NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Jun. 8, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 1, 2, 25, and 26 have been amended and incorporate no new matter.
Claims 3, 5, 7, 12-14, 17, 19, 21-24, and 28-50 stand withdrawn as drawn to nonelected inventions and/or species.
No claims are canceled, and no new claims have been added.
Thus, claims 1, 2, 4, 6, 8-11, 15-16, 18, 20, and 25-27 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
MAINTAINED REJECTIONS
The following rejections are maintained from the previous Office Action dated Mar. 6, 2026, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Claim Rejections - 35 U.S.C. § 102
Claims 1, 2, 4, 6, 8-11, 15, 16, 18, and 27 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (WO 2022/068921, of record).
Zhang et al. exemplify compound 280a (pp. 717, 932), having the structural formula,
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which reads on formula (I) as recited by claims 1, 2, 4, 6, 8, 9, 11, 15, 16, and 18, wherein:
A is aryl (naphthyl), substituted by two R1 (fluoro and ethyl);
B is pyrrolizidine, wherein R2 is halogen (fluoro) and n is 1; and R3 is H or n is 0;
L is a bond;
Z is C and R10 is halogen (fluoro);
R4 is halogen (fluoro) and each R6 is hydrogen;
Y1 and Y2 join to form an azepane ring,
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where X is -CH2-CH2-; p is 2; and two R7 on non-adjacent atoms of the azepane ring join to form a one-membered nitrogen (-NH-) bridge, yielding 3,8-diazabicyclo[3.2.1]oct-3-yl.
Zhang et al. further exemplify compound 285a (pp. 734, 934), having the structural formula,
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which reads on formula (I) as recited by claims 1, 2, 4, 6, 8, 10, 11, 15, 16, and 18, wherein:
A is aryl (naphthyl), substituted by two R1 (hydroxy and ethyl);
B is pyrrolizidine, wherein R2 is halogen (fluoro) and n is 1; and R3 is H or n is 0;
L is a bond;
Z is C and R10 is halogen (fluoro);
R4 is halogen (fluoro) and each R6 is hydrogen;
Y1 and Y2 join to form an azepane ring,
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where X is -CH2-CH2-; p is 2; and two R7 on non-adjacent atoms of the azepane ring join to form a one-membered nitrogen (-NH-) bridge, yielding 3,8-diazabicyclo[3.2.1]oct-3-yl.
The compounds of Zhang et al. are disclosed in pharmaceutical compositions together with one or more pharmaceutical excipients (claim 19), as recited by claim 27.
Thus, Zhang et al. anticipates claims 1, 2, 4, 6, 8-11, 15, 16, 18, and 27.
Claims 1, 2, 4, 6, 9-11, 15, 16, 18, and 27 stand rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xiao et al. (WO 2023/138583, of record).
Xiao et al. disclose compounds of formula (I-0) as KRAS G12D inhibitors, useful in the treatment of tumors, and pharmaceutical compositions comprising the compounds (para. [0006]).
In particular, Xiao et al. exemplify the compound of example 45 (p. 135; claim 12), having the structural formula,
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which reads on formula (I) as recited by claims 1, 2, 4, 6, 9-11, 15, 16, and 18, wherein:
A is aryl (naphthyl), substituted by three R1 (fluoro, hydroxy, and ethynyl);
B is pyrrolizidine, wherein R2 is halogen (fluoro) and n is 1; and R3 is H or n is 0;
L is a bond;
Z is C and R10 is halogen (chloro);
R4 is halogen (fluoro) and each R6 is hydrogen;
Y1 and Y2 join to form an azepane ring,
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where X is -CH2-CH2-; p is 2; and two R7 on non-adjacent atoms of the azepane ring join to form a one-membered nitrogen (-NH-) bridge, yielding 3,8-diazabicyclo[3.2.1]oct-3-yl.
The compounds of Xiao et al. are disclosed in pharmaceutical compositions together with pharmaceutical excipients (claim 17), as recited by claim 27.
Thus, Xiao et al. anticipates claims 1, 2, 4, 6, 9-11, 15, 16, 18, and 27.
Double Patenting
Claims 1, 2, 4, 6, 10, 11, 15, 16, 18, and 27 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9-12, and 14-35 of copending Application No. 18/034,852 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims encompass compounds falling within the scope of the examined claims.
Specifically, reference claim 26 recites the compound species,
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which reads on formula (I) as recited by examined claims 1, 2, 4, 6, 10, 11, 15, 16, 18, and 27, wherein:
A is aryl (naphthyl), substituted by one R1 (hydroxy);
B is pyrrolizidine, wherein R2 is halogen (fluoro), and R3 is H or n is 0;
L is a bond;
Z is C and R10 is hydrogen or absent;
R4 is halogen (fluoro) and each R6 is hydrogen; and
Y1 and Y2 join to form an azepane ring,
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where X is -CH2-CH2-; p is 2; and two R7 on non-adjacent atoms of the azepane ring join to form a one-membered nitrogen (-NH-) bridge, yielding 3,8-diazabicyclo[3.2.1]oct-3-yl.
