UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________
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`WATSON LABORATORIES, INC.
`Petitioner
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`v.
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`UNITED THERAPEUTICS CORP.
`Patent Owner
`Patent No. 9,358,240
`Issue Date: June 7, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
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`Inter Partes Review No. 2017-01621
`__________________________________________________
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`
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`PATENT OWNER REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71
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`4825-8954-3515.1
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`
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`
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`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________
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`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`Patent No. 9,358,240
`Issue Date: June 7, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
`
`Inter Partes Review No. 2017-01621
`__________________________________________________
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`
`
`PATENT OWNER REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71
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`4825-8954-3515.1
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`IPR2017-01621
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`Request for Rehearing
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`TABLE OF CONTENTS
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`
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`I. INTRODUCTION ..................................................................................................................... 1
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`II. LEGAL STANDARD .............................................................................................................. 1
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`III. ARGUMENT .......................................................................................................................... 2
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`A.
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`B.
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`The Board Misapprehended Controlling Precedent By Requiring
`More Evidence Than Necessary To Prove Ghofrani Is Not By
`“Another” .............................................................................................................. 3
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`The Board Erred In Finding Voswinckel’s Authorship Created A
`Genuine Issue Of Material Fact Regarding Whether Ghofrani
`Constitutes the Work of Another. ....................................................................... 9
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`IV. CONCLUSION ..................................................................................................................... 11
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`TABLE OF AUTHORITIES
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`
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`Cases
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`Applied Materials Inc. v. Gemini Research Corp.,
`835 F.2d 279 (Fed. Cir. 1987) .............................................................................. 5
`
`Biotec Biologische Naturverpackungen v. Biocorp.,
`Inc., 249 F.3d 1341 (Fed. Cir. 2011) .................................................................. 10
`
`Celotex Corp. v. Catrett,
`477 U.S. 317 (1986) ............................................................................................ 10
`
`Ethicon Inc. v. U.S. Surgical Corp.,
`135 F.3d 1456 (Fed. Cir. 1998) ............................................................................ 8
`
`In re Katz,
`687 F.2d 450 (CCPA 1982) .......................................................... 4, 5, 7, 8, 9, 10
`
`In re Land,
`368 F.2d 866 (CCPA 1966) ..................................................................... 3, 4, 6, 7
`
`Palo Alto Networks, Inc. v. Juniper Networks, Inc.,
`IPR2013-00369 (PTAB Feb. 14, 2014) ................................................................ 2
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`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005) ............................................................................ 2
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`Varian Med. Systs. v. Wm. Beaumont Hosp.,
`IPR2016-00163 (PTAB May 4, 2017) ......................................................... 5, 7, 8
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`Statutes
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`35 U.S.C. § 102(a) .................................................................................................3, 4
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`35 U.S.C. § 103 ......................................................................................................4, 8
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`35 U.S.C. § 103(a) ................................................................................................... 11
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`35 U.S.C. § 116(a) ..................................................................................................... 7
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`35 U.S.C. § 315(b) ..................................................................................................... 1
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`4825-8954-3515.1
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`IPR2017-01621
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`Other Authorities
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`Request for Rehearing
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`MPEP § 2132.01 ............................................................................................... 4, 6, 7
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`Regulations
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`37 C.F.R. § 42.108(c) .................................................................................... 3, 10, 11
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`37 C.F.R. § 42.71(c) ................................................................................................... 2
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`37 C.F.R. § 42.71(d) .................................................................................................. 1
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`4825-8954-3515.1
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`IPR2017-01621
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`I. INTRODUCTION
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`
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`Request for Rehearing
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`United Therapeutics Corporation (“Patent Owner”) respectfully requests
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`under 37 C.F.R. § 42.71(c) and (d) that the Patent Trial and Appeal Board
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`(“Board”) reconsider one aspect of its Decision Instituting Inter Partes Review of
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`U.S. Patent No. 9,358,240 (“the ’240 patent”), entered Jan. 11, 2018 (Paper 10,
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`hereinafter “Decision”). The Decision instituted trial as to whether claims 1–9 of
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`the ’240 patent would have been obvious over Voswinckel, Patton, and Ghofrani.
