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5 Mandatory Notice: Patent Owners Mandatory Notices

Document IPR2019-00450, No. 5 Mandatory Notice - Patent Owners Mandatory Notices (P.T.A.B. Feb. 19, 2019)
The patent owner provides the following notice pursuant to 37 CFR §42.8(a)(2).
Real parties-in-interest Neurelis, Inc. (“Neurelis”) owns the involved patent.
Related matters The petitioner has filed two additional inter partes review petitions
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.
above counsel, is of record for the involved patent.
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1 Power of Attorney: Power of Attorney

Document IPR2019-00450, No. 1 Power of Attorney - Power of Attorney (P.T.A.B. Jan. 29, 2019)
In accordance with 37 CPR.
I have authority to sign this document on behalf of Petitioner Aquestive
Mark Sc e1 Aquestive Therapeutics, Inc.
Title: Chief Innovation & Technology Officer Date
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2002 Exhibit: Food Drug Administration, Grant Fast Track IND 112621 NRL 1 diazepam intranasal solution 27 Dec 2016

Document IPR2019-00450, No. 2002-70 Exhibit - Food Drug Administration, Grant Fast Track IND 112621 NRL 1 diazepam intranasal solution 27 Dec 2016 (P.T.A.B. May. 6, 2019)
Neurelis, Inc. c/o Pacific Link Consulting, LLC Attention: Richard Lowenthal, MS, MSEL President, Pacific-Link Consulting 8195 Run of the Knolls Court San Diego, CA 92127 Dear Mr. Lowenthal: Food and Drug Administration Silver Spring MD 20993
We have reviewed your request and concluded that it meets the criteria for Fast Track designation.
Therefore, we are designating as a Fast Track development program the investigation of NRL-1 for the management of selected, refractory patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizures.
Please note that if the clinical development program you pursue does not continue to meet the criteria for Fast Track designation, the application will not be reviewed under the Fast Track program.
Sincerely, {See appended electronic signature page} Billy Dunn, MD Director Division of Neurology Products Office of Drug Evaluation I Center for Drug Evaluation and Research Reference ID: 4034029 Neurelis - EX. 2002 Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00450
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2005 Exhibit: KM Fiest et al, Prevalence and Incidence of Epilepsy, A Systematic Review and Meta Analysis of International Studies, 88 Neurology 296 17 Jan 2017

Document IPR2019-00450, No. 2005-73 Exhibit - KM Fiest et al, Prevalence and Incidence of Epilepsy, A Systematic Review and Meta Analysis of International Studies, 88 Neurology 296 17 Jan 2017 (P.T...
... • Not original (61) • Pre-1985 data (41) • No estimate provided (36) • Foreign language (33) • Not population-based (29) • Status epilepticus only (13) • Neonatal seizures only (13) • Abstract only (7) • Febrile seizures only (5) • Nonepileptic ...
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2001 Exhibit: Centers for Disease Control and Prevention, Epilepsy Fast Facts 9 Apr 2019, available at httpswwwcdcgovepilepsyaboutfast factshtmCDC AA refValhttps%3A%2F%2Fwwwcdcgov%2Fepilepsy%2Fbasics%2Ffast factshtm

Document IPR2019-00450, No. 2001-69 Exhibit - Centers for Disease Control and Prevention, Epilepsy Fast Facts 9 Apr 2019, available at httpswwwcdcgovepilepsyaboutfast factshtmCDC AA refValhttps%...
4/9/2019 Epilepsy Fast Facts | CDC Tire Centers for Disease Control and Prevention .
These seizures are not caused by a temporary underlying medical condition such as a high fever.
These factors play a major role in determining both the severity of the person’s condition and the impact it has on his or her life.
Learn more about active epilepsy and find state-specific prevalence estimates on our Data and Statistics page.
Russ SA, Larson K, Halfon N. A national profile of childhood epilepsy and seizure disorder.
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2004 Exhibit: Centers for Disease Control and Prevention, Putting Collective Wisdom to Work for People with Epilepsy Nov 2016

Document IPR2019-00450, No. 2004-72 Exhibit - Centers for Disease Control and Prevention, Putting Collective Wisdom to Work for People with Epilepsy Nov 2016 (P.T.A.B. May. 6, 2019)
Provision of an address does not constitute an endorsement by CDC or the federal government, and none should be inferred.
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2003 Exhibit: Howard LeWine, MD, Quick Injection Helps Stop Epileptic Seizures, Harvard Health Blog 23 Feb 2012, available at httpswwwhealthharvard edublogquick injection helps stop epileptic seizures 201202234319print

Document IPR2019-00450, No. 2003-71 Exhibit - Howard LeWine, MD, Quick Injection Helps Stop Epileptic Seizures, Harvard Health Blog 23 Feb 2012, available at httpswwwhealthharvard edublogquick in...
4/19/2019 Harvard Health Blog Quick injection helps stop epileptic seizures - Harvard Health Blog - Harvard Health Blog - https://www.health.harvard.edu/blog - Quick injection helps stop epileptic seizures Posted By Howard LeWine, M.D.
A study published last week in the New England Journal of Medicine indicates that a hand-held auto-injector—much like the epi pens used by people with life-threatening allergies—could be used to treat seizures that don’t stop on their own.
Muscle trumps vein For the trial, more than 4,000 emergency medical technicians were trained to administer seizure-stopping drugs called benzodiazepines two ways: through an intravenous line inserted into a vein in the arm (the current standard treatment), and with a device that automatically injects the drug into the thigh.
Looking ahead This one study isn’t the green light for doctors to give auto-injectors filled with anti-seizure medication to all of their patients who have seizures.
This could spare these people and their families the agonizing wait for an ambulance to arrive in order to halt the seizure.
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1045 Exhibit: Maitani, et al, Design of ocularlacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 49, Issues 23, 15 December 1997, Pages 185 192

