Integrated Dna Technologies, Inc. v. Pillar Biosciences, Inc.

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
INTEGRATED DNA TECHNOLOGIES, INC.,
Appellant
v.
PILLAR BIOSCIENCES, INC.,
Appellee
______________________
2022-2172
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2021-
00401.
______________________
Decided: December 20, 2024
______________________
RONALD E. CAHILL, Barnes & Thornburg LLP, Boston,
MA, argued for appellant. Also represented by MATTHEW
S. GIBSON, MARK CHRISTOPHER NELSON, Dallas, TX;
STEVEN SHIPE, Washington, DC.
BRIAN ROBERT MATSUI, Morrison & Foerster LLP,
Washington, DC, argued for appellee. Also represented by
MATTHEW IAN KREEGER, San Francisco, CA; JIAN XIAO,
Palo Alto, CA.
______________________
Case: 22-2172 Document: 42 Page: 1 Filed: 12/20/2024

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INTEGRATED DNA TECHNOLOGIES, INC. v.
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Before REYNA, MAYER, and CUNNINGHAM, Circuit Judges.
CUNNINGHAM, Circuit Judge.
Integrated DNA Technologies, Inc. (“IDT”) appeals
from a final written decision of the Patent Trial and Appeal
Board in an inter partes review, finding claims 1–6 of U.S.
Patent No. 10,316,359 unpatentable. Pillar Biosciences,
Inc. v. Swift Biosciences, Inc., No. IPR2021-00401, 2022 WL
2308112, at *1 (P.T.A.B. June 27, 2022) (“Decision”).1 On
appeal, IDT challenges the Board’s claim construction,
argues that the Board’s factual findings were not supported
by substantial evidence, and asserts that the Board erred
in ruling that IDT had forfeited2 certain arguments. For
the reasons below, we affirm the Board’s decision.
I. BACKGROUND
The ’359 patent is titled “Methods for Multiplex PCR.”
It is generally directed to methods for the preparation of
polymerase chain reaction (“PCR”) mixtures and for
performing multiplex PCR amplification that limit the
production of non-target amplicons. ’359 Patent, Abstract.
Claim 1 is illustrative of the issues on appeal and recites:
1 Swift Biosciences, Inc. was the named patent
owner when the IPR was filed. J.A. 608. While the IPR
was pending Swift Biosciences merged with IDT, making
IDT the real party-in-interest. J.A. 609.
2 The parties and the Board use the term “waiver,”
but for consistency we use “forfeiture” throughout this
opinion. See In re Google Tech. Holdings LLC, 980 F.3d
858, 862 (Fed. Cir. 2020) (“By and large, in reviewing this
court’s precedent, it is evident that the court mainly uses
the term ‘waiver’ when applying the doctrine of
‘forfeiture.’”).
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INTEGRATED DNA TECHNOLOGIES, INC. v.
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1. A method of multiplex PCR amplification of a
target nucleic acid substrate comprising the steps
of:
(i) combining a plurality of target-specific
primers with the target nucleic acid
substrate to yield a single polymerase
chain reaction (PCR) reaction mixture,
wherein the plurality of target-specific
primers comprise a first forward primer, a
second forward primer, a first reverse
primer and a second reverse primer,
wherein each of the first and second
forward and reverse primers comprise a 3′
complementary sequence that is
complementary to the target nucleic acid
substrate and a 5′ noncomplementary
sequence that is not complementary to the
target nucleic acid substrate, wherein the
3′ complementary sequence for each of the
first and second forward and reverse
primers is different;
(ii) subjecting the PCR reaction mixture to
a multiplex polymerase chain reaction
thereby generating at least three
amplicons, wherein the at least three
amplicons comprise a first amplicon
produced by the first forward primer and
the first reverse primer, a second amplicon
produced by the second forward primer and
the second reverse primer, and a third
amplicon produced by the second forward
primer and the first reverse primer,
wherein at least a portion of the 5′
noncomplementary sequence of the second
forward primer and the first reverse primer
is the same such that each strand of the
third amplicon comprises a 3′ end and a 5′
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end that are complementary to each other,
wherein the third amplicon possesses
overlapping sequence with the first and
second amplicons, wherein the first
amplicon possesses overlapping sequence
with the second amplicon, wherein when
the third amplicon is denatured, each
strand of the third amplicon forms a
secondary structure as a result of the 3′ end
being complementary to the 5′ end, and
wherein the secondary structure is stable
during a primer annealing step of the
multiplex polymerase chain reaction.
Id. col. 133 ll. 56–67, col. 134 l. 55 to col. 135 l. 12.
