Prosecution Insights
Last updated: April 18, 2026
Application No. 18/249,421

METHOD OF PRODUCING 3-METHYL-4-HALO-INDOLE DERIVATIVE

Non-Final OA §112§DP
Filed
Apr 18, 2023
Examiner
ISMAIL, REHANA
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Daiichi Sankyo Company Limited
OA Round
1 (Non-Final)
79%
Grant Probability
Favorable
1-2
OA Rounds
3y 4m
To Grant
99%
With Interview

Examiner Intelligence

Grants 79% — above average
79%
Career Allow Rate
56 granted / 71 resolved
+18.9% vs TC avg
Strong +29% interview lift
Without
With
+29.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
41 currently pending
Career history
112
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
27.3%
-12.7% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
25.5%
-14.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 71 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. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Election/Restrictions Applicant’s reply filed on 01/16/2026 is acknowledged. Applicant cancelled claims in Group I and claims 16-20 of Group II of the restriction /election requirements of 10/16/2025 . R endering moot restriction requirements . Thus, restriction requirements of 10/16/2025 are withdrawn. Applicant provided complaint species of disease: brain tumor. Examiner did not find prior art on applicant elected species. Therefore, Markush search was extended to the full scope of independent claim 15. Examiner did not find prior art or double patenting art on the full scope of independent claim 15, therefore election of species requirement is withdrawn Claims 15 and 21- 35 are examined in this office action. Current Status of 18 / 249 , 421 This Office Action is in response to the amended claims of 01/16/2026 . Claim s 15 and 24 are currently amended; claims 21- 23 and 25 were previously presented, claims 26-35 are new. Claims 15 and 21-35 are examined in this office action. Priority Effective filing date is 10 / 30 /2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) was submitted on 06 / 1 2 /202 3, 05/17/2024, 06/12/2023 and 1/16/2026 . The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. 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. Claim 33 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. The term “ substantially” in claim 33 , is a relative term which renders these claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention . As drafted, the term “substantially” renders the metes and bounds of claims 33 undefined (hence rendering claim 33 indefinite) since the artisan has no idea by which objective standard “substantially” should be measured (since neither the claims nor Specification provide an objective standard or definition of “substantially”). 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. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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. Claims 26-33 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Dependent claims 26-33 are not further limiting and are rejected under 35 USC 112(d). As drafted, independent claim 15 recites “ mono (2-methylpropan-2-ammonium) (2E)-3-(1-{[5- (2-fluoropropan-2-yl)-3-(2,4,6-trichlorophenyl)-1,2-oxazol-4-yl] carbonyl}-3-methyl-1H-indol- 4-yl) propa-2-enoate , wherein the crystal has at least three peaks at a diffraction angle … ” which inherently contains all the elements found in the XRPD data of depen dent claims 26-33 . If claim 15 did not inherently have these peaks, it would not be the crystalline polymorph of claim 15. Thus, claims 26-33 do not add any additional limitation. Thus, claims 26-33 do not truly further limit what is already (inherently) disclosed within claim 15 . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Conclusions Claims 26-33 is rejected . Claims 15 , 21- 25 and 34 -35 are allowable as written. Saito et.al ( US 20170313696 ) discloses the compound mono (2-methylpropan-2-ammonium) (2E)-3-(1-{[5- (2-fluoropropan-2-yl)-3-(2,4,6-trichlorophenyl)-1,2-oxazol-4-yl] carbonyl}-3-methyl-1H-indol- 4-yl) propa-2-enoate , (Saito paragraph [0924]) (formula VI from file 371P(specification)) . Saito does not disclose crystal form or the diffraction angle of compound mono (2-methylpropan-2-ammonium) (2E)-3-(1-{[5- (2-fluoropropan-2-yl)-3-(2,4,6-trichlorophenyl)-1,2-oxazol-4-yl] carbonyl}-3-methyl-1H-indol- 4-yl) propa-2-enoate . A person skilled in the art would not reasonably determine diffraction angle of compound mono (2-methylpropan-2-ammonium) (2E)-3-(1-{[5- (2-fluoropropan-2-yl)-3-(2,4,6-trichlorophenyl)-1,2-oxazol-4-yl] carbonyl}-3-methyl-1H-indol- 4-yl) propa-2-enoate , therefore Saito is a close art not a prior art. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Rehana Ismail whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4776 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Andrew D Kosar can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-913 . 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. /R.I./ Examiner, Art Unit 1625 /JOHN S KENYON/ Primary Patent Examiner, Art Unit 1625
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Prosecution Timeline

Apr 18, 2023
Application Filed
Apr 18, 2023
Response after Non-Final Action
Jun 10, 2024
Response after Non-Final Action
Mar 30, 2026
Non-Final Rejection — §112, §DP (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
79%
Grant Probability
99%
With Interview (+29.4%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 71 resolved cases by this examiner. Grant probability derived from career allow rate.

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