Prosecution Insights
Last updated: April 19, 2026
Application No. 18/043,357

PLASMA KALLIKREIN INHIBITORS

Final Rejection §103§112§DP
Filed
Feb 28, 2023
Examiner
HERNANDEZ, JACKSON J
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Merck Sharp & Dohme LLC
OA Round
2 (Final)
50%
Grant Probability
Moderate
3-4
OA Rounds
3y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
15 granted / 30 resolved
-10.0% vs TC avg
Strong +51% interview lift
Without
With
+51.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
87 currently pending
Career history
117
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
34.9%
-5.1% vs TC avg
§102
11.8%
-28.2% vs TC avg
§112
24.7%
-15.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 30 resolved cases

Office Action

§103 §112 §DP
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 . Status of the Claims Claims 1-14 and 17-18 are pending in this application. Claims 15-16 have been cancelled by applicant. Allowable Subject Matter Claims 1-8, 10-14, and 17-18 are allowed. 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. Claim 9 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. Claim 9 recites the limitation "compounds 1-208." There is insufficient antecedent basis for this limitation in the claim. Furthermore, the compounds in the specification are labeled as “Examples” not as “compounds”. Applicant may either cancel the claim or clearly incorporate compounds 1-208 into the claim. Applicant is advised, as stated in MPEP 2173.05(s), claims should be complete to themselves and the reference to tables renders the claims incomplete. Claims which recite figures or tables are only permitted in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into a claim. Response to Arguments Claims Claim amendments are acknowledged. No new matter has been introduced. Specification Applicant’s comments are acknowledged. Objections to the specification are withdrawn. Claim Rejections - 35 USC § 112(b) Applicant’s arguments, see page 7, filed 12/19/2025, with respect to the 35 USC § 112(b) rejection of claim 1 have been fully considered and are persuasive. The 35 USC § 112(b) rejection of claim 1 has been withdrawn. Applicant, however, has failed to acknowledge the 35 USC § 112(b) rejection of claim 9, therefore, the 35 USC § 112(b) rejection of claim 9 is maintained. Claim Rejections - 35 USC § 103 Applicant’s arguments, see pages 7-8, filed 12/19/2025, with respect to the 35 USC § 103 rejections have been fully considered and are persuasive. The 35 USC § 103 rejection of the claims has been withdrawn. Double Patenting The terminal disclaimer filed on 12/19/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12,459,927 (cited as Copending App. No. 18/007,787 (Copending ‘787) in the non-final action filed 08/01/2025) has been reviewed and is accepted. The terminal disclaimer has been recorded. The obviousness-type double patenting rejections over Copending App. No. 18/007,787 (Copending ‘787) (now US Patent No. 12,459,927) have been withdrawn. Conclusion THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5. Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. 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. /JACKSON J HERNANDEZ/Examiner, Art Unit 1627 /Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Feb 28, 2023
Application Filed
Jul 29, 2025
Non-Final Rejection — §103, §112, §DP
Dec 19, 2025
Response Filed
Jan 11, 2026
Final Rejection — §103, §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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CRYSTAL FORM OF RESMETIROM, PREPARATION METHOD THEREFOR, AND USE THEREOF
2y 5m to grant Granted Apr 07, 2026
Patent 12565495
VMAT2 INHIBITOR AND PREPARATION METHOD THEREFOR AND APPLICATION THEREOF
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Patent 12565494
INHIBITORS OF HUMAN RESPIRATORY SYNCYTIAL VIRUS AND METAPNEUMOVIRUS
2y 5m to grant Granted Mar 03, 2026
Patent 12559485
CDK6/DYRK2 DUAL-TARGET INHIBITOR, AND PREPARATION METHOD THEREFOR AND USE THEREOF
2y 5m to grant Granted Feb 24, 2026
Patent 12522584
3,4-DIHYDROISOQUINOLINE COMPOUND AND USE THEREOF
2y 5m to grant Granted Jan 13, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
50%
Grant Probability
99%
With Interview (+51.1%)
3y 2m
Median Time to Grant
Moderate
PTA Risk
Based on 30 resolved cases by this examiner. Grant probability derived from career allow rate.

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