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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
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`v.
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`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
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`Inter Partes Review No. IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`PATENT OWNER’S REQUEST FOR REHEARING
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`4855-7660-5999.1
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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`TABLE OF CONTENTS
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`I.
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`II.
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`Introduction and Background .......................................................................... 1
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`Legal Standard ................................................................................................. 3
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`III. Argument ......................................................................................................... 3
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`A.
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`B.
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`C.
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`Liquidia failed to demonstrate that the Voswinckel abstracts are
`prior art .................................................................................................. 4
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`The Board’s conclusion that Voswinckel JESC and Voswinckel
`JAHA are prior art conflicts with settled legal principles ..................... 7
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`But for the Board’s legal error, the challenged claims would
`have been upheld ................................................................................. 12
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`IV. Conclusion ..................................................................................................... 14
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`TABLE OF AUTHORITIES
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`Cases:
`Argentum Pharm. LLC v. Research Corp. Tech., Inc.,
`IPR2016-00204, Paper 19 (P.T.A.B. May 23, 2016) ......................................... 11
`Blue Calypso, LLC v. Groupon, Inc.,
`815 F.3d 1331 (Fed. Cir. 2016) ........................................................................ 7, 8
`Caterpillar Inc. v. Wirtgen Am., Inc.,
`IPR2017-02185, Paper 48 (P.T.A.B. July 11, 2019) ............................................ 3
`Constant v. Advanced Micro-Devices, Inc.,
`848 F.2d 1560 (Fed. Cir. 1988) ............................................................................ 7
`Handi Quilter, Inc. v. Bernina International AG,
`IPR2013-00364, Paper 39 (P.T.A.B. Sept. 25, 2014) ......................................... 12
`Kyocera Wireless Corp. v. ITC,
`545 F.3d 1340 (Fed. Cir. 2008) ............................................................................ 8
`In re Lister,
`583 F.3d 1307 (Fed. Cir. 2009) ........................................................................ 2, 8
`Minnesota Min. & Mfg. Co. v. Chemque, Inc.,
`303 F.3d 1294 (Fed. Cir. 2002) ............................................................................ 1
`Samsung Elecs. Co. v. Infobridge Pte. Ltd.,
`929 F.3d 1363 (Fed. Cir. 2019) .......................................................................... 10
`Teoxane S.A. v. Allergan,
`IPR2017-01906, Paper 15 (P.T.A.B. Mar. 9, 2018) ................................... 2, 7, 10
`Statutes:
`35 U.S.C. §102(a) ...................................................................................... 6, 7, 12, 13
`35 U.S.C. §102(b) ................................................................... 1, 2, 6, 8, 9, 10, 11, 12
`Regulations:
`37 C.F.R. §42.71 ........................................................................................................ 3
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`37 C.F.R. §42.104(b)(2) ........................................................................................... 12
`Other Authorities:
`M.P.E.P. §2127 .......................................................................................................... 8
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`iii
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`Patent Owner United Therapeutics Corporation (UT) respectfully requests
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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`that the Board reconsider its Final Written Decision (Paper 78) (FWD) finding
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`claims 1–8 of U.S. Patent No. 10,716,793 unpatentable.
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`I.
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`Introduction and Background
`The Board ruled that all eight claims of the ’793 patent are obvious, relying
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`in part on two references: Voswinckel JESC (Ex. 1007) and Voswinckel JAHA (Ex.
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`1008). The Final Written Decision concluded that these references qualify as prior
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`art under pre-AIA 35 U.S.C. §102(b) because research aids made them publicly
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`accessible. FWD at 8–12. But that prior-art determination rests on a substantial
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`legal error, because the supposed research aids were published after the critical
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`§102(b) date of May 15, 2005.
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`Public accessibility prior to the critical date is the defining feature of a §102(b)
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`“printed publication.” See, e.g., Minnesota Min. & Mfg. Co. v. Chemque, Inc., 303
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`F.3d 1294, 1301 (Fed. Cir. 2002). The Board did not find that Liquidia proved that
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`either Voswinckel abstract was itself publicly accessible, such as if they had been
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`indexed and catalogued in public libraries more than a year before the priority date.
