Docket No.: CGR500 lUSCNTl
`
`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:
`
`July 3, 2012
`
`Signature: /Laurie A. Phillips/ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Application No.‘
`Fi1iiig‘i)a{£e:“‘
`
`Mail Stop Amendment
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 223 13-1450
`
`RESPONSE
`
`Dear Sir:
`
`In response to the Office Action mailed February 3, 2012, Applicants submit the
`
`following amendments and remarks.
`
`Remarks/Arguments begin on page 2 of this paper.
`
`Page 1 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 1
`
`
`
`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:
`
`July 3, 2012
`
`Signature: /Laurie A. Phillips/ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Application No.‘
`Fi1iiig‘i)a{£e:“‘
`
`Mail Stop Amendment
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 223 13-1450
`
`RESPONSE
`
`Dear Sir:
`
`In response to the Office Action mailed February 3, 2012, Applicants submit the
`
`following amendments and remarks.
`
`Remarks/Arguments begin on page 2 of this paper.
`
`Page 1 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 1
`
`
`
`Docket No.: CGR500 lUSCNTl
`
`Remarks
`
`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 (l996)). Applicant respectfully traverses this rejection.
`
`The invention is directed to a method for treating prostate cancer by
`
`administering both abiraterone acetate and prednisone to a patient. The Office alleges
`
`this invention is obvious by a combination of O’Donnell, which discloses administration
`
`of certain doses of abiraterone acetate to castrated prostate cancer patients, and Tannock,
`
`which discloses administration of prednisone in combination with a chemotherapy agent
`
`to prostate cancer patients.
`
`Applicant believes that the Office has failed to establish a case of obviousness.
`
`At the very most, the cited art may suggest that a combination of abiraterone acetate and
`
`prednisone would be obvious to try; along with a myriad of other combinations of two
`
`cancer drugs. Nothing in the art teaches or suggests that abiraterone acetate in
`
`combination with prednisone would be a particularly useful combination for cancer
`
`treatment.
`
`Even if one of ordinary skill would have been motivated to combine both modes
`
`of treatment, the claimed invention produces unexpected results. Applicants enclose
`
`herewith Sartor, Nature Reviews Clinical Oncology, 8:515-516 (2011) (“Sartor”). Sartor
`
`reports on the results of a clinical study on patients with prostate cancer who were treated
`
`with the claimed invention. According to Sartor, “Abiraterone plus prednisone prolongs
`
`overall survival relative to prednisone alone. . .” Sartor, abstract. Additionally, “reported
`
`pain was markedly reduced in the abiraterone plus prednisone arm. Second, preliminary
`
`reports indicate that circulating tumors cells (CTCs)—a novel biomarker indicative of
`
`poor prognosis —were reduced in the experimental arm and that a combination of levels
`
`Page 2 of 4
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`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 2
`
`
`
`Docket No.: CGR5001USCNT1
`
`of lactate dehydrogenase (LDH) and CTCs at baseline and changes in these levels after
`
`treatment may predict survival, independently of therapy, in patients with an elevated
`
`baseline CTC coun .” Thus, the claimed invention produces the unexpected results of
`
`increased survival, reduced pain, and lower levels of a biomarker connected with
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`survival.
`
`The claimed invention has experienced an impressive commercial success.
`
`Applicant attaches herewith the label for abiraterone acetate, sold under the tradename
`
`ZYTIGA. According to the label, “ZYTIGA in combination with prednisone is indicated
`
`for the treatment of patients with metastatic castration-resistant prostate cancer who have
`
`received prior chemotherapy containing docetaxel.” Thus, the ZYTIGA label directs
`
`patients to practice the claimed invention.
`
`ZYTIGA was approved for sale in the U.S. in April 2011. Within the first year of
`
`release, worldwide sales were over $400 million. Sales for the truncated 2011 year
`
`totaled $200 million worldwide. Sales for just the first quarter of 2012 were also $200
`
`million. Thus, not only did the claimed invention enjoy immediate commercial success,
`
`this commercial success grew over the first year of commercial availability.
`
`The claimed invention displays unexpected results over the prior at, and shows
`
`commercial success. Thus, the present claims are non-obvious over the cited art.
`
`Accordingly, Applicant requests reconsideration and withdrawal of the rejection under 35
`
`USC §103(a).
`
`Double Patenting Rejection
`
`Claims 37-56 are rejected on the ground of non-statutory obviousness-type double
`
`patenting as being unpatentable over claims 9, 19, 21, 24, 29-32 of copending U.S. Patent
`
`Application No. 12/898,149 (the ‘ 149 application). The ‘149 application has been a
`
`abandoned. Thus, this rejection is now moot.
`
`Page 3 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 3
`
`
`
`Docket No.: CGR500 lUSCNTl
`
`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.
`
`JOHNSON & JOHNSON
`
`One Johnson & Johnson Plaza
`
`New Brunswick, NJ 08933-7003
`(732) 524-3957
`Dated: July 3, 2012
`Customer No.: 27777
`
`Respectfully submitted,
`
`/Andrea Jo Kamage/
`By:
`Andrea Jo Kamagc
`Reg. No. 43,703
`
`Page 4 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 4
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