Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper No. 12
`Entered: September 9, 2019
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00688
`Patent 9,468,747 B2
`____________
`
`Before ERICA A. FRANKLIN, ZHENYU YANG,
`and JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`
`
`YANG, Administrative Patent Judge.
`
`
`
`
`SCHEDULING ORDER
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper No. 12
`Entered: September 9, 2019
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00688
`Patent 9,468,747 B2
`____________
`
`Before ERICA A. FRANKLIN, ZHENYU YANG,
`and JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`
`
`YANG, Administrative Patent Judge.
`
`
`
`
`SCHEDULING ORDER
`
`
`
`
`
`
`IPR2019-00688
`Patent No. 9,468,747 B2
`
`A. GENERAL INSTRUCTIONS
`1.
`Initial Conference Call
`The parties are directed to contact the Board within a month of this
`Order if there is a need to discuss proposed changes to this Scheduling Order
`or proposed motions that have not been authorized in this Order or other
`prior Order or Notice. See Office Patent Trial Practice Guide, 77 Fed. Reg.
`48,756, 48,765–66 (Aug. 14, 2012) (“Practice Guide”) (guidance in
`preparing for the initial conference call). A request for an initial conference
`call shall include a list of proposed motions, if any, to be discussed during
`the call.
`2.
`
`Standing Procedure for Requests for Conference Calls and
`Email Communications to the Board
`The following procedures apply to all requests for a conference call
`with the Board and all email communications to the Board:
`a. The parties may request a conference call by jointly contacting the
`Board at the email address or telephone number listed above the
`caption of this Order. Requests via email are expected and
`preferred; requests via telephone should be reserved for
`timecritical circumstances.
`b. Prior to requesting a conference call or sending any email
`communication to the Board, the parties must confer in an effort to
`resolve any issue to be presented to the Board.
`c. Any email communication to the Board must be sent on behalf of
`all parties and must copy all counsel.
`d. Any request for a conference call or other email communication to
`the Board must identify the issue(s) presented, identify the precise
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`IPR2019-00688
`Patent No. 9,468,747 B2
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`relief sought by each party, and state whether the other party
`opposes the relief sought.
`e. The email may include a brief discussion of the background that
`led to the issue(s), but must not include arguments.
`f. Any request for a conference call must include a list of dates and
`times when both parties are available for the call.
`Protective Order
`3.
`No protective order shall apply to this proceeding until the Board
`enters one. If either party files a motion to seal before entry of a protective
`order, a jointly proposed protective order shall be filed as an exhibit with the
`motion. The Board encourages the parties to adopt the Board’s default
`protective order if they conclude that a protective order is necessary. See
`Practice Guide, App’x B (Default Protective Order). If the parties choose to
`propose a protective order deviating from the default protective order, they
`must submit the proposed protective order jointly along with a marked-up
`comparison of the proposed and default protective orders showing the
`differences between the two and explain why good cause exists to deviate
`from the default protective order.
`The Board has a strong interest in the public availability of trial
`proceedings. Redactions to documents filed in this proceeding should be
`limited to the minimum amount necessary to protect confidential
`information, and the thrust of the underlying argument or evidence must be
`clearly discernible from the redacted versions. We also advise the parties
`that information subject to a protective order may become public if
`identified in a final written decision in this proceeding, and that a motion to
`expunge the information will not necessarily prevail over the public interest
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`IPR2019-00688
`Patent No. 9,468,747 B2
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`in maintaining a complete and understandable file history. See Practice
`Guide 48,761.
`4.
`Discovery Disputes
`The Board encourages parties to resolve disputes relating to discovery
`on their own. To the extent that a dispute arises between the parties relating
`to discovery, the parties must meet and confer to resolve such a dispute
`before contacting the Board. If attempts to resolve the dispute fail, a party
`may request a conference call with the Board.
`5.
`Testimony
`The parties are reminded that the Testimony Guidelines appended to
`the Trial Practice Guide, Appendix D, apply to this proceeding. The Board
`may impose an appropriate sanction for failure to adhere to the Testimony
`Guidelines. 37 C.F.R. § 42.12. For example, reasonable expenses and
`attorneys’ fees incurred by any party may be levied on a person who
`impedes, delays, or frustrates the fair examination of a witness.
`6.
