Prosecution Insights
Last updated: April 19, 2026
Application No. 18/006,197

3-(1H-IMIDAZOL-2-YL)-2,3,8,8A-TETRAHYDROINDOLIZIN-5(1H)-ONE DERIVATIVES USEFUL AS FACTOR XIA INHIBITORS

Non-Final OA §102§112§DP
Filed
Jan 20, 2023
Examiner
AULAKH, CHARANJIT
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Janssen Pharmaceutica NV
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
2y 3m
To Grant
65%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
1407 granted / 1741 resolved
+20.8% vs TC avg
Minimal -16% lift
Without
With
+-16.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
54 currently pending
Career history
1795
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
15.2%
-24.8% vs TC avg
§102
21.0%
-19.0% vs TC avg
§112
42.6%
+2.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1741 resolved cases

Office Action

§102 §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 . According to paper filed on Sep. 15, 2025, the applicants have elected group I and furthermore, have elected a specific species (compound of formula Ix) within group I for further prosecution. The applicants have also withdrawn claims 9, 12-13 and 16-22. Claims 1-8, 10-11 and 14 are pending in the application. The elected species is allowable over the prior art. Therefore, search has now been extended to additional species. Claim Rejections - 35 USC § 112 5. 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 1 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. In independent claim 1, the values of variables RA and RB (part of variable R1) is defined as H and C1-4alkyl. However, the values of variables RA and RB (part of formula I) is defined as H and halogen. It is confusing since it is not clear what are the actual values of variables RA and RB? A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation substituted C1-2 alkyl for variable R7, and the claim also recites hydroxy-substituted alkyl and fluorinated alkyl which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim Rejections - 35 USC § 102 (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim 1 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by PubChem CID-146247689, cited on applicant’s form 1449). The compound with CID-146247689 (create date 6/27/20) anticipates the instant claim when variable A represents phenyl and variable R7 represents substituted C1 alkyl (substituted with COOH) group in the instant compounds of formula (I). 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 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/006,261 (recently allowed reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of the cited application anticipates the instant claim when variable A represents pyridine and variable R7 represents substituted C1alkyl (substituted with deuterium and OH) group in the instant compounds of formula (I). Furthermore, it would have been obvious to one skilled in the art to use this compound in a pharmaceutical composition with reasonable expectation of success since these compounds have therapeutic utility for treating thromboembolic disorder (see claims10-13, 28 and 30 of the this cited application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Allowable Subject Matter Claims 2-8, 10-11 and 14 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30. 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, 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. /CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
Read full office action

Prosecution Timeline

Jan 20, 2023
Application Filed
Jan 20, 2023
Response after Non-Final Action
Jan 11, 2026
Non-Final Rejection — §102, §112, §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
81%
Grant Probability
65%
With Interview (-16.0%)
2y 3m
Median Time to Grant
Low
PTA Risk
Based on 1741 resolved cases by this examiner. Grant probability derived from career allow rate.

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