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`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
`_______________
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`Patent No. 9,339,507
`Issue Date: May 27, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
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`Inter Partes Review No. 2017-01622
`__________________________________________________
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`PATENT OWNER REPLY TO PETITIONER’S RESPONSE TO
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71
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`4821-4577-4686.1
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`IPR2017-01622
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`PO Reply to Response to Request for Rehearing
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`TABLE OF CONTENTS
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`I. INTRODUCTION ..................................................................................................................... 1
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`II. ARGUMENT ............................................................................................................................ 1
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`A.
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`B.
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`Petitioner cannot manufacture a genuine issue of material fact with
`speculation ............................................................................................................. 1
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`There is no legal requirement to analyze inventorship in order to
`disqualify Ghofrani as prior at “by another.” ................................................... 4
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`III. CONCLUSION ....................................................................................................................... 5
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`TABLE OF AUTHORITIES
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`Cases
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`Applied Materials Inc. v. Gemini Research Corp.,
`835 F.2d 279 (Fed. Cir. 1987) .............................................................................. 5
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`Emerachem Holdings, LLC v. Volkswagen Group of America, Inc.,
`859 F.3d 1341 (Fed. Cir. 2017) ........................................................................2, 3
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`Ex parte Kroger,
`Appeal No. 442-62 (BPAI November 22, 1982) .................................................. 4
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`In re Katz,
`687 F.2d 450 (CCPA 1982) .............................................................................1, 4
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`Nelson Prods., Inc. v. Bal Seal Eng’g, Inc.,
`IPR2014-00573 (PTAB September 29, 2014) ..................................................3, 4
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`Varian Med. Systs. v. Wm. Beaumont Hosp.,
`IPR2016-00163 (PTAB May 4, 2017) ..............................................................3, 5
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`Regulations
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`37 C.F.R § 42.108(c) .................................................................................................. 2
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`4821-4577-4686.1
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`IPR2017-01622
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`I. INTRODUCTION
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`PO Reply to Response to Request for Rehearing
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`The Patent Trial and Appeal Board’s conclusion that Ghofrani was the work
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`of another (Decision, 14-15) was premised on an incorrect legal standard.
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`Petitioner’s speculation and inapposite authority do not remedy this error.
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`II. ARGUMENT
`A. Petitioner cannot manufacture a genuine issue of material fact with
`speculation
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`Patent Owner filed four sworn declarations from Ghofrani authors, both a
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`named inventor and other authors, showing that Ghofrani is not prior art. Yet
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`Petitioner argues that the authorship of a separate reference, Voswinckel,
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`“contradict[s]” the declarations. Response, 4,6. Thus, Petitioner is arguing—
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`based entirely on its own speculation about Voswinckel—that the four sworn
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`declarations are untrue.
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`Petitioner’s speculation that Voswinckel’s authorship is inconsistent with
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`Ghofrani’s cannot create a genuine issue of material fact as a matter of law. In re
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`Katz, 687 F.2d 450, 455 (CCPA 1982) (“[J]oint inventorship cannot be inferred in
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`the face of sworn statements to the contrary”). First, Ghofrani contains material
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`concededly absent from Voswinckel, which makes Voswinckel’s authorship of
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`little to no value in evaluating Ghofrani’s authorship. See, e.g., Petition, 29.
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`Second, even if Petitioner has raised a peripheral question about the naming of
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`authors on Voswinckel, that does not contradict the authors’ testimony about who
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`“contributed” the relevant subject matter of Ghofrani. Ex. 2020, ¶ 7 (this material
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`“was contributed” by Voswinckel and Seeger); Ex. 2026 at ¶ 5, Ex. 2027 at ¶ 5,
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`and Ex. 2028 at ¶ 5 (Ghofrani, Reichenberger, and Grimminger “did not
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`contribute” to this material). At best, Petitioner has raised a question about why
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`certain authors were included on Voswinckel, but Petitioner has not presented a
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`sufficient basis to dispute Patent Owner’s corroborated testimony about who
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`contributed the relevant portion of Ghofrani. Thus, the Board was not obliged by
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`37 C.F.R. § 42.108(c) to resolve this issue in favor of Petitioner.
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`Furthermore, the Seeger Declaration directly addressed Petitioner’s
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`speculation and establishes that the determination of authorship in Voswinckel is
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`not a determination of inventorship. Ex. 2020, ¶¶10-11. Contrary to Petitioner’s
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`assertion (Response, 5-6), the Board’s institution decision provides no indication
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`that the Board considered this portion of the Seeger Declaration in view of
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`Petitioner’s arguments.
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`Petitioner relies on Emerachem Holdings, LLC v. Volkswagen Group of
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`America, Inc., 859 F.3d 1341 (Fed. Cir. 2017), for the proposition that the four
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`declarations are insufficient to disqualify Ghofrani as prior art because Emerachem
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`supposedly requires contemporaneous documentary evidence to support the
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`testimony of an interested party (i.e., the inventor). Response, 4-5. But
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`Emerachem did not require contemporaneous documentary evidence. In
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`Emerachem, the uncorroborated testimony of a single inventor co-author was
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`insufficient to disqualify a reference listing other non-inventor co-authors as prior
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`art “by another.” Id at 1345-46. In fact, Emerachem mentioned at least one other
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`alternative to contemporaneous documentary evidence to corroborate such
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`testimony: testimony from the non-inventor co-authors of the cited reference. Id.