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`In instituting trial, the Board concluded “that Petitioner has provided a sufficient
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`basis on which to conclude that Ghofrani was the work of another.” Decision, p.
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`14. The Board misapprehended the legal standard in reaching this conclusion, and
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`Petitioner failed to establish Ghofrani as prior art under the appropriate standard.1
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`II. LEGAL STANDARD
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`A party may request rehearing of a Board institution decision. 37 C.F.R. §
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`42.71(d). “The request must specifically identify all matters the party believes the
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`Board misapprehended or overlooked, and the place where each matter was
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`previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d).
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`1 Patent Owner disagrees with other parts of the decision and does not waive or
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`forfeit its right to contest those issues in its Response or on appeal, specifically
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`including the determination under 35 U.S.C. § 315(b), if relief is not granted on
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`this request.
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`Request for Rehearing
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`The Board will review the previous decision for an abuse of discretion. 37 C.F.R. §
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`42.71(c). “An abuse of discretion may be indicated if a decision is based on an
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`erroneous interpretation of law, if a factual finding is not supported by substantial
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`evidence, or if the decision represents an unreasonable judgment in weighing
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`relevant factors.” Palo Alto Networks, Inc. v. Juniper Networks, Inc., IPR2013-
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`00369, Paper 39, 2–3 (PTAB Feb. 14, 2014) (citing Star Fruits S.N.C. v. United
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`States, 393 F.3d 1277, 1281 (Fed. Cir. 2005)).
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`III. ARGUMENT
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`Patent Owner submitted declarations from multiple authors of Ghofrani,
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`both a ’240 patent inventor and non-inventor authors, stating that the relevant
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`portions of Ghofrani were the work of the inventors and not the work of the non-
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`inventor authors. Patent Owner Preliminary Response, pp. 21-24. Yet the Board
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`concluded “that Petitioner has provided a sufficient basis on which to conclude that
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`Ghofrani was the work of another” and, thus, prior art under § 102(a). Decision, p.
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`14. The Board based this conclusion on (a) a perceived ambiguity in the
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`Declaration of Dr. Seeger (Ex. 2020, “Seeger Declaration”) as to the contribution
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`of the non-author co-inventors to the relevant portion of Ghofrani, and (b) the
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`authorship of Voswinckel (Ex. 1003, which includes the non-inventor Ghofrani co-
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`authors). Decision, p. 14. The Board’s decision regarding the Seeger Declaration
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`is a result of an erroneous interpretation of the law because it required a showing
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`not required by relevant precedent or PTO practice. In addition, the Board’s
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`reliance on Voswinckel represents both an error of law and an inappropriate
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`judgment in weighing the facts of record. Id. Neither the authorship of
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`Voswinckel nor the Seeger Declaration creates a “genuine issue of material fact”
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`that must be resolved in favor of the Petitioner under 37 C.F.R. § 42.108(c).
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`A. The Board Misapprehended Controlling Precedent By Requiring More
`Evidence Than Necessary To Prove Ghofrani Is Not By “Another”
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`The question of whether Ghofrani is prior art turns on “whether Ghofrani is
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`the work of another.” Decision, p. 12; 35 U.S.C. § 102(a). And the Board
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`acknowledges that the four Ghofrani author declarations disclaim any contribution
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`by the non-inventor authors to Ghofrani’s relevant passage and that the Seeger
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`Declaration states that the relevant portion of Ghofrani originated with the
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`inventors. Decision, pp. 12-13. Yet the Board found this evidence insufficient to
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`disqualify Ghofrani as prior art. Specifically, the Board suggests that In re Land,
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`368 F.2d 866, 881 (CCPA 1966), requires an additional evidentiary showing – that
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`each named inventor, including the non-author co-inventors, contributed to the
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`relevant portion of Ghofrani. Decision, pp. 13-14. This was legal error.
