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Aquestive Therapeutics, Inc. formerly Monosol RX, LLC v. Neurelis, Inc.

Docket IPR2019-00449, Patent Trial and Appeal Board (Jan. 28, 2019)
Jamie Wisz, Jon Tornquist, Zhenyu Yang, presiding
Case TypeInter Partes Review
Patent9763876
Orange Book Patent9763876
Patent Owner Neurelis, Inc.
Petitioner Aquestive Therapeutics, Inc. formerly Monosol RX, LLC
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12 Refund Approval: Notice of Refund

Document IPR2019-00449, No. 12 Refund Approval - Notice of Refund (P.T.A.B. Nov. 18, 2019)
Petitioner’s request for a refund of certain post-institution fees paid on January 28, 2019 in the above proceeding is hereby granted.
The amount of $15,000 has been refunded to Petitioner’s deposit account.
The parties are reminded that unless otherwise permitted by 37 C.F.R. § 42.6(b)(2), all filings in this proceeding must be made electronically in the Patent Trial and Appeal Board End to End (PTAB E2E), accessible from the Board Web site at http://www.uspto.gov/PTAB.
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10 Decision Denying Request for Rehearing Petitioner: Decision Denying Petitioners Request for Rehearing of Decision Denying Institution of Inter Partes Review 37 CFR 4271d

Document IPR2019-00449, No. 10 Decision Denying Request for Rehearing Petitioner - Decision Denying Petitioners Request for Rehearing of Decision Denying Institution of Inter Partes Review 37 CFR ...
Formulations 1 and 2 also include, inter alia, a polyhydric alcohol in the form of polyethylene glycol (PEG-600) and a carboxyvinyl polymer (Carbopol 940) that acts as a gelling agent.
Petitioner does not explain sufficiently why one of ordinary skill in the art would have continued to use the same amounts of ethanol and benzyl alcohol in Cartt ’865 in the absence of the 15% or 20% polyethylene glycol and the 0.8% or 0.6% carboxyvinyl polymer used in formulations 1 and 2 of Ueda.
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.
Patent 9,763,876 B2 ordinary skill in the art would have sought to use the same levels of ethanol and benzyl alcohol in Cartt ’865’s benzodiazepine-based nasal spray, especially in the absence of the additional 15% or 20% polyethylene glycol and 0.8% or 0.6% gelling agent used in formulations 1 and 2 of Ueda.
In view of the foregoing, we are not persuaded that we erred in not instituting an inter partes review with respect to Petitioner’s obviousness ground based on Cartt ’865 and Ueda.
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7 Institution Decision: Decision Denying Inter Partes Review

Document IPR2019-00449, No. 7 Institution Decision - Decision Denying Inter Partes Review (P.T.A.B. Aug. 1, 2019)
Critical to its obviousness arguments, Petitioner asserts that “none of the recited ranges (either separately or combined) have been shown to have any criticality or to result in unexpected effects.” Id. at 57; see id. at 45.
None of the compositions set forth in Tables 12A and 12B contain ethanol and benzyl alcohol in combination, and only three of the disclosed compositions contain ethanol.
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3 Notice of Filing Date Accorded to Petition: Notice of Accord Filing Date

Document IPR2019-00449, No. 3 Notice of Filing Date Accorded to Petition - Notice of Accord Filing Date (P.T.A.B. Feb. 6, 2019)
For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.
Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.
The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.
Many non-profit organizations, both inside and outside the intellectual property field, offer alternative dispute resolution services.
If the parties actually engage in alternative dispute resolution, the Case IPR2019-00449 Patent No. 9,763,876 PTAB would be interested to learn what mechanism (e.g., arbitration, mediation, etc.) was used and the general result.
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11 Refund Request: PETITIONER¿¿¿S REQUEST FOR REFUND OF POST INSTITUTION FEES

Document IPR2019-00449, No. 11 Refund Request - PETITIONER¿¿¿S REQUEST FOR REFUND OF POST INSTITUTION FEES (P.T.A.B. Nov. 7, 2019)
On August 1, 2019, the PTAB denied institution of IPR2019-00449, see Paper
On September 27, 2019, the PTAB denied Petitioner’s Request for Rehearing of the denial of institution of IPR2019-00449, see Paper 10.
Therefore, Petitioner Aquestive Therapeutics, Inc. hereby requests a refund of $15,000.00 for the post- institution fee Petitioner paid for IPR2019-00449.
See copy of portion of fee payment receipt below:
The refund should be deposited into the deposit account from which it was paid, namely, Hoffmann & Baron LLP Deposit Account No. 08-2461, as provided for in the Petition, page 3, Paper 2 (“The undersigned further authorizes payment from and to the above referenced Deposit Account [i.e., 08-2461] for any additional fees or refund that may be due in connection with this petition and IPR proceeding.”).
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2 Petition: Petition

Document IPR2019-00449, No. 2 Petition - Petition (P.T.A.B. Jan. 28, 2019)
While Cartt’865 does disclose that alcohols may be present in the following ranges (all prefaced with “about”), none of the following disclosed ranges correspond to (or fall within) the ranges recited in Claims 8-10 and 15: 5-70%, 10-40%, ...
56 IPR2019-00449 U.S. Patent No. 9,763,876 B2 • Claim 32: “7.5 to 12.5% (w/v)” • Claim 33: “10 to 12% (w/v)” Claims 30-33 recite various combinations of ranges for ethanol and benzyl alcohol; none of the recited ranges (either ...
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9 Notice: Patent Owner Neurelis Incs Mandatory Change of Information Notices

Document IPR2019-00449, No. 9 Notice - Patent Owner Neurelis Incs Mandatory Change of Information Notices (P.T.A.B. Sep. 5, 2019)
Case IPR2019-00449 Patent No. 9,763,876 Pursuant to 37 C.F.R. § 42.8(a)(3), the undersigned on behalf of and acting in a representative capacity for Patent Owner Neurelis, Inc. (Patent Owner), hereby submits the following mandatory change-of-information notices in connection with the petition for inter partes review identified in the caption.
Date: 5 September 2019
Respectfully submitted, /Richard Torczon/ Richard Torczon Reg. No. 34,448 Case IPR2019-00449 Patent No. 9,763,876
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