`571-272-7822
`Date: November 12, 2021
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________________________________
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
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`Patent Owner.
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`________________________________________
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
`________________________________________
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
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`NEW, Administrative Patent Judge.
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`
`JOINT SCHEDULING ORDER1
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`1 This Scheduling Order sets due dates that are identical in the listed cases.
`The combined caption is for administrative convenience only and does not
`indicate a joined case. The parties are not authorized to use this caption
`without express permission of the Board.
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`
`
`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`
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`A. GENERAL INSTRUCTIONS
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`1.
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`Initial Conference Call
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`The parties are directed to contact the Board within a month of this
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`Order if there is a need to discuss proposed changes to this Scheduling Order
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`or proposed motions that have not been authorized in this Order or other
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`prior Order or Notice. See USPTO, Consolidated Trial Practice Guide, 9–10
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`(November 2019) (“Practice Guide”)2 (guidance in preparing for the initial
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`conference call). A request for an initial conference call shall include a list
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`of proposed motions, if any, to be discussed during the call.
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`2.
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`Protective Order
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`No protective order shall apply to this proceeding until the Board
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`enters one. If either party files a motion to seal before entry of a protective
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`order, a jointly proposed protective order shall be filed as an exhibit with the
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`motion. The Board encourages the parties to adopt the Board’s default
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`protective order if they conclude that a protective order is necessary. See
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`Practice Guide, Appendix B (Default Protective Order). If the parties
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`choose to propose a protective order deviating from the default protective
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`order, they must submit the proposed protective order jointly along with a
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`marked-up comparison of the proposed and default protective orders
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`showing the differences between the two and explain why good cause exists
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`to deviate from the default protective order.
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`2 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`2
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`The Board has a strong interest in the public availability of trial
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`proceedings. Redactions to documents filed in this proceeding should be
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`limited to the minimum amount necessary to protect confidential
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`information, and the thrust of the underlying argument or evidence must be
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`clearly discernible from the redacted versions. We also advise the parties
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`that information subject to a protective order may become public if
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`identified in a final written decision in this proceeding, and that a motion to
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`expunge the information will not necessarily prevail over the public interest
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`in maintaining a complete and understandable file history. See Practice
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`Guide 19–21.
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`3.
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`Discovery Disputes
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`The Board encourages parties to resolve disputes relating to discovery
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`on their own. To the extent that a dispute arises between the parties relating
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`to discovery, the parties must meet and confer to resolve such a dispute
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`before contacting the Board. If attempts to resolve the dispute fail, a party
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`may request a conference call with the Board.
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`In any request for a conference call with the Board to resolve a
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`discovery dispute, the requesting party shall: (a) certify that it has conferred
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`with the other party in a good faith effort to resolve the dispute; (b) identify
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`with specificity the issues for which agreement has not been reached; (c)
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`identify the precise relief to be sought; and (d) propose specific dates and
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`times at which both parties are available for the conference call.
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`3
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`4.
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`Testimony
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`
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`The parties are reminded that the Testimony Guidelines appended to
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`the Practice Guide, Appendix D, apply to this proceeding. The Board may
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`impose an appropriate sanction for failure to adhere to the Testimony
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`Guidelines. 37 C.F.R. § 42.12. For example, reasonable expenses and
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`attorneys’ fees incurred by any party may be levied on a person who
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`impedes, delays, or frustrates the fair examination of a witness.
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`5.
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`Cross-Examination
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`Cross-examination ordinarily takes place after any supplemental
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`evidence is due. 37 C.F.R. § 42.53(d)(2).
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`Cross-examination ordinarily ends no later than a week before the
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`filing date for any paper in which the cross-examination testimony is
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`expected to be used. Id.
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`6. Motion to Amend
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`Patent Owner may file a motion to amend without prior authorization
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`from the Board. Nevertheless, Patent Owner must confer with the Board
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`before filing such a motion. 37 C.F.R. § 42.121(a). To satisfy this
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`requirement, Patent Owner should request a conference call with the Board
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`no later than two weeks prior to DUE DATE 1. See Section B below
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`regarding DUE DATES.
