DETAILED 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 .
Status of the Claims and Response to Restriction Requirement
Claims 1-20 are pending as of the response filed on 02/18/2026. Applicant’s election of the species shown below is acknowledged.
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The elected species is encompassed by claims 1-10, 12 and 15-20. Claims 11 and 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Therefore, claims 1-10, 12 and 15-20 have been examined to the extent to which they are readable on the above identified elected invention and elected species.
The elected species was examined and found to be free of prior art. Therefore, the examiner has extended the search to include the entire genus of compounds of formula (I) as in claim 1. The compounds of formula (I) as in claim 1 was found to be free of prior art.
In view of the pending claims, the following rejections are made, as discussed below.
Priority
This application is a CON of PCT/CN2022/089956 filed 04/28/2022, which claims foreign priority to CHINA 202110486972.6 filed 05/03/2021, CHINA 202110806606.4 filed 07/16/2021, CHINA 202111514025.X filed 12/13/2021, CHINA 202210062340.1 filed 01/19/2022.
Acknowledgment is made of Applicant's claim for foreign priority. It is noted, however, that Applicant has not provided English translations of the certified copies of the applications filed in China. Without the English translations, one cannot ascertain if the instant invention is supported in the Chinese applications. Therefore, art prior to the PCT date, but not before the date of the earliest Chinese application may be cited against the claims.
Information Disclosure Statement
The information disclosure statements submitted on 05/29/2025 and 11/29/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The IDS dated 03/26/2025 does not include an IDS size fee assertion statement and thus, was not considered. It is noted that the IDS dated 05/29/2025 is an updated version of the same with the required IDS size fee assertion statement and thus, was considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-4, the claims recite “each n is independently an integer”. However, there is only one occurrence of “n” in the structure of formula (I), rendering some ambiguity with respect to the of scope of claims 1-4.
For the purpose of applying prior art, claims 1-4 have been interpreted to read “ [[each]] n is independently an integer”.
Regarding claim 8, the claim recites “each s is independently an integer”. However, there is only one occurrence of “s” in the structure of formula (II-5), rendering some ambiguity with respect to the scope of claim 8.
For the purpose of applying prior art, claim 8 has been interpreted to read “[[each]] s is independently an integer”.
Claim Rejections - 35 USC § 101 - Nonstatutory (Not One of the Four Statutory Categories)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a method for manufacturing a medicament for treating and/or preventing a disease mediated by USP1 and a disease related thereto by using the compound or the pharmaceutically acceptable salt, ester, deuterated compound or stereoisomer thereof according to claim 1.
It is unclear if claim 18 is drawn to a method of preparation of a medicament comprising the compound or the pharmaceutically acceptable salt, ester, deuterated compound or stereoisomer thereof according to claim 1 OR a method for treating and/or preventing a disease mediated by USP1 using the compound or the pharmaceutically acceptable salt, ester, deuterated compound or stereoisomer thereof according to claim 1. However, the claims do not recite any positive method of preparation OR method of treatment steps.
Therefore, the claims do not clearly identify the statutory class to which it belongs and are deemed patent ineligible subject matter.
Allowable Subject Matter
Claims 5-7, 9-10, 12, 15-17 and 19-20 are objected to as being dependent upon a rejected base claim. Except for the 35 USC § 112(b) rejection, all claims drawn to a compound, formulation/composition and method of preparation of the compound or the pharmaceutically acceptable salt, ester, deuterated compound or stereoisomer thereof according to claim 1, would be allowable.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Brenneman et al. (WO 2020/132269 A1, 25 June 2020, hereinafter Brenneman, in the IDS). Brenneman teaches substituted pyrazolopyrimidines and substituted purines of Formula I and their use as ubiquitin-specific-processing protease 1 (USP1) inhibitors (Title; Abstract; Paras. [005]-[0016]).
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Brenneman teaches the following exemplary compound having an IC50 value “+++”, i.e., 10 nM to 100 nM for USP1 inhibitory activity (Para. [0796], TABLE 2).
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The above compound of Brenneman substantially overlaps the instantly elected species of compound but differs in the presence of a tricyclic pyrazolo[3,4-d]pyrimidine fused ring, which is not taught or suggested by the prior art. Therefore, the instant compounds are novel and non-obvious variants of the compounds taught in the prior art.
Conclusion
Claims 1-4, 8 and 18 are rejected.
Claims 5-7, 9-10, 12, 15-17 and 19-20 are objected to.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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