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8 Rehearing Request in re Petition Institution Decision Denied: PETITIONERS REQUEST FOR REHEARING PURSUANT TO 37 CFR 4271d

Document IPR2019-00449, No. 8 Rehearing Request in re Petition Institution Decision Denied - PETITIONERS REQUEST FOR REHEARING PURSUANT TO 37 CFR 4271d (P.T.A.B. Sep. 3, 2019)
Pursuant to 37 C.F.R. § 42.71(d), Petitioner Aquestive Therapeutics, Inc. respectfully requests rehearing of the Decision Denying Institution of Inter Partes Review of claims 8-10, 15 and 30-36 of U.S. Patent No. 9,763,876 (the ‘876 Patent”) entered August 1, 2019 (Paper 7) in IPR2019-00449 (“Decision”).1
Importantly, Ueda discloses examples of its inventive formulations comprising combinations of ethanol and benzyl alcohol in various amounts for the purpose of increasing absorption and penetration of the drug.
U.S. Patent No. 9,763,876 7.5 to 12.5% (w/v)”4, because Ueda’s combined amounts of ethanol and benzyl alcohol do not expressly fall with the claimed ranges, Petitioner argued unexpected results/criticality/optimization.
§ 2144.05(II)(A) (concentration differences generally don’t support patentability of subject matter encompassed by prior art, absent evidence of criticality).
The Board misapprehended and/or overlooked Petitioner’s obviousness argument that “Cartt ‘865 in view of Ueda” expressly discloses all the limitations of claims 1 and 8 of the ‘876 Patent and that a POSITA would have been motivated to combine their teachings.
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8 Rehearing Request in re Petition Institution Decision Denied: PETITIONER¿¿¿S REQUEST FOR REHEARING PURSUANT TO 37 CFR ¿¿ 4271d

Document IPR2019-00449, No. 8 Rehearing Request in re Petition Institution Decision Denied - PETITIONER¿¿¿S REQUEST FOR REHEARING PURSUANT TO 37 CFR ¿¿ 4271d (P.T.A.B. Sep. 3, 2019)
Pursuant to 37 C.F.R. § 42.71(d), Petitioner Aquestive Therapeutics, Inc. respectfully requests rehearing of the Decision Denying Institution of Inter Partes Review of claims 8-10, 15 and 30-36 of U.S. Patent No. 9,763,876 (the ‘876 Patent”) entered August 1, 2019 (Paper 7) in IPR2019-00449 (“Decision”).1
Importantly, Ueda discloses examples of its inventive formulations comprising combinations of ethanol and benzyl alcohol in various amounts for the purpose of increasing absorption and penetration of the drug.
U.S. Patent No. 9,763,876 7.5 to 12.5% (w/v)”4, because Ueda’s combined amounts of ethanol and benzyl alcohol do not expressly fall with the claimed ranges, Petitioner argued unexpected results/criticality/optimization.
§ 2144.05(II)(A) (concentration differences generally don’t support patentability of subject matter encompassed by prior art, absent evidence of criticality).
The Board misapprehended and/or overlooked Petitioner’s obviousness argument that “Cartt ‘865 in view of Ueda” expressly discloses all the limitations of claims 1 and 8 of the ‘876 Patent and that a POSITA would have been motivated to combine their teachings.
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12 Notice: Patent Owner Neurelis Incs Mandatory Change of Information Notices

Document IPR2019-00451, No. 12 Notice - Patent Owner Neurelis Incs Mandatory Change of Information Notices (P.T.A.B. Sep. 5, 2019)
Case IPR2019-00451 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 IPR2019-00451 Patent No. 9,763,876
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10 Rehearing Request in re Petition Institution Decision Denied: Neurelis, Inc Request for Rehearing

