Prosecution Insights
Last updated: April 19, 2026
Application No. 17/831,843

THERAPEUTIC DRUG FOR DISEASES RELATED TO ENDOPLASMIC RETICULUM CELL DEATH IN CORNEAL ENDOTHELIUM

Final Rejection §DP
Filed
Jun 03, 2022
Examiner
SCHMITT, MICHAEL J
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Senju Pharmaceutical Co. Ltd.
OA Round
2 (Final)
57%
Grant Probability
Moderate
3-4
OA Rounds
2y 10m
To Grant
79%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allow Rate
363 granted / 640 resolved
-3.3% vs TC avg
Strong +22% interview lift
Without
With
+22.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
34 currently pending
Career history
674
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
36.7%
-3.3% vs TC avg
§102
16.6%
-23.4% vs TC avg
§112
18.8%
-21.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 640 resolved cases

Office Action

§DP
DETAILED ACTION Claims 1-14 were pending. Claims 1 and 5-6 have been amended, claim 4 has been canceled per the Reply of 12/17/2025. Claims 1-3 and 5-14 are pending. 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 . Priority The instant application, filed 6/3/2022 is a Continuation of 15031183, filed 4/21/2016, now U.S. Patent 11382904 and having 2 RCE-type filing therein. 15031183 is a National Stage entry of PCT/JP2014/079513, International Filing Date 10/30/2014 and claims foreign priority to 2013-227048, filed 10/31/2013 and to 2014-184172, filed 9/10/2014. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. Claims 1-3 and 5-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-19 of U.S. Patent No. 11382904. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘904 claim 1 is directed towards, “a method of treating Fuchs' endothelial corneal dystrophy (FECD) induced by transforming growth factor-β (TGF-β) induced endoplasmic reticulum (ER) stress in a corneal endothelium, said method comprising a step of administering an effective amount of a means for inhibiting TGF-β signal to a subject in need thereof that has the FECD, thereby treating the FECD in the subject.” This disease, FECD, is an anticipatory species to the instant claims and is being treated by the same mechanism of action. Conclusion No claims allowed. 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 MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached on M-F 8-6 MidDay Flex. 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, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL J SCHMITT/Examiner, Art Unit 1629 /JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Read full office action

Prosecution Timeline

Jun 03, 2022
Application Filed
Jun 10, 2025
Non-Final Rejection — §DP
Dec 17, 2025
Response Filed
Mar 17, 2026
Final Rejection — §DP (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

3-4
Expected OA Rounds
57%
Grant Probability
79%
With Interview (+22.2%)
2y 10m
Median Time to Grant
Moderate
PTA Risk
Based on 640 resolved cases by this examiner. Grant probability derived from career allow rate.

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