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 .
Claims 1-20 are pending and under examination.
Priority
Acknowledge is made that this application is this application is continuation of US patent application 17710972, filed on 03/31/2022; which claims priority claiming from US provisional application 63/169.171, filed on 03/31/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/09/2024 and 03/10/2025 is being considered by the examiner.
Objection to Claim
Claim 1 is object to reciting “psilicin-containing” appears to be typo of psilocin-containing. Proper correctio is required.
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 1-7 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Plakogiannis et al. (US20210322447).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Plakogiannis et al. teaches e transdermal administration of psychedelics, such as psilocybin, psilocin, lysergic acid diethylamine ( LSD ), and / or ibogaine , and derivatives of these compounds (abstract). In Transdermal drug delivery, a transdermal patch or transdermal composition is applied topically to the skin surface. Throughout the duration of topic application of a transdermal patch or transdermal composition drug is continuously released and delivered through the intact skin (via transcellular, intercellular and transappenda geal routes) to achieve systemic effect. Therefore, once applied transdermal composition or transdermal patch can deliver drug into systemic circulation throughout the day or even for more than one day depending on the duration of its application which can be even up to a week or up to 15 days (page 2, [0027]). The disclosure provides a transdermal and / or topical pharmaceutical composition comprising: about 0.1 % to about 20 % of an active agent selected from the group consisting of psilocybin, psilocin, lysergic acid diethylamine (LSD), and / or ibogaine, derivatives of these compounds, and combinations thereof, about 80 % to about 99.9 % of an adhesive and / or polymer; optionally, about 0.1 % to about 20 % of a permeation enhancer; optionally, about 0.1 % to about 20 % of a solvent. The adhesive and / or polymer includes polyisobutylene, and the enhancer includes dimethylsulfoxide, dimethylacetamide, dimethylformamide, decymethylsulfo ide, dimethylisosorbide, azone, pyrrolidones , N-methyl-2 pyrrolidone, 2-pyrrolidon , esters, fatty acid esters, propylene glycol monolaurate, butyl ethanoate, ethyl ethanoate , isopropyl myristate; and the solvent includes ethanol. wherein the transdermal patch is selected from the group such as to reservoir patch, a microreservoir patch, a matrix patch, a pressure sensitive adhesive patch, extended release transdermal film a liquid reservoir system, a microreservoir patch, a matrix patch, a pressure sensitive adhesive patch, a film forming gel, a film forming spray, a micro-dosing patch, a mucoadhesive patch, and combinations thereof (page 3, [0036]; claims 1-9). Additional active ingredients include anti-inflammatory agent, bifemelane and phenelzine sulfate (page 7-13, [0066, 0068-0069]). Transdermal formulation includes liquid formulation such as cream. Emulsion, lotion and paster and the transdermal patch includes reservoir patch as well as adhesive which allows the transdermal patch to adhere to the skin (page 16, [0071-0075). In yet further embodiment, the transdermal patches described herein provide a plasma concentration of the active components of the transdermal patches in a therapeutic range in a patient over a predetermined time. In some embodiments, the predetermined time period is 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 7 days, 8 to 13 days, two weeks, or 15 days. In exemplary embodiments as disclosed herein, the transdermal patch provides a blood serum level of active agent of, for example, about 0.01 ng / mL, about 0.02 ng / mL, about 0.05 ng / ml, about 0.1 ng / mL, about 0.2 ng / mL, about 0.5 ng / mL, about 1 ng / mL, about 2 ng / mL, about 5 ng / ml, and ranges thereof (page 16, [0079-0082]). Surfactant type enhancer includes sodium lauryl sulfate (page 19, [0095]). The transdermal formulation further includes antioxidant such as ascorbic acid at about 1% to about 20%; and preservative (page 21, [0105]). Materials to make the transdermal delivery system of the disclosure in patch form known to those skilled in the art, for example, such as but not limited to reservoir patch and backing film (page 21, [0107]). The transdermal formulation includes pH buffer, stabilizer such as common buffer, acid and base such as sodium bicarbonate at an amount of about 1% to about 20% to have pH in the range of 4-8 (page 20, [0104]). The composition is used for treating inflammation (page 21, [0108]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Plakogiannis et al. is that Plakogiannis et al. is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding claim 1-2, 4, 6-7 and 14-15, Plakogiannis et al. teaches a method of administrating psilocin by applying to skin a transdermal patch includes a back film (outer surface) and a reservoir comprising psychedelics such as psilocin from 0.1% to 20%, solvent ethanol (also enhancer) from 0.1% to about 20%, enhancer fatty acid esters from 0.1% to about 20%, pH stabilizer sodium bicarbonate at about 1% to about 20% to have pH from 4-8, antioxidant ascorbic acid from about 1% to about 20%, and adhesive polymer polyisobutylene, and in one embodiment which allows the transdermal patch to adhere to the skin, thus, reservoir comprising adhesive polymer polyisobutylene is considered as skin-containing basal surface.
