Incept LLC v. Palette Life Sciences, Inc.

United States Court of Appeals
for the Federal Circuit
______________________
INCEPT LLC,
Appellant
v.
PALETTE LIFE SCIENCES, INC.,
Appellee
KATHERINE K. VIDAL, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Intervenor
______________________
2021-2063, 2021-2065
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2020-
00002, IPR2020-00004.
______________________
Decided: August 16, 2023
______________________
T IMOTHY E. G RIMSRUD, Faegre Drinker Biddle & Reath
LLP, Minneapolis, MN, argued for appellant. Also repre-
sented by L AUREN J.F. BARTA ; CHRISTOPHER J. BURRELL ,
BETHANY N. MIHALIK, Washington, DC.
T UNG O N K ONG, Wilson, Sonsini, Goodrich & Rosati,
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 2
PC, San Francisco, CA, argued for appellee. Also repre-
sented by T ASHA T HOMAS , RICHARD T ORCZON, Washington,
DC; L ORELEI WESTIN, San Diego, CA.
MARY L. K ELLY , Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, for interve-
nor. Also represented by P ETER J. AYERS , D ANIEL
K AZHDAN, T HOMAS W. K RAUSE, F ARHEENA YASMEEN
RASHEED.
______________________
Before N EWMAN, SCHALL , and T ARANTO, Circuit Judges.
Opinion for the court filed by Circuit Judge SCHALL .
Opinion concurring-in-part and dissenting-in-part filed by
Circuit Judge N EWMAN.
Incept LLC owns U.S. Patent Nos. 8,257,723 (“the ’723
patent”) and 7,744,913 (“the ’913 patent”). It now appeals
from two final written decisions of the U.S. Patent and
Trademark Office Patent Trial and Appeal Board (“the
Board”) holding the claims of the ’723 patent and the ’913
patent unpatentable as anticipated by, or obvious in view
of, the asserted prior art. For the following reasons, we af-
firm.
BACKGROUND
I
The ’723 and ’913 patents relate to improved methods
for treating cancer, particularly prostate cancer, using ra-
diation. The patents describe methods of introducing a
filler between a radiation target tissue and other tissue to
increase the distance between the two and thereby de-
crease the amount of radiation received by the non-tar-
geted tissue. ’723 patent at Abstract, col. 2 ll. 28–31; ’913
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 3
patent at Abstract, col. 2 ll. 28–31.1 The ’723 patent has
one independent claim and twenty-three dependent claims.
’723 patent col. 16 l. 49–col. 18 l. 23. The ’913 patent has
two independent claims and twenty-three dependent
claims. ’913 patent col. 16 l. 43–col. 18 l. 32.
Independent claim 1 of the ’723 patent recites:
1. A method of delivering a therapeutic dose of ra-
diation to a patient comprising
introducing a biocompatible, biodegradable filler
between an organ and a nearby tissue to increase a
distance between the organ and the tissue, and
treating the tissue with the therapeutic dose of ra-
diation so that the presence of the filler causes the
organ to receive less of the dose of radiation com-
pared to the amount of the dose of radiation the or-
gan would receive in the absence of the filler,
wherein the filler is introduced as an injectable ma-
terial and is a gel in the patient, and wherein the
filler is removable by biodegradation in the patient.
’723 patent col. 16 ll. 49–59. Independent claim 1 of the
’913 patent is similar to claim 1 of the ’723 patent but in-
cludes the additional limitation that the filler is introduced
specifically between a patient’s prostate gland and rectum.
’913 patent col. 16 ll. 43–57. Accordingly, the claims of both
patents recite a filler that is (1) biocompatible, (2) injecta-
ble, (3) a gel in the patient, (4) biodegradable/removable by
biodegradation, and (5) introduced between a radiation
target and nearby tissue.2
1 The ’723 patent is a continuation of, and has a spec-
ification identical to, the ’913 patent.
2 Independent claim 17 of the ’913 patent differs be-
cause it recites additional limitations and does not include
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 4
II
Palette Life Sciences, Inc. (“Palette”) filed petitions for
inter partes review challenging the claims of the ’723 and
’913 patents as unpatentable over prior art, including U.S.
Patent No. 6,624,245 to Wallace et al. (“Wallace”).
Wallace describes a method for the “rapid formation of
a biocompatible gel . . . at a selected site within a patient’s
body.” Wallace at Abstract. Wallace explains that its bio-
compatible gels can be formed from reaction mixtures that
are injected at a specific site within a patient’s body and
allowed to crosslink at the site of the injection. Id. col. 10
ll. 8–12. Wallace provides that its gels may be formed from
polymers that include biodegradable segments or blocks
that are hydrolyzed in the presence of water or enzymati-
cally cleaved in situ. Id. col. 19 ll. 3–19. According to Wal-
lace, the “preferred application” of its compositions is for
use as a “tissue sealant[] and adhesive[].” Id. col. 28 ll. 44–
62. Wallace explains, however, that “[t]he compositions
can also be used as a large space-filling device for organ
displacement in a body cavity during surgical or radiation
procedures, for example, to protect the intestines during a
planned course of radiation to the pelvis.” Id. col. 33 ll. 64–
67.
