Prosecution Insights
Last updated: July 17, 2026
Application No. 18/488,215

SUBSTITUTED N-ACETYL-L-CYSTEINE DERIVATIVES AND RELATED COMPOUNDS

Non-Final OA §101§DOUBLEPATENT
Filed
Oct 17, 2023
Priority
Nov 08, 2013 — provisional 61/902,052 +5 more
Examiner
BARSKY, JARED
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Promentis Pharmaceuticals Inc.
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
73%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
469 granted / 933 resolved
-9.7% vs TC avg
Strong +23% interview lift
Without
With
+23.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
71 currently pending
Career history
1009
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
56.3%
+16.3% vs TC avg
§102
4.4%
-35.6% vs TC avg
§112
4.7%
-35.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 933 resolved cases

Office Action

§101 §DOUBLEPATENT
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 . Status of the Claims Claim 1 is pending and examined. 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. Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 10,961,187. This is a statutory double patenting rejection. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,012,674. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same art specific subject matter. The ‘674 patent is drawn to an enantiomer of the racemic compound presently claimed and a pharmaceutical composition comprising the compound. The claims of the ‘674 patent are not drawn to a method of treating trichotillomania. However, the ‘674 patent discloses that the compound is suitable for treating trichotillomania among a limited listing of conditions and/or diseases to be treated. See Abstract. MPEP 804 states: “To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.” As the disclosed use of the ‘674 patent overlaps with the present claim, the claims conflict. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims and 47 of U.S. Patent No. 9,630,937. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same art specific subject matter. The ‘937 patent is drawn to a method of treating trichotillomania by administering a pharmaceutically acceptable ester of the compound PNG media_image1.png 102 190 media_image1.png Greyscale . The ‘937 patent describes the ethyl ester of the structure claimed as a pharmaceutically acceptable ester. See column 20, line 54, through column 21, line 34. As the presently claimed compound would be encompassed by the claim of the ‘937 patent and the compound is specifically exemplified, the claims conflict. Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,112,897. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same art specific subject matter. The ‘897 patent claims a method of treating trichotillomania with the same compound as presently claimed. Therefore, the ‘897 patent would anticipate the present claim. Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of U.S. Patent No. 10,358,414. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same art specific subject matter. The ‘414 patent is drawn to a method of treating trichotillomania by administering a pharmaceutically acceptable ester of the compound PNG media_image1.png 102 190 media_image1.png Greyscale . The ‘414 patent describes the ethyl ester of the structure claimed as a pharmaceutically acceptable ester. See column 21, line 31, through column 22, line 35. As the presently claimed compound would be encompassed by the claim of the ‘414 patent and the compound is specifically exemplified, the claims conflict. As such, no claim is allowed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. 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. /JARED BARSKY/Primary Examiner, Art Unit 1628
Read full office action

Prosecution Timeline

Oct 17, 2023
Application Filed
Jan 08, 2026
Non-Final Rejection mailed — §101, §DOUBLEPATENT (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
50%
Grant Probability
73%
With Interview (+23.1%)
2y 7m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 933 resolved cases by this examiner. Grant probability derived from career allowance rate.

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