Rule 210.28 on August 13, 2019.
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analogous and 3Shape’s argument is unavailing.
For example, claim 1 of the ’192 patent recites a method where the “first virtual model
fails to properly represent a first physical part of the physical structure[.]” (JX-0004 at cl.1.).
The ’192 patent contemplates instances where part of a physical structure surface “was obscured
with a material including one or more of saliva, debris, [or] blood,” thereby producing an
inaccurate first virtual model. (See, e.g., JX-0004 at 5:45-51, 8:58-63, 12:10-15.).
The ’192 patent describes removing such material as saliva and blood, that is other than
the teeth alone, to obtain unobstructed access to the physical structure surface before generating
a second virtual model. (Id.). Rubbert, in contrast, does not disclose the removal of brackets
around the teeth to obtain unobscured access to the patient’s teeth for a virtual model. Critically,
Rubbert does not disclose “delet[ing] the scan data that is in close vicinity to the registered
bracket model” because the scan data “fails to properly represent” the physical structure, as
recited by the ’192 patent. Instead, in the example 3Shape cited, Rubbert is concerned with
generating a modified virtual model showing the position and orientation of a tooth without the
bracket currently bonded to it. (See RBr. at 52 (citing RX-0229 at 29:28-31:3).). In other words,
the brackets in Rubbert are part of the physical structure being scanned, not an obstruction that
prevents the first virtual model from “properly represent[ing]” the underlying physical structure.
(JX-0004 at cl. 1.). (See Tr. (Saber) at 1432:18-20; 1434:5-14; RX-0229 at 19:32-33, 20:26-27,
21:18-21.).
Ultimately, it is not clear that a person of ordinary skill in the art would understand
Rubbert to disclose first and second virtual models of the same physical structure, as recited by
independent claims 1 and 28, and dependent claims 2 and 29. Accordingly, 3Shape has not
proven by clear and convincing evidence that Rubbert anticipates asserted claims 2, 28, and 29
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of the ’192 patent.
5. 	Obviousness
a) 	The Asserted Claims are Obvious Under Paley-Kriveshko
3Shape argued that Paley-Kriveshko renders asserted claims 2, 28, and 29 obvious.
(RBr. at 54.). 3Shape asserted that only “trivial differences” exist between Paley-Kriveshko and
the asserted claims such that a person of ordinary skill in the art would have found it obvious to
modify Paley-Kriveshko to incorporate such differences. (Id.). Considering the deletion of data,
3Shape identified Dr. Saber’s expert testimony as supporting a finding that deleting portions of a
model was well known in the art and that it would have been obvious to a person of ordinary
skill in the art to overwrite existing data, or alternatively, to delete old model and then add new
data. (Id. (citing Tr. (Saber) at 1407:21-1408:4, 1427:2-1428:12, 1443:2-1443:15).).
In response, Align contended that 3Shape relied upon Dr. Saber’s conclusory expert
testimony to prove obviousness without providing references in support. (CRBr. at 44.). Align
asserted that Dr. Saber’s opinion regarding overwriting data was tainted with hindsight bias and
could not support obviousness. (Id.). Align also argued that 3Shape and its expert failed to
explain why modification of Paley-Kriveshko to include the “replacing at least …” limitation
would be obvious. (Id. at 44-45.). Align contended that the available record “does not suggest a
benefit or rationale that would have caused a skilled artisan to modify Paley-Kriveshko to delete
and replace data.” (Id. at 45.). For these reasons, Align argued that Paley Kriveshko does not
render the asserted claims obvious. (Id.).
Under KSR, an obviousness inquiry involves a flexible analysis reflecting, among other
things, that “[t]he combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416-18. As
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discussed above in Section X.C.4(a),
Paley-Kriveshko explicitly discloses all limitations of claim 1 aside from the “replacing
at least …” element of limitation 1[d]. As described above, Paley-Kriveshko does not explicitly
describe the deletion of original inadequate model data after the creation of a modified virtual
model. However, 3Shape argued persuasively that overwriting, deleting, or otherwise removing
such old model data in the modified virtual model represents a only a small change from the
explicit disclosures of Paley-Kriveshko. While Paley-Kriveshko does disclose one embodiment
of a modified virtual model having both old and new model data (see RX-0227 at ¶ 99), there is
no teaching away from the “replacing at least …” limitation in Paley-Kriveshko. Furthermore,
3Shape, through its expert Dr. Saber, successfully demonstrated that overwriting, or deleting and
then adding, data was well known in the art at the time. (See Tr. (Saber) at 1445:12-22).). Thus,
Paley-Kriveshko does not require significant modification to reach the “replacing at least …”
element of limitation 1[d].
At the same time, Align correctly noted that 3Shape and its expert, Dr. Saber, are less
than clear about why a person of ordinary skill in the art would be motivated to make this
modification. It is 3Shape’s burden to demonstrate “that a skilled artisan would have been
motivated to combine the teachings of the prior art references to achieve the claimed invention,
and that the skilled artisan would have had a reasonable expectation of success in doing so.”
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–68 (Fed. Cir. 2016)
(quoting Kinetic Concepts, Inc. v. Smith & Nephew, Inc. 688 F.3d 1342, 1360 (Fed. Cir. 2012)).
Following KSR, “some kind of motivation must be shown from some source, so that the jury can
understand why a person of ordinary skill would have thought of either combining two or more
references or modifying one to achieve the patented [invention].” Innogenetics, N.V. v. Abbott
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Labs., 512 F.3d 1363, 1374 (Fed .Cir. 2008).
However, “a reason ‘to modify a reference can come from . . . the prior art reference
itself, or from the nature of the problem to be solved.’” Microsoft Corp. v. Parallel Networks
Licensing, LLC, 715 F. App'x 1013, 1022 (Fed. Cir. 2017) (quoting SIBIA Neurosciences, Inc. v.
Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed. Cir. 2000)). Here, Paley-Kriveshko is directed
to correcting “omitted or missing scan data” as well as “incomplete scan data, inaccurate scan
data, insufficient scan detail . . . and the like.” (RX-0226 at ¶¶ 59-60.). Paley-Kriveshko is
described as having an advantage over prior art methods wherein “[u]nrecoverable errors or gaps
in incremental data cannot be identified and fixed without initiating a new scan, possibly a full
scan to completely replace the defective results.” (Id. at ¶ 7 (emphasis added).). Moreover,
Paley-Kriveshko teaches that “[t]he system may be used to aid in error-free completion of three-
dimensional scans.” (RX-0227 at ¶ 8, Abstract.).
Paley-Kriveshko highlights the priority of generating accurate virtual models. A person
of ordinary skill in the art would understand that Paley-Kriveshko teaches the undesirability of
omitted or inadequate scan data. (See Tr. (Saber) at 1392:7-1393:12 (regarding inaccurate data
in Paley, “you would like to replace that inaccurate data with accurate data”).). Paley-Kriveshko
supplies a person of ordinary skill in the art with motivation to overwrite or delete omitted or
inadequate scan data, as part of generating error-free virtual models. In application, a person of
ordinary skill in the art would be motivated to slightly modify the method of Paley-Kriveshko
and generate an error-free modified virtual model that replaced inaccurate data from a first
virtual model. Furthermore, a person of ordinary skill in the art would have a reasonable
expectation of success from such a modification, because replacing or deleting data was well-
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established in the art. (See Tr. (Saber) at 1445:12-22).).99
For these reasons, the “replacing at least …” element of claim limitation 1[d] is obvious
in view of Paley-Kriveshko. As described above in Section X.C.4, Paley-Kriveshko explicitly
recites the remaining limitations in the asserted claims. Accordingly, 3Shape has met its burden
of providing clear and convincing evidence that Paley-Kriveshko establishes a prima facie case
of obviousness as to asserted claims 2, 28, and 29 of the ’192 patent under 35 U.S.C. §103.
i. 	Secondary Considerations
In its Pre-Hearing brief, Align identified evidence that was allegedly relevant to
secondary considerations of non-obviousness for the ’192 patent. (See CPBr. at 101-102.).
However, Align does not address secondary considerations of non-obviousness for the ’192
patent in its post-hearing briefs and has therefore waived any arguments as to that issue. (See
CBr. at 55-76; CRBr. at 34-48; see also Ground Rules 10.1, 10.2). Accordingly, Align has not
shown secondary considerations of non-obviousness that overcome the finding that Paley-
Kriveshko renders claims 2, 28, and 29 of the ’192 patent obvious.
b) 	The Asserted Claims are Not Obvious Under Rubbert
3Shape argued that a person of ordinary skill in the art would have found it obvious to
modify Rubbert to overcome any “trivial differences” between it and the asserted claims of the
’192 patent. (RBr. at 54.). Unlike its Paley-Kriveshko position, 3Shape’s obviousness argument
for Rubbert was wholly conclusory and without any citation to record evidence. (Id.).
Accordingly, 3Shape failed to show by clear and convincing evidence that Rubbert rendered
99 Dr. Saber’s opinions directed to obviousness of the ’192 patent in view of Paley-Kriveshko, which have
been stricken by Order No. 46, have not been given any weight in this analysis. Consistent with Order
No. 46, Dr. Saber’s testimony has been considered only to the extent it pertains to the teachings of Paley-
Kriveshko, and the knowledge of a person of ordinary skill in the art at the time of the invention.
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obvious asserted claims 2, 28, and 29 of the ’192 patent.
6. 	Enablement
3Shape argued that the asserted claims of the ’192 patent are invalid for lack of
enablement. (RBr. at 54-55.). 3Shape contended that a person of ordinary skill in the art could
not practice the full scope of independent claims 1 and 28 without undue experimentation
because of the “wherein said first virtual model fails to properly represent a first physical part of
the physical structure” limitation found in these claims. (Id.; JX-0004 at cls. 1, 28.).
Specifically, 3Shape and its expert, Dr. Saber, asserted that a person of ordinary skill in the art
would not recognize “when the first virtual model fails to ‘properly’ represent a physical part.”
(Id. (citing Tr. (Saber) at 1390:19-1391:11.). 3Shape contended that a person of ordinary skill in
the art for the ’192 patent lacks a background in dentistry and could not overcome the omissions
of the ’192 patent. (RBr. at 55).100 3Shape asserted that dependent claims 2 and 29 are invalid
for the same reasons. (Id.).
Align argued that 3Shape did not analyze the Wands factors required for a showing of
undue experimentation. (CRBr. at 45.). Align noted that 3Shape and its expert admitted that
enabled embodiments existed, and that 3Shape failed to identify a single embodiment that is not
enabled. (Id. (citing RBr. at 54-55.)). Align asserted that the specification discloses that “the
virtual part DVM1 [the undesirable part of virtual model VM1] may be distorted or otherwise
100 The Parties stipulated that a person of ordinary skill in the art for the ’192 patent “would have had at
least a bachelor's degree in electrical engineering, computer science, applied mathematics, or an
equivalent field, as well as at least one or two years of industry experience in three-dimensional modeling,
or at least five years of comparable industry experience in three-dimensional modeling, or an equivalent
combination of academic study and work experience.” (Joint Stip. Regarding Person of Ordinary Skill in
the Art, Doc. ID No. 692583 at ¶ 2 (Oct. 23, 2019).). Therefore, 3Shape waived its right to make an
argument that undermines its own Stipulation about a person of ordinary skill. Clearly, dentistry would
be encompassed in the “industry experience” or in “an equivalent combination of academic study and
work experience” that the Parties agreed upon.
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defective and does not properly correspond to the real part DRM1 [the dental surface part that
was inadequately scanned], for example due to some defect in the actual scanning process.”
(CRBr. at 46 (citing JX-0004 at 20:50-54).). Align argued that the specification expressly
teaches instances in which a three-dimensional intraoral scan produces a model with some
unacceptable portion corresponding to a physical dental surface. (Id. (citing JX-0004 at 20:39-
49).).
3Shape’s argument does not establish that the asserted claims of the ’192 patent are
invalid for lack of enablement by clear and convincing evidence. To satisfy the enablement
requirement, a patent specificaiton must “contain a written description of the invention . . . to
enable any person skilled in the art . . . to make and use the same.” 35 U.S.C. §112, ¶1.101 In
this regard, the specification must enable a person of ordinary skill in the art to practice the
claimed invention without undue experimentation. See Transocean, 617 F.3d 1296 at 1405.
3Shape’s argument is rooted in its contention that a person of ordinary skill in the art would not
be able to identify every instance that a first visual model fails to properly identify an underlying
physical structure. This is unpersuasive. Here, a person or ordinary skill in the art has “at least
one or two years of industry experience in three-dimensional modeling,” or as much as five years
of similar experience. (See Doc. ID 692583 at ¶ 2.). 3Shape and its expert, Dr. Saber, do not
adequately explain why someone with this background would be unable to determine whether a
scanned physical dental surface is accurately and clearly depicted by a corresponding three-
dimensional virtual intraoral model.
Additionally, 3Shape does not address why one of ordinary skill in the art would be
101 Because the ’192 patent has an effective filing date prior to March 16, 2013, enablement is examined
under pre-AIA §112.
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uanble to practice the claimed subject matter absent undue experimentation. Indeed, 3Shape’s
briefing does not examine the various factors considered when assessing undue experimentation
(i.e. the Wands factors). See In re Wands, 858 F.2d at 737. Accordingly, 3Shape has failed to
prove by clear and convincing evidence that asserted claims 2, 28, and 29 of the ’192 patent are
invalid for lack of enablement.
7. 	Patent Eligibility
3Shape argued that the asserted claims of the ’192 patent are invalid under 35 U.S.C. §
101. (RBr. at 55-56.). Specifically, 3Shape asserted that the creation and modification of a
plaster model of a patient’s teeth was a “well-known procedure” and that the ’192 patent simply
applies a computer to this method. (RBr. at 55.). According to 3Shape, the “creation and
modification of a virtual model . . . involves the use of a general purpose computer to perform
mathematical calculations.” (Id.). 3Shape contended that the asserted claims fail Alice step one
because they are directed to an abstract concept such as “mathematical formulae.” (Id.; see also
Alice Corp. Pty. v. CLS Bank Int’l, 573 U.S. 208, 220. (2014)).
3Shape also contended that the asserted claims fail Alice step two because “they do not
offer a technical improvement or inventive step sufficient to transform the patent ineligible
concept of the independent claims into patent-eligible subject matter.” (Id. at 56.). 3Shape
argued that the asserted claims contemplate only the use of a generic computer functioning in a
routine manner, and are therefore ineligible. (Id. at 56.).
In response, Align noted that 3Shape offered no expert opinion and virtually no record
evidence in support of its argument. (CRBr. at 47.). Align argued that the inventor of the ’192
patent, Mr. Ari Kopelman, testified that the claims were directed to an improved method that was
not well-understood, routine, or conventional. (Id. (citing Tr. (Kopelman) at 129:5-142:7).).
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Specifically, Align asserted that Mr. Kopelman demonstrated that the ’192 patent recites a novel
superior technique for modeling a patient’s teeth in a manner that was not possible with analog
models. (Id. (citing Tr. (Kopelman) at 129:5-142:7).).
Align argued that 3Shape’s position is based on attorney argument without any rigorous
analysis of either step one or step two of Alice. (CRBr. at 47.). Align contended that 3Shape’s
lack of analysis and nonexistent consideration of the evidence is fatal to its eligibility argument.
(Id. at 48.).
3Shape’s argument is unpersuasive. The ’192 patent is directed generally to a
“computer-based method for modifying a virtual model of a physical structure . . . using
additional 3D data from the physical structure being modeled.” (JX-0004 at 4:4-15.).
Considering Alice step one, 3Shape submitted virtually no analysis on this point, and relied on a
single cite to the ’192 patent’s “Background of the Invention” section. (See RBr. (citing JX-
0004 at 1:63-2:3).). This is insufficient to demonstrate that the asserted claims are limited to an
abstract idea under Alice step one. 3Shape’s position on Alice step two is similarly deficient.
3Shape offered only conclusory attorney argument, without any meaningful discussion of
whether there is an inventive concept in the claim elements, considered individually or as an
ordered combination. See Alice, 573 U.S. at 217-18 (2014). In sum, 3Shape’s approach fails to
establish that asserted claims 2, 28, and 29 of the ’192 patent are ineligible under §101 by clear
and convincing evidence.
XI. 	INDIRECT INFRINGEMENT
A. 	Legal Standard
1. 	Induced Infringement
“Whoever actively induces infringement of a patent shall be liable as an infringer.” 35
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U.S.C. § 271(b). A patentee asserting a claim of inducement must show: (i) that there has been
direct infringement and (ii) that the alleged infringer “knowingly induced infringement and
possessed specific intent to encourage another’s infringement.” Minnesota Mining & Mfg. Co. v.
Chemque, Inc., 303 F.3d 1294, 1304-05 (Fed. Cir. 2002); see also DSU Med. Corp. v. JMS Co.,
471 F.3d 1293, 1306 (Fed. Cir. 2006) (“DSU”). With respect to the direct infringement
requirement, the patentee “must either point to specific instances of direct infringement or show
that the accused device necessarily infringes the patent in suit.” ACCO Brands, Inc. v. ABA
Locks Mfrs. Co., Ltd., 501 F.3d 1307, 1313 (Fed. Cir. 2007) (citation omitted). This requirement
may be shown by circumstantial evidence. Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d
1317, 1326 (Fed. Cir. 2009). “[A] finding of infringement can rest on as little as one instance of
the claimed method being performed during the pertinent time period.” Lucent Techs., Inc. v.
Gateway, Inc., 580 F.3d 1301, 1317 (Fed. Cir. 2009); Toshiba Corp. v. Imation Corp., 681 F.3d
1358, 1364 (Fed. Cir. 2012) (citing Lucent Techs., 580 F.3d at 1317).).
The specific intent requirement for inducement necessitates a showing that the alleged
infringer was aware of the patent, induced direct infringement, and that he knew that his actions
would induce actual direct infringement. Commil USA, LLC v. Cisco Sys., Inc., 720 F.3d 1361,
1367 (Fed. Cir. 2013), aff’d and vacated in part on other grounds, 135 S. Ct. 1920, 1926-28
(2015); Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060, 2068-70 (2011). Specific
intent can be shown by, for example: (1) changes in importation practices effectuated to shift
infringement liability;102 (2) the infringer’s copying of patented technology; and (3) the
102 There is some evidence, that Align changed its practice of importing the TRIOS with software
sometime after April 2018. The exact date is unclear. See Section III.A on In Rem Jurisdiction and
Importation.
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infringer’s willful blindness of the underlying direct infringement. Certain Network Devices,
Related Software and Components Thereof (I), Inv. No. 337-TA-944, Initial Determination at 82;
see also Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1924-25 (2015) (“It was not only
knowledge of the existence of [the asserted] patent that led the Court to affirm the liability
finding but also it was the fact that [the accused infringer] copied ‘all but the cosmetic features of
the [patented product],’ demonstrating [the accused infringer] kn[ew] it would be causing
customers to infringe [the asserted] patent.”) (quoting Global-Tech, 131 S. Ct. at 2071).).
Willful blindness, which also constitutes “knowledge,” has two basic requirements: “(1)
the defendant must subjectively believe that there is a high probability that a fact exists”; and
“(2) the defendant must take deliberate actions to avoid learning of that fact.” Global-Tech, 131
S. Ct. at 2070. The intent to induce infringement may be proven with circumstantial or direct
evidence and may be inferred from all the circumstances. Commil, 720 F.3d at 1366; Global-
Tech, 131 S. Ct. 2071-72.
2. 	Contributory Infringement
Like induced infringement, contributory infringement requires knowledge of the patent in
suit and knowledge of patent infringement. Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632, 135
S. Ct. 1920, 1926, 191 L. Ed. 2d 883 (2015) (quoting Aro Mfg. Co. v. Convertible Top Replacement
Co., 377 U.S. 476, 488, 84 S.Ct. 1526, 12 L.Ed.2d 457 (1964)).
35 U.S.C. § 271(c) sets forth the rules for contributory infringement:
Whoever offers to sell or sells within the United States or imports into the United
States 	a 	component 	of 	a 	patented 	machine, 	manufacture, 	combination, 	or
composition, or a material or apparatus for use in practicing a patented process,
constituting a material part of the invention, knowing the same to be especially
made or especially adapted for use in an infringement of such patent, and not a
staple article or commodity of commerce suitable for substantial noninfringing use,
shall be liable as a contributory infringer.
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35 U.S.C. § 271(c).
Specifically, with respect to Section 337 investigations, the Federal Circuit has held that
“to prevail on contributory infringement in a Section 337 case, the complainant must show inter
alia: (1) there is an act of direct infringement in violation of Section 337; (2) the accused device
has no substantial non-infringing uses; and (3) the accused infringer imported, sold for
importation, or sold after importation within the United States, the accused components that
contributed to another’s direct infringement.” Spansion, Inc. v. Int’l Trade Comm’n, 629 F.3d
1331, 1353 (Fed. Cir. 2010). “[N]on-infringing uses are substantial when they are not unusual,
far-fetched, illusory, impractical, occasional, aberrant, or experimental.” Vita-Mix, 581 F.3d at
1327. To determine whether a use is substantial, an Administrative Law Judge may evaluate
“the use’s frequency, . . . the use’s practicality, the invention’s intended purpose, and the
intended market.” i4i Ltd. Partnership v. Microsoft Corp., 598 F.3d 831, 851 (Fed. Cir. 2010).
Section 271(c) also requires knowledge of the existence of the patent that is infringed. Global-
Tech, 131 S. Ct. at 2068.
To satisfy the contributory infringement’s knowledge requirement, it is necessary to
establish that “the accused contributory infringer knows that its component is included in a
combination that is patented and infringing[,]” which requires knowledge of the patent. Global-
Tech, 131 S. Ct. at 2068. In addition, the Federal Circuit has held that it is not sufficient to know
of the patent and the relevant acts, but must also know that “these acts constituted infringement.”
Fujitsu Ltd. v. LG Elecs., 620 F.3d 1321, 1320 (Fed. Cir. 2010). For purposes of contributory
infringement, knowledge is inferred when the article at issue has no substantial non-infringing
uses. See Certain Semiconductor Chips with Minimized Chip Package Size and Prods.
Containing Same, Inv. No. 337-TA-605, Comm’n Op., 2009 WL 8144934, at *28 (June 3,
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2009).
Where infringement allegations address a “separate and distinct” feature of a product, the
contributory infringement analysis (for example, with respect to the existence of non-infringing
uses) may address the particular feature in question rather than the product as a whole. See i4i
Partnership v. Microsoft Corp., 598 F.3d 831, 849 (Fed. Cir. 2010); Lucent Techs., Inc. v.
Gateway, Inc., 580 F.3d 1301, 1320-21 (Fed. Cir. 2009); Ricoh Co. Ltd. v. Quanta Comput. Inc.,
550 F.3d 1325, 1338 (Fed. Cir. 2008) (“Ricoh”).
B. 	3Shape Indirectly Infringed the ’647, ’661, and ’192 Patents
1. 	’647 Patent
Align argued that it has proven that 3Shape induced infringement and contributory
infringement of the ’647 patent. (CBr. at 26-28.). With respect to inducement, Align argued that
3Shape had actual knowledge of the ’647 patent since at least the filing of the Complaint in this
Investigation on December 10, 2018. (CBr. at 26.). Alternatively, Align contended that 3Shape
demonstrated willful blindness in connection with its launch of the TPM product, despite having
knowledge that the TPM product infringes an Align patent. (Id. at 27-28 (citing Tr.
(Bogdanic)103 at 824:11-828:6; CX-2220C (Fisker Dep. Tr.) at 122:9-13).). Align asserted that
3Shape “[knew] or should have known that their actions would induce actual infringement of the
asserted claims of the ’647 patent. (Id. at 26).
According to Align, 3Shape “provide[s] training manuals, user guides, online instruction
103 When he testified during the Hearing on October 28, 2019, Mr. Alen Bogdanic was a Project Manager
at 3Shape. (Tr. at 810:4-6.). 3Shape identified Mr. Bogdanic as a fact witness who was called to testify
with respect to 3Shape’s design and development of its Patient Monitoring software and the structure,
function, and operation of that software. (RPSt. at 3.).
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videos, and other training materials that encourage resellers and end users in the U.S. to infringe
the asserted claims.” (Id. (citing Tr. (Mozeko)104 at 751:6-20; CX-0025 (Mozeko Decl.); CX-
0026 (Lake Decl.); RX-2420 (Lake Dep. Tr.) 105 at 20:2-22:2.). Align contended that 3Shape’s
actions included instruction on “Virtual Setup and TPM’s segmentation, alignment and
comparison functionality.” (Id. at 26-27.). Align noted that the “alignment feature is disabled by
default and the accused Automatic Alignment is the default choice for the user.” (Id. at 27
(citing CX-0923.0010; CX-2220C (Fisker Dep. Tr.) at 68:18-69:7).).
Align also identified evidence that 3Shape’s customers and end users of TPM and Ortho
System in the United States follow 3Shape’s training and instruction. 3Shape’s customers buy
and sell the TRIOS scanner and software, thereby directly infringing the ’647 patent. (Id.).106
According to Align, 3Shape’s training and instruction involves leading “customers and end users
to load a treatment plan into TPM for comparison, as the user guide explicitly states that it is the
intended use of the product to track a treatment plan.” (Id. (citing CX-0923.0003).).
104 When he testified during the Hearing on October 28, 2019, Mr. Charlie Mozeko was a Products
Manager at Great Lakes Dental Technologies Ltd. (“Great Lakes”). (Tr. at 747:3-748:17.). Align
identified Mr. Mozeko as a corporate representative of Great Lakes, who was called to testify with respect
to 3Shape’s U.S. sales activity, infringement of the Asserted Patents, and related activity. (CPSt. at 5.).
105 At the time of Mr. Richard Lake’s deposition that was taken on November 20, 2019 on behalf of
Patterson Dental, and held pursuant to Commission Rule 210.28, Mr. Lake was the Senior Category
Manager at Patterson Dental Holdings, Inc. (RX-2420C at 6:20-9:22.). As Senior Category Manager, he
was responsible for overseeing the marketing efforts at Patterson Dental in connection with 3Shape
products and was familiar with Patterson Dental’s recordkeeping practices. (Id.).
106 Align additionally argued that “each 3Shape entity induces the other 3Shape entities to import, test,
service, download, flash, repair, operate, demonstrate, offer to sell, and/or sell TPM and Ortho System in
the U.S. that directly infringe the ’647 patent.” (CBr. at 28.). Align thus accused each named 3Shape
Respondent as well as non-party 3Shape Manufacturing of inducing each other to directly infringe the
asserted claims of the ’647 patent. (Id.). Yet, Align did not offer evidence in support of its claims against
these entities. Align failed to specify precisely how one Respondent induces another (or non-party
3Shape Manufacturing) to infringe the ’647 patent. Align also made similar threadbare arguments for
the ’661 and ’538 patents. (CBr. at 49, 93.). Align has not proven that these entities induced each other’s
infringement using this generalized approach.
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With respect to contributory infringement, Align asserted that evidence shows instances
of direct infringement by 3Shape’s resellers and end users in the United States. (Id.). Align
contended that 3Shape had knowledge that its actions would lead to infringement of Align’s
patent. (Id. at 28.). Align argued that there are no substantial non-infringing uses of TPM,
noting that the accused Automatic Alignment feature is the default and easier method of
alignment. (Id. (citing CX-0923.0010; CX-2220C (Fisker Dep. Tr.) at 68:18-69:7).).
Contrary to Align’s arguments, 3Shape argued that TPM does not directly infringe the
’647 patent, making indirect infringement impossible. (RBr. at 23.). 3Shape argued that Align
has not proven that 3Shape encourages the importation of a “virtual setup” into TPM or the
comparison of a “virtual setup” with an actual scan. (Id.). 3Shape contended that it discourages
these activities with resellers. (Id. (citing (CX-2229C (Isleifsson Dep. Tr.) at 45:12-47:14,
47:18-48:11, 50:16-52:7.)). 3Shape also contended that Align asserted that only one of three
alignment methods of TPM infringes, and that this too has substantial non-infringing uses. (Id.
(citing CX-0923.10).).
As described above, Align presented evidence that demonstrated at least one instance of
direct infringement of the asserted claims of the ’647 patent. See Lucent Techs., 580 F.3d at
1317; Toshiba Corp., 681 F.3d at 1364. With respect to inducement, 3Shape did not dispute that
it had knowledge of the ’647 patent since at least December 10, 2018, the date that Align filed
the Complaint in this Investigation. (See RRBr. at 23.). The weight of the evidence supports a
finding that 3Shape’s instruction and training efforts encouraged resellers and end users to
infringe the ’647 patent. The evidence also reflects that 3Shape provides a range of training
materials to resellers and end users that include step-by-step instruction and demonstration of the
functionality of 3Shape’s TRIOS products. (See, e.g., CX-0025 (Mozeko Decl.); CX-0026 (Lake
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Decl.); Tr. (Mozeko) at 751:6-20; 2275C (Siandre Dep. Tr.)107 at 13:18-15:10, 24:15-25:1-23,
27:2-19, 28:9-29:17, 31:16-33:22, 35:7-21, 41:22-42:12, 67:17-68:19.). 3Shape trains users on
all features of a TRIOS scanner, including TPM and Ortho System. (See CX-2265C (Rindom
Dep. Tr.) at 56:15-22, 57:10-25; CX-2275C (Siandre Dep. Tr.) at 28:9-29:17.).
As part of its training, 3Shape instructs and intends that resellers and end users operate
the TPM and Ortho System products in the manner described in 3Shape’s training materials.
(See CX-2265C (Rindom Dep. Tr.) at 51:21-53:5, 80:19-81:2.). At least one third-party reseller
affirmed that it uses 3Shape’s training materials and instructions to train and teach customers and
end users on the TRIOS product, including the functionality of TPM with Ortho System. (See
CX-0026 (Lake Decl.).). 3Shape’s user manual explicitly recites that an intended use of TPM is
to track a patient’s treatment plan. (See CX-0923.0003.). Patterson Dental demonstrates this
product by loading a patient’s treatment plan into TPM for comparision to a virtual model. (See
CX-0026 (Lake Decl.) at ¶ 3(i)(iii).).
The evidence is compelling that 3Shape’s instruction and training efforts result in its
resellers and end users directly infringing the accused claims of the ’647 patent. 3Shape’s
counter-argument is that it discourages the importation of Virtual Setup into TPM, or a
comparison of a Virtual Setup with an actual scan. (RRBr. at 23.). 3Shape’s argument is
supported only by testimony by its software developer. (See CX-2229C (Isleifsson Dep. Tr.) at
45:12-47:14, 47:18-48:11, 50:16-52:7.). However, this argument and testimony is unpersuasive
and does not refute the weight of the evidence As an initial matter, 3Shape merely argued that it
107 When she provided her deposition testimony on May 31, 2019, Ms. Simone Siandre was an employee
of 3Shape, Inc. and held the title of Training Manager, North America. (2275C at 7:12-11:7). Her job
responsibilities included handling logistics for trainers and responding to reseller and customer training
needs. (Id. at 11:1-16.).
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merely “discourages” this practice. (RBr. at 23.). Furthermore, the evidence 3Shape cited
reveals that a user may import a Virtual Setup by taking some “extra steps.” (See id. at 51:25-
52:7.). This evidence does not overcome evidence that Patterson Dental regularly uses a Virtual
Setup with TPM. (See CX-0026 (Lake Decl.) at ¶ 3(i)(iii).).
Moreover, the combined documentary and testimonial evidence demonstrates that 3Shape
possesed the specific intent requirement for induced infringement. As described above, 3Shape