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`Instead, the Board reasoned that two references the Board described as “research
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`aids”—Ghofrani (Ex. 1010) and Sulica (Ex. 1104)—provided a skilled artisan with
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`a roadmap to the Voswinckel abstracts. FWD at 10–12.
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`That ruling contravenes settled legal principles. Where a research aid is relied
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`upon as a “roadmap” to establish public accessibility to a skilled artisan under
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`§102(b), the date of public accessibility is the date of the research aid, not the date
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`of the underlying reference. See In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009)
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`(holding that the date of accessibility through a searchable index was the effective
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`date of an asserted reference). That is because “[t]he touchstone of public
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`accessibility is whether an ordinary artisan exercising reasonable diligence would
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`have been able to locate the document prior to the critical date.” Teoxane S.A. v.
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`Allergan, IPR2017-01906, Paper 15, at 11 (P.T.A.B. Mar. 9, 2018) (quotation marks
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`omitted). Ghofrani was clearly published within a year of the priority date (see Ex.
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`1121, at 1; Paper 55, at 9), and Liquidia provided no evidence that Sulica was
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`published outside that one-year window (see Ex. 1104, at 1; Paper 55, at 9). Thus,
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`even assuming Ghofrani and Sulica provide a skilled artisan with the requisite
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`“roadmap” to find the Voswinckel abstracts (see FWD at 11), neither could have led
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`the skilled artisan to the relevant abstract more than one year before the priority date.
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`The Final Written Decision erred in failing to address this critical distinction and
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`allowing Liquidia to use research aids published within a year of the applicable date
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`to establish the Voswinckel abstracts as publicly accessible more than a year before
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`the applicable date.
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`With this error corrected, the obviousness conclusion falls apart. Aside from
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`Voswinckel JESC and Voswinckel JAHA, the Board found no evidence that either
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`the claimed drug quantity (15 to 90 micrograms) or the claimed delivery duration
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`(one to three breaths) was disclosed in the prior art. None of Liquidia’s other
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`asserted obviousness grounds are viable, either. Each of the other grounds relies on
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`Voswinckel JESC, Voswinckel JAHA, or another reference that the Board
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`concluded does not constitute prior art. See FWD at 3–4.
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`For these reasons, the Board should grant rehearing, vacate the Final Written
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`Decision, and issue a new decision upholding the challenged claims.
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`II. Legal Standard
`A party dissatisfied with a final written decision of the Board may file one
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`rehearing request, without prior authorization, within 30 days of the Board’s
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`decision. 37 C.F.R. §42.71. The requesting party “must specifically identify all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, an opposition, a reply, or
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`a sur-reply.” Id. The Board reviews its decision for abuse of discretion, which
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`occurs when “the decision is based on an erroneous interpretation of law, if a factual
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`finding is not supported by substantial evidence, or if an unreasonable judgment is
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`made in weighing relevant factors.” Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-
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`02185, Paper 48, at 2 (P.T.A.B. July 11, 2019).
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`III. Argument
`A long-established legal principle governs the Voswinckel abstracts’ status as
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`prior art: if a skilled artisan must rely on a research aid to provide a roadmap to
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`access an underlying reference, then the underlying reference cannot have been
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`publicly accessible until the research aid was. The Final Written Decision
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`contravenes this principle by allowing Liquidia to use two later-published research
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`aids (Ghofrani and Sulica) to smuggle those earlier, otherwise-inaccessible abstracts
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`into the record as prior art. But for this legal error, the Board would have been
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`required to uphold the asserted claims.
