Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 50
`Date: May 21, 2024
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO S.A.,
`Patent Owner.
`____________
`
`IPR2023-00480 (Patent 7,713,947 B2)
` IPR2023-00481 (Patent 8,377,903 B2)1
`____________
`
`
`
`Before ZHENYU YANG, ROBERT A. POLLOCK, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`MAJORS, Administrative Patent Judge.
`
`
`
`
`ORDER
`Setting Oral Argument
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`
`1 This Order addresses issues that are the same in the identified proceedings.
`We exercise our discretion to issue one Order to be filed in each proceeding.
`The parties are not, however, authorized to use this style heading.
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`I. ORAL ARGUMENT
`We instituted inter partes review in the above-identified proceedings
`on September 22, 2023. Paper 10.2 The Scheduling Order sets the date for
`oral argument as June 25, 2024, if requested by the parties and granted by
`the Board. Paper 11, 12. On May 9, 2024, and May 10, 2024, Petitioner and
`Patent Owner each filed a request for oral argument, respectively. Papers 48
`and 49. The parties agree that oral argument for IPR2023-00480 and
`IPR2023-00481 should be conducted in one consolidated hearing. Id.
`Petitioner’s and Patent Owner’s requests for oral argument are granted.
`
`A. Time and Format3
`Oral arguments will commence at 1:00 PM Eastern Time on June
`25, 2024, on the ninth floor of the Madison Building East, 600 Dulany
`Street, Alexandria, Virginia, in Hearing Room A.4 The Board will provide
`a court reporter for the hearing, and the reporter’s transcript will constitute
`the official record of the hearing.
`As requested by the parties, Petitioner will have a total of sixty (60)
`minutes to present argument and Patent Owner will have a total of
`sixty (60) minutes to respond (i.e., total argument time for the consolidated
`hearing will not exceed two hours absent further allowance from the Board).
`Paper 48, 1; Paper 49, 1. Petitioner will open the hearing by presenting its
`
`
`2 All citations are to IPR2023-00480 with the understanding that
`corresponding papers were entered in IPR2023-00481.
`3 If a party is no longer able to appear for the hearing, the party must contact
`PTABHearings@uspto.gov as soon as possible.
`4 If there are any concerns about disclosing confidential information, and
`such concerns are not otherwise addressed in this Order, the parties must
`contact the Board at Trials@uspto.gov at least ten (10) business days before
`the hearing date.
`
`2
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`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 Guide5
`(“CTPG”), issued in November 2019, Patent Owner may request to reserve
`time for a brief sur-rebuttal. See CTPG 83. Neither party may reserve more
`than fifteen (15) minutes from the time allotted for their respective rebuttal
`or sur-rebuttal.
`The parties may request a pre-hearing conference in advance of the
`hearing. 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 oral 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 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.
`If the parties anticipate disclosing information that is alleged to be
`confidential during oral argument, the parties should segregate, if possible,
`such disclosure of confidential information to a certain portion of their
`respective presentations. The parties should inform the Board during the
`argument, and before such disclosure is made, that they intend to argue a
`point or cite an exhibit that requires disclosure of confidential or potentially
`confidential information so that the Board may take appropriate action to
`safeguard such information. The parties should also consider whether it is
`
`
`5 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`
`3
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`possible to make their oral arguments without specific disclosure of
`confidential information (e.g., referring to the evidence generally, and
`directing the Board’s attention to papers and/or exhibits to which the Board
`and parties have access, but which are presently filed subject to a motion to
`seal). Objections during the other party’s portions of oral argument are
`generally not expected, except to the extent necessary to preserve
`information as confidential. These efforts will assist the Board in
`maintaining, to the full extent possible, these proceedings as open to the
`public, consistent with our rules. 37 C.F.R. § 42.14.
`
`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.
`Demonstratives also must be filed no later than three (3) business days
`before the hearing date.6
`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
`
`
`6 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.
`
`4
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`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 86; 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).
`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 two (2) business days before 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
`
`5
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`any objections, and may reserve ruling on the objections.7 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
`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 in person.
`
`D. 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
`deaf or hard-of-hearing individuals and blind or low vision individuals, 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.
`
`E. 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
`
`
`7 If time permits, the Board may schedule a conference call with the parties
`to discuss any filed objections.
`
`6
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`practitioner as a patent agent or attorney having three (3) or fewer
`substantive oral arguments in any federal tribunal, including PTAB.8
`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
`at least five (5) business days before the oral hearing, by email to the Board
`at PTABHearings@uspto.gov.9
`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.10 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
`
`8 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.
`9 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.
`10 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.
`
`7
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`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
`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 June 25, 2024, and shall take place on the ninth
`floor of the Madison Building East, 600 Dulany Street, Alexandria, Virginia,
`in Hearing Room A, and proceed in the manner set forth herein.
`
`
`
`8
`
`

`

`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`FOR PETITIONER:
`
`Eldora Ellison
`Olga Partington
`Chandrika Vira
`John Rozendaal
`Christina Dashe
`Tyler Liu
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`eellison-PTAB@sternekessler.com
`opartington-PTAB@sternekessler.com
`cvira-PTAB@sternekessler.com
`jcrozendaal-PTAB@sternekessler.com
`cdashe-PTAB@sternekessler.com
`tliu-PTAB@sternekessler.com
`mbond-PTAB@sternekessler.com
`
`
`FOR PATENT OWNER:
`
`Emily R. Whelan
`Deric Geng
`Cindy Kan
`David B. Bassett
`Vinita Ferrera
`David Mlaver
`Mary Pheng
`Asher S. McGuffin
`Scott Bertulli
`WILMER CUTLER PICKERING HALE AND DORR LLP
`Emily.Whelan@wilmerhale.com
`Deric.Geng@wilmerhale.com
`Cindy.Kan@wilmerhale.com
`David.Bassett@wilmerhale.com
`Vinita.Ferrera@wilmerhale.com
`David.Mlaver@wilmerhale.com
`Mary.Pheng@wilmerhale.com
`Asher.McGuffin@wilmerhale.com
`Scott.Bertulli@wilmerhale.com
`WHMerckMavencladIPRs@wilmerhale.com
`
`9
`
`