Palette’s petition challenging the ’723 patent asserted
that claims 1, 6, 8–12, 14, 15, and 17–22 would have been
anticipated by Wallace, that claims 1–6, 8–12, and 14–24
would have been obvious in view of Wallace, and that
claims 7 and 13 would have been obvious over Wallace in
combination with PCT Publication No. WO 94/25080 to
some of the limitations of independent claim 1 of both pa-
tents (e.g., the filler being injectable and a gel in the pa-
tient). We need not separately address claim 17, however,
because Incept does not provide any argument based on
those differences. See Appellant’s Br. 2–3, 6, 8.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 5
Griffith-Cima et al. (“Griffith-Cima”). J.A. 149. In its pe-
tition challenging the ’913 patent, Palette asserted that
claims 1–18 and 20–24 would have been obvious over Wal-
lace in combination with U.S. Patent No. 6,210,314 to Ein-
Gal (“Ein-Gal”), and that claims 19 and 25 would have been
obvious over the combination of Wallace, Ein-Gal, and Grif-
fith-Cima. J.A. 5479.
The Board instituted inter partes review and ulti-
mately issued final written decisions in which it held that
Palette had established the challenged claims to be un-
patentable on the Wallace-based grounds set forth in the
two petitions. Palette Life Scis., Inc. v. Incept LLC, No.
IPR2020-00002, 2021 WL 1393447 (P.T.A.B. April 13,
2021) (’723 Final Written Decision); Palette Life Scis., Inc.
v. Incept LLC, No. IPR2020-00004, 2021 WL 1395258
(P.T.A.B. April 13, 2021) (’913 Final Written Decision).3
Incept appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A).
D ISCUSSION
I
We review the Board’s legal conclusions de novo and
its factual findings for substantial evidence. Becton, Dick-
inson & Co. v. Baxter Corp., 998 F.3d 1337, 1339 (Fed. Cir.
2021). Anticipation is a question of fact. Mylan Pharms.
Inc. v. Merck Sharp & Dohme Corp., 50 F.4th 147, 152 (Fed.
Cir. 2022). Obviousness is a question of law based on un-
derlying factual determinations. KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 427 (2007). Those underlying factual
determinations include: (1) the scope and content of the
prior art; (2) differences between the prior art and the
3 Palette’s petitions set forth other grounds for un-
patentability of the ’723 and ’913 patents’ claims that the
Board declined to reach in its final written decisions.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 6
claims at issue; (3) the level of ordinary skill in the perti-
nent art; and (4) secondary considerations such as commer-
cial success, long felt but unsolved needs, and failure of
others. Graham v. John Deere Co., 383 U.S. 1, 17–18
(1966).
Substantial evidence is “such relevant evidence as a
reasonable mind might accept as adequate to support a
conclusion.” Consol. Edison Co. v. NLRB, 305 U.S. 197, 229
(1938). The possibility of drawing two inconsistent conclu-
sions from the evidence does not prevent the Board’s find-
ings from being supported by substantial evidence. See
Consolo v. Fed. Mar. Comm’n, 383 U.S. 607, 620 (1966).
II
We begin with anticipation. Under 35 U.S.C. § 102, a
prior art reference will anticipate a patent claim if it dis-
closes all of the limitations of the claim “arranged or com-
bined in the same way as in the claim.” Net MoneyIN, Inc.
v. VeriSign, Inc., 545 F.3d 1359, 1369–70 (Fed. Cir. 2008).
Incept argues on appeal that the Board committed legal er-
ror because it engaged in a “patchwork approach” that in-
volved “picking and choosing” from Wallace’s different
teachings to piece together the elements of the ’723 patent
claims. Appellant’s Br. 31–33 (citing In re Arkley, 455 F.2d
586, 587–88 (CCPA 1972)). According to Incept, Wallace
“teaches a complex, multi-step process for its gel that in-
volves picking and choosing among numerous materials
and properties,” such that Wallace “describes millions, if
not billions, of different possible compositions, each with
different properties.” Id. at 34–35. Incept relies on cases
from this court explaining that, when a prior art reference
describes a genus and the challenged claim recites a spe-
cies of that genus, anticipation turns on whether the genus
was of such a defined and limited class that one of ordinary
skill in the art could have “at once envisaged” each member
of the genus. Id. at 36 (citing Eli Lilly & Co. v. Zenith Gold-
line Pharms., Inc., 471 F.3d 1369, 1376 (Fed. Cir. 2006);
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 7
Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999
(Fed. Cir. 2006); Metabolite Lab’ys, Inc. v. Lab’y Corp. of
Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004)).
We see no legal error in the Board’s anticipation anal-
ysis. The Board did not engage in “picking and choosing”
features from different teachings of Wallace. Instead, it
found that Wallace expressly describes compositions that
have the claimed characteristics of, and are used for the
same displacement purpose as, the compositions referred
to in the ’723 patent claims challenged as anticipated. As
the Board explained, although Wallace discloses various
options for each component of its compositions, the charac-
teristics of those compositions required for anticipation
would remain, even if the degree to which those character-
istics would be present could vary (in ways immaterial to
anticipation). ’723 Final Written Decision, 2021 WL
1393447, at *12 (“Wallace’s disclosure of various options for
each component of its composition does not change those
characteristics of its filler composition that are recited by
claim 1 [of the ’723 patent].”). Moreover, the claims of the
’723 patent are not directed to a “species” of fillers that fall
within the “genus” of compositions described in Wallace.