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`Land does not articulate, much less apply, a requirement that a patent owner
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`must demonstrate an individual contribution of any and all co-inventors to
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`demonstrate that a reference is not by “another.” Indeed, no declarations were at
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`issue in Land. Rather than imposing a per se rule, Land addressed the facts of that
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`case, which included explicit admissions of prior art individual work not present
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`here. 368 F.2d at 881. Land merely stands for the proposition that a patent
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`reference invented by Inventor A and a patent reference invented by Inventor B are
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`not the same entity (i.e., they are “by another”) relative to a patent application
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`being examined with A and B named together jointly as inventors.2 The Board’s
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`extension of Land imposes an unprecedented requirement and burden inconsistent
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`with the law.
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`To determine whether a reference under 35 U.S.C. §102(a) is by “another”
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`when it has overlapping authorship with an inventive entity, the patent owner
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`needs only to provide declarations from non-inventor co-authors of the reference
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`stating that they did not contribute to the relevant portion of the reference. In re
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`Katz, 687 F.2d 450, 455 (CCPA 1982) (stating that “disclaimer” declarations from
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`the non-inventor co-authors would have “ended the inquiry” even though not
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`required). This is also consistent with PTO practice. See MPEP § 2132.01
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`(“[W]here the applicant is one of the co-authors of a publication cited against his
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`2 By contrast, the present case involves only a portion of Ghofrani applied under 35
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`U.S.C. § 103 based on qualifying as a reference under 35 U.S.C. § 102(a) in
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`combination with other references, where declarations have been provided to show
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`that the only relevant portion of the Ghofrani reference originated with inventors
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`named on the present patent.
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`or her application, the publication may be removed as a reference by the filing of
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`affidavits made out by the other authors establishing that the relevant portions of
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`the publication originated with, or were obtained from, applicant.”).3
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`Even when a patent’s named inventors are not listed as authors of the
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`publication, no additional evidence is required. “Unlike the inclusion of a non-
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`inventor co-author on a publication, however, the omission of a named inventor
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`from co-authorship has no significance for whether the publication is the work of
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`‘others.’” Varian Med. Systs. v. Wm. Beaumont Hosp., IPR2016-00163, Paper 79,
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`31 (PTAB May 4, 2017);4 Applied Materials Inc. v. Gemini Research Corp., 835
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`F.2d 279 (Fed. Cir. 1987) (“[T]he fact that an application has named a different
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`inventive entity than a patent does not necessarily make that patent prior
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`3 Katz involved an anticipation rejection based upon the sole named inventor’s own
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`work disclosed in conjunction with non-inventor co-authors.
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`4 In Varian, the Board found that Jaffray 1999 JRO was not by another, even
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`though only two of three co-inventors were named as co-authors, and a third non-
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`author co-inventor, Dr. Siewerdsen, had not been shown to have contributed to the
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`relevant portion of the publication. IPR2016-00163, Paper No. 79 at 21. The
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`Board specifically rejected petitioner’s argument that the absent declarations from
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`the non-author co-inventors “leave unresolved questions regarding the inventive
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`entity of Jaffray 1999.” Id. at 31.
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`art….When the joint and sole inventions are related, as they are here, inventor A
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`commonly discloses the invention of A & B in the course of describing his sole
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`invention and when he so describes the invention of A & B he is not disclosing
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`“prior art” to the A& B invention, even if he has legal status as “another.”)
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`(citations and quotations omitted; quoting Land). The mere absence of co-
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`inventors from Ghofrani’s authorship is not a sufficient basis upon which to
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`require further evidence from Patent Owner where, as here, the non-inventor co-
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`authors have stated that they did not contribute to the relevant portion of Ghofrani.
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`See MPEP § 2132.01 (stating that “the publication may be removed as a reference
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`by the filing of affidavits made out by the other [non-inventor] authors establishing
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`that the relevant portions of the publication originated with, or were obtained from,
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`applicant. Such affidavits are called disclaiming affidavits.”).
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`Here, not only did Patent Owner provide disclaimer declarations from the
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`non-inventor co-authors of Ghofrani, but Patent Owner also provided a declaration
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`from co-inventor and co-author Dr. Seeger stating that the relevant portion of
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`Ghofrani originated with the inventors.5 Patent Owner has thus exceeded the
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`5 Dr. Seeger states that “[t]he idea to perform the underlying work described in this
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`section originated with Dr. Voswinckel and myself, in view of our work with the
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`other inventors listed on the ’507 patent” (emphasis added). Ex. 2020. Whether or
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`not all of the other named co-inventors contributed to each claim in the patent and
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`requirements for disclaiming declarations and provided a “reasonable showing
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`supporting” its position. Katz, 687 F.2d at 455.
