Prosecution Insights
Last updated: July 17, 2026
Application No. 18/563,357

HETEROCYCLIC COMPOUNDS AS KRAS INHIBITOR, AND PREPARATION THEREFOR AND USE THEREOF IN TREATMENT

Non-Final OA §102§112
Filed
Nov 21, 2023
Priority
May 22, 2021 — CN 202110561238.1 +2 more
Examiner
SAEED, KAMAL A
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shanghai Kechow Pharma Inc.
OA Round
1 (Non-Final)
84%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
93%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allowance Rate
1010 granted / 1205 resolved
+23.8% vs TC avg
Moderate +10% lift
Without
With
+9.6%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 0m
Avg Prosecution
16 currently pending
Career history
1227
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
5.8%
-34.2% vs TC avg
§102
3.1%
-36.9% vs TC avg
§112
3.1%
-36.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1205 resolved cases

Office Action

§102 §112
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 . Claims 1-20 are currently pending in this Application. Claims 18-20 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. Priority CONTINUING DATA This application is a 371 of PCT/CN2022/094300 05/22/2022 FOREIGN APPLICATIONS CHINA CN202110561238.1 05/22/2021 CHINA CN202210508194.0 05/10/2022 Information Disclosure Statement Applicant’s Information Disclosure Statement, filed on November 19, 2024 has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith. Response to Restriction Applicants’ election, without traverse, the invention of Group I, claims 1-17, drawn to products of Formula I, PNG media_image1.png 203 217 media_image1.png Greyscale and the specific compound of Example 226, PNG media_image2.png 322 234 media_image2.png Greyscale , in response filed April 28, 2026 is acknowledged. Therefore, the restriction requirement is considered proper and is maintained. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a petition under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i). The scope of the invention of the elected subject matter is as follows: Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id. The elected species was searched and no prior art was identified. Therefore, the scope of the examined subject matter was expanded to include products of Formula I, PNG media_image1.png 203 217 media_image1.png Greyscale , depicted in claim 1, wherein: PNG media_image3.png 105 72 media_image3.png Greyscale is PNG media_image4.png 192 107 media_image4.png Greyscale , PNG media_image5.png 170 103 media_image5.png Greyscale or PNG media_image6.png 173 106 media_image6.png Greyscale ; Q1 is N; Q2 is CH; Q3 is N; M1 is N; M2 is CH; L is O; R1 is as defined; R3 is as defined; R4 is as defined; R2 alkyl substituted by PNG media_image7.png 28 674 media_image7.png Greyscale ; and the rest of the variables are as defined. As result of the election and the corresponding scope of the invention identified supra, the remaining subject matter of claims 1-17, are withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to non-elected inventions. The withdrawn compounds contain varying functional groups, which are chemically recognized to differ in structure and function from the elected variables. For example R2 could be alkyl group, which is different from the elected heterocyclyl group. This recognized chemical diversity of the functional groups can be seen by the various classifications of these functional groups in the CPC classification system. Therefore the subject matter which are withdrawn from consideration as being non-elected subject differ materially in structure and composition and have been restricted properly a reference which anticipated but the elected subject matter would not even render obvious the withdrawn subject matter and the fields of search are not co-extensive. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173). Claims, 5, 7, 8, 9, 10, 12-14, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Regarding claim 5, lines 3 and 4, the phrases “preferably” and “more preferably” render the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 6-9 are similarly rejected as these claims depend either directly or indirectly from claim 5 and don’t provide further clarity. Appropriate correction is required. Regarding claim 7, line 3, the phrase “preferably” render the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. Regarding claim 9, lines 6 and 7, the phrases “preferably” and “more preferably” render the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. Regarding claim 10, lines 6 and 7, the phrases “preferably” and “more preferably” render the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. Regarding claim 12, lines 3, and 5-7, the term “e.g” render the claims indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required. PNG media_image8.png 200 400 media_image8.png Greyscale The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173). Claim 16, is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Appropriate correction is required. Claim 16 recites the limitation “wherein the compound is a specific compound disclosed by the invention”. Hundreds of compounds are disclosed in the specification. It is unclear which are the specific compounds intended by Applicants. It is suggested that Applicants included the specific compounds into the claim. Appropriate correction is required. Claim Objections Claims 11 and 15 are objected to because of the following informalities: claim 11 and 15 recite the definition of variables L-R2 and R3 respectively. The claims list the definition of the aforementioned variables, however the list is not written in the alternative. The word “or” should precede the last depicted structures to present a proper Markush claim. Appropriate correction is required. Claims 1-17 are also objected to for containing non-elected subject matter. Appropriate correction is required. 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. (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 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by . WO 2021041671. The elected invention is drawn to products of Formula I, PNG media_image1.png 203 217 media_image1.png Greyscale , depicted in claim 1, wherein: PNG media_image3.png 105 72 media_image3.png Greyscale is PNG media_image4.png 192 107 media_image4.png Greyscale , PNG media_image5.png 170 103 media_image5.png Greyscale or PNG media_image6.png 173 106 media_image6.png Greyscale ; Q1 is N; Q2 is CH; Q3 is N; M1 is N; M2 is CH; L is O; R1 is as defined; R3 is as defined; R4 is as defined; R2 alkyl substituted by PNG media_image7.png 28 674 media_image7.png Greyscale ; and the rest of the variables are as defined. Claims 2-15 further define the substituents of in the products of Formula I. Clam 17 is directed to a pharmaceutical composition comprising products of Formula I. WO 2021041671 teach products that anticipate the instant claims. Please see the compound depicted in pages 20-62. The following are some of the compounds:: PNG media_image9.png 153 172 media_image9.png Greyscale ; PNG media_image10.png 141 192 media_image10.png Greyscale ; PNG media_image11.png 142 174 media_image11.png Greyscale ; PNG media_image12.png 143 184 media_image12.png Greyscale ; PNG media_image13.png 136 180 media_image13.png Greyscale ; PNG media_image14.png 142 206 media_image14.png Greyscale etc Therefore, claims 1-17 are anticipated by WO 2021041671. Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000 /Kamal A Saeed/ Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Nov 21, 2023
Application Filed
Jun 29, 2026
Non-Final Rejection mailed — §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
84%
Grant Probability
93%
With Interview (+9.6%)
2y 0m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1205 resolved cases by this examiner. Grant probability derived from career allowance rate.

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