UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`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
`__________________________________________________
`
`
`
`PATENT OWNER REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71
`
`
`
`
`
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`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
`__________________________________________________
`
`
`
`PATENT OWNER REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71
`
`
`
`
`
`
`
`IPR2017-01621
`
`
`
`Request for Rehearing
`
`TABLE OF CONTENTS
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`
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`I. INTRODUCTION ....................................................................................................................... 1
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`II. LEGAL STANDARD ................................................................................................................ 2
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`III. ARGUMENT ............................................................................................................................ 2
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`A.
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`B.
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`The Supreme Court’s decision in SAS did not require the Board to institute
`trial on the additional grounds ................................................................................ 2
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`Grounds 2 and 3 fail to satisfy threshold statutory requirements ........................... 4
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`IV. CONCLUSION......................................................................................................................... 6
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`i
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`IPR2017-01621
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`
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`Request for Rehearing
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`TABLE OF AUTHORITIES
`
`Cases
`
`Palo Alto Networks, Inc. v. Juniper Networks, Inc.,
`IPR2013-00369 (PTAB Feb. 14, 2014) ................................................................ 2
`
`SAS Institute Inc. v. Iancu, 584 U.S. ___,
`138 S. Ct. 1348 (2018) (April 24, 2018) ............................................. 1, 2, 3, 4, 6
`
`SAS Institute, Inc. v. ComplementSoft, LLC,
`IPR2013-00226, (PTAB August 12, 2013) .......................................................... 6
`
`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005) ............................................................................ 2
`
`Statutes
`
`35 U.S.C. § 102(a) ..................................................................................................... 5
`
`35 U.S.C. § 311(b) ........................................................................................ 1, 2, 4, 5
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`35 U.S.C. § 312(a)(3) ................................................................................................. 5
`
`35 U.S.C. § 316 .......................................................................................................... 6
`
`35 U.S.C. § 318 ......................................................................................................3, 4
`
`Rules
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`37 C.F.R. § 42.1(b) .................................................................................................... 6
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`37 C.F.R. § 42.71(c) ...............................................................................................1, 2
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`37 C.F.R. § 42.71(d) ..............................................................................................1, 2
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`
`
`ii
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`IPR2017-01621
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`I. INTRODUCTION
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`
`
`Request for Rehearing
`
`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 its decision instituting trial on additional grounds because
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`that decision is based on a misinterpretation of SAS Institute Inc. v. Iancu, 584 U.S.
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`___, 138 S. Ct. 1348 (2018) and improperly institutes review based on references
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`that are not patents or printed publications under 35 U.S.C. § 311(b). Specifically,
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`the Board entered an Order on April 30, 2018 (Paper 42, hereinafter “Order”)
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`modifying the Decision Instituting Inter Partes Review of U.S. Patent No.
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`9,358,240 (“the ’240 patent”), entered January 11, 2018 (Paper 10, hereinafter
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`“Decision”). The Decision instituted trial as to whether claims 1–9 of the ’240
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`patent would have been obvious over Voswinckel, Patton, and Ghofrani (Ground
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`1). The Order modifies the Decision to institute trial as to whether claims 1-9 of
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`the ’240 patent would have been obvious over two additional grounds:
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`1) Voswinckel, Patton, and the OptiNeb Manual (Ground 2); and
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`2) Voswinckel, Ghofrani, and the EU Community Register (Ground 3).
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`In so doing, the Board interpreted SAS to require a final written decision on all
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`grounds in a petition. Order, 2. Yet SAS requires a final written decision not on all
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`grounds, but rather on all challenged claims, which will be achieved without
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`instituting trial on the additional grounds. In addition, and as an independent basis
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`4825-0796-3237.2
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`1
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`IPR2017-01621
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`
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`Request for Rehearing
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`for rehearing, the two additional grounds rely on two new references that are not
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`prior art patents or printed publications, contrary to 35 U.S.C. § 311(b), and thus
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`cannot be the subject of a final written decision.
