DETAILED ACTION
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 .
Claim 1-22 and 26 are cancelled. Therefore, claims 23-25 and 27-43 are currently pending in the instant application.
Information Disclosure Statement
Applicant’s Information Disclosure Statement, filed on November 04, 2025 has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
Response to Remarks/Amendment
Applicants’ Response, submitted February 05, 2026, has been reviewed by the Examiner and entered of record in the file.
Previous Claim Rejections - Withdrawn
Claims 1 and 43 were previously rejected under 35 U.S.C. § 112(a) as allegedly failing to comply with the enablement requirement. In view of Applicants' amendment filed February 10, 2025, the rejection is withdrawn.
Previous Rejections-Maintained
Applicant's arguments, in regards to the double patenting rejections, filed February 05, 2026 have been fully considered but they are not persuasive.
Claims 23-25 and 27-43 remain rejected on the ground of nonstatutory obviousness type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,717,509 B2.
Claim 23 reads as follows:
A composition comprising (a) a carbamate compound of the following Formula 1, or a pharmaceutically acceptable salt, solvate or hydrate thereof; (b) an antipsychotic
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Applicants argument is as follows:
(i) Applicants argue that claim 23 is patentably distinct from US '509 because US '509 recite a combination comprising two components, whereas claim 23 recites a composition comprising three components. In regards to the this argument, the instant claims of US ‘509 recite the term “comprising” which allows the presence of additional unrecited components and therefore cover the presence of the third component recited in the instant claims.
(ii) Applicants further argue that claim 23, recite additional antipsychotic agents, including haloperidol and chlorpromazine which are absent in the claims of US ‘509. This argument is not persuasive because, in claim 23, the antipsychotic agent is not limited to haloperidol and chlorpromazine. The claim covers other antipsychotic agents such as aripiprazole, asenapine, clozapine, iloperidone, olanzapine, lurasidone, paliperidone, quetiapine, risperidone, ziprasidone. The patented claims of ‘509 cover antipsychotic agents that overlap with claim 23. See below claim 1 of ‘509.
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(iii) Applicants further argue that claim 23, recite a narrower set of substituents for R1 and R2 when compared to the claims of US ‘509. This argument is not persuasive because, the definition of the variable R1 and R2 in the claims of US ‘509 overlap with the definition of the variables in the instant claims. Therefore, Applicants have already coverage in the patented claims in the overlapping subject matter and therefore, the rejection is maintained..
Although the conflicting claims are not identical, they are not patentably distinct from each other because there is a huge overlap on the subject matter claimed in both sets of claims and both sets of claims are directed to the same art specific subject matter. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claims are either anticipated by, or would have been obvious over, the reference claims.
MPEP 804 states : “where the claims of an application are not the "same” as those of the first patent, but the grant of a patent with the claims in the application would unjustly extend the rights granted by the first patent, a double patenting rejection under nonstatutory grounds is proper.”
Accordingly, U.S. Patent No. 11,717,509 B2 renders the instant claims obvious absent a showing of unpredictability or comparative evidence suggesting otherwise.
Conclusion
Claims 1-22 and 26 are cancelled.
Claims 23-25 and 27-33 are rejected.
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626