EX1069 is hearsay because it is an out-of-court statement offered to prove the truth of the matter asserted, namely—as Petitioner states— related to Petitioner’s argument for a motivation to combine alcohols and rebuttal to Patent Owner’s showing of long-felt need.

EX1081 appears to be a webpage showing “Diazepam Prices and Coupons.” EX1081 is hearsay because it is an out-of-court statement offered to prove the truth of the matter asserted—purportedly, related to Dr. Wermeling’s argument of lack of secondary considerations and commercial success.

Dr. Wermeling does not set forth the principles used nor does he demonstrate the methods or 10 (finding improper incorporation by reference of block cites to expert declaration without sufficient explanation of those portions).

French et al., Pharmacopeial Standards and Specifications for Bulk Drugs and Solid Oral Dosage Forms, Journal of Pharmaceutical Sciences, December 1967, Vol.

EX1050 Table of Various Diazepam Solutions Described in or Modified From Sonne’s Example 11 (“DS11”) EX1065 Maggio, Provisional Patent Appl’n Serial No. 60632038 EX1069 Florida Regional Common EMS Protocols Field Guide, Jones and Barlett Publishers, MA (2005) EX1080 Valium® Tablet Label, Roche, January 2008 EX1081 Drug Prices from Internet

The exhibit’s probative value is substantially outweighed by its confusion of the issues to be decided, its waste of the Board’s and the Petitioner’s 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 the Board’s and the Petitioner’s 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 the Board’s and the Petitioner’s time, and the danger that it will lead to unfair prejudice if used later in the proceeding or on appeal.

Paragraphs 2, 5, 7, 67 of Exhibit 2012 are not relevant to any instituted ground and their probative value is substantially outweighed by its confusion of the issues to be decided, its waste of the Board’s and the Petitioner’s 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 the Board’s and Petitioner’s time, and the danger that it will lead to unfair prejudice if used later in the proceeding or on appeal.

The Reply materials consistently disregard and misstate the evidence— including Dr. Wermeling’s clear recognition of a “significant unmet medical need to serve the pharmacotherapeutic requirements of epilepsy patients through commercial development and marketing of intranasal antiepileptic products” in 2009.

1 Aquestive’s Reply shenanigans are part of an ongoing harassment campaign against Neurelis—here, at the FDA, and in the press—to distract investors from Aquestive’s failure to produce its buccal epilepsy therapy and has forced Neurelis to pursue a tort action against Aquestive in California superior court.

that a “reply may only respond to arguments raised in the corresponding opposition or patent owner response,” which does not include the Institution Decision.3 Aquestive’s remaining explanations also lack merit, ranging from again changing the POSA definition (“transmembrane” becomes “transmembrane/transmucosal”, Paper 26, 2), to avoiding the Petition’s complete failure to address the SIGMA Catalog (EX2006) incorporation in the ‘558 provisional (Petition, 5-6).

Aquestive Fails to Rebut the Absence of Any Motivation to Combine or Reasonable Expectation of Success for the References The Reply provides another new, baseless theory that a POSA would have circumvented benzodiazepine precipitation by cutting the dose in half and administering the drug in both nostrils.

Aquestive would attribute the lack of a viable alternative to Diastat®13 to “regulatory requirements, investment, market size, cost of competing products, and existing off-label use of benzodiazepines (diazepam, lorazepam) administered intranasally.” Reply, 29 (citing EX1150, ¶¶46-12614).

- PO argued the challenged claims exclude - New argument for a new theory that water and a POSA would therefore not be should have appeared, if anywhere, in motivated to use Meezan’s alkyl glycosides.

solution does not disclose particulate - New argument in support of new formulations and a POSA therefore would not theory, not appearing in petition or in consider Cartt ‘784, Ex. 1015 in connection EX1041 [Peppas].

POSA definition which included experience Contradicts use of Peppas, confirming in transmembrane/transmucosal, e.g., this is not supplementation of his intranasal, rectal, buccal development.

A & B); EX1150, ¶¶178- 27 and elaborates on why there was no 207. demonstration of criticality or unexpected - The reply does not identify anything in results based on the data in Figs. 1–3, Tables the opposition to which this responds— 4-1, 11-1, 11-2, and 11-3 relied on by the classic improper bolstering.

EX1150, ¶¶65-81, 92- PO’s expert, Dr. Gizurarson regarding 109. alleged commercial success and purported - No explanation why these factors and problems with formulating intranasal references were not in EX1041 solutions.

