Prosecution Insights
Last updated: October 04, 2026
Application No. 18/033,481

INHIBITORS OF BTK

Final Rejection §112
Filed
Apr 24, 2023
Priority
Oct 30, 2020 — provisional 63/108,094 +2 more
Examiner
FERGUSON, JALISA HOLMES
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Newave Pharmaceutical Inc.
OA Round
2 (Final)
61%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
22 granted / 36 resolved
+1.1% vs TC avg
Strong +44% interview lift
Without
With
+43.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
27 currently pending
Career history
58
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
17.0%
-23.0% vs TC avg
§102
22.0%
-18.0% vs TC avg
§112
36.5%
-3.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 36 resolved cases

Office Action

§112
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 1-8 are currently pending. Claim 6 is rejected. Claim 8 is objected to. Claims 1-5 and 7 are allowed. Information Disclosure Statement The Information Disclosure Statement (IDS) dated 07/28/2026 has been considered. Response to Amendment/Arguments The amendment filed 07/28/2026 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below: Objection to the Claims The objection of the claims for informalities has been overcome by the amendment correcting said informalities. The objection has been withdrawn. 35 USC § 112 Rejections The rejections of claims 1-5 and 7 under 35 USC 112 have been overcome by the amendments to said claims. The rejections have been withdrawn. 35 USC § 102 Rejection The rejection of claims 1-4 and 7 under 35 USC 102 for being anticipated by Angst et al. in WO 2016/164580 A1 has been overcome by the amendments to said claims. The rejection has been withdrawn. Double Patenting Rejection The rejections of claims 1-2 and 7 for nonstatutory obvious double patenting over US Patent 11,501,284 and applications 18/798,308; 17/431,460 (now US Patent 12,637,467); 17/764,329; and 18/020,980 have been overcome by the amendments to the present formula. Namely, the amendment wherein Z of Formula (I) is NH and W of Formula (II) is N. The rejections have been withdrawn. Scope of the Elected Invention In accordance with the MPEP 803.02, examination of the Markush-type claims has been extended, as necessitated by amendment, to the full scope of Formula (I) of claim 1. Claims 1-5 and 7 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claim 8, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104. Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 10/01/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. New Claim Objections Claim 8 is objected to because of the following informalities: Line 1 should change “and” to “or”; and Line 3 should state “claim 1” instead of “claims 1”. Appropriate correction is required. New Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 6 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The structure of the compound recited in claim 6 is PNG media_image1.png 223 469 media_image1.png Greyscale , however parent claim 1 recites Formula (I) wherein Q4 is a 6-membered heteroaryl. Since the dependent claim discloses a phenyl ring as Q4 as indicated by the square, the claim does not properly limit the claim upon which it depends. Applicant may overcome the rejection by cancelling the claim or making it independent. Conclusion Claim 6 is rejected. Claim 8 is objected to. Claims 1-5 and 7 are allowed. Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm. 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, Amy L. Clark can be reached on (571) 272-1310. 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. /J.H.F./Examiner, Art Unit 1626 /KAMAL A SAEED/Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Apr 24, 2023
Application Filed
Apr 28, 2026
Non-Final Rejection mailed — §112
Jul 28, 2026
Response Filed
Sep 01, 2026
Final Rejection mailed — §112 (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
61%
Grant Probability
99%
With Interview (+43.8%)
3y 3m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 36 resolved cases by this examiner. Grant probability derived from career allowance rate.

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