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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 June 2026 has been entered.
Status of the Claims
Claims 1-6, 10-11, and 16 are pending in the instant application.
Claims 1-6, 10-11, and 16 are examined herein.
Priority
The instant application claims no benefit of priority. As such, the effective filing date of the claims is 24 October 2024.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on [date], is acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 05 May 2026 has been entered.
The Applicant presents experimental results as a part of their remarks, particularly Figures B and C, demonstrating that BRITE-338733 binds in the same active site as ATP in RecA but not RAD51. The Examiner requests the experimental results be submitted as a declaration so they may be considered against the 103 rejection as evidence. As it stands, the experimental results have not been considered. As such, the rejection is maintained.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10-11, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sexton et al. (Curr Chem Genomics. 2010;4:34-42) in view of Huang et al. (ACS Chem Biol. 2011;6(6):628-635) and Gu et al. (Front. Oncol.2022;12:1-14).
Regarding claims 1 and 2, Sexton discloses inhibitors of the bacterial RecA protein for inhibiting the mechanism leading to drug resistance in bacteria. Sexton discloses the inhibitor BRITE-338733 (pictured below) which is a species of the instant Formula (I) when R1 is alkyl, R2 is N, the linking R3 is NH, the heterocyclic R3 is NH, the ortho R4 is hydroxy, and the meta R4 is alkyl.
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Sexton does not disclose or suggest using the inhibitor in the method of treating breast cancer.
Huang teaches the bacterial RecA is an ortholog to the human RAD51, and identifies two RAD51 inhibitors as also inhibiting RecA (page 629).
Huang teaches that RAD51 is overexpressed in BRCA-1-deficient breast tumors, but does not demonstrate that a RAD51 inhibitor can be used to treat breast cancer.
Gu et al. teaches the treatment of cancer, including breast cancer (page 5), by targeting RAD51.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. Sexton teaches the instant compound as an inhibitor of RecA, Huang teaches RecA and RAD51 to be orthologs, and Gu teaches RAD51 inhibitors in the treatment of breast cancer. Therefore it would be prima facie obvious to substitute Sexton’s target protein of RecA, for the ortholog, RAD51, as taught by Huang and to substitute the RAD51 inhibitor, taught by Sexton, for the one taught by Gu, arriving at the instantly claimed compound.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claims 3 and 4, Gu teaches RAD51 inhibitors in human cells.
Regarding claims 5 and 6, Gu teaches the administration of a RAD-51 inhibitor formulated in PEG400, vitamin E TPGS, and water (page 3).
Regarding claim 10, Gu teaches that RAD51 inhibitors can synergize with the PARP inhibitor, Olaparib (page 8).
Regarding claim 11, the method recited is a property which would flow naturally from following the suggestion of the prior art. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding claim 16, Gu teaches administering a RAD51 inhibitor concurrently with cisplatin (page 3).
Conclusion
Claims 1-6, 10-11, and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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