Rather, the ’723 patent claims are directed to a method of
introducing fillers having certain general qualities, which
general qualities Wallace’s compositions are also described
as having. Incept cannot use the fact that Wallace de-
scribes multiple compositions to evade an anticipation find-
ing where Wallace provides “as complete detail as is
contained in the patent claim,” such that a skilled artisan
would have understood that Wallace’s compositions had
the same generic properties as those in the ’723 patent
claims. See Richardson v. Suzuki Motor Co., Ltd., 868 F.2d
1226, 1236 (Fed. Cir. 1989) (providing that, to anticipate,
“[t]he identical invention must be shown in as complete de-
tail as is contained in the patent claim”).
Incept next takes issue with what it refers to as the
Board’s failure to identify a teaching in Wallace that any of
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 8
its compositions are “entirely removable by biodegrada-
tion.” Appellant’s Br. 40 (emphasis added). Wallace’s
teaching of “biodegradable segments,” Incept contends,
“[a]t most . . . suggests only that, at least in some applica-
tions, a portion of the polymer may be biodegradable,” par-
ticularly because Wallace elsewhere teaches that its
compositions “are not readily degradable in vivo.” Id. at
40–41 (citing Wallace col. 19 ll. 3–9, ll. col. 34 ll. 11–14).
We are not persuaded that the Board’s finding of biodegra-
dability was insufficient. To begin, the Board expressly
found Wallace’s filler compositions not only to be “biode-
gradable” but also to specifically be “removable by biodeg-
radation,” as the claims require. ’723 Final Written
Decision, 2021 WL 1393447, at *12. In support of this find-
ing, the Board relied on the below excerpt of Wallace:
The polymer may include biodegradable segments
and blocks, either distributed throughout the poly-
mer’s molecular structure or present as a single
block, as in a block copolymer. Biodegradable seg-
ments are those that degrade so as to break cova-
lent bonds. Typically, biodegradable segments are
segments that are hydrolyzed in the presence of
water and/or enzymatically cleaved in situ.
Wallace col. 19 ll. 3–9. Thus, Wallace teaches that a poly-
mer can have “biodegradable segments,” distributed
throughout its molecular structure, that degrade so as to
break the polymer’s covalent bonds. While this excerpt of
Wallace alone constitutes substantial evidence to support
the Board’s finding, the finding is also supported by Pal-
ette’s expert’s testimony, noted by the Board, that a skilled
artisan would have appreciated that Wallace teaches that
the filler is removable by biodegradation. ’723 Final Writ-
ten Decision, 2021 WL 1393447, at *7 (citing J.A. 1083
(¶ 126)). Incept points to a statement in Wallace to the ef-
fect that polymers, generally, are “essentially nondegrada-
ble in vivo over a period of at least several months” and
another statement in Wallace to the effect that its
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 9
compositions are “not readily degradable.” See Appellant’s
Br. 17, 40–41 (quoting Wallace col. 7 ll. 25–29, col. 34 ll.
11–14 (emphasis added)). But the Board could reasonably
read those statements as not contradicting the Board’s
finding that Wallace teaches compositions that have the
only biodegradability properties required by the claims at
issue, for which no narrowing construction of the biodegra-
dability term was adopted by the Board. Our role is not to
reweigh evidence or make factual findings, but to review
the Board’s findings for substantial evidence. Roku, Inc. v.
Universal Elecs., Inc., 63 F.4th 1319, 1326 (Fed. Cir. 2023);
Consolo, 383 U.S. at 620 (“[T]he possibility of drawing two
inconsistent conclusions from the evidence does not pre-
vent an administrative agency’s finding from being sup-
ported by substantial evidence.”).
Incept next contends that the Board failed to identify a
teaching in Wallace that any of its compositions are placed
“between an organ and a nearby tissue,” as required by the
’723 patent claims. As the Board explained, however, “Wal-
lace states that ‘[t]he compositions can also be used as a
large space-filling device for organ displacement in a body
cavity during surgical or radiation procedures, for example,
to protect the intestines during a planned course of radia-
tion to the pelvis.’” ’723 Final Written Decision, 2021 WL
1393447, at *8 (citing Wallace col. 33 ll. 64–67). Before the
Board, Incept argued that Wallace’s “space-filling device”
use did not apply to all of Wallace’s compositions. See J.A.
442–44, 923–26. The Board expressly found, though, that
a skilled artisan “would have understood Wallace’s disclo-
sure that its compositions may be used as a space-filling
device applies generally to all its compositions.” ’723 Final
Written Decision, 2021 WL 1393447, at *9. This finding is
supported by substantial evidence in the form of Wallace’s
teachings that its “compositions of the present invention
can be used in a variety of different applications” and Wal-
lace’s general statement that “[t]he compositions,”
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 10
generally, can serve as a space-filling device. Wallace col.
