| 1/29/2019 | 01-29-2019-Petitioner | - Petitioner Exhibit 1001: U.S. Patent No. 9,763,876, Administration Of Benzodiazepine Compositions, filed October 29, 2014 (¿¿¿876 Patent)
- Petitioner Exhibit 1002: Part 1 - Pages 1-270 - File History for ¿¿¿876 Patent, Ser. No. 14/527,613 (¿¿¿876 FH)
- Petitioner Exhibit 1002: Part 2 - Pages 271-530 - File History for ¿¿¿876 Patent, Ser. No. 14/527,613 (¿¿¿876 FH)
- Petitioner Exhibit 1003: U.S. Patent No. 8,895,546, Administration Of Benzodiazepine Compositions, filed June 13, 2012 (¿¿¿546 Patent)
- Petitioner Exhibit 1004: Part 2 ¿¿¿ Pages 351-700 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1004: Part 3 ¿¿¿ Pages 701-1050 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1004: Part 4 ¿¿¿ Pages 1051-1400 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1004: Part 5 ¿¿¿ Pages 1401-1750 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1004: Part 6 ¿¿¿ Pages 1751-2100 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1004: Part 1 ¿¿¿ Pages 1-350 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1004: Part 7 ¿¿¿ Pages 2101-2450 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1004: Part 8 ¿¿¿ Pages 2451-2681 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)
- Petitioner Exhibit 1005: Provisional Patent Application No. 61/497,017, filed June 14, 2011 (¿¿¿017 Provisional)
- Petitioner Exhibit 1006: Provisional Patent Application No. 61/570,110, filed December 13, 2011 (¿¿¿110 Provisional)
- Petitioner Exhibit 1007: Part 2 ¿¿¿ Pages 401-800 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 3 ¿¿¿ Pages 801-1200 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 1 ¿¿¿ Pages 1-400 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 4 ¿¿¿ Pages 1201-1600 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 5 ¿¿¿ Pages 1601-2000 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 9 ¿¿¿ Pages 3201-3488 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 6 ¿¿¿ Pages 2001-2400 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 7 ¿¿¿ Pages 2401-2800 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1007: Part 8 ¿¿¿ Pages 2801-3200 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)
- Petitioner Exhibit 1008: Provisional Patent Application No. 61/040,558, filed March 28, 2008 (¿¿¿558 Provisional)
- Petitioner Exhibit 1009: Cartt et al., WO 2009/121039, Administration Of Benzodiazepine Compositions, published October 1, 2009, International Filing Date March 27, 2009 (PCT/US2009/038696) (Cartt ¿¿¿039)
- Petitioner Exhibit 1010: U.S. Patent Application Publication No. US 2009/0258865, Administration of Benzodiazepine Compositions, Serial No. 12/413,439 (Cartt¿¿¿865)
- Petitioner Exhibit 1011: Meezan et al., U.S. Patent Application Publication No. US 2006/0046962, Absorption Enhancers for Drug Administration, Serial No. 11/127,786, published March 2, 2006 (Meezan¿¿¿962)
- Petitioner Exhibit 1012: Jamieson et al., U.S. Patent Application Publication No. US 2008/0070904, Pharmaceutical Compositions of Benzodiazepines and Method of Use Thereof, Serial No. 11/897,028, published March 20, 2008 (Jamieson)
- Petitioner Exhibit 1013: Sonne, U.S. Patent No. 6,193,985, Tocopherol Compositions For Delivery Of Biologically Active Agents, issued February 27, 2001 (Sonne)
- Petitioner Exhibit 1014: Gwozdz et al., WO 2009/120933, Pharmaceutical Solutions And Method For Solubilizing Therapeutic Agents, published October 1, 2009, International Filing Date March 27, 2009 (PCT/US2009/038518) (Gwozdz)
- Petitioner Exhibit 1015: Cartt et al., U.S. Patent Application Publication No. US 2008/0279784, Nasal Administration Of Benzodiazepines, Serial No. 12/116,842, published November 13, 2008 (Cartt ¿¿¿784)
- Petitioner Exhibit 1016: Kee et al., U.S. Patent No. 5,369,095, Compositions And Method Comprising Substituted Glycosides As Mucus Membrane Permeation Enhancers, issued November 29, 1994 (Kee)
- Petitioner Exhibit 1017: Cartt et al., WO 2008/137960, Nasal Administration Of Benzodiazepines, published November 13, 2008, International filing date May 7, 2008 (PCT/US2008/062961) (Cartt ¿¿¿960)
- Petitioner Exhibit 1018: Tenta, U.S. Patent No. 3,949,072, Topical Composition for Treatment of Seborrheic Keratosis, issued April 6, 1976 (Tenta)
- Petitioner Exhibit 1019: Ueda et al., U.S. Patent No. 4,657,901, Pharmaceutical Composition, issued April 14, 1987 (Ueda)
- Petitioner Exhibit 1020: Meezan et al., U.S. Patent No. 5,661,130, Absorption Enhancers For Drug Administration, issued August 26, 1997 (Meezan¿¿¿130)
- Petitioner Exhibit 1021: Merkus, U.S. Patent Application Publication No. US 2005/0153956, Serial No. 11/034,474, published July 14, 2005 (Merkus)
- Petitioner Exhibit 1022: Liversidge et al., U.S. Patent Application Publication No. US 2006/0198896, Serial No. 11/354,249, published September 7, 2006 (Liversidge)