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`Patent Owner has the option to receive preliminary guidance from the
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`Board on its motion to amend. See Notice Regarding a New Pilot Program
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`Concerning Motion to Amend Practice and Procedures in Trial Proceedings
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`4
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`
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`
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`under the America Invents Act before the Patent Trial and Appeal Board, 84
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`
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`Fed. Reg. 9497 (Mar. 15, 2019) (“MTA Pilot Program Notice”); see also
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`Practice Guide at 67. If Patent owner elects to request preliminary guidance
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`from the Board on its motion, it must do so in its motion to amend filed on
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`DUE DATE 1.
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`Any motion to amend and briefing related to such a motion shall
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`generally follow the practices and procedures described in MTA Pilot
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`Program Notice unless otherwise ordered by the Board in this proceeding.
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` The parties are further directed to the Board’s Guidance on Motions to
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`Amend in view of Aqua Products (https://go.usa.gov/xU6YV), and
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`Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, Paper 15 (PTAB Feb.
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`25, 2019) (precedential).
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`As indicated in the MTA Pilot Program Notice, Patent Owner has the
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`option at DUE DATE 3 to file a revised motion to amend (instead of a reply,
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`as noted above) after receiving petitioner’s opposition to the original motion
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`to amend and/or after receiving the Board’s preliminary guidance (if
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`requested). A revised motion to amend must provide amendments,
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`arguments, and/or evidence in a manner that is responsive to issues raised in
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`the preliminary guidance and/or petitioner’s opposition.
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`If Patent Owner files a revised motion to amend, the Board shall enter
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`a revised scheduling order setting the briefing schedule for that revised
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`motion and adjusting other due dates as needed. See MTA Pilot Program
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`Notice, Appendix 1B.
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`As also discussed in the MTA Pilot Program Notice, if the Board
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`issues preliminary board guidance on the motion to amend and the Patent
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`5
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`Owner does not file either a reply to the opposition to the motion to amend
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`or a revised motion to amend at DUE DATE 3, Petitioner may file a reply to
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`the Board’s preliminary guidance, no later than three (3) weeks after DUE
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`DATE 3. The reply may only respond to the preliminary guidance. Patent
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`Owner may file a sur-reply in response to Petitioner’s reply to the Board’s
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`preliminary guidance. The sur-reply may only respond to arguments made
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`in the reply and must be filed no later than three (3) weeks after the
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`Petitioner’s reply. No new evidence may accompany the reply or the sur-
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`reply in this situation.
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`7.
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`Oral Argument
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`Requests for oral argument must comply with 37 C.F.R. § 42.70(a).
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`To permit the Board sufficient time to schedule the oral argument, the
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`parties may not stipulate to an extension of the request for oral argument
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`beyond the date set forth in the Due Date Appendix.
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`Unless the Board notifies the parties otherwise, oral argument, if
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`requested, will be held at the USPTO headquarters in Alexandria.
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`Seating in the Board’s hearing rooms may be limited, and will be
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`available on a first-come, first-served basis. If either party anticipates that
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`more than five (5) individuals will attend the argument on its behalf, the
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`party should notify the Board as soon as possible, and no later than the
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`request for oral argument. Parties should note that the earlier a request for
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`accommodation is made, the more likely the Board will be able to
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`accommodate additional individuals.
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`6
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`B. DUE DATES
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`This Order sets due dates for the parties to take action after institution
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`of the proceeding. The parties may stipulate different dates for DUE
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`DATES 1 through 3, 5, and 6 (earlier or later, but no later than DUE DATE
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`7). In stipulating to move any due dates in the scheduling order, the parties
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`must be cognizant that the Board requires four weeks after the filing of an
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`opposition to the motion to amend (or the due date for the opposition, if
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`none is filed) for the Board to issue its preliminary guidance, if requested by
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`Patent Owner. A notice of the stipulation, specifically identifying the
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`changed due dates, must be promptly filed. The parties may not stipulate an
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`extension of DUE DATES 4, 7, and 8.
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`In stipulating different times, the parties should consider the effect of
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`the stipulation on times to object to evidence (37 C.F.R. § 42.64(b)(1)), to
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`supplement evidence (§ 42.64(b)(2)), to conduct cross-examination
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`(§ 42.53(d)(2)), and to draft papers depending on the evidence and cross-
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`examination testimony.
