UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
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`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
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`
`_______________
`
`Case IPR2020-00770
`Patent 9,604,901
`_______________
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`PATENT OWNER’S REQUEST FOR PANEL REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
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`4877-5178-5218.1
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`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`_______________
`
`Case IPR2020-00770
`Patent 9,604,901
`_______________
`
`
`PATENT OWNER’S REQUEST FOR PANEL REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
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`4877-5178-5218.1
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`
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`Case IPR2020-00770
`Patent 9,604,901
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`
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`Request for Panel Rehearing
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`
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`Patent Owner respectfully requests panel rehearing of the limited portion of the
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`October 8, 2021 Final Written Decision (“FWD”) (Paper 45) finding that Petitioner
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`established that claims 1-5, 8, and 9 of U.S. Patent No. 9,604,901 (“the ’901
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`patent”) are obvious over the combination of Moriarty and Phares. 37 C.F.R.
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`§ 42.71(d). The Board’s decision relied on inadmissible, unsworn expert
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`statements submitted by Petitioner that, when timely objected to by Patent Owner,
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`Petitioner failed to timely cure as required by 17 C.F.R. § 42.64(b)(2). Because
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`Petitioner did not timely submit admissible evidence that would support the
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`Board’s conclusion, the Board should find that claims 1-5, 8, and 9 are not
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`unpatentable. The FWD found claims 1-5, 8, and 9 obvious only over the
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`combination of Moriarty and Phares and does not address the other asserted ground
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`of obviousness over Phares alone in relation to these claims. FWD at p. 50. To the
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`extent that the panel grants this rehearing request, the panel should also hold that
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`the other ground of obviousness based on Phares alone similarly fails to establish
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`obviousness of these claims because it too is only supported by unsworn
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`statements as to several critical elements of obviousness. Patent Owner Response
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`(Paper No. 12) at pp. 29, 30-32, and 34.
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`4877-5178-5218.1
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`2
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`Case IPR2020-00770
`Patent 9,604,901
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`I. APPLICABLE STANDARDS
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`Request for Panel Rehearing
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`
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`Under 37 C.F.R. § 42.71(d), a party may request panel rehearing of a Final
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`Written Decision by the Board. “The request must specifically identify all matters
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`the party believes the Board misapprehended or overlooked, and the place where
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`each matter was previously addressed in a motion, an opposition, or a reply.” 37
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`C.F.R. § 42.71(d).
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`II. ARGUMENT
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`A. Affidavits Submitted in IPRs Must Be Sworn.
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`Under the Board’s rules, non-deposition testimony must be in the form of an
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`“affidavit.” 37 C.F.R. § 42.63(a). The “affidavit” must be either testimony given
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`under oath (such as a true sworn affidavit) or a declaration acknowledging that it is
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`given under penalty of perjury, such as “a declaration under 28 U.S.C. § 1746.” 37
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`C.F.R. § 42.2 (“Affidavit”). That is consistent with the statutes governing
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`testimony in the Patent and Trademark Office. 35 U.S.C. §§ 23, 25. Under
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`§ 1746, a declaration does not qualify unless it is “subscribed by [the declarant],
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`under penalty of perjury,” and “substantially” adheres to the form of the prescribed
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`attestation. 28 U.S.C. § 1746. That attestation is simple, but necessary: without it,
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`an unsworn statement is inadmissible evidence because the speaker is not
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`prosecutable for perjury.
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`4877-5178-5218.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Request for Panel Rehearing
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`The procedure and time limits for identifying and curing defective declarations
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`are straightforward. The Board’s rules require a party challenging the
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`admissibility of evidence to raise its objection promptly, 37 C.F.R. § 42.64(b)(1),
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`and any objection must be preserved with a motion to exclude, 37 C.F.R.
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`§ 42.64(c). And the Board’s rules create a simple avenue for parties to cure any
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`defectively submitted affidavits: they afford the party relying on timely challenged
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`evidence ten days to serve admissible supplemental evidence. 37 C.F.R.
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`§ 42.64(b)(2). But if, after receiving a timely objection, the party fails to cure, then
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`the declaration must stand or fall as originally submitted. A party cannot see
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`whether an objection gets traction and then submit untimely supplemental
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`evidence.
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`B. The FWD Improperly Relied on Unsworn Statements That Were Not
`Timely Cured in Compliance with § 42.64(b).
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`The Board’s decision here is inconsistent with the clear rules described above.
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`The Winkler Declaration (EX1002) is not an affidavit: it is unsworn and did not
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`include any attestation that it was submitted under penalty of perjury, yet the FWD
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`specifically relies upon EX1002 at pp. 32-34, 36-38, 41, and 42. Patent Owner
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`timely objected to it in Paper No. 10 (as acknowledged at the final hearing, see
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`Paper 44 at 21:12-25), and rather than addressing that objection as required by the
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`4877-5178-5218.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Request for Panel Rehearing
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`rules, Petitioner ignored the objection and engaged in self-help months after the
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`deadline (Paper 44 at 22:8-23:17, 25:3-14). The Board’s reliance on the Winkler
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`Declaration despite Patent Owner’s timely, meritorious objection is contrary to the
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`Board’s own rules and the statute.
