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

Docket IPR2019-00450, 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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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
Patent
9763876
Orange Book Patent
9763876
Patent Owner Neurelis, Inc.
Petitioner Aquestive Therapeutics, Inc. formerly Monosol RX, LLC
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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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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 Refund Approval: Notice of Refund

Document IPR2019-00450, No. 10 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 29, 2019 in the above proceeding is hereby granted.
The amount of $27,600 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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