DETAILED ACTION
Claims 1-3, 5-7, and 14-24, submitted 18 March 2026, are pending in the application and subject to examination in the instant Office Action.
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 .
Objections/Restrictions – Withdrawn and Maintained
The status of the previous objection and rejected claims in the Office Action mailed 18 December 2025 are set out below.
Objection to Specification
The amendment to the specification is sufficient to overcome the previous objection.
Rejections under 35 U.S.C. § 112(a)
The Applicant has amended claim 1 to add a wherein clause to specify that the cancer is homologous recombination deficient (HRD) cancer. However, this amendment is not sufficient to overcome the previous rejection.
Response to Arguments
Applicant's arguments filed 18 March 2026 have been fully considered but they are not persuasive. The Applicant argues that the instant specification provides adequate support for the treatment of HRD cancer. In the previous Office Action, the Examiner acknowledged that the instant specification provided support for the treatment of breast cancer wherein the cancer has the mutated BRCA1 or BRCA2 gene through administration of a combination with AZD5305 and carboplatin. However, there is no support in the specification that would lead one skilled in the art to conclude that all cancers comprising an HRR mutation can be treated with the above-mentioned combination of pharmaceuticals as the Applicant is asserting. To rebut the Applicant’s argument that the mechanism-based rationale applies across all cancers with HRD, the Examiner would like to cite a new reference, explicitly to address this argument. Specifically, the Examiner cites Hurley et al. ("53BP1 as a potential predictor of response in PARP inhibitor-treated homologous recombination-deficient ovarian cancer." Gynecologic oncology 153.1 (2019): 127-134.), which states “Not all cancers with defects in homologous recombination (HR) demonstrate clinical responses to PARP inhibitors.” (pg. 127, Section “Highlights”, 1st Bullet Point). Hurley also states that “Poly(ADP-ribose) polymerase (PARP) inhibitors have shown substantial activity in homologous recombination- (HR-) deficient ovarian cancer and are undergoing testing in other HR-deficient tumors. For reasons that are incompletely understood, not all patients with HR-deficient cancers respond to these agents.”. Thus, there remains unpredictability in the treatment of all claimed HRD cancers to be treated with the same pharmaceutical combination.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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