Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 67
`Entered: April 22, 2022
`
`
`
`
`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
`Setting Oral Argument
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`
`Paper 67
`Entered: April 22, 2022
`
`
`
`
`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
`Setting Oral Argument
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`I. ORAL ARGUMENT
`Both parties have requested oral argument in this proceeding.
`Paper 57; Paper 58. Those requests are granted subject to the guidelines
`below.
`
`A. Time and Format
`Oral arguments will commence at 1:00 pm Eastern Time on May 13,
`2022, by video.1 The Board will provide a court reporter for the hearing,
`and the reporter’s transcript will constitute the official record of the hearing.
`Petitioner will have a total of sixty (60) minutes to present argument
`in this case and Patent Owner will have a total of sixty (60) minutes to
`respond, with the time divided as follows. Petitioner will open the hearing
`by presenting its case regarding the challenged claims for which the Board
`instituted trial. Thereafter, Patent Owner will respond to Petitioner’s
`argument. Petitioner may reserve rebuttal time to respond to arguments
`presented by Patent Owner. In accordance with the Consolidated Trial
`Practice Guide2 (“CTPG”), issued in November 2019, Patent Owner may
`request to reserve time for a brief sur-rebuttal. See CTPG 83.
`The parties may request a pre-hearing conference in advance of the
`hearing. See id. at 82. “The purpose of the pre-hearing conference is to
`afford the parties the opportunity to preview (but not argue) the issues to be
`discussed at the hearing, and to seek the Board’s guidance as to particular
`issues that the panel would like addressed by the parties.” Id. If either party
`
`1 If there are any concerns about disclosing confidential information, the
`parties must contact the Board at Trials@uspto.gov at least ten (10) business
`days before the hearing date.
`2 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`
`2
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`desires a pre-hearing conference, the parties should jointly contact the Board
`at Trials@uspto.gov at least seven (7) business days before the hearing date
`to request a conference call for that purpose.
`
`B. Demonstratives
`As set forth in 37 C.F.R. § 42.70(b), demonstratives shall be served on
`opposing counsel at least seven (7) business days before the hearing date and
`filed no later than two (2) business days before the hearing.3
`Demonstratives are not a mechanism for making new arguments.
`Demonstratives also are not evidence, and will not be relied upon as
`evidence. Rather, demonstratives are visual aids to a party’s oral
`presentation regarding arguments and evidence previously presented and
`discussed in the papers. Accordingly, demonstratives shall be clearly
`marked with the words “DEMONSTRATIVE EXHIBIT – NOT
`EVIDENCE” in the footer. See Dell Inc. v. Acceleron, LLC, 884 F.3d 1364,
`1369 (Fed. Cir. 2018) (holding that the Board is obligated under its own
`regulations to dismiss untimely argument “raised for the first time during
`oral argument”). “[N]o new evidence may be presented at the oral
`argument.” CTPG 85; see also St. Jude Med., Cardiology Div., Inc. v. The
`Bd. of Regents of the Univ. of Mich., IPR2013-00041, Paper 65, 2–3 (PTAB
`Jan. 27, 2014) (explaining that “new” evidence includes evidence already of
`record but not previously discussed in any paper of record).
`
`
`3 The parties may stipulate to an alternative schedule for serving and filing
`demonstratives, and request that the Board modify the schedule for filing
`and serving demonstratives at least seven (7) business days before the
`hearing date.
`
`3
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`Furthermore, because of the strict prohibition against the presentation
`of new evidence or arguments at a hearing, it is strongly recommended that
`each demonstrative include a citation to a paper in the record, which allows
`the Board to easily ascertain whether a given demonstrative contains “new”
`argument or evidence or, instead, contains only that which is developed in
`the existing record.
