Guardant Health, Inc. v. University of Washington

N OTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
GUARDANT HEALTH, INC.,
Appellant
v.
UNIVERSITY OF WASHINGTON,
Appellee
______________________
2024-1129
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2022-
00817.
______________________
Decided: January 23, 2026
______________________
E. J OSHUA ROSENKRANZ, Orrick, Herrington & Sutcliffe
LLP, New York, NY, argued for appellant. Also repre-
sented by S AMANTHA MICHELLE L EFF ; T RAVIS J ENSEN,
Menlo Park, CA; RAGHAV K RISHNAPRIYAN, ELIZABETH
MOULTON, San Francisco, CA; S ONJA ROCHELLE G ERRARD,
J AD ALLEN MILLS , M ICHAEL T. ROSATO, Wilson, Sonsini,
Goodrich & Rosati, PC, Seattle, WA; RICHARD T ORCZON,
Washington, DC.
WILLIAM MILLIKEN, Sterne Kessler Goldstein & Fox
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 2
PLLC, Washington, DC, argued for appellee. Also repre-
sented by RICHARD C RUDO, D AVID HOLMAN , BYRON L EROY
P ICKARD, RALPH WILSON P OWERS , III.
______________________
Before M OORE, Chief Judge, HUGHES and STOLL , Circuit
Judges.
STOLL , Circuit Judge.
Guardant Health Inc. appeals the final written deci-
sion of the Patent Trial and Appeal Board holding
claims 1–30 of the University of Washington’s U.S. Patent
No. 10,760,127 not unpatentable under 35 U.S.C. § 103.
On appeal, Guardant challenges the Board’s decision re-
quiring a motivation to combine and a reasonable expecta-
tion of success where the elements of amplification followed
by sequencing were disclosed together in a single embodi-
ment in a single reference. Guardant also asserts that sub-
stantial evidence does not support the Board’s findings of
no motivation to combine or reasonable expectation of suc-
cess. We determine that the Board erred by requiring
Guardant to show that a skilled artisan would have had a
motivation to combine the steps of amplification followed
by sequencing and would have had a reasonable expecta-
tion of success in performing the amplification and se-
quencing steps because the prior art reference expressly
discloses performing those steps in sequence and the Peti-
tion did not rely on modifying these two steps to arrive at
the claimed invention. Thus, we vacate the Board’s un-
patentability determination and remand for further pro-
ceedings consistent with this opinion.
BACKGROUND
I
The ’127 patent is directed to a method for reducing the
error rate in massively parallel DNA sequencing using Du-
plex Consensus Sequencing (DCS). U.S. Patent
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 3
No. 10,760,127 Title, Abstract, col. 17 ll. 3–10. The specifi-
cation explains that massively parallel DNA sequencing
has been used for clinical applications such as prenatal
screening for aneuploidy and early detection of cancer and
monitoring its response to therapy with nucleic acid-based
serum biomarkers. The specification further states that
massively parallel DNA sequencing has the “unique ability
to detect minor variants within heterogenous mixtures.”
’127 patent col. 1 ll. 32–41. According to the specification,
however, this type of sequencing has limitations, including
errors that may occur during sample preparation and se-
quencing. These errors create “a practical limit of detec-
tion” leading to “approximately 1% of bases” being
incorrectly identified. Id. at col. 1 l. 60–col. 2 l. 8. The
specification goes on to state that “[t]his background level
of artifactual heterogeneity establishes a limit below which
the presence of true rare variants is obscured.” Id. at col. 2
ll. 8–10. The specification then states that “[i]t would be
desirable to develop an approach for tag-based error correc-
tion, which reduces or eliminates artifactual mutations
arising from DNA damage, PCR errors, and sequencing er-
rors; allows rare variants in heterogenous populations to
be detected with unprecedented sensitivity; and . . . capi-
talizes on the redundant information stored in complexed
double-stranded DNA.” Id. at col. 2 l. 63–col. 3 l. 2.
