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 .
Status of the Application
This Office Action is in response to applicant’s arguments filed on 9/21/26. Claims 113-131 are pending. Claims 118-119 have been withdrawn. Claims 113-117, 120-131 are examined herein.
Applicant’s arguments have been fully considered but found not persuasive. The rejection of the last Office Action is maintained for reasons of record and repeated below for Applicant’s convenience.
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 113-117, 120-131 are rejected under 35 U.S.C. 103 as being unpatentable over Ray (“Constructing the ecstasy of MDMA from its component mental organs: Proposing the primer/probe method,” Medical Hypothesis, 2016, 87, 48-60, of record) in view of Pearson et al. (WO 2014/004676, of record) and Federal Register (“Schedules of Controlled Substances: Placement of 4-hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT), 5-methoxy-alpha-methyltryptamine (5-MeO-AMT), 5-methoxy-N-methyl-N-isopropyltryptamine (5-MeO-MiPT), 5-methoxy-N,N-diethyltryptamine (5-MeO-DET), and N,N-diisopropyltryptamine (DiPT) in Schedule I,” 2022, vol. 87, no. 10, 2376-2383, of record).
The instant claims are directed to a composition comprising an imidazoline-1 (I1) receptor agent and a serotonin 7 (5-HT7) receptor agent.
Ray proposes a “primer/probe” method to test a hypothesis that originated from the “mental organ” theory to elucidate the mechanism of action of the drug MDMA, commonly known as ecstasy (abstract). The primer/probe method consists of using a primer to load the mental organs activated through probed receptors into consciousness, and is a proposed new method of studying the mind which consists of a double-blind controlled experiment, which has three treatments. One of the three treatments consists of administering the primer (DOB, MEM, DOET, or 2C-B-fly) and the probe (selective imidazoline-1 agonist: rilmenidine or moxonidine) together (page 53, right column, last full paragraph). Rilmenidine and moxonidine have their primary affinity at imidazoline-1. Other drugs, such as MDMA, DIPT, mescaline, 5-MeO-DIPT, DMT, and DPT are also known to act on imidazoline-1 (page 55, left column, paragraphs 3-4). Survey studies have shown that cannabis is used to enhance the effects of MDMA, and controlled clinical studies have shown that THC enhances the effects of MDMA. Studies have shown that more than 90% of MDMA users also use cannabis and the two drugs are often taken together (page 55, right column, last paragraph). Given the possible need for THC in the proposed primer/probe construction of the MDMA entactogenic mental state, a more complex set of conditions would be needed for a fully controlled experiment: the primer, the probe, and THC taken together (page 56, left column, second paragraph).
However, Ray fails to disclose a therapeutic composition comprising 5-MeO-MiPT.
Pearson et al. teaches a therapeutic composition comprising the neuroprotective agent, FAAH inhibitor of formula I, in combination with one or more additional therapeutic agents for the treatment or prevention of neuronal injury or neurodegeneration in a patient in need thereof (title and abstract). Additional therapeutic agents include imidazoline-1 receptor agonists, such as rimenidine and moxonidine (page 69 and claim 52). The compositions may be administered orally (paragraph 00147). Pharmaceutically acceptable carriers, diluents, excipients, kits, single or multiple dosing, instructions, packaging are taught (paragraph 00112, 00126, 00132). Controlled drug delivery systems, such as sustained or extended release, are taught (paragraphs 00140-00141).
The Federal Register teaches that 5-MeO-MiPT is 15-fold more potent than DMT when comparing doses that produce hallucinogenic effects (page 2379, middle column, second paragraph). The Federal Register also teaches that 5-MeO-MiPT and DIPT are structural analogs of schedule I hallucinogens: 5-MeO-DIPT, 5-MeO-DMT, and DMT (page 2379, left column, fourth paragraph).
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 modify the Ray invention to provide 5-MeO-MiPT, as taught by the Federal Register, in order to provide an agent that is more potent than DMT, as previously used in Ray, in a therapeutic composition, as taught by Pearson et al.
A person of ordinary skill in the art would have been motivated to use 5-MeO-MiPT because this will in effect cause a greater entactogenic response, thereby producing a more robust “primer/probe” method to test the hypothesis. A person of ordinary skill in the art would have been motivated to formulate a therapeutic composition because both Ray and Pearson et al. teach the use of imidazoline-1 receptor agonists, such as moxonidine. Furthermore, Pearson et al. teaches that such therapeutic compositions are useful in the treatment or prevention of neuronal injury or neurodegeneration in a patient in need thereof. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating or preventing neuronal injury or neurodegeneration by administering a therapeutic compositions comprising a imidazoline-1 (I1) receptor agent and a serotonin 7 (5-HT7) receptor agent.
Response to Arguments
Applicant argues that Ray does not identify DMT as either a primer or a probe. Even if 5-MeO-MiPT is preferred to DMT, there is no DMT in Ray’s proposed combinations to replace, because no component or function is identified. The Federal Register does not explain why the hallucinogenic effects of 5-MeO-MiPT would be selected for combination with rilmenidine.
This is not persuasive because Applicant is reminded that Ray clearly teaches that the disclosed probes, rilmenidine and moxonidine, are taught to have their primary affinity at imidazoline-1. Ray also teaches that other drugs, such as MDMA, DIPT, mescaline, 5-MeO-DIPT, DMT, and DPT are also known to act on imidazoline-1. Therefore, since these drugs are functional equivalent, it would be obvious to combine or substitute one for another. Moreover, since the Federal Register teaches that 5-MeO-MiPT is 15-fold more potent than DMT, it would similarly be obvious to substitute or combine 5-MeO-MiPT for DMT.
Applicant argues that the limitation regarding “wherein the Il receptor agent exhibits a selectivity for the Il receptor over the alpha-2 (a2) adrenergic receptor of at least about 30-fold” and “wherein the 5-HT7 receptor agent has a 5-HT7 receptor Ki of less than 10 nM.”
This is not persuasive because these limitations are drawn to inherent properties of the I1 or 5-HT7 agent that will necessarily occur. “Products of identical chemical composition cannot have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
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 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam 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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/Yong S. Chong/Primary Examiner, Art Unit 1623