had knowledge of the ’647 patent by at least December 10, 2018. It induced direct infringement
by resellers and end users as described above. There is also evidence that 3Shape attempted to
. (See Tr. (Bogdanic) at
824:11-828:6; CX-2220C (Fisker Dep. Tr.) at 122:9-13).). The evidence of 3Shape’s actions
strongly indicate that 3Shape was aware that the actions it induced would lead to direct
infringement of Align’s patent. See Commil, 720 F.3d at 1366. Thus, Align offered sufficient
evidence that 3Shape “knowingly induced infringement and possessed specific intent to
encourage another’s infringement.” Minnesota Mining, 303 F.3d at 1304-05; DSU, 471 F.3d at
1306. For these reasons, 3Shape induced infringement of the ’647 patent.
With respect to contributory infringement, the evidence is that TPM contains three
alignment methods: Automatic Alignment, 3-Point Alignment, and Manual Alignment. (CX-
0923.10.). Of these, only the Automatic Alignment method is accused of infringing the ’647
patent. “[N]on-infringing uses are substantial when they are not unusual, far-fetched, illusory,
impractical, occasional, aberrant, or experimental.” Vita-Mix Corp. v. Basic Holding, Inc., 581
F.3d 1317, 1327 (Fed. Cir. 2009). Here, while the Automatic Alignment is the default method,
the other two (2) non-infringing methods are accessible and can also “be used to perform Lower
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and Upper Jaw Alignment.” (CX-0923.0010.). Thus, the two available non-infringing methods
qualify as “substantial.” Because TPM has substantial non-infringing uses, Align has not proven
contributory infringement of the ’647 patent.
2. 	’661 Patent
Align contended that it has proven that 3Shape committed both induced infringement and
contributory infringement of the ’661 patent. (CBr. at 48-49.). Align relied on virtually the
same arguments and evidence it cited to support it claims of 3Shape’s induced and contributory
infringement of the ’647 patent. (Id.). Align added that 3Shape instructed resellers and end
users how to use “Compare Model Sets and TPM’s segmentation, alignment and comparison
functionality,” leading to direct infringement. (Id.). Align noted that CMS does not have a
substantial non-infringing use, thereby supporting Align’s claims that 3Shape’s actions constitute
contributory infringement. (Id. at 49 (citing CX-0827C.0123-.017).).
In response, 3Shape contended that TPM and CMS do not directly infringe the ’661
patent, thereby precluding indirect infringement. (RRBr. at 34.). 3Shape asserted that Align did
not establish the intent necessary for a finding of induced infringement. (Id.). 3Shape also
argued that TPM and CMS have substantial non-infringing uses, citing the default alignment
method of TPM and the manual alignment method of CMS. (Id.). 3Shape asserted that there
was no contributory infringement because of these substantial non-infringing uses. (Id.).
As described above, Align presented evidence that demonstrated at least one instance of
direct infringement of the asserted claims of the ’661 patent. Regarding inducement, 3Shape had
knowledge of the ’661 patent since at least the December 10, 2018 filing of the Complaint in this
Investigation. Evidence shows that 3Shape’s instruction and training efforts also result in its
resellers and end users directly infringing the accused claims of the ’661 patent. (See Section
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VIII.A.2.). “[S]pecific intent may be inferred from circumstantial evidence where a defendant
has both knowledge of the patent and specific intent to cause the acts constituting infringement.”
Ricoh Co. v. Quanta Computer Inc., 550 F.3d 1325, 1342 (Fed. Cir. 2008) (citing MEMC Elec.
Materials, Inc. v. Mitsubishi Materials Silicon Corp., 420 F.3d 1369, 1378 n. 4 (Fed. Cir. 2005));
see also DSU, 471 F.3d at 1306. Such is the case here. Thus, 3Shape possessed the specific
intent required for induced infringement.
Accordingly, the weight of the evidence supports a finding that 3Shape had knowledge of
the ’661 patent and acted with the specific intent to induce resellers and end users into directly
infringing. For these reasons, 3Shape induced infringement of the ’661 patent.
With respect to contributory infringement, 3Shape persuasively argued that Align accuses
only certain alignment methods of TPM. 3Shape contended that it thereby has established
substantial non-infringing uses. Indeed, Align did not argue that threre was no substantial non-
infringing use for TPM. Align only made the “no substantial non-infringing use for CMS.” (See
CBr. at 49.). Accordingly, Align has waived argument with respect to “substantial non-
infringing uses” for TPM pursuant to Ground Rule 10.1. Moreover, the availability of the
default Automatic Alignment method in TPM represents a substantial non-infringing use. (See
CX-0923.10.). Thus because TPM has at least one substantial non-infringing use, Align has not
proven that 3Shape is liable for contributory infringement of the ’661 patent.
3. 	’538 Patent
Align argued that 3Shape is liable for induced infringement and contributory
infringement of the ’538 patent. (CBr. at 92-93.). Align argued that 3Shape had actual
knowledge of the ’538 patent since at least as of Align’s filing of the Complaint in this
Investigation. Align also argued that that by then, 3Shape also knew or was willfully blind that
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the TRIOS product infringes the ’538 patent. (Id.). Align contended that 3Shape induced end
users and resellers to directly infringe by “making, using, selling, and/or offering to sell the
TRIOS.” (Id. at 93 (citing Tr. (Mozeko) at 750:10-17, 751:25-752:14; CX-0026C (Lake Decl.);
CX-2113C; CX-2114C; CX-2265C (Rindom Dep. Tr.) at 22:9-87:7; CX-2220C (Fisker Dep.
Tr.) at 215:5-219:20; CX-2275C (Siandre Dep. Tr.) at 12:12-29:17, 94:4-104:21.). Align also
argued that 3Shape provided training and instruction to end users and resellers in the United
States that encouraged infringement of the asserted claims. (Id. (citing Tr. (Mozeko) at 751:6-24;
CX-2264C (Rindom Dep. Tr.) 72:13-20.).
With respect to contributory infringement, Align asserted that “Respondents offer to sell
or sell in the United States or import into the United States the TRIOS scanners.” (Id. (citing Tr.
(Petersen) at 1137:15-19, 1139:9-1140:5; CX-2164C).). Align contended that the “TRIOS
scanner constitutes a material part of the inventions of the ’538 patent, and does not have any
substantial non-infringing use.” (Id. (citing CX-2276C (Van der Poel Dep. Tr.) 99:21-
100:18).).108
In response, 3Shape argued that Align has not proven that TRIOS directly infringes the
asserted claims of the ’538 patent, precluding any indirect infringement. (RRBr. at 62-63.).
Considering induced infringement, 3Shape contended that Align did not submit evidence of the
intent necessary for inducement. (Id. at 62-63.).
As described above in Section IX.A.2, Align has failed to establish that TRIOS directly
infringes claims 1 and 2 of the ’538 patent. (See Sections IX.A.2, supra.). Thus, Align cannot
establish that 3Shape induced infringement. Limelight Networks v. Akamai Techs., 134 S. Ct.
108 When he gave his deposition testimony on May 24, 2018, Mr. Mike van der Poel held the position of
Scanner Manager and Director of New Business Ventures with 3Shape. (CX-2276 at 10:25-11:9.).
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2111, 2117 (2014) (“[O]ur case law leaves no doubt that inducement liability may arise ‘if, but
only if, [there is]…direct infringement.”).
In the alternative, should the Commission determine that the 538 Accused Products
practice one or more claims of the ’538 patent, an analysis of induced infringement is included.
The available evidence demonstrates that 3Shape possesed the specific intent requirement
to induce infringement. As described above, 3Shape had knowledge of the ’538 patent by at
least December 10, 2018. There is compelling evidence that 3Shape induced its resellers and
end users to use, sell, and/or offer to sell the TRIOS, that resulted in direct infringement by
3Shape’s resellers and end users. (See, e.g., Tr (Mozeko) at 750:10-17, 751:25-752:14; CX-
0026C (Lake Decl.); CX-2113C; CX-2114C; CX-2265C (Rindom Dep. Tr.) at 35:24-37:21,
56:7-57:25, 65:3-68:1; CX-2220C (Fisker Dep. Tr.) at 215:5-219:20; CX-2275C (Siandre Dep.
Tr.) at 12:12-29:17, 94:4-104:21.). Because 3Shape had knowledge of the ’538 patent when it
induced infringing actions, the specific intent required for induced infringement is present here.
See Ricoh, 550 F.3d at 1342; DSU, 471 F.3d at 1306.
Accordingly, Align has proven each of the necessary elements of induced infringement,
other than direct infringement. If the Commission were to ultimately find direct infringement of
the asserted claims of the ’538 patent, then Align would have successfully demonstrated induced
infringement of the asserted claims of the ’538 patent.
Like induced infringement, contributory infringement requires proof of an act of direct
infringement. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, 424 F.3d 1293, 1312 (Fed.
Cir. 2005). As discussed above, Align has failed to establish that TRIOS directly infringes the
’538 patent, thus precluding a finding of contributory infringement. (See Section IX.A.2 supra.).
In the alternative, should the Commission determine on review that 3Shape’s resellers
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and/or end users directly infringe the ’538 patent, an analysis of contributory infringement is
included. The weight of the evidence is that 3Shape offers to sell or sells the TRIOS products in
the United States. (Tr. (Petersen) at 1137:15-19, 1139:9-1140:5; CX-2164C.). 3Shape was
aware of the ’538 patent, and potential infringement by the 538 Accused Products, at least by
December 10, 2018, when Align filed the Complaint in this Investigation. (CX-2280C (Van der
Poel Dep. Tr.) at 11:20-13:4.). The record evidence supports a finding that the TRIOS scanner is
used only for infringing intraoral scanning. (See, e.g., CX-2276C (Van der Poel Dep. Tr.) at
99:21-100:18). Moreover, 3Shape did not contend that the TRIOS scanner possesses substantial
non-infringing uses. (See RPBr. at 109; RRBr. at 63.). Therefore, 3Shape has waived this
argument pursuant to Ground Rule 10.2.
For the reasons explained above, Align has shown by a preponderance of the evidence
each of the necessary elements of contributory infringement. If the Commission were to
ultimately find direct infringement of asserted claims 1 and 2 of the ’538 patent, then Align
would have successfully demonstrated contributory infringement of asserted claims 1 and 2 of
the ’538 patent.
4. 	’192 Patent
Align argued that it has shown 3Shape induced infringement of the ’192 patent. (CBr. at
68.). Align contended that 3Shape had knowledge of the ’192 patent as early as November 2017,
when it was asserted against 3Shape in a Federal District Court proceeding. (Id. (citing D. Del.
Case No. 17-cv-1646-LPS).).
Align argued that 3Shape conducts 	training
in the United States, and that it
(Id. (citing CX-2265C (Rindom Dep. Tr.) at 65:19-24; CX-2309C (Ellersgaard Dep.
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Tr.) at 18:10-13.).109 Align argued that 3Shape 	to help users operate the TRIM
tool, which includes “how to remove blood and saliva from a model to make it more accurate.”
(Id. (citing CX-2265C (Rindom Dep. Tr.) at 9:18-25, 60:24-61:5).). Additionally, Align argued
that 3Shape provided “numerous TRIOS level 1 and level 2 trainings in the United States in
2019” that taught users how to use the TRIM tool and the Pre-Preparation Workflows. (Id.
(citing CX-1116C at 2-8; CX-1145C).). According to Align, 3Shape indirectly infringes the
asserted claims of the ’192 patent by demonstrating the 	, Align
also argued that 3Shape then induces others to infringe as those users independently
. (Id.).
In response, 3Shape contended the TRIOS software does not directly infringe the ’192
patent, thereby precluding induced infringement. (RRBr. at 42.). Additionally, 3Shape
challenged Align’s reliance on Mr. Mozeko’s testimony. (Id. at 42-43.). 3Shape noted that Mr.
Mozeko admitted that he had not drafted his own declaration and did not have knowledge of how
models in the TRIOS App are modified. (Id. at 43 (citing Tr. (Mozeko) at 760:5-14, 761:15-
17).). Additionally, 3Shape argued that Mr. Mozeko did not have access to 3Shape source code,
the ’192 patent, or its file history, which undermined his testimony with respect to infringement.
(Id. (citing Tr. (Mozeko) at 759:15-760:4; 764:24-765:8).).
As described above, Align presented evidence that demonstrated at least one instance of
direct infringement of the asserted claims of the ’192 patent. Regarding inducement, 3Shape had
109 When she gave her deposition testimony on April 11, 2018, Ms. Sophie Ellersgaard held the position
of Director of Customer Care at 3Shape A/S. (CX-2309C at 13:24-16:2.). In this position, Ms.
Ellersgaard was responsible for 3Shape A/S’s customer support team and its training team, which
manages both internal and external training. (Id. at 14:14-17:7.).
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knowledge of the ’192 patent since at least November 14, 2017, when Align previously accused
3Shape of infringing the ’192 patent in a Federal District Court case. (See Compl., Case. No. 17-
cv-1646 (D. Del.).). The complaint in this district court case specifically alleged that TRIOS
products are associated with the direct and induced infringement of the ’192 patent. (See id.)
The adduced evidence indicates that 3Shape knowingly administers or distributes training
programs that induce actual infringement by its resellers and/or end users. 3Shape’s criticism of
Mr. Mozeko’s testimony is unpersuasive. It does not undermine Align’s evidence of 3Shape’s
inducement.110 Mr. Mozeko testified that although he did not draft his declaration, he reviewed
his declaration, and confirmed with the assistance of knowledgeable people that the information
contained in his declaration was true. (See Tr. (Mozeko) at 764:2-17.). Because 3Shape had
knowledge of the ’192 patent when it induced infringing actions, the specific intent required for
induced infringement is present here. See Ricoh, 550 F.3d at 1342; DSU, 471 F.3d at 1306.
Accordingly, the weight of the evidence supports a finding that 3Shape had knowledge of
the ’192 patent and acted with the specific intent to induce resellers and end users into directly
infringing. For these reasons, 3Shape induced infringement of the ’192 patent.
XII. 	DOMESTIC INDUSTRY REQUIREMENT: ECONOMIC PRONG
A. 	Legal Standard
The Commission may only find a violation of Section 337 “if an industry in the United
States relating to the articles protected by the patent . . . exists or is in the process of being
established.” 19 U.S.C. § 1337(a)(2) (emphases added). Typically, a complainant must show
110 As a representative of Great Lakes Dental Technologies, Ltd., Mr. Mozeko may properly relate what
his company’s sales and technical support staff have observed during demonstrations of the TRIM tool
functionality. (See Tr. (Mozeko) at 752:15-753:2, 760:22-761:7.). Align has not shown why knowledge
of its source code, the ’192 patent, or the file history is required for Mr. Mozeko to testify about Great
Lakes’ demonstrations of the TRIM tool on the TRIOS scanner. (See CX-0025 (Mozeko Decl.) at 4.u.i.).
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that a domestic industry existed at the time the complaint was filed. See Motiva LLC v. Int’l
Trade Comm’n, 716 F.3d 596, 601 n.6 (Fed. Cir. 2013).
The domestic industry requirement consists of a “technical prong” and an “economic
prong.” See, e.g., Certain Elec. Devices, Including Wireless Commc’n Devices, Portable Music
& Data Processing Devices, & Tablet Computs., Inv. No. 337-TA-794, Order No. 88, 2012 WL
2484219, at *3 (June 6, 2012); Certain Unified Commc’ns Sys., Prods. Used with Such Sys., and
Components Thereof, Inv. No. 337-TA-598, Order No. 9 at 2 (Sept. 5, 2007) (“Communications
Systems”). A complainant satisfies the “technical prong” of the domestic industry requirement
when it proves that its activities relate to an article “protected by the patent.” See
Communications Systems, Order No. 9 at 2. A complainant satisfies the “economic prong” of the
domestic industry requirement when it demonstrates that the economic activities set forth in
subsections (A), (B), and/or (C) of Section 337(a)(3) have taken place or are taking place with
respect to the protected articles. See id.
Subsection 337(a)(3) states that:
(3) For purposes of paragraph (2), and industry in the United States
shall be considered to exist if there is in the United States, with
respect to the articles protected by the patent, copyright, trademark,
mask work, or design concerned –
(A) significant investment in plant and equipment;
(B) significant employment of labor, or capital; or
(C) substantial investment in its exploitation, including
engineering, research and development, or licensing.
19 U.S.C. § 1337(a)(3).
Because the criteria are listed in the disjunctive, satisfaction of any one of them will be
sufficient to meet the economic prong of the domestic industry requirement. Certain Integrated
Circuits, Chipsets and Prods. Containing Same, Inv. No. 337-TA-428, Order No. 10, Initial
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Determination (May 4, 2000) (“Integrated Circuits”) (unreviewed). Establishment of the
“economic prong” is not dependent on any “minimum monetary expenditure” and there is no
need for a complainant “to define the industry itself in absolute mathematical terms.” Certain
Stringed Musical Instruments and Components Thereof, Inv. No. 337-TA-586, Comm’n Op. at
25-26 (May 16, 2008) (“Stringed Instruments”). However, a complainant must substantiate the
nature and the significance of its activities with respect to the articles protected by the patent at
issue. Certain Printing and Imaging Devices and Components Thereof, Inv. No. 337-TA-690,
Comm’n Op. at 30 (Feb. 17, 2011) (“Imaging Devices”).
The Commission has interpreted Sections 337(a)(3)(A) and (B) to concern “investments
in plant and equipment and labor and capital with respect to the articles protected by the patent.”
Certain Ground Fault Circuit Interrupters and Prods. Containing Same, Inv. No. 337-TA-739,
2012 WL 2394435, at *50, Comm’n Op. at 78 (June 8, 2012) (“Circuit Interrupters”) (emphasis
in original) (quoting 19 U.S.C. §§ 1337(a)(3)(A), (B)).
When a complainant proceeds under Section 337(a)(3)(C), it is not sufficient for the
“substantial investment” under subsection (C) to merely relate to articles protected by the
asserted patents. Rather, “the complainant must establish that there is a nexus between the
claimed investment and asserted patent regardless of whether the domestic-industry showing is
based on licensing, engineering, research and development.” Certain Integrated Circuit Chips &
Prods. Containing, Inv. No. 337-TA-845, Final Initial Determination, 2013 WL 3463385, at *14
(June 7, 2013).
In addition, the Commission has definitively stated that investments in plant and
equipment or labor and capital that relate to engineering and research and development (“R&D”)
(that are expressly identified under subsection (C)), are properly considered under subsections
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(A) and (B):
The statutory text of section 337 does not limit sections 337(a)(3)(A) and (B) to
investments related to manufacturing or any other type of industry. It only requires
that the domestic investments in plant and equipment, and employment of labor or
capital be “with respect to the articles protected by the patent.” 	19 U.S.C.
§ 1337(a)(3). 	Moreover, 	even 	though 	subsection 	(C) 	expressly 	identifies
“engineering” and “research and development” as exemplary investments in the
“exploitation” of the patent, that language does not unambiguously narrow
subsections (A) and (B) to exclude those same types of investments.
Certain Solid State Storage Drives, Stacked Elecs. Components, and Prods. Containing Same,
Inv. No. 337-TA-1097, Comm’n Op. at 8 (June 29, 2018) (“Storage Drives”); see also, e.g.,
Certain Marine Sonar Imaging Devices, Including Downscan and Sidescan Devices, Prods.
Containing the Same, and Components Thereof, Inv. No. 337-TA-921, Comm’n Op. at 57-64
(Jan. 6, 2016) (“Sonar Imaging Devices”).
There is no mathematical threshold test or a “rigid formula” for determining whether a
domestic industry exists. Certain Male Prophylactic Devices, Inc., Inv. No. 337-TA-292,
Comm’n Op. at 39, USITC Pub. 2390 (June 1991) (“Male Prophylactic Devices”). However, to
determine whether investments are “significant” or “substantial,” the actual amounts of a
complainant’s investments or a quantitative analysis must be performed. Lelo Inc. v. Int’l Trade
Comm’n, 786 F.3d 879, 883-84 (Fed. Cir. 2015). Even after Lelo, which requires some
quantification of a complainant’s investments, there is still no bright line as to a threshold
amount that might satisfy an economic industry requirement.
It is the complainant’s burden to show by a preponderance of evidence that each prong of
the domestic industry requirement is satisfied. Certain Prods. Containing Interactive Program
Guide and Parental Control Tech., Inv. No. 337-TA-845, Final Initial Determination, 2013 WL
3463385, at *14 (June 7, 2013.). Moreover, the Commission makes its determination by “an
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examination of the facts in each investigation, the article of commerce, and the realities of the
marketplace.” Male Prophylactic Devices, Comm’n Op. at 39 (quoting Certain Double Sided-
Floppy Disk Drives and Components Thereof, Inv. No. 337-TA-215, Comm’n Op. at 17, USITC
Pub. 1859 (May 1986)).
B. 	Align’s Investments in Plant and Equipment Are Significant Under Section
337 (a)(3)(A)
Align made and continues to make significant domestic investments in the iTero DI
Products111 in the form of facility and equipment costs in relation to activities that include R&D,
product development, and management.112 Align is headquartered in San Jose, California, and
has purchased additional facilities in Raleigh, North Carolina. (Tr. (Morici) at 589:5-590:6,
703:6-705:13.).113 To prove it has significant investments under Subsection 337(a)(3)(A), Align
relies upon its plant and equipment expenses related to these two (2) referenced U.S. facilities.
111 The relevant DI Products are the Element, Element 2, and Element Flex versions of Align’s iTero
scanner. (Tr. (Kling) at 356:18-23; Tr. at 705:14-18 (Bakewell).). Align and its expert argued in the
alternative that Align’s “Invisalign System” is a domestic industry product. (CBr. at 104; Tr. at 738:4-
739:4.). However, neither Align nor Mr. Bakewell articulated this argument with any significant detail or
specificity during the Hearing. (See Tr. (Bakewell) at 705:16-706:9, 738:4-25.). Furthermore, as detailed
below, the domestic industry issue can be resolved without considering the Invisalign System as a
domestic industry product.
112 In two (2) previous Investigations involving Align and 3Shape, administrative law judges (“ALJs”)
determined that Align established a domestic industry related to its iTero scanners under both Subsections
337(a)(3)(A) and (B). See 1090 Investigation, Initial Determination (Apr. 26, 2019); 1091 Investigation,
Initial Determination (Mar. 1, 2019). The Commission vacated the Initial Determination in the 1090
Investigation on unrelated grounds (see 1090 Investigation, Comm’n Op. (Aug. 20, 2019), and took no
position on the economic prong findings of the 1091 Investigation. See 1091 Investigation, Comm’n Op.
at 2 (Nov. 22, 2019).
113 When he testified during the Hearing on October 28, 2019, Mr. John Morici was Align’s Chief
Financial Officer. (Tr. (Morici) at 580:14-19.). Align identified Mr. Morici as a fact witness to testify on
the background and business of Align; domestic industry in the Asserted Patents; secondary
considerations of non-obviousness; issues related to remedy and bond; and related issues. (CPSt. at 9.).
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(CBr. at 108.).
Mr. W. Christopher Bakewell,114 Align’s expert witness on the economic requirement of
domestic industry, analyzed Align’s investments at its two U.S. facilities between 2015 to the
December 10, 2018 filing date of the Complaint in this Investigation. (Tr. (Bakewell) 726:5-
727:17; CDX-0013C.0030-31.). The San Jose facility is Align’s worldwide headquarters, and
serves as a significant location for engineering and product development. (Tr. (Bakewell) at
703:6-18; CDX-0013C.0006.). Align’s Raleigh facility performs similar engineering and
product development functions. (Id.).
Mr. Bakewell began his analysis by calculating Align’s total plant and equipment
acquisition costs for the San Jose and Raleigh facilities. (Tr. (Bakewell) at 726:5-727:17; CX
2147C; CX-0107C; CX-0108C; CDX-0013C.0030-31.). He then determined the depreciation
and rental costs of these acquisition expenses from 2015 to December 10, 2018, referring to
these as “period costs.” (Id.).115 Mr. Bakewell valued Align’s plant and equipment period costs
as 	. (Tr. (Bakewell) at 726:5-727:25; CX 2147C; CX-0107C; CX-0108C; CDX-
0013C.0030-31.). Align’s period costs are summarized below in Table No. 11.
Table No. 11: Align’s Period Costs
114 When he testified during the Hearing on October 28, 2019, Mr. W. Christopher Bakewell was the
Managing Director and the leader of the intellectual property advisory services practice at Duff & Phelps.
(CPSt. Ex. 2.). Align identified Mr. Bakewell as an expert to testify about the economic prong of the
domestic industry requirement, as well as the appropriate remedy and bond. (CPSt. at 3-4).
115 The Commission has previously granted summary determination on the economic prong of a domestic
industry inquiry based in part upon depreciation in manufacturing facilities, factory equipment, and
buildings. See Certain Crawler Cranes & Components Thereof, Inv. No. 337-TA-887, Order No. 17, ID
at 4 (Feb. 14, 2014); Comm’n Notice (Mar. 20, 2014) (upholding Order No. 17).
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(CDX-0013C.0031 (citing CX-2147C, CX-0107C, CX-0108C.).
Mr. Bakewell conducted a floor plan allocation of these period costs based on his review
of Align’s office space dedicated to R&D generally. (Tr. (Bakewell) at 728:1-730:12; CDX-
0013C.0032-37.). Mr. Bakewell testifies that 	of Align’s current San Jose
facility is attributable to R&D. (Tr. (Bakewell) at 728:7-21; CDX-0013C.0032.). At Align’s
previous San Jose facility that was used in 2015 and 2016 as part of the “period costs,” Mr.
Bakewell testified that between 	of the area was used for R&D. (Tr. (Bakewell) at
728:22-729:9; CDX-0013C.0033.). He opined that the aggregate results were “pretty much the
same” regardless of whether a 	allocation rate was used for the older San Jose
facility, and ultimately attributed 	of both Align’s San Jose facilities to R&D. (Tr.
(Bakewell) at 728:22-729:9.). Mr. Bakewell conducted a similar analysis of Align’s Raleigh
facility by focusing on the space used by individual R&D employees. He calculated an R&D
allocation of roughly 	of space for 2015, 2016, 2017, and the year ending
on December 10, 2018 respectively. (Tr. (Bakewell) at 729:10-730:12; CX-2147C.0001; CDX-
0013C.0034, .0036.). Mr. Bakewell testified that the allocated portion of Align’s facilities
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relating to R&D, taken together, totaled roughly 	million from 2015-January 2018. (Tr.
(Bakewell) at 729:21-730:16; CX-2147C.0002 CDX-0013C.0037.). The floor plan-based
allocation of Align’s period costs is summarized below in Table No. 12.
Table No. 12: Floor Plan-Based Allocation of Align’s Period Costs
(CDX-0013C.0037 (citing CX-2147C).).
Mr. Bakewell applied three (3) different allocation methodologies to determine the
investment amounts attributable to the DI Products.116 The first method is a sales-based
allocation, the second method is a management-based allocation, and the third method is a
responsibilities-based allocation. (Tr. (Bakewell) at 730:17-732:1.).
For the sales-based allocation, Mr. Bakewell determined that U.S. sales of the DI
Products ranged between 	of Align’s total revenue. (Tr. (Bakewell) at 717:18-718:12,
730:17-731:10; CX-0100C; CDX-0013C.0020.). This figure excludes international iTero sales,
clear Aligner sales, scanner-related services, and software renewals. (Tr. (Bakewell) at 717:18-
116 These three (3) methodologies were selected in part because Align does not track its expenses by
product. (See Tr. (Morici) at 584:17-585:9, (Bakewell) at 717:18-718:12.).
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719:8; CX-0100C; CDX-0013C.0020.). Using a 	allocation of Align’s revenue to iTero
scanners for 2015, a 	allocation for 2016, a 	allocation for 2017, and a 	allocation for
2018, Mr. Bakewell allocated roughly 	for plant and equipment investments for the
DI Products. (Tr. (Bakewell) at 730:17-731:10; CX-0100C; CX-2143C.).
Align relied for its management-based allocation on the testimony of Align’s CFO, John
Morici. (Tr. (Bakewell) at 720:8-721:9.). Mr. Morici testified that Align splits its revenue and
costs between 	(Tr. (Morici) at 583:13-17.). Mr.
Morici analyzed the division of labor between these two (2) segments by: (a) reviewing financial
materials; (b) consulting with other employees; (c) reviewing the history of Align’s 2011
acquisition of Cadent (including Cadent’s iTero scanners); and (d) relying on Mr. Morici’s
familiarity with Align’s business operations. (Id. at 582:13-584:16; CX-0233.). While the
majority of Align employees perform work in both segments, Mr. Morici testified that at least
of the work performed by Align’s U.S. workforce during this time, i.e. 2015-2018, was
dedicated to the iTero. (Tr. (Morici) at 584:17-25; CX-2146C; CX0021C; CDX-0013C.0023.).
Mr. Bakewell considered this analysis and concluded it was a reasonable means to
allocate Align’s domestic industry investments. (Tr. (Bakewell) at 720:8-722:15.). Applying a
allocation rate, Mr. Bakewell opined that by using the management-based allocation, he
valued Align’s plant and equipment investments in the DI Products at roughly 	. (Id.
at 731:13-21; CX-2146C.0002; CDX-0013C.0039.).
The responsibilities-based allocation represents a “person-by-person” or “operations
center by operations center” examination of employee functions. (Id. at 710:23-712:3.). This
method is based upon a review of human resources and financial records, performed by five (5)
Align executives: Mr. Zelko Relic, Ms. Kerri Kling, Ms. Sree Kolli (VP of Information
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Technology), Mr. Srini Kaza (VP of Product Innovation), and Mr. Eric Meyer (VP of Software).
(Id. at 710:23-712:3; 722:16-723:10; CX-1838C; CX-2154C; CX-2155C; CX-0116C; CX-
0117C.). Mr. Bakewell examined their data, spoke to the individuals who prepared the data, and
concluded that a responsibilities-based allocation was a reasonable means by which to allocate
Align’s domestic industry investments. (Id. at 710:23-712:3; 722:16-723:10.). Using a
responsibilities-based allocation, Mr. Bakewell evaluated how much time Align employees
dedicated to the DI Products, and allocated Align’s plant and equipment investments
accordingly. (Id. at 731:13-732:8.). Mr. Bakewell opined that using a responsibilities-based
allocation, he valued Align’s plant and equipment investments in the DI Products at roughly
during the time period specified in Table No. 13, below. (Id. at 731:13-732:8; CX-
2146C.0002; CDX-0013C.0039.).
The comparative results of Mr. Bakewell’s three (3) allocations are summarized below in
Table No. 13.
Table No. 13: Align’s Allocated Domestic Industry Investments in Plant and Equipment
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(CDX-0013C.0039 (annotated) (citing CX-2146C).)117
3Shape and its expert, Mr. Philip Green,118 disputed Mr. Bakewell’s allocations of
Align’s domestic industry investments for several reasons. (RRBr. at 67-78.). While the
challenges to Mr. Bakewell’s management-based and responsibilities-based allocations will be
discussed in connection with Section 337(a)(3)(B) below, Section XII.B, 3Sharp also disagreed
with Mr. Bakewell’s floor plan-based allocations. (Id. at 77-78.). Specifically, 3Sharp objected
to the application of a 	floor space allocation factor for Align’s former San Jose facility,
despite Mr. Bakewell’s estimate that R&D accounted for a range of 	of floor space in
that facility. (Id.). 3Sharp pointed out that if the 	allocation is used for the former San Jose
facility, Mr. Bakewell’s management-based allocation should be reduced by approximately
(Id. (citing CDX-0013C.0039 n.3.). 3Shape’s argument has merit. There is a large
swing both a 	allocation and a 	allocation.
Nonetheless, even if the lower floor space allocation of 	is applied to Align’s
former San Jose facility, the weight of the evidence supports a finding that Align has met its
burden of proving that its domestic industry investments in support of Subsection 337(a)(3)(A)
are significant from both a quantitative and a qualitative standpoint. Even applying the full
reduction to the management-based allocation that 3Sharp urged, the management-
based and responsibilities-based allocations yield plant and equipment expenditures of roughly
117 Align stated that the chart in CDX-0013C.0039 “has a column labeled ‘Jan.-Mar. 2018,’ but those
numbers reference allocations from January through December 10, 2018.” (CBr. at 108 n. 53.).
118 When he testified during the Hearing on October 30, 2019, Mr. Philip Green was a Principal of
Hoffman Alvary & Company LLC. (RPSt. at Ex. B.). 3Shape identified Mr. Green as an expert to testify
about the economic prong of the domestic industry requirement as well as the appropriate remedy and
bond. (RPSt. at 4.).
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million dollars, respectively, from 2015 to December 10, 2018.1!° These figures
are quantitatively significant. See Lelo, 786 F.3d at 883-884. Evidence shows that these
amounts (as well as Align’s underlying R&D period costs) steadily increased during this time
period. (See CX-2146C; Tr. (Bakewell) at 730:13-16.).