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`A. Liquidia failed to demonstrate that the Voswinckel abstracts are
`prior art
`Liquidia’s Petition contained only the most conclusory evidence that
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`Voswinckel JESC and Voswinckel JAHA were prior art. The Petition asserted that
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`the abstracts were published in 2004 (see Paper 2, at 22, 24), and an accompanying
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`expert declaration speculated that the abstracts likely would have been received,
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`catalogued, and indexed by libraries by late 2004—without providing any evidence
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`that they actually were. See Ex. 1036 ¶¶59–75.
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`As UT explained in the Patent Owner Response, this cursory showing did not
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`come close to satisfying Liquidia’s burden of proof. Liquidia’s Petition failed to
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`demonstrate that any library actually received either abstract, let alone more than a
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`year before the priority date. See Paper 29, at 12–14. And the Petition further failed
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`to show that any library had indexed or catalogued the abstracts or even the
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`supplements in which they appeared before that date. See id. at 14–18.
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`Evidently recognizing the threadbare nature of its prior submissions, Liquidia
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`shifted stances and sought to rely on new evidence and arguments in its Reply. As
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`relevant here, Liquidia argued for the first time that Voswinckel JESC “was cited in
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`the June 2005 Ghofrani article in the journal Herz,” and that a skilled artisan “would
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`have relied on Ghofrani’s disclosures to … access the JESC abstract.” Paper 44, at
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`3–4. Liquidia advanced effectively the same argument for Voswinckel JAHA,
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`contending that a skilled artisan “would have been able to access JAHA with Sulica
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`as a research aid.” Id. at 7–8. Finally, Liquidia suggested that Sulica’s citation to
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`Voswinckel JAHA itself demonstrated public accessibility of that reference, because
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`it showed that “[t]he Sulica authors were able to access” it. Id. at 7.
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`UT explained in its Surreply that Liquidia failed to show that either
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`Voswinckel abstract was prior art. Instead, Liquidia’s “belated argument
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`establishe[d], at best, that a POSA may have been able to find the Abstract as of the
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`date the alleged ‘research aids’ became available.” Paper 55, at 9. Crucially,
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`“Ghofrani bears a July 2005 date-stamp, while Sulica shows only the year 2005”
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`without any actual evidence demonstrating the March 2005 date that Liquidia
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`asserted. Id. (citations omitted); see id. at 9 n.4.
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`UT further explained that the mere fact that Sulica and Ghofrani contain
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`citations to the Voswinckel abstracts cannot establish that the abstracts were publicly
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`accessible to persons of ordinary skill in the art more than a year before the priority
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`date. The Sulica and Ghofrani authors are not persons of ordinary skill with respect
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`to the Voswinckel abstracts because the Voswinckel abstracts’ authors had a close
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`affiliation with the supposed research aids’ authors: Voswinckel JESC and the
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`relevant portions of Ghofrani shared coauthors (Dr. Voswinckel and Dr. Seeger),
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`Paper 29, at 46–47 (citing Ex. 2066 at 3, ¶7); Paper 55, at 10, and Dr. Sulica was a
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`principal investigator in the TRIUMPH study group (there, too, along with Dr.
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`Seeger) who participated in the clinical trials reported in the Voswinckel
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`publications, Paper 55, at 10. Thus, the fact that the authors of Sulica and Ghofrani
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`had access to and could cite the Voswinckel abstracts, given their affiliation with
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`those abstracts, is irrelevant to whether a person of ordinary skill could have publicly
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`accessed them, much less accessed them more than a year before the priority date.
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`See Paper 55, at 10.
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`As UT explained, “if the Abstracts only became publicly accessible (via these
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`alleged ‘research aids’) after May 15, 2005, they do not qualify as prior art under 35
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`U.S.C. §102(b).” Id. at 10. “And if the Abstracts are not Section 102(b) prior art,
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`they are not prior art at all because they are not ‘by another’ under Section 102(a),
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`given Patent Owner’s showing that the subject matter of both Abstracts is the
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`inventors’ own work.” Id.1
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`B.