The ’127 patent then discloses the use of DCS for low-
ering the error rate of sequencing. The specification dis-
closes that DCS involves: (1) “ligating [i.e., attaching] a
double-stranded target nucleic acid molecule to at least one
[single molecule identifier (SMI)] adaptor molecule to form
a double-stranded SMI-target nucleic acid complex;”
(2) “amplifying [i.e., copying] the double stranded SMI-
target nucleic acid complex;” and (3) “sequencing [i.e., de-
termining the linear sequence of] the amplified SMI-target
nucleic acid products.” Id. at col. 3 ll. 18–27.
Claim 1 is illustrative of the claims on appeal and re-
cites:
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 4
1. A method of sequencing DNA comprising:
a) attaching adapters to double-stranded DNA
fragments to generate a plurality of partially-com-
plementary, asymmetrical double-stranded
adapter-DNA molecules, wherein the adapters
comprise barcodes selected from a plurality of dis-
tinct barcode sequences;
b) amplifying original strands of at least a portion
of the double-stranded adapter-DNA molecules to
produce first and second strand copies;
c) sequencing a plurality of first and second strand
copies to obtain first and second strand sequence
reads for at least a portion of the adapter-DNA mol-
ecules; and
d) for at least some of the adapter-DNA molecules
comprising barcodes—
confirming the presence of at least one sequence
read derived from each of the original first and sec-
ond strands of the adapter-DNA molecules;
comparing at least one of the confirmed first and
second strand sequence reads to a reference se-
quence; and
analyzing one or more correspondences between at
least one of the confirmed first and second strand
sequence reads and the reference sequence to iden-
tify a sequence variation.
Id. at col. 37 ll. 31–52 (emphases added to highlight the
claim limitations in dispute). Limitation 1.b, which in-
volves “amplifying,” and limitation 1.c, which involves “se-
quencing,” are relevant on appeal.
II
The claims were challenged as unpatentable under
35 U.S.C. § 103 in light of four prior art references, though
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 5
not all four are relevant on appeal. We describe only the
two prior art references necessary to address Guardant’s
challenges on appeal. The obviousness ground at issue on
appeal is Travers ’0751 in view of Travers 2010.2 We de-
scribe each reference below.
T RAVERS ’075
Travers ’075 is a patent application publication di-
rected to compositions and methods for nucleic acid se-
quencing assigned to PacBio. J.A. 1501. Travers ’075
mainly teaches Single Molecule Real Time (SMRT™) se-
quencing. J.A. 1522 ¶ 43. SMRT sequencing uses a nucleic
acid synthesis complex comprising a polymerase enzyme, a
template sequence, and a primer sequence, which is com-
plementary to a portion of the template sequence.
J.A. 1522 ¶ 43. This complex is immobilized within a con-
fined illumination volume, or wells, which are part of a zero
mode waveguide (ZMW) array. Id.; J.A. 1535 ¶ 141. The
complex is surrounded by a reaction mixture containing
the four different nucleotides (A, G, T, and C), each of
which is labeled with a spectrally distinguishable fluores-
cent label attached to its terminal phosphate group.
J.A. 1522 ¶ 44. The fluorescent label of the free nucleotides
provides a short signal while a nucleotide incorporated by
the polymerase in a primer extension provides a longer sig-
nal. Id. This technique allows the identity of each base to
be detected in real time. J.A. 1522 ¶ 45.
One of the exemplary embodiments in Travers ’075
teaches a circular template comprising a double-stranded
1 U.S. Patent Application No. 2009/0298075 A1.
2 Kevin J. Travers et al., A Flexible and Efficient
Template Format for Circular Consensus Sequencing and
SNP Detection, 38 Nucleic Acids Research e159 (2010).
Travers 2010 was authored by Pacific Biosciences (PacBio)
employees.
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 6
portion linked by two single stranded portions. J.A. 1504
Fig. 2B; J.A. 1523 ¶ 50. Travers ’075 teaches the applica-
tion of the SMRT sequencing process to the circular tem-
plate. J.A. 1505 Fig. 3B; J.A. 1523–24 ¶ 55.
