NON-FINAL REJECTION
This application, filed May 30, 2024, claims benefit of foreign priority to PCT/CN2024/090756, filed Apr. 30, 2024; PCT/CN2023/125498, filed Oct. 19, 2023; and PCT/CN2023/097387, filed May 31, 2023.
Claims 77-80 and 83-103, as amended, 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
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d) to PCT applications PCT/CN2024/090756, filed Apr. 30, 2024; PCT/CN2023/125498, filed Oct. 19, 2023; and PCT/CN2023/097387, filed May 31, 2023. It is noted, however, that applicant has not filed a certified copy of these applications as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/8/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, drawn to compounds and compositions, and Compound 91 as the compound species, having the structural formula,
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in the reply filed on Jun. 29, 2026 is acknowledged.
The traversal is on the ground(s) that search and examination of Groups I and II does not present an undue burden to the Office. Further, since method claims 79, 80, and 103 ultimately depend from and include all of the limitations of claim 77, Applicant requests rejoinder of Group II, method claims 79, 80, and 103, upon allowance of the Group I claims (Remarks, p. 2).
Applicant’s election in the reply filed on Jun. 29, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 79, 80, 83, and 85-103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Jun. 29, 2026.
Claims 77, 78, and 84 are currently pending and under consideration.
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.
1. Claims 77, 78, and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52-53 of copending Application No. 18/676,648 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 52 recites a compound that is an obvious structural variant of the elected compound species.
Specifically, compound 468 as recited by reference claim 52 is shown below for comparison with compound 91 as recited by examined claims 77 and 84:
Examined claims 77 and 84
Compound 91
Reference Claim 52
Compound 468
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Reference compound 468 is identical to examined compound 91 except that the pyrazole ring has a hydrogen atom instead of a methyl substituent; inverted configuration at a single chiral center; and the macrocycle comprises a cyclopropyl moiety instead of cyclopentyl.
However, stereoisomers are generally regarded as prima facie obvious. See MPEP § 2144.09 (II); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); and Aventis Pharma Deutschland GmbH v. Lupin Ltd. 84 USPQ2d 1197 at 1204, 499 F.3d 1293 (Fed. Cir. 2007).
Hydrogen and methyl substitutions are known in the art and have been held to be obvious variants of each other. See MPEP § 2144.09 and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
Small cycloalkyl ring-size variations are homologous forms of each other (i.e., compounds differing regularly by the successive addition of the same functional group, e.g., CH2). As recognized by MPEP § 2144.09, compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Reference claim 53 is drawn to a pharmaceutical composition comprising a compound of claim 52 or a pharmaceutically acceptable salt, stereoisomer, tautomer or prodrug thereof, together with a pharmaceutically acceptable excipient, as recited by examined claim 78.
The reference compounds are disclosed to have the same mechanism as the claimed compounds, as EGFR inhibitors, and to be useful for treating the same diseases, e.g., cancer (abstract; claims 54-57).
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 77, 78, and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35-36 of copending Application No. 19/204,126 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 35 recites a compound that is an obvious structural variant of the elected compound species.
Specifically, compound 27 as recited by reference claim 35 is shown below for comparison with compound 91 as recited by examined claims 77 and 84:
Examined claims 77 and 84
Compound 91
Reference Claim 35
Compound 27
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Reference compound 27 is identical to examined compound 91 except that the pyrazole ring has a hydrogen atom instead of a methyl substituent; and the macrocycle comprises a cyclobutyl moiety instead of cyclopentyl, with inverted stereochemistry.
However, stereoisomers are generally regarded as prima facie obvious. See MPEP § 2144.09 (II); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); and Aventis Pharma Deutschland GmbH v. Lupin Ltd. 84 USPQ2d 1197 at 1204, 499 F.3d 1293 (Fed. Cir. 2007).
Hydrogen and methyl substitutions are known in the art and have been held to be obvious variants of each other. See MPEP § 2144.09 and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
Small cycloalkyl ring-size variations are homologous forms of each other (i.e., compounds differing regularly by the successive addition of the same functional group, e.g., CH2). As recognized by MPEP § 2144.09, compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Reference claim 36 is drawn to a pharmaceutical composition comprising a compound of claim 35 or a pharmaceutically acceptable salt, stereoisomer, tautomer or prodrug thereof, together with a pharmaceutically acceptable excipient, as recited by examined claim 78.
The reference compounds are disclosed to have the same mechanism as the claimed compounds, as EGFR inhibitors, and to be useful for treating the same diseases, e.g., cancer (abstract; claim 37).
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 77, 78, and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-50 of copending Application No. 19/402,615 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 49 recites a compound that is an obvious structural variant of the elected compound species.
Specifically, compound 26 as recited by reference claim 49 is shown below for comparison with compound 91 as recited by examined claims 77 and 84:
Examined claims 77 and 84
Compound 91
Reference Claim 49
Compound 26
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Reference compound 26 is identical to examined compound 91 except that the pyrazole ring has a hydrogen atom instead of a methyl substituent; inverted configuration at a single chiral center; and the macrocycle comprises a cyclopropyl moiety instead of cyclopentyl.
However, stereoisomers are generally regarded as prima facie obvious. See MPEP § 2144.09 (II); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); and Aventis Pharma Deutschland GmbH v. Lupin Ltd. 84 USPQ2d 1197 at 1204, 499 F.3d 1293 (Fed. Cir. 2007).
Hydrogen and methyl substitutions are known in the art and have been held to be obvious variants of each other. See MPEP § 2144.09 and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
Small cycloalkyl ring-size variations are homologous forms of each other (i.e., compounds differing regularly by the successive addition of the same functional group, e.g., CH2). As recognized by MPEP § 2144.09, compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Reference claim 50 is drawn to a pharmaceutical composition comprising a compound of claim 35 or a pharmaceutically acceptable salt, stereoisomer, tautomer or prodrug thereof, together with a pharmaceutically acceptable excipient, as recited by examined claim 78.
The reference compounds are disclosed to have the same mechanism as the claimed compounds, as EGFR inhibitors, and to be useful for treating the same diseases, e.g., cancer (abstract; claims 51-52).
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure: US Pub. 2025/0243210 (English equivalent of WO 2023/066350); see Table 4, pp. 477-497.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
Prosecution Insights