Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This is a response to Applicant’s communication filed on April 16, 2025. Application No. 18/837,956, is a 371 of PCT/EP2023/053555, filed February 14, 2023, and claims the benefit of U.S. Provisional application No. 63/268,026, filed February 15, 2022. In a preliminary amendment filed April 16, 2025, Applicant cancelled claims 22-46. Claims 1-21 are pending.
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al., 37(7) J. Clin. Oncology, Abstract (March 1, 2019) (cited on the November 12, 2024, IDS), in view Adashek et al., 8(8) Cells, p. 860 (August 9, 2019) (cited on the November 12, 2024, IDS); Kang et al., US2022/040173 (publ’d February 10, 2022) (cited on the November 12, 2024, IDS); and Chen et al. 42(12) Acta Pharmacologica Sinica 1870-1980 (February 5, 2021) (cited on the November 12, 2024, IDS). Clark teaches the claimed method of treating metastatic castration-resistant prostate cancer (mCRPC) in a subject, wherein the subject is treatment naive, the method comprising: administering olaparib in combination with abiraterone acetate. (See Clark et al., Abstract; see Id. also for the claimed dosage ranges.) The difference between the prior art and present invention is that Clark, alone, does not, at least clearly demonstrate the progression free survival is at least about 6 months greater than for subjects receiving abiraterone acetate alone.
Nonetheless, Adashek teaches that abiraterone acetate alone treats mCRPC. See Adashek, Abstract. Furthermore, Kang et al. teaches that Olaparib alone treats mCRPC. Kang et al., US PGpub ‘173, para. [0027]-[0028]. Notably, Chen shows that abiraterone and olaparib demonstrated a combined effect of increasing the efficacy of each other (i.e., a synergistic effect). See Chen et al., Conclusion, p. 1978, Col. 1.. Accordingly, all the elements of the present invention were known in the art at the time of the invention.
It would have been obvious to the ordinary artisan to combine abiraterone acetate and olaparib with a reasonable expectation of success (i.e., naïve patients resulting in progression free survival of at least 6 months, greater than abiraterone acetate alone). The prior art shows the olaparib and abiraterone work the same individually as they do together and as taught by Chen, the combined effect is synergistic, improving the efficacy of each other. Therefore, based on the teachings of the prior art there is a reasonable expectation of success. According, the present invention combines prior art elements according to known methods yielding predictable results.
Conclusion
No claims are allowed.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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