Prosecution Insights
Last updated: April 18, 2026
Application No. 18/034,890

SMALL MOLECULE INHIBITORS OF NF-kB INDUCING KINASE

Non-Final OA §102§112
Filed
May 02, 2023
Examiner
HEITMEIER, KENDALL NICOLE
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Janssen Pharmaceutica NV
OA Round
1 (Non-Final)
67%
Grant Probability
Favorable
1-2
OA Rounds
3y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allow Rate
14 granted / 21 resolved
+6.7% vs TC avg
Strong +50% interview lift
Without
With
+50.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
56 currently pending
Career history
77
Total Applications
across all art units

Statute-Specific Performance

§103
26.4%
-13.6% vs TC avg
§102
23.0%
-17.0% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 21 resolved cases

Office Action

§102 §112
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. DETAILED ACTION Status of 18/034,890 Claims 1-2, 4-5, 7, 10, 13-16, 20, 24, 26 -27 , 39-41, and 43-45 are currently pending. Priority Instant application 18/034,890, filed 5/2/2023, claims priority as follows: The provisional application does not contain support for instant Formula I and thus, claims 1-2, 4-5, 7, 10, 13-16, 20, 24 , 40, and 43-45, drawn to that feature, are granted the effective filing date of 11/11/2021 . However, the specific compounds recited in the instant claims are present in the provisional application , and thus claims 26-27, 39, and 41 are granted the effective filing date of 11/12/2020 . Information Disclosure Statement All references from the IDS submitted on 7/12/2023 have been considered unless marked with a strikethrough. Election/Restriction Applicant’s election of Group I , claims 1-2, 4-5, 7, 10, 13-16, 20, 24, 26-27, and 39-41 , drawn to compounds and compositions of Formula I, without traverse , in the reply filed 2/20/2026 is acknowledged. Applicant’s election of the following compound: In the same reply, is also acknowledged. Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. The elected species was searched and no prior art was identified. The search was expanded to the full scope of Formula I, and was found to be free of the prior art. However, additional rejections were identified within Group I . Claims 1-2, 4-5, 7, 10, 13-16, 20, 24, 26-27, and 39-41 are the subject of this Office Action. Claims 43-45 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim. The Examiner notes the withdrawn claims are not in condition for allowance. Claim Interpretation Claims 40 and 41 recite the term, “therapeutically effective amount”, in reference to the amount of a compound or pharmaceutically acceptable salt thereof in a pharmaceutical composition. The term “therapeutically effective amount” is not explicitly defined in the specification; however, the term “effective amount” is defined as an amount or dose sufficient to generally bring about the desired therapeutic or prophylactic benefit in patients in need of such treatment for the designated disease, disorder, or medical condition (page 19, lines 32- 34), which is a broad definition . Further, the instant disclosure gives the illustrative range of about 1 to 1000 mg/day for a 70-kg human (page 20, lines 5-6), and thus the limitation is currently being interpreted as this example . Claim Rejections - 35 USC § 112 (b) 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 appl icant regards as his invention. Claim 4 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. Claim 4 recites the limitation “wherein R 2 is a 5-8 membered heteroaryl containing one or more nitrogen atoms”. Claim 1, the claim from which claim 4 depends, only allows R 2 to be a 5 or 6 membered heteroaryl. Thus, there is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required. Claim Objections Claim 1 is objected to for reciting present tense singular instead of present tense plural in reference to groups of variables. Specifically, claim 1 recites “is” but should recite “are” in reference to variables R 6a -R 6c , R 8a -R 8c , R 9 , R 10a and R 10b . Appropriate correction is required. Claims 26 - 27 and 39 are objected to for minor informalities. Specifically, the claims do not include a colon or another separation technique between the preamble of the claim and the list of compounds recited. For example, claim 26 recites, “A compound selected from”, but should read, “A compound selected from:”. Appropriate correction is required. Claims 2, 5, 7, 10, 13-16, 20, 24, and 40-41 are objected to as being dependent upon a n objected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Close Prior Art Not Cited under 35 U.S.C. 102 or 103 Close prior art identified during the search is F. Hoffman-La Roche Ag (WO 2015/025025 A1, cited in the IDS of 7/12/2023, herein after “ Roche ”), which is drawn to compounds and compositions useful in the treatment of diseases and disorders with undesired or over-activation of NF-kβ signaling (abstract). Specifically, Roche teaches Formula (0) (page 427, claim 1): Which overlaps with Formula I: When A 1 -A 4 generate a substituted or unsubstituted heteroaryl that maps to instant W-Z, A 5 -A 8 generate a phenyl ring that maps to the aryl core of instant Formula I, the hydroxyl group of Roche maps to the C I variable of instant Formula I, and R 4 and R 5 maps to instant R 1 and R 2 , respectively. Further, the compounds of Roche are known to be active against NIK (page 422, Table 2). The compounds of Roche differ from the compounds of the instant claims because they contain an internal alkynyl linker and a terminal amide, which are not required by instant Formula I. Further, Roche lacks the Het C variable of instant Formula I. Thus, there is no motivation, teaching, or suggestion, in Roche or in view of the prior art, to modify the compounds of Roche to arrive at instant Formula I and compounds thereof. Conclusion Claim 4 is rejected. Claims 1 -2, 5, 7, 10, 13-16, 20, 24, 26-27 , and 39 -41 are objected to. Claims 43-45 are withdrawn. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Kendall Heitmeier whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1555 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8:30AM-5:00PM ET . 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 Clinton Brooks can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /K.N.H./ Examiner, Art Unit 1621 /CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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Prosecution Timeline

May 02, 2023
Application Filed
Jun 17, 2024
Response after Non-Final Action
Apr 01, 2026
Non-Final Rejection — §102, §112 (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
67%
Grant Probability
99%
With Interview (+50.0%)
3y 8m
Median Time to Grant
Low
PTA Risk
Based on 21 resolved cases by this examiner. Grant probability derived from career allow rate.

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