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`Filing Date
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`INFORMATION DISCLOSURE First Named Inventer|GANT, Thomas G.
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`STATEMENT BY APPLICANT
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`LOTZ, Wolfgang
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`ITO, etal
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`ANDOet al.
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`2001-04-24
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`FOSTER, Robert
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`2002-08-27
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`KEINANet al.
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`Application Number 12562671
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`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas CG.
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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` Pharmaceuticals, Inc. University of
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`Pennsylvania, University
`of Michigan
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`Auspex Pharmaceuticals,
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`Eutick, Malvin
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`Columbia University in
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`Application Number 12562671
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`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas CG.
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`STATEMENT BY APPLICANT
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`Include nameof the author (in CAPITAL LETTERS},title of the article (when appropriate), title of the item
`Examiner] Cite
`an
`(book, magazine, journal, 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.
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`[|
`Bauer, LA et. al.; Olnfluence of long-term infusions on lidocaine kinetics, Clin. Pharmacol. Ther. 1982, 433-7
`1
`
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`Ol
`Borgstrom, L_ et al.; Comparative Pharmacokinetics of Unlabeled and Deuterium-Labeled Terbutaline: Demonstration
`2
`of a Small Isotope Effect, J Pharm Sci, 1988, 77(11}, 952-4
`
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`[|
`Browne, T.R.; Chapter 2. Isotope Effect: Implications for Pharmaceutical Investigations, Pharm_Lib_1997_13
`3
`
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`Ol
`Browne, T.R. et al.; Pharmacokinetic Equivalence of Stable-lsotope-Labeled and Unlabeled Drugs. Phenobarbital in
`4
`Man, J Clin Pharmacol, 1982, 22, 309-315
`
`
`Ol
`Burm, AGLet al.; Pharmacokinetics of Lidocaine and bupivacaine and stable isotope-labeled analogs: a study in
`5
`healthy volunteers, Biopharmaceutics and Drug Disposition, 1988, 9, 85-95
`
`
`6
`
`7
`
`Elison, C et al.;Effect of Deuteration of N-CH$_{3}$ Group on Potency and Enzymatic N-Demethylation of Morphine,
`Science, 1961, 134(3485), 1078-9
`
`Farmer, PB, et al.;Synthesis, Metabolism, and Antitumor Activity of Deuterated Analogues of 1-{2-Choloroethyl)-3-
`cyclohexyl-1-nitrosourea, Journal of Medicinal Chemistry, 1978, Vol. 21, No. 6, 514-20
`
`Ol
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`Ol
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`Application Number 12562671
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`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas CG.
`
`
`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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`Fisher, MB, et al.;The complexities inherent in attempts to decrease drug clearance by blocking sites of CYP-mediated
`metabolism, Curr Opin Drug Discov Develop; 2006, 9(1), 101-9
`
`Foster, AB; Deuterium Isotope Effects in Stucies of Drug Metabolism, Trends in Pharmacological Sciences, Dec 1984,
`524-7
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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
`
`Lee, H et al.; Deuterium Magic Angle Spinning Studies of Substrates Bound to Cytochrome P450, Biochemistry 1999,
`38, 10808-16813
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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
`
`Nelson, SD et al.;The Use of Deuterium Isotope Effect to Probe the Active Site Properties, Mechanism of Cytochrome
`P450-catalyzed Reactions, and Mechanisms of Metabolically Dependent Toxicity, DRUG METABOLISM AND
`DISPOSITION 31:1481-1498, 2003
`
`Nelson, SD et al.; Primary and B-Secondary Deuterium Isotope Effects in N-Deethylation Reactions, Journal of
`Medicinal Chemistry, 1975, Vol. 18, No. 11
`
`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
`
`Toronto Research Chemicals, Inc.; Tetrabenazine-d7, http:/Avww.trc-canada.com/details. php? CatNumber=T284002
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`Application Number 12562671
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`| APX0125-201-US Environmental Mass Spectrometry, 1987, 14, 653-657 DaSilva, JN et al.; Synthesis of [11C]Tetrabenazine, a Vesicular Monoamine Uptake Inhibitor, for PET Imaging
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`Filing Date
`2009-09-18
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas CG.
