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1040 Exhibit: Part 1 Pages 1 250 File History for EP 128 013729, based on WO 2012174158 and PCTUS2012042311

Document IPR2019-00449, No. 1040-56 Exhibit - Part 1 Pages 1 250 File History for EP 128 013729, based on WO 2012174158 and PCTUS2012042311 (P.T.A.B. Jan. 28, 2019)
Furthermore, due to the nature of seizures and muscle spasms, it can be extremely difficult for either a patient or a care-giver to administer the benzodiazepine drug orally and care-givers may be reluctant to place their hands in patients’ mouths.
[011] - Some embodiments described herein provide a method oftreating a patient with a disorder which may be treatable with a benzodiazepine drug, comprising: administering to one or more nasal mucosal membranes of a patient a pharmaceutical solution for nasal administration consisting of a benzodiazepine drug, one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, in an amount from about 30% to about 95% (w/w); one or more alcohols or glycols, or any combinations thereof, in an amount from about 10% to about 70% (w/w); and an alkyl glycoside.
[054] In some embodiments, the composition contains a benzodiazepine drug that at least partially in a paniculate form suspended in a carrier system containing a natural or synthetic tocopherol or tocotrienol and one or more alcohols or glycols.
[055] In some embodiments, the composition contains a benzodiazepine drug that at least partially in a particulate form suspended in a carrier system containing a natural or synthetic tocopherol or tocotrienol, one or more alcohols or glycols, and an alkyl glycoside.
In some embodiments, benzodiazepine comprises a member of the group consisting of alprazolam, diazepam, flurazepam, loracham, medazepam, mexazolam, midazolam, temazepam and pharmaceutically acceptable salts and combinations thereof.
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1010 Exhibit: US Patent Application Publication No US 20090258865, Administration of Benzodiazepine Compositions, Serial No 12413,439 Cartt¿¿¿865

Document IPR2019-00449, 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...
In some embodiments, the composition consists essentially of a benZodiaZepine drug that is fully dissolved in a solvent con sisting of one or more natural or synthetic tocopherols or tocotrienols, one or more alcohols or glycols, and optionally one or more alkyl glycosides Wherein the solution is at least substantially free of Water.
In some embodiments, the composition consists essentially of a benZodiaZepine drug that is fully dissolved in a solvent con sisting of one or more natural or synthetic tocopherols or tocotrienols, one or more alcohols or glycols, and optionally one or more alkyl glycosides.
In some embodiments, the composition con sists of a benZodiaZepine drug in a form including benZodi aZepine microparticles and/or nanoparticles suspended in a carrier system consisting of Vitamin E TPGS, methylparaben, propylparaben, propylene glycol, povidone and Water.
[0049] In some embodiments, the composition contains a benZodiaZepine drug that at least partially in a particulate form suspended in a carrier system containing a natural or synthetic tocopherol or tocotrienol, one or more alcohols or glycols, and an alkyl glycoside.
In some embodiments, benzo diazepine comprises a member of the group consisting of alprazolam, diazepam, ?urazepam, lorazepam, medazepam, mexazolam, midazolam, temazepam and pharmaceutically acceptable salts and combinations thereof.
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1012 Exhibit: Jamieson et al, US Patent Application Publication No US 20080070904, Pharmaceutical Compositions of Benzodiazepines and Method of Use Thereof, Serial No 11897,028, published March 20, 2008 Jamieson

Document IPR2019-00449, No. 1012-28 Exhibit - Jamieson et al, US Patent Application Publication No US 20080070904, Pharmaceutical Compositions of Benzodiazepines and Method of Use Thereof, Se...
Visual inspection of the appearance of the spray plume of three solutions in the viscosity range from 5.8 to 41.7 revealed that a plume was formed and none of them “squirted.” [0265] These results demonstrated that at 20-25° C. all ...
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1043 Exhibit: Knoester, et al, Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray A study in healthy volunteers, Br J Clin Pharmacol 2002 May535501 7

Document IPR2019-00449, No. 1043-61 Exhibit - Knoester, et al, Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray A study in healthy volunteers, Br...
None had a history of cardiac or neurological disease.
The symptoms disappeared within 10 min in all but one subject, in whom intranasal irritation lasted for 25 min All subjects tolerated intranasal administration well and none found it to be painful.
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1015 Exhibit: Cartt et al, US Patent Application Publication No US 20080279784, Nasal Administration Of Benzodiazepines, Serial No 12116,842, published November 13, 2008 Cartt ¿¿¿784

