PTOlSB/30 (08-00)
`Approved for use through 10/31/2002. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paervvork Reduction Act of1995, no ersons are reuired to resond to a collection of information unless it disla s a valid OMB control number.
`
`Application Number
`
`13/034340
`
`CONTIN UED EXAMINATION
`
`Alan H_ Auerbach
`First Named Inventor
`(RC
`1628
`G’°””A”“””
`TRANSMITTAL
`Examiner Name
`Subsection (b) of 35 U.S.C. § 132, effective on May 29, 2000,
`provides for continued examination ofan utility or plant application San Mlng R‘ Hul
`
`~
`
`~
`
`filed on or after June 8,1995.
`See The American Inventors Protection Act of 1999 (AIPA).
`
`Attorney Docket Number
`
`CGR500 IUSCNTI
`
`This is a Request for Continued Examination (RCE) under 37 C. F. R. § 1.114 of the above-identified application.
`NO TE:
`37 C.F.R. § 1.114 is effective on May 29, 2000. If the above-identified application was filed prior to May 29, 2000, applicant may
`wish to consider filing a continued prosecution application (CPA) under37 C.F.R. § 1. 53 (d) (PTO/SB/29) instead of a RCE to be eligible for
`the patent term adjustment provisions of the AIPA. See Changes to Application Examination and Provisional Application Practice, Final Rule, 65
`Fed. Reg. 50092 (Aug. 16, 2000); Interim Rule, 65 Fed. Reg. 14865 (Mar. 20, 2000), 1233 Off. Gaz. Pat. Office 47 (Apr. 11, 2000), which
`established RCE ractice.
`
`. Submission reuired under 37 C.F.R. ~ 1.114
`
`a.
`
`I:I Previously submitted
`i.
`I:I Consider the amendment(s)/reply under 37 C.F.R. § 1.116 previously filed on
`(any unentered amendment(s) referred to above will be entered).
`I:I Consider the arguments in the Appeal Brief or Reply Brief previously filed on
`
`ii.
`
`b.
`
`iii.
`
`|:| Other
`Enclosed
`IZI Amendment/Reply
`i.
`I:I Affidavit(s)/Declaration(s)
`ii.
`I:I
`Information Disclosure Statement (IDS)
`iii.
`I:I Other
`iv.
`2. Miscellaneous
`
`a.
`months.
`b.
`
`3.
`
`a.
`
`b.
`c.
`
`I:I Suspension of action on the above-identified application is requested under 37 C.F.R. § 1.103(c) for a period of
`(Period of suspension shall not exceed 3 months; Fee under 37 C.F.R. § 1.17(i) required.)
`I:I Other
`- The RCE fee under 37 C.F.R. § 1.17(e) is required by 37 C.F.R. § 1.114 when the RCE is filed
`IE The Director is hereby authorized to charge the following fees, or credit any overpayments,
`to Deposit Account No. 10-0750.
`i. E RCE fee is required under 37 C.F.R. § 1.17(e)
`ii.
`I:I Extension of Time (37 C.F.R. §§ 1.136 and 1.17)
`iii.
`I:I Other
`enclosed
`I:I Check in the amount of $
`I:I Pa merit b credit card Form PTO-2038 enclosed
`
`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT RE I UIRED
`
`Name (print/type)
`Sinature
`
`Andrea Jo Kamage
`/Andrea Jo Kamael
`
`Registration No.
`Date
`CERTIFICATE OF TRANSMISSION
`
`43,703
`Janua
`
`11, 2013
`
`I hereby certify that this correspondence is being electronically filed via EFS-Web to the Commissioner for Patents with the U.S.
`Patent and Trademark Office on: January 11, 2013
`
`Name (print/type)
`Sinature
`
`Laurie A. Phillips
`/Laurie A. Phillipsl
`
`11,2013
`
`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 1
`
`