`Cross-Examination
`Except as the parties might otherwise agree, for each due date:
`Cross-examination ordinarily takes place after any supplemental evidence is
`due. 37 C.F.R. § 42.53(d)(2).
`Cross-examination ordinarily ends no later than a week before the
`filing date for any paper in which the cross-examination testimony is
`expected to be used. Id.
`7. Motion to Amend
`Patent Owner may file a motion to amend without prior authorization
`from the Board. Nevertheless, Patent Owner must confer with the Board
`before filing such a motion. 37 C.F.R. § 42.121(a). To satisfy this
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`IPR2019-00688
`Patent No. 9,468,747 B2
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`requirement, Patent Owner should request a conference call with the Board
`no later than two weeks prior to DUE DATE 1. See Section B below
`regarding DUE DATES.
`Patent Owner has the option to receive preliminary guidance from the
`Board on its motion to amend. See Notice Regarding a New Pilot Program
`Concerning Motion to Amend Practice and Procedures in Trial Proceedings
`under the America Invents Act before the Patent Trial and Appeal Board, 84
`Fed. Reg. 9497 (Mar. 15, 2019) (“MTA Pilot Program Notice”). If Patent
`Owner elects to request preliminary guidance from the Board on its motion,
`it must do so in its motion to amend filed on DUE DATE 1.
`Any motion to amend and briefing related to such a motion shall
`generally follow the practices and procedures described in MTA Pilot
`Program Notice unless otherwise ordered by the Board in this proceeding.
`The parties are further directed to the Board’s Guidance on Motions to
`Amend in view of Aqua Products (https://go.usa.gov/xU6YV), and
`Lectrosonics, Inc. v. Zaxcom, Inc., Case IPR2018-01129 (Paper 15) (PTAB
`Feb. 25, 2019) (precedential).
`As indicated in the MTA Pilot Program Notice, Patent Owner has the
`option at DUE DATE 3 to file a revised motion to amend (instead of a reply,
`as noted above) after receiving petitioner’s opposition to the original motion
`to amend and/or after receiving the Board’s preliminary guidance (if
`requested). A revised motion to amend must provide amendments,
`arguments, and/or evidence in a manner that is responsive to issues raised in
`the preliminary guidance and/or petitioner’s opposition.
`If Patent Owner files a revised motion to amend, the Board shall enter
`a revised scheduling order setting the briefing schedule for that revised
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`IPR2019-00688
`Patent No. 9,468,747 B2
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`motion and adjusting other due dates as needed. See MTA Pilot Program
`Notice, App’x B 1B.
`As also discussed in the MTA Pilot Program Notice, if the Board
`issues preliminary board guidance on the motion to amend and the Patent
`Owner does not file either a reply to the opposition to the motion to amend
`or a revised motion to amend at Due Date 3, Petitioner may file a reply to
`the Board’s preliminary guidance, no later than three (3) weeks after Due
`Date 3. The reply may only respond to the preliminary guidance. Patent
`Owner may file a sur-reply in response to Petitioner’s reply to the Board’s
`preliminary guidance. The sur-reply may only respond to arguments made
`in the reply and must be filed no later than three (3) weeks after the
`Petitioner’s reply. No new evidence may accompany the reply or the sur-
`reply in this situation.
`8.
`Oral Argument
`Requests for oral argument must comply with 37 C.F.R. § 42.70(a).
`To permit the Board sufficient time to schedule the oral argument, the
`parties may not stipulate to an extension of the request for oral argument
`beyond the date set forth in the Due Date Appendix.
`Unless the Board notifies the parties otherwise, oral argument, if
`requested, will be held at the USPTO headquarters in Alexandria.
`Seating in the Board’s hearing rooms may be limited, and will be
`available on a first-come, first-served basis. If either party anticipates that
`more than five (5) individuals will attend the argument on its behalf, the
`party should notify the Board as soon as possible, and no later than the
`request for oral argument. Parties should note that the earlier a request for
`
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`IPR2019-00688
`Patent No. 9,468,747 B2
`
`accommodation is made, the more likely the Board will be able to
`accommodate additional individuals.
