Prosecution Insights
Last updated: April 19, 2026
Application No. 18/254,623

SALT AND CRYSTAL FORM OF NITROGEN-CONTAINING HETEROCYCLIC DERIVATIVE, PREPARATION METHOD THEREFOR AND APPLICATION THEREOF

Non-Final OA §DP
Filed
May 26, 2023
Examiner
HUI, SAN MING R
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
3y 1m
To Grant
79%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
757 granted / 1284 resolved
-1.0% vs TC avg
Strong +20% interview lift
Without
With
+19.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
51 currently pending
Career history
1335
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
47.9%
+7.9% vs TC avg
§102
8.8%
-31.2% vs TC avg
§112
19.6%
-20.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1284 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. Claims 1-20 are pending. 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 . Claim 1-6, 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 30, 31, 33 of copending Application No. 17/614,652 (‘652 ) ( reference application) in view of Gould, International Journal of Pharmaceutics, 33 (1986) 201-217 . Although the claims at issue are not identical, they are not patentably distinct from each other because ‘652 teaches a pharmaceutical acceptable salt of the herein claimed compound (see claim 27 and 30 ) . ‘652 does not expressly teach the specific acid salts of the compounds recited in the claims. Gould teaches salt formation provides a means of altering the physiochemical and resultant biological characteristics of a drug without modifying its chemical structure (see page 201, col.1, first paragraph). Gould teaches that one of the most common acid salt as HCl salt among many other salts (see page 202, Table 1). Although potential problem may occur, it seems formulating HCl salt would be the first move. And if problem arises, selecting other salts would be warranted (see page 204, col. 1, fourth paragraph). It would have been obvious to one of ordinary skill in the art at the time of filing to formulate an acid salt of the herein claimed compounds of formula (II) . One of ordinary skill in the art would have been motivated to formulate an acid salt of the herein claimed compounds as producing HCl salt would be reasonably expected to improve the formulating process, stability, or solubility of the compound of formula (II) . Furthermore, the mixing and reacting the acid with the free base to form the salt would be considered obvious as neing within the purview of skilled artisans. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Allowable Subject Matter Claims 7-15 and 19-20 are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SAN MING R HUI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0626 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon - Fri 9:30-5:30 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney Klinkel can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /SAN MING R HUI/ Primary Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

May 26, 2023
Application Filed
Dec 04, 2025
Non-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

1-2
Expected OA Rounds
59%
Grant Probability
79%
With Interview (+19.7%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 1284 resolved cases by this examiner. Grant probability derived from career allow rate.

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