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`Us Patent and Trazzflfk O‘;;:(:_eU;"E)§’EPARTMENT OF COMMERCE
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`'“F°R"’"“'°“°'S°L°S”RE
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`14608644
`
`2015-01-29
`
`Art Unit
`
`1627
`
`| Jean—Louis Samira JM
`Examiner Name
`Attorney Docket Number
`PAT034678—US-CNT
`
`Examiner Cite
`|nitia|*
`No
`
`Patent Number
`
`Kind
`Codet Issue Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Co|umns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`U .S. PATENTS
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`Rem°‘-'9
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`U.S.PATENT APPLICATION PUBLICATIONS
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`Rem°Ve
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`Examiner Cite NO Publication
`|nitia|*
`Number
`
`Publication
`Kind
`Codet Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Co|umns,Lines where
`Relevant Passages or Relevant
`Figures Appear
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`FOREIGN PATENT DOCUMENTS
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`R9m°Ve
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`Examiner Cite Foreign Document
`|nitia|*
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`Publication
`Kind
`Code4 Date
`
`Name of Patentee or
`
`Applicant of cited
`Document
`
`Pages,Co|umns,Lines
`where Relevant
`
`Passages or Relevant
`Figures Appear
`
`WO9409010
`
`1994-04-28
`
`Sandoz—Erfindungen
`Verwaltungsgesellschaft
`MBH
`
`2022498
`
`2009-02-1 1
`
`Novartis AG
`
`EFS Web 2.1.17
`
`West-Ward Pharm.
`Exhibit 1056
`Page 001
`
`West-Ward Pharm.
`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
`
`Wayne Marks
`
`Art Unit
`
`1627
`
`Examiner Name
`
`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
`
`Add
`
`Examiner
`|nitia|s*
`
`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 lnterferon—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.orglwiki/
`Response_Evaluation_Criteria_ln_Solid_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
`
`West-Ward Pharm.
`Exhibit 1056
`
`West-Ward Pharm.
`Exhibit 1056
`Page 002
`
`

`

`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`14608644
`
`2015-01-29
`
`First Named Inventor
`
`Wayne Marks
`
`Art Unit
`
`1627
`
`Examiner Name
`
`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, Vo|.17 (2) , 2003
`
`Excerpt from the ATCC catalogue (HCT116) http:/lwww_lgestandards-atcc_orglProducts/All/CCL-247_aspx last
`accessed March 31, 2015
`
`Excerpt from the ATCC catalogue (A549) httpzl/www.lgestandards—atcc.org/ProductslAlI/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., “|ssues 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., “Everolimus for advanced pancreatic neuroendocrine tumors* The New England Journal of
`Medecine, Vol_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 Vol.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
`
`West-Ward Ph
`Exhibit 1
`Page
`
`West-Ward Pharm.
`Exhibit 1056
`Page 003
`
`

`

`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`14608644
`
`2015-01-29
`
`First Named Inventor
`
`Wayne Marks
`
`Art Unit
`
`1627
`
`Examiner Name
`
`Louis Samira JM
`
`Attorney Docket Number
`
`PAT034678-US-CNT
`
`21
`
`Von Wichert et al., “lnsulin-like Growth Factor-I 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
`EXAMINER SIGNATURE
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`2 Enter office that issued the document, by the tvvo-letter code (WIPO
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`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible.
`5 Applicant is to place a check mark here i
`English language translation is attached.
`
`EFS Web 2.1.17
`
`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
`
`Filing Date
`
`14608644
`
`2015-01-29
`
`First Named Inventor
`
`Wayne Marks
`
`Art Unit
`
`1627
`
`Examiner Name
`
`Louis Samira JM
`
`Attorney Docket Number
`
`PAT034678-US-CNT
`
`CERTIFICATION STATEMENT
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate se|ection(s):
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`That each item of information contained in the information disclosure statement was first cited in any communication
`D from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
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`That no item of information contained in the information disclosure statement was cited in a communication from a
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`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`See attached certification statement.
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`The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`A certification statement is not submitted herewith.
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`SIGNATURE
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`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
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`Signature
`
`Name/Print
`
`lGregory Ferrarol
`
`Gregory Ferraro
`
`Date (YYYY-M M-DD)
`
`2015-04-01
`
`Registration Number
`
`36134
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`VA 22313-1450.
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`EFS Web 2.1.17
`
`West-Ward Pharm.
`Exhibit 1056
`Page 005
`
`West-Ward Pharm.
`Exhibit 1056
`Page 005
`
`

`

`Privacy Act Statement
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`EFS Web 2.1.17
`
`West-Ward Pharm.
`Exhibit 1056
`Page 006
`
`West-Ward Pharm.
`Exhibit 1056
`Page 006
`
`