Case: 20-1886 Document: 88 Page: 1 Filed: 11/09/2021
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
CARIS MPI, INC.,
Appellant
v.
FOUNDATION MEDICINE, INC.,
Cross-Appellant
______________________
2020-1886, 2020-1890, 2020-1930
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2019-
00166, IPR2019-00203.
-------------------------------------------------
CARIS MPI, INC.,
Appellant
v.
FOUNDATION MEDICINE, INC.,
Appellee
______________________
2020-1887, 2020-1888, 2020-1889
______________________
Case: 20-1886 Document: 88 Page: 2 Filed: 11/09/2021
2 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2019-
00164, IPR2019-00170, IPR2019-00171.
______________________
Decided: November 9, 2021
______________________
JONATHAN ELLIOT SINGER, Fish & Richardson P.C., San
Diego, CA, argued for appellant. Also represented by
OLIVER RICHARDS; DEANNA JEAN REICHEL, Minneapolis,
MN.
MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
Washington, DC, argued for Foundation Medicine, Inc.
Also represented by JENNIFER SKLENAR; WALLACE WU, Los
Angeles, CA; DAVID B. BASSETT, Wilmer Cutler Pickering
Hale and Dorr LLP, New York, NY; DAVID LANGDON
CAVANAUGH, THOMAS SAUNDERS, Washington, DC, VINITA
FERRERA, KEVIN M. YURKERWICH, Boston, MA.
______________________
Before LOURIE, O’MALLEY, and CHEN, Circuit Judges.
LOURIE, Circuit Judge.
Foundation Medicine, Inc. (“FMI”) petitioned for inter
partes review of U.S. Patent 9,292,660 (the “’660 patent”),
owned by Caris MPI, Inc. (“Caris”). In two decisions, the
United States Patent and Trademark Office Patent Trial
and Appeal Board (“the Board”) held that claims 1–11 and
13–24 of the ’660 patent would have been obvious over prior
art at the time the invention was made 1 but that FMI failed
1 Because the challenged claims of the ’660 patent
have an effective filing date before March 16, 2013, we ap-
ply the version of 35 U.S.C. § 103 in effect before the
Case: 20-1886 Document: 88 Page: 3 Filed: 11/09/2021
CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 3
to demonstrate by a preponderance of the evidence that
claim 12 would have been obvious. See Found. Med., Inc.
v. Caris MPI, Inc., No. IPR2019-00166,
2020 WL 2478691
(P.T.A.B. May 13, 2020) (“Decision I”); Found. Med., Inc. v.
Caris MPI, Inc., No. IPR2019-00203,
2020 WL 2487140
(P.T.A.B. May 13, 2020) (“Decision II”).
Caris appeals (the 2020-1886 appeal) the Board’s hold-
ing that claims 1–11 and 13–24 would have been obvious
and FMI cross-appeals the Board’s holding that it failed to
demonstrate unpatentability of claim 12.
FMI also petitioned for inter partes review of claims 1–
14 of U.S. Patent 8,880,350 (the “’350 patent”), claims 1–14
of U.S. Patent 9,372,193 (the “’193 patent”), and claims 1–
14 of U.S. Patent 9,383,365 (the “’365 patent”), all owned
by Caris. In three decisions, the Board held that claims 1–
14 of each of the ’350, ’193, and ’365 patents would have
been obvious over prior art at the time the invention was
made. 2 See Found. Med., Inc. v. Caris MPI, Inc.,
No. IPR2019-00164,
2020 WL 2781576 (P.T.A.B. May 28,
2020) (“Decision III”); Found. Med., Inc. v. Caris MPI, Inc.,
No. IPR2019-00170,
2020 WL 2789713 (P.T.A.B. May 28,
2020) (“Decision IV”); Found. Med., Inc. v. Caris MPI, Inc.,
No. IPR2019-00171,
2020 WL 2789714 (P.T.A.B. May 28,
2020) (“Decision V”). Caris appeals (the 2020-1887 appeal).
We consolidated the two appeals for briefing and argu-
ment and decide both of them in this opinion. For the rea-
sons detailed below, we affirm the 2020-1887 appeal, and
affirm-in-part, vacate-in-part, and remand the 2020-1886
appeal to the Board for further proceedings.
adoption of the Leahy-Smith America Invents Act (“AIA”),
Pub. L. No. 112-29, 125 Stat. 284 (2011).
