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PTO/SBI08a (O·I-10)
`Doc code: IDS
`Approved for use through OI/31i20·I2. OMB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Fiied
`U.S. Patent and Trademark Office: U.S. DEP/\fHMENT OF COMMEHCE
`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.
`
`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
`
`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
`
`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
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`1
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`Ill' you wish to add additional U.S. Published Application citation information please click the Add button.
`
`FOREIGN PATENT DOCUMENTS
`
`Examine Cite Foreign Document
`No Nurnber3
`Initial*
`
`Country
`Code2i
`
`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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`TS
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`1
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`2
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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
`
`MYLAN PHARMS. INC. EXHIBIT 1076 PAGE 1
`
`

`
`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 ~t Auerbach
`Art Unit
`1621
`
`Jsan Ming R. Hui
`Examiner Name
`-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.
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`2
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`3
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`4
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`Sahu, B., et al., "FoxA1 Specifies Unique Androgen and Glucocotiicoid Receptor Binding Events in Prostate Cancer
`Celis", Cancer Research (2013), Vol. 73, pg. 1570--1580
`
`D
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`Storlie, ,l.A., et al., "Prostate Specific Antigen Levels and Clinical t~esponse to Low Dose Dexamethasone for
`Hormone-Refractory ~v1etastatic Prostate Carcinoma", Cancer (1995) VoL 76, No. 1, pg. 96-·1 00
`
`Tanagho, E.A., et al., "The Leading Single-Volume Resource in Urology", Smith's General Urology, 16th Edition,
`(2004), Chapter ·19, pgs. 321··323; Chapter 22, pgs. 380-385
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`D
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`D
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`5
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`Tomic, H., et aL, "Hormonal Effects of High Dose Medroxyprogesterone Acetate Treatment in Males with Renal or
`1 Prostatic Adenocarcinoma", (1 988), VoL 22 (1 ), Abstract
`-----------------------+------------L------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------·------------
`
`0
`
`Venkitararnan, R., et al., "Efficacy of Low-Dose Dexamethasone in Castration-Refractory Prostate Cancer", BJU lnt
`(2008), 1 01, pgs 1756-1764
`
`Vogelzang, N.J., Curriculum Vitae, 15 pages
`
`Yano, A., et al., "Giucocorticoids Suppress Tumor Lymphangiogenesis of Prostate Cancer Cells", Clin Cancer Res
`(2006), Vol. ·12, pgs. 6012-6017
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`D
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`D
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`D
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`6
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`7
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`8
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`EFSWeb2.1.17
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`MYLAN PHARMS. INC. EXHIBIT 1076 PAGE 2
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`

`
`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
`
`Jsan Ming R. Hui
`Examiner Narne
`-Att~~-~~;--c;~~-k~t----N~~-t;~~-------Tc8Rso-o1-usc_N_:ri----------------------------------------------------------------------------
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`12
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`13
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`14
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`1 15
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`D
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`D
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`c=J
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`c=J
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`c=J
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`21
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`EFSWeb2.1.17
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`D
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`D
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`MYLAN PHARMS. INC. EXHIBIT 1076 PAGE 3
`
`

`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1 .99)
`
`Application Number
`
`13034340
`
`2011-02-24
`Filing Date
`First Narned Inventor I Alan ~t Auerbach
`Art Unit
`1621
`
`Jsan Ming R. Hui
`Examiner Name
`-Att~~-~~;--c;~~-k~t----N~~-t;~~-------Tc8Rso-o1-usc_N_:ri----------------------------------------------------------------------------
`
`23
`
`24
`
`25
`
`D
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`D
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`D
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`If you wish to add additional non-patent literature document citation information please click the Add button
`
`Examiner Signature I
`
`EXAMINER SIGNATURE
`
`I Date Considered
`
`*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
`
`1 See Kind Codes of USPTO Patent Documents at Wl'f_'i'-L~L~?f'IQJ;}_~l'i 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
`4 Kind of document by the ilppropriate syn1bols as indicated on the document under WI PO Standard ST.16 if possible 5 App!icant is to p!ace a check mark here i
`English l;m[JUa[Je translation is attached.
`
`EFSWeb2.1.17
`
`MYLAN PHARMS. INC. EXHIBIT 1076 PAGE 4
`
`

`
`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 ~t Auerbach
`Art Unit
`1621
`
`Examiner Name
`Jsan Ming R. Hui
`-Att~~-~~;--c;~~-k~t----N~~-t;~~-------Tc8Rso-o1-usc_N_:ri·---------------------------------------------------------------------------
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`CERTIFICATION STATEMENT
`
`That each item of information contained in the information disclosure staternent 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 ).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no itern 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).
`
`0
`
`D See attached certification statement.
`~ The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`D A certification statement is not submitted herewith.
`
`SIGNATURE
`A signature of the applicant or representative is required in accordance with CFR 1 .~n, 10. ·18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature
`
`Name/Print
`
`/Timothy E. Tracy, Heg. No. 39,401/
`
`Date (YYYY -~,t1rv1-DD)
`
`20 14--05··30
`
`Timothy E. Tracy
`
`Registration Number
`
`39,401
`
`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.
`
`EFSWeb2.1.17
`
`MYLAN PHARMS. INC. EXHIBIT 1076 PAGE 5
`
`

`
`Privacy Act Statement
`
`The Privacy Act of 197 4 (P .L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent Accordingly, pursuant to the requirements of the Act, please be advised
`that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2): (2) furnishing of the information solicited
`is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to
`process and/or examine your submission related to a patent application or patent. If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether the Freedom of Information Act requires disclosure of these record s.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance from the
`Member with respect to the subject matter of the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
`may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant
`to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or
`his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to ~~5 U.S.C. 151. Further, a record
`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in
`an application which became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
`
`9.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`EFS Web 2.1. i7
`
`MYLAN PHARMS. INC. EXHIBIT 1076 PAGE 6

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