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

Docket IPR2019-00451, Patent Trial and Appeal Board (Jan. 29, 2019)
Jamie Wisz, Jon Tornquist, Zhenyu Yang, presiding
Case TypeInter Partes Review
Patent
9763876
Orange Book Patent
9763876
Patent Owner Neurelis, Inc.
Petitioner Aquestive Therapeutics, Inc. formerly Monosol RX, LLC
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44 Termination Decision Document: Termination Decision Document

Document IPR2019-00451, No. 44 Termination Decision Document - Termination Decision Document (P.T.A.B. Aug. 6, 2020)
First, Patent Owner, with supporting testimony from Dr. Gizurarson, asserts that “the formulation of a benzodiazepine for intranasal administration is a difficult and complex science requiring a higher skill set and knowledge than a POSA with a bachelor’s degree ‘with several years of experience.’” Id. at 15 (citing Ex. 2012 ¶¶ 28–29).
Specifically, according to Patent Owner and Dr. Gizurarson, “the POSA would be working against physiological constraints of active ingredient uptake due to the nasal anatomy, as well as the very low solubility of benzodiazepines in formulating the pharmaceutical composition disclosed in the ’876 patent.” Id. at 15–16 (citing Ex. 2012 ¶¶ 28–29).
In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) (“In the absence of such blazemarks, simply describing a large genus of compounds
Motivation to combine/reasonable expectation of success Petitioner argues that, since neither Gwozdz nor Meezan ’962 provide specific dosing regimens for benzodiazepines/diazepam, one of ordinary skill in the art would look to the similar reference of Cartt ’784, titled “Nasal Administration of Benzodiazepines,” for these teachings.
On this record, and upon review of Petitioner’s arguments and supporting evidence, we determine that Petitioner sufficiently explains why one of ordinary skill in the art would have looked to Cartt ’784’s disclosure when seeking dosing regimens for the compositions disclosed in Gwozdz and Meezan ’962, and would have had a reasonable expectation of success in achieving the claimed invention.
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43 Hearing Transcript: Hearing Transcript

Document IPR2019-00451, No. 43 Hearing Transcript - Hearing Transcript (P.T.A.B. May. 27, 2020)
JUDGE WISZ: I realize Ariad stands for the proposition that there doesn't have to necessarily be examples, but do you agree for 112 support there has to be some sort of indication that one of skill in the art would choose alkyl glycosides from that list of, I believe it's 150 compounds, that's disclosed in the SIGMA Catalog?
Well, if you go down to Paragraph 144, Meezan states that many benzodiazepines, including diazepam, are so slightly soluble in water that a therapeutically effective amount cannot be dissolved in a volume of aqueous solvents that is amenable to nasal insufflation in such an aerosol spray.
In 2009, Dr. Wermeling published Exhibit 1151, in which he stated, there remains a significant unmet medical need to serve the pharmotherapeutic requirements of epilepsy patients through commercial development and marketing of intra-nasal anti-epileptic products.
The EMS field guide, Petitioner states, instructs emergency medical professionals to place a full milliliter of intravenous solution into a patient's nose for seizure rescue.
To address Petitioner's Counsel's statements just now, regarding Dr. Wermeling's testimony about what was and wasn't done in the prior art with intravenous solutions in the nose, as reflected in our motion to exclude, it's largely uncorroborated hearsay.
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36 Order: Order Trial Hearing

Document IPR2019-00451, No. 36 Order - Order Trial Hearing (P.T.A.B. Apr. 23, 2020)
The parties are directed to contact the Board at least ten (10) days in advance of the hearing if there are any concerns about disclosing confidential information.
The Board asks the parties to confine demonstrative exhibit objections to those identifying egregious violations that are prejudicial to the administration of justice.
The parties are directed to St. Jude Medical, Cardiology Division, Inc. v. The Board of Regents of the University of Michigan, IPR2013-00041 (PTAB Jan. 27, 2014) (Paper 65), for guidance regarding the appropriate content of demonstrative exhibits.
The parties are reminded that each presenter must identify clearly and specifically each demonstrative exhibit (e.g., by slide or screen number) referenced during the hearing to ensure the clarity and accuracy of the reporter’s transcript.
Jeffrey Guise Richard Torczon Lorelei Westin Lee Johnson Nathaniel Leachman Alina L. Litoshyk
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17 Order: Order Denying POP Request

