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`Application Number
`12562621
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`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
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`STATEMENT BY APPLICANT
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`2830993
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`BROSSI, A
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`LOTZ, Wolfgang
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`2001-04-24
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`FOSTER, Robert
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`2002-08-27
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`KEINANetal.
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 1
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 1
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`Application Number 12562621
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`
`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE
`
`First Named Inventor|GANT, Thomas G.
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`20100113496
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`GANT, ThomasG. et al
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`WILLIS, Gregory
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`7
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`20120003330
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`Al
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`GANT, ThomasG. et al
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`1
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`199526325
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`1995-10-05
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`Isotechnika, Inc.
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`{i
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 2
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 2
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`Application Number 12562621
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`
`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
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`STATEMENT BY APPLICANT
`Art Uninit
`| 1614
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`( Not for submission under 37 CFR 1.99)
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`Examiner Name
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`Attorney Docket Number
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`| APX0125-201-US
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`2007130365
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`=o
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`aaiO
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`2007-11-15
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`University of
`Pennsylvania, University
`of Michigan
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`2008058261
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`=S
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`=
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`2008-05-15
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`Neurocrine Biosciences,
`Inc
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`2005077946
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`=5
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`=
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`2005-08-25
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`Cambridge Laboratories
`Limited
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`2
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`2009124357
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`2010018408
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`=oO
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`>
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`2010-04-22
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`Auspex Pharmaceuticals,
`Inc.
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`2010-06-17
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`Auspex Pharmaceuticals,
`Inc.
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`2011-02-17
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`Biovail Laboratories
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`International
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`2009-10-15
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`Eutick, Malvin
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`2010-02-18
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`Biovail Laboratories
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`International
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`Columbia University in
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`the City of New York
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`11
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`2009003226
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`=S
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`=
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`2009-01-08
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`Clarencew PTY LTD
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`Prestwick
`=o
`aBo
`2006-05-18
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`12|2006053067 Pharmaceuticals, Inc.
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`/R.D./
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 3
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 3
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`

`

`
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`Application Number 12562621
`
`
`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
`
`
`STATEMENT BY APPLICANT
`Art Uninit
`| 1614
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`( Not for submission under 37 CFR 1.99)
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`Examiner Name
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`| APX0125-201-US
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`Examiner] Cite
`ew
`(book, magazine, joumal, serial, symposium, catalog, etc}, date, pages(s), volume-issue number(s),
`TS
`Initials
`No
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`publisher, city and/or country where published.
`
`1
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`Browne, T.R.; Chapter 2. Isotope Effect: Implications for Pharmaceutical Investigations, Pharm_Lib_1997_13
`E]
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`O
`Browne, T.R. et al; Pharmacokinetic Equivalence of Stable-Isotope-Labeled and Unlabeled Drugs. Phenobarbitalin
`4
`Man, J Clin Pharmacol, 1982, 22, 309-315
`
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`Ol
`Burm, AGLet al.; Pharmacokinetics of Lidocaine and bupivacaine and stable isotope-labeled analogs: a study in
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`healthy volunteers, Biopharmaceutics and Drug Disposition, 1988, 9, 85-95
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`Elison, C et al.;Effect of Deuteration of N-CH$_{3}$ Group on Potency and Enzymatic N-Demethylation of Morphine, O
`Science, 1961, 134(3485), 1078-9
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`Farmer, PB,et al Synthesis, Metabolism, and Antitumor Activity of Deuterated Analogues of 1-{2-Choloroethyl}3-
`cyclohexyl-1-nitrosourea, Joumal of Medicinal Chemistry, 1978, Vol. 21, No. 6, 514-20
`
`Ol
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`EFS Web 2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/R.D./
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 4
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 4
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`