`Due to the nature of the Board’s consideration of demonstratives and
`the opportunity afforded for the parties to reach an agreement without
`involving the Board, the Board does not anticipate that objections to
`demonstratives are likely to be sustained. Nevertheless, to the extent that a
`party objects to the propriety of any demonstrative, the parties shall meet
`and confer in good faith to resolve any objections to demonstratives prior to
`filing the objections with the Board. If such objections cannot be resolved,
`the parties may file any objections to demonstratives with the Board no later
`than the time of the hearing. The objections shall identify with particularity
`which portions of the demonstratives are subject to objection (and should
`include a copy of the objected-to portions) and include a one (1) sentence
`statement of the reason for each objection. No argument or further
`explanation is permitted. The Board will consider any objections, and may
`reserve ruling on the objections.4 Any objection to demonstratives that is
`not timely presented will be considered waived.
`Finally, the parties are reminded that each presenter should identify
`clearly and specifically each paper (e.g., by slide or screen number for a
`
`
`4 If time permits, the Board may schedule a conference call with the parties
`to discuss any filed objections.
`
`4
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`demonstrative) referenced during the hearing to ensure the clarity and
`accuracy of the court reporter’s transcript and for the benefit of all
`participants appearing electronically.
`
`C. Presenting Counsel
`The Board generally expects lead counsel for each party to be present
`at the hearing. See CTPG 11. Any counsel of record may present the
`party’s argument as long as that counsel is present by video.
`
`D. Video Hearing Details5
`To facilitate planning, each party must contact the Board at
`PTABHearings@uspto.gov at least five (5) business days prior to the
`hearing date to receive video set-up information. As a reminder, all
`arrangements and the expenses involved with appearing by video, such as
`the selection of the facility from which a party will attend by video, must be
`borne by that party. If a video connection cannot be established, the parties
`will be provided with dial-in connection information, and the hearing will be
`conducted telephonically.
`If one or both parties would prefer to participate in the hearing
`telephonically, they must contact the Board at PTABHearings@uspto.gov at
`least five (5) business days prior to the hearing date to receive dial-in
`connection information.
`
`
`5 USPTO facilities remain closed to the public. If and when conditions
`allow in-person hearing attendance, the parties will be notified and will be
`permitted to submit a joint request to convert the current video hearing to an
`in-person hearing. The requests will be considered on a case-by-case basis
`and subject to resource availability.
`
`5
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`Counsel should unmute only when speaking. The panel will have
`access to all papers filed with the Board, including demonstratives. During
`the hearing, the parties are reminded to identify clearly and specifically each
`paper referenced (e.g., by slide or screen number for a demonstrative) to
`ensure the clarity and accuracy of the court reporter’s transcript and for the
`benefit of all participants appearing electronically. In addition, the parties
`are advised to identify themselves each time they speak. Furthermore, the
`remote nature of the hearing may also result in an audio lag, and thus the
`parties are advised to observe a pause prior to speaking, so as to avoid
`speaking over others.
`If at any time during the hearing, counsel encounters technical or
`other difficulties that fundamentally undermine counsel’s ability to
`adequately represent its client, please let the panel know immediately, and
`adjustments will be made.6
`
`E. Remote Attendance Requests
`Members of the public may request to listen to this hearing. If
`resources are available, the Board generally expects to grant such requests.
`If either party objects to the Board granting such requests, for example,
`because confidential information may be discussed, the party must notify the
`Board at PTABHearings@uspto.gov at least ten (10) business days prior to
`the hearing date.
`
`
`6 For example, if a party is experiencing poor video quality, the Board may
`provide alternate dial-in information.
`
`6
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`F. Audio/Visual Equipment Requests
`Any special requests for audio-visual equipment should be directed to
`PTABHearings@uspto.gov. A party may also indicate any special requests
`related to appearing at a video hearing, such as a request to accommodate
`visual or hearing impairments, and indicate how the PTAB may
`accommodate the special request. Any special requests must be presented in
`a separate communication at least five (5) business days before the hearing
`date.
