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`U_S_ Patent and Tragzggfk Oc;;:(:.eUl:lE,%EPARTMENT OF COMMERCE
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`14608644
`
`2015-01-29
`
`First Named Inventor
`
`Peter Wayne Marks
`
`Jean-Louis Samira JM
`Attorney Docket Number
`PAT034678-US-CNT
`
`U.S.PATENTS
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`U.S.PATENT APPLICATION PUBLICATIONS
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`FOREIGN PATENT DOCUMENTS
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`Publication
`Date
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`Name of Patentee or
`Applicant of cited
`Document
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`Pages,Co|umns,Lines
`where Relevant
`Passages or Relevant
`.
`Figures Appear
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`WO9409010
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`1994-04-28
`
`Sandoz-Erfindungen
`Verwaltungsgesellschaft
`MB H
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`2022498
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`2009-02-1 1
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`Novartis AG
`
`EFS Web 2.1.17
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`Par Pharm., Inc.
`Exhibit 1056
`Page 001
`
`
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`14608644
`
`2015-01-29
`
`First Named Inventor
`
`Peter Wayne Marks
`
`Art Unit
`
`Examiner Name
`
`| Jean-Louis Samira JM
`Attorney Docket Number
`PAT034678—US-CNT
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`NON-PATENT LITERATURE DOCUMENTS
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`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
`publisher, city and/or country where published.
`
`Hofsli et al., Molecular and Cellar Endocrinology, 2002, Vol.194, 165-173 “ Expression of chromogranin A and
`somatostatin receptors in pancreatic AR42J cells"
`
`Dor|and’s illustrated Medical Dictionnary,32nd Ed., p955, 2011
`
`Excerpt of the Merck Index for Everolimus P718, section 3950, Merck Index, 15th edition, 2013
`
`Hanin et al. “Effect of Interferon-a Treatment on Octreoide uptake in CA20948 tumors: A small animal PET study” The
`journal of Nuclear Medecine, 2011,52, N°4 pp580-585
`
`Oberg, “Guidelines for the Management of Gastroenteropancreatic Neuroendocrine Tumors (including
`Bronchopulmonray and Thymic Neoplasms)" Acta Oncologica, Vol 7, 2004
`
`Excerpt from Wikipedia “Response Evaluation Criteria in Solid Tumors” available at http:/lde.wikipedia.org/wikil
`Response_Eva|uation_Criteria_|n_So|id_Tumors last accessed March 21, 2015
`
`Oberg, Kjell et al., “Guidelines for the Management of Gastroenteropancreatic Neuroendocrine Tumors (including
`Bronchopulmonary and Thymic Neoplasms) Part II'' Acta Oncologica, Vol 43, 2004
`
`Tabernero et al., " A phase Study with Tumor molecular pharmacodynamics (MPD) evaluation of dose and schedule of
`the oral mTOR-inhibitor Everolimus (RAD001) in patients (pts) with advanced solid tumors" Journal of Clinical
`Oncology Vol.23, 2005
`
`Vignot et al., “mTOR targeted therapy of cancer with rapamycin derivatives” Annals of Oncology, Vol.16, 22 Feb 2005
`pp525-537
`
`EFS Web 2.1.17
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`Par Pharm., Inc.