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`The Board’s conclusion that Voswinckel JESC and Voswinckel
`JAHA are prior art conflicts with settled legal principles
`The Board erroneously concluded that Voswinckel JESC and Voswinckel
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`JAHA were prior art. According to the Final Written Decision, because “both the
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`Ghofrani article and the Sulica article” cite the Voswinckel abstracts, they are
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`research aids that serve as “roadmaps” to establish public accessibility of those
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`abstracts. FWD at 11–12 (citing Blue Calypso, LLC v. Groupon, Inc., 815 F.3d
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`1331, 1350 (Fed. Cir. 2016)). That conclusion conflicts with settled legal principles.
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`As the Board has previously explained, “[t]he touchstone of public
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`accessibility is whether an ordinary artisan exercising reasonable diligence would
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`have been able to locate the document prior to the critical date.” Teoxane, IPR2017-
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`01906, Paper 15, at 11 (quotation marks omitted). Indeed, the decisions of both the
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`1 This showing was uncontested. Liquidia did not object to or move to exclude
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`any of Exhibits 2003, 2061, and 2071, which were first filed with the Patent Owner
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`Response (Paper 29) and later cited in the Surreply (Paper 55, at 10) to show that the
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`abstracts were not §102(a) prior art. Furthermore, Liquidia declined the opportunity
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`to depose Dr. Seeger in the IPR in relation to Exhibits 2003 and 2071 following their
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`submission with the Patent Owner Response, and it made no request to submit any
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`rebuttal evidence on this issue following the Surreply.
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`Federal Circuit and this Board have repeatedly underscored the point: what matters
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`is public accessibility as of the critical date. See, e.g., Constant v. Advanced Micro-
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`Devices, Inc., 848 F.2d 1560, 1568 (Fed. Cir. 1988) (“The statutory phrase ‘printed
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`publication’ has been interpreted to mean that before the critical date the reference
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`must have been sufficiently accessible to the public interested in the art[.]”); In re
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`Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009) (analyzing whether a reference was
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`“publicly accessible as of the critical date”); Kyocera Wireless Corp. v. ITC, 545
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`F.3d 1340, 1350 (Fed. Cir. 2008) (similar).
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`These principles apply with equal force regardless of whether a reference is
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`publicly accessible on its own or instead becomes publicly accessible only by way
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`of a “research aid.” As the Federal Circuit has explained, “the presence of a
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`‘research aid’ can … establish public accessibility” by “provid[ing] a skilled artisan
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`with a sufficiently definite roadmap leading to … the potentially invalidating
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`reference.” Blue Calypso, 815 F.3d at 1350. By simple logic, that roadmap can
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`“lead[] to … the potentially invalidating reference” only if and when it becomes
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`publicly accessible—before then, there is nothing to guide the skilled artisan to the
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`underlying reference. See Lister, 583 F.3d at 1312 (for a reference that becomes
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`publicly accessible through a searchable index, the relevant date is the date of
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`indexing); cf. M.P.E.P. §2127 (“An abandoned patent application may become
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`evidence of prior art only when it has been appropriately disclosed, as, for example,
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`when the abandoned patent application is referenced in the disclosure of another
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`patent, in a publication, or by voluntary disclosure[.]” (brackets omitted)). The key
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`issue in this case is therefore when the research aid providing the roadmap became
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`publicly accessible, and whether that was before the §102(b) critical date.
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`The Final Written Decision did not address that question and overlooked UT’s
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`arguments doing so. Even assuming that “the Ghofrani article and the Sulica article
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`provide roadmaps directing a person of ordinary skill in the art … straight to
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`Voswinckel JESC or Voswinckel JAHA” (FWD at 11–12), the question is when
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`those roadmaps became available to an ordinary artisan in this field. The answer:
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`not before the critical May 15, 2005, §102(b) date. Ghofrani is an article from the
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`June 2005 issue of Herz; the exhibit in the record bears a July 2005 date-stamp. See
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`Ex. 1121, at 1. And Sulica bears a “2005” date with no indication of when in 2005
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`it was published—much less when it became publicly accessible.2 See Ex. 1104, at
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`2.