Align’s allocated plant and equipment investments are significant when considered in the
context of its foreign facilities. Between Q1 2015 and Q4 2018, Align has facilities in Russia,
Mexico, Costa Rica, and Israel. Align reported unallocated accumulated depreciation values for
these facilities as approximately
respectively.!?° (CX-2157C: Tr. (Bakewell) at 737:5-738:3.). While 3Shape correctly noted that
these unallocated depreciation figures exclude foreign rent, they are still evidence of quantitative
significance. (RRBr. at 80-81; citing Tr. (Bakewell) at 790:12-21.). Align’s allocated domestic
industry plant and equipment investments are significant when compared to Align’s unallocated
121

depreciation values for its foreign facilities, both individually and in the aggregate.

Qualitatively, the evidence demonstrates that Align’s allocated domestic industry plant and

119 Align’s cited investments it made between 2015 and up to the filing date of the Complaint in this
Investigation relate to developing a domestic industry under Subsections 337(a)(3)(A) and (B). See
Motiva LLC, 716 F.3d at 601 n.6.

20 Align maintained other international facilities during this time. (Tr. (Bakewell) at 787:11-24.). Mr.
Bakewell considered that “the direction of global activities really occurs from the United States” when he
compared Align’s U.S. investments to its facilities in Russia, Mexico, Costa Rica, and Israel. (Tr.
(Bakewell) at 732:19-733:15.). He further testified that the

(Tr. (Bakewell) at 732:19-733:15: 787:11-24.).
21 As Align explained certain values, Align’s unallocated values represent total investments in an area,

whereas allocated values approximate the portion of the total investment relating to the DI Products. (See
CBr. at 106; Tr. (Bakewell) at 710:23-712:7.).

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equipment expenditures are important to the DI Products because they facilitate the coordination
of domestic and global R&D activities for software and hardware underlying the DI Products.
(See, e.g. Tr. (Relic) at 216:13-217:6; (Morici) 589:5-22.).
For these reasons, Align has met its burden and proven that its investments in plant and
equipment for the DI Products under the management-and responsibilities-based models are
significant.122
C. 	Align’s Investments in Employment of Labor and Capital Are Significant
Under Section 337(a)(3)(B)
Align made and continues to make significant domestic investments in labor and capital
to support its DI Products. Align relies on the its U.S. workforce employee salary and
compensation expenditures as they pertained to Align’s DI Products between 2015 to December
10, 2018. (Tr. (Bakewell) at 713:2-714-24, CX-2154C.). As of December 10, 2018, Align had
approximately 	employees of whom some 	work in the United States. (See Tr.
(Bakewell) at 703:6-705:13; CX-2158C.). Mr. Bakewell analyzed which of Align’s U.S.
employees performed work on the DI Products, and then used the same three (3) allocation
methods described above that he applied to Align’s investments in plant and equipment. (Tr.
(Bakewell) at 710:23-712:7.).
Mr. Bakewell’s analysis identified the following relevant categories of Align’s U.S.
employees for the years 2015-2018: Engineering (R&D), Product Development, and Clinical
Education. (Tr. (Bakewell) at 703:6-705:13; CDX-0013.6, 13.). Mr. Bakewell described
Engineering as the most “upstream” employee category (i.e. closely related to engineering of the
122 There is insufficient evidence to determine the significance of Align’s roughly 	investment
under the sales-based model. (See CDX-0013C.0039 (annotated) (citing CX-2146C).).
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DI Products), followed by Product Development and Clinical Education in that order. (Tr.
(Bakewell) at 703:6-705:13, 712:8-713:1; CDX-0013.6, 13.). Mr. Bakewell excluded other
employees, including those in technical sales and marketing, general management, legal, part-
time employees, contractors, and marketing-oriented employees. (Tr. (Bakewell) at 703:6-
705:13, 712:8-713:1; CDX-0013.6, 13.). Mr. Bakewell determined the relevant head counts of
U.S. Align employees in the Engineering (R&D), Product Development, and Clinical Education
groups based upon: (a) reports taken from Align’s payroll system; (b) interviews with Align
executives Mr. Relic, Ms. Kling, Ms. Kolli, Mr. Kaza, and Mr. Meyer; (c) an examination of the
activities performed by U.S. employees; and (d) whether each employee directed her efforts
towards the DI Products, Invisalign, or both. (Tr. (Bakewell) at 713:2-714:13.). Mr. Bakewell’s
employee categorizations and head counts are summarized below in Table No. 14.
Table No. 14: Categorization of and Head Counts of Align’s U.S. Employees
(CDX-0013C.0013 (citing CX-2154C; CX-2156C).).
At the same time, Mr. Bakewell used salary and compensation data for relevant U.S.
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Align employees to determine Align’s domestic investment in labor for the Engineering (R&D),
Product Development, and Clinical Education groups. (Tr. (Bakewell) at 713:2-714:13.). Mr.
Bakewell opined that between 2015 and 2018, Align’s unallocated U.S. labor investments for the
Engineering (R&D), Product Development, and Clinical Education groups totaled approximately
. (Tr. (Bakewell) at 714:14-715:1.). These unallocated U.S. labor expenses are
summarized below in Table No. 15.
Table No. 15: Align’s Relevant Unallocated Investments in Labor
(CDX-0013C.0015 (citing CX-2154C; CX-2155C; CX-0166C).).
Mr. Bakewell then allocated these amounts to the DI Products using the same
methodologies deployed for his section 337(a)(3)(A) analysis. (CBr. at 117.). Using the sales-
based allocation, Align’s domestic industry labor investment is approximately 	. Using
the management-based allocation, Align’s domestic industry labor investment is roughly
. Applied to labor and capital expenditures, Mr. Bakewell’s responsibilities-based
allocation classifies Align employees as iTero-dedicated, Invisalign-dedicated, or split between
the two. (Tr. (Bakewell) at 774:11-15.). Under a responsibilities-based allocation, Mr. Bakewell
allocated approximately 	of investments related to relevant split employees, and 100% of
investments related to relevant iTero-dedicated employees, yielding a total allocation factor of
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roughly 	.123 (See CX-2152 at n.2; CX 2154C; CX-0099C.). Using the responsibilities-
based allocation, Align’s domestic industry labor investment is about 	million. (Tr.
(Bakewell) at 719:9-19, 723:11-725:15; CX-0099C; CDX-0013C.0021, .0027.). The results of
Mr. Bakewell’s three allocations are summarized below in Tables Nos. 16 and 17.
Table No. 16: Align’s Domestic Industry Investments in Plant and Equipment – Sales-
Based Allocation
(CDX-0013C.0021 (annotated) (citing CX-0099C).).
123 Align testified that its Clinical Education employees’ duties include training and educating customers
on its scanners. (Tr. (Kling) at 336:10-337:19.). While these employees likely also have other duties that
are not relevant to the domestic industry analysis (see RRBr. at 75-76), the Clinical Education category
contributed the least of the three (3) categories to Align’s allocated DI Product employment of labor. (See
CX-2152C.). Mr. Bakewell’s responsibilities-based allocation may, therefore, overstate Align’s true
employment of labor but not to a degree that calls his ultimate opinion into question.
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Table No. 17: Align’s Domestic Industry Investments in Plant and Equipment –
Management-Based and Responsibilities-Based Allocations
(CDX-0013C.0027 (annotated) (citing CX-0099C).).
3Shape and its expert challenged the reasonableness of Mr. Bakewell’s allocations.
(RRBr. at 67-76.). 3Shape urged that Mr. Bakewelll’s allocations conflict with Align’s public
financial disclosures, and that the Align executives’ analysis of efforts dedicated to the DI
Products cited by Mr. Bakewell are insufficient. (Id.). 3Shape claimed that it is unreasonable to
rely upon a handful of Align executives to accurately assess the fraction of work attributable to
the DI Products for the Align workforce and that the true allocation factor is likely far lower than
what Mr. Bakewell opines. (Id.).
3Shape’s focus on deviations from Align’s “ordinary course financials,” such as its 10-K
Securities and Exchange Commission (“SEC”) disclosures, overlooks the realities of Align’s
business operations as well as different reporting requirements for SEC disclosures. (See RRBr.
at 67-79 (citing CX-0059).). Align’s 10-K disclosures reflect that Align has two (2) primary
business segments, Scanners and Services (which include the DI Products) and Clear Aligners;
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Align employees are 	of these two (2)
segments. (See CX-0059.0004-7, CX-0021C at 2-3; Tr. (Morici) at 623:10-18, 633:17-634:8.).
However, Mr. Morici testified that despite this 	classification for SEC purposes,
. (Tr. (Morici) at 588:2-25; 633:9-634:8.). Approximately 	of Align’s
employees’ efforts are directed to both business segments. (Tr. (Morici) at 584:17-585:6.). SEC
reporting involves a different set of accounting standards than those Mr. Bakewell used for this
Investigation.
3Shape failed to show that Mr. Bakewell’s allocations are unreasonable. Mr. Bakewell’s
allocation methods for his management-based and responsibilities-based methods are based upon
the analysis and assessment of multiple Align executives who reported their information to him.
This is uncontroversial. Align executives, working independently or with subordinates, are well-
positioned to examine and determine where labor was dedicated in the recent past. These
determinations appear credible and reasonable. The remaining issues that 3Shape identified
relate to the margins of Mr. Bakewell’s management-based and responsibilities-based methods
but do not call his ultimate opinions into question. 3Shape did not raise a serious challenge to
Mr. Bakewell’s sales-based allocation.
The weight of the evidence supports a finding that Align’s expenditures in support of
Subsection 337(a)(3)(B) are significant from both a quantitative and a qualitative standpoint.
Mr. Bakewell’s sales-based method indicates that Align’s domestic industry labor investment is
approximately 	, the management-based method yields roughly 	, and the
responsibilities-based method yields about 	. Quantitatively, even if taken separately
all three (3) methods demonstrate significant employment of labor and capital between 2015 and
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December 10, 2018. See Lelo, 786 F.3d at 883-84. These figures are also supported by the fact
that roughly 	of Align’s U.S. labor force is focused on the DI Products. (See Tr. (Bakewell)
at 734:17-735:23; CX-2154C; CX-2158C (allocating 	of split employees to the DI
Products); CDX-0013C.0043.).
Align’s labor and capital expenditures are qualitatively significant as well.124 Many of
Align’s top executives are based in the U.S., where they make product development and R&D
decisions for the DI Products that impact the entire company. (Tr. (Relic) at 216:13-217:6,
589:5-22, 732:19-733:15.). The U.S. dental market is recognized as “the most advanced dental
market in the world.” According to unrebutted testimony, Align’s U.S. workforce typically leads
development of new product features and innovations, ultimately distributing them worldwide.
(Tr. 343:5-17 (Kerri Kling), 216:13-217:6.).125
Evidence also reflects that Align’s average U.S. labor costs are substantially higher than
its average labor costs worldwide. Between 2015 and 2018, Align’s average domestic labor cost
per person was about 	times that of its average worldwide labor cost per person. (Tr.
(Bakewell) at 733:16-734:10; CX-2158C; CX-0123C; CDX-0013C.0041.). This trend is
reflected in Align’s U.S. DI Product workforce, which comprised about 	of Align’s
124 Align’s Mr. Bakewell suggested that Align’s U.S. executives add “value” to Align’s operations, but
without conducting a metric analysis of the value that those executives added. See, e.g. Certain Beverage
Dispensing Systems and Components Thereof, Inv. No. 337-TA-1130, Comm’n Op. at 20 (Mar. 11, 2020)
(noting that when evaluating significance, it is appropriate to “consider[] the value added to the product
from a complainant’s activities in the United States” (quotation omitted)).
125 When she testified during the Hearing on October 25, 2019, Ms. Kerri Kling was the vice president of
global marketing, education, laboratory and strategic accounts for Align. (Tr. (Kling) at 326:24-327:4.).
Align identified Ms. Kling as a fact witness to testify on the background and business of Align;
background and business of Cadent; domestic industry in the Asserted Patents; and related issues. (CPSt.
at 7.).
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worldwide labor force while accounting for more than 	of its worldwide labor
expenditures.126 (Tr. (Bakewell) at 734:17-735:23; CX-2158C; CX-0123C; CDX-0013C.0043.).
Align’s share of its U.S. labor-related expenditures is indicative of the qualitative significance of
Align’s U.S. workforce to the DI Products.
For the reasons explained, Align has proven that its employment of labor and capital in
relation to the DI Products is significant.
XIII. 	REMEDY AND BOND
This determination recommends: (1) a Limited Exclusion Order; and (2) a Cease and
Desist Order with a standard service and repair exception. A bond is not recommended during
the Presidential Review Period.
A. 	Legal Standard
Pursuant to Commission Rule 210.42, an Administrative Law Judge (“ALJ”) must issue a
recommended determination on: (i) an appropriate remedy if the Commission finds a violation of
Section 337, and (ii) an amount, if any, of the bond to be posted. 19 C.F.R. § 210.42(a)(1)(ii).
When a Section 337 violation has been found, as has been found in this Investigation, “the
Commission has the authority to enter an exclusion order, a cease and desist order, or both.”
Certain Flash Memory Circuits and Prods. Containing the Same, Inv. No. 337-TA-382,
Comm’n Op. on the Issues Under Review and on Remedy, the Public Interest and Bonding, at 26
(June 9, 1997).
B. 	A Limited Exclusion Order Is Warranted
Upon a finding of infringement, the Commission’s enabling statute, 19 U.S.C. § 1337(d)
126 This comparison relies on a total domestic industry labor expense for 2015 to 2018 of roughly
million for 2015-2018, which appears to reflect Mr. Bakewell’s responsibilities-based method. (See CX-
0123C.0001.).
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provides for a Limited Exclusion Order (“LEO”), that can be directed to any articles that infringe
one or more claims of the asserted patent(s) of any of the named respondents. 19 U.S.C.
§ 1337(d). A limited exclusion order instructs the U.S. Customs and Border Protection (“CBP”)
to exclude from entry all articles that are covered by the patent at issue that originate from a
named respondent in the investigation. Fuji Photo Film Co. Ltd. v. 1nt’l Trade Comm’n, 474
F.3d 1281, 1286 (Fed. Cir. 2007).
Align requested that the Commission issue a LEO which would bar the entry of all the
Accused Products found to infringe the Asserted Patents. (CBr. at 122-23.). Specifically, Align
requested that the Commission issue a LEO directed to “all named Respondents, as well as any
affiliated entities, including 3Shape Manufacturing.” (Id. at 122.).
In response, 3Shape asserted that the Commission should limit any issued LEO to exempt
products that were imported prior to the effective date of any exclusion order. (RRBr. at 91.).
3Shape argued that the replacement and refurbished parts and devices it holds in or sends into the
United States also should be exempt from a LEO in order to mitigate harm to 3Shape’s existing
customers. (Id.). 3Shape also requested that a LEO, if issued, should include a certification
provision. (Id.).
The recommendation here is that the Commission issue a LEO directed to 3Shape’s
Accused Products that infringe one or more claims of the Asserted Patents. However, including
non-party entities within the scope of the LEO is contrary to settled law. Kyocera Wireless
Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1356 (Fed. Cir. 2008) (“[I]f a complainant wishes
to obtain an exclusion order operative against articles of non-respondents, it must seek a GEO by
satisfying the heightened evidentiary burdens of §§ 1337(d)(2)(A) and (B).”)(“Kyocera”).
Moreover, Align has not requested a General Exclusion Order. Kyocera does not apply here.
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3Shape also seeks to allow the continued importation of its Accused Product models prior
to the effective date of a LEO. (RRBr. at 91 (citing Certain Baseband Processor Chips and
Chipsets, Transmitter and Receiver (Radio) Chips, Power Control Chips, and Prods. Containing
Same, Including Cellular Telephone Handsets, Inv. No. 337-TA-543, Comm’n Op at 28, 124,
151-54 (June 7, 2007)(“Certain Baseband Chips”.). Certain Baseband Chips discusses an
exemption related to possible adverse effects on the public interest. The public interest factors
have not been delegated for fact-finding or consideration by the ALJ in this instant case. See
Notice of Institution (Doc. ID No. 669028 (Mar. 9, 2019).). Accordingly, any exemption to the
recommended LEO based upon public interest factors is beyond the scope of the
recommendation here. Similarly, 3Shape’s requested exemption for replacement and refurbished
parts and devices cites a prior Investigation that also implicates public interest factors. See
Certain Automated Mechanical Transmission Sys. for Medium-Duty and Heavy-Duty Trucks and
Components Thereof, Inv. No. 337-TA-503, Comm’n Op. at 4-5 (May 9, 2005). (RRBr. at 91.).
For similar reasons, the recommendation here does not take a position on the application
of public interest factors to a LEO. However, as discussed below, 3Shape’s existing domestic
inventory is significant and suitable for warranty, replacement, and repair. Therefore, a
modification is warranted to allow 3Shap to service, repair and replace its existing Accused
Products in the United States. (See, e.g., RRBr. at 92 (citing CX-2259C (Mikael Petersen Dep.
Tr.) at 69:4-14).).127
Finally, 3Shape requested a certification provision. (RRBr. at 91). Yet, 3Shape failed to
127 When he testified during his deposition taken pursuant to Commission Rule 210.28 on May 9, 2019,
on behalf of 3Shape, Mr. Mikael Petersen was 3Shape’s Vice President for supply chain, group IT, and
facilities. (CX-2259 at 7:4-8:15.). 3Shape identified Mr. Petersen as a corporate designee for 3Shape
who was called to testify with respect to 3Shape’s supply chain for the Accused Products. (RPSt. at 2.).
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provide an explanation why a certification provision would be warranted. In sum, the
recommendation here is that a LEO issue without the exemptions and certifications that 3Shape
requested.
C. 	A Cease and Desist Order Is Warranted
Section 337 provides that in addition to, or in lieu of, the issuance of an exclusion order,
the Commission may issue a Cease and Desist Order (“CDO”) as a remedy for violation of
Section 337. See 19 U.S.C. § 1337(f)(1). The Commission generally issues a cease and desist
order directed to a domestic respondent when there is a “commercially significant” amount of
infringing, imported product in the United States that could be sold so as to undercut the remedy
provided by an exclusion order. See Certain Crystalline Cefadroxil Monohydrate, Inv. No. 337-
TA-293, Comm’n Op. on the Issue Under Review, and on Remedy, the Public Interest and
Bonding at 37-42, Pub. No. 2391 (U.S.I.T.C., June 1991). Cease and desist orders have been
declined when the record contains no evidence concerning infringing inventories in the United
States. Certain Condensers, Parts Thereof and Prods. Containing Same, Including Air
Conditioners for Automobiles, Inv. No. 337-TA-334, Comm’n Op. at 28 (U.S.I.T.C. Aug. 27,
1997).
Align requested that the Commission issue a CDO because 3Shape “maintain[s] a
‘commercially significant’ inventory of infringing products in the United States and there are
significant domestic operations that could undercut the remedy provided by an exclusion order.”
(CBr. at 123.). The Parties stipulated to the amount of 3Shape’s U.S. inventory of the Trios 3
and Trios 4 products as of September 11, 2019. (CX-2296C.). Align’s expert testified that
3Shape’s domestic inventory could be sold in the U.S., and that the Trios Accused Products are
“relatively expensive.” (Tr. (Bakewell) at 739:19-740:24.). 3Shape did not provide an estimate
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of the value of its inventory in the United States, or otherwise dispute Mr. Bakewell’s testimony
with respect to the value of the Trios Accused Products. (RRBr. at 91-92). Therefore, it is
unclear what Mr. Bakewell meant when he described 3Shape’s inventory in the United States as
“relatively expensive.” Align argued that the quantity of 3Shape’s domestic inventory is
undisputed and that it is commercially significant. (CBr. at 123 (citing CX-2296C; Tr.
(Bakewell) at 739:19-740:24).).
3Shape has waived any argument on the issue of the value of its inventory pursuant to
Ground Rule 10.2. 3Shape only responded that its domestic inventory
that are “for warranty, replacement, repair, training, and demonstration, not for
sale.” (RRBr. at 92 (citing CX-2259C (Petersen Dep. Tr.) at 69:4-14).). 3Shape argued that
because its domestic inventory is not intended for sale, it is not commercially significant.
(RRBr. at 91-92). 3Shape requested that a CDO should not prohibit it from providing technical
support to U.S. customers, or from honoring its existing warranty and service obligations. (Id.).
The recommendation here is that the Commission issue a CDO. The Parties’ stipulation
on the quantity of 3Shape’s inventory contains 	but does not clearly
indicate whether each item corresponds to a component or fully assembled Trios scanner units
with software. (See CX-2296C.). Despite Mr. Petersen’s inexact testimony, the Parties
stipulated that 3Shape 	, which is
the better evidence. (See RRBr. at 92 (citing CX-2259C (Petersen Dep. Tr.) at 69:4-14).). Given
the quantity of 3Shape’s domestic inventory, and Mr. Bakewell’s testimony with respect t its
value and ability to be sold in the United States, there is no compelling reason to decline Align’s
request for a CDO. (See CX-2296C; Tr. (Bakewell) at 739:19-740:24.).
Additionally, it is the recommendation here that a CDO contain a limited service and
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repair exception. 3Shape’s uses part of its inventory in the United States to facilitate its service
and repair activities. (See CX-2259C (Petersen Dep. Tr.) at 69:4-14). A limited service and
repair exception would protect 3Shape customers who use 3Shape’s Accused Products under
existing service and warranty agreements. Such an arrangement would be consistent with
Commission precedent. See Certain Systems for Detecting and Removing Viruses or Worms,
Components Thereof, and Prods. Containing Same, Inv. No. 337-TA-510, Comm’n Op. at 6
(Aug. 23, 2005) (excepting from a CDO “service and replacement parts” on the ground that
consumers might otherwise suffer).
D. 	A Bond During the Presidential Review Period Is Not Warranted
During the Presidential Review Period, imported articles otherwise subject to a remedial
order are entitled to conditional entry under bond. See Certain Beverage Dispensing Sys. &
Components Thereof, Comm'n Opinion, Inv. No. 337-TA-1130 at 26 (Mar. 26, 2020) (citing 19
U.S.C. § 1337(j)(3)). The amount of bond is determined by the Commission and must be enough
to protect the complainant from any injury. See id. “The Commission typically sets the bond
based on the price differential between the imported infringing product and the domestic industry
article or based on a reasonable royalty. However, where the available pricing or royalty
information is inadequate, the bond may be set at one hundred (100) percent of the entered value
of the infringing product.” Certain Loom Kits for Creating Linked Articles, Inv. No. 337-TA-
923, Comm’n Op., 2015 WL 5000874, *11 (citations omitted).
As Complainant, Align bears the burden of establishing the need for a bond, including the
amount of bond. See, e.g., Certain L-Tryptophan, L-Tryptophan Products, and their Methods of
Production, Inv. No. 337-TA-1005, Comm’n Op. at 53 (Jan. 11, 2018) (“L-Trypophan”) (setting
zero bond where a complainant failed to show why a 100% bond was warranted, or to properly
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explain why price comparison or reasonable royalty was impractical); Certain Rubber
Antidegradants, Components Thereof & Prods. Containing Same, USITC Pub. No. 3975, Inv.
No. 337-TA-533, Comm’n Opinion at 40 (April 2008); Certain Coenzyme Q10 Prods. and
Methods of Making Same, Inv. No. 337-TA-790, Initial and Recommended Determination (Sept.
27, 2012) (recommending Commission not impose a bond because complainant failed in its
burden to demonstrate the appropriate bond amount).
Align urged that the Commission impose a 100% bond during the Presidential Review
Period. (CBr. at 124-25).). Align contended that it competes directly with 3Shape in the same
market and with the same products. (Id. at 124 (citing Tr. (Bakewell) at 740:25-741:5).).
However, Align argued that “a price comparison is not a practical approach” to determine a bond
amount. (Id. at 125 (citing Tr. (Bakewell) at 741:6-743:11).). Align discouraged a price
comparison because the Parties “have different business models and selling strategies,” and “sell
multiple versions of their respective products for varying ranges of prices.” (CBr. at 125.).
Align also argued that the record evidence does not permit a reasonable royalty analysis. (Id.
(citing Tr. (Bakewell) at 743:12-744:7).). Align argued that, because “a bond rate cannot be
readily calculated,” and it will be harmed by the continued importation of 3Shape’s infringing
products, a 100% bond rate is appropriate. (Id.).
3Shape disputed that a price comparison is impractical and argued instead that such a
comparison of 3Shape’s and Align’s products is possible. (RRBr. at 93.). To that end, 3Shape
identified Patterson Dental as a U.S. reseller of both 3Shape and Align scanners. (Id. (citing RX-
2330); see also CX-2071C.). 3Shape argued that Patterson Dental had price lists for both
3Shape and Align products. (RRBr. at 93 (citing RX-2420C (Richard Lake Dep. Tr.) at 45:16-
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25).).!?8 3Shape argued that a price differential analysis would not be impacted by the fact that
Align and 3Shape sell multiple versions of their products. (RRBr. at 93 (citing Certain Robotic
Vacuum Cleaning Devices and Components Thereof Such as Spare Parts, Inv. No. 337-TA-
1057, Comm’n Op. at 70-71 (Feb. 1, 2019) (holding a price differential analysis may be
conducted where product lines are not identical). 3Shape did not perform its own price
differential analysis. Additionally, 3Shape did not provide a product-by-product comparison for
which it argued conceptually. As a result, it was not possible to determine which 3Shape models
were comparable in price to Align’s models. That analysis was missing.

