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`Under the Paperwork Reduction Act of 1995. no persons are required to respond to a collection of information unless it contains a valid OMB control number.
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`Application Number
`
`13034340
`
`Filing Date
`2011-02-24
`------------------------------------------------------T-------------------------------------------------------------------------------------------------------------------------------
`First Named Inventor
`Alan H. Auerbach
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`1621
`I San Ming H. Hui
`--------------------------------------------------------------------------------------------------------------- -~-~~~:~_:x __ ~-=-~~:-~---~-~-~:::~:_: _______ ___t __ ~-~-~-~-~~~-~-~-~~~-~----------------------------------------------------------------------------
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`Art Unit
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`Examiner Name
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`Examinerl Cite
`Initial*
`No
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`Patent Number
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`Kind
`Code·l 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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`U.S.PATENTS
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`1
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`Ill' you wish to add additional U.S. Patent citation information please click the Add button.
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`U.S.PATENT APPLICATION PUBLICATIONS
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`Publication
`Examinerl Ct N
`1 e 0 Number
`Initial*
`
`Kind Publication
`Code·l 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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`20060030608
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`A1
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`2006-02-09
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`Nelson. et al.
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`If you wish to add additional U.S. Published Application citation information please click the Add button.
`
`FOREIGN PATENT DOCUMENTS
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`Examine Cite Foreign Document
`No Nurnber3
`Initial*
`
`Country
`Code2i
`
`Kind Publication
`Code4 Date
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`Name of Patentee or
`Applicant of cited
`Document
`
`Pages, Columns, Lines
`where Relevant
`Passages or Relevant
`Figures Appear
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`TS
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`1
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`247890'1
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`EP
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`2012-07-25
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`Cougar Biotechnology,
`Inc.
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`2
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`200602'126(-3
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`wo
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`2006-03--16
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`Nitec Pharrna AG
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`D
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`D
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`If you wish to add additional Foreign Patent Document citation information please click the Add button
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`NON-PATENT LITERATURE DOCUMENTS
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`EFSWeb2.1.17
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1074, p. 1 of 5
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`

`

`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1 .99)
`
`Application Number
`
`13034340
`
`Filing Date
`2011-02-24
`First Named Inventor I Alan ~t Auerbach
`Art Unit
`1621
`
`Examiner Name
`Jsan Ming R. Hui
`-Att~~-~~;--c;~~-k~t----N~~-t;~~-------Tc8Rso-o1-usc_N_:ri·---------------------------------------------------------------------------
`
`Exarninerl Cite
`Initials*
`I No
`I
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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, syrnposiurn, catalog, etc), date, pages(s), volurne-issue nurnber(s),
`publisher, city andior country where published.
`
`1 Assessment Report for Zytiga (abiraterone) published 2011 by the CHMP of the EMA
`
`MJCHUS, r·LL, "The genetics, pathophysiology, and the management of human deficiencies of P450c17", Endocrinol
`Metab Clin North Am (2001 ), 30, p.1 o·l-119
`
`AYUB, M., "Inhibition of testicular '1la-hydroxylase and 1"1,20-lyase but not 38-hydroxysteroid dehydrogenase(cid:173)
`isomerase or 17B-hydroxysteroid oxidoreductase by ketoconazole and other imidazole drugs, Journal of Steroid
`Bioc~;emistry (1987) 28(5), p.521-531
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`Campbell-Walsh Urology, Ninth Edition, Saunders, VoL 3, Chapters 104 and ·1 05
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`1 1
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`2
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`3
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`4
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`Cecil Textbook of Medicine, Wyngaarden & Smith 18th edition; Chapter on "Giucocorticosteroid Therapy",
`Wyngaarden & Smith ·:8th edition, (1988) p.1n--:31
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`5
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`1
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`6
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`7
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`8
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`Cougar Biotechnoiogy Inc. with the U.S. Securities and Exchange Commission, Form 1 0-QSB
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`CZOCK, et al., "Pharmacokinetics and Pharmacodynamics of Systemically Administered Glucocorticoids",
`Pharmacokinet (2005), 44( 1 ), p.61-98
`
`ERGUN-LONmv11RE, Berrin, eta!., 'Two Novel Mutations Found in a Patient with 17a-Hydroxylase Enzyme
`Deficiency", The Journai of Ciinical Endocrinology & Metaboiism (2006), 91 ('1 0), p.41l9-4182
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`D
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`D
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`D
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`!
`! ·1 0
`I
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`! FRIEL, Patrick N., et al., "Suppression of adrenal function by low-dose prednisone: assessment with 24-hour urinary
`! steroid hormone profiles-A review of five cases", Alternative Medicine Review (2006), 11 (1)
`I
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`I
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`EFSWeb2.1.17
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1074, p. 2 of 5
`
`

