DETAILED ACTION
Claims 1-6, 8-10, and 41-42 are pending.
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 .
Priority
The instant application filed 10/2/2024 is a National Stage entry of PCT/EP2023/059123, International Filing Date: 4/6/2023. 18853520 Claims Priority from Provisional Application 63362614, filed 4/7/2022.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 1/9/2025 and 6/19/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
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 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, 8-10, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Packer WO2021013735A1 published 1/28/2021; and Snyder US20180296574A1 published 10/18/2018.
Instant claim 1 is directed to a method of treating metastatic prostate cancer, hormone sensitive prostate cancer (HSPC) or castrate resistant prostate cancer (CRPC) in a subject in need thereof, comprising administering to the subject a first amount of AZD5305 or a pharmaceutically acceptable salt thereof, and a second amount of abiraterone acetate, wherein the first amount and the second amount together comprise a therapeutically effective amount.
Packer teaches the compounds of Formula (I), including Example 29: 6-{difluoromethyl)-5-[4-[{7-ethyl-6-oxo-5H-1,5-naDhthyridin-3-yl)methyl]DiDerazin-1-yl]-N- methyl-oyridine-2-carboxamide. This chemical name is also known as saruparib or AZD5305. Packer teaches the compounds for use in treatment or prophylaxis of diseases and conditions in which inhibition of PARP1 is beneficial.
Packer states, “It is believed that PARP inhibitors having improved selectivity for PARP1 may possess improved efficacy and reduced toxicity compared to other clinical PARP1 /2 inhibitors… An unmet medical need therefore exists for effective and safe PARP inhibitors. Especially PARP inhibitors having selectivity for PARP1.”
Packer teaches the PARP1 selective inhibitors can be used in prostate cancer.
Packer teaches the treatment of cancer, comprising administering to a subject in need of treatment a therapeutically-effective amount of a compound of Formula I (including AZD5305) in combination, preferably in the form of a pharmaceutical composition, simultaneously or sequentially with ionizing radiation or chemotherapeutic agents.
Parker doesn’t teach either of the 2 species of prostate cancer, hormone sensitive prostate cancer (HSPC) or castrate resistant prostate cancer (CRPC), and Parker doesn’t teach treating those cancers in combination with abiraterone acetate. Parker does suggest using these new compounds in place of non-selective PARP inhibitors (PARP1/2 inhibitors) as they “may possess improved efficacy and reduced toxicity” in comparison.
The prior art, Snyder, teaches the combination of a non-selective PARP inhibitor (niraparib), abiraterone acetate, and prednisone to treat a prostate cancer (Claim 1). Snyder also teaches wherein the prostate cancer is hormone-sensitive or castration-resistant prostate cancer (Claim 2).
A person of ordinary skill in the art would find it obvious to substitute AZD5305 in the method of treating prostate cancer taught by Snyder because Parker suggests that AZD5305 might “possess improved efficacy and reduced toxicity” when used in place of the non-selective PARP inhibitor (niraparib). Therefore, one would expect the substitution to yield improved efficacy with reduced side effects.
Instant claim 2 requires “wherein prednisone or prednisolone are administered to the subject.” Snyder teaches this using prednisone.
Instant claim 3 requires “metastatic prostate cancer is metastatic hormone sensitive prostate cancer (mHSPC) or metastatic castrate resistant prostate cancer (mCRPC).” Snyder teaches the combination for metastatic cancer [0006].
Instant claims 4, are to daily administration of the PARP inhibitor, Snyder teaches this [0040].
Instant claims 5 and 6 require, “wherein AZD5305 is administered in a dose of up to about 60 mg per day.” Packer states, “Oral formulations are preferred, particularly tablets or capsules which may be formulated by methods known to those skilled in the art to provide doses of the active compound in the range of 0.1 mg to 1000 mg.” And Snyder states, “Niraparib is provided as 200 mg capsules or tablets for once daily oral administration to a patient, abiraterone acetate is provided as capsules or tablets (4×250 mg, total dose 1000 mg) for once daily oral administration, and prednisone is provided as tablets or capsules (2×5 mg) for twice daily oral administration (one 5 mg tablet each of two times daily). Dosing of niraparib is initiated at a starting dose of 200 mg once daily, 67% of the current clinical dose for niraparib monotherapy.” The art clearly teaches the broader range of dosing for AZD5305, and the art clearly notes that dose will vary based on the compound, as Snyder notes the reduced dose in combination, as such one would find the dose of 60 mg per day obvious unless Applicant can show some significance.
Instant claim 8 is to abiraterone acetate is administered once daily, this is taught by Snyder.
Instant claim 9 is to wherein abiraterone acetate is administered in a dose of 1000 mg once daily. This is taught by Snyder.
Instant claim 10 is to wherein AZD5305 and abiraterone acetate, are taken together, on an empty stomach, with no food two hours before. Snyder states, “with or without food” an shows them being taken together. [0073].
Instant claims 41 and 42 are directed to a pharmaceutical product and kit comprising i) AZD5305 or a pharmaceutically acceptable salt thereof, and ii) abiraterone acetate. The kit is obvious for the same rationale, given Snyder teaches the combination and kit. See claims 31-36 and [0012].
Conclusion
No claims allowed.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
