PTOISB/81 (O1-D9)
`Approved for use through 11/30.l20‘l 1. OMB 0651-0035
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Papenlvork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`POWER OF ATTORNEY
`OR
`REVOCATION OF POWER OF ATTORNEY
`WITH A NEW POXVNEDR OF ATTORNEY
`Examiner Name
`CHANGE OF CORRESPONDENCE ADDRESS Attorney Docket Number
`
`”"""'°""‘°" "“'""°'
`Filing Date
`F!""“ ”°'“""' "“°“'°'
`
`‘"544-44°
`August 24, 2007
`“'3” ” A”e’“*’°"
`Methods and Compositions for Treating Cance
`1628 - Confirmation No. 6850
`HUI, San Ming R.
`11 515_004_999
`
`I hereby revoke all previous powers of attomey given in the above-identified application.
`
`D A Power of Attorney is submitted herewith.
`OR
`
`I hereby appoint Practitioner(s) associated with the following Customer
`Number as mylour attomey(s) or agent(s) to prosecute the application
`identified above, and to transact all business in the United States Patent
`and Trademark Office connected therewith:
`OR
`
`B I hereby appoint Practitioner(s) named below as mylour attomey(s) or agent(s) to prosecute the application identified above, and
`to transact all business in the United States Patent and Trademark Office connected therewith:
`
`Practitioner(s) Name
`
`Registration Number
`
`Please recognize or change the correspondence address for the above—identified application to:
`
`The address associated with the above-mentioned Customer Number.
`OR
`
`B The address associated with Customer Number:
`OR
`
`Firm or
`Individual Name
`Address
`
`City
`
`Telephone
`I am the:
`
`E] Applicantllnventor.
`RO
`
`Assignee of record of the entire interest. See 37 CFR 3.71.
`Statement under 37 CFR 3. 73(b) (Form PTO/SB/96) submitted herewith or filed on
`SIGNATURE of Applicant or Assignee of Record
`
`Signature
`Name
`
`G,-‘fix;-,a
`Telephone
`Andrea Kamage, Esq.
`Asst. Secretary, Cougar Biotechnology, Inc./Johnson & Johnson
`NOTE: Signatures of all the inventors or assignees of record of the entire interest or their representative(s) are required. Submit multiple forms it more than one
`signature is required, see below*.
`
`(732) 524-3957
`
`forms are submitted.
`
`This collection of information is required by 37 CFR 1.31, 1.32 and 1.33. 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 1.11 and 1.14. This collection is estimated to take 3 minutes 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 andlor suggestions for reducing this burden. should be sent to the Chief Inforrnaticn 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.
`
`if you need assistance in completing the form, call’ 1-800-PTO-9199 and select option 2.
`
`WCK1031
`Page 1
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`WCK1031
`Page 1
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`