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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
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`the 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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`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-
`
`00369, Paper 39, 2–3 (PTAB Feb. 14, 2014) (citing Star Fruits S.N.C. v. United
`
`States, 393 F.3d 1277, 1281 (Fed. Cir. 2005)).
`
`III. ARGUMENT
`A. The Supreme Court’s decision in SAS did not require the Board to
`institute trial on the additional grounds
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`In the Order, the Board modifies the Decision to institute on all grounds
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`identified in the Petition “[p]ursuant to the holding in SAS.” Order, 2. The holding
`
`in SAS, however, did not impose any such requirement. Rather, SAS held that “the
`
`
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`2
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`IPR2017-01621
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`Request for Rehearing
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`Board must address every claim the petitioner has challenged.” 138 S. Ct. 1348, at
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`1354 (emphasis in original). Indeed, SAS addressed a proceeding where the Board
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`had not in fact instituted on all challenged claims in the patent — the issue of
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`instituting on less-than-all grounds was not before the Court. Id. at 1352-54.
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`Consistent with this holding, the Order stated that the Board must “decide the
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`patentability of all claims challenged in the petition” in view of SAS. Order, 2
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`(emphasis added) (citing SAS, 2018 WL 1914661 at *10 (138 S. Ct. at 1359-60)).
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`The Board is not required to institute trial on the additional grounds to abide
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`by this holding. Nowhere in SAS did the Court address whether the Board was
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`obligated to issue a final written decision on every alleged ground on which the
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`claims were challenged. Indeed, the question presented to the Court and the statute
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`at issue in SAS, 35 U.S.C. § 318(a), states only that “the [Board] shall issue a final
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`written decision with respect to the patentability of any patent claim challenged by
`
`the petitioner and any new claim added under section 316(d).” Id. at 1361
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`(emphasis added). SAS and the statute do not mandate the Board to institute on
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`additional grounds when a final written decision would necessarily be reached on
`
`all the challenged claims under the original Decision. And that is precisely the
`
`situation here. The Decision instituted trial on all claims of the ’240 patent based
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`on Ground 1. Pet., 6; Decision, 38. Thus, prior to issuing the Order, the Board had
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`already instituted trial on all claims challenged in the Petition in full compliance
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`3
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`IPR2017-01621
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`Request for Rehearing
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`with 35 U.S.C. § 318 and its interpretation in SAS.
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`If the Board properly interpreted SAS as requiring only institution on all
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`challenged claims, but nevertheless reinstituted on all challenged grounds out of an
`
`abundance of caution or relying on dicta or the “spirit” of the majority opinion in
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`SAS, then the Board’s Order should be reheard and vacated in this instance.
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`Reinstituting on additional grounds past the date permitted for Patent Owner’s
`
`response and contrary to the Board’s Scheduling Order, when not required by SAS
`
`and where all challenged claims were already subject to the ground instituted, was
`
`an abuse of discretion.
`
`B. Grounds 2 and 3 fail to satisfy threshold statutory requirements
`The Petition fails to meet threshold statutory requirements for institution
`
`with respect to Grounds 2 and 3, because each relies on documents that do not
`
`qualify as prior art within the requirement of the statute. 35 U.S.C. § 311(b). Even
`
`if SAS can be interpreted as requiring institution on each prior art ground, the
`
`statute still permits review “only on the basis of prior art consisting of patents or
`
`printed publications.” 35 U.S.C. § 311(b) (emphasis added). Grounds 2 and 3 fail
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`to meet this threshold statutory requirement because each one relies on documents
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`(the OptiNeb Manual and the EU Community Register, respectively) that do not
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`qualify as prior art. The Board confirmed in its Decision that the EU Community
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`Register is not prior art: “Petitioner has not sufficiently demonstrated that the EU
`
`
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`4
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`IPR2017-01621
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`Request for Rehearing
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`Community Register is a prior art printed publication under 35 U.S.C. § 102(a).”