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`The FWD relies extensively upon the Winkler Declaration in concluding that
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`Petitioner established obviousness of claims 1-5, 8, and 9 based on the
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`combination of Moriarty and Phares. FWD at pp. 32-34, 36-38, 41, and 42.1 But
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`as noted in the Patent Owner Response (Paper No. 12) at pp. 1 and 60 and in Patent
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`Owner’s Motion to Exclude (Paper No. 31), Dr. Winkler’s statements were not
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`admissible as submitted. And when Patent Owner timely objected to its
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`1 For example, the FWD relies upon EX1002 in stating “we agree with Dr. Winkler
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`that ‘Kawakami teaches the purification of a methanoprostacyclin derivative by
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`salt formation with a secondary amine, which is the same reaction as taught in
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`Phares for the formation of the diethanolamine salt of treprostinil.’” FWD at 42.
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`Thus, the Board supports its conclusion that there would be an expectation of
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`successfully purifying treprostinil by combining a diethanolamine salt formation
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`step from Phares with Moriarty based on Dr. Winkler’s testimony, as well as for
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`other key findings at pp. 32-34 and 36-38 of the FWD.
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`4877-5178-5218.1
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`5
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`Case IPR2020-00770
`Patent 9,604,901
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`Request for Panel Rehearing
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`admissibility (Paper No. 10), Petitioner did not take the opportunity to serve a
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`supplemental sworn affidavit within ten business days as required by § 42.64(b)(2).
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`Instead, months later, Petitioner filed a new declaration at the Reply stage
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`(EX1039)—without even attempting to obtain the necessary permission from the
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`Board—which the Board itself acknowledged does not cure Petitioner’s violation
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`of § 42.64(b)(2). FedEx Corp. v. Ronald A Katz Tech. Lisc., CBM2015-00053,
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`Paper 9, pp. 7–8 (P.T.A.B. June 29, 2015) (giving no weight to a non-compliant
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`declaration); FWD at 55-56; see Paper 44 at 23:22-24:7.
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`Although the Board correctly determined that the unauthorized, late-filed
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`Winkler Declaration is entitled to no weight (FWD at pp. 56-57), it erred by
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`considering and relying extensively on the inadmissible original Winkler
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`Declaration. The Board cannot waive the statutory sworn-testimony requirement;
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`the Patent Act requires that testimony in “cases in the Patent and Trademark
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`Office” be under oath or, at a minimum, under penalty of perjury. 35 U.S.C.
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`§§ 23, 25. A paper that is “unsworn” “can be taken merely as argument and not to
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`establish facts.” In re Mehta, 347 F.2d 859, 866 (C.C.P.A. 1965). And the Board
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`has not waived its procedural or admissibility rules for Petitioner. Doing so would
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`be particularly inappropriate where, as here, the rules create a simple and clear
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`mechanism for quickly curing evidentiary defects. Petitioner not only failed to
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`4877-5178-5218.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Request for Panel Rehearing
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`comply with those rules—choosing to stand on its original, defective submission—
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`but then four months later improperly filed additional evidence without even
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`seeking leave to do so. The Board’s rules do not permit “resort[ing] to self-help.”
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`FWD at p. 57.
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`The Board appeared to rely on a purported lack of prejudice in considering the
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`unsworn statements, but the governing statutes and rules contain neither a good-
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`cause exception nor a no-prejudice exception. Indeed, the Board implicitly
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`acknowledged in refusing to consider untimely-submitted evidence that 37 C.F.R.
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`§ 42.64 does not contain a no-prejudice exemption from the requirement that
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`evidentiary defects be timely cured. If, as the Board correctly held, untimely-
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`submitted evidence cannot be considered, neither can the original declaration
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`whose defect Petitioner was improperly trying to repair. The Board does not have
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`discretion to allow unsworn statements that fail to comply with the statutory
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`sworn-testimony requirements, and it cannot rely on such statements over a timely,
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`uncured objection just by asserting a lack of “prejudice.”2 The prejudice to Patent
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`2 The FWD declined to exclude EX1002 in response to the Motion to Exclude
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`(Paper No. 31, pp. 1-3). Regardless of whether or not this exhibit is excluded, the
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`FWD cannot rely upon it given the statutory requirements for sworn declarations.
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`4877-5178-5218.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Request for Panel Rehearing
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`Owner is now apparent in light of the FWD: the Board actually relied on the
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`challenged document. On the Board’s reasoning, it appears “prejudice” could be
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`proved only if the objecting party identified a lie punishable by prosecution for
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`perjury. That is an impossible standard that would license parties to disregard the
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`oath and penalty-of-perjury requirements and suffer no consequences.
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`Accordingly, the FWD cannot rely upon unsworn testimony for its conclusion
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`that it would be obvious to apply the diethanolamine salt-forming step of Phares to
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`the treprostinil process of Moriarty or for any other critical finding at pp. 32-34 and
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`36-38 of the FWD supporting its conclusion as to claims 1-5, 6, and 8.
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`III. CONCLUSION
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`For at least the reasons provided above, rehearing by the panel is requested to
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`issue an FWD that does not rely upon EX1002, and which concludes that
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`Petitioner has failed to establish that claims 1-5, 8, and 9 are unpatentable.
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`Respectfully submitted,
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`Date: Nov. 8, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`4877-5178-5218.1
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`8
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`Case IPR2020-00770
`Patent 9,604,901
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`
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`Request for Panel Rehearing
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Request for
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`Panel Rehearing was served on counsel of record on Nov. 8, 2021, by filing this
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`document through the PTAB E2E System as well as delivering a copy via email to
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`the counsel of record for the Petitioner at the following addresses:
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`zLiquidiaIPR@cooley.com
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`ielrifi@cooley.com
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`emilch@cooley.com
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`dkannappan@cooley.com
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`Date: Nov. 8, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4877-5178-5218.1
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