28 ll. 30–31, col. 33 ll. 64–67.
In sum, we see no legal error in the Board’s anticipa-
tion analysis for the ’723 patent, and substantial evidence
supports the Board’s findings that Wallace discloses each
element of claim 1 of the ’723 patent, arranged as in that
claim. We therefore affirm the Board’s determination that
claims 1, 6, 8–12, 14, 15, and 17–22 of the ’723 patent are
anticipated by Wallace.
III
We turn now to obviousness.4 Incept argues that the
Board’s obviousness analysis for both patents was errone-
ous because the Board: (1) merely reiterated its anticipa-
tion analysis; (2) disregarded statements in Wallace that
teach away from the claimed biodegradable compositions;
(3) did not separately analyze the obviousness of the de-
pendent claims; and (4) improperly disregarded Incept’s
evidence of commercial success. We address each argu-
ment in turn.
4 Having held that claims 1, 6, 8–12, 14, 15, and 17–
22 of the ’723 patent are anticipated by Wallace, we need
not address whether those claims are also rendered obvious
by Wallace. See In re Paulsen, 30 F.3d 1475, 1481 (Fed.
Cir. 1994) (“[S]ince anticipation is the ultimate of obvious-
ness, the subject matter of these claims is necessarily obvi-
ous and we need not consider them further.” (quoting In re
Baxter Travenol Lab’ys, 952 F.2d 388, 391 (Fed. Cir.
1992))). Therefore, this section of our opinion pertains to
those claims of the ’723 patent (claims 2–5, 7, 13, 16, 23,
and 24) for which the Board made only obviousness-based
unpatentability determinations.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 11
A
Incept first contends that the Board’s obviousness
analysis for both patents was based entirely on its “flawed”
anticipation analysis for the ’723 patent claims. Appel-
lant’s Br. 48. Incept takes issue with what it contends is a
“conclusory” finding of motivation to combine, particularly
with respect to the combination of Wallace with Ein-Gal for
the ’913 patent. Id. at 50–51.
To begin, having found no error in the Board’s antici-
pation analysis, we fail to see how the Board’s reliance
upon that analysis was in error. As discussed above, Wal-
lace discloses, and thereby renders obvious, the use of a gel
that is both biocompatible and biodegradable. See ’723 Fi-
nal Written Decision, 2021 WL 1393447, at *13–14; ’913 Fi-
nal Written Decision, 2021 WL 1395258, at *8, *14 (noting
Palette’s assertion that, “to the extent Wallace does not ex-
plicitly disclose the use of a gel that is both biocompatible
and biodegradable, Wallace teaches use of such a gel, ren-
dering it obvious.”).
We also disagree that the Board’s obviousness analysis
for the ’913 patent was based entirely on its anticipation
analysis for the ’723 patent claims. Instead, in its obvious-
ness analysis for the claims of the ’913 patent, the Board
explained that the petition relied on Ein-Gal as teaching
the ’913 patent’s limitation of displacement of the rectum
relative to the prostate gland. ’913 Final Written Decision,
2021 WL 1395258, at *7. In addition, the Board noted Pal-
ette’s contention that “[b]oth Wallace and Ein-Gal recog-
nize and appreciate the benefit of displacing tissue away
from a site intended to be irradiated, as doing so would pro-
tect the tissue from the harmful effects of radiation.” Id. at
*8 (citing J.A. 5508). The Board ultimately determined:
Petitioner has shown by a preponderance of the ev-
idence that the combined teachings of Wallace and
Ein-Gal teach or suggest each limitation of inde-
pendent claim 1, and that based on those teachings,
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 12
along with the knowledge in the art, a person of or-
dinary skill in the art would have been motivated,
with a reasonable expectation of success, to use
Wallace’s compositions for its disclosed purpose of
displacing an organ for radiation therapy, includ-
ing displacing the rectum relative to the prostate
gland, wherein the composition is eventually re-
moved by biodegradation, as required by claim 1.
’913 Final Written Decision, 2021 WL 1395258, at *13. The
Board therefore made findings of motivation to combine
that are not merely conclusory. Those findings are sup-
ported by substantial evidence in the form of the references
themselves and Palette’s expert’s detailed testimony,
which the Board found to be “persuasive.” Id. at *14; ’723
Final Written Decision, 2021 WL 1393447, at *14; see Wal-
lace col. 33 ll. 64–67; Ein-Gal col. 1 ll. 31–36; J.A. 1091–98
(¶¶ 143–57), 6376–90 (¶¶ 132–52).
B
In an argument parallel to its argument regarding an-
ticipation, Incept contends that the Board ignored Wal-
lace’s teaching away from biodegradable compositions.
Appellant’s Br. 52–54 (citing Wallace col. 34 ll. 11–14, col.
