Prosecution Insights
Last updated: July 17, 2026
Application No. 18/158,089

COMPOSITIONS AND METHODS FOR TREATING GALACTOSEMIA

Non-Final OA §DP
Filed
Jan 23, 2023
Priority
Jul 28, 2017 — provisional 62/538,443 +2 more
Examiner
COLEMAN, BRENDA LIBBY
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Applied Therapeutics, Inc.
OA Round
3 (Non-Final)
75%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allowance Rate
1217 granted / 1629 resolved
+14.7% vs TC avg
Strong +16% interview lift
Without
With
+15.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
46 currently pending
Career history
1664
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
9.8%
-30.2% vs TC avg
§102
12.5%
-27.5% vs TC avg
§112
49.8%
+9.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1629 resolved cases

Office Action

§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 . A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Claims 1, 17-20 and 26-49 are pending in the application. This action is in response to applicants' RCE and IDS dated June 17, 2026. In view of the RCE and IDS dated June 17, 2026, the following new grounds of rejection apply: 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, 17-20 and 26-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,528,823. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of use of the compounds of Formula (III) of the instant invention are taught by U.S. 823 where X5 is Q-R10; Q is a bond; R10 is C(O)R11; and R11 is H, (C1-C6)-alkyl optionally substituted with OH or amino (Example 24 and the method of use is stated in column 13, line 19 and the abstract). Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (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 H. Murray can be reached at 571-272-9023. 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. /BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Show 2 earlier events
Apr 23, 2025
Response Filed
May 28, 2025
Final Rejection mailed — §DP
Nov 24, 2025
Request for Continued Examination
Dec 01, 2025
Response after Non-Final Action
Jan 12, 2026
Response Filed
Jun 17, 2026
Request for Continued Examination
Jun 22, 2026
Response after Non-Final Action
Jun 26, 2026
Non-Final Rejection mailed — §DP (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

3-4
Expected OA Rounds
75%
Grant Probability
90%
With Interview (+15.5%)
2y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 1629 resolved cases by this examiner. Grant probability derived from career allowance rate.

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