USITC Publication 5025

Texto completo

U.S. International Trade Commission
Publication 5025 	February 2020
Washington, DC 20436
In the Matter of
337-TA-1110
CERTAIN STRONTIUM-RUBIDIUM
RADIOISOTOPE INFUSION SYSTEMS, AND
COMPONENTS THEREOF INCLUDING
GENERATORS

U.S. International Trade Commission
COMMISSIONERS
David S. Johanson, Chairman
Rhonda K. Schmidtlein, Commissioner
Jason E. Kearns, Commissioner
Randolph J. Stayin, 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 5025 	February 2020
In the Matter of
337-TA-1110
CERTAIN STRONTIUM-RUBIDIUM
RADIOISOTOPE INFUSION SYSTEMS, AND
COMPONENTS THEREOF INCLUDING
GENERATORS

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington,D.C.
In the Matter of
CERTAIN STRONTIUM-RUBIDIUM
RADIOISOTOPE INFUSION SYSTEMS,
AND COMPONENTS THEREOF
INCLUDING GENERATORS
Investigation No.337-TA-1110
NOTICE OF COMMISSION FINAL DETERMINATION OF 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
determined to affirm with modification a final initial determination("FID")ofthe presiding
administrative law judge("AU")finding no violation of section 337 ofthe Tariff Act of 1930,
as amended. The investigation is terminated.
FOR FURTHER INFORMATION CONTACT: Houda Morad, Office ofthe General
Counsel, U.S. International Trade Commission,500 E Street SW., Washington, DC 20436,
telephone(202)708-4716. 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
SW., Washington, D.C. 20436, telephone(202)205-2000. General information concerning the
Commission may also be obtained by accessing its Internet server at https://www.usitc.gov. The
public record for this investigation may be viewed on the Commission's electronic docket
(EDIS)at https://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
May 1, 2018, based on a complaint, as amended, filed by Bracco Diagnostics Inc. of Monroe
Township, New Jersey ("Bracco"). See 83 FR 19112(May 1, 2018). The complaint, as
amended, alleges violations of section 337 of the Tariff Act of 1930, as amended(19 U.S.C.
1337)("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 strontium-rubidium
radioisotope infusion systems, and components thereof including generators, by reason of
infringement of U.S. Patent Nos. 9,814,826; 9,750,869; and 9,750,870(collectively,"the
asserted patents"). See id. The notice of investigation names Jubilant DraxImage Inc. of
Kirkland, Quebec, Canada; Jubilant Pharma Limited of Singapore; and Jubilant Life Sciences of
Noida, Uttar Pradesh, India (collectively,"Respondents" or "Jubilant") as respondents in this
1

investigation. See id. The Office of Unfair Import Investigations is also a party to this
investigation. See id.
On February 8, 2019,the AU issued an initial determination("ID")(Order No. 27)
finding by summary determination that Jubilant's RUBY Rubidium Elution System Version 3.0
directly infringes the asserted patents. See Order No. 27(Feb. 8,2019), unreviewed, Comm'n
Notice(Mar. 8, 2019). In addition, the II) determines that Jubilant's RUBY Rubidium Elution
System Version 3.1 and the RUBY Rubidium Elution System Version 4 do not directly infringe
the asserted patents. See id. The ID(Order No. 27)declines to reach indirect infringement on
summary determination. See id.
The AUJ conducted an evidentiary hearing on February 11-12 and 15-17, 2019, and on
August 1, 2019, issued the FID finding no violation of section 337. Specifically, the FID finds
that the domestic industry requirement is satisfied and that all the asserted claims are infringed
but invalid as obvious over the prior art. The FID also contains the All's Recommended
Determination("RD")recommending, should the Commission find a section 337 violation, that
the Commission issue a limited exclusion order("LEO")barring entry of articles that infringe
the asserted claims. The RD does not recommend that the Commission issue a cease and desist
order or impose a bond during the period of Presidential review. Furthermore, as directed by the
Commission,the RD provides findings with respect to the public interest and recommends a
determination that the public interest factors do not preclude entry ofthe proposed LEO.
On August 14, 2019, both Bracco and the Commission's Investigative Attorney("IA")
filed petitions for review of the FID. Bracco petitioned for review ofthe FID's findings with
respect to invalidity, while the IA petitioned for review ofthe FID's findings with respect to
domestic industry. On August 22,2019, the parties filed responses to the respective petitions.
On September 30, 2019, the Commission determined to review the FID in part with
respect to invalidity and domestic industry. See 84 FR 53177(Oct. 4, 2019). The Commission
determined not to review the remainder ofthe FID. See id
Having considered the FID, the parties' petitions, responses thereto, and the record in this
investigation, the Commission has determined to affirm with modification the FID's findings and
conclusion of no violation of section 337. Specifically, as explained in the Commission Opinion
issued concurrently herewith, the Commission has determined to affirm with modification and to
supplement the FID's findings with respect to the invalidity ofthe asserted patent claims. The
Commission has further determined to affirm in part and vacate in part the FID's findings with
respect to the domestic industry requirement. All findings in the FID that are not inconsistent
with the Commission's final determination are affirmed. The investigation is terminated except
with respect to the declassification proceeding presently before the Commission.
2

The authority for the Commission's determination is contained in section 337 ofthe
Tariff Act of 1930, as amended(19 U.S.C. 1337), and in part 210 ofthe Commission's Rules of
Practice and Procedure(19 CFR part 210).
By order ofthe Commission.
Issued: December 2,2019
Lisa R. Barton
Secretary to the Commission
3

CERTAIN STRONTIUM-RUBIDIUM RADIOISOTOPE
INFUSION SYSTEMS,AND COMPONENTS THEREOF
INCLUDING GENERATORS
PUBLIC CERTIFICATE OF SERVICE
Inv. No.337-TA-1110
I, Lisa R. Barton, hereby certify that the attached NOTICE has been served by hand upon the
Commission Investigative Attorney, Brian Koo,Esq., and the following parties as indicated, on
December 2,2019.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW,Room 112
Washington, DC 20436
On Behalf of Complainant Bracco Diaanostics Inc.:
Mark G. Davis, Esq.
GOODWIN PROCTER LLP
1900 N Street, NW
Washington, DC 20036
On Behalf of Respondents Jubilant DraxImage Inc., Jubilant
Pharma Limited, and Jubilant Life Sciences:
T. Cy Walker, Esq.
Baker & Hostetler, LLP
1050 Connecticut Avenue, NW
Washington, DC 20036
D Via Hand Delivery
CE Via Express Delivery
El Via First Class Mail
El Other:
El Via Hand Delivery
El Via Express Delivery
0 Via First Class Mail
0 Other:

PUBLIC VERSION
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington,D.C.
In the Matter of
CERTAIN STRONTIUM-RUBIDIUM
RADIOISOTOPE INFUSION SYSTEMS,
AND COMPONENTS THEREOF
INCLUDING GENERATORS
Inv. No.337-TA-1110
COMMISSION OPINION
On August 1, 2019, the presiding Administrative Law Judge("All")in the above-
identified investigation issued a final initial determination("FID")finding no violation of section
337 ofthe Tariff Act of 1930, as amended, 19 U.S.C. § 1337("section 337"). Having
considered the FID,the parties' petitions, responses thereto, and the record in this investigation,
the Commission has determined to affirm with modification the FID's findings and ultimate
conclusion of no violation of section 337. Specifically, the Commission has determined to
affirm the FID's conclusion with respect to the invalidity ofthe asserted claims and supplements
the FID's findings on that issue. In addition, the Commission has determined to affirm in part
and vacate in part the FID's findings with respect to the domestic industry requirement. All
findings in the FID that are consistent with this opinion are affirmed.
I. BACKGROUND
A. Procedural Background
The Commission instituted this investigation on May 1, 2018, based on a complaint, as
amended, filed by Bracco Diagnostics Inc.("Bracco")of Monroe Township, New Jersey. See
83 Fed. Reg. 19112(May 1, 2018). The complaint, as amended, alleges violations of section
337 based upon the importation into the United States, the sale for importation, and the sale
1

PUBLIC VERSION
within the United States after importation of certain strontium-rubidium radioisotope infusion
systems, and components thereof including generators, by reason ofinfringement of claims 1-3,
5, 9-14, 17-19, 26, and 28 of U.S. Patent No. 9,814,826("the '826 patent")(JX-1); claims 1-5, 8,
14, 24, and 27-30 of U.S. Patent No. 9,750,869("the '869 patent")(JX-2); and claims 1, 2, 8-13,
16, 17, 22, and 27 of U.S. Patent No. 9,750,870("the '870 patent")(JX-3)(collectively,
"Asserted Patents"). See id. The notice of investigation names Jubilant DraxImage Inc. of
Kirkland, Quebec, Canada; Jubilant Pharma Limited of Singapore; and Jubilant Life Sciences of
Noida, Uttar Pradesh, India (collectively,"Jubilant") as respondents in this investigation. See
id. The Office of Unfair Import Investigations is also a party to this investigation. See id.
On August 8,2018,the Commission partially terminated the investigation as to claims 10
and 26 ofthe '826 patent, claims 27 and 28 ofthe '869 patent, and claims 9 and 22 ofthe '870
patent based on the withdrawal ofthe allegations pertaining to those claims. See Order No. 15
(Aug. 8, 2019), unreviewed, Comm'n Notice (Sept. 6, 2019). On September 4,2018,the All
partially terminated the investigation as to claim 13 ofthe '870 patent based on the withdrawal of
the allegations pertaining to that claim. See Order No. 18 (Sept. 4, 2019), unreviewed, Comm'n
Notice (Sept. 26, 2019).1
On February 8, 2019, the AUJ issued an ID (Order No. 27) granting Bracco's motion for
summary determination that Jubilant's RUBY Rubidium Elution System Version 3.0("the
Version 3 product") infringes the Asserted Patents. See Order No. 27(Feb. 8, 2019),
unreviewed, Comm'n Notice(Mar. 8, 2019). In addition, the ID grants Jubilant's motion for
summary determination that Jubilant's RUBY Rubidium Elution System Version 3.1 ("the
1 Hereinafter,"Asserted Claims" means claims 1-3, 5, 9, 11-14, 17-19, and 28 ofthe '826 patent,
claims 1-5, 8, 14, 24, and 29-30 ofthe '869 patent, and claims 1, 2, 8, 10-12, 16, 17, and 27 of
the '870 patent.
2

PUBLIC VERSION
Version 3.1 product") and the RUBY Rubidium Elution System Version 4("the Version 4
product") do not directly infringe the Asserted Patents. See id The ID (Order No. 27)declines
to reach indirect infringement on summary determination. See id at 20.
The AUJ conducted an evidentiary hearing on February 11-12 and 15-17, 2019, and on
August 1, 2019, issued the FID finding no violation of section 337. Specifically, the FID finds
that the domestic industry requirement is satisfied and that all the Asserted Claims are infringed
but invalid as obvious over the prior art. In addition, the FID also contains the AL's
recommended determination("RD"),recommending, should the Commission find a violation of
section 337, that the Commission issue a limited exclusion order("LEO")barring entry of
articles that infringe the Asserted Claims. However,the RD recommends delaying the effective
date of the LEO by 12 months to allow sufficient time for facilities with infringing systems to
switch to other models. The RD does not recommend that the Commission issue a cease and
desist order("CDO")or impose a bond during the period of Presidential review. Furthermore,
as directed by the Commission,the RD provides findings with respect to the public interest and
recommends a determination that the public interest factors do not preclude entry ofthe
recommended remedy.
On August 14, 2019, both Bracco and the Commission's Investigative Attorney("IA")
filed petitions for review ofthe FID.2 Bracco petitioned for review ofthe FID's findings with
2 See Complainant Bracco Diagnostics Inc.'s Petition for Review of Initial Determination
(hereinafter,"Bracco's Pet"); Office of Unfair Import Investigations' Petition for Review ofthe
Final Initial Determination (hereinafter,"IA's Pet.").
3

PUBLIC VERSION
respect to invalidity while the IA petitioned for review ofthe FID's findings with respect to
domestic industry. On August 22,2019, the parties filed responses to the petitions.3
On September 30, 2019, the Commission issued a notice determining to review the FID
in part. See 84 Fed. Reg. 53177(Oct. 4, 2019). Specifically, the Commission determined to
review the FID's findings with respect to invalidity and domestic industry.
B. The Asserted Patents
The Asserted Patents are related and share the same specification. The Asserted Patents
issued between September 5 and November 14, 2017.4 See FID at 4. The Asserted Patents,
titled "Integrated Strontium-Rubidium Radioisotope Infusion Systems," relate to computer-
assisted medical devices that generate and infuse radiopharmaceuticals (e.g., rubidium-82 or Rb-
82)into a patient. See JX-1,'826 patent at Abstract, 1:27-30. The infused dose of
radiopharmaceutical is absorbed by the cells of a target organ ofthe patient and emits radiation,
which is detected by positron emission tomography ("PET"),thereby generating an image ofthe
organ. See id. at 1:35-42.
For example,the common specification explains that:
[C]ircuit 300 includes: an eluant reservoir 15, for example, a bag,
bottle or other container, containing saline as the eluant, . . . ; a
syringe pump 33, for pumping the eluant from reservoir 15, and a
pressure syringe 34 (or other device or sensor), for monitoring
pumping pressure; a filter 37, which may also serve as a bubble trap,
3 See Complainant Bracco Diagnostics Inc.'s Response to Office of Unfair Import
Investigations' Petition for Review of Initial Determination (hereinafter,"Bracco's Resp.");
Respondents' Response to Complainant's Petition for Review (hereinafter,"Jubilant's Resp.");
Office of Unfair Import Investigations' Response to Complainant's Petition for Review ofthe
Final Initial Determination (hereinafter,"IA's Resp.").
4 On their face, the earliest priority date ofthe Asserted Patents appears to be June 11, 2008.
However,the parties agree that the relevant priority date for all three patents is June 11, 2009.
Jubilant argued for a later priority date in the context of an invalidity (anticipation) challenge but
the FID rejected that challenge and determined that the priority date ofthe Asserted Patents was
indeed June 11, 2009. See FID at 122-25. Jubilant did not petition for review ofthe finding.
4

PUBLIC VERSION
for the pumped eluant; a radioisotope generator 21, through which
the filtered eluant is pumped to create a radioactive eluate, for
example an eluate carrying Rubidium-82 that is generated by the
decay of Strontium-82, via elution, within a column ofgenerator 21;
and an activity detector 25, for measuring the activity of the eluate
discharged from generator 21, in order to provide feedback for
directing the flow ofthe eluate, via a divergence valve 35WP,either
to a waste bottle 23 or through a patient line 305p, for example, to
inject a dose of the radiopharmaceutical eluate into a patient."
See id. at 5:3-20, Figure 1D (reproduced below).5
.21
15
301
3Q0B
302 - 37 35BG
•;) frfi Do	/1 ( 302
317 -311
, 34
yr
304 --""
Fig. 1D
303
,-- 300
--305P
1-315
-OP
; r
35WP is% f"--305W
25 .43‘214
Pik	-305
23
-305P
00
• 33
200
The specification also states that "circuit 300[can be] expanded to include elements for
an automated collection of eluate samples for activity measurements, via the on board dose
calibrator." See id. at 8:13-16. The specification explains that "a sample collection reservoir
5 As noted in the FID,"[a]s the generator ages, strontium starts to detach from the column and
contaminate the eluate, posing a risk to patient health"(known as "strontium breakthrough").
To prevent any patient exposure from strontium breakthrough, operators must perform frequent
quality-control checks on the generator. See FID at 7.
5

PUBLIC VERSION
[can be] integrated into circuit 300, downstream of divergence valve 35WP and in
communication with tubing line 305P,in order to receive quality control test samples of eluate,
via tubing line 305P,and both the reservoir and the dose calibrator are located in a separate
shielded well." See id. at 8:17-23.
The specification further explains that "[a]ctivity detector 25 is mounted in a shielded
well 255 that extends downward from opening 325(shown in FIG. 3B,reproduced below), and,
with reference to FIG. 3B,tubing line 305 passes over opening 325 so that detector 25 can detect
an activity of the eluate, which passes therethrough." See id. at 12:21-25.
301
302
..tf Fig. 3B
302- 231 -
201
251b
251g
303 —
304
35BG-
305p
35wp
305
The Asserted Claims recite a method or a system relating to a strontium-rubidium
infusion system "on-board" a cart. See, e.g.,'826 patent at claim 1 (reproduced below). In
particular, the system is configured to "determine a strontium breakthrough test result on [a]
sample ofthe rubidium radioactive eluate filled into the eluate reservoir in the shielded well on-
,23
—205
2150
255
--233
-305w
-- 203
05p
— 305w
-- 325
305
25
6

PUBLIC VERSION
board the cart while the eluate reservoir remains in the shielded well onboard the cart" and "not
allow a patient infusion if the strontium breakthrough test result is greater than or equal to an
allowed limit." See id.
Claims 1, 9, and 13 of the '826 patent are representative and recite (with disputed
limitations in bold):
1. A method of building an infusion system to deliver a rubidium
radioactive eluate comprising:
installing a first shielding compartment,6 a second shielding
compartment, and a shielded wed on a platform of a cart, wherein:
the first shielding compartment has a first opening facing
vertically upwardly,
the first opening is configured for a strontium-rubidium
radioisotope generator to be inserted into and removed from the first
shielding compartment,
the second shielding compartment has a second opening facing
vertically upwardly,
the second opening is configured for a waste bottle to be inserted
into and removed from the second shielding compartment,
thefirst opening is located at a lower elevation than the second
opening,8 and
the shielded well is configured to receive an eluate reservoir that
is configured to receive a sample ofthe rubidium radioactive eluate;
configuring a computer with a touch screen display for the
infusion system to:
fill the eluate reservoir in the shielded well on-board the cart
with the sample of the rubidium radioactive eluate by pumping
saline from a saline reservoir into the strontium-rubidium
radioisotope generator via a saline tubing line thereby generating the
rubidium radioactive eluate that is discharged through an eluate
tubing line,
determine a strontium breakthrough test result on the sample
of the rubidium radioactive eluate filled into the eluate reservoir in
the shielded well on-board the cart while the eluate reservoir
remains in the shielded well onboard the cart, and not allow a
6 The "first shielding compartment" element is referred to, hereinafter, as "claim limitation (i)."
7 The "shielded well" element is referred to, hereinafter, as "claim limitation (ii)."
8 The element reciting "the first opening [] located at a lower elevation than the second opening"
element is referred to, hereinafter, as "claim limitation (iii)."
7

PUBLIC VERSION
patient infusion ifthe strontium breakthrough test result is greater
than or equal to an allowed limit.9
9. The method of claim 2, further comprising configuring the
computer to:
present on the touch screen display a screen for starting the
patient infusion by touching a button on the touch screen display;
present on the touch screen display a screen reminding a user
to insert the eluate reservoir in the shielded well on-board the cart;
present on the touch screen display a screen indicating that the
patient infusion is in process, wherein the screen indicating that the
patient infusion is in process displays a stop button to abort the
patient infusion; and
present on the touch screen display the strontium
breakthrough test result.1°
13. The method of claim 12, wherein the infusion system is
configured for the saline tubing line and the eluate tubing line to be
routed through two tubing passageways formed in a perimeter
surface of the first opening, wherein each of the two tubing
passageways has a depth configured to prevent pinching or
crushing of a corresponding tubing line routed therethrough
when afirst door is closed over thefirst opening."
An additional disputed limitation appears in claim 1 ofthe '869 patent which recites "[a]n
infusion system on-board a cart comprising... an opening through the exterior shell
configured to provide access to the strontium-rubidium radioisotope generator,""afirst door
accessible via the opening through the exterior shell, the first door being configured to provide
9 The element reciting "configuring a computer ... to fill the eluate reservoir... with the
sample ofthe rubidium radioactive eluate,... determine a strontium breakthrough test result,...
and not allow a patient infusion if the strontium breakthrough test result is greater than or equal
to an allowed limit" is referred to, hereinafter, as "claim limitation (iv)."
I° The elements reciting "present on the touch screen display a screen reminding a user to insert
the eluate reservoir in the shielded well on-board the cart... and present on the touch screen
display the strontium breakthrough test result it" are referred to, hereinafter, as "claim limitation
(vii)."
11 The element reciting "two tubing passageways formed in a perimeter surface ofthe first
opening, wherein each of the two tubing passageways has a depth configured to prevent pinching
or crushing of a corresponding tubing line routed therethrough when a first door is closed over
the first opening" is referred to, hereinafter, as "claim limitation (v)."
8

PUBLIC VERSION
access to the first shielding compartment and to close over the first opening," and "a second
door accessible via the opening through the top surface ofthe exterior shell, the second door
being configured to provide access to the second shielding compartment and to close over the
second opening."12 See JX-2,'869 patent at 24:24-25:33. The '870 patent also recites several
disputed claim limitations which are cumulative ofthe limitations discussed above.
C. Bracco's Domestic Industry Products
As noted in the FID,the domestic industry product is Bracco's CardioGen 1700 rubidium
infusion system ("Model 1700").13 See FID at 8. There is no dispute that the CardioGen1700
practices at least one claim of each ofthe Asserted Patents and thus satisfies the domestic
industry requirement as to the "article[sr protected by the patents. See id. at 128-29. The FID
further determines that Bracco's investments with respect to the articles protected by the asserted
patents are sufficient to satisfy the domestic industry requirement under subsections
337(a)(3)(A)-(C). See id. at 129-49. As noted above, the Commission determined to review
the FID's findings with respect to domestic industry.
D. Jubilant's Accused Products
The accused products in this investigation are Jubilant's RUBY Rubidium Elution
Systems(Versions 3, 3.1, and 4)as well as the generators(RUBY-FILL generators) and tubing
sets(RUBY Sets) used with those systems.14 See FID at 7. As noted above,the Commission
previously determined that the Version 3 product directly infringes the Asserted Patents but that
12 The elements reciting "an opening through the exterior shell,""a first door," and "a second
door" are referred to, hereinafter, as "claim limitation (vi)."
13 Bracco's CardioGen 1700 is not on the market and is currently awaiting FDA approval.
14 Jubilant's Version 3.1 and Version 4 products are not on the market and are currently awaiting
FDA approval.
9

PUBLIC VERSION
the Version 3.1 and 4 products do not directly infringe the Asserted Patents. See Order No. 27
(Feb. 8, 2019), unreviewed, Comm'n Notice(March 8, 2019). The FID finds that Jubilant
indirectly infringes the Asserted Patents when it ships a RUBY-FILL generator or RUBY Set to
a customer that possesses a Version 3 system. See FID at 127-28. No party petitioned for
review of the FID's findings with respect to indirect infringement, and the Commission
determined not to review these findings. See 84 Fed. Reg. at 53177.
STANDARD ON REVIEW
Commission Rule 210.45(c) provides that "[o]n review, the Commission may affirm,
reverse, modify, set aside or remand for further proceedings, in whole or in part, the initial
determination ofthe administrative law judge" and that "Nile Commission also may make any
findings or conclusions that in its judgment are proper based on the record in the proceeding."
See 19 C.F.R. § 210.45(c). In addition, as explained in Certain Polyethylene Terephthalate
Yarn and Products Containing Same,"[o]nce the Commission determines to review an initial
determination, the Commission reviews the determination under a de novo standard." Inv. No.
337-TA-457, Comm'n Op., 2002 WL 1349938, *5(June 18, 2002)(citations omitted). This is
"consistent with the Administrative Procedure Act which provides that once an initial agency
decision is taken up for review,'the agency has all the powers which it would have in making
the initial decision except as it may limit the issues on notice or by rule." Id. (citing 5 U.S.C.
§ 557(b)).
III. DISCUSSION
As discussed below, the Commission has determined to affirm with modification and to
supplement the FID's findings with respect to the invalidity ofthe Asserted Claims. In addition,
10

PUBLIC VERSION
the Commission has determined to affirm in part and vacate in part the FID's findings with
respect to the domestic industry requirement.
A. Invalidity
The FID finds that all of the Asserted Claims are obvious over Klein15 (RX-106)alone or
in combination with Tate16 (RX-103), the MedRad Intego system, which is the commercial
embodiment ofthe Tate device17 (RX-200C), Chaffin18 (RX-96),IEC 6236619 (RX-114), or
Bracco's CardioGen-82 Model 51020 (JX-112C; RX-357). See FID at 25-112. The FID also
considers the evidence of secondary considerations but finds such evidence unpersuasive and
insufficient to overcome the finding ofprimafacie obviousness. See id. at 112-121.
As explained below, the Commission has determined to affirm the FID with
modification. The Commission supplements the FID's findings and conclusion of obviousness.
The Commission finds that Jubilant has satisfied its burden on obviousness and has established
by clear and convincing evidence that the Asserted Claims are obvious over Klein alone or in
15 Klein refers to a thesis published in 2006 describing a rubidium infusion system developed by
Ran Klein as part of his graduate studies at the University of Ottawa. See FID at 25.
16 Tate refers to U.S. Publication 2008/0177126 filed by MedRad on October 31, 2007.
17 The MedRad Intego system is the commercial embodiment ofthe device disclosed in Tate.
See FID at 35. The MedRad Intego system was sold and offered for sale in the United States
prior to June 2009. See id
18 Chaffin refers to an ergonomics and biomechanics reference. See Chaffin, et al.,
Occupational Biomechanics, 2d ed.(1991). Chaffin teaches sensible ways to physically arrange
heavy objects used by humans. See FID at 37.
19 IEC 62366 is an international standard for medical device design. See FID at 38. As stated
in the FID,"IEC 62366 teaches medical device developers to provide a user interface that
enables users 'to be aware of the use ofthe correct consumable, the remaining amount of[the
consumable], whether accessories might be used with the MEDICAL DEVICE,how to assemble
them and how to check their correct functioning.' See FID at 62-63.
20 Bracco's CardioGen-82 Model 510("Model 510")is a strontium-rubidium cardiac PET
infusion system first approved by the FDA in 1989. See FID at 26.
11

PUBLIC VERSION
combination with Tate/Medrad, Chaffin, IEC 62366, or Model 510.21 The Commission has also
determined that Bracco has established copying but no other indicia of non-obviousness, and that
such copying is insufficient to overcome Jubilant's strong showing of obviousness.
1. Disputed Claim Limitations
The FID identifies several claim limitations that are in dispute, including four limitations
that appear in claim 1 of each ofthe Asserted Patents: (1)"a shielded well onboard the cart"
("claim limitation (i)");(2)"a first shielding compartment for the generator" having "a first
opening facing vertically upwardly"("claim limitation (ii)");(3)"the first opening [(ofthe
generator compartment)] at a lower elevation than the second opening [(ofthe waste bottle
compartment)]"("claim limitation (iii)"); and(4)"a computer [configured] to fill an on-cart
reservoir with a sample of radioactive material, determine a strontium breakthrough test result on
the sample, and not allow a patient infusion if the strontium breakthrough test result is greater
than or equal to an allowed limit."("claim limitation (iv)"). See FID at 40-54. Bracco
petitioned for review ofthe FID's findings with respect to each ofthe four above-identified
limitations. See Bracco'g Pet. at 25-52, 56-59.
In addition, Bracco petitioned for review ofthe FID's findings with respect to three
additional limitations:(1)'two tubing passageways formed in a perimeter surface ofthe first
opening' where 'each of the two tubing passageways has a depth configured to prevent pinching
or crushing of a corresponding tubing line routed therethrough when a/the first door is closed,"
which is recited in claim 13 ofthe '826 patent, claims 4 and 24 ofthe '869 patent, and claim 12
21 Klein, Tate, and the user manual for Bracco's Model 510 were before the U.S. Patent and
Trademark Office("USPTO")during prosecution ofthe Asserted Patents. Based on the
evidence presented in this investigation, the Commission finds that Jubilant satisfies the "added
burden" of overcoming those references. See McGinley v. Franklin Sports, Inc., 262 F.3d 1339,
1353(Fed. Cir. 2001)(citation omitted).
12

PUBLIC VERSION
ofthe '870 patent("claim limitation (v)");(2)"opening through the top surface' and the first /
second 'door," which are recited in claim 1 ofthe '869 patent("claim limitation (vi)"); and
(3)"reminders, warnings, or alerts," which are recited in claim 9 ofthe '826 patent and claim 8
ofthe '870 patent("claim limitation (vii)"). See id. 52-56, 60-67.
2. Supplemental Analysis
(i) Claim Limitation (i)
There is no dispute that Klein does not expressly disclose a "shielded well on-board the
cart"(claim limitation (i)). See FID at 40. But while Klein's dose calibrator sits on a
laboratory shelf, i.e., off the cart, the parties did not dispute that the dose calibrator satisfies the
"shielded well" limitation. See id.; Jubilant's Resp. at 5 (citing Klein at RX-106.34(showing
the Klein system and dose calibrator on the laboratory shelf)(reproduced below as annotated)).
RX.0106.0034(annotated)
13

PUBLIC VERSION
The Commission agrees with the FID that the record evidence shows that Klein alone
teaches or suggests a "shielded well on-board the cart" by clear and convincing evidence. See
FID at 40-45. It is black letter law that "when a patent 'simply arranges old elements with each
performing the same function it had been known to perform' and yields no more than one would
expect from such an arrangement, the combination is obvious." KSR Intl Co. v. Teleflex Inc.,
550 U.S. 398,416(2007). As in KSR,there is no evidence in the record that "the [claimed]
improvement is more than the predictable use of prior art elements according to their established
functions." See id. at 417; id. ("If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability."); see also FID at 44(finding that "mov[ing] the
Klein dose calibrator onto the cart" was "nothing more than routine design work well within the
ability of a person of skill in the art")(citing Hr'g Tr. at 847:10-848:14(Stone22), id. ("[T]he
only two passages in the patent specification describing the dose calibrator on-board the cart
simply announce that fact without describing any difficulty in making or using that
arrangement.")(citing JX-1,'826 patent at 11:8-19, 27:9-12); see also Jubilant's Resp. at 33-34
("A dose calibrator is a well-known component of a rubidium infusion system, and a movable
cart provides a convenient location to place a dose calibrator in a rubidium infusion system, but
it adds nothing to the nature or quality ofthe dose calibrator.")(citing Anderson's-Black Rock v.
Pavement Co., 396 U.S. 57(1969); KSR,550 U.S. at 416); IA's Resp. at 16-20("Dr. Stone's
testimony ... makes clear that Klein contemplates improvements to disclosed system.")(citing
Hr'g Tr. at 823:13-18 (Stone)).
The FID also correctly finds that several design incentives would have motivated a
person of ordinary skill in the art to move the dose calibrator on board the cart, including
22 Dr. Robert Stone is Jubilant's technical expert in this investigation.
14

PUBLIC VERSION
mobility, operational simplicity, and minimizing radiation exposure to the operator. See FID at
41-42(citing Klein at RX-106.24-25, 27,29, 38,44,46, 141; Hr'g Tr. at 623:9-22(Stone)
(describing the difficulty ofrepeatedly rolling the cart back to a stationary dose calibrator)),
619:17-620:1, 622:23-624:1 (Stone)(testifying that it would have been obvious to a person of
ordinary skill in the art using the Klein system for commercial clinical applications to put
components used together on the same cart)).
The Commission also finds that clear and convincing evidence in the record establishes
that the combination of Klein with Tate or Medrad teaches or discloses a "shielded well on-board
the cart." The parties did not dispute that Tate/Medrad disclose infusion systems that place dose
calibrators(shown below in blue) on-board the cart. See Jubilant's Resp. at 40(citing Tate at
RX-103.5, Figure 1D; Medrad at RX-200C.18(both reproduced below as annotated)).
FIG. 1D
Tate at RX-103.5, Figure 1D (annotated) Medrad at RX-200C.18(annotated)
Bracco argued that Tate and Medrad are not analogous prior art and that the USPTO
found Tate to be "too far afield." See Bracco's Pet. at 70. Bracco is wrong; the USPTO
Examiner made no such finding. Indeed, neither the patentee nor the Examiner stated during
prosecution of the parent patent application that Tate was non-analogous art. Rather, the
15

PUBLIC VERSION
Examiner considered Tate relevant and pertinent prior art and cited it against the pending claims
of the parent patent application. See CX-169,Prosecution History at 2139; see also id. at 2150
•
("Tate et al. and Varrichio et al. are analogous art because they are from a similar problem
solving area of using pumps to infuse liquid into a patient."). Moreover, the patentee
distinguished Tate on the basis that it does not generate radiopharmaceuticals, not because it was
non-analogous art. See id. at 2223-2224("Tate is directed to a fluid delivery system for
delivering doses of pharmaceuticals to a patient. ... Unlike the fluid delivery system of Tate,
independent claim 1 recites a system that includes a radioisotope generator."). Subsequently,
the Examiner withdrew the rejection over Tate but nowhere suggested that she considered Tate
non-analogous or "too far afield," as Bracco contends. See id at 2243,2286. Rather, the
prosecution history suggests no more than the typical negotiation between the patentee and the
USPTO Examiner over the scope of relevant prior art.
Importantly, there is no requirement for analogous prior art to be similar in all respects.
As the FID correctly notes,"Nile field ofendeavor of a patent is not limited to the specific point
of novelty, the narrowest possible conception ofthe field, or the particular focus within a given
field." See FID at 34 (citing Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001 (Fed. Cir.
2016)). Rather, as the FID determines, Tate and Medrad are analogous because "Tate is in the
same field of endeavor as the present invention, as both are 'systems that... infuse
radiopharmaceuticals,... including computer-facilitated maintenance and/or operation." See
Ed The FID also correctly finds that "Tate was directed to at least some ofthe same problems
as the asserted patents, namely calculating and delivering accurate and effective doses of
radiopharmaceuticals to patients, while reducing the exposure of administering or other medical
personnel' caused by manual handling of samples for calibration." See id at 35 (citing Tate,
, 16

PUBLIC VERSION
RX-103.89-90; JX-1,'826 Patent at 1:25-30; Hr'g Tr. at 616:22-617:23, 867:11-17(Stone); id at
1113:25-1114:4 (Pe1c23)); FID at 33("Tate is directed to a system for use with
fluorodeoxyglucose(`FDG'), a different radiopharmaceutical than the rubidium-82 described in
the asserted patents" but "because 'radioisotopes, such as... Rubidium-82 .. .' and FDG are
useful in medical imaging due to their 'relatively short half-lives,' systems that use these
isotopes face the same problem oftracking the level of radioactivity delivered to the patient with
each dose.")(citing R)(-103.89, Tate); id. at 35-36(finding Medrad "pertinent...for the same
reasons addressed above concerning Tate"); accord Jubilant's Resp. at 26-27(citing JX-1,'826
patent at 1:25-30; Tate at RX-103.89-90, 100; Hr'g Tr. at 616:22-617:23, 867:11-17(Stone);
Hr'g Tr. at 1113:25-1114:4(Pelc)); see also id. at 27("Dr. Pelc ultimately admitted that FDG
systems and rubidium systems 'have similarities and they have differences.")(citing Hr'g Tr. at
1071:5-7(Pelc)).24
Bracco also argued that there is no motivation to combine Tate or Medrad with Klein.
See Bracco's Pet. at 74-75. Bracco focuses on the fact that Tate does not generate
radiopharmaceuticals, but that is not dispositive because, as discussed above at page 16, there is
no requirement that Tate disclose every claimed limitation. What is significant is that Tate is
analogous prior art(both Tate and Klein relate to systems that infuse radiopharmaceuticals), and
Tate discloses the missing claim limitation, i.e., Tate places the dose calibrator on-board the cart
in FDG systems. Given the design incentives discussed above and in the FID, and given that
Tate expressly discloses placing a dose calibrator on-board the cart, a person of ordinary skill in
23 Dr. Norbert J. Pelc is Bracco's technical expert in this investigation.
24 The FID also notes that "Dr. Pelc testified to the contrary" but that "his testimony [is] less
credible on this point than that of Dr. Stone's." See FID at 35 n.2 (citing Hr'g Tr. at 961:20-
962:9(Pelc)).
17

PUBLIC VERSION
the art would be motivated to combine Klein with Tate and place Klein's dose calibrator on
board Klein's cart. See, e.g., Hr'g Tr. at 623:9-22(Stone)(describing the difficulty of
repeatedly rolling the cart back to a stationary dose calibrator)), 619:17-620:1, 622:23-624:1
(Stone)(testifying that it would have been obvious to a person of ordinary skill in the art using
the Klein system for commercial clinical applications to put components used together on the
same cart); see also FID at 55("Because 'the physical process' of radioactive transfer 'is well
understood' and accounted for in Klein's model, a person of skill would know how to
successfully implement Tate's on-board dose calibrator within the Klein system.")(citing Klein
at RX-106.119); accord Jubilant's Resp. at 28. While Dr. Pelc testified that"a person of skill in
the art would read [Klein] and say, the last thing in the world I want to do is compromise the
accuracy of my dose calibrator" and "[s]o I would argue that Klein teaches against making the
change proposed by Dr. Stone," the Commission finds that such testimony is conclusory and not
credible in view of the level of skill in this art.25 See Hr'g Tr. at 978:2-979:13 (Pelc).
The combination of Klein with Tate or Medrad "simply arranges old elements with each
performing the same function it had been known to perform' and yields no more than one would
expect from such an arrangement." Sundance, Inc. v. DeMonte Fabricating Ltd,550 F.3d
1356, 1367(Fed. Cir. 2008)(citing KSR,550 U.S. 417); see also KSR,550 U.S. at 417("When a
work is available in one field of endeavor, design incentives and other market forces can prompt
variations ()fit, either in the same field or a different one."), id. ("[I]f a technique has been used
to improve one device, and a person of ordinary skill in the art would recognize that it would
25 See FID at 20("A person of ordinary skill in the art at the time ofthe inventions described in
the asserted patents would have at least a master's degree in physics, electrical engineering,
systems engineering, mechanical engineering, or a related field with at least two years of work
experience with designing and/or developing nuclear medical devices or medical imaging
devices."). The parties do not contest this level of skill in the art.
18

PUBLIC VERSION
improve similar devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill.").
Thus,the Commission finds that Jubilant has established by clear and convincing
evidence that Klein, alone or in combination with Tate/Medrad,teaches or discloses claim
limitation (i). Accordingly, the Commission has determined to affirm and supplement the FID,
as discussed above.
(ii) Claim Limitation (ii)
The parties disputed whether Klein teaches or suggests claim limitation (ii), i.e.,"a first
shielding compartment" having "a first opening facing vertically upwardly." In particular, the
parties disputed whether Klein's stack of lead rings teaches or discloses the "first shielding
compartment" because the rings do not "completely enclose" the generator. See FID at 46;
Bracco's Pet. at 58.
The FID finds that Klein's "stack oflead rings on the shelf housing the generator... is a
'first shielding compartment' [i.e., claim limitation (ii),] as that term is understood by those of
skill in the art." See FID at 46(citing Hr'g Tr. at 727:6-14(Stone)). The FID states that"when
Klein's generator is in place for use, as shown in Klein Figure 2-3, the cart shelfforms a solid
bottom for the compartment and there is no opening facing downwards." See id. (citing Klein at
R)(-106.33); accord Jubilant's Resp. at 59-62(citing Klein at RX-106.33-34, Figure 2-3,
reproduced below as annotated). The FID further notes that "even if the Klein compartment did
have a bottom opening, nothing in the claim language would prohibit such a feature." See FID
at 46.
19

PUBLIC VERSION
Bracco disagreed and argued that the stack oflead rings is not a shielding compartment
because it is "an open-ended cylinder, and at least the bottom opening prevented the stack of
rings from being the requisite shielding compartment." See Bracco's Pet. at 56 (citing (Hr'g. Tr.
at 995:22-996:17 (Pelc)).
The Commission agrees with the FID that Klein's stack of lead rings corresponds to a
"first shielding compartment." As the FID notes,"claim 1 does not require the compartment to
be completely enclosed" and Klein's "stack oflead rings on the shelf housing the generator... is
a 'first shielding compartment' [i.e., claim limitation (ii),] as that term is understood by those of
skill in the art." See FID at 46(citing Hr'g Tr. at 727:6-14(Stone)); accord Jubilant's Resp. at
61 ("The claims merely require that the compartment provide shielding, and Klein's rings
indisputably do)(citing Klein at RX-106.33("Mead rings [] provide maximum radiation
shielding.")); see also IA's Pet at 36-37. The Commission also agrees that Dr. Pelc's testimony
20

PUBLIC VERSION
that "the word 'compartment' in the claim requires structure that must 'completely enclose' a
portion of space" is unpersuasive and inconsistent with the claim language which requires that
the shielding compartment have an "opening." See FID at 46(citing Hr'g Tr. at 995:22-996:17
(Pelc)).
The Commission also finds that the FID correctly determines that Klein in combination
with Model 510 teaches or discloses claim limitation (ii), i.e.,"a first shielding compartment"
having "a first opening facing vertically upwardly." As the FID finds,"[i]t is... beyond
dispute that the Model 510 has shielding compartments with openings facing vertically
upwards." See FID at 57. Moreover,"as Dr. Stone credibly testified, a person of ordinary skill
would be motivated to incorporate the upward-facing openings ofthe Model 510 in order to
reduce radiation exposure of operators." See id. (citing Hr'g Tr. at 666:2-15(Stone)(vertical
openings in shielding "very common" as "it allows a user to approach a radioisotope source and
be able to get easy access to it without being exposed to radiation")); accord Jubilant's Resp. at
62-63 (citing RX-357.10, reproduced below, as annotated).
21

PUBLIC VERSION
Thus, design incentives would have motivated a person of ordinary skill in the art to
combine Klein with Model 510 to arrive at the claimed invention. See KSR,550 U.S. at 417
("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.").
Thus, the Commission finds that Jubilant established by clear and convincing evidence
that Klein, alone or in combination with Model 510,teaches or discloses claim limitation (ii).
Accordingly, the Commission has determined to affirm and supplement the FID, as discussed
above.
(iii) Claim Limitation (iii)
As noted in the FID,the parties agreed that "Klein does not expressly show [that] the
opening at the top ofthe shielded generator compartment [is] at a lower elevation tha[n] the
opening at the top ofthe shielded waste bottle compartment"(claim limitation (iii)). See FID at
48. The FID finds that "claim element [(iii)] would be an obvious design choice in view of
Klein, which discloses every component ofthe claimed invention in only a slightly different
physical configuration." See id. at 49(citing KSR,550 U.S. at 421). The FID reasons that
"[w]hen considering the arrangement ofthe openings ofthe generator compartment and the
waste bottle compartment, the skilled artisan would have three choices: the generator
compartment opening could be at a higher elevation than the waste bottle compartment opening,
the two openings could be at the same elevation, or the generator compartment opening could be
at a lower elevation than the waste bottle compartment opening." See id at 48; accord Jubilant's
Resp. at 42-43. The FID also finds that the common specification ofthe asserted patents
"entirely lacks any teaching of advantage to having the generator compartment opening higher
than the waste bottle compartment opening." See FID at 48-49.
22

PUBLIC VERSION
The FID thus finds that "[a] skilled artisan would find the arrangement in claim element
[1.1.e] obvious even without consulting the Chaffin ergonomics reference." See id. The FID
further states that "[t]o the extent that any teaching of Chaffin is necessary to arrive at the
claimed invention, the claimed invention is obvious in view of Klein, Tate, and Chaffin." See
Id. at 56. The FID reasons that "[t]he generator in Klein is a weighty object that must be moved
by a human every two months...,and an ordinary skilled designer would look to references
like Chaffin to understand best practices for positioning the generator on the cart." See id.
(citing Klein at RX-106.18-19); accord Jubilant's Resp. at 29-31; IA's Resp. at 26.
Bracco responded that Jubilant's corporate witness, Mr. Donnelly, testified that "it's
common in the industry that you don't make changes if not necessary." See Bracco's Pet. at 43
(citing Hr'g Tr. at 349:7-19(Donnelly)). Bracco also argued that "there simply is not room in
the Klein Thesis's cart to access the generator in its shielding if moved to the lower shelf." See
id. at 44.
The Commission finds that Jubilant established by clear and convincing evidence that
Klein, alone or in combination with Chaffin or Bracco's Model 510, teaches or discloses claim
limitation (iii). The Commission agrees with the FID that the generator elevation is an obvious
design choice. See FID at 48-49. In addition, Chaffin supplies the motivation to have the
generator at a lower elevation to "minimize the distance required to lift [heavier objects], thus
reducing strain or injury to the person lifting the object." See id. at 56 (citing Chaffin, RX-96.170-
178); accord IA's Resp. at 26. As noted by Jubilant,"Chaffin's teachings are clear, straightforward,
and highly relevant to the design of medical devices.... The ID commits no error in finding this
subject matter obvious over Klein and Chaffin." Jubilant's Resp. at 45-46 (citing Hr'g Tr. at
1083:6-15 (Pelc)("I think that a designer of medical instruments would think about ergonomics,
yes."); id. at 46("Dr. Stone's testimony...and other record evidence provide further support for the
23

PUBLIC VERSION
[FID's] findings. For example, Bracco's prior art product, the Model 510, placed generators at a
low elevation in a cart, also.")(citing R)(-357, Model 510, reproduced above)); see also Hr'g Tr.
618:5-619:16 (Stone). Thus, design incentives would have motivated a person of ordinary skill
in the art to combine Klein with Chaffin or Model 510 to arrive at the claimed invention. See
KSR,550 U.S. at 417("When a work is available in one field ofendeavor, design incentives and
other market forces can prompt variations of it, either in the same field or a different one.").
The Commission further finds Bracco's argument that there is no "room in Klein's cart to
access the generator in its shielding if moved to the lower shelf' unpersuasive. As Jubilant
argued,"[a] skilled worker simply would select a larger cart to accommodate additional
components." See Jubilant's Resp. at 45;see also Tokai Corp. v. Easton Enters., Inc., 632 F.3d
1358, 1371-72(Fed. Cir. 2011)("It would have been obvious to one of ordinary skill and
creativity to adapt the safety mechanisms ofthe prior art cigarette lighters, as disclosed in [the
prior art], even if it required some variation in the selection or arrangement of particular
components.").
Accordingly, the Commission has determined to affirm and supplement the FID with
respect to claim limitation (iii), as discussed above.
(iv) Claim Limitation (iv)
Claim limitation (iv)requires "configuring a computer to fill an on-cart reservoir with a
sample ofradioactive material, determine a strontium breakthrough test result on the sample, and
not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an
allowed limit." See FID at 49. The FID finds that although "Klein does not teach a computer
interacting with a sample on-board the cart... Klein expressly discloses a computer ...[which]
controls a pump and valves to fill the dose calibrator reservoir with a test sample" and which
"operate[s] a 'daily protocol,'[to] determine[] a strontium breakthrough test result on the
24