2 The challenged claims of the ’350, 193, and 365 pa-
tents also have an effective filing date before March 16,
2013, so the pre-AIA version of § 103 applies.
Case: 20-1886 Document: 88 Page: 4 Filed: 11/09/2021
4 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
BACKGROUND
Caris owns the ’660, ’350, ’193, and ’365 patents. These
patents relate to the field of personalized medicine, which
uses results from molecular profiling to identify treatments
for individuals. The patents describe systems and methods
for identifying individualized medical intervention using
molecular profiling.
A chart showing the claims that the Board addressed
in each decision is shown below.
Decision IPR Claims Patent
Decision I 2019-00166 Claims 1–16, ’660 patent
18, 22, 23
Decision II 2019-00203 Claims 17, 19– ’660 patent
21, 24
Decision III 2019-00164 Claims 1–14 ’350 patent
Decision IV 2019-00170 Claims 1–14 ’193 patent
Decision V 2019-00171 Claims 1–14 ’365 patent
I. THE ’660 PATENT
FMI petitioned for inter partes review of claims 1–24 of
the ’660 patent. Claim 1 is the only independent claim at
issue, with claims 2–24 depending directly or indirectly
therefrom. Claims 1 and 12 are specifically relevant to this
appeal and are reproduced below.
1. A system for generating a report identifying a
therapeutic agent for an individual with lung can-
cer comprising:
a. at least one device configured to assay a
plurality of molecular targets in a
Case: 20-1886 Document: 88 Page: 5 Filed: 11/09/2021
CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 5
biological sample from the individual with
lung cancer to determine molecular profile
test values for the plurality of molecular
targets, wherein the plurality of molecular
targets comprises PTEN, CTNNB1, cKIT,
BRAF and PIK3CA;
b. at least one computer database compris-
ing:
i. a reference value for each of the
plurality of molecular targets;
ii. a listing of available therapeutic
agents for the plurality of molecu-
lar targets;
c. a computer-readable program code com-
prising instructions to input the molecular
profile test values and to compare each of
the molecular profile test values with a cor-
responding reference value from the at
least one computer database in (b)(i);
d. a computer-readable program code com-
prising instructions to access the at least
one computer database in (b)(ii) and to
identify at least one therapeutic agent if
present in the at least one computer data-
base for each of the plurality of molecular
targets wherein said comparison to the ref-
erence values in (c) indicates a likely bene-
fit of the at least one therapeutic agent; and
e. a computer-readable program code com-
prising instructions to generate a report
that comprises a listing of the members of
the plurality of molecular targets for which
the comparison to the reference value indi-
cated a likely benefit of the at least one
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6 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
therapeutic agent in (d) and the at least
one therapeutic agent identified in (d).
’660 patent at col. 164 l. 39–col. 165 l. 2.
12. The system of claim 1, wherein the report fur-
ther comprises a listing of at least one additional
molecular target for which the comparison to the
reference value in (c) indicates a likely lack of ben-
efit of at least one therapeutic agent and the at
least one additional therapeutic agent.
Id. at col. 165 ll. 31–35.
Concerning the ’660 patent, FMI alleged that
(1) claims 1–16, 18, 22, and 23 would have been obvious
over Von Hoff et al., U.S. Patent Pub. 2008/0014146 A1
(“Von Hoff”), Illumina® Gene Expression Profiling, Tech-
nical Bulletin, RNA Profiling with the DASL® Assay
(2005) (“Illumina”), and Marina Bibikova et al., Gene Ex-
pression Profiles in Formalin-Fixed, Paraffin-Embedded
Tissues Obtained with a Novel Assay for Microarray Anal-
ysis, 50 Clinical Chemistry 2384 (2004) (“Bibikova”);
(2) claims 17 and 19 would have been obvious over Von
Hoff, Illumina, Bibikova, and Ashish Guatam et al., RRM1-
induced Metastasis Suppression Through PTEN-Regulated
Pathways, 22 Oncogene 2135 (2003) (“Guatam”);
(3) claims 20 and 24 would have been obvious over Von
Hoff, Illumina, Bibikova, and Andreas Gnirke et al., Solu-
tion Hybrid Selection with Ultra-Long Oligonucleotides for
Massively Parallel Targeted Sequencing, 27 Nature Bio-
technology 182 (2009) (“Gnirke”); and (4) claim 21 would
have been obvious over Von Hoff, Illumina, Bibikova, Gua-
tam, and Gnirke.
