Prosecution Insights
Last updated: October 04, 2026
Application No. 18/381,121

SUBSTITUTED HETEROCYCLIC FUSED CYCLIC COMPOUND, PREPARATION METHOD THEREFOR AND PHARMACEUTICAL USE THEREOF

Final Rejection §112§DOUBLEPATENT
Filed
Oct 17, 2023
Priority
Oct 30, 2019 — CN 201911045542.X +4 more
Examiner
COLEMAN, BRENDA LIBBY
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Zhejiang Genfleet Therapeutics Co. Ltd.
OA Round
4 (Final)
75%
Grant Probability
Favorable
5-6
OA Rounds
0m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allowance Rate
1230 granted / 1643 resolved
+14.9% vs TC avg
Strong +16% interview lift
Without
With
+15.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
52 currently pending
Career history
1670
Total Applications
across all art units

Statute-Specific Performance

§101
3.4%
-36.6% vs TC avg
§103
8.5%
-31.5% vs TC avg
§102
15.8%
-24.2% vs TC avg
§112
52.8%
+12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1643 resolved cases

Office Action

§112 §DOUBLEPATENT
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 3, 4, 6, 7, 10, 11, 14, 15, 19-21, 23, 24, 31, 36 and 39-46 are pending in the application. This action is in response to applicants' amendment dated July 7, 2026. Claims 3, 4, 6, 10, 23, 24 and 36 have been amended, claim 5 has been canceled and claims 41-46 are newly added. Response to Amendment Applicant's arguments filed July 7, 2026 have been fully considered with the following effect: The applicants’ amendments are sufficient to overcome the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 4) in the last office action, which is hereby withdrawn. With regards to the provisional nonstatutory double patenting rejection as being unpatentable over claims 1-4, 7-9, 11-13 and 16-18 of copending Application No. 18/723,594 of the last office action, the applicants request that the Examiner hold the rejection over Application in abeyance until there is allowable subject matter. Claims 3, 4, 6, 15, 19, 20, 23, 24, 31, 36, 39-42, 44 and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/723,594, for reasons of record and stated above. The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 8a) and b) in the last office action, which are hereby withdrawn. However, with regards to the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 8c), d) and e) of the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. c) The applicants’ stated that the amendment to claim 23 is based on the technical solution recited in paragraph [0087] of the description. However, there is no definition of deuterium substitution on the alkyl within the definition of Rm’ in claim 3, thus the lack of antecedent basis is herein maintained. Claim 23 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 applicant regards as the invention, for reasons of record and stated above. d) The applicants’ stated that they have reviewed the specification and note that the limitation is supported by the definitions provided therein. Specifically, the specification states: "As used herein, the term 'deuteroalkyl' refers to alkyl substituted by one or more (e.g., 1, 2, 3, 4, or 5) deuterium atoms, where the alkyl is as defined above. The term C1-10 deuteroalkyl' refers to deuteroalkyl having 1 to 10 carbon atoms, preferably C1-6 deuteroalkyl, more preferably C1-4 deuteroalkyl, and further preferably C1-3 deuteroalkyl. Specific examples of deuteroalkyl include but are not limited to monodeuteromethyl, dideuteromethyl, trideuteromethyl, monodeuteroethyl, 1,2-dideuteroethyl, trideuteroethyl, etc.". However, there is no definition of deuterium substitution on the alkyl within the definition of Rm’ in claim 3, thus the lack of antecedent basis is herein maintained. Claim 24 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 applicant regards as the invention, for reasons of record and stated above. e) The applicants’ stated that the amendment to claim 23 is based on the technical solution recited in paragraph [0088] of the description. However, there is no definition of deuterium substitution on the alkyl within the definition of Rm’ in claim 3, thus the lack of antecedent basis is herein maintained. Claim 40 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 applicant regards as the invention, for reasons of record and stated above. Claim Objections Claims 7, 10, 11, 14, 21, 43 and 46 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. 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 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 1 earlier event
Dec 02, 2024
Non-Final Rejection mailed — §112, §DOUBLEPATENT
May 30, 2025
Response Filed
Jun 17, 2025
Final Rejection mailed — §112, §DOUBLEPATENT
Nov 17, 2025
Request for Continued Examination
Nov 18, 2025
Response after Non-Final Action
Jan 08, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT
Jul 07, 2026
Response Filed
Aug 10, 2026
Final Rejection mailed — §112, §DOUBLEPATENT (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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USE OF AN ORGANOMETALLIC COMPOUND AS A DNA-DEMETHYLATING AGENT
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Patent 12723038
ALPHA1A-ADRENERGIC RECEPTOR AGONISTS AND METHODS OF USE
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Patent 12708629
METHODS AND COMPOSITIONS FOR REDUCING PARATHYROID LEVELS
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Patent 12709621
TYK2 INHIBITORS
3y 1m to grant Granted Aug 18, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
75%
Grant Probability
90%
With Interview (+15.5%)
2y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 1643 resolved cases by this examiner. Grant probability derived from career allowance rate.

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