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`Paper No. 22
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
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`AQUESTIVE THERAPEUTICS, INC.
`
`
`Petitioner
`
`v.
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`NEURELIS, INC.
`
`Patent Owner
`
`_______________________
`
`Case: IPR2019-00451
`
`U.S. Patent No. 9,763,876
`
`______________________
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`
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`PETITIONER’S FIRST UPDATED
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`EXHIBIT LIST
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`IPR2019-00451
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`EXHIBIT NO.
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`1001
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`1002
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`1003
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`1004
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`U.S. Patent No. 9,763,876
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`EXHIBIT DESCRIPTION
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`U.S. Patent No. 9,763,876, Administration Of Benzodiazepine
`
`Compositions, filed October 29, 2014 (‘876 Patent)
`
`File History for ‘876 Patent, Ser. No. 14/527,613 (‘876 FH)
`
`1002 Part 1 - Pages 1-270
`
`1002 Part 2 - Pages 271-530
`
`U.S. Patent No. 8,895,546, Administration Of Benzodiazepine
`
`Compositions, filed June 13, 2012 (‘546 Patent)
`
`File History for ‘546 Patent, Ser. No. 13/495,942 (‘546 FH)
`
`1004 Part 1 – Pages 1-350
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`1004 Part 2 – Pages 351-700
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`1004 Part 3 – Pages 701-1050
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`1004 Part 4 – Pages 1051-1400
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`1004 Part 5 – Pages 1401-1750
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`1004 Part 6 – Pages 1751-2100
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`1004 Part 7 – Pages 2101-2450
`
`1004 Part 8 – Pages 2451-2681
`
`1005
`
`Provisional Patent Application No. 61/497,017, filed June 14,
`
`2011 (‘017 Provisional)
`
`1
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`IPR2019-00451
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`1006
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`
`
`U.S. Patent No. 9,763,876
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`Provisional Patent Application No. 61/570,110, filed December
`
`13, 2011 (‘110 Provisional)
`
`1007
`
`File History for Non-Provisional Patent Application Serial No.
`
`12/413,439, filed March 27, 2009 (‘439 FH)
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`
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`1008
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`1009
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`
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`1007 Part 1 – Pages 1-400
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`1007 Part 2 – Pages 401-800
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`1007 Part 3 – Pages 801-1200
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`1007 Part 4 – Pages 1201-1600
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`1007 Part 5 – Pages 1601-2000
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`1007 Part 6 – Pages 2001-2400
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`1007 Part 7 – Pages 2401-2800
`
`1007 Part 8 – Pages 2801-3200
`
`1007 Part 9 – Pages 3201-3488
`
`Provisional Patent Application No. 61/040,558, filed March 28,
`
`2008 (‘558 Provisional)
`
`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)
`
`2
`
`
`
`
`
`IPR2019-00451
`
`
`1010
`
`
`
`U.S. Patent No. 9,763,876
`
`U.S. Patent Application Publication No. US 2009/0258865,
`
`Administration of Benzodiazepine Compositions, Serial No.
`
`12/413,439 (Cartt‘865)
`
`1011
`
`Meezan et al., U.S. Patent Application Publication No. US
`
`2006/0046962, Absorption Enhancers for Drug Administration,
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`Serial No. 11/127,786, published March 2, 2006 (Meezan‘962)
`
`1012
`
`Jamieson et al., U.S. Patent Application Publication No. US
`
`2008/0070904, Pharmaceutical Compositions of
`
`Benzodiazepines and Method of Use Thereof, Serial No.
