NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/US2021/054663, filed Oct. 13, 2021, which claims benefit of priority to Provisional Application 63/091,486, filed Oct. 14, 2020.
Claims 1-6, 8-20, and 22, 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
Applicant' s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Jan. 26, 2024 and Jun. 17, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compounds of formula (I), and Compound 1 as the compound species, having the structural formula,
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and reading on claims 1, 3, 4, 6, 8, 10-17, and 22, in the reply filed on Dec. 1, 2025, is acknowledged.
Claims 2, 5, 9, and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Dec. 1, 2025.
Claims 1, 3, 4, 6, 8, 10-17, and 22 are currently pending and under consideration.
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 following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 3, 4, 6, 8, 10-17, and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bie et al. (WO2019/034128, cited on the IDS dated 1/26/2024).
Bie et al. disclose pyrrolotriazine derivatives of formula (I) and methods of use thereof as a therapeutic agent, particularly as a c-KIT inhibitor (abstract).
In particular, Bie et al exemplify compound 22 (table, p. 11), shown side-by-side with claimed formula (I) and the elected compound species for comparison:
Claimed Formula (I)
Elected Species (Compound 1)
Bie et al. Compound 22
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Compound 22 of Bie et al. reads on claimed formula (I) to the extent that Y is N; Z is CH; X1 is N, X2 is C, a is a single bond, and b is a double bond; and B is NH2.
Compound 22 of Bie et al. differs from the claimed compounds only in that the pyrazole substituent is substituted by methyl, rather than A, having the structural formula,
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as recited by claim 1;
and as required by the elected species, wherein A is hydroxyethyl (-CH2CH2OH).
However, Bie et al. disclose compound 22 as a species of formula (I),
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wherein R4 is selected from, e.g., alkyl, which is optionally further substituted by, e.g., -OR8, wherein R8 is hydrogen; i.e., hydroxyl (-OH) (claim 1). Thus, Bie et al. contemplate both unsubstituted alkyl (methyl) and substituted alkyl (hydroxyethyl) pyrazole ring substituents as equivalent alternatives at R4.
Further, the compounds of Bie et al. are disclosed and claimed for use in treating diseases mediated by wildtype c-KIT or PDFGRα, or mutated c-KIT or PDFGRα, e.g., gastrointestinal stromal tumors (GIST), systemic mast cell hyperplasia, acute myeloid leukemia, ovarian cancer, breast cancer, melanoma, cervical cancer, seminoma, dysgerminoma, teratoma, or mast cell tumors or leukemia (claims 28 and 30).
Therefore, it would have been predictable to one of ordinary skill in the art as of the effective filing date to modify the pyrazole substituent of compound 22 of Bie et al., from methyl to hydroxyethyl, to arrive at the elected compound with a reasonable expectation of success, because the compounds of Bie et al. share extremely close structural similarity with the claimed compounds, differing only in the substituents on the identical pharmacophore, and are disclosed to have the same mechanism of action, as inhibitors of c-KIT and PDGFRα, as well as utility for treating the same diseases, e.g., gastrointestinal stromal tumors and systemic mastocytosis.
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).
The closer the chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., In re Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904 (and cases cited therein); and In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995).
Conclusion
No claims are allowed.
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 9:00 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 ELIZABETH TOWNSLEY/Examiner, Art Unit 1629