`571.272.7822
`
`
`Paper No. 50
`Entered: March 3, 2022
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`IPR2021-00406
`Patent 10,716,793 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, CHRISTOPHER M. KAISER,
`and DAVID COTTA, Administrative Patent Judges.
`
`KAISER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`
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`IPR2021-00406
`Patent 10,716,793 B2
`
`On March 1, 2022, Judges Franklin, Cotta, and Kaiser held a
`conference call with counsel for both parties to discuss Patent Owner’s email
`request for authorization to submit rebuttal evidence with its Sur-Reply. A
`transcript of the conference call was made by a court reporter, and that
`transcript will be entered in the record of this proceeding in due course. For
`the reasons discussed below, we deny Patent Owner’s request.
`
`
`BACKGROUND
`Petitioner challenges claims 1–8 of U.S. Patent No. 10,716,793 on
`grounds that rely on, inter alia, Exhibits 1007 and 1008, which Petitioner
`asserts are prior art to the ’793 patent. Paper 2 (Petition), 30–68. In its
`Response to the Petition, Patent Owner argues that Petitioner has not proven
`that Exhibits 1007 and 1008 are prior art because Petitioner has not shown
`that they were publicly accessible at an early enough date. Paper 29 (Patent
`Owner Response), 11–18. In particular, Patent Owner argues that Petitioner
`has not shown that Exhibits 1007 and 1008 were received, catalogued, and
`indexed sufficiently by a library to show that a person of ordinary skill in the
`art could have located them. Id. In connection with its Reply to Patent
`Owner’s Response, Petitioner submitted evidence in addition to that
`submitted with the Petition. Exs. 1087–1132. Petitioner argues that this
`evidence, considered together with the evidence submitted with the Petition,
`supports the public accessibility of Exhibits 1007 and 1008. Paper 44, 1–9.
`Patent Owner has the right to file a Sur-Reply to Petitioner’s Reply,
`but, under 37 C.F.R. § 42.23(b), the Sur-Reply “may only respond to
`arguments raised in the corresponding reply and may not be accompanied by
`new evidence other than deposition transcripts of the cross-examination of
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`IPR2021-00406
`Patent 10,716,793 B2
`any reply witness.” Here, Patent Owner seeks relief beyond what
`Rule 42.23(b) permits, by requesting authorization to submit additional
`evidence with its Sur-Reply that rebuts the evidence Petitioner submitted
`with its Reply.
`
`
`ANALYSIS
`As noted above, Rule 42.23(b) does not, in general, permit Patent
`Owner to submit evidence along with its Sur-Reply, except for “deposition
`transcripts of the cross-examination of any reply witness.” Although Patent
`Owner could not identify during the conference call the specific evidence it
`would seek to submit along with its Sur-Reply, it represented that the
`evidence in question would not be limited to deposition transcripts
`authorized by Rule 42.23(b). Thus, to grant Patent Owner the relief it seeks,
`we would need to waive the provisions of Rule 42.23(b).
`We are permitted to “waive or suspend a requirement of [our rules].”
`37 C.F.R. § 42.5(b). In deciding whether to do so, we construe our rules “to
`secure the just, speedy, and inexpensive resolution of every proceeding.” Id.
`§ 42.1(b). In particular, we note the requirement that “the final
`determination in an inter partes review be issued not later than 1 year after
`the date on which the Director notices the institution of a review.”
`35 U.S.C. § 316(a)(11). In accordance with these requirements, our rules
`provide for the closure of the evidentiary record with the Petitioner’s Reply,
`with the only subsequent additions being any cross-examination Patent
`Owner conducts of Petitioner’s Reply witnesses. Neither the requirement to
`resolve disputes within twelve months nor the requirement to resolve
`proceedings in a speedy and inexpensive manner would be served by
`waiving the requirements of Rule 42.23(b) here for Patent Owner to submit
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`IPR2021-00406
`Patent 10,716,793 B2
`its rebuttal evidence, followed by Petitioner filing the equivalent of a Sur-
`Reply commenting upon the new evidence submitted by Patent Owner.
