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Parties Involved:
Merck Sharp & Dohme B.V.
Appellant
Merck Sharp & Dohme Corp.
Appellant
Microspherix LLC
Appellee
Organon USA, Inc.
Appellant

Document Text:

NOTE: This disposition is nonprecedential.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, Chicago, IL, for appellee. Also represented by JAMES F. HURST; 

Case: 19-2197 Document: 45 Page: 1 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 Appeal 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 establish 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 supported 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 implantation into a subject, comprising: 

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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 diagnostic agent, wherein the marker, biocompatible component and agent are disposed 

within the hollow interior;

wherein the length of the marker component is greater than the diameter of the 

hollow interior, and

wherein the substantially continuous wall 

includes at least one opening adapted to allow the agent to pass out of the hollow interior wherein the strand do not contain a 

radioisotope.

’401 patent col. 25 ll. 2–19.

Merck manufactures and markets Nexplanon®, an implantable 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 surgically 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 artisan 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 priority from U.S. Provisional App. 60/249,128 (“Microspherix 

provisional”), which was filed in November 2000. The earliest nonprovisional application in the Microspherix patents’ priority chain was filed in May 2001.

A timeline may be instructive. 

Jan. 2000

Zamora provisional filed

Nov. 2000

Microspherix provisional filed

Jan. 2001

Zamora nonprovisional filed

May 2001

Microspherix nonprovisional filed

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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. Additionally, Zamora would still be prior art to Microspherix’s 

patents if it was entitled to the date of the Zamora provisional. 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 application and that Zamora was entitled to the date of the Zamora 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 medium 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 provisional 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 substantial 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. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).

Obviousness is a question of law, supported by underlying fact questions. In re Baxter Int’l, Inc. 678 F.3d 1357, 

1361 (Fed. Cir. 2012). In evaluating obviousness, we consider the scope and content of the prior art, differences between the prior art and the claims at issue, the level of 

ordinary skill in the pertinent art, and any relevant secondary 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 combination of de Nijs and Schopflin and (2) the Board’s determination 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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polymer and release of heavy metal toxins”); U.S. Patent 

App. 2003/0010929 ¶ [0010] (“Barium sul[f]ate is to be considered as critical for use in a long-term implant, because 

of the toxicity of barium ions, if it is not sufficiently encapsulated.”). Although the claims do not require that the implant 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 subset of claims, Merck argues that Microspherix’s patents are 

not entitled to the date of Microspherix provisional application 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 argues that the provisional failed to disclose a polymeric coating on a non-radioactive strand. Merck also contends that 

the Zamora reference is entitled to the filing date of its provisional.

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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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 challenged claims without a strand length limitation, and substantial 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 spacers of between 0.5 mm and 50 mm in length. Microspherix 

provisional col. 5 ll. 3–17. This description adequately supports 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 nonbiodegradable polymer, no claim at issue in this appeal recites 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 patents 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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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 decision. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 

2141 (2016). Having considered Merck’s arguments regarding the Microspherix provisional, we conclude that the 

Board’s decision is correct. 

Next, we consider whether Zamora is entitled to the filing 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 requirement].” 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 radiopaque medium placement: on at least a portion of the external 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 radiopaque medium on the external surface of the tube—is 

absent from the provisional. While the Zamora provisional 

describes admixing the radiopaque material into the complex, 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 

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