`
`I hereby certify that this correspondence is being transmitted via The Office
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`Electronic Filing System (EFS) in accordance with 37 CFR l.6(a)(4).
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`Signature: /I.nurie A. Phillips/ Name: Laurie A. Phillips
`
`Date of Ijlcctronic (El-‘ S) Transmission:
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`December 21 201 1
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`App1i¢}int(s3§'
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`'2 A153’Hi'}3;Iiéit5éié1iW”
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`"CioinffNo§: I
`
`ii
`
`FilingiDatc:
`:Title:
`
`I
`
`WiiExamincri:
`A
`I
`I _iHFcbruary 24, 201
`in Methods and Compositionsufor :1‘reating Cancer
`
`SaniMing
`H A
`
`I
`
`I
`
`A
`
`I
`
`Mail Stop Amcndmcnt
`Commissioner for Patents
`
`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`RESPONSE TO RESTRICTION REQUIREMENT
`
`Dear Sir:
`
`The Office has issued a two-way restriction rcquircmcnt rclating to the present
`
`invention. Applicants hereby elect the invention of Group 1, represented by newly
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`prcscntcd claims 37 et seq. This election is made without travcrsc.
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`Page 1 of6
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`ARGENTUM EX1038
`ARGENTUM EX1038
`Page 1
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`Page 1
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`
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`Docket No.: CGR500 l USCNTI
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`Listing of Claims:
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`1-36. (Canceled).
`
`37". (New) A method for the treatment of a prostate cancer in a human comprising
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`administering to said human a therapeutically effective amount of abiraterone acetate or a
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`pharmaceutically acceptable salt
`
`thereof and a therapeutically effective amount of
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`prcdnisonc.
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`38. (New) The method of claim 37, wherein the therapeutically effective amount of the
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`abiraterone acetate or pharmaceutically acceptable salt thereof is from about 50 mg/day
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`to about 2000 mg/day.
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`39. (New) The method of claim 38, wherein the therapeutically effective amount of the
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`abiraterone acetate or pharmaceutically acceptable salt thereof is from about 500 mg/day
`
`to about I500 mg/day.
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`40. (New) The method of claim 39, wherein the therapeutically effective amount of the
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`abiraterone acetate or pharmaceutically acceptable salt thereof is about 1000 mg/day.
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`4]. (New) The method of claim 3?‘, wherein the therapeutically effective amount of the
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`abiraterone acetate or a pharmaceutically acceptable salt thereof is administered in at
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`Page 2 of6
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`Page 2
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`Page 2
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`
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`Dockcl No.: CGR500 l USCNTI
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`least one dosage form Comprising about 250 mg of abiraterone acetate or a
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`pharmaceutically acceptable salt thereof.
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`42. (New) The method of claim 37, wherein the therapeutically effective amount of the
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`prednisone is from about 0.0] mg/day to about 500 mg/day.
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`43. (New) The method of claim 42, wherein the therapeutically effective amount of the
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`prednisone is from about 10 mg/day to about 250 mgfday.
`
`44. (New) The method of claim 44, wherein the therapeutically effective amount of the
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`prednisonc is about 10 mg/day.
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`45. (New) The method of claim 37, wherein the therapeutically effective amount of the
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`prednisone is administered in at
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`least one dosage form comprising about 5 mg of
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`prednisone.
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`46. (New) The method of claim 37, Comprising administering to said human about 500
`
`mg/day to about 1500 mg/day of abiraterone acetate or a pharmaceutical ly acceptable salt
`
`thereof and about 0.0] mg/day to about 500 mg/day of prednisone.
`
`47. (New) The method of claim 46, comprising administering to said human about 1000
`
`mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10
`
`mg/day of prednisone.
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`Page 3 of6
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`Page 3
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`Page 3
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`
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`Dockcl No.: CGR500 l USCNT1
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`48. (New) The method of claim 37, wherein said prostate cancer is refractory prostate
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`cancer.
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`49.
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`(New) The method of claim 48, wherein the refractory prostate cancer is not
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`responding to at least one anti-cancer agent.
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`50. (New) The method of claim 49, wherein the at least one anti-cancer agent comprises a
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`hormonal ablation agent, an anti-androgen agent, or an anti-neoplastic agent.
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`51. (New) The method of claim 50, wherein the hormonal ablation agent comprises
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`deslorelin, leuprolide, goserelin, or triptorelin.
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`52.
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`(New) The method of claim 50, wherein the anti-androgen agent comprises
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`biealutamide, flutamide, or nilutamide.
`
`53.
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`(New) The method of claim 50, wherein the anti-neoplastic agent comprises
`
`docetaxel.
`
`54. (New) The method of claim 48, comprising administering to said human about 500
`
`mg/day to about 1500 mg/day of abiraterone acetate or a pharmaceutically acceptable salt
`
`thereof and about 0.0] mg./day to about 500 mg/day of prednisone.