7 ll. 25–29). We disagree. The Board specifically noted
that “Wallace’s teaching that all suitable polymers dis-
closed are ‘essentially nondegradable in vivo over a period
of at least several months,’ . . . teaches, or at least suggests,
that those polymers are essentially degradable in the body
over a period of more than at least several months.” ’723
Final Written Decision, 2021 WL 1393447, at *14; ’913 Fi-
nal Written Decision, 2021 WL 1395258, at *14 (both citing
Wallace col. 7 ll. 25–29). In any event, “a reference does
not teach away if it ‘merely expresses a general preference
for an alternative invention but does not criticize, discredit
or otherwise discourage investigation into the invention
claimed.’” UCB, Inc. v. Actavis Laby’s UT, Inc., 65 F.4th
679, 692 (Fed. Cir. 2023) (quoting DePuy Spine, Inc. v.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 13
Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327
(2009)). The portions of Wallace that Incept points to
clearly lack such a teaching. As discussed above, substan-
tial evidence supports the Board’s finding with respect to
the scope of Wallace’s teaching. Wallace col. 19 ll. 3–19.
C
Incept next contends that the Board did not separately
analyze certain dependent claims of the two patents, for
example, dependent claim 16 of the ’723 patent and de-
pendent claim 6 of the ’913 patent, both of which provide
biodegradability time limits. Appellant’s Br. 54–56 & n.7
(addressing claims 2–6, 8–12, and 14–24 of the ’723 patent,
and claims 2–16, 18, and 20–24 of the ’913 patent); ’723 pa-
tent col. 17 ll. 24–25; ’913 patent col. 17 ll. 3–4. Palette,
however, identified disclosures in the prior art that teach
each of the elements of these claims, and Incept did not
separately argue their patentability before the Board. ’723
Final Written Decision, 2021 WL 1393447, at *14; ’913 Fi-
nal Written Decision, 2021 WL 1395258, at *14 & n.13.
Where a party “does not raise any arguments with respect
to any other claim limitation, nor does it separately argue
[the] dependent claim,” “[the] dependent claim . . . stands
or falls together with [the] independent claim.” Genentech,
Inc. v. Hospira, Inc., 946 F.3d 1333, 1340 (Fed. Cir. 2020).5
5 For claim 16 of the ’723 patent and claim 6 of the
’913 patent, Incept did note that these claims require par-
ticular biodegradation properties. It did so in the context
of its argument (pertaining to the independent claims) that
“the range of compositions within the ambit of Wallace’s
disclosure is so vast that a [skilled artisan] could neither
have ‘at once envisaged’ all of them nor have known what
properties any particular one of them would have.” J.A.
467–68, 5814–15. As the Board noted, however, Incept dis-
cussed claim 16 of the ’723 patent only in its discussion of
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 14
D
Incept’s final argument is that the Board erred in its
obviousness analysis because it “imposed an overly strin-
gent standard for showing commercial success.” Appel-
lant’s Br. 57. Incept contends that it presented “clear[]
evidence of commercial success that the Board was not en-
titled to ignore.” Id. at 59. According to Incept, that evi-
dence was (1) a table reflecting “annual unit shipments” to
external customers (i.e., physicians and hospitals) in the
United States” of SpaceOAR®, an injectable synthetic hy-
drogel marketed by Boston Scientific Corporation through
its subsidiary Augmentix, Inc., the exclusive licensee of the
anticipation by Wallace, J.A. 467–68, ’723 Final Written
Decision, 2021 WL 1393447, at *13 n.12, despite claim 16
not having been challenged as anticipated.
And, as for claim 6 of the ’913 patent, the Board ex-
plained that Palette had “established persuasively,
through the teachings of Wallace and the testimony of [Pal-
ette’s expert] Dr. Dicker, that a [skilled artisan] would
have known how to configure Wallace’s compositions to bi-
odegrade within a predetermined time, such as less than
approximately 90 days.” ’913 Final Written Decision, 2021
WL 1395258, at *14 n.13. This finding is supported by sub-
stantial evidence. See Wallace col. 1 ll. 34–38 (acknowledg-
ing that it was known that “synthetic polymer compositions
can be formulated to exhibit predetermined . . . biological
characteristics, such as biodegradability”), col. 20 ll. 44–47
(“Gelatin may have the added benefit of being degradable
faster than collagen.”); J.A. 6400–01 (¶ 175) (Dr. Dicker ex-
plaining that a skilled artisan “would have known how to
configure the gel compositions taught by Wallace to biode-
grade within a predetermined time, including less than ap-
proximately 90 days.”). Therefore, even if it could be said
that Incept argued this claim separately, we agree with the
Board’s ultimate obviousness conclusion.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 15
’723 and ’913 patents, for the years 2015–2019; and (2) tes-
timonial evidence from Incept’s expert that he estimated
about 55% of all prostate cancer radiation therapy treat-
ments in 2019 to have included SpaceOar® placement.
’723 Final Written Decision, 2021 WL 1393447, at *15–17;
’913 Final Written Decision, 2021 WL 1395258, at *15–17;
Appellant’s Br. 8.
In its final written decisions, the Board concluded that
the evidence Incept relied upon was insufficient. We see
no reversible error in that determination, whether viewed
as a factual one about the level of success or a legal one
about the weight of any such success in the overall obvious-
ness analysis. Commercial success is “usually shown by
significant sales in a relevant market.” J.T. Eaton & Co. v.
Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997).
Incept relied on its table of “annual unit shipments” to sup-
port its assertion that the “case volume” of SpaceOAR® “in
the U.S. ha[d] roughly doubled year-on-year through 2019.”
J.A. 480, 5827; see also J.A. 632, 5980. A senior accountant
for Boston Scientific explained, however, that Incept’s table
reflected not only SpaceOAR® sales numbers, but also re-
placement units and free sample units. See J.A. 5110–13,
5117.6 Moreover, for two of the years in the table, 2018 and
2019, Incept did not provide a breakdown of the number of
units sold as compared to those given away for free or pro-
vided as a replacement, and instead merely relied upon tes-
timony that the number of replacement and sample units
was “small.” J.A. 5113–16 (¶¶ 16–21). Thus, as the Board
noted, “the record does not demonstrate whether the year-
6 As the Boston Scientific accountant explained,
units requiring “replacement” would include units where,
for example, the delivery syringe clogged. J.A. 5110–11
(¶ 7). In addition, “free sample units” were “sent to cus-
tomers (i.e., physicians or hospitals) at the discretion of the
sales and customer service teams.” Id.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 16
over-year increase in units shipped is attributable to in-
creased sales as opposed to an increase in samples and re-
placements that were shipped.” ’723 Final Written
Decision, 2021 WL 1393447, at *17; ’913 Final Written De-
cision, 2021 WL 1395258, at *16. And, while Incept did
provide a breakdown of the units “sold” for the years 2015–
2017, it did not argue before the Board in its Patent Owner
Response or Sur-Reply that the data for these years demon-
strated commercial success. J.A. 480, 632, 5827, 5980.
Finally, Incept takes issue with the Board’s statement
that Incept did not provide “commercial success in the con-
text of the market as a whole.” ’723 Final Written Decision,
2021 WL 1393447, at *17; ’913 Final Written Decision, 2021
WL 1395258, at *16. This statement is contrary to our
holding in Chemours Co. FC, LLC v. Daikin Industries,
Ltd., 4 F.4th 1370, 1378 (Fed. Cir. 2021), Incept asserts. In
Chemours, we held that “market share data, though poten-
tially useful, is not required to show commercial success.”
Id. Contrary to Incept’s argument, the Board did not re-
quire Incept to provide market share data. Instead, the
Board weighed the evidence provided by Incept and merely
found that evidence insufficient, alone, to show commercial
success. See id. (“The Board is certainly entitled to weigh
evidence and find, if appropriate, that Chemours’s gross
sales data were insufficient to show commercial success
without market share data.”). To the extent Incept also
contends that the Board improperly dismissed the market
share data that Incept did provide, we defer to the Board’s
findings concerning the credibility of expert witnesses, see
Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010), and
Incept has not otherwise demonstrated that those findings
are unsupported by substantial evidence.7
7 Incept provided testimonial evidence from an ex-
pert, Dr. Timothy Showalter, estimating that 55% of all
prostate cancer radiation therapy treatments in the United
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 17
CONCLUSION
We have considered Incept’s remaining arguments and
find them unpersuasive. Accordingly, and for the reasons
set forth above, we affirm the Board’s final written deci-
sions.
AFFIRMED
States in 2019 included SpaceOAR® placement. J.A. 5121.
The Board found this testimony to be not credible because
it found Dr. Showalter’s calculations to be insufficiently
supported by the evidence. As the Board noted, in his cal-
culations, Dr. Showalter inexplicably relied on (a) a radia-
tion therapy rate from a United Kingdom trial and (b) the
number of new cases of prostate cancer in 2019, as opposed
to all existing cases. ’723 Final Written Decision, 2021 WL
1393447, at *17; ’913 Final Written Decision, 2021 WL
1395258, at *17.
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United States Court of Appeals
for the Federal Circuit
______________________
INCEPT LLC,
Appellant
v.
PALETTE LIFE SCIENCES, INC.,
Appellee
KATHERINE K. VIDAL, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Intervenor
______________________
2021-2063, 2021-2065
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2020-
00002, IPR2020-00004.
______________________
N EWMAN, Circuit Judge, concurring-in-part and dissent-
ing-in-part.
I share the conclusion that claim 1 of Incept’s U.S. Pa-
tent No. 8,257,723 (“the ’723 patent”) and claim 1 of U.S.
Patent No. 7,744,913 (“the ’913 patent”) are invalid, for
these broadest claims can reasonably be read to include
prior art. Whether viewed under section 102 or 103 of Title
35, these claims are not patentable. I would sustain the
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 2
Board’s decision invalidating claim 1 of both patents.1
However, for the more detailed claims of these patents,
written in dependent form, neither the Board nor the panel
majority adequately determined patentability of their
claimed inventions as a whole. I respectfully dissent from
the panel majority’s affirmance of the Board’s invalidation
of all the challenged claims.