PUBLIC VERSION
sample." See id. at 50(citing Hr'g Tr. at 755:21-756:3 (Stone); Klein at RX-106.28-29, 39).
See id at 50; accord Jubilant's Resp. at 47-53; IA's Resp. at 32-34. The FID also finds that
Klein discloses "a sample screenshot in Figure 3-12(c), which shows some elution test runs
grayed out to prevent user selection" and "the conditionality of'options presented to the user' for
starting a run,[include that] the software interface 'ensures that the daily protocol is followed,
including a flush and calibration (including a test of breakthrough activity) at the start of each
day." See id. at 51 (citing Klein at RX-106.64-65). The FID concludes that "[v]iewed
together, these teachings indicate that the user would not be able to select the radio button on the
touchscreen for a patient elusion without a successful breakthrough test." See id.
Bracco argued that "Klein only describes how the computer facilitates taking
measurements to test for strontium breakthrough, and does not 'lock out' the system if
breakthrough is detected." See Bracco's Pet. at 46. Bracco stated that "there is no dispute that
Klein's computer requires running the daily protocol, and that the daily protocol includes taking
activity measurements that can be used to perform breakthrough testing," but that "[t]here's
nothing in the Klein thesis that says that based on the calculation ofthe breakthrough test, the
computer prevents patient elutions." See id. at 49(citing Hr'g Tr. at 983:7-9(Pelc)). Bracco
also acknowledged that Klein discloses that "[o]nce the daily [strontium-breakthrough] protocol
has been completed successfully, patient elutions are enabled until the end ofthe day." See id.
at 50(citing Klein at RX-106.28). Bracco, however, argued that this is merely "an instruction to
the operator," and "it's up to the operator to decide whether to carry on the patient elutions."
See id. (citing Hr'g at 1077:25-1078:7(Pelc)).
The Commission agrees with the FID that Klein's computer teaches or discloses claim
limitation (iv). See FID at 49-54. Dr. Pelc's opinion is unpersuasive and inconsistent with
25

PUBLIC VERSION
Klein. In particular, Dr. PeIc's opinion cannot be reconciled with Klein's express disclosure
that "[t]he system must ensure compliance with the daily protocol... and successful
breakthrough measurement must be completed in order to enable patient elutions for the
remainder ofthe day." See Klein at RX-106.39(emphasis added); accord IA's Resp. at 34. As
noted by Jubilant,"Klein discloses that the computer performs a daily protocol, which ensures
that the system is in proper operational order," "[a]t midnight each night, the computer disables
patient infusions," and "[i]t re-enables them only after a daily 'flush' run and a successful
'calibration' run are performed." Jubilant's Resp. at 48 (citing Klein at RX-106.27-29). "Only
after a calibration run with low Sr breakthrough has been successfully completed can patient
elutions be carried out." See id. at 49(citing Klein at RX-106.28).
Thus, the Commission finds that Jubilant established by clear and convincing evidence
that Klein teaches or discloses claim limitation (iv), i.e.,"configuring a computer to fill an on-
cart reservoir with a sample ofradioactive material, determine a strontium breakthrough test
result on the sample, and not allow a patient infusion if the strontium breakthrough test result is
greater than or equal to an allowed limit." Accordingly, the Commission has determined to
affirm and supplement the FID, as discussed above.
(v) Claim Limitation(v)
The parties disputed whether Klein, alone or in combination with Tate/Medrad, teaches
or suggests two tubing passageways configured so that tubing is not pinched or crushed, i.e.,
claim limitation (v). The FID finds that "Klein does not show two passageways formed in the
perimeter surface ofthe opening of a compartment that has all ofthe features ofthe generator
compartment required by claim 1, from which claim 13 [ofthe '826 patent] depends" but that
"Klein's teachings would make such an arrangement obvious to person ofordinary skill." See
26

PUBLIC VERSION
FID at 73. The FID reasons that "Klein provides a person of ordinary skill with motivation to
avoid crushing or pinching tubing lines running into or out of a shielding compartment when the
lid ofthat compartment is closed." See id. (citing Klein at RX-106.76("high pressure is an
indication of a blockage or pinched line and could result in backwash through the pump head or
rupturing ofthe saline lines.")); accord Jubilant's Resp. at 54-58; IA's Resp. at 27.
The FID also finds that claim limitation(v)is obvious over Klein in combination with
Tate/Medrad. See FID at 74-77. The FID reasons that "Tate discloses forming a passageway
in the perimeter surface of the opening into a shielded chamber for the radiopharmaceutical
source." See id. at 75 (citing Tate, RX-103.19). The FID explains that "Tate's shielded well
(element 111, shown in yellow below) has a first opening in the top surface ofthe cart" and
"Tate discloses a trough (element 113, shown in green below)formed in the perimeter surface of
that opening allowing a tubing line (element 210, shown in blue below)to pass into the shielding
compartment without being crushed while a cap (element 684)is closed over the top ofthe
compartment." See id. (citing Tate, RX-103.19(Figure 6E,reproduced below)). And
laPthough Tate teaches only one passageway and one tubing line," the FID continues,"Klein
teaches two tubing lines." See id. at 76. The FID finds that "[d]uplicating the tubing
passageways of either Tate or Klein, to provide separate passageways for both the tubing line
into and out ofthe generator, would have been obvious to one of skill in the art." See id. (citing
In re Harza, 274 F.2d 669,671 (C.C.P.A. 1960)(duplication of elements is not patentable unless
a new or unexpected result is produced); Hr'g Tr. at 702:7-12(Stone)).
27

PUBLIC VERSION
FIG.
Thus,the FID concludes,"a person of ordinary skill would be motivated, as noted above,
to incorporate Tate's passageway when moving the tubing below the top surface of Klein's cart
in order to avoid crushing oftubing lines." See id. at 75-76 (citing Tate at R)(-103.19,93; RX-
200C, Medrad at 18); accord IA's Resp. at 27-28; Jubilant's Pet. at 58-59.
Bracco argued that "neither Jubilant nor Staff identified any tubing passageways in
Klein" and that "Jubilant's technical expert admitted at the hearing that Klein does not disclose
this claim element." See Bracco's Pet. at 53(citing Hr'g Tr. at 822:13-823:8 (Stone)). But
Bracco did not address the FID's findings that claim limitation(v)is obvious over Klein in
combination with Tate or Medrad (Bracco only disputed that Klein and Tate/Medrad are
analogous art). See Jubilant's Pet. at 58-59.
The Commission agrees with the FID that Klein, alone or in combination with Tate or
Medrad, teaches or discloses claim limitation (v). As the FID finds,"Klein provides a person of
ordinary skill with motivation to avoid crushing or pinching tubing lines running into or out of a
28

PUBLIC VERSION
shielding compartment when the lid ofthat compartment is closed." See FID at 73(citing Klein
at RX-106.76). In addition, there is motivation to combine Klein with Tate or Medrad. See id.
at 75-76. Bracco did not dispute the FID's findings with respect to Klein in combination with
Tate or Medrad. And while Bracco argued that Tate and Medrad are not analogous art, the
Commission disagrees as explained supra section (III)(A)(2)(i). The Commission finds that the
FID correctly determined that "a person ofordinary skill would be motivated...to incorporate
Tate's passageway when moving the tubing below the top surface of Klein's cart in order to
avoid crushing oftubing lines." See FID at 75-77(citing Klein at RX-106.46; Tate at R)(-
103.19, 93; Hr'g Tr. at 702:7-12(Stone), 822:13-823:2(Stone)); see also id. ("[A] person
looking to commercialize Klein would be motivated to cover the visible tubing lines along the
top surface ofthe cart, as those lines can be a source ofradiation exposure.")(citing Klein at RX-
106.46; Hr'g Tr. at 617:20-22(Stone)). Thus, design incentives would have motivated a person
of ordinary skill in the art to combine Klein with Tate or Medrad to arrive at the claimed
invention. See KSR,550 U.S. at 417("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.").
For the reasons stated in the FID as supplemented above,the Commission finds that
Jubilant established by clear and convincing evidence that Klein, alone or in combination with
Tate or Medrad, teaches or discloses claim limitation (v). Accordingly, the Commission has
determined to affirm and supplement the FID, as discussed above.
(vi) Claim Limitation (vi)
The FID finds that Klein discloses the elements of an "opening through the top surface"
and the first / second "door" elements, which are recited in claim 1 ofthe '869 patent(claim
29

PUBLIC VERSION
limitation (vi)). See FID at 85-86. The FID finds that Klein expressly discloses a "Generator
Access Lid" on top surface of the exterior shell ofthe cart." See id. at 84 (citing Klein at RX-
106.34(Figure 2-4), indicating "Generator Access Lid" on top surface of cart, reproduced
below).
The FID explains that "the Generator Access Lid disclosed in Klein is positioned over
both the shielded generator compartment and the shielded waste bottle compartment." See id. at
85 (citing Hr'g Tr. at 661:19-662:12(Stone))(crediting the testimony of Dr. Stone that the
opening beneath the lid would allow the waste bottle to be inserted and removed from the
shielded waste container). The FID further finds that "the Generator Access Lid disclosed in
Klein is a door," i.e., the first door. See id. at 86(citing Hr'g Tr. at 665:11-666:1 (testimony of
Dr. Stone that Klein had "an access door ... that could give access to the generator"), 686:1-24
(testimony of Dr. Stone that: "doors are conventional structures for shielding in my entire history
oflooking at radioisotopes and radioactive sources. They are very common."). Still further,
30

PUBLIC VERSION
the FID finds that "Klein discloses that the shielded waste compartment has a lid," i.e., the
second door, and "[t]hat lid is a door." See id. (citing Klein at RX-106.35 ("the waste container
was mounted on the top shelf inside a lead container with a lid," i.e., the second door)).
Bracco argued that "the [FID]incorrectly [finds] that Klein discloses the element of an
'opening through the top surface' and the first / second 'door' elements"(claim limitation (vi)).
See Bracco's Pet. at 60. Bracco faults the FID for "erroneously" relying on a document(a high
quality copy ofthe Klein thesis) that is not in evidence and that is inconsistent with expert
testimony relating to this claim element. See id. In addition, Bracco argued that the FID fails
to explain how "the Generator Access Lid can be both 'the opening through the top surface of
the exterior shell' and a first door 'accessible via the opening through the exterior shell." See
id. at 62-63.
The Commission finds clear and convincing evidence that Klein teaches or discloses the
claimed "opening" and first and second "door" elements. As noted by the IA,even though the
outline ofthe generator access lid is not visible,"the annotated Klein figure discloses under no
uncertain terms that a lid to access the generator exists on the top surface ofthe exterior shell ofthe
cart." See IA's Resp. at 29(citing Klein at RX-106.34, Figure 2-4, reproduced above); accord
Jubilant's Resp. at 64-68. Thus,the Commission agrees with the IA that the absence ofthe "high
quality copy ofthe Klein thesis" from the record "does not alter the fact that the [FID]cited and
discussed figure 2-4" and that figure "expressly discloses the generator access lid that logically
covers an opening on the exterior top surface ofthe shell." See IA's Resp. at 29.
The Commission also disagrees with Bracco that the FID conflates the opening with the door
elements. The FID makes clear that the "door" is the "lid" and that the opening which is "beneath
the lid would allow the waste bottle to be inserted and removed from the shielded waste container."
See FID at 85 (citing Hr'g Tr. at 661:19-662:12(Stone)); id. at 86(stating that the "opening" is
31

PUBLIC VERSION
covered by the Generator Access Lid, i.e., the first door)(citing Klein at RX-106.34, Figure 2-3));
see also Hr'g Tr. at 665:11-666:1 (Stone)(testifying that Klein had "an access door...that
could give access to the generator"); accord Jubilant's Resp. at 66-67.
The FID also correctly determines that "Klein discloses that the shielded waste compartment
has a lid," i.e., the second door. See FID at 86(citing Klein at RX-106.35 (stating that "the waste
container was mounted on the top shelf inside a lead container with a lid," i.e., the second door));
accord Jubilant's Resp. at 67. Furthermore, the Commission finds that the FID properly relies
on Dr. Stone's credible testimony that doors are "conventional" and "common" in this art. See
FID at 86(citing Hr'g Tr. at 686:1-24(Stone)(testifying that "doors are conventional structures
for shielding in my entire history oflooking at radioisotopes and radioactive sources" and that
"Whey are very common")).
Thus, the Commission finds that Jubilant established by clear and convincing evidence
that Klein teaches or discloses claim limitation (vi). Accordingly, the Commission has,
determined to affirm and supplement the FID, as discussed above.
(vii) Claim Limitation (vii)
The FID finds that Klein, alone or in combination with IEC 62366,teaches or discloses
the reminders, warnings, or alerts recited in claim limitation (vii). See FID at 61-63. Bracco
disputed that Klein teaches a touch screen display showing "a screen reminding a user to insert
the eluate reservoir" and "the strontium breakthrough test result." See Bracco's Pet. at 64-65.
The FID explains that "the computer in Klein's system communicates with the dose
calibrator at the start ofthe daily protocol to make sure that the calibrator has the 'proper
settings' and "[i]f something is wrong with the dose calibrator,'warnings are presented to the
user with detailed explanations.' See FID at 61 (citing Klein at RX-106.65). The FID further
finds that "Klein also describes how to use a sensor to detect a physical property of a reservoir
32

PUBLIC VERSION
and issue a warning if a user attempts to start an elution with the reservoir in the wrong
condition." See id. (citing Klein at RX-106.44-45)(describing an overflow sensor in the waste
reservoir). The FID concludes that "[i]n light ofthese disclosures, a person of ordinary skill in
the art would find it obvious to display a reminder to the user to insert the eluate reservoir ifthe
user attempts to start the calibration run without doing so." See id. at 62. The FID concludes
that "Klein alone renders the reservoir reminder obvious" but"No the extent that any teaching
ofIEC 62366 is necessary to arrive at the claimed invention, the invention is obvious in view of
Klein and IEC 62366." See id. at 63.
The FID also finds that "Klein expressly discloses a touch screen display ofthe strontium
breakthrough test result." See id (citing Klein at RX-106.64(Fig. 3-12(f) and (g)); id. at RX-
106.41 ("On successful completion a grey screen must list statistics relevant to the elution ... a
separate window must list a comprehensive display of all statistics in addition to activity
curves"); id. at RX-106.65); accord IA's Resp. at 38. In the alternative, the FID continues,"a
person of ordinary skill in the art would find it obvious to display the results ofthe Klein
system's breakthrough tests on Klein's touch screen." See FID at 62.
Bracco argued that "Dr. Stone admitted that the Klein thesis does not disclose
configuring a computer to present on a touch screen display a screen reminding the user to insert
the eluate reservoir in the shielded well on-board the cart." See Bracco's Pet. at 65 (citing Hr'g
Tr. at 819:8-13 (Stone)). Bracco further argued that "Mlle [FID's] cited figures and text from
Klein do not depict or mention the strontium breakthrough test result." See id. at 66.
The Commission finds that the FID correctly determines that the elements relating to the
eluate reservoir reminder and the strontium breakthrough test result (i.e., claim limitation (vii))
are obvious over Klein alone or in combination with IEC 62366. As noted by the FID,
33

PUBLIC VERSION
"Klein... describes how to use a sensor to detect a physical property of a reservoir and issue a
warning if a user attempts to start an elution with the reservoir in the wrong condition." See FID
at 61 (citing RX-106.44-45). And as noted by the IA,"[w]hether it is called a 'warning' or a
'reminder,' it is unreasonable to argue that this disclosure is somehow insufficient to disclose to
a person of ordinary skill in the art that a warning or reminder to insert an eluate reservoir in the
dose calibrator can be displayed on the screen." See IA's Resp. at 37-38; accord Jubilant's
Resp. at 72("[A] skilled worker would have considered it obvious to display a reminder to insert
an eluate reservoir if the user attempted to start a calibration run without doing so."). The
Commission also agrees with Jubilant that "Nile [IEC 62366] standard teaches medical device
developers to build user interfaces that instruct users ofthe correct use of consumables," e.g.,
eluate, including "the remaining amount ofthem." See id. at 74.(citing IEC 62366, RX-114.63).
The Commission further agrees that there is motivation to combine Klein with IEC 62366. See
Id at 75 (citing Hr'g Tr. at 1083:20-22(Pelc)); see also KSR,550 U.S. at 417("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. Ifa person ofordinary skill can
implement a predictable variation, § 103 likely bars its patentability.").
With respect to the "strontium breakthrough test result," the Commission finds that the
FID correctly determines that "Klein expressly discloses a touch screen display ofthe strontium
breakthrough test result" or, in the alternative, that "a person of ordinary skill in the art would
find it obvious to display the results ofthe Klein system's breakthrough tests on Klein's touch
screen." See FID at 62(citing Klein at RX-106.64(Figures 3-12(f) and (g)), RX-106.41 ("On
successful completion a grey screen must list statistics relevant to the elution... a separate
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PUBLIC VERSION
window must list a comprehensive display of all statistics in addition to activity curves"), RX-
106.65).
The Commission also agrees with the IA that "[i]t defies logic that Klein would disclose
'comprehensive display of all statistics' and 'test for communication and proper settings' with a
confirmation that `display[s]... all the inputs for the user to review,' but then specifically not
display the result ofthe breakthrough test, whether it is measurement made by the system or
calculated by the system." See IA's Resp. at 38; accord Jubilant's Resp. at 73 (citing Klein at
RX-106.64, Figures 3-12(f) and (g), reproduced below); see also id. (citing Klein at RX-106.18-
19)("As Klein explains, the strontium breakthrough level is the most significant statistic
obtained from a calibration run.").
Klein at RX-106.64(Figure 3-12(f)) Klein at RX-106.64(Figure 3-12(g))
Thus,the Commission finds that Jubilant established by clear and convincing evidence
that Klein, alone or in combination with IEC 62366,teaches or discloses claim limitation (vii).
Accordingly, the Commission has determined to affirm and supplement the FID, as discussed
above.
(viii) Conclusion
Accordingly, the Commission finds that Jubilant established by clear and convincing
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PUBLIC VERSION
evidence that the asserted prior art teaches or discloses all ofthe limitations ofthe Asserted
Claims.
3. Secondary Considerations
The FID finds that Bracco provided no evidence on the nexus between the claimed
invention and the asserted indicia of non-obviousness, and instead "rel[ied] on an erroneous
presumption of nexus." See FID at 114. The FID also suggests that the presumption only
applies to the "commercial success" factor, which "Bracco does not advance." See id. at 113.
The Commission agrees with Bracco that the FID incorrectly limits the presumption of nexus to
"commercial success." See WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330 n.4(Fed. Cir. 2016)
(stating that the presumption of nexus is not limited to commercial success but applies to other
indicia of non-obviousness including praise and copying).
The FID does analyze Bracco's indicia of non-obviousness "as if nexus had been shown"
and concludes that they are unpersuasive and [deserve] little weight. See id. at 114. With
respect to copying, the FID finds "strong evidence that Jubilant did not copy Bracco's design"
and that the "circumstantial evidence on which Bracco relies" to establish such copying is
"weak." See id. at 114-19; accord Jubilant Resp. at 77-80. The FID therefore determines to
"accord no weight to this factor." See FID at 119.
As to "long felt but unresolved need," the FID finds that "Bracco points to no competent
evidence tied to the novel elements ofthe asserted patents showing [such] long felt but unmet
need." See id. at 119; accord Jubilant Resp. at 81-82. The FID reasons that "Klein describes
no unsolved need" and that "having the dose calibrator on the bench was not a problem because,
as explained above, it could just as easily be placed on the cart." See FID at 120. The FID
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PUBLIC VERSION
further states that "[i]t was a matter of design choice, not a matter oftechnical impediment."
See id.
The FID similarly rejects Bracco's arguments with respect to "failure of others." See id.
at 120-21; accord Jubilant Resp. at 83-85. The FID reasons that "Jubilant's Version 2.0
[product] was rejected by the FDA not because it lacked an on-board dose calibrator or any other
features ofthe asserted patent claims but because it was not developed in compliance with FDA
guidelines." See FID at 121.
Bracco responded that the prestunption of nexus is not limited to commercial success.
See Bracco's Pet. at 82(citing WBIP,829 F.3d at 1329-30); accord Jubilant's Resp. at 76-77.
With respect to copying, Bracco argued that Jubilant hired Bracco's former employees, including
"one ofthe named inventors ofthe asserted patents, Ms. Gelbach, as the Ruby-Fill product
manager." See Bracco's Pet. at 87. Bracco also argued that contrary to the FID's suggestion,
copying does not require the presence of a "commercial product." See id. at 89(citing DePuy
Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1328-29(Fed. Cir. 2009)).
With respect to "long-felt need," Bracco argued that "there is substantial evidence that as
early as 2003 there was an unmet need for a rubidium-based elution system configured for more
efficient set up, maintenance and operation as described in the asserted patents." See id. at 90-
92. Bracco further argued that "the inventions described in the asserted patents met this long-
felt need because they provide for a system that reduces user input during set up, maintenance
and operational procedures for each patient administration." See id. at 92.
Bracco also faults the FID for rejecting its arguments relating to "failure of others." See
id. at 92-94. Bracco contends that "the evidence demonstrated that Jubilant failed to
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PUBLIC VERSION
commercialize an elution system until it gained access to Bracco's know-how in the form of
published patent applications, and hiring Bracco's employees and contractors." See id at 94.
After examining Bracco's arguments, the Commission finds that Bracco established
copying, although not long-felt need or failure of others. Specifically, with respect to "long-felt
need" and "failure of others," the Commission agrees with the FID that the evidence merely
points to the passage of time rather than any specific or discernible unmet need. See FID at 119.
The Commission also agrees with the FID that placing the dose calibrator on-board a cart was"a
matter of design choice, not a matter oftechnical impediment." See id at 120.
The Commission, however, agrees with Bracco that copying does not require a
commercial product but may be based on a published patent or patent application, which in
Bracco's case, was published in December 2009. See DePuy Spine, 567 F.3d at 1329("[W]e
agree with the district court that [defendants'] initial attempt at making a rigid pedicle screw
without a compression member,together with [defendants] prompt adoption ofthe claimed
feature soon after the patent issued, are relevant indicia of nonobviousness."). The record
evidence, particularly the documentary evidence, shows that Jubilant designed a rubidium
elution system with an on-board dose calibrator right around the time that Jubilant hired several
Bracco former employees, including Ms. Gelbach, one ofthe inventors ofthe Asserted Patents.26
See CX-386C (showing correspondence dated July 28,2010 discussing the design of Jubilant's
Version 3 product which includes an on-board dose calibrator); Hr'g Tr. 1046:15-20(Pelc).
Jubilant also hired North Pole Engineering, a software technology firm that worked with Bracco
on the technology described in the Asserted Patents, which resulted in multiple North Pole
26 The FID assigns little or no weight to the testimony of Messrs. Donnelly and Riddoch on this
issue. See FID at 117. The Commission similarly disregards that testimonial evidence and
finds the documentary evidence more persuasive.
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PUBLIC VERSION
Engineering team members being named as inventors on the asserted patents. See id. at
1029:16-18 (Pelc); id at 1042:20-1044:4(Pelc); CX-396C; accord Bracco's Pet. at 88. The
evidence also shows that those employees were directly involved in design decisions for
Jubilant's Version 3 Ruby-Fill product, which unlike the Versions 1 and 2, included the claimed
on-board dose calibrator. See JX-13C; Hr'g Tr. at 1038:2-1039:11 (Pelc). And even though it
is not clear whether Jubilant had a copy ofthe published patent publication, Jubilant had
knowledge ofthat patent application or the substance ofthat application at least as ofthe date
that Ms. Gelbach was hired in July 2010. Thus, the Commission finds sufficient circumstantial
evidence in the record to establish copying in this case, at least with respect to the on-board dose
calibrator.
Nevertheless, the Commission finds that the evidence of copying alone is insufficient to
overcome Jubilant's strong showing ofprimafacie obviousness in this case. See Sundance, 550
F.3d at 1368("Secondary considerations of nonobviousness ... simply cannot overcome this
strong prima facie case of obviousness."); Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d
1157, 1162(Fed. Cir. 2007)(finding substantial evidence of commercial success, industry praise,
and long-felt need insufficient to overcome strong evidence ofprimafacie obviousness).
4. Conclusion
For the foregoing reasons, the Commission finds that Jubilant has established by clear
and convincing evidence that the Asserted Claims are invalid as obvious over Klein, alone or in
combination with other prior art. Accordingly, the Commission has determined to affirm with
modification and to supplement the FID as discussed above.
39

PUBLIC VERSION
B. Domestic Industry
The FID finds that Bracco has satisfied the domestic industry requirement under
subsections 337(a)(3)(A)(significant investment in plant and equipment), 337(a)(3)(B)
(significant employment of labor or capital), and 337(a)(3)(C)(substantial investment in
engineering, research, and development). See 19 U.S.C. § 1337(a)(3)(A),(B), and (C).
Specifically, the FID notes that Bracco paid its subcontractor[ ]for[ ]finished Model
1700 units and that such payment could be "a combination of(1)rent paid to[ ]for use of
[ ]plant and equipment to manufacture the[ ]Model 1700 units;(2)payment for the work of
[ ]employees who built the devices...; and(3)payment for the materials used to make
the devices." See FID at 139. Although the FID notes that "[o]nly the first category would be
considered plant and equipment," the FID finds that"a significant proportion ofthe[
payment represents a significant investment in plant and equipment relating to [Bracco's] Model
1700," in satisfaction of subsection 337(a)(3)(A). See FID at 139-40.
The FID also finds that "[i]n 2016 and 2017, Bracco invested approximately[ ]in
salaries for... employees" who support the FDA regulatory approval activities for the Model
1700 system, and that such "amount is a significant employment of labor and capital in the
United States," in satisfaction of subsection 337(a)(3)(B). See id. at 143. The FID further
credited "at least[ ]in salary to U.S.-based engineers for work on the Model 1700 in 2016
and 2017" and found that such amount qualifies as a significant employment oflabor and capital
in the United States, in satisfaction of subsection 337(a)(3)(B). See id. at 145.
Still further, the FID finds that "Bracco's expenditure of at least[ ]on[
]for services to design and develop the Model 1700 would constitute a
substantial investment in research and development to exploit the inventions claimed in the
40

PUBLIC VERSION
asserted patents, consistent with section 337(a)(3)(C)" and that "[t]he same[
investment also would constitute a substantial employment of capital, consistent with section
337(a)(3)(B)." See id. at 146. The FID concludes that "[e]ven without FDA approval ...
Bracco's industry presently exists" and "the industry is not dwindling." See id. at 149.
The IA (but not Jubilant) petitioned for review ofthe FID's finding with respect to
Bracco's investment under subsection 337(a)(3)(A)(significant investment in plant and
equipment). The IA argued that "[t]he [FID] does not cite any evidence to support that 'a
significant portion ofthe[ ]payment represents a significant investment in plant and
equipment relating to the Model 1700." IA's Pet. at 7. The IA did not seek review ofthe
FID's findings of domestic industry under subsections 337(a)(3)(B) and (C). See id at 4-5.
Bracco responded that, because "[n]o party has petitioned for review ofthe [FID's]
finding that a domestic industry exists under subsections 337(a)(3)(B) and(C)... granting the
[IA's] petition would not change the determination that Bracco demonstrated that a domestic
industry exists." See Bracco's Resp. at 1. In addition, Bracco argued that there is no dispute
that "Bracco paid[ ]to purchase ...[ ]units ofthe Model 1700 cart" and that "the
[ ]Model 1700 carts constitute equipment under [subsection 337(a)(3)(A)]." See id at 1-2.
The Commission agrees with the IA that the FID does not cite any evidence to support its
finding that"a significant portion ofthe[ ]payment represents a significant investment
in plant and equipment relating to the Model 1700." See FID at 139-40; Lelo Inc. v. Intl Trade
Comm 'n, 786 F.3d 879, 884-85 & n.4(Fed. Cir. 2015). Thus,the Commission has determined
to vacate the FID's findings with respect to the domestic industry under subsection 337(a)(3)(A).
41

PUBLIC VERSION
Because, however, Bracco has established that a domestic industry exists under
subsections 337(a)(3)(B) and (C),the Commission affirms the FID's conclusion that Bracco has
satisfied the domestic industry requirement/7
IV. CONCLUSION
For the foregoing reasons, the Commission has determined to affirm the FID with
modification. The Commission supplements the FID's findings and conclusion of no violation
of section 337 as discussed herein.
By order ofthe Commission.
Lisa R. Barton
Secretary to the Commission
Issued: December 11, 2019
27 Commissioner Kearns observes that, because FDA regulatory approval is required for a
strontium rubidium infusion system from any source, efforts to obtain FDA regulatory approval
may not on their own distinguish a complainant's activities from those of an importer. He
notes that the evidence submitted by Bracco does not describe the types of FDA-related activities
its employees performed, including whether the activities are of a nature that can only be
performed in the United States. See Rx-310C,1141113-14. He finds that the evidence cited in
the FID on expenses for engineering and development related to the Model 1700 system
performed by Bracco and by the[ ]are sufficient to establish a domestic
industry under section 337(a)(3)(B).
42

CERTAIN STRONTIUM-RUBIDIUM RADIOISOTOPE
INFUSION SYSTEMS,AND COMPONENTS THEREOF
INCLUDING GENERATORS
PUBLIC CERTIFICATE OF SERVICE
Inv. No.337-TA-1110
I, Lisa R. Barton, hereby certify that the attached OPINION has been served by hand upon the
Commission Investigative Attorney, Brian Koo,Esq., and the following parties as indicated, on
December 11,2019.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW,Room 112
Washington, DC 20436
On Behalf of Complainant Bracco Diagnostics Inc.:
Mark G. Davis, Esq.
GOODWIN PROCTER LLP
1900 N Street, NW
Washington, DC 20036
On Behalf of Respondents Jubilant DraxImage Inc., Jubilant
Pharma Limited, and Jubilant Life Sciences:
T. Cy Walker, Esq.
Baker & Hostetler, LLP
1050 Connecticut Avenue,NW
Washington, DC 20036
1=1 Via Hand Delivery
1E1 Via Express Delivery
1=1 Via First Class Mail
O Other:
[3 Via Hand Delivery
El Via Express Delivery
El Via First Class Mail
El Other:

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN STRONTIUM-RUBIDIUM . .
RADIOISOTOPEINFUSIONSYSTEMS, I“"°s"g“"°“ N°' 337'TA'm0
AND COMPONENTS THEREOF
INCLUDING GENERATORS
NOTICE OF COMMISSION DETERMINATION TO REVIEW IN PART A FINAL
INITIAL DETERNIINATION FINDING NO SECTION 337 VIOLATION
AGENCY: U.S. Intemational Trade Commission.
ACTION: Notice.
SUMMARY: Notice is hereby given that the U.S. International Trade Commission has
detennined to review in part a final initial determination (“FID”) of the presiding administrative
law judge (“ALJ”) finding no violation of section 337 ofthe Tariff Act of 1930, as amended.
FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General
Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436,
telephone (202) 708-4716. 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. Intemational Trade Commission, 500 E Street
SW., Washington, D.C. 20436, telephone (202) 205-2000. General information concerning the
Commission may also be obtained by accessing its Internet server at httgs://www.usitc.gov. The
public record for this investigation may be viewed on the Commission’s electronic docket
(EDIS) at hl‘lQ.S‘.'//6dl'S.1/lSl'l‘C. gov. Hearing-impaired persons are advised that information on this
matter can be obtained by contacting the Commissiorfs TDD terminal on (202) 205-1810.
SUPPLEMENTARY INFORIVIATION: The Commission instituted this investigation on
May 1, 2018, based on a complaint, as amended, tiled by Bracco Diagnostics Inc. of Monroe
Township, New Jersey (“Complainant” or “Bracco”). See 83 FR 19112-13 (May 1, 2018). The
complaint, as amended, alleges violations of section 337 of the Tariff Act of 1930, as amended
(19 U.S.C. 1337) (“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 strontium-rubidium
radioisotope infusion systems, and components thereof including generators, by reason of
infringement of U.S. Patent Nos. 9,814,826; 9,750,869; and 9,750,870 (collectively, “the
asserted patents”). See id The notice of investigation names Jubilant Draxlrnage Inc. of
Kirkland, Québec, Canada; Jubilant Pharma Limited of Singapore; and Jubilant Life Sciences of
Noida, Uttar Pradesh, India (collectively, “Respondents” or “Jubilant”) as respondents in this
1
1

investigation. See id. The Office of Unfair Import Investigations is also a party to this
investigation. See id.
On February 8, 2019, the ALJ issued an ID (Order No. 27) finding by summary
determination that Jubilant’s RUBY Rubidium Elution System Version 3.0 directly infringes the
asserted patents. See Order No. 27 (Feb. 8, 2019), unreviewed, Conmr’n Notice (Mar. 8, 2019).
In addition, the ALJ detennined that Iubilant’s RUBY Rubidimn Elution System Version 3.1 and
the RUBY Rubidium Elution System Version 4 do not directly infringe the asserted patents. See
id. The ID (Order No. 27) declined to reach indirect infringement on summary determination.
See id.
The ALJ conducted an evidentiary hearing on February 11-12 and 15-17, 2019, and on
August 1, 2019, issued the FID finding no violation of section 337. Specifically, the FID finds
that the domestic industry requirement is satisfied and that all the asserted claims are infringed
but invalid as obvious over the prior art. In addition, the ALJ issued a Recommended
Determination (“RD”) recommending, should the Commission find a section 337 violation, that
the Commission issue a limited exclusion order (“LEO”) barring entry of articles that infringe
the asserted claims. The RD does not recommend that the Commission issue a cease and desist
order or impose a bond during the period of Presidential review. Furthennore, as directed by the
Corrnnission, the RD provides findings with respect to the public interest and recommends a
determination that the public interest factors do not preclude entry of the proposed LEO.
On August 14, 2019, both Bracco and the Comrnission’s Investigative Attorney (“IA”)
filed petitions for review of the FID. Bracco petitions for review of the FID’s findings with
respect to invalidity, while the IA petitions for review of the FID’s findings with respect to
domestic industry. On August 22, 2019, the parties filed responses to the respective petitions.
The Commission has determined to review the FID in part. Specifically, the Commission
has determined to review the FID’s findings with respect to invalidity and domestic industry.
The Commission has determined not to review the remainder of the FID. At this time, the
Commission does not request any briefing from the parties.
The authority for the Commission’s detennination is contained in section 337 of the
Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 ofthe Commissi0n’s Rules of
Practice and Procedure (19 CFR part 210).
By order of the Commission.
Lisa R. Barton
Secretary to the Commission
Issued: September 30, 2019
2

CERTAIN STRONTIUM-RUBIDIUM RADIOISOTOPE 	Inv. N0. 337-TA-1110
INFUSION SYSTEMS, AND COMPONENTS THEREOF
INCLUDING GENERATORS
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached NOTICE has been served by hand upon the
Commission Investigative Attorney, Brian K00, Esq., and the following parties as indicated, on
September 30, 2019.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112 t
‘ Washington, DC 20436
On Behalf of Complainant Bracco Diagnostics Inc.:
Mafk G~DflVi$,E$q- 	E] Via Hand Delivery
GOODWIN PROCTER LLP 	[3 via ExpressDdivew
901 New York AVenue=NW 	Via First Class Mail
Washington, DC 20001 	U Other
On Behalf of Respondents Jubilant Draxlmage Inc.. Jubilant
Pharma Limited. and Jubilant Life Sciences:
T~ CY Wa1k@Y=E$q- U Via Hand Delivery
Baker & Hostetler, LLP 	B Via Expl-assDelivery
1050 COIl1’l6CtiGL11l	Avenue, NW 	Via First Class Man
Washington, DC 20036 	E other

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN STRONTIUM-RUBIDIUM
RADIOISOTOPE INFUSION SYSTEMS, AND
COMPONENTS THEREOF INCLUDING
GENERATORS
INV. NO. 337-TA-1110
INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
RECOMMENDED DETERMINATION ON REMEDY AND BOND
Administrative Law Judge Clark S. Cheney
(August 1, 2019)
Appearances:
For the Complainant Bracco Diagnostics, Inc.:
Mark G. Davis, Esq., and Patrick J. McCarthy, Esq. of Goodwin Procter LLP of Washington, DC
Scott Bornstein, Esq., and Brian J. Prew, Esq. of Greenberg Traurig, LLP of New York, NY
For the Respondents Jubilant Draximage, Inc., Jubilant Pharma Limited, and Jubilant Life
Sciences.:
T. Cy Walker, Esq., Robert L. Hails, Esq., Jason F. Hoffman, Esq., and Michael E. Anderson,
Esq. of Baker & Hostetler LLP of Washington, DC
Jared A. Brandyberry, Esq. of Baker & Hostetler LLP of Denver, CO
Kevin P. Flynn, Esq. of Baker & Hostetler LLP of Cincinnati, OH
Lesley Grossberg, Esq. of Baker & Hostetler LLP of Philadelphia, PA
Andrew E. Samuels, Esq. of Baker & Hostetler LLP of Columbus, OH
Katrina Quicker, Esq. and Theresa M. Weisenberger, Esq. of Baker & Hostetler LLP of Atlanta,
GA
PUBLIC VERSION

II
John T. Gallagher, Esq. and James F. Harrington, Esq. of Hoffman & Baron, LLP of Syosset,
NY
PUBLIC VERSION

III
Table of Contents
I. Introduction ......................................................................................................................... 2
A. Procedural History ........................................................................................................... 2
B. The Parties ....................................................................................................................... 3
1. Complainant Bracco Diagnostics Inc. .......................................................................... 3
2. The Jubilant Respondents ............................................................................................. 3
C. The Asserted Patents ........................................................................................................ 4
1. U.S. Patent No. 9,814,826 (JX-0001) ........................................................................... 5
2. U.S. Patent No. 9,750,869 (JX-0002) ........................................................................... 5
3. U.S. Patent No. 9,750,870 (JX-0003) ........................................................................... 5
D. The Technology at Issue .................................................................................................. 5
E. The Accused Products...................................................................................................... 7
F. The Domestic Industry Products ...................................................................................... 8
II. Jurisdiction & Importation .................................................................................................. 9
A. Subject Matter Jurisdiction .............................................................................................. 9
B. Personal Jurisdiction ........................................................................................................ 9
C. In Rem Jurisdiction .......................................................................................................... 9
D. Importation ....................................................................................................................... 9
E. Standing ......................................................................................................................... 10
III. Legal Principles ................................................................................................................ 10
A. Claim Construction ........................................................................................................ 10
B. Validity .......................................................................................................................... 12
1. Anticipation ................................................................................................................ 12
2. Obviousness ................................................................................................................ 13
C. Assignor Estoppel .......................................................................................................... 14
D. Infringement ................................................................................................................... 15
1. Direct Infringement ................................................................................................... 16
2. Inducement of Infringement ..................................................................................... 16
3. Contributory Infringement .......................................................................................... 17
E. Domestic Industry .......................................................................................................... 17
1. Economic Prong ......................................................................................................... 18
2. Technical Prong .......................................................................................................... 18
IV. Level of Ordinary Skill in the Art ..................................................................................... 19
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V. Validity ............................................................................................................................. 21
A. Assignor Estoppel .......................................................................................................... 21
1. Staff Is Not Estopped .................................................................................................. 25
B. Obviousness ................................................................................................................... 25
1. The Prior Art ............................................................................................................... 26
2. Comparing the Claims to the Prior Art ....................................................................... 39
3. Secondary Considerations Bearing on Obviousness ................................................ 112
4. Conclusion ................................................................................................................ 122
C. Anticipation.................................................................................................................. 122
VI. Infringement .................................................................................................................... 125
1. Inducement of Infringement ..................................................................................... 127
2. Contributory Infringement ........................................................................................ 128
VII. Domestic Industry ........................................................................................................... 128
A. Technical Prong ........................................................................................................... 128
B. Economic Prong ........................................................................................................... 129
1. The History of Bracco’s Rubidium Infusion Systems .............................................. 129
2. Whether FDA Approval Is Required for a Domestic Industry ................................. 132
3. Plant and Equipment ................................................................................................. 136
4. Labor and Capital ..................................................................................................... 140
5. Engineering, Research, and Development ................................................................ 145
C. Status of the Industry ................................................................................................... 147
1. A Domestic Industry Exists ...................................................................................... 147
2. Whether the Domestic Industry Will Persist ............................................................ 148
VIII. Conclusions of Law ........................................................................................................ 149
IX. Recommended Determination on Remedy & Bond ....................................................... 150
A. Background Facts......................................................................................................... 151
1. The CardioGen-82 Model 510 .................................................................................. 154
2. The RUBY Version 3 System .................................................................................. 157
B. The Public Interest Factors .......................................................................................... 160
1. Public Health and Welfare ........................................................................................ 160
2. Competitive Conditions in the United States Economy ........................................... 166
3. Production of Like or Directly Competitive Products in the United States ............. 168
4. United States Consumers .......................................................................................... 169
5. Conclusion ................................................................................................................ 170
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C. Limited Exclusion Order.............................................................................................. 170
D. Cease and Desist Order ................................................................................................ 173
E. Bond During Presidential Review ............................................................................... 175
X. Initial Determination ....................................................................................................... 177
PUBLIC VERSION

VI
TABLE OF ABBREVIATIONS
CDX Complainant’s demonstrative exhibit
CIB Complainant’s initial post-hearing brief
CPB Complainant’s pre-hearing brief
CPX Complainant’s physical exhibit
CRB Complainant’s reply post-hearing brief
CX Complainant’s exhibit
Dep. Deposition
JX Joint Exhibit
RDX Respondent’s demonstrative exhibit
RIB Respondent’s initial post-hearing brief
RPX Respondent’s physical exhibit
RPB Respondent’s Pre-hearing brief
RRB Respondent’s reply post-hearing brief
RRX Respondent’s rebuttal exhibit
RX Respondent’s exhibit
SIB Staff’s initial post-hearing brief
SPB Staff’s Pre-hearing brief
SRB Staff’s reply post-hearing brief
Stip. Stipulation of the parties
Tr. Transcript
PUBLIC VERSION

