Prosecution Insights
Last updated: August 15, 2026
Application No. 18/605,398

SIGMA-1 RECEPTOR ANTAGONISTS AND THEIR APPLICATIONS

Non-Final OA §102§112
Filed
Mar 14, 2024
Priority
Mar 14, 2023 — provisional 63/452,034
Examiner
ROZOF, TIMOTHY R
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Yichang Humanwell Pharmaceutical Co. Ltd.
OA Round
2 (Non-Final)
73%
Grant Probability
Favorable
2-3
OA Rounds
0m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
699 granted / 962 resolved
+12.7% vs TC avg
Strong +24% interview lift
Without
With
+23.9%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 0m
Avg Prosecution
52 currently pending
Career history
995
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
21.6%
-18.4% vs TC avg
§102
32.5%
-7.5% vs TC avg
§112
25.7%
-14.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 962 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 . This Office action replaces the Non-Final office action mailed July 22, 2026, and resets the period of reply to expire 3 months from the mailing date of this communication. DETAILED ACTION This is a response to Applicant’s communication filed on June 1, 2026. Application No. 18/605,398, is a U.S. Nonprovisional application, filed March 14, 2024, which claims the benefit of U.S. Provisional application No. 63/452,034, filed March 14, 2023. Claims 1-15 are pending. Election/Restriction Applicant's elections with traverse of the invention of Group I and the species of Compound 37 in the reply filed on June 1, 2026, are acknowledged. The traversal is on the ground(s) that the inventions have met the requirements of Unity of Invention. This is not found persuasive because the requirements have not been met. Applicant is correct that the related technical feature of both inventions are the compounds of formula (I). However, compounds of formula (I) are known in the art and therefore do not rise to the level of special technical feature for purposes of Unity of Invention. See the 35 U.S.C. 102(a)(1) rejection(s) below. The requirement is still deemed proper and is therefore made FINAL. Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Claims 5-8, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species. Applicant timely traversed the restriction (election) requirement in the reply filed on June 1, 2026. Claims 1-4, 9, and 11 are examined below. 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. Claims 1-4, 9, and 11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). In this case, there are multiple discrepancies between the compounds claimed, at least the compounds of claim 9, and what is encompassed by Markush formula (I) of claim 1. For example, R3 is depicted as a single moiety. However, at least in the elected species R3 appears twice as two halogens. In the definition of subgroup Y, the heteroaryl is defined as having a minimum of 5 carbons (5C), where the elected species has only 3 carbon atoms as a 5-membered heteroaryl. Furthermore, R4 is defined as the group consisting of: “. . . hydrogen, halogens, cyano, C1-C6 alkyl groups, substituted C1-C6 alkyl groups, C3-C6 cycloalkyl groups, substituted C3-C6 cycloalkyl groups, aryl groups, substituted aryl groups, heterocycles, and substituted heterocycles; wherein the substituted C1-C6 alkyl, substituted C3-C6 cycloalkyl, substituted aryl, and substituted heteroaryl are substituted by 1-3 substituents independently selected from the following groups: halogens, C1-C3 alkyl, C1-C3 alkoxy, halogenated C1-C3 alkyl, heteroaryl, heterocycle.” (emphasis added.) As presently construed it is unclear if R4 is intended to encompass heteroaryls (as heterocycles?). Claims 2-4 which depends from claim 1, contain the same inconsistency. Notably in claim 4, R4 includes pyridine which is a heteroaryl. As presently construed it impossible to perform a complete search. Nonetheless, in order to advance prosecution, the claims are interpretated broadly. Claim Rejections - 35 USC § 102(a)(1) 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, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anantanarayan et al., U.S. 6,514,977 (citing the CAS Abstract for the compounds depicted therein). Anantanarayan discloses the following compounds and pharmaceutical compositions thereof: PNG media_image1.png 235 433 media_image1.png Greyscale PNG media_image2.png 235 436 media_image2.png Greyscale (Anantanarayan, citing the CAS Abstract for the compounds depicted above; see Anantanarayan et al., ‘977 patent, Col. 330, ln. 44 – Col. 335, ln. 67, for pharmaceutical compositions of the compounds disclosed therein; see Id., claims 73-77 for the same.) These compounds read on compounds of formula (I), wherein formula (I), R3 is a halogen; Q is a phenyl; Y is a 5 membered heteroaryl (similar to the elected species) further substituted with pyridine (a 6-membered heteroaryl); X is C; n is 0; L is -(CH2)m-, where m is 0; R1 and R2 are taken together to form a 4-piperidinol. Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al., U.S. 9,227,967 (citing the CAS Abstract for the compound depicted therein). The CAS Abstract for Evans discloses the following compound and pharmaceutical compositions thereof: PNG media_image3.png 274 358 media_image3.png Greyscale (Evans et al., citing the CAS Abstract for the compounds depicted above; see Evans et al., ‘967 patent, Abstract, for pharmaceutical compositions of the compounds disclosed therein.) This compound reads on a compound of formula (I), wherein formula (I), R3 is a halogen; Q is a phenyl; Y is a 9 membered heteroaryl; X is C; n is 0; L is -(CH2)m-, where m is 0; R1 and R2 are taken together to form a 4-piperidinol. Conclusion No claims are allowed. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m.. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TIMOTHY R ROZOF/ Primary Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

Mar 14, 2024
Application Filed
Jul 22, 2026
Non-Final Rejection mailed — §102, §112
Jul 30, 2026
Non-Final Rejection mailed — §102, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

2-3
Expected OA Rounds
73%
Grant Probability
97%
With Interview (+23.9%)
2y 0m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 962 resolved cases by this examiner. Grant probability derived from career allowance rate.

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