D ISCUSSION
The Board held, and the majority agrees, that the Wal-
lace reference (U.S. Patent No. 6,624,245) shows all the
limitations of claim 1, the broadest claim, of the ’723 pa-
tent, and that the combination of the Wallace and Ein-Gal
references (U.S. Patent No. 6,210,314) shows all the limi-
tations stated in the broadest claims. Claim 1 of the ’723
patent is illustrative:
1. A method of delivering a therapeutic dose of
radiation to a patient comprising
introducing a biocompatible, biodegradable
filler between an organ and a nearby
tissue to increase a distance between
the organ and the tissue, and
treating the tissue with the therapeutic
dose of radiation so that the presence of
the filler causes the organ to receive
less of the dose of radiation compared
to the amount of the dose of radiation
the organ would receive in the absence
of the filler,
wherein the filler is introduced as an inject-
able material and is a gel in the
1 Palette Life Sciences, Inc. v. Incept LLC, 2021 WL
1393447 (P.T.A.B. Apr. 13, 2021) (“Board ’723 Op.”); 2021
WL 1395258 (P.T.A.B. Apr. 13. 2021) (“Board ’913 Op.”).
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 3
patient, and wherein the filler is re-
movable by biodegradation in the pa-
tient.
Incept argues that all the challenged claims of the ’723
and ’913 patents, including the broadest claims, when con-
strued in light of the specification and the prosecution his-
tory, are distinguished from Wallace and thus are neither
anticipated nor obvious. I respectfully dissent from the
panel majority’s applications of the laws of anticipation
and obviousness to invalidate all of the challenged claims
of the ’723 and ’913 patents.
I
ANTICIPATION
Anticipation requires that the invention was previ-
ously known; that is, that the invention as claimed is not
new. See, e.g., Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d
1359, 1371 (Fed. Cir. 2008) (to anticipate, a single reference
must disclose the same invention, including each claimed
limitation).
My concern is with the invalidation of the dependent
claims, without analysis of these claims’ additional limita-
tions in view of the prior art. The panel majority states:
In sum, we see no legal error in the Board’s antici-
pation analysis for the ’723 patent, and substantial
evidence supports the Board’s findings that Wal-
lace discloses each element of claim 1 of the ’723
patent, arranged as in that claim. We therefore af-
firm the Board’s determination that claims 1, 6, 8–
12, 14, 15, and 17–22 of the ’723 patent are antici-
pated by Wallace.
Maj. Op. at 10. The majority appears to hold that, when
the broader claim is anticipated, the dependent claims are
automatically anticipated. That is not the law. Each claim
must be considered as a whole, including all its limitations.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 4
The panel majority observes that the Wallace reference
generically discloses “multiple compositions,” id. at 7, de-
scribed by Incept as embracing “millions, if not billions, of
different possible compositions, each with different proper-
ties,” id. at 6, quoting Incept Br. 34–35. A generic prior
disclosure does not anticipate all of its embodiments, in-
cluding novel specific embodiments, whether or not the
facts are such that the generic disclosure may render the
embodiment obvious.
Precedent illustrates an assortment of considerations
relevant to patentability of such discoveries as a new spe-
cies of a known genus, but these precedents establish the
different rule for anticipation in comparison to obvious-
ness. For example, it is relevant whether the disclosure of
a genus in the prior art was so specific that it would rea-
sonably be understood that the genus encompasses all po-
tential species, as in Eli Lilly & Co. v. Zenith Goldline
Pharmaceuticals, Inc., 471 F.3d 1369, 1376 (Fed. Cir.
2006). Compare Wasica Fin. GmbH v. Cont’l Auto. Sys.,
Inc., 853 F.3d 1272, 1285–86 (Fed. Cir. 2017) (finding no
anticipation by a genus disclosure that was “too ambigu-
ous” and too broad for an ordinary skilled artisan to “at
once envisage” every member of the genus).
Here the majority expands the law of anticipation by
holding that, if “Wallace expressly describes compositions
that have the claimed characteristics of, and are used for
the same displacement purpose as, the compositions re-
ferred to in the ’723 patent claims challenged as antici-
pated,” then it is irrelevant whether all the elements of the
dependent claims are shown in the “anticipating” refer-
ence. The majority concludes that “a skilled artisan would
have understood that Wallace’s compositions had the same
generic properties as those in the ’723 patent claims.” Maj.
Op. at 7–8. However, Wallace does not support anticipa-
tion of claim limitations that are not explicitly described in
the reference.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 5
This departure from the law of anticipation is manifest
in the majority’s treatment of the limitation concerning “bi-
odegradation.” Wallace states: “The polymer may include
biodegradable segments and blocks, either distributed
throughout the polymer’s molecular structure or present in
a single block, as in a block copolymer.” Wallace, col.19,
ll.3–9. But Wallace also states that polymers “generally,
are ‘essentially nondegradable in vivo over a period of at
least several months.’” Maj. Op. at 8, quoting Wallace, col.
7, ll. 25-29. Nonetheless, the majority concludes that “sub-
stantial evidence supports the Board’s findings that Wal-
lace discloses each element of claim 1 of the ’723 patent”
and thus anticipates the biodegradability of the Incept pol-
ymers, Maj. Op. at 10, even though Wallace states that its
compositions are “not readily degradable[,]” id. at 8, 9,
quoting Wallace, col. 34, ll.11-14.