`In addition, there is no clear need for additional evidence on the issue
`of the public accessibility of Exhibits 1007 and 1008. Petitioner is permitted
`some “limited opportunities . . . to present new evidence [after the Petition],
`including . . . in a reply to the patent owner response,” as long as that new
`evidence is “responsive to the prior briefing.” Hulu, LLC v. Sound View
`Innovations, LLC, IPR2018-01039, Paper 29, at 14 (PTAB Dec. 20, 2019)
`(precedential). “The opportunity to submit additional evidence does not
`allow a petitioner to completely reopen the record, by, for example,
`changing theories after filing a petition.” Id. at 15. Here, Petitioner has
`submitted new evidence with the Reply, and the parties dispute whether the
`evidence represents a change from the Petition’s theory of public
`accessibility. Papers 47, 49. Ultimately, we will consider only properly
`submitted evidence that satisfies Hulu’s requirements and from that evidence
`determine whether Petitioner shows sufficiently that the exhibits in question
`were publicly accessible. It is unclear how any additional evidence
`submitted by Patent Owner—as opposed to Patent Owner’s arguments for
`ignoring Petitioner’s evidence, giving Petitioner’s evidence little weight, or
`finding a lack of public accessibility in light of Petitioner’s evidence, all of
`which Patent Owner is already permitted to assert in its Sur-reply—would
`assist in resolving the issue of public accessibility. This lack of clarity also
`weighs against granting Patent Owner’s request for relief from
`Rule 42.23(b).
`Moreover, during the conference call, we asked Patent Owner to
`describe the nature of the evidence it seeks to submit along with the Sur-
`Reply and how that evidence might help show a lack of public accessibility,
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`IPR2021-00406
`Patent 10,716,793 B2
`but Patent Owner answered only by listing vague types of evidence that
`might be submitted. Thus, we are unable to consider whether the specific
`evidence that Patent Owner seeks to submit would help resolve the public
`accessibility issue in its favor. This also weighs against granting Patent
`Owner’s request.
`Thus, to summarize, there is no right to submit additional evidence
`with Patent Owner’s Sur-Reply; Rule 42.23(b) provides precisely the
`opposite. To the extent that we are permitted to waive Rule 42.23(b), we
`may do so only in the interest of resolving this proceeding in a just, speedy,
`and inexpensive manner. Waiving the rule would work at cross-purposes to
`two of those three factors, and might threaten our ability to resolve this inter
`partes review within one year of institution. As to the remaining factor, in
`the absence of a clear explanation of what the evidence in question is, what
`that evidence might show, how that evidence might support Patent Owner’s
`position, or why Patent Owner’s already-existing opportunity to provide
`arguments rather than evidence is insufficient, we cannot say that providing
`Patent Owner the opportunity it seeks to present additional evidence is
`necessary in order to promote the just resolution of this proceeding.
`Accordingly, we are not persuaded that we should waive the limits imposed
`on the Sur-Reply by Rule 42.23(b).
`
`It is
`ORDERED that Patent Owner’s request for authorization to submit
`evidence with its Sur-Reply beyond the limits placed on that evidence by
`37 C.F.R. § 42.23(b) is denied.
`
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`IPR2021-00406
`Patent 10,716,793 B2
`For PETITIONER:
`
`Ivor R. Elrifi
`Erik B. Milch
`Deepa Kannappan
`Sanya Sukduang
`Jonathan R. Davies
`COOLEY LLP
`ielrifi@cooley.com
`emilch@cooley.com
`dkannappan@cooley.com
`ssukduang@cooley.com
`jdavies@cooley.com
`zLiquidiaIPR@cooley.com
`zpatdocketing@cooley.com
`
`
`For PATENT OWNER:
`
`Stephen B. Maebius
`Michael R. Houston
`Jason N. Mock
`FOLEY & LARDNER LLP
`smaebius@foley.com
`mhouston@foley.com
`jmock@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas H. Carsten
`April E. Weisbruch
`Judy Mohr, Ph.D.
`Arthur P. Dykhuis
`Jiaxiao Zhang
`Amy L. Mahan
`Mandy H. Kim
`MCDERMOTT WILL & EMERY LLP
`dcarsten@mwe.com
`
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`IPR2021-00406
`Patent 10,716,793 B2
`aweisbruch@mwe.com
`jmohr@mwe.com
`adykhuis@mwe.com
`jiazhang@mwe.com
`amahan@mwe.com
`mhkim@mwe.com
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