`

`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1 .99)
`
`Application Nurnber
`
`13034340
`
`Filing Date
`2011-02-24
`First Narned Inventor I Alan ~t Auerbach
`Art Unit
`1621
`
`Examiner Narne
`Jsan Ming R. Hui
`-Att~~-~~;--c;~~-k~t----N~~-t;~~-------Tc8Rso-o1-usc_N_:ri·---------------------------------------------------------------------------
`
`Information concerning Zytiga (abiraterone acetate) frorn http://www.kornpendiurn.ch/prodlpnr/1183238/de?
`Platform=Desktop as of March 25, 2014
`
`Internet article: http://clinicaltrials.gov/ct2/show/study/NCT00485303?sec==X501
`
`12
`
`13
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`MOSTAGHEL, E.A.. "Abiraterone in the treatment of metastatic castration-resistant prostate cancer", Cancer
`Management f~es. (2014) G, p.39 .. 51
`
`14
`
`OSABA, D., et al., "Health-Heiated Quality of Life in Men with Metastatic Prostate Cancer Treated with Prednisone
`1 alone or Mitoxantrone and Prednisone", J. Clin. Oncol. (1999), 17(6), p.1654-1663
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`1 ·15
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`_____________________ __! ____________ _!_ ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ .;. __________ _
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`PETRYLAK, D.P., "New Paradigms for Advanced Prostate Cancer", Rev. Urol. (200"7), 9, Suppl. 2, S3-S"12
`
`16
`
`Prostate Cancer Principles and Practice, Taylor & Francis (2006) Chapter 93
`
`18
`
`f~EID, A., et al., "Annals of Oncology", Educational and Abstract Book of the ESMO Conference Lugano (ECLU).
`(2007), 18(Supplernent 9), ix173-ix174. Abstract 50PD
`
`19
`
`, REMINGTON, "The Science and Practice of Pharmacy, 20th Edition (2000), p."1363-"1370
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`RUNGE, Marschall S., et al., "Principles of Molecular ~v1edicine; Second edition; (2006) Hurnana Press Inc. ISBN:
`1-58829-202-9. pgs.365-376 and 482-484
`
`20
`
`SILLS, Irene N., et al., ''17a-hydroxylase deficiency in a genetic male and fernale sibling pair", Int. J. Gynaecol. Obstet.
`(1981). ·19, p.473-4l9
`
`21
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`0
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`EFSWeb2.1.17
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1074, p. 3 of 5
`
`

`

`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1 .99)
`
`Application Number
`
`13034340
`
`Filing Date
`2011-02-24
`First Narned Inventor I Alan ~t Auerbach
`Art Unit
`1621
`
`Examiner Name
`Jsan Ming R. Hui
`-Att~~-~~;--c;~~-k~t----N~~-t;~~-------Tc8Rso-o1-usc_N_:ri·---------------------------------------------------------------------------
`
`23
`
`TANNOCK., et al., "Docetaxel Plus Prednisone or ~v1itoxantrone Plus Prednisone for Advanced Prostate Cancer'',
`Journal of Urology (2005), 1 "13(2), p.456
`
`The reply of applicant (i.e. the Proprietor of herein opposed patent) dated June 4, 2013 in relation to the corresponding
`US2011/0144016A1 US proceedings.
`
`24
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`0
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`0
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`25 WANG, C., et al., "Hypertension due to 17a--Hydroxylase deficiency", Australian and New Zealand Journal of Medicine 0
`(1978), 8(3), p.295-299
`
`YANO, A., et al., "Giucocorticoids Suppress Tumor Angiogensis and In vivo Growth of Prostate Cancer Cells", Clin.
`1 Cancer Res., (2006) 12, 3003-3009
`~
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`1 26
`I
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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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`1 See Kind Codes of USPTO Patent Documents at WY'L''L~}~?EIQJ;}_~)_'y~ or MPEP 901.04. 2 Enter office that issued the document, by tile two-letter code (WI PO
`Standard ST.3). 3 For Japanese patent documents, tt1e indication of the year of the reign of the Ernpemr must precede the seriai number of the patent document
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`English IBn[JUa[Je translation is attached.
`
`EFSWeb2.1.17
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1074, p. 4 of 5
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`EFS Web 2.1. i7
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1074, p. 5 of 5
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