Thus, it remains that the compound(s) of reference claim 26 would have anticipated the examined claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO ARGUMENTS
Applicant's arguments filed Jun. 8, 2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102(a)(1) over Zhang et al. and under 35 U.S.C. § 102(a)(2) over Xiao et al., Applicant argues that the claim amendments exclude compounds 280a and 285a of Zhang et al. and compound 45 of Xiao et al. (Remarks, pp. 43-44).
Similarly, with respect to the nonstatutory double patenting rejection over co-pending application 18/034,852, Applicant argues that the claim amendments exclude the compounds of reference claim 26 (Remarks, p. 46).
However, as set forth above, the cited compounds continue to read on the amended claims, wherein Y1 and Y2 join to form an azepane ring,
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where X is -CH2-CH2-; p is 2; and two R7 on non-adjacent atoms of the azepane ring join to form a one-membered nitrogen (-NH-) bridge, yielding 3,8-diazabicyclo[3.2.1]oct-3-yl.
Applicant’s arguments, see Remarks, pp. 44-45, filed Jun. 8, 2026, with respect to the rejection under 35 U.S.C. § 103 over Xiao et al. in view of Zhang et al., have been fully considered and are persuasive.
Specifically, Applicant agrees that the elected species is entitled to a priority date of Jun. 14, 2022. Applicant argues that compound 153 of Xiao et al. is entitled to a priority date no earlier than Jan. 4, 2023, when compound 153 was first disclosed. Thus, because the priority date of compound 153 of Xiao et al. (Jan. 4, 2023) is later than that of the elected species (Jun. 14, 2022), Applicant argues that Xiao et al. is not available as prior art (Remarks, pp. 44-45).
To clarify, the Xiao et al. reference (WO 2023/138583) claims benefit of priority to the following earlier-filed Chinese applications (all cited on PTO-892):
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As recognized by MPEP § 2154.01(b), AIA 35 U.S.C. 102(d) requires that a prior-filed application to which a priority or benefit claim is made must describe the subject matter from the U.S. patent document relied upon in a rejection.
Compound 153 of Xiao et al. is not disclosed in priority applications CN 2023-10069864.3 (filed Jan. 21, 2022) or CN 2022-10500130.6 (filed May 6, 2022). Because compound 153 of Xiao et al. was not disclosed before the priority date of the elected species (Jun. 14, 2022), the rejection under 35 U.S.C. § 103 over Xiao et al. in view of Zhang et al. is withdrawn.
However, upon further consideration, new ground(s) of rejection are set forth below.
NEW REJECTIONS
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, 4, 9, 11, 15, 16, 18, 20, and 25-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Li et al. (WO 2022/173870, cited on PTO-892).
Li et al. exemplify compound 598 (Table 1, p. 698), which is identical to the compound of Example 211 recited by claim 26,
Li et al. Compound 598
Claimed Formula (I)
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which reads on formula (I) as recited by claims 1, 4, 9, 11, 15, 16, 18, 25, and 26, wherein:
A is heteroaryl (benzo[b]thiophene), substituted with three R1: halogen (fluoro); N(R5)2 (amino); and cyano;
Z is C and R10 is halogen (chloro);
R4 is halogen (fluoro);
Y1 and Y2 join to form an oxazepane ring,
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where X is -O-CH2-, and R7 is H or p is 0;
each R6 is hydrogen;
L is a bond; and
B is pyrrolizidine, wherein R2 is halogen (fluoro) and n is 1; and R3 is H or n is 0.
In addition, Li et al. exemplify compound 623 (Table 1, p. 703),
Li et al. Compound 623
Claimed Formula (I)
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which reads on formula (I) as recited by claims 1, 4, 9, 11, 15, 16, 18, 20, and 25, wherein:
A is heteroaryl (benzo[d]thiazole), substituted with two R1: halogen (fluoro), N(R5)2 (amino);
Z is C and R10 is halogen (chloro);
R4 is halogen (fluoro);
Y1 and Y2 join to form a piperidine ring,
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where X is -CH-, p is 2, and two R7 on adjacent atoms join to form a fused heterocyclic ring (pyrrolidine);
each R6 is hydrogen;
L is a bond; and
B is pyrrolizidine, wherein R2 is halogen (fluoro) and n is 1; and R3 is H or n is 0.
The compounds of Li et al. are disclosed in a pharmaceutical composition together with a pharmaceutically acceptable excipient (para. [0034]; claim 94), as recited by claim 27.
Thus, Li et al. anticipates claims 1, 4, 9, 11, 15, 16, 18, 20, and 25-27.
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 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
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