Case: 19-2197 Document: 45 Page: 1 Filed: 06/09/2020
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
MERCK SHARP & DOHME CORP., MERCK SHARP
& DOHME B.V., ORGANON USA, INC.,
Appellants
v.
MICROSPHERIX LLC,
Appellee
______________________
2019-2197, 2019-2200, 2019-2208
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2018-
00393, IPR2018-00402, IPR2018-00602.
______________________
Decided: June 9, 2020
______________________
JESSICA LYNN ELLSWORTH, Hogan Lovells US LLP,
Washington, DC, for appellants. Also represented by SEAN
MAROTTA, MICHAEL WEST; TRACEY DAVIES, Gibson, Dunn
& Crutcher LLP, Dallas, TX; YU-CHIEH ERNEST HSIN, San
Francisco, CA.
MARCUS EDWARD SERNEL, Kirkland & Ellis LLP, Chi-
cago, IL, for appellee. Also represented by JAMES F. HURST;
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2 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC
STEFAN MICHAEL MILLER, New York, NY; WILLIAM H.
BURGESS, JOHN C. O'QUINN, Washington, DC.
______________________
Before LOURIE, MAYER, and REYNA, Circuit Judges.
LOURIE, Circuit Judge.
Merck appeals from three decisions of the United
States Patent and Trademark Office’s Patent Trial and Ap-
peal Board (“the Board”) in three inter partes reviews that
Merck Sharp & Dohme Corp., Merck Sharp & Dohme B.V.,
and Organon USA, Inc. (collectively “Merck”) failed to es-
tablish by a preponderance of the evidence that claims 1–5
and 9–25 of U.S. Patent 9,636,401 (“the ’401 patent”),
claims 1–19 of U.S. Patent 9,636,402 (“the ’402 patent”),
and claims 1–4, 9–12, and 14–20 of U.S. Patent 8,821,835
(“the ’835 patent”) are unpatentable. Merck Sharp &
Dohme Corp. v. Microspherix LLC, IPR No. 2019-00402,
(P.T.A.B. July 8, 2019) (“401 Decision”); Merck Sharp &
Dohme Corp. v. Microspherix LLC, IPR No. 2019-00393,
2019 WL 2932663 (P.T.A.B. July 8, 2019) (“402 Decision”);
Merck Sharp & Dohme Corp. v. Microspherix LLC, IPR No.
2018-00602,
2019 WL 2932664 (P.T.A.B. July 8, 2019)
(“835 Decision”). Because the Board’s decisions are sup-
ported by substantial evidence, we affirm.
BACKGROUND
Microspherix LLC (“Microspherix”) owns the ’401, ’402,
and ’835 patents, which are directed to implantable devices
that deliver therapeutics and have a radiopaque marker for
detecting the device’s position after insertion. The claimed
devices are small strands, open on both ends with a drug
contained in the hollow interior. Claim 1 of the ’401 patent
is illustrative:
1. A flexible non-radioactive strand for implanta-
tion into a subject, comprising:
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MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 3
a marker component configured to allow for
the determination of the position of the
strand within a target tissue, the marker
component having a length extending
along a centerline of the marker component
between a first end and a second end and
having a substantially continuous wall
bounding a hollow interior; a biocompatible
component; and
a therapeutic, prophylactic, and/or diag-
nostic agent, wherein the marker, biocom-
patible component and agent are disposed
within the hollow interior;
wherein the length of the marker compo-
nent is greater than the diameter of the
hollow interior, and
wherein the substantially continuous wall
includes at least one opening adapted to al-
low the agent to pass out of the hollow in-
terior wherein the strand do not contain a
radioisotope.
’401 patent col. 25 ll. 2–19.
Merck manufactures and markets Nexplanon®, an im-
plantable contraceptive containing progestin and marked
by a radiopaque medium. Microspherix sued Merck in the
United States District Court for the District of New Jersey,
alleging that Merck’s product infringes the ’401, ’402, and
’835 patents. Amended Complaint, Microspherix LLC v.
Merck Sharp & Dohme Corp., No. 2:17-cv-03984-CCC-MF
(D.N.J. Oct. 18, 2017), ECF No. 27. Merck then filed the
instant petitions for inter partes review.
Merck relied on four U.S. patents as references in the
proceedings: (1) U.S. Patent 5,150,718 (“de Nijs”), which
discloses contraceptive implants; (2) U.S. Patent 4,012,497
(“Schopflin”), which teaches using barium sulfate as a
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4 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC
radiopaque marker; (3) U.S. Patent 6,575,888 (“Zamora”),
which discloses bioabsorbable brachytherapy devices for
treating cancers; and (4) U.S. Patent 5,626,862 (“Brem”),
which discloses delivery of chemotherapy drugs using sur-
gically implantable discs deposited near tumors. In three
decisions, the Board upheld all claims of the three patents
except for claims 1–5, 7, 8, 10–19 of the ’402 patent.