`Exhibit 1056
`Page 002
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`
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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`(Not for submission under 37 CFR1.99)
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`Application Number
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`Filing Date
`First Named Inventor
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`Art Unit
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`14608644
`
`2015-01-29
`
`Peter Wayne Marks
`
`Examiner Name
`
`| Jean-Louis Samira JM
`Attorney Docket Number
`PAT034678—US-CNT
`
`Suzuki et al.: “Monitoring of response to radiation therapy for human tumor xenografts using 99mTc—HL91 (4,9-
`diaza-3,3,10,10-tetramethyldodecan-2,11-dione dioxime)” Annals of Nuclear Medecine, Vol.1? (2) , 2003
`
`Excerpt from the ATCC catalogue (HCT116) http:/lwww.lgestandards-atcc.org/Products/All/CCL-247.aspx last
`accessed March 31, 2015
`
`Excerpt from the ATCC catalogue (A549) http://wvvw.lgestandards—atcc.org/Products/AlI/CCL—185.aspx.geo_country—
`de last accessed March 31, 2015
`
`Excerpt from the database clinical tria|s.gov Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in
`Patients V Neuroendocrine Tumors (Radiant—3) January 4, 2015
`
`Dancey, Janet et al., “lssues and progress with Protein Kinase inhibitors for Cancer Treatment” Nature: Reviews Drug
`Discovery, Vol.2, 2003
`
`Yao et al., “Phase II Study of RAD001 (everolimus) and depot octreotide (Sandostatin LAR) in patients with advanced
`low grade neuroendocrine carcinoma (LGNET) Journal of Clinical Oncology, Vol.24, No18S, 2006
`
`Excerpt of the Merck lnex for Everolimus, section 3907, Merck Index, 14th edition, 2005
`
`Yao, James C. et al., “Evero|imus for advanced pancreatic neuroendocrine tumors* The New England Journal of
`Medecine, Vo|.364, 2011 pp514—523
`
`Oberg, K “Treatment of Neuroendocrine Tumours of the Gastrointestinal tract" Oncologia, Vol.27, N04, 2004
`pp185—189
`
`Rosewiecz et al., “An Amphicrine pancreatic cell line :AR42J cells combine exocrine and neuroendocrine properties"
`European Journal of Cell Biology vo|.59, pp80—91, 1992
`
`Ohnishi et al., “Conversion of Amylase-secreting Rat pancreatic AR42J Cells to Neuronlike Cells by Activin A" Journal
`of Clinical Investigation, The American Society for Clinical Investigations, Vol.95, May 1995 pp2304-2314
`
`EFS Web 2.1.17
`
`Par Pharm., Inc.
`Exhibit 1056
`Page 003
`
`
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR1.99)
`
`Application Number
`
`Filing Date
`
`14608644
`
`2015-01-29
`
`First Named Inventor
`
`Peter Wayne Marks
`
`Art Unit
`
`| Jean—Louis Samira JM
`Examiner Name
`Attorney Docket Number
`PAT034678—US-CNT
`
`Von Wichert et al., “|nsu|in—|ike Growth Factor—| is an Autocrine Regulator of Chromogranin A Secretion and Growth in
`Human Neuroendocrine Tumor Cells’’, Cancer Research, Vol.60, pp4573-4581 15 Aug 2000
`
`Evers et al., “The Human Carcinoid Cell Line , BON a Model System for the Study of Carcinoid Tumors”, Annals of
`New York Academy Sciences, Vo|.733, pp393—406, 1992
`
`Dutcher Janice P., “Mammalian Target of Rapamyicin Inhibition”, Clinical Cancer Research, Vol.10, pp6382s—6387s,
`2004
`
`Crewe et al, “Regulation of Cell Growth and Cyclin D1 Expression by the Constitutievly Active FRAP-p70s6k Pathway
`in Human Pancreatic Cancer Cells”, Cancer Research, Vol.59, pp3581—3587, 1 August 1999
`
`Shah et al., “ FRAP—p70s6k Signaling is Required for Pancreatic Cancer Cell Proliferation”, Journal of Surgical
`Research, Vol.97, pp123-130, 2001
`
`Novartis Press Release on Pivotal Phase III trial of Novartis drug Afinitor®, June 2010
`
`Guidance for Industry _ Information Program on Clinical Trials for Serious Diseases and Conditions
`US Dpt of Health nad Human Services FDA March 2002
`
`— M. A. Kouvaraki: "Fluorouracil, Doxorubicin, and Streptozocin in the Treatment of Patients With Locally Advanced
`and Metastatic Pancreatic Endocrine Carcinomas", Journal of Clinical Oncology, vol. 22, no. 23, 13 October 2004
`(2004-10-13), pages 4762-4771, XP055093883, ISSN: 0732-183X, DOI: 10.1200/JCO.2004.04.024
`
`If you wish to add additional non-patent literature document citation information please click the Add button Add
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`EFS Web 2.1.17
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`Par Pharm., Inc.
`Exhibit 1056
`Page 004
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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`(Not for submission under 37 CFR1.99)
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`Application Number
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`Filing Date
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`14608644
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`2015-01-29
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`First Named Inventor
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`Peter Wayne Marks
`
`Art Unit
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`| Jean-Louis Samira JM
`Examiner Name
`Attorney Docket Number
`PAT034678-US-CNT
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`2015-04-01
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`36134
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`Par Pharm., Inc.
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`Par Pharm., Inc.
`Exhibit 1056
`Page 006