Prosecution Insights
Last updated: April 19, 2026
Application No. 18/143,793

PROCESS FOR THE PRODUCTION OF LEVETIRACETAM AND INTERMEDIATE THEREOF

Non-Final OA §101§DP
Filed
May 05, 2023
Examiner
SHAMEEM, GOLAM M
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Suzhou BrightHope Pharmatech Co., Ltd.
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

§101 §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 Status of Claims Claims 1-6 are currently pending in the application. Information Disclosure Statement Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 10/15/2024, which has been entered in the file. 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 Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the conflicting claims 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 and 3-6 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 5, 6, 11 and 12 of co-pending Application No. 18/143,785. This is a provisional double patenting rejection because the conflicting claims have not in fact been patented. 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 1-6 are rejected under the judicially created doctrine of obviousness-type double patenting, as being unpatentable over claims 1-6 of co-pending Application No. 18/143,790 (US ‘790) and also over claims 1, 5, 6, 11 and 12 of co-pending Application No. 18/143,785 (US ‘785). Although the conflicting claims are not identical, they are not patentably distinct from each other because all sets of claims are drawn to the same art recognized subject matter. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. The process for the production of Levetiracetam including (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide of formula (I) taught by co-pending applications are similar to instant application, because a reference anticipating one set of claim will render the other obvious and it would have been obvious to one of ordinary skill in the art at the time of the invention was made, since US ‘790 and US ‘785 co-pending applications teach the generic process of preparing (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide of formula (I), which are similar to the instantly claimed invention. The subject matter claimed in the instant application is fully disclosed and covered in the US ‘790 and US ‘785 co-pending applications. Therefore, the disclosure of US ‘790 and US ‘785 co-pending applications that teach all the essential elements for the process of preparing (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide of formula (I) [including various reagents and reaction conditions, such as, PNG media_image1.png 324 566 media_image1.png Greyscale etc., (claim 1, US ‘785 )] under specific set of reaction conditions, which would easily place Applicants invention in possession of the public before the effective filing date of the claimed invention. The claimed process of preparing (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide of formula (I) is so closely related methodically in terms of reagents and reaction conditions as to be analogous method / process of the references and therefore obvious in the absence of any unobviousness or unexpected properties. Moreover, any other differences are but obvious technical modifications, which would be apparent to one skilled in the chemical art that can use similar reagents, reaction steps / conditions, would expect to have the same or essentially the same results. Therefore, in looking at the instantly claimed invention as a whole, the claimed process for the production of (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide of formula (I) would have been suggested to one skilled in the art 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

May 05, 2023
Application Filed
Oct 02, 2025
Non-Final Rejection — §101, §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

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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