Prosecution Insights
Last updated: September 17, 2026
Application No. 18/611,908

DOSAGE FORMS AND THERAPEUTIC USES OF L-4-CHLOROKYNURENINE

Non-Final OA §101§103
Filed
Mar 21, 2024
Priority
Jan 22, 2013 — provisional 61/849,191 +4 more
Examiner
HUI, SAN MING R
Art Unit
Tech Center
Assignee
Vistagen Therapeutics Inc.
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
5m
Est. Remaining
80%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
783 granted / 1316 resolved
-0.5% vs TC avg
Strong +20% interview lift
Without
With
+20.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
43 currently pending
Career history
1352
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
47.1%
+7.1% vs TC avg
§102
7.5%
-32.5% vs TC avg
§112
20.5%
-19.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1316 resolved cases

Office Action

§101 §103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Claims 1-18 are pending. Double Patenting A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claims 1-18 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-8 of prior U.S. Patent No. 12,036,198 (‘198). This is a statutory double patenting rejection. ‘198 teaches the exact same invention as claimed in the instant application. Claim Rejections - 35 USC § 103 The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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. Claims 1, 4-6, 9-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over CA 2 796 774 (‘774). ‘744 teaches a method of treating pain such as neuropathic pain using a combination of a 3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol compound and a NMDA antagonist (see the abstract; claim 23). ‘744 teaches NMDA antagonists include 4-chlorokynurenine as one of the NMDA antagonists useful in the method of treating neuropathic pain (see page 5, third paragraph). ‘744 teaches the suitable route of administration include oral (see page 9, second-to-last paragraph). ‘744 does not expressly teach the conditions in which the neuropathic pain being associated to. ‘744 does not expressly teach the dosage of l-4-chlorokynurenine. It would have been obvious to one of ordinary skill in the art at the time of filing to employ 4-chlorokynurenine, in a method of treating neuropathic pain including those associated with various conditions recited in the claims. One of ordinary skill in the art would have been motivated to employ 4-chlorokynurenine, in a method of treating neuropathic pain including those associated with various conditions recited in the claims. Since the combination of NMDA antagonist and a 3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol compound is known in the art to neuropathic pain, treating neuropathic pain associated with any conditions would have been reasonably expected to be useful. As for the dosage of l-4- chlorokynurenine, adjusting the dosage based on the neuropathic-pain-therapeutic effect would be since to be obvious as being within the purview of the skilled in artisan. The examiner notes that the racemic mixture of 4-chlorokynurenine include both the l- and d- optical isomers. Administering such racemic mixture would be considered as administering the l-4- chlorokynurenine. Since the claims recite the transitional phrase “comprising”, the teachings of ‘744 meet the limitation of the instant claims. The resulting effects of the administration of the compound would be considered intrinsically present in the administration of l-4-chlorokynurenine. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30. 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, Kortney Klinkel can be reached at 571-270-5239. 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. /SAN MING R HUI/Primary Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Mar 21, 2024
Application Filed
Jul 03, 2024
Response after Non-Final Action
Aug 11, 2026
Non-Final Rejection mailed — §101, §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
60%
Grant Probability
80%
With Interview (+20.1%)
2y 11m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1316 resolved cases by this examiner. Grant probability derived from career allowance rate.

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