- Petitioner Exhibit 1023: Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36 (Bioavailability and Bioequivalence), Drug Intelligence Publications, Illinois, 1992 (Ritschel)
- Petitioner Exhibit 1024: Osborne et al., Skin Penetration Enhancers Cited in the Technical Literature, Pharmaceutical Technology, November 1997 (Osborne)
- Petitioner Exhibit 1025: 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)
- Petitioner Exhibit 1026: Kibbe, editor, Handbook of Pharmaceutical Excipients, Third Edition (2000), American Pharmaceutical Association, Washington DC (Kibbe)
- Petitioner Exhibit 1027: Illum, Nasal drug delivery-possibilities, problems and solutions, Journal of Controlled Release 87 (2003) 187-198 (Illum)
- Petitioner Exhibit 1028: Ivaturi et al., Pharmacokinetics and tolerability of intranasal diazepam and midazolam in healthy adult volunteers, Acta Neurol Scand. 2009 Nov;120(5):353-7. doi: 10.1111/j.1600-0404.2009.01170.x. Epub 2009 May 14 (Ivaturi)
- Petitioner Exhibit 1029: O¿¿¿Dell et al., School nurses¿¿¿ experience with administration of rectal diazepam gel for seizures, J Sch Nurs., June 2007, 23(3):166-9 (O¿¿¿Dell)
- Petitioner Exhibit 1030: Gizurarson et al., Intranasal Administration of Diazepam Aiming at the Treatment of Acute Seizures: Clinical Trials in Healthy Volunteers, Biological and Pharmaceutical Bulletin, Volume 22 (1999) Issue 4 Pages 425-427 (Gizurarson)
- Petitioner Exhibit 1031: Rowe et al., Handbook of Pharmaceutical Excipients, Fourth Edition (2003), Monographs, American Pharmaceutical Association, Washington DC (Rowe)
- Petitioner Exhibit 1032: Edman [II] et al., Microspheres as a nasal delivery system for peptide drugs, Journal of Controlled Release, Vol. 21 (1992) 165-l72 (Edman II)
- Petitioner Exhibit 1033: French et al., Pharmacopeial Standards and Specifications for Bulk Drugs and Solid Oral Dosage Forms, Journal of Pharmaceutical Sciences, December 1967, Vol. 56(12):1622-1641 (French)
- Petitioner Exhibit 1034: Edman [I] et al., (D) Routes of Delivery: Case Studies - (1) Nasal delivery of peptide drugs, Advanced Drug Delivery Reviews, 8 (1992) 165-177 (Edman I)
- Petitioner Exhibit 1035: Davis, Delivery of peptide and non-peptide drugs through the respiratory tract, Pharmaceutical Science & Technology Today, Vol. 2, No. 11 November 1999, pages 450-456 (Davis)
- Petitioner Exhibit 1036: Deshmukh et al., Lorazepam in the Treatment of Refractory Neonatal Seizures, Am J Dis Child. 1986;140(10):1042-1044 (Deshmukh)
- Petitioner Exhibit 1037: Colombo, Mucosal Drug Delivery, Nasal, pp. 592-605, Vol 2, Encyclopedia of Controlled Drug Delivery (Mathiowitz, editor), John Wiley & Sons, 1999 (Colombo)
- Petitioner Exhibit 1038: Bara, U.S. Patent Application Publication No. US/2006/0178290, Serial No. 10/563,967, published August 10, 2006 (Bara)
- Petitioner Exhibit 1039: Behl et al., Effects of physicochemical properties and other factors on systemic nasal drug delivery, Advanced Drug Delivery Reviews 29 (1998) 89¿¿¿116 (Behl)
- Petitioner Exhibit 1040: Part 1 - Pages 1-250 - File History for EP 128 01372.9, based on WO 2012/174158 and PCT/US2012/042311
- Petitioner Exhibit 1040: Part 2 - Pages 251-500 - File History for EP 128 01372.9, based on WO 2012/174158 and PCT/US2012/042311
- Petitioner Exhibit 1040: Part 3 ¿¿¿ Pages 501-662 - File History for EP 128 01372.9, based on WO 2012/174158 and PCT/US2012/042311
- Petitioner Exhibit 1041: Declaration of Dr. Nicholas A. Peppas
- Petitioner Exhibit 1042: PDR 54th Edition 2000, DIASTAT¿¿ (diazepam rectal gel); MIACALCIN¿¿ (Calcitonin Nasal Spray); VALIUM¿¿ (diazepam injection), Physicians¿¿¿ Desk Reference.
- Petitioner Exhibit 1043: Knoester, et al., Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers, Br J Clin Pharmacol. 2002 May;53(5):501-7.
- Petitioner Exhibit 1044: USP NF 2003, The United States Pharmacopeia, The National Formulary, United States Pharmacopeial Convention, Inc. (¿¿¿USP/NF¿¿¿)
- Petitioner Exhibit 1045: Maitani, et al., Design of ocular/lacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 49, Issues 2¿¿¿3, 15 December 1997, Pages 185-192.
- Petitioner Exhibit 1046: Provisional Patent Application No. 61/040,281, Pharmaceutical Solutions and Method for Solubilizing Therapeutics Agents, filed March 28, 2008, Gwozdz, (Gwozdz ¿¿¿281 Provisional)
- Petitioner Exhibit 1047: Gwozdz Assignment of Provisional in Non-Provisional Case, dated April 21, 2008, recorded September 23, 2010 (Gwozdz Assignment).
- Petitioner Exhibit 1048: Kagatani, et al., U.S. Patent No. 4,690,952, Pharmaceutical Compositions for Nasal administration Comprising Calcitonin and an Absorption-Promoting Substance, issued September 1, 1987 (Kagatani).
- Petitioner Exhibit 1049: Cartt¿¿¿784 Assignment, dated March 6, 2012, recorded March 29, 2012 (Cartt¿¿¿784 Assignment)
- Petitioner Exhibit 1050: Table of Various Diazepam Solutions Described in or Modified From Sonne¿¿¿s Example 11 (¿¿¿DS11¿¿¿)
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