On January 7, 2021, Pillar Biosciences, Inc. (“Pillar”)
filed the IPR underlying this appeal, challenging claims 1–
6 of the ’359 patent. Decision at *1; see also J.A. 162.
Among other things, Pillar asserted that the claims of the
’359 patent were obvious over the combination of prior art
references Lao3 and Gardner.4 Decision at *1. The Board
instituted review on July 19, 2021. Id. The Board
subsequently held that Pillar proved by a preponderance of
the evidence that all challenged claims were unpatentable
under 35 U.S.C. § 103(a) over Lao and Gardner. Decision
at *13.
IDT timely appeals. We have jurisdiction under 28
U.S.C. § 1295(a)(4)(A).
3 U.S. Patent Application 2009/0291475 (filed Apr.
22, 2009), J.A. 940–87 (“Lao”).
4 Shea N. Gardner et al., Multiplex Degenerate
Primer Design for Targeted Whole Genome Amplification of
Many Viral Genomes, Advances in Bioinformatics, Aug. 3,
2014, J.A. 1000–07 (“Gardner”).
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II. STANDARD OF REVIEW
“We review the Board’s legal conclusions de novo and
its fact findings for substantial evidence.” Game & Tech.
Co. v. Wargaming Grp. Ltd., 942 F.3d 1343, 1348 (Fed. Cir.
2019). “Substantial evidence means such relevant
evidence as a reasonable mind might accept as adequate to
support a conclusion.” Fanduel, Inc. v. Interactive Games
LLC, 966 F.3d 1334, 1343 (Fed. Cir. 2020) (internal
quotation marks and citation omitted).
“Whether a claimed invention is unpatentable as
obvious is a question of law that is reviewed de novo, based
on underlying findings of fact reviewed for substantial
evidence.” Redline Detection, LLC v. Star Envirotech, Inc.,
811 F.3d 435, 449 (Fed. Cir. 2015). “The Court can review
de novo, however, whether the Board failed to consider the
appropriate scope of the patent’s claimed invention in
evaluating the reasonable expectation of success.”
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821
F.3d 1359, 1366–67 (Fed. Cir. 2016) (cleaned up).
“Decisions related to compliance with the Board’s
procedures are reviewed for an abuse of discretion.” Id. at
1367. “An abuse of discretion is found if the decision: (1) is
clearly unreasonable, arbitrary, or fanciful; (2) is based on
an erroneous conclusion of law; (3) rests on clearly
erroneous fact finding; or (4) involves a record that contains
no evidence on which the Board could rationally base its
decision.” Ericsson Inc. v. Intell. Ventures I LLC, 901 F.3d
1374, 1379 (Fed. Cir. 2018) (quoting Bilstad v.
Wakalopulos, 386 F.3d 1116, 1121 (Fed. Cir. 2004)).
III. DISCUSSION
IDT presents several arguments on appeal. IDT
argues that the Board erred in construing “each strand of
the third amplicon forms a secondary structure . . . and
wherein the secondary structure is stable during a primer
annealing step.” Appellant’s Br. 31–35; Appellant’s Reply
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Br. 17–18. IDT also argues that the Board’s finding of a
motivation to combine the prior art contained factual and
legal errors. See Appellant’s Br. 46–55. IDT further
contends that the Board’s finding of a reasonable
expectation of success was based on hindsight. See id. at
35–46. Lastly, IDT argues that the Board erred in ruling
that IDT had forfeited arguments based on an additional
reference, Schenk.5 Id. at 55–57. We address each
argument in turn.
A.
IDT argues that the Board erred in its claim
construction of “each strand of the third amplicon forms a
secondary structure . . . and wherein the secondary
structure is stable during a primer annealing step” by
concluding that “the claims did not require complete
elimination of short amplicons.” Appellant’s Br. 31
(internal quotation marks omitted). At oral argument, IDT
presented a different construction, arguing that the
quantity of short amplicons “needs to be reduced to a level
[at which] it doesn’t dominate.” Oral Arg. 12:50–13:02,
https://oralarguments.cafc.uscourts.gov/default.aspx?fl=22
-2172_02092024.mp3.
Regardless of which claim construction position IDT
presents, we need not reach the merits of IDT’s claim
construction arguments because it has forfeited them. See
In re Google Tech. Holdings LLC, 980 F.3d 858, 862 (Fed.
Cir. 2020) (explaining that Google forfeited the claim
construction arguments that it failed to present to the
Board). IDT concedes in its briefing that neither party
5 Desiree Schenk et al., Amplification of Overlapping
DNA Amplicons in a Single-Tube Multiplex PCR for
Targeted Next-Generation Sequencing of BRCA1 and
BRCA2, PLoS ONE, July 12, 2017, J.A. 1700–15
(“Schenk”).