There are two aspects of the Board’s decisions that are
relevant in this appeal. First, the Board rejected Merck’s
argument that a skilled artisan would have combined de
Nijs and Schopflin. According to the Board, a skilled arti-
san would not have been motivated to combine the barium
sulfate marker taught in Schopflin with the open-ended
tube in de Nijs because barium sulfate was known to be
toxic and could leach out.
Second, the Board rejected Merck’s argument that the
challenged claims would have been anticipated or obvious
over Zamora alone or in combination with other references.
Acceptance of Merck’s Zamora-based arguments required
acceptance of Merck’s arguments regarding Zamora and
the Microspherix’s patents’ priority dates. Zamora claims
priority from U.S. Provisional App. 60/178,083 (“Zamora
provisional”), which was filed in January 2000. The
nonprovisional application issued as Zamora was filed in
January 2001. All three Microspherix patents claim prior-
ity from U.S. Provisional App. 60/249,128 (“Microspherix
provisional”), which was filed in November 2000. The ear-
liest nonprovisional application in the Microspherix pa-
tents’ priority chain was filed in May 2001.
A timeline may be instructive.
Jan. 2000 Jan. 2001
Zamora provisional filed Zamora nonprovisional filed
Nov. 2000 May 2001
Microspherix provisional filed Microspherix nonprovisional filed
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MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 5
Based on this timeline, if the Microspherix patents cannot
claim priority from the Microspherix provisional, Zamora
would qualify as 35 U.S.C. § 102(e) (2006) prior art. Addi-
tionally, Zamora would still be prior art to Microspherix’s
patents if it was entitled to the date of the Zamora provi-
sional. The Board found that neither is the case here.
Merck argued that the Microspherix patents were not
entitled to the date of the Microspherix provisional appli-
cation and that Zamora was entitled to the date of the Za-
mora provisional, but the Board rejected both arguments.
The Board found that 37 of the 39 claims at issue in these
appeals were supported by the Microspherix provisional.
For the two unsupported claims, claims 2 and 3 of the ’401
patent, the Board found on the merits that Zamora and
Bren failed to disclose open-ended devices because Zamora
teaches a device with closed ends, and Bren teaches a tube
without specifying whether the ends are open or closed.
The Board also found that the Zamora provisional
failed to provide written description support for Zamora’s
claim 1. Claim 1 of Zamora recites that a “radiopaque me-
dium is disposed either on at least a portion of an external
surface of the tube, within at least [a] portion of a structure
of the tube, or within the radioactive material.” Zamora
col. 14 ll. 19–22. According to the Board, the Zamora pro-
visional did not disclose coating a radiopaque material on
the external surface of the tube, and therefore Zamora was
not entitled to the date of its provisional.
Merck appealed. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A) and 35 U.S.C. § 141(c).
DISCUSSION
We review the Board’s legal determinations de novo, In
re Elsner,
381 F.3d 1125, 1127 (Fed. Cir. 2004), and its fact
findings for substantial evidence, In re Gartside,
203 F.3d
1305, 1316 (Fed. Cir. 2000). A finding is supported by sub-
stantial evidence if a reasonable mind might accept the
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6 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC
evidence as sufficient to support the finding. Consol. Edi-
son Co. v. NLRB,
305 U.S. 197, 229 (1938).
Obviousness is a question of law, supported by under-
lying fact questions. In re Baxter Int’l, Inc.
678 F.3d 1357,
1361 (Fed. Cir. 2012). In evaluating obviousness, we con-
sider the scope and content of the prior art, differences be-
tween the prior art and the claims at issue, the level of
ordinary skill in the pertinent art, and any relevant sec-
ondary considerations. Graham v. John Deere Co. of Kan.
City,
383 U.S. 1, 17–18 (1966).
Merck argues that two of the Board’s determinations
lacked substantial evidence: (1) the Board’s determination
that the claims would not have been obvious over the com-
bination of de Nijs and Schopflin and (2) the Board’s deter-
mination that Zamora was not prior art to the challenged
claims. We address each issue in turn.
First, Merck argues that the Board erred in holding
that the challenged claims would not have been obvious in
view of De Nijs and Schopflin. Specifically, Merck contests
the Board’s finding that a skilled artisan would not have
been motivated to use barium sulfate with an open-ended
implant because of toxicity concerns. According to Merck,
the Board improperly required that the radiopaque marker
used in the device be nontoxic because the claims do not
require nontoxicity. Even if toxicity were relevant, Merck
submits that the Board’s findings lack substantial evidence
and urges us to adopt and credit its view of the facts.
We disagree with Merck. The Board’s finding that a
skilled artisan would not have been motivated to combine
Schopflin’s barium sulfate, a known toxic radiopaque
marker, with de Nijs’s open-ended implant is supported by
substantial evidence. Specifically, several references in the
record teach that barium sulfate leaching was a known
problem in the art. See, e.g., U.S. Patent 4,866,132 col. 2
ll. 8–15 (explaining that inorganic barium salts “gradually
leached out of the matrix causing discoloration of the
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MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 7
polymer and release of heavy metal toxins”); U.S. Patent
App. 2003/0010929 ¶ [0010] (“Barium sul[f]ate is to be con-
sidered as critical for use in a long-term implant, because
of the toxicity of barium ions, if it is not sufficiently encap-
sulated.”). Although the claims do not require that the im-
plant be nontoxic, the Board was permitted to consider the
known problem of barium leaching in evaluating whether
a person of skill in the art would have been motivated to
combine barium sulfate with an open-ended implant. See
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
821
F.3d 1359, 1368 (Fed. Cir. 2016).