Even though Travers ’075 is mainly directed to SMRT
sequencing, paragraph 122 discloses an embodiment in
which replication occurs followed by SMRT sequencing as
follows:
Although the constructs of the invention are de-
scribed primarily, and preferably, for use directly
as templates for, e.g., sequencing applications, it
will be appreciated that these structures may also
serve as intermediate structures in the preparation
of templates that provide for sequence redundancy
in line with that provided by such constructs. For
example, the structurally circular nucleic acid seg-
ments described herein, may be used as templates
in a rolling circle replication process to produce con-
catemer molecules that include repeating copies of
both the sense and antisense strands of the origi-
nating double stranded segment included within
the circular nucleic acid. These replicated products
may then be employed directly as template mole-
cules in a template dependent sequencing pro-
cess . . . .
J.A. 1532–33 ¶ 122 (emphases added).
Rolling circle replication (RCR) is only mentioned once
in Travers ’075—i.e., in paragraph 122—making this the
sole disclosure of sequentially performing RCR amplifica-
tion followed by sequencing.
T RAVERS 2010
As in Travers ’075, Travers 2010 teaches the same
SMRT sequencing method, using a SMRTbell template,
similar to the circular template in Travers ’075, for SMRT
sequencing. J.A. 1585. Like the circular template in
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 7
Travers ’075, the SMRTbell template taught by Trav-
ers 2010 has a double-stranded region flanked by two hair-
pin loops or single-stranded regions. Id. According to
Travers 2010, “this format resembles a linear double-
stranded molecule, and yet it is topologically circular.”
J.A. 1583, Abstract. Like Travers ’075, Travers 2010
teaches applying the SMRTbell template to SMRT se-
quencing. J.A. 1585. Travers 2010 states that the SMRT
sequencing process “does not depend on amplification.”
J.A. 1587.
III
Guardant petitioned for inter partes review of
claims 1–30 of the ’127 patent based on the combination of
Travers ’075 and Travers 2010. Guardant referred to
Travers ’075 and Travers 2010 collectively as the Travers
Publications in its Petition. In its Petition, Guardant ar-
gued the Travers Publications disclose limitation 1.b,
which involves “amplifying,” and limitation 1.c, which in-
volves “sequencing,” and thus render claim 1 obvious.
J.A. 183–85. Regarding limitation 1.b, Guardant cited par-
agraph 122 of Travers ’075’s disclosure of “rolling circle
replication” of SMRT bell templates as evidence that Trav-
ers ’075 discloses the amplification step. J.A. 183–84.
Guardant argued that the sequencing step taught by limi-
tation 1.c was also disclosed by paragraph 122 of Trav-
ers ’075, where the products of RCR amplification are then
employed in a sequencing process. J.A. 184–85. The Board
instituted review. J.A. 333–55.
In its Patent Owner Response, UW argued that Guar-
dant failed to show that a skilled artisan would have had a
motivation to modify the SMRT sequencing process with
the RCR amplification step disclosed in Travers ’075 with
a reasonable expectation of success. J.A. 426–66. UW also
argued that Travers ’075 did not enable RCR amplification
followed by SMRT sequencing. J.A. 466–68.
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 8
In its Final Written Decision, the Board determined
that Guardant did not demonstrate by preponderant evi-
dence that a skilled artisan would have had a reason to
combine, or a reasonable expectation of success in perform-
ing RCR amplification followed by SMRT sequencing.
J.A. 21–22. Specifically, the Board found that a skilled ar-
tisan would not have modified the Travers Publications to
perform RCR amplification followed by SMRT sequencing
because it would render the SMRT sequencing on ZMWs
disclosed in the Travers Publications unworkable. J.A. 45.
The Board did not reach the issue of whether Travers ’075
enabled RCR amplification followed by SMRT sequencing.
