DETAILED ACTION
This office action is in response to applicant’s filing dated May 19, 2026.
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 claims
Claims 1 - 20 are pending in the instant application.
Election/Restrictions
Applicant’s election of Group I (claims 1 – 15) in the reply filed on May 19, 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Claims 16 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 19, 2026.
Applicant’s election without traverse of compound of Example 147:
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( specification, page 150) as a songle species of compound of Formula (I) in the reply filed on May 19, 2026 is acknowledged.
Claims 1 – 15 are presently under consideration, as related to elected invention and species (compound of Example 147).
Priority
The present application is a 371 of PCT/JP2022/023210, filed May 27, 2022, and claims the benefit of priority to U.S. Provisional Application No. 63/194,852, filed May 28, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/13/2024, 02/25/2026 and 05/19/2026 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
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 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, 2, 4 – 9, 12, 14 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al (WO 2022/133038 A1, cited in IDS, filed 12/13/2024, hereinafter Wang).
Instant claims are drawn to a compounds of formula (I)
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, where X is
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,
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113
89
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or
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142
129
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Z is
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72
143
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,
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121
206
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or
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105
113
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; Y is
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, Ring Y is unsubstituted or independently substituted by 1 to 4 RY substituents selected from the group consisting of halo, hydroxy, amino, C1-C3 alkyl, C2-C3 alkynyl, and C1-C3 fluoroalkyl; n is 2; m is 0. Instant claims are further drawn to a pharmaceutical composition comprising compound of formula (I), an additional anticancer agent and a pharmaceutically acceptable carrier.
Wang teaches compounds of Formula (I):
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(page 16, [0082]), exemplary compounds of Formula (I) are:
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,
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190
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,
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200
231
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,
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179
211
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,
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201
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,
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(pages 29 – 56, [00191]). Wang further teaches pharmaceutical composition comprising compound of Formula (I) and a pharmaceutically acceptable carrier. The compound of Formula (I) also may be co-administered with other anti-neoplastic compounds (page 56, [00193] and page 62, [00208]).
Thus, Wang teaches compounds exhibiting KRAS inhibitory activity and having a structure identical to instantly claimed compounds encompassed by claims 1, 2, 4 – 9 and 12.
Thus, teachings of Wang anticipate the compounds and composition of instant claims 1, 2, 4 – 9, 12, 14 and 15.
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kawai et al (WO 2021/107160 A1, cited in IDS, filed 12/13/2024, hereinafter Kawai).
The applied reference has a common applicant and/or join inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Instant claims are drawn to a compound of formula (I):
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, where X is a 6- to 9-membered monocyclic- or fused bicyclic- or bridged bicyclic- heterocycloalkyl, wherein said heterocycloalkyl is saturated and contains 1 to 2 heteroatoms selected from the group consisting of N, S, and O, X is unsubstituted or independently substituted by 1 to 4 RX substituents selected from the group consisting of C1-C6 alkyl, carbamoyl, cyano, cyanomethyl, amino, C1-C3 alkoxy and NHC(O)C5-C10heteroaryl; Z is
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111
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and P is 5- to 8-membered monocyclic- or fused bicyclic- or bridged bicyclic-heterocycloalkyl, wherein said heterocycloalkyl is saturated and contains 1 to 2 heteroatoms selected from the group consisting of N and O; Ring Y is unsubstituted or independently substituted by 1 to 4 RY substituents selected from the group consisting of halo, hydroxy, amino, C1-C3 alkyl, C2-C3 alkynyl, and C1-C3 fluoroalkyl; e.g.: Y is
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105
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or
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97
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; n is 1 or 2; m is 1.
Kawai teaches compounds of formula (1):
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, such as compound:
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(page 152, ex. 13).
Thus, Kawai teaches compounds exhibiting KRAS inhibitory activity and having a structure identical to instantly claimed compounds encompassed by claims 1 and 10.
Thus, teachings of Kawai anticipate compounds of instant claims 1 and 10.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (WO 2022/133038 A1, cited in IDS, filed 12/13/2024).
Instant claims are drawn to a compound of formula (I):
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, where X is
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105
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,
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113
89
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or
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Z is
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,
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121
206
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or
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; Y is
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, Ring Y is unsubstituted or independently substituted by 1 to 4 RY substituents selected from the group consisting of halo, hydroxy, amino, C1-C3 alkyl, C2-C3 alkynyl, and C1-C3 fluoroalkyl; such as Y is
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,
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97
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or
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; n is 2; m is 0. The exemplary structures are:
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,
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.