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`2 Liquidia asserted that Sulica is a “March 2005 article” (Paper 44, at 7), and the
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`Final Written Decision quoted that statement (FWD at 11). But there is no evidence
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`that it appeared in any publication in March 2005. The document itself, Exhibit
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`1104, only references the year “2005” and offers no other date information. Paper
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`55, at 9. And there was no other evidence supporting Liquidia’s March 2005 date.
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`In short, neither of the alleged research aids were shown to have been publicly
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`accessible before the critical §102(b) date. And Liquidia essentially conceded this
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`point—it argued, for example, that Ghofrani would have provided a roadmap to an
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`ordinary skilled artisan to locate Voswinckel JESC “before May 15, 2006.” Paper
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`44, at 4 (emphasis added); accord id. at 7–8 (arguing that Sulica would have allowed
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`an ordinary skilled artisan exercising reasonable diligence to access Voswinckel
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`JAHA “before 2006” (emphasis added)). In nevertheless concluding that Sulica and
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`Ghofrani establish the Voswinckel abstracts as prior art under §102(b), the Board
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`effectively blessed an end-run around the principle that a reference must be publicly
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`accessible before the critical date. That legal error infected the Board’s decision,
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`and warrants rehearing.
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`Furthermore, to the extent the Board concluded that Ghofrani and Sulica’s
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`mere citations to the Voswinckel abstracts demonstrated that those references were
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`publicly accessible because it demonstrated that the authors of Ghofrani and Sulica
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`were able to access the abstracts—as Liquidia argued in its Reply (Paper 44, at 7)—
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`that conclusion is equally erroneous. Section 102(b) requires prior-art references to
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`be “publicly accessible” to an “ordinary” skilled artisan. Teoxane, IPR2017-01906,
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`Paper 15, at 11; Samsung Elecs. Co. v. Infobridge Pte. Ltd., 929 F.3d 1363, 1369
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`(Fed. Cir. 2019) (whether “persons of ordinary skill in the art” were able to locate
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`the abstracts through the exercise of “reasonable diligence”). The authors of
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`Ghofrani and Sulica were not ordinary skilled artisans with respect to the
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`Voswinckel abstracts. Rather, they were coauthors of one Voswinckel abstract
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`(citing their own prior work) and a principal investigator of the team conducting the
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`clinical work described in the other abstract; they therefore would naturally have
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`known about (and had access to) those documents irrespective of their public
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`accessibility. Paper 55, at 10.
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`In other words, if a petitioner is relying on a research aid to establish public
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`accessibility of a reference by a hypothetical person of ordinary skill, it is not enough
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`for a petitioner to point to the mere existence of a citation in a research aid authored
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`by someone affiliated with the cited reference. Doing so simply demonstrates that
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`the research aid’s author was aware of the work he or she contributed to—not that
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`the public (or an ordinary skilled artisan) had access to it. Argentum Pharm. LLC v.
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`Research Corp. Tech., Inc., IPR2016-00204, Paper 19 at 11 (P.T.A.B. May 23,
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`2016) (concluding that references citing a disputed prior-art thesis, authored either
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`by the student who wrote the thesis or by the student’s thesis advisor, only indicated
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`that the authors “had personal knowledge regarding the cited thesis”).3 Nor, of
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`3 Although the Board mentioned Liquidia’s argument that Voswinckel JESC was
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`publicly presented, see FWD at 10, the Board did not adopt that argument, and
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`Liquidia offered no evidence of what was presented or to whom. Nor did Liquidia
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`course, does it demonstrate that an affiliated author who published after the critical
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`§102(b) date had access to the reference before that date.
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`C. But for the Board’s legal error, the challenged claims would have
`been upheld
`For the foregoing reasons, the Board erred in concluding that Voswinckel
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`JESC and Voswinckel JAHA are prior art under §102(b). And without that
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`erroneous conclusion, the Board’s decision cannot stand.