`
`PTOISBIQS (07-09)
`Approved for use through 071311201 2. 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 control number.
`
`STATEMENT UNDER 37 CFR 3.73§b)
`
`Applican-bipatent Owner: Cougar Biotechnology, Inc.
`Application No..’Patent No.2 111344.440
`Titled
`
`METHODS AND COMOSITIONS FOR TREATING CANCER
`
`Filed/Issue Date: AUQU5t 24. 2007
`
`Cougar Biotechnology, Inc.
`(Name of Assig nee}
`
`states that it is:
`
`, a
`
`Corporation
`{Type of Assignee, e.g., corporation. partnership, university, government agency, etc.
`
`the assignee of the entire right, title, and interest in;
`
`an assignee of less than the entire right, title, and interest in
`(The extent (by percentage) of its ownership interest is
`
`%); or
`
`the assignee of an undivided interest in the entirety of (a complete assignment from one of the joint inventors was made)
`
`the patent applicationlpatent identified above, by virtue of either:
`
`A. D An assignment from the inventor(s) of the patent applicationlpatent identified above. The assignment was recorded in
`the United States Patent and Trademark Office at Reel
`, Frame
`, or for which a
`copy therefore is attached.
`
`OR
`
`B.
`
`A chain of title from the inventor(s), of the patent application/patent identified above, to the current assignee as follows:
`
`1_ prom; Alan H. Auerbach and Arie S. Belldegrun
`
`T0; Cougar Biotechnology, Inc.
`
`The document was recorded in the United States Patent and Trademark Office at
`
`Reel 018339
`
`,
`
`Frame 0027
`
`,
`
`or for which a copy thereof is attached.
`
`2. From: Alan H. Auerbach
`
`To: Cougar Biotechnology, Inc.
`
`The document was recorded in the United States Patent and Trademark Office at
`
`Ree]
`
`Fl-ar-ne
`
`,
`
`or for which a copy thereof is attached.
`
`3_ From; Arie S. Bellclegmn
`
`To: Cougar Biotechnology, Inc.
`
`The document was recorded in the United States Patent and Trademark Office at
`
`Reel 020040
`
`,
`
`Frame 0690
`
`,
`
`or for which a copy thereof is attached.
`
`E Additional documents in the chain of title are listed on a supplemental sheet(s).
`
`As required by 37 CFR 3.73(b)(1)(i), the documentary evidence of the chain of title from the original owner to the assignee was,
`or concurrently is being, submitted for recordation pursuant to 37 CFR 3.11.
`
`[NOTE: A separate copy (r'.e., a true copy of the original assignment document(s)) must be submitted to Assignment Division in
`accordance with 37 CFR Part 3, to record the assignment in the records of the USPTO. E MPEP 302.08]
`
`The u?,r1ersigned (whose title is supplied below) is authorized to act on behalf of the assignee.
`LJ»l’\xC‘ir'bto'L
`
`Signature
`
`Andrea Kamage, Esq.
`
`aiaalrr
`
`Date
`
`Assistant Secretary
`
`Title
`Printed or Typed Name
`This collection of infonnation is required by 37 CFR 3.73(b). 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 1.11 and 1.14. This collection is estimated to take 12 minutes to complete, including
`gathering, preparing, and submitting the completed application fonn to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time
`you require to complete this form andlor suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office. U.S.
`Department of Commerce, PO. 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.
`
`ifyou need‘ assistance in completing the form, cal.‘ 1-800-PTO-9199 andselect option 2.
`
`VVCPKa1g0e3;
`
`WCK1031
`Page 2
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`

`
`Electronic Patent Application Fee Transmittal
`
`— F
`
`iling Date:
`
`Title of Invention:
`
`Methods and Compositions for Treating Cancer
`
`First Named Inventor/Applicant Name:
`
`Alan H. Auerbach
`
`Attorney Docket Number:
`
`CGR5001USCNT1
`
`Filed as Large Entity
`
`Utility under 35 USC111(a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD($)
`
`Claims:
`
`Independent claims in excess of3
`
`1201
`
`1
`
`220
`
`220
`
`Miscellaneous-Filing:
`
`WCK1031
`Page 3
`
`WCK1031
`Page 3
`
`

`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD($)
`
`Patent Appeals and Interference
`
`Post-AIIowance-and-Post-Issuance:
`
`Extenslon of-Tlme
`
`Miscellaneous.
`
`Total in USD ($)
`
`2142
`
`WCK1031
`Page 4
`
`WCK1031
`Page 4
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`

`
`Electronic Acknowledgement Receipt
`
`m—
`
`Title of Invention:
`
`Methods and Compositions for Treating Cancer
`
`I
`
`—
`
`Payment information:
`
`yes—
`Submitted with Payment
`
`—Auth°“zedUser
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`P36 5
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees)
`
`WCK1031
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
`
`WCK1031
`Page 5
`
`

`
`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
`File Listing:
`
`Document
`
`Information:
`
`.
`
`.
`
`File Size(Bytes)/
`
`Multi
`
`Pages
`
`Application Data Sheet
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`CGR5001USCNTAPPL|CAT|OND
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`1031200
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`0997e1bece1ad81a95897fd4e7556e09e91
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`1649829
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`ALLYF|LED.pdf
`
`9b0f93c22c6b033155e73cc04a189006792
`
`Multipart Description/PDF files in .zip description
`
`c044f69ffb40b471b2e4909aacd40d005591
`1ee1
`
`Assignee showing of ownership per 37
`CFR 3.73(b).
`
`b7bfddbc2b3dbba4b04935ef24ce3e0c691
`10307
`
`Fee Worksheet (PTO-875)
`
`fee-info.pdf
`
`2aa3ea7e51ac8b33a96fbf7bee79bde5f4d7
`589e
`
`Warnings:
`
`WCK1031
`Page 6
`
`WCK1031
`Page 6
`
`

`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`lfa timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`lfa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and ofthe International Filing Date (Form PCT/R0/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`WCK1031
`Page 7
`
`WCK1031
`Page 7
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`