Wang teaches compounds of Formula (I):
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(page 16, [0082]), where fragment
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is
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,
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(
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) or
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, R4, R5 and R6 is hydrogen; A is a
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or
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optionally substituted with 1 – 4 R1, each R1 is halogen, cyano, hydroxy, C1-C4 alkyl or C1-C3 haloalkyl; B is
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,
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or
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; such as compounds:
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,
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190
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,
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200
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,
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179
211
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,
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,
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(pages 29 – 56, [00191]). Although exemplary compounds taught by Wang have three substituents in ring A, whereas instantly claimed compounds have two substituents in the same fragment (ring Y), the description of claims allows 1-4 substituents of the same structure in fragment A of Wang and corresponding ring Y of instantly claimed compounds.
Thus, since Wang teaches compounds, where all structural elements are identical to those of instantly claimed compounds, and where compounds taught by prior art are useful for the same purpose (KRAS inhibitors), it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to make various known in the art structurally analogous compounds by selecting and combining known variables to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an effective KRAS inhibiting agent with improved desired properties, with the reasonable expectation of success.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tian et al (WO 2021/219072 A1, cited in IDS, filed 12/13/2024, hereinafter Tian).
Instant claims are drawn to a compound of formula (I):
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, where X is a 6- to 9-membered monocyclic- or fused bicyclic- or bridged bicyclic- heterocycloalkyl, wherein said heterocycloalkyl is saturated and contains 1 to 2 heteroatoms selected from the group consisting of N, S, and O, X is unsubstituted or independently substituted by 1 to 4 RX substituents selected from the group consisting of C1-C6 alkyl, carbamoyl, cyano, cyanomethyl, amino, C1-C3 alkoxy and NHC(O)C5-C10heteroaryl; Z is
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72
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,
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121
206
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or
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105
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; Y is
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, Ring Y is unsubstituted or independently substituted by 1 to 4 RY substituents selected from the group consisting of halo, hydroxy, amino, C1-C3 alkyl, C2-C3 alkynyl, and C1-C3 fluoroalkyl; such as Y is
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105
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,
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97
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or
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; n is 1; m is 0.
Tian teaches compounds of formula (I-3):
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(page 8, line 1), where ring W is a 4- to 12-element saturated or partially saturated monocyclic ring or bridged ring; R1 is -L1-T, where L1 is a bond, -O-, -NRaC(O)-, Ra is hydrogen, and T is an alkyl, or heterocyclyl; Q and M is N; L-R2 is
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or
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; R3 is naphthyl or heteroaryl group, optionally substituted with 1, 2, or 3 substituents e.g.: halogen; cyano; -ORd, where Rd is hydrogen , alkyl or haloalkyl; such as R3 is
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or
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(see English translation, [0011], [0014], [0016] – [0031]). The compounds taught by Tian have an equivalent or similar structure to instantly claimed compounds, if all the variables as described above.
Thus, since Tian teaches compounds, where all structural elements are identical to those of instantly claimed compounds, and where compounds taught by prior art are useful for the same purpose (KRAS inhibitors), it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to make various known in the art structurally analogous compounds by selecting and combining known variables to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an effective KRAS inhibiting agent with improved desired properties, with the reasonable expectation of success.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1, 2, 3, 9 – 12 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 - 16, 18 and 19 of copending Application No. 17780597 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are drawn to a compound of formula (I):
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, where X is a 6- to 9-membered monocyclic- or fused bicyclic- or bridged bicyclic- heterocycloalkyl, wherein said heterocycloalkyl is saturated and contains 1 to 2 heteroatoms selected from the group consisting of N, S, and O, X is unsubstituted or independently substituted by 1 to 4 RX substituents selected from the group consisting of C1-C6 alkyl, carbamoyl, cyano, cyanomethyl, amino, C1-C3 alkoxy and NHC(O)C5-C10heteroaryl; Z is
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,
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121
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or
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; Y is
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, Ring Y is unsubstituted or independently substituted by 1 to 4 RY substituents selected from the group consisting of halo, hydroxy, amino, C1-C3 alkyl, C2-C3 alkynyl, and C1-C3 fluoroalkyl; such as Y is
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,
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or
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; n is 1 or 2; m is 0 or 1. Instant claims are further drawn to a pharmaceutical composition comprising compound of formula (I) and a pharmaceutically acceptable carrier.
Claims of copending application are directed to a compound of formula:
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, such as compound:
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(specification, page 149, ex. 7) or
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(specification page 158, ex. 31). Claims of copending application are further directed to a pharmaceutical composition comprising compound of formula (1) and a pharmaceutically acceptable carrier.
Thus, copending application discloses compounds of identical or similar structure to instantly claimed compounds.
Thus, compounds disclosed in copending application would anticipate instantly claimed compounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 – 15 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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