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`Decision, 38; POPR, 29-33 (noting Petitioner’s failure to demonstrate public
`
`accessibility of the EU Community Register). Further, Petitioner has not
`
`sufficiently demonstrated that the OptiNeb Manual was a publicly accessible
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`printed publication. POPR, 24-29 (noting the Petitioner’s failure to demonstrate
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`public accessibility of the OptiNeb Manual, Decision), 33-38 (determining a lack
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`of reliability in the calculations offered by Petitioner under Ground 2 but declining
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`to address the issue of prior art). There is no indication on which “crawl” the
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`OptiNeb Manual was located or which “frame” directed one to the OptiNeb
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`Manual. Id. Thus, the Petition failed to establish that an ordinary skilled artisan,
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`exercising reasonable diligence, could have located this document as of the critical
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`date. The institution of additional grounds based on references that do not meet the
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`threshold statutory requirement of prior art printed publications is not reasonable
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`and is an independent ground for rehearing of the Board’s Order.
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`Under 35 U.S.C. § 312(a)(3), a petition is required to identify “in writing
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`and with particularity, each claim challenged, the grounds on which the challenge
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`to each claim is based, and the evidence that supports the grounds for the challenge
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`to each claim, including—(A) copies of patents and printed publications that the
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`petitioner relies upon in support of the petition.” This requirement is not met for
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`Ground 2 or Ground 3, since neither the EU Community Register nor the OptiNeb
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`5
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`IPR2017-01621
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`Request for Rehearing
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`Manual qualifies as a prior art patent or printed publication.
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`In issuing the Order based on SAS (seemingly automatically in the slew of
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`other such orders), the Board appears to have overlooked its previous finding that
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`the EU registry is not prior art and the failure of the Petition to establish whether
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`the OptiNeb Manual was prior art. The Order reinstituting on additional Grounds
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`2 and 3 contravenes the statutory requirements that review is “only on the basis of
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`prior art consisting of patents or printed publications” and that this evidence be
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`provided in the Petition, and, thus, amounts to an abuse of discretion.1 Further,
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`reinstituting these grounds runs contrary to the Board’s stated policy of securing a
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`“just, speedy, and inexpensive resolution in every proceeding” (37 C.F.R.
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`§ 42.1(b)) and impedes the Board’s ability to timely complete the originally
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`instituted proceeding (35 U.S.C. § 316).
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`IV. CONCLUSION
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`Patent Owner respectfully requests reconsideration of the institution decision
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`by modifying it to deny institution of Grounds 2 and 3. SAS does not require that
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`1 Notably, in the inter partes review underlying SAS, the Board’s findings were
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`based on deficient teachings in the references rather than a failure to meet
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`threshold requirements (e.g., public accessibility). SAS Institute, Inc. v.
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`ComplementSoft, LLC, IPR2013-00226, Paper 9, 11-17 (PTAB August 12, 2013).
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`6
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`IPR2017-01621
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`Request for Rehearing
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`trial be instituted on these grounds, and regardless, these grounds fail to meet the
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`threshold statutory requirements for trial.
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`Date: May 14, 2018
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Foley & Lardner LLP
`3000 K Street, N.W.
`Suite 600
`Washington, D.C. 20007
`
`Shaun R. Snader
`Registration No. 59,987
`United Therapeutics Corporation
`1735 Connecticut Avenue, N.W.
`Second Floor
`Washington, DC 20009
`
`Counsel for Patent Owner
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`
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`7
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`IPR2017-01621
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`Request for Rehearing
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`CERTIFICATE OF SERVICE
`
`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 May
`14, 2018, by filing this document through the PTAB E2E System as well 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
`
`Kurt A. Mathas
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: kmathas@winston.com
`
`/Stephen B. Maebius/
`
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Shaun R. Snader
`Registration No. 59,987
`
`Counsel for Patent Owner
`
`
`
`
`
`
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