`
`Electronic Acknowledgement Receipt
`
`m—
`
`Title of Invention:
`
`Methods and Compositions for Treating Cancer
`
`I
`
`—
`
`Payment information:
`
`yes—
`Submitted with Payment
`
`—Auth°“zedUser
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`P36 8
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees)
`
`WCK1031
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
`
`WCK1031
`Page 8
`
`

`
`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
`File Listing:
`
`Document
`
`Information:
`
`.
`
`.
`
`File Size(Bytes)/
`
`Multi
`
`Pages
`
`Application Data Sheet
`
`CGR5001USCNTAPPL|CAT|OND
`A_|_ASHEE_|_.pdf
`
`1031200
`
`0997e1bece1ad81a95897fd4e7556e09e91
`73a7b
`
`CGR5001USNPAPPLNASOR|G|N
`
`1649829
`
`ALLYF|LED.pdf
`
`9b0f93c22c6b033155e73cc04a189006792
`
`Multipart Description/PDF files in .zip description
`
`c044f69ffb40b471b2e4909aacd40d005591
`1ee1
`
`Assignee showing of ownership per 37
`CFR 3.73(b).
`
`b7bfddbc2b3dbba4b04935ef24ce3e0c691
`10307
`
`Fee Worksheet (PTO-875)
`
`fee-info.pdf
`
`2aa3ea7e51ac8b33a96fbf7bee79bde5f4d7
`589e
`
`Warnings:
`
`WCK1031
`Page 9
`
`WCK1031
`Page 9
`
`

`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`lfa timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`lfa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and ofthe International Filing Date (Form PCT/R0/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`WCK1031
`Page 10
`
`WCK1031
`Page 10
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`

`
`PTOISBI14 (11-OB)
`Approved for use through 09/30/2010. OMB 0651-0032
`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 contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`_
`_
`Application Number
`
`CGR5001USCNT1
`
`Title of Invention
`
`Methods and Compositions for Treating Cancer
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2
`
`|:| Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`Applicant Information:
`Applicant 1
`Applicant Authority @|nventor | OLegal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`Na"
`Residence Information (Select One) @ US Residency Q Non US Residency O Active US Military Service
`
`|OParty of Interest under 35 U.S.C. 118
`Family Name
`Suffix
`
`
`
`StateIProvince
`
`CA
`
`Country of Residencei
`
`US
`
`City
`
`Hermosa Beach
`
`Citizenship under 37 CFR 1.41(b) I
`
`US
`
`Mailing Address of Applicant:
`Address 1
`One Johnson 8. Johnson Plaza
`
`Address 2
`
`Applicant 2
`Applicant Authority @|nventor OLegal Representative under 35 U.S.C. 117
`Prefix Middle Name
`
`
`
`C)Party of Interest under 35 U.S.C. 118
`Family Name
`Suffix
`Be"de9wm
`Residence Information (Select One) @ US Residency O Non US Residency O Active US Military Service
`Los Angeles
`StateIProvince
`Country of Residence i
`S
`Citizenship under 37 CFR1.41(b)i
`
`Mailing Address of Applicant:
`One Johnson & Johnson Plaza
`Address 1
`
`
`
`Address 2
`
`
`
`Postal Code
`
`S*a*elPr°vl"ce
`US
`
`Inventor Information blocks may be
`Inventors Must Be Listed - Additional
`All
`generated within this form by selecting the Add button.
`
`Add
`
`Correspondence Information:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`
`For further information see 37 CFR 1.33(a). |:| An Address is being provided for the correspondence Information of this application.
`
`EFS Web 2.2.2
`
`WCK1031
`Page 11
`
`