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`1. DUE DATE 1
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`Patent Owner may file—
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`a. A response to the petition (37 C.F.R. § 42.120). If Patent
`Owner elects not to file a response, Patent Owner must
`arrange a conference call with the parties and the Board.
`Patent Owner is cautioned that any arguments for
`patentability not raised in the response may be deemed
`waived.
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`b. A motion to amend the patent (37 C.F.R. § 42.121).
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`7
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`2. DUE DATE 2
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`Petitioner may file a reply to the Patent Owner’s response.
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`Petitioner may file an opposition to the motion to amend.
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`3. DUE DATE 3
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`Patent Owner may file a sur-reply to Petitioner’s reply.
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`Patent Owner may also file either:
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`a. a reply to the opposition to the motion to amend and
`preliminary board guidance (if provided); or
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`b. a revised motion to amend. NOTE: If Patent Owner files
`neither of the above papers (a reply to the opposition or a
`revised motion to amend), and the Board has issued
`preliminary guidance, Petitioner may file a reply to the
`preliminary guidance, no later than three (3) weeks after
`DUE DATE 3. Patent Owner may file a sur-reply to
`Petitioner’s reply to the preliminary guidance no later than
`three (3) weeks after Petitioner’s reply.
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`4. DUE DATE 4
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`Either party may file a request for oral argument (may not be extended
`by stipulation).
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`5. DUE DATE 5
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`Petitioner may file a sur-reply to Patent Owner’s reply to the
`opposition to the motion to amend.
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`Either party may file a motion to exclude evidence (37 C.F.R.
`§ 42.64(c)).
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`8
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`6. DUE DATE 6
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`Either party may file an opposition to a motion to exclude evidence.
`Either party may request that the Board hold a pre-hearing conference.
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`7. DUE DATE 7
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`Either party may file a reply to an opposition to a motion to exclude
`evidence.
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`8. DUE DATE 8
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`The oral argument (if requested by either party) shall be held on this
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`date. Approximately one month prior to the argument, the Board will issue
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`an order setting the start time of the hearing and the procedures that will
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`govern the parties’ arguments.
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`9
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`DUE DATE APPENDIX
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`DUE DATE 1 .............................................................. February 2, 2022
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`Patent Owner’s response to the petition
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`Patent Owner’s motion to amend the patent
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`DUE DATE 2 ................................................................. April 27, 2022
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`Petitioner’s reply to Patent Owner’s response to the petition
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`Petitioner’s opposition to Patent Owner’s motion to amend
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`DUE DATE 3 .................................................................... June 8, 2022
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`Patent Owner’s sur-reply to Petitioner’s reply to the response to the
`petition
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`Patent Owner’s reply to Petitioner’s opposition to the motion to
`amend OR Patent Owner’s revised motion to amend
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`DUE DATE 4 .................................................................. June 29, 2022
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`Request for oral argument (may not be extended by stipulation)
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`DUE DATE 5 ................................................................... July 20, 2022
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`Petitioner’s sur-reply to the opposition to the motion to amend
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`Motion to exclude evidence
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`DUE DATE 6 ................................................................... July 27, 2022
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`Opposition to motion to exclude
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`Request for pre-hearing conference
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`DUE DATE 7 .................................................................August 2, 2022
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`Reply to opposition to motion to exclude
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`10
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`IPR2021-00880, Patent No. 9,669,069 B2
`IPR2021-00881, Patent No. 9,254,338 B2
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`DUE DATE 8 ............................................................... August 10, 2022
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`Oral argument (if requested)
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`For Petitioner:
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`Heinz Salmen
`Neil McLaughlin
`Paul Molino
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`hsalmen@rmmslegal.com
`nmclaughlin@rmmslegal.com
`paul@rmmslegal.com
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`For Patent Owner:
`
`Deborah Fishman
`Alice Sin Yu Ho
`ARNOLD & PORTER KAYE SCHOLER LLP
`deborah.fishman@kayescholer.com
`alice.ho@arnoldporter.com
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`11
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