Merck also argues that the Board erred in its analysis
of Zamora in relation to Microspherix’s patents. For a sub-
set of claims, Merck argues that Microspherix’s patents are
not entitled to the date of Microspherix provisional appli-
cation because the provisional does not reasonably convey
to a skilled artisan that the inventor had possession of an
implantable unitary seed or strand that could be longer
than 10 mm. 1 For claims 10–15 of the ’402 patent, Merck
argues that the provisional did not disclose a strand with a
biocompatible component comprising a non-biodegradable
polymer, and for claims 1–19 of the ’402 patent, Merck ar-
gues that the provisional failed to disclose a polymeric coat-
ing on a non-radioactive strand. Merck also contends that
the Zamora reference is entitled to the filing date of its pro-
visional.
We disagree with Merck here as well. Microspherix’s
claims are entitled to the priority date of the Microspherix
provisional if the provisional meets the requirements of
1 Merck’s strand-length arguments concern claims 1,
3, 4, 9–12, 15–19 of the ’835 patent, claims 1, 4, 5, 9–25 of
the ’401 patent, and claims 1–6, 9, 10, 13, 16, 17 of the ’402
patent. Appellants’ Br. 43.
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8 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC
35 U.S.C. § 112 ¶ 1. 35 U.S.C. § 119(e)(1) (2006). 2 Written
description is adequate if “the disclosure of the application
relied upon reasonably conveys to those skilled in the art
that the inventor had possession of the claimed subject
matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly
& Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citing
Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1562–63 (Fed.
Cir. 1991)).
Merck faults the Microspherix provisional for failing to
disclose strands of greater than 10 mm, but while there are
claims in the Microspherix patents that recite discrete
strand lengths, Merck has not challenged those claims as
unsupported by the provisional. Instead, Merck has chal-
lenged claims without a strand length limitation, and sub-
stantial evidence supports the Board’s decision that the
claims without explicit strand or seed length requirements
are supported by the provisional. The provisional discloses
seeds and strands of 2–10 mm with certain needles and 4–
6 mm with other needles and the use of a plurality of spac-
ers of between 0.5 mm and 50 mm in length. Microspherix
provisional col. 5 ll. 3–17. This description adequately sup-
ports the claimed strand recited in Microspherix’s patent
claims.
As for Merck’s argument about the provisional’s failure
to describe a biocompatible component comprising a non-
biodegradable polymer, no claim at issue in this appeal re-
cites this limitation, and claims 10–15 of the ’402 patent,
which do recite the limitation, were ruled invalid on other
grounds. Even if Merck were correct that these claims are
2 The application that led to the Microspherix pa-
tents was filed before March 16, 2013, and the pre-Leahy–
Smith America Invents Act, Pub L. No. 112-29, 125 Stat.
284 (2011), version of § 112 applies.
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MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 9
unsupported by the provisional, they have already been
held invalid, and this court can provide no additional relief.
Finally, the polymeric coating argument for claims 6
and 9 of the ’402 patent was not raised before the Board
during the proceedings, and Merck is challenging a finding
made only in the institution decision. We need not address
Merck’s argument because our review of Board proceedings
does not include review of the merits of the institution de-
cision. Cuozzo Speed Techs., LLC v. Lee,
136 S. Ct. 2131,
2141 (2016). Having considered Merck’s arguments re-
garding the Microspherix provisional, we conclude that the
Board’s decision is correct.
Next, we consider whether Zamora is entitled to the fil-
ing date of the Zamora provisional. “A reference patent is
only entitled to claim the benefit of the filing date of its
provisional application if the disclosure of the provisional
application provides support for the claims in the reference
patent in compliance with [the written description require-
ment].” Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
800 F.3d 1375, 1381 (Fed. Cir. 2015) (citing In re Wertheim,
646 F.2d 527, 537 (CCPA 1981)). On this record, we are
not persuaded that Zamora is supported by its provisional.
Zamora’s claim 1 explicitly recites three options for radio-
paque medium placement: on at least a portion of the ex-
ternal surface of the tube, within at least a portion of the
structure of the tube, or within the radioactive material.
Zamora col. 14 ll. 19–22. The first option—locating the ra-
diopaque medium on the external surface of the tube—is
absent from the provisional. While the Zamora provisional
describes admixing the radiopaque material into the com-
plex, Zamora provisional at 5, that disclosure falls short of
teaching coating the external surface of the tube.
CONCLUSION
We have considered the parties’ remaining arguments
but find them unpersuasive. Accordingly, the decisions of
the Board are affirmed.
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10 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC
AFFIRMED
