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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/24/2026 has been entered.
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2020/044745, filed 08/03/2020, which claims the priority benefit of Application No. PRO62/883,295, filed 08/06/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of claims
Claims 1-13, 18, and 20-30 are pending. Claim 1 has been amended. Claims 14-17 and 19 are cancelled by the applicant without prejudice or disclaimer. Claims 4-13 are withdrawn from consideration. Claims 1-3, 18 and 20-30 are currently under examination.
Applicant’s arguments, filed 04/24/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
The obviousness rejection below is repeated from the 11/25/2025 Office Action and modified in order to address the most recent amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 18 and 20-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “related” in claim 1, line 4 is a relative term which renders the claim indefinite. The term “related” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A skilled artisan would be unable to determine if the limitation “endocrine related mechanisms” in instant claim 1 refers to a condition stemming from the endocrine system or a mechanism similar to that found in the endocrine system. The specification provides limited direction in [0025] and [0058], but does not disclose what endocrine related mechanisms are.
This rejection may be overcome by amending claim language to clearly indicate which endocrine related mechanisms applicant intends. Claims 2-3, 18 and 20-30 are rejected for being dependent on claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-3, 18 and 20-30 are rejected under 35 U.S.C. 103 as being unpatentable over Rothman (WO 2018/031216 Al) in view of Garovoy et al. (WO 2013/003708 Al).
The instant claims are directed to a method of treating sexual dysfunction and increasing orgasmic ability, sexual satisfaction, desire in a male or female subject in need thereof wherein the sexual dysfunction is due to a psychogenic mechanism, a vasogenic mechanism, an endocrine related mechanism, or a medication induced mechanism by orally administering 3,4- diaminopyridine (3,4-DAP or amifampridine) for at least 4 weeks. Rothman et al. teach a method for treating sexual dysfunction in a subject in need thereof comprising topically administering a composition comprising a potassium channel blocker [0012]. Rothman teaches 3,4-diaminopyridine (3,4 DAP) as a particularly suitable potassium channel blocker [0023]. Rothman discloses the actual amount of the potassium channel blocker can depend on the patient's age, weight, sex, medical condition, disease or any other medical criteria and can be administered one or more times a day [0025]. Rothman discloses “Suitable subjects include female subjects and male subjects. Further, the subjects are referred to herein as "subjects in need thereof". As used herein," subjects in need thereof" refers to a subset of subjects in need of increasing sexual arousal. In one embodiment, subjects that are in specific need may include subjects who are susceptible to, or at elevated risk of, diagnosed as suffering from low sex
drive, sexual dysfunction, and the like, as well as menopausal and post-menopausal women.” [0043]. Rothman teaches enhancing sensitivity of cutaneous sensory afferent nerve endings by increasing the rate of peripheral nerve firing, increased neuronal sensitivity and should increase the probability of reaching orgasm [0059].
However, Rothman et al. fail to disclose administration of 3,4-diaminopyridine in an oral dose range of 9.5-189.5 mg comprising scored tablets or in 3 or 4 doses per day as required by instant claim 28.
Garovoy et al. teach methods for treatment of any 3,4-diaminopyridine (3, 4 DAP) responsive disorder [0007]. Garovoy teaches 3,4 DAP can be used for treatment of motor neuron diseases including Parkinson's disease by improving neuromuscular transmission and thus increasing the entry of cellular calcium which improves the acetylcholine in the nerve endings [0003]. Garovoy teaches an investigational product, dose, route regimen in where orally administering scored tablets of 10 mg amifampridine to subjects [000346]. Garovoy teaches a single dose study in the investigational product, dose, route regimen where the dose range of 3,4 DAP were 5-30 mg [000347]. Garovoy discloses 3,4 DAP phosphate salt is administered between 30-240 mg per day and 1-5 times per day [000142]. Garovoy discloses a therapeutically effective amount of 3, 4 DAP will vary depending on the condition to be treated, and can be readily determined by the treating physician based on improvement in desired clinical symptoms [00065].
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to treat all variants of sexual dysfunction caused by biologic or medication induced mechanisms in a patient in need thereof by orally administering a 14 day regimen of 3, 4 DAP following Rothman's disclosure of a treatment of sexual dysfunction of female sexual interest/arousal disorder in a subject by administering 3,4 DAP in combination with Garovoy's method of administering 3, 4 DAP via 30-240 mg tablet administration because of the improved consistency of maximized oral bioavailability from one administration to the next. See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
A person of ordinary skill in the art would have been motivated to administer 3,4 DAP in tablet form to treat the sexual dysfunction of female sexual interest/arousal disorder to a subject in need thereof because of the accuracy in dosing and desirable bioavailability of an effective amount of 3,4 DAP. Given the combined teachings of Rothman and Garovoy, a skilled artisan would have a reasonable expectation of success in treating a patient with female sexual interest/arousal disorder by administering 3,4 DAP in an oral tablet dose 1-5 times a day. Therefore, based on the prior art of current record, the instantly claimed subject matter, taken as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the instant application was filed.
Response to Arguments
Applicant's arguments filed 04/24/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Rothman (WO 2018/031216 Al) does not disclose or suggest treating sexual dysfunction arising from psychogenic, vasogenic, endocrine-related, or medication-induced mechanisms, nor does it contemplate chronic oral administration or sustained systemic exposure to treat sexual dysfunction arising from these mechanisms and that Garovoy (WO 2013/003708 A1) does not cure these deficiencies. Applicant further argues Garovoy does not disclose or suggest treating sexual dysfunction arising from psychogenic, vasogenic, endocrine-related, or medication-induced mechanisms. In this case, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicants amendment of claim “wherein the sexual dysfunction is due to a psychogenic mechanism, a vasogenic mechanism, an endocrine related mechanism, or a medication induced mechanism.” Is a narrower scope of sexual dysfunction in a patient, however the prior art applies to sexual dysfunction in a subject in general and is therefore given the broadest reasonable interpretation that it necessarily includes all forms of sexual dysfunction in a subject. See MPEP 2111 and MPEP 2112.02 II. Furthermore, no dosages or structural changes were made to the compound of 3,4-diaminopyridine in the instant claims to differentiate it from the 3,4-diaminopyridine compound of the references. See 2112.01 which states,
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not."
Examiner also notes that the use of the compound of 3,4-diaminopyridine in a method of treating sexual dysfunction is used by both applicant and Rothman. See MPEP 2112.02 II
“The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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/E.V./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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