`
`Page 4 of6
`
`Page 4
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`Page 4
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`
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`Docket No.: CGR500 l USCNT1
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`55. (New) The method of claim 54, comprising administering to said human about 1000
`
`mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10
`
`mg/“day of prcdnisone.
`
`56. (New) The method of claim 53, comprising administering to said human about 1000
`
`mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10
`
`mg/day of prcdnisone.
`
`Page 5 of6
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`Page 5
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`Page 5
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`
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`Docket NO.: CGR500 l USCNTI
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`Applicants respectfully request that a timely Notice of Allowance be issued in the
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`present application. Should the office require anything further, it is invited to contact
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`applicants’ representative at the telephone number below.
`
`JOHNSON & JOHNSON
`
`One Johnson & Johnson Plaza
`
`New Brunswick, NJ 08933-7003
`(732) 524-3957
`Dated: December 21, 201 I
`Customer No.: 27777
`
`Respectfully submitted,
`
`By: fAndrea Jo Kamagef
`Andrea Jo Kamage
`Reg. No. 43,703
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`Page 6 01°6
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`Page 6
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`Page 6
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`
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`Electronic Acknowledgement Receipt
`
`Application Number:
`
`13034340
`
`International Application Number:
`
`Confirmation N um ber:
`
`Title of Invention:
`
`Methods and Compositions forTreating Cancer
`
`First Named |nventor!Applicant Name:
`
`Alan H. Auerbach
`
`Customer Number:
`
`27777
`
`Filer:
`
`Andrea J. Kamage/Laurie Phillips
`
`Filer Authorized By:
`
`Andrea J. Kamage
`
`Attorney Docket Number:
`
`CGFI5001 USCNT1
`
`Receipt Date:
`
`21 —DEC—2011
`
`Filing Date:
`
`24-FEB-2011
`
`Time Stamp:
`
`11:00:17
`
`Application Type:
`
`Utility under 35 USC 111(a]
`
`Payment information:
`
`Submitted with Payment
`
`no
`
`File Listing:
`
`Document
`Number
`
`.
`.
`Document Descnpmm
`
`.
`me Name
`
`File Size(Bytesh'
`Message Digest
`192109
`
`Part Lzip (ifappI.)
`
`ctllill Warnings:
`
`Response to Election I Restriction Filed
`
`CGR5001USCNT1ResponsetoRR
`
`Ibi.I'I.rJ'5|.‘l‘.F|5!.D()4lIL|'2 J:28.bl.n_[I I .|'.’dl3 EH98
`
`Info rmation:
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`Page 7
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`Page 7
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`
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the 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.
`
`Total Files Size (in bytesll
`
`192109
`
`New Agplications Under 35 U.S.C. 111
`Ifa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53[b)-{dl and MPEP 506], a Filing Receipt (37 CFR 1.54} will be issued in due course and the date shown on this
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`
`National Stage of an International Agplication under 35 U.S.C. 371
`Ifa timely submission to enter the national stage ofan international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCTlD0lE0!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.
`
`the application.
`
`New International Application Filed with the USPTO asa Receiving Office
`Ifa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP1810], a Notification of the International Application Number
`and ofthe International Filing Date (Form PCTIROH 05) will be issued in due course, subject to prescriptions concerning
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`
`Page 8
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`Page 8
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`
`
`PTOI'SBI’06 (0?-06}
`Approved for use through 1I'31I'200'I". OMB 0651-0032
`U.S. Patent and Trademark Ollice: US. DEPARTMENT OF COMMERCE
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`Subgfitute fgr Farm PTQ_875
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`T D To be Mailed
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`APPLICATION AS FILED — PART I
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`OTHER THAN
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`FOR
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`El B1‘\S'C FEE
`37CFR1.16a. b.or c
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`El SEARcH FEE _
`STCFFI I 15k. Il.or m
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`_
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`D EXAMINATION FEE
`3?CFR1.160.p.or u
`TOTAL CLAIMS
`3? cFR1.1SI
`INDEPENDENT CLAIMS
`3?CFFl1.t6h
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`l:lAPP'-'C'°‘T'ON SIZE FEE
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`ICOILHTIH 11
`NUMBER FILED
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`(COII-||'W1 21
`NUMBER EXTRA
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`RATE ($)
`FEE {$)
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`OR
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`SMALL ENTITY
`RATE {$)
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`(Column 2}
`HIGHEST
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`PAID FOR
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`(Column 3)
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`PRESENT
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`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (3? CFR 1 16“)!
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`CLAIMS
`REMAINING
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`HIGHEST
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`PREVIOUSLY
`PAID FOR
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`PRESENT
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`I:I Application Size Fee (37 SFR 1.1513);
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`OTHER THAN
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`Page 9