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`It is unclear if the Board is additionally citing Land for (1) the proposition
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`that Ghofrani is prior art unless every named inventor contributed to the relevant
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`portion of Ghofrani or (2) the proposition that any reference listing some, but not
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`all, inventors shifts the burden to Patent Owner to prove inventorship. Both
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`propositions are incorrect.
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`As noted above, not every named inventor needs to have contributed to the
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`relevant portion of the publication in order to prove that it is not by another.
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`Varian, IPR2016-00163, Paper 79 at 28. Also, the MPEP does not require any
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`particular level of contribution by the inventors, only a showing from the non-
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`inventor authors that the relevant portion was “obtained from” the inventors.
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`MPEP § 2132.01.
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`Applying Land to require Patent Owner to show that non-author inventors
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`contribute equally to the relevant portion of Ghofrani is also inconsistent with
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`statute because different joint inventors may make different contributions. 35
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`U.S.C. § 116(a) (amended after Land in relevant part in Pub. L. 98–622, title I,
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`§104(a), Nov. 8, 1984, 98 Stat. 3384, to liberalize joint inventorship requirements);
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`how much they contributed to each claim has no bearing on whether Ghofrani is
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`the work of another.
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`see Ethicon Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998)
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`(noting “each [joint inventor] needs to perform only a part of the task which
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`produces the invention” and “a co-inventor need not make a contribution to every
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`claim…. A contribution to one claim is enough.”). Moreover, not all of their
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`contributions need to be reflected in the cited portion, particularly where, as here,
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`the reference is part of a 35 U.S.C. § 103 combination. The Seeger Declaration
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`accounted for the communication of the relevant contributions of all of the
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`inventors to the article. Neither the law of inventorship nor any evidence of record
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`provide any basis for viewing the declaration evidence as insufficient. Patent
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`Owner has amply met its burden of production, and Petitioner has not met its
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`burden of production or proof.
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`Furthermore, the burden does not shift to the Patent Owner to prove
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`inventorship based merely upon an absence of detail as to how each individual
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`contributed to the relevant portion of the reference. The Board has rejected the
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`assertion that submitting “declarations from only a subset of named inventors is
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`per se insufficient to satisfy Katz.” Varian, IPR2016-00163, Paper 79 at 28. To
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`the extent the Board requires more inventor testimony and overlooks the
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`corroboration provided by the non-inventor testimony already of record, it
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`misapprehended the proper focus of the inquiry. The Seeger Declaration’s
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`uncontradicted, unequivocal statement clearly establishes the fact that the relevant
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`portion of Ghofrani was obtained from the inventors of the ’240 patent.
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`B. The Board Erred In Finding Voswinckel’s Authorship Created A
`Genuine Issue Of Material Fact Regarding Whether Ghofrani
`Constitutes the Work of Another.
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`The Board suggests that there is a genuine issue of material fact raised by
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`the “narrow focus of Voswinckel and the potential that Voswinckel involved the
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`same study as disclosed in Ghofrani.” Decision, p. 14; see Petitioner’s Reply, pp.
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`4-5. This cannot create any “genuine issue of material fact as to the contribution of
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`these non-inventors…by extension, to the relevant portions of Ghofrani”
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`(Decision, p. 14) under the proper legal standard and proper weighing of the
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`undisputed facts of record. Voswinckel is a conference abstract containing
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`different material than Ghofrani, which is a journal publication. Nothing in the
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`stated authorship of Voswinckel does or ought to affect the unrebutted statements
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`in the declarations of the Ghofrani authors. Speculation of Petitioner’s counsel
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`about a separate reference cannot create a genuine issue of material fact in the face
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`of four sworn declarations regarding the authorship of Ghofrani. Katz, 687 F.2d at
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`455 (finding that the Board should not have engaged in speculation as to coauthor
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`roles in publication in view of inventor declaration that the coauthors worked
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`under his direction and did not contribute to joint inventorship). To hold otherwise,
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`improperly exalts attorney argument over record evidence. Id. (“[J]oint
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`inventorship cannot be inferred in the face of sworn statements to the contrary.”)