`
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`
`1013
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`Sonne, U.S. Patent No. 6,193,985, Tocopherol Compositions
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`For Delivery Of Biologically Active Agents, issued February 27,
`
`2001 (Sonne)
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`1014
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`
`And Method For Solubilizing Therapeutic Agents, published
`
`October 1, 2009, International Filing Date March 27, 2009
`
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`
`Cartt et al., U.S. Patent Application Publication No. US
`
`2008/0279784, Nasal Administration Of Benzodiazepines,
`3
`
`
`
`1015
`
`
`
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`
`
`
`IPR2019-00451
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`
`
`
`
`U.S. Patent No. 9,763,876
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`Serial No. 12/116,842, published November 13, 2008 (Cartt
`
`‘784)
`
`1016
`
`Kee et al., U.S. Patent No. 5,369,095, Compositions And
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`Method Comprising Substituted Glycosides As Mucus
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`Membrane Permeation Enhancers, issued November 29, 1994
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`1017
`
`Cartt et al., WO 2008/137960, Nasal Administration Of
`
`Benzodiazepines, published November 13, 2008, International
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`filing date May 7, 2008 (PCT/US2008/062961) (Cartt ‘960)
`
`1018
`
`Tenta, U.S. Patent No. 3,949,072, Topical Compositions for
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`Treatment of Seborrheic Keratosis Treatment, issued April 6,
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`1976 (Tenta)
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`Ueda et al., U.S. Patent No. 4,657,901, Pharmaceutical
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`
`Meezan et al., U.S. Patent No. 5,661,130, Absorption
`
`Enhancers For Drug Administration, issued August 26, 1997
`
`(Meezan‘130)
`
`4
`
`1019
`
`1020
`
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`
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`
`
`IPR2019-00451
`
`
`1021
`
`
`
`U.S. Patent No. 9,763,876
`
`Merkus, U.S. Patent Application Publication No. US
`
`2005/0153956, Serial No. 11/034,474, published July 14, 2005
`
`(Merkus)
`
`1022
`
`Liversidge et al., U.S. Patent Application Publication No. US
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`2006/0198896, Serial No. 11/354,249, published September 7,
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`2006 (Liversidge)
`
`1023
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`Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36
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`(Bioavailability and Bioequivalence), Drug Intelligence
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`Publications, Illinois, 1992 (Ritschel)
`
`1024
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`Osborne et al., Skin Penetration Enhancers Cited in the
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`Technical Literature, Pharmaceutical Technology, November
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`1997 (Osborne)
`
`1025
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`Lindhardt et al., Electroencephalographic effects and serum
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`concentrations after intranasal and intravenous administration
`
`of diazepam to healthy volunteers, Blackwell Science Ltd Br J
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`Clin Pharmacol, 52, 521-527, 2001 (Lindhardt)
`
`1026
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`Kibbe, editor, Handbook of Pharmaceutical Excipients, Third
`
`Edition (2000), American Pharmaceutical Association,
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`Washington DC (Kibbe)
`
`
`
`
`
`5
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`IPR2019-00451
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`1027
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`Illum, Nasal drug delivery-possibilities, problems and
`
`solutions, Journal of Controlled Release 87 (2003) 187-198
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`1028
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`Ivaturi et al., Pharmacokinetics and tolerability of intranasal
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`diazepam and midazolam in healthy adult volunteers, Acta
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`Neurol Scand. 2009 Nov;120(5):353-7. doi: 10.1111/j.1600-
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`0404.2009.01170.x. Epub 2009 May 14 (Ivaturi)
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`1029
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`O’Dell et al., School nurses’ experience with administration of
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`rectal diazepam gel for seizures, J Sch Nurs., June 2007,
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`23(3):166-9 (O’Dell)
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`1030
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`Gizurarson et al., Intranasal Administration of Diazepam
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`Aiming at the Treatment of Acute Seizures: Clinical Trials in
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`Healthy Volunteers, Biological and Pharmaceutical Bulletin,
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`Volume 22 (1999) Issue 4 Pages 425-427 (Gizurarson)
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`1031
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`Rowe et al., editors, Handbook of Pharmaceutical Excipients,
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`Fourth Edition (2003), Monographs for “Alcohol” (i.e.,
`
`ethanol), “Alpha Tocopherol”, “Benzyl Alcohol”, “Glycerin”,
`
`“Olive Oil”, “Polyethylene Glycol”, “Propylene Glycol”,
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`“Sesame Oil”, and “Triacetin”, American Pharmaceutical
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`Association, Washington DC (Rowe)
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`Edman [II] et al., Microspheres as a nasal delivery system for
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`peptide drugs, Journal of Controlled Release, Vol. 21 (1992)
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`Encyclopedia of Controlled Drug Delivery (Mathiowitz,
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`editor), John Wiley & Sons, 1999 (Colombo)
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`IPR2019-00451
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`1038
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`U.S. Patent No. 9,763,876
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`Bara, U.S. Patent Application Publication No. US
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`2006/0178290, Serial No. 10/563,967, published August 10,
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`2006 (Bara)
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`1039
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`Behl et al., Effects of physicochemical properties and other
`
`factors on systemic nasal drug delivery, Advanced Drug
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`1040
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`File History for EP 128 01372.9, based on WO 2012/174158
`
`
`
`
`
`
`
`1041
`
`1042
`
`and PCT/US2012/042311
`
`1040 Part 1 - Pages 1-250
`
`1040 Part 2 - Pages 251-500
`
`1040 Part 3 – Pages 501-662
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`Declaration of Dr. Nicholas A. Peppas
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`
`MIACALCIN® (Calcitonin Nasal Spray); VALIUM®
`
`(diazepam injection), Physicians’ Desk Reference.
