Prosecution Insights
Last updated: April 19, 2026
Application No. 18/555,640

SMALL MOLECULE INHIBITORS OF KRAS G12D MUTANT

Non-Final OA §112
Filed
Oct 16, 2023
Examiner
OH, TAYLOR V
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Merck Sharp & Dohme LLC
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
2y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
1415 granted / 1742 resolved
+21.2% vs TC avg
Strong +15% interview lift
Without
With
+15.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
35 currently pending
Career history
1777
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
33.6%
-6.4% vs TC avg
§102
19.5%
-20.5% vs TC avg
§112
37.3%
-2.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1742 resolved cases

Office Action

§112
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 . Non-Final Rejection The Status of Claims: Claims 1-7 are pending. Claims 6-7 are rejected. Claims 1-5 are allowable. DETAILED ACTION 1. Claims 1-7 are under consideration in this Office Action. Priority 2. It is noted that this application is a 371 of PCT/US2022/025132 04/15/2022 PCT/US2022/025132 , which has a priority date of 63176135 04/16/2021. Drawings 3. None. IDS 4. The IDS filed on 12/12/24 were reviewed by the examiner. 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. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 6-7 set forth the treatment of cancer generally. However, there never has been a compound capable of treating cancer generally. There are compounds that treat a range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers. Thus, the existence of such a “silver bullet” is contrary to our present understanding in oncology. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, such as viruses (e.g. EBV, HHV-8, and HTLV-1), exposure to chemicals such as tobacco tars, genetic disorders, ionizing radiation, and a wide variety of failures of the body’s cell growth regulatory mechanisms. Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities. Thus, it is beyond the skill of oncologists today to get an agent to be effective against cancers generally, evidence that the level of skill in this art is low relative to the difficulty of such a task. When the best efforts have failed to achieve a goal, it is reasonable for the PTO to require evidence that such a goal has been accomplished, In re Ferens, 163 USPQ 609. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs Novo Nordisk, 42 USPQ2nd 1001, 1006. The Close Prior Art The close prior art to the current invention is Wang et al (WO 2021/041671 A1), which discloses the following compound: PNG media_image1.png 150 171 media_image1.png Greyscale . However, this prior art compound is different from one of the claimed compounds as shown : PNG media_image2.png 268 373 media_image2.png Greyscale with respect to the core structure of PNG media_image3.png 72 115 media_image3.png Greyscale as well as other different substituents around the claimed compound. Thus, it would have been unobvious ove the claimed invention. Conclusion Claims 6-7 are rejected. Claims 1-5 are allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00. 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, Andrew Kosar can be reached at 571-272-0913. 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. /TAYLOR V OH/Primary Examiner, Art Unit 1625 1/24/2026
Read full office action

Prosecution Timeline

Oct 16, 2023
Application Filed
Jan 24, 2026
Non-Final Rejection — §112 (current)

Precedent Cases

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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
81%
Grant Probability
96%
With Interview (+15.3%)
2y 5m
Median Time to Grant
Low
PTA Risk
Based on 1742 resolved cases by this examiner. Grant probability derived from career allow rate.

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