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).