1
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN STRONTIUM-RUBIDIUM
RADIOISOTOPE INFUSION SYSTEMS, AND
COMPONENTS THEREOF INCLUDING
GENERATORS
INV. NO. 337-TA-1110
INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
RECOMMENDED DETERMINATION ON REMEDY AND BOND
Administrative Law Judge Clark S. Cheney
(August 1, 2019)
Pursuant to the Notice of Investigation, 83 Fed. Reg. 19112 (May 1, 2018), this is the final
Initial Determination in the matter of Certain Strontium-Rubidium Radioisotope Infusion Systems,
and Components Thereof Including Generators, Investigation No. 337-TA-1110. 19 C.F.R.
§§ 210.10(b), 210.42(a)(1)(i).
For the reasons stated herein, I have determined that no violation of section 337 of the
Tariff Act of 1930, as amended (19 U.S.C. § 1330 or “section 337”), has occurred in the
importation into the United States, the sale for importation, or the sale within the United States
after importation of certain strontium-rubidium radioisotope infusion systems, and components
thereof, including generators, alleged to infringe U.S. Patent Nos. 9,814,826 (“the ’826 patent”),
9,750,869 (“the ’869 patent”), and 9,750,870 (“the ’870 patent”).
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I. INTRODUCTION
A. Procedural History
On April 3, 2018, complainant Bracco Diagnostics Inc. (“Bracco”) filed a complaint
alleging 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 strontium-rubidium
radioisotope infusion systems, and components thereof, including generators, by reason of
infringement of one or more of U.S. Patent No. 9,814,826 (JX-0001, hereinafter “the ’826 patent”);
U.S. Patent No. 9,750,869 (JX-0002, hereinafter “the ’869 patent”); and U.S. Patent No. 9,750,870
(JX-0003, hereinafter “the ’870 patent”). 83 Fed. Reg. 14294 (April 3, 2018).
On May 1, 2018, the Commission instituted this investigation to determine:
whether there is a violation of subsection (a)(1)(b) of section 337 in the importation
into the United States, the sale for importation, or the sale within the United States
after importation of certain strontium-rubidium radioisotope infusion systems, and
components thereof including generators by reason of infringement of one or more
claims 1-3, 5, 9-14, 17-19, 26, and 28 of the ’826 patent; claims 1-5, 8, 14, 24 and
27-30 of the ’869 patent; and claims 1, 2, 8-13, 16, 17, 22, and 27 of the ’870 patent;
and whether an industry in the United States exists, or is in the process of being
established, as required by subsection (a)(2) of section 337.
83 Fed. Reg. 19112 (May 1, 2018).
The named respondents were Jubilant DraxImage Inc. of Quebec, Canada, Jubilant Pharma
Limited of Singapore, and Jubilant Life Sciences of Uttar Pradesh, India (collectively “Jubilant”).
See id. at 19113.
The Commission investigative staff (“Staff”) is a party to this investigation. Id. at 19112.
On August 8, 2018, Administrative Law Judge Shaw granted Bracco’s unopposed motion
for termination of the investigation with respect to claims 10 and 26 of the ’826 patent, claims 27
and 28 of the ’869 patent, and claims 9 and 22 of the ’870 patent. Order No. 15; see also Notice
of a Comm’n Det. not to Review an Initial Det. Granting an Unopposed Mot. for Partial Term. of
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the Inv. As to Certain Patent Claims (Sept. 6, 2018) (EDIS Doc. ID 655032). On September 20,
2018, Administrative Law Judge Shaw granted Bracco’s unopposed motion for termination of the
investigation with respect to claim 13 of the ’870 patent. Order No. 18; see also Notice of a
Comm’n Det. not to Review an Initial Det. Granting an Unopposed Mot. for Partial Term. of the
Inv. As to a Patent Claim (Sept. 26, 2018) (EDIS Doc. ID 656868).
On February 8, 2019, I granted Bracco and Jubilant’s cross motions for summary
determination with respect to whether certain accused products and proposed products practiced
the asserted patent claims. Order No. 27, not reviewedNotice of a Comm’n Det. not to Review an
Initial Det. Granting Summary Det. as to Certain Patent Infringement Issues (March 12, 2019)
(EDIS Doc. ID 669522).
I convened an evidentiary hearing on February 11-12 and 15-17, 2019, to determine
whether section 337 has been violated by reason of the importation into the United States, the sale
for importation, or the sale within the United States after importation of the infringing strontium-
rubidium radioisotope infusion systems and components thereof.
B. The Parties
1. Complainant Bracco Diagnostics Inc.
Bracco is a corporation organized and existing under the laws of Indiana, with its
headquarters and principal place of business located at 259 Prospect Plains Road, Building H,
Monroe Township, NJ, 08831. Compl. at ¶ 5. Bracco is the owner by assignment of the asserted
patents in this investigation. See ’862 patent at Cover; ’869 patent at Cover; ’870 patent at Cover.
2. The Jubilant Respondents
Respondents Jubilant DraxImage Inc., Jubilant Pharma Limited, and Jubilant Life Sciences
are related corporations. Response at ¶¶ 17-18. The companies sell a range of medical products,
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4
including the radiopharmaceutical infusion and generation products at issue in this investigation.
RPB at 2-3.
a) Jubilant DraxImage Inc.
Jubilant DraxImage Inc. is a Canadian corporation with its principal place of business at
16751 TransCanada Highway Kirkland, Quebec, Canada, H9H 4J4. Amended Response at ¶ 13.
Jubilant DraxImage Inc. is a subsidiary of Jubilant Pharma Limited. Id. at 17.
b) Jubilant Pharma Limited
Jubilant Pharma Limited is a Singaporean corporation with its principal place of business
at 6 Temasek Boulevard, #20-06 Suntec City Tower Four, Singapore, 038986. Id. at ¶ 15. Jubilant
Pharma Limited is a subsidiary of Jubilant Life Sciences Limited. Id. at 18.
c) Jubilant Life Sciences
Jubilant Life Sciences Limited is an Indian company with its principal place of business at
Plot 1-A Sector 16-A Institutional Area Noida, Uttar Pradesh, 201301, India. Id. at ¶ 16.
C. The Asserted Patents
Bracco asserts claims of three related patents in this investigation: the ’826 patent, the ’869
patent, and the ’870 patent. The appropriate priority date for the claimed inventions is disputed.
On their face, all three patents claim priority to June 11, 2008. The parties agree that the earliest
relevant priority date for all three patents is no earlier than June 11, 2009, the date Application No.
PCT/US2009/047031 was filed. See CPB at 438; RPB at 91; SIB at 6. Jubilant alone asserts the
priority date is later. RIB at 2-8. The named inventors on all three patents are Stephen E. Hidem,
Aaron M. Fontaine, Janet L. Gelbach, Patrick M. McDonald, Kathryn M. Hunter, Rolf E. Swenson,
and Julius P. Zodda. ’826 patent at Cover; ’869 patent at Cover; ’870 patent at Cover. All three
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patents are assigned to Bracco. The asserted patents relate to strontium-rubidium elution and
infusion systems used in positron emission tomography (“PET”) for cardiac imaging.
1. U.S. Patent No. 9,814,826 (JX-0001)
U.S. Patent No. 9,814,826, titled “Integrated Strontium-Rubidium Radioisotope Infusion
Systems,” was issued by the U.S. Patent and Trademark Office (“PTO”) on November 14, 2017,
from U.S. Application No. 15/620,320, filed on June 12, 2017. Bracco asserts claims 1-3, 5, 9,
11-14, 17-19, and 28 of the ’826 patent.
2. U.S. Patent No. 9,750,869 (JX-0002)
U.S. Patent No. 9,750,869, titled “Integrated Strontium-Rubidium Radioisotope Infusion
Systems,” was issued by the PTO on September 5, 2017, from U.S. Application No. 15/389,200,
filed on December 22, 2016. Bracco asserts claims 1-5, 8, 14, 24, and 29-30 of the ’869 patent.
3. U.S. Patent No. 9,750,870 (JX-0003)
U.S. Patent No. 9,750,870, titled “Integrated Strontium-Rubidium Radioisotope Infusion
Systems,” was issued by the PTO on September 5, 2017, from U.S. Application No. 15/490,484,
filed on April 18, 2017. Bracco asserts claims 1, 2, 8, 10-12, 16-17, and 27 of the ’870 patent.
D. The Technology at Issue
All three asserted patents are directed to the same technology and share the same
specification. The patents describe a computer-controlled medical device that generates the
radioisotope rubidium-82 (Rb-82) and safely infuses a patient with the isotope in conjunction with
PET imaging of the patient’s heart. The asserted claims are apparatus claims directed to the
structure of the generator and infusion device, method claims for making the device, and method
claims for using the device.
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Rubidium-82 has been used as a radiation source for cardiac PET imaging for many
decades, well before the invention in the patents at issue. See, e.g., RX-0207 (CardioGen-82
Model 510 user manual); Tr. at 137:15-24, 589:18-590:8. Rubidium-82 is useful because of its
relatively short half-life of 76 seconds and because it is absorbed by cardiac tissue proportionally
to coronary-artery blood flow. RX-106.000017. Although the short half-life minimizes the
patient’s radiation exposure, it requires that rubidium-82 be generated on-demand for each patient
infusion. Id. at .0017-0018.
For several decades, the medical imaging field has been generating rubidium-82 by passing
.9% NaCl saline over another radioactive isotope, strontium-82 (Sr-82), in a device called a
generator, a process called elution. RX-106.000018. The saline picks up rubidium atoms
generated by the strontium as it decays and the resulting fluid, called an eluate, is infused into the
patient.
Some additional details about strontium will be helpful to understand the risks of rubidium
infusion and the field of the claimed inventions. Strontium-82 is created in a very large, very
expensive piece of equipment called a cyclotron particle accelerator. Ideally, the product of the
cyclotron would be pure strontium-82, but the resultant material may have strontium-85 (Sr-85)
impurities. Id. Strontium-82 has a half-life of 25.5 days, and strontium-85 has a substantially
longer 65-day half-life. Id. Because strontium shares chemical properties with calcium, the human
body readily absorbs it and binds it to bones and teeth. Id. at .000019. Consequently, if either
Sr-82 or Sr-85 is accidentally administered to a patient during infusion, the patient will have a
radiation source in his or her body emitting radiation for months. Id. Bone marrow is also
particularly susceptible to damage from radiation exposure, rendering strontium exposure
particularly dangerous for patient health. Id.
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Inside a strontium-rubidium generator, strontium-82 is affixed to a tin oxide (SnO2)
column. RX-106.000018. As the generator ages, strontium eventually starts to detach from the
column and contaminate the eluate, posing a risk to patient health. Id. Such an occurrence is
known as strontium “breakthrough.” Id. Strontium breakthrough can also be caused by a user
putting the wrong solution into the generator. For example, one solution regularly used in medical
settings, called ringer’s lactate, can displace substantial amounts of strontium from the core.
Tr. at 451:9-452:1. On at least six occasions, operators have mistakenly run ringer’s lactate
through a strontium-rubidium infusion system and injected a patient with strontium. Tr. at
433:18-24.
To prevent inadvertent patient exposure to strontium resulting from strontium
breakthrough, operators must perform daily quality-control checks on the generator. RX-106 at
.0019-.0020. In the prior art, such as with Bracco’s CardioGen-82 device, operators performed
breakthrough tests manually. The test involved the operator manually transporting the radioactive
eluate for testing and required the operator to accurately perform complex calculations.
Tr. at 428:23-431:14.
The asserted patents describe a strontium-rubidium infusion system “on-board” a cart. See,
e.g., ’869 patent at claim 1. The system is configured to determine a strontium breakthrough test
result from a sample on the cart and “not allow a patient infusion if the strontium breakthrough
test result is greater than or equal to an allowed limit,” such as would occur in a strontium
breakthrough event. See id.
E. The Accused Products
The accused products in this investigation are Jubilant’s RUBY Rubidium Elution
Systems, the generators used in those systems, and the tubing sets used for the systems. Jubilant
currently markets and sells the RUBY Rubidium Elution System Version 3 (“RUBY Version 3”)
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in the United States, and the Commission has already found that the RUBY Version 3 practices all
asserted patent claims. See Order No. 27, not reviewed Comm’n Det. not to Review an Initial Det.
Granting Summary Det. (March 12, 2019) (EDIS Doc. ID 669522). Jubilant is also seeking
approval of the U.S. Food and Drug Administration (“FDA”) to market the RUBY Rubidium
Elution System Version 3.1 (“RUBY Version 3.1”) and RUBY Rubidium Elution System Version
4 (“RUBY Version 4”) in the United States. See Tr. at 323:9-11. The Commission has found the
designs of those two devices do not practice any claim of the asserted patents. Comm’n Det. not
to Review an Initial Det. Granting Summary Det. (March 12, 2019) (EDIS Doc. ID 669522).
All three RUBY Versions use the same generator, called the RUBY-FILL rubidium-82
generator. The generators have a one or two month life before they must be replaced. Tr. at
319:16-320:2. The eluate tubing for a rubidium infusion system must also be replaced regularly.
Id. All three RUBY Versions use the same set of tubing called the RUBY Set. Tr. at 323:3-8.
Typically, both Jubilant and Bracco sell their own branded tubing sets and generators, which are
not interchangeable between the two manufacturer’s systems. See CX-0033C (“RUBY-FILL
‘Family’ of Products”); CX-0566C (Gentilcore Dep. Tr.) at 149:3-150:1; RX-0411C (Troger Dep.
Tr.) at 121:3-10; Tr. at 381:17-382:4; 876:20-25.
F. The Domestic Industry Products
Bracco’s CardioGen 1700 rubidium infusion system is the only potential domestic industry
product at issue in this investigation. There is no dispute that the CardioGen1700 practices at least
one claim of each of the asserted patents. Tr. at 28:7-10. Because the CardioGen 1700 is not FDA
approved, however, the parties dispute whether a domestic industry exists or is in the process of
being established for products that practice the asserted patents.
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II. JURISDICTION & IMPORTATION
A. Subject Matter Jurisdiction
Section 337 confers subject matter jurisdiction on the Commission to investigate, and if
appropriate, to provide a remedy for, unfair acts and unfair methods of competition in the
importation of articles into the United States and the sale of such articles. See 19 U.S.C.
§§ 1337(a)(1)(B) and (a)(2). Bracco filed a complaint alleging a violation of section 337, and the
Commission has subject matter jurisdiction over the complaint. See Amgen, Inc. v. Int’l. Trade
Comm’n, 902 F.2d 1532, 1536 (Fed. Cir. 1990).
B. Personal Jurisdiction
Jubilant has appeared and participated in this investigation. The Commission therefore has
personal jurisdiction over Jubilant. See, e.g., Certain Magnetic Tape Cartridges and Components
Thereof, Inv. No. 337-TA-1058, ID at 12 (Aug. 17, 2018) (EDIS Doc. No. 653306) (unreviewed
in relevant part).
C. In Rem Jurisdiction
The parties have stipulated that Jubilant Labs has imported the RUBY Version 3.1 and
Version 4, as well as the generators and tubing used for all three RUBY Versions (3, 3.1, and 4).
RPB at 40; Stip. at ¶ 2 (EDIS Doc. ID 664016, at Ex. H). Accordingly, the Commission has in
rem jurisdiction over the accused products. See Sealed Air Corp. v. Int’l Trade Comm’n, 645 F.2d
976, 985-86 (C.C.P.A. 1981) (noting that the Commission has jurisdiction over imported goods).
D. Importation
The RUBY Version 3 infusion device is made in the United States; it is not imported.
But the generator and tubing sets used with Jubilant’s products are imported. Specifically, the
parties have stipulated that Jubilant DraxImage Inc. has imported the RUBY-FILL rubidium
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generator and the RUBY Set. Stip. at ¶¶ 2, 4. The parties have also stipulated that Jubilant has
imported other components of the system, including the RUBY Saline Line, the RUBY IN Line,
and RUBY Connectors. Id. It is undisputed that Jubilant also imported prototypes of the RUBY
Version 3.1 and Version 4 designs. Order No. 27 at 18. I find that the importation requirement
of section 337 has been satisfied.
E. Standing
The evidence of record demonstrates that Bracco, as assignee of the asserted patents, has
standing to bring its complaint. See ’826 patent at Cover; ’869 patent at Cover; ’870 patent at
Cover. Accordingly, I find that Bracco has standing in this investigation.
III. LEGAL PRINCIPLES
A. Claim Construction
“An infringement analysis entails two steps. The first step is determining the meaning and
scope of the patent claims asserted to be infringed. The second step is comparing the properly
construed claims to the device accused of infringing.” Markman v. Westview Instruments, Inc., 52
F.3d 967, 976 (Fed. Cir. 1995) (en banc) (internal citations omitted), aff’d, 517 U.S. 370 (1996).
Claim construction resolves legal disputes between the parties regarding claim scope. See Eon
Corp. IP Holdings v. Silver Spring Networks, 815 F.3d at 1314, 1319 (Fed. Cir. 2016).
Evidence intrinsic to the application, prosecution, and issuance of a patent is the most
significant source of the legally operative meaning of disputed claim language. See Bell Atl.
Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). The
intrinsic evidence includes the claims themselves, the specification, and the prosecution history.
See Phillips v. AWH Corp, 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc); see also
Markman, 52 F.3d at 979. As the Federal Circuit explained in Phillips, courts must analyze each
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of these components to determine the “ordinary and customary meaning of a claim term” as
understood by a person of ordinary skill in the art at the time of the invention. 415 F.3d at 1313.
“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to
which the patentee is entitled the right to exclude.’” Phillips, 415 F.3d at 1312 (quoting
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir.
2004)). “Quite apart from the written description and the prosecution history, the claims
themselves provide substantial guidance as to the meaning of particular claims terms.” Id. at 1314;
see Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (“In
construing claims, the analytical focus must begin and remain centered on the language of the
claims themselves, for it is that language that the patentee chose to use to ‘particularly point[ ] out
and distinctly claim[ ] the subject matter which the patentee regards as his invention.”’). The
context in which a term is used in an asserted claim can be “highly instructive.” Phillips, 415 F.3d
at 1314. Additionally, other claims in the same patent, asserted or unasserted, may also provide
guidance as to the meaning of a claim term. Id.
The specification “is always highly relevant to the claim construction analysis. Usually, it
is dispositive; it is the single best guide to the meaning of a disputed term.” Id. at 1315 (quoting
Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “[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.” Id. at 1316. “In
other cases, the specification may reveal an intentional disclaimer, or disavowal, of claim scope
by the inventor.” Id. As a general rule, however, the particular examples or embodiments
discussed in the specification are not to be read into the claims as limitations. Id. at 1323. In the
end, “[t]he construction that stays true to the claim language and most naturally aligns with the
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patent’s description of the invention will be . . . the correct construction.” Id. at 1316 (quoting
Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998)).
When the intrinsic evidence does not establish the meaning of a claim, then extrinsic
evidence (i.e., all evidence external to the patent and the prosecution history, including
dictionaries, inventor testimony, expert testimony, and learned treatises) may be considered. Id.
at 1317. Extrinsic evidence is generally viewed as less reliable than the patent itself and its
prosecution history in determining how to define claim terms. Id. “The court may receive extrinsic
evidence to educate itself about the invention and the relevant technology, but the court may not
use extrinsic evidence to arrive at a claim construction that is clearly at odds with the construction
mandated by the intrinsic evidence.” Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 977 (Fed.
Cir. 1999).
B. Validity
A patent is presumed valid. See 35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd. P’ship, 131
S. Ct. 2238, 2242 (2011). A respondent who has raised patent invalidity as an affirmative defense
has the burden of overcoming this presumption by clear and convincing evidence. See Microsoft,
131 S. Ct. at 2242.
1. Anticipation
Under 35 U.S.C. § 102, a claim is anticipated, and therefore invalid, when “the four comers
of a single, prior art document describe every element of the claimed invention, either expressly
or inherently, such that a person of ordinary skill in the art could practice the invention without
undue experimentation.” Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282
(Fed. Cir. 2000). To be considered anticipatory, the prior art reference must be enabling and
describe the applicant’s claimed invention sufficiently to have placed it in possession of a person
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of ordinary skill in the field of the invention. See Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339,
1346 (Fed. Cir. 2000).
2. Obviousness
Under 35 U.S.C. § 103, a patent may be found invalid as obvious if “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 to which said subject matter pertains.” 35 U.S.C. § 103(a). Because obviousness is
determined at the time of invention, rather than the date of litigation, “[t]he great challenge of the
obviousness judgment is proceeding without any hint of hindsight.” Star Scientific, Inc. v. R.J.
Reynolds Tobacco Co., 655 F.3d 1364, 1375 (Fed. Cir. 2011).
The critical inquiry in determining the differences between the claimed invention and the
prior art is whether there is an apparent reason to combine the known elements in the fashion
claimed by the patent at issue. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417-418 (2007)
(hereinafter “KSR”). Thus, when a combination of several prior art references is asserted, “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). Though rare, “in appropriate circumstances, a patent can be obvious in light
of a single prior art reference if it would have been obvious to modify that reference to arrive at
the patented invention.” Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1361 (Fed. Cir. 2016).
Prior art for an obviousness determination must be analogous to the claimed invention.
In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992). Prior art is considered analogous when it meets at
least one of two separate tests: “(1) whether the art is from the same field of endeavor, regardless
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of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor,
whether the reference still is reasonably pertinent to the particular problem with which the inventor
is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citing In re Deminski, 796 F.2d
436, 442 (Fed.Cir.1986)).
Obviousness is a determination of law based on underlying determinations of fact. Star
Scientific, 655 F.3d at 1374. The factual determinations behind a finding of obviousness include:
(1) the scope and content of the prior art, (2) the level and content of the prior art, (3) the differences
between the claimed invention and the prior art, and (4) secondary considerations of non-
obviousness. KSR, 550 U.S. at 399 (citing Graham v. John Deere Co., 383 U.S. 1, 17 (1966)).
Secondary considerations of non-obviousness include commercial success, long felt but
unresolved need, and the failure of others. Id. Evidence of direct copying may also be an objective
indicator of non-obviousness. Apple Computer, Inc. v. Articulate Sys., Inc., 234 F.3d 14, 26 (Fed.
Cir. 2000). When present, secondary considerations “give light to the circumstances surrounding
the origin of the subject matter sought to be patented,” but they are not dispositive on the issue of
obviousness. Geo. M. Martin Co. v. Alliance Mach. Sys. Int’l., 618 F.3d 1294, 1304-06 (Fed. Cir.
2010). For evidence of secondary considerations to be given substantial weight in the obviousness
determination, its proponent must establish a nexus between the evidence and the merits of the
claimed invention. See W. Union Co. v. MoneyGram Payment Sys. Inc., 626 F.3d 1361, 1372-73
(Fed. Cir. 2010) (citing In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995)).
C. Assignor Estoppel
Assignor estoppel is an equitable doctrine that prevents one who has assigned the rights to
a patent from later contending that the patent is invalid. Pandrol USA, LP v. Airboss Ry. Prods.,
Inc., 424 F.3d 1161, 1166-67 (Fed. Cir. 2005). Those in privity with the assignor are likewise
estopped from arguing the patent’s invalidity. MAG Aerospace Indus., Inc. v. B/E Aerospace, Inc.,
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816 F.3d 1374, 1379-81 (Fed. Cir. 2016); Checkpoint Sys., Inc. v. All-Tag Sec. S.A., 412 F.3d 1331,
1336-37 (Fed. Cir. 2005).
Privity depends on the nature and extent of the relationship between the assignor and the
other party. For example, “if an inventor assigns his invention to his employer company A and
leaves to join company B, whether company B is in privity and thus bound by the doctrine will
depend on the equities dictated by the relationship between the inventor and company B in light
of the act of infringement. The closer that relationship, the more the equities will favor applying
the doctrine to company B.” MAG Aerospace Indus., 816 F.3d at 1374.
The factors considered when examining assignor-estoppel privity include: (1) the
assignor’s leadership role at the new employer; (2) the assignor’s ownership stake in the defendant
company; (3) whether the defendant company changed course from manufacturing non-infringing
goods to infringing activity after the inventor was hired; (4) the assignor’s role in the infringing
activities; (5) whether the inventor was hired to start the infringing operations; (6) whether the
decision to manufacture the infringing product was made partly by the inventor; (7) whether the
defendant company began manufacturing the accused product shortly after hiring the assignor; and
(8) whether the inventor was in charge of the infringing operation. Id. (citing Shamrock Techs.,
Inc. v. Med. Sterilization, Inc., 903 F.2d 789, 793 (Fed. Cir. 1990)). The Federal Circuit has also
considered whether the accused infringer availed itself of the knowledge and assistance of the
named inventor to develop the accused product. Intel Corp. v. U.S. Int’l Trade Comm’n, 946 F.2d
821, 837-39 (Fed. Cir. 1991) (citing Shamrock, 903 F.2d at 793).
D. Infringement
In a section 337 investigation, the complainant bears the burden of proving infringement
of the asserted patent claims by a preponderance of the evidence. See Spansion Inc. v. Int’l Trade
Comm’n, 629 F.3d 1331, 1349 (Fed. Cir. 2010). This standard “requires proving that infringement
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was more likely than not to have occurred.” Warner-Lambert Co. v. Teva Pharm. USA, Inc., 418
F.3d 1326, 1341 n.15 (Fed. Cir. 2005). Section 271 of the Patent Act defines both direct
infringement and the two categories of indirect infringement—active inducement of
infringement and contributory infringement. 35 U.S.C. § 271(a), (b), and (c). There can be
no indirect infringement absent direct infringement. See Limelight Networks, Inc. v. Akamai
Technologies, Inc., 134 S. Ct. 2111, 2117 (2014); Aro Manufacturing Co. v. Convertible Top
Replacement Co., 365 U.S. 341 (1961); see also Met-Coil Sys. Corp. v. Korners Unltd., Inc.,
803 F.2d 684, 687 (Fed. Cir. 1986) (“Absent direct infringement of the patent claims, there
can be neither contributory infringement . . . nor inducement of infringement.”) (citations
omitted).
1. Direct Infringement
Direct infringement of an apparatus claim requires the accused device to contain each
and every limitation set forth in a claim. Centrak, Inc. v. Sonitor Techs., Inc., 915 F.3d 1360,
1371 (Fed. Cir. 2019). A method claim is directly infringed only if each step of the claimed
method is performed. Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1328 (Fed. Cir.
2008) (distinguished on other grounds by Travel Sentry, Inc. v. Tropp, 877 F.3d 1370, 1383
(Fed. Cir. 2017)).
2. Inducement of Infringement
Section 271(b) of the Patent Act prohibits inducement of infringement: “[w]hoever
actively induces infringement of a patent shall be liable as an infringer.” 35 U.S.C. § 271(b).
Inducement of infringement is the “active[] and knowing[] aid[ing] and abet[ing] [of] another’s
direct infringement.” See DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1305 (Fed. Cir. 2006) (en
banc). A violation of section 337 may arise from inducement of infringement via imported
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articles. Suprema, Inc. v. International Trade Com’n, 796 F.3d 1338, 1351-52 (Fed. Cir. 2015)
(en banc).
3. Contributory Infringement
Section 271(c) of the Patent Act prohibits contributory infringement. See 35 U.S.C.
§ 27l(c). “Under 35 U.S.C. § 27l(c), a party who sells a component with knowledge that the
component is especially designed for use in a patented invention, and is not a staple article of
commerce suitable for substantial noninfringing use, is liable as a contributory infringer.”
Wordtech Sys., Inc. v. Integrated Networks Solutions, Inc., 609 F.3d 1308, 1316 (Fed. Cir.
2010). To establish contributory infringement in a section 337 investigation, it must be shown
that “(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, 629 F.3d at 1353.
E. Domestic Industry
For a patent-based complaint, a violation of section 337 can be found “only if an industry
in the United States, relating to the articles protected by the patent . . . concerned, exists or is in
the process of being established.” 19 U.S.C. § 1337(a)(2). This domestic industry requirement of
section 337 is often described as having an economic prong and a technical prong. InterDigital
Commc’ns, LLC v. Int'l Trade Comm’n, 707 F.3d 1295, 1298 (Fed. Cir. 2013); Certain Stringed
Musical Instruments and Components Thereof, Inv. No. 337-TA-586, USITC Pub. 4120, 2009 WL
5134139 (Dec. 2009), Comm’n Op. at 12-14. The complainant bears the burden of establishing
that the domestic industry requirement is satisfied. See Certain Set-Top Boxes and Components
Thereof, Inv. No. 337-TA-454, ID at 294, 2002 WL 31556392 (June 21, 2002) (unreviewed by
Commission in relevant part).
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1. Economic Prong
Section 337(a)(3) sets forth the following economic criteria for determining the existence
of a domestic industry in such investigations:
(3) For purposes of paragraph (2), an 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.
Given that the statutory 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. See Certain Variable
Speed Wind Turbines and Components Thereof, Inv. No. 337-TA-376, USITC Pub. 3003, (Nov.
1996), Comm’n Op. at 15.
2. Technical Prong
The technical prong of the domestic industry requirement is satisfied when the complainant
in a patent-based section 337 investigation establishes 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, 1996 WL 1056095 (Jan. 16, 1996). “The test for satisfying the
‘technical prong’ of the industry requirement is essentially [the] same as that for infringement, i.e.,
a comparison of domestic products to the asserted claims.” Alloc, Inc. v. Int’l Trade Comm’n, 342
F.3d 1361, 1375 (Fed. Cir. 2003). To prevail, the patentee must establish by a preponderance of
the evidence that the domestic product practices one or more claims of the patent. It is sufficient
to show that the products practice any claim of that patent, not necessarily an asserted claim of that
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patent. See Certain Male Prophylactic Devices, Inv. No. 337-TA-546, Comm’n Op. at 38
(Aug. 1, 2007).
IV. LEVEL OF ORDINARY SKILL IN THE ART
A person of ordinary skill in the art is a hypothetical person who is presumed to be aware
of all pertinent prior art. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955,
962 (Fed. Cir. 1992). Determining the appropriate level of skill for this hypothetical person can
involve consideration of the types of problems encountered in the art, prior art solutions to those
problems, rapidity with which innovations are made, sophistication of the technology at issue, the
educational level of active workers in the field, and the level of education of the inventors
themselves. Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).
Bracco proposes that a person of ordinary skill in the art would possess “a graduate degree
in medicine and/or in a medical related science, including physics, chemistry, biology, physiology,
and/or biophysics, or a related field, and would generally have at least some clinical, research,
and/or design experience with respect to PET imaging and/or PET imaging systems.” CIB at 11
(citing CDX-0002.04). Bracco also asserts that an individual with a relevant undergraduate degree
along with significant experience could be sufficiently skilled. Id. Further, according to Bracco,
the amount of experience following an undergraduate degree would depend on the level of formal
education and amount of experience working with radiopharmaceuticals. Id. In its reply, Bracco
additionally argues that because the claims pertain to both the use and design of the claimed elution
systems, its definition is more appropriate than that of Jubilant. CRB at 3.
Jubilant proposes that a person of ordinary skill in the art would possess a graduate degree
with some emphasis in equipment design, automation, or controls, such as electrical engineering,
systems engineering, mechanical engineering, or a related field, or an undergraduate degree in one
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of those fields with two to three years’ work experience in radioactive protection systems or in
medical device product, automation, or instrumentation design and development, including
working with prototypes and finished products. RDX-0002C.0083. Jubilant further notes that such
a person would have had a basic understanding, through education or experience, of general design
control principles and processes and practices for partial or full automation of existing processes
or test procedures. RDX-0002C.0083.
Finally, Staff proposes that a person of ordinary skill in the art would possess “at least a
master’s degree in physics, electrical engineering, systems engineering, mechanical engineering,
or a related field with at least two years of work experience with designing and/or developing
nuclear medical devices or medical imaging devices.” SPB at 10. Staff allows that superior
qualifications with respect to either education or experience may compensate for a deficit in the
other. Id. Staff’s proposal is closer to Jubilant’s than Bracco’s. Id. at 10-11.
No party, however, expressly contends that the different proposals will lead to different
outcomes with respect to any issue before me, rendering any dispute immaterial. Nevertheless, to
the extent I must make a determination about the appropriate level of skill in the art, I adopt the
definition proposed by Staff. A person of ordinary skill in the art at the time of the inventions
described in the asserted patents would have at least a master’s degree in physics, electrical
engineering, systems engineering, mechanical engineering, or a related field with at least two years
of work experience with designing and/or developing nuclear medical devices or medical imaging
devices. Superior qualification with respect to either education or experience may compensate for
a deficit in either.
This definition is supported by credible expert testimony. See, e.g., Tr. at 615:12-616:24
(testimony of Dr. Stone as to level of ordinary skill, rejecting Bracco’s proposed definition because
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the patents “deal[] with a system to inject a fluid safely” not “the practice of medicine” or “the
[PET] imaging process”). I also find, as a factual matter, that this definition better matches the
education level of workers in the field and the inventors themselves, as reflected in the record.
See, e.g., JX-0176C.012-24 (educational and professional background of inventor Janet Gelbach).
V. VALIDITY
A. Assignor Estoppel
Bracco contends that Jubilant is prohibited from challenging the validity of the asserted
patents under the equitable doctrine of assignor estoppel. CIB at 35-38. Bracco’s argument turns
on facts relating to Janet Gelbach, one of the inventors listed on the asserted patents. See, e.g.,
’826 patent at Cover (showing Janet Gelbach as a listed inventor and Bracco as assignee); ’869
patent at Cover (same); ’870 patent at Cover (same). Ms. Gelbach was an employee of Bracco at
the time of the invention and she assigned her rights in the patents to Bracco. CX-147-150
(assignments without reservation of rights to challenge validity). Jubilant later hired Ms. Gelbach
during the period of development of the RUBY Version 3. JX-0176C (Gelbach Dep. Tr.) at 120:7-
13. Bracco contends that Ms. Gelbach and Jubilant are estopped from arguing the patent is invalid.
CIB at 35. Jubilant and Staff disagree that Jubilant is estopped. RRB at 31-38; SIB at 141-145,
SRB at 7.
No one disputes that Janet Gelbach is personally prohibited from challenging the validity
of the asserted patents. See Mentor Graphics Corp. v. Quickturn Design Sys., Inc., 150 F.3d 1374,
1378 (Fed. Cir. 1998) (because an assignor “has already been fully paid for the patent rights,”
public policy prohibits a challenge) (citing Diamond Sci. Co. v. Ambico, Inc., 848 F.2d 1220 (Fed.
Cir. 1988)). If Ms. Gelbach were the respondent, Jubilant would have carried its burden.
But Ms. Gelbach is not the respondent, Jubilant is. Bracco argues that Jubilant is in
“privity” with Ms. Gelbach, thereby seeking to extend the equitable prohibition on her challenging
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the patents to her new employer. CIB at 35. The Federal Circuit has laid out an eight-factor test
to determine whether privity extends the estoppel in this context. See Shamrock Techs., Inc. v.
Med. Sterilization, Inc., 903 F.2d 789, 793 (Fed. Cir. 1990). Those factors are:
(1) whether the assignor was a high level employee at his new employer;
(2) whether the assignor owned shares in his new employer;
(3) whether, as soon as the assignor was hired, the new employer built facilities for
performing the infringing activity;
(4) whether the assignor oversaw the design and construction of those new facilities;
(5) whether the inventor was hired to start-up the infringing operations;
(6) whether the decision to begin the infringing operation was made jointly by the assignor
and the leadership of his new employer;
(7) whether the defendant company began manufacturing the infringing product shortly
after hiring the assignor; and
(8) whether the inventor was in charge of the infringing operation.
Id.
An examination of the facts of Shamrock is helpful in understanding the list of factors. In
Shamrock, an inventor joined the accused infringer as Vice President in charge of operations.
Shamrock, 903 F.2d. at 794. Upon joining the infringer, he was given 50,000 shares of the accused
infringer’s stock. Id. The infringer built facilities to perform infringing acts as soon as the inventor
was hired, and the inventor oversaw design and construction of those facilities. Id. The inventor
was hired specifically to start up the infringing operations, and the inventor was in charge of those
infringing operations. Id.
Now consider the facts here: Ms. Gelbach joined the accused infringer, Jubilant, as a
Product Manager. Ms. Gelbach’s primary role in that position was to “develop a marketing plan
and commercialization plan for the PET products . . . specifically for the rubidium infusion
system.” JX-0176C (Gelbach Dep. Tr.) at 120:7-13. There is no evidence Ms. Gelbach has ever
had any ownership interest in Jubilant. There is no evidence Jubilant built any new facilities to
perform infringing acts as soon as Ms. Gelbach was hired. Ms. Gelbach did not oversee design
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and construction of any facilities or even the design of products. The record shows Ms. Gelbach’s
responsibility was to “develop a marketing plan,” while others on the team were tasked with project
management and engineering responsibilities. See JX-013C.010 (project overview document
between Jubilant and Kluge listing Ms. Gelbach’s responsibility for V3 project as “Marketing
product manager for the Rubidium Elution System”).
Although Bracco argues Jubilant “changed course” to developing an infringing system
shortly after hiring Ms. Gelbach, the record reflects Jubilant first began developing the Version 3
in 2010, and by no later than July 28, 2010, Jubilant had begun designs for a system with an on-
board dose calibrator.1 Tr. at 313:8-10 (“When did JDI first begin developing the Version 3? A:
2010.”); see CX-0386C.0001 (Jubilant internal email dated July 28, 2010 stating “we [are]
currently designing the V3 infuser cart and we are wondering how much lead shielding is needed
for the generator . . . the dose calibrator chamber [vial inside . . .] the waste container. . . All this
shielding is on the cart . . .”). Though Ms. Gelbach was hired no earlier than that July, Tr. 1046:17-
20, there is record testimony that the development of the on-board dose calibrator began at least
as early as May of that year. See Tr. at 316:18-317:9. And although Bracco argues Ms. Gelbach
was hired to provide her insights as an inventor, she testified that she did not provide the idea to
move the dose calibrator on-board the cart; she said the idea came from customers. JX-0176C
(Gelbach Dep. Tr.) at 125:16-126:6.
Bracco also argues that, although Jubilant built no new facilities immediately upon hiring
Ms. Gelbach (Shamrock factor (3)), Ms. Gelbach’s hiring directly lead to the hiring of two former
1 As demonstrated in Order No. 27 (granting summary determination of infringement) and in the
obviousness analysis below, the on-board dose calibrator was a central point of dispute in this
investigation.
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Bracco contractors: medical device designers Worrell and Kluge. CIB at 36. But the record
reflects that Jubilant had a preexisting relationship with Worrell, and that neither Worrell nor
Kluge was hired for at least six months after Ms. Gelbach. Tr. at 313:20-21 (“in 2011, [Jubilant]
hired Kluge Design and Worrell”), 314:16-315:12 (JDI had worked with Worrell in 2008).
These facts are a far cry from those before the Shamrock court in total, but particularly
salient is the lack of any direct tie between Jubilant’s financial position and Ms. Gelbach’s.
Shamrock directs that no privity exists between a “mere employee” and their employer. Id.
Although Shamrock does not define “mere employee,” in each case the Shamrock court cited as
an example of privity, the assignor had an ownership or financial stake in the new company. See,
e.g., Douglass v. U.S. Appliance Corp., 177 F.2d 98, 99 and 101 (9th Cir. 1949) (assignor formed
new corporation; “[t]he word ‘privity’ implies co-operation, but it also includes the thought of
sharing and of participation in profits”); U.S. Appliance Corp. v. Beauty Shop Supply Co., 121 F.2d
149, 151 (9th Cir. 1941) (company started by assignor and partner), cert. denied, 314 U.S. 680
(1941); Stubnitz-Green Spring Corp. v. Fort Pitt Bedding Co., 110 F.2d 192, 195 (6th Cir. 1940)
(assignor was principal stockholder); Buckingham Prods. Co. v. McAleer Mfg. Co., 108 F.2d 192,
195 (6th Cir. 1939) (assignor was director and held 500 of 3000 shares); Frick Co. v.Lindsay, 27
F.2d 59, 61 (4th Cir. 1928) (wife and business partner estopped from challenging validity); Mellor
v. Carroll, 141 F. 992, 993-94 (C.C.D. Mass. 1905) (assignor was part owner of company). Other
Federal Circuit assignor estoppel cases follow that trend. See, e.g., Diamond Scientific, 848 F.2d
at 1222 (assignor left Diamond and formed defendant company); Carroll Touch, Inc. v. Electro
Mech. Sys., 15 F.3d 1573, 1579 (Fed. Cir. 1993) (assignor was founder, president, principal
executive officer and owner of controlling interest of defendant company); Intel, 157 F.3d 837-38
(holding assignor estoppel applied to assignor’s company as well as joint development company
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for which assignor spent 100% of time working and who would not have entered the agreement
absent assignor’s personal indemnification).
As noted above, there is no evidence that Ms. Gelbach has ever had any ownership stake
in Jubilant. The evidence does not even reflect that Ms. Gelbach was a particularly senior
employee, or that she had any substantial role in the design of the RUBY Version 3. I thus find
that Ms. Gelbach was a “mere employee” of Jubilant, precluding a finding of privity.
Considering all of the facts and argument presented, I find that Jubilant was not in privity
with Janet Gelbach. As a result, I find that Jubilant should not be estopped from challenging the
validity of the asserted patents.
1. Staff Is Not Estopped
Bracco admits that assignor estoppel does not apply to Staff. CIB at 38. As discussed in
detail below, Staff presented clear and convincing evidence that the patents are obvious. Thus,
even if Bracco’s estoppel argument was meritorious, it would not change the outcome of my
validity determination.
B. Obviousness
Jubilant and Staff contend that the asserted patent claims are obvious in view of the prior
art. They rely primarily on a thesis published in 2006 describing a rubidium infusion system
developed by Ran Klein as part of his graduate studies at the University of Ottawa. CPB at 82-87
and SPB at 45-54, analyzing RX-106 (hereinafter “Klein” or “Klein thesis”); see also Klein,
RX-0333, RX-0034. Jubilant and Staff argue that the Klein thesis, either alone or in combination
with certain other references, render all asserted claims invalid as obvious.
Bracco largely concedes that the Klein thesis discloses a rubidium infusion system
comprising all of the functional elements of the asserted patent claims, but Bracco contends the
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arrangement of those elements in the configurations described by the patent claims would not have
been obvious to a skilled artisan. See CRB at 29. Although scores of claim elements are at issue,
the parties’ dispute focuses on about a dozen. For ease of reference, I have organized my analysis
into several sections below. Section 1 describes the main elements of the Klein thesis, identifies
certain secondary prior art advanced in combination with Klein, and addresses arguments about
whether that art is analogous. Section 2 compares the scope and content of the prior art to each
asserted claim of each asserted patent, giving particular attention to the claim elements the parties
dispute. Section 3 analyzes secondary considerations of non-obviousness in connection with the
claimed inventions. Section 4 contains my conclusions after considering the totality of the record
the evidence material to obviousness.
1. The Prior Art
a) The Klein thesis
This section contains factual findings about what the Klein thesis discloses. The Klein
thesis describes a system to elute rubidium at a constant level of radioactivity “for use in a clinical
and experimental setting.” Klein at .000011. Klein explained that prior art cyclotrons used to
generate radioactive material for imaging were known to be expensive and immobile. Klein at
.000024-25. By the time of Klein’s work, the disadvantages of cyclotrons had already motivated
the development of mobile PET imaging systems to serve smaller communities. Klein at
.000024-25. One such mobile system known to Klein was Bracco’s CardioGen-82 Model 510
(“Model 510”), a rubidium elution system approved by the FDA in 1989 that was small enough
and inexpensive enough to allow PET scanning to reach “regions of low population density as well
as to less wealthy communities.” Id. at .000017-18, -25.
Klein provided an overview of the components of his system in the diagram below:
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Id. at .000029.
Following the flow of fluid through the system diagram above provides an overview of the
Klein system. The process starts with a reservoir of saline held in an IV bag or bottle connected
to a pump, which permits the saline to flow through a strontium-rubidium (Sr-Rb) generator, then
to an activity counter, and then to a patient. Id. The system executes different flow patterns using
valves. A first valve, called the generator valve, is placed between the pump and the generator. It
controls the flow of saline in two lines: a line into the generator and a saline bypass line. The line
out of the generator contains radioactive material. It mixes with saline from the saline bypass line
and flows past the activity counter. Id. at .000051. The activity monitor measures the radioactivity
of the eluate in real time. Id. at .000043. A second valve, called the patient valve, is placed
between the activity detector and the patient. Id. at .000029. The patient valve controls the flow
of the radioactive eluate into two more lines, a line to the patient and a line to a waste bottle.
The Klein thesis discloses that the components of the system are arranged on a stainless
steel cart. Klein explained “the cart must be moved around the imaging room” and time constraints
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in moving the cart “can be tight.” Klein at .000046. The following photo of the Klein cart appears
in the thesis:
Id. at .000034. The yellow annotation bubbles are Klein’s.
A pervasive concern in Klein’s design was minimizing patient and operator exposure to
radiation. See, e.g., id. at .000038, -44, -46. As shown in the photo and explained in the thesis
text, Klein placed the rubidium generator within a column of stacked lead rings for shielding and
placed the waste bottle within a lead shielded container having a lid. Id. at .000033-34. Both the
generator and the waste bottle are located on the same shelf within the cart, with the opening to
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the waste bottle container at a lower elevation than the top of the stacked lead rings around the
generator. Id.
Klein’s system also includes a dose calibrator. Id at .000056. The dose calibrator is used
for both calibration and testing. During calibration, readings from the activity counter are
compared to dose calibrator readings to calibrate the activity counter. Id. at .000033, .000053.
During test runs, dose calibrator readings are used to verify the expected results. Id. Readings are
also taken 20 minutes after the end of an elution to compare the breakthrough strontium-82 and
strontium-85 activity. Id. at .000028, .000053, .000060-.000062. At the end of an elution, high
levels of rubidium-82 activity will be present; due to its short half-life, the rubidium’s activity
decays exponentially over a short period compared to residual activity of any strontium, allowing
for detection of breakthrough. Id. at .000060-.000061.
Klein used a dose calibrator that was commercially available at the time. Id. The dose
calibrator includes a vial, which is placed within an ionization chamber. Id. at .0055-.0057.
Although the dose calibrator possessed its own off-the-shelf shielding, Klein added additional
shielding in the form of stacked lead rings. Id. at .000056. The system photo in Klein shows the
dose calibrator sitting on the lab countertop, not on the stainless steel cart. Id. at 27-28 (“external
dose calibrator”).
The tubing and other system components of the infusion system were enclosed within a
high density plastic enclosure on the top surface of the cart, again to shield the operator from
radiation exposure. Id. at .000033. Klein annotated a closer photograph of the top of the cart:
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Id. at .000034. This detailed photograph shows that the constructed Klein device has components
arranged as shown in Klein’s block diagram of the system. Compare id. at .000034 with id. at
.000029. In the bottom center of the photograph, the top of the generator is identified and visible
beneath a stainless steel lid labeled “Generator Access Lid.”
The Klein thesis also describes a computer for controlling the system, including a touch
screen entering user commands. Id. at .000034 (FIG. 2-3), .000064 (FIG.3-12(c)). Software on
the computer controls the pump and valves, which in turn sets the flow of the elution to the patient.
Id. at .000029, -43. The computer controls the valves in response to real-time data gathered by the
activity counter, the dose calibrator, and other sensors. Id.
Software on the computer enforces compliance with a daily safety protocol. Id. at
.000027-28, -54. The software only enables patient elusions after completion of the protocol. Id.,
see also id. at .000038-39, -43. The safety protocol includes a daily “flush” of the generator and
all tubes to remove air bubbles and any strontium breakthrough from the system. Id. at .000028.
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It also includes a “calibration run” to elute rubidium to the dose calibrator for strontium
breakthrough testing and to calibrate readings from the activity counter. Id. at .000028, -33, -54.
“Only after a calibration run with low SR breakthrough has been successfully completed can
patient elutions be carried out.” Id. at .000028. This “remove[s] operator intervention” in
completion of the protocol. Id. Once the daily protocol completes successfully, patient elutions
are enabled until the end of the day. Id. The system disables elutions at midnight each night, when
the daily protocol expires. Id. at .000029.
b) Secondary Prior Art
Jubilant and Staff also advance obviousness arguments based on the Klein thesis in view
of certain secondary prior art. That art includes a patent to Tate, an ergonomics reference authored
by Chaffin, the Bracco Model 510 prior art device, and the MedRad Intego prior art device. Tr. at
119:5-12, 618:14-619:16. An overview of these secondary prior art references follows, though
additional details are discussed in connection with relevant claims below.
(1) U.S. Publication 2008/0177126 (“Tate”)
U.S. Publication 2008/0177126 is a patent application filed by MedRad on October 31,
2007 (RX-0103.000001) (“Tate”). Tate discloses “methods, systems, and components thereof for
delivering . . . radiopharmaceuticals to patients for positron emission tomography (PET).” Id. at
.000089 (1:002). Tate’s system is a cart that includes a radiopharmaceutical source, a dose
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calibrator, and a waste bottle in separate shielded recesses within an upper surface of the cart. Id.
at .000092 (4:72). Figure 1E shows a cross-section view of Tate’s fluid delivery system (10):
The recesses for the dose calibrator and the waste bottle open vertically upwards. Id.
at .000093 (5:78). The upper surface also includes troughs or other depressions for tubing and the
other elements necessary to deliver fluids containing the radiopharmaceuticals to patients without
kinking or pinching. Id. at .000093 (5:78). Those elements are then enclosed by a lid (10) or cover
(20), which includes radioactive shielding to minimize radiation exposure from the
radiopharmaceutical source and waste receptacle. Id. at .000092 (4:72-73). The recess for the
radioactive source is additionally covered by a cap. Id. .000097 (6:139-142).
Tate also discloses a touchscreen computer control system. Id. at .000100 (12:171-172).
This system is intended to enable “(1) system preparation, (2) patient treatment, (3) injection
history (i.e. obtaining information regarding previous treatments), and (4) system configuration.”
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Id. 13:182. Tate teaches using the computer to track consumables depleted during use, such as
saline and the radiopharmaceutical. Id. at .000056 (FIG. 29), .000061 (FIG.32B).
Tate is directed to a system for use with fluorodeoxyglucose (“FDG”), a different
radiopharmaceutical than the rubidium-82 described in the asserted patents. Id. at .000089. FDG
is generated by a cyclotron, transferred to the location of the cart, and loaded in the cart as needed.
Id. Tate explains, however, that because “radioisotopes, such as . . . Rubidium-82. . . .” and FDG
are useful in medical imaging due to their “relatively short half-lives, systems that use these
isotopes face the same problem of tracking the level of radioactivity delivered to the patient with
each dose. Id.
Tate is concerned with “calculating and delivering accurate and effective doses of
radiopharmaceuticals to patients, while reducing the exposure of administering or other medical
personnel” caused by manual handling of samples for calibration. Id. at .000089-.000090. Tate
suggests its teachings “can be used in a very wide variety of drug delivery and therapeutic
procedures.” Id. .000109 (¶0276). Tate advises accounting for the “elapsed time (and
corresponding decrease in radioactivity level of the radioisotope)” between the time the radioactive
material was created and the time it is administered to the patient. Id. (1:008).
Jubilant and Staff rely on Tate’s teachings concerning an on-board dose calibrator, tubing
passageways, and various computer functions.
(a) Analogous Art
Bracco argues that Tate is not analogous art and thus should not be considered for
obviousness of the patents. Bracco primarily argues that rubidium elution-infusion systems, which
generate and infuse the short-lived rubidium-82, have many technical hurdles not present or
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addressed in FDG systems, and therefore a person of skill in the art would not be motivated to
combine the teachings of the two references. CIB at 16-26.
Bracco has sliced the art too thinly. Art is analogous when it is “from the same field of
endeavor, regardless of the problem addressed” or, if not from the same field of endeavor, when
“the reference is still reasonably pertinent to the particular problem with which the inventor is
involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (toothbrush was analogous art to
hairbrush). Put another way, a given piece of prior art need not address all of the exact same
problems in order to be considered analogous to the claimed invention, as it need only be
“reasonably pertinent to the particular problem with which the inventor is involved.” Id.
A reference is reasonably pertinent if, “even though it may be in a different field from the
inventor’s endeavor, it is one which, because of the matter with which it deals, logically would
have commended itself to an inventor’s attention in considering his problem.” In re Klein, 647
F.3d 1343, 1348 (Fed. Cir. 2011).
I find that, as a factual matter, Tate is in the same field of endeavor as the present invention,
as both are “systems that . . . infuse radiopharmaceuticals, . . . including computer-facilitated
maintenance and/or operation.” ’826 Patent at 1:27-30. The field of endeavor of a patent is not
limited to the specific point of novelty, the narrowest possible conception of the field, or the
particular focus within a given field.” Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001
(Fed. Cir. 2016). Here, based on the “explanations of the invention’s subject matter in the patent
application, including the embodiments, function, and structure of the claimed invention,” Bigio,
381 F.3d at 1325, that field of endeavor is computerized devices to safely administer
radiopharmaceutical tracers. See Tr. at 616:22-617:23 (Dr. Stone: “We are dealing with a system
to inject a fluid safely.”); 867:11-17 (Dr. Stone: “we are dealing with a device to administer
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radiopharmaceutical”); ’826 Patent at 1:25-30 (“The present invention pertains to systems that
generate and infuse radiopharmaceuticals, and, more particularly, to systems including computer-
facilitated maintenance and/or operation”).2
I additionally find that Tate was directed to at least some of the same problems as the
asserted patents, namely “calculating and delivering accurate and effective doses of
radiopharmaceuticals to patients, while reducing the exposure of administering or other medical
personnel” caused by manual handling of samples for calibration. Tate at .0089-.0090; see also
id. (“The present invention relates to methods, systems and components thereof for delivering
pharmaceutical substances to patients for imaging procedures and, more particularly, for delivering
radiopharmaceuticals to patients for positron emission tomography (PET)”). Bracco’s own expert
Dr. Pelc admitted that the asserted patents are directed at least in part to that same problem. Tr. at
1113:25-1114:4 (Q. “Would you agree that the patents-in-suit are directed, at least in part, toward
the problem of delivering radiopharmaceuticals to patients for positron emission tomography?”
A. “Yes”). Because Tate is directed to solving one of the same problems as the asserted patents, I
find it is reasonably pertinent to the problem to be solved and thus constitutes analogous prior art.
(2) MedRad Intego
The MedRad Intego system (see, e.g., RX-200C) is essentially the commercial embodiment
of the invention disclosed in the Tate patent. Indeed, the Intego system is marketed by the assignee
of Tate. See Tate at Cover. The record shows the MedRad Intego system was publicly sold in the
United States, offered for sale in the United States, and installed in the United States prior to June
2009. RX-0202C (April 2009 invoice showing installation of an Intego system in April 2009);
2 Though Dr. Pelc testified to the contrary, I find his testimony less credible on this point than
that of Dr. Stone’s. See 961:20-962:9.
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RX-0203C.0001 (May 2009 order for delivery of Intego system in Massachusetts);
RX-0203C.0002 (October 2008 price quote for Intego system offered to customer in Tennessee);
JX-0176C at 167:8-170:5 (testimony that Janet Gelbach saw an Intego system at a trade show no
later than June 2009). The MedRad Intego system is thus prior art under 35 U.S.C. §§ 102(a)
and (g). I further find it is pertinent art for the same reasons addressed above concerning Tate.
See supra V.B.1.b)(1)(a).
Bracco challenges the use of the MedRad Intego as prior art. First, Bracco argues that the
MedRad Intego user manual (RX-200) may not be considered when analyzing proposed
combinations of prior art. CRB at 11-12. Bracco apparently misapprehends the relevance of that
manual. Neither Jubilant nor Staff rely on the MedRad Intego manual as a prior art printed
publication. See, e.g., SIB at 44 (“Bracco asserts that Jubilant is relying on a MedRad Intego
manual . . . However, the evidence establishes that the Medrad Intego System. . . ”); RIB at 21
(listing “The Medrad Intego PET Infusion System” as the relevant art). Instead, the manual,
bearing a 2009 copyright date, is advanced as corroborating evidence of the features embodied in
the Intego system offered for sale by MedRad in 2008 and installed for use in April 2009, prior to
the asserted patents’ priority date of June 11, 2009.
Bracco next asserts the MedRad Intego manual was subject to a confidentiality provision
when it was given to customers. That contention is irrelevant because no party relies on the manual
as an invalidating printed publication. Bracco’s contention is also unsupported by the record.
There is no evidence in the record that the manual was subject to confidentiality agreements, and
the non-party that produced the manual in discovery has since withdrawn its confidentiality
designation. Bracco does not argue, and certainly points to no evidence, that clinicians using the
MedRad Intego system were subject to the type of nondisclosure agreement that would qualify the
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use as experimental. Compare New Railhead Mfg. v. Vermeer Mfg. Co., 298 F.3d 1290, 1298-
1300 (Fed. Cir. 2002) (finding that performance of the claimed method of drilling in rock at a
commercial jobsite under public land, hidden from view, constituted public use); Baxter Int'l v.
COBE Labs., 88 F.3d 1054 (Fed. Cir. 1996) (finding that a scientist’s use of a machine
implementing the claimed method in a laboratory at the National Institutes of Health, without the
public’s awareness of the method employed by the machine, was a prior public use); Elec. Battery
Co. v. Shimadzu, 307 U.S. 5, 20 (1939) (“The ordinary use of a machine or the practise [sic] of a
process in a factory in the usual course of producing articles for commercial purposes is a public
use”), with W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (no
public use where company told all employees that the prior art machine was confidential and
required them to sign confidentiality agreements, thus concealing the machine and viewer of the
machine could not learn anything of its processes of operation); Motionless Keyboard Co. v.
Microsoft Corp., 486 F.3d 1376 (Fed. Cir. 2007) (finding that the prior art user was required to
sign a non-disclosure agreement related to the prior art, thus concealing the prior art).
Jubilant and Staff rely on features of the MedRad Intego system that are similar to the
features they highlight in the Tate patent, including an on-board dose calibrator, tubing
passageways, and various computer functions.
(3) Chaffin, et al., Occupational Biomechanics, 2d ed. (1991)
(RX-0096)
Occupational Biomechanics, 2d ed. (1991) (RX-0096), is an ergonomics and biomechanics
reference authored by Chaffin, et al. (hereinafter “Chaffin”). Chaffin teaches sensible ways to
physically arrange heavy objects used by humans. For example, Chaffin teaches that heavier
objects should be placed so as to minimize the distance required to lift them in order to reduce
strain or injury to the person lifting the object. See RX-0096.0170-.0178.
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Jubilant and Staff rely on Chaffin for its teachings concerning the relative heights of
openings for heavy objects, such as the generator.
(4) IEC 62366
IEC 62366 (RX-0114) is an international standard for medical device design. IEC 62366
teaches medical device developers to provide a user interface that enables users “to be aware of
the use of the correct consumable, the remaining amount of [the consumable], whether accessories
might be used with the MEDICAL DEVICE, how to assemble them and how to check their correct
functioning.” IEC 62366 at .0063.
Jubilant and Staff rely on IEC 62366 for its teachings relating to various computer warnings
based on system state and readiness, such as tracking consumable use and reminding a user to
replace or empty system components.
(5) Bracco CardioGen-82 Model 510
The Bracco CardioGen-82 Model 510 is a strontium-rubidium cardiac PET infusion system
first approved by the FDA in 1989. Tr. at 589:18-590:3. Until the introduction of the RUBY
Version 3, the Model 510 was the only rubidium infusion system available in the United States.
Id. Although the Model 510 shares the same core operational principles and much of the same
physical configuration as the systems described in the asserted patents, see Tr. 137:15-138:6, the
Model 510 lacked many of the features claimed in the patents, including an on-board dose
calibrator and computer. JX-112C at .0003 (Model 510 system controlled by instrument panel),
.0009 (Model 510 had manual breakthrough testing); Tr. at 1069:4-20 (Model 510 lacks
computer).
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Jubilant and Staff rely on the Model 510 for its teachings relating to configuration of
various physical components of a rubidium infusion system, such as the openings of shielding
compartments facing vertically upwards.
2. Comparing the Claims to the Prior Art
a) ’826 Patent
Bracco asserts claims 1-3, 5, 9, 11-14, 17-19, and 28 of the ’826 patent. Due to
intermediate dependencies, the structure recited in claim 10 is also at issue for the purposes of my
invalidity analysis.
(1) Claim 1
Claim 1 of the ’826 patent follows, with disputed limitations emphasized:
[1] A method of building an infusion system to deliver a rubidium radioactive eluate comprising:
[1.1] installing a first shielding compartment, a second shielding compartment, and a
shielded well on a platform of a cart, wherein:
[1.1.a] the first shielding compartment has a first opening facing vertically
upwardly,
[1.1.b] the first opening is configured for a strontium-rubidium radioisotope
generator to be inserted into and removed from the first shielding compartment,
[1.1.c] the second shielding compartment has a second opening facing vertically
upwardly,
[1.1.d] the second opening is configured for a waste bottle to be inserted into and
removed from the second shielding compartment,
[1.1.e] the first opening is located at a lower elevation than the second
opening, and
[1.1.f] the shielded well is configured to receive an eluate reservoir that is
configured to receive a sample of the rubidium radioactive eluate;
[1.2] configuring a computer with a touch screen display for the infusion system to:
[1.2.a] fill the eluate reservoir in the shielded well on-board the cart with the
sample of the rubidium radioactive eluate by pumping saline from a saline
reservoir into the strontium-rubidium radioisotope generator via a saline tubing
line thereby generating the rubidium radioactive eluate that is discharged through
an eluate tubing line,
[1.2.b] determine a strontium breakthrough test result on the sample of the
rubidium radioactive eluate filled into the eluate reservoir in the shielded well
on-board the cart while the eluate reservoir remains in the shielded well on-
board the cart, and
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[1.2.c] not allow a patient infusion if the strontium breakthrough test result is
greater than or equal to an allowed limit.
Jubilant and Staff assert this claim is obvious in light of Klein, either alone or in certain
combinations of other prior art. Bracco argues that Klein does not teach (1) a shielded well on-
board a cart, (2) a first shielded compartment configured for a generator, (3) a generator
compartment opening lower than a waste bottle compartment opening, and (4) a computer
configured in the manner claimed. I address the parties’ arguments below.
(a) Klein Thesis Alone
I begin my obviousness determination by considering whether the invention of claim 1
would have been obvious in view of only the Klein thesis. While I have considered the claim and
the prior art as a whole, I organize my findings around the four claim limitations particularly
disputed by Bracco.
“shielded well on-board the cart”
The parties dispute whether Klein discloses the shielded well recited in claim 1. Limitation
[1.1] requires that the shielded well be installed on a platform of the cart, limitation [1.1.f] states
that the well has an eluate reservoir, and element [1.2.b] states that a computer determines a
strontium breakthrough test result on radioactive material in the eluate reservoir. Limitation
[1.2.b] also requires that the test result is determined while the shielded well and reservoir are “on-
board the cart.” The parties agree that Klein does not teach a shielded well on-board the cart.
Jubilant and Staff argue, however, that Klein’s dose calibrator would meet all of the claim
limitations relating to the shielded well if that dose calibrator were located on Klein’s cart. RIB at
25, 40-41; SIB at 41. Jubilant and Staff argue it would have been obvious to a person of ordinary
skill in the art reading Klein to make a rubidium infusion system with the dose calibrator on the
cart. See, e.g., RIB at 25; SIB at 41. Bracco argues that a person of skill in the art would not be
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motivated to put Klein’s dose calibrator on the cart because doing so “poses significant technical
challenges.” CIB at 44.
I find the Klein thesis expressly discloses at least three motivations for building a system
with the dose calibrator on-board the cart. The first motivation is mobility. Klein explains that
prior art cyclotrons used to generate radioactive material for imaging were known to be expensive
and immobile. Klein at .000024-25. By the time of Klein’s work, the disadvantages of cyclotrons
had already motivated the development of mobile PET imaging systems to serve smaller
communities. Id. Klein also expressly states that one of his design objectives was to make a
system that could be “moved around the imaging room” because time constraints in performing
imaging were known to be “tight.” Id. at .000046. Reading these teachings, a person of skill in
the art would readily understand that having the dose calibrator on the cart would allow the entire
Klein system to be moved around the imaging room quickly and would make it easier to transport
the system to remote locations. Experts from both parties corroborated that a person of skill in the
art would be motivated by these factors. See, e.g., Tr. at 623:9-22 (Jubilant’s expert Dr. Sone
describing the difficulty of repeatedly rolling the cart back to a stationary dose calibrator);
964:19-20 (Bracco’s expert Dr. Pelc testifying that “everything with respect to handling rubidium
is very rushed”); id. at 987:9-14 (same).
Second, Klein teaches that one goal of his project was to achieve a system for “routine
clinical use,” which requires “operational simplicity.” Klein at .000024. Klein also contemplates
additional refinements as part of “preparing the system for distribution to external facilities.”
Klein at .000141. Moving the dose calibrator onto the cart would simplify operation by eliminating
a step of connecting and disconnecting the dose calibrator whenever the cart is moved. Dr. Stone’s
testimony corroborates that a person of skill in the art motivated to commercialize the Klein system
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would make such modifications. Dr. Stone’s experience in commercializing prototypes for
medical devices is undisputed. See Tr. at 581:20-585:15. Dr. Stone credibly testified that it would
have been obvious to a skilled person preparing the Klein system for commercial clinical use to
put components used together on the same cart. Tr. at 619:17-620:1; 622:23-624:1.
Third, Klein teaches that it was known that, when designing a device used to administer
radioactive material, choices should be made to minimize the operator’s exposure to radiation.
See, e.g., Klein at .000027, -38, -44, -46.3 Reading these teachings, a person of skill in the art
would readily understand that putting the dose calibrator on the cart would shorten and enclose
within shielding the tubing carrying radioactive material from the lead-shielded generator to the
lead-shielded calibrator, thereby minimizing exposure to the operator. See Klein at .000029
(Figure 2-2).
Significantly, Bracco does not address the passages in Klein containing the express
motivations for moving the dose calibrator identified above. Instead, Bracco criticizes Staff’s
assertion that Bracco got the idea to put the dose calibrator on its cart from customers. RRB at
41-42. Bracco’s subjective motivations for developing its own system are immaterial to an
obviousness determination, and I do not rely on them.4 Otsuka Pharma. Co. v. Sandoz Inc., 678
F.3d 1280, 1296 (Fed. Cir. 2012) (an “inventor’s own path never leads to a conclusion of
obviousness; that is hindsight”). The standard for obviousness is an objective one. KSR, 550 U.S.
3 This principle is known as ALARA and is widely recognized in the medical imaging field.
Tr. at 504:7-505:1, 913:2-16.
4 Bracco’s expert Dr. Pelc did not believe that Jubilant’s expert Dr. Stone relied on this evidence
either. See Tr. at 977:24-978:1 (“In my view, Dr. Stone is relying more on the person of skill in
the art thinking of moving the dose calibrator on board the cart” than on testimony about
customer comments from former Bracco employee Janet Gelbach).
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at 419. The Klein reference alone provides ample evidence that a person of skill in the art at the
time of the invention would have been motivated to put the dose calibrator on the cart.
Bracco also argues that Klein “teaches against carelessly changing its dose calibrator
arrangement” because the dose calibrator is a sensitive instrument that could be influenced by
background radiation if it is used in another configuration. RRB at 43. Bracco’s argument ignores
Klein’s express teachings about how to overcome difficulties like “radiation from the
surroundings.” See Klein at .000056. Klein explains that even in the configuration Klein built,
“[t]he exact region of measurement of the dose calibrator [was] unknown and dependent on its
geometry.” Klein at .000057. But that was not an impediment to Klein’s invention. Klein
developed a method of analyzing dose calibrator readings that “accounts for all available data and
therefore decreases the effect of noise” in dose calibrator measurements. Id. at .000057-58.
Because “the physical process” of radioactive transfer “is well understood” and accounted for in
Klein’s model, a person of skill would know how to successfully rearrange the components Klein
expressly discloses. Id. at .000119.
Other record evidence corroborates that conclusion. For example, even though Klein
expressly acknowledged unknowns about detection geometry and background noise with his
system, Bracco’s expert Dr. Pelc admitted that Klein had no problems obtaining accurate
measurements from the dose calibrator in those conditions. Tr. at 978:17-22; 997:1-4. And
although Dr. Pelc said a skilled artisan would “think twice” before rearranging components in
Klein’s system, he did not testify that such an artisan would be unable to successfully rearrange
parts. Tr. at 988:1-8. Instead, he admitted Klein advises an artisan rearranging parts to “make
sure [to] consider delay time and decay of the radioisotope” in the eluate tubes as the length of
those tubes change. Id. When Dr. Pelc was directly asked if a person of skill in the art at the
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relevant time would know how to compensate for changes in tube length, he did not say “no”; he
said “it’s complicated.” Tr. at 989:16-22. But complicated changes can still be obvious to skilled
artisans. See In re Greene, 217 F.3d 860 (Fed. Cir. 1999) (level of complexity in adopting claimed
invention “is not a telling question in an obviousness inquiry”).
Bracco next cites evidence purporting to show that Jubilant had difficulty developing
adequate shielding “between the waste pot and dose calibrator” when designing the accused RUBY
Version 3 system. CRB at 44. Bracco contends this evidence shows it would not be obvious to
move the Klein dose calibrator onto the cart. Id. Bracco’s argument is unconvincing. Again, the
standard for obviousness is an objective one. KSR, 550 U.S. at 419. At best, the cited Jubilant
emails are anecdotal evidence of a few designers’ subjective experience. Even considering
Jubilant’s emails as somehow probative of the state of the art generally, the evidence does not
support Bracco’s conclusion. The emails show nothing more than routine design work well within
the ability of a person of skill in the art. See Tr. at 847:10-848:14.
Although Bracco claims that a skilled artisan would have difficulty resolving a host of
technical issues in order to build a system with the dose-calibrator on-board the cart, it is interesting
to note none of the asserted patents describe any such difficulty. Indeed, the only two passages in
the patent specification describing the dose calibrator on-board the cart simply announce that fact
without describing any difficulty in making or using that arrangement. See, e.g., ’826 patent at
11:8-19, 27:9-12. I need not and do not rely on disclosures from the asserted patents in my
obviousness analysis. But if those succinct disclosures are enabling to a person of ordinary skill
in the art at the time of the invention, as Bracco contends (see CRB at 2), then such a person would
need little guidance indeed on how to build a system with the dose calibrator on-board the cart.
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After considering the evidence in record as a whole, I find that a person of ordinary skill
in the art would be motivated to relocate Klein’s dose calibrator onto the cart so that the entire
system would be mobile, so that operation would be simplified, and so that the operator would be
better shielded from radiation in the tube leading from the generator into the dose calibrator. See,
e.g., Klein at .000024., -38, -44, -46, 141. Klein teaches principles that would allow a skilled
artisan to successfully rearrange the components. Id. at .000057-58, -119. Putting the dose
calibrator on the cart in Klein therefore would have been obvious. In re Kuhle, 526 F.2d 553, 555
(CCPA 1975) (the particular placement of a component in a device was obvious matter of design
choice); In re Japikse, 181 F.2d 1019, 1023 (CCPA 1950) (shifting the position of a component
from prior art position would not have modified the operation of the device and was therefore
unpatentable); In re Larson, 340 F.2d 965, 968 (CCPA 1965) (“the use of a one piece construction
instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering
choice.”).5
“first shielding compartment”
Limitations [1.1.a] and [1.1.b] require a first shielding compartment for the generator. Staff
and Jubilant argue that Klein discloses installing a column of lead rings on the shelf of the cart for
shielding the generator. SPB at 45; JPB at 110-11. They contend the lead structure corresponds
to the claimed first shielding compartment. Id. Bracco argues the stack of lead rings have an
5 In making this determination, I have considered the claim as a whole as well as Bracco’s
arguments concerning secondary considerations of non-obviousness. In re Cyclobenzaprine
Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1079 (Fed. Cir. 2012). I
