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1005 Exhibit: Provisional Patent Application No 61497,017, filed June 14, 2011 ¿¿¿017 Provisional

Document IPR2019-00450, No. 1005-13 Exhibit - Provisional Patent Application No 61497,017, filed June 14, 2011 ¿¿¿017 Provisional (P.T.A.B. Jan. 29, 2019)
... If Required, Foreign Filing License Granted: 06/27/2011 The country code and number of your priority application, to be used for filing abroad under the Paris Convention, is US 61/497,017 Projected Publication Date: None ...
... If Required, Foreign Filing License Granted: 06/27/2011 The country code and number of your priority application, to be used for filing abroad under the Paris Convention, is US 61/497,017 Projected Publication Date: None ...
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1007 Exhibit: Part 8 ¿¿¿ Pages 2801 3200 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH

Document IPR2019-00450, No. 1007-22 Exhibit - Part 8 ¿¿¿ Pages 2801 3200 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019...
Certified copies: a)LJ All b)[] Some** c)L] None ofthe: 1.) Certified copies of the priority documents have been received.
Thus, none of these Examples provides sufficient motivation or teaching for one of ordinary skill in the art to modify the teaching of Lehat to practice the claimed methods.
And none of the cited references provides the necessary motivation to modify the Sonne formulationsto arrive at the formulations recited in the instant claims.
... supporting such statement Statement Novelty (N) Inventive step (IS) Industrial applicability (IA) Claims Claims Claims Claims Claims Claims 2, 3, 6, 10-13, 17-26, 46-60 1, 4, 5, 7-9, 14-16, 27-45, and 61-65 NONE 1-65 1-65 NONE ...
Certified copies: a)LJ All b)[] Some** c)L] None ofthe: 1.) Certified copies of the priority documents have been received.
Compositions in which the oil phase comprises 1 to 35% Ov/w) ofvitamin E are neither disclosed nor suggested, 19 is Nonetheless, there is an unmet need for benzodiazepine {and especially midazolam) compositions that contain high ...
Certified copies: a)L] All b)[-] Some** c)L] None ofthe: 1..
Noneof the nose drop preparations consists of a benzodiazepine drug, one or more natural or synthetic tocopherols or tocotrienols, one or more alcohols or glycols, and an alkyl glycoside.
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1007 Exhibit: Part 6 ¿¿¿ Pages 2001 2400 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH

Document IPR2019-00450, 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. 29, 2019...
None ofthese references describe nanoparticulate compositions of olanzapine.
... ammonium compound, a secondary ammonium compound, a tertiary ammonium compound, and quarternary ammonium compounds ofthe formula NRRoRsRa”, For compoundsof the formula NR{RoR3Ry: (i) (i1) (iii) (iv) (v) (vi) none ...
However, none of these documents describe aerosols of a nanoparticulate benzodiazepine, such as lorazepam.
... compositions of nanoparticulate drugs include U.S. Pat. No. 6,153,225 for "Injectable Formulations of Nanoparticulate Naproxen," and U.S. Pat. Nos. 5,399,363 and 5,494,683, both for "Surface Modified Anticancer Nanoparticles." None ...
... 934® (Union Carbide)), polyoxyethylene stearates, colloidal silicon dioxide, phosphates, carboxymethylcellulose calcium, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, nonerystalline ...
... WO 2006/088894 PCT/US2006/005224 ammonium compound,a tertiary ammonium compound, and quarternary ammonium compounds of the formula NRIR2R3R4(+), For compoundsof the formula NRIR2R3R4(+): (i) {it) (iii) (iv) (v} none ...
... polyethylene glycols, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, carboxymethylcellulose calcium, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, bypromellose phthalate, nonerystalline ...
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1022 Exhibit: Liversidge et al, US Patent Application Publication No US 200601988...

Document IPR2019-00450, No. 1022-38 Exhibit - Liversidge et al, US Patent Application Publication No US 20060198896, Serial No 11354,249, published September 7, 2006 Liversidge (P.T.A.B. Jan. 29, ...

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1039 Exhibit: Behl et al, Effects of physicochemical properties and other factors on...

Document IPR2019-00450, No. 1039-55 Exhibit - Behl et al, Effects of physicochemical properties and other factors on systemic nasal drug delivery, Advanced Drug Delivery Reviews 29 1998 89¿¿¿116 Beh...

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1025 Exhibit: Lindhardt et al, Electroencephalographic effects and serum concentr...

Document IPR2019-00450, 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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1002 Exhibit: Part 2 Pages 271 530 File History for ¿¿¿876 Patent, Ser No 14527,613...

Document IPR2019-00450, No. 1002-3 Exhibit - Part 2 Pages 271 530 File History for ¿¿¿876 Patent, Ser No 14527,613 ¿¿¿876 FH (P.T.A.B. Jan. 29, 2019)

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1027 Exhibit: Illum, Nasal drug delivery possibilities, problems and solutions, Journ...

Document IPR2019-00450, No. 1027-43 Exhibit - Illum, Nasal drug delivery possibilities, problems and solutions, Journal of Controlled Release 87 2003 187 198 Illum (P.T.A.B. Jan. 29, 2019)

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1018 Exhibit: Tenta, US Patent No 3,949,072, Topical Composition for Treatment o...

Document IPR2019-00450, No. 1018-34 Exhibit - Tenta, US Patent No 3,949,072, Topical Composition for Treatment of Seborrheic Keratosis, issued April 6, 1976 Tenta (P.T.A.B. Jan. 29, 2019)

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1040 Exhibit: Part 3 ¿¿¿ Pages 501 662 File History for EP 128 013729, based on WO...

Document IPR2019-00450, No. 1040-58 Exhibit - Part 3 ¿¿¿ Pages 501 662 File History for EP 128 013729, based on WO 2012174158 and PCTUS2012042311 (P.T.A.B. Jan. 29, 2019)

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1023 Exhibit: Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36 Bioavaila...

Document IPR2019-00450, No. 1023-39 Exhibit - Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36 Bioavailability and Bioequivalence, Drug Intelligence Publications, Illinois, 1992 Ritschel (P.T.A...

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1024 Exhibit: Osborne et al, Skin Penetration Enhancers Cited in the Technical Lite...

Document IPR2019-00450, No. 1024-40 Exhibit - Osborne et al, Skin Penetration Enhancers Cited in the Technical Literature, Pharmaceutical Technology, November 1997 Osborne (P.T.A.B. Jan. 29, 201...

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1040 Exhibit: Part 1 Pages 1 250 File History for EP 128 013729, based on WO 201...

Document IPR2019-00450, 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. 29, 2019)

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1020 Exhibit: Meezan et al, US Patent No 5,661,130, Absorption Enhancers For Dr...

Document IPR2019-00450, No. 1020-36 Exhibit - Meezan et al, US Patent No 5,661,130, Absorption Enhancers For Drug Administration, issued August 26, 1997 Meezan¿¿¿130 (P.T.A.B. Jan. 29, 2019)

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1046 Exhibit: Provisional Patent Application No 61040,281, Pharmaceutical Solutio...

Document IPR2019-00450, No. 1046-64 Exhibit - Provisional Patent Application No 61040,281, Pharmaceutical Solutions and Method for Solubilizing Therapeutics Agents, filed March 28, 2008, Gwozdz, G...

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