Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2026 has been entered.
Current Status of 17/937,948
This Office Action is responsive to the amended claims of 8/11/2026.
The Markush search has been extended to celecoxib. Claims 3-7, 9, 17-18 and 30-31 are still withdrawn.
Claims 1-2 and 22-29 are examined on the merits.
Response to Arguments
Applicants’ claim amendments and Remarks of 8/11/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the obviousness rejection, this rejection is withdrawn at least for the reason that applicants amended the instant claims. Applicants Remarks are summarized below:
Applicants submit that Nofziger does not teach dextromethorphan and a CYP2D6 inhibitor in a single combined dosage (se pages 77 and 79).
Applicants submit that dextromethorphan does not show significant antidepressant activity (page 80).
Applicants submit that there would be no motivation to combine dextromethorphan with levomilnacipran for treating depression.
Applicants amended the claimed CYP2D6 inhibitor to be celecoxib, levomilnacipran, vilazodone, and vortioxetine.
This excludes the compounds described by Nofziger.
Response to Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-2 and 22-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flesher (WO2009/006194 A1) and LOFTSSON (Thorsteinn Loftsson, “Chapter 5- Pharmacologic response and Drug Dosage Adjustments”, A Primer for Pharmaceutical Scientists”, 2015).
Flesher teaches an oral preparation (i.e. a dosage form) containing dextromethorphan or a salt thereof and CYP2D6 enzyme inhibitor (ref claim 1). The reference claims use the preferred example of quinidine. This helps teach claims 1 and 21.
Flesher teaches Celecoxib as a CYP2D6 enzyme inhibitor (page 56).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP 2123 (II). This helps teach claims 1- 2, 22.
In regards to the limitation wherein dextromethorphan and celecoxib are the sole therapeutically active ingredients in the dosage form as recited in claim 1. Flesher does not disclose administering any other additional active ingredients for the method of use [see Study 3, p.82 and ref claim 1].
Flesher teaches the composition is administered once a day (claim 19). This helps teach claims 23 and 26.
Flesher teaches that the composition when administered yields a plasma concentration of dextromethorphan of at least about 20 ng/mL and an integrated total area under a plasma concentration curve for dextromethorphan of at least about 200 ng per hour/mL (ref claim 1). Flesher also teaches that dextromethorphan can be used up to 120 mg per day (page 21). This helps teach claims 24-25.
Flesher teaches weight ratios of dextromethorphan and an inhibitor of the CYP2D6 enzyme in a combined dose as being anywhere from 1:1.5 ratio or less OR also 1:4 ratio or more (page 48). This helps teach claims 27-29.
Flesher does not disclose an example which has dextromethorphan and Celecoxib as a dosage. Flesher also does not disclose specific amounts in Flesher’s claims.
LOFTSSON teaches that dosage regimens are based on average pharmacokinetic parameters (page 120). LOFTSSON also teaches that these parameters may vary with patients’ gender, age, weight, and disease state (page 120). Furthermore, dosage adjustment is known (examples 5.1-5.4 on pages 120-124).
An artisan would have found it obvious to replace quinidine with celecoxib therefore arriving at the instant invention. Flesher teaches a dosage form of dextromethorphan and CYP2D6 enzyme inhibitor (the preferred inhibitor is quinidine); Flesher also teaches celecoxib as an equivalent CYP2D6 enzyme inhibitor. Therefore, the artisan would have been motivated by Flesher’s teachings and expected to substitute one CYP2D6 inhibitor for another. This teaches claims 1, 2, 21, 22, 23, and 26.
The artisan would have been motivated to optimize the amount of dextromethorphan and Celecoxib. One would be motivated to adjust the amount because this is something that is routinely practiced in the pharmaceutical arts (LOFTSSON pages 120-124; Flesher pages 21 and 48). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)A. Thus, the artisan would be motivated and expected to optimize the dosage of dextromethorphan and Celecoxib. This teaches claims 24-25 and 27-29.
Conclusion
No claims are allowed as currently written.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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