3Shape also argued that Align declined to evaluate reasonable royalty evidence found in
a , in favor of an assertion that a 100%
bond was appropriate. 3Shape cited an

as containing evidence relevant to a reasonable royalty

analysis, without advancing its own reasonable royalty proposal. (RRBr. at 93 (citing (CX-
1752C).).!”° Align also did not explain with any clarity of detail why a sole royalty rate was
applicable here.

3Shape did not argue for a specific royalty rate. (RRBr. at 93.). 3Shape argued only that

Align did not demonstrate why the referenced agreement was not considered in a reasonable

28 At the time of his deposition on November 20, 2019, on behalf of Patterson Dental, held pursuant to
Commission Rule 210.28, Mr. Richard Lake was the Senior Category Manager at Patterson Dental
Holdings, Inc. (RX-2420C at 6:20-9:22.). As Senior Category Manager, he was responsible for
overseeing the marketing efforts at Patterson Dental in connection with 3Shape products and was familiar
with Patterson Dental’s recordkeeping practices. (Id.).

129 The

(See CX-1752.).

Page 283 of 287

Page 284 of 287
royalty analysis. (Id.). Accordingly, 3Shape argued that Align did not meet its evidentiary
burden, and that no bond should be imposed. (Id. at 92-94.).
Here, Align has not satisfied its burden of establishing an amount of a bond that should
enter. Align’s position rests on limited conclusory testimony from its expert about the obstacles
to a price comparison. (See Tr. (Bakewell) at 740:25-741:5.). Mr. Bakewell’s testimony is
largely unpersuasive, and on the issue of differing product models, unsupported by precedent.
See, e.g., Certain Dental Ceramics, Products Thereof and Methods of Making the Same, Inv. No.
337-TA-1050, Initial Determination at 107-110 (Aug. 28, 2018) (differences in distribution
models did not prevent experts from conducting price comparisons based on retail prices).
Furthermore, evidence indicates that at least one reseller sells both iTero and Trios scanners to
end users. Align did not adequately establish why a price differential analysis could not be
performed. (See Tr. (Bakewell) at 768:22-769:4; RX-2330; CX-2071C; RX-2420C (Lake Dep.)
at 45:16-25).).
Similarly, Align and its expert disregarded evidence related to a reasonable royalty
estimation without offering meaningful discussion or legal authority in support. Mr. Bakewell’s
unsupported assertion that the
was not “a good benchmark for a royalty” is not compelling. (Tr. (Bakewell)
at 743:12-744:7)). Ultimately, the weight of the evidence supports a finding that Align declined
to rigorously pursue a price differential or reasonable royalty analysis. Furthermore, Align has
not demonstrated that it faces sufficient harm from the continued sales of 3Shape scanners to
warrant a bond of 100%.
Thus, Align has not satisfied its burden of proof that a bond is justified. See L-
Tryptophan, Comm’n Op. at 5. Based upon the explanation of the evidence discussed above,
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this Initial Determination recommends that a bond should not issue during the Presidential
Review Period.
XIV. 	WAIVER OR WITHDRAWAL OF 3SHAPES’ DEFENSES
3Shape did not raise in its Pre-Hearing Brief or offer any evidence during the Hearing to
support its following Affirmative Defenses: (i) Fourth Affirmative Defense of Disclaimer and
Prosecution History Estoppel (except where noted with respect to the ’538 patent); (ii) Seventh
Affirmative Defense of Waiver, Laches, Equitable Estoppel, Unclean Hands and/or
Acquiescence; and (iii) Eighth Affirmative Defense of License and/or Exhaustion. (Resp. at 25-
26.).
Consequently, it is a finding of this decision that 3Shape has withdrawn, waived and/or
abandoned its Fourth, Seventh, and Eighth Affirmative Defenses consistent with Ground Rules
7.2 and 10.1. Kinik Co. v. Int’l Trade Comm’n, 362 F.3d 1359, 1367 (Fed. Cir. 2004).
XV. 	CONCLUSIONS OF FACT OR LAW: THIS INITIAL DETERMINATION
FINDS A SECTION 337 VIOLATION BASED UPON INFRINGEMENT OF U.S.
PATENT NO. 7,188,751
1. 	Jurisdiction and standing requirements are satisfied;
2. 	Claims 1 and 18 of U.S. Patent No. 7,077,647 are valid and satisfied by the 647
Accused Products;
3. 	Claims 2 and 20 of U.S. Patent No. 7,156,661 are valid and satisfied by the 661
Accused Products;
4. 	Claims 1 and 2 of U.S. Patent No. 8,102,538 are valid but not satisfied by the 538
Accused Products;
5. 	Claims 2, 28, and 29 of U.S. Patent No. 9,299,192 are invalid and satisfied by the
192 Accused Products;
6. 	Align’s domestic activities with respect to its DI Products are found to satisfy the
economic prong of the domestic industry requirement under 19 U.S.C. §
337(a)(3)(A) and (B);
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7. 	At least one of Align’s DI Products practices one or more claims of U.S. Patent
Nos. 7,077,647; 7,156,661; 8,102,538; and 9,299,192; and
8. 	3Shape has violated Section 337 of the Tariff Act of 1930, as amended, by
importing into the United States, selling for importation, or selling within the
United States after importation certain dental and orthodontic scanners and
software by infringing claims 1 and 18 of U.S. Patent No. 7,077,647; claims 2 and
20 of U.S. Patent No. 7,156,661; and claims 2, 28, and 29 of U.S. Patent No.
9,299,192.
9. 	A Limited Exclusion Order and Cease and Desist Orders, with repair and
warranty exceptions, are recommended based upon the evidence and findings of
infringement.
10. 	A Bond is not recommended because of Align’s failure to meet its burden of
proof.
The lack of discussion of any matter raised by the Parties, or any portion of the record,
does not indicate that it has not been considered. Rather, any such matter(s) or portion(s) of the
record has/have been determined to be irrelevant, immaterial or meritless. Arguments made on
briefs, which were otherwise unsupported by record evidence or legal precedent, have been
accorded no weight.
XVI. 	CONCLUSION AND ORDER
This Initial Determination on Violation of Section 337 of the Tariff Act of 1930 is
certified to the Commission. All orders and documents, filed with the Secretary, including the
exhibit lists enumerating the exhibits received into evidence in this Investigation, that are part of
the record, as defined in 19 C.F.R. § 210.38(a), are not certified, since they are already in the
Commission’s possession in accordance with Commission Rules. See 19 C.F.R. § 210.38(a). In
accordance with 19 C.F.R. § 210.39(c), all material found to be confidential under 19 C.F.R.
§ 210.5 is to be given in camera treatment.
After the Parties have provided proposed redactions of confidential business information
(“CBI”) that have been evaluated and accepted, the Secretary shall serve a public version of this
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ID upon all parties of record. The Secretary shall serve a confidential version upon counsel who
are signatories to the Protective Order (Order No. 1) issued in this Investigation.
Pursuant to 19 C.F.R. § 210.42(h), this Initial Determination shall become the
determination of the Commission unless a party files a petition for review pursuant to 19 C.F.R.
§ 210.43(a) or the Commission, pursuant to 19 C.F.R. § 210.44, orders on its own motion a
review of the Initial Determination or certain issues therein.
Within fourteen (14) days of the date of this document, the Parties shall submit to the
Office of Administrative Law Judges a joint statement through McNamara337@usitc.gov
whether or not they seek to have any portion of this document deleted from the public version.
The Parties’ submission must include a copy of this ID with yellow highlighting, with or without
red brackets, indicating any portion asserted to contain CBI to be deleted from the public
version. The Parties’ submission shall also include an index identifying the pages of this
document where proposed redactions are located. If the Parties disagree, they should explain
why, again by identifying the pages of the disagreement. The Parties’ submission concerning the
public version of this document need not be filed with the Commission Secretary.
SO ORDERED.
Public Version

CERTAIN DENTAL AND ORTHODONTIC SCANNERS
AND SOFTWARE
Inv. No. 337-TA-1144
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached INITIAL DETERMINATION
has been served upon the following parties as indicated, on June 1, 2020.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainant Align Technology, Inc.:
Blair M. Jacobs, Esq.
PAUL HASTINGS LLP
875 15th Street NW
Washington, DC 20005
Email: blairjacobs@paulhastings.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download
On Behalf of Respondents 3Shape A/S, 3Shape Trios A/S, and
3Shape Inc.:
Goutam Patnaik, Esq.
PEPPER HAMILTON LLP
2000 K Street NW
Suite 600
Washington, DC 20006
Email: patnaikg@pepperlaw.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download

/ .
UNITED STATES INTERNATIONAL TRADE COMMISSION

Washington, D.C.

In the Matter of

CERTAIN DENTAL AND Inv. No. 337-TA-1144
ORTHODONTIC SCANNERS AND |
SOFTWARE

ORDER NO. 36: a CONSTRUING CERTAIN TERMS OF THE ASSERTED
CLAIMS OF THE PATENTS AT ISSUE (MARKMAN
CLAIM CONSTRUCTION)

(October 1, 2019)

Table of Contents ,

I. RELEVANT BACKGROUND AND SUMMARY OF CLAIM CONSTRUCTION

PROCEEDINGS .......cccccscsssssesscsscescessesscssessecseesecsnesesacecesacecesscenecsesesseeeaesaceaseneeseseaseseeseesee®
I. PATENTS AND CLAIMS AT ISSUE....sessssssccsssssssssssssssssecsssssssesssssssusnssecnesnnsessnssee
III. | TERMS CONSTRUED IN THIS ORDER.......... cc seceeeeseeeeeees cessceseescenesaceaeeseeseeeasoneeeseees
A. Claim Construction and Current Ground Rules............ccescsesseseseeeeseeseseneeseeseeceees
B. Markman Chart in Appendix A scsussussusssssucsassnussucssesaseneceussassatsnsssssssssssesseseaseseesess
TV. APPLICABLE LAW .......ceccscsssssssssesseesseseesesesseseneeenesnsasanensaeeseueneneeaceseasacneensscaesesasseaneneasens
V. PERSON OF ORDINARY SKILL IN THE ART.......c.ccssssesecsessesscsssseeeeseesessssceeserseeeteeeares
VI. FUTURE PROCEEDINGS ..... oc eceessceccseesecseeeeeneeeeenessesesssesseeenes seseeeeeaeescenecesseseeeeees 10
A. Supplementation in Response to This Order ...........ccecccesesseseseeeesseeeseeneneeeeeeeees 10
_ B. Streamlining the Investigation ............ccccsssessceeeeeeeeeceeseeeseseecesesensessasssessesenescerseees 11
C. Settlement .........:cccesesereseeeneees sterseoeeserassetencarsessersoeneenes sesasessesstneesunsessaesseenee 11
VII. CONCLUSION............ sevsscessusecesnuseessusieesnetensnnueensnnece secosuseeesnnsccessneeecesnseecsantecesnneessuseessens 11

Appendix A

Complainant Align
Technology, Inc.

Respondents 3Shape A/S,
3Shape Trios A/S, and
3Shape Inc.

Parties

COMBr.
CRMBr.
ROMBr.
RRMBr.

~ Joint CC Chart

CPBr.

Attachments

Markman Chart: Court’s Adopted Constructions of Agreed-Upon and
Disputed Claims Terms

Table of Abbreviations

Align

3Shape

Align and 3Shape

Align’s Opening Claim Construction Brief (in
abbreviation, “M” stands for Markman)

Align’s Reply Claim Construction Brief (in abbreviation,
“M”’ stands for Markman)

‘ 3Shape’s Opening Claim Construction Brief (in

abbreviation, “M” stands for Markman)

3Shape’s Rebuttal Claim Construction Brief (in
abbreviation, ““M” stands for Markman)

Joint Post-Hearing Final Claim Construction Chart (Doc.
ID No. 685923 (Aug. 21, 2019))

Align’s Pre-Hearing Brief

ii

I. RELEVANT BACKGROUND AND SUMMARY OF CLAIM CONSTRUCTION
PROCEEDINGS

The Complaint in this Investigation was filed on December 10, 2018. (See Doc. ID No.
663673 (Dec. 10, 2018).). The Complaint was filed by Align Technology, Inc. (“Align” or
“Complainant”) and names as Respondents 3Shape A/S (“3Shape A/S”), 3Shape, Inc. (“3Shape
US”) and 3Shape Trios A/S (“3Shape Trios,” collectively, “3 Shape” or “Respondents,” and with
Align, “the Parties.”).

On June 19, 2019, consistent with Order No. 4 (Doc. ID No. 671192 (Mar. 25, 2019)),
the Parties filed a Revised Joint Claim Construction Chart, (Doc. ID No. 678972 (June 19,
2019)). On the same day, 3Shape filed its Opening Claim Construction Brief (““ROMBr.”).

' (Doc. ID No. 678980 (June 19, 2019).). One day later, on June 20, 2019, Align filed its Opening
Claim Construction Brief (““COMBr.”). (Doc. ID No. 679028 (June 20, 2019).).

On June 28, 2019, Align filed a Reply Claim Construction Brief (““CRMBr.”). (Doc. ID No.
679765 (June 28, 2019).). The same day 3Shape filed a Rebuttal Claim Construction Brief
(“RRMBr.”). (Doc. ID No. 679756 (June 28, 2019).).

Order No. 21 issued on July 10, 2019, which scheduled the Markman hearing for August
8, 2019. (Doc. ID No. 680811 (July 10, 2019).). On August 5, 2019, the Parties filed a Joint
Claim Construction Chart “identifying the construction of those terms on which the parties agree
and are no longer in dispute,” “the terms in dispute that will be argued during the Markman
hearing,” and “each party’s proposed construction of the disputed terms.” (Doc. ID No. 684285
(Aug 5, 2019).).

A Markman hearing took place on August 8, 2019. (Markman Hearing Tr. at 1 (Doc. ID

No. 684877 (Aug. 9, 2019).). Shortly thereafter, the Parties filed a Joint Post-Hearing Final

Claim Construction Chart (“Joint CC Chart”). (Doc. ID No. 685923 (Aug. 21, 2019).). The

Page 1 of 11

Joint CC Chart identifies the claim terms for which the Parties agree on a meaning and the claim
terms for which a meaning remains in dispute.’ (/d.).

In their Joint CC Chart, the Parties identified twelve (12) disputed terms, and eight (8)
terms upon which they agree. (See id.). Each of those patents and claim terms is addressed in
Appendix A to this Order. The evidentiary hearing (“Hearing”) in this Investigation is scheduled
to occur on October 24-25, 2019 and October 28-30, 2019. (Order No. 4 at 1.).

Il. PATENTS AND CLAIMS AT ISSUE

Align’s Complaint in this Investigation alleges 3Shape’s infringement of the following
five (5) patents: (1) U.S. Patent No. 9,299,192 (‘‘the ’192 patent’’); (2) U.S. Patent No.
7,077,647 (‘‘the °647 patent”); (3) U.S. Patent No. 7,156,661 (‘‘the ’661 patent’’); (4) U.S.
Patent No. 9,848,958 (‘‘the °958 patent’’); and (5) U.S. Patent No. 8,102,538 (“‘the °538
patent’’). See, e.g., 84 Fed. Reg. 7933 (Mar. 5, 2019). Align initially alleged 3Shape’s
infringement of approximately 88 claims: claims 1-32 of the ’192 patent; claims 1—13 and 18—
21 of the 647 patent; claims 1-9 and 19-26 of the 661 patent; claims 1—20 of the °958 patent,
and claims 1 and 2 of the 538 patent. (See id.).

On July 2, 2019, Order No. 17 issued as an Initial Determination which granted Align’s
“unopposed motion for partial termination of this Investigation ... with respect to allegations of
infringement of the asserted claims of U.S. Patent No. 9,848,958].]” Consequently, the four (4)

patents remaining in this Investigation (“the Asserted Patents”) are: (1) the ’192 patent; (2)

' Following the Markman hearing, and consistent with the Parties’ discussions during the Markman
hearing, the Parties met and conferred on two terms to see if they could reach a compromise construction
with respect to two (2) claim terms: (1) “individually matching each/match each of the dental objects” in
the 647 patent; and (2) “region(s)” in the ’661 patent. However, the Parties reported that they were
unable to reach an agreement on a compromise construction for these 2 claim terms. (Joint CC Chart at

1).

Page 2 of 11

the ’647 patent; (3) the ’661 patent; and (4) the *538 patent. It appears that, across.these four (4)
patents, as of July 2019, approximately 68 asserted patent claims remain in this Investigation.

In its Pre-Hearing Brief (““CPBr.”), Align has whittled down its infringement case. (Doc.
ID No. 686919 (Aug. 30, 2019) at 27-116.).

However, Align’s case is still too unwieldy for the upcoming five-day Hearing. 2 As
reflected in below in Table No. 1, Align has alleged that 3Shape has infringed 19 claims (“the
Asserted Claims”): (1) 8 claims of the °192 patent; (2) 5 claims of the ’647 patent; (3) 4 claims
of the 661 patent; and (4) 2 claims of the ’538 patent. (/d.). It appears that, as of the filing of
Pre-Hearing Briefs, each of the disputed claims identified in the Joint CC Chart remains in
dispute. (Jd. at 27 (addressing ’674 patent: “The terms and proposed constructions at issue, as
well as the agreed-upon terms, aré listed in the parties’ August 21, 2019 Joint Post-Hearing
Claim Construction Chart.”), 58 (same for 661 patent), 82 (same for ’192 patent), 104 (same
for °538 patent).). | |

_ Table No. 1: Presently Asserted Patents and Asserted Claims

Asserted Patents Asserted Claims
"192 patent 1-5, 22, 28-29 (8 claims)
°647 patent | ~~ 1.2, 4, 18, 20 (5 claims)
°661 patent 1-2, 19-20 (4 claims)

2 On September 3, 2019, Align filed a “contingent” motion for more Hearing time, to which 3Shape
objects. (See Motion Docket No. 1144-038 (Sept. 3, 2019), and Doc. ID No. 687187 (Sept. 4, 2019),
respectively. An Order on Align’s Motion has not yet issued. However, there are too many patents and
claims even if an additional day is added. Align is urged to winnow its case by the end of this week.