explain my analysis of secondary considerations infra part V.B.3.
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opening facing upwards and an opening facing downwards and thus “cannot be the first shielding
compartment.” CPB at 48-50 (citing Tr. at 995:22-996:17). To support this position, Bracco relies
on the opinion of its expert Dr. Pelc that the word “compartment” in the claim requires structure
that must “completely enclose” a portion of space. Id. Jubilant argues in response that Dr. Pelc’s
definition contradicts claim elements [1.1.a] through [1.1.e], all of which teach openings in the
first and second shielded compartments, indicating that the compartments do not completely
enclose an area. RRB at 111-112.
I find that Klein teaches a first shielding compartment. Contrary to Dr. Pelc’s opinion,
claim 1 does not require the compartment to be completely enclosed. Instead, claim 1 requires
that the shielding compartment have an “opening.” Dr. Pelc cites no evidence intrinsic to the ’826
patent to support his opinion that the word “compartment” should be limited beyond its ordinary
meaning, and I therefore give his opinion little weight. See Phillips, 415 F.3d at 1313.
Bracco next argues that Klein’s lead compartment does not disclose limitation [1.1.a]
because it has an opening facing “downwards.” CPB at 48-50. Bracco is factually and legally
incorrect. Factually, when Klein’s generator is in place for use, as shown in Klein Figure 2-3, the
cart shelf forms a solid bottom for the compartment and there is no opening facing downwards.
Klein at .000033. Legally, even if the Klein compartment did have a bottom opening, nothing in
the claim language would prohibit such a feature. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
200 F.3d 795, 811 (Fed. Cir. 1999) (absent special circumstances, infringement is not avoided by
the presence of elements or steps in addition to those specifically recited in the claim). I find that
the stack of lead rings on the shelf housing the generator in the Klein thesis is a “first shielding
compartment” as that term is understood by those of skill in the art. See Tr. at 727:6-14.
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Bracco additionally argues that the generator in the Klein thesis “was not inserted into” the
first shielded compartment as purportedly required by limitation [1.1.b]. CRB at 50. Instead,
Bracco contends, Klein placed the generator on a cart and afterwards placed lead rings surrounding
it. Id. Bracco’s contention is again premised on an incorrect reading of limitation [1.1.b]. The
claim does not require inserting a generator into a pre-formed compartment. The claim recites “[a]
method of building an infusion system” comprising a step of “installing a first shielding
compartment” wherein that compartment has an opening “configured for a strontium-rubidium
radioisotope generator to be inserted into and removed.” According to Bracco’s own description,
Klein performed that step. When Klein built his infusion system, he installed a shielding
compartment of lead rings on the cart. Klein at .000033. The photograph of the Klein device
shows the generator inside the lead ring shielding compartment, so clearly the compartment is
“configured” to be an appropriate size for housing the generator. Id. at .000034. Additionally, the
photograph shows the lead rings around the generator are uniformly sized, so the structure has
nothing that would impede inserting and removing the generator through the top opening of the
lead shield. Moreoever, Klein confirms that the generator can be removed from the compartment
with its disclosure of a “Generator Access Lid” in Figure 2-4 and Klein confirms that the generator
was in fact replaced at least four times. Id.; see also id. at .000116; Tr. at 665:11-666:1 (testimony
of Dr. Stone that Klein had “an access door . . . that could give access to the generator”). .
Limitation [1.1.b] is disclosed in Klein.
“the first opening at a lower elevation than the second opening”
Claim limitation [1.1.e] requires the top opening of the first shielding compartment (the
one for the generator) to be at a lower elevation than the top opening of a second shielding
compartment (the one for the waste bottle). The photograph of the system in the Klein thesis
shows a shielded generator and a shielded waste bottle on a shelf in the cart cabinet. Klein at
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.000034. All parties agree, however, that Klein does not expressly show the opening at the top of
the shielded generator compartment at a lower elevation that the opening at the top of the shielded
waste bottle compartment. SIB at 40; RIB at 38-39; CRB at 31.
Jubilant and Staff propose that the Klein thesis, viewed in combination with an ergonomics
and biomechanics reference called Chaffin, renders obvious an invention with openings at different
heights. SIB at 51 (citing Tr. at 833:3-9); RIB 112-116. Bracco, on the other hand, argues that
Klein teaches away from the rearrangement of its components as advocated by Jubilant and Staff.
CRB at 35-36 (citing Klein at .000049 (“The layout of the saline lines, sensors and actuators is
crucial to implementing a physical system that is easy to control.”)).
I have already determined that a person of skill in the art reading Klein would be motivated
to move the dose calibrator onto the cart. Such a move would prompt the artisan to consider how
the various components of the system should be arranged on the cart, particularly because Klein
expressly advises those of skill to consider how a physical configuration can affect measurements
of radioactivity. Klein at .000057-58, -119. Klein also contains express motivation to refine the
system for commercialization. See Klein at .000024, -141. Corroborating that chain of logic,
Dr. Stone credibly testified that a person of skill with the motivation to commercialize the Klein
system would consider how the components are arranged. Tr. at 616:25-618:4.
When considering the arrangement of the openings of the generator compartment and the
waste bottle compartment, the skilled artisan would have three choices: the generator
compartment opening could be at a higher elevation than the waste bottle compartment opening,
the two openings could be at the same elevation, or the generator compartment opening could be
at a lower elevation than the waste bottle compartment opening. The patent entirely lacks any
teaching of advantage to having the generator compartment opening higher than the waste bottle
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compartment opening. I find that claim element [1.1.e] would be an obvious design choice in view
of Klein, which discloses every component of the claimed invention in only a slightly different
physical configuration. See KSR at 421; In re Weber, 312 F.2d 810, 813 (C.C.P.A. 1963) (holding
claimed subject matter “would be no more than an obvious reversal of arrangement and not
patentable.”); In re Gazda, 219 F.2d 449, 451 (C.C.P.A. 1955) (claimed subject-matter
unpatentable as obvious where “only a matter of choice amounting to a mere reversal of parts”);
In re Kuhle, 526 F.2d at 555; In re Japikse, 181 F.2d 1019 (C.C.P.A. 1950). A skilled artisan
would find the arrangement in claim element [1.1.e] obvious even without consulting the Chaffin
ergonomics reference.
“computer”
Claim limitations [1.2]-[1.2.c] require configuring a computer to fill an on-cart reservoir
with a sample of radioactive material, determine a strontium breakthrough test result on the
sample, and not allow a patient infusion if the strontium breakthrough test result is greater than or
equal to an allowed limit. Jubilant and Staff contend Klein expressly teaches a computer that fills
a dose calibrator reservoir, performs a strontium breakthrough test, and locks out a patient infusion
if the test fails. RIB at 85-86, 120-122; SIB at 52-53. According to Jubilant and Staff, the only
difference between the Klein system and the claimed computer is that Klein’s computer
coordinates a test in a dose calibrator that is not on the cart. See, e.g., RIB at 88; SIB at 54. Jubilant
and Staff contend an invention with the computer in claim element [1.2] would have been obvious
in view of Klein. RIB at 85-87; SIB at 51-54.
Bracco concedes that Klein teaches running a daily strontium breakthrough test on the
system. See CRB at 52 (citing Klein at .00043, .00132). Bracco also concedes that if the Klein
system detects significant strontium activity, “the generator cannot be used on humans.” See id.
However, Bracco disputes the contention that Klein’s computer will “lock out” a patient elution if
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breakthrough is detected. Id. at 52-55. And, of course, Bracco maintains that the Klein computer
does not perform a break-through test on a sample in a reservoir on-board the cart. Id. at 55.
I find that Klein does not teach a computer interacting with a sample on-board the cart, but
Klein expressly discloses a computer with all other elements in limitations [1.2] to [1.2.c]. The
Klein computer controls a pump and valves to fill the dose calibrator reservoir with a test sample.
See, e.g., Tr. at 755:21-756:3; Klein at .000029. Klein also discloses configuring the computer
control system to operate a “daily protocol,” which determines a strontium breakthrough test result
on the sample. Klein at .000028, -39.
With respect to lock-out of patient elutions, Bracco’s understanding of Klein is incorrect.
Klein discloses that computer software in his system “remove[s] operator intervention” and
“enable[s]” infusion to a patient “only after the prerequisites have been completed successfully.”
Id. at .000027-28, -54. These features are in keeping with Klein’s “first concern” that the “design
must have multiple robust mechanisms to ensure that in any case of failure, the patient is not at
risk.” Id. at .000042. One prerequisite for a patient infusion is successful completion of a daily
safety protocol. Id. at .00028. The safety protocol includes a “calibration run” to elute rubidium
to the dose calibrator for strontium breakthrough testing. Id. at .000028, -33, -54. Klein’s system
detects values and compares them to an expected range. Id. at .000078 (“Patient elution and test
runs are tested for discrepancy with the expected values of eluted activity.”); .000062 (“to confirm
that the breakthrough is less than” an allowed amount, the system must wait sufficient time before
breakthrough measurement). If a value is out of range, an error is generated and “the program is
halted.” Id. at .000063-64 (Figure 3-12(d), screenshot with the caption “Out of range data”). “The
sequence will not continue until all errors are resolved.” Id. at .000063.
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Klein also describes what an operator sees when the operator is locked out from performing
patient elusions. A user interacts with the computer using a touchscreen that displays “buttons and
radio buttons.” Id. at .000031, -40. But these buttons are available to the user “only at relevant
states” and are “immediately removed at the end of each state.” Id. at .000040-41. Klein explains
that these restrictions “limit the user input to ensure validity” of the process. Id. at .000040. Klein
expressly teaches that when a user wants to start an elution run, “[t]he options presented to the user
vary,” depending on several conditions. Id. at .000063-65. Klein illustrates this point with a
sample screenshot in Figure 3-12 (c), which shows some elution test runs grayed out to prevent
user selection. Id. at .000064. In the same paragraph where Klein describes the conditionality of
“options presented to the user” for starting a run, he states the software interface “ensures that the
daily protocol is followed, including a flush and calibration (including a test of breakthrough
activity) at the start of each day.” Id. at .000065. Viewed together, these teachings indicate that
the user would not be able to select the radio button on the touchscreen for a patient elusion without
a successful breakthrough test.
Klein is also express when distinguishing between action taken by the operator and action
performed by the system. For example, “[t]he screen can…be pressed” by a user to initiate a pre-
run sequence, but if errors are detected by the system during that sequence “an appropriate message
is displayed and the program is halted.” Id. at .000063 (emphasis added). “The sequence will not
continue until all errors are resolved.” Id. (emphasis added). Klein expressly states the system
will only “enable patient elutions” with a successful breakthrough measurement. Klein at .000039
(emphasis added); see also id. at .000028. If there were no system lock-out, as Bracco contends,
then there would be no need to “enable” patient elutions. See also id. at .000029 (system disables
patient elusion runs each night at midnight, when the validation from the calibration run expires),
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.000075 (showing error code 40009, “No calibration file found for today. Conduct calibration run
before proceeding.”). Klein clearly states, “Only after a calibration run with low Sr breakthrough
has been successfully completed can patient elutions be carried out.” Id. at .000028 (emphasis
added), .000043 (“The amount of Sr breakthrough activity must be strictly limited to the Health
Canada guidelines. This issue is addressed by daily breakthrough tests as part of the daily protocol
ensured by the system.”) (emphasis added). Viewed together, these disclosures show that the
system will not enable an operator to perform patient elutions unless “low Sr breakthrough has
been successfully completed.” Id.
Bracco contends that the ability to enter manual test results shows there is no lock-out in
Klein. Bracco’s expert Dr. Pelc focuses on a passage where Klein teaches that “[i]f the the dose
calibrator is not sufficiently sensitive to measure breakthrough, the activity can be entered
manually after measurement in a more sensitive device.” See CRB at 43 (citing Klein at .000053).
Bracco is incorrect, as additional context from Klein demonstrates. Klein describes a special case
in which, depending on the sensitivity of the dose calibrator selected for the system and the
radioactivity of rubidium in a test sample, the dose calibrator might not accurately measure
strontium breakthrough. Klein at .000062. In that circumstance, Klein teaches that “automatic
measurement” of strontium breakthrough may be “skipped” and the system allows the operator to
“manually enter the breakthrough activity from a more sensitive instrument.” Id.
The special circumstance highlighted by Bracco does not negate Klein’s other fulsome
disclosures. See Application of Reynaud, 331 F.2d 625, 628 (C.C.P.A. 1964) (prior art may be
relied upon “for all that it discloses”). The system Klein actually built and tested did not require
manual entry of breakthrough data due to poor readings from a dose calibrator. Klein described
the dose calibrator he selected for his system as “the gold standard” (Klein at .000033), and it is
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undisputed that Klein had no problems obtaining accurate measurements from the dose calibrator
he used. Tr. at 978:17-22; 997:1-4d. The system Klein built performed “automatic measurement”
of strontium breakthrough. Id. at .000062. Klein also states, unequivocally, that “[o]nly after a
calibration run with low Sr breakthrough has been successfully completed” did the system
“enable” patient elusions. Id. at .000028 (emphasis added).
Bracco’s expert Dr. Pelc seemed to testify that allowing manual entry of breakthrough data
was actually just hypothetical in the Klein thesis; he said Klein was “envisioning the possibility”
of a system state that allowed manual entry of breakthrough data. See Tr. at 984:8-23 (emphasis
added). But even if Klein’s statement were not hypothetical, there would be no “successful
breakthrough measurement” in a system where the dose calibrator is not sensitive enough or in a
run where the eluted rubidium activity is insufficient to measure breakthrough. See Klein at
.000039 (emphasis added). Without a successful breakthrough measurement, the calibration run
would not have been “successfully completed.” See id. at .000028. Without a successful
calibration run, Klein expressly states the system would not “enable patient elutions.” Klein at
.000028, -39. I find that a person of ordinary skill in the art would understand the software on the
Klein computer will not allow a patient elution until the computer determines that results from a
strontium breakthrough test are acceptable.
Alternatively, to the extent that Klein does not expressly teach a computer that will “not
allow a patient infusion if the strontium breakthrough test result is greater than or equal to an
allowed limit,” I find that a system having this lock-out feature would have been obvious to a
person of skill in the art reading Klein. Klein instructs the skilled artisan that the elution system
“must have multiple robust mechanisms to ensure that in any case of failure the patient is not at
risk.” Klein at .000042. Klein advises the person of skill to “remove operator intervention” to
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enforce compliance with a daily safety protocol, including breakthrough testing. Id. at
.000027-.000028. With that motivation in mind, Klein teaches that “[i]f errors are detected during
the initial testing an appropriate message is displayed and the program is halted . . . The sequence
will not continue until all errors are resolved.” Id. at .000063. Klein also illustrates a software
state machine that does not allow the software to progress to the next step in a protocol unless the
desired state is achieved. Id. at .000073 (“If the transition condition is met for the current state an
initialization of the next state is executed…”).
I have already explained why a person of skill in the art would have been motivated to
move Klein’s dose calibrator onto the cart, and why such a person would have been able to
successfully build and use a system with that configuration. No changes to Klein’s computer
system would be necessary when the dose calibrator is on the cart. Viewing the record evidence
as a whole, an invention having the computer lock-out described in claim 1 would have been
obvious.
Conclusion
It is rare that a single prior art reference renders a claimed invention obvious. But this is
one of those rare circumstances. I find the rubidium infusion system shown in the Klein thesis
includes all of the same functional components recited in claim 1, but Klein physically arranges
the components differently than the claim. For the reasons discussed above, and after considering
secondary indicia of non-obviousness advanced by Bracco,6 I find that rearranging the components
in Klein would have been obvious to a person of ordinary skill in the art at the time of the invention.
claim 1 is therefore invalid under 35 U.S.C. § 103.
6 I fully address Bracco’s arguments concerning secondary indicia infra part IV.D.2.
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(b) Klein Thesis in Combination with Tate and
Chaffin
Jubilant and Staff argue a person of ordinary skill in the art would look to combine the
teachings of the Klein thesis with the Tate patent and a chapter on occupational ergonomics from
Chaffin. Jubilant and Staff contend that Tate teaches a computer controlling radioactive elusions
based on calibration readings from a dose calibrator on-board the cart. RIB at 19-20, 25; SIB at
43-44. They also assert that the Chaffin reference would lead an artisan designing an infusion
system to place the heavy generator at a lower elevation than the waste bottle. RIB at 112-113;
SIB at 50. Jubilant and Staff contend the invention in claim 1 and would have been obvious in
light of Klein, Tate, and Chaffin.
I have previously explained the motivations expressed in Klein that would lead one of skill
to the claimed invention. Those same motivations (mobility, simplicity, and reducing radiation
exposure) would lead one of skill to combine Klein and Tate. Tate discloses a dose calibrator on-
board a radiopharmaceutical infusion system, and I have already determined that a person of skill
would understand from Klein how to adapt the Klein system for a different physical configuration.
To review, Klein expressly teaches how to overcome difficulties like “radiation from the
surroundings” and unknowns introduced by system geometry. See Klein at .000056-57. Klein’s
method of analyzing dose calibrator readings “accounts for all available data and therefore
decreases the effect of noise” in dose calibrator measurements. Id. at .000057-58. Because “the
physical process” of radioactive transfer “is well understood” and accounted for in Klein’s model,
a person of skill would know how to successfully implement Tate’s on-board dose calibrator
within the Klein system. See id. at .000119. The combination of Klein and Tate, even without
Chaffin, render the claimed invention obvious.
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Staff and Jubilant suggest a person of ordinary skill would be motivated to further combine
Klein and Tate with Chaffin, an occupational safety reference. Chaffin teaches that heavier objects
should be placed so as to minimize the distance required to lift them in order to reduce strain or
injury to the person lifting the object. See RX-0096.0170-.0178. Bracco largely admits that
Chaffin is relevant prior art, but denies that the record reflects any motivation to combine it with
Klein and Tate. See Tr. at 1083:6-15 (Bracco’s expert, Dr. Pelc, agrees that a medical device
designer would be interested in teachings of ergonomics); CRB at 32-33.
Chaffin teaches sensible ways to physically arrange heavy objects used by humans. To the
extent that any teaching of Chaffin is necessary to arrive at the claimed invention, the claimed
invention is obvious in view of Klein, Tate, and Chaffin. The generator in Klein is a weighty
object that must be moved by a human every two months (Klein at .000018-19), and an ordinary
skilled designer would look to references like Chaffin to understand best practices for positioning
the generator on the cart. Of the limited options available for positioning the generator, having the
generator compartment opening lower than the opening of the waste bottle compartment would
have been obvious, as I described above. See KSR at 421; Weber, 312 F.2d at 813; Gazda, 219
F.2d at 451 Kuhle, 526 F.2d at 555; Japikse, 181 F.2d at 1023.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find the invention of claim 1 would have been obvious in view
of Klein and Tate, or in view of Klein, Tate, and Chaffin. Claim 1 is therefore invalid under 35
U.S.C. § 103.
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(c) Klein Thesis in Combination with the MedRad
Intego Device and Chaffin
Jubilant and Staff also propose a combination nearly identical to Klein-Tate-Chaffin,
replacing Tate with the MedRad Intego. As I noted in section VI.B.1.b)(2), the MedRad Intego
system is the commercial embodiment of the invention disclosed in the Tate patent.
For the same reasons as outlined above in the Klein-Tate-Chaffin analysis, and after
considering secondary indicia of non-obviousness advanced by Bracco, I find the proposed
combination of Klein and the MedRad Intego device, and the proposed combination of Klein, the
MedRad Intego device, and Chaffin each render obvious claim 1 of the ’826 patent.
(d) Klein Thesis in Combination with CardioGen,
Tate/Medrad Intego, Model 510, and Chaffin
Jubilant and Staff also contend that a person of skill in the art would consider the Bracco
CardioGen-82 Model 510 device (RX-0357) in combination with Klein, Tate/MedRad Intego, and
Chaffin. Jubilant and Staff particularly point to the Model 510 for elements [1.1.a] and [1.1.c]
concerning upwards facing openings for the generator compartment and the waste bottle
compartment.
There is no dispute that the Model 510 is prior art. It is also beyond dispute that the Model
510 has shielding compartments with openings facing vertically upwards. And as Dr. Stone
credibly testified, a person of ordinary skill would be motivated to incorporate the upward-facing
openings of the Model 510 in order to reduce radiation exposure of operators. Tr. at 666:2-15
(vertical openings in shielding “very common” as “it allows a user to approach a radioisotope
source and be able to get easy access to it without being exposed to radiation”). Additionally, I
have determined above that the relative heights of the compartment openings constitute an obvious
design choice with no expressed benefit over the prior art. See KSR at 421; Weber, 312 F.2d at
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813; Gazda, 219 F.2d at 451 Kuhle, 526 F.2d at 555; Japikse, 181 F.2d at 1023. Accordingly, for
the reasons discussed above, and after considering secondary indicia of non-obviousness advanced
by Bracco, I find the invention of claim 1 would have been obvious in view of Klein, the Model
510 system, Tate/MedRad Intego, and Chaffin. Claim 1 is therefore invalid under 35 U.S.C. §
103.
(2) Claim 2
Claim 2 of the ’826 patent recites the following:
[2] The Method of claim 1, further comprising configuring the computer to:
[2.1] measure a radioactivity of the sample of the rubidium radioactive eluate
while the sample is flowing through the eluate tubing line to the eluate reservoir;
[2.2] measure a calibration radioactivity of the sample while the sample remains
in the eluate reservoir in the shielded well on-board the cart; and
[2.3] compare the radioactivity of the sample measured while flowing through the
eluate tubing line with the calibration radioactivity of the sample measured in the eluate
reservoir in the shielded well on-board the cart.
Jubilant and Staff assert claim 2 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that Klein discloses all of the
additional limitations of claim 2 not already addressed. See RIB at 87-88; SIB at 54-55. In
response, Bracco raises no dispute about claim 2 beyond its contention that Klein does not disclose
a “shielded well on-board the cart.”
Klein discloses measuring the radioactivity of the eluate while the sample is flowing to the
reservoir in the dose calibrator using an activity counter [2.1]. Tr. at 731:20-732:18 (citing Klein
at .000029). Klein also teaches measuring the calibration radioactivity while the sample is in the
dose calibrator. Klein at .000028 (describing the calibration constant (as calculated by sample
eluate in the dose calibrator) as a “measure of the [in-line radioactivity counter]’s efficiency”).
Klein teaches comparing those two measurements. Id. at .000053 (“integral activity recorded from
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the dose calibrator is used to calibrate the activity counter and verify that the calibration constant
is within tolerance”), .000080 (figures showing calibration results comparing detector and
calibrator measurements). I have previously explained why it would have been obvious to make
the Klein system with the dose calibrator on the cart. Such a system would have each limitation
of claim 2. The other combinations of prior art advanced by Jubilant and Staff with respect to
claim 1 also would have each element of claim 2. For the reasons discussed above, and after
considering secondary indicia of non-obviousness advanced by Bracco, I find the invention of
claim 2 would have been obvious.
(3) Claim 3
Claim 3 of the ’826 patent recites the following:
[3] The Method of claim 1, further comprising installing a dose calibrator in the shielded
well on-board the cart, wherein the dose calibrator is in communication with the
computer to measure the strontium breakthrough test result and the calibration
radioactivity of the sample pumped into the eluate reservoir.
Jubilant and Staff assert claim 3 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that Klein discloses all of the
additional limitations of claim 3 not already addressed. See RIB at 87-88; SIB at 55. Bracco does
not dispute these contentions beyond its argument that Klein does not disclose a “shielded well
on-board the cart.” See CRB at 40.
The dose calibrator of Klein communicates with the computer to measure breakthrough
and calibration radioactivity. See, e.g., Klein at .000060 (the dose calibrator detects breakthrough
activity as part of the calibration test), -65 (“dose calibrator is tested for communication” with
computer). I have previously explained why it would have been obvious to make the Klein system
with the dose calibrator on the cart. Such a system would have each limitation of claim 3. The
other combinations of prior art advanced by Jubilant and Staff with respect to claim 1 also would
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have each element of claim 3. For the reasons noted above, and after considering secondary indicia
of non-obviousness advanced by Bracco, I find the invention of claim 3 would have been obvious.
(4) Claim 5
Claim 5 of the ’826 patent recites the following:
[5] The method of claim 2, further comprising configuring the computer to allow a user
to: initiate a purging process through the touch screen display to purge a patient tubing
line of air, wherein the patient tubing line is in fluid communication with the eluate
tubing line.
Jubilant and Staff assert claim 5 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that Klein discloses all of the
additional limitations of claim 5 not already addressed. See RIB at 87-88; SIB at 55. In response,
Bracco does not expressly dispute that Klein discloses all of the additional limitations of claim 5.
Klein discloses a flush run initiated by the operator on a touch to remove air bubbles from
the system. Klein at .000028, -40, -54. For the reasons discussed above, and after considering
secondary indicia of non-obviousness advanced by Bracco, I find the invention of claim 5 would
have been obvious. See Tr. at 747:19-749:13, 765:21-766:8; Klein at .000029, -53, -54, -64.
(5) Claim 9
Claim 9 of the ’826 patent recites the following:
[9.0] The method of claim 2, further comprising configuring the computer to:
[9.1] present on the touch screen display a screen for starting the patient infusion
by touching a button on the touch screen display;
[9.2] present on the touch screen display a screen reminding a user to insert the
eluate reservoir in the shielded well on-board the cart;
[9.3] present on the touch screen display a screen indicating that the patient
infusion is in process, wherein the screen indicating that the patient infusion is in
process displays a stop button to abort the patient infusion; and
[9.4] present on the touch screen display the strontium breakthrough test result.
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Jubilant and Staff assert claim 9 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that those combinations also
disclose all of the additional limitations of claim 9 not already addressed, as outlined below.
(a) Klein Thesis Alone
Staff, but not Jubilant, argues that Klein alone discloses all of the additional limitations of
claim 9, which concern the display of certain messages on the computer system touch screen. See
SIB at 57. Bracco does not dispute that Klein discloses displaying a start button (limitation [9.1])
but disputes that Klein discloses displaying a reminder to insert the eluate reservoir (limitation
[9.2]), displaying elution progress and a stop button (limitation [9.3]), and displaying the strontium
breakthrough test result (limitation [9.4]). See CRB at 46-48.
I find Klein expressly discloses the start button of limitation [9.1]. Klein teaches a
graphical user interface having large buttons displayed on a touch screen. Klein at .000031, -
.000040. To start an elution, the system displays the screen shown in Figure 3-12 (e) of Klein. Id.
at .000064. The screen prompts the user, “Start Constant Activity Elution?” and displays “Yes”
and “No” buttons. Id.
With respect to the dose calibrator reservoir reminder (limitation [9.2]), I find that the
computer in Klein’s system communicates with the dose calibrator at the start of the daily protocol
to make sure that the calibrator has the “proper settings.” Klein at .000065. If something is wrong
with the dose calibrator, “warnings are presented to the user with detailed explanations.” Id. Klein
also describes how to use a sensor to detect a physical property of a reservoir and issue a warning
if a user attempts to start an elution with the reservoir in the wrong condition. Id. at .000044-45
(describing an overflow sensor in the waste reservoir). In light of these disclosures, a person of
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ordinary skill in the art would find it obvious to display a reminder to the user to insert the eluate
reservoir if the user attempts to start the calibration run without doing so.
I find that Klein expressly discloses the progress display and stop button found in limitation
[9.3]. Klein states that “progress bars must be included for each stage of the elution so as to
facilitate monitoring of the system” and that “an emergency stop button must be enabled
throughout the elution.” Klein at .000041; see also id. at .000065, -75, -76. Patient infusions are
a type of elution disclosed by Klein. See, e.g., id. at .0000053. Klein also shows a screen shot of
a progress message and stop button. Klein at .000064 (Fig. 3-12 (h)).
I find that Klein expressly discloses a touch screen display of the strontium breakthrough
test result. Klein at .000064 (Fig. 3-12(f) and (g)); see also id. at .000041 (“On successful
completion a grey screen must list statistics relevant to the elution . . . a separate window must list
a comprehensive display of all statistics in addition to activity curves”), .000065. In the alternative,
a person of ordinary skill in the art would find it obvious to display the results of the Klein system’s
breakthrough tests on Klein’s touch screen.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find the invention of claim 9 would have been obvious in view
of the Klein thesis.
(b) Klein Thesis in Combination with IEC 62366
With respect to the dose calibrator reservoir reminder in element [9.2], Jubilant and Staff
also argue that a person of ordinary skill would combine Klein with an international standard for
medical device design known as IEC 62366. RIB at 92-94, 126-129; SIB at 57-60. IEC 62366
teaches medical device developers to provide a user interface that enables users “to be aware of
the use of the correct consumable, the remaining amount of [the consumable], whether accessories
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might be used with the MEDICAL DEVICE, how to assemble them and how to check their correct
functioning.” IEC 62366 at .0063.
Jubilant and Staff argue that because Klein discloses warnings to replace generators (Klein
at .000064) and waste bottles (id. at .000044-.0045), a person of ordinary skill would have reason
to consider warnings about other consumables, as advised in IEC 62366. Jubilant and Staff argue
the eluate reservoir is just such a consumable. Bracco’s sole argument concerning IEC 62366 is
that “[e]ven if a [person of skill in the art] were to look to this directive, it does not require the
particular alert of the claims—reminder to insert the eluate reservoir.” CRB at 47.
I have determined above that Klein alone renders the reservoir reminder obvious. To the
extent that any teaching of IEC 62366 is necessary to arrive at the claimed invention, the invention
is obvious in view of Klein and IEC 62366.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find the invention of claim 9 would have been obvious in view
of the Klein thesis and IEC 62366.
(c) Klein Thesis in Combination with IEC 62366 and
Tate/MedRad Intego
Jubilant, but not Staff, also propose a combination of Klein with Tate/MedRad Intego as
teaching the progress display and stop button (limitation [9.3]) and the display of the breakthrough
test result (limitation [9.4]). RIB at 128 (citing Tate at .0059, .0105 (¶0232) (describing progress
bar 1233 and highlighting of fluid path 1008 during injections), 129-130 (citing Tate at .000039
and Intego at .0039).
With respect to element [9.3], Bracco argues that “[t]he image Jubilant cites from Tate . . .
relates to a screen showing a progress bar” but that “showing a progress bar does not indicate that
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a patient infusion is in process.” CRB at 48 (citing Tr. at 1000:1-11 (Dr. Pelc)). Bracco’s point is
not well taken. The figure in Tate expressly shows that the progress bar is for “injecting”:
Tate at .000059. In the context of the PET infusion system of Tate, a person of skill in the art
would understand a progress bar for “injecting” to be a progress bar for a patient infusion. As
noted above, I find that Klein expressly disclosed the progress display and stop button of element
[9.3]. To the extent that any teaching of Tate is necessary to arrive at the claimed invention, the
invention is obvious in view of Klein and Tate.
With respect to element [9.4], Jubilant argues that Tate/MedRad Intego “display results of
PET infusion system quality control tests,” thus rendering element [9.4] obvious. RIB at 130.
Bracco responds that Tate and the MedRad Intego are FDG systems, which do not perform
strontium breakthrough tests. Consequently, Bracco argues, neither disclose the presenting
strontium breakthrough test results on touch screen. CRB at 48.
As noted above, I find Klein expressly discloses displaying a strontium breakthrough test
result. Accordingly, an invention having limitation [9.4] would have been obvious to a person of
skill in the art in view of Klein and Tate/MedRad Intego.
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(6) Claim 10 (Unasserted)
Claim 10 of the ’826 patent, which is not asserted but is relevant due to intermediate
dependencies of other asserted claims, recites the following:
[10.0] The method of claim 9, further comprising configuring the computer to allow the
user to:
[10.1] log into the computer by entering a user login credential on the touch screen
display,
[10.2] enter a patient ID on the touch screen display,
[10.3] enter a patient dose on the touch screen display, and
[10.4] enter a flow rate on the touch screen display.
Jubilant and Staff assert claim 10 is obvious in light of the combinations of prior art
advanced above in connection with claims 1 and 9. Staff and Jubilant argue that Klein discloses
all of the additional limitations of claim 10 not already addressed. SIB at 60-6 and RIB at 94-95.
Bracco does not appear to dispute that Klein alone discloses all of the additional limitations of
claim 10 not otherwise addressed.
Klein alone discloses all of the additional elements of claim 10. See Klein at .000040
(touch screen of Klein is sole user interface with system), .000063 (disclosing prompt for user ID
code, as in element [10.1]), .000065 (patient ID [10.2], patient dose [10.3], flow rate [10.4]).
Accordingly, an invention having all of the elements of limitation [10] would have been obvious
to a person of skill in the art in view of Klein alone or the art combinations analyzed above in
connection with claims 1, 2, and 9.
(7) Claim 11
Claim 11 of the ’826 patent recites the following:
[11] The method of claim 10, further comprising configuring the computer to:
[11.1] track time passed from completion of pumping the sample of the rubidium
radioactive eluate into the eluate reservoir to measuring the strontium
breakthrough test result,
[11.2] track a volume of saline remaining in the saline reservoir,
[11.3] provide an alert via the touch screen display when the volume of saline
remaining in the saline reservoir is below a predetermined volume threshold,
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[11.4] track a volume of the rubidium radioactive eluate discharged from the
strontium-rubidium radioisotope generator to the waste bottle, and
[11.5] present on the touch screen display a screen reminding the user to empty
the waste bottle.
Jubilant and Staff assert claim 11 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 9, and 10. Staff and Jubilant argue that those
combinations disclose all of the additional limitations of claim 11 not already addressed.
(a) Klein Thesis Alone
Staff, but not Jubilant, argues that Klein alone renders the additional claims of claim 11
obvious. SIB at 61-63. Bracco appears to concede that Klein discloses limitation [11.1], a
computer that tracks time from completion of pumping an eluate sample into the eluate reservoir
to determine the strontium breakthrough test. See CRB at 52 (acknowledging the computer in
Klein performed the daily protocol, which included time tracking). Bracco also did not contest
Staff’s assertion that Klein discloses tracking eluate discharged into a waste bottle and reminding
the use to empty the waste bottle as described in limitations [11.4] and [11.15]. Id. at 55-57.
Bracco contends, however, that Klein does not disclose tracking saline as required by limitations
[11.2] and [11.3]. CRB at 55-57.
I find Klein discloses the time tracking of limitation [11.1]. Klein at .000028 (“the activity
in the dose calibrator is registered 30 minutes after the end of the elution to compute the
breakthrough”); Tr. at 763:-24-764:18 (testimony of Dr. Stone). I also find Klein discloses
limitations [11.4] and [11.5]. Klein discloses tracking the volume of eluate in a waste bottle using
an electro-optic level switch and displaying a reminder to empty the bottle when the switch is
triggered. Klein at .000044-45.
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As for the saline tracking limitations in [11.2] and [11.3], Klein discloses real-time
software to control of the flow of saline from a saline bag into a generator. Klein at .000029. The
computer accurately computes the volume of eluted saline, a critical value for the algorithms that
control the Klein system. Id. at .000012. When the computer determines that the volume of eluted
saline passes a threshold, the computer displays an alert to the user on a touch screen display.
Klein at .000064 (Figure 3-12(b)), -78. Klein discloses that these capabilities can be used to
determine when the amount of eluted saline has passed 90% of the volume allowed by the
generator specifications. Id. When that volume is reached, the user is reminded to replace the
generator. Id. Klein teaches the saline supply must be replaced just as the generator must be
replaced when exhausted. Compare Klein at .000028 with id. at .000018-19.
Klein does not expressly disclose using his saline tracking and alert system to determine
how much saline is left in the saline bag. However, such a use of the system would have been
obvious to a person of skill in the art. Klein states two of his main goals are to automate the
infusion system and allow monitoring from a distance. Id. at .000036. Bracco’s expert testified
that a user of the Klein system would visually track the remaining volume of saline in the bag
Klein discloses. Tr. at 856:3-14. Motivated by Klein’s goals of automation and remote
monitoring, it would have been obvious to a person of ordinary skill in the art to automate the
visual inspection of remaining saline. See In re Venner, 262 F.2d 91, 95 (C.C.P.A. 1958) (“It is
well settled that it is not ‘invention’ to broadly provide a mechanical or automatic means to replace
manual activity which has accomplished the same result.”) Having the Klein computer keep track
of remaining saline also furthers Klein’s goal of monitoring while the user is away from the system.
See Klein at .000039, -46 (distance is the best shielding for an operator, and the operator may be
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several meters from the device). And Klein teaches structures and methods to monitor saline
volume and set an alert based on reaching a threshold. Klein at .000064 (Figure 3-12(b)), -78.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find the invention of claim 11 would have been obvious in
view of the Klein thesis.
(b) Klein Thesis in Combination with IEC 62366
IEC 62366 teaches medical device developers to provide a user interface that enables users
“to be aware of the use of the correct consumable [and] the remaining amount” of the consumable.
IEC 62366 at .0063. Jubilant and Staff both argue that the Klein thesis in combination with IEC
62366 renders the additional limitations of claim 11 obvious. SIB at 63; RIB at 95-96. In response,
Bracco argues that Jubilant’s expert Dr. Stone admitted that IEC 62366 does not disclose using a
computer to track consumables. CRB at 57 (citing Tr. at 866:6-867:10),IEC 62366 at .0063.
As noted above, Klein discloses a computer to track saline elution and provide warnings.
To the extent that any teachings beyond Klein are necessary to arrive at the invention of claim 11,
IEC 62366 in combination with Klein only would have made the invention more obvious.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find the invention of claim 11 would have been obvious in
view of the Klein thesis and IEC 62366.
(c) Klein Thesis in Combination with MedRad Intego
Jubilant and Staff also argue that Klein in combination with the MedRad Intego device
renders the additional limitations of claim 11 obvious. RIB at 96; SIB at 63. Jubilant contends
that the MedRad Intego system tracks saline and provides alerts, as in limitations [11.2] and [11.3].
RIB at 132-133; see also SIB at 63.
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Bracco responds that the Intego device is not pertinent art because it is an FDG system.
CRB at 56. However, as explained above, supra V.B.2.a)(1), the Intego device is pertinent art.
Bracco also argues that the saline in the Klein system is used for rubidium generation, but the
saline in the Intego system is not used to generate a radiopharmaceutical, so it would not be obvious
to combine those references. Id.
It is true that Klein uses saline to generate a rubidium eluate, but Klein also discloses using
saline to “transport” radioactive tracer into the patient’s body. Klein at .000049. The Intego
system similarly uses saline to transport FDG into the patient’s body. RX-200C (Intego manual)
at .0014 (“the dose of FDG / saline is injected into the patient.”); Tr. at 817:12-818:4. A person
of skill in the art would understand that a sufficient supply of saline is necessary for both systems
and would be motivated to understand the way each system addresses that issue.
I have explained above why a person of skill in the art would have been motivated to use
the saline monitoring and alert system of Klein to monitor the remaining saline in a saline bag. To
the extent that any additional understanding is necessary for a skilled artisan to arrive at the claimed
invention, the Intego device provides that understanding. When a user installs a new saline bag
with the Intego system, the computer prompts the user to enter the volume of saline.
RX-200C.0057. The Intego system then monitors saline usage and displays an alert when the
saline level falls below a threshold. Id. at .0116.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find the invention of claim 11 would have been obvious in
view of the Klein Thesis and the MedRad Intego device.
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(8) Claim 12
Claim 12 of the ’826 patent recites the following:
[12.0] The method of claim 11 further comprising configuring the computer to allow the
user to:
[12.1] initiate a generator column wash through the touch screen display, wherein
a predetermined amount of saline is pumped through the strontium-rubidium
radioisotope generator and directed to the waste bottle during the generator,
column wash, and
[12.2] initiate a purging process through the touch screen display to purge a
patient tubing line of air, wherein the patient tubing line is in fluid communication
with the eluate tubing line.
Jubilant and Staff assert claim 12 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 9, 10, and 11. Staff and Jubilant argue that those
combinations disclose all of the additional limitations of claim 12 not already addressed. RIB at
96-98; SIB at 63-65. Bracco does not address these arguments.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find the invention of claim 12 would have been obvious. See
Tr. at 765:21-766:8, 747:19-749:13; Klein at .000029, .000053, .000054, .000064.
(9) Claim 13
Claim 13 of the ’826 patent recites the following:
[13.0] The method of claim 12, wherein the infusion system is configured for the saline
tubing line and the eluate tubing line to be routed through
[13.1] two tubing passageways formed in a perimeter surface of the first opening,
wherein
[13.2] each of the two tubing passageways has a depth configured to prevent pinching or
crushing of a corresponding tubing line routed therethrough when a first door is closed
over the first opening.
Jubilant and Staff assert claim 13 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 9, 10, 11, and 12. Staff and Jubilant argue that
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those combinations also disclose or render obvious all of the additional limitations of claim 13 not
already addressed, as outlined below.
(a) Klein Thesis Alone
Staff argues that Klein discloses or renders obvious all additional limitations of claim 13.
Staff argues that a person of ordinary skill in the art would recognize that Klein’s system was not
“market-ready” and would therefore be motivated to consolidate and hide components when
commercializing the system. SIB at 65 (citing Tr. at 617:20-22).
Bracco responds that Klein fails to teach either “tubing passageways” [13.1] or “a first
door” [13.2], and Klein has no motivation to change the physical arrangement of the disclosed
system. CRB at 58-63.
I find Klein discloses three different shielding compartments with lids or doors and
passageways for tubes to enter and exit those compartments without being pinched when those
lids or doors are closed.
First, Klein discloses the generator compartment discussed above in connection with
claim 1. Klein expressly points out a “Generator Access Lid” over that compartment in a
photograph of the Klein system. See Klein at .000034 (Figure 2-4); Tr. at 665:11-666:1 (testimony
of Dr. Stone that Klein had “an access door . . . that could give access to the generator”). Klein’s
generator access door is located proximately above the first opening of the first shielding
compartment, and thus “closes over” that opening. Id.
Klein also shows a tubing passageway that is configured so that tubing is not pinched or
crushed when the Generator Access Lid is closed. See Klein at .000034 (Figure 2-4, excerpt 1
below). In Figure 2-4, the passageway is the opening in the stainless steel surface seen at the tip
of the yellow “Generator” annotation bubble. The passageway has a depth sufficient to allow for
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tubes to run into the generator shielding compartment without being crushed when the first door
(the “Generator Access Lid” in Figure 2-4) is closed, as pictured. Id.
Klein Figure 2-4, Excerpt 1
Second, Klein discloses a shielding enclosure comprised of high-density plastic on top of
the cart to limit radiation exposure from tubing. Klein at .000046. The plastic shielding
compartment has two tubing passageways formed in its perimeter to allow tubing to enter and exit
the compartment without being crushed when the plastic lid of the enclosure is closed. See Klein
at .000034 (Figure 2-4, excerpts 2 and 3 below). Those passageways are square-shaped notches
in the vertical perimeter of the high-density plastic enclosure. In Figure 2-4, one of those
passageways is shown in the left rear corner of the plastic enclosure, where the saline line enters
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the enclosure. Another passageway is in the right rear corner of the plastic enclosure, where the
patient line exits the enclosure:
Klein Figure 2-4, Excerpt 2 Klein Figure 2-4, Excerpt 3
Third, Klein discloses a shielding compartment for the waste bottle. See Klein at .000034
(Figure 2-3). Figure 2-4 shows a “Waste Line” tube running into that compartment. Id. (Figure
2-4). Klein expressly discloses that the shielded waste container has a lid. Id. at .000025 (“the
waste container was mounted … inside a lead container with a lid.”).
Klein does not show two passageways formed in the perimeter surface of the opening of a
compartment that has all of the features of the generator compartment required by claim 1, from
which claim 13 depends. But Klein’s teachings would make such an arrangement obvious to
person of ordinary skill. Klein provides a person of ordinary skill with motivation to avoid
crushing or pinching tubing lines running into or out of a shielding compartment when the lid of
that compartment is closed. See Klein at. 000076 (“high pressure is an indication of a blockage or
pinched line and could result in backwash through the pump head or rupturing of the saline lines.”).
Klein also discloses the means for avoiding crushing or pinching: passageways formed in the
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perimeter of a shielding compartment. Klein further discloses two passageways formed in the
perimeter of the plastic shielding compartment, one for the saline line and one for the patient line.
Forming two tubing passageways in the perimeter surface of the opening of a generator
compartment as required by the claim would be an obvious alternative design choice operating on
the same principle disclosed by Klein. See Philips Lighting N. Am. Corp., 727 F. App’x at 681
(affirming rejection of patent as “obvious matter of design choice” where two prior art designs
“were known in the art, recognized as solutions to the particular problem, and functionally
equivalent”); Tr. at 822:13-823:2. Upon review of the evidence cited and after considering
secondary indicia of non-obviousness, I find that Klein alone renders an invention having the
additional elements of claim 13 obvious.
(b) Klein Thesis in Combination with Tate and/or
MedRad Intego
Staff and Jubilant both argue that a person of ordinary skill would find claim 13 obvious
in light of Klein combined with Tate and/or the Intego device. SIB at 66-67; RIB at 98-99. They
argue that because Klein was not “market-ready,” Tr. at 617:20-22, a person of skill would look
to hide tubing and make other improvements; by looking at Tate and Intego, the person of skill
would know to include two passageways of sufficient depth to not pinch the tubing lines flowing
into the generator when the lid over the generator is closed. Although they acknowledge Tate and
the Intego device show only one such passageway, they argue it would be obvious to a person of
skill in the art to use two passageways to accommodate the needs of a rubidium system. Id. They
also note that Tate teaches “a recess or trough” to accommodate tubing that “holds the tubing in
place and prevents it from getting kinked or tangled” on the top surface of the cart over which the
shielded lid closes. Id. (citing Tate at .000093 ¶ 0078).
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Bracco argues that Tate and the FDG Intego system are not pertinent art, that Tate and the
Intego device do not show even a first passageway for tubing, and that the lid disclosed by Tate
would not function if combined with Klein as Jubilant and Staff propose. CRB at 60-63.
As noted above, I find that Tate and the Intego device are pertinent art, see supra V.B.1.b).
I find that a person looking to commercialize Klein would be motivated to cover the visible tubing
lines along the top surface of the cart, as those lines can be a source of radiation exposure. See
Klein at .000046; Tr. at 617:20-22. And both Klein and Tate present the motivation to avoid
crushing and pinching of tubing lines when configuring system layout. See Klein at. 000076 (“high
pressure is an indication of a blockage or pinched line and could result in backwash through the
pump head or rupturing of the saline lines”); Tate at .000093 ¶¶ 0078-79 (describing troughs for
tubing lines to prevent kinking, including a “second trough that leads to a first well”).
Tate discloses forming a passageway in the perimeter surface of the opening into a shielded
chamber for the radiopharmaceutical source. Tate at .000019. Tate’s shielded well (element 111,
show in yellow below) has a first opening in the top surface of the cart. Id. Tate discloses a trough
(element 113, shown in green below) formed in the perimeter surface of that opening allowing a
tubing line (element 210, shown in blue below) to pass into the shielding compartment without
being crushed while a cap (element 684) is closed over the top of the compartment. I find that a
person of ordinary skill would be motivated, as noted above, to incorporate Tate’s passageway
when moving the tubing below the top surface of Klein’s cart in order to avoid crushing of tubing
lines.
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Tate Figure 6E (annotated)
Although Tate teaches only one passageway and one tubing line, Klein teaches two tubing
lines. Duplicating the tubing passageways of either Tate or Klein, to provide separate passageways
for both the tubing line into and out of the generator, would have been obvious to one of skill in
the art. See In re Harza, 274 F.2d 664, 671 (C.C.P.A. 1960) (duplication of elements is not
patentable unless a new or unexpected result is produced.”); Tr. at 702:7-12.
I further find that Tate discloses channels formed in a surface for tubing lines to prevent
obstruction of those tubing lines when a hinged lid is closed over them. Tate at .000093 ¶ 0078.
The MedRad Intego device shows a similar passage. RX-0200C at .0018. Forming such
passageways in the perimeter surface of the first opening rather than the opening for the generator
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access lid would be an obvious alternative design choice operating on the same principle. See
Philips Lighting N. Am. Corp., 727 F. App’x at 681 (affirming rejection of patent as “obvious
matter of design choice” where two prior art designs “were known in the art, recognized as
solutions to the particular problem, and functionally equivalent.”); Tr. at 822:13-823:2.
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein in combination with Tate and/or the MedRad Intego device renders an invention
with the additional elements of claim 13 obvious.
(10) Claim 14
Claim 14 of the ’826 patent recites the following:
[14.0] The method of claim 13, wherein the infusion system further comprises
[14.1] an exterior shell extending upwardly above the platform, wherein the
platform and the exterior shell, collectively define an interior space of a cabinet
structure,
[14.2] a handle configured for the user to grasp in order to move the infusion
system, and
[14.3] four wheels mounted to an underside of the platform of the cabinet
structure.
Jubilant and Staff assert claim 14 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 9, 10, 11, 12, and 13. Jubilant and Staff both argue
the Klein thesis alone discloses all of the additional elements of claim 14. SIB at 67-68; RIB at
99-100. Jubilant and Staff contend the Model 510 system, the Tate patent, and the Intego device
also each independently have the elements recited in claim 14. Id. Bracco does not appear to rebut
that contention in its briefs.
I find that Klein, the Model 510 system, the Tate patent, and the Intego device each fully
disclose the additional elements of claim 14. See Klein at .000034; RX-0207.0013 (Model 510);
Tate at .002; RX-200C at .0042 (Intego manual).
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For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein alone or in combination with the Model 510 system, the Tate patent, or the Intego
device renders an invention with the additional elements of claim 14 obvious.
(11) Claim 17
Claim 17 of the ’826 patent recites the following:
The method of claim 14, wherein the infusion system further comprises a dose calibrator
in the shielded well on-board the cart and wherein the dose calibrator is in
communication with the computer to measure the strontium breakthrough test result.
Jubilant and Staff assert claim 17 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 9, 10, 11, 12, 13, and 14. SIB at 69; RIB at
101-102.
Klein discloses a dose calibrator located in a shielded well in communication with a
computer. Klein at .000060 (the dose calibrator detects breakthrough activity as part of the
calibration test performed by computer), -65 (“dose calibrator is tested for communication” with
computer). For the reasons discussed above in connection with claim 1, it would have been
obvious to move the dose calibrator in Klein on-board the cart.
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein alone renders an invention with the additional elements of claim 17 obvious. The
other art combinations analyzed above in connection with claim 1 also render obvious an invention
with the additional elements of claim 17.
(12) Claim 18
Claim 17 of the ’826 patent recites the following:
[18.0] The method of claim 17,
[18.1] wherein the cabinet structure has a lowermost portion and the platform has
a lower surface,
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[18.2] the first opening is at a first elevation,
[18.3] the second opening is at a second elevation,
[18.4] the first elevation is between approximately 1 foot and approximately 2
feet, with respect to the lowermost portion of the cabinet structure, and the second
elevation is between approximately 2 feet and approximately 3 feet, with respect
to the lower surface of the platform.
Jubilant and Staff assert claim 18 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 9, 10, 11, 12, 13, 14, and 17. Staff and Jubilant
argue that, for the reasons discussed concerning limitation [1.1.e] of claim 1, it would have been
obvious to a person of skill in the art to modify Klein to place the generator at a lower elevation.
SIB at 69-70; RIB at 102-103. They also point to the testimony of Dr. Stone to that effect. Id.
(citing Tr. at 617:20-619:20, 699:16-700:21, 833:3-9). Bracco rests on the same arguments it
advanced in connection with claim 1. CRB at 39.
I credit Dr. Stone’s testimony estimating the heights of elements of the Klein cart and
surroundings. His description of hypothetical elevations of repositioned components is also
reasonable. Tr. at 699:17-700:21. For the same reasons given in connection with claim 1, an
invention with the specific heights and other arrangement limitations in claim 18 are obvious
design choices with no discernible benefit over any other possible choice. See KSR at 421.
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein alone renders an invention with the additional elements of claim 18 obvious. The
other art combinations analyzed above in connection with claim 1 also render obvious an invention
with the additional elements of claim 18.
(13) Claim 19
Claim 19 of the ’826 patent recites the following:
[19.0] The method of claim 1, further comprising configuring the computer to:
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[19.1] control a fluid communication between the strontium-rubidium
radioisotope generator and the saline reservoir,
[19.2] control a fluid communication between the eluate tubing line and the eluate
reservoir,
[19.3] control a fluid communication between the eluate tubing line and the waste
bottle,
[19.4] place the eluate tubing line in fluid communication with a patient,
[19.5] pump a dose of the rubidium radioactive eluate to the patient; and
[19.6] flush the rubidium radioactive eluate remaining in at least a portion of the
eluate tubing line into the patient by pumping saline from the saline reservoir to
the eluate tubing line through a by-pass line that by-passes the strontium-rubidium
radioisotope generator.
Jubilant and Staff assert claim 19 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that Klein discloses or renders
obvious all of the additional limitations of claim 19 not already addressed. SIB at 71-72; RIB at
104-105. Bracco does not appear to dispute that Klein discloses all of the additional elements of
claim 19.
I find that Klein describes a computer that controls fluid communication between the
generator and the saline reservoir via the pump and generator valve, controls fluid communication
between the eluate tubing line and the eluate reservoir via the patient valve, and controls a fluid
communication between the eluate tubing line and the waste bottle via the patient valve. Klein at
.000029-30, -53-55. Klein further describes a computer that places the eluate tubing line output
from the generator in fluid communication with a patient via the patient valve, pumps a dose of
the rubidium radioactive eluate to the patient, and flushes the eluate remaining in a portion of the
eluate tubing line downstream of the patient valve into the patient by pumping saline from the
saline reservoir through a by-pass line that by-passes the generator. Id.; Tr. at 739:1-741:7.
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein alone renders an invention with the additional elements of claim 19 obvious. The
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other art combinations analyzed above in connection with claim 1 also render obvious an invention
with the additional elements of claim 19.
(14) Claim 28
Claim 28 of the ’826 patent recites the following:
[28] The method of claim 1, further comprising configuring the computer to allow a user
to: initiate a generator column wash through the touch screen display, wherein a
predetermined amount of saline is pumped through the strontium-rubidium radioisotope
generator and directed to the waste bottle during the generator column wash.
Jubilant and Staff assert claim 28 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that Klein discloses or renders
obvious all of the additional limitations of claim 28 not already addressed. SIB at 72-73; RIB
at 105-106. Bracco does not appear to dispute that Klein discloses all of the additional elements
of claim 19.
I find that Klein discloses a computer that initiates a generator column wash, called a “flush
run,” through the touch screen control of the Klein system’s computer. Klein at .000029, -64.
Klein discloses that during the flush run, a predetermined amount of saline (50mL) is flushed a
through the system, including the generator to the waste bottle, to clear the lines and generator of
air bubbles and strontium breakthrough. Id. at .000053 (“Flush Run - flushing of all the lines in
the system as well as a 50ml flush of the generator at 15ml/min. Ensures flushing of air bubbles
in the saline and Sr breakthrough from the generator.”); id. at .000054 (“Flush Bypass-to-Waste -
The volume in the lines from the pump head to the patient valve (Point P) is flushed through the
bypass to the waste container in order to remove air bubbles and activity that may remain from a
previous run.”).
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein alone renders an invention having the additional elements of claim 28 obvious. The
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other art combinations analyzed above in connection with claim 1 also render obvious an invention
with the additional elements of claim 28.
b) ’869 Patent
Bracco asserts claims 1-5, 8, 14, 24, and 29-30 of U.S. Patent No. 9,750,869. Due to
intermediate dependencies, claims 28 and 29 are also at issue for the purposes of the invalidity
analysis.
(1) Claim 1
Claim 1of the ’869 patent recites the following:
[1] An infusion system on-board a cart comprising:
[1.1] a cabinet structure that comprises:
[1.1.a] a platform, an exterior shell that extends upwardly above the
platform and has a front side; a rear side; two sidewalls connecting the front
side to the rear side; and a top surface; wherein the platform and the exterior
shell, collectively define an interior space of the cabinet structure and
[1.1.b] wherein the interior space of the cabinet structure is configured to
receive a strontium-rubidium radioisotope generator having an inlet tubing
port configured to receive saline and an outlet tubing port configured to
discharge a rubidium radioactive eluate,
[1.1.c] an opening through the exterior shell configured to provide access to
the strontium-rubidium radioisotope generator within the interior space of
the cabinet structure, and
[1.1.d] an opening through the top surface of the exterior shell configured
to provide access for inserting a waste bottle into or removing the waste
bottle from the interior space of the cabinet structure;
[1.1.e] a computer with a touch screen display configured to receive an input
from a user for controlling operation of the infusion system, wherein the
touch screen display is mounted on a vertical post having a top end
extending above the cabinet structure;
[1.2] a first shielding compartment in the interior space of the cabinet structure
having a first opening facing vertically upwardly through which the strontium-
rubidium radioisotope generator can be inserted into and removed from the first
shielding compartment;
[1.3] a first door accessible via the opening through the exterior shell, the first door
being configured to provide access to the first shielding compartment and to close
over the first opening;
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[1.4] a second shielding compartment having a second opening facing vertically
upwardly through which the waste bottle can be inserted into and removed from
the second shielding compartment;
[1.5] a second door accessible via the opening through the top surface of the exterior
shell, the second door being configured to provide access to the second shielding
compartment and to close over the second opening;
[1.6] wherein the first opening is located at a lower elevation than the second
opening;
[1.7] a radioactivity detector positioned to measure radioactivity of the rubidium
radioactive eluate flowing through an eluate tubing line in fluid communication
with the outlet tubing port of the strontium-rubidium radioisotope generator;
[1.8] a shielded well on-board the cart configured to receive an eluate reservoir,
wherein the eluate reservoir is configured to receive a test sample; and
[1.9] wherein the computer of the infusion system is configured to:
[1.9.a] provide a stop button on the touch screen display to abort a function
of the infusion system in response to a user input activating the stop button,
[1.9.b] pump saline from a saline reservoir positioned outside of the interior
space of the cabinet structure into the strontium-rubidium radioisotope
generator through the inlet tubing port of the strontium-rubidium
radioisotope generator thereby generating the rubidium radioactive eluate
that is discharged through the outlet tubing port,
[1.9.c] fill the eluate reservoir in the shielded well on-board the cart with
the test sample of the rubidium radioactive eluate,
[1.9.d] determine a strontium breakthrough test result on the test sample
filled into the eluate reservoir in the shielded well on-board the cart while
the eluate reservoir remains in the shielded well on-board the cart, and
[1.9.e] not allow a patient infusion if the strontium breakthrough test result
is greater than or equal to an allowed limit.
Jubilant and Staff assert this claim is obvious in light of Klein, either alone or in
combination with other prior art. SIB at 74-85; RIB at 33-45.
I incorporate by reference my prior analysis of the Klein thesis alone and combinations of
Klein with other prior art discussed above in connection with the ’826 patent. I briefly highlight
below the claim limitations particularly disputed by Bracco.
“shielded well on-board the cart”
Klein discloses a shielded well that receives an eluate reservoir that is configured to receive
a test sample of eluate from the generator, such operation controlled by the computer. See Tr.
at 693:18-694:18; Klein at. 000029, -57, -62 (describing computer operation of elution tests eluting
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to the dose calibrator). As noted above concerning claim 1 of the ’826 patent, a person of ordinary
skill in the art would find it obvious to move Klein’s shielded well and dose calibrator on-board
the cart. See also Tr. at 757:14-25.
“first shielding compartment”
As discussed above, Klein discloses a first shielding compartment having a first opening
facing vertically upwardly through which the generator can be inserted into and removed from the
first shielding compartment. Supra V.B.2.a)(1)(a) (analysis of ’826 patent claim 1). I find that
the first shielding compartment of Klein is within the interior space of the cabinet structure of
Klein’s system. See, e.g., Klein at .0034.
“opening through the exterior shell”
Bracco argues that Klein does not disclose an “opening through the top surface of the
exterior shell” configured to provide access for inserting into or removing the waste bottle from
the interior space of the cabinet, as required by element [1.1.d]. CRB at 65.
I find Klein expressly discloses a “Generator Access Lid” on top surface of the exterior
shell of the cart. See Klein at .000034 (Figure 2-4, indicating “Generator Access Lid” on top
surface of cart). It is difficult to see the perimeter of that lid in Klein’s photographs, but by
enlarging a high quality copy of the Klein thesis in the record,7 the perimeter of the lid can be
discerned. For example, the left edge of the lid is visible in Figure 2-4 below the center of the
yellow call-out box labeled “Generator Valve.” The rounded top right corner of the lid is visible
in the lower right corner of Figure 2-4, with the edge of the lid seen extending to the right of the
yellow call-out box labeled “Generator Access Lid.” My observation of the perimeter of the lid is
shown below in an orange annotation of Figure 2-3 of Klein:
7 See http://www.sce.carleton.ca/faculty/adler/publications/2005/rklein-MASc-thesis-2005.pdf
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Klein at .000034 (Figure 2-3, annotated).
As shown above, the Generator Access Lid disclosed in Klein is positioned over both the
shielded generator compartment and the shielded waste bottle compartment. I credit the testimony
of Dr. Stone that the opening beneath the lid would allow the waste bottle to be inserted and
removed from the shielded waste container. See Tr. at 661:19-662:12.
“first door”
Bracco disputes that Klein discloses “a first door accessible via the opening through the
exterior shell” to provide access to the first shielding compartment and to “close over” the first
opening, as required by elements [1.3].8 CRB at 63.
8 Although Bracco contends it is “undisputed” that Klein does not disclose a first door, Bracco is
mistaken. See, e.g., SIB at 78 (arguing the generator access lid constitutes a first door).
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The Generator Access Lid disclosed in Klein is a door. See Tr. at 665:11-666:1 (testimony
of Dr. Stone that Klein had “an access door . . . that could give access to the generator”), 686:1-24
(testimony of Dr. Stone that “doors are conventional structures for shielding in my entire history
of looking at radioisotopes and radioactive sources. They are very common.”). The opening
covered by Klein’s Generator Access Lid is in the exterior shell of the cart. Klein at .000034. The
opening is located the generator shielding compartment, and it gives access to the generator. Id.
“second door”
The parties agree that Klein discloses the second shielding compartment and second
opening for a waste bottle required by element [1.4], but Bracco disputes that Klein discloses a
“second door accessible via the opening through the top surface of the exterior shell” with the door
“configured to . . . close over the second opening” of element [1.5]. CRB at 63.
Klein discloses that the shielded waste compartment has a lid. Klein at .000035 (“the waste
container was mounted on the top shelf inside a lead container with a lid.”). That lid is a door.
That door is accessible through an opening in the exterior shell over the shielded waste container,
which opening is covered by the Generator Access Lid. See Klein at .000034 at Figure 2-3
(annotated above).
“lower elevation”
I have addressed this limitation above in connection with element [1.1.e] of the ’826 patent.
“computer”
Klein discloses all of the limitations of elements [1.9.a]-[1.9.e] other than those concerning
the location of the dose calibrator. See Tr. at 691:12-696:9. Specifically, as noted above in
connection with claim 9 of the ’826 patent, the computer in Klein discloses a stop button to abort
the operation of the infusion system via the LCD touch screen. Id. at 691:12-24; Klein at .000064
(Fig. 3-12(h)). Klein discloses a computer controlling a peristaltic pump to pump saline from a
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saline reservoir positioned outside the interior space of the cabinet structure into the generator
through the inlet tubing port of the generator thereby generating the rubidium eluate that is
discharged through the outlet tubing port. Tr. at 691:25-693:17; Klein at .000029 (system flow
diagram), .000034 (photograph of system). And as discussed concerning elements [1.2.c] and
[1.2.b] of the ’826 patent, Klein discloses that as part of the “daily protocol” the computer
determines a strontium breakthrough test result of the test sample filled into the eluate reservoir in
the shielded well while the eluate reservoir remains in the shielded well. Supra V.B.2.a)(1).
The only limitations of elements [1.9.a]-[1.9.e] not disclosed by Klein are those concerning
the dose calibrator being located on-board the cart. I have addressed why a person of skill in the
art would be motivated to put Klein’s dose calibrator on the cart in connection with claim 1 of the
’826 patent above.
Remaining Elements and Conclusion
Klein discloses most of the remaining limitations of claim 1 of the ’869 patent, and I have
identified those disclosures at length above in connection with the ’826 patent, supra
V.B.2.a)(1)(a). Klein discloses an infusion system on-board a cart with a cabinet structure, in
accordance with limitation [1.1] of the ’869 patent. Klein at .000034. The system in Klein had a
platform, an exterior shell extending upwardly above the platform with front and rear sides
connected by sidewalls, and a top surface collectively defining an interior space of the cabinet, as
required by element [1.1.a] of the ’869 patent. Id. (annotated version reproduced below); id. (door
hinges and edge of attached door visible on right side of cart); Tr. at 862:13-863:10 (noting that
system pictured in Klein had a door that closed over the front side attached at hinges on juncture
of the front side and right sidewall).
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Klein discloses an interior space of the cart that receives a generator having tubing ports to
receive saline and output/discharge radioactive rubidium eluate, and an opening in the exterior
shell to access the generator as in limitations [1.1.b] and [1.1.c] of the ’869 patent. Tr. at
660:7-661:4; Klein at .000029, .000034 (disclosing “Generator Access Lid”).
Klein also discloses a cart having a computer with an LCD touch screen mounted on a post
above the cabinet structure, as required by limitation [1.1.e] of the ’869 patent. See Klein at
.000034 (disclosing screen mounted on post above shell), .000064 (Fig. 3-12(c) demonstrating
touchscreen data input), .000040-.000041 (“The interface must be solely through the touch
screen.”).
Klein further discloses a radioactivity counter positioned to measure radioactivity of the
rubidium radioactive eluate flowing through an eluate tubing line in fluid communication with the
outlet tubing port of the strontium-rubidium radioisotope generator, as in limitation [1.7] of the
’869 patent. Tr. at 689:16-690:13; Klein at .000040, .000043-.000044.
For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find claim 1 of the ’869 patent is invalid under 35 U.S.C. § 103.
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I further find that the combinations of art discussed in connection with claim 1 of the ’826 patent
would also render claim 1 of the ’869 patent obvious for the same reasons.
(2) Claim 2
Claim 2 of the ’869 patent recites the following:
[2.0] The infusion system of claim 1, further comprising:
[2.1] the strontium-rubidium radioisotope generator in the first shielding compartment in
the interior space of the cabinet structure, and
[2.2] the eluate reservoir located in the shielded well on-board the cart and in fluid
communication with the eluate tubing line.
Jubilant and Staff assert claim 2 is obvious in light of the combinations of prior art
advanced above in connection with claim 1 of the ’869 patent. Jubilant and Staff argue that Klein
alone discloses and/or renders obvious all the additional limitations of claim 2 not already
addressed. Bracco responds that Jubilant and Staff have failed to show a combination of prior art
disclosing or rendering obvious either a “first shielding compartment” or a “shielded well on-board
the cart.” CRB at 39-46 (shielded well), 48-51 (first shielding compartment).
For the reasons laid out above concerning the corresponding claim limitations of claim 1
of the ’826 patent, and after considering secondary indicia of non-obviousness, I find that Klein,
either alone or in combination with the other asserted prior art, renders an invention with all of the
additional elements of claim 2 obvious.
(3) Claim 3
Claim 3 of the ’869 patent recites the following:
[3.0] The infusion system of claim 2, wherein
[3.1] the cabinet structure has a lowermost portion and the platform has a lower
surface,
[3.2] the first opening is at a first elevation,
[3.3] the second opening is at a second elevation,
[3.4] the first elevation is between approximately 1 foot and approximately 2 feet,
with respect to the lowermost portion of the cabinet structure, and the second
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elevation is between approximately 2 feet and approximately 3 feet, with respect
to the lower surface of the platform.
Jubilant and Staff assert claim 3 is obvious in light of the combinations of prior art
advanced above in connection with claims 1 and 2. Staff and Jubilant argue that prior art discloses
or renders obvious all of the additional limitations of claim 3 not already addressed. SIB at 87-88;
RIB at 47-48.
The additional claim elements here are fundamentally identical to claim 18 of the ’826
patent. For substantially the same reasons as laid out concerning that claim, supra V.B.2.a)(12),
and after considering secondary indicia of non-obviousness, I find that claim 3 of the ’869 patent
is rendered obvious by Klein, either alone or in combination with the other asserted prior art.
(4) Claim 4