`
`PTOISBI14 (11-OB)
`Approved for use through 09/30/2010. OMB 0651-0032
`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 contains a valid OMB control number.
`
`
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`Application Number
`
`CGR5001USCNT1
`
`Title of Invention
`
`Methods and Compositions for Treating Cancer
`
`
`
`|:|
`
`Customer Number
`
`27777
`
`Email Address
`
`jnjuspatent@corus.jnj.com
`
`Application Information:
`
`
`
`Title of the Invention
`Methods and Compositions for Treating Cancer
`Attorney Docket Number CGR5001USCNT1
`| Small Entity Status Claimed
`Nonprovisional
`Application Type
`Subject Matter
`Utility
`
` Suggested Technology Center (if any)
`Suggested Class (if any)
`Sub Class (if any)
`
`Total Number of Drawing Sheets (if any) - Suggested Figure for Publication (if any)
`
`
`Publication Information:
`
`
`
`|:| Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`Request N012 t0 Publish. I hereby request that the attached application not be published under 35 U.S.
`E] C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of
`an application filed in another country, or under a multilateral international agreement, that requires publication at
`eighteen months after filing.
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Enter
`either Customer Number
`or
`complete
`the
`Representative Name
`section
`below.
`If
`both
`are completed the Customer Number will be used for the Representative Information during processing.
`
`sections
`
`27777
`
`Please Select One:
`Customer Number
`
`@ Customer Number
`
`0 US Patent Practitioner 0 Limited Recognition (37 CFR 11.9)
`
`Domestic BenefitINational Stage Information:
`
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(0) or indicate National Stage
`entry from a PCT application. Providing this information in the application data sheet constitutes the specific reference required by
`35 U.S.C. 119(e) or 120, and 37 CFR 1.78(a)(2) or CFR 1.78(a)(4), and need not otherwise be made part of the specification.
`
`Prior Application Status
`
`Expired
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`non provisional of
`
`60/921506
`
`2006-08-25
`
`Prior Application Status
`
`Pending
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`Continuation of
`
`11/344440
`
`2007-08-24
`
`Wgalfgleofg
`
`EFS Web 2.2.2
`
`WCK1031
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`

`
`PTOISBI14 (11-08)
`Approved for use through 09/30/2010. OMB 0651-0032
`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 contains a valid OMB control number.
`
`
`
` Attorney Docket Number
`CGR5001USCNT1
`
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`
`
`Methods and Compositions for Treating Cancer
`
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`Title of Invention
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`Add
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`Foreign Priority Information:
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`This section allows for the applicant to claim benefit of foreign priority and to identify any prior foreign application for which priority is
`not claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U_S_C_ 119(b)
`and 37 CFR 1.55(a).
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`Assignee Information:
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`of the CFR to have an assignment recorded in the Office.
`
`Assi nee 1
`
`
`
`If the Assignee is an Organization check here.
`|:|
`Prefix Middle Name
`
`Family Name
`
`Mailing Address Information:
`
`Address 1
`
`Address 2
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`P“°"eN“mbe' —
`Email Address
`
`Additional Assignee Data may be generated within this form by selecting the Add
`button.
`
`Add
`
`Signature:
`
`A signature of the applicant or representative is required in accordance with 37 CFR 1.33 and 10.18. Please see 37
`CFR 1.4(d) for the form of the signature.
`
`
`
`/Andrea Jo Kamage] Date (YYYY-MM-DD)Signature 2011-02-24
`
`
`
`
`
`First Name
`
`Andrea Jo
`
`Last Name
`
`Kamage
`
`Registration Number
`
`43703
`
`EFS Web 2.2.2
`
`WCK1031
`Page 13
`
`WCK1031
`Page 13
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`