Page 3 of 11

”538 patent - 1-2 (2 claims)

(Ia.).

The ’192 patent, which issued on March 29, 2016, is entitled “Methods and Systems for
Creating and Interacting with Three Dimensional Virtual Models.” (JX-0004-(7192 patent) at
Cover.). The ’192 patent pertains to “[s]ystems and methods are provided for modifying a
virtual model of a physical structure with additional 3D data obtained from the physical structure
to provide a modified virtual model.” (/d.). | Align is the assignee named on the °192 patent.
(Id.).

The related °661 and *647 patents are entitled “Systems and Methods for Treatment
Analysis by Teeth Matching.” (JX-0001 (°647 patent) at Cover; JX-0002 (°661 patent) at |
Cover.). The ’661 patent is a continuation-in-part of the °647 patent and shares most of the ’647
patent’s specification. (/d.). Align is the assignee named on the ’661 and 647 patents. (/d.).

‘' The °647 patent issued on July 18, 2006, and pertains to “[s]ystems and methods ... for
matching computer models of two sets of teeth includes calculating a difference for two sets of
teeth shapes; finding the position of one set of teeth with respect to the other set of teeth;
calculating a positional difference of the corresponding teeth; and finding a corrective path to _
bring one set of teeth to the other set of teeth.” (JX-0001 (7647 patent) at Cover.).

The 661 patent issued on January 2, 2007, and pertains to “[s]ystems and methods ...
for matching computer models of two sets of teeth each having corresponding matching regions
includes calculating a difference for two sets of teeth shapes; finding the position of one set of
teeth with respect to the other set of teeth; calculating a positional difference of the
corresponding teeth based on the matching regions; and finding a corrective path to bring one set

of teeth to the other set of teeth.” (JX-0002 (°661 patent) at Cover.).

Page 4 of 11

Finally, the °538 patent issued on January 24, 2012, and is entitled “Method and
| Apparatus for Colour Imaging a Three-Dimensional Structure.” (JX-0003 (°538 patent) at
Cover.). The ’538 patent pertains to:
a device for determining the surface topology and associated color of a structure,
such as a teeth segment, including a scanner for providing depth data for points
along a two-dimensional array substantially orthogonal to the depth direction, and
an image acquisition means for providing color data for each of the points of the
array, while the spatial disposition of the device with respect to the structure is
maintained substantially unchanged. A processor combines the color data and depth
data for each point in the array, thereby providing a three-dimensional color virtual

model of the surface of the structure. A corresponding method for determining the
surface topology and associated color of a structure is also provided.

(Id.).

Align is not the named assignee on the face of the 538 patent; instead the named
assigned is Cadent Ltd (“Cadent”). (/d.). However, in its Pre-Hearing Brief, Align asserted that
“fo]n October 24, 2014, Cadent assigned the ’538 patent to Align.” Align filed a copy of the
assignment of the ’538 patent with its Complaint. (CPBr. at 6; Compl. Ex. 10.).

Ill. TERMS CONSTRUED IN THIS ORDER
A. Claim Construction and Current Ground Rules

Claim terms are construed in this Order solely for the purposes of this Section 337
_ Investigation. Only claim terms in controversy need to be construed, and then only to the extent

necessary to resolve the controversy. Vanderlande Indus. Nederland BV v. Int’l Trade Comm.,
366 F.3d 1311, 1323 (Fed. Cir. 2004); Vivid Tech., Inc. vy. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
803 (Fed. Cir. 1999).

As this Investigation proceeds, the Parties will be limited to the constructions adopted in
this Order. This applies to the Hearing, during which no new arguments will be permitted.
Ground Rule 1.14 states that “tt]he parties will be bound by their claim construction positions set .

forth on the date they are required to submit a joint list showing each party’s final proposed

Page 5 of 11

construction of the disputed claim terms and will not be permitted to alter these absent a timely
showing of good cause.” Modified or new constructions which the Parties attempt to set forth
will not be considered, and will be considered to have been waived.

Similarly, it will not be appropriate for any party to seek additional claim construction
during the Hearing or merely to state that a claim term implicated in an expert report or expert
testimony has either a “plain or ordinary” meaning, or that a claim term is “indefinite.” (See
Order No. 2 at 8; G.R. 1.14.).

B. Markman Chart in Appendix A

The Markman Chart attached as Appendix A contains terms for which the Parties have
agreed to a construction and terms by patent for which the Parties dispute the proper
construction. The Parties’ agreed-upon claim constructions have been adopted without a
rationale or explanation. (See App. A, Markman Chart.).

For disputed terms, there are five (5) columns in the chart: (1) Claim Term to be
Construed; (2) Align’s Proposed Construction; (3) 3Shape’s Proposed Construction; (4) Adopted

Construction; and (5) Support for Construction. (See id.).

IV. APPLICABLE LAW?

Claim construction begins with the language of the claims themselves. Claims should be
given their ordinary and customary meaning as understood by a person of ordinary skill in the
art, viewing the claim terms in the context of the entire patent. Phillips v. AWH Corp., 415 F.3d
1303, 1312-13 (Fed. Cir. 2005). In some cases, the plain and ordinary meaning of claim

language is readily apparent and claim construction will involve little more than “the application

3 The constructions in the Markman Chart of Appendix A generally follow and apply the law as described
above. To the extent possible, the case law that applies to a construction is either identified explicitly, or
implicitly in adopting a party’s argument or construction.

Page 6 of 11

of the widely-accepted meaning of commonly understood words.” Jd. at 1314. In other cases,
claim terms have a specialized meaning and it is necessary to determine what a person of
ordinary skill in the art would have understood disputed claim language to mean by analyzing

_ “the words of the claims themselves, the remainder of the specification, the prosecution history,
and extrinsic evidence concerning relevant scientific principles, as well as the meaning of
technical,terms, and the state of the art.” Jd. (quoting Innova/Pure Water, Inc. v. Safari Water
Filtration Sys., Inc., 381 F.3d-1111, 1116 (Fed. Cir. 2004)).

The claims themselves provide substantial guidance with regard to the meaning of
disputed claim language. Phillips, 415 F.3d at 1314. “[T]he context in which a term is used in
the asserted claim can be highly instructive.” Jd. Similarly, other claims of the patent at issue,
regardless of whether they have been asserted against respondents, may show the scope and
meaning of disputed claim language. Jd.

In cases in which the meaning of a disputed claim term in the context of the patent’s
claims was uncertain, the specification was used as the “single best guide to the meaning of a
disputed term.” Jd. at 1321. Moreover, “[t]he construction that stays true to the claim language
and most naturally aligns with the patent’s description of the invention will be, in the end, the
correct construction.” Jd. at 1316. As a general rule, however, the particular examples or
embodiments discussed in the specification are not to be read into the claims as limitations. Jd.
at 1323.

The prosecution history may also explain the meaning of claim language, although “it
often lacks the clarity of the specification and thus is less useful for claim construction

purposes.” /d. at 1317. The prosecution history consists of the complete record of the patent

examination proceedings before the U.S. Patent and Trademark Office, including cited prior art.

Page 7 of 11

Id. The prosecution history may reveal “how the inventor understood the invention and whether
the inventor limited the invention in the course of prosecution, making the claim scope narrower
than it would otherwise be.” Jd.

If the intrinsic evidence is insufficient to establish the clear meaning of a claim, a court
may resort to an examination of the extrinsic evidence. Zodiac Pool Care, Inc. v. Hoffinger
Indus., Inc., 206 F.3d 1408, 1414 (Fed. Cir. 2000). Extrinsic evidence may shed light on the .
relevant art, and “consists of all evidence external to the patent and prosecution history,
including expert and inventor testimony, dictionaries, and learned treatises.” Phillips, 415 F.3d
at 1317. In evaluating expert testimony, a court should disregard any expert testimony that is
conclusory or “clearly at odds with the claim construction mandated by the claims themselves,
the written description, and the prosecution history, in other words, with the written record of the
patent.” (/d. at 1318.). Moreover, expert testimony is only of assistance if, with respect to the
disputed claim language, it identifies what the accepted meaning in the field would be to one
skilled in the art. Symantec Corp. v. Comput. Assocs. Int’l, Inc., 522 F.3d 1279, 1289 n.3., 1290-
91 (Fed. Cir. 2008). Testimony that recites how each expert would construe the term should be
accorded little or no weight. Jd. Extrinsic evidence is inherently “less reliable” than intrinsic
evidence, and “is unlikely to result in a reliable interpretation of patent claim scope unless
considered in the context of the intrinsic evidence.” Phillips, 415 F.3d at 1318-19.

Extrinsic evidence is a last resort: “[i]n those cases where the public record

unambiguously describes the scope of the patented invention, reliance on any extrinsic evidence

is improper.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996).

Vz. PERSON OF ORDINARY SKILL IN THE ART

A hypothetical person of ordinary skill in the art is a person of ordinary skill and

“ordinary creativity.” KSB Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 420 (2007). “Factors that

Page 8 of 11

may be considered in determining [the] level of ordinary skill in the art include: (1) the

educational level of the inventor[s]; (2) type of problems encountered in the art; (3) prior art

solutions to the problems; (4) rapidity with which inventions are made; (5) sophistication of the

technology; and (6) educational level of active workers in the field.” Envtl. Designs Ltd. v.

Union Oil Co. of California, 713 F.2d 693, 696-97 (Fed. Cir.) (citations omitted). “These factors

are not exhaustive but merely a guide to determining the level of ordinary skill in the art.”

Daiichi Sankyo Co. v. Apotex, Inc., 501 F 3d 1254, 1256 (Fed. Cir. 2007).). The hypothetical

person of skill is also separately presumed to have knowledge of all the relevant prior art in the

field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 693, 697 (Fed. Cir. 1983).

As set forth below in Table No. 2, the Parties disagree with respect to the qualifications

of a person of ordinary skill in the art for the Asserted Patents. The Parties have not clearly

articulated the reasons for their disagreement. (See, generally, COMBr.; CRMBr.; ROMBr.;

RRMBr.).

Table No. 2: Competing Person of Ordinary Skill in the Art (“POSA”) Definitions

Asserted
Patents

_ Align’s Definition

3Shape’s Definition

192
/°647
/°661

patents

“would have had (1) at least a
bachelor’s degree in electrical
engineering, computer science,
applied mathematics, or an equivalent
field, as well as at least one or two
years of industry experience in three-
dimensional modeling, (2) at least five
years of comparable industry
experience in three-dimensional
modeling, or (3) an equivalent
combination of academic study and
work experience”

“would have at least (1) a bachelor’s
degree in electrical and/or computer
engineering, or computer science (or
equivalent course work) with two to
three years of work experience in
_ computer modelling of physical
structures or (2) a master’s degree in
electrical and/or computer engineering,
or computer science (or equivalent
course work) with a focus in computer
modelling of physical structures”

°538
patent

“would have had (1) at least a
bachelor’s degree in electrical
engineering, computer science,

“would have (1) a bachelor’s degree in
electrical engineering, optical
engineering, or physics (or equivalent

Page 9 of 11

physics or an equivalent field, as well
as at least one or two years of industry
experience in optical scanning, (2) at
least five years of comparable industry
experience in optical scanning, or (3)
an equivalent combination of
academic study and work experience”

course work) and two to three years of

work experience in the areas of optical

imaging systems and image processing,
or (2) a master's degree in electrical

engineering or physics (or equivalent

course work) with a focus in the area of

optical imaging systems and image
processing”

(COMBr. at 7-8; ROMBr at 8-9, 26, 38, 54.).

This Order does not resolve the definition of a person of ordinary skill in the art because

it is not germane to the claim construction that the Parties have requested. In arguing for their

proposed constructions of disputed terms, the Parties have appropriately focused on other

matters, such as the intrinsic evidence. None of the Parties has indicated in any of their filed

documents that the person of ordinary skill in the art definition is necessary or dispositive for

construction of the disputed claim terms.

To the extent this issue could affect the outcome of the Hearing, the Parties should

attempt to agree on a person of ordinary skill in the art definition for each of the Asserted

Patents. If the Parties instead reserve their person of ordinary skill in the art positions for the

Hearing, at the Hearing they must address each of the factors set forth in Envtl. Designs, supra.

The Parties will be expected to state during the Hearing: (1) why their POSA definition should

be applied and they will be required to cite to the factors described above; and (2) whether their

definition of POSA would eliminate any of the experts in this Investigation.

VI. FUTURE PROCEEDINGS

A. Supplementation in Response to This Order

The Parties may-not file supplemental expert reports in response to this Order. No

additional discovery will be permitted because of this Order. No re-argument of constructions

announced in this Order may occur.

Page 10 of 11

\

VIL.

As the Investigation proceeds, the Parties will be expected to notify Chambers, through a
filing on EDIS, of any issues that have become moot or have been eliminated for any reason.
The Parties’ substantive issue outlines (Ground Rule 7.3) must identify any issues, claims,
defenses, prior art, theories, or any other content that was originally asserted or argued that have
been dropped or become moot. Similarly, the Parties should identify also all issues or
contentions and patents that have been dropped or become moot for any reason.

The Parties should redact from expert reports, and from any other documents upon which
they intend to rely, any issues, claims, defenses, prior art, theories, or any other content that has
been rendered moot or disallowed as a result of this or other Orders or because of the termination
of patent claims or allegations from this Investigation. The Parties must file on EDIS any expert
reports or other documents upon which they intend to rely that have been redacted for the
reasons stated above, and additionally provide two (2) copies to Chambers.

B. Streamlining the Investigation

To the extent that this Markman Order will enable the Parties to streamline the
Investigation, the Parties are encouraged to drop issues now in advance of the Hearing.
Moreover, the Parties are encouraged to resolve promptly each issue in this Investigation for _
which there is no reasonable dispute or little, or weak, evidentiary support.

Cc. Settlement

The Parties should engage in serious settlement discussions.

CONCLUSION

The constructions of claim terms contained in Appendix A to this Order are incorporated
by reference as part of this Order.

SO ORDERED.

Administrative Law Judge

Page 11 of 11

rn

Order No. 36, Appendix A
AInv. No. 337-TA-1144

APPENDIX A.

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Chart 1. Constructions of Disputed Claim Terms with Adoption of Agreed-Upon Claim Terms

1. U.S. PATENT NO. 9,299,192 !

Claim Terms to Be

Align’s Proposed

3Shape’s Proposed

Adopted

from the first virtual
model.”

Construed Construction Construction ‘Construction Support for Construction
Align asserted that the adopted construction of
“second virtual model” should remain
consistent with the agreed-upon construction of
“virtual model,” which is “3D virtual
representation.” (COMBr. at 33-34.). Indeed,
| Align’s proposed construction is “second 3D
“A singular and virtual representation.” (/d.). 3Shape, on the
collected three- other hand, rejected Align’s proposed
Plain and ordinary dimensional virtual construction for lacking “distinctions between
. tae ar ee: . the first virtual model and second virtual
“second virtual model” | 7°2™ne: which 1S depiction of a real second 3D virtual model.” (ROMBr. at 38-39.). Those purported
“second 3D virtual | object in a computer representation” “distinctions” hat: (1) th d virtual
representation” environment separate istinctions” are that: (1) the second vi

_model is “separate” from the first virtual

model; (2) the “second virtual model is not
simply a manipulated version of the first
virtual model”; and (3) “the claims,
specification, and prosecution history
consistently describe the ‘second virtual
model’ as . . . [a] singular and collected 3D
virtual depiction of a real object.” (/d.). As
explained below, each of 3Shape’s purported

1 All references to briefs in this Appendix A are consistent with the abbreviated terms that are identified in the Table of Abbreviations in Order No. 36.

Page 1 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed —

Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

distinctions lacks merit, and Align’s
construction is adopted.

As Align noted, language found in the asserted
claims accounts for 3Shape’s first two (2)
purported distinctions. (CRMBr. at 21-22.).
Each independent claim refers to “the first
virtual model [] generated from first 3D scan
data” and “the second virtual model []
generated from second 3D scan data,” thereby
distinguishing the first virtual model and the
second virtual model in terms of being distinct
models generated from distinct scans. (JXM-
0004 (°192 patent), cls. 1, 28, 30.). “Where a

claim lists elements separately, the clear

implication of the claim language is that those
elements are distinct components of the patent
invention.” Becton, Dickinson & Co. v. Tyco
Healthcare Group, LP, 616 F.3d 1249, 1254
(Fed. Cir. 2010) (internal quotation marks and
citations omitted). In other words, the claim
language makes clear that the second virtual
model is not simply a manipulated version of
the first virtual model. Each independent
claim of the ’192 patent unambiguously
requires that the first and second virtual models
are generated from different data scans. .

Page 2 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

With respect to 3Shape’s third and final
distinction, the intrinsic evidence simply does
not characterize the “second virtual.model” as
“singular and collected.” The words “singular”
and “collected” do not appear in the claims or
specification of the °192 patent. (See,
generally, SXM-0004 (°192 patent).). The
words “singular” and “collected” do not appear
verbatim, in any meaningful way, in the
prosecution history of the ’192 patent. (See,
generally, JKM-0009 (7192 patent prosecution
history).). Consistent with this dearth of
intrinsic evidence in favor of 3Shape’s
“singular and collected” distinction, it is also
unclear exactly what “singular and collected,”
if included in the adopted construction, would
actually mean in the context of the ’192 patent.

3Shape is correct that, in response to a
rejection during patent prosecution, the
patentee amended claims during prosecution of
the °192 patent to add the “second virtual
model” limitation. (ROMBr. at 40-42; JXM-
0009 (’192 patent prosecution history) at 317.).
The patentee apparently did so to distinguish
prior art that purportedly invalidated pending
claims prior to their amendment. (JXM-0009 —

Page 3 of 79

(’192 patent prosecution history) at 290.). The

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction —

Adopted
Construction

Support for Construction

prior art purportedly taught modification of an
existing virtual model with “additional 3D data
obtained from the physical structure,” without
specifying the source of the “additional 3D
data.” (Id.).

To overcome the prior art, the patentee
amended the pending claims to specify that a
second 3D scan was the source of the
additional 3D data. (/d. at 317.). That

| amendment distinguished the first virtual

model and the second virtual model in terms of
being distinct models generated from distinct
scans. (Id. at 308-15.). In other words, the
amendment already provided narrowing claim
limitations of the sort that 3Shape now seeks to
import via a construction of “second virtual
model.” This claim construction does not
adopt a construction of “second virtual model”
that would introduce such redundancy. MEMS
Tech. Berhad v. Int'l Trade Comm’n, 447 F.
App’x 142, 151 (Fed. Cir. 2011) (constructions
which introduce redundancy are “disfavored”).

Likewise, nothing in the prosecution history of
the °192 patent suggests that Align’s
construction of “second virtual model” would
amount to an inappropriate recapture of

Page 4 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

—~

previously disavowed claim scope. (ROMBr.
at 42.). To the contrary, Align’s seemingly
broad construction of “second virtual model” is
constrained by surrounding claim language
added by the aforementioned amendment to
pending claims made during prosecution.
3Shape’s assertion to the contrary is plainly
inconsistent with the intrinsic record.

On the other hand, Align’s construction
adopted herein (“second virtual model” means
“second 3D virtual representation”) is
consistent with the agreed-upon construction
that a “virtual model” is a “3D virtual
representation.” There is copious binding
authority on the importance of construing
claim terms found in a given patent in a way
that preserves internal consistency. See, e.g.,
Callicrate v. Wadsworth Mfg., Inc., 427 F.3d
1361, 1371 (Fed. Cir. 2005) (“interpret[] claim
terms consistently throughout various claims of
the same patent”); Research Plastics, Inc. v.
Fed. Packaging Corp., 421 F.3d 1290, 1295
(Fed. Cir. 2005) (“claim terms are presumed to
be used consistently throughout the patent,
such that the usage of a term in one claim can
often illuminate the meaning of the same term
in other claims.”); Phonometrics, Inc. v.

Page 5 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed 3Shape’s Proposed Adopted
Construction Construction _ Construction

Support for Construction

Northern Telecom Inc., 133 F.3d 1459, 1465
(Fed. Cir. 1998) (“[a] word or phrase used
consistently throughout a claim should be

interpreted consistently”).

Moreover, the specification of the ’192 patent.
supports the agreed-upon construction of
“virtual model” and Align’s construction of
“second visual model.” Specifically, the
specification defines “virtual models” as
“three-dimensional virtual representations.”
(JIXM-0004 (7192 patent) at 1:30-36.). The
specification also explains that “[t]he term ‘3D
virtual model’ is used herein synonymously
with digital model, virtual model, 3D virtual
model, 3D model, . . . 3D representation, and
other such terms” (/d. at 3:26-38). This
definitional guidance from the specification
confirms the correctness of Align’s proposed

Agreed: Plain and ordinary meaning, which is “3D virtual

construction and supports its adoption.

“virtual model” ake n/a
representation
“identifying at least a
portion of the first Agreed: “identifying at least a portion on the first virtual model that n/a

virtual model that is
desired to be modified”

is desired to be replaced”

Page 6 of 79

APPENDIX A to ORDER NO. 36

Markman Order
Inv. No. 337-TA-1144
2. U.S. PATENT NO. 7,156,661
Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Construction Support for Construction

“reference point”

No construction
necessary

If the ALJ believes
construction is
necessary, the proper
construction is plain
and ordinary
meaning, which is
“points used to
determine the
position of a
computer model
relative to another
computer model”

“a point on a stable
anatomical structure”

“a point used to
determine
the position of a
computer model, or
part thereof,
relative to another
computer model, or
part thereof”

According to Align, this term required no
construction because it was clear and had a plain
meaning understood by those skilled in the art.
(COMBr. at 13.). In the alternative, Align
proposed a construction that identified the
purported function of a “reference point” as set
forth in the ’661 patent: determining the position
of a computer model relative to another
computer model. (/d. at 14 (citing JKM-0002
(7661 patent) at 6:56-7:25).). In rebuttal, 3Shape
asserted that Align’s proposed construction
misrepresented the function of a “reference
point” and ignored specification disclosures
included in the ’661 patent (but omitted from the
related ’647 patent) that purportedly clarified that
a “reference point” must be located “on a stable
anatomical structure.” (ROMBr. at 26-27.).

A close examination of the ’661 patent
specification reveals that neither of 3Shape’s
arguments has merit. As explained below,
“reference point” warrants a broad construction,
and none of the additional specification material
included in the 661 patent (but omitted from the

telated ’647 patent) requires otherwise.

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Claim Terms to Be
Construed

Align’s Proposed
Construction

‘3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

As an initial matter, a construction of the term
“reference point” is necessary because the Align
and 3Shape dispute the term’s meaning. O2
Micro Intern. Ltd. v. Beyond Innovation
Technology Co., Ltd., 521 F.3d 1351, 1360 (Fed.
Cir. 2008).

3Shape concedes that the °661 patent teaches a
two-step matching process. (ROMBr. at 36.).
The first step involves matching individual teeth
or individual regions across models. (See, e.g.,
JXM-0002 (°661 patent) at 6:18-24, 9:14-20.).

The second step involves “jaw matching.” (Jd. at
6:32-34, 9:21-23.). The second step “‘is
performed to determine the position of the new
jaw relative to the original coordinate system[.]”
(Id. at 6:32-34.).

To complete the second step, “the entire jaw .
needs an external reference to set the position. A
fixed external reference such as rugae in the
patient’s mouth can be used. Ifa fixed external

reference is not available, some teeth can be used

for the reference as well.” (/d. at 8:66-9:2.). For
example, in the context of using certain teeth as
an external reference, for “positioning of the new

Page 8 of 79

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Claim Terms to Be
Construed

' Align’s Proposed

Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

jaw in the original coordinate system,” “the
process generates various sample points on the
reference teeth and corresponding points on the
current teeth (344). Next, it calculates position
transformation using the sample points (346).”
(Id. at 7:36-39.).

3Shape appears to suggest that “reference point”
in the °661 patent is used only in the context of
“stable teeth” or “[s]table structures such as the
palatal rugae.” (ROMBr. at 27 (“The ’661 patent
further establishes that a ‘reference point’ relates
to stable and anatomic structures”); JXM-0002
(°661 patent) at 11:2-3.). The problem with this
argument is that the 661 patent discloses using
“reference points” in the context of non-stable
anatomic structures. For example, the 661 patent
teaches a first step of tooth matching, including
teeth that move or shift, whereby “[t]he process
finds points on the original tooth crown and finds

‘| corresponding points on the current tooth.”

(JXM-0002 (’661 patent) at 7:10-15 (emphasis |
added).). This teaching is also found in the related

647 patent. (IXM-0001 (°647 patent) at 6:2-4.).

Consequently, the specification of the ’661 patent
as a whole, including any additional material
included in the ’661 patent (but omitted from the

Page 9 of 79

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Claim Terms to Be
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Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

related °647 patent) does not restrict the location
of a “reference point” to “a stable anatomical
structure.” This interpretation is consistent, with
the language of claim 1 of the 661 patent, where

| “reference point” appears in the context of “using

the matched regions as non-moving reference
regions.” (JXM-0002 (661 patent) at 13:30.).
Under. 3Shape’s unsupported construction of
“reference point” as “a point on a stable
anatomical structure,” the phrase “using the
matched regions as non-moving reference
regions” would appear to be somewhat redundant.
See MEMS, 447 F. App’x at 151 (constructions
which introduce redundancy are “disfavored”).

Next, 3Shape argues that “[w]hile the claims [of
the ’661 patent] teach using the matched regions
to match the computer models as a whole,
Align’s proposed construction would effectively
read out the explicit two-step matching process
taught by the 661 patent claims.” (ROMBr. at
29.). Here, 3Shape’s argument has merit. As
discussed above, “reference points” can play a

| role in both the first and second matching steps.
However, Align’s proposed construction (“points

used to determine the position of a computer
model relative to another computer model’’)
could be interpreted to cover only instances in

Page 10 of 79

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Claim Terms to Be
‘Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

| which “reference points” are used in the second

matching step to match jaw models.

A minor modification of Align’s construction
addresses 3Shape’s valid concern in this regard,
while preserving the breadth of “reference point”
as disclosed in the 661 patent specification.
Based on the above, “reference point” in the ’661
patent is “a point used to determine the position
of a computer model, or part thereof, relative. to
another computer model, or part thereof.” This
construction covers the use of a “reference point”
to match individual teeth, for example, in a first
matching step and the use of a “reference point”
to match jaw models in a second matching step.

