Trials@uspto.gov
`Tel: 571-272-7822
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`Paper 10
`Entered: September 27, 2019
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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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`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
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`v.
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`NEURELIS, INC.,
`Patent Owner.
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`
`Case IPR2019-00449
`Patent 9,763,876 B2
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`Before ZHENYU YANG, JON B. TORNQUIST, and
`JAMIE T. WISZ, Administrative Patent Judges.
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`TORNQUIST, Administrative Patent Judge.
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`DECISION
`Denying Petitioner’s Request for Rehearing of
`Decision Denying Institution of Inter Partes Review
`37 C.F.R. § 42.71(d)
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`

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`IPR2019-00449
`Patent 9,763,876 B2
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`I.
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`INTRODUCTION
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`Aquestive Therapeutics, Inc. (“Petitioner”) requests rehearing of the
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`Board’s Decision (Paper 7, “Dec. on Inst.”) denying institution of an inter
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`partes review (Paper 8, “Request for Rehearing” or “Req. Reh’g”). For the
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`reasons set forth below, Petitioner’s Request for Rehearing is denied.
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`II.
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`STANDARD FOR REHEARING
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`Pursuant to 37 C.F.R. § 42.71(d):
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`A party dissatisfied with a decision may file a single request for
`rehearing without prior authorization from the Board. The
`burden of showing a decision should be modified lies with the
`party challenging the decision. The request must specifically
`identify all matters the party believes the Board misapprehended
`or overlooked, and the place where each matter was previously
`addressed in a motion, an opposition, or a reply.
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`When reconsidering a decision on institution, we review the decision for an
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`abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists
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`where a “decision [i]s based on an erroneous conclusion of law or clearly
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`erroneous factual findings, or . . . a clear error of judgment.” PPG Indus.
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`Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed.
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`Cir. 1988).
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`III. ANALYSIS
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`In our Decision, we found Petitioner did not demonstrate a reasonable
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`likelihood of prevailing with respect to its obviousness ground based on
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`Cartt ’865 and Ueda (claims 8–10, 15, and 30–33), because this ground
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`“relies on a perceived lack of criticality in the choice of ranges for ethanol
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`and benzyl alcohol” that is unsupported by the record. Dec. on Inst. 21. In
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`its Request for Rehearing, Petitioner contends we overlooked that the
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`Petition asserts an additional obviousness rationale with respect to at least
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`2
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`IPR2019-00449
`Patent 9,763,876 B2
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`claim 8 that does not rely on a perceived lack of criticality in the choice of
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`ranges for ethanol and benzyl alcohol. Req. Reh’g 4–11.
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`We agree that in addressing Petitioner’s arguments related to a lack of
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`criticality in the recited ranges, we did not address Petitioner’s specific
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`arguments regarding the combination of Cartt ’865 and Ueda for at least
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`claim 8. Thus, we provide an analysis of that proposed combination below.
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`Alleged Obviousness of Claim 8 over Cartt ’865 and Ueda
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`Petitioner contends the subject matter of claim 8 would have been
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`obvious over the combined disclosures of Cartt ’865 and Ueda. Paper 2, 61–
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`63 (“Pet.”).
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`1. Cartt ’865
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`Cartt ’865 discloses pharmaceutical compositions for nasal
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`administration comprising a benzodiazepine drug, one or more natural or
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`synthetic tocopherols or tocotrienols, or any combinations thereof, in an
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`amount from about 30% to about 95%, and one or more alcohols or glycols,
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`or any combinations thereof, in an amount from about 5% to about 70%,
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`preferably about 10% to about 70%. Ex. 1010 ¶ 10.
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`In some embodiments, the one or more alcohols used in Cartt ’865
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`“are selected from the group consisting of: ethanol, propyl alcohol, butyl
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`alcohol, pentanol, benzyl alcohol, and isomers thereof, or any combinations
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`thereof.” Id. ¶ 13. Cartt ’865 does not disclose, however, a specific
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`example or embodiment utilizing ethanol and benzyl alcohol in combination.
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`2. Ueda
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`Ueda discloses “a preparation for topical application intended for the
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`treatment of acne.” Ex. 1019, 1:4–5. This composition contains
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`(1) “Compound [I],” which possesses inhibitory activity against hormones of
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`IPR2019-00449
`Patent 9,763,876 B2
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`the male type, (2) a keratolytic agent, and (3) a pharmaceutically acceptable
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`carrier. Id. at 1:41–56.
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`Ueda instructs that “a gelling agent and/or alcohol are preferably used
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`as carriers,” as “[a] gelling agent and an alcohol improves poor solubility
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`being so far regarded as the defect of the Compound [I] from the standpoint
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`of processing it into preparations.” Id. at 3:27–32. Acceptable alcohols for
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`use as a carrier include monohydric alcohols and polyhydric alcohols, such
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`as ethanol, benzyl alcohol, and polyethylene glycol. Id. at 3:55–4:11. Ueda
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`explains that “[a]mong others, ethanol and benzyl alcohol are frequently
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`used, and these alcohols, making up for low solubility of the Compound [I],
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`function to increase absorption and penetration of the composition of the
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`present invention.” Id. at 3:65–4:1.
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`Ueda contains one unnumbered Table, which is reproduced below:
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`The Table of Ueda shows the composition of eight example formulations,
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`with formulation 1 containing 5% benzyl alcohol and 20% ethanol and
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`IPR2019-00449
`Patent 9,763,876 B2
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`formulation 2 containing 10% benzyl alcohol and 25% ethanol. Id. at Table.
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`Formulations 1 and 2 also include, inter alia, a polyhydric alcohol in the
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`form of polyethylene glycol (PEG-600) and a carboxyvinyl polymer
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`(Carbopol 940) that acts as a gelling agent. Id. at Table, 3:33–45.
