PTO/SB/OSA (08-00)
`Approved for use through 10/31/2002. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB oontrol number.
`Application Number
`13/034,340
`Substitute for form 1449AIPTO
`Filing Date
`February 24, 2011
`Alan H. Auerbach
`First Named Inventor
`Group Art Unit
`1629
`Examiner Name
`San Ming R. Hui
`Attorney Docket Number
`CGR5001 USCNT1
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(use as many sheets as necessary)
`Sheet 1 of 2
`
`U.S. Patent Document
`
`US PATENT DOCUMENTS
`
`Examiner
`Initials
`
`Cite
`No. 1
`
`Number
`
`Kind Code
`(if known)
`
`Name of Patentee or Applicant
`of Cited Document
`
`Date of Publication
`of Cited Document
`mm-dd-yyyy
`
`Pages, Columns, Lines,
`where relevant passages or
`relevant figures appear
`
`Foreign Patent Document
`
`Examiner
`Initials
`
`Cite
`No. 1
`
`Office' Number4
`
`KindCode 5
`
`Name of Patentee or
`Applicant of Cited Document
`
`Date of Publication
`of Cited Document
`mm-dd-yyyy
`
`Pages, Columns, Lines,
`where relevant
`passages or relevant
`figures appear
`
`T'
`
`FOREIGN PATENT DOCUMENTS
`
`~~
`Considered
`Signature
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
`
`~ I
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`1 Unique citation designation number. 2 See attached Kinds of U.S. Patent Documents. 3 Enter Office that issued the document, by the two-letter
`code (WI PO Standard ST.3). 4 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial
`number of the patent document. s Kind of document by the appropriate symbols as indicated on the document under WI PO Standard ST. 16 if
`possible. s Applicant is to place a check mark here if English language Translation is attached.
`
`Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the needs of the individual case. Any
`comments on the amount of time you are required to complete this form should be sent to the Chief Information Officer, U.S. Patent and Trademark
`Office, Washington, DC 20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS,SEND TO: Commissioner for Patents, P.O. Box
`1450, Alexandria, VA 22313-1450
`
`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 1
`
`

`
`PTO/SB/OSA (08-00)
`Approved for use through 10/31/2002. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB oontrol number.
`Substitute for form 1449AIPTO
`Application Number
`13/034,340
`Filing Date
`February 24, 2011
`Alan H. Auerbach
`First Named Inventor
`Group Art Unit
`1629
`Examiner Name
`San Ming R. Hui
`Attorney Docket Number
`CGR5001 USCNT1
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(use as many sheets as necessary)
`Sheet 2 of 2
`
`Examiner's
`Initials*
`
`Cite
`No. 1
`
`T2
`
`OTHER PRIOR ART -NON PATENT LITERATURE DOCUMENTS
`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, page(s), volume-issue number(s),
`publisher, city and/or country where published
`Berry, W. et al. Phase III Study of Mitoxantrone Plus Low Dose Prednisone Versus Low
`Dose Prednisone Alone in Patients with Asymptomatic Hormone Refractory Prostate Cancer,
`The Journal ofUrology, 2002, pages 2439-2443, Volume 168.
`Chang, Ching-Yi, et al. Glucocorticoids Manifest Androgenic Activity in a Cell Derived from
`a Metastatic Prostate Cancer, Cancer Research, 2001, pages 8712-8717, Volume 61.
`Dorff, TB, Crawford, ED. Management and challenges of corticosteroid therapy in men with
`metastatic castrate-resistant prostate cancer, Annals of Oncology, 2013, pages 31-8, Volume
`24(1 ).
`Efstathiou, Eleni, et al. Effects of Abiraterone Acetate on Androgen Signaling in Castrate-
`Resistant Prostate Cancer in Bone, American Society of Clinical Oncology, Journal of
`Clinical Oncology, 2011, pages 1-8.
`Huggins, Charles, et al. Studies on Prostatic Cancer.!. The Effect of Castration, of Estrogen
`and of Androgen Injection on Serum Phosphatases in Metastatic Carcinoma of the Prostate,
`Cancer Research, 1941, pages 293-297, Volume 1.