`
`Docket No.: CGR5001USCNT1
`
`I hereby certify that this correspondence is being transmitted Via The Office
`
`Electronic Filing System (EFS) in accordance with 37 CFR 1.6(a)(4).
`
`Date of Electronic (EFS) Transmission:
`
`January 11, 2013
`
`Signature: /Laurie A. Phillips/ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`§App1i¢;n£(s53’
`ApplicationNo.:
`
`13/034,340
`
`in Title:
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Group Art:
`
`Cancer
`
`7
`
`RESPONSE
`
`In response to the final Office Action mailed September 11, 2012, Applicants
`
`submit the following amendments and remarks.
`
`A list of the Claims are reflected in the listing of claims, which begins on page 2
`
`of this paper.
`
`Remarks/Arguments begin on page 4 of this paper.
`
`Page 1 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 2
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`

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`Docket No.: CGR500 lUSCNTl
`
`Listing of Claims:
`
`1-36. (Canceled).
`
`37. (Previously presented) A method for the treatment of a prostate cancer in a human
`
`comprising administering to said human a therapeutically effective amount of abiraterone
`
`acetate or a pharrnaceutically acceptable salt thereof and a therapeutically effective
`
`amount of prednisone.
`
`38. (Previously presented) The method of claim 37, wherein the therapeutically effective
`
`amount of the abiraterone acetate or pharrnaceutically acceptable salt thereof is from
`
`about 50 mg/day to about 2000 mg/day.
`
`39. (Previously presented) The method of claim 38, wherein the therapeutically effective
`
`amount of the abiraterone acetate or pharrnaceutically acceptable salt thereof is from
`
`about 500 mg/day to about 1500 mg/day.
`
`40. (Previously presented) The method of claim 39, wherein the therapeutically effective
`
`amount of the abiraterone acetate or pharrnaceutically acceptable salt thereof is about
`
`1000 mg/day.
`
`Page 2 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 3
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`

`
`Docket No.: CGR500 lUSCNT1
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`41. (Previously presented) The method of claim 37, wherein the therapeutically effective
`
`amount of the abiraterone acetate or a pharrnaeeutically acceptable salt thereof is
`
`administered in at least one dosage for1n comprising about 250 mg of abiraterone acetate
`
`or a pharrnaceutically acceptable salt thereof.
`
`42. (Previously presented) 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. (Previously presented) 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. (Previously presented) The method of claim 44, wherein the therapeutically effective
`
`amount of the prednisone is about 10 mg/day.
`
`45. (Previously presented) 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. (Previously presented) The method of claim 37, comprising administering to said
`
`human about 500 mg/day to about 1500 mg/day of abiraterone acetate or a
`
`pharrnaceutically acceptable salt thereof and about 0.01 mg/day to about 500 mg/day of
`
`prednisone.
`
`Page 3 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 4
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`

`
`Docket No.: CGR500 lUSCNT1
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`47. (Previously presented) 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.
`
`48. (Previously presented) The method of claim 37, wherein said prostate cancer is
`
`refractory prostate cancer.
`
`49.
`
`(Previously presented) The method of claim 48, wherein the refractory prostate
`
`cancer is not responding to at least one anti-cancer agent.
`
`50. (Previously presented) 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. (Previously presented) The method of claim 50, wherein the hormonal ablation agent
`
`comprises deslorelin, leuprolide, goserelin, or triptorelin.
`
`52. (Previously presented) The method of claim 50, wherein the anti-androgen agent
`
`comprises biealutamide, flutamide, or nilutamide.
`
`53. (Previously presented) The method of claim 50, wherein the anti-neoplastic agent
`
`comprises docetaxel.
`
`Page 4 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 5
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`

`
`Docket No.: CGR500 lUSCNT1
`
`54. (Previously presented) The method of claim 48, comprising administering to said
`
`human about 500 mg/day to about 1500 mg/day of abiraterone acetate or a
`
`pharrnaceutically acceptable salt thereof and about 0.01 mg/day to about 500 mg/day of
`
`prednisone.
`
`55. (Previously presented) 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. (Previously presented) 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 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 6
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`