The ’660 patent is a continuation-in-part of Von Hoff.
Von Hoff describes methods for determining individualized
medical intervention for a particular disease state utilizing
molecular profiling of a patient’s biological specimen. De-
cision I,
2020 WL 2478691, at *9; Decision II, 2020 WL
Case: 20-1886 Document: 88 Page: 7 Filed: 11/09/2021
CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 7
2487140, at *9. Caris has not disputed Von Hoff’s status
as 35 U.S.C. § 102(b) prior art based on the February 12,
2010 priority date attributed to the ’660 patent. Decision
I,
2020 WL 2478691, at *4, *9; Decision II,
2020 WL
2487140, at *4, *9.
Illumina is a technical bulletin regarding RNA profil-
ing with its cDNA-mediated annealing, selection, exten-
sion, and ligation (“DASL®”) assay. Decision I,
2020 WL
2478691, at *9–11; Decision II,
2020 WL 2487140, at *9–
10. Illumina discloses a gene expression assay that can
monitor up to 1536 RNA-derived sequence targets. J.A.
6887. The cancer panel targets 502 genes. J.A. 6890. The
Board determined that Caris waived any argument ques-
tioning Illumina’s prior art status. Decision I,
2020 WL
2478691, at *11; Decision II,
2020 WL 2487140, at *10.
Bibikova is an article discussing Illumina’s DASL® assay.
Decision I,
2020 WL 2478691, at *9; Decision II,
2020 WL
2487140, at *9.
The Board instituted two trials and issued two written
decisions concluding that FMI had demonstrated that
claims 1–11 and 13–24 would have been obvious over the
prior art, but that FMI failed to demonstrate that claim 12
would have been obvious. Decision I,
2020 WL 2478691, at
*16; Decision II,
2020 WL 2487140, at *13. The Board first
resolved the claim construction issue: whether claim 1 (and
by extension all the challenged dependent claims) requires
the claimed system to test for contraindications. The
Board agreed with FMI that the claimed system does not
require contraindication testing. Decision I,
2020 WL
2478691, at *6–8; Decision II,
2020 WL 2487140, at *6–9.
The Board found “nothing in the language of claim 1 that
requires the claimed system to specifically test for any con-
traindications or otherwise determine whether any thera-
peutic agents have a likely lack of benefit.”
Id.
The Board determined that the prior art disclosed all
the limitations of claims 1–11 and 13–24 and that a person
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8 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
of ordinary skill would have been motivated to combine the
teachings to arrive at the claimed system with a reasonable
expectation of success. Decision I,
2020 WL 2478691, at
*11–15; Decision II,
2020 WL 2487140, at *11–12. Apply-
ing its construction, the Board found that “Von Hoff
teaches most of the limitations” but “does not specifically
mention lung cancer or identify the molecular targets.”
Id.
The Board determined that a person of skill in the art
“would have been motivated to modify or substitute Von
Hoff's micro array analysis with the DASL Assay as taught
by Illumina and Bibikova in order to provide a more com-
prehensive molecular profile that could be used to identify
potential therapeutic agents for an individual with lung
cancer.”
Id.
The Board determined, however, that the prior art did
not disclose all the limitations of claim 12. The Board con-
strued claim 12 such that “the report generated . . . must
do more than simply indicate that expression of the addi-
tional molecular target falls within a ‘normal’ range or that
there is no change from the reference value for expression
of that molecular target.” Decision I,
2020 WL 2478691, at
*9. The Board required that “the report lists at least one
additional molecular target (the contraindication target)
for which the comparison to the reference value indicates a
likely lack of benefit (contraindication) of at least one ther-
apeutic agent as well as the additional therapeutic agent
(the contraindicated agent).”
Id.
The Board determined that FMI did not demonstrate
that the prior art references disclose or render obvious the
additional limitation in claim 12 “wherein the report fur-
ther comprises a list of at least one additional molecular
target for which the comparison to the reference value in
(c) indicates a likely lack of benefit of at least one therapeu-
tic agent and the at least one additional therapeutic agent.”
