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.
Cite Document
IPR2019-00450, No. 5 Mandatory Notice - Patent Owners Mandatory Notices (P.T.A.B. Feb. 19, 2019)
+ More Snippets
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
Cite Document
IPR2019-00450, No. 1 Power of Attorney - Power of Attorney (P.T.A.B. Jan. 29, 2019)
+ More Snippets
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
Cite 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)
+ More Snippets
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 ...
Cite 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.A.B. May. 6
+ More Snippets
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%...
Cite 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%3A%2F%2Fwwwcdc
+ More Snippets
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)
Cite 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)
+ More Snippets
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...
Cite 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 injection helps
+ More Snippets
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...
Cite 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 49, Issue
+ More Snippets
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)
Cite 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)
+ More Snippets
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...
Cite 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, 2019)
+ More Snippets
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...
Cite 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)
+ More Snippets
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...
Cite 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.B. Jan. 29, 2019
+ More Snippets
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...
Cite 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 49, Issue
+ More Snippets
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...
Cite 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. 29, 2019)
+ More Snippets
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...
Cite 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 November 29, 1994 Kee (
+ More Snippets