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`(“Mr. Campbell did not call Mr. Danzinger or Ms. Padron as witnesses or produce
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`any contemporaneous documentary evidence in support of the Campbell
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`Declaration.”). Here, Patent Owner has provided both testimony from an inventor
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`co-author and corroborating testimony from multiple non-inventor co-authors.
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`Thus, the record evidence is more than sufficient to disqualify Ghofani as prior art
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`“by another.”
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`The institution decisions in Varian Med. Systs. v. Wm. Beaumont Hosp. and
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`Nelson Prods., Inc. v. Bal Seal Eng’g, Inc. are likewise distinguishable. Response,
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`10; IPR2016-00163, Paper 14 (PTAB May 4, 2017); IPR2014-00573, Paper 9
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`(PTAB September 29, 2014). At the institution stage of Varian, no declaration
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`testimony was submitted to disqualify the prior art as “by another.” Varian, Papers
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`11 and 14. Here, four declarations were provided to support disqualification of
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`Ghofrani as prior art “by another.” In Nelson, the sole declaration was neither
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`corroborated nor unequivocal regarding the relevant authors’ contributions.
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`Nelson, Paper 9, 10-11 (“Mr. Poon indicates that the subject matter of Figures 1-
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`10 may have involved contribution from both co-inventors [of the alleged prior
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`art]” and “Patent Owner offered the Poon Declaration, but nothing further, and
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`notably, no declaration by [the inventor on both the prior art and the patent at
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`issue].”) Here, the statements are both corroborated and unequivocal.
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`Petitioner’s citation of Ex parte Kroger does not contradict this conclusion.
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`Appeal No. 442-62 (BPAI November 22, 1982); Response, 5. The Board in
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`Varian clarified that Ex Parte Kroger “does not stand for the proposition that
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`declarations from only a subset of named inventors is per se insufficient to satisfy
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`Katz.” Paper 79, 28. Rather, “the issue in Ex Parte Kroger was that a co-author of
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`the publication being relied upon as prior art refused to agree that he was not a co-
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`inventor.” Id. No such disagreement is evidenced by the testimony presented by
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`Patent Owner. Rather, the statements of the four Ghofrani authors are unequivocal
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`that the non-inventor co-authors did not contribute to the relevant portion of
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`Ghofrani and that the material originated with the inventors.
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`B. There is no legal requirement to analyze inventorship in order to
`disqualify Ghofrani as prior at “by another.”
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`Petitioner’s remaining arguments (Response, 6-10) rest on the assumption
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`that “the inventive entity of Ghofrani is Seeger, Voswinckel, Ghofrani,
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`Grimminger and Richenberg [sic.].” Response, 7. As explained above and in the
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`Request for Rehearing, the four sworn statements from the Ghofrani authors
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`explicitly contradict this assumption and suffice to remove the non-inventor co-
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`authors as authors of the relevant portion of Ghofrani. Supra II.A.; Request for
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`Rehearing, 2-11. Petitioner offers no alternative “inventive entity” other than the
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`full list of authors on Ghofrani. Petitioner does not comment on whether
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`additional evidence regarding inventorship should be required if the “inventive
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`entity” of the relevant portion of Ghofrani was found to exclude the non-inventor
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`co-authors.
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`No additional evidence should have been required, and the decision
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`misapprehends the test in requiring it. Indeed, as the Board held in Varian,
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`“[u]nlike the inclusion of a non-inventor co-author on a publication, however, the
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`omission of a named inventor from co-authorship has no significance for whether
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`the publication is the work of ‘others.’” Varian, Paper 79, 31; Applied Materials
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`Inc. v. Gemini Research Corp., 835 F.2d 279, 281 (Fed. Cir. 1987). Thus, once
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`Ghofrani, Grimminger, and Reichenberger disclaimed the relevant portion of
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`Ghofrani, and Seeger confirmed that it originated with the inventors, the reference
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`was no longer “by another,” and should have been disqualified as prior art.
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`III. CONCLUSION
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`Patent Owner disqualified Ghofrani. Its rehearing request should be granted.
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`Date: February 28, 2018
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`4821-4577-4686.1
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
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`IPR2017-01622
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`PO Reply to Response to Request for Rehearing
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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
`2nd Fl., 1735 Connecticut Avenue, N.W.
`Washington, DC 20009
`Counsel for Patent Owner
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`4821-4577-4686.1
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`IPR2017-01622
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`PO Reply to Response to Request for Rehearing
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing PATENT OWNER
`REPLY TO PETITIONER’S RESPONSE TO REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71 is being served on February 28, 2018, by filing this
`document through the PTAB E2E System as well as delivering copies via email to
`the following counsel for the Petitioner:
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`Michael K. Nutter (Reg. No. 44,979)
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: mnutter@winston.com
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`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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`4821-4577-4686.1
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