Regarding extended release about 6h to about 84h for plasma concentration of about 1.0 ug/L to about 7.5 ug/L (1.5 ug/L to about 5.0 ug/L in claim 2), Plakogiannis et al. teaches extended release of 24h to 72h for plasma level of about 1 ng / mL to about 5 ng / ml, which is about 1 ug /L to about 5ug /L; inside or overlapped with claimed range.
Regarding the ratio of Ls to Jp and JT patch-controlled in claims 1 and 5; 5-HT2A occupancy level about 5% to about 60% in claim 1 and about 20% to about 50% in claim 13; and psilocin dose range in claim 3, they are considered as results of prior art process. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, prior art teaches, either expressly or inherently implied, each and every limitation of the instant claims. it remains the Examiner's position that the instantly claimed method is not only anticipated in the prior art but also obvious.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 8-12 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Plakogiannis et al. (US20210322447), as applied for the above 103 rejection for Claims 1-7 and 13-15, further in view of Stamets (US20210069170) and Buyske (US4861800).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Plakogiannis et al. teaching have already been discussed in the above 103 rejection and is incorporated herein by reference.
Stamets teaches neurotrophic and nootropic compositions and methods for treating subjects with such compositions. In one aspect the composition comprises one or more tryptamines (abstract). In one embodiment, the composition is in the form of transdermal patch (page 12, [1018]). In one embodiment, tryptamines is psilocin (page 15, [0130]). Another embodiment is a composition of one or more tryptamines or in pure form or extracts from psilocybin containing mushrooms, or combinations thereof combined with one or more monamine oxidase (MAO) inhibitors, such as beta-carbolines (e.g., harmane, harmine, norharmine, perlolyrine, harmol, cordysinin, inter alia), to any of the above mentioned compositions to enhance the pharmaceutical efficacy of the tryptamine(s ) (page 17, [0142]). In the composition, the dosage of psilocin is from 10 ng to 10 mg, and the dosage of MAO inhibitor is 10 ng and 10 mg (page 15, [0129]). Thus, MAO inhibitor has the same percentage as psilocin in the composition.
Buyske teaches an example of a transdermal patch incorporating LDY. Five to fifty milligrams of this drug is dissolved in a mixture of mineral oil and poly(isobutylene) to provide a liquid-center reservoir of active drug. This reservoir is enclosed in a sealed, flat disc-shaped pouch, one to six centimeters in diameter. The top of the pouch consists of a thin aluminized polyester film that is impermeable to the pouch contents. The bottom of the pouch that will be in contact with the skin in use consists of a thin polypropylene membrane that is slowly porous to LDY, allowing the drug to continuously come into contact with the skin, so long as the bottom of the pouch is in contact with the skin (column 4, line 10-25).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Plakogiannis et al. is that Plakogiannis et al. do not expressly teach MAO and pouch reservoir. This deficiency in Plakogiannis et al. is cured by the teachings of Stamets and Buyske.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Plakogiannis et al, as suggested by Stamets and Buyske, and produce the instant invention.
One of ordinary skill in the art would have been motivated to include monamine oxidase (MAO) inhibitors in the transdermal formulation comprising psilocin because monamine oxidase (MAO) inhibitors can enhance the pharmaceutical efficacy of the tryptamine(s) such as psilocin as suggested by Stamets. Since it is advantage to do so, it is obvious for one of ordinary skill in the art to include monamine oxidase (MAO) inhibitors in the transdermal formulation comprising psilocin and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to have a pouch reservoir in transdermal patch because pouch reservoir is a suitable type of reservoir as suggested by Buyske, especially for liquid transdermal formulation; therefore, it is obvious for one of ordinary skill in the art to have a pouch reservoir in transdermal patch and produce instant claimed invention with reasonable expectation of success.
Regarding claims 8-12 and 17-20, prior arts teach a reservoir comprising psychedelics such as psilocin from 0.1% to 20%, MAO 0.1% to 20%, solvent ethanol (also enhancer) from 0.1% to about 20%, enhancer fatty acid esters (lipid disrupting enhancer) from 0.1% to about 20%, pH stabilizer sodium bicarbonate at about 1% to about 20% to have pH from 4-8, antioxidant ascorbic acid from about 1% to about 20%, and adhesive polymer polyisobutylene
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/ Primary Examiner, Art Unit 1613