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proposed a construction for the term at issue, and neither
party briefed a construction for this term before the
Board. Appellant’s Br. 33; Oral Arg. 12:34–
13:23. Generally, absent exceptional circumstances, we
will not consider on appeal claim construction arguments
that were not first presented to the Board.
IDT argues that it has not forfeited its claim
construction arguments because the Board construed the
“each strand” limitation in its final written decision
inconsistently with the plain and ordinary meaning of the
term after both parties had relied on the plain and ordinary
meaning throughout the proceedings below. Appellant’s
Reply Br. 16–18. However, the Board was only applying
the plain and ordinary meaning of the challenged claims,
which nowhere reference “complete elimination of short
amplicons.” See, e.g., Decision at *9. To the extent that
IDT thinks that complete elimination of short amplicons is
required, or that the short amplicons had to be reduced to
a level that does not dominate the PCR amplification
process, IDT was required to raise those arguments to the
Board to preserve them on appeal.
B.
IDT further argues that the Board’s finding of a
motivation to combine Gardner and Lao was not supported
by substantial evidence because there was allegedly no
dispute that the combination “does not work for its
intended purpose[;] Gardner teaches away from the
combination[;] and the combination would result in the loss
of key functionality in Gardner.” Appellant’s Br. 46. IDT
additionally faults the Board for purportedly short-
circuiting the proper analysis without considering whether
the proposed combination would provide the advantages
that Gardner specifically sought. Id.; see also id. at 48–49.
IDT’s arguments are unpersuasive.
IDT’s main argument for why the Board lacked
substantial evidence for its determination that a skilled
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artisan would have had a motivation to combine Gardner
and Lao concerns the size of the overlapping amplicons in
each of the references. See Appellant’s Br. 46–55.
According to IDT, there is no motivation to combine the
prior art references because 30 of the 36 overlapping
amplicons in Gardner exceeded 100 base pairs and Lao
does not suppress amplicons of that size. Id. at 38, 49. The
Board addressed this argument in the final written
decision, finding that “even under the most restrictive
reading of Lao,” “six of the amplicons listed in Gardner’s
example are shorter than 100 nucleotides and therefore
would have been removed.” Id. at *10. There is no dispute
about the relevant teachings of Gardner and Lao. Oral
Arg. 4:24–4:30 (IDT agreeing “that Gardner discloses at
least some amplicons that are within Lao’s size
limitations”). For example, Gardner expressly teaches “a
step to remove short amplicons before sequencing,” J.A.
1003, and Lao discloses the ability of “shorter insert
sections to self-hybridize, and thus take themselves out of
a reaction.”6 J.A. 972 ¶ 116. In summary, we conclude that
there is substantial evidence support for the Board’s
conclusion that a skilled artisan would have had a
motivation to combine Gardner with Lao, see Decision at
*7–9, and thus we conclude that the Board did not err in
its motivation-to-combine determination.
C.
Substantial evidence also supports the Board’s factual
finding that a skilled artisan would have a reasonable
6 Lao defines insert sections as the portion of the
amplicon between the complementary ends of the linear
primers used to form the amplicon. J.A. 965 ¶ 0064. The
size comparisons in this case were done on an apples-to-
apples basis, and “amplicons,” “insert sections,” and “insert
regions” are terms all used by the parties. J.A. 1800–01;
see Appellant’s Br. 42 n. 5.
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expectation of success in combining Lao and Gardner to
achieve the claimed invention. IDT argues that the Board’s
conclusion was unsupported by substantial evidence
because there is “undisputed evidence that the
combination of Gardner with Lao will fail abjectly . . . for
the purpose of claim 1 of the ’359 patent, . . . for the
purpose of Gardner, and . . . for the stated motivation for
making the combination.” Appellant’s Br. 30. “The
reasonable-expectation-of-success analysis must be tied to
the scope of the claimed invention.” Teva Pharms. USA,
Inc. v. Corcept Therapeutics, Inc., 18 F.4th 1377, 1381 (Fed.
Cir. 2021). IDT does not demonstrate any flaw with the
evidence the Board did rely on in reaching its conclusion
regarding reasonable expectation of success. Decision at
*10 (citing evidence from Lao, Gardner and the testimony
of Pillar’s expert in support of a reasonable expectation of
success); Appellant’s Br. 35–43. The Board did not err in
finding that a skilled artisan would have a reasonable
expectation of success in combining Gardner with Lao to
achieve the claimed invention.
