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`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`14161007
`2014-01-22
`Filing Date
`Frank Himmelsbach
`
`First Named Inventor
`
`
`Art Unit
`
`| 1629
`
`Examiner Name
`
`K. E. Weddington
`
`Attorney Docket Number
`
`| PO1-2051/US/3
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`7754481
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`2010-07-13
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`Eberhardtet al.
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`8865729
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`2014-10-21
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`Siegeretal.
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`8962636
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`2015-02-24
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`Pfrengle etal.
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`20040037883
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`Al
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`2004-02-26
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`Zhou etal.
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`2
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`20100033177
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`Al
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`2010-02-11
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`Ochi et al.
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`Application Number 14161007
`
`
`
`Filing Date 2014-01-22
`
`INFORMATION DISCLOSURE
`First Named Inventor|Frank Himmelsbach
`STATEMENT BY APPLICANT
`
`Art Unit | 1629
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`K. E. Weddington
`
`
`
` an
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` Attorney Docket Number
`
`| P01-2051/US/3
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`1989-11-23
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`Chugai Pharmaceutical
`Co Ltd
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`1999-08-05
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`Trustees Of Tufts
`University,
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`zoosca-g|Beeingegee
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`4
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`2009111200
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`2009-09-11
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`Merck & Co., Inc,
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`5
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`2011163206
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`2011-12-29
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`Twi Pharmaceuticals, Inc,
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`NON-PATENT LITERATURE DOCUMENTS
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`Include nameof the author (in CAPITAL LETTERS},title of the article (when appropriate), title of the item
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`(book, magazine, journal, serial, symposium, catalog, etc}, date, pages(s), volume-issue number(s),
`TS
`Initials
`No
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`:
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`publisher, city and/or country where published.
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`1
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`BAETTA,R.et al., "Pharmacology of Dipeptidyl Peptidase-4 Inhibitors." Drugs, 2011, Vol. 71, No. 11, Pgs. 1441-1467. [|
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` British Medical Journal, 2008, Vol. 337, Pgs. 812-815.
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`BLECH,et al, Drug Metabolism and Deposition, "The Metabolism and Disposition of the Oral Dipeptidyl Peptidase-4
`Inhibitor, Linagliptin, in Humans", 2009, Vol. 38, No. 4, p. 667-678.
`
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`CHEON, et al., Biochemical Pharmacology, "Inhibition of dipeptidy! IV by novel inhibitors with pyrazolidine scaffold",
`2005, Vol. 70, p. 22-29.
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`CROWE,E.et al., "Early identification and managementof chronic kidney disease: summary of NICE guidance."
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`Ol
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`4
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`Application Number 14161007
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`Filing Date 2014-01-22
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` Attorney Docket Number
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`| P01-2051/US/3 GREISCHEL, et al., Drug Metabolism and Deposition, "The Dipeptidyl Peptidase-4 Inhibitor Linagliptin Exhibits Time-Journal of Endocrinology and Metabolism, 2012, Vol. 16, Supplement 1, Pgs. $41-S46.
`
`
`INFORMATION DISCLOSURE
`First Named Inventor|Frank Himmelsbach
`STATEMENT BY APPLICANT
`
`Art Unit | 1629
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
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`K. E. Weddington
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`and Dpse-DependentLocalization in Kidney, Liver, and Intestine after Intravenous Dosing: Results from High
`Resolution Autoradiography in Rats", 2010, Vol. 38, No.9, p. 1443-1448.
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`GUGLIELMI, C. et al., "Latent autoimmune diabetesin the adults {_LADA)in Asia: from pathogenesis and epidemiology
`to therapy." Diabetes/Metabolism Research and Reviews, 2012, Vol. 28, Supplement 2, Pgs. 40-46.
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`HEISE, et al., Diabetes, Obesity and Metabolism, "Pharmacokinetics, pharmacokinetics and tolerability of mutilple oral
`doses oflinagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients", 2009, Vol. 11, No. 8, p.
`786-794.
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`HULL, R. et al., "Nephrotic syndromein adults." British Medical Journal, 2008, Vol. 336, Pgs. 1185-1190.
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`ISOMAA,B. et al., "Cardiovascular Morbidity and Mortality Associated With the Metabolic Syndrome." Diabetes Care,
`2001, Vol. 24, No. 4, Pgs. 683-689.
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`KLEIN, T. et al., "Linagliptin alleviates hepatic steatosis and inflammation in a mouse model of non-alcoholic
`steatohepatitis." Medical Molecular Morphology, 2014, Vol. 47, Pas. 137-149.
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`KONSTANTINOU, D. M. et al., "Pathophysiology-based novel pharmacotherapy for heart failure with preserved
`ejection fraction.” Pharmacology & Therapeutics, 2013, Vol. 140, No. 27, Pgs. 156-166.
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`LAKATOS, P. L. et al., "Elevated serum cipeptidyl peptidase IV (CD26, EC 3.4.14.5) activity in patients with primary
`biliary cirrhosis." Journal of Hepatol, 1999, Vol. 30, Pg. 740.
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`NAIK, R. et al., "Latent Autoimmune Diabetes in Adults." The Journal of Clinical Endocrinology and Metabolism, 2009,
`Vol. 94, No. 12, Pgs. 4635-4644.
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`National Program for Care Guidelines, "Type 2 Diabetes mellitus." 2002, First Edition, Pgs. 1-50.
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`POUDEL, RESHAM R., "Latent autoimmune diabetesof adults: From oral hypoglycemic agents to early insulin.” Indian
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`EFS Web 2.1.17
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`

`

`
`
`
`Application Number
`14161007
`
`
`Filing Date
`2014-01-22
`
`INFORMATION DISCLOSURE
`First Named Inventor|Frank Himmelsbach
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`Art Unit
`
`| 1629
`
`
`
`
`
`Examiner Name
`
`K. E. Weddington
`
`Attorney Docket Number
`
`| P01-2051/US/3
`
`STANDL, E. et al., "Diabetes and the Heart." Diabetes Guidelines (DDG), 2002, Pgs. 1-25.
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`TASKINEN, M.-R. et al., "Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2
`diabetes: a randomized, double-blind, placebo-controlled study." Diabetes, Obesity and Metabolism, 2011, Vol. 13,
`Pgs. 65-74.
`
`
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`WITTELES, R. M. et al., "Dipeptidyl Peptidase 4 Inhibition Increases Myocardial Glucose Uptake in Nonischemic
`Cardiomyopathy.” Journal of Cardiac Failure, 2012, Vol. 18, No. 10, Pgs. 804-809.
`
`YAMAGISHI, S. et al., "Pleiotropic Effects of Glucagon-like Peptide-1 (GLP-1)-Based Therapies on Vascular
`Complications in Diabetes." Current Pharmaceutical Design, 2012, Vol. 17, Pas. 4379-4385.
`
`ZHIMEI, Xiao et al., "Study progression of oral drugs for treatmentof type II diabetes." Drug Evaluation, 2004, Vol. 1,
`No. 2, Pgs. 138-143.
`
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`Application Number 14161007
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`
`
`Filing Date 2014-01-22
`
`Art Unit
`
`| 1629
`
`K. E. Weddington Attorney Docket Number
`
`
`
`
`| P01-2051/US/3
`
`INFORMATION DISCLOSURE
`First Named Inventor|Frank Himmelsbach
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