Docket N0.: CGRSOOIUSCNTI
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`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
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`Date of Ijlcctronic (El-‘ S) Transmission:
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`December 21 201 1
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Application of:
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`App1i¢}int(s3§'
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`'2 A153’Hi'}3;Iiéit5éié1iW”
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`"CioinffNo§: I
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`ii
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`FilingiDatc:
`:Title:
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`I
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`WiiExamincri:
`A
`I
`I _iHFcbruary 24, 201
`in Methods and Compositionsufor :1‘reating Cancer
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`SaniMing
`H A
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`I
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`I
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`A
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`I
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`Mail Stop Amcndmcnt
`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`RESPONSE TO RESTRICTION REQUIREMENT
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`Dear Sir:
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`The Office has issued a two-way restriction rcquircmcnt rclating to the present
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`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).
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`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
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`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
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`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.
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`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
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`mg/day to about 1500 mg/day of abiraterone acetate or a pharmaceutical ly acceptable salt
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`thereof and about 0.0] mg/day to about 500 mg/day of prednisone.
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`47. (New) The method of claim 46, comprising administering to said human about 1000
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`mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10
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`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.
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`53.
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`(New) The method of claim 50, wherein the anti-neoplastic agent comprises
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`docetaxel.
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`54. (New) The method of claim 48, comprising administering to said human about 500
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`mg/day to about 1500 mg/day of abiraterone acetate or a pharmaceutically acceptable salt
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`thereof and about 0.0] mg./day to about 500 mg/day of prednisone.
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`Page 4 of6
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`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
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`mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10
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`mg/“day of prcdnisone.
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`56. (New) The method of claim 53, comprising administering to said human about 1000
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`mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10
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`mg/day of prcdnisone.
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`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.
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`JOHNSON & JOHNSON
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`One Johnson & Johnson Plaza
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`New Brunswick, NJ 08933-7003
`(732) 524-3957
`Dated: December 21, 201 I
`Customer No.: 27777
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`Respectfully submitted,
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`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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`Electronic Acknowledgement Receipt
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`Application Number:
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`13034340
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`International Application Number:
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`Confirmation N um ber:
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`Title of Invention:
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`Methods and Compositions forTreating Cancer
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`First Named |nventor!Applicant Name:
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`Alan H. Auerbach
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`Customer Number:
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`27777
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`Filer:
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`Andrea J. Kamage/Laurie Phillips
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`Filer Authorized By:
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`Andrea J. Kamage
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`Attorney Docket Number:
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`CGFI5001 USCNT1
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`Receipt Date:
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`21 —DEC—2011
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`Filing Date:
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`24-FEB-2011
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`Time Stamp:
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`11:00:17
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`Application Type:
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`Utility under 35 USC 111(a]
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`Payment information:
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`Submitted with Payment
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`no
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`File Listing:
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`Document
`Number
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`.
`.
`Document Descnpmm
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`.
`me Name
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`File Size(Bytesh'
`Message Digest
`192109
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`Part Lzip (ifappI.)
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`ctllill Warnings:
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`Response to Election I Restriction Filed
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`CGR5001USCNT1ResponsetoRR
`pdf
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`Ibi.I'I.rJ'5|.‘l‘.F|5!.D()4lIL|'2 J:28.bl.n_[I I .|'.’dl3 EH98
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`Info rmation:
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`Page 7
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`Page 7
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
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`192109
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`New Agplications Under 35 U.S.C. 111
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`New International Application Filed with the USPTO asa Receiving Office
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`Page 8
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`Page 8
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`

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