Prosecution Insights
Last updated: April 19, 2026
Application No. 19/313,605

TOPICAL OCULAR DELIVERY OF CROMAKALIM

Non-Final OA §DP
Filed
Aug 28, 2025
Examiner
RAMOS LEWIS, JOSMALEN MILAGROS
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Mayo Foundation for Medical Education and Research
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
2y 6m
To Grant
78%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
30 granted / 56 resolved
-6.4% vs TC avg
Strong +24% interview lift
Without
With
+24.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
31 currently pending
Career history
87
Total Applications
across all art units

Statute-Specific Performance

§103
51.8%
+11.8% vs TC avg
§102
24.4%
-15.6% vs TC avg
§112
14.7%
-25.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 56 resolved cases

Office Action

§DP
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 . Claim Status Claims 1-24 are pending examination. Priority Status PNG media_image1.png 106 326 media_image1.png Greyscale Examiner acknowledged the effective filing date of the application as 11/04/2022. Examiner also acknowledges this application is a CON of PCT/US2023/078754. Information Disclosure Statement All references have been considered in the IDS(s) filed 09/02/2025 unless marked with a strikethrough. Drawings Examiner accepts 08/28/2025 submission of drawings for the Instant Application. 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 1-29 of Application No. 19/313,605 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable Claims 1-24 of copending U.S. Application No. 18/907,300 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the methods and compounds used in the instant claims are similar to products and methods of use in U.S. Application No. 18/907,300. This is a provisional nonstatutory double patenting rejection. Claims 1, 11-29 of Application No. 19/313,605 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable Claims 1-30 of copending Application No. 18/907,296 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the methods and compounds used in the instant claims are similar to products and methods of use in U.S. Application No. 18/907,296. This is a provisional nonstatutory double patenting rejection. Objections to Claims Claims 2-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusions Claims 1, 11-29 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 pm. 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, Clinton A. Brooks can be reached at (571) 270-7682. 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. Josmalen M. Ramos-Lewis, Ph.D. Patent Examiner Art Unit 1621 /CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Read full office action

Prosecution Timeline

Aug 28, 2025
Application Filed
Jan 13, 2026
Non-Final Rejection — §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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SMALL MOLECULE INHIBITORS OF MAMMALIAN SLC6A19 FUNCTION
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2y 5m to grant Granted Mar 03, 2026
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2y 5m to grant Granted Mar 03, 2026
Patent 12564573
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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
54%
Grant Probability
78%
With Interview (+24.4%)
2y 6m
Median Time to Grant
Low
PTA Risk
Based on 56 resolved cases by this examiner. Grant probability derived from career allow rate.

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