Prosecution Insights
Last updated: April 19, 2026
Application No. 18/243,095

PHARMACEUTICAL COMPOSITIONS COMPRISING 2,3,5-TRIMETHYL-6-NONYLCYCLOHEXA-2,5-DIENE-1,4-DIONE

Non-Final OA §DP
Filed
Sep 06, 2023
Examiner
SHAMEEM, GOLAM M
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ptc Therapeutics Inc.
OA Round
1 (Non-Final)
87%
Grant Probability
Favorable
1-2
OA Rounds
2y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 87% — above average
87%
Career Allow Rate
760 granted / 875 resolved
+26.9% vs TC avg
Strong +16% interview lift
Without
With
+15.9%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 1m
Avg Prosecution
20 currently pending
Career history
895
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
4.9%
-35.1% vs TC avg
§102
19.8%
-20.2% vs TC avg
§112
23.3%
-16.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 875 resolved cases

Office Action

§DP
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 . DETAILED ACTION Priority PNG media_image1.png 16 310 media_image1.png Greyscale , is acknowledged. Status of Claims Claims 1-4, 7-9, 11, 15, 17, 20-22, 33-34, 48-49, 51, 54, and 61 are currently pending in the application. Information Disclosure Statement Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 12/11/2023, which has been entered in the file. Double Patenting 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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b). Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 1-4, 7-9, 11, 15, 17, 20-22, 33-34, 48-49, 51, 54, and 61 are rejected under the judicially created doctrine of obviousness-type double patenting, as being unpatentable over claims 1-27 of US 11,786,486 (US ‘486) and if allowed, would improperly extend the “right to exclude” already granted in the patent. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same art recognized subject matter. A reference anticipating one set of claim will render the other obvious and it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, since US ‘486 patent teaches the generic compounds and their pharmaceutical compositions which are similar to the instantly claimed inventions. The subject matter claimed in the instant application is fully recited and covered in the claims of US ‘486 patent, such as, PNG media_image2.png 262 260 media_image2.png Greyscale PNG media_image3.png 110 264 media_image3.png Greyscale (claim 1, column 50-51, US ‘486). Therefore, the disclosure of US ‘486 patent that teaches all the essentials of pharmaceutical composition comprising elements including Compound 1 and/or the hydroquinone form thereof, which would easily place Applicant’s invention in possession of the public before the effective filing date of the claimed invention. Therefore, in the instant case, one skilled in the chemical art would be motivated to prepare a desired pharmaceutical compositions comprising a known compound with a “flavorant is present” thereof, in view of the known teaching of the art. The claimed compounds, and their compositions are so closely related structurally to the homologous and /or analogous compounds of the reference as to be structurally obvious, therefore in the absence of any un-obviousness or unexpected properties. Moreover, any other differences are but obvious structural / chemical or pharmaceutical modifications, which would be apparent to one skilled in the chemical art that can use similar variations in pharmaceutical compositions, would expect to have the same or essentially the same results and therefore, is obvious, absent evidence to the contrary. Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682. 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://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600. /GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621
Read full office action

Prosecution Timeline

Sep 06, 2023
Application Filed
Nov 18, 2025
Non-Final Rejection — §DP (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
87%
Grant Probability
99%
With Interview (+15.9%)
2y 1m
Median Time to Grant
Low
PTA Risk
Based on 875 resolved cases by this examiner. Grant probability derived from career allow rate.

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