“region(s)”

No construction
necessary

If the ALJ believes
construction is
necessary, the proper
construction is plain
and ordinary
meaning, which is

66, ”

area

“portion(s)”

v

area

According to Align, this term requires no
construction because it is clear and had a plain
meaning understood by those skilled in the art.
(COMBr. at 15-16.). In the alternative, Align
proposed a construction that “region(s)” be
construed as “area.” (/d. at 14 (citing JKM-0002
(661 patent) at 2:41-50 (describing “nontooth

‘areas”’).).

In rebuttal, 3Shape asserted that its “construction
establishes that matching the ‘region(s)’ cannot
be the same limitation as matching the computer

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Claim Terms to Be
Construed

Align’s Proposed

3Shape’s Proposed
Construction.

Adopted
Construction

Support for Construction

Construction

‘models as a whole.” (ROMBr. at 32.).

According to 3Shape, Align’s proposed
construction “would effectively read out the
expressly recited two-step matching process
required by the ’661 patent claims.” (/d.).
3Shape argued that Align abandoned a one-step
matching process during prosecution, where, to
distinguish a prior art reference, the patentee
“amended claim 1 [of the ’661 patent] to include
the two-step matching process of first using __
reference points to match corresponding regions,
and then using matched regions to match the
computer models as a whole.” (Jd. at 33.).

As an initial matter, a construction of the term
“region(s)” is necessary because Align and
3Shape dispute the term’s meaning. O2 Micro
Intern., 521 F.3d at 1360. .

3Shape’s proposed construction, “portion(s),” is
problematic for at least two reasons. First, the
term “portion” is already found in the claims of
the °661 patent alongside “region(s),” suggesting
that the patentee sought to draw a distinction
between “portion” and “region(s).” See Takeda
Pharm. Co. Ltd. v. Zydus Pharms. USA, Inc., 743 -

Page 12 of 79

F.3d 1359, 1365 (Fed. Cir. 2014) (refusing to

APPENDIX A to ORDER NO. 36
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Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

limit claim when inventors knew to include those
limitations “when they so desired”).

Second, 3Shape need not construe “region(s)” to
narrow its scope to “portion(s).” Claim 1 already
requires that the claimed “regions” comprise
only a “portion of the jaw other than the teeth” ~
and not the entire jaw. (JXM-0002 (’661 patent),
cl. 1.). The parties agreed that “portion of the
jaw other than the teeth” means “including at
least a non-tooth portion of the jaw.” (Joint
Post-Hearing Final Claim Construction Chart
(“Revised Joint CC Chart”) (Doc. ID No. 685923
(Aug. 21, 2019)) at 4.). Thus, the express
language of claim 1 prevents Align’s broad
construction of “region(s)” from collapsing the
°661 patent’s two-step matching process into
only one step. In other words, adopting
3Shape’s construction of “region(s)” would
introduce redundancy. See MEMS, 447 F. App’x
at 151 (constructions which introduce
redundancy are “disfavored”).

Based on the explanation provided above,

3Shape’s argument is rejected that Align’s:
construction of “area” “provides no clarity as to
whether “region(s)” can be the entire computer

model.” (ROMBr. at 32.). A proper

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Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .

Construed Construction Construction Construction Support for Construction
construction need not provide this clarity because
the surrounding claim language already makes
clear that the claimed “region(s)” cannot consist
of entire jaw models. Align’s construction of
“region(s),” which does not introduce
redundancy, is hereby adopted.

According to Align, this term required no
No construction construction because it is clear and has a plain
necessary meaning understood by those skilled in the art.
(COMBr. at 17-18.). In the alternative, Align
If the ALJ believes proposed that “matching/match ... using the
construction 1s “using the identified reference points” be construed as
necessary, the proper identified reference | “matching the region on the first and second
construction is plain points to determine | computer models using the identified points to
and ordinary “positioning/position |/ the positionofa | determine the position of a computer model
“matching/match ... meaning, which is ... using the region of the first

using the identified
reference points”

“matching the region
on the first and
second computer
models using the
identified points to
determine the
position of a
computer model
relative to another
computer model”

identified points on
the stable anatomical
structures”

computer model
‘relative to the
corresponding
region of the
second computer
model”

relative to another computer model.” (/d. at 19.).

3Shape disagreed. (ROMBr. at 35.). 3Shape
asserted that Align’s construction merely
rearranged words found in the claim term and did
so in a manner that left out key terms and created
ambiguity around whether the construction ~
“reads out the claimed two-step matching
process of using the identified corresponding
reference points to match corresponding regions
— not the models as a whole.” (Jd. at 36.).
According to 3Shape, “the 661 patent

Page 14 of 79

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Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

specification teaches that the corresponding
regions are ‘positioned’ during the process of
matching corresponding regions [and not entire
models] using the identified reference points.”
(1d.).

While 3Shape has a valid point, its substitution
of “positioning/position” for “matching /match”
is misplaced. 3Shape is correct that the
specification appears to equate use of these terms
in at least one snippet. (JXM-0002 (’661 patent)
at 9:17-20 (“These points are then matched such
that the models are positioned so they closely
align in the regions around the points-(i.e. the
rugae region), by applying a transform Tyrer to one
of the models.”).). It appears from the
specification of the ’661 patent that “positioning”
and “matching” are related concepts. (See, e.g.,
id. at 6:32-34 (“a second matching operation is
performed to determine the position of the new
jaw relative to the original coordinate system’’).).

However, other parts of the specification, and in
particular Figures 4 and 5, indicate that
“matching/match” is nevertheless distinct from
“pnositioning/position.” (See id. at 7:6-13 (“The
process of FIG. 4 positions the current teeth with
respect to original teeth using an approximate

Page 15 of 79

APPENDIX A to ORDER NO. 36
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Claim Terms to Be

Align’s Proposed
Construction

| 3Shape’s Proposed
Construction

' Adopted
Construction

Support for Construction

Construed

position. In one embodiment, the process
positions two teeth approximately based on each
crown center and tooth local coordinate system.
Then, for each tooth, a matching operation is
performed. The matching operation is an
iteration process that minimizes an error value
while trying to find the appropriate tooth
location.”), Figs. 4-5.). This repeated use of
“positioning” and “matching” in the ,
specification, mostly as distinct terms, suggests
that the patentee knew that substituting
“positioning” for “matching” in a claim would
result in a change of claim scope. See Takeda,
743 F.3d at 1365.

In one, non-limiting embodiment found in the
°661 patent (and the ’647 patent as well),
“matching” appears to relate to both computation
and positioning/repositioning based on that
computation (e.g., by way of a transform). (See,
e.g., id. at 6:56-7:51.). The adopted construction
attempts to reference both of these concepts
without limiting “matching/match” to a single
disclosed embodiment or denying the patentee
the full scope of its invention. The adopted
construction is also consistent with the adopted
construction of “reference point” set forth above.

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Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Support for Construction

Construction

Next, the phrase “stable anatomical structures,”
found in 3Shape’s proposed construction, is not
warranted for the reasons set forth above in the
context of “reference point.” The specification
of the 661 patent as a whole, including any
additional material omitted from the related ’647
patent, does not restrict the location of a
“reference point” to “a stable anatomical
structure.” To the contrary, the specification of
the 661 patent teaches the use of “reference
points” to match-non-stable structures, such as
moving teeth, across models. (/d. at 7:10-15
(emphasis added).). This interpretation is
consistent with the language of claim 1 of the
661 patent, where the patentee explicitly
constrained the claimed use of the “reference
point” to a “non-moving reference region.” (Jd.
at 13:30.). This fettered use of “reference point”
also makes clear that it would be redundant to
adopt 3Shape’s construction of “matching/match
... using the identified reference points” as
requiring “a point on a stable anatomical
structure.” See MEMS, 447 F. App’x at 151
(constructions which introduce redundancy are
“disfavored”).

However, 3Shape is correct that Align’s
proposed construction falls short. Specifically,

Page 17 of 79

r

APPENDIX A to ORDER NO. 36
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Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

the construction substituted “identified points”
for “identified reference points,” creating a hint
of ambiguity with respect to the identity of the
“identified points.”* Align’s construction also
creates some ambiguity around whether claims |
of the 661 patent cover using the “identified
reference points” to match computer models, as
opposed to just selected regions of those models.
Align’s construction could be interpreted to read
out the claimed two-step matching process, the
first of which uses identified reference points to
match corresponding regions across models, not
models. (JXM-0002 (’661 patent), cl. 1.).

Consequently, Align’s proposed construction is
adopted with appropriate modifications. In
particular, the adopted construction clarifies that
“identified points” are indeed “identified
reference points” and that the “matching/match
... using the identified reference points”
limitation refers to the first of two matching
steps, whereby matching occurs over
corresponding regions of models and not across
the rest of the models.

* Yet, it appears that 3Shape’s proposed construction contains the same ambiguous “identified points” language.

Page 18 of 79

APPENDIX A to ORDER NO. 36
- Markman Order .
Inv. No. 337-TA-1144

model relative to

the corresponding

tooth in the initial
digital model”

Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Construction Support for Construction
“comprising a
portion of the _ . ; . 45
jaw/model other than Agreed: “including at least a non-tooth portion of the jaw n/a.
the teeth”
3. U.S. PATENT NO. 7,077,647
Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Construction Support for Construction
| | Align asserted that the plain and ordinary
« _ || meaning of this term is “matching tooth by
for each onthe tooth.” (COMBr. at 23.). Align lifted this
subsequent divital language directly from the specification. (JXM-
‘a . “A 0001 (°647 patent) at 5:19-23 (“The process 206
. demif ° diefe © | of FIG.3 matches data using a tooth by tooth
“individually Plain and ordinary “one by one, entice reretence approach. By matching tooth by tooth, the
matching/match each meaning, which is positioning/position points to determine process determines the difference between tooth
. — the position of a . ; . .
” 66 ”
of the dental objects matching tooth by each of the dental tooth in the geometry in two different impressions.”)
tooth” objects” subsequen t digital (emphasis added), Fig. 8 (item 406); see also id.

at 5:66-67 (“Then, for each tooth, a matching
operation is performed.”), Fig. 4 (item 302).).
By contrast, “one my one,” the corresponding
language offered in 3Shape’s proposed
construction, does not appear in the specification
of the ’647 patent. The remainder of 3Shape’s

Page 19 of 79

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Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

- Adopted
Construction

Support for Construction

proposed construction attempts to characterize
“matching/match” as “positioning/ position.”
(ROMBr. at 11.). For the reasons explained
below, neither of the Parties’ constructions has ~
been adopted verbatim.

First, for the reasons explained above in the
context of “matching/match ... using the
identified reference points” found in the ’661
patent, 3Shape’s attempt to equate
“matching/match” with “positioning/position”
was misplaced.

Next, 3Shape’s “one by one” language is
rejected in favor of the “tooth by tooth” language
used in Align’s construction and the
specification of the °647 patent. As Align noted,
“3Shape cites no claim language or limiting
disclosure in the specification or the file history
that requires the injection of a ‘one by one’
limitation into the claims.” (CRMBr. at 4.). To
the extent that the “one by one” language was an
attempt by 3Shape to impose a specific order of
operations as part of the “matching” process
(e.g., matching teeth separately and in
succession), that is improper because it is not
rooted in the intrinsic evidence. -

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Markman Order .
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

However, 3Shape is correct that Align’s |
construction appears to read out the requirement
that “matching” occur “for each of the dental
objects” or teeth in the “subsequent digital
model.” (See JXM-0001 (647 patent) at cl. 1
(“individually matching each of the dental
objects in the subsequent digital model with a
dental object in the initial digital model”).).
Consequently, to avoid any ambiguity, the
adopted construction substitutes “for each of the
teeth” in place of “tooth by tooth.”

3Shape is also correct that Align’s construction
does hot adequately address the meaning of
“matching/match.” 3Shape is entitled to
guidance with respect to ‘the metes and bounds’
of “matching/match” limitations because the
Align and 3Shape appear to dispute the proper
scope of those limitations. O2 Micro Intern.,
521 F.3d at 1360.

As addressed above, in the context of a first
matching step required in claim 1 of the ’661
patent, “matching/match ... using the identified
reference points” means “using the identified
reference points to determine the position of a
region of the first computer model relative to the
corresponding region of the second computer

Page 21 of 79

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Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

model.” In the context of the ’647 patent, the
first matching step entails “individually
matching/match each of the dental objects” or
teeth, not “matching/match” regions. Thus, to
remain consistent across the related ’661 and
°647 patents, the proper construction of .
“matching/match each of the dental objects”
requires “using identified reference points to
determine the position of a tooth in the
subsequent digital model relative to the
corresponding tooth in the initial digital model.”

Importantly, this construction is copacetic with
limitations of claim 1 of the ’647 patent that
“compris[e]” the “individually matching/match

.each of the dental objects” step. These

limitations include “identifying ... reference _
points,” “approximately matching each set of
corresponding dental objects,” and “matching
each set of corresponding dental objects more
closely by iteratively minimizing error ....”
JXM-0001 (°647 patent) at cl. 1.).

“reference points”

No construction
necessary

If the ALJ believes
construction is

“sample points on the
tooth surface”

“points used to
determine
the position of a
digital model, or
part thereof,

According to Align, this term does not require
construction because it is clear and has a plain
meaning understood by those skilled in the art.
(COMBr. at 24-25.). In the alternative, Align
has proposed a construction that incorporates the

_ Page 22 of 79

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Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

necessary, the proper
construction is plain
and ordinary

meaning, which is ~

“points used to
determine the
position of a digital
model relative to
another digital
model”

relative to another
digital model, or
part thereof” -

purported function of a “reference point” as set
forth in the ’647 patent: determining the
position of a digital model relative to another
digital model. (/d. at 26-27.). In rebuttal,
3Shape argued that Align’s proposed
construction misrepresented the function of a
“reference point” and ignored specification
disclosures in the’647 patent that purportedly
clarified that a “reference point” must locate “on
the tooth surface.” (ROMBr. at 12.).

A close examination of the ’647 patent
specification reveals that neither of 3Shape’s
arguments has much merit. For the reasons -
stated above in the context of the construction of
“reference point” in the ’661 patent, “reference
points” here warrants a broad construction, and
none of the specification disclosures (in either
the ’647 patent or the ’661 patent) require
otherwise.

As an initial matter, a construction of the term
“reference points” is necessary because Align
and 3Shape dispute the term’s meaning. O2
Micro Intern., 521 F.3d at 1360.

3Shape conceded that the ’647 patent teaches a
two-step matching process. (ROMBr. at 15.).

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The first step involves matching individual teeth
or individual regions across models. (See, e.g.,
JXM-0001 (647 patent) at 5:19-25.).

‘The second step involves “jaw matching” or,

stated another way, the matching of one jaw
model to another jaw model. (/d. at 6:32-34.).
The second step “is performed to determine the
position of the new jaw relative to the original
coordinate system[.]” (/d.).

3Shape appeared to suggest that “reference

points” in the °647 patent is used only in the

context of the first matching step using “sample
points” located on “a tooth’s surface.” (ROMBr.
at 13 (“passages in the ’647 patent specification
that correspond to this particular series of steps
establishes that ‘reference points’ in the claims
refers to the ‘sample points’ in the ’647

patent specification”); see also JXM-0001 (’647
patent) at 5:49-61.). The problem with this
argument is that the ’647 patent appears to
disclose using “reference points” also in the
context of the second “jaw matching” step.

For example, the °647 patent describes using an
“external reference,” including teeth, in the
second matching step, for “positioning of the

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Construed Construction Construction Construction Support for Construction

new jaw in the original coordinate system.”
(JXM-0001 (°647 patent) at 6:15-16, 7:55-59.).
In one embodiment, “the process generates
various sample points on the reference teeth and
corresponding points on the current teeth (344).”
| Ud. at 6:25-27.). However, in another
embodiment, a “rugae in the patients mouth can
be used” as an “external reference.”? (Id. at
7:55-59.). Thus, a person of ordinary skill in the
art would appreciate that sample points (or
reference points) could be used to perform the
jaw-matching step with a rugae, which is not
located on the surface of a tooth.

Moreover, as Align notes, 3Shape’s proposed
construction presents ambiguity with respect to _
what constitutes the “tooth’s surface.” (COMBr.
at 25-26.). In particular, it is unclear whether
3Shape’s proposed construction is limited to the
portion of the teeth that are visible or includes
the root. According to Align, one of ordinary
skill in the art would likely understand that the
claimed “tooth” is not limited to only the crown
“surface,” but can also include the crown and the
root. (/d.).

3 “Rugae” means roof of the mouth. (CKM-0035 (Declaration of Norman Badler, PhD.) at 12.).

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Construed

Align’s Proposed 3Shape’s Proposed

Adopted
Construction

Support for Construction

Construction Construction

Consequently, 3Shape’s proposed construction
fails. The specification of the °647 patent does
not restrict the location of a “reference point” to
“a tooth’s surface.” To the contrary, as -
explained above, the specification of the 647
patent uses “reference points” broadly to match
tooth and non-tooth structures. This
interpretation is consistent with the language of
claim 1 of the °647 patent, where the patentee
specified the location of the “reference points”:
“on each set of corresponding dental objects” or
teeth. (IXM-0001 (647 patent) at 10:8-10.).
Under 3Shape’s unsupported construction of
“reference points” as “sample points on the tooth
surface,” it seems that the qualifying phrase “on
each set of corresponding dental objects” would
be redundant, at least in part. See MEMS, 447 F.
App’x at 151 (constructions which introduce
redundancy are “disfavored”).

Next, 3Shape argued that Align’s proposed
construction would effectively read out the
explicit two-step matching process taught by the
°647 patent claims.” (ROMBr. at 15.). Here,

3Shape has a legitimate point. Align’s

construction could be interpreted to cover only
instances in which “reference points” were used
in the second matching step to match jaw

Page 26 of 79

APPENDIX A to ORDER NO. 36

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Claim Terms to Be
Construed

Align’s Proposed
Construction

| 3Shape’s Proposed ;
Construction

Adopted |
Construction

Support for Construction

models. As discussed above, “reference points”
can play a role in both the first and second
matching steps.

A minor modification of Align’s construction
addresses 3Shape’s valid concern in this regard,
while preserving the breadth of “reference
points” as disclosed in the ’647 patent
specification. Based on the above, “reference
points” in the ’647 patent is construed as “points
used to determine the position of a digital model,
or part thereof, relative to another digital model, ~
or part thereof.”

The juxtaposition of this construction with the
above-mentioned construction of “reference
point” in the context of the ’661 patent reveals
that, in this situation, “3Shape cannot propose a
different construction for the same term of a
patent family.” (COMBr. at 14.). For the
reasons stated above, 3Shape is mistaken that the
new matter added to the ’661 patent expressly
justifies restricting “reference point” to a
location on a “stable anatomical structure” in the
context of the ’661 patent, while restricting the
location of the nearly identical term “reference
points” to “on the tooth surface” in the context
of the °647 patent.

Page 27 of 79

APPENDIX A to ORDER NO. 36
. Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

Moreover, as discussed above, not only is the
misalignment of 3Shape’s constructions for
nearly identical claim terms unjustified, an
examination of each construction in isolation
reveals that the corresponding specification does
not support the narrowness of 3Shape’s proposed
construction. In both cases, it appears that
3Shape is trying not to hew to the intrinsic
evidence, but instead to manufacture non-
infringement arguments.

“iteratively
' minimizing error”

Plain and ordinary
meaning, which is
“repeating a process
to minimize the

distance” ‘

“repeatedly
minimizing, until a
criteria is met, the
sum of distances”

“repeating a
process to
minimize the error
until the error is
less than a
termination criteria
or a maximum
number of
iterations has been
reached”

For constructions of this term, Align and 3Shape
each attempted to read in limitations from a
single, disclosed embodiment. See Liebel-
Flarsheim Co. v. Medrad, Inc., 358 F.3d 898,
913 (Fed. Cir. 2004) (“[I]t is improper to read
limitations from a preferred embodiment
described in the specification—even if it is the
only embodiment—into the claims absent a clear
indication in the intrinsic record that the patentee
intended the claims to be so limited.”). Align
attempted to limit the claimed “error” to a
“distance.” (COMBr. at 27-28.). 3Shape on the
other hand attempted to import a particular
metric for measuring error, namely “a sum of
distances.” (ROMBr. at 17.). For the reasons

Page 28 of 79

APPENDIX A to ORDER NO. 36

. Markman Order
Inv. No. 337-TA-1144
Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted :
Construed Construction Construction Construction Support for Construction

explained below, neither construction comports
with the intrinsic evidence.

The specification of the °647 patent discloses
what Align describes as an “exemplary
embodiment” teaching “iteratively minimizing
error.” (COMBr. at 27.). That embodiment is
described as follows: “Referring onto FIG. 4,
the matching of the original teeth data with the
current teeth data of box 206.is detailed. In FIG.
4, the process approximates the current
positioning of the current teeth (300). Next, the -
process (304) is iterated for each tooth in 302.
The process 304 creates sample points Pi on the
current tooth crown surface (306). Next, it finds
the corresponding closet point Qi for each Pi on
the original tooth crown surface (308). The
process then calculates an error of value in this
case, the error value is computed as the sum of
the distance between Pi and Qi (310). The
process then computes a rigid transformation
between two teeth that minimizes the error
(312). The current tooth is then repositioned with
the transform (314). The process of FIG. 4 is
repeated until an error value is less than a
predetermined termination criterion or the
number of iterations exceeds a predetermined

Page 29 of 79

value (316). Finally, the process provides a

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Y

| ‘Claim Terms to Be’
;Construed =~

‘Align’s Proposed -3Shape’s Proposed ' Adopted .

Construction Construction Construction

Support for Construction:

»

visual report of the deviation (318).” (JXM-
0001 (°647 patent) at 5:45-61; see also id. at
5:62-6:14.).

According to Align, the “parties appear to agree
that ‘iteratively’ means repeating a process to
minimize the error.” (CRMBr. at 9.). We are in
agreement. Moreover, Align is correct that
“iteratively minimizing error” does not require a
specific iterative method, but only that the
iteration minimize the error between two
corresponding reference points to match the
teeth. (COMBr. at 28.). As shown below in
Figure-4 of the ’647 patent, and as described in a
corresponding portion of the specification, “[t]he
above steps are iterated until the error is less
than termination criteria or a maximum number
of iteration is reached.” (JXM-0001 (°647
patent) at 6:11-13, Fig. 4.).

Page 30 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted

Construed Construction Construction Construction Support for Construction

Approximate positioning of current teeth
300

Create sample points P; on
the current tooth crown surface

=

Find closest point Q; of
each P; on original tooth crown surface

. | i

Calculate error = sum{ P; - Q;)
30

*

Compute the rigid form Tx b two teeth
that minimizes the square sum of the error

$

Reposition the current tooth with Tx
a4

oc
Until error < termination criterion
a or iteration times>specified value
316.
=

:
Visualize the deviation
318

FIG. 4

Page 31 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed |

Construction

Adopted
Construction

Support for Construction

The claims of the °647 patent do not require a
specific error calculation. (See, e.g., id., cl. 1
(“iteratively minimizing error between
corresponding reference points on corresponding
dental objects”).). Nowhere does the
specification commit to a particular error
calculation, such as “minimizing the distance” or
“minimizing ... the sum of distances.” By
contrast, Figure 8 discloses a variety of ways to
“specify[] an error reference (420),” including

“translation, rotation, move dist, deviation[.]”

(id. at Fig. 8.). Rotation presumably entails a
measurement in degrees, not units of distance.

Therefore, the proper construction of “iteratively
minimizing error” set forth above retains the
agreed-upon concept of repeating a process to
minimize the error while omitting, and rejecting,
the Parties’ attempts to confine the term to a
particular type of error calculation.

“matching the
subsequent digital
model as a whole with
the initial digital
model”

No construction
necessary

If the ALJ believes
construction is
necessary, the proper
construction is plain

“superimposing in its
entirety the second
digital model after

some dental
treatment with the
first digital model

“determining the
position of the
subsequent digital
model as a whole
‘relative to the
initial digital
model”

According to Align, this term requires no
construction because it is clear and has a plain
meaning understood by those skilled in the art.
(COMBr. at 29.). In the alternative, Align
proposed construing this term as “matching the
jaw of the subsequent digital model with the
initial digital model.” (/d.). In rebuttal, 3Shape

Page 32 of 79 »

APPENDIX A to ORDER NO. 36

Markman Order
Inv. No. 337-TA-1144
Claim Terms to Be Align’s Proposed | .3Shape’s Proposed Adopted ;
Construed Construction Construction Construction Support for Construction
and ordinary before treatment is argued that Align’s proposed construction fails

meaning, which is
“matching the jaw of
. the subsequent
digital model with
the initial digital
model”

complete.”

to address the meaning of “matching/match,”
specify that the “matching” occurs after a dental
treatment, and recognize that this second jaw-
matching step means
superimpose/superimposing” entire models, “a
more specific type of positioning” than the
“nositioning/position” purportedly used in the
context of the first matching step (individual
matching of teeth). (ROMBr. at 12.).

As an initial matter, a construction of the
limitation “matching the subsequent digital
model as a whole with the initial digital model”
is necessary because Align and 3Shape dispute
the term’s meaning. O2 Micro Intern., 521 F.3d
at 1360.

A close examination of the intrinsic evidence
reveals that 3Shape’s arguments have little merit
with one notable exception: a construction of
“matching” is warranted. While generally
consistent with the intrinsic evidence, Align’s
proposed construction is flawed insofar as it

Page 33 of 79

lacks a description of “matching” and fails to

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

clarify that the second matching step (jaw’
matching) involves the matching of at least the
subsequent digital model as a whole with (all or
part of) the initial digital model.

Align is correct that “3Shape’s construction
attempts to inject yet another definition for
‘matching’ into the claims[.]” (CRMBr. at 10.).
In particular, while 3Shape construed
“matching” as “positioning” in the context of the
first matching step (tooth by tooth matching)
addressed above, here 3Shape construed
“matching” as “superimposing.” This sort of
claim construction inconsistency is disfavored.
Rexnord Corp. v. Laitram Corp., 274 F.3d 1336,
1342 (Fed. Cir. 2001) (“[A] claim term should
be construed consistently with its appearance in
other places in the same claim or in other claims

| of the same patent.”); Phonometrics, Inc. v.

Northern Telecom Inc., 133 F.3d 1459, 1465

| (Fed. Cir. 1998) (“A word or phrase used

consistently through a claim should be
interpreted consistently.”).

4 As Align noted, “[t]he ‘jaw’ is easily understood as the upper or lower teeth of the patient’s dentition.” (CRMBr. at 12 (citing 3:24-58, Figs, 1, 2A).). The
specification explains that “jaws” can refer to both the upper and lower jaws together, while “jaw” can refer to either the upper or lower jaw.” (JXM-0001 (°647
patent) at 3:27-32 (“The upper jaw bone 22 is associated with an upper jaw 101, while the lower jaw bone 20 is associated with a lower jaw 100. A computer
model of the jaws 100 and 101 is generated, and a computer simulation models interactions among the teeth on the jaws 100 and 101.”).).