`
`G. Legal Experience and Advancement Program
`The Board has established the “Legal Experience and Advancement
`Program,” or “LEAP,” to encourage advocates with less legal experience to
`argue before the Board to develop their skills. The Board defines a LEAP
`practitioner as a patent agent or attorney having three (3) or fewer
`substantive oral arguments in any federal tribunal, including PTAB.7
`The parties are encouraged to participate in the Board’s LEAP
`program. Either party may request that a qualifying LEAP practitioner
`participate in the program and conduct at least a portion of the party’s oral
`argument. The Board will grant up to fifteen (15) minutes of additional
`argument time to that party, depending on the length of the proceeding and
`the PTAB’s hearing schedule. A party should submit a request, no later than
`
`
`7 Whether an argument is “substantive” for purposes of determining whether
`an advocate qualifies as a LEAP practitioner will be made on a case-by-case
`basis with considerations to include, for example, the amount of time that
`the practitioner argued, the circumstances of the argument, and whether the
`argument concerned the merits or ancillary issues.
`7
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`at least five (5) business days before the oral hearing, by email to the Board
`at PTABHearings@uspto.gov.8
`The LEAP practitioner may conduct the entire oral argument or may
`share time with other counsel, provided that the LEAP practitioner is offered
`a meaningful and substantive opportunity to argue before the Board. The
`party has the discretion as to the type and quantity of oral argument that will
`be conducted by the LEAP practitioner.9 Moreover, whether the LEAP
`practitioner conducts the argument in whole or in part, the Board will permit
`more experienced counsel to provide some assistance to the LEAP
`practitioner, if necessary, during oral argument, and to clarify any statements
`on the record before the conclusion of the oral argument. Importantly, the
`Board does not draw any inference about the importance of a particular issue
`or issues, or the merits of the party’s arguments regarding that issue, from
`the party’s decision to have (or not to have) a LEAP practitioner argue.
`In instances where an advocate does not meet the LEAP eligibility
`requirements due to the number of “substantive” oral hearing arguments, but
`nonetheless has a basis for considering themselves to be in the category of
`advocates that this program is intended to assist, the Board encourages
`argument by such advocates during oral hearings. Even though additional
`
`
`8 Additionally, a LEAP Verification Form shall be submitted by the LEAP
`practitioner, confirming eligibility for the program. A combined LEAP
`Practitioner Request for Oral Hearing Participation and Verification Form is
`available on the LEAP website, www.uspto.gov/leap.
`9 Examples of the issues that a LEAP practitioner may argue include claim
`construction argument(s), motion(s) to exclude evidence, or patentability
`argument(s) including, e.g., analyses of prior art or objective indicia of non-
`obviousness.
`
`8
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`argument time will not be provided when the advocate does not qualify for
`LEAP, a party may share argument time among counsel and the Board will
`permit the more experienced counsel to provide some assistance, if
`necessary, during oral argument, and to clarify any statements on the record
`before the conclusion of the oral argument.
`All practitioners appearing before the Board shall demonstrate the
`highest professional standards. All practitioners are expected to have a
`command of the factual record, the applicable law, and Board procedures, as
`well as the authority to commit the party they represent.
`
`II. ORDER
`
`Accordingly, it is
`ORDERED that oral argument for this proceeding shall commence at
`1:00 pm Eastern Time on May 13, 2022, by video, and proceed in the
`manner set forth herein.
`
`
`
`
`9
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`For PETITIONER:
`
`Ivor R. Elrifi
`Erik B. Milch
`Deepa Kannappan
`Sanya Sukduang
`Jonathan R. Davies
`Lauren Krickl
`Douglas Cheek
`COOLEY LLP
`ielrifi@cooley.com
`emilch@cooley.com
`dkannappan@cooley.com
`ssukduang@cooley.com
`jdavies@cooley.com
`lkrickl@cooley.com
`dcheek@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.
`
`10
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`Arthur P. Dykhuis
`Jiaxiao Zhang
`Amy L. Mahan
`Mandy H. Kim
`MCDERMOTT WILL & EMERY LLP
`dcarsten@mwe.com
`aweisbruch@mwe.com
`jmohr@mwe.com
`adykhuis@mwe.com
`jiazhang@mwe.com
`amahan@mwe.com
`mhkim@mwe.com
`
`
`
`11
`
`
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