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 .
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.
Current Status of 18/481,723
This Office Action is responsive to the amended claims of 6 February 2024.
Claims 1-3, 6, 7, 9-17, 23, 24, 27, 28, 30, 33, 43, 46-48 and 53-56 have been examined on the merits. Claims 1, 2, 54 and 56 are original. Claims 4, 5, 8, 18-22, 25, 26, 29, 31, 32, 34-42, 44, 45, 49-52 have been canceled.
Priority
The effective filing date of the instant application is October 6, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 February 2024; and 5 October 2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 9, 48, 53 and 55 are objected to because of the following informalities:
In claim 9, line 3 “± 25.31 0.2°” should read “25.31 ± 0.2°”.
In claim 48, line 1, “a crystalline form” should read “the crystalline form of compound 1”.
In claim 53, line 2, “a crystalline form” should read “the crystalline form of compound 1”.
In claim 55, line 2, “a crystalline form” should read “the crystalline form of compound 1”.
Appropriate correction is required.
Claim Rejections - 35 USC §102
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)(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 1, 48 and 53-56 are rejected under 35 USC § 102(a)(2) as being anticipated by LI (US 2024/0391937 A1, pub. November 28, 2024, effectively filed September 30, 2022).
Regarding claim 1, drawn to a crystalline form of compound 1 (hereinafter, referred as to “the claimed compound 1”), or pharmaceutical acceptable salt or solvate thereof.
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Compound 1
LI teaches making pharmaceutically acceptable salt and solvate (among others) of the claimed compound 1 (Abstract; structure VII, Ra1=Me; paras [0140] and [0141], p 21). LI further exemplifies the synthesis of the claimed compound 1 (Example 2 and compound 2, p 43). Thus, the instant claim 1 is anticipated by LI.
Examiner interprets a pharmaceutically acceptable salt of the compound 2 of reference LI (page 43) as a crystalline form of the claimed compound 1.
In order to facilitate patent prosecution and overcome the rejection, the Applicants are encouraged to add physical data such as XRPD peaks from various dependent claims to claim 1 to render moot this rejection.
Regarding claim 48, LI teaches a pharmaceutical composition, comprising the claimed compound 1, or pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient and/or carrier (para [0146], p 34). Therefore, LI anticipates the instant claim 48.
Regarding Claim 53, LI teaches the use of the compound, or pharmaceutically acceptable salt thereof, or the pharmaceutical composition for treating/preventing a PARP-1-mediated disease including cancer (para [0148], p 34). Claim 53 is anticipated by LI.
LI anticipates the crystalline compound’s use to treat breast cancer (paras [0001] [0004], page 1 and para [0294], Table 2, page 50), thereby anticipating instant claims 54-56.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 2 drawn to a crystalline form of the freebase claimed compound 1 and dependent claim 3, the closest art is from the following art references: ZHANG (WO 2022/222965 A1, pub. October 27, 2022, effectively filed April 20, 2022, provided by Applicants and referenced in IDS of 10/05/2023. WIPO translate is attached herein). First, ZHANG discloses a series of pyridine derivatives or pharmaceutical acceptable salts or solvates as PARP inhibitors for cancer treatment, including the claimed compound 1 whose synthesis is exemplified in paras [0119] – [0164], but makes no mention of crystal forms of the invented compounds. The claimed compound 1 (free base) is described as a white solid, but NOT in any crystal form as recited in instant claim 2. Secondly, another art reference LI also reveals the same structure of the claimed compound 1 (Example 2 and compound 2 on page 43) as discussed above, but does not reveal the state of the compound. The subtle differences make a crystalline form of free base of the claimed compound 1 distinct from the solid product/pharmaceutically acceptable salt of compound 1 disclosed in the art references. Furthermore, the art search reveals no record of a crystalline, crystal, or amorphous form of the claimed compound 1 and of free base of the claimed compound 1. So, instant claims 2 and 3 are free of the prior arts.
Related Art
Other 102(a)(2) related references, not cited in the Office Action, include TRZOSS (WO 2022/225934 A1, pub. date: October 27, 2022, effectively filed April 19, 2021, which corresponds to U.S. Provisional 63/176,610) and CHEN (WO 2022/222995 A1, pub. date: October 27, 2022, effectively filed April 21, 2022).
Conclusion
Claims 2 and 3 are presently allowable as written.
Claims 1, 48 and 53-56 are rejected under 35 USC §102(a)(2).
Claims 6, 7, 9-17, 23, 24, 27, 28, 30, 33, 43, 46 and 47 are objected to as being dependent upon a rejected base claim, but would be allowable after proper modifications as indicated above.
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/B.T./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625