Prosecution Insights
Last updated: April 19, 2026
Application No. 18/014,156

COMPOUND SERVING AS BTK INHIBITOR, PREPARATION METHOD THEREFOR, AND USE THEREOF

Final Rejection §112§DP
Filed
Dec 31, 2022
Examiner
HERNANDEZ, JACKSON J
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shenzhen Hyperway Pharmaceuticals Co. Ltd.
OA Round
3 (Final)
50%
Grant Probability
Moderate
4-5
OA Rounds
3y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
15 granted / 30 resolved
-10.0% vs TC avg
Strong +51% interview lift
Without
With
+51.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
87 currently pending
Career history
117
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
34.9%
-5.1% vs TC avg
§102
11.8%
-28.2% vs TC avg
§112
24.7%
-15.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 30 resolved cases

Office Action

§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 . Status of the Claims Claims 2, 4, and 6 are pending in this application. Claims 1, 3, 5, and 7-11 have been cancelled by applicant. Allowable Subject Matter Claim 4 is allowed. Examiner Notes Claims 2 and 6 are free of the prior art, and would be allowable if not for the formal matters indicated in this office action. Claim Rejections - 35 USC § 112 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. Claims 2 and 6 are 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. 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 2 recites the broad recitation “C1-6 alkyl” and “C3-C6 cycloalkyl” when defining R1, and the claim also recites “methyl, ethyl, . . . and cyclopropyl” which are the narrower statement of the range/limitation. Similar issues are observed with the definitions of all variables in claim 2, in all the statements following the term “further”. The claim is 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. Examiner suggests deleting the narrower limitations (all limitations following the term “further”). Claim 6 is rejected for depending upon the limitations of claim 2. Response to Arguments Claims Claim amendments are acknowledged. No new matter has been introduced. Claim Rejections - 35 USC § 112(b) Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive. Applicant’s arguments, shown below, fail to acknowledge or remedy indefiniteness issues pointed out in the non-final action mailed 12/11/2025 (pages 2-3). In this 35 USC § 112(b) rejection, Examiner never indicated that claim 2 was limited to the compounds of Formula III or IV, and it is unclear what Applicant means by “there are three compounds (49, 56 and 81)” as there are no such compounds in instant claim 2. PNG media_image1.png 75 677 media_image1.png Greyscale As such, claim 2 stands rejected under 35 USC § 112(b). Claim 6 is rejected for depending upon the limitations of claim 2. Claim Rejections - 35 USC § 112(d) Applicant’s arguments, see page 15, filed 02/03/2026, with respect to 35 USC § 112(d) rejection have been fully considered and are persuasive. The 35 USC § 112(d) rejection of the claims has been withdrawn. Double Patenting The terminal disclaimer filed on 02/03/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Copending Application 18/014,157 has been reviewed and is accepted. The terminal disclaimer has been recorded. The non-statutory double patenting rejections of record are withdrawn. Conclusion 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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5. Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (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. /JACKSON J HERNANDEZ/Examiner, Art Unit 1627 /Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Dec 31, 2022
Application Filed
Aug 10, 2025
Non-Final Rejection — §112, §DP
Oct 27, 2025
Response Filed
Nov 30, 2025
Non-Final Rejection — §112, §DP
Feb 03, 2026
Response Filed
Mar 22, 2026
Final Rejection — §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12595254
CRYSTAL FORM OF RESMETIROM, PREPARATION METHOD THEREFOR, AND USE THEREOF
2y 5m to grant Granted Apr 07, 2026
Patent 12565495
VMAT2 INHIBITOR AND PREPARATION METHOD THEREFOR AND APPLICATION THEREOF
2y 5m to grant Granted Mar 03, 2026
Patent 12565494
INHIBITORS OF HUMAN RESPIRATORY SYNCYTIAL VIRUS AND METAPNEUMOVIRUS
2y 5m to grant Granted Mar 03, 2026
Patent 12559485
CDK6/DYRK2 DUAL-TARGET INHIBITOR, AND PREPARATION METHOD THEREFOR AND USE THEREOF
2y 5m to grant Granted Feb 24, 2026
Patent 12522584
3,4-DIHYDROISOQUINOLINE COMPOUND AND USE THEREOF
2y 5m to grant Granted Jan 13, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

4-5
Expected OA Rounds
50%
Grant Probability
99%
With Interview (+51.1%)
3y 2m
Median Time to Grant
High
PTA Risk
Based on 30 resolved cases by this examiner. Grant probability derived from career allow rate.

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