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`Application Number 14608644
`Filing Date
`2015-01-29
`
`| Jean-Louis Samira JM
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`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`1627
`Art Unit
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`( Not for submission under 37 CFR 1.99)
`Examiner Name
`Attorney Docket Number
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`PAT034678-US-CNT
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`U.S.PATENTS
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`FOREIGN PATENT DOCUMENTS
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`Examiner Cite|Foreign Document Kind|Publication Nameof Patenteeor
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`where Relevant
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`Initial* No|Number? Code‘4| Date Applicantofcited
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`Passages or Relevant
`Document
`Figures Appear
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`Sandoz-Erfindungen
`Verwaltungsgesellschaft
`MBH
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`1
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`wos40s010
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`1994-04-28
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`2022498
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`2009-02-11
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`Novartis AG
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`EFS Web 2.1.17
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`West-Ward Pharm.
`Exhibit 1056
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`West-Ward Pharm.
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`Application Number
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`14608644
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`2015-01-29
`Filing Date
`Wayne Marks
`First Named Inventor
`1627
`Art Unit
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Examiner Name
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`Jean-
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`Louis Samira JM
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`Attorney Docket Number
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`PAT034678-US-CNT
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`If you wish to add additional Foreign Patent Documentcitation information please click the Add button
`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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`Examiner] Cite
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`“ey
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
`Initials
`No
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`publisher, city and/or country where published.
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`Hofsli et al., Molecular and Cellar Endocrinology, 2002, Vol.194, 165-173 “ Expression of chromogranin A and
`1
`somatostatin receptors in pancreatic AR42J cells”
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`Dorland’sillustrated Medical Dictionnary,32nd Ed., p955, 2011
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`Excerpt of the Merck Index for Everolimus P/18, section 3950, Merck Index, 15th edition, 2013
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`Hanin etal. “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
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`Oberg, “Guidelines for the Managementof Gastroenteropancreatic Neuroendocrine Tumors(including
`5
`Bronchopulmonray and Thymic Neoplasms)’ Acta Oncologica, Vol 7, 2004
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`Excerpt from Wikipedia “Response Evaluation Criteria in Solid Tumors” available at http://de.wikipedia.org/wiki/
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`Response_Evaluation_Criteria_In_Solid_Tumors last accessed March 21, 2015
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`Oberg, Kjell et al., “Guidelines for the Management of Gastroenteropancreatic Neuroendocrine Tumors(including
`Bronchopulmonary and Thymic Neoplasms) Part Il” Acta Oncologica, Vol 43, 2004
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`Tabernero et al., “ A phase Study with Tumor molecular pharmacodynamics (MPD) evaluation of dose and schedule of
`the oral mTOR-inhibitor Everolimus (RADOO1) in patients (pts) with advanced solid tumors” Journal of Clinical
`Oncology Vol.23, 2005
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`Vignot et al., “MTORtargeted therapy of cancer with rapamycin derivatives” Annals of Oncology, Vol.16, 22 Feb 2005
`pp525-537
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`EFS Web 2.1.17
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`West-Ward Pharm.
`Exhibit 1056
`Page 002
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`West-Ward Pharm.
`Exhibit 1056
`Page 002
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`Application Number
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`14608644
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`2015-01-29
`Filing Date
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`First Named Inventor Wayne Marks
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`Art Unit 1627
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
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`Jean-Louis Samira JM
`
`Attorney Docket Number
`
`PAT034678-US-CNT
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`O
`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.17 (2) , 2003
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`Excerpt from the ATCC catalogue (HCT116) http:/Avww_igestandards-atcc.org/Products/AI/CCL-247 aspx last
`accessed March 31, 2015
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`LE]
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`Excerpt from the ATCC catalogue (A549) http:/Avww.igestandards-atcc.org/Products/All/CCL-185.aspx.geo_country-
`de last accessed March 31, 2015
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`Excerpt from the databaseclinicaltrials.gov Efficacy and Safety of Everolimus (RADO01} Compared to Placeboin
`Patients V Neuroendocrine Tumors (Radiant-3) January 4, 2015
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`13
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`Dancey, Janet et al., “Issues and progress with Protein Kinase inhibitors for Cancer Treatment” Nature: Reviews Drug
`Discovery, Vol.2, 2003
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`Yao et al., “Phase II Study of RADOO1 (everolimus)} and depot octreotide (Sandostatin LAR)in patients with advanced
`low grade neuroendocrine carcinoma {LGNET) Journal of Clinical Oncology, Vol.24, No18S, 2006
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`16
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`Excerpt of the Merck Inex for Everolimus, section 3907, Merck Index, 14th edition, 2005
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`17
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`Yao, James C.et al., “Everolimus for advanced pancreatic neuroendocrine tumors” The New England Journal of
`Medecine, Vol.364, 2011 pp514-523
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`Oberg, K “Treatment of Neuroendocrine Tumours of the Gastrointestinal tract” Oncologia, Vol.27, No4, 2004
`18
`LE]
`pp185-189
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`19
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`Rosewiecz et al., “An Amphicrine pancreatic cell line -AR42J cells combine exocrine and neuroendocrine properties” O
`European Journal of Cell Biology vol.59, pp80-91, 1992
`
`Ohnishi et al., “Conversion of Amylase-secreting Rat pancreatic AR42J Cells to Neuronlike Cells by Activin A” Journal O
`20
`of Clinical Investigation, The American Society for Clinical Investigations, Vol.95, May 1995 pp2304-2314
`
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`EFS Web 2.1.17
`
`West-Ward Pharm.
`Exhibit 1056
`Page 003
`
`West-Ward Pharm.
`Exhibit 1056
`Page 003
`
`

