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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`ADAPT PHARMA OPERATIONS LIMITED, AND
`OPIANT PHARMACEUTICALS, INC.
`Patent Owners.
`_____________________
`
`CASE IPR2019-00694
`U.S. Patent No. 9,629,965
`_____________________
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`PETITIONER NALOX-1 PHARMACEUTICALS, LLC’s
`REQUEST FOR ORAL ARGUMENT
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`IPR2019-00694 – U.S. Patent No. 9,629,965
` Petitioner’s Request for Oral Argument
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`Pursuant to 37 C.F.R. § 42.70(a) and the Scheduling Order entered on
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`September 11, 2019, and the Conduct of Proceedings Order entered on November
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`25, 2019, Petitioner Nalox-1 Pharmaceuticals, LLC (“Petitioner”) respectfully
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`requests oral argument on May 19, 2020. Petitioner proposes (and Patent Owners
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`agree) that the Board conduct a consolidated proceeding in Inter Partes Review
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`Nos. IPR2019-00685, -00688, and -00694, as well as any matters joined therewith,
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`as these cases all are scheduled for hearing on the same date, relate to related
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`patents, and the challenge is on identical art.
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`For these proceedings, the parties have agreed that Petitioner will have a
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`total of forty-five (45) minutes to present its arguments, including time to be
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`reserved for rebuttal, and that Patent Owners will have a total of forty-five (45)
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`minutes to present its responsive arguments, subject to approval by the Board.
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`The parties will exchange demonstrative exhibits seven (7) business days in
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`advance of the oral hearing in accordance with 37 C.F.R. § 42.70(b). The parties
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`have agreed that any demonstratives will address the issues for all three of
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`IPR2019-00685, -00688, and -00694 per side, and that any references to exhibits
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`and papers will be made to the exhibits and papers filed in IPR2019-00688 for
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`issues common across all IPRs, except that references to other proceedings’
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`pleadings and exhibits may be made only when necessary to address issues specific
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`to those proceedings.
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`IPR2019-00694 – U.S. Patent No. 9,629,965
` Petitioner’s Request for Oral Argument
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`Without waiving any issue not specifically listed below, Petitioner identifies
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`the following issues to be argued at the May 19, 2020 hearing:
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`1) Whether it would have been obvious to a person of ordinary skill in
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`the art (“POSA”) to use benzalkonium chloride (“BAC”) in an intranasal naloxone
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`formulation;
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`2) Whether the claimed dose of 4 mg of naloxone hydrochloride would
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`have been obvious to a POSA;
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`3) Whether any evidence of secondary considerations supports
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`patentability, including the following:
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`a. Unexpected results;
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`b. Skepticism;
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`c. Failure of others;
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`d. Long-felt but unresolved need; and
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`e. Commercial success.
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`4)
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`Arguments and evidence presented in any motions to exclude
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`evidence or response thereto.
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`5)
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`Any other issues that the Board deems necessary to issue a final
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`written decision.
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`Petitioner
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`requests
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`the use of audio/visual equipment
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`to display
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`demonstrative exhibits, including the use of a document camera or “Elmo,” and a
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`2
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`IPR2019-00694 – U.S. Patent No. 9,629,965
` Petitioner’s Request for Oral Argument
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`computer/projector/screen system. In accordance with Trial Practice Guide, 77
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`Fed. Reg. at 48768, Petitioner will work with the Board Trial Division regarding
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`this request.
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`3
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`Date: April 6, 2020
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`IPR2019-00694 – U.S. Patent No. 9,629,965
` Petitioner’s Request for Oral Argument
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`Respectfully submitted,
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`/s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`Counsel for Petitioner
`Nalox-1 Pharmaceuticals, LLC
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`4
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`IPR2019-00694 – U.S. Patent No. 9,629,965
` Certificate of Service
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`The undersigned hereby certifies that the above-captioned “Petitioner Nalox-
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`1 Pharmaceuticals, LLC’s Request for Oral Argument,” was served in its entirety
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`on April 6, 2020, upon the following parties via e-mail:
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`Jessamyn S. Berniker (jberniker@wc.com)
`Ana C. Reyes (areyes@wc.com)
`David M. Krinsky (dkrinsky@wc.com)
`Anthony H. Sheh (asheh@wc.com)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, NW
`Washington, DC 20005
`(202) 434-5000
`Counsel for Patent Owner
`Adapt Pharma Operations Limited
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`Jessica Tyrus Mackay (jmackay@greengriffith.com)
`Ann K. Kotze (akotze@greengriffith.com)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue, Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
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`/s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, D.C. 20006
`(202) 857-6000
`yelee.kim@arentfox.com
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`Counsel for Petitioner
`Nalox-1 Pharmaceuticals, LLC
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