Claim 4 of the ’869 patent recites the following:
[4.0] The infusion system of claim 1, wherein the first shielding compartment comprises
[4.1] two tubing passageways formed in a perimeter surface of the first opening,
and
[4.2] each of the two tubing passageways has a depth configured to prevent
pinching or crushing of a corresponding tubing line routed therethrough when the
first door is closed thereover.
Jubilant and Staff assert claim 4 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that prior art discloses or
renders obvious all of the additional limitations of claim 4 not already addressed. SIB at 89-91;
RIB at 48-49.
This claim is fundamentally identical to claim 13 of the ’826 patent. For substantially the
same reasons as laid out concerning that claim, supra V.B.2.a)(9)(a), I find that claim 4 of the ’869
patent is rendered obvious by Klein alone, as well as Klein in combination with Tate and/or the
MedRad Intego device.
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(5) Claim 5
Claim 5 of the ’869 patent recites the following:
[5] The infusion system of claim 1, wherein the opening through the exterior shell
configured to provide access to the strontium-rubidium radioisotope generator within the
interior space of the cabinet structure is through the front side of the exterior shell.
Jubilant and Staff assert claim 5 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that prior art discloses or
renders obvious all of the additional limitations of claim 5 not already addressed. SIB at 91-92;
RIB at 49-50.
Klein discloses that a front side opening of the exterior shell provides access to the
strontium-rubidium radioisotope generator within the interior of the cabinet. Klein at. 0034; Tr. at
703:17-704:9.
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein, either alone or in combination with the other asserted prior art references, renders
claim 5 of the ’869 patent obvious.
(6) Claim 8
Claim 8 of the ’869 patent recites the following:
[8] The infusion system of claim 1, wherein the infusion system is configured to
determine the strontium breakthrough test result on the test sample at least once a day.
Jubilant and Staff assert claim 8 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that prior art discloses or
renders obvious all of the additional limitations of claim 8 not already addressed. SIB at 92-93;
RIB at 50.
This claim is fundamentally identical to multiple previously addressed claims, such as
elements [1.2.b] and [1.2.c] of the ’826 patent. As with those claims, Klein alone renders the
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additional limitations of claim 8 obvious. As discussed above concerning elements [1.2.c] and
[1.2.b] of the ’826 patent, Klein discloses that as part of the “daily protocol” the computer
determines a strontium breakthrough test result of a test sample. Klein at .000028, .000039. The
system software of Klein requires successful completion of the daily protocol, including a
breakthrough test with acceptable results, in order for patient elutions to be enabled for the day.
Id. at .000028 (“Only after a calibration run with low Sr breakthrough has been successfully
completed can apatient elutions be carried out.”), .000029 (flow chart showing calibration run as
necessary precondition to patient elutions resetting daily at midnight), .000039 (“Successful
breakthrough measurement must be completed in order to enable patient elutions for the remainder
of the day.”).
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein, either alone or in combination with the other asserted prior art, renders claim 8 of
the ’869 patent obvious.
(7) Claim 14
Claim 14 of the ’869 patent recites the following:
[14.0] The infusion system of claim 1, wherein the computer of the infusion system is
further configured
[14.1] to track a volume of the saline remaining in the saline reservoir and
[14.2] to alert the user via the touch screen display when the volume of the saline
remaining in the saline reservoir is below a predetermined volume threshold.
Jubilant and Staff assert claim 14 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that prior art discloses or
renders obvious all of the additional limitations of claim 14 not already addressed. SIB at 93-94;
RIB at 51.
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This claims is fundamentally identical to claim elements [11.2] and [11.3] of the ’826
patent. For substantially the same reasons as discussed in relation thereto, supra V.B.2.a)(7), and
after considering secondary indicia of non-obviousness, I find that Klein, either alone or in
combination with the other asserted prior art, renders claim 14 of the ’869 patent obvious.
(8) Claim 24
Claim 24 of the ’869 patent recites the following:
[24.0] The infusion system of claim 1, further comprising:
[24.1] a hanger configured to hold the saline reservoir at an elevation above the top
surface of the exterior shell,
[24.2] a handle configured for the user to grasp in order to move the infusion system,
[24.3] four wheels mounted to an underside of the platform,
[24.4] a power inlet port for connecting the infusion system to a power source, and
[24.5] a printer configured to print a document concerning a patient infusion or a quality
control test result generated by the infusion system;
[24.6a] wherein the first shielding compartment comprises two tubing passageways
formed in a perimeter surface of the first opening,
[24.6b] each of the two tubing passageways has a depth configured to prevent pinching or
crushing of a corresponding tubing line routed therethrough when the first door is closed
thereover,
[24.6c] the first door is mounted via a hinge,
[24.6d] access to an operation of the computer is regulated through a user login
credential,
[24.6e] the strontium breakthrough test result is for at least one of strontium-82 and
strontium-85, and
[24.6f] the exterior shell further includes a saline tubing opening configured for a saline
tubing line to pass from the saline reservoir outside of the exterior shell to the interior
space of the cabinet structure; and
[24.7] wherein the computer of the infusion system is further configured to:
[24.7a] determine the strontium breakthrough test result on the test sample at least
once a day,
[24.7b] pump saline through the strontium-rubidium radioisotope generator at a
rate less than approximately 70 ml/min,
[24.7c] track a volume of the rubidium radioactive eluate discharged from the
strontium-rubidium radioisotope generator to the waste bottle and to control the
touch screen display to display a user screen guiding the user to empty the waste
bottle, and
[24.7d] track a volume of the saline remaining in the saline reservoir and to alert
the user via the touch screen display when the volume of the saline remaining in
the saline reservoir is below a predetermined volume threshold.
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Jubilant and Staff assert claim 24 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that prior art discloses or
renders obvious all of the additional limitations of claim 24 not already addressed. SIB at 95-104;
RIB at 52-57.
There is no serious dispute that Klein and the other prior infusion systems disclose many
of the additional claim limitations of claim 24. For example, Klein teaches an infusion system
with hangers [24.1], handles [24.2], and wheels [24.3]. Klein (at .000034); see also Tate at .0002,
RX-200C at .0042 (Intego manual). Though Klein’s saline bag hangs off the side of the cart in the
photograph in Figure 2-3 (Klein at .000034), rather than above the top surface as in limitation
[24.1], Figure 2-2 of Klein illustrates the saline bag positioned above all of the elements on the
cart. Klein at .000029. In any event, rearranging known elements in known configurations for
known results constitutes an obvious design choice. KSR at 421.
The power inlet of limitation [24.4] is likewise disclosed by Klein. See Klein at .000046
(the system “is plugged into a wall socket at all times.”). And Klein discloses a printer for printing
infusion data, as in limitation [24.5]. Klein at .000034; see also Tate at .000002, ¶75 (printer 23),
RX-200C at .0091 (Intego manual showing a printer).
As for the tubing passageways in limitations [24.6a] and [24.6b], Klein alone (or
alternatively Klein in combination with Tate and/or the MedRad Intego device renders an
invention having those elements obvious, as I have explained above in connection with claim 4 of
the ’869 patent and claim 13 of the ’826 patent.
As discussed in relation to limitation [10.1] of the ’826 patent, Klein discloses restriction
of access by user login credentials, which corresponds to limitation [24.6d]. Klein also discloses
limitation [24.6e] as it performs a strontium breakthrough test result for both strontium-82 and
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strontium-85. Klein at .000061 (disclosing the formula and method of calculating breakthrough
of strontium-82 and strontium-85). Klein additionally discloses limitation [24.6f] as the Klein
device has an opening in the exterior shell to allow saline line to pass from the saline reservoir into
the interior space of the cart. See Klein at .000034 (Fig. 2-3 and 2-4 disclosing “Saline Bag” with
“Saline Line” running from exterior reservoir to interior space of cart); Tr. at 712:15-713:6.
For the same reasons discussed concerning claim 8 of the ’869 patent, supra V.B.2.b)(6),
Klein discloses limitations [24.7] and [24.7a].
Klein discloses the limitation [24.7b]: Klein discloses performing “flush runs” and
“calibration runs” that pump saline through the generator at a rate of 15 ml/min, which is less than
the claimed limit of 70 ml/min. See, e.g., Klein at .000053 (“50 ml flush of the generator at
15ml/min.”).
For the same reasons discussed concerning claim elements [11.2] and [11.5] of the ’826
patent, Klein also discloses elements [24.7c] and [24.7d]. See supra V.B.2.a)(7)(a).
Bracco argues that [24.7c]’s requirement of displaying “a user screen guiding the user to
empty the waste bottle” is distinct from presenting “a screen reminding the user to empty the waste
bottle.” Id. CRB at 57 n.6. But Bracco provides no argument why “a user screen guiding the user
to empty the waste bottle” would not be met by Klein’s disclosure of an automated warning of the
waste bottle overflow. See Klein at .000044-45 (mechanism for warning about overflow). Indeed,
I find that Klein specifically discloses displaying a warning on its touchscreen guiding the user to
empty the waste bottle. Id. at .0075 (“If at any point the flag changes to a value other than zero,
the elution will terminate with the error message screen” with error 70001 “Waste container full.
Empty container and restart elution.”).
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Limitation [24.6c] concerns mounting the door over the generator compartment by a hinge.
As noted above in relation to claim element [1.9], Klein discloses both doors and hinges. See, e.g.,
Klein at .000034 (Fig. 2-3 showing hinged door on side of cart); id. (Fig. 2-4 showing hinged lid
on top of cart); Tr. at 862:13-863:10 (noting that system pictured in Klein had a door that closed
over the front side attached at hinges on juncture of the front side and right sidewall). Dr. Stone
testified credibly that it was commonplace in the art for shielding compartments to have enclosures
including doors mounted in a variety of ways, including hinges. Tr. at 711:3-12. Indeed, doors
attached by hinges are among the most common mechanical elements in the world. Combining
familiar elements, such as doors and hinges, according to known methods, is obvious when the
combination does no more than yield predictable results. KSR at 401. Nowhere does the ’869
patent teach any specific advantage or unexpected result of a hinged door design. Limitation
[24.6c] is simply matter of design choice. See Philips Lighting N. Am. Corp. v. Wangs All. Corp.,
727 F. App’x 676, 681 (Fed. Cir. 2018) (affirming rejection of patent as “obvious matter of design
choice” where two prior art designs “were known in the art, recognized as solutions to the
particular problem, and functionally equivalent.”); KSR at 421 (“When there is a design need or
market pressure to solve a problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the product not of innovation of
ordinary skill and common sense.”).
I also find that Tate discloses a door over the first shielding compartment attached via a
hinge. Tate at .000079.
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For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein, either alone or in combination with the other asserted prior art, renders claim 24
obvious.
(9) Claim 27 (Unasserted)
Claim 27 of the ’869 patent recites the following:
[27.0] The infusion system of claim 24, further comprising
[27.1] a dose calibrator located in the shielded well on-board the cart and in
communication with the computer,
[27.2] wherein the dose calibrator is configured to determine the strontium
breakthrough test result; and
[27.3] wherein the opening through the exterior shell configured to provide access
to the strontium-rubidium radioisotope generator within the interior space of the
cabinet structure is through the front side of the exterior shell.
Jubilant and Staff assert claim 27 is obvious in light of the combinations of prior art
advanced above in connection with claim 1 and claim 24 of the ’869 patent. Staff and Jubilant
argue that prior art discloses or renders obvious all of the additional limitations of claim 27 not
already addressed. SIB at 104-105; RIB at 57-59.
I find that Klein alone discloses or renders obvious an invention with all the additional
limitations of claim 27. See Tr. at 716:20-718:12. As discussed above regarding multiple other
claim elements, I find that Klein discloses an infusion system with a dose calibrator located in a
shielded well in communication with the computer that determines the breakthrough test result.
Klein at .000029 and .000057. Klein discloses that the dose calibrator detects strontium
breakthrough activity as part of the calibration run. Id. at .000060-.000061. And for the same
reasons as discussed above concerning claim 1 of the ’826 patent, it was obvious to relocate the
dose calibrator in the shielded well of Klein on-board the cart. Klein further discloses a front side
opening of the exterior shell that could provide access to the generator within the interior of the
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cabinet. Klein at .000034 (showing the entire front side of the exterior shell was a moveable door
with access to the first shielding compartment containing the generator).
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein, either alone or in combination with the other asserted prior art, renders claim 27
of the ’869 patent obvious.
(10) Claim 28 (Unasserted)
Claim 28 of the ’869 patent recites the following:
[28.0] The infusion system of claim 27, further comprising:
[28.1] the strontium-rubidium radioisotope generator with the inlet tubing port
configured to receive saline and the outlet tubing port configured to discharge the
rubidium radioactive eluate,
[28.2] the eluate reservoir located inside the shielded well on-board the cart and in
fluid communication with the eluate tubing line,
[28.3] a waste tubing line in fluid communication with the eluate tubing line and
the waste bottle, and
[28.4] a valve configured to control fluid flow between the eluate tubing line and
the waste bottle via the waste tubing line.
Jubilant and Staff assert claim 28 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 24, and 27. Staff and Jubilant argue that prior art
discloses or renders obvious all of the additional limitations of claim 28 not already addressed.
SIB at 106-107; RIB at 59-61.
Klein renders an invention with the additional limitations of this claim obvious. See Tr. at
718:10-721:12. I find that Klein discloses a system having a generator (red, in the figure below)
with an inlet port (pink) that receives saline from the saline IV (brown) and an outlet port (also
pink) that discharges eluate, satisfying limitation [28.1]. Klein at .000029 (as annotated in SIB at
106, reproduced below). The system also has an eluate reservoir (blue) in a shielded well in
communication with an eluate tubing line (pink) from the generator (red), satisfying limitation
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[28.2]. Id. Klein further teaches a waste tubing line (pink) in fluid communication with the eluate
tubing line (pink) and the waste bottle (bright green), satisfying limitation [28.3]. Id. The Klein
system has a valve (orange) that controls flow between the eluate tubing line (pink) and the waste
bottle (bright green) via the waste tubing line (pink), satisfying limitation [28.4]. Id. And for the
same reasons as discussed above concerning claim 1 of the ’826 patent, it would have been obvious
to relocate the dose calibrator in the shielded well of Klein on-board the cart.
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein, either alone or in combination with the other asserted prior art, renders claim 28
obvious.
(11) Claim 29
Claim 29 of the ’869 patent recites the following:
[29.0] The infusion system of claim 28, wherein the computer of the infusion system is
configured to:
[29.1] measure an activity of the test sample filled into the eluate reservoir in the
shielded well on-board the cart while the eluate reservoir remains in the shielded
well on-board the cart, wherein the activity is measured with the dose calibrator in
the shielded well on-board the cart, and
[29.2] calibrate the infusion system based on the activity measured by the dose
calibrator.
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Jubilant and Staff assert claim 29 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 24, and 27. Staff and Jubilant argue that prior art
discloses or renders obvious all of the additional limitations of claim 29 not already addressed.
SIB at 107-108; RIB at 61-62.
Klein discloses and/or renders obvious an invention with all additional limitations of
claim 29. Tr. at 721:9-723:7. Klein describes a computer that calibrates the activity counter by
measuring activity of a test sample while it is in the shielded well of the dose calibrator. Klein at
.000034 (showing system configuration), .000055-.000060 (describing use of dose calibrator to
calculate calibration constant for use with activity monitor). For the same reasons as discussed
above concerning claim 1 of the ’826 patent, it was obvious to relocate the dose calibrator in the
shielded well of Klein on-board the cart.
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein, either alone or in combination with other prior art, renders claim 29 obvious.
(12) Claim 30
Claim 30 of the ’869 patent recites the following:
[30.0] The infusion system of claim 29, wherein
[30.1] the cabinet structure has a lowermost portion and the platform has a lower
surface,
[30.2] the first opening is at a first elevation,
[30.3] the second opening is at a second elevation,
[30.4] the first elevation is between approximately 1 foot and approximately 2
feet, with respect to the lowermost portion of the cabinet structure, and the second
elevation is between approximately 2 feet and approximately 3 feet, with respect
to the lower surface of the platform.
Jubilant and Staff assert claim 30 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 24, 27, 28, and 29. Staff and Jubilant argue that prior
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art discloses or renders obvious all of the additional limitations of claim 30 not already addressed.
SIB at 108-110; RIB at 62-63.
The additional claim limitations here are identical to those of claim 3. For the same reasons
as laid out concerning that claim, supra V.B.2.b)(3), and after considering secondary indicia of
non-obviousness, I find that claim 30 of the ’869 patent is rendered obvious by Klein, either alone
or in combination with the other asserted prior art.
c) ’870 Patent
Bracco asserts claims 1, 2, 8, 10-12, 16-17, and 27 of U.S. Patent No. 9,750,870. Due to
intermediate dependencies, claims 9 and 13 are also at issue for the purposes of the invalidity
analysis.
(1) Claim 1
Claim 1 of the ’870 patent recites the following:
[1.0] A method of using an infusion system on-board a cart to deliver a rubidium
radioactive eluate comprising:
[1.1] installing a saline reservoir on the infusion system, wherein the infusion
system comprises a platform and an exterior shell extending upwardly above the
platform, and wherein the platform and the exterior shell, collectively define an
interior space of a cabinet structure;
[1.2] placing the saline reservoir in fluid communication through a saline tubing
line with an inlet tubing port of a strontium-rubidium radioisotope generator
located in a first shielding compartment in the interior space of the cabinet
structure, wherein the strontium-rubidium radioisotope generator further
comprises an outlet tubing port configured to discharge the rubidium radioactive
eluate, and wherein the first shielding compartment has a first opening facing
vertically upwardly;
[1.3] inserting a waste bottle into a second shielding compartment on-board the
cart, wherein the second shielding compartment on-board the cart has a second
opening facing vertically upwardly and being at a higher elevation than the first
opening;
[1.4] placing the waste bottle in fluid communication with the outlet tubing port
of the strontium-rubidium radioisotope generator through an eluate tubing line;
[1.5] wherein a computer on-board the cart is configured to control the fluid
communication between the waste bottle and the outlet tubing port, and
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[1.6] wherein the computer has a touch screen display mounted on a vertical post
with a top end extending above the cabinet structure;
[1.7] inserting an eluate reservoir in a shielded well on-board the cart;
[1.8] placing the eluate reservoir in fluid communication with the eluate tubing
line, wherein the computer is further configured to control the fluid
communication between the eluate reservoir and the eluate tubing line;
[1.9] pumping a sample of the rubidium radioactive eluate into the eluate
reservoir in the shielded well on-board the cart;
[1.10] measuring a radioactivity of the sample of the rubidium radioactive eluate
flowing through the eluate tubing line with a radioactivity detector on-board the
cart while the sample of the rubidium radioactive eluate is flowing through the
eluate tubing line;
[1.11] measuring a calibration radioactivity of the sample pumped into the eluate
reservoir in the shielded well on-board the cart while the eluate reservoir remains
in the shielded well on-board the cart;
[1.12] comparing the radioactivity of the sample of the rubidium radioactive
eluate flowing through the eluate tubing line measured by the radioactivity
detector on-board the cart while the sample of the rubidium radioactive eluate is
flowing through the eluate tubing line with the calibration radioactivity of the
sample pumped into the eluate reservoir in the shielded well on-board the cart;
and
[1.13] determining a strontium breakthrough test result on the sample pumped
into the eluate reservoir in the shielded well on-board the cart while the eluate
reservoir remains in the shielded well on-board the cart, wherein the computer of
the infusion system is further configured to not allow a patient infusion if the
strontium breakthrough test result is greater than or equal to an allowed limit.
The parties’ arguments concerning this claim are largely derivative of arguments relating
to similar claims of the ’826 patent and ’869 patent. I incorporate by reference my prior analysis
of the Klein thesis alone and combinations of Klein with other prior art discussed above in
connection with the ’826 patent and the ’869 patent. Below I briefly examine each limitation of
claim 1 of the ’870 patent, referring to relevant prior analysis where appropriate.
Klein discloses a method for using an infusion system that is on-board a cart to deliver
rubidium-82 eluate, as in element [1.0]. Tr. at 724:10-15; Klein at .000005. Klein discloses
installing a saline reservoir on the infusion system comprising a platform and exterior shell that
define an interior space of a cabinet structure, as in limitation [1.1]. Id. at .000029 (system
diagram), .000034 (system photographs). Klein likewise discloses all of limitation [1.2]. Klein
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describes placing the saline reservoir in fluid communication with the generator via a tubing line
and input port. Id. at .000029 (system diagram), .000034 (system photograph). The generator is
inside the cabinet within a first shielding compartment (the stacked lead rings) with an upwardly-
facing opening. Id. at .000033 (lead rings around generator as shielding), .000034 (Fig. 2-4
showing the generator is visible through an upward opening of the lead rings).
Klein describes inserting a waste bottle into a shielding compartment on-board the cart,
wherein the shielding compartment has a second opening facing vertically upward, as in
limitation [1.3]. See supra V.B.2.a)(1)(a) (discussions of claim limitations [1.1.c] and [1.1.d] of
claim 1 of the ’826 patent). Although Klein’s second shielding compartment has an upward
opening at a lower elevation than the first opening, for the reasons discussed in connection with
limitation [1.1.e] in claim 1 of the ’826 patent, the relative opening heights are an obvious design
choice with no patentable distinction over the prior art.
Klein discloses placing the waste bottle in fluid communication with the outlet tubing port
of the generator through an eluate tubing line, as in limitation [1.4]. See, e.g., Klein at .000029
(system diagram). Klein likewise discloses limitation [1.5], as it describes configuring the
computer to control the path of eluate from the generator to either the patient output port or the
waste bottle via control of a valve. Tr. at 728:23-729:14; Klein at .000029 (“[R]eal-time software
controls the pumps and valves. These in turn affect the flow of saline through the generator or its
bypass line to the patient, dose calibrator, or waste container.”), .000057 (discussing computer
control of valves).
Klein also discloses a cart having a computer with an LCD touch screen mounted on a post
above the cabinet structure, as required by limitation [1.6]. See id. at .000034 (disclosing screen
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mounted on post above shell), .000064 (Fig. 3-12(c) demonstrating touchscreen data input),
.000040-41 (“The interface must be solely through the touch screen”).
Concerning limitation [1.7], as discussed multiple times above, see supra V.B.2.a)(1)(a),
Klein describes inserting an eluate reservoir (such as a vial) within a shielded well of the dose
calibrator. See Tr. at 730:3-13; Klein at .000057. For the reasons set forth above in connection
with claim 1 of the ’826 patent, relocating that shielded well assembly to the cart would have been
obvious.
Concerning elements [1.8] and [1.9], Klein describes configuring the system to place the
eluate reservoir in fluid communication with the eluate tubing line and configuring the computer
to control that communication, as well as pumping a sample of the eluate into the eluate reservoir
in the shielded well. Tr. at 731:6-23; Klein at .0029 (“[R]eal-time software controls the pumps
and valves. These in turn affect the flow of saline through the generator or its bypass line to the
patient, dose calibrator, or waste container.”). For the reasons set forth above concerning claim
element 1 of the ’826 patent, relocating that shielded well assembly to the cart was obvious.
Klein also discloses an in-line radioactivity detector on-board the cart that measures
radioactivity of eluate flowing through tubing, as in limitation [1.10]. Tr. 731:20-732:18 (citing
Klein at .000029, -56).
Klein further discloses using the dose calibrator to measure radioactivity of a test sample
pumped into the dose calibrator vial in the shielded well, as in limitation [1.11]. Klein at .000053.
Klein’s computer is configured to compare radioactivity of the eluate flowing through the tubing
line with radioactivity of the sample in the dose calibrator, satisfying limitation [1.12]. Id.; see
also id. at .000028, .000053 (“integral activity recorded from the dose calibrator is used to calibrate
the activity counter and verify that the calibration constant is within tolerance”). For the reasons
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set forth above in connection with claim 1 of the ’826 patent, relocating that shielded well assembly
to the cart would have been obvious. Klein thus renders obvious an invention having limitations
[1.11] and [1.12].
Limitation [1.13] is substantively identical to limitation [1.2] of claim 1 of the ’826 patent.
For the reasons set forth above in connection with the ’826 patent, Klein renders obvious an
invention with limitation [1.13]. See supra V.B.2.a)(1)(a).
I thus find the rubidium infusion system shown in the Klein thesis includes all of the same
functional components recited in claim 1, but Klein physically arranges the components differently
than the claim. For the reasons discussed above, and after considering secondary indicia of non-
obviousness advanced by Bracco, I find that rearranging the components in Klein would have been
obvious to a person of ordinary skill in the art at the time of the invention. Claim 1 is therefore
invalid under 35 U.S.C. § 103. I further find that the prior art combinations discussed above in
connection with claim 1 of the ’826 patent and claim 1 of the ’869 patent would render claim 1 of
the ’870 patent obvious for substantially the same reasons.
(2) Claim 2
Claim 2 of the ’870 patent recites the following:
[2.0] The method of claim 1 further comprising:
[2.1] placing the eluate tubing line in fluid communication with a patient, wherein
the computer is further configured to control the fluid communication between the
eluate tubing line and the patient;
[2.2] pumping a dose of the rubidium radioactive eluate to the patient; and
[2.3] flushing the rubidium radioactive eluate remaining in at least a portion of the
eluate tubing line into the patient by pumping saline from the saline reservoir to
the eluate tubing line through a by-pass line that by-passes the strontium-rubidium
radioisotope generator, wherein the computer is further configured to control fluid
communication via the by-pass line.
Jubilant and Staff assert claim 2 is obvious in light of the combinations of prior art
advanced above in connection with claim 1 of the ’870 patent. Staff and Jubilant argue that the
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prior art discloses or renders obvious all of the additional limitations of claim 2 not already
addressed. SIB at 118-120; RIB at 70-71.
I find that Klein alone discloses all of the additional elements of claim 2. Klein describes
a computer that controls fluid communication between the eluate tubing line output from the
generator and a patient via the patient valve, as in limitation [2.1]. See, e.g., Klein at .000029
(“[R]eal-time software controls the pumps and valves. These in turn affect the flow of saline
through the generator or its bypass line to the patient, dose calibrator, or waste container.”). The
computer of Klein also pumps doses of the eluate to the patient via the pump, as in limitation [2.2].
Id. And Klein discloses computer operation of a post-elution patient flush that flushes the
remaining radioactive eluate into the patient through a line that bypasses the generator. Id.; see
also id. at .000055 (“Bypass-to-Patient Flush – The final state flushes saline through the bypass to
the patient outlet in order to push the activity in the lines to the patient outlet.”).
For the foregoing reasons, and after considering secondary indicia of non-obviousness, I
find that Klein, either alone or in combination with the other asserted prior art, renders the
invention in claim 2 obvious.
(3) Claim 8
Claim 8 of the ’870 patent recites the following:
[8.0] The method of claim 2 wherein the computer of the infusion system is further
configured to:
[8.1] present on the touch screen display a screen for starting the patient infusion
by touching a button on the touch screen display;
[8.2] present on the touch screen display a screen reminding a user to insert the
eluate reservoir in the shielded well on-board the cart;
[8.3] present on the touch screen display a screen indicating that the patient
infusion is in process, wherein the screen indicating that the patient infusion is in
process displays a stop button to abort the patient infusion; and
[8.4] present on the touch screen display the strontium breakthrough test result.
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Jubilant and Staff assert claim 8 is obvious in light of the combinations of prior art
advanced above in connection with claims 1 and 2. Staff and Jubilant argue that the prior art
discloses or renders obvious all of the additional limitations of claim 8 not already addressed. SIB
at 120-123; RIB at 71-74.
The additional elements of claim 8 are identical to those of claim 9 of the ’826 patent. For
those reasons set forth above in connection with that claim, and after considering secondary indicia
of non-obviousness, claim 8 of the ’870 patent is obvious in light of the Klein thesis alone or in
combination with the other asserted prior art. See supra V.B.2.a)(5).
(4) Claim 9 (Unasserted)
Claim 9 of the ’870 patent recites the following:
[9.0] The method of claim 8, further comprising:
[9.1] logging into the computer by entering a user login credential on the touch
screen display,
[9.2] entering a patient ID on the touch screen display,
[9.3] entering a patient dose on the touch screen display,
[9.4] entering a flow rate on the touch screen display.
Jubilant and Staff assert claim 9 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, and 8. Staff and Jubilant argue that the prior art
discloses or renders obvious all of the additional limitations of claim 9 not already addressed.
SIB at 124; RIB at 74.
The additional elements of claim 9 are substantively identical to those of claim 10 of the
’826 patent. For those reasons set forth above concerning that claim, and after considering
secondary indicia of non-obviousness, claim 9 of the ’870 patent is obvious in light of the Klein
thesis alone or in combination with the other asserted prior art. See supra V.B.2.a)(6).
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(5) Claim 10
Claim 10 of the ’870 patent recites the following:
[10.0] The method of claim 9, wherein the computer of the infusion system is further
configured to:
[10.1] track a volume of saline remaining in the saline reservoir,
[10.2] provide an alert via the touch screen display when the volume of saline
remaining in the saline reservoir is below a predetermined volume threshold, and
[10.3] present on the touch screen display a screen reminding the user to empty
the waste bottle.
Jubilant and Staff assert claim 10 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 8, and 9. Staff and Jubilant argue that the prior art
discloses or renders obvious all of the additional limitations of claim 10 not already addressed.
SIB at 124; RIB at 74.
Limitations [10.1], [10.2], and [10.3] are identical to limitations [11.2], [11.3], and [11.5]
in claim 11 of the ’826 patent. For the reasons discussed above in connection with claim 11 of the
’826 patent, and after considering secondary indicia of non-obviousness, I find the invention of
claim 10 of the ’870 patent is obvious in view of the Klein thesis alone or in combination with the
other asserted prior art. See supra V.B.2.a)(7).
(6) Claim 11
Claim 11 of the ’870 patent recites the following:
[11.0] The method of claim 10, further comprising:
[11.1] initiating a generator column wash through the touch screen display,
wherein a predetermined amount of saline is pumped through the strontium-
rubidium radioisotope generator and directed to the waste bottle during the
generator column wash, and
[11.2] initiating a purging process through the touch screen display to purge a
patient tubing line of air, wherein the patient tubing line is in fluid communication
with the eluate tubing line.
Jubilant and Staff assert claim 11 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, and 8-10. Staff and Jubilant argue that the prior
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art discloses or renders obvious all of the additional limitations of claim 11 not already addressed.
SIB at 126-26; RIB at 75-77.
The additional limitations of claim 11 are substantially identical to those of claim 12 of the
’826 patent. For the reasons discussed concerning claim 12 of the ’826 patent, and after
considering secondary indicia of non-obviousness, claim 11 of the ’870 is rendered obvious in
light of the Klein thesis alone or in combination with the other asserted prior art. See
supra V.B.2.a)(8).
(7) Claim 12
Claim 12 of the ’870 patent recites the following:
[12.0] The method of claim 11, wherein the saline tubing line and the eluate tubing line
are routed through
[12.1] two tubing passageways formed in a perimeter surface of the first opening,
wherein
[12.2] each of the two tubing passageways has a depth configured to prevent
pinching or crushing of a corresponding tubing line routed therethrough when a
first door is closed over the first opening.
Jubilant and Staff assert claim 12 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, and 8-11. Staff and Jubilant argue that the prior
art discloses or renders obvious all of the additional limitations of claim 12 not already addressed.
SIB at 128-130; RIB at 77-78.
The additional limitations of claim 12 are substantially identical to those of claim 13 of the
’826 patent. For the reasons discussed concerning claim 13 of the ’826 patent, and after
considering secondary indicia of non-obviousness, claim 12 of the ’870 patent is rendered obvious
in light of the Klein thesis alone or in combination with the other asserted prior art. See
supra V.B.2.a)(9).
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(8) Claim 13 (Unasserted)
Claim 13 of the ’870 patent recites the following:
[13.0] The method of claim 12, wherein the infusion system further comprises:
[13.1] a handle configured for the user to grasp in order to move the infusion system, and
[13.2] four wheels mounted to an underside of the platform of the cabinet structure.
Jubilant and Staff assert claim 13 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, and 8-12. Staff and Jubilant argue that the prior
art discloses or renders obvious all of the additional limitations of claim 13 not already addressed.
SIB at 130; RIB at 78-79.
The additional limitations of claim 13 are substantially identical to limitations [14.2] and
[14.3] in claim 14 of the ’826 patent. For the reasons discussed above in connection with claim 14
of the ’826 patent, and after considering secondary indicia of non-obviousness, claim 13 of the
’870 patent is rendered obvious in light of the Klein thesis alone or in combination with the other
asserted prior art. See supra V.B.2.a)(10).
(9) Claim 16
Claim 16 of the ’870 patent recites the following:
[16] The method of claim 13, wherein the infusion system further comprises a dose
calibrator in the shielded well on-board the cart and in communication with the computer
to determine the strontium breakthrough test result.
Jubilant and Staff assert claim 16 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, and 8-13. Staff and Jubilant argue that the prior
art discloses or renders obvious all of the additional limitations of claim 16 not already addressed.
SIB at 131; RIB at 79-80.
The additional limitations of claim 16 are substantially identical to those of claim 17 of the
’826 patent. For the reasons discussed above in connection with claim 17 of the ’826 patent, and
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after considering secondary indicia of non-obviousness, claim 16 of the ’870 patent is rendered
obvious in light of the Klein thesis alone or in combination with the other asserted prior art. See
supra V.B.2.a)(11).
(10) Claim 17
Claim 17 of the ’870 patent comprises:
[17.0] The method of claim 16, wherein
[17.1] the cabinet structure has a lowermost portion and the platform has a lower
surface,
[17.2] the first opening is at a first elevation,
[17.3] the second opening is at a second elevation,
[17.4] the first elevation is between approximately 1 foot and approximately 2
feet, with respect to the lowermost portion of the cabinet structure, and the second
elevation is between approximately 2 feet and approximately 3 feet, with respect
to the lower surface of the platform.
Jubilant and Staff assert claim 17 is obvious in light of the combinations of prior art
advanced above in connection with claims 1, 2, 8-13, and 16. Staff and Jubilant argue that the
prior art discloses or renders obvious all of the additional limitations of claim 17 not already
addressed. SIB at 131-33; RIB at 81.
The additional limitations of claim 17 are substantially identical to those of claim 18 of the
’826 patent. For the reasons discussed above in connection with claim 18 of the ’826 patent, and
after considering secondary indicia of non-obviousness, claim 17 of the ’870 patent is obvious in
light of the Klein thesis alone or in combination with the other asserted prior art. See supra
V.B.2.a)(12).
(11) Claim 27
Claim 27 of the ’870 patent recites the following:
[27] The method of claim 1, wherein the computer of the infusion system is further
configured to track time passed from completion of pumping the sample of the rubidium
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radioactive eluate into the eluate reservoir to determining the strontium breakthrough test
result.
Jubilant and Staff assert claim 27 is obvious in light of the combinations of prior art
advanced above in connection with claim 1. Staff and Jubilant argue that prior art discloses or
renders obvious all of the additional limitations of claim 27 not already addressed. SIB at 133;
RIB at 82.
The additional limitations of claim 27 are substantially identical to those of limitation
[11.1] in claim 11 of the ’826 patent. For the reasons discussed above in connection with claim
11 of the ’826 patent, and after considering secondary indicia of non-obviousness, claim 27 of the
’870 patent is obvious in light of the Klein thesis alone or in combination with the other asserted
prior art. See supra V.B.2.a)(7); see also Tr. at 763:-24-764:18 (testimony of Dr. Stone); Klein at
.000028 (“the activity in the dose calibrator is registered 30 minutes after the end of the elution to
compute the breakthrough”); CRB at 52 (acknowledging the computer in Klein tracks the time
after performing a breakthrough test).
3. Secondary Considerations Bearing on Obviousness
Bracco provides several arguments directed to secondary considerations bearing on the
obviousness of the asserted claims. Though I have considered the proffered evidence and
arguments in considering each claim, I ultimately find them unpersuasive and give them little
weight. I address each category proffered by Bracco in turn.
a) Nexus
To begin, Bracco erroneously relies on statements in Brown & Williamson Tobacco Corp.
v. Philip Morris Inc., 229 F.3d 1120, 1129 (Fed. Cir. 2000) and Polaris Indus., Inc. v. Arctic Cat,
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Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018) (citing the same language in Brown & Williamson) for
the proposition that “nexus is presumed when the patentee shows that the evidence is tied to a
specific product and that product ‘embodies the claimed features and is coextensive with them.”
CIB at 5, 34-35. Despite the loose language in Polaris, the two cases Bracco relies on are
discussing the “commercial success” factor from Graham—a factor Bracco does not advance. Cf.
Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir. 2004) (“[N]exus may
be inferred when the patentee shows both that there is commercial success, and that the thing
(product or method) that is commercially successful is the invention disclosed and claimed in the
patent.”).
As Bracco more correctly recognized, “for evidence of secondary considerations to be
given substantial weight in the obviousness determination, its proponent must establish a nexus
between the evidence and the merits of the claimed invention.” See W. Union Co. v. MoneyGram
Payment Sys. Inc., 626 F.3d 1361, 1372-73 (Fed. Cir. 2010) (citing In re GPAC Inc., 57 F.3d 1573,
1580 (Fed. Cir. 1995)); see also In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
Patent Litig., 676 F.3d 1063, 1079 n.6 (Fed. Cir. 2012) (when examining evidence of secondary
considerations “courts must exercise care in assessing proffered evidence of objective
considerations, giving such evidence weight only where the objective indicia are attributable to
the inventive characteristics of the discovery as claimed in the patent.”); Ormco Corp. v. Align
Tech., Inc., 463 F.3d 1299, 1311-12 (Fed. Cir. 2006) (“evidence of commercial success, or other
secondary considerations, is only significant if there is a nexus between the claimed invention
and” the cited factor) (emphasis added). Bracco was required to make such a showing of nexus
for its evidence of copying, unmet need, and failure of others to be given weight. See, e.g., Wm.
Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (“Just as with
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the commercial success analysis, a nexus between the copying and the novel aspects of the claimed
invention must exist for evidence of copying to be given significant weight in an obviousness
analysis.”). Because Bracco has not expressly proffered any argument or evidence on such nexus
at all, instead relying on an erroneous presumption of nexus, see CIB at 34-35, I accord its
arguments for objective indicia little weight. Nevertheless, in the interest of thoroughness, I have
considered the each of Bracco’s arguments as if nexus had been shown. My analysis of those
arguments follows.
b) Copying
Though Bracco asserts that there “is substantial evidence that Jubilant used Bracco
information to develop a system that infringes the [a]sserted [p]atents,” CPB at 17, it never
identifies what Bracco information, specifically, it alleges Jubilant copied. I infer from Bracco’s
brief an allegation that three specific features of the asserted patents were copied: “[1] an on-board
dose calibrator, [2] determining a strontium breakthrough test on-board the cart, [3] configuring a
computer to not allow a patient infusion if there is strontium breakthrough.” CIB at 24-25. The
first two features both relate to placing the dose calibrator on-board the cart, and the third was a
feature present in the Klein thesis on which Jubilant had been basing its development since at least
2007. See supra V.B.2.a)(1) (“computer,” concerning element [1.2.c]); Tr. at 307:5-11; RX-78C.
As such, the only element that could plausibly have been copied is the placement of the dose
calibrator “on-board the cart.”
To show copying of the on-board dose calibrator, Bracco cites the “design shift” in
Jubilant’s development timeline, relying on DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
567 F.3d 1314 (Fed. Cir. 2009). In DePuy Spine, the Federal Circuit affirmed a legal determination
by a district court that an asserted patent was nonobviousness where underlying factual findings
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showed a change in the defendants’ design one month after the patent was published. Id. at
1328-29. But the Circuit was only reviewing those factual findings for clear error, in a context
where the accused infringer did not allege that it independently conceived the idea. Id. at 1324,
1329. DePuy Spine does not stand for the proposition that any design change after publication of
a patent is per se copying. Secondary considerations are fact-dependent. W. Union Co. v.
MoneyGram Payment Sys., Inc., 626 F.3d 1361, 1369 (Fed. Cir. 2010) (“An obviousness
determination is not the result of a rigid formula disassociated from the consideration of the facts
of a case.”). For example, in Iron Grip, the defendant abandoned a non-infringing design and
produced an infringing design after the asserted patent issued, but the court held that fact “does
not establish that [the defenant] engaged in copying.” 392 F.3d at 1325; see also Wyers v. Master
Lock Co., 616 F.3d 1321, 1246 (Fed. Cir. 2010) (“Not every competing product that falls within
the scope of a patent is evidence of copying, otherwise every infringement suit would
automatically confirm the non-obviousness of the patent.”).
“Copying requires proof of replication of a specific product, not just the making of a
product that arguably falls within the scope of the patent’s claims.” Iron Grip, 392 F.3d at 1325.
Here, it is undisputed that when Jubilant designed a system with a dose calibrator on-board the
cart, Bracco had no product with an on-board dose calibrator. Tr. at 313:8-10 (“When did JDI first
begin developing the Version 3? A: 2010.”); see CX-0386C.0001 (Jubilant internal email dated
July 28, 2010 stating “we [are] currently designing the V3 infuser cart and we are wondering how
much lead shielding is needed for the generator . . . the dose calibrator chamber [vial inside . . .]
the waste container. . . All this shielding is on the cart . . .”). Bracco’s only existing products in
the critical time frame were its legacy Model 510 system and possibly its “NextGen”
device. Both of those systems and
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Tr. at 175:11-176:2. By the time Jubilant’s design included an on-board dose calibrator,
Bracco of its old designs that would eventually lead to a
design specification requiring an on-board dose calibrator. And implementation of that design
specification in a specific product was . See Tr. at 174:9-176:2, 183:22-184:12;
JX-0058C, JX-0112C.0009-12. When the various former Bracco employees and former Bracco
contractors were hired by Jubilant, there was no product design those employees and contractors
could convey to Jubilant.
The patents at issue here are also insufficient to be the basis of any alleged copying. The
patent figures do not illustrate a dose calibrator “on board the cart,” Tr. at 1057:5-20, and Bracco’s
own expert admitted that the patents are devoid of any description of “the steps a person should
take” to achieve an on-board dose calibrator and other implementation details. Compare Tr. at
1057:5-1059:4, with ’826 patent at 8:12-28, 19:13-29. And even if the patents did have such
details, there is no direct evidence Jubilant ever accessed or consulted Bracco’s patents during the
development of the RUBY Version 3. Tr. at 1034:1-8, 1084:14-1085:8.
Bracco has cited nothing even vaguely similar to “direct evidence such as disassembling a
patented prototype, photographing its features, and using the photograph as a blueprint to build a
virtually identical replica, . . . or access to, and substantial similarity to, the patented product,”
factors the court considered in Iron Grip, 392 F.3d at 1325. Indeed, Bracco’s experts admitted
there is no direct evidence Jubilant copied Bracco’s technology. See Tr. at 1034:1-5, 1084:8-20,
1085:1-8
The sole fact witness presented at the hearing with knowledge of Jubilant’s development
process was Mr. Donnelly, Medical Device Product Manager at Jubilant. Mr. Donnelly testified
that Jubilant had the idea to put the dose calibrator on board the cart around May 2010, and his
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understanding was based on his review of Jubilant documents. Tr. at 316:18-317:9. Bracco argues
that Mr. Donnelly could not have personal knowledge of Jubilant’s actions around 2010 because
he did was not employed at Jubilant until November 2013. Bracco also objects in its post-hearing
brief that the documents he relied on were not admitted in the hearing. It is possible that Mr.
Donnelly’s testimony was based on RX-0515C, which I previously ruled was inadmissible for
untimely disclosure. See CRB at 73; Order No. 33. But Bracco did not ask Mr. Donnelly which
documents he had in mind when Mr. Donnelly was on the stand. Nor did Bracco object when the
testimony was elicited. Bracco failed to preserve any objection as to the basis of Mr. Donnelly’s
knowledge. Mr. Donnelly’s testimony may be unsupported hearsay to which I accord little weight,
but it is still largely unrebutted sworn testimony from a witness I was able to personally observe,
and light evidence is still heavier than no evidence at all.
Bracco attempts to contradict Mr. Donnelly’s testimony with deposition testimony of
Jubilant’s corporate representative Mr. Riddoch, who stated he believed Ms. Gelbach contributed
the idea of Jubilant’s on-board dose calibrator after her hiring in the summer of 2010. CIB at 22.
But Mr. Riddoch also stated that Ms. Gelbach got the idea for an on-board dose calibrator from
customers. CX-0570C at 120:11-22. Not surprisingly, Bracco asks me to credit Mr. Riddoch’s
testimony that Jubilant got the idea for an on-board dose calibrator from Ms. Gelbach but reject
Mr. Riddoch’s testimony that Ms. Gelbach got the idea from customers. Bracco’s inconsistency
undermines its argument. In any event, I decline to give much weight to the hearsay in
Mr. Riddoch’s deposition testimony.
Instead, I give more weight to unambiguous documentary evidence indicating that Jubilant
had already begun designing a cart with the dose calibrator on board as early as July 28, 2010.
CX-0386C.0001 (“We [are] currently designing the V3 infuser cart and we are wondering how
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much lead shielding is needed for the generator . . . the dose calibrator chamber [vial inside . . .]
the waste container. . . All this shielding is on the cart . . . .”). Ms. Gelbach was hired no earlier
than the same month as that design document, and she was not hired as an engineer or senior
manager. Tr. 1046:17-20. I find it unlikely that a newly hired non-engineer convinced Bracco to
shift a major design initiative without creating a single written document to that effect.
Bracco also points to documents showing Jubilant’s awareness of Bracco’s patents. Some
undisputed facts belie that argument. It is undisputed that the RUBY Version 3 was submitted to
the FDA with the allegedly copied features in August 2013. RX-0017; JX-0200.04-48. The
documents Bracco points to are from years after Jubilant submitted its device to the FDA and years
after Jubilant had shown its system at a trade show. See CIB at 27-29 (citing JX-0017C.022-.023;
Tr. at 1031:2-24, 1032:3-1033:10, 1033:11-23; CX-0409C.004; CX-0408C.001). Jubilant’s
awareness of Bracco’s patents after Jubilant had already brought its product to market does not
indicate copying the invention in those patents.
Even if Bracco’s evidence of alleged copying were from the correct time frame, all of the
cited documents are a far cry from those the Federal Circuit has countenanced as indicative of
copying. See Akamai Techs., Inc. v. Cable & Wireless Internet Servs., Inc., 344 F.3d 1186,
1196-97 (Fed. Cir. 2003) (accused infringer’s “redesign process was documented in the record in
internal emails from [their] engineers discussing [the patent holder’s] approach, identifying
weaknesses in [the accused infringer’s] approach, and ultimately deciding to switch to the
[patentee’s] system.”). The only example Bracco cites of Jubilant having affirmative possession
of Bracco design details during the relevant time is a user manual for Bracco’s legacy product, the
Model 510, which has been on the market since 1989 and does not have an on-board dose
calibrator. See CX-0401C.001; Tr. at 1085:1-3.
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In any event, despite Bracco’s focus on copying, “a showing of copying is only equivocal
evidence of non-obviousness in the absence of more compelling objective indicia of other
secondary considerations.” Geo. M. Martin Co. v. All. Mach. Sys. Int'l, LLC, 618 F.3d 1294, 1305
(Fed.Cir.2010) (finding a patent owner’s reliance on an accused infringer’s internal memos
suggesting copying to be “hardly compelling” because evidence of other secondary considerations,
while present, was minimal) (quoting Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1380
(Fed. Cir. 2000)); see also Am. Innotek, Inc. v. United States, 128 Fed. Cl. 135, 167 (2016), aff’d,
706 F. App’x 686 (Fed. Cir. 2017). Given the strong evidence that Jubilant did not copy Bracco’s
design, as well as the weak and circumstantial evidence on which Bracco relies, and the lack of
more compelling evidence with respect to other factors, see infra IV.D.1.c.1 and 2, I accord no
weight to this factor.
c) Long-felt but Unresolved Need
Bracco points to no competent evidence tied to the novel elements of the asserted patents
showing a long felt but unmet need. I find no evidence in the record of when the need arose, how
long it was felt, or how the inventions in the asserted claims solved it. See Perfect Web Techs.,
Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1332 (Fed. Cir. 2009). Those deficiencies undermine
Bracco’s argument on this point.
Turning to the evidence Bracco did marshal, Bracco first points to its own failure, as the
sole provider of rubidium infusion systems, to create a product embodied by the asserted patents.
But “the mere passage of time without the claimed invention is not evidence of nonobviousness,”
and Bracco cites no evidence that Bracco was aware of an unmet need to improve its own system
during that time. Iron Grip, 392 F.3d at 1325. Bracco next points to a generic claim from its 2009
PCT application that “there is a need for new system configurations that facilitate more efficient
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set up, maintenance and operation.” CIB at 31. But any number of patents contain boilerplate
sentences in the background of the invention describing a need for more efficiency. I find that
statement to be too vague to give any weight.
Finally, Bracco points to Klein’s failure to fully anticipate the asserted patents. CIB at 32.
But Klein describes no unsolved need. For Klein, having the dose calibrator on the bench was not
a problem because, as explained above, it could just as easily be placed on the cart. It was a matter
of design choice, not a matter of technical impediment. See In re Gershon, 372 F.2d 535, 539
(C.C.P.A. 1967) (“The failure of the prior art to mention a problem may be due to the fact that in
practice the problem is not a serious one or that a large number of satisfactory solutions is readily
apparent.”).
I find Bracco has not presented sufficient evidence of a long-felt but unmet need or a nexus
between such a need and the novel features of the claimed inventions. I give this factor no weight
in my analysis of obviousness.
d) Failure of Others
Bracco argues Jubilant tried to obtain FDA approval of a RUBY Version 2 but failed, and
that failure indicates the claimed inventions were not obvious at the relevant time. CIB at 33-34.
Bracco points to Knoll Pharm. Co. v. Teva Pharm. USA, Inc., 367 F.3d 1381, 1385 (Fed. Cir. 2004)
to argue that failure to achieve FDA approval is proof of a failure of others. But Knoll
Pharmaceutical stands only for the proposition that FDA rejections “may be relevant” to the
obviousness inquiry, and it reversed solely because the district court had not applied the correct
standard of review at summary judgment. See Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1291
(Fed. Cir. 2013) (citing Knoll Pharmaceutical for the proposition that “FDA approval may be
relevant to the obviousness inquiry.”) (emphasis added).
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The record reflects that Jubilant’s Version 2.0 was rejected by the FDA not because it
lacked an on-board dose calibrator or any other features of the asserted patent claims but because
it was not developed in compliance with FDA guidelines. See, e.g., Tr. at 312:25-313:5; 316:16-
25; JX-0178C, 38:6-19. I find, as a factual matter, there is no nexus between Jubilant’s failure to
obtain FDA approval and the features of the claimed invention. The Federal Circuit has made
clear such a connection is required. See AstraZeneca LP v. Breath Ltd., 603 Fed. Appx. 999, 1003
(Fed. Cir. 2015) (secondary considerations evidence properly rejected when FDA record identified
issues separate from absence of claimed features as cause of rejection); Ormco Corp., 463 F.3d at
1313 (rejecting failure of others evidence for lack of connection of failure to claimed features of
asserted patents).
Bracco also relies broadly on a theory that Jubilant failed “to commercialize” the RUBY
Versions 1 and 2, and succeeded only by creating the infringing Version 3. See CIB at 33-34. But
as noted above, I find nothing in the record supports a claim that Jubilant’s failure, or eventual
success, to get to market was related to technical failings, let alone tied to novel features of the
asserted patents. A “failure to commercialize” for reasons entirely disconnected from the
technology claimed by the patents does not constitute evidence the patents were nonobvious. See
AstraZeneca, 603 Fed. Appx. at 1003.
None of the evidence cited by Bracco shows the devices of others failed “because the
devices lacked the claimed features” of the inventions. Ormco, 463 F.3d at 1313. I give Bracco’s
evidence no weight in my obviousness analysis.
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e) Simultaneous Invention
Jubilant asserts, for the first time in its post-hearing brief, that it invented the on-board dose
calibrator “simultaneously” with Bracco. RIB at 140. Because this argument was not presented
in its prehearing brief, however, it is waived. GR 11.2.
4. Conclusion
Considering both the evidence of obviousness and secondary considerations together, I
conclude that all of the asserted claims are obvious in light of the prior art. See Eli Lilly & Co. v.
Perrigo Co., 718 F. App’x 953, 956 (Fed. Cir. 2017) (affirming finding of obviousness where
panel was “satisfied that the district court thoroughly considered all the arguments and evidence
presented before reaching its decision”); In re Cyclobenzaprine Hydrochloride Extended-Release
Capsule Patent Litig., 676 F.3d at 1079 (same).
C. Anticipation
Jubilant alone9 argues that the asserted patents are invalid as anticipated by the RUBY
Version 3 system. RIB at 2-8. Jubilant’s argument is elegant. It starts with the proposition that
the Commission has already determined that the RUBY Version 3 infringes the asserted patents.
See Order No. 27. Necessarily then, if the RUBY Version 3 was in public use or on-sale prior to
the priority date of the patents, it would anticipate them. Peters v. Active Mfg. Co., 129 U.S. 530,
537 (1889) (“That which infringes, if later, would anticipate, if earlier.”).
The asserted patents were filed in December 2016, but all parties agree that the earliest
possible priority date for the asserted claims in this investigation is the date a parent PCT
application was filed in 2009. See ’826 patent at Cover, ’869 patent at Cover, ’870 patent at Cover.
9 Staff argues Jubilant has failed to meet its burden on anticipation. SRB at 13-15.
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Jubilant contests Bracco’s claim of priority to 2009, and it’s easy to see why. If Bracco’s priority
date were limited to the date of the 2016 application, Jubilant’s RUBY Version 3 would render the
claims anticipated. RIB at 2-8.
To get the benefit of priority to its earlier applications, Bracco must meet the requirements
of 35 U.S.C. § 120: (1) the earlier application has § 112 support for the later-filed claims, (2) there
is an overlap of named inventors with the earlier filing, (3) the applications were co-pending, and
(4) the application contains or is amended to contain a specific reference to the earlier filed
application. 35 U.S.C. § 120. When a patent application satisfies all of these requirements, it is
“as though [it were] filed on the date of the prior application.” Id. “For a patent’s claims to be
entitled to an earlier priority date, the patentee must demonstrate that the claims meet the
requirements of 35 U.S.C. § 120.” Nat. Alternatives Int’l, Inc. v. Iancu, 904 F.3d 1375, 1380
(Fed. Cir. 2018) (emphasis in original). The Federal Circuit has instructed that “when neither the
PTO nor the Board has previously considered priority,” the trier of fact may place the burden on
the patent owner to “come forward with evidence to prove entitlement to claim priority to an earlier
filing date.” Id. (citing PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305-06
(Fed. Cir. 2008)).
Jubilant does not dispute that the asserted claims have § 112 support in at least the 2009
PCT application, satisfying the first element of § 120. Tr. at 1130:3-1131:19; 807:16-20; see also
955:17-956:3 (no written description issue). And Jubilant does not dispute that the asserted patents
satisfy the co-pendency and specific reference requirements. See RIB at 2-8. But Jubilant argues
Bracco has failed to meet its burden of showing an overlap in named inventors between the asserted
patents and the prior application to which they draw priority, because, according to Jubilant,
Bracco has not provided evidence of the true inventors on the asserted claims. RIB at 2.
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But all § 120 requires is that the subsequent patent name an inventor or joint inventor in
common with the prior application. 35 U.S.C. § 120 (“An application . . . which names an
inventor or joint inventor in the previously filed application.”) (emphasis added). The record is
clear that the asserted patents list at least one inventor in common with the 2009 PCT; in fact, they
list all of them. Compare ’826 patent at Cover (listing Hidem, Fontaine, Gelbach, McDonald,
Hunter, Swenson, and Zodda as inventors), ’869 patent at Cover (same), and ’870 patent at Cover
(same), with JX-202.0001 (same). When a patent issues, a presumption attaches that it names the
true inventor(s) of the invention(s) described in the patent. Trovan, Ltd. v. Sokymat SA, Irori, 299
F.3d 1292, 1303 (Fed. Cir. 2002). Thus even if I shifted the burden to Bracco, it has shown it is
entitled to the priority date of the 2009 PCT application. To the extent Jubilant is challenging
entitlement to earlier priority date under § 120 by challenging the asserted patents’ listed inventors,
it was Jubilant, not Bracco, that bore that burden. See Tech. Licensing Corp. v. Videotek, Inc.,
545 F.3d 1316, 1328 (Fed. Cir. 2008) (under all circumstances, burden of showing invalidity is on
the challenger; prima facie showing of entitlement to priority under § 120 is all that is required of
patentee).
Jubilant’s inventorship argument hinges on an overlap in claim elements between the
asserted patents and elements in other earlier related patents, namely U.S. Patent Nos. 7,862,534
(“the ’534 patent”); 8,317,674 (“the ’674 patent”); and 8,708,352 (“the ’352 patent”). Jubilant
asserts that those overlapping elements include the tubing circuit, shielding assembly, and cabinet
structure. RIB at 4-6. The ’534 and ’674 patents list six and eight inventors each, respectively,
but none in common with the seven inventors named in all three asserted patents. See RIB at 4.
Similarly, the ’352 patent names six inventors, five of whom are not named in any of the three
asserted patents. Id. Jubilant argues that if the overlapping features were previously claimed to
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be invented by the inventors named in the ’534, ’674, and ’352 patents, at least some of those
inventors should be named as inventors in the asserted patents. RIB at 2-8. But even where two
“patents contain ‘overlapping subject matter,’ that alone is insufficient to prove by clear and
convincing evidence that” an inventor on the first patent invented part of the invention in the
second patent.” Trovan, 299 F.3d at 1303. To succeed in challenging priority under § 120, Jubilant
needed to prove by clear and convincing evidence that none of the inventors named in the asserted
patents was properly listed, such that there was no overlap with the 2009 PCT. Id;
35 U.S.C. § 120. Merely pointing to overlapping subject matter between claims of the asserted
patents and the earlier patents is insufficient to overcome the presumption of true inventorship that
follows an issued patent. Id. I additionally note that Jubilant relies on an overlap of mere claim
elements, without an analysis of the invention as a whole. That is a deficient showing. Trovan,
299 F.3d at 1302 (inventorship analysis is done by examining contribution to claim, rather than
individual elements).
In sum, I find no reason that Bracco is not entitled to a 2009 priority date. Jubilant has not
shown by clear and convincing evidence that the asserted patents are invalid as anticipated.
VI. INFRINGEMENT
As noted above, I have found that the defense of patent invalidity due to obviousness is
meritorious for every asserted patent claim. It follows, then, that Jubilant is not liable for
infringement. Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1929, 191 L. Ed. 2d 883
(2015) (“To be sure, if at the end of the day an act that would have been an infringement or an
inducement to infringe pertains to a patent that is shown to be invalid, there is no patent to be
infringed.”). Nevertheless, in the interest of thoroughness, below I make findings about whether
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Jubilant’s actions would have constituted infringement under 35 U.S.C. § 271 if the asserted
patents were valid.
I previously found, and the Commission affirmed, that the RUBY Version 3 practices each
element of the asserted patent claims and the RUBY Version 3.1 and Version 4 do not. Comm’n
Det. not to Review an Initial Det. Granting Summary Det. (Mar. 8, 2019); Order No. 27 at 7. The
Commission also affirmed that Jubilant induced infringement of method claims of the ’870 patent
by instructing users on how to use the RUBY Version 3 system and that Jubilant induced
infringement of the method claims of the ’826 patent by instructing its contract manufacturer,
Kluge Design Inc., on how to build the RUBY Version 3 system. Id. The Commission additionally
affirmed a determination that Jubilant contributorily infringed the asserted patents by selling the
imported RUBY-FILL rubidium generator for use with the RUBY Version 3 system. Id. at 8.
Presuming validity, the central remaining infringement question is whether Jubilant
indirectly infringes the asserted patent claims when it imports and sells generators and tubing sets
used with the RUBY infusion systems. All three RUBY systems—the infringing Version 3 and
the non-infringing Version 3.1 and 4—use the same imported RUBY-FILL generators and RUBY
Sets. The fact that the RUBY Version 3.1 and Version 4 do not infringe the asserted patents raises
a question as to potential non-infringing uses for the imported generators and tubing sets. Bracco
asserts that regardless of whether Version 3.1 and Version 4 infringe, Jubilant still induces
infringement by importing and selling generators and tubing sets to customers that own the
infringing RUBY Version 3. CPB at 13-17. Staff largely agrees with these contentions. SPB
at 15. Jubilant did not address these contentions in its briefs. I address these issues below.
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1. Inducement of Infringement
The record shows that Jubilant knows which generators and tubing sets are manufactured
for, imported for, and sold to each customer, and Jubilant knows which customers have infringing
RUBY Version 3 systems. See Tr. at 319:16-321:15. Jubilant instructs Version 3 customers to
use the imported RUBY-FILL generator and RUBY Set with the Version 3 system. See CX-0007
(package insert directing customers to use generators only with a RUBY elution system); see also
Order 27. And Jubilant has been aware, at least since my determination on February 8, 2019, that
the accused generators and tubing sets practice the patent claims when used with the RUBY
Version 3 infusion system. Comm’n Det. Not to Review an Initial Det. Granting Summary Det.
(March 12, 2019) (EDIS Doc. ID 669522). I find that Jubilant intends to cause practice of the
patent claims every time it ships a RUBY-FILL generator or RUBY Set to a customer that
possesses a Version 3 system. Vanda Pharm. Inc. v. W.-Ward Pharm. Int'l Ltd., 887 F.3d 1117,
1133 (Fed. Cir. 2018) (“A person can be liable for inducing an infringing use of a product even if
the product has substantial noninfringing uses. . . .”).
The fact that the RUBY Version 3.1 and Version 4 systems do not practice the patent claims
does not save Jubilant from a finding of inducement. It is undisputed that there is currently no use
of the RUBY Version 3.1 or Version 4 in the United States by third parties because those systems
have not been approved by the FDA. See, e.g., Tr. at 323:9-18. Consequently, the only use for an
imported RUBY-FILL generator or an imported RUBY Set is to practice the patent claims with
the Version 3 system, and I find Jubilant intends that use. It may well be that the facts relevant to
inducement will change if different Jubilant products are approved by the FDA, but such an
analysis must wait for another day and a different factual record.
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2. Contributory Infringement
The resolution of the contributory infringement issue should by now be apparent. It is
undisputed that currently there are no substantial uses for the accused generators and tubing sets
other than to practice the patent claims. I find that the RUBY-FILL generator and RUBY Set have
no substantial use with the RUBY Version 3.1 or Version 4 because those systems have not been
approved by the FDA. Presuming patent validity, the importation and sale of generators and tubing
sets with no substantial non-infringing use constitutes contributory infringement.
35 U.S.C. § 271(c); see Order No. 27; Comm’n Det. not to Review an Initial Det. Granting
Summary Det. (March 12, 2019) (EDIS Doc. ID 669522). And again, any change in FDA approval
will require additional fact finding beyond the record presently before me.
VII. DOMESTIC INDUSTRY
A violation of section 337 can be found “only if an industry in the United States, relating
to the articles protected by the patent . . . concerned, exists or is in the process of being established.”
19 U.S.C. § 1337(a)(2). Because I find the patents are invalid, the patents protect no articles and
Bracco necessarily cannot satisfy the domestic industry requirement. Certain Vision-Based Driver
Assistance System Cameras and Components Thereof, Inv. No. 337-TA-907, USITC Pub. 4866,
(February 2019), Comm’n Op. at 36. Nevertheless, in the interest of thoroughness, below I make
findings about whether Bracco’s own design practices the asserted patent. I also consider Bracco’s
investments related to its design.
A. Technical Prong
It is undisputed that the Bracco Model 1700 elution system practices at least one claim of
each of the asserted patents. Tr. at 28:7-24; RRB at 5. Jubilant contends, however, that the Model
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1700 cannot be a domestic industry “article” because it is not for sale in the United States. I
address that argument in my economic prong analysis below. To the extent that the two-prong
domestic industry analysis can be separated, I find that the technical prong of the domestic industry
requirement would be satisfied if the asserted patents were valid.
B. Economic Prong
Staff and Jubilant contend Bracco’s investments in its Model 1700 system cannot satisfy
the domestic industry requirement because the Model 1700 device has not been approved by the
FDA and is not commercially available. CIB at 38-45; RRB at 5-15; SRB at 1-6. Staff and Jubilant
also challenge some of the investments relied upon Bracco to prove up its industry.
Whether the Bracco Model 1700 is an article protected by the asserted patents under section
337(a)(3) “is not determined by a rigid formula, but by an examination of the facts in each
investigation, the article of commerce, and realities of the marketplace.” Certain Batteries &
Electrochemical Devices Containing Composite Separators, Components Thereof, & Prod.
Containing Same, Inv. No. 337-TA-1087, Notice of Comm’n Decision (Sept. 7, 2018). I examine
the relevant facts in this investigation below.
1. The History of Bracco’s Rubidium Infusion Systems
The story begins with the Bracco CardioGen-82 Model 510, which was approved by the
FDA in 1989. Tr. at 589:18-590:3. The Model 510 remains the only Bracco rubidium infusion
system commercially available in the United States to date. Id. It is undisputed that the Model
510 does not practice any asserted patent claim because all of the asserted claims require a dose
calibrator on-board the cart and a computer configured to perform a strontium breakthrough test.
The Model 510 does not have either of those features. JX-112C at .0003 (Model 510 system
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controlled by instrument panel), .0009 (Model 510 had manual breakthrough testing); Tr. at
1069:4-20 (Model 510 lacks computer).
Around , Bracco began developing a new product called the CardioGen-82 NextGen
(“NextGen”). JX-0137C.038. The NextGen had a and could
features the Model 510 . Tr. at 205:16-206:6; see generally JX-112C (internal
Bracco comparison of Model 510 and NextGen). But the NextGen design still did not have a
and did not use a .
Tr. at 171:11-14, 174:10-176:2; CX-0515C.004; RX-408C; JX-112C at .0009. It therefore did not
practice any asserted patent claim. By , Bracco had paid a contractor to build
units of the NextGen design. Tr. at 168:22-169:7, 172:16-21. Bracco and its witnesses often call
those units “prototypes,” but the record shows that the devices were finished articles ready for
sale to customers . Id.; see also id. at 193:8-22. Bracco
of the NextGen system in . JX-0105C (
NextGen product). The the NextGen in . JX-0111C.
After the , the record shows that Bracco received reports from the field
about patients receiving excess radiation from the original Bracco Model 510. Tr. at 210:11-25.
Bracco initiated a voluntary recall of the Model 510 in 2011. Id. Bracco’s senior director of
regulatory affairs Patrice Marchildon testified that these events caused Bracco to “put on hold” its
design efforts and its efforts to for the NextGen model. Id.; see also id. at
255:3-10. By , Bracco had for the NextGen product.
JX-0137C.039; Tr. at 210:11-25, 252:3-6, 253:14-23, 255:3-10.
Years after the NextGen, Bracco set to work on another design, which it
designated the CardioGen-82 Model 1700. The first concrete fact relating to the Model 1700
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design occurred in late , when Bracco hired a firm called to analyze the NextGen
model and make a proposal for a new design. Tr. at 149:2-4; 176:3-20; CX-0515C.016 (referring
to non-disclosure agreement signed ). concluded that the only
components of the NextGen system that
. CX-0515C.004; Tr. at 179:11-180:8. Bracco contracted with
to overhaul the design. CX-0515.003. The overhaul included “major design improvements” over
the NextGen model, including and, in
, . Tr. at 261:4-23; 184:8-12. worked with
another contractor called to build units of the Model 1700. Tr. at 166:17-167:3, 192:25-
193:7; CX-0515.003 (“ will oversee the manufacture . . . .), -.007 (“ will build the
units”). Although Bracco again calls the units of the Model 1700 made under the contract
“prototypes,” the record shows that the devices are finished articles ready for sale to customers.
JX-0162C.005 (showing under the contract was to build of the units); Tr. at 194:4-
195:7. The record evidence shows Bracco made payments for the manufacture of units of the
Model 1700 starting in . See JX-0162C.001 (showing line items for “ ” and
“ ” under “Less: Cost of Prototype Units”).
Bracco applied to the FDA in seeking approval for the Model 1700. JX-0137C.
The FDA initially set a goal date of , for providing a final determination on the
application. JX-0181C; Tr. at 264:1-8, 271:19-22.
After Bracco submitted its FDA application for the Model 1700, two adverse events
occurred in the field at facilities using Bracco’s original Model 510. First, in December 2018,
eight patients were injected with high levels of strontium from a Bracco Model 510 system,
apparently because a technician erroneously used Ringer’s lactate as an eluate instead of saline.
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Tr. at 437:10-11, 440:2-44:19; RX-0534C.000009. Then in March 2019, four more patients at a
different facility were injected with high levels of strontium when a Bracco Model 510 system was
again incorrectly used with Ringer’s lactate. Tr. at 446:12-447:12; RX-0531C;
RX-0534C.000013.
In response to these incidents, the FDA mandated a new warning be placed on rubidium
generators instructing technicians of the importance of using saline. Tr. at 909:1-910:22; see also
RX-0528C; CX-0788; RX-524C. The record also reflects that the 2018 and 2019 strontium
breakthrough events likely have had an
. Tr. at 277:9-21; 293:21-24; RX-0526C.0004 (
). The FDA did not approve the Model 1700 by the goal date, and to date
the FDA still has not approved the Model 1700 for sale or use with patients. Tr. at 264:9-12.
2. Whether FDA Approval Is Required for a Domestic Industry
Jubilant contends that without FDA approval for the Model 1700 Bracco cannot prove a
domestic industry. RRB at 5-6. For that proposition, Bracco relies on Certain Minoxidil Powders,
Salts, and Compositions for Use in Hair Treatment, Inv. No. 337-TA-267, Comm’n Op. at 1-2
(Sept. 23, 1988) (“Minoxidil”) and Certain Monoclonal Antibodies Used for Therapeutically
Treating Humans Having Gram Negative Bacterial Infections, Inv. No. 337-TA-323, Comm’n
Op., 1991 WL 788550, at *2 n.6 (June 28, 1991) (“Monoclonal Antibodies”). But those
Commission opinions do not stand for the rule Bracco advances.
To understand the Commission’s opinion in Minoxidil, some background is in order. The
Minoxidil investigation occurred concurrently with efforts to amend the domestic industry
requirements of section 337 in 1988. The administrative law judge (“ALJ”) in Minoxidil issued
the initial determination before the amendments were passed and while FDA approval for
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minoxidil was pending. Minoxidil, Comm’n Op. at 1-2. The ALJ found that a domestic industry
in minoxidil did exist, even though FDA approval had not been granted. Minoxidil, Final Initial
Determination (February 26, 1988), at 59-62. The ALJ further determined that infringing imports
would have a tendency to injure that industry, and would in fact injure the industry when FDA