Document IPR2019-00449, No. 1015-31 Exhibit - Cartt et al, US Patent Application Publication No US 20080279784, Nasal Administration Of Benzodiazepines, Serial No 12116,842, published November 1...
In some embodiments, the nanoparticulate benZodiaZepine particles comprise at least one member of the group consisting of alpraZolam, brotiZolam, chlordiaZepoxide, clobaZam, clon aZepam, cloraZepam, demoxaZepam, ?umaZenil, ?uraZepam, halaZepam, midaZolam, nordaZepam, medaZepam, diaZ AQUESTIVE EXHIBIT 1015 page 0006
In some embodiments, the nanoparticulate benZodi aZepine particles comprise at least one member of the group consisting of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, midaZolam, temaZepam and phar maceutically acceptable salts and combinations thereof.
In some embodiments, the benZodiaZepine particles comprise at least one member of the group consist ing of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, midaZolam, temaZepam and phar maceutically acceptable salts and combinations thereof.
In some embodiments, the nanoparticulate benZodiaZepine particles comprise at least one member of the group consisting of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, mida Zolam, temaZepam and pharmaceutically acceptable salts and combinations thereof.
In some embodiments, the nanoparticulate benZodiaZepine particles comprise at least one member of the group consisting of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, mida Zolam, temaZepam and pharmaceutically acceptable salts and combinations thereof.
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1007 Exhibit: Part 9 ¿¿¿ Pages 3201 3488 File History for Non Provisional Patent App...

Document IPR2019-00449, 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. 28, 2019...

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1029 Exhibit: O¿¿¿Dell et al, School nurses¿¿¿ experience with administration of recta...

Document IPR2019-00449, No. 1029-45 Exhibit - O¿¿¿Dell et al, School nurses¿¿¿ experience with administration of rectal diazepam gel for seizures, J Sch Nurs, June 2007, 233166 9 O¿¿¿Dell (P.T.A.B. Jan. 2...

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1006 Exhibit: Provisional Patent Application No 61570,110, filed December 13, 201...

Document IPR2019-00449, No. 1006-14 Exhibit - Provisional Patent Application No 61570,110, filed December 13, 2011 ¿¿¿110 Provisional (P.T.A.B. Jan. 28, 2019)

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1004 Exhibit: Part 5 ¿¿¿ Pages 1401 1750 File History for ¿¿¿546 Patent, Ser No 1349...

Document IPR2019-00449, No. 1004-9 Exhibit - Part 5 ¿¿¿ Pages 1401 1750 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH (P.T.A.B. Jan. 28, 2019)

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1004 Exhibit: Part 4 ¿¿¿ Pages 1051 1400 File History for ¿¿¿546 Patent, Ser No 1349...

Document IPR2019-00449, No. 1004-8 Exhibit - Part 4 ¿¿¿ Pages 1051 1400 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH (P.T.A.B. Jan. 28, 2019)

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1004 Exhibit: Part 7 ¿¿¿ Pages 2101 2450 File History for ¿¿¿546 Patent, Ser No 1349...

Document IPR2019-00449, No. 1004-11 Exhibit - Part 7 ¿¿¿ Pages 2101 2450 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH (P.T.A.B. Jan. 28, 2019)

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1007 Exhibit: Part 6 ¿¿¿ Pages 2001 2400 File History for Non Provisional Patent App...

Document IPR2019-00449, No. 1007-20 Exhibit - Part 6 ¿¿¿ Pages 2001 2400 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019...

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

Document IPR2019-00449, 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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1025 Exhibit: Lindhardt et al, Electroencephalographic effects and serum concentr...

Document IPR2019-00449, No. 1025-41 Exhibit - Lindhardt et al, Electroencephalographic effects and serum concentrations after intranasal and intravenous administration of diazepam to healthy voluntee...

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1007 Exhibit: Part 1 ¿¿¿ Pages 1 400 File History for Non Provisional Patent Applicat...

Document IPR2019-00449, No. 1007-15 Exhibit - Part 1 ¿¿¿ Pages 1 400 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019)

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