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.
Election/Restrictions
It is acknowledged that Applicant’s election of Group I (claims 105-107 and 110-124), and the following species in Group I, in the reply filed on 07/20/2026. Because Applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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The elected species reads on claims 105-107 and 112. Claims 108-109 are withdrawn from further consideration pursuant to 37 CFR 1.42(b) as being to nonelected invention of Groups II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/20/2026.
The prior art search of the elected species did not retrieve prior art. The extended Markush search to the full scope of claim 105 retrieved prior art. The search will not be unnecessarily extended further in this office action, in line with Markush search practice.
The prior art search of the elected species and extended Markush search read on claims 105-107 and 110-124.
Current Status of 18/600,161
This Office Action is responsive to the amended claims of 04/03/2025. Claims 106-107 have been amended. Claims 110-124 are newly added. Claims 108-109 have been withdrawn. Claims 105-107 and 110-124 are pending and have been examined on the merits.
Priority
This application is a CON of PCT/US2023/025368, filed 06/15/2023, which claims benefit of 63/407,247, filed 09/16/2022 and claims benefit of 63/352,872, filed 06/16/2022.
Information Disclosure Statement
Two information disclosure statements (IDSs) submitted on 04/03/2025 and 07/20/2026 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 § 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.
Claim(s) 105-107 and 114 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by ZHANG (WO 2023/208143 Al, pub date: 02/11/2023, effectively filed on 07/15/2022, the priority document is referenced as “PD”) and evidenced by LUKASIK (Lukasik et al. “Cyclin-Dependent Kinases (CDK) and Their Role in Diseases Development–Review” Int. J. Mol. Sci. 2021, 22, 2935). Zhang teaches the following compound (Claim 15, line 1, #1, p. 20, PD) and its preparation is exemplified as Example 26 on pages 56-57 (“PD”):
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Thus, Zhang anticipates claims 105 and 114.
Regarding claims 106-107 directed to composition and medical use of the compound, Zhang further teaches a pyrazole-substituted cyclopentyl ester of formula (I), its isomer or its pharmaceutically acceptable salt, a pharmaceutical composition containing an effective amount of the compound, optionally, with a pharmaceutically acceptable excipient (claim 16, PD) and use of the compound in the preparation of a drug for treating or preventing CDK2-mediated diseases (claim 17, PD).
The connection of CDK2 with diseases is evidenced by Lukasik’s teaching that CDK2 has been associated with a variety of cancer types, including breast, colon, and prostate carcinomas (Section 6.2, pages 11 of 34). The oral administration is interpreted as a form of use of the compound (composition) to treat disease. Therefore, claims 106-107 are anticipated by Zhang as evidenced by Lukasik.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 105, 110-118, 120 and 122-124 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 73-74 and 76 of copending Application No. PCT/US2023/025368 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the reference and instant applications disclose anilino-pyrazole compounds as CDK2 inhibitors, including compositions and methods for treating cancer. However, the reference application is much broader in scope regarding the chemical structures covered. As demonstrated in Table 1, most of the currently claimed compounds are structurally identical to those disclosed in the reference application.
Table 1. Location of the reference structures in ‘368.
Instant Claim
Reference Claim
Ref. Structure Location
(Line-position #)
Reference
Page Number
110
73
1-1
303
111
73
2-2
304
112
73
3-1
304
113
73
3-2
303
114
73
3-1
297
115
74
3-1
312
116
73
2-1
297
117
74
5-2
308
118
73
1-2
297
123
74
1-1
305
124
76
2-1
320
The instant claims 110-118 and 123-124 are anticipated by the corresponding reference claims since they are identical and have same application as a CDK2 inhibitor for treatment of cancer.
In addition, claims 120 and 122 are obvious over the structure in reference claim 74 (Line 3-1, p. 312) because claim 120 differs from reference claim 74 solely in the ring size connecting the pyrazole ring and the carbamate group, specifically reciting a 6-membered ring (indicated by the arrow) whereas the ’368 reference discloses a 5-membered ring. Claim 122 differs from reference claim 74 solely in the sulfone ring size, reciting a 6-membered sulfone ring whereas the ’368 reference discloses a 5-membered sulfone ring.
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Ref claim 74 Instant claim 120 Instant claim 122
However, the ’368 reference expressly teaches varying both ring sizes between 5-membered and 6-membered structures. This teaching is evidenced by Line 3-1 and 3-2, Line 1-1 and 2-1, claim 73, and page 304 of the reference (shown below). Because the reference explicitly contemplates interchanging 5-membered and 6-membered rings for these structures, it would have been obvious to the artisan to modify the 5-membered rings of reference claim 74 to arrive at the 6-membered rings of claims 120 and 122.
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MPEP 2144.09(I). REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
MPEP 2144.09(II). HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 119 and 121 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding the instant claims 119 and 121, There is no known prior art reference that teaches or anticipates the instant claims, nor is there any double patenting.
Conclusion
Claims 105-107, 110-118, 120 and 122-124 are rejected.
Claims 119 and 121 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
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/B.T./
Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
