Prosecution Insights
Last updated: April 19, 2026
Application No. 18/561,962

CRYSTALLINE FORM OF TRICYCLIC DERIVATIVE COMPOUND, METHOD FOR PREPARING SAME, AND PHARMACEUTICAL COMPOSITION COMPRISING SAME

Non-Final OA §103
Filed
Nov 17, 2023
Examiner
YOO, SUN JAE
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Onconic Therapeutics Inc.
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
2y 11m
To Grant
71%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
869 granted / 1225 resolved
+10.9% vs TC avg
Minimal +0% lift
Without
With
+0.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
43 currently pending
Career history
1268
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
14.6%
-25.4% vs TC avg
§102
29.8%
-10.2% vs TC avg
§112
32.5%
-7.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1225 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions 2. Applicant’s election without traverse of Group I and species of anhydride crystalline form in the reply filed on March 6, 2026 is acknowledged. 3. Examination followed guidelines provided by MPEP 803.02. The elected species appeared to be novel and nonobvious over the prior art. However, prior art was found that makes obvious nonelected species within the Markush claims. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The claims were searched to the extent of the elected species, claims 26, 27 and further to the extent of the nonelected species denoted below. 4. Claims 28-41 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on March 6, 2026. Priority 5. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement 6. The information disclosure statements (dated November 17, 2023 and February 11, 2025 and May 2, 2025) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith. Status of Claims 7. Claims 24-41 are pending. Claims 24- 25 are in the elected Group I, encompass the elected species and are under examination; of these claims, claim 24 is independent. Claims 28-41 are nonelected and withdrawn. Claim Objections 8. Claim s 26 and 27 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. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . 9. Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016200101 in view of Berge et al . and evidenced by WO2016200101-machine-translation. Determining the scope and contents of the prior art WO 2016200101 teaches tricyclic compounds and pharmaceutically acceptable salts thereof and compositions thereof . The reference teaches as a preferred embodiment the species of (page 56) in solid form (see page 22 of machine translation). Ascertaining the differences between the prior art and the claims at issue The difference between the present claims and the prior art is the salt form of the crystalline compound. Resolving the level of ordinary skill in the pertinent art - considering objective evidence present in the application indicating obviousness The reference teaches and suggests to the skilled artisans the chemical compounds and pharmaceutical salts of the chemical compounds. Therefore, the skilled artisan has the teaching and suggestion to prepare other pharmaceutical salts of the compound in solid form following the synthetic procedures provided by the reference. Moreover, the reference specifically suggests citrate salts as a pharmaceutically acceptable salt. See page 12 of machine translation. Within the state of the art it is also known that the preparation of pharmaceutical salts of compounds is within the level of ordinary skill. See reference of Berge et al. Therefore, the skilled artisan has the teaching, suggestion, and reasonable expectation of success in practicing the present invention of crystalline forms of . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SUN JAE YOO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9074 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 8-5 . 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. 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. /SUN JAE YOO/ Primary Examiner, Art Unit 1621
Read full office action

Prosecution Timeline

Nov 17, 2023
Application Filed
Apr 01, 2026
Non-Final Rejection — §103 (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

1-2
Expected OA Rounds
71%
Grant Probability
71%
With Interview (+0.4%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 1225 resolved cases by this examiner. Grant probability derived from career allow rate.

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