Document IPR2019-00450, No. 1045-63 Exhibit - Maitani, et al, Design of ocularlacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 4...
Of particular interest is the delivery of peptides and proteins through these routes, as it is known that peptidase activity is reduced or mini mired in the nasal cavity or the eyes [5], thus allowing a significant absorption of the bioactive agent.
Values of kinetic constants The compartmental model developed above can be used to investigate the influence of various processes on the absorption and distribution of drugs adminis- tered by the ocular/lacrimal and nasal routes.
Rogers, E. Shefter, Comparison of nasal, rectal, sublingual and intramuscular insulin efficacy and the effects of a bile salt absorption promoter, Exp.
[9] Y. Maitani, T. Yamamoto, K. Takayama, T. Nagai, The effect of soybean-derived sterol and its gincoside as an enhancer of nasai absorption of insulin in rabbits in vitro and in vivo, Int.
[10] N. Uchida, Y. Maitani, Y. Machida, M. Nakagaki, T. Nagai, Influence of bile salts on the permeability of insulin through the nasal mucosa of rabbits in compatison with dcxtran derivatives, Int.
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1007 Exhibit: Part 2 ¿¿¿ Pages 401 800 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH

Document IPR2019-00450, No. 1007-16 Exhibit - Part 2 ¿¿¿ Pages 401 800 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019)
For compounds of the formula NR1R2R3R4(+): (i) (ii) (iii) (iv) (V) (vi) 20 25 none of R1-R4 are CH3 ...
Priority under 35 U.S.C. § 119 12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f). a)I:I All b)I:I Some * c)I:I None of: 1.I:I Certified copies of the priority documents have been received.
AQUESTIVE EXHIBIT 1007 AQUESTIVE EXHIBIT 1007 page 0450 page 0450 Application/Control Number: 12/413,439 Page 4 Art Unit: 1612 fl claims directed to a nonelected process invention must require all the limitations of an ...
Priority under 35 U.S.C. § 119 12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). a)|:l AII b)I:l Some * c)|:l None of: 1.I:I Certified copies of the priority documents have been received.
Claims 1-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Indeed, consistent with Sonne’s general teaching at column 3, lines 65- 67, none of the Examples taught by Sonne suggest nasal administration of a benzodiazepine drug formulation that contains only tocopherol or tocotrienol, a alcohol ...
... EXHIBIT 1007 AQUESTIVE EXHIBIT 1007 page 0501 page 0501 Application No. 12/413,439 Response to March 18, 2011 Office Action Attorney Docket No.: 35401—716201 This teaching away is underscored by the fact that none ...
... teaching at column 3, lines 65-67, none of the Examples taught by Sonne suggest M administration of a benzodiazepine drug formulation that contains only tocopherol or tocotrienol, a alcohol and optionally an alkylglcoside. And none ...
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1013 Exhibit: Sonne, US Patent No 6,193,985, Tocopherol Compositions For Delivery Of Biologically Active Agents, issued February 27, 2001 Sonne

Document IPR2019-00450, No. 1013-29 Exhibit - Sonne, US Patent No 6,193,985, Tocopherol Compositions For Delivery Of Biologically Active Agents, issued February 27, 2001 Sonne (P.T.A.B. Jan. 29, 2...
None of the siX volunteers had local irritation of the nostrils 30 minutes after application, see table 2.
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1007 Exhibit: Part 9 ¿¿¿ Pages 3201 3488 File History for Non Provisional Patent App...

Document IPR2019-00450, No. 1007-23 Exhibit - Part 9 ¿¿¿ Pages 3201 3488 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019...

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1031 Exhibit: Rowe et al, Handbook of Pharmaceutical Excipients, Fourth Edition 2...

Document IPR2019-00450, No. 1031-47 Exhibit - Rowe et al, Handbook of Pharmaceutical Excipients, Fourth Edition 2003, Monographs, American Pharmaceutical Association, Washington DC Rowe (P.T.A...

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1045 Exhibit: Maitani, et al, Design of ocularlacrimal and nasal systems through an...

Document IPR2019-00450, No. 1045-63 Exhibit - Maitani, et al, Design of ocularlacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 4...

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1010 Exhibit: US Patent Application Publication No US 20090258865, Administratio...

Document IPR2019-00450, No. 1010-26 Exhibit - US Patent Application Publication No US 20090258865, Administration of Benzodiazepine Compositions, Serial No 12413,439 Cartt¿¿¿865 (P.T.A.B. Jan. 2...

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1016 Exhibit: Kee et al, US Patent No 5,369,095, Compositions And Method Compr...

Document IPR2019-00450, No. 1016-32 Exhibit - Kee et al, US Patent No 5,369,095, Compositions And Method Comprising Substituted Glycosides As Mucus Membrane Permeation Enhancers, issued No...

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