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 Meezan ’962’s disclosure when seeking to enhance the bioavailability of the therapeutic agents in the compositions disclosed in Gwozdz.

For the reasons stated supra with regard to claims 8–10 and 15, Petitioner’s assertion that Patent Owner never showed any unexpected results with respect to the amount of ethanol and benzyl alcohol is not sufficiently supported by the evidence of record.

We are not persuaded that Petitioner and Dr. Peppas have provided sufficient argument and supporting evidence to explain why one of ordinary skill in the art would have reasonably expected success in achieving the bioavailabilities recited in claims 34–36 of the ’876 patent when combining the teachings of Gwozdz and Meezan ’962.

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.

Patent Owner may file a preliminary response to the petition no later than three months from the date of this notice.

Patent Owner may also file an election to waive the preliminary response to expedite the proceeding.

Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.

The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.

Such motions shall be filed in accordance with the “Order -- Authorizing Motion for Pro Hac Vice Admission” in Case IPR2013-00639, Paper 7, a copy of which is available on the Board Web site under “Representative Orders, Decisions, and Notices.” 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 Review Processing System (PRPS), accessible from the Board Web site at http://www.uspto.gov/PTAB.

Aquestive fails to show why EX1013—a document that is cited only in support of a non-instituted ground—(and Dr. Peppas’ discussion thereof, EX1041, ¶¶171-191, 264-362, Appendix A (pp. 197-224), and EX1050) is relevant to the instituted grounds.

Aquestive’s reliance on Genzyme Therapeutic and/or Ariosa Diagnostics is disingenuous given that neither of those decisions involved the lack of notice, and resultant prejudice, that is present here.

The declaration does not provide any “personal knowledge” as required by FRE 901(b)(1), or any other evidence that EX1069 is what Aquestive purports it to be—a manual available to, and followed by, medical technicians in Florida prior to the priority date.

Separately, Dr. Wermeling’s experience in drug development does not qualify him to provide expert opinions on economics and/or regulatory procedures.

Aquestive block cites portions of Dr. Wermeling’s testimony in support of the alleged “expertise”—but, a closer look at the testimony reveals that he (1) is merely “familiar with economic principles” (EX2031, 8:19-22) and otherwise collaborated with trained economists for his written work (id., 10:2-14); (2) has never worked at, or received any formal certifications related to, FDA practice and procedure (id., 10:22-11:7); (3) has limited experience with pricing (id., 77:2-7) and could not make any pricing decisions on his own (id., 79:24-80:81:5), and; (4) is only “pretty familiar” with the 505(b)(2) pathway and would need to consult the “regulatory person at the company” for the answer to a complex question on the same (id., 85:6-86:13).