Prosecution Insights
Last updated: May 29, 2026
Application No. 19/322,058

NOVEL B0AT1 INHIBITOR

Final Rejection §102§112
Filed
Sep 08, 2025
Priority
Apr 06, 2023 — JP 2023-062369 +2 more
Examiner
KENYON, JOHN S
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Mitsubishi Tanabe Pharma Corporation
OA Round
2 (Final)
80%
Grant Probability
Favorable
3-4
OA Rounds
1y 7m
Est. Remaining
98%
With Interview

Examiner Intelligence

Grants 80% — above average
80%
Career Allowance Rate
749 granted / 933 resolved
+20.3% vs TC avg
Strong +17% interview lift
Without
With
+17.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
49 currently pending
Career history
974
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
20.2%
-19.8% vs TC avg
§102
25.6%
-14.4% vs TC avg
§112
30.1%
-9.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 933 resolved cases

Office Action

§102 §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 . 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 Applicants’ claim 1 amendments have rendered moot the prior art rejection of record. The Examiner has extended the Markush search to the compound: PNG media_image1.png 200 584 media_image1.png Greyscale which is a species of genus formula I of instant claim 1, wherein “R” is a phenyl (C6aryl)-ethenyl group that is substituted with one chlorine (halogen); “A” is divalent nitrogen-containing 5-membered heterocyclic group; “L” is methylene (C1alkylene group); and R1 is PNG media_image2.png 78 114 media_image2.png Greyscale (see penultimate line of paragraph [0106] on page 52 of Specification defining this as an exemplary “group biologically equivalent to a carboxy group”), which Specification paragraph [0105]-[0106] (pages 51-52) lists as an exemplary “group biologically equivalent to a carboxy group”. This extended Markush search has prior art. Therefore, per Markush search practice the Markush search will not be extended unnecessarily to additional species in this Office Action. The extended Markush search reads on claims 1-2. Claims 3-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9 January 2026. Current Status of 19/322,058 This Office Action is responsive to the amended claims of 23 March 2026. Claims 1-2 have been examined on the merits. Claim 1 is currently amended. Claim 2 is original. Priority The effective filing date is 5 April 2024. Specification All amendments to the Specification (the 8 September 2025 and 23 March 2026 amendments) have been reviewed and formally accepted/entered into the record. Response to Arguments The Examiner acknowledges receipt of and has reviewed Applicants’ claim amendments and Reply of 23 March 2026. Applicants deleted “Novel” and therefore rendered moot the objection to the title made within paragraph 17 of the previous Office Action. Applicants moved the phrase “or a pharmaceutically acceptable salt thereof” to the appropriate location in the claims thereby rendering moot the objection made within paragraph 18 of the previous Office Action. Applicants removed the parentheticals from the claims 1 and 11 thereby rendering moot the indefiniteness rejection made within paragraphs 19-21 of the previous Office Action. Applicants’ amended claim 1 to require certain substituents on the “substituted ‘R’ ”, which are not taught or anticipated by the reference ACS, thereby rendering moot the prior art rejection made within paragraphs 22-24 of the previous Office Action. Response to Amendment 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 1-2 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. As amended, claim 1 now says “a substituted C6-10 aryl-ethenyl group” and then says “which is optionally substituted by … ” followed by a list of alternative embodiments. The “substituted C6-10 aryl-ethenyl group” followed by the “optionally substituted” renders the metes and bounds of the claim 1 undefined (hence rendering claim 1 indefinite). The Remarks of 23 March 2026, which helped render moot the prior art rejection made in the last Office Action, leads the Examiner to believe that Applicants intend the substituents of the C6-10aryl-ethenyl group to be one of the recently added substituents beginning with “halogen atom”; however, this list is preceded by “optionally substituted” within claim 1. Furthermore, Examiner believes Applicants intend these substituents to be required (hence the presence of “substituted” immediately preceding “C6-10aryl-ethenyl group” within the claim 1). Against the backdrop of the amendments made to claim 1 and the Remarks, the metes and bounds of claim 1 are unclear because how can the C6-10aryl-ethenyl group be both 1) substituted (again, see “substituted” immediately preceding “C6-10aryl-ethenyl group” within claim 1) and 2) “optionally substituted”? (this phrase immediately precedes the underlined/added list of substituents beginning with “halogen atom” within claim 1). Examiner wonders if the “optionally” of “optionally substituted” is an artifact from previous revisions of the claim 1? Claim 2 is similarly rejected as indefinite since it refers back to claim 1 but does not remedy the rationale underpinning the basis for rejecting claim 1. To render moot this rejection: please strike “optionally” preceding “substituted” in the fourth line of claim 1 dedicated to substituents of variable “R”. This rejection is properly made FINAL due to Applicants’ claim amendments. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by: BANNISTER (WO 2020/210662 A1, provided by Applicants and referenced in IDS of 8 September 2025). The prior art reference BANNISTER teaches compound 3: PNG media_image3.png 78 410 media_image3.png Greyscale , which is a species of genus formula I of instant claim 1, or a pharmaceutically acceptable salt thereof (page 15), wherein “R” is a phenyl (C6aryl)-ethenyl group that is substituted with one chlorine (halogen); “A” is divalent nitrogen-containing 5-membered heterocyclic group; “L” is methylene (C1alkylene group); and R1 is PNG media_image2.png 78 114 media_image2.png Greyscale (see penultimate line of paragraph [0106] on page 52 of Specification), which Specification paragraph [0105]-[0106] (pages 51-52) lists as an exemplary “group biologically equivalent to a carboxy group”. This anticipates instant claims 1-2. Applicants could strike “group biologically equivalent to a carboxy group” from all the claims to render moot this rejection. Please note that BANNISTER teaches other compounds that arguably could also anticipate the genus formula I of instant claim 1, including compound 2 on page 15. These compounds will be the subject of future Markush search extensions. This rejection is properly made FINAL due to Applicants’ claim amendments. Conclusion No claims are presently allowable as written. 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 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 JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p. 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, Andrew D Kosar can be reached at (571) 272-0913. 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. /JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

Sep 08, 2025
Application Filed
Mar 03, 2026
Non-Final Rejection mailed — §102, §112
Mar 23, 2026
Response Filed
Apr 20, 2026
Final Rejection mailed — §102, §112
May 15, 2026
Interview Requested

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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
80%
Grant Probability
98%
With Interview (+17.4%)
2y 3m (~1y 7m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 933 resolved cases by this examiner. Grant probability derived from career allowance rate.

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