The Board thus held that FMI failed to demonstrate un-
patentability of claim 12. Decision I,
2020 WL 2478691, at
*15–16. The Board also determined that Von Hoff’s system
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CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 9
and its report at Figures 3A–3D were insufficient to satisfy
the requirements of claim 12.
Id. at *16. The Board re-
jected FMI’s purported motivation to modify Von Hoff’s
teachings to include “one additional target” in the report.
Id.
Caris appealed, and FMI cross-appealed. We have ju-
risdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).
II. THE ’350, ’193, AND ’365 PATENTS
FMI petitioned for inter partes review of claims 1–14 of
each of the ’350, ’193, and ’365 patents. Claim 1 of the ’193
patent is a representative independent claim.
1. A system for generating a report identifying at
least one therapeutic agent for an individual with
a cancer comprising:
a. at least one device configured to assay a
plurality of molecular targets in a biologi-
cal sample to determine molecular profile
test values for the plurality of molecular
targets, wherein the plurality of molecular
targets comprises AR, EGFR, HER2, KIT,
MLH1, PTEN, and PDGFRA; and
b. at least one computer database compris-
ing:
i. a reference value for each of the
plurality of molecular targets; and
ii. a listing of available therapeutic
agents for each of the plurality of
molecular targets;
c. a computer-readable program code com-
prising instructions to input the molecular
profile test values and to compare each of
the molecular profile test values with a
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10 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
corresponding reference value from the at
least one computer database in (b)(i);
d. a computer-readable program code com-
prising instructions to access the at least
one computer database and to identify at
least one therapeutic agent from the listing
of available therapeutic agents for the plu-
rality of molecular targets wherein the
comparison to the reference values in (c) in-
dicates a likely benefit of the at least one
therapeutic agent; and
e. a computer-readable program code com-
prising instructions to generate a report
that comprises a listing of the molecular
targets for which the comparison to the ref-
erence value indicated a likely benefit of
the at least one therapeutic agent in (d)
and the at least one therapeutic agent iden-
tified in (d).
’193 patent at col. 17, ll. 2–32.
FMI alleged that claims 1–14 of each of the ’350, ’193,
and ’365 patents would have been obvious over Mou-Ying
Fu Lu and Rong Yu, WO 03/017038 A2 (“Lu”) and Illumina.
Lu teaches a computerized decision support system for se-
lecting an optimum treatment for cancer based on a pa-
tient’s genotype. J.A. 6864. Lu’s physician interface
module presents “recommendations as to the optimum
drugs based on a patient genotype to the doctor” by “listing
the benefits of the drug, the efficacy for the patient’s par-
ticular genotype, the drug’s side effects based upon the pa-
tient’s genotype and other relevant information.” J.A.
6876. Lu notes that the software may be “customized for a
single disease or multiple diseases.” J.A. 6875. The “sys-
tem can be used to identify an optimum drug for treating
virtually any disease for which there exists an established
correlation between a patient genotype and the efficacy
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CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 11
and toxicity of each of a group of drugs developed to treat
the general condition.” J.A. 6879.
The Board instituted three trials and issued three writ-
ten decisions concluding that FMI had demonstrated that
claims 1–14 of each of the ’350, ’193, and ’365 patents
would have been obvious over the prior art. Decision III,
2020 WL 2781576, at *23; Decision IV,
2020 WL 2789713,
at *23; Decision V,
2020 WL 2789714, at *23. The Board
first resolved the claim construction issue: whether the
claims require a system that is cancer-lineage independ-
ent. Caris argued that “a ‘cancer-lineage independent’ sys-
tem is one that ‘identif[ies] treatment options for a cancer
patient independent of cancer type, based on groups of mo-
lecular targets not traditionally or conventionally associ-
ated with the patient’s specific cancer type.” Decision III,
2020 WL 2781576, at *8; Decision IV,
2020 WL 2789713, at
*8; Decision V,
2020 WL 2789714, at *8. It is understood
that the word lineage as used here means organ-based
(e.g., lung, breast, kidney) as opposed to molecular target-
based.
The Board, however, concluded that the claims were
not restricted to a cancer-lineage independent approach.
