Doc code: IDS
`Doc description: Information Disclosure Statement (IDS) Filed
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`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`13034340
`
`2011-02-24
`Filing Date
`First Named Inventor I ALAN H. AUERBACH
`1629
`Art Unit
`I San Ming R. Hui
`CGR5001 USCNT1
`Attorney Docket Number
`
`Examiner Name
`
`U.S.PATENTS
`
`Examiner Cite
`Initial*
`No
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`Patent Number
`
`Kind
`Code1
`
`Issue Date
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`Name of Patentee or Applicant
`of cited Document
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`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
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`1
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`U.S.PATENT APPLICATION PUBLICATIONS
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`Examiner
`Initial*
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`Cite No
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`Publication
`Number
`
`Kind Publication
`Code1 Date
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`Name of Patentee or Applicant
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`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
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`1
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`FOREIGN PATENT DOCUMENTS
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`Examiner Cite Foreign Document
`No Number3
`Initial*
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`Country
`Code2i
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`Kind Publication
`Code4 Date
`
`Name of Patentee or
`Applicant of cited
`Document
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`Pages, Columns, Lines
`where Relevant
`Passages or Relevant
`Figures Appear
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`1
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`NON-PATENT LITERATURE DOCUMENTS
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`Examiner Cite
`Initials* No
`
`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.
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`T5
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`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 1
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`

`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`13034340
`
`2011-02-24
`Filing Date
`First Named Inventor I ALAN H. AUERBACH
`1629
`Art Unit
`I San Ming R. Hui
`CGR5001 USCNT1
`Attorney Docket Number
`
`Examiner Name
`
`1
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`ASCO CANCER FOUNDATION, Poster Session F: Hormone Refractory, ASCO, 2005, -,-
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`D
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`D
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`BRUNO ET AL, Targeting cytochrome P450 enzymes: A new approach in anti-cancer drug development, Elsevier,
`2007, pages 5047-5060, vol. 15
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`CANNELL, 1 Oath Annual Meeting of the American Association for Cancer Research, Los Angeles, CA, USA;, http://
`oncology.thelancet.com, 2007, pp 471, Volume 8
`
`D
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`Collins, et al. "A Systematic Review of the effectiveness of Docetaxel and Mitoxantrone for the Treatement of
`Metastatic Hormone-Refractory Prostate Cancer", British J. of Cancer, 95, pp 457-462 (2006)
`
`D
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology Announces Initiation of Phase 1/11 Trial for CB7630 (Arbiraterone D
`
`Acetate), Cougar Biotechnology, 12-14-2004, -,-
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at
`AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Cougar Biotechnology, D
`10-2007, -, -
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at
`ESMO Conference, Drugs.com, 7-2007, -,-
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`D
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology announces presentation of positive phase I and phase II data at D
`ASCO Prostate Cancer Symposium, Cougar Biotechnology, 02-23-2007, -,-
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology presents CB7630 Phase I clinical data at the 2005 Prostate
`Cancer Symposium, AIIBusiness, 2005, -, -
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`10
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology presents positive CB7630 Clinical Data at AACR Annual
`Meeting Late-Breaking Clinical Trials Session, Cougar Biotechnology, 04-17-2007, -,-
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`11
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`COUGAR BIOTECHNOLOGY, Cougar Technology Announces Presentation of Positive CB7630 Clinical Data at
`ASCO Annual Meeting, The Free Library, 06-04-2007, -,-
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`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 2
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`

`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`13034340
`
`2011-02-24
`Filing Date
`First Named Inventor I ALAN H. AUERBACH
`1629
`Art Unit
`I San Ming R. Hui
`CGR5001 USCNT1
`Attorney Docket Number
`
`Examiner Name
`
`12
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`13
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`DE BONO ET AL, Inhibition of CYP450c17 by abiraterone administered once daily to castrate patients with prostate
`cancer resistant to LHRH analogues, anti-androgens and steriod therapy is well tolerated ... , The institute of Cancer
`Research, 2007, -,-
`
`DE COSTER, ET AL., Effects of High-Dose Ketoconazole and Dexamethason on ACTH-Stimulated Adrenal
`Steriodogenesis in Orchiectomized Prostatic Cancer Patients, Acta Endocrinologica (Copen h), 1987, pp 265-271,
`Volume 115
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`14
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`DUC ET AL, In Vitro and in vivo models for the evaluation of potent inhibitors of male rat 17 -hydroxylase/C-Iyase,
`Pergamon, 2003, pages 537-542, vol. 84
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`15
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`ENDOCRINOLOGY, Inhibition of Androgen Synthesis in Human Testicular and Prostatic Microsomes and in Male Rats D
`by Novel Steroidal Compounds, Endocrinology, 1999, pages 2891-2897, vol. 140 No.6
`
`16
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`FOSSA, ET AL., Weekly Docetaxel and Prednisone Versus Prednisolone Alone in Androgen-Independent Prostate
`Cancer: A Randomized Phase II Study, European Urology, 2007, pp 1691-1699, Volume 52
`
`D
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`17
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`GERBER, ET AL., Prostate Specific Antigen for Assessing Response to Ketoconazole and Prednisone in Patients with D
`Hormone Refractory Metastatic Prostate Cancer, The Journal of Urology, 1990, pp 1177-1179, Volume 144, Number 5
`
`18
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`HAKKI ET AL, CYP17- and CYP11 B-dependent steriod hydroxylases as drug development targets, Elsevier, 2006,
`pages 27-52, vol. 11
`
`19
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`HARRIS, ET AL., Low Dose Ketoconazole with Replacement Doses of Hydrocortisone in Patients with Progressive
`Androgen Independent Prostate Cancer, The Journal of Urology, 2002, pp 542-545, Volume 168
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`20
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`MOREIRA ET AL, Synthesis and evaluation of novel17-indazole androstene derivatives designed as CYP17
`inhibitors, Elsevier, 2007, pages 939-948, vol. 72
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`D
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`D
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`21
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`NEWELL ET AL, The Cancer Research UK experience of pre-clinical toxicology studies to support early clinical trials D
`with novel cancer therapies, Elsevier, 2004, pages 899-906, vol. 40
`
`22
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`PETRYLAK, ET AL., Future Directions in the Treatment of Androgen-Independent Prostate Cancer, Urology, 2005, pp D
`8-13, Volume 65, Supplement 6A
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`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 3
`
`

`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`13034340
`
`2011-02-24
`Filing Date
`First Named Inventor I ALAN H. AUERBACH
`1629
`Art Unit
`I San Ming R. Hui
`CGR5001 USCNT1
`Attorney Docket Number
`
`Examiner Name
`
`23
`
`SCHOLZ, ET AL., Long-Term Outcome for Men with Androgen Independent Prostate Cancer Treated with
`Ketoconazole and Hydrocortisone, The Journal of Urology, 2005, pp 1947-1952, Volume 173
`
`24
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`SMALL ET AL, The Case for Secondary Hormaonal Therapies in the Chemotherapy Age, The Journal of Urology,
`2006, pages S66- S71, vol. 176
`
`25 WIKIPEDIA, Corticosteriod, undated, website
`
`26
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`If you wish to add additional non-patent literature document citation information please click the Add button
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`EXAMINER SIGNATURE
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`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered. Include copy of this form with next communication to applicant.
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`I Date Considered
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`1 See Kind Codes of USPTO Patent Documents at 'N'N'N ... V.Sf'IQJ~.QYor MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WI PO
`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 WI PO Standard ST.16 if possible. 5 Applicant is to place a check mark here
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`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 4