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 .
Priority
The instant application is a 35 USC 371 National Stage filing of international application No. PCT/US2021/064653, filed December 21, 2021, which claims the benefit of an effective US filing date under 35 USC 119(e) from US Provisional application 63/128,317, filed December 21, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 23, 2024, February 23, 2024 and November 13, 2025 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Status of Claims
Currently, claims 30-43 are pending in the instant application and are under consideration herein.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 30-43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0326139 (“the ‘139 publication”).
The ‘139 publication teaches pharmaceutical formulations containing a serotonin reuptake inhibitor and a smooth muscle relaxant for the treatment of premature ejaculation (Abstract). Mesembrine is specifically disclosed as the SSRI (paragraph [0013], claim 12). The reference teaches the administration of a PDE5 inhibitor and SRI combination (which read son the combination required by instant claim 43) for on-demand (i.e. as needed prior to coitus) or for daily administration, “within about 36 hours, within about 35 hours, within about 34 hours, within about 33 hours, within about 32 hours, within about 31 hours, within about 30 hours, within about 29 hours, within about 28 hours, within about 27 hours, within about 26 hours, within about 25 hours, within about 24 hours, within about 23 hours, within about 22 hours, within about 21 hours, within about 20 hours, within about 19 hours, within about 18 hours, within about 17 hours, within about 16 hours, within about 15 hours, within about 14 hours, within about 13 hours, within about 12 hours, within about 11 hours, within about 10 hours, within about 9 hours, within about 8 hours, within about 7 hours, within about 6 hours, within about 5 hours, within about 4 hours, within about 3 hours, within about 2 hours, within about 90 minutes, within about 1 hour, or within about 30 minutes of coitus,” all of which read on the instantly claimed administration schedule for instant claims 35, 36 and 38 (paragraph [0031], [0048]). Notably, each of the disclosed dosages in paragraph [0040] anticipates the instant claim 37 requiring “at least 0.001 mg”. The smallest recited dose of the SRI drug is 1 mg, the largest is 20 mg, and each recited option anticipates the instant claims. Regarding instant claim 34, “the drug agents that are co-administered, contemporaneously administered, or administered in a single combined form, the drug(s) is/are formulated as a tablet, a capsule, a liquid, a powder, a lyophilized cake, an oral film, troche, or an intranasal preparation. In one embodiment, the drugs are formulated as an oral disintegrating tablet.” (paragraph [0046]).
Finally, with respect to claims 40-42, it is noted that the limitations read as product-by-process limitations, reciting only the source process for obtaining mesembrine. MPEP 2113 provides the following guidance: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). The facts here are similar to those in Amgen above since the prior art and instantly claimed process both utilize mesembrine such that the outcome (i.e. the treatment of the medical condition) will be the same.
Since the prior art teaches all required limitations of the claimed invention, the claims are anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699