approval was granted. Id. at 62-68. The Commission investigative staff sought Commission
review of the ALJ’s initial determination, arguing that the finding of a violation of section 337
found by the ALJ was too speculative. Id., Comm’n Op. at 1. In the alternative, the Commission
investigative staff sought a stay pending FDA approval. Id. The Commission then determined to
review the ID and issued a series of stays, eventually suspending the investigation until the FDA
made its determination. Id. at 1-2.
While the investigation was suspended, the 1988 amendments to section 337 took effect
and the FDA granted approval of minoxidil. Id. at 2. The Commission then resumed the
investigation and affirmed the ALJ’s initial determination on domestic industry in part, noting
much of the analysis had become moot due to the change in law and FDA approval. Id. at 3-4.
The Commission vacated the ALJ’s findings about injury to the domestic industry because the
statute had been amended to eliminate any injury requirement and broaden the criteria for the
industry requirement for investigations based on patent infringement. Id. at 4. But the
Commission affirmed the ALJ’s finding that a domestic industry existed based on evidence of
plant and equipment expenditures. Id. at 5-6. Those expenditures of record were necessarily prior
to FDA approval. Minoxidil, Comm’n Op. at 2 (Rogaine approved by FDA on August 17, 1988);
id., Final Initial Determination at 60 (“Upjohn’s Rogaine business is already active. . . . The
formulation, bottling, and packaging plant was started up this year and has been run on a
commercial scale in order to build up the inventory necessary to meet the projected initial demand
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. . . following FDA approval”), id., Final Initial Determination at 61 (“The domestic industry for
Rogaine has not yet reached the point of commercial sales. Sales can begin only after approval by
the FDA”). See also Scanning Multiple-Beam Equalization Sys. for Chest Radiography &
Components Thereof, Inv. No. 337-TA-326, Order No. 21 (Aug. 2, 1991) (in Minoxidil “[t]he
Commission did not have reason to address the question presented here: whether the requirement
of an industry in the process of being established would be satisfied under the amended statute if
the complainant needed FDA approval before the product could be marketed, and the product was
not ready to submit to FDA for approval”). The Commission never stated in Minoxidil that FDA
approval is required for a domestic industry based on a pharmaceutical or medical device.
As for Monoclonal Antibodies, the other opinion cited by Bracco, that opinion disposed of
a request for a stay in favor of concurrent district court litigation. It merely cited Minoxidil as an
illustration of a circumstance for which the Commission has stayed an investigation. Monoclonal
Antibodies, 1991 WL 788550, at *2 (citing Minoxidil in footnote 6 for proposition that “the
Commission has suspended investigations where an imminent decision by an agency was expected
to have an important impact on the Commission’s investigation”). It did not lay down a rule for
when a domestic industry is established.
Other Commission decisions illustrate that commercial availability of a patented article in
the United States is not necessary to show either that a domestic industry exists or that an industry
in the process of being established. For example, in Certain Non-Volatile Memory Devices, Inv.
No. 337-TA-1046 (October 26, 2018) (“Memory Devices”), the Commission considered whether
investments to develop and produce a certain type of semiconductor wafer should be considered
in a domestic industry analysis when the wafer had not been incorporated into a commercial
product. Memory Devices, Comm’n Op. at 40-45. The Commission found that the complainant
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had invested in a large research team and dedicated facilities in New York and Vermont to develop
and manufacture the wafer. Memory Devices, Comm’n Op. at 40. The Commission determined
those investments contributed to a domestic industry in “articles protected by the patent,” as recited
in section 337(a)(2). Id. at 41. The Commission explained that the text of the statute, the
legislative history, and past Commission practice demonstrate that the term “article” in section
337(a)(2) “is sufficiently capacious to embrace pre-commercial or non-commercial items.” Id.
The Commission ultimately found that the complainant in Memory Devices had proved a domestic
industry in the process of being established. Id. at 44.
The Commission has also applied the reasoning in Memory Devices to an existing industry.
In Certain Road Construction Machines and Components Thereof, Inv. No. 337-TA-1088 (“Road
Construction Machines”), the Commission addressed whether the complainant must prove that
domestic industry articles were on sale in the United States as of the time of the complaint. Road
Construction Machines, ID at 74 (Feb. 14, 2019). Four prototypes of the patented machines were
being used in the United States when the complaint was filed. Id. at 71. Examining the statute
and prior Commission decisions, the ALJ determined that there is no requirement that articles be
commercialized to satisfy the domestic industry requirement. Id. at 74-75. The ALJ found that
the complainant’s investment included “labor on the claimed technology” that resulted in “a
complete machine incorporating the features of the patent.” Id. The ALJ found that a domestic
industry existed at the time of the complaint even without commercial sales of the machines. Id.
at 75-79. The Commission did not review the relevant part of the ALJ’s determination. Road
Construction Machines, Notice of Comm’n Determination to Review-in-Part a Final Initial
Determination (Apr. 12, 2019), at 2.
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Here, as in Road Construction Machines, it is undisputed that articles exist in the United
States that embody the claims of the asserted patents. A subcontractor manufactured at least
units of the Model 1700 system for Bracco by the time the , and Bracco
. Tr. at 154:11-16. Those articles would
be “articles protected by” the asserted patents if those patents were valid. This record contains no
facts that would preclude those articles from being the subject of an existing domestic industry or
a domestic industry in the process of being established under section 337(a)(2).
Bracco presents evidence of the money it spent to bring its Model 1700 into existence. I
examine the significance and substantiality of those investments next.
3. Plant and Equipment
Bracco argues it satisfies the economic domestic industry requirement under
section 337(a)(3)(A) based on significant investments in plant and equipment. Bracco points to a
claimed payment to subcontractor “to purchase equipment in connection with the
manufacture of Model 1700 carts.” CIB at 41. Bracco also claims that it “[a]ditionally” invested
in “prototype units of the Model 1700 system” and “interim models.” Id. at 42. These
statements are misleading, as I explain below, but Staff also raises a threshold problem with
Bracco’s argument. Staff contends that Bracco claimed only dollars in the “plant and
equipment” section of its pre-hearing brief. CPB at 378 ¶ 641. Under Ground Rule 11.2, “[a]ny
contentions not set forth in detail in the pre-hearing brief” are deemed abandoned or withdrawn,
unless the party “is not aware and could not be aware in the exercise of reasonable diligence at the
time of filing the pre-hearing brief.” Staff argues Bracco has waived claiming any plant and
equipment investment over . SRB at 2-3.
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The “plant and equipment” section of Bracco’s pre-hearing brief concludes, “Thus, the
evidence will show that between 2009 and 2017 Bracco has invested over (USD) into
plant and equipment related to the Model 1700, which indisputably practices the [a]sserted
[p]atents.” CPB at 378 ¶ 641. Bracco did not identify any other amounts as plant and equipment
in its pre-hearing brief. Bracco’s pre-hearing brief did identify a payment to , but
Bracco’s pre-hearing brief characterized that payment as engineering, research, and development
under section 337(a)(3)(C). CPB at 384, ¶ 656. While it is possible for the same investment to be
categorized under multiple subparagraphs of section 337(a)(3), see Certain Solid State Storage
Drives, Stacked Electronics Components, and Products Containing Same, Inv. No. 337-TA-1097,
Comm’n Op. at 8-14 (June 29, 2019), Bracco was still required in its pre-hearing brief to “set forth
in detail” how it would characterize investments so that all parties could prepare for trial. See
Ground Rule 11.2. I find that Bracco did not give adequate notice of the arguments about plant
and equipment in its post-hearing brief. Bracco therefore is precluded from relying on more than
in plant and equipment in this final initial determination. The misleading nature of
statements in Bracco’s domestic industry briefing make it all the more appropriate to find waiver.
I discuss those misleading statements next.
In its post-hearing brief, Bracco claimed “to purchase equipment in connection
with the manufacture of Model 1700 carts.” CIB at 41. But that is misleading; the was
a purchase of finished NextGen units and Model 1700 units from a subcontractor. See
JX-0162C.001; Tr. at 144:22-145:8, 161:19-162:2, 168:22-169:7, 172:16-21, 194:4-195:7.
Bracco’s own witness, Mr. Troger, confirmed that the payment was not for “the actual physical
plant” or “special equipment” inside a plant. See id. at 190:12-19.
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Next, Bracco claims that its investment in “prototypes” was made
“[a]dditionally” to the expenditure. CIB at 42. That statement too is misleading. The
record shows the figure cited by Bracco includes the for purported
prototypes; it was not spent “[a]dditionally.” Compare CIB at 42, with JX-0162C.001 (labeling
the figure as “Including Cost of Prototype Units”).
Moreover, as I have already explained, Bracco’s assertion of investments of for
“prototype units” is misleading. The testimony of Bracco’s own witness under cross-examination
is that the so-called “prototypes” were finished, user-ready products produced under a
manufacturing contract. Tr. at 168:22-169:7, 172:16-21, 194:4-195:7; see also JX-0162C.001;
CX-0740C.
I find that the investment cited by Bracco in its pre-hearing brief represent fees
paid to contractors between 2009 and 2017 for the manufacture of units of the NextGen
product and units of the Model 1700. Compare CPB at 378 with JX-0162C at .001,
.005; Tr. at 161:19-162:2 (Mr. Troger testifying that “this reflects units”); see also
168:22-169:7, 172:16-21, 194:4-195:7; RX-0310C.000005. Payment for the finished NextGen
units was of the . See JX-0162C at .001, .005. I find that investments to
produce the NextGen units in 2009 and 2010 are not related to “articles protected by”
the asserted patents. While Bracco attempts to cast the NextGen units as “interim prototypes”
related to the Model 1700, I reject that characterization for several reasons. First, the NextGen
system lacked features of the patented invention, including a and
a . Second, the record shows the
NextGen units were not prototypes; they were finished articles that were ready to be sold to
customers . Tr. at 168:22-169:7, 172:16-21, 194:4-195:7. Third, the record
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does not show a continuum of development between the NextGen system and the Model 1700.
Bracco put its design process “on hold” in 2011 and for the
NextGen system at the same time. Tr. at 210:11-25, 252:3-6, 253:14-23, 255:3-10; JX-0137C.039.
The record reflects no concrete design effort by Bracco or any subcontractor from to
. Tr. at 176:3-20; CX-0515C.016 (referring to non-disclosure agreement signed
). Moreover, no major components of the NextGen system
. CX-0515C.004; Tr. at 179:11-180:8. For at least those reasons, I decline to credit
of the claimed by Bracco as an investment in plant and equipment related to
manufacturing the Model 1700.
The question remains whether the payment from Bracco to for
finished Model 1700 units constitutes an investment in plant and equipment. See JX-0162C.001.
Staff and Jubilant argue that Bracco failed to establish that those units have a nexus to the
asserted patents. SRB at 3-4, CRB at 8-9. Staff and Jubilant’s argument is understandable, given
that Bracco misleadingly characterized those units as “prototypes” in many places. I have found,
however, that the units in question are in fact finished, commercially ready devices. See
JX-0162C.005; Tr. at 194:4-195:7. There is no question that manufactured the Model
1700 units in the United States. Tr. at 155:4-18. Thus, Bracco’s payment could be
considered to be a combination of (1) rent paid to for use of plant and equipment to
manufacture the Model 1700 units; (2) payment for the work of employees who built
the devices (Tr. at 165:2-5); and (3) payment for the materials used to make the devices. Only the
first category would be considered plant and equipment, and the record does not indicate what that
amount is. Nevertheless, I find it is more likely than not that a significant proportion of the
payment represents a significant investment in plant and equipment relating to the Model
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1700. I need not calculate the amount to the penny. Certain Stringed Musical Instruments and
Components Thereof, Inv. No. 337-TA-586, USITC Pub. 4120 (December 2009), Comm’n Op. at
25-26 (“A precise accounting is not necessary, as most people do not document their daily affairs
in contemplation of possible litigation.”); Certain Optoelectronic Devices for Fiber Optic
Communications Thereof, and Products, Containing Same, Inv. No. 337-TA-860,
USITC Pub. 4852 (Nov. 2018), Comm’n Op. at 18-19 (“[W]hether investment activities are
significant or substantial ‘is not evaluated according to any mathematical formula,’ but rather,
‘entails an examination of the facts in the investigation, the article of commerce, and the realities
of the marketplace.”) (quoting Certain Printing and Imaging Devices and Components Thereof,
Inv. No. 337-TA-690, Comm’n Op. at 27 (Feb. 17, 2011)).
4. Labor and Capital
Bracco argues it satisfies the economic domestic industry requirement under
section 337(a)(3)(B) based on significant employment of labor and capital in the United States.
CIB at 43-45. Bracco contends in 2016 and 2017 it paid in salaries to Bracco
employees in the United States for work relating to the Model 1700 system. These employees
include engineers and technical personnel and regulatory employees who worked on the FDA
approval process. Id.
a) FDA Compliance Expenses
Staff asserts that FDA approval and compliance related expenses should not be credited
toward satisfaction of the domestic industry requirement, likening them to patent prosecution
activities and maintenance fees that the Commission has disregarded in past investigations. SIB
at 22-23.
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Staff’s comparison of patent prosecution to FDA compliance is inapt. First, Staff’s
argument is built on the incorrect premise that patent prosecution categorically cannot be
considered in connection with domestic industry investments. To my knowledge the Commission
has never stated that rule. The only two authorities that Staff cites certainly do not stand for that
proposition. In Video Game Systems, a majority of the Commission stated that “patent prosecution
activities alone would be insufficient to establish the domestic industry requirement under section
337(a)(3)(C),” but a footnote from Commissioner Aranoff makes clear that the Commission
majority preserved the option for considering patent prosecution expenses if appropriate
circumstances arose in the future. Certain Video Game Systems and Controllers, Inv. No.
337-TA-743, Comm’n Op. (Apr. 15, 2011) at 8 n.1. In the other opinion cited by Staff, Certain
Loom Kits for Creating Linked Articles, Inv. No. 337-TA-923, Comm’n Op. at 6 (May 21, 2015)
(EDIS Doc. No. 559662), the Commission set aside without comment the ALJ’s statements about
patent prosecution fees. That means the Commission took no position on the issue. Beloit Corp.
v. Valmet Oy, 742 F.2d 1421, 1422 (Fed. Cir. 1984) (it is not appropriate “to assume that the
Commission has adopted all findings” of an ALJ when the Commission took no position on an
issue).
Next, Staff has not addressed Commission determinations contrary to the rule it proposes.
On at least two occasions the Commission has credited investments to obtain FDA approval as
part of the domestic industry. For example, Certain Salinomycin Biomass and Preparations
Containing Same, Inv. No. 337-TA-370, USITC Pub. 2978 (July 1996), Initial Determination at
128 (not reviewed), concerned a chemical compound regulated by the FDA. See id. at 297 (FF H
14), 298 (FF H 23). The Commission supported its finding of a domestic industry in part based
on findings that (1) many employees of the patent owner’s licensee spent time on “regulatory
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activities” (id. at 128); (2) the licensee had an FDA-approved plant for making the chemical (id.
at 299); (3) the complainant had “a consultant in the United States that it uses in connection with
FDA matters related to” the chemical (id. at 296), and (4) the licensee had “plans to submit
elements of the package seeking FDA approval” for use of the chemical in animals (id. at 301).
Similarly, Certain Diltiazem Hydrocholoride and Diltiazem Preparations Containing
Same, Inv. No. 337-TA-348, USITC Pub. 2902 (June 1995), Initial Determination at 120-28
(unreviewed in relevant part), also involved a chemical compound regulated by the FDA. Id. at
126, 143, 292. The Commission supported its finding of a domestic industry in part based on
findings that the complainant (1) “conducts research and development . . . in order to comply with
FDA requirements” (ID at 142, 323, see also id. at 144); (2) maintains processes and equipment
in accordance with “FDA requirements” (id. at 143, 323); (3) spent an amount on the order of at
least $1 million “on research and development including FDA approval, clinical trials, formulation
research,” and other activities (id. at 324); (4) employed personnel “responsible for the research
and development activities relating to FDA-required clinical testing from development phase 1
through phase 3” (id. at 325-26); and (5) employed other personnel responsible for research on
“products for which FDA approval is pending (phase 3B) and for those products which have
already been approved” (id. at 326).
Staff’s argument is also somewhat internally contradictory. On the one hand, Staff argues
that FDA approval is necessary for Bracco to have a viable domestic industry, but on the other
Staff argues that investments to obtain that approval should not be considered as part of the
domestic industry analysis. Compare SIB at 22-23, with id. at 28-29. If FDA approval is necessary
for Bracco to exploit its invention, as Staff apparently concedes, it follows that expenditures to
obtain that approval contribute to the domestic industry. Certain Magnetic Tape Cartridges and
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Components Thereof, Inv. No. 337-TA-1058, Comm’n Op. at 53 (Apr. 9, 2019) (The Commission
“has defined the domestic industry to include investments necessary to bring to market the patented
technology as embodied in the asserted domestic industry products.”).
I determine that, if the asserted patents were valid, Bracco’s efforts to obtain FDA approval
of the Model 1700 would have been central to enabling exploitation of the patented invention.
Bracco employs at least people at a facility in Melville, New York, who support the
regulatory approval activities for the Model 1700 system. RX-0310C.000003. In 2016 and 2017,
Bracco invested approximately in salaries for those employees. Id. at .000005-6. That
amount is a significant employment of labor and capital in the United States, consistent with
section 337(a)(3)(B).
The record also shows Bracco expended in consulting fees to a contractor
assisting Bracco with FDA approval. RX-0310C.000005-6. The contractor is located in the
, but has some employees in the United States. Id. at .000004; Tr. at
155:16-156:14. The amount Bracco paid its own employees in the United States for their work on
FDA compliance is significantly greater that the contract expenditure. I need not rely on this
particular contract expenditure in my domestic industry analysis.
b) Engineering Labor Expenses
The record demonstrates that in 2016 and 2017 Bracco employed approximately to
engineers and technical personnel in the United States who spent a substantial amount of their time
working on development of the Model 1700 system. RX-0310C.000006. The record also indicates
that other engineers worked on the project during that same time, but not as extensively. In 2016,
Bracco estimates that U.S.-based engineering employees worked on some aspect of the
development of the Model 1700 system. Id. at .000007. In 2017, Bracco estimates that number
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was engineering employees. Id. Pro-rating the time each employee spent on the Model 1700,
Bracco paid U.S.-based engineers for work exclusive to the Model 1700 device in 2016
and 2017. Id. at .000006; Tr. at 164:1-12.
Staff and Jubilant critique the engineering salaries cited by Bracco as lacking foundation
and not being sufficiently tied to the Model 1700. RRB at 9-10; SRB at 3-4. Neither objection is
valid. First, as to foundation, Bracco’s project manager Mr. Troger testified about the salaries in
question. Tr. at 136:10-20. Mr. Troger testified that he had personal knowledge of who worked
on the Model 1700 and the time they spent because he made project assignments. Id. at 188:18-22;
RX-0411C at 225:3-11, 227:8-14, 228:2-17. He also corroborated his knowledge by talking to
other employees. Tr. at 191:20-192:8; RX-0411C at 225:3-11, 227:8-14, 228:2-17. After
Mr. Troger made time estimates, he provided them to the Bracco HR department, who calculated
expenditures with salary information corresponding to the employees in question. Tr. at
197:11-17. I find sufficient foundation for Mr. Troger’s testimony about engineering salaries paid
in 2016 and 2017.
As for the connection of the salaries to the Model 1700, Staff appears to contend that it is
possible that the cited above was for work related to “prototypes” that did not practice
the asserted patents. SRB at 3-4. I have already determined that Bracco the non-
practicing NextGen system in , and engineering salaries from that era do not demonstrate a
domestic industry in articles practicing the asserted patents. But the pro-rated portion of
engineering salaries paid in 2016 and 2017 are reasonably attributed to the Model 1700 system.
By that time, the record shows that Bracco was paying a contractor to build Model 1700 units, not
“prototypes” that lacked features of the asserted patent claims. See Tr. at 194:4-195:7. See Certain
Solid State Storage Drives, Stacked Elecs. Components, & Prods. Containing Same, Inv. No.
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337-TA-1097, Comm’n Op. at 21 (June 29, 2018) (“[A]ll that is required is the use of reasonable
allocations for the purposes of establishing the economic prong of the domestic industry
requirement.”) (citing Certain NOR and NAND Flash Memory Devices, Inv. No. 337-TA-560,
2006 WL 3775919, at 2 (Order No. 37) (Nov. 17, 2006) (“Certain NOR and NAND Flash Memory
Devices”), not reviewed, Notice of Comm’n Decision (Dec. 8, 2006)).
Based on the record, I find that Bracco paid at least in salary to U.S.-based
engineers for work on the Model 1700 in 2016 and 2017. If the asserted patents were valid, that
amount would be considered a significant employment of labor and capital in the United States,
consistent with section 337(a)(3)(B).
5. Engineering, Research, and Development
Bracco asserts that between 2009 and 2018 Bracco has invested over into
research and development (“R&D”) related to the Model 1700, including over in
payments to third parties. CIB at 40-41 (citing JX-0162C).10 Bracco provided an exhibit
summarizing expenditures by vendor. JX-0162C.002 (payments to ); JX-0162C.003
(payments to ); JX-0162C.004 (payments to ); JX-0162C.005 (payments to and
for prototype units).
I have explained above why I do not credit Bracco’s investments in the non-practicing
NextGen system as part of a domestic industry in articles practicing the asserted patents. Setting
those investments aside, the record shows that Bracco has worked with
10 Staff asserts that Bracco’s pre-hearing brief was limited to a claim of in R&D, and
according to Ground Rule 11.2 any claim beyond that is waived. See SRB at 4. But Bracco’s
pre-hearing brief asserted, “Quantitatively, the evidence is expected to show that Bracco’s Model
1700 investments have surpassed (USD).” CPB at 376, ¶ 634. I find Bracco
provided adequate notice of the contention.
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(“ ”) since at least to design, develop, and test the Model 1700 system. Tr. at
176:3-20; CX-0515C.016 (referring to non-disclosure agreement signed ).
acted as the program manager for the Model 1700 development program, facilitating
design and development and managing various sub-contractors. JX-0116C.003; Tr. at 150:11-22.
To this end, employed about employees in the United States in 2016 and 2017
specifically for the development of Bracco’s Model 1700 system. Tr. at 164:23-165:1;
RX-0310C.000007. The record supports the following payments from Bracco to , by year:
Year Amount
Total
JX-0162C.001; RX-0310C.000007-8. The record reflects these outlays to were
exclusively for the Model 1700 and were made exclusively in the United States. See Tr. at
149:2-21, 156:15-158:7; RX-0310C.000007-.000008; JX-0119C. I find that, if the asserted
patents were valid, Bracco’s expenditure of at least on for services to design
and develop the Model 1700 would constitute a substantial investment in research and
development to exploit the inventions claimed in the asserted patents, consistent with section
337(a)(3)(C). The same investment also would constitute a substantial employment
of capital, consistent with section 337(a)(3)(B). See Certain Solid State Storage Drives, Stacked
Electronics Components, and Products Containing Same, Inv. No. 337-TA-1097, Comm’n Op. at
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11-12 (June 29, 2018) (noting that the same expenditures may be credited under multiple
subsections ).11
C. Status of the Industry
1. A Domestic Industry Exists
I have found above that Bracco has made a significant investment in plant and equipment
and a significant employment of labor and capital for articles protected by the asserted patents. I
have also found that Bracco has made a substantial investment in research and development to
exploit the inventions claimed in the asserted patents. At least of these investments
were made as of the time the complaint was filed in this investigation on April 3, 2018. That
amount includes at least paid to in 2014-2017 and the salary Bracco paid to
engineers ( ) and regulatory personnel ( ) in its employ in 2016 and 2017.
I therefore find that a domestic industry exists under section 337, subparagraphs (a)(2) and (3).
See Certain Video Game Sys. & Controllers, Inv. No. 337-TA-743, Comm’n Opinion at 5
(Jan. 20, 2012) (normally, “the appropriate date for determining whether a domestic industry exists
or is in the process of being established is the date of filing of the complaint”), affirmed by Motiva,
LLC v. Int’l Trade Comm’n, 716 F.3d 596, 601 n.6 (Fed. Cir. 2013).
11 Before I move on from the topic of domestic industry accounting, I observe that this litigation
has followed an unfortunate recent trend of losing sight of the domestic industry forest by
concentrating on each line item tree. There is no serious dispute that Bracco and its contractors
designed and manufactured the Model 1700 system in the United States at great expense, and
that the Model 1700 practices the inventions in the asserted patents. Nevertheless, Bracco
aggressively identified an over-inclusive bucket of expenses, likely learning from past
Commission determinations that line items would be whittled away in litigation. And Staff and
Jubilant were no doubt following a well-worn path when challenging individual expenditures
asserted by the complainant. This investigation did present serious questions about FDA
approval, but surely nitpicking line items is not what Congress intended on these facts. Perhaps
all concerned about this area of the law can do better in the future.
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2. Whether the Domestic Industry Will Persist
Jubilant and Staff contend that, even if Bracco has met its burden of showing that a
domestic industry exists, the continued existence of that domestic industry uncertain because it is
unknown whether the FDA will approve the Model 1700. SIB at 27-29; RRB at 12-14. Bracco
avers it has no intention of abandoning commercialization of the Model 1700. CRB at 7-8.
The future of any industry is speculative. As a general matter, however, “the only activities
that are relevant to the determination of whether a domestic industry exists or is in the process of
being established are those that occurred before the complaint was filed.” See Certain Video Game
Sys. & Controllers, Inv. No. 337-TA-743, Comm’n Opinion at 5 (Jan. 20, 2012) (citing Certain
Coaxial Cable Connectors, Inv. No. 337-TA-650, Comm'n Op. at 51 n.17 (April 14, 2010)). In
appropriate circumstances, the Commission may consider activities and investments beyond the
filing of the complaint, such as when there is evidence that a complainant’s domestic industry is
dwindling. See id. (citing Certain Electronic Devices, Including Mobile Phones, Portable Music
Players, and Computers, Inv. No. 337-TA-701, Order No. 58, at 6 (Nov. 18, 2010) (unreviewed)
and Certain Electronic Imaging Devices, Inv. No. 337-TA-726, Order No. 18 (Feb. 7, 2011)
(unreviewed)).
Here, the facts indicate that Bracco submitted an application to the FDA in
seeking approval for the Model 1700. JX-0137C. The FDA initially set a goal date of
, to dispose of the application. JX-0181C; Tr. at 264:1-4. The FDA endeavors to review and
act on 90% of applications by their goal dates. Tr. at 264:5-8; 271:19-22. The FDA did not
approve the Model 1700 by the goal date, and it still has not approved the Model
1700. Tr. at 264:9-12. The record reflects that the 2018 and 2019 strontium breakthrough events
likely have had an .
Tr. at 277:9-21, 293:21-24; RX-0526C.0004 ( ).
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The evidence also shows that Bracco’s FDA application
. Tr. at 266:9-267:20.
Even without FDA approval, however, Bracco’s industry presently exists, as I have found
above. And the industry is not dwindling. To the contrary, after the filing of the complaint Bracco
continues to have . Tr. at 154:11-16.
If the Commission ever issues a remedy in this investigation, I find that any uncertainty relating to
the domestic industry’s continued existence can be addressed by including a reporting requirement
for Bracco in the remedy. See Variable Speed Wind Turbines, Comm’n Op. at 18 (imposing
reporting requirement and limited exclusion order where record reflected uncertainty concerning
continued existence of domestic industry).
VIII. CONCLUSIONS OF LAW
1. The Commission has personal jurisdiction over the parties, subject-matter jurisdiction over
the investigation, and in rem jurisdiction over the accused products.
2. The importation requirement of section 337 is satisfied with respect to the accused Jubilant
RUBY Version 3.1 and 4.0 strontium-rubidium infusion systems, as stated in Order No.
27. See Notice of a Comm’n Det. not to Review an Initial Det. Granting Summary Det. as
to Certain Patent Infringement Issues (March 12, 2019) (EDIS Doc. ID 669522)
3. The importation requirement of section 337 is satisfied with respect to the accused
RUBY-FILL rubidium generator and RUBY Set.
4. The asserted claims of all asserted patents (U.S. Patent No. 9,814,826, U.S. Patent No.
9,750,869, and U.S. Patent No. 9,750,870) are invalid as obvious.
5. No asserted claim of any asserted patent (U.S. Patent No. 9,814,826, U.S. Patent No.
9,750,869, and U.S. Patent No. 9,750,870) has been shown to be invalid as anticipated.
6. The technical prong of the domestic industry requirement for all asserted patents (U.S.
Patent No. 9,814,826, U.S. Patent No. 9,750,869, and U.S. Patent No. 9,750,870) would
have been satisfied if the patents were not invalid.
7. The economic prong of the domestic industry requirement for all asserted patents (U.S.
Patent No. 9,814,826, U.S. Patent No. 9,750,869, and U.S. Patent No. 9,750,870) would
have been satisfied if the patents were not invalid.
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8. Jubilant induced others to practice every asserted patent claim of all asserted patents (U.S.
Patent No. 9,814,826, U.S. Patent No. 9,750,869, and U.S. Patent No. 9,750,870), which
actions would have constituted inducement of infringement under 35 U.S.C. § 271(b) if the
patents were not invalid.
9. Jubilant contributed to the practice every asserted patent claim of all asserted patents (U.S.
Patent No. 9,814,826, U.S. Patent No. 9,750,869, and U.S. Patent No. 9,750,870) by others,
which actions would have constituted contributory infringement under 35 U.S.C. § 271(c)
if the patents were not invalid.
10. Jubilant is not estopped from asserting a patent invalidity defense under the doctrine of
assignor estoppel, as Jubilant is not in privity with any of the named inventors who assigned
their inventions.
11. No violation of section 337 has occurred based on the importation or sale of articles alleged
to infringe the asserted claims of U.S. Patent No. 9,814,826.
12. No violation of section 337 has occurred based on the importation or sale of articles alleged
to infringe the asserted claims of U.S. Patent No. 9,750,869.
13. No violation of section 337 has occurred based on the importation or sale of articles alleged
to infringe the asserted claims of U.S. Patent No. 9,750,870.
IX. RECOMMENDED DETERMINATION ON REMEDY & BOND
The Commission’s Rules provide that the administrative law judge shall issue a
recommended determination concerning the appropriate remedy in the event that the Commission
finds a violation of section 337, and the amount of bond to be posted by respondents during
Presidential review of the Commission action under section 337(j). See 19 C.F.R.
§ 210.42(a)(l)(ii).
In connection with this Recommended Determination, and pursuant to Commission Rule
210.50(b)(1), 19 C.F.R. § 210.50(b)(1), the Commission directed me to take evidence concerning
the public interest pursuant to section 337(d)(1), (f)(1), and (g)(1). See 83 Fed. Reg. 19112 (May
1, 2018).
Before issuing a remedy for a violation of section 337, the Commission must consider the
effect of the remedy on the following public interest factors: (1) the public health and welfare;
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(2) competitive conditions in the United States economy; (3) the production in the United States
of articles that are like or directly competitive with those that are the subject of the investigation;
and (4) United States consumers. See 19 U.S.C. §§ 1337(d)(1), (f)(1). The Commission begins
this analysis with the understanding that the public interest favors the protection of intellectual
property rights by excluding infringing products. See, e.g., Certain Two-Handle Centerset Faucets
& Escutcheons & Components Thereof, Inc. No. 337-TA-422, Comm’n Op. at 9 (July 21, 2000).
Only in rare circumstances will the Commission to determine that the public interest considerations
outweigh the patent holder’s rights. See Spansion, 629 F.3d at 1360. The Commission can,
however, tailor the remedy to minimize the impact on the public interest. See e.g., Certain
Personal Data and Mobile Commc’ns Devices & Related Software, Inv. No. 337-TA-710,
Comm’n Op. at 83 (delaying the effective date of an exclusion order based on competitive
conditions in the United States economy).
Pursuant to that mandate, I make the following factual determinations relevant to the four
statutory public interest factors. My final initial determination relays some of the facts below, but
I repeat them here for clarity and convenience.
A. Background Facts
Coronary artery disease (“CAD”) is a major public health issue in the United States,
affecting millions of Americans. RX-0351. It is the leading cause of death in the United States in
both men and women. RX-0419.0007. For decades, nuclear molecular imaging has been a leading
medical tool for diagnosing diseases like CAD. JX-0096.0011. Positron emission tomography,
also called PET imaging or a PET scan, is one type of nuclear medicine imaging. JX-0096.0003;
RX-0392; RX-0400; RX-0403. In PET imaging, a radioactive isotope or “tracer” is introduced
into a patient’s blood stream intravenously. As the tracer decays, it emits radiation (positrons),
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which can be detected by a scanner and converted into images by software. RX-0106.0014.
Physicians then use these images to determine if the patient’s heart is functioning properly.
In this investigation, it is important to note that neither the alleged Bracco domestic
industry device nor the accused Jubilant infusion system can perform PET on its own. The systems
at issue only inject the patient with radioactive eluate; they do not capture images and they do not
process image data. A clinic uses the Bracco or Jubilant infusion system with a scanner and image
software of the clinic’s choice to perform PET. See Tr. at 452:21-453:3, 458:17-459:7, 471:13-25,
484:20-485:17, 564:24-10, 577:21-25.
There are many factors that contribute to the usefulness of a PET image independent of the
infusion system used. Tr. at 543:15-544:4, 566:17-567:8. One major factor is the scanner or
camera used to detect the positrons emitted from the tracer. JX-0186.003-4. Different types of
scanners have different sensitivities to positron emissions. Id.; JX-0096.003; Tr. at 507:17-508:8,
544:5-545:7. Radiation dosage also plays a role. JX-0186.012. Higher radioactivity can cause
detector saturation on some scanners, resulting in inaccurate readings. JX-0096.003, .006-7;
Tr. at 413:16-23. Patient idiosyncrasies also have an effect. JX-0186.020. Imaging of larger
patients may require higher doses of radioactive tracer. JX-0186.009. An image may also be
influenced by the time at which it is captured compared to the time of elution injection.
JX-0186.012-14. Another important factor is the software used to process the data gathered by
the scanner’s detectors. JX-0186.020; JX-0096.008, .017-18; Tr. at 458:17-459:7.
All of the factors above combine to yield PET images. Physicians may visually inspect
PET images of the heart and observe relative differences in radiotracer uptake in different regions
of the heart tissue or differences in uptake at different times. JX-0186.009, .018; JX-0096.002;
Tr. at 405:25-406:4. Differences in myocardial uptake, or “perfusion,” can indicate disease.
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JX-0186.018-19; JX-0096.002. Some conditions may not be detected by visual inspection of
images. For example, if a patient has equally balanced reduction in blood flow in all three vascular
territories of heart, also termed “balanced ischemia,” a visual interpretation of a perfusion study
may not detect the condition because no difference between regions is noticeable. JX-0186.011,
.016; Tr. at 408:8-409:19.
Physicians may also use software that analyzes PET data to quantify myocardial blood
flow (“MBF”). JX-0186.020; Tr. at 923:16-924:1. Measuring MBF in absolute terms—milliliters
per gram of tissue per minute—is called quantitative MBF analysis. JX-0186.001. Quantitative
MBF analysis is inherently more reproducible than visual analysis and can improve diagnostic and
prognostic accuracy over visual interpretation of perfusion images alone. JX-0186.020;
JX-0096.010-11; Tr. at 407:15-19, 483:12-484:12. For example, quantitative MBF studies can
detect balanced ischemia. JX-0186.011; Tr. at 408:8-409:19. MBF studies are also the only non-
invasive approach to reliably identify cardiac allograft vasculopathy, a common form of rejection
in heart transplant patients and a leading cause of death for such patients. Id. at 627:9-528:1;
JX-0096.0014 (MBF data allows identification of allograft vasculopathy); JX-0186.0021;
JX-0173.0001 (MBF data provides advantages over invasive coronary angiography for identifying
early stage allograft vasculopathy); see also Tr. at 528:2-529:18 (invasive coronary angiography
procedures have attendant risks not present in PET studies).
Rubidium-82 has been used as a radiation source for cardiac PET imaging for many
decades, well before the invention in the patents at issue. See, e.g., RX-0207 (CardioGen-82
Model 510 user manual); Tr. at 137:15-24, 589:18-590:8. Rubidium-82 is generated in portable
generators by passing .9% NaCl saline over strontium-82 (Sr-82). RX-106.000018. The saline
picks up rubidium atoms generated by the strontium as it decays and the resulting eluate is injected
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into the patient’s vein. As the generator ages, strontium eventually starts to detach from the column
and contaminate the eluate, posing a risk to patient health. Id. Such an occurrence is known as
strontium “breakthrough.” Id. Strontium breakthrough can also be caused by a user putting the
wrong solution into the generator. Tr. at 451:9-452:1. To prevent inadvertent patient exposure to
strontium resulting from strontium breakthrough, operators must perform daily quality-control
checks on the generator. RX-106 at .0019-.0020.
As with any exposure of humans to radioactive materials, physicians performing PET
diagnostics adhere to the principle of “ALARA,” namely, exposure of patients and operators to
radioactivity should be “as low as reasonably achievable.” See RX-0318.0001; RX-0419.0091;
see also RX-0422; Tr. at 504:7-505:1.
1. The CardioGen-82 Model 510
The Bracco CardioGen-82 Model 510 has been on the market since 1989. Tr. at 589:18-24.
The record shows that there are roughly units of the Model 510 currently in use in the United
States, constituting over of the rubidium infusion market. RX-413C.084, .113.
The FDA-approved dose of radiation using the Model 510 is from 30 mCi to 60 mCi, with
a recommended dose of 40 mCi. RX-0257. The Model 510 does not control the profile of the
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rubidium dose’s radioactivity, resulting in a “bolus” profile having an initial sharp spike in
radioactivity followed by a long tapering:
RX-0106.000021; Tr. at 413:10-13.
Because calibration of the Model 510 requires recalibration after each dosage change,
dosing is generally set for the day regardless of patient weight in clinical settings. Tr. at
505:19-507:2.
The Model 510 does not automate breakthrough testing. While the FDA requires operators
to complete a daily safety protocol before using the Model 510, the system has no mechanism to
ensure user compliance with the protocol. Tr. at 214:12-16, 215:7-19; see also RX-0257.000001.
Breakthrough tests for the Model 510 are performed manually using stopwatches and complex
worksheets. Tr. at 590:21-591:15, 933:8-12; RX-216.
The Model 510 has been involved in at least six incidents involving patients being dosed
with unsafe elutions tainted by strontium breakthrough. Tr. at 436:3-447:12. In 2011, a number
of patients at two different facilities in the United States were injected with high levels of strontium
due to technicians failing to perform proper daily quality control procedures. Tr. at 436:3-437:5.
This triggered Bracco to issue a voluntary recall on all strontium-rubidium generators in the United
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States. Tr. at 433:25-434:11, 436:3-437:5. Four years later, in 2016, a technician mistakenly used
Ringer’s lactate instead of saline as an eluent, triggering a strontium breakthrough and infusing
patients with high levels of strontium. Tr. at 444:20-446:11; RX-0534C; RX-0530C. In December
2018, a routine radiation sweep of a facility in Colorado uncovered another breakthrough. A
technician had again used Ringer’s lactate with the Model 510 and eight patients were injected
with high levels of strontium over a ,
. Tr. at 437:10-11, 440:2-444:19, 515:10-517:17; RX-530-C; RX-0534C.
Compounding the erroneous use of Ringer’s lactate, the technicians at the Colorado facility had
failed to properly perform the required daily quality control procedures which would have detected
the resulting breakthrough. Tr. at 440:9-444:19. On March 21st of this year, four patients were
injected with high levels of strontium at a facility in Kentucky. Id. at 446:12-447:12; RX-0531C;
RX-0534C. Subsequent investigation revealed that this event was also caused by the use of
Ringer’s lactate. Tr. at 446:12-447:12.
In response to some of these incidents, the FDA mandated a new “boxed warning” for
rubidium generators instructing technicians about the importance of using saline. Tr. at
909:1-910:22; see also RX-0528C; CX-0788; RX-524C.
The foregoing breakthrough incidents notwithstanding, the Model 510 has administered
millions of doses to patients during its 30 years on the market, and it continues to be considered
safe and effective. See RX-0410C; Tr. at 227:2-8, 908:23-25.
Many clinicians use the Model 510 to perform quantitative MBF studies, a technique that
has been known since at least the 1990s. See Tr. at 921:20-922:20, RX-0076. On the other hand,
there is evidence that a minority of Model 510 users do not have the proper camera and software
technology to perform quantitative MBF studies. See Tr. at 485:3-17.
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2. The RUBY Version 3 System
In September 2016, the FDA approved Jubilant’s RUBY Version 3 system. Tr. at
318:16-17, 328:4-6. The record shows that there are units of the RUBY Version 3 currently in
use in the United States, less than 10% of the rubidium infusion market. Tr. 328:4-6; see RX-
413C.113.
Whereas the Bracco Model 510 is largely manual, the RUBY Version 3 includes
computerized calculations, computer-controlled functions, and automated safety features. Each
day, the RUBY system software prevents patient infusions until an automated breakthrough test is
performed with satisfactory results. JX-0007.037; JX-0027.0043. The user interface walks the
operator through the steps for performing an automated strontium breakthrough test.
JX-0007.037-44; JX-0027.0043-49; Tr. at 522:1-18. The technician must acknowledge each step
of the process to go on to the next screen. Id.; RX-0083C.0007-8. The RUBY system also has
automatic lock-outs that prevent patient elutions from occurring if strontium breakthrough is
detected, or if the generator is past its expiration limits. JX-0027.0043-49; RX-0083C.0007-8.
The automated system in the RUBY Version 3 will ensure breakthrough events are caught
within 24 hours. The breakthrough would not be detected until an operator runs the safety protocol
the next day after the breakthrough event, however. Tr. at 462:5-15. The same lag in breakthrough
detection exists in the manual calculation protocol prescribed for Bracco’s Model 510. Id. Thus,
in both systems, patients injected later the same day as the breakthrough event will be exposed to
high levels of strontium.
Also like the Model 510, the RUBY Version 3 system instructs users to only use saline
with the generator. Tr. at 423:4-12. Several warnings appear on the screen of the RUBY system
reminding technicians to use saline. Id. Although these warnings are designed to deter user error,
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the RUBY system has no feature to physically prevent a technician from using Ringer’s lactate
instead of saline. Tr. at 521:3-522:18.
To date, there are no documented cases of patients treated with a RUBY Version 3 being
injected with high levels of strontium. Tr. at 935:2-15.
Unlike the bolus injection profile of CardioGen Model 510’s, the RUBY Version 3 can
perform elutions with a more even “constant activity” profile. To achieve the constant activity
profile, the RUBY Version 3 monitors eluate radioactivity in real time and makes adjustments to
the eluate flow to provide a consistent average level of radioactivity throughout the injection. Tr.
at 415:19-416:2; JX-0007.0046. The image below compares a bolus injection profile with a
constant activity profile:
RX-0360.000006.
The RUBY Version 3 system allows a broader range of dosing, and lower dosing, than the
Model 510. The FDA has approved the RUBY Version 3 for doses between 10 mCi and 60 mCi,
compared with the Model 510 range of 30 mCi to 60 mCi. Compare CX-0007.001-002, with
RX-0257.001. With constant activity infusions and lower approved dosing ranges, at least one
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physician reported he was able to more reliably obtain MBF data than with the Model 510. Tr. at
414:19-416:19, 526:14-21.
The RUBY Version 3 has features absent from the Model 510 to reduce patient and
operator radiation exposure and increase image quality. Tr. at 913:2-16; RX-0318. One such
feature is simplified weight-based dosing. Weight-based dosing allows a technician to use lower
amounts of radiation when appropriate based on a patient’s weight. Tr. at 505:8-506:8; JX-0096,
Public Interest Statement of University of Ottawa, EDIS Doc. ID 641744, at 2. Both the RUBY
Version 3 and the Model 510 allow weight-based dosing, but the Model 510 system often requires
a technician to recalibrate the system after each dose change. Id.; cf. JX-097. The RUBY system
does not need to be recalibrated for each dose change because it performs an automated saline
flush at the end of each infusion. The flush pushes any residual radioactivity out of the system
that might otherwise cause the system to require recalibration. Tr. at 508:9-15.
The post-elution flush in the RUBY Version 3 also contributes to better image quality. The
flush is performed while the patient is connected to system. That ensures that all generated
rubidium is pushed out of the IV line, through the patient’s arm vein, and into the patient’s heart.
Without the flush, radioactive tracer can linger or “pool” in the IV line and the patient’s arm.
Positron emissions from those areas can degrade the image of the heart. Tr. at 508:9-509:18;
RX-0418; Public Interest Comment of Statement of University of Ottawa, EDIS Doc. ID 641744,
at 2.
Additionally, the RUBY system flush pushes residual radioactivity away from any medical
staff, reducing staff exposure. Tr. at 508:25-509:2 509:9-18. Operator exposure is also reduced
by on-board breakthrough testing that does not require a technician to transport radioactive eluate
samples.
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B. The Public Interest Factors
1. Public Health and Welfare
Currently, the only FDA approved rubidium infusion systems available in the United States
are the Model 510 and the RUBY Version 3 system. Tr. at 502:15-25, 574:19-24. Jubilant claims
that the RUBY Version 3 system is significantly superior to the Model 510 with respect to both
safety and diagnostic accuracy. RIB at 140. Bracco counters that there are no peer-reviewed
scientific studies supporting Jubilant’s claims. CIB at 50. For the reasons set forth below, I find
that, although the RUBY Version 3 offers some safety improvements over the Model 510 and the
potential for easier quantification of MBF, those improvements are not substantial or definite
enough to militate against entry of a remedy. I find that the effect of a remedy on the public health
and welfare does not weigh against entry of a remedy.
a) Relative Radiation Exposure
Jubilant claims its RUBY Version 3 is safer for both patients and operators. RIB
at 141-142. While the RUBY Version 3 has features that logically would appear to make that
system at least marginally safer than the Model 510, I find there is no dispute that the FDA—the
agency with expertise on this matter—still considers the Model 510 to be safe and effective when
used properly. The record evidence in this investigation does not show otherwise.
First, while the RUBY Version 3 offers automation and lock-out features, it has not been
demonstrated that those features substantially reduce patient exposure to strontium when compared
to proper use of the Model 510. Exposure to strontium from the Model 510 has occurred at least
six times, but each time due to a technician using the wrong eluent. Tr. at 436:3-447:12. Neither
the RUBY Version 3 nor the Model 510 prevent breakthrough caused by the use of the wrong
eluent. Tr. at 462:5-15. Additionally, the RUBY Version 3 system will detect breakthrough no
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sooner than the Model 510; the protocols of both systems discover the problem the next day. Id.
Though the RUBY system eliminates the chance of user error in daily calibration calculations, the
record reflects at most three instances where daily quality controls failed to catch breakthrough.
See Tr. at 437:10-11, 440:2-44:19; RX-0534C. Given that the Model 510 has been used
consistently for nearly thirty years across millions of injections, Jubilant’s argument, RIB at 157,
that the manual quality control process of the Model 510 is less safe than the automated RUBY
Version 3 process is not supported by the record. I find that any safety improvements from
automation of the breakthrough test in the RUBY Version 3 system have not been shown to have
a statistically significant reduction in patient exposure to strontium.
Nor do differences in ordinary use radiation exposure tip the scale. Although weight-based
dosing is easier with the RUBY Version 3 because it does not require recalibration with each dose
change, the Model 510 is still capable of performing weight-based dosing. Compare Tr. at
508:9-509:2, with id. at 555:19-23. There is even evidence that weight-based dosages can be
implemented with the Model 510 without recalibration, depending on the range of the dose. See
JX-0097; Tr. at 549:15-551:6. Weight-based dosing may marginally reduce radiation exposure to
some patients and medical staff, but even without it Model 510 dosing is still within limits
determined by the FDA to be safe. Tr. at 505:19-506:8, 542:20-543:13, 911:11-913:1; JX-0096.
Moreover, the record indicates that physicians only rarely performed weight-based dosing during
the decades when the Model 510 was the only available rubidium PET infusion device on the
market, which tends to support a conclusion physicians do not view weight-based dosing to be a
priority for public health. Tr. at 506:9-20; JX-0097; see Public Interest Statement by Howard
Lewin, MD of Cardiac Imaging Nuclear Associates (Apr. 11, 2018) (EDIS Doc. No. 641725).
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Next, the different infusion profile of each system (bolus versus constant activity) does not
make one safer than the other. Both systems expose patients to roughly the same amount of total
radioactivity through their injections. Tr. at 416:3-4. And even though the FDA has approved the
RUBY Version 3 for a lower range of doses (10 mCi to 60 mCi) than the Model 510 (30 mCi to
60 mCi), there is evidence that various clinics consistently use dosages higher than the minimal
dosage approved by the FDA for all patients. See Tr. at 548:14-23.
Finally, although the on-board breakthrough test and saline flush of the RUBY Version 3
would seem to reduce radiation exposure for medical staff at least nominally when compared with
the Model 510, nothing in the record quantifies that effect. Again, the FDA considers operator
exposure with the Model 510 to be within safe limits.
These facts fall short of prior Commission determinations rejecting a remedy after finding
a violation of section 337. For instance, in Certain Fluidized Supporting Apparatus, Inv. No.
337-TA-182/188 (“Burn Beds”), the Commission denied relief on the basis of the public interest
where exclusion would reduce supply below that of demand for specialized beds for burn patients
to the point that burn victims would, with certainty, be forced to use ordinary hospital beds
unconducive to recovery and certain to cause pain. See, e.g., Burn Beds, Inv. No. 337-TA-182/188,
USITC Pub. 1667 (1984), Comm’n Op. at 23-25. Here, exclusion of the generators used in RUBY
Version 3 systems and transfer of RUBY patients to the Model 510 would, at most, maintain
patient and technician radiation exposure to levels considered by the FDA to be safe for the last
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thirty years. I find that the evidence of reduced radiation exposure when using the RUBY Version
3 infusion system is insufficient to weigh against entry of a remedy in this investigation.12
b) Relative Diagnostic Capacities
Jubilant also argues the RUBY Version 3 system provides physicians more accurate
quantitative MBF data, which leads to more accurate diagnoses and prognoses. RIB at 141-142.
However, as described in the background section above, neither the RUBY Version 3 nor the
Model 510 calculate MBF data. A clinic uses the Bracco or Jubilant infusion system with a scanner
and image software of the clinic’s choice to obtain quantitative MBF data. See Tr. at 452:21-453:3,
458:17-459:7, 471:13-25, 484:20-485:17, 564:24-10, 577:21-25.
The record demonstrates that many factors beyond the choice of infusion system contribute
to the calculation of MBF data. Tr. at 543:15-544:4, 566:17-567:8. One major factor is the scanner
or camera used to detect the positrons emitted from the tracer. JX-0186.003-4. Different types of
scanners have different sensitivities to positron emissions. Id.; JX-0096.003; Tr. at 507:17-508:8,
544:5-545:7. Radiation dosage also plays a role. JX-0186.012. Higher radioactivity can cause
detector saturation on some scanners, resulting in inaccurate readings. JX-0096.003, .006-7;
Tr. at 413:16-23. The software used to process the data gathered by the scanner’s detectors also
affects MBF results. JX-0186.020; JX-0096.008, .017-18; Tr. at 458:17-459:7. All of this means
that the Model 510 might produce more accurate MBF data in one set of circumstances, while the
RUBY Version 3 might produce more accurate MBF data in another.
12 If the CardioGen-82 Model 1700, RUBY Version 3.1, or RUBY Version 4.0 are approved
before the entry of a remedy in this case, the Commission should conduct additional fact-finding
about the relative risks and benefits of those systems.
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For instance, although Jubilant’s expert Dr. Lewin testified he was unable to consistently
achieve MBF data with the Model 510, he admitted that was because he used an inferior PET
imaging camera compared to more advanced cameras available on the market. See, e.g., Tr. at
471:18-19. He further acknowledged that physicians using other imaging equipment were able to
get accurate results with the Model 510, and that only 40% of the market use the inferior camera
equipment. Tr. at 470:2-471:25.
In fact, Jubilant’s other expert, Dr. Murthy, testified that he used the Model 510 to obtain
quantitative MBF data from 117 heart transplant patients. Tr. at 556:12-557:18. His published
findings state that quantitative MBF data was computed with commercially available software and
previously validated methods. JX-0173.003. Dr. Murthy’s publication also states quantitative
MBF is “routinely measured during PET imaging.” Id. at .002.13 Dr. Murthy also did not dispute
that another physician he knew, Dr. Gould, obtained quantitative MBF data for 5,800 different
patients using the Model 510. Tr. at 562:1-11.
Further in contrast to Dr. Lewin’s experience, one hospital in the United Kingdom reported
impressive MBF results using the Model 510. With a cohort of 271 consecutive patients, the
hospital was able to achieve accurate MBF quantification in 85% of patients using a 40 mCi dose.
RX-0076.000001-2. After lowering the dose to 30 mCi dose to correct for some scanner saturation,
the clinic achieved accurate MBF quantification in 99% of a second cohort of 159 patients.
RX-0076.000001-2.
13 The article states that myocardial flow reserve (“MFR”) is “a well-validated evaluation of
abnormal coronary vasodilatory capacity that is now routinely measured during PET imaging.”
JX-0173.002. The article explains that MFR is “ratio of stress to rest myocardial blood flow
(MBF).” Id. Thus, Dr. Murthy’s article concedes that quantitative MBF is “routinely measured
during PET imaging,” including the imaging he performed using the Model 510, and is valid.
See id.
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Jubilant points to the bolus infusion profile of the Model 510 (which, as discussed, delivers
a higher radioactive peak than the RUBY Version 3’s constant activity infusion) as the cause of
the Model 510’s supposed diagnostic inferiority. Jubilant contends the bolus spike in radioactivity
at the beginning of a Model 510 infusion saturates the sensors in certain cameras, preventing
successful MBF imaging. See Tr. at 413:3-414:11, 525:3-15; RX-0360. The record shows,
however, that using different cameras or different dosing mitigates that concern. See Tr.
at 469:5-471:25, 472:14-473:24, 484:13-485:17; RX-0076. The record also shows that the correct
MBF software model can account for the bolus profile. See RX-0360.000009 (“In theory, the
quantitative MBF results should not depend on the shape of the input function, because the
compartment model is formulated to predict the myocardial tissue response curve for any arbitrary
shape of input.”). In fact, Jubilant’s expert Dr. Murthy used bolus profile injections from the
Model 510 and obtained quantitative MBF studies using validated methods. JX-0173.002, .003;
Tr. at 556:12-557:18.
Finally, Jubilant’s own experts both confirmed the lack of any studies showing statistically
significant difference in outcomes between patients treated with the RUBY Version 3 and those
treated with the Model 510. Tr. at 489:19-22, 575:13-19.
These facts do not support a finding that entry of a remedy is against the public interest.
As noted above, in Certain Fluidized Supporting Apparatus, Inv. No. 337-TA-182/188 the
Commission denied relief on the basis of the public interest where exclusion would reduce supply
of specialized beds for burn patients to the point that burn victims would, with certainty, be forced
to use non-specialized hospital beds and, as a result, caused extreme pain and have reduced
recovery prospects. See, e.g., Burn Beds, Comm’n Op. at 23-25. Here, exclusion of RUBY
generators would require the small portion of the population treated with the nineteen RUBY
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Version 3 machines currently in use to switch to a clinic with one of the hundreds of Model 510
units currently in use. See Tr. at 328:4-6, 492:5-12. The record shows the Model 510 is widely
available. See JX-0173.008 (published paper of Jubilant expert Dr. Murthy opining that most
transplant centers have access to technology that can obtain quantitative MBF data using the
Model 510). It appears that many of those Model 510 units, if not a majority, have been combined
with cameras and software that allow accurate quantitative MBF studies. JX-0173.002 (MBF is
“routinely measured”). That situation is far short of the certainty of pain and poor recovery for all
burn patients west of the Mississippi. Cf. Burn Beds, Inv. No. 337-TA-182/188, USITC Pub. 1667
(1984), Comm’n Op. at 23-25.
This investigation is also unlike Certain Inclined Field Acceleration Tubes, Inv.
No. 337-TA-67, where the Commission declined to order a remedy because the violating articles
were “greatly superior,” “substantially less expensive,” and “indispensable” to fundamental
research in nuclear physics. See Certain Inclined Field Acceleration Tubes, Inv. No. 337-TA-67,
USITC Pub. 1119 (1980), Comm’n Op. at 21-31, 37. Here, the record shows that if the RUBY
Version 3 were no longer in use due to excluded generators, hundreds of Model 510 systems would
still be available for MBF quantification and other research.
In sum, the effect of an exclusion order or cease and desist order on the public health and
welfare factor does not weigh against entry of a remedy.
2. Competitive Conditions in the United States Economy
Jubilant argues that exclusion of their generators will cause a single-supplier market and
eliminate all competition in the rubidium PET infusion market. RIB at 169. While the Model 510
would become the only rubidium PET infusion system on the market after an exclusion order,
multiple noninvasive cardiac imaging tools would remain available, including other forms of PET.
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Rubidium-82 is only one of two FDA-approved PET tracers; the other is nitrogen-13-ammonia.
Tr. at 574:21-25. Still other PET tracers, such as 15-O water, are in use in Europe and are being
investigated for approval in the United States. Id. These other options provide competitive
pressure for innovation and price. Invasive alternatives like angiography are also available. See
Tr. at 528:13-17, 489:23-492:23; see JX-0173.0001 (comparing cardiac PET imaging and
angiography). Given the multiple competing cardiac imaging products on the market, even with
Jubilant’s exclusion, competition will remain in the marketplace.
The record also indicates that, even if the relevant marketplace is only rubidium PET
infusion systems, the market operated for almost thirty years with Bracco as the sole supplier of
such systems. Tr. at 885:3-886:1. In that time, consumer satisfaction was “moderate to high.”
Tr. at 886:2-11; CX-0041C.012. There is no evidence in the record that prices were supra-
competitive during Bracco’s time as the sole supplier of rubidium infusion systems. In fact, there
was no evidence of a change in market prices with the introduction of competition by the RUBY
Version 3 system. Even if there were evidence an exclusion order might lead to higher prices, “the
Commission has consistently held that the benefit of lower prices to consumers does not outweigh
the benefit of providing complainants with an effective remedy for an intellectual property-based
section 337 violation.” See Certain Ink Cartridges and Components Thereof, Inv. No. 337-TA-565
(Consolidated Enforcement Proceeding and Enforcement Proceeding II) (“Ink Cartridges II”),
Comm’n Op. at 27 (Aug. 28, 2009) (EDIS Doc. No. 411051).
Jubilant also argues in connection with competitive conditions that a single-supplier market
will create the risk of supply disruptions in the market. RIB at 169. That argument appears more
relevant to the next factor, but to the extent it is related to competitive conditions I address it here.
The record shows that Bracco has never had a supply issue during its nearly thirty years as a single-
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supplier. Tr. at 887:17-20. The only supply disruptions in the market have been a voluntary recall
in 2011, resulting from consumer misuse rather than production issues, RX-0142C, and Jubilant’s
own supply chain problems. Tr. at 335:12-336:25, 879:4-15. I find that if Bracco were the only
supplier, it could adequately supply the market without disruption.
In view of the foregoing, I do not find that the effect of an exclusion order or cease and
desist order on competitive conditions in the United States weighs against entry of an exclusion
order.
3. Production of Like or Directly Competitive Products in the United
States
As mentioned above, Jubilant argues Bracco will be unable to meet demand with domestic
supply. The Commission has previously denied a remedy based on demand only when the
domestic industry was unable to meet the demand of the United States market. See, e.g., Certain
Automatic Crankpin Grinders, Inv. No. 337-TA-60, USITC Pub. 1022 (1979), Comm’n Op. at
18-21 (denying remedy where domestic industry could not meet demand of automotive component
necessary to meet stated public policy of increased automotive fuel efficiency). The record shows
that Bracco has the present capacity to produce , Tr. at 151:13-23;
RX-0412C.153 at 153:22-155:2; see also Tr. at 897:13-898:6, and that there are no known supply
constraints in producing the Model 510 carts themselves. Tr. at 893:8-9. Bracco also anticipates
the , Tr. at 151:24-152:7,
and, with FDA approval, .
Tr. at 151:18-23. Thus, if Jubilant’s generators were excluded, Bracco could and likely would
increase its production of like or directly competitive goods in the United States.
The record contains other information relevant to this factor. Kluge, the U.S. contractor
who manufactures the RUBY Version 3, submitted public interest comments about production.
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Public Interest Statement of Kluge Design Inc., EDIS Doc. ID 641724. Kluge noted that Jubilant
sells infusion systems both in the United States and abroad. Id., see also Tr. at 318:23-319:3.
Kluge speculated that if an exclusion order issues, Jubilant might move manufacture of the RUBY
infusion carts from the United States to another country. I find Kluge’s comments are speculative
and uncorroborated. Indeed, Jubilant itself presented no evidence that it would disrupt its own
supply chain to relocate manufacturing abroad.
Viewing the record as a hole, I do not find that the effect of an exclusion order or cease
and desist order on competitive conditions in the United States weighs against entry of an exclusion
order. See, e.g., Certain Crystalline Cefadroxil Monohydrate, Inv. No. 337-TA-293, USITC Pub.
2391 (Mar. 21, 1990), Comm’n Op. at 46-47 (rejecting public interest argument where domestic
supply was sufficient to meet demand).
4. United States Consumers
Neither Jubilant nor Bracco nor Staff presented any direct argument concerning the effect
that an exclusion order would have on United States consumers. Here, the relevant consumers are
physicians and healthcare facilities who purchase and use cardiac imaging systems. As noted
above concerning competitive conditions, there is no evidence in the record that an exclusion order
will lead to increased prices. And although the small number of facilities with RUBY systems
might bear some immediate cost to lease a new infusion systems, the record shows that cost is
rather modest compared to other medical devices related to PET imaging. Tr. at 496:15-19
(Cyclotrons cost $25 million), 880:17-24 (monthly lease cost of Model 510 is a month);
RDX-0006C.000011-12 (compiling system lease price analysis). A small cost to a handful of
United States facilities does not outweigh the public interest in the enforcement in patent rights.
See Ink Cartridges II, Inv. No. 337-TA-565, USITC Pub. 4196 (December 2010), Comm’n Op. at
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27 (Aug. 28, 2009) (“The Commission has consistently held that the benefit of lower prices to
consumers does not outweigh the benefit of providing complainants with an effective remedy for
an intellectual property-based section 337 violation.”).
To the extent that consumer choice is relevant to this factor, I have noted above that after
an exclusion order medical facilities will still have the choice between Bracco’s rubidium infusion
system and other cardiac imaging systems.
I find no evidence has been presented showing an exclusion order or a cease and desist
order would have a substantial negative impact on United States consumers as a whole. This factor
does not weigh against a remedy
5. Conclusion
If an exclusion order or a cease and desist order were to issue in this investigation, I find
that the effect of those orders on the four public interest factors would not counsel against issuing
a remedy.
C. Limited Exclusion Order
Because I do not find a violation of section 337, I do not recommend that a limited
exclusion order should issue. However, if the Commission determines that a violation of section
337 has occurred, I recommend that the Commission issue a limited exclusion order barring entry
of articles that directly or indirectly infringe the asserted patent claims. That order would
encompass the currently imported RUBY-Fill generators and RUBY sets. As explained above,
the effect of an exclusion order on the public interest factors does not counsel against such a
remedy.
However, I also recommend that any exclusion order not take immediate effect. The record
contains unrebutted comments from members of the public suggesting it may take up to twelve
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months for some cardiac imaging clinics to switch from the RUBY Version 3 to the Model 510.
Public Interest Statement of Venkatesh L. Murthy, EDIS Doc. ID 641727, at 2 (estimating 6-12
months to revert to use of Bracco system, with patient risk in the interim); Public Interest Statement
of April Mann, EDIS Doc. ID 64172, at 2 (estimating 3-6 months, if possible at all, to switch);
Public Interest Statement of Howard C. Lewin, EDIS Doc. ID 641725, at 2 (substantial time to
switch). Patients served by the dozen or so clinics using the RUBY Version 3 could face delays
in obtaining images, potentially leading to undiagnosed and untreated cardiac disease. The risk of
such delays is particularly concerning for cardiac transplant patients currently being treated at a
facility with a RUBY Version 3 system but without a camera sufficient to produce MBF studies
with the Model 510 (such as Dr. Lewin’s clinic). If the patient cannot travel to an existing facility
with the Model 510 system or another imaging option, that patient might risk more dangerous,
invasive procedures or risk having potentially deadly complications from the heart transplant go
undetected. See Tr. at 527:9-529:18. Bracco does not oppose giving patients and clinics time to
transition the Model 510. CIB at 56.
In light of those facts, I find the sudden effect of an exclusion order could be harmful to
the public health and welfare. I therefore recommend that effect of any remedy be delayed by a
period of at least 12 months to allow sufficient time for facilities with RUBY Version 3 systems
to switch to the Model 510 and maintain the standard of care for their current patients without
interruption. See Certain Personal Data and Mobile Communication Devices and Related
Software, Inv. No. 337-TA-710, Comm’n Op. at 83 (Dec. 19, 2011) (EDIS Doc. No. 467457)
(delaying the effective date of an exclusion order based on competitive conditions in the United
States economy).
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Staff and Jubilant argue any limited exclusion order should expressly permit users who
currently have a RUBY system to continue to receive imported generators and other imported
components from Jubilant. SIB at 63, RIB at 173-174. Both argue that clinics and patients
currently using the RUBY Version 3 should not be denied access to the purportedly superior
attributes of the RUBY system.
I do not find that the record supports the proposed carve-out. Though Jubilant’s experts
testified they personally preferred the RUBY system and could obtain better results more easily
with that system, they both acknowledged there is no statistically significant clinical proof that the
RUBY system provides superior patient outcomes to the Model 510. Tr. at 489:19-22, 575:13-19.
The record also contains ample evidence that equivalent functionality to the RUBY Version 3 is
widely available at facilities using the Model 510. Additionally, I have taken the interests of
existing users into account in my recommendation that the effect of any exclusion order be delayed.
One other issue remains. I have noted above that Bracco’s alleged domestic industry
product has not yet been approved by the FDA. If FDA approval is not granted sometime soon, it
is unlikely that Bracco will continue manufacturing the Model 1700. It is even possible that if the
FDA denies approval for the Model 1700 that Bracco will abandon that project and go back to the
drawing board. I do not consider that outcome to be the most likely scenario, but it is a non-trivial
scenario. Accordingly, there remains some degree of uncertainty concerning the continued
existence of a domestic industry. In order to ensure that a domestic industry justifying the
Commission’s remedial order continues to exist, I recommend that Bracco be required to file
quarterly reports on the first day of each calendar quarter describing the status of FDA approval of
its domestic industry product and its continued manufacturing expenditures for the Model 1700. I
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recommend this reporting requirement commence with the first day of the next calendar quarter
after the issuance of any remedy and continue for eighteen (18) months after that day.
If Bracco’s domestic industry product has not been approved for use in the United States
by the expiration of that period or if Bracco has ceased making substantial expenditures to exploit
the patents, I recommend the limited exclusion order be rescinded. See Variable Speed Wind
Turbines, Comm’n Op. at 18. (“If it becomes clear from its reports that complainant has suspended
or ceased practice of [a claim from the asserted patents], the Commission [should] consider
whether to suspend or revoke the exclusion order, as may be appropriate.”).
D. Cease and Desist Order
Because I do not find a violation of section 337, I do not recommend the issuance of a
cease and desist order. And even if the Commission determines that a violation of section 337 has
occurred, I still do not recommend entry of a cease and desist order, for the reasons discussed
below.
Under Commission precedent, “[c]ease and desist orders are generally issued when, with
respect to the imported infringing products, respondents maintain commercially significant
inventories in the United States or have significant domestic operations that could undercut the
remedy provided by an exclusion order.” Certain Air Mattress Systems, Components Thereof, and
Methods of Using the Same, Inv. No. 337-TA-971, Comm’n Op. at 49 (May 17, 2017) (EDIS Doc.
No. 614743) (citations and footnote omitted). “A complainant seeking a [cease and desist order]
must demonstrate, based on the record, that this remedy is necessary to address the violation found
in the investigation so as to not undercut the relief provided by the exclusion order.” Id. at 50.
The imported articles in question are RUBY-FILL rubidium generators and RUBY Sets.
Those articles are presently used with RUBY Version 3 systems, which Jubilant makes
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domestically. The evidence shows that Jubilant DraxImage Inc. currently leases out to customers
approximately installed RUBY Version 3 carts for a list price of a month per cart.
RX-081C.000007-8; Tr. 323:4-6. Each installed system requires a RUBY generator to operate,
and each generator is replaced every 60 days. CX-0569C at 55:6-16. The generators, imported
by Jubilant DraxImage Inc., are sold at a list price of . RX-081C.000007-8.
Bracco admits that Jubilant does not maintain an inventory of either RUBY-FILL rubidium
generators or RUBY Sets; those articles are made to order only when orders are placed by specific
customers. CIB at 14-15 (citing Tr. at 320:12-14, CX-0569C at 40:9-19). Nevertheless, Bracco
and Staff argue a cease and desist order is appropriate. CIB at 56; SIB at 164. Jubilant, for its
part, does not address the question of a cease and desist order separately from its treatment of a
potential limited exclusion order. RIB at 172-74. Jubilant only argues that, should a cease and
desist order enter, it should be directed only to Jubilant DraxImage Inc. and should not include
Jubilant Pharma Limited or Jubilant Life Sciences Limited, as only Jubilant DraxImage Inc.
engages in the allegedly infringing conduct. RRB at 55 (citing Tr. at 302:17-22, 303:5-8).
If a limited exclusion order is issued and Jubilant can no longer import RUBY-FILL
generators and RUBY Sets, the RUBY Version 3 carts Jubilant has installed in the field will no
longer be able to be used in a manner that violates section 337. Accordingly, a cease and desist
order would no longer be “necessary to address the violation.” See Certain Air Mattress Systems,
Comm’n Op. at 50.
If the Commission nevertheless determines that a cease and desist order is appropriate, the
order should be limited to Jubilant DraxImage Inc. The record indicates that Jubilant DraxImage
Inc. is the only respondent that performs, induces, or contributes to the practice of the asserted
patent claims. Tr. 302:17-22, 303:5-8. I therefore recommend any cease and desist order be issued
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solely against Jubilant DraxImage Inc. See Road Construction Machines, 337-TA-1088, Comm’n
Op. at 51-53 (July 15, 2019) (determining cease and desist order was appropriate only against
respondents that record reflected had domestic activities and/or inventory).
Staff recommends that any cease and desist order expressly permit users who currently
have a RUBY system to continue to receive imported generators and other imported components
from Jubilant. SIB at 164. For the reasons stated above in connection with the limited exclusion
order, I do not find that such a carve-out is justified. I do recommend, however, the effect of any
cease and desist order be delayed for 12 months, for the same reasons I have explained above in
connection with the limited exclusion order.
E. Bond During Presidential Review
In the event that the Commission determines to issue a remedy, the Commission must
determine the amount of bond to be required of a respondent during the 60-day Presidential review
period. See 19 U.S.C. §1337(j)(3). The purpose of the bond is to protect the complainant from
any injury. See 19 C.F.R. §§ 210.42(a)(1)(ii), 210.50(a)(3).
When reliable price information is available, the Commission has often set the bond by
eliminating the differential between the domestic product and the imported, infringing product.
See Microsphere Adhesives, Processes for Making Same, and Prods. Containing Same, Including
Self-Stick Repositionable Notes, Inv. No. 337-TA-366, USITC Pub. 2949 (Dec. 8, 1995), Comm’n
Op. at 24. In other cases, the Commission has turned to alternative approaches, especially when
the level of a reasonable royalty rate could be ascertained. See, e.g., Certain Integrated Circuit
Telecomm. Chips and Prods. Containing Same, Including Dialing Apparatus, Inv. No.
337-TA-337, USITC Pub. 2670 (June 22, 1993), Comm’n Op. at 41. A 100 percent bond has been
required when no effective alternative existed. See, e.g., Certain Flash Memory Circuits and
PUBLIC VERSION