Guardant appeals. We have jurisdiction under
28 U.S.C. § 1295(a)(4)(A).
D ISCUSSION
“We review the Board’s legal conclusions de novo and
its factual findings for substantial evidence.” Univ. of
Strathclyde v. Clear-Vu Lighting LLC, 17 F.4th 155, 160
(Fed. Cir. 2021). “The substantial evidence standard asks
‘whether a reasonable fact finder could have arrived at the
agency’s decision,’ and ‘involves examination of the record
as a whole, taking into account evidence that both justifies
and detracts from an agency’s decision.’” OSI Pharms.,
LLC v. Apotex, Inc., 939 F.3d 1375, 1381–82 (Fed. Cir.
2019) (quoting In re Gartside, 203 F.3d 1305, 1312
(Fed. Cir. 2000)).
Obviousness is a legal question based on underlying
findings of fact. Strathclyde, 17 F.4th at 160. A claim is
unpatentable 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
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 9
having ordinary skill in the art.” 35 U.S.C. § 103(a).3 The
inquiries of whether the prior art discloses a claim limita-
tion, whether a skilled artisan would have been motivated
to modify or combine teachings in the prior art, and
whether she would have had a reasonable expectation of
success in doing so are questions of fact, reviewed for sub-
stantial evidence. Strathclyde, 17 F.4th at 160.
On appeal, Guardant asserts that the Board erred by
requiring a motivation to combine and a reasonable expec-
tation of success because the amplification and sequencing
steps are both taught by paragraph 122 of Travers ’075.
We address these issues in turn.
I
Guardant argues that the Board erred when it required
Guardant to show a persuasive motivation to modify Trav-
ers to perform RCR amplification before SMRT sequencing
when those steps are disclosed in Travers ’075. According
to Guardant, a motivation to combine the steps was not re-
quired because the two steps were disclosed in a single em-
bodiment in a single prior art reference. We agree. When
the disputed elements of a claim are disclosed in a single
embodiment in a single reference, no finding regarding a
motivation to combine to arrive at those claimed elements
is required. Our case law supports this conclusion. In
General Electric Co. v. Raytheon Technologies Corp., for ex-
ample, we held that it is error to “require a motivation to
combine each element of the claim—even those present to-
gether in a reference.” 983 F.3d 1334, 1352 (Fed. Cir.
2020). We reasoned that such an approach “unduly
3 The Leahy-Smith America Invents Act (“AIA”),
Pub. L. No. 112-29, 125 Stat. 284, 287–88 (2011), amended
35 U.S.C. § 103, effective March 16, 2013. Because the
’127 patent has an effective filing date before March 16,
2013, the pre-AIA version of § 103 applies.
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 10
dissects prior art references into collections of individual
elements, requiring a party showing obviousness to re-do
the work already done in the prior art reference.” Id.
The Board erred when it required Guardant to show
that a skilled artisan would have been motivated to com-
bine the steps of performing RCR amplification followed by
SMRT sequencing because both steps were expressly dis-
closed in a single embodiment in Travers ’075 para-
graph 122. It is undisputed that the claimed method
requires the amplification step to occur before the sequenc-
ing step, and that the sequencing step requires sequencing
the amplified adapter-DNA products from the amplifica-
tion step. J.A. 10. The parties do not dispute that the RCR
process taught by Travers ’075 is a type of amplification
process. Appellant’s Br. 35; Appellee’s Br. 25. The parties
also do not dispute that the SMRT sequencing process is a
type of sequencing process. Appellant’s Br. 35; Appellee’s
Br. 25–26. The parties do not dispute that paragraph 122
of Travers ’075 teaches amplification followed by sequenc-
ing. As such, there is no need to show that a skilled artisan
would have been motivated to modify a reference to per-
form two claim steps one after the other when the reference
itself already discloses those limitations together in the
same sequence required by the claims.