`

`Application Number 12562621
`
`
`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
`
`
`STATEMENT BY APPLICANT
`Art Uninit
`| 1614
`
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`Attorney Docket Number
`
`| APX0125-201-US
`
`Fisher, MB,et al.;The complexities inherent in attempts to decrease drug clearance by blocking sites of CYP-mediated Ol
`metabolism, Curr Opin Drug Discov Develop: 2006, 9(1), 101-9
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`Helfenbein, J et al.; Isotopic Effect Study of Propofol Deuteration on the Metabolism, Activity, and Toxicity of the
`Anesthetic, J. Med. Chem. 2002, 45, 5806-5808
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`Kushner, DJ et al.; Pharmacological uses and perspectives of heavy water and deuterated compounds, Can J Phys
`Pharm 1999, 77, 79-88
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`Lee, H et al.; Deuterium Magic Angle Spinning Stucies of Substrates Bound to Cytochrome P4530, Biochemistry 1999,
`38, 10808-10813
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`Mamada, K et al.; Pharmacokinetic Equivalence of Deuterium-Labeled and Unlabeled Phenytoin, Drug Metabolism
`and Disposition, 1986, 14{4), 509-11
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`Nelson, SD et al.; Primary and B-Secondary Deuterium Isotope Effects in N-Deethylation Reactions, Journal of
`Medicinal Chemistry, 1975, Vol. 18, No. 11
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`Pohl, LR et al.; Determination of toxic Pathways of Metabolism by Deuterium Substitution,
`Drug_Metabolism_Rev_1985_ 1335
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`Rampe,D et al.; Deuterated Analogs of verapamil and nifedipine. Synthesis and biological activity, Eur J Med Chem
`(1993) 28,259-263
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`Toronto Research Chemicals, Inc.; Tetrabenazine-d7, http:/Avww.irc-canada.com/details.php?CatNumber=T284002
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`Cy
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 5
`
`

`

`
`
`
`Application Number
`12562621
`
`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
`
`
`STATEMENTBY APPLICANT |,
`[tera
`
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`Attorney Docket Number
`
`| APX0125-201-US
`
`
`
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`
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`
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`19
`
`DaSilva, JN et al.; Synthesis of [11C]Tetrabenazine, a Vesicular Monoamine Uptake Inhibitor, for PET Imaging
`Studies, Appl. Radiat. Isot. Vol. 44, No. 4, pp. 673-676, 1993
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`0 Kilbourn, MRet al.; Absolute Configuration of (+}-a-Dihydrotetrabenazine, an Active Metabolite of Tetrabenazine,
`CHIRALITY 9:59-62 (1997)
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`Bloavailability and Dose Dependency Studies, Drug Met Disp. 1987, 15(2), 250-255
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`Paleacu, D et al.; Tetrabenazine Treatment in Movement Disorders, Clin Neuropharmacol 2004°27:230-233
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`23
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`Popp, FDet al.; Synthesis of potential antineoplastic agents XXVI: 1,3,4,6,7,11b-hexahydro-9, 10-dimethoxy-2H-benzo Ol
`[a]2-quinolizinone derivatives, Journal of Pharmaceutical Sciences, 1978, 67(6), 871-873
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`4 Roberts, MS et al.; The Pharmacokinetics of Tetrabenazine and its Hycroxy Metabolite in Patients Treated for
`Involuntary Movement Disorders, Eur J Clin Pharmacol {1986) 29: 703-768
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`Schwartz, DE et al.; Metabolic stucies of tetrabenazine, a psychotropic drug in animals and manBiochemical
`Pharmacology, 1966, 15, 645-655
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`6 Zheng, G et al.; Vesicular Monoamine Transporter 2: Role as a Novel Target for Drug Development, The AAPS
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`1981, 33(2), 81-132
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`EVALUATION, J. Clin. Pharmacol., 1998, 38, 213-220
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`Cherrah et al; STUDY OF DEUTERIUM ISOTOPE EFFECTS ON PROTEIN BINDING BY GAS
`CHRGMATOGRAPHY/MASS SPECTROMETRY. CAFFEINE AND DEUTERATED ISOMERS, Biomedical and
`Environmental Mass Spectrometry, 1987, 14, 653-657
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`Cy
`
`
`
`|
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/R.D./
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 6
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 6
`
`