Decision III,
2020 WL 2781576, at *9–12; Decision IV,
2020
WL 2789713, at *9–12; Decision V,
2020 WL 2789714, at
*9–12. The Board determined that nothing in the plain
claim language requires the system to be a cancer-lineage
independent system.
Id. The Board also determined that
the written descriptions and prosecution histories did not
make clear that the claims require cancer-lineage inde-
pendence.
Id. The Board noted that adding a cancer-line-
age independence requirement would result in ambiguity.
Id.
Applying its construction, the Board determined that
Lu and Illumina disclose all the limitations of the claims.
Decision III,
2020 WL 2781576, at *15–17; Decision IV,
2020 WL 2789713, at *15–17; Decision V, 2020 WL
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12 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
2789714, at *15–17. The Board noted that Caris had con-
ceded that, if the Board “construed the claims as encom-
passing a ‘lineage dependent analysis,’ then the prior art
taught the claimed subject matter.”
Id. Furthermore, the
Board determined that even if the claims did require a can-
cer-lineage approach, Lu and Illumina teach or suggest all
elements of the claims because Illumina teaches a pan-can-
cer microarray of molecular targets and Lu, or the combi-
nation of Lu and Illumina, suggests a cancer-lineage
independent system.
Id.
Caris appealed. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(4)(A).
DISCUSSION
We review claim construction de novo except for sub-
sidiary factual findings based on extrinsic evidence, which
we review for substantial evidence. Teva Pharms. USA,
Inc. v. Sandoz, Inc.,
574 U.S. 318, 331–33 (2015). Obvious-
ness is a question of law that “lends itself to several basic
factual inquiries,” including the scope and content of the
prior art, the level of ordinary skill in the art, and differ-
ences between the prior art and the claimed invention.
Graham v. John Deere Co.,
383 U.S. 1, 17–18 (1966) (citing
Great Atl. & Pac. Tea Co. v. Supermarket Equip. Corp.,
340
U.S. 147, 155 (1950)). We review the Board’s legal deter-
minations de novo, In re Elsner,
381 F.3d 1125, 1127 (Fed.
Cir. 2004), and the Board’s factual findings underlying
those determinations for substantial evidence, In re Gart-
side,
203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is sup-
ported by substantial evidence if a reasonable mind might
accept the evidence to support the finding. See Consol. Ed-
ison Co. of New York v. NLRB,
305 U.S. 197, 229 (1938).
Caris contends that the Board erred in concluding that
claims 1–11 and 13–24 of the ’660 patent would have been
obvious over the references. FMI asserts, in its cross-ap-
peal, that the Board erred in concluding that FMI failed to
demonstrate that claim 12 of the ’660 patent would have
Case: 20-1886 Document: 88 Page: 13 Filed: 11/09/2021
CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 13
been obvious. Caris also contends that the Board erred in
concluding all of the ’350, ’193, and ’365 patent claims
would have been obvious. We address the parties’ argu-
ments on appeal below.
I. CARIS’S APPEAL CONCERNING THE ’660 PATENT
Caris argues that the Board erred in construing the
claims as not requiring utilization of contraindication in-
formation from molecular testing. Caris acknowledged
that the Board’s conclusion that claims 1–11 and 13–24
would have been obvious over the prior art was dependent
on the Board’s claim construction. See Appellant’s Br. 32,
54. Resolution of this claim construction issue thus re-
solves the dispute as to whether the challenged ’660 patent
claims were unpatentable as obvious.
Caris contends that the Board’s refusal to accept its
proposed construction led to an unreasonably broad mean-
ing, even under the broadest reasonable interpretation
standard. Specifically, Caris argues that the Board’s con-
struction is inconsistent with the specification’s description
of the invention and with how a person of skill in the art
would understand the claim language. Caris asserts that
claim 1 recites testing for two markers that could only be
used for contraindication testing: BRAF and PIK3CA. See
’660 patent at col. 164, l. 46. In support of its argument,
Caris points to Tables 1 and 2 and the report shown in Fig-
ures 40A–J. J.A. 199–238; J.A. 162–71.