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`8
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`1044
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`USP NF 2003, The United States Pharmacopeia, The National
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`1045
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`
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`Gwozdz Assignment of Provisional in Non-Provisional Case,
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`
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`
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`IPR2019-00451
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`1050
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`
`U.S. Patent No. 9,763,876
`
`Table of Various Diazepam Solutions Described in or Modified
`
`From Sonne’s Example 11 (“DS11”)
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`USP/NF 2003, The Official Compendia of Standards, Ethanol,
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`Valium® Tablet Label, Roche, January 2008.
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`Drug Prices from Internet
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`Pharmaceutical Sciences, Vol. 39, Marcel Decker, 1989.
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`1126
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`.
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`1127
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`U.S. Patent No. 9,763,876
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`Gudmundsdottir H, Sigurjonsdottir JF, Masson M, et al.,
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`1132-1133
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`1134
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`and pharmacokinetics of lorazepam after intranasal,
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`seizures in children. Epilepsy and Behavior 2004; 5: 253-255.
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`Bhattacharyya M, Kalra V, Gulati S. Intranasal midazolam vs
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`rectal diazepam in acute childhood seizures. Pediatric
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`Neurology 2006; 34: 355-359.
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`Wilson, M.T., S. Macleod, and M.E. O'Regan, Nasal/buccal
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`midazolam use in the community. Arch Dis Child, 2004. 89(1):
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`p. 50-1.
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`Harbord, M.G., et al., Use of intranasal midazolam to treat
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`acute seizures in paediatric community settings. J Paediatr
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`Child Health, 2004. 40(9-10): p. 556-8.
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`Jeannet, P.Y., et al., Home and hospital treatment of acute
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`seizures in children with nasal midazolam. Eur J Paediatr
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`Neurol, 1999. 3(2): p. 73-7.
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`Ahmad S, Ellis J, Kamwendo H, et al. Efficacy and safety of
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`intranasal lorazepam versus intramuscular paraldehyde for
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`protracted convulsions in children: an open label trial. Lancet
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`2006; 367: 1591-1597.
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`Wolfe T, Bernstone T, Intranasal Drug Delivery: An
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`Alternative to Intravenous Administration in Selected
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`Emergency Cases, J Emerg Nurs. 2004 Apr;30(2):141-7.
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`FDA GUI FINAL, Determining Whether to Submit an ANDA
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`or a 505(b)(2) Application, Published May 2019,
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`https://www.fda.gov/media/123567/download
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`CDER 2019-09-19-Abbreviated Approval Products:
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`505(b)(2) or ANDA? https://www.fda.gov/drugs/cder-small-
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`business-industry-assistance-sbia/abbreviated-approval-
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`pathways-drug-product-505b2-or-anda-september-19-2019-
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`issue
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`FDA GUIDANCE FOR INDUSTRY (1999), Applications
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`Covered by Section 505(b)(2),
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`https://www.fda.gov/media/72419/download
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`Transcript of the January 14, 2020 deposition of Dr.
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`Gizararson,
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`Declaration of Daniel P. Wermeling, Pharm.D.
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`Wermeling, D.P., Intranasal delivery of antiepileptic
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`medications for treatment of seizures, Neurotherapeutics,
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`April 2009, Volume 6, Issue 2, pp 352–358
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`IPR2019-00451
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`Dated: January 28, 2020.
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`U.S. Patent No. 9,763,876
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`Respectfully submitted,
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`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
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`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
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`
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`First Back-Up Counsel for
`Petitioner Aquestive Therapeutics, Inc.
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`19
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`U.S. Patent No. 9,763,876
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that on this the 28th day of January 2020, the foregoing
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`PETITIONER’S FIRST UPDATED EXHIBIT LIST, and all listed exhibits not
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`already filed and served, were served in their entirety on the following counsel of
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`record by electronic service by email at the email addresses as set forth below.
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` Jeffrey Guise
`Richard Torczon
`Lorelei Westin
`Lee Johnson
`Nathaniel Leachman
`Alina L. Litoshyk
`Wendy Devine
`WILSON SONSINI GOODRICH & ROSATI
`jguise@wsgr.com
`rtorczon@wsgr.com
`lwestin@wsgr.com
`ljohnson@wsgr.com
`nleachman@wsgr.com
`alitoshyk@wsgr.com
`wdevine@wsgr.com
`35401.652.palib1@matters.wsgr.com
`
`
`
`
`By:
`/Michael I. Chakansky/
`
`
`Michael I. Chakansky (Reg. No. 31,600)
`
`
`Hoffmann & Baron, LLP
`
`
`4 Century Drive
`
`
`
`Parsippany, N.J. 07054
`
`
`mchakansky@hbiplaw.com
`
`
`Tel: 973.331.1700
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`20
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