Prosecution Insights
Last updated: April 19, 2026
Application No. 17/358,920

STABILIZED FORMULATIONS OF CNS COMPOUNDS

Non-Final OA §102§112§DP
Filed
Jun 25, 2021
Examiner
THOMAS, TIMOTHY P
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Supernus Pharmaceuticals, Inc.
OA Round
3 (Non-Final)
26%
Grant Probability
At Risk
3-4
OA Rounds
3y 6m
To Grant
64%
With Interview

Examiner Intelligence

Grants only 26% of cases
26%
Career Allow Rate
237 granted / 906 resolved
-33.8% vs TC avg
Strong +38% interview lift
Without
With
+38.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
52 currently pending
Career history
958
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
38.5%
-1.5% vs TC avg
§102
18.3%
-21.7% vs TC avg
§112
24.0%
-16.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 906 resolved cases

Office Action

§102 §112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Acknowledgement of Receipt Applicant's response filed on 09/05/2023 to the Office Action mailed on 06/05/2024 is acknowledged. Claim Status Claims 1, 2, and 4-27 are pending. Claims 1 is currently amended. Claim 3 is cancelled. Claims 1, 2, and 4-27 have been examined. Claims 1, 2, and 4-27 are rejected. Priority Priority to 16/175207 filed on 10/30/2018, which claims priority to DIV 14/261709 filed on 04/25/2014, which claims priority to CON 13/075607 filed on 03/30/2011 is acknowledged. Information Disclosure Statement The information disclosure statements (IDSs) submitted on 06/25/2021 and 03/18/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Drawings The drawings filed on 06/25/2021 are accepted. Withdrawn Claim Rejections - 35 USC § 112 Response to Applicant’s Arguments The rejection of claims 1-27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendments to the claims. Withdrawn Claim Rejections - 35 USC § 102 Response to Applicant’s Arguments The rejection of claim(s) 1-7, 10, 11, 21-23, 26 and 27 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Comings et al. (US Patent Application Publication 2002/0156078 A1, Published 10/24/2002) is withdrawn in view of Applicant’s arguments and the amendments to the claims. Maintained 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. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer. Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-44 of U.S. Patent No. 8748472 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because while the instant formulation is not identical to the formulation of U.S. Patent No. 8748472 B2, the instant claims encompass that formulation. Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 21 of U.S. Patent No. 10149853 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because while the instant formulation is not identical to the formulation of U.S. Patent No. 10149853 B2, the instant claims encompass that formulation. Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 20, and 26 of U.S. Patent No. 11077114 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because while the instant formulation is not identical to the formulation of U.S. Patent No. 11077114 B2, the instant claims encompass that formulation. Response to Applicant’s Arguments The rejection of claim 2 on the ground of nonstatutory double patenting as being unpatentable over claims 41-44 of U.S. Patent No. 8748472 B2 is moot since the claim is cancelled. The rejection of claim 2 on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 21 of U.S. Patent No. 10149853 B2 is moot since the claim is cancelled. The rejection of claim 2 on the ground of nonstatutory double patenting as being unpatentable over claims 19, 20, and 26 of U.S. Patent No. 11077114 B2 is moot since the claim is cancelled. The rejection of claims 1, 2, and 4-27 on the ground of nonstatutory double patenting as being unpatentable over claims 41-44 of U.S. Patent No. 8748472 B2 is maintained as Applicant has not made any arguments in the response filed on 09/05/2024. The rejection of claims 1, 2, and 4-27 on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 21 of U.S. Patent No. 10149853 B2 is maintained as Applicant has not made any arguments in the response filed on 09/05/2024. The rejection of claims 1, 2, and 4-27 on the ground of nonstatutory double patenting as being unpatentable over claims 19, 20, and 26 of U.S. Patent No. 11077114 B2 is maintained as Applicant has not made any arguments in the response filed on 09/05/2024. Conclusion THIS ACTION IS MADE FINAL. 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 extension fee 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 ALI SOROUSH whose telephone number is (571)272-9925. The examiner can normally be reached M-F 9:30am-6pm. 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, Johann R Richter can be reached on (571) 272-0646. 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. /ALI SOROUSH/Primary Examiner, Art Unit 1617
Read full office action

Prosecution Timeline

Jun 25, 2021
Application Filed
May 31, 2024
Non-Final Rejection — §102, §112, §DP
Sep 05, 2024
Response Filed
Sep 22, 2024
Final Rejection — §102, §112, §DP
Jan 17, 2025
Response after Non-Final Action
Mar 21, 2025
Notice of Allowance
May 30, 2025
Interview Requested
Jun 13, 2025
Applicant Interview (Telephonic)
Jun 13, 2025
Examiner Interview Summary
Oct 20, 2025
Request for Continued Examination
Oct 21, 2025
Response after Non-Final Action
Dec 19, 2025
Non-Final Rejection — §102, §112, §DP (current)

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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
26%
Grant Probability
64%
With Interview (+38.2%)
3y 6m
Median Time to Grant
High
PTA Risk
Based on 906 resolved cases by this examiner. Grant probability derived from career allow rate.

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