`Mostaghel, EA. et al. Molecular Pathways: Targeting resistance in the androgen receptor for
`therapeutic benefit, Clin Cancer Res, 2013 Dec 4. [Epub ahead of print].
`Nishimura, Kazuo, et al. Potential Mechanism for the Effects of Dexamethasone on Growth
`of Androgen-Independent Prostate Cancer, Journal of the National Cancer Institute, 2001,
`pages 1739-1746, Volume 93.
`Oudar, Stephane, et al. Actualite dans le cancer de la prostate, Synthese, Bull Cancer 2005;
`92 (10), pgs. 865-873 (relevance in English abstract)
`Petrylak, et al. Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone
`for Advanced Refractory Prostate Cancer, The New England Journal of Medicine, 2004,
`pages 1513-20, Volume 351.
`Ryan, et al., Aberaterone Acetate in Metastatic Prostate Cancer Without Previous
`Chemotherapy, The New England Journal of Medicine, 2013, 368:138-148.
`Sartor, et al, Abiraterone Prolongs Survival in Metastatic Prostate Cancer, Nature Reviews
`Clinical Oncology, 2011, pages 515-16, Volume 8.
`Tannock, IF, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced
`prostate cancer, The New England Journal of Medicine, 2004, pages 1502-1512, Volume
`351(15).
`
`Examiner
`Date
`S1qnature
`Considered
`*EXAMINER: Initial if reference considered, whether or not citation is in confonnance with MPEP 609. Draw line through citation if not in conformance and not considered. Include copy of this fonn with
`next communication to applicant.
`
`I
`
`1 Unique citation designation number. 2 Applicant is to place a check mark here if English language Translation is attached.
`
`Burden Hour Statement: This form is estimated to take 2.0 hours to complete. lime will vary depending upon the needs of the individual case. Any comments on the amount of time you are required to
`complete this form should be sent to the Chief Information Officer, U. S. Patent and Trademark Office, Washington, DC 20231.
`DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 2
`
`

`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Confirmation Number
`Application Number
`Filing Date
`First Named Inventor
`Group Art Unit
`Examiner Name
`Attorney Docket Number
`
`1597
`13/034340
`February 24, 2011
`Alan H. Auerbach
`1629
`San Ming R. Hui
`CGR5001 USCNT1
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
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`CERTIFICATION STATEMENT
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`D
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`OR
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`D
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`That each item of information contained in the information disclosure statement was first cited in any
`communication 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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`Fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
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`Attached are copies of search report(s) from corresponding patent application(s), which are listed on
`the attached Submission Under MPEP 609.06.
`
`~ In accordance with §1.97(b), since this Information Disclosure Statement is being filed either within
`three months of the filing date of the above-identified national application (other than a continued
`prosecution application under §1.53(d)), within three months of the date of entry into the national
`stage of the above identified application as set forth in §1.491, or before the mailing date of a first
`Office Action on the merits of the above-identified application, or before the mailing date of a first
`Office Action after the filing of a request for continued examination under §1.114, no additional fee is
`required.
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`~ Please charge any deficiency or credit any overpayment to Deposit Account No. 10- 0750/
`CGR5001 USCNT1/TET.
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`D
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`None
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`SIGNATURE
`
`A signature of the applicant or representative is required in accordance with CFR 1.33, 1 0.18. Please see
`CFR 1.4(d) for the form of the signature.
`
`Date (YYYY-MM-DD)
`
`2014-01-10
`
`39,401
`
`Signature
`
`Name/Print
`
`/Timothy E. Tracy, Reg. No.
`39,401/
`Timothy E. Tracy
`Registration Number
`CERTIFICATE OF TRANSMISSION
`I hereby certify that this correspondence is being electronically filed via EFS-Web to the Commissioner
`for Patents with the U.S. Patent and Trademark Office on: January 14, 2014
`I
`I Name (prinUtype)
`I Denise Mattos-Bosque
`I Signature
`I
`I January 10, 2014
`I Date
`I !Denise Mattos-Bosque/
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public
`which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This
`collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed application form to the
`USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form
`and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S.
`Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 3