176
Prods. Containing Same, Inv. No. 337-TA-382, USITC Pub. 3046 (July 1997), Comm’n. Op. at
26-27 (imposing a 100% bond when price comparison was not practical because the parties sold
products at different levels of commerce, and the proposed royalty rate appeared to be de minimis
and without adequate support in the record).
Bracco seeks a “default bond” of 100%, suggesting that all sales of RUBY Systems will
be at the expense of Bracco’s CardioGen-82. CIB at 57-58. But as Staff and Jubilant point out,
SRB at 22-23, RRB at 55-56, Bracco has not even attempted to meet the burden required for a
100% bond. In fact, Bracco contradicts its argument for a 100% bond by elsewhere seeking a 95%
bond based on Jubilant’s purportedly . Id. (citing CX-0566C.119;
RX-0413C.148). Bracco’s admission that a price comparison is possible necessitates rejection of
its requested 100% bond. Additionally, Bracco’s argument that all sales to Jubilant are necessarily
lost profits for Bracco is unpersuasive. While it may be true that a site using a Jubilant product is
“a sales opportunity that Bracco did not win,” Tr. at 884:9-24, the converse does not follow.
Bracco supplied no evidence that Bracco would have won that business but for Jubilant’s presence
in the market, and the record reflects there are competing substitute goods. See Tr. at 574:19-575:5
(noting existence of at least one competing FDA approved cardiac PET radiotracer to rubidium).14
14 Jubilant argues that, because the domestic industry product is not yet commercially available,
it does not compete with the RUBY Version 3 and so causes no injury to sales of that product.
That may well be true, but the purpose of the bond is to protect the complainant from any injury.
See 19 C.F.R. § 210.50(a)(3). And Bracco certainly competes with Jubilant’s RUBY Version 3
with its CardioGen-82 Model 510. Tr. at 875:8-876:2.
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177
I find that Bracco has failed to meet its burden to show a bond is necessary to prevent it
from any harm. I thus recommend that, should the Commission find a violation of section 337, a
bond of zero percent should be imposed.
X. INITIAL DETERMINATION
I hereby certify to the Commission this Initial Determination and the Recommended
Determination.
The Secretary shall serve the confidential version of this Initial Determination upon
counsel who are signatories to the Protective Order (Order No. 1) issued in this investigation. A
public version will be served at a later date upon all parties of record.
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 seven days of the date of this document, the parties must jointly submit a statement
to Cheney337@ustic.gov stating whether or not each seeks to have any portion of this document
redacted from the public version. Should either or both parties seek to have any portion of this
document redacted from the public version thereof, the parties shall attach a copy of a joint
proposed public version of this document indicating with red brackets any portion asserted to
contain confidential business information.15 To the extent possible, the proposed redactions should
15 If the parties submit excessive redactions, they may be required to provide an additional
written statement, supported by declarations from individuals with personal knowledge,
justifying each proposed redaction and specifically explaining why the information sought to be
redacted meets the definition for confidential business information set forth in Commission Rule
201.6(a). 19 C.F.R. § 201.6(a).
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178
be made electronically, in a PDF of the issued order, using the “Redact Tool” within Adobe
Acrobat, wherein the proposed redactions are submitted as “marked” but not yet “applied.” The
parties’ submission concerning the public version of this document should not be filed with the
Commission Secretary.
SO ORDERED.
PUBLIC VERSION