`
`B. DUE DATES
`This Order sets due dates for the parties to take action after institution
`of the proceeding. The parties may stipulate different dates for DUE
`DATES 1 through 3, 5, and 6 (earlier or later, but no later than DUE DATE
`7). In stipulating to move any due dates in the scheduling order, the parties
`must be cognizant that the Board requires four weeks after the filing of an
`opposition to the motion to amend (or the due date for the opposition, if
`none is filed) for the Board to issue its preliminary guidance, if requested by
`Patent Owner. A notice of the stipulation, specifically identifying the
`changed due dates, must be promptly filed. The parties may not stipulate an
`extension of DUE DATES 4, 7, and 8.
`In stipulating different times, the parties should consider the effect of
`the stipulation on times to object to evidence (37 C.F.R. § 42.64(b)(1)), to
`supplement evidence (§ 42.64(b)(2)), to conduct cross-examination
`(§ 42.53(d)(2)), and to draft papers depending on the evidence and cross-
`examination testimony.
`1. DUE DATE 1
`Patent Owner may file—
`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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`IPR2019-00688
`Patent No. 9,468,747 B2
`
`
`b. A motion to amend the patent (37 C.F.R. § 42.121).
`2. DUE DATE 2
`Petitioner may file a reply to the Patent Owner’s response.
`Petitioner may file an opposition to the motion to amend.
`3. DUE DATE 3
`Patent Owner may file a sur-reply to Petitioner’s reply.
`Patent Owner may also file either:
`a. a reply to the opposition to the motion to amend and preliminary
`board guidance (if provided); or
`b. a revised motion to amend.
`4. DUE DATE 4
`Either party may file a request for oral argument (may not be extended
`by stipulation).
`5. DUE DATE 5
`Petitioner may file a sur-reply to Patent Owner’s reply to the
`opposition to the motion to amend.
`Either party may file a motion to exclude evidence (37 C.F.R.
`§ 42.64(c)).
`6. DUE DATE 6
`Either party may file an opposition to a motion to exclude evidence.
`Either party may request that the Board hold a pre-hearing conference.
`7. DUE DATE 7
`Either party may file a reply to an opposition to a motion to exclude
`evidence.
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`IPR2019-00688
`Patent No. 9,468,747 B2
`
`8. DUE DATE 8
`The oral argument (if requested by either party) shall be held on this
`date. Approximately one month prior to the argument, the Board will issue
`an order setting the start time of the hearing and the procedures that will
`govern the parties’ arguments.
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`IPR2019-00688
`Patent No. 9,468,747 B2
`
`
`DUE DATE APPENDIX
`
`DUE DATE 1 .................................................................. November 25, 2019
`Patent Owner’s response to the petition
`Patent Owner’s motion to amend the patent
`
`DUE DATE 2 ..................................................................... February 10, 2020
`Petitioner’s reply to Patent Owner’s response to petition
`Petitioner’s opposition to motion to amend
`
`DUE DATE 3 ......................................................................... March 16, 2020
`Patent Owner’s sur-reply to reply
`Patent Owner’s reply to opposition to motion to amend
`(or Patent Owner’s revised motion to amend)
`DUE DATE 4 ............................................................................. April 6, 2020
`Request for oral argument (may not be extended by stipulation)
`
`DUE DATE 5 ............................................................................ April 27, 2020
`Petitioner’s sur-reply to reply to opposition to motion to amend
`Motion to exclude evidence
`
`DUE DATE 6 .............................................................................. May 4, 2020
`Opposition to motion to exclude
`Request for prehearing conference
`
`DUE DATE 7 ............................................................................ May 11, 2020
`Reply to opposition to motion to exclude
`
`DUE DATE 8 ............................................................................ May 20, 2020
`Oral argument (if requested)
`
`
`10
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`
`
`IPR2019-00688
`Patent No. 9,468,747 B2
`
`For PETITIONER:
`Yelee Kim
`Janine Carlan
`Richard Berman
`Bradford Frese
`Christopher Yaen
`ARENT FOX LLP
`yelee.kim@arentfox.com
`janine.carlan@arentfox.com
`richard.berman@arentfox.com
`bradford.frese@arentfox.com
`christopher.yaen@arentfox.com
`
`For PATENT OWNER:
`
`Robert Green
`Jessica Mackay
`GREEN, GRIFFITH & BORG-BREEN, LLP
`rgreen@greengriffith.com
`jmackay@greengriffith.com
`
`
`
`11
`
`
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