`
`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 IPR2019-00685, IPR 2019-00686, IPR 2019-00687
`Patent 9,211,253
`__________________
`
`PATENT OWNER’S RESPONSE TO PETITIONER’S NOTICE
`
`
`
`
`
`
`
`
`Case IPR2019-00685, -00686, and -00687
`Patent 9,211,253
`
`Petitioner’s Notice confirms that the Wang and Davies Petitions are redundant
`
`
`
`of the Wyse Petition. Like Patent Owner, Petitioner ranks the Wyse Petition
`
`(IPR2019-00685) first, ahead of the Wang and Davies Petitions (-00686 and -00687).
`
`Petitioner largely dodges the Board’s request for an explanation of the
`
`differences among the Petitions. Petitioner’s handful of examples of alleged
`
`differences largely boil down to reasons why Wang and Davies teach fewer claim
`
`limitations and are even weaker references than Wyse. As Patent Owner explained
`
`in its Preliminary Responses, all three Petitions have fatal deficiencies, and the Board
`
`should decline institution of all three in the face of the likely-imminent district court
`
`trial. But if the Board institutes anything, it should institute only the Wyse Petition.
`
`First, Petitioner asserts that the Wyse Petition presents different issues because
`
`Wyse may not be prior art if the claims that were ultimately granted in the ’253 patent
`
`are entitled to the provisional application date of March 14, 2014. Notice at 1. For
`
`the purpose of these proceedings, however, Patent Owner will not dispute that Wyse,
`
`Davies, and Wang are all prior art. Thus, there is no need to institute a second petition
`
`as a precaution, and Petitioner’s comment that different statutory provisions apply to
`
`whether Wyse, Davies and Wang are prior art is irrelevant and moot. Notice at 1–2.
`
`Petitioner also argues that the Petitions are non-redundant because Petitioner
`
`has submitted a certified translation of Wang, rather than the machine translation that
`
`was before the Examiner. Notice at 2. But Petitioner fails to point out any differences
`
`1
`
`
`
`
`between the translations, and whether and how the various references were translated
`
`Case IPR2019-00685, -00686, and -00687
`Patent 9,211,253
`
`has no bearing on whether they differ in substance. Petitioner’s translation argument
`
`is just a convoluted way of stating the truism that the three Petitions do not cite
`
`exactly the same references. This misses the point that the Petitioner’s arguments are
`
`substantially the same for each of the references.
`
`When Petitioner finally turns to purported differences among its obviousness
`
`arguments, it simply points to a few (unavailing) examples of purported differences,
`
`making no effort to catalog “the similarities and differences” as the Board directed.
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`Order at 4. And it does not deny the Petitions’ similarities—and, in many cases,
`
`word-by-word sameness—on critical issues, including the volume of the nasal spray,
`
`the naloxone dose, the choice of excipients (including BZK and EDTA), etc. As a
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`striking example, the Wang and Davies Petitions cite Wyse—not Wang or Davies—
`
`for the dose limitation of all claims, which is likely to be a central issue in any
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`instituted proceedings. 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 clearly 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
`
`2
`
`
`
`
`incorrect. All three Petitions rely on HPE, not Wyse. The Wyse Petition states that
`
`Case IPR2019-00685, -00686, and -00687
`Patent 9,211,253
`
`“Wyse does not specifically identify . . . the types of antimicrobial agents that may
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`be used.” Wyse Pet. at 32 (emphasis added). It then proceeds to rely on HPE for the
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`teaching of BZK, id. at 32–33, 35–36, as do the other two Petitions, see Wang Pet. at
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`31–32; Davies Pet. at 30–31. As for Wyse’s teaching—or, more precisely, teaching
`
`away—on BZK, the three Petitions contain the same discussion on this topic,
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`verbatim. See Wyse Pet. at 54–56; Wang Pet. at 56–58; Davies Pet. at 58–60.
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`Petitioner also argues that Wyse anticipates certain claim limitations relating
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`to device, pH, and plasma concentration, and that the other two primary references
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`do not. But the question is not whether the disclosures of the references are different
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`but rather whether “the Petitions rely on substantially overlapping grounds and
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`theories.” Order at 4. Critically, for these limitations, all three Petitions similarly
`
`rely on Wyse. The Wang and Davies Petitions both cite to Wyse to demonstrate the
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`alleged obviousness of the pH, the device, and the plasma concentration. See Wang
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`Pet. at 19 (pH), 21 (device), 49–51 (plasma concentration), Davies Pet. at 19 (pH),
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`21 (device), 45–46, 53–54 (plasma concentration). All Petitioner has established is
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`that the disclosures of Wang and Davies are even further removed from the claimed
`
`invention than that of Wyse, and so Petitioner must bring in additional references to
`
`allege obviousness in the Wang and Davies Petitions. That does not make the
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`Petitions non-redundant or serve as a reason that they should be instituted.
`
`3
`
`
`
`
`Date: June 24, 2019
`
`
`
`Case IPR2019-00685, -00686, and -00687
`Patent 9,211,253
`
`
`
`Respectfully submitted,
`
`/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
`
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
`
`
`
`
`
`
`4
`
`
`
`Case IPR2019-00685, -00686, and -00687
`Patent 9,211,253
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
`
`
`
`
`
`and correct copy of the foregoing was served on June 24, 2019, by delivering a copy
`
`via electronic mail on the following attorneys of record:
`
`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
`
`
`
`/Jessica Tyrus Mackay/
`
`Jessica Tyrus Mackay (Reg. No. 64,742)
`
`
`
`
`
`
`
`
`
`5
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`
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