UW argues that Guardant never presented an argu-
ment solely relying on Travers ’075 before the Board, and
thus the Board did not err in requiring that Guardant show
a motivation to combine. Appellee’s Br. 33–38. We disa-
gree. In its Petition, Guardant cited the embodiment in
paragraph 122 of Travers ’075 that expressly teaches the
steps of amplification followed by sequencing. Regarding
claim limitation 1.b, Guardant’s Petition specifically
stated: “Travers[ ’075] further describes amplification of
template molecules prior to redundant sequencing. For ex-
ample, Travers[ ’075] explains that ‘rolling circle replica-
tion’ of SMRTbell templates produces concatemer
molecules comprising ‘repeating copies of both the sense
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 11
and antisense strands of the originating double stranded
segment.’” J.A. 183–84 (quoting Travers ’075 J.A. 1532–
33, ¶ 122). The Petition also cited Figures 1 and 4 of Trav-
ers 2010, but Figures 1 and 4 are not directed to RCR or
any other amplification process. J.A. 184; J.A. 1585, 1588.
Instead, these figures illustrate and disclose the details re-
garding sequencing of the SMRTbell template. With re-
spect to limitation 1.c, Guardant’s Petition
stated: “Travers[ ’075] discloses that either SMRTbell
templates or replication products therefrom (i.e., concatem-
ers) may be sequenced using the disclosed template-de-
pendent sequencing process.” J.A. 184 (citing Travers ’075
J.A. 1532–33, ¶ 122). The Petition also cited Travers 2010
for its teaching regarding SMRT sequencing. J.A. 166,
175–76.
The Petition, however, did not rely on modifying Trav-
ers ’075 or Travers 2010 to perform RCR replication of
SMRTbell templates followed by SMRT sequencing and the
Board abused its discretion to the extent it found other-
wise.4 As such, the Board erred in requiring Guardant to
provide a motivation to so modify the Travers Publications.
Our decision in Realtime Data, LLC v. Iancu, 912 F.3d
1368 (Fed. Cir. 2019), is instructive. There, the petitioner
argued that all the elements of challenged claim 1 were dis-
closed in a single prior art reference, O’Brien. Realtime
Data, 912 F.3d at 1371. The petitioner alternatively ar-
gued that the claims would have been obvious in view of
O’Brien combined with a secondary prior art reference—
which did not disclose all elements of the claim on its own.
Id. The Board agreed that O’Brien taught every limitation
of the challenged claims and determined that the claims
thus would have been unpatentable under both references.
Id. at 1371–72. The patent owner appealed, arguing that
4 The Board never explicitly found that the Petition
relied on modifying Travers ’075 or Travers 2010.
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 12
the Board erred in determining a skilled artisan would
have been motivated to combine the references. Id.
at 1372. We held that the Board was free to conclude that
O’Brien alone disclosed every element of the challenged
claims. Id. at 1373. We further determined that, because
the Board did not rely on the secondary reference as dis-
closing any particular claim element or teaching, there was
no obligation for the Board to combine the references and
no need to show a motivation to combine. Id.
Here, the Petition asserted that Travers ’075 expressly
disclosed performing amplification followed by sequencing
by quoting paragraph 122 of Travers ’075. As discussed,
paragraph 122 of Travers ’075 itself teaches not only limi-
tations 1.b and 1.c, but the specific order of amplification
followed by sequencing. Like Realtime Data, a single em-
bodiment in Travers ’075 teaches both the amplification
and sequencing steps of claim 1, while Travers 2010 only
teaches the sequencing step. And similar to Realtime Data,
Guardant did not need to show a motivation to combine
when relying on only the single reference. Accordingly, the
Board erred here by treating the Petition as if it were rely-
ing on modifying the SMRT sequencing as disclosed in the
Travers Publications by performing RCR amplification se-
quencing as disclosed in Travers ’075.
We do, however, acknowledge that the Petition here
could have been clearer. While the Petition relies on para-
graph 122 of Travers ’075, it also cites other parts of Trav-
ers ’075 and Travers 2010 without expressly stating that it
is presenting alternative theories or explaining how these
different cites support its position. Despite these addi-
tional cites, however, the main theory in the Petition is that
the steps of amplification followed by sequencing are
taught by paragraph 122 of Travers ’075 alone.