Page 34 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

Additionally, 3Shape’s proposed construction of
“matching” finds no support in the intrinsic
record. The term “superimposing” is mentioned
only twice in the specification and only in the
background of the invention. (JKM-0001 (647
patent) at 2:19-25.). “Superimposed” is used
once in the specification, but only in the context
of the first matching step, not the second
matching step addressed here. (JXM-0001 (°647
patent) at 7:44-48 (“The search algorithm finds
the relative position of the teeth by minimizing
the distance between two superimposed teeth.
The matching process is completed throughout
the entire teeth of a jaw.”).). .

Consequently, 3Shape has provided little
justification for adopting fundamentally different
“matching” constructions (positioning v.
superimposing) for the first and second matching
steps. As explained above, in the context of the
first matching step, the adopted construction of
the “matching/match” limitation was “using
identified reference points to determine the
position of a tooth in the first computer model
relative to the corresponding tooth in the second
computer model.” Consistent with this
construction, in the context of the second

Page 35 of 79

APPENDIX A to ORDER NO. 36
Markman Order’
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

matching step of the ’647 patent, the “matching”
limitation is properly construed as “determining

the position of the subsequent digital model as a

whole relative to the initial digital model.” The

‘| specification provides explicit support for

synchronizing constructions of the “matching”
limitations, with slight modifications to account
for distinct claim language used in each
limitation, by explaining that the first
“matching” step “provides a foundation for” the
second matching step. (See id. at 7:51-53 (“This
teeth matching provides a foundation for jaw
matching so that each new tooth position can be
represented relative to the original tooth
position.”).).

That said, the adopted constructions for the first
and second matching steps are not identical. The

| term “reference point(s)” is not included in the
| construction of the second “matching” step

because the second matching step in the

independent claims of the ’647 patent does not
explicitly require the use of “reference points.”
Moreover, as depicted below in Figure 3 of the

| °647 patent, the intrinsic evidence makes clear

that the second matching step entails matching
jaws at the model level, not at the level of

| “regions” of jaw models or individual teeth of

Page 36 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

jaw models as in the first matching step. (/d. at
2:43-45 (“Finding the position can include
placing two jaw impressions in a single
coordinate system; selecting a positioning ~
reference”); 5:11-12 (“the new jaw data is
positioned in the original coordinate system
(208).”)).). Nevertheless, the crux of matching
in the 647 patent—determining the position of
one thing relative to another—appears in both
adopted constructions, for the first and for the
second matching steps. -

Page 37 of 79

APPENDIX A to ORDER NO. 36

Markman Order
Inv. No. 337-TA-1144
Claim Terms to Be i Align’s Proposed | 3Shape’s Proposed | Adopted : :
" Construed . _., Construction Construction — Construction Support for Construction

X

Load original treatment case

+

Load current jaw impression

204

é

Matching. original teeth with
current teeth
206

i

Position the new jaw model
in the original coordinate
system

T

Compare original jaw model
and the new jaw model
210

j

- 200

¥

y

Report analysis
result
220

Create MCC ADF
230

Visualize
discrepancy

FIG. 3

‘Finally, language in 3Shape’s proposed
_construction pertaining to the timing of the

Page 38 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
‘Construction

Support for Construction

second matching step is unnecessary. The claim
language already confirms that the second
matching step occurs after a dental treatment.
For example, claim 1 of the ’647 patent requires
“providing a subsequent digital model of the set
of dental objects in their moved positions after at
least some of them have been moved by the
dental treatment.” MEMS, 447 F. App’x at 151
(constructions which introduce redundancy are
“disfavored”). This interpretation finds
additional support in the specification. (JXM-
0001 (°647 patent) at 7:34-36 (“[t]he above
described system matches two different
impressions of a patient, one before treatment
and one after treatment.”).).

Moreover, there is no support in the intrinsic
evidence for 3Shape’s proposed limitation that
the second matching step occur before treatment
is complete. The claims are directed to ©
“determining/determine” the progress of a dental
treatment, but are not limited to any point in time
regarding the progress of the dental treatment,
e.g., “before treatment is complete.” Here, it

| appears that 3Shape is trying to manufacture

from attorney argument a non-infringement
position that finds no support in the patent.
(ROMBr. at 21.).

Page 39 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

Finally, as Align has requested, clarification is
appropriate with respect to the term “as a
whole.” (CRMBr. at 12 (“Align would not
object to a minimal clarifying construction”).).
According to Align, “because the subsequent
and initial digital models are of the same patient
dentition, Align’s proposed construction is easily
understood as matching the ‘jaw” (upper or
lower) of both models.’” (/d. (emphasis added)).
3Shape appeared to disagree, asserting that “the
°647 patent claims require that the two digital
models are matched ‘as a whole’” and “[t]he
°647 patent specification explains this means the
entire jaw is matched.” (ROMBr. at 21.).

On this issue, Align prevails in part. Contrary to
3Shape’s position, the claims require the
performance of the second matching step on “the
subsequent digital model as a whole,” not the jaw
as a whole. Claim 1 of the ’647 patent clarifies
that the subsequent digital model, like the initial
digital model, pertains to a “set of dental objects”
and not necessarily to all of the dental objects
available to scan in a particular mouth. (JXM-
0001 (647 patent), cl. 1.). The matching steps
build upon the claimed models. (/d.). Thus, claim
1 does not require the performance of the first and

Page 40 of 79

r

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction

Adopted
Construction

Support for Construction

second matching steps on an entire set of teeth
available in a particular set of jaws or even all
teeth available in an upper jaw or a lower jaw.

That said, the express language of claim 1
requires that, for the second matching step, at
least the whole of the subsequent digital model be
matched with the initial digital model. (/d.).
Importantly, the inverse is not explicitly
required—that is, matching the whole of the
initial digital model with the subsequent digital
model. (/d.). This interpretation is consistent
with the claimed first matching step, which
requires “individually matching each of the dental
objects in the subsequent digital model with a
dental object in the initial digital model,” not the
inverse. (/d.). These distinctions suggest that
claim 1 of the °647 patent could read on a scenario
where the subsequent digital model is less
comprehensive than the initial digital model in
terms of dental objects modeled, so long as the
initial digital model contains all the dental objects
found in the subsequent digital model. In other
words, claim 1 appears broader than the scenario
envisioned by Align, where “subsequent and
initial digital models are of the same patient
dentition.” (CRMBr. at 12.).

Page 41 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Construction. Support for Construction
“dental object” / _ 09 / «6 9
“dental objects” Agreed: “tooth” / teeth’ n/a
“approximately
matching/match each Agreed: “initially aligning/align each set of corresponding nia
set of corresponding teeth”
dental objects”
“statistical filtering” Agreed: “teeth with small standard error as reference teeth” n/a
“sum of the «“ : ”
differences” Agreed: “sum of the distances n/a
“planned positions” Agreed: “target positions” n/a
4. U.S. PATENT NO. 8,102,538
Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Construction. . Support for Construction
Plain and ordinary means-plus-function Align asserted that “optical scanner” was not

“optical scanner”

meaning, which is “a
device that uses light
projection and image
capture for scanning”

Alternatively, if
subject to 112, 6th :

term subject to
construction under
35 USC. § 112, 96

structure: “confocal
' optical system,
including one or
more lasers and an

image sensor for

Not subject to §
112, 6.

“a device that uses
light projection to
capture data other
than color image
data”

subject to § 112, J 6 treatment and instead
possessed a broad meaning: “a device that uses
light projection and image capture for
scanning.” (COMBr. at 38.). According to
3Shape, “[t]he term ‘optical scanner’ fails to
connote sufficient structure to a person of
ordinary skill in the art, and as such, should be
interpreted to be limited to the structures

‘disclosed in the specification for performing the

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APPENDIX A to ORDER NO. 36
' Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Construction Support for Construction
“providing depth receiving returned claimed function.” (ROMBr. at 55.). As
data of the portion light through a explained below, the proper construction of
corresponding to a spatial filter” “optical scanner” is a modified version of
two-dimensional function: providing Align’s construction that accounts for
reference array depth data of the statements of claim scope disavowal made by
substantially portion . the patentee during the prosecution of a related
orthogonal to a depth patent.
direction” If the term is not
found to be means- The first order of business is determining
Structure: plus-function, then: whether § 112, § 6 applies. There is a

“a probing member,
a light source for
providing arrayed
illumination along

said depth direction;

light focusing optics
defining one or more
focal planes forward
said probing member
at a position
changeable by said
optics; a translation
mechanism for
displacing said focal
plane relative to the
structure along the
depth direction; an
image sensor for

“laser confocal
scanner, operating
separately from an

imaging means”

presumption against treating this claim term,
which does not recite the word “means,” as a
means-plus-function term. Williamson v. Citrix
Online LLC, 792 F.3d 1339, 1348 (Fed. Cir.
2015) (“the failure to use the word ‘means’...
creates a rebuttable presumption . . . that § 112,
[{]] 6 does not apply.”). 3Shape bears the -
burden of overcoming that presumption. Jd.

To escape § 112, J 6 treatment, “optical
scanner” need only convey to one of ordinary
skill in the art a variety of structures
encompassed by that term. Personalized Media
Commc’ns, LLC v. Int’l Trade Comm’n, 161
F.3d 696, 703 (Fed. Cir. 1998) (“Even though
the term ‘detector’ does not specifically evoke a
particular structure, it does convey to one
knowledgeable in the art a variety of structures

Page 43 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be
Construed

Align’s Proposed
Construction

3Shape’s Proposed
Construction _

Adopted
Construction

Support for Construction

measuring intensity
of light returning
from the portion of
the three-
dimensional
structure; and a
processor coupled to
the image sensor for
determining for each
region of the three-
dimensional structure
an in-focus position,
and based on the
determined in-focus
positions, generating
data representative of
the topology of said
portion or
equivalents thereof”
See, e.g., °538 patent
at 5:17-44, 12:60-
13:5.

299

known as ‘detectors.’”). Moreover, “a term
need not connote a precise physical structure in
order to avoid the ambit of” § 112, 6. CCS
Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359,
1370 (Fed. Cir. 2002); Watts v. XL Sys., Inc.,
232 F.3d 877, 880 (Fed. Cir. 2000). As set forth
below, 3Shape failed to carry its burden of
showing that the “optical scanner” limitation
lacked “sufficiently definite structure’ or else
recites ‘function without reciting sufficient
structure for performing that function.’”
Williamson, 792 F.3d at 1348.

3Shape is correct that, when viewed in isolation,
claim 1 of the ’538 patent identifies the function
of “optical scanner” without revealing much
corresponding structure. (ROMBr. at 56.).
Specifically, claim 1 requires an “optical
scanner configured for providing depth data of
the portion corresponding to a two-dimensional
reference array substantially orthogonal to a
depth direction[.]” (JXM-0003 (°538 patent),
cl. 1.).

However, when read within the context of the
°538 patent specification, “optical scanner”
possesses a Clear structural identity.
Specifically, the °538 patent references several

Page 44 of 79

_ APPENDIX A to ORDER NO. 36

_ Markman Order ‘
Inv. No. 337-TA-1144
Claim Terms to Be Align’s Proposed 3Shape’s Proposed Adopted .
Construed Construction Construction Construction Support for Construction

prior art 3D scanners. (/d. at 1:25-2:40 (“Many
methods have been developed for obtaining the
three dimensional location of surface points of
an object, for a host of applications including,
inter alia, the intraoral cavity. ... Such systems -
typically include an optical probe coupled to an
optical pick-up or receiver such as charge
coupled device (CCD) and a processor
implementing a suitable image processing
technique to design and fabricate virtually the
desired product. Such methods include, for
example, confocal imaging techniques as
described in WO 00/08415 assigned to the

_present assignee. These methods provide a
digital three-dimensional surface model that is
‘inherently monochromatic, i.e., no color

| information is obtained in the imaging

process.”).). Notably, against this prior art
backdrop, the °538 patent explains that “any
suitable means for providing 3D scanning can
be used so long as the 3D scan and the color 2D.
scan correspond substantially to the same object
or portion thereof being scanned, and the same
frames of references are maintained.” (/d. at
25:7-16.)

In addition to referencing the prior art, the 538
patent explicitly discloses embodiments of the

Page 45 of 79

APPENDIX A to ORDER NO. 36

Markman Order
Inv. No. 337-TA-1144
Claim Terms to Be — . Align’s Proposed | 3Shape’s Proposed | Adopted - . 3.
Construed <— Construction ~ Construction Construction Support for Construction

invention with “optical scanner” structural

| components. (See, e.g., id. at 5:16-6:9.). For

example, Figures 4A and 4B of the *538 patent
shown below “schematically illustrate the main
elements of a portion of the invention used for
providing a three dimensional monochrome
entity,” which is the function of the claimed
“optical scanner.” (Jd. at 12:21-23.).

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Page 46 of 79

APPENDIX A to ORDER NO. 36
Markman Order
Inv. No. 337-TA-1144

Claim Terms to Be Align’s Proposed 3Shape’s Proposed — Adopted Support for Construction
Construed Construction Construction Construction PP
AB
IMAGE CAPTURE|__-80
DEVICE
8B
| f TO
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FIG. 4B

Based on the discussion above, the ’538 patent
appears to disclose an adequate structure for the
claimed “optical scanner configured for
providing depth data of the portion
corresponding to a two-dimensional reference
array substantially orthogonal to a depth
direction[.]” This structural detail distinguishes
the case cited by 3Shape in support of applying
§ 112,96. In that case, there was no record
evidence that the limitation at issue, “lever
moving element,” had “a known structure in the

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lock art.” Mas-Hamilton Group v. LaGard,
Inc., 156 F. 3d 1206, 1213-1214 (Fed. Cir.
1998). Consequently, the term could cover
“any device that can cause the lever to move.”
(Id.). Here, by contrast, the specification of the
°538 patent confirms that “optical scanner” had
a known structure in the prior art. (IXM-0003
(°538 patent) at 1:25-2:40.).

3Shape next argued that “prosecution history of
the application leading to the ’538 patent further
confirms that the term ‘optical scanner’ should
be construed as a means-plus-function term.”
(ROMBr. at 56.). 3Shape’s primary argument
here is that “optical scanner” should receive §
112, J 6 treatment because claim 1 of the 538
patent was originally claimed in a means-plus-
function format. (See JXM-0008 (538 patent
prosecution history) at 175.). ;

However, there is little factual or legal support
for 3Shape’s position that amending claim 1 to
remove the word “means” amounted to a .
disavowal of claim scope. The amendment was
not based on a rejection or otherwise offered to
traverse prior art. (Jd. at 149.). Instead, the
amendment was made post-allowance and had
the effect of broadening, not narrowing, claim

3Shape’s Proposed Adopted
Construction Construction
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scope. (/d. at 149, 175.).. See, e.g., Interactive
Pictures Corp. v. Infinite Pictures, Inc., 44 274
F.3d 1371, 1378 (Fed. Cir. 2001) (“[T]he
amendment was not made for a ‘substantial
reason related to patentability’ and thus does not
create prosecution history estoppel.”);
TurboCare Div. of Demag Delaval
Turbomachinery Corp. v. Gen. Elec. Co., 264
F.3d 1111, 1126 (Fed. Cir. 2001). :

For the above reasons, § 112, J 6 does not apply
to the term “optical scanner.”

3Shape next argued that the Court should adopt
a construction that limits “optical scanner” to a
“laser confocal scanner” that “operat[es]
separately from an imaging means.” (ROMBr.
at 54.). Align, as mentioned above, offered a

99, 66

‘broad construction of “optical scanner”: “a

device that uses light projection and image
capture for scanning.” (COMBr. at 38.).

A claim term, such as “optical scanner,” is
ordinarily accorded its plain and ordinary
meaning. Hill-Rom Servs. v. Stryker Corp., 755
F.3d 1367, 1371 (Fed. Cir. 2014). “There are
only two exceptions to this general rule: 1)
when a patentee sets out a definition and acts as

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his own lexicographer or 2) when the patentee
disavows the full scope of the claim term either
in the specification or during prosecution.” Jd. ;
see also. Thorner v. Sony Computer
Entertainment America LLC, 669 F.3d 1362,
1367 (Fed. Cir. 2012) (“The patentee is free to
choose a broad term and expect to obtain the
full scope of its plain and ordinary meaning
unless the patentee explicitly redefines the term
or disavows its full scope.”).

3Shape argued that Align could not claim a
broad “optical scanner” because the patentee
disavowed such claim scope in the prosecution
history. In particular, during prosecution of an
earlier patent application in the 538 patent
family,° in response to a rejection, the patentee
amended a claim to overcome the Mueller prior
art reference (U.S. Patent No. 7,098,435).
(RXM-0010 (°829 patent file history) at 127,
158.). The patentee’s amendment was limited
to the addition of the following language:
“processing means for associating said color
data with said depth data for corresponding data

> That application issued as U.S. Patent No. 7,511,829 (“the ’829 patent”). The ’829 patent and 538 patent have the same sole inventor, Noam Babayoff, and
specification. (See, generally, JXM-0003 (’538 patent); RXM-0010 (829 patent file history).). Both patents also claim priority to the same provisional

application. (See id.).

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points of said reference array.” (/d. at 158.). As
the patentee explained, in the pending claim,
“depth data is obtained independently of the
colour data, and the two sets of data are
combined by conformally mapping or
associating the colour data with the depth data
for a given two-dimensional array of points.”
(Ud. at 170-72.). In Mueller, obtaining depth
data was not independent of obtaining color
data. (/d. at 171-72.). Instead, Mueller taught
processing multiple 2D color images taken from
different angles of displacement to create 3D
surface models. (/d. at 238 (“Mueller discloses
using the color information from a series of two
dimensional color images to drive the three
dimensional location in space of the surface
points which produced the color images”).).
Thus, according to the patentee, Mueller lacked
(and even taught away from) the extra
processing step of combining independently-
obtained depth and color data. (/d. at 171.).
The examiner agreed. (/d. at 237.).

The critical issue here is whether the patentee
disavowed scope of “optical scanner” during
prosecution of the related ’829 patent.
According to 3Shape, Align did clearly disavow
claim scope and is now trying to “claim a

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Construed

generic 3D scanner, without acknowledging the
distinctions the patentee [drew] to overcome the
prior art — that the claimed invention captures a
color 3D scan through two systems: one for 3D
depth and one for 2D color.” (RRMBr. at 25.).

3Shape’s concern in this regard is warranted.
Mueller is cited as prior art in the °538 patent
and thus presumably was considered by the
examiner during prosecution of the *538 patent,
just as it was considered during the prosecution
of the ’829 patent (indeed the same examiner
oversaw both prosecutions). (See, generally,
JXM-0003 (°538 patent); RXM-0010 (829
patent file history).). Yet, the treatment of
Mueller was inconsistent across the prosecution
histories of the ’829 and °538 patents. During
the prosecution of the ’829 patent, Mueller was
cited as invalidating prior art. (RXM-0010
(’829 patent file history) at 127.). However,
during the relatively uneventful prosecution of
the °538 patent (claims rejected only once based
on double patenting), Mueller was not cited as
invalidating prior art. (See, generally, JXM-
0008 (°538 patent file history).). This was the
case even though at least one claim pending
during prosecution of the ’829 patent (and
eventually amended as explained above to

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overcome Mueller) was nearly identical to
issued claim 1 of the ’538 patent. (RXM-0010
(°829 patent file history) at 56; JXM-0003
(538 patent), cl. 1.). Indeed, the former was
arguably narrower than the latter insofar as the
former recited “optical scanning means” in
place of “optical scanner.” (/d.)

Consequently, statements of claim scope
disavowal made to overcome Mueller during the
prosecution of the 829 patent are applicable
here in the context of the °529 patent. In
particular, as the patentee explained during the
prosecution of the ’829 patent, “depth data is
obtained independently of the colour data[.]”
(RXM-0010 (°829 patent file history) at 170.).
The Abstract of the °538 patent echoes the
consequences of this arrangement, explaining
that “[a] processor combines the color data and
depth data for each point in the array, thereby
providing a three-dimensional color virtual
model of the surface of the structure.” (JXM-
0003 (°538 patent) at Abstract.).

However, this critical concept of depth and
color data independence does not explicitly
appear in claim 1.of the 538 patent. In other
words, claim | could in theory read on a device

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with an “optical scanner” and separate “imaging
means,” where the former collects depth and
color data and never combines that data with 2D
imaging data provided by the imaging means to
create a 3D color model. That possibility poses
a problem for Align’s claim construction.

The adopted construction of “optical scanner” is
an opportunity to set the record straight. To
prevent the patentee from recapturing claim
scope disavowed during prosecution, “optical
scanner” is construed as “a device that uses light
projection to capture data other than-color
image data.” Specifying that the “optical
scanner” does not capture color image data
effectively restores the depth and color data
independence touted by the patentee and used
by the patentee to overcome Mueller.

However, 3Shape’s additional arguments with.
respect to the narrowing of “optical scanner” are
without merit. They amount to attempts to limit
the claims to preferred embodiments. SanDisk
Corp. v. Memorex Prods., Inc., 415 F.3d 1278,
1286 (Fed. Cir. 2005) (“[r]eferences to a
preferred embodiment, such as those often
present in a specification, are not claim
limitations.”) (quoting Laitram Corp. v.

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Cambridge Wire Cloth Co., 863 F.2d 855, 865
(Fed. Cir. 1988)); Gillette Co. v. Energizer
Holdings, Inc., 405 F.3d 1367, 1374 (Fed. Cir.
2005) (cautioning against “limiting the claimed
\|| invention to preferred embodiments or specific
examples in the specification.”) (quoting Texas
Instruments, Inc. v. U.S. Int’l Trade Comm’n,
805 F.2d 1558, 1563 (Fed. Cir. 1986)).

For example, pursuant to the doctrine of claim
differentiation, the claimed “optical scanner” is
not limited to a “confocal” technique because
claim 2 of the ’538 patent specifically recites
that “the operation of the optical scanner is
based on confocal imaging techniques.” See
SRI Int'l v. Matsushita Elec. Corp. of Am., 775
F.2d 1107, 1122 (Fed. Cir. 1985) (en banc) (“It
is-settled law that when a patent claim does not
contain a certain limitation and another claim
does, that limitation cannot be read into the
former claim term in determining either validity
or infringement.”); see also Phillips v. AWH
Corp., 415 F.3d 1303, 1314-15 (Fed. Cir. 2005)
(“For example, the presence of a dependent
claim that adds a particular limitation gives rise
to a presumption that the limitation in question
is not present in the independent claim.”).

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Construed

Moreover, as discussed above, the specification
describes a variety of prior art optical scanners,
including those using confocal and non-
confocal imaging techniques. (JXM-0003 (538
patent) at 1:18-2:37.). The *538 patent does not
limit itself to laser or confocal scanners and
instead teaches that “any suitable means for
providing 3D scanning can be used so long as
the 3D scan and the color 2D scan correspond
substantially to the same object or portion
thereof being scanned, and the same frames of
references are maintained.” (/d. at 25:11-14;
see also id. at 4:32-35 (“the device of the
invention provides advantages over
monochrome 3D scanners, including [but not
limited to] such scanners that are based on
confocal focusing techniques.”).).

Finally, in claim 1 of the ’538 patent, there is no
requirement that the “optical scanner” operate
“separately” from the “imaging means.”
(RRMBr. at 27.). According to Align, this
purported requirement advanced by 3Shape
amounts to an assertion that the “optical
scanner” and “imaging means” must operate at
different times—i.e., acquire depth data and
color image data at different times. (CRMBr. at
38.). Yet, in direct contravention of 3Shape’s

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construction, the ’538 patent contemplates
concurrent, or at least overlapping, operation of
the “optical scanner” and “imaging means.”
(JIXM-0003 (538 patent) at 21:55-57 (“a set of >
[color] images is taken (concurrently with or
alternately with the depth scan)”), 21:46-47
(“one or more color scans may also be taken
during the depth scan”’).).

The ’538 patent also teaches using some of the
same components for both the optical scanner
and color imaging means. (See, e.g., id. at
17:27-31 (“In particular such operations include
the transmission of the illuminating radiation for
the confocal focusing operations, and also the
transmission of reflected light from the object
26 to the main optics 41 to provide the 3D entity
or the 2D color entity.”), 19:44-48 (“red laser is
used as the illumination source 31 for the main
optics 41 when creating the 3D entity. As such,
and as in other embodiments, this illumination
means is also used to obtain the red
monochromatic image for the creation of the 2D
color image.”), 24:13-14 (“Alternatively, the
CCD of the detection optics 60 is a color CCD
and is also used for the 2D scan.”).). These
disclosures eviscerate 3Shape’s separateness
argument. ~

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Consequently, based on discussion above, the
proper construction of “optical scanner” is a
modified version of Align’s construction that
accounts for statements of the claim scope
disavowal (and corresponding amendment)
made by the patentee during the prosecution of
a nearly identical claim in a related patent.
Subject to 112, 6th 4: | means-plus-function | Subject to 112,96. | Align and 3Shape agree that “imaging means”
term is subject to 35 U.S.C. § 112, 6. (COMBr. at
Function: subject to” Function: 53; ROMBr. at 66.). They also agree that the
“providing two- construction under “providing two- specification of the °538 patent discloses two

“imaging means”

dimensional color
image data of the
portion associated
with the reference
array”

Structure:
“white illumination
and a color image
sensor (e.g., a color
CCD) for detecting
intensity of the white
illuminating
radiation after
reflection from the

35 USC. § 112, 6

structure:
(1) one or more light
sources sequentially
illuminating the 3D
structure with three
or more different
colored
illuminations, optics,
and an
image sensor; OR
(2) a white light
source, separate from

dimensional color —

image data of the
portion associated

- with the reference

array”

Structure:
“white illumination,
optics, and a color
image sensor (e.g., a
color CCD) for
detecting intensity
of the white
illuminating
radiation after

categories of associated structures for
performing the function of “providing two-
dimensional color image data,” one directed to
using white light illumination and the other
directed to individual color illumination applied
in sequence. (/d.).

