Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 74
`Date: August 23, 2024
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`
`v.
`
`
`MERCK SERONO SA,
`Patent Owner.
`____________
`
`IPR2023-00049 (Patent 7,713,947 B2)
` IPR2023-00050 (Patent 8,377,903 B2)1
`____________
`
`
`
`Before ULRIKE W. JENKS, ZHENYU YANG, and TINA E. HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`
`
`
`ORDER
`Setting Oral Argument
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`
`1 We exercise our discretion to issue one Order to be filed in each
`proceeding. The parties are not authorized to use this style heading for any
`subsequent papers.
`
`
`Tel: 571-272-7822
`
`
`
`
`
`Paper 74
`Date: August 23, 2024
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`
`v.
`
`
`MERCK SERONO SA,
`Patent Owner.
`____________
`
`IPR2023-00049 (Patent 7,713,947 B2)
` IPR2023-00050 (Patent 8,377,903 B2)1
`____________
`
`
`
`Before ULRIKE W. JENKS, ZHENYU YANG, and TINA E. HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`
`
`
`ORDER
`Setting Oral Argument
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`
`1 We exercise our discretion to issue one Order to be filed in each
`proceeding. The parties are not authorized to use this style heading for any
`subsequent papers.
`
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)
`
`
`I. ORAL ARGUMENT
`
`A. Time and Format2
`Oral arguments will commence at 1pm Eastern Time on October 1,
`2024, in person at the USPTO headquarters in Alexandria, VA.3 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. 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 Guide4 (“CTPG”), issued in
`November 2019, Patent Owner may request to reserve time for a brief sur-
`rebuttal. See CTPG 83.
`
`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 September 26, 2024. 5
`
`2 If a party is no longer able to appear in-person for the hearing, the party
`must contact PTABHearings@uspto.gov as soon as possible.
`3 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.
`4 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`5 The parties may stipulate to an alternative schedule for serving and filing
`demonstratives, and request that the Board modify the schedule for filing
`2
`
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)
`
`
`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).
`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
`
`
`and serving demonstratives at least seven (7) business days before the
`hearing date.
`
`3
`
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)
`
`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.6 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.
`
`
`6 If time permits, the Board may schedule a conference call with the parties
`to discuss any filed objections.
`
`4
`
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)
`
`D. Remote Attendance Requests
`Members of the public may request to listen to and/or view 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.
`
`E. 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.
`
`F. 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
`
`
`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.
`5
`
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)
`
`
`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.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
`
`
`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.
`
`6
`
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)
`
`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
`1pm Eastern Time on October 1, 2024, in person at the USPTO
`headquarters in Alexandria, VA, and proceed in the manner set forth
`herein.
`
`
`
`
`7
`
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)
`
`FOR PETITIONER:
`
`Philip Segrest
`Nathan Sportel
`Stephen Howe
`HUSCH BLACKWELL, LLP
`philip.segrest@huschblackwell.com
`nathan.sportel@huschblackwell.com
`steve.howe@huschblackwell.com
`
`
`FOR PATENT OWNER:
`
`Emily Whelan
`Deric Geng
`Cindy Kan
`Asher McGuffin
`Scott Bertulli
`Wenli Gu
`WILMER CUTLER PICKERING HALE AND DORR LLP
`emily.whelan@wilmerhale.com
`deric.geng@wilmerhale.com
`cindy.kan@wilmerhale.com
`asher.mcguffin@wilmerhale.com
`scott.bertulli@wilmerhale.com
`wenli.gu@wilmerhale.com
`
`8
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