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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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`Studies, Appl. Radiat. Isot. Vol. 44, No. 4, pp. 673-676, 1993
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`Kilbourn, MR et al.; Absolute Configuration of (+)-a-Dihydrotetrabenazine, an Active Metabolite of Tetrabenazine,
`CHIRALITY 9:59-62 (1997)
`
`Mehvar, R, et al. ;PHARMACOKINETICS OF TETRABENAZINE AND ITS MAJOR METABOLITE IN MAN AND RAT
`Bloavailability and Dose Dependency Studies, Drug Met Disp. 1987, 15(2), 250-255
`
`Paleacu, D et al.; Tetrabenazine Treatment in MovementDisorders, Clin Neuropharmacol 2004 °27:230—233
`
`Popp, FD et al.; Synthesis of potential antineoplastic agents XXVI: 1,3,4,6,7,11b-hexahydro-9, 10-dimethoxy-2H-benzo
`[aJ2-quinolizinone derivatives, Journal of Pharmaceutical Sciences, 1978, 67(6), 871-873
`
`Roberts, MS et al.; The Pharmacokinetics of Tetrabenazine and its Hydroxy Metabolite in Patients Treated for
`Involuntary Movement Disorders, Eur J Clin Pharmacol {1986) 29: 703-708
`
`Schwartz, DE et al.; Metabolic studies of tetrabenazine, a psychotropic drug in animals and manBiochemical
`Pharmacology, 1966, 15, 645-655
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`Zheng, G et al.; Vesicular Monoamine Transporter 2: Role as a Novel Target for Drug Development, The AAPS
`Journal 2006; 8 (4) Article 78
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`Baillie, Thomas; THE USE OF STABLE ISOTOPES IN PHARMACEUTICAL RESEARCH, Pharmacological Reviews,
`1981, 33(2), 81-132
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`Browne, Thomas; STABLE ISOTOPE TECHNIQUES IN EARLY DRUG DEVELOPMENT: AN ECONOMIC
`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
`CHROMATOGRAPHY/MASS SPECTROMETRY. CAFFEINE AND DEUTERATED ISOMERS, Biomedical and
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`Application Number 12562671
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`Paleacu et al., Tetrabenazine Treatment in Movement Disorders,Clin. Neuropharmacol., 2004, 27{5), 230-233.
` Dyck et al.; EFFECTS OF DEUTERIUM SUBSTITUTION ON THE CATABOLISM OF BETA-PHENETHYLAMINE: AN
`
`| APX0125-201-US
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` Attorney Docket Number
`
`Filing Date
`2009-09-18
`
`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas CG.
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`STATEMENT BY APPLICANT
`Art Uninit
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`Examiner Name
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`IN VIVO STUDY’, J. Neurochem., 1986, 46(2), 399-404
`
`Gouyette, Alain; USE OF DEUTERIUM-LABELLED ELLIPTINIUM AND ITS USE IN METABOLIC STUDIES,
`Biomedical and Environmental Mass Spectrometry, 1988, 15, 243-247
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`Haskins, N.J.; THE APPLICATION OF STABLE ISOTOPESIN BIOMEDICAL RESEARCH, Biomedical Mass
`Spectrometry, 1982, 9{7), 269-277
`
`Wolenet al.; THE APPLICATION OF STABLE ISOTOPES TO STUDIES OF DRUG BIOAVAILIBILITY AND
`BIOEQUIVALENCE, J. Clin. Pharmacol., 1986, 26, 419-424
`
`Tonn et al.; SIMULTANEOUS ANALYSIS OF DIPHENYLHYDRAMINE AND A STABLE ISOTOPE ANALOG (2H10)
`DIPHENYLHYDRAMINE USING CAPILLARY GAS CHROMATOGRAPHY WITH MASS SELECTIVE DETECTION IN
`BIOLOGICAL FLUIDS FROM CHRONICALLY INSTRUMENTED PREGNANT EWES, Biomedical Mass Spectrometry,
`1993, 22, 633-642
`
`Honma et al.; THE METABOLISM OF ROXATIDINE ACETATE HYDROCHLORIDE, Drug Metabolism and Disposition,
`1987, 15(4), 551-559
`
`Pieiaszek et al.; MORICIZINE BIOAVAILABILITY VIA SIMULTANEOUS, DUAL, STABLE ISOTOPE
`ADMINISTRATION: BICEQUIVALENCE IMPLICATIONS, J. Clin. Pharmacol., 1999, 39, 817-825
`
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`INFORMATION DISCLOSURE First Named Inventor|GANT, Thomas CG.
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