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`Furthermore, authorship creates no presumption regarding inventorship. Id.; see
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`Biotec Biologische Naturverpackungen v. Biocorp., Inc., 249 F.3d 1341, 1353
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`(Fed. Cir. 2011) (conclusory assertions do not create issue of material fact).
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`The standard for a “genuine issue of material fact” does not require a Patent
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`Owner to answer every possible question that might be asked about a series of
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`publications with overlapping material and authors. 37 C.F.R. § 42.108(c); cf.
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`Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986) (a party moving for summary
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`judgment need not show an absence of a genuine issue of material fact but rather
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`an absence of evidence supporting the non-moving party’s case).
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`The issue of Voswinckel’s relevance to the veracity of the “disclaimer”
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`declarations was first raised in Petitioner’s Reply. Because the issue was raised in
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`Petitioner’s Reply, Patent Owner did not have the opportunity to direct the Board’s
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`attention to paragraphs 10 and 11 of the Seeger Declaration (Ex. 2020), which
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`address the contributions of the non-inventor co-authors of Ghofrani to
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`Voswinckel:
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`In general, when my research center submits abstracts to a conference
`or articles for publication, we include members of the research group
`who contributed in some way to the abstract or article as authors.
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`For example, the abstract titled ‘Pulmonary Arterial Hypertension:
`New Therapies,’ [Voswinckel] which I understand was submitted by
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`Watson as Exhibit 1003, lists as authors members of my research
`center who contributed by performing the administrative work
`supporting the trial, taking care of patients enrolled in the trial, and/or
`collecting data for the trial. Drs. Ghofrani, Reichenberger, and
`Grimminger are among the authors who contributed to the trial in this
`manner.
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`Ex. 2020, ¶¶10-11. Notably, Petitioner’s Reply regarding Voswinckel failed to
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`address this portion of the Seeger Declaration, which clearly explains
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`Voswinckel’s inclusion of the non-inventor Ghofrani authors.
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`Overlooking this portion of the Seeger Declaration amounts to an
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`unreasonable weighing of the facts of record. 37 C.F.R. § 42.108(c). The Board
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`misapprehended the material-fact standard in 37 C.F.R. § 42.108(c) in Petitioner’s
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`favor by giving weight to mere attorney speculation and unpermitted presumptions,
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`rather than record evidence.
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`IV. CONCLUSION
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`For at least the reasons provided above, Patent Owner respectfully requests
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`reconsideration on the institution decision regarding claims 1–9 of the ’240 patent
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`under 35 U.S.C. § 103(a) as obvious over Voswinckel, Patton, and Ghofrani.
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`Date: January 25, 2018
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`4825-8954-3515.1
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
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`IPR2017-01621
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`George E. Quillin
`Registration No. 32,792
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`Foley & Lardner LLP
`3000 K Street, N.W.
`Suite 600
`Washington, D.C. 20007
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`Shaun R. Snader
`Registration No. 59,987
`United Therapeutics Corporation
`1735 Connecticut Avenue, N.W.
`Second Floor
`Washington, DC 20009
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`Counsel for Patent Owner
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`4825-8954-3515.1
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`IPR2017-01621
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing PATENT OWNER
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71 is being served on
`January 25, 2018, by filing this document through the PTAB E2E System as well
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`as delivering copies via email to the following counsel for the Petitioner:
`Michael K. Nutter (Reg. No. 44,979)
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: mnutter@winston.com
`
`Andrew R. Sommer (Reg. No. 53,932)
`WINSTON & STRAWN LLP
`1700 K Street, N.W.
`Washington, DC 20006-3817
`Email: asommer@winston.com
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`Kurt A. Mathas
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: kmathas@winston.com
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`/Stephen B. Maebius/
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`Stephen B. Maebius
`Registration No. 35,264
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`George E. Quillin
`Registration No. 32,792
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`Shaun R. Snader
`Registration No. 59,987
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`Counsel for Patent Owner
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`
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`4825-8954-3515.1
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