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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,
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`v.
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`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`__________________
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`Cases IPR2019-00694, IPR 2019-00695, and IPR 2019-00696
`Patent 9,629,965
`__________________
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`PATENT OWNER’S RESPONSE TO PETITIONER’S NOTICE
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`Cases IPR2019-00694, -00695, and -00696
`Patent 9,629,965
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`Petitioner’s Notice confirms that the Wang and Davies Petitions are redundant
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`of the Wyse Petition. Like Patent Owner, Petitioner ranks the Wyse Petition
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`(IPR2019-00694) first, ahead of the Wang and Davies Petitions (-00695 and -00696).
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`Petitioner largely dodges the Board’s request for an explanation of the
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`differences among the Petitions. Petitioner’s handful of examples of alleged
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`differences largely boil down to reasons why Wang and Davies teach fewer claim
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`limitations and are even weaker references than Wyse. As Patent Owner explained
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`in its Preliminary Responses, all three Petitions have fatal deficiencies. In addition,
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`the district court trial related to these Petitions is scheduled to start in two weeks. The
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`Board should thus decline to institute any of these IPR proceedings. But if the Board
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`institutes anything, it should institute only the Wyse Petition.
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`First, Petitioner asserts that the Wyse Petition presents different issues because
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`Wyse may not be prior art if the claims that were ultimately granted in the ’965 patent
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`are entitled to the provisional application date of March 14, 2014. Notice at 1. But
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`for the purpose of these proceedings Patent Owner will not dispute that Wyse, Davies,
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`and Wang are all prior art. Petitioner’s comment that different statutory provisions
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`apply to whether Wyse, Davies and Wang are prior art is thus moot. Notice at 1–2.
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`Petitioner also argues that the Petitions are non-redundant because Petitioner
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`has submitted a certified translation of Wang, rather than the machine translation that
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`was before the Examiner. Notice at 2. But Petitioner fails to point out any differences
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`between the translations, or how the way the various references were translated has
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`Cases IPR2019-00694, -00695, and -00696
`Patent 9,629,965
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`any bearing on the references’ substance. Petitioner’s translation argument is just a
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`convoluted way of stating the truism that the three Petitions do not cite exactly the
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`same references. This does not change the point that the Petitioner’s arguments are
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`substantially the same for each of the references.
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`When Petitioner finally turns to purported differences among its obviousness
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`arguments, it simply points to a few (unavailing) examples of purported differences,
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`making no effort to catalog “the similarities and differences” as the Board directed.
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`Order at 4. Petitioner does not deny the Petitions’ similarities—and that, in many
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`cases, they exhibit word-by-word sameness—on critical issues, including the volume
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`of the nasal spray, the naloxone dose, the choice of excipients (including BZK and
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`EDTA), etc. For example, the Wang and Davies Petitions cite Wyse—not Wang or
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`Davies—for the recited dose limitation. Wang Pet. at 18–19; Davies Pet. at 18–19.
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`Petitioner’s chart, Notice at 3, reflects that there are no issues which Petitioner
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`asserts are taught by Wang and Davies but not Wyse. In other words, according to
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`Petitioner, Wang and Davies are inferior references to Wyse. According to
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`Petitioner, the Wyse Petition relies on Wyse for the teaching of benzalkonium
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`chloride (“BZK”), while the other Petitions do not. See Notice at 2–3. If true, this
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`would merely demonstrate the superiority of the Wyse Petition. But in fact, it is
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`incorrect. All three Petitions rely on HPE, not Wyse. The Wyse Petition states that
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`“Wyse does not specifically identify . . . the types of antimicrobial agents that may
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`Cases IPR2019-00694, -00695, and -00696
`Patent 9,629,965
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`be used.” Wyse Pet. at 33 (emphasis added). It then proceeds to rely on HPE for the
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`teaching of BZK, id. at 33–35, as do the other two Petitions, Wang Pet. at 32–34;
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`Davies Pet. at 31–32. And the three Petitions contain the same discussion on Wyse’s
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`teaching of BZK—or, more precisely, teaching away—verbatim. Wyse Pet. at 51–
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`52; Wang Pet. at 55–57; Davies Pet. at 54–55.
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`Petitioner also argues that Wyse anticipates certain claim limitations relating
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`to device, pH, stabilizing agent, disodium edetate, and plasma concentration, and that
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`the other two primary references do not. But the question is not whether the
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`disclosures of the references are different but rather whether “the Petitions rely on
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`substantially overlapping grounds and theories.” Order at 4. Critically, for these
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`limitations, all three Petitions similarly rely on Wyse. The Wang and Davies
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`Petitions both cite to Wyse to demonstrate the alleged obviousness of device, pH,
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`stabilizing agent, disodium edetate, and plasma concentration. See Wang Pet. at 20,
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`21, 45–47; Davies Pet. at 20, 21, 45–47. All Petitioner has established is that the
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`disclosures of Wang and Davies are even further removed from the claimed invention
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`than that of Wyse, and so Petitioner must bring in additional references to allege
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`obviousness in the Wang and Davies Petitions. That does not constitute a “rare”
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`instance in which two—let alone three—petitions may be needed. July 2019 TPG
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`Update at 26.
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`Date: August 12, 2019
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`
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`Cases IPR2019-00694, -00695, and -00696
`Patent 9,629,965
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`Respectfully submitted,
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`/Jessica Tyrus Mackay/
`Robert F. Green (Reg. No. 27,555)
`Jessica Tyrus Mackay (Reg. No. 64,742)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue
`Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`jmackay@greengriffith.com
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`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
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`Cases IPR2019-00694, -00695, and -00696
`Patent 9,629,965
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
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`and correct copy of the foregoing was served on August 12, 2019, by delivering a
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`copy via electronic mail on the following attorneys of record:
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`Yelee Y. Kim
`Janine A. Carlan
`Richard Berman
`Bradford Frese
`Christopher Yaen
`ARENT FOX LLP
`1717 K Street NW
`Washington, DC 20036
`Yelee.Kim@arentfox.com
`Janine.Carlan@arentfox.com
`Richard.Berman@arentfox.com
`Bradford.Frese@arentfox.com
`Christopher.Yaen@arentfox.com
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`/Jessica Tyrus Mackay/
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`Jessica Tyrus Mackay (Reg. No. 64,742)
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