IDT argues that the evidence the Board relied on was
merely conclusory and that its finding was based on
hindsight. See Appellant’s Br. 42–43. We disagree. IDT’s
argument is premised on its claim construction arguments,
which IDT forfeited. See id. at 42 (“This finding can only
be justified by applying the Board’s faulty claim
construction where it found that removal of some
amplicons met the claim.”). Regardless, the Board found
that Lao discloses “self-hybridizing,” a process where
amplicons take themselves out of the reaction. Decision at
*4, 9. Contrary to IDT’s assertions, that finding was not
hindsight; it was based on the express disclosure of Lao.
J.A. 972 ¶ 116. (“[T]he double extended linear primers
having shorter insert sections to self-hybridize, and thus
take themselves out of a reaction . . . .”). Indeed, several
parts of Lao support the Board’s determination. See, e.g.,
J.A. 950 (Fig. 8), 961 ¶ 0034, 964 ¶ 0053. The expert
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testimony the Board relied on provides additional support
for this finding. Decision at *10.
IDT attempts to incorporate one reference’s
embodiments into the other reference. See, e.g.,
Appellant’s Br. 38, 40 (focusing its analysis on the
interaction between a limitation present “in some
embodiments” of Lao, J.A. 966 ¶ 73, and a subset of
overlapping amplicons in an example in Gardner). Here
too, we disagree with IDT’s approach. “[A] determination
of obviousness based on teachings from multiple references
does not require an actual, physical substitution of
elements.” In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir.
2012). The correct inquiry is instead whether a skilled
artisan would reasonably expect success in combining the
prior art’s teachings to achieve the claimed invention.
Intelligent Bio-Sys., 821 F.3d at 1367–68; see also In re
Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir.
2012) (“A reference must be considered for everything that
it teaches, not simply the described invention or a preferred
embodiment.”). We agree with Pillar that because
“Gardner . . . teaches a multiplex PCR reaction with
primers that produce overlapping amplicons” and “never
suggests that its overlapping amplicons in multiplex PCR
reactions must exceed Lao’s supposed size limitation,” the
Board did not err in holding that a skilled artisan would
reasonably expect to succeed in combining the prior art
references to achieve the subject matter claimed by the ’359
patent. Appellee’s Br. 37–38; Decision at *12.
IDT argues that the Board erred by failing to consider
all of IDT's arguments against finding a reasonable
expectation of success. Appellant’s Br. 43 (quoting Decision
at *9). But the Board is “not required to address every
argument raised by a party or explain every possible
reason supporting its conclusion.” Yeda Rsch. v. Mylan
Pharms. Inc., 906 F.3d 1031, 1046 (Fed. Cir. 2018) (cleaned
up). The Board committed no reversible error here, and it
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supported its factual determination with substantial
evidence.
D.
IDT’s contention that the Board erred by finding IDT’s
arguments based on Schenk forfeited under 37 C.F.R.
§ 42.23(b) is similarly unavailing. See Appellant’s Br. 56–
57. IDT argues that it maintained its reliance on the
Schenk reference throughout the proceedings, id., but
IDT’s characterization of the procedural history does not
align with the record, and its argument therefore fails.
During the IPR, the Board cautioned IDT “that any
arguments not raised in the response may be deemed
[forfeited].” J.A. 315. Although IDT had extensively
discussed Schenk in its preliminary response, J.A. 272–76,
IDT’s citations to Schenk in the Patent Owner’s Response
were minimal and without much elaboration. See, e.g., J.A.
350, 353–55, 392. The Board did not abuse its discretion
in finding that IDT had therefore forfeited the argument.
See Decision at *11; In re NuVasive, Inc., 842 F.3d 1376,
1380 (Fed. Cir. 2016) (finding the patent owner “[forfeited]
its public accessibility arguments” where it challenged
public accessibility “during the preliminary proceedings of
the inter partes review but failed to challenge public
accessibility during the trial phase” (citations omitted));
Broadcom Corp. v. ITC, 28 F.4th 240, 252 (Fed. Cir. 2022)
(declining to address argument not raised with the Board
and explaining that “[t]he Board’s scheduling order
specifically informed [patent owner] that ‘any arguments
not raised in the response may be deemed [forfeited]’”).
The Board acted within its discretion when it found that
IDT had forfeited the argument and that it would not
consider the parties’ arguments with respect to Schenk.
IV. CONCLUSION
We have considered IDT’s remaining arguments and
find them unpersuasive. For the above reasons, we affirm.
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AFFIRMED
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