`
`I hereby certifY that this correspondence is being transmitted via The Office
`
`Electronic Filing System (EFS) in accordance with 37 CFR l.6(a)(4).
`
`Date of Electronic (EFS) Transmission:
`
`December 21. 20 ll
`
`Signature: /Laurie A. Phillips/ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Applicant(s ):
`
`Title:
`
`Methods and Compositions for Treating Cancer
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-14 50
`
`RESPONSE TO RESTRICTION REQUIREMENT
`
`Dear Sir:
`
`The Office has issued a two-way restriction requirement relating to the present
`
`invention. Applicants hereby elect the invention of Group I, represented by newly
`
`presented claims 37 et seq. This election is made without traverse.
`
`Page 1 of6
`
`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1069, p. 1 of 6
`
`
`
`Docket No.: CGR5001USCNT1
`
`Listing of Claims:
`
`1-36. (Canceled).
`
`37. (New) A method for the treatment of a prostate cancer m a human comprising
`
`administering to said human a therapeutically effective amount of abiraterone acetate or a
`
`pharmaceutically acceptable salt thereof and a therapeutically effective amount of
`
`prednisone.
`
`38. (New) The method of claim 37, wherein the therapeutically effective amount of the
`
`abiraterone acetate or pharmaceutically acceptable salt thereof is from about 50 mg/day
`
`to about 2000 mg/day.
`
`39. (New) The method of claim 38, wherein the therapeutically effective amount of the
`
`abiraterone acetate or pharmaceutically acceptable salt thereof is from about 500 mg/day
`
`to about 1500 mg/day.
`
`40. (New) The method of claim 39, wherein the therapeutically effective amount of the
`
`abiraterone acetate or pharmaceutically acceptable salt thereof is about 1000 mg/day.
`
`41. (New) The method of claim 37, wherein the therapeutically effective amount of the
`
`abiraterone acetate or a pharmaceutically acceptable salt thereof is administered in at
`
`Page 2 of6
`
`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1069, p. 2 of 6
`
`
`
`Docket No.: CGR5001USCNT1
`
`least one dosage form compnsmg about 250 mg of abiraterone acetate or a
`
`pharmaceutically acceptable salt thereof.
`
`42. (New) The method of claim 37, wherein the therapeutically effective amount of the
`
`prednisone is from about 0.01 mg/day to about 500 mg/day.
`
`43. (New) The method of claim 42, wherein the therapeutically effective amount of the
`
`prednisone is from about 10 mg/day to about 250 mg/day.
`
`44. (New) The method of claim 44, wherein the therapeutically effective amount of the
`
`prednisone is about 10 mg/day.
`
`45. (New) The method of claim 37, wherein the therapeutically effective amount of the
`
`prednisone is administered in at least one dosage form comprising about 5 mg of
`
`prednisone.
`
`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 pharmaceutically acceptable salt
`
`thereof and about 0.01 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.
`
`Page 3 of6
`
`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1069, p. 3 of 6
`
`
`
`Docket No.: CGR5001USCNT1
`
`48. (New) The method of claim 37, wherein said prostate cancer is refractory prostate
`
`cancer.
`
`49.
`
`(New) The method of claim 48, wherein the refractory prostate cancer IS not
`
`responding to at least one anti-cancer agent.
`
`50. (New) The method of claim 49, wherein the at least one anti-cancer agent comprises a
`
`hormonal ablation agent, an anti-androgen agent, or an anti-neoplastic agent.
`
`51. (New) The method of claim 50, wherein the hormonal ablation agent comprises
`
`deslorelin, leuprolide, goserelin, or triptorelin.
`
`52. (New) The method of claim 50, wherein the anti-androgen agent compnses
`
`bicalutamide, flutamide, or nilutamide.
`
`53. (New) The method of claim 50, wherein the anti-neoplastic agent compnses
`
`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 0.01 mg/day to about 500 mg/day of prednisone.
`
`Page 4 of6
`
`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1069, p. 4 of 6
`
`
`
`Docket No.: CGR5001USCNT1
`
`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 prednisone.
`
`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 prednisone.
`
`Page 5 of6
`
`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1069, p. 5 of 6
`
`
`
`Docket No.: CGR5001USCNT1
`
`Applicants respectfully request that a timely Notice of Allowance be issued in the
`
`present application. Should the office require anything further, it is invited to contact
`
`applicants' representative at the telephone number below.
`
`JOHNSON & JOHNSON
`One Johnson & Johnson Plaza
`New Brunswick, NJ 08933-7003
`(732) 524-3957
`Dated: December 21, 2011
`Customer No.: 27777
`
`Respectfully submitted,
`
`By: I Andrea Jo Kamage I
`Andrea Jo Kamage
`Reg. No. 43,703
`
`Page 6 of6
`
`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1069, p. 6 of 6
`
`