Court Opinion

ID: 4540024
Source: CourtListenerOpinion
Date Created: 2020-06-09 15:01:46.130721+00
Date Added: 2024-06-11T12:45:20.369124
License: Public Domain

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        NOTE: This disposition is nonprecedential.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;
Case: 19-2197    Document: 45     Page: 2    Filed: 06/09/2020

 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