The majority holds that Wallace’s teaching that a pol-
ymer can have biodegradable segments “alone constitutes
substantial evidence to support the Board’s finding” that
the ’723 patent’s limitation of biodegradation is antici-
pated. Id. at 8. This holding disregards Wallace’s state-
ments of the difficulties and uncertainties of
biodegradation, and concludes, without analysis, that since
the broadest claim 1 of the ’723 patent is anticipated, the
narrower dependent claims are also anticipated.
The majority discusses some of the dependent claims,
noting “dependent claim 16 of the ’723 patent and depend-
ent claim 6 of the ’913 patent both of which provide biodeg-
radability time limits,” although the majority also states
that Incept did not separately argue the dependent claims
before the board (noting that the record shows such argu-
ment for at least some claims). Id. at 13. The majority
recites that “Palette, however, identified disclosures in the
prior art that teach each of the elements of these claims[.]”
Id. Although the appeal briefing is sparse for the depend-
ent claims, the majority acknowledges that “[f]or claim 16
of the ’723 patent and claim 6 of the ’913 patent, Incept did
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 6
note that these claims require particular biodegradation
properties.” Id. at 13 n.5. The majority misstates that In-
cept did not argue any claims separately.
For anticipation in patent law terms, an anticipating
reference must describe the same invention in reasonable
detail and clarity as appropriate to the subject matter. The
panel majority recognizes that Wallace states that its pol-
ymers are not degradable, yet the majority does not find
fault with the Board’s statement that “Wallace’s teaching
that all suitable polymers disclosed are ‘essentially
nondegradable in vivo over a period of at least several
months,’ . . . teaches, or at least suggests, that those poly-
mers are essentially degradable in the body over a period
of more than at least several months.” Id. at 12, quoting
Board ’723 Op at *14, ’Board 913 Op. at *14. We are not
told how a nondegradable polymer anticipates a degrada-
ble polymer.
Incept stresses Wallace’s recognition that most poly-
mers are not biodegradable and that controlled degrada-
tion is not easy.2 The Board observed that petitioner
Palette had “established persuasively, through the teach-
ings of Wallace (U.S. Patent No. 6,624,245) and the testi-
mony of [Palette’s expert] Dr. Dicker, that a POSITA would
have known how to configure Wallace’s compositions to bi-
odegrade within a predetermined time, such as less than
approximately 90 days.” Maj. Op. at 13 n.5, quoting Board
’913 Op. at *14 n.13. However, neither the Board nor the
panel majority explains how the cited references teach this
knowledge.
2 One need only peruse the news reports of fouling of
oceans, rivers, and reefs with non-degradable polymers.
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 7
I would remand to the Board for determination, on the
correct law, of whether the limitations of the challenged de-
pendent claims are anticipated.
II
O BVIOUSNESS – COMMERCIAL SUCCESS
The law of obviousness has extensive precedent,
providing guidance in a vast variety of technological situa-
tions. The majority holds that for the claims that the Board
found anticipated, this court need not consider the question
of obviousness. I agree that claims properly invalidated
need not be reviewed on other grounds. However, since the
Board erred in finding all the claims anticipated, determi-
nation of obviousness is appropriate and warrants remand
to the Board for full consideration.
On remand, it will also be appropriate to instruct the
Board to correct its application of the objective factor of
commercial success. Commercial success is one of the “sec-
ondary considerations” that guide the ultimate determina-
tion of obviousness. See Graham v. John Deere Co., 383
U.S. 1 (1966). However, the majority adopts a new rule for
commercial success, a rule that does not conform to routine
market measures. It is undisputed that the Incept product
experienced regular increases in annual commercial sales,
and at the time of trial Incept had obtained 55% of the mar-
ket for comparable products. Palette’s only criticism of In-
cept’s commercial information was that Incept also gave
free samples. The majority now holds that Incept’s com-
mercial sales cannot be considered as a measure of com-
mercial success because some product was provided free of
charge. Maj. Op. at 15–16.
It is not correct that because free samples were pro-
vided, the commercial sales and market share data are not
relevant measures of commercial success. The majority’s
concern that “the Board did not require Incept to provide
market share data,” id. at 16, does not warrant ignoring
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INCEPT LLC v. PALETTE LIFE SCIENCES, INC. 8
the evidence of commercial sales and increases in market
share. I respectfully dissent from the finding that there
was not substantial evidence of commercial success, for
commercial success is measured by commercial sales, not
free samples. I would remand for the Board to apply the
evidence of commercial activity and market growth to the
determination of obviousness.
CONCLUSION
I concur in the holdings of invalidity of claim 1 of both
the ’723 and ’913 patents, for these claims, in their breadth,
do not distinguish from the prior art. However, the subor-
dinate claims of both patents were incorrectly analyzed un-
der the laws of anticipation and obviousness. I would
vacate the Board’s decisions as to the subordinate claims,
and remand for redetermination of anticipation and obvi-
ousness on correct law. From my colleagues’ contrary rul-
ings, I respectfully dissent.
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