For the limited purpose of providing the Director of the United States Patent and Trademark Office with the information specified in 37 C.F.R. §90.2(a)(3)(ii), the issues on appeal include the Board’s determination that claims 1-36 of U.S. Patent No. 9,763,876 (“’876 Patent”) were shown to be unpatentable under 35 U.S.C. §103 in view of the grounds of unpatentability identified in the Board’s Final Written Decision.

The issues on appeal also include any Board finding or conclusion supporting or related to this determination, as well as all other decisions adverse to Patent Owner in any Board order, decision, ruling, or opinion.

These issues include, but are not limited to, the following: (1) whether the Board erred in applying the wrong standards and burdens to conclude that the claims of the ’876 Patent were not entitled to benefit of the priority filing date of U.S.

Publication No. 2006/0046962 to Meezan, and PCT Publication No. WO 2009/1209033 to Gwozdz; (3) whether the Board misconstrued dependent claims of the ’876 Patent to require a generic “alkyl glycoside”, thereby overlooking uncontested express support in the ’558 Provisional for those claims; and (4) whether the Board violated administrative- law requirements by introducing its own new and erroneous legal theories without providing Patent Owner adequate opportunity to respond.

Dated: October , 2020 Respectfully submitted, Jeffrey W. Guise, Lead Counsel Reg. No. 34,613

Found on those six SIGMA catalog pages are approximately 150 different compounds divided among four discrete sub-classes: (i) anionic, (ii) cationic, (iii) zwitterionic (amphoteric) and (iv) nonionic (polar).

); see Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (“It is not sufficient for purposes of the written description requirement of § 112 that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to the modifications that the inventor might have envisioned, but failed to disclose.”).

Ex parte Maziere, 27 USPQ2d 1705 (BPAI 1993), cited by PO (POR24), is inapplicable –it was directed to foreign (not provisional) applications and is contrary to public policy reasons against incorporation-by-reference of essential material from non-patent documents.

Many benzodiazepines, including diazepam, are so slightly soluble in water that a therapeutically effective amount cannot be dissolved in a volume of aqueous solvent that is amenable to nasal insufflation as an aerosol or non-aerosol spray.” Cartt’784.Ex.1015¶[0139]-[0144](emphasis supplied).

Referring to the ‘876 Patent’s Figs. 1–3, Tables 4-1, 11-1, 11-2, and 11-3, and the same data from an EPO prosecution, the Board stated that “Petitioner’s assertion that Patent Owner never showed any unexpected results is not sufficiently supported by the evidence of record.” Decision17-21,24-27.

U.S. 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 Petitioner Aquestive Therapeutics, Inc., hereby submits the following mandatory change-of-information notices in connection with the petition for inter partes review identified in the caption.

In particular, John T. Gallagher (Reg. No. 35,516) has been added as an additional back-up counsel; he should be served with all documents.

First Back-Up Counsel for Petitioner Aquestive Therapeutics, Inc.

US 2008/0070904, Pharmaceutical Compositions of Benzodiazepines and Method of Use Thereof, Serial No. 11/897,028, published March 20, 2008 (Jamieson) 1013 Sonne, U.S. Patent No. 6,193,985, Tocopherol Compositions For Delivery Of Biologically Active Agents, issued February 27, 2001 (Sonne) 1014 Gwozdz et al., WO 2009/120933, Pharmaceutical Solutions And Method For Solubilizing Therapeutic Agents, published October 1, 2009, International Filing Date March 27, 2009 (PCT/US2009/038518) (Gwozdz) Cartt et al., U.S. Patent Application Publication No.

21 (1992) 165-l72 (Edman II) 1033 French et al., Pharmacopeial Standards and Specifications for Bulk Drugs and Solid Oral Dosage Forms, Journal of Pharmaceutical Sciences, December 1967, Vol.

1045 Maitani, et al., Design of ocular/lacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 49, Issues 2–3, 15 December 1997, Pages 185-192.

1144 Ahmad S, Ellis J, Kamwendo H, et al. Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open label trial.

Wermeling, D.P., Intranasal delivery of antiepileptic medications for treatment of seizures, Neurotherapeutics, April 2009, Volume 6, Issue 2, pp 352–358 1152 Declaration of Michael I, Chakansky, dated and served February 19, 2020 pursuant to 37 C.F.R. § 42.64(b)(2), filed