`
`Docket No.: CGR500 lUSCNTl
`
`Remarks
`
`Claims 37-56 are pending.
`
`Re°ections Under 35 U.S.C.
`
`103
`
`Claims 37-56 are rejected under 35 USC §103(a) as allegedly being unpatentable
`
`over O’Donell et al. (British Journal of Cancer (2004)),
`
`in view of Tannock et al.
`
`(Journal of Clinical Oncology (1996)). Applicants respectfially traverse this rejection.
`
`None of the cited prior art teaches or suggests the specific combination of the
`
`present invention, namely treating prostate cancer with a combination of abiraterone and
`
`prednisone. As stated by the Office, “O’Donnell does not expressly teach the use of
`
`prednisone in the method of treating prostate cancer. O’Donell does not expressly teach
`
`the use of the herein claimed dosage and regimen for prednisone and abiraterone acetate.”
`
`Office Action, page 3. Further, according to the Office, “Tannock teaches 10mg of
`
`prednisone in combination with other anti—cancer drug as effective in treating refractory
`
`horrnonal—resistance prostate cancer.” Office Action, page 3. Neither of these references
`
`teach or suggest combining prednisone and abiraterone to treat prostate cancer.
`
`Even assuming, arguendo, that the cited references establish a prima facie case of
`
`obviousness, the present invention has shown unexpected results. Applicants submit
`
`herewith Ryan et al., New Engl. J. Med, 2012, 3682138-148 (“Ryan”), which shows
`
`some of the unexpected results for the present invention.
`
`Ryan reports on a clinical trial of abiraterone acetate plus prednisone for treating
`
`prostate cancer. Ryan states that the “median radiographic progression-free survival was
`
`16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone.
`
`.
`
`.
`
`treatment with abiraterone plus prednisone, as compared with placebo plus prednisone,
`
`results in a 57% reduction in the risk of radiographic progression or death. .
`
`. There was a
`
`25% decrease in the risk of death in the abiraterone-prednisone group, indicating a strong
`
`trend toward improved survival with abiraterone-prednisone.
`
`.
`
`. Radiographic
`
`progression-free survival was positvely correlated with overall survival.”
`
`In contrast,
`
`Tannock teaches that “[t]here was no significant difference in overall survival [between
`
`Page 6 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 7
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`

`
`Docket No.: CGR500 1USCNT1
`
`prednisone alone and prednisone plus mitoxantrone].” One of ordinary skill would have
`
`expected, from the prior art, no differences in survival. However, Ryan shows the
`
`unexpected survival benefit of abiraterone in combination with prednisone.
`
`Ryan further teaches that “Abiraterone-prednisone showed superiority over
`
`prednisone alone with respect to time to initiation of cytotoxic chemotherapy, opiate use
`
`for cancer—related pain, prostate—specific antigen progression, and decline in performance
`
`status.” The present invention delayed initiation of cytotoxic chemotherapy by over 8
`
`months, delayed prostate-specific antigen progression over 5 months, and delayed time to
`
`increase in pain over 8 months as compared with prednisone alone. See Table 1 of Ryan.
`
`None of these unexpected effects could have been predicted from the prior art.
`
`Additionally, in Ryan, over 62% of patients showed a decline of greater than or
`
`equal to 50% in prostate specific antigen level.
`
`In contrast, only 33% of patients treated
`
`with the combination regimen in Tannock showed a decline of greater than or equal to
`
`50% in prostate specific antigen level. This higher percentage could not have been
`
`predicted from the prior art.
`
`Thus, none of the cited art, either alone or in combination, teaches or suggests the
`
`methods of the present invention. The present inventions shows several surprising
`
`unexpected results over the prior art. Accordingly, Applicant requests reconsideration
`
`and withdrawal of the rejection under 35 USC §l03 (a).
`
`Page 7 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 8
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`

`
`Docket No.: CGR500 lUSCNT1
`
`III. CONCLUSION
`
`Early consideration and prompt allowance of the claims are respectfully requested.
`
`Should the office require anything further,
`
`it
`
`is
`
`invited to contact applicants’
`
`representative at the telephone number below.
`
`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:
`January 11, 2013
`Customer No.: 27777
`
`Respectfully submitted,
`
`/Andrea Jo Kamage /
`By:
`Andrea Jo Kamage
`Reg. No. 43,703
`
`Page 8 of 8
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`MYLAN PHARMS. INC. EXHIBIT 1010 PAGE 9