FMI responds that the Board reasonably construed the
claims as not requiring contraindication testing. Specifi-
cally, FMI argues that there is no textual basis in the claim
language for requiring contraindication testing and that
contraindication testing is only one of many embodiments
in the ’660 patent’s written description. FMI also noted
that Caris deleted a contraindication limitation from the
claims of a parent application of the ’660 patent, implying
that lack of express inclusion confirms its absence. See
Cross-Appellant’s Br. 3 (describing the prosecution history
Case: 20-1886 Document: 88 Page: 14 Filed: 11/09/2021
14 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
of U.S. Patent Application 12/658,770 (the ’770 applica-
tion)).
We conclude that the Board’s construction was not un-
reasonably broad. Claim 1’s language is not plainly limited
to systems that use contraindication testing. The language
of the claims and the ’660 patent’s written description sup-
port the Board’s decision to refuse to import a contraindi-
cation requirement into all of the claims. Although the ’660
patent may not describe available therapeutic agents for
two of the targets recited in claim 1, claim 1 is not limited
to specific assays and the ’660 patent contemplates that the
therapeutic agent database would be “continuously up-
dated” as new agents and associations were discovered.
’660 patent at col. 57 ll. 33–35. Although the claims may
encompass systems that use contraindication information,
Caris failed to demonstrate that a narrow construction is
required. Considering the intrinsic evidence and the
broadest reasonable interpretation standard, the Board did
not err in its construction.
Regarding the parties’ arguments about the prosecu-
tion history of the ’770 application, although not disposi-
tive, it is relevant that Caris previously sought claims that
more clearly recited a system that identifies a treatment if
a comparison “does not contraindicate the treatment for
treating the cancer.” See Decision I,
2020 WL 2478691, at
*7; Decision II, 2020 WL , at *8. Although an exact term or
phrase is not necessarily required to convey a limitation,
the absence of the explicit terminology that Caris already
used in a related application to claim contraindication test-
ing further supports the Board’s construction.
Given the construction of the claims, the Board’s find-
ing that FMI demonstrated that the prior art teaches or
suggests all elements of claims 1–11 and 13–24 is sup-
ported by substantial evidence. As the Board noted, Caris’s
arguments in support of patentability are primarily de-
pendent upon its claim construction position. J.A. 33. The
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CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 15
Board determined that Von Hoff teaches the identification
of a therapeutic agent that is of likely benefit for a partic-
ular molecular target. See Decision I,
2020 WL 2478691,
at *14–15; Decision II, 2020 WL , at *12. The Board cred-
ited the testimony of FMI’s expert in concluding that the
prior art teachings are sufficient to satisfy the claim re-
quirements and that a person of skill in the art would have
been motivated to combine the prior art references.
Id. In
view of the evidence relied upon by the Board, the Board’s
conclusion was well supported. Accordingly, we affirm the
Board’s decision that claims 1–11 and 13–24 would have
been obvious over the cited prior art. See Decision I,
2020
WL 2478691, at *16; see also Decision II, 2020 WL , at *13.
II. FMI’S CROSS-APPEAL
In its cross-appeal, FMI argues that the Board erred in
construing claim 12’s “likely lack of benefit” as “contraindi-
cation.” FMI asserts that a “likely lack of benefit” means
possibly not beneficial or effective. See Cross-Appellant’s
Br. 50–51. Under a correct interpretation, according to
FMI, Von Hoff discloses this claim limitation. However,
FMI argues that, even under the Board’s construction, the
Board’s conclusion that Von Hoff fails to disclose this limi-
tation is unsupported by substantial evidence.
FMI argues that the Board erred by construing
claim 12 to require contraindication testing. FMI argues
that the intrinsic evidence does not support importing con-
traindication requirements into claim 12. Caris responds
that the Board’s conclusion on claim 12 should be affirmed.
Caris contends that there is no question that claim 12 re-
citing “a lack of clinical benefit” requires identification of
contraindicated treatments.
We conclude that, in two respects, the Board’s con-
struction of claim 12 was overly narrow. First, the Board
construed claim 12 such that “the report generated . . .
must do more than simply indicate that expression of the
additional molecular target falls within a ‘normal’ range or
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16 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
that there is no change from the reference value for expres-
sion of that molecular target.” However, this requirement
imports extraneous detail into the claim 12 that is not sup-
ported by the intrinsic evidence. We discern no disclaimer
or special definition in the intrinsic record that warrants
excluding a “normal” or “no change” test value of a molec-
ular target from the scope of claim 12.