Document IPR2019-00451, No. 17 Order - Order Denying POP Request (P.T.A.B. Nov. 15, 2019)
Before ANDREI IANCU, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, ANDREW HIRSHFELD, Commissioner for Patents, and SCOTT R. BOALICK, Chief Administrative Patent Judge.
The Office received a request for Precedential Opinion Panel (POP) review of an issue raised in this case.
The request was referred to the POP panel referenced above.
Upon consideration of the request, it is ORDERED that the request for POP review is denied; and FURTHER ORDERED that the original panel maintains authority over all matters.
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15 Notice: Notification of Receipt of POP Request

Document IPR2019-00451, No. 15 Notice - Notification of Receipt of POP Request (P.T.A.B. Oct. 2, 2019)
The Office has received a request for Precedential Opinion Panel (POP) review of an issue raised in these cases.
The request is under review.
The Office will provide another notification after a decision on the request has been made.
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14 Decision Denying Request for Rehearing Patent Owner: Decision Denying Patent Owners Request on Rehearing of Decision on Institution 37 CFR 4271d

Document IPR2019-00451, No. 14 Decision Denying Request for Rehearing Patent Owner - Decision Denying Patent Owners Request on Rehearing of Decision on Institution 37 CFR 4271d (P.T.A.B. Sep...
Neurelis, Inc. (“Patent Owner”) requests rehearing of the Board’s Decision (Paper 8) (“Decision”) instituting inter partes review of claims 1– 36 of U.S. Patent No. 9,763,876 B2 (Ex. 1001, “the ’876 patent”).
First, Petitioner did challenge the ’876 patent priority claim in contending that “the presence of any alkyl glycosides (either generally or particularly) – regardless of amount – was not disclosed, described, or enabled by [the] ’558 Provisional.” Petition 20.
Furthermore, with supporting testimony from Dr. Nicholas A. Peppas, Petitioner further asserted that the ’558 provisional’s “generic disclosure of ‘surface active agents (especially non-ionic materials)’ ... does not disclose, describe, and/or enable alkyl glycosides in general (or dodecyl maltoside in particular).” Id. (citing Ex. 1008 ¶ 152; Ex. 1041 ¶ 68).
As explained in Dynamic Drinkware, a petitioner has the initial burden of going forward to show that there is invalidating prior art.
On this record, Patent Owner fails to satisfy its burden of production to show entitlement to an earlier filing date.
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9 Order: SCHEDULING ORDER

Document IPR2019-00451, No. 9 Order - SCHEDULING ORDER (P.T.A.B. Aug. 13, 2019)
Reasonable expenses and attorneys’ fees incurred by any party may be levied on a person who impedes, delays, or frustrates the fair
To satisfy this requirement, Patent Owner should request a conference call with the Board no later than two weeks prior to DUE DATE 1.
The parties are further directed to the Board’s Guidance on Motions to Amend in view of Aqua Products (https://go.usa.gov/xU6YV), and Lectrosonics, Inc. v. Zaxcom, Inc., Case IPR2018-01129 (Paper 15) (PTAB Feb. 25, 2019) (precedential).
As indicated in the MTA Pilot Program Notice, Patent Owner has the option at DUE DATE 3 to file a revised motion to amend (instead of a reply, as noted above) after receiving petitioner’s opposition to the original motion to amend and/or after receiving the Board’s preliminary guidance (if requested).
Jeffrey Guise Richard Torczon Lorelei Westin Lee Johnson Nathaniel Leachman Alina L. Litoshyk
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