`

`
`
`Application Number
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`14608644
`
`2015-01-29
`Filing Date
`
`First Named Inventor Wayne Marks
`
`Art Unit 1627
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`
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` *EXAMINER: Initial if reference considered, whetheror notcitation is in conformance with MPEP 609. Draw line through a
` m4
`(2004-10-13), pages 4762-4771, XP055093883, ISSN: 0732-183X, DOI: 10.1200/JCO.2004.04.024
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`Jean-Louis Samira JM
`
`Attorney Docket Number
`
`PAT034678-US-CNT
`
`
`
`Von Wichert et al., “Insulin-like Growth Factor-l is an Autocrine Regulator of Chromogranin A Secretion and Growth in O
`Human Neuroendocrine Tumor Cells”, Cancer Research, Vol.60, pp4573-4581 15 Aug 2000
`
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`22
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`Evers et al., “The Human Carcinoid Cell Line , BON a Model System for the Study of Carcinoid Tumors”, Annals of
`New York Academy Sciences, Vol.733, pp393-406, 1992
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`O
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`23
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`Dutcher Janice P., “Mammalian Target of Rapamyicin Inhibition”, Clinical Cancer Research, Vol.10, pp6382s-6387s,
`2004
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`24
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`Creweet 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
`
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`5 Shahet al., “ FRAP-p70s6k Signaling is Required for Pancreatic Cancer Cell Proliferation”, Journal of Surgical
`Research, Vol.97, pp123-130, 2001
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`26
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`Novartis Press Release on Pivotal PhaseIII trial of Novartis drug Afinitor®, June 2010
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`Guidance for Industry _ Information Program on Clinical Trials for Serious Diseases and Conditions
`US Dptof 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
`
`2f
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`28
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`EFS Web 2.1.17
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`West-Ward Pharm.
`Exhibit 1056
`Page 004
`
`West-Ward Pharm.
`Exhibit 1056
`Page 004
`
`

`

`
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`Application Number
`
`14608644
`
`2015-01-29
`Filing Date
`
`First Named Inventor
`Wayne Marks
`
`
`
`Art Unit 1627
`
`Examiner Name
`
`Jean-Louis Samira JM
`
`Attorney Docket Number
`
`PAT034678-US-CNT
`
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`EFS Web 2.1.17
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`West-Ward Pharm.
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`EFS Web 2.1.17
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`West-Ward Pharm.
`Exhibit 1056
`Page 006
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`West-Ward Pharm.
`Exhibit 1056
`Page 006
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