`

`
`
`Application Number 12562621
`
`
`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
`
`
`STATEMENT BY APPLICANT
`Art Uninit
`| 1614
`
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`Attorney Docket Number
`
`| APX0125-201-US
`
`Dyck et al.; EFFECTS OF DEUTERIUM SUBSTITUTION ON THE CATABOLISM OF BETA-PHENETHYLAMINE: AN Ol
`IN VIVO STUDY", J. Neurochem., 1986, 46(2)}, 399-404
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`Gouyette, Alain; USE OF DEUTERIUM-LABELLED ELLIPTINIUM AND ITS USE IN METABOLIC STUDIES,
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`Haskins, N.J.; THE APPLICATION OF STABLE ISOTOPESIN BIOMEDICAL RESEARCH, Biomedical Mass
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`Wolenet al.; THE APPLICATION OF STABLE ISOTOPES TO STUDIES GF DRUG BIOAVAILIBILITY AND
`BIOEQUIVALENCE,J. Clin. Pharmacol., 1986, 26, 419-424
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`37
`
`Paleacu et al.,Tetrabenazine Treatment in Movement Disorders ,Clin. Neuropharmacol., 2064, 27(5), 230-233.
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 7
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`

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`Application Number 12562621
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`
`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
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`STATEMENT BY APPLICANT
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
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`EFS Web 2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/R.D./
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 9
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 9
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`

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`PTO/SB/08a (01-10)
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`Approved for use through 07/31/2012. OMB 0651-0031
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`Application Number
`12562621
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`Filing Date
`2009-09-18
`
`INFORMATION DISCLOSURE
`First Named Inventor|GANT, Thomas G.
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Examiner Name
`
`DESAI, RITA J
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`RD! 2008-05-29|Rigel Pharmaceuticals1 2008064274 Wo Al |
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`AAD/ 2006-07-27|Rigel Pharmaceuticals|2 2006078846 ie) Al CI
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 10
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 10
`
`

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`Ol
`Gant et al, Benzoquinoline Inhibitors of Vesicular Monoamine Transporter 7, Auspex Pharmaceuticals, Inc_,
`1
`(RD
`W0O2010044981 International Preliminary Report on Patentability, Publication Date: 4/22/2010.
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`O
`Gantet al., Benzoquinoline Inhibitors of VMAT2, Auspex Pharmaceuticals, Inc., WO 2011106246 International
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`Preliminary Report on Patentability, Publication Date: 9/1/2611.
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`RDS|4 Gantet al., Benzoquinoline Inhibitors of Vesicular Monoamine Transporter 2, Auspex Pharmaceuticals,Inc., O
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`EP2009820972 - Prosecution History, Downloaded 10/3/2012.
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`Gant et al, Benzoquinoline Inhibitors of Vesicular Monoamine Transporter 7, Auspex Pharmaceuticals, Inc., N7591614 Ol
`15
`- Office Action, Publication Date: 2011-07-21.
`iR.D
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`RD 6
`aes
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`Application Number 12562621
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`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
`
`
`STATEMENT BY APPLICANT
`Art Uni
`wo
`nit
`| 1625
`
`( Not for submission under 37 CFR 1.99)
`Examiner Name
`
`DESAI, RITA J
`
`| APX0125-201-US
`
` Attorney Docket Number
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 11
`
`

`

`Filing Date
`2009-09-18
`
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas G.
`
`
`STATEMENT BY APPLICANT
`Art Uni
`wo
`nit
`| 1625
`
`( Not for submission under 37 CFR 1.99)
`Examiner Name
`
`DESAI, RITA J
`
`| APX0125-201-US
`
` Attorney Docket Number
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`
`
`Application Number 12562621
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`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 12
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 12
`
`

`

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`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
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`EFS Web 2.1.17
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 13
`
`Auspex Exhibit 2025
`Apotex v. Auspex
`IPR2021-01507
`Page 13
`
`