Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Current Status of 17/937,948
This Office Action is responsive claims of 3/3/2026.
Claims 1, 3, 21, and 23-25 are examined on the merits. The elected species is still levomilnacipran. Claims 2, 4-7, 9, 17-18, 22, 26-29 and 30-31 are still withdrawn.
Priority
This application is continuation in part of PCT/US2022/012768, which claims priority to US provisional application 63/138,757. The instant application also claims priority to US application 15/856,853 (abandoned), which is a continuation of US application 14/878,980 (abandoned), which is a continuation of US application 13/943, 729 (abandoned), which is a continuation in part of US application 13/857,017 (abandoned), which claims priority to US provisional application 61/624,694.
The instant application finds support from US provisional application 63/138, 757. Therefore, the effective filing date is 1/18/2021.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 3/3/2026, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicants’ claim amendments and Remarks of 3/3/2026 are acknowledged and have been considered.
In regard to the 102 rejections, these rejections are withdrawn. Applicants have narrowed the CYP2D6 inhibitors in base claim 1 (bupropion, fluoxetine, and paroxetine are no longer in the scope of the instant claims).
In regard to the 103 rejection, this rejection is maintained. Applicant’s remarks with Examiner’s reply are summarized below:
Applicants have narrowed the CYP2D6 inhibitors in base claim 1.
This is true; however, the basis for the 103 rejection is combining levomilnacipan with dextromethorphan with Kerhovan logic. Bruno teaches levomilnacipan.
Applicants submit that Nofziger does not teach a dosage form.
Examiner agrees because the basis for the obviousness rejection is to combine both compounds into a single dosage form (see page 7 of the Nonfinal Rejection).
Response to Amendment
Claim Rejections - 35 USC § 103- MAINTAINED
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, 3, 21, and 23-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over NOFZIGER (Nofziger et al., “Evaluation of dextromethorphan with select antidepressant therapy for the treatment of depression in the acute care psychiatric setting”, Ment. Health Clin., March 1, 2019) in view of BRUNO (Bruno et al., “The Role of Levomilnacipran in the Management of Major Depressive Disorder: A Comprehensive Review”,Current Neuropharmacology, February, 2016) as evidenced by FDA NDA #21-620 (“FDA Application Number: 21-620”, Center for Drug Evaluation and Research, January 14, 2004)
NOFZIGER teaches a pharmaceutical composition of dextromethorphan and a CYP2D6 inhibitor such as bupropion, fluoxetine and paroxetine for treating depression (see Abstract and Results), whilst prolonging the metabolism of dextromethorphan.
NOFZIGER teaches that Dextromethorphan is extensively metabolized via cytochrome P450 (CYP) 2D6, and its half-life in extensive metabolizers is 2 to 4 hours (Introduction). The purpose of this study was to evaluate the effects of DXM in combination with a moderate-to-strong CYP2D6 inhibitor antidepressant on depression in an acute care psychiatric setting (Introduction). This helps teach the elected species of CYP2D6 inhibitor.
NOFZIGER teaches dosage for DXM from 30 mg to 90 mg a day (page 5). This teaches claims 24-25.
FDA NDA #21-620 is relied upon for the beneficial teaching that Dextromethorphan dosage of 30 and 60 mg (page 4). Therefore, NOFZIGER’s dosage is a “therapeutically effective amount of dextromethorphan” of claim 21.
NOFZIGER teaches the patients were dosed once or twice daily (page 5). This teaches claim 23.
BRUNO teaches that Levomilnacipran is a treatment for major depressive disorder (title). This helps teach claim 3 (the elected species of CYP2D6 inhibitor).
The artisan would have found it obvious to combine Levomilnacipran and Dextromethorphan, which are both known be depression treatments. It is prima facie obvious to combine one depression treatment with another in order to form a composition to be used for the very same purpose (treating depression). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I).
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144.IV.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical, Levomilnacipran, and its properties, being a CYP2D6 inhibitor, are inseparable. See MPEP 2112.01 (II). This teaches claims 1 and 3.
NOFZIGER teaches claims 21, and 23-25 above.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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