`
`PTOISBI14 (11-OB)
`Approved for use through 09/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Application Data Sheet 37 CFR 1.76
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`Aeemev eeeke Number
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`_
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`Aeeheeeee Nemeer T Title of Invention
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`Methods and Compositions for Treating Cancer
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`Attorney Docket No. 11515-004-999
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`METHODS AND COMPOSITIONS FOR TREATING CANCER
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`FIELD OF THE INVENTION
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`[0001]
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`Methods and compositions for treating cancer are described herein. More
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`particularly, the methods for treating cancer comprise administering a 17a-hydroxylase/C17,
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`20-lyase inhibitor, such as abiraterone acetate (i.e., 3[3—acetoxy—l 7—(3—pyridyl) androsta—5,
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`l6—diene), in combination with at least one additional therapeutic agent, such as an anti-
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`cancer agent or a steroid. Furthermore, disclosed are compositions comprising a l7ot-
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`hydroxylase/C17_20-lyase inhibitor, and at least one additional therapeutic agent such as an
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`anti—cancer agent or a steroid, e. g., a corticosteroid or, more specifically, a glucocorticoid.
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`BACKGROUND
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`[0002]
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`The number of people diagnosed with cancer has significantly increased. Of
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`special interest are individuals diagnosed with androgen-dependent disorders, such as
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`prostate cancer, and estrogen-dependent disorders, such as breast cancer since such
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`diagnoses are increasing in number at an alarming rate.
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`[0003]
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`Prostate cancer is currently the most common non—skin cancer and the
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`second leading cause of cancer-related death in men after lung cancer. The primary course
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`of treatment for patients diagnosed with organ—conf1ned prostate cancer is usually
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`prostatectomy or radiotherapy. Not only are these treatments highly invasive and have
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`undesirable side effects, such localized treatments are not effective on prostate cancer after
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`it has metastasized. Moreover, a large percent of individuals who receive localized
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`treatments will suffer from recurring cancer.
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`[0004]
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`Additionally, breast cancer incidence in women has increased from one out
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`of every 20 women in 1960 to one out of every eight women in 2005. Moreover, it is the
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`most common cancer among white and African-American women. Similar to treating
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`prostate cancer, most options for women diagnosed with breast cancer are highly invasive
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`and have significant side—effects. Such treatments include surgery, radiation and
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`chemotherapy.
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`[0005]
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`Hormone therapy is another treatment option for individuals diagnosed with
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`prostate or breast cancer. Hormone therapy is a form of systemic treatment for prostate or
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`breast cancer wherein hormone ablation agents are used to suppress the production or block
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`-1-
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`the effects of hormones, such as estrogen and progesterone in the body, which are believed
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`to promote the growth of breast cancer, as well as testosterone and dihydrotestosterone,
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`which are believed to promote the growth of prostate cancer. Moreover, hormone therapy is
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`less invasive than surgery and does not have many of the side effects associated with
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`chemotherapy or radiation. Hormone therapy can also be used by itself or in addition to
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`localized therapy and has shown to be effective in individuals whose cancer has
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`metastasized.
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`[0006]
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`Even though hormone therapy is less invasive and can be used on more
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`advanced stages of cancer, some individuals administered current hormone therapy
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`treatments may not show a significant response or may not show any response at all to such
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`treatments. Additionally, some patients treated with current hormone therapy treatments
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`may also suffer from relapsing or recurring cancer. Currently, such refractory cancer
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`patients are left with very few treatment options.
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`[0007]
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`Despite the progress made in the treatment of cancer, there remains a need
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`for more effective ways to treat cancer such as, but not limited to, prostate cancer and breast
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`cancer. Additionally, there is a need for effective anti—eaneer treatment options for patients
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`who are not responding to current anti-cancer treatments. Also, there is a need for effective
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`anti-cancer treatment options for patients whose cancer has recurred.
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`SUMMARY OF THE INVENTION
`
`[0008]
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`Described herein are methods for treating a cancer in which a therapeutically
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`effective amount of a 17a—hydroxylase/Cm, 20-lyase inhibitor, such as abiraterone acetate
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`(tie. 3[3-acetoxy—17—(3-pyridyl)androsta—5,l6—diene), is administered to a patient, e. g., a
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`patient in need thereof, in combination with a therapeutically effective amount of at least
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`one additional therapeutic agent including, but not limited to, an anti—cancer agent or
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`steroid. Such methods can also provide an effective treatment for individuals with a
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`refractory cancer, including individuals who are currently undergoing a cancer treatment.
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`Therefore, in certain embodiments, the method is directed to treating a refractory cancer in a
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`patient, in which a therapeutically effective amount of 17a-hydroxylase/C17, 20—lyase
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`inhibitor is administered to a patient currently receiving an anti—eancer agent.
`
`[0009]
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`For example, in certain embodiments, the method for the treatment of a
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`cancer in a mammal comprises administering an amount of about 0.01 mg/kg/day to about
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`100 mg/kg/day of abiraterone acetate and an amount of about 0.1 mg/m2 to about 20 mg/ml
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`of mitoxantrone.
`
`[0010]
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`In another embodiment, the method for the treatment of a cancer in a
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`mammal comprises administering an amount of about 0.01 mg/kg/day to about 100
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`mg/kg/day of abiraterone acetate and an amount of about 1 mg/ml to about l75 mg/m2 of
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`paclitaxel.
`
`[001 1]
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`In still other embodiments, the method for the treatment of a cancer in a
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`mammal comprises administering an amount of about 0.01 mg/kg/day to about I()()
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`mg/kg/day of abiraterone acetate and an amount of about 1 mg/ml to about 100 mg/ml of
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`docetaxel.
`
`[0012]
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`Furthermore, described herein is a method for the treatment of a cancer in a
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`mammal comprising administering an amount of about 0.01 mg/kg/day to about 100
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`mg/kg/day of abiraterone acetate; and an amount of about 0.01 mg to about 200 mg of
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`leuprolide, wherein the leuprolide is administered over a period of about 3 days to about l2
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`months.
`
`[0013]
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`In other embodiments, the method for the treatment of a cancer in a mammal
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`comprises administering an amount of about 0.01