II
Guardant also argues that substantial evidence does
not support the Board’s finding that a person of ordinary
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 13
skill in the art would not have had a reasonable expecta-
tion of success in first performing RCR replication of
SMRTbell templates and then performing SMRT sequenc-
ing. Like our conclusion regarding motivation to combine,
however, we conclude that the Board erred by requiring
Guardant to show that a skilled artisan would have had a
reasonable expectation of success in performing RCR repli-
cation of SMRTbell templates followed by SMRT sequenc-
ing because Guardant’s Petition relies on paragraph 122 of
Travers ’075 as disclosing these steps in sequence.
We have explained that “[t]he reasonable expectation
of success requirement refers to the likelihood of success in
combining references to meet the limitations of the claimed
invention.” Intelligent Bio-Sys., Inc. v. Illumina Cam-
bridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). And nei-
ther the Board nor UW has cited a case that requires a
party to demonstrate a reasonable expectation of success
in combining two elements to arrive at the claimed inven-
tion when those elements are disclosed in a single embodi-
ment of a single prior art reference. UW cites In re Stepan
Co., 868 F.3d 1342 (Fed. Cir. 2017), to argue that Guardant
had the burden to show that a skilled artisan would have
been motivated to arrive at the claimed invention with a
reasonable expectation of success:
Whether a rejection is based on combining disclo-
sures from multiple references, combining multiple
embodiments from a single reference, or selecting
from large lists of elements in a single reference,
there must be a motivation to make the combina-
tion and a reasonable expectation that such a com-
bination would be successful, otherwise a skilled
artisan would not arrive at the claimed combina-
tion.
Stepan, 868 F.3d at 1346 n.1; see also Appellee’s Br. 43–44.
This quote is inapposite, however, because it addresses
combinations. In other words, Stepan is distinguishable
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 14
from the present case because, here, the elements of the
challenged claim are expressly taught by Travers ’075.
Travers ’075 discloses performing RCR amplification fol-
lowed by SMRT sequencing in a single embodiment. There
is no combination of references, combination of multiple
embodiments in a single reference, or selection from a large
list of elements.
UW also argues that Travers ’075 only provides a “pass-
ing mention” of performing RCR amplification prior to
SMRT sequencing. Appellee’s Br. 49. But a reference is
prior art for all that it teaches, including less preferred em-
bodiments. See In re Inland Steel Co., 265 F.3d 1354, 1361
(Fed. Cir. 2001) (explaining that all disclosures of the prior
art, including unpreferred embodiments, must be consid-
ered); see also Beckman Instruments, Inc. v. LKB Produkter
AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989) (“Even if a refer-
ence discloses an inoperative device, it is prior art for all
that it teaches.” (citation omitted)).
III
As an alternate ground for affirmance, UW asserts that
the Board’s fact findings are sufficient for this court to af-
firm the Board’s final written decision on the basis that
paragraph 122 of Travers ’075 is not enabled. Appellee’s
Br. 67–68. Specifically, UW argues that “Travers ’075 does
not enable the sequencing of an RCR concatemer using
PacBio’s SMRT sequencing,” and therefore because para-
graph 122 is not enabled, it cannot be relied on for disclos-
ing amplification followed by sequencing. Appellee’s
Br. 67. The Board did not reach this issue. As an appellate
court, we will not address this issue in the first instance.
TriMed, Inc. v. Stryker Corp., 608 F.3d 1333, 1339
(Fed. Cir. 2010) (“A federal appellate court does not con-
sider an issue not passed upon below.” (quoting Singleton
v. Wulff, 428 U.S. 106, 120 (1976))). Rather we remand the
case for consideration of this issue by the Board in the first
instance.
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GUARDANT HEALTH , INC. v. UNIVERSITY OF WASHINGTON 15
CONCLUSION
We have considered the parties’ remaining arguments,
and we find them unpersuasive. We vacate the Board’s de-
cision and remand the case to the Board for further pro-
ceedings consistent with this opinion.
VACATED AND REMANDED
COSTS
Costs to Appellant.
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