However, Align and 3Shape disagree on the
contours of these illumination categories. Align
proposed relatively broad categories. 3Shape
took the opposite approach. For example, in the
context of the sequential color illumination
category, 3Shape’s construction required that
the light illuminate “the 3D structure” and
consist of “three or more different colored

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portion; or sequential | and in addition to the | reflection from the | illuminations.” (ROMBr. at 66.). In the context
monochromatic light source of the portion; or of the white light illumination category,
illumination (e.g., optical scanner, sequential 3Shape’s construction required that the white
RGB) and an image | optics, and an image monochromatic light source be “separate from and in addition to

sensor (e.g., a CCD)
for detecting
intensity of the
monochromatic
illuminating
radiation after
reflection from the
portion; or
equivalents thereof”
See, e.g., 538 patent
at 6:26- 31, 6:31-36,
6:36-38, 6:49-53,
7:29-33, 7:35-40,
7:41-43, 7:43-48,
7:48-53, 7:57-59,
7:60-8:1, 8:6-8, 8:9-
20, 13:8- 13:13,
13:33-38, 13:38-42,
16:33-41, 16:41-47,
17:12-15, 17:15-19,
17:20-23, 17:23-25,
17:61-64, 17:64-66,

- 18:21-30, 18:30-33;

18:41-51, 19:3-6,

sensor

function: providing
two-dimensional
color image data

illumination (e.g.,
RGB), optics, and
an image sensor
(e.g., a CCD) for
detecting intensity
of the
monochromatic
illuminating

radiation after —
reflection from the
portion; or
equivalents thereof”

°538 patent at 6:26-
31, 6:31-36, 6:36-
38, 6:49-53, 7:29-
33, 7:35-40, 7:41-
43, 7:43-48, 7:48-
53, 7:57-59, 7:60-
8:1, 8:6-8, 8:9-20,
13:8- 13:13, 13:33-
38, 13:38-42, 16:33-
41, 16:41-47, 17:12-
15, 17:15-19, 17:20-

the light source of the optical scanner.” (/d.).

Unlike Align, 3Shape failed to cite to portions
of the ’538 patent specification that discloses
specific structure for the two illumination
categories. (/d.).

3Shape’s construction also required that the
corresponding structure include “optics.” (/d.).
By contrast, Align’s construction does not

| include “optics” as a requirement but

nevertheless cites to specific structure
(including optics) in the specification.
(COMBr. at 53.). -

Aside from the omission of “optics,” Align’s §
112, § 6 construction hews to the intrinsic
evidence. For the reasons set forth below,
3Align’s construction is adopted with the
addition of “optics” as required structure.

Construing a means-plus-function claim term is
a two-step process. The court must first identify
the claimed function. Noah Sys., Inc. v. Intuit

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19:6-14, 19:44-51,
19:51-55, 19:55-58,
19:58-61, 19:61-65,
20:19-46, 20:46-49,
20:55-64, 22:6-14,
22:28-33, 22:34-41,
23:8-14, 23:32-37,
23:43-46, 23:46-52,
24:3-7, 24:13-14,
24:23-29, 24:33-36,
24:36-39, 24:39-41.

23, 17:23-25, 17:61-

| 64, 17:64-66, 18:21-

30, 18:30-33; 18:41-
51, 19:3-6, 19:6-14,
19:44-51, 19:51-55,
19:55-58, 19:58-61,
19:61-65, 20:19-46,
20:46-49, 20:55-64,
22:6-14, 22:28-33,
22:34-41, 23:8-14,
23:32-37, 23:43-46,
23:46-52, 24:3-7,
24:13-14, 24:23-29,
24:33-36, 24:36-39,
24:39-41, including
figures cited therein.

Inc., 675 F.3d 1302, 1311 (Fed. Cir. 2012).
Then, the court must determine what structure,
if any, disclosed in the specification
corresponds to the claimed function.
Williamson, 792 F.3d at 1352. “Structure
disclosed in the specification qualifies as
‘corresponding structure’ if the intrinsic
evidence clearly links or associates that
structure to the function recited in the claim.”
Id. (citing Noah Sys., 675 F.3d at 1311).

Align and 3Shape did not agree on the entirety
of the claimed function. According to 3Shape,
the claimed function was only “providing two-
dimensional color image data.” (ROMBr. at 66-
67.). According to Align, quoting verbatim
from the asserted claims of the ’538 patent,
3Shape’s claimed function was incomplete and

should included the qualifying phrase: “of the

portion associated with the reference array.”
(COMBr. at 53-54.). According to 3Shape, this
qualifying phrase “merely describes the
characteristics of the ‘two-dimensional color
image data’ and does not describe the claimed
function and, as such, 3Shape’s proposed
construction more concisely reflects the claimed
function.” (ROMBr. at 67.). Yet, as 3Shape
noted, “[d]espite these differences in the parties’

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identified functions, the difference does not
appear to be a material one.” (/d.). For the sake
of adhering to the verbatim claim language
provided by the patentee in describing the metes
and bounds of the invention, this Order adopts
Align’s full version of the claimed function and
not 3Shape’s “concise” one. See In re Teles AG
Informationstechnologien, 747 F.3d 1357,
1367-68 (Fed. Cir. 2014) (“[t]he statute does not
permit limitation of a means-plus-function
claim by adopting a function different from that
explicitly recited in the claim’’) (citing Micro
Chem., Inc. v. Great Plains Chem. Co., 194
F.3d 1250, 1258 (Fed. Cir. 1999)).

Turning to corresponding structure, the intrinsic
evidence belies 3Shape’s attempt to import
narrowing limitations. As an initial matter, the
asserted claims require that “color image data”
collected via illumination relate to “the portion
associated with the reference array” identified in
the “optical scanner” limitation, not that light
illuminate “the 3D_ structure,” as 3Shape
asserted. (JXM-0003 (°538 patent), cl. 1.).

Additionally, disclosed embodiments of the
sequential color illumination category associated
with the “imaging means” do not require “three

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or more different colored illuminations,” as
3Shape contended. While the specification does
describe forming a color image from three or
more monochromatic light sources, there is no
requirement that the “imaging means” provide all
three light sources. (/d. at 26:35-40.). Instead,
the specification of the 538 patent discloses an
embodiment in which the “imaging means”
sequentially illuminates with only two different
colored illuminations while the “optical scanner”
provides a third colored illumination. (/d. at
6:49-53 (“[t]he color illumination means may
comprise second illumination means for
providing two said second illuminating
radiations, and wherein said first illumination
means provides another said second illuminating
radiation each said second illuminating radiation
being of a different color.”).). Thus, 3Shape’s
construction is rejected in this regard for failing
to include a disclosed embodiment. See Oatley
Co. v. IPS Corp., 514 F.3d 1271, 1276 (Fed. Cir.
2008) (“We normally do not interpret claim
terms in a way that excludes embodiments
disclosed in the specification.”).

Next, disclosed embodiments of the white light
illumination category associated with “imaging
means” do not require that the white light source

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be “separate from and in addition to the light
source of the optical scanner,” as 3Shape
contended. (/d.). The ’538 patent discloses an
embodiment that uses white light illumination for
collecting both depth data by the “optical
scanner” and color image data by the “imaging
means.” (See, e.g., JKM-0003 (538 patent) at
24:33-47 (describing the illumination source 31
of device 100 as “white light illumination
means” that may be used to “in order to provide
the 3D surface topology data.”).). | Thus,
3Shape’s construction is rejected in this regard
for failing to include a disclosed embodiment.
See Oatley Co. v. IPS Corp., 514 F.3d 1271, 1276
(Fed. Cir. 2008) (“We normally do not interpret
claim terms in a way that excludes embodiments
disclosed in the specification.”).

Finally, 3Shape . asserted that the required
structure included “optics.” (ROMBr. at 66.).
While Align omitted this term from its
construction, it appears that the corresponding
structure cited by Align invariably included
optics. (JXM-0003 (538 patent) at 13:35-38
(“The second illumination means may comprise
radiation transmission elements that are
configured to be located out of the path of said
light beams or said returned light beam at least

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within said light focusing optics.”) (emphasis
added), 16:41-47, 23:49-58, 24:48-52 (“In each
of the embodiments described herein, the
illumination radiation that is used for obtaining
the 2D color image is injected into the optical
axis OA of the confocal optics 42 without
affecting the operation thereof or degrading the
3D image capture.”) (emphasis added).). Thus,
optics is included as a structural requirement in
the adopted construction.

For the reasons explained above, Align’s
construction is adopted with the addition of
“optics” as required structure. -

“wherein the device
is configured for
‘maintaining a spatial
disposition with
respect to the portion
that is substantially
fixed during
operation of the
optical scanner and
the imaging means”

Plain and ordinary
meaning, which is “a
movable device
where the operation
by the optical
scanner and the
imaging means is at
least substantially or
effectively
simultaneous such
that movement (i.e.,
a change in spatial
disposition) can be

“wherein the device
is configured for
maintaining a spatial
disposition with
respect to the portion
that is substantially
fixed during the
separate operations
of the optical scanner
and the imaging
means”

“operation by the
optical scanner and
the imaging means

is at least
substantially or
effectively
simultaneous such
that movement (i.e.,
a change in spatial
disposition) can be
ignored and depth
data and color data
correspond to the

Align asserted that the plain and ordinary
meaning of this term requires a limitation that
the device is “movable” along with a
clarification that the operation of the “optical
scanner” and “imagine means” is “at least
substantially or effectively simultaneous.”
(COMBr. at 56.). By contrast, 3Shape’s
construction consisted of a nearly verbatim
recitation of the claim term modified slightly to
require separate operation of “the optical
scanner and the imaging means.” (ROMBr. at
71-72.). For the reasons stated below, the
adopted construction incorporates much of

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Construed Construction Construction Construction Support for Construction
ignored and depth same reference Align’s construction while rejecting the

data and color data
correspond to the
same reference
array”

array”

separateness argument in 3Shape’s construction.

As mentioned above in the context of “optical
scanner,” 3Shape is mistaken that “[t]he
specification describes that there is a short time
interval between the operation of the optical
scanner to obtain depth data and the imaging
means to obtain 2D color image data.” (/d. at
72.). The specification provides examples of
concurrent operation of the “optical scanner”
and “imaging means.” (JXM-0003 (°538
patent) at 21:55-57 (“a set of [color] images is
taken concurrently with or alternately with the
depth scan”), 21:46-47 (“Advantageously, one
or more color scans may also be taken during
the depth scan”).). Such a concurrent operation
undermines any attempt by 3Shape to inject a
required separateness (e.g., non-zero period of
time or, stated another way, in seriatim and not
simultaneous) with respect to the operation of
the “optical scanner” and “imaging means.”

‘The plain and ordinary meaning of the claim |

term in dispute is that the device would
experience little or no movement during the
operation of the “optical scanner” and “imaging
means.” However, in the specification, the

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Construction

patentee explained that the meaning of the term
in dispute is related to, but a bit different from,
the plain and ordinary meaning. See Bell Atl.
Network Services, Inc. v. Covad Comme’ns
Group, Inc., 262 F.3d 1258, 1269 (Fed. Cir.
2001) (“[T]he patentee may act as his own
lexicographer by using the specification to
define terms either expressly or by
implication.”); Phillips, 415 F.3d at 1316

“| (“[T]he specification may reveal a special

definition given to a claim term by the patentee
that differs from the meaning it would otherwise
possess. In such cases, the inventor's
lexicography governs.”).

The patentee explained: “operation of the
scanning means and the imaging means is
substantially or effectively simultaneous in
practical terms, and thus the actual time interval
that may exist between operation of the two
means is so short that the amplitude of any

mechanical vibration of the device or movement

of the oral cavity will be so small as can be ~
ignored.” (JXM-0003 (’538 patent) at 4:61-5:3
(emphasis added); see also id. at 8:56-65
(explaining that the spatial disposition with
respect to the scanned tooth is substantially
fixed with respect to the capturing of the depth

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data and the two-dimensional image data); id. at
13:33-38 (same).).

This definition is clear. It is also sufficiently
broad such that the “optical scanner” and
“imaging means” can operate concurrently or
separated by a small duration of time. The 7538
patent also provides examples of specific time
intervals that qualify as “effectively
simultaneous,” such as “about 0 seconds to _
about 100 milliseconds, for example 5, 10, 20,
30, 40, 50, 60, 70; 80, 90 or 100 milliseconds,
and preferably between about 0 to about 50
milliseconds, and more preferably between
about 0 and 20 milliseconds.” (Jd. at 5:7-12;
see also id. at 16:46-51 (same).).

“[M]aintaining a spatial disposition with respect
to the portion that is substantially fixed during
operation” serves the important purpose of
facilitating the combination of the depth and
color data corresponding to or associated with a
“two-dimensional reference array” of x-y
coordinates. (See id. at 13:49-57 (explaining
that the three-dimensional information and the
two-dimensional information are obtained
almost simultaneously so the coordinates of the
three dimensional and two-dimensional

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information represent the same part of the
tooth); id. at 3:58-4:11 (same); 13:20-25 (same);
25:11-23 (so long as “the same frames of
references are maintained” when capturing the
three-dimensional scan and the two-dimensional
scan, then “color values at particular x, y
coordinates of the 2D color image” can be
“matched to the same x, y coordinates of the 3D
images which also have a z coordinate.”).

Based on the explanation provided above, most
of Align’s construction is adopted. However,

this construction explicitly rejects and we

decline to import a limitation that the device is
“movable.” While the specification speaks of
“relative movement between the device and the
intra oral cavity,” it appears that none of the
intrinsic evidence characterizes the claimed
device alone as “movable.” (/d. at 10:53-54.).
Further, Align provides no explanation for why
the limitation is necessary other than by citing
to extrinsic evidence. ((CRMBr. at 31 (“One of
ordinary skill would understand that the phrase
depth data relates to data indicating depth in |
three dimensional space, and the phrase optical
scanner includes a scanner, with the terms
collectively referring to a movable 3D scanner
in the context of the’ preamble and the

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. specification of the patent. (CXM-0036
(Stevenson Declaration) at ff 15-18.”).).
Align’s proposed construction remains true to
the meaning of “confocal,” sharing a common
focus, but also imported an “optical scanner”
limitation. (CRMBr:. at 46.). 3Shape’s
proposed construction, on the other hand,
tethered “confocal” not to the sharing of a
common focus, but instead to point illumination-
and detection. (RRMBr. at 35.). Faced with
. . limited intrinsic evidence, both constructions
Plain and ordinary cs . . .
. tse imaging draw support from the extrinsic record. For the
meaning, which is “a . sy
n, techniques reasons set forth below, Align’s proposed
technique that uses ; . . . . . ,
‘ . . . ‘techniques that use characterized by construction is adopted, in-part, while 3Shape’s
confocal imaging an optical scanner ve awe . . ae ye
. > . . ae point illumination illumination and proposed construction is rejected.
techniques with the illumination . . 59 . .
and detection paths and point detection detection paths with
conjugate focal By way of background, dependent claim 2

sharing the same
focus”

planes”

contains the claim term in question: “The
device according to claim 1, wherein the
operation of the optical scanner is based on
confocal imaging techniques.” (JXM-0003
(538 patent), cl. 2 (emphasis added).).

Unfortunately, the intrinsic evidence does not
explicitly define “confocal imaging techniques”
or even “confocal.” Based on the structure of
the word “con-focal,” which combines the

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prefix “con” with the root “focal,” it is clear that
the term refers to a common or shared focus of
some kind. (See, e.g., CKM-0024 (Dictionary
of Computer Vision and Image Processing, 2nd
Ed.) (“confocal: In optics, two lens that share
the same focal plane or focal point (i.e., co-
incident focal)”); see also CXKM-0026
(Dictionary of Science and Technology) at 497
(“confocal: Mathematics. having the same focus
or foci’”).). Align’s construction reflects this;
3Shape’s construction does not.

Importantly, nothing in the. specification of the
°538 patent explicitly restricts confocal imaging
techniques to point illumination/detection.® The
specification does disclose using relatively

6 Align made a similar but a more narrow point that “nothing in the specification restricts the confocal imaging techniques to a single point of illumination, yet
3Shape’s proposed construction mandates such a restriction.” (COMBr. at 61 (“The patent specification also discloses one embodiment that uses a grating or
microlens array to form an array of spots on an object and an arrayed image sensor to detect the returning light, which is not a single point illumination and point
detection.”) (emphasis added), 63 (“As such, the specification of the 538 patent provides examples of confocal. imaging arrangements which are not restricted by
the user of pinholes nor the use of a single point of illumination or detection, in direct contradiction of 3Shape’s claim construction.”) (emphasis added); CRMBr.
at 47 (“Beyond this, nothing in the specification restricts the confocal imaging techniques to a single point of illumination, yet 3Shape’s proposed construction
mandates such a restriction. ... 3Shape’s proposed construction is incorrect because nothing in the specification limits confocal imaging techniques to a single
point of detection.”) (emphasis added).). However, in response, 3Shape clarified that its proposed construction covered ‘techniques that use [multiple] point
illumination and point detection’ — not ‘single point illumination’ or ‘single point detection.’ Rather, confocal systems often have arrays of pinholes for
illumination and detection.” (RRMBr. at 39.). In other words, Align’s “single point of illumination” critique of 3Shape’s construction appears to be moot.

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narrow apertures for obtaining 3D depth data as
compared to 2D color data. (JXM-0003 (538
patent) at 9:49-52 (“Preferably, the illumination
sources are configured to have a relatively low
numerical aperture compared with that of the
first array of light beams.”).). As the °538
patent explains, using narrow apertures results
in more accurate scanning. (/d. at 20:8-11 (“the
numerical aperture of the confocal system itself
is relatively high to maximize accuracy of the
depth measurements, and thus provides a
relatively narrower depth of field.”).).
However, a disclosed preference for narrow
apertures is not an express requirement.

In certain embodiments, the specification refers
to the use of illuminated “spots” to collect 3D
depth data. (See, e.g., 2:67-3:12, 14:65-15:5
(“The aperture in the mirror 40 improves the
measurement accuracy of the apparatus. Asa
result of this mirror structure the light beams
will yield a light annulus on the illuminated area |.
of the imaged object as long as the area is not in
focus; and the annulus will turn into a
completely illuminated spot once in focus. This
will ensure that a difference between the
measured intensity when out-of- and in-focus

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will be larger”).). In its argument, 3Shape
equates “spots” and “points.” (RRMBr. at 36
(“In particular, confocal imaging uses point
(spot) illumination, which is achieved by
illuminating an object through a pinhole located
at a focal plane and detecting the illumination
point through a pinhole located at a focal plane

| and detecting the illumination point through a

pinhole located at a focal plane.”).). However,
the specification explicitly uses the term
“point(s)” only in the context of array
coordinates associated with 3D depth and 2D
color data, not specific techniques used to
obtain 3D depth data. (See, e.g., Abstract (“a
scanner for providing depth data for points
along a two-dimensional array ... and an image
acquisition means for providing color data for
each of the points of the array”).).

In support of 3Shape’s proposed construction,
the specification of the ’538 patent appears to
describe an embodiment with point detection.
In particular, the specification describes light
returning from “spots” and passing through a
“pinhole array” en route to an image sensor.
(Id. at 15:51-65 (“The returned polarized light
beam 54 pass through ... a matrix 66

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comprising an array of pinholes. CCD camera
has a matrix or sensing elements each
representing a pixel of the image and each one
corresponding to one pinhole in the array”).).

Based on disclosures such as these, 3Shape
stated that a “person of ordinary skill in the art
would understand the claimed “confocal
imaging technique” to refer to a technique that
uses point illumination and point detection.”
(ROMBr. at 75 (emphasis added).). However,
according to Align, 3Shape’s point illumination/
detection restriction on “confocal imaging
techniques” excludes disclosed embodiments
within the *538 patent. (COMBr. at 62.). For
example, the specification purportedly teaches
using “a grating or microlens array—not point
illumination—to form an array of illumination
beams.” (CRMBr. at 47 (citing JKM-0003
(538 patent) at 5:49-52).). Moreover, the use
of pinholes, in the context of “sensing
elements,” appears to be optional. (JXM-0003
(’538 patent) at 6:5-9 (“Typically, the sensing
elements are an array of charge coupled devices
(CCD). The detector unit may comprise a
pinhole array, each pinhole corresponding to
one of the CCDs in the CCD array.”’).).

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‘In rebuttal, citing only extrinsic evidence in the
form of an expert declaration, 3Shape asserted

that “all of the examples cited by Align as using
a grating or microlens array in place of pinholes
are still using the grating, microlens array, or
other structures as spatial filters that perform the
same function of pinholes, namely to filter out
unwanted light.” (RRMBr. at 39 (citing RXM-
0029 (Zavislan Rebuttal Decl.) at § 27)
(emphasis added).). Yet, what 3Shape did not
say is that the °538 patent’s “array of
illumination beams” embodiment necessarily
satisfies 3Shape’s criteria for “confocal imaging
techniques,” namely “point illumination and
point detection.” This appears to be a key
admission by omission.

Consequently, it appears that adopting 3Shape’s
construction would amount to importing point
illumination and detection (and by association,
“pinholes’) into the term “confocal imaging
techniques,” without a clear justification in the
intrinsic evidence to do so. This would run
contrary to the teachings of the specification,
which appears to disclose a system flexible
enough to perform 3D depth scanning using

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varying imaging techniques, with a declared
preference for confocal imaging using narrow
aperture scanning to increase accuracy. (JXM-
0003 (°538 patent) at 9:49-52.).

Align’s WO 00/08415 application, referenced in
the ’538 specification, appears to support this
conclusion that 3Shape is attempting
impermissibly to restrict the scope of asserted
claims to certain disclosed embodiments. In
that application, independent claim 1! recites “a
plurality of illuminated spots.” (CXM-0033
(WO 00/08415 application) at 17.). However,
“detector unit comprises a pinhole array”
appears only in a dependent claim. (/d. at 21.).

In 3Shape’s favor, the extrinsic evidence does
appear to link “confocal” and point illumination
/ detection via a discussion of “high-numerical-
aperture,” at least in the context of confocal
microscopy. A technical book 3Shape cites that
compares and contrasts a standard optical
microscope and a CSOM (confocal scanning
optical microscope) states that “[bJoth
instruments can use a high-numerical-aperture
lens to illuminate and image the sample; thus
both microscopes fit the definition of confocal,

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two lenses sharing a common focus.”” (RXM-
0015 (Excerpts from Corle, Timothy R. and
Gordon S. Kino, “Confocal Scanning Optical
Microscopy and Related Imaging Systems”
(1996)) at 14.) (emphasis added).).

However, “can use” is not “must use.” Also,
the link drawn by this reference between point
illumination/detection and “confocal” is tenuous
because the reference separately makes clear
that a confocal scanning microscope using
“point illumination” and “point detection” is not
synonymous with “a confocal lens system.”
(d.). “Strictly speaking,” both a confocal .
scanning microscope and conventional
microscope are considered “confocal.” (d.).
However, the former appears distinct from the

7 This is reflected in an Initial Determination on Violation issued in 337-TA-1091, which construed “confocal imaging techniques” in the context of a continuation
patent in the same family as the 538 patent. (Certain Color Intraoral Scanners and Related Hardware and Software, Inv. No. 337-TA-1091, Initial
Determination, Doc. ID No. 668859 (Mar. 1, 2019).). There, Judge Cheney found, based on extrinsic evidence, that “a ‘confocal imaging’ system requires
conjugal focal planes as well as point illumination, imaging, and detection.” (Jd. at 47.). This Markman Order agrees with the 1091 ID that “the specification
makes it clear that the use of point illumination, imaging, and detection is consistent with confocal imaging, but it is not clear from the specification that those
elements are required.” (Id. at 41-42.). Yet, based mostly on intrinsic evidence, this Markman Order respectfully departs from the 1091 1D’s finding that
“{c]onjugate focal planes on their own, however, are not sufficient to define a ‘confocal imaging’ technique or system within the context of the color scanner
patents.” (/d. at 45.). For the reasons set forth above this Markman Order finds that “[c]onjugate focal planes” are sufficient. It should be noted that the 1091 ID
is on appeal with the Commission. Since Judge Cheney’s Markman construction of “confocal imaging techniques” has been appealed, the Commission’s decision,
which is due shortly, may affect the construction adopted in this Order.

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latter insofar as the former is characterized by
pinhole illumination and detection: “(CSOM)
differs from a conventional optical microscope
in that it illuminates and images the object one
point at a time through a pinhole[.]” (/d. at 12.).

Consequently, it appears that 3Shape falls short
in its attempt to equate point illumination /
detection with “confocal imaging” as used in
the °538 patent. The above-mentioned technical
book does describe “confocal microscope” as a
synonym for CSOM, but this disclosure (much
like most of 3Shape’s extrinsic evidence) is of
little relevance here because the ’538 patent is
directed to confocal imaging in general, not
confocal microscopy. (RXM-0015 (Excerpts
from Corle, Timothy R. and Gordon S. Kino,
“Confocal Scanning Optical Microscopy and
Related Imaging Systems” (1996)) at 6; RXM-
0014 (Excerpts from Wilson, T., “Confocal
Microscopy” (1990)) at 8.).

Moreover, at least one piece of extrinsic
evidence identified by Align appears to disclose
an “alternative confocal arrangement” that does
“not require point illumination or detection
(since, for example, projection and detection of

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parallel stripes, which are alternatively clear and
opaque, might be used.).” (CKM-0032
(Declaration of Robert Stevenson) § 61 (citing
CXM-0028 (U.S. Patent No. 5,381,236) at 5:9-
12).). While 3Shape provided extrinsic
evidence that this “alternative confocal
arrangement[]” still “required spatial filters that
perform the same function of pinholes, namely
to filter out unwanted light,” this evidence did
not demonstrate that the “arrangement[]”
satisfied 3Shape’s criteria for “confocal imaging
techniques,” namely “point illumination and
point detection.” (RXM-0029 (Declaration of
James Zavislan) § 27 (emphasis added).).

Finally, Align’s proposed construction includes
“an optical scanner.” This appears redundant.
See MEMS, 447 F. App’x at 151 (constructions
which introduce redundancy are “disfavored”).
The term under construction, “confocal imaging
techniques,” appears in claim 2 of the 538
patent. As Align acknowledged, “[t]he express
(and sole) requirement of claim 2 is that “the
operation of the optical scanner [required in
claim 1] is based on confocal imaging
techniques.” (COMBr. at 45; cl. 2.). In other
words, based on the express language of claim

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2, “there can be little doubt that the claimed
confocal imaging technique uses an optical
scanner[.]” (/d. at 59.). Thus, to avoid
redundancy, the adopted construction does not
include “an optical scanner.”

The adopted construction is “imaging
techniques characterized by illumination and
detection paths with conjugate focal planes.”
This construction departs from Align’s
construction only to remove a redundant
“optical scanner” requirement and to clarify
what Align means by “the same focus.”

Page 79 of 79

CERTAIN DENTAL AND ORTHODONTIC SCANNERS
AND SOFTWARE
Inv. No. 337-TA-1144
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached ORDER has been served upon the
following parties as indicated, on October 1, 2019.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants Align Technology, Inc.:
Blair M. Jacobs, Esq.
PAUL HASTINGS LLP
875 15th Street, N.W.
Washington, DC 20005
On Behalf of Respondents 3Shape AIS, 3Shape
Trios AIS, 3Shape Inc.:
Goutam Patnaik
PEPPER--HAMMILTON LLP
2000 K Street, N.W., Suite 600
Washington, DC 20006
D Via Hand Delivery
,S,:Via Express Delivery
�Via First Class Mail
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