CERTAIN STRONTIUM-RUBIDIUM RADIOISOTOPE
INFUSION SYSTEMS, AND COMPONENTS THEREOF
INCLUDING GENERATORS
Inv. No. 337-TA-1110
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached Initial Determination on Violation of
Section 337 and Recommended Determination on Remedy and Bond has been served by
hand upon Commission Investigative Attorney, Brian Koo, Esq., and the following parties as
indicated, on August 13, 2019.
_____________________________
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainant Bracco Diagnostics, Inc.:
Mark G. Davis, Esq.
GOODWIN PROCTER LLP
901 New York Avenue, NW
Washington, DC 20001
☐ Via Hand Delivery
☒ Via Express Delivery
☐ Via First Class Mail
☐ Other:_____________
On Behalf of Respondents Jubilant Draximage, Inc., Jubilant Pharma Limited, and
Jubilant Life Sciences:
T. Cy Walker, Esq.
BAKER & HOSTETLER LLP
1050 Connecticut Avenue, NW
Washington, DC 20036
☐ Via Hand Delivery
☒ Via Express Delivery
☐ Via First Class Mail
☐ Other:_____________

Certain Strontium-Rubidium Radioisotope Infusion Systems, and Components Thereof Including Generators, Inv. 337-TA-1110

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