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`3. Analysis
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`Petitioner contends Ueda’s disclosures that benzyl alcohol and ethanol
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`are frequently used together to make up for the low solubility of compound
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`[I], and “to increase absorption and penetration” of compound [I], are
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`“relevant and useful to a [person of ordinary skill in the art] with respect to
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`the use of ethanol/benzyl alcohol to increase intranasal absorption and
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`penetration of a drug.” Pet. 61 (citing Ex. 1041 ¶ 322) (“Thus, Ueda teaches
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`the combination of ethanol/benzyl alcohol as useful for solubilizing a low
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`solubility drug and also for increasing its absorption/penetration.”). And
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`because Ueda discloses examples containing 20% ethanol and 5% benzyl
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`alcohol (formulation 1) and 25% ethanol and 10% benzyl alcohol
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`(formulation 2) that fall within the ranges recited in claim 8, Petitioner
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`contends the combination of Cartt ’865 and Ueda renders obvious the
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`amounts of benzyl alcohol and ethanol recited in claims 8–10 and 30–31. Id.
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`at 62.
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`We are not persuaded by Petitioner’s arguments. Ueda’s example
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`formulations utilize other compounds that serve to increase the solubility of
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`compound [I], including 0.8% or 0.6% carboxyvinyl polymer
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`(Carbopol 940) and 15% or 20% polyethlyene glycol (PEG-600)
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`(formulations 1 and 2, respectively). See Ex. 1019, Table (disclosing the use
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`of both carboxyvinyl polymer and polyethylene glycol in Formulations 1
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`and 2), 3:29–30 (noting that a gelling agent and an alcohol improve poor
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`IPR2019-00449
`Patent 9,763,876 B2
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`solubility of Compound [I]), 3:33–41 (identifying Carbopol 940 as a gelling
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`agent), 3:55–4:11 (identifying monohydric alcohols and polyhydric alcohols,
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`such as polyethylene glycol, as “alcohols”). Petitioner does not explain
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`sufficiently why one of ordinary skill in the art would have continued to use
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`the same amounts of ethanol and benzyl alcohol in Cartt ’865 in the absence
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`of the 15% or 20% polyethylene glycol and the 0.8% or 0.6% carboxyvinyl
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`polymer used in formulations 1 and 2 of Ueda. Nor does Petitioner’s
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`obviousness analysis direct us to disclosure in Ueda of applying its topical
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`compositions to nasal mucosa, or provide persuasive reasoning or evidence
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`to suggest that the combination of 20% ethanol and 5% benzyl alcohol or
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`25% ethanol and 10% benzyl alcohol used in Ueda would provide the same
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`successful results for a benzodiazepine drug (as opposed to compound [I]).
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`Thus, although it was known in the art that 20% ethanol and
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`5% benzyl alcohol and 25% ethanol and 10% benzyl alcohol had previously
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`been used in combination to improve the solubility of compound [I] in a
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`topical formulation for the treatment of acne, it is not evident from
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`Petitioner’s arguments set forth on pages 61–63 of the Petition1 why one of
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`1 Petitioner’s Request for Rehearing includes additional citations to
`Dr. Peppas’ declaration that were not provided in the section addressing
`Petitioner’s obviousness ground based on Cartt ’865 and Ueda. Compare
`Pet. 61–63 (citing various portions of Exhibit 1019 and Ex. 1041 ¶ 322) with
`Req. Reh’g 6 n.3 (citing Ex. 1041 ¶¶ 127, 127, 140, 142). The Petition also
`provides a string cite to paragraphs 375–387 of Dr. Peppas’ declaration, but
`provides no analysis as to why these paragraphs support its conclusions with
`respect to claim 8. Pet. 63; 37 C.F.R. § 42.6(a)(3) (“Arguments must not be
`incorporated by reference from one document into another document.”).
`A request for rehearing is not an opportunity to assert arguments that were
`not made, or not sufficiently explained, in the Petition for a particular
`ground of unpatentability.
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`IPR2019-00449
`Patent 9,763,876 B2
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`ordinary skill in the art would have sought to use the same levels of ethanol
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`and benzyl alcohol in Cartt ’865’s benzodiazepine-based nasal spray,
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`especially in the absence of the additional 15% or 20% polyethylene glycol
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`and 0.8% or 0.6% gelling agent used in formulations 1 and 2 of Ueda.
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`In view of the foregoing, we are not persuaded that we erred in not
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`instituting an inter partes review with respect to Petitioner’s obviousness
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`ground based on Cartt ’865 and Ueda. Thus, Petitioner’s request for
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`rehearing is denied.
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`IV. CONCLUSION
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`Outcome of Decision on Rehearing:
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`Claims
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`8
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`Overall Outcome
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`It is
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`§ 103
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`35 U.S.C. § Basis
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`Cartt ’865,
`Ueda
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`Granted
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`Denied
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`8
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`8
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`V. ORDER
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`ORDERED that the Petitioner’s Request for Rehearing is denied.
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`IPR2019-00449
`Patent 9,763,876 B2
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`For PETITIONER:
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`Daniel Scola
`Michael Chakansky
`James Harrington
`Matthew Solow
`HOFFMAN & BARON, LLP
`dscola@hbiplaw.com
`mchakansky@hbiplaw.com
`jfhdocket@hbiplaw.com
`msolow@hbiplaw.com
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`For PATENT OWNER:
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`Jeffrey Guise
`Richard Torczon
`Lorelei Westin
`Lee Johnson
`Nathaniel Leachman
`WILSON SONSINI GOODRICH & ROSATI
`jguise@wsgr.com
`rtorczon@wsgr.com
`lwestin@wsgr.com
`ljohnson@wsgr.com
`nleachman@wsgr.com
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