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 .
Status of Claims
Claims 10, 12, 16, 18, 20, 72, 74, 81, 83, 87, 89, 91-92, 96, 114-118 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C.
120, 121, or 365(c) is acknowledged. This application claims priority to PRO Application Serial No. 63/592,176, 63,582/504, 63/506,829, 63/496,008, 63/493,309, 63/434,813, 63/418,926, and 63/418,927, filed 10/21/2023, 9/13/2023, 6/7/2023, 4/13/2023, 3/30/2023, 12/22/2022, and 10/24/2022, respectively.
Information Disclosure Statement
All references from IDS(s) received 2/29/2024, 05/30/2024, 6/11/2024, 10/28/2024, and 1/28/2025 have been considered unless marked with a strikethrough.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10, 12, 16, 18, 20, 72, 74, 81, 83, 87, 89, 91-92, 96, 114-118 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Crew, A. et al. (WO2021127443A1; published 6/24/2021; cited in IDS filed 02/29/2024; “Crew”).
Crew teaches a bifunctional compound, including the compound required by the instant claims (Claim 40 and Compound 1, Example 1, Page 130) for use in prostate cancer, including metastatic and/or castrate-resistant prostate cancer (Abstract) in a dosage of 5 mg to 750 mg (Claim 52), as required by instant claim 10. Crew also teaches the compound can be used in combination with abiraterone acetate (Claim 58 and Spec. Page 32, Para. 0070-0071), as required by instant claim 12. Crew also teaches the subject may have at least one somatic AR tumor mutation (Claim 59 and Spec. Para. 0205), as required by instant claims 72, 74, and 81.
Crew does not explicitly state whether the subjects are naïve to novel hormonal agents, however Crew does teach the treatment is for “in subjects in need thereof” when referring to the treatment of subjects with prostate cancer, including metastatic and/or castrate-resistant prostate cancer. Therefore, one could reasonably infer this would include subjects naïve to novel hormonal agents, as required by instant claims 16, 18, 20, 87, 89, and 91-92.
Finally, Crew also teaches that the AR somatic mutation can be L702H (Claim 69), which according to the instant Specification is considered a ligand binding domain missense mutation, as required by instant claims 96 and 114-118.
Therefore, claims 10, 12, 16, 18, 20, 72, 74, 81, 83, 87, 89, 91-92, 96, 114-118 are anticipated by Crew.
Conclusion
Claims 10, 12, 16, 18, 20, 72, 74, 81, 83, 87, 89, 91-92, 96, 114-118 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621