Document IPR2019-00451, No. 10 Rehearing Request in re Petition Institution Decision Denied - Neurelis, Inc Request for Rehearing (P.T.A.B. Aug. 27, 2019)
The Federal Circuit has explained that “the description must ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.’” Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562-63 (Fed. Cir. 1991).
By sua sponte adding an extra-legal requirement for priority, the decision misapprehends the proper scope of the test and legally errs, significantly prejudicing Neurelis.
1348, 1356-57, 1360 (2018).2 Indeed, the rule itself does not 2 In Atmel Corp. v. Information Storage Devices, Inc., the court in dicta considered whether incorporation might be inappropriate for the corresponding structure of a means-plus-function claim, but ultimately held that the specification had sufficient
As noted previously, a Rule 57(h) requirement begins with the Office setting a time for response bounded by close of prosecution or abandonment, neither of which apply to a provisional application.
The formal objection raised sua sponte in the decision misapprehends a patentee’s legal obligations and the scope of the invoked rule, and overlooks contrary case law, Office guidance, and due-process requirements.
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11 Objection: Neurelis, Inc Objections

Document IPR2019-00451, No. 11 Objection - Neurelis, Inc Objections (P.T.A.B. Aug. 27, 2019)
The exhibit’s probative value is substantially outweighed by its confusion of the issues to be decided, its waste of Board and Neurelis time, and the danger that it will lead to unfair prejudice if used later in the proceeding or on appeal.
The exhibit’s probative value is substantially outweighed by its confusion of the issues to be decided, its waste of Board and Neurelis time, and the danger that it will lead to unfair prejudice if used later in the proceeding or on appeal.
The exhibit’s probative value is substantially outweighed by its confusion of the issues to be decided, its waste of Board and Neurelis time, and the danger that it will lead to unfair prejudice if used later in the proceeding or on appeal.
The exhibit’s probative value is substantially outweighed by its confusion of the issues to be decided, its waste of Board and Neurelis time, and the danger that it will lead to unfair prejudice if used later in the proceeding or on appeal.
The exhibit’s probative value is substantially outweighed by its confusion of the issues to be decided, its waste of Board and Neurelis time, and the danger that it will lead to unfair prejudice if used later in the proceeding or on appeal.
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6 Notice: Patent Owners Mandatory Notices

Document IPR2019-00449, No. 6 Notice - Patent Owners Mandatory Notices (P.T.A.B. May. 21, 2019)

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7 Notice: Patent Owners Mandatory Notices

Document IPR2019-00450, No. 7 Notice - Patent Owners Mandatory Notices (P.T.A.B. May. 21, 2019)

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6 Notice: Patent Owners Mandatory Notices

Document IPR2019-00451, No. 6 Notice - Patent Owners Mandatory Notices (P.T.A.B. May. 21, 2019)

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7 Preliminary Response: Patent Owner Preliminary Response

Document IPR2019-00451, No. 7 Preliminary Response - Patent Owner Preliminary Response (P.T.A.B. May. 21, 2019)

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5 Preliminary Response: Patent Owners Preliminary Response

Document IPR2019-00449, No. 5 Preliminary Response - Patent Owners Preliminary Response (P.T.A.B. May. 6, 2019)

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6 Preliminary Response: Patent Owners Preliminary Response

Document IPR2019-00450, No. 6 Preliminary Response - Patent Owners Preliminary Response (P.T.A.B. May. 6, 2019)

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4 Mandatory Notice: Patent Owners Mandatory Notices

Document IPR2019-00449, No. 4 Mandatory Notice - Patent Owners Mandatory Notices (P.T.A.B. Feb. 19, 2019)

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5 Mandatory Notice: Patent Owners Mandatory Notices

Document IPR2019-00450, No. 5 Mandatory Notice - Patent Owners Mandatory Notices (P.T.A.B. Feb. 19, 2019)

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4 Mandatory Notice: Patent Owners Mandatory Notices

Document IPR2019-00451, No. 4 Mandatory Notice - Patent Owners Mandatory Notices (P.T.A.B. Feb. 19, 2019)

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1 Power of Attorney: Power of Attorney

Document IPR2019-00450, No. 1 Power of Attorney - Power of Attorney (P.T.A.B. Jan. 29, 2019)

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