Second, the language concerning “contraindications”
was not required in claim 12’s construction. The parties do
not dispute that the generally accepted meaning of a drug
that is “contraindicated” is that the drug will be expected
to have harmful effects on a patient. See, e.g., Appellant’s
Br. 8 n.2; Cross-Appellant’s Br. 16. But a “likely lack of
benefit” encompasses more than merely scenarios in which
an agent is harmful. The intrinsic evidence does not
demonstrate the applicant’s intent to narrow the under-
standing of the term “likely lack of benefit.” We under-
stand that Caris views “contraindication” to have a
different meaning from the generally accepted one in the
context of the specification and the Board’s construction.
But we find the intrinsic evidence does not support equat-
ing “likely lack of benefit” to Caris’s specialized interpreta-
tion of “contraindication” either. It was therefore error for
the Board to include the “contraindication” concept in its
construction of claim 12. We therefore vacate the Board’s
decision construing claim 12 and concluding that claim 12
was not unpatentable as obvious. See Decision I,
2020 WL
2478691, at *16.
III. CARIS’S APPEAL CONCERNING THE ’350, ’193, AND ’365
PATENTS
Caris argues that the Board erred in not construing the
claims to require a cancer-lineage independent system. It
argues that claim 1 does not reference any type of cancer,
instead linking therapeutic agents to a group of lineage-
independent targets such that a recommended therapeutic
agent would necessarily be lineage independent. Caris
Case: 20-1886 Document: 88 Page: 17 Filed: 11/09/2021
CARIS MPI, INC. v. FOUNDATION MEDICINE, INC. 17
contends that the Board’s construction is inconsistent with
the specification and reads on prior art. Under a correct
construction, according to Caris, the Board’s conclusion
that the claims would have been obvious over the prior art
is unsupported by substantial evidence because the prior
art only uses lineage-dependent systems.
FMI responds that there is no basis for interpreting the
claims to require cancer-lineage independence. FMI as-
serts that the ’350, ’193, and ’365 patents use phrases such
as “independent of disease lineage diagnosis” and “not sin-
gle disease restricted” to convey the concept of identifying
a therapeutic agent independently of cancer lineage. See,
e.g., ’350 patent at col. 2 ll. 28–33;
id. at col. 2 ll. 39–47. Ac-
cording to FMI, there is no disclaimer or special definition
in any of the written descriptions that justifies importing a
requirement that the systems must be lineage independ-
ent.
We conclude that the Board’s construction was con-
sistent with the intrinsic evidence. Under the broadest
reasonable interpretation standard, the Board properly an-
alyzed the claim language and the patent specifications but
found no evidence that the claims must exclude lineage-de-
pendent systems. We thus conclude that the Board did not
err in declining to construe the claims as requiring lineage
independence.
Our affirmance of the Board’s construction essentially
requires that we affirm the Board’s obviousness conclusion.
Caris does not contest the Board’s determination that, un-
der the construction applied by the Board, the claims would
have been obvious, and we discern no error with the
Board’s analysis of the prior art. In view of the evidence
relied upon by the Board, we find the Board’s conclusion to
be supported by substantial evidence. Accordingly, we af-
firm the Board’s decision that claims 1–14 of each of the
’350, ’193, and ’365 patents would have been obvious over
the cited prior art.
Case: 20-1886 Document: 88 Page: 18 Filed: 11/09/2021
18 CARIS MPI, INC. v. FOUNDATION MEDICINE, INC.
CONCLUSION
We have considered the parties’ remaining arguments
but find them unpersuasive. For the foregoing reasons,
with respect to the ’660 patent, we affirm the portion of the
Board’s decision concluding that claims 1–11 and 13–24
would have been obvious and vacate the portion of the
Board’s decision construing claim 12 and concluding that
claim 12 was not unpatentable as obvious (Appeal
Nos. 2020-1886, -1890, -1930). We remand the Board’s de-
cision in IPR2019-00166 for further proceedings consistent
with this opinion. With respect to the ’350, ’193, and ’365
patents, we affirm the decisions of the Board (Appeal
Nos. 2020-1887, -1888, -1889).
AFFIRMED-IN-PART, VACATED-IN-PART, AND
REMANDED
COSTS
No costs.
