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.

A patentee may define a claim term in a manner that differs from its ordinary and customary meaning; however, any special definitions must be set forth in the specification with reasonable clarity, deliberateness, and precision.

The Examiner subsequently issued a final rejection of the claims on November 21, 2011, disagreeing with the Applicants “teaching away” arguments and concluding that “one of ordinary skill in the art would have found it obvious to nasally administer a benzodiazepine composition that contains only tocopherol or tocotrienol, an alcohol and optionally one or more alkyl glycosides.” Id. at 514–515.

In subsequent Office Actions of July 14, 2016, March 30, 2017, and October 19, 2017, the Examiner maintained his position that Sonne’s broad disclosures would have led one of ordinary skill in the art to the claimed formulations.

Petitioner contends that because the nosedrop of DS-11 “may be too viscous to spray,” one of ordinary skill in the art would have followed Sonne’s teachings and reduced the viscosity of the solution by replacing the triacetin co-solvent with ethanol.

Likewise, in a July 14, 2016 Office Action in the ’439 application, the Examiner stated that Sonne teaches “[v]iscosity can be reduced by the addition of co-solvents such as ethanol” and that “[a] co-solvent such as ethanol can be used in order to optimize the formulations bioadhesion, sprayability, and viscosity.” Ex. 1007, 3096–3097 (citing Ex. 1013, 3:65– 66, 6:47–53).

For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.

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.

Many non-profit organizations, both inside and outside the intellectual property field, offer alternative dispute resolution services.

If the parties actually engage in alternative dispute resolution, the Case IPR2019-00450 Patent No. 9,763,876 PTAB would be interested to learn what mechanism (e.g., arbitration, mediation, etc.) was used and the general result.

On August 1, 2019, the PTAB denied institution of IPR2019-00450, see Paper

See copy of portion of fee payment receipt below:

The refund should be deposited into the deposit account from which it was paid, namely, Hoffmann & Baron LLP Deposit Account No. 08-2461, as provided for in the Petition, page 3, Paper 2 (“The undersigned further authorizes payment from and to the above referenced Deposit Account [i.e., 08-2461] for any additional fees or refund that may be due in connection with this petition and IPR proceeding.”).

1031 Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36 (Bioavailability and Bioequivalence), Drug Intelligence Publications, Illinois, 1992 (Ritschel) Osborne et al., Skin Penetration Enhancers Cited in the Technical Literature, Pharmaceutical Technology, November 1997 (Osborne) Lindhardt et al., Electroencephalographic effects and serum concentrations after intranasal and intravenous administration of diazepam to healthy volunteers, Blackwell Science Ltd Br J Clin Pharmacol, 52, 521-527, 2001 (Lindhardt) Kibbe, editor, Handbook of Pharmaceutical Excipients, Third Edition (2000), American Pharmaceutical Association, Washington DC (Kibbe) Illum, Nasal drug delivery-possibilities, problems and solutions, Journal of Controlled Release 87 (2003) 187-198 (Illum) Ivaturi et al., Pharmacokinetics and tolerability of intranasal diazepam and midazolam in healthy adult volunteers, Acta Neurol Scand.

‘876 Patent defines “bioavailability” as: “Bioavailability” “it is intended that bioavailability be determined by a suitable pharmacodynamics method, such as comparison of area under the blood plasma concentration curve (AUC) for the nasally and intravenously administered drug.

General Teachings Sonne is directed to: “…the use of a tocopherol or a derivative thereof as a solvent…for substantially insoluble and sparingly soluble biologically active agents, especially in the manufacture of pharmaceutical compositions.

[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (internal citations and quotations omitted) See also Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1344 (Fed.Cir.

A POSITA would therefore routinely experiment by varying the relative amounts of tocopherols, ethanol, and benzyl alcohol in order to optimize the sprayability, solubility, and viscosity – while simultaneously minimizing potential irritation.

The patent owner provides the following notice pursuant to 37 CFR §42.8(a)(2).

Real parties-in-interest [no change] Neurelis, Inc. (“Neurelis”) owns the involved patent.

Related matters [no change] The petitioner has filed two additional inter partes review petitions (IPR2019-00449 and IPR2019-00451) against the involved patent.

Neurelis has an application (15/470,498) that claims benefit under 35 U.S.C. 120 to the application that issued as the involved patent.

Date: 21 May 2019 /Richard Torczon/ Richard Torczon Reg. No. 34,448

Epilepsy actively affects over 3.4 million people in the United States (about 1.2% of the total population), ranks as the second-most burdensome neurologic disorder worldwide in terms of disability-adjusted life years, with associated stigma, psychiatric co-morbidity and high economic costs.

Uncontrolled seizures may result in injury, anxiety, depression, brain damage and death, while also interfering with normal day-to-day activities, such as working, going to school, and socializing with friends and family.

Techs., LLC, IPR2017-00642, Paper 31, 10-11 n.6, 19-20 (2018) (collecting cases) (“Consistent with the Office’s need to provide streamlined examination and to utilize Office resources effectively, a petitioner must articulate error in the Examiner’s evaluation of the previously considered prior art.”).

First, Neurelis did not mislead the examiner from proper consideration of Example 11 of Sonne.2 Aquestive contends the applicant mistakenly argued that 2 Indeed, Petitioner’s misrepresentation of the fact raises is of concern in light of 37 C.F.R. § 42.1(c) requiring the parties to “act with courtesy and decorum in all

Yet, even assuming arguendo that these statements were incorrect, the examiner considered the entirety of Sonne, including Example 11, in depth, which the Board has found sufficient in similar circumstances in declining to institute review.