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`Nor would there have been any basis for concluding that the two Voswinckel
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`abstracts are prior art under §102(a). First, it would be improper for the Board to
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`entertain the Voswinckel abstracts as §102(a) prior art because the Petition alleges
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`them only to be §102(b) art. Compare Paper 2, at 22, 24 (addressing the abstracts
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`and identifying §102(b)), with id. at 25, 27 (addressing Ghofrani and Voswinckel
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`2006 as prior art under §102(a)). The Board has held that belated conversion from
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`§102(a) to §102(b) is not permitted. See Handi Quilter, Paper 39, at 6; see also SAS
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`Inst. v. Iancu, 138 S. Ct. 1348, 1356 (2018) (holding that an inter partes review must
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`anywhere argue or explain how any public presentation could have served as a
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`“research aid” that establishes any specific date of public accessibility sufficient to
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`render JESC a §102(b) reference, especially given that the only reference of record
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`which actually cites JESC (Ghofrani) was published less than a year before the
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`priority date.
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`proceed “in accordance with or in conformance to the petition”); 37 C.F.R.
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`§42.104(b)(2) (providing that a petition must state “[t]he specific statutory grounds
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`under 35 U.S.C. 102 or 103 on which the challenge to the claim is based and the
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`patents or printed publications relied upon for each ground.”). Second, even if
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`Liquidia had raised a §102(a) argument, the argument would have failed on the
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`merits. Section 102(a) applies only to printed publications by “others”—i.e.,
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`individuals other than the inventors. As already explained, Voswinckel JESC and
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`Voswinckel JAHA are not by “others”: they reflect the inventors’ own work. See
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`Paper 55, at 10; Ex. 2003 ¶27; Ex. 2061 ¶¶12–13; Ex. 2071¶¶6–8; supra, pp. 5–6,
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`10.
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`There is also no basis for adopting any of the other obviousness grounds in
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`the Petition. Ground 2 also relies on Voswinckel JESC. FWD at 3. Ground 3 relies
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`on Ghofrani, which the Board correctly found not to constitute prior art because it
`
`was not by “others.” See id. at 37–40. Ground 4 relies on Voswinckel JESC and
`
`Ghofrani. Id. at 3. And Grounds 5 and 6 rely on Voswinckel 2006, see id. at 3–4,
`
`which the Board correctly found not to constitute prior art because it was not by
`
`others, see id. at 40–41.
`
`In short, the Board’s erroneous conclusion that Ghofrani and Sulica could
`
`establish public accessibility—without any proof that those sources provided a
`
`roadmap to the Voswinckel abstracts before the critical date—was an outcome-
`
`4855-7660-5999.1
`
`13
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`
`
`
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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`
`determinative error.
`
`IV. Conclusion
`The Board should grant rehearing, vacate its prior final written decision, and
`
`enter a revised final written decision confirming that Liquidia has not shown that
`
`claims 1–8 of the ’793 patent are unpatentable.
`
`
`
`August 18, 2022
`
`Respectfully submitted.
`
`/Stephen B. Maebius/
`Stephen B. Maebius (Reg. No. 35,264)
`FOLEY & LARDNER LLP
`3000 K Street, NW
`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile: (202) 672-5399
`
`Counsel for Patent Owner
` United Therapeutics Corporation
`
`4855-7660-5999.1
`
`14
`
`
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
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`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing “Patent Owner’s
`
`Request for Rehearing” was served on August 18, 2022, via e-mail on the following
`
`/Stephen B. Maebius/
`Stephen B. Maebius (Reg. No. 35,264)
`FOLEY & LARDNER LLP
`3000 K Street, NW
`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile: (202) 672-5399
`
`Counsel for Patent Owner
` United Therapeutics Corporation
`
`counsel of record for the Petitioner:
`
`zLiquidiaIPR@cooley.com
`ielrifi@cooley.com
`emilch@cooley.com
`dkannappan@cooley.com
`ssukduang@cooley.com
`
`August 18, 2022
`
`
`
`
`4855-7660-5999.1
`
`
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