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 Claims
Claims 1-20 are pending and under consideration.
Priority
This application claims priority from US provisional application 63/437,448 filed on 1/6/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/5/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objection
Claim 14 is objected to for missing the word “in” between the recitation of “psychedelic agent” and the recitation of “an amount”.
Claim 16 is objected to for reciting SNEDDS for the first time without providing its full name of “self-nano-emulsifying drug delivery system”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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 2-5, 8-10, 16, and 19 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 terms “lower alkyl” or “lower chain” in claims 2, 3 and 16 are relative terms which renders the claim indefinite. The terms “lower chain or lower alkyl” are 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. The art is subjective on what may be a lower alkyl or chain depending on the kind of compound or purposes of the producer. The specification mentions suitable transient lower alcohols include C2-C4 alcohols, but this does not limit “lower” to C2-C4 or another particular range. Thus, it is unclear if it should be read as C2-C4 or if it could read on C1-C5 or C1-C6 or C2-C5, etc. The use of “comprises ethanol” in claim 3 does not limit the alcohol in the claim to just ethanol. For the purpose of compact prosecution, the examiner will consider lower chain or lower alkyl as being C2-C4 as indicated as suitable by applicant’s specification. Applicant might amend the claims to indicate C2-C4 alkyl alcohol.
Claim 3 recites the limitation "said lower chain alcohol" in the claim where the prior recitation in claim 2 is “a lower alkyl alcohol”. There is insufficient antecedent basis for this limitation in the claim. As “chain” does not have to be an alkyl, the claim is not necessarily referring back to “lower alkyl alcohol”. The use of “comprises ethanol” in claim 3 does not limit the alcohol to just ethanol. For the purpose of compact prosecution the examiner will consider the claim as lower chain being lower alkyl.
Claim 4 recites the limitation "said sorbitan monooleate" in the claim without a prior recitation of a sorbitan monooleate in the claim or claim 1, on which it depends. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is indefinite for the parenthetical (lipophilic) as it is unclear if this means the polyglycol mono-esters and di-esters have to be lipophilic or if this is merely an option or example of what these compounds can be. For the purpose of compact prosecution if the prior art teaches polyglycol mono-esters and di-esters or compounds that fit this description, it will read on the limitation.
Claim 5 recites the limitation "wherein nonionic surfactant comprises…" in the claim but does not introduce nonionic surfactant in claim 1. Although the limitation does not use “the” or “said”, it also does not add it as a new language with the language “further”. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the claim to provide “…wherein said nano-emulsion further includes a nonionic surfactant and the nonionic surfactant comprises….”.
Claim 8 is indefinite as the claim indicates “said tryptamine-scaffold psychedelic comprises” but one of the options is mescaline which is not a tryptamine compound. Thus, the claim allows for a situation where a tryptamine-scaffold psychedelic is not present. It is unclear if the claim is now opening up to other compounds that are not tryptamine-scaffold psychedelics or if the claim should exclude this option. For the purpose of compact prosecution, if the prior art teaches mescaline, the examiner will consider it as being a psychedelic of the claims. The applicant may remove mescaline from the group in claim 8 to correct the issue.
Claims 8-10 recites the limitation “said tryptamine-scaffold psychedelic " in the claim where the prior recitation in claim 1 is “one or more tryptamine-scaffold psychedelics”. There is insufficient antecedent basis for this limitation in the claim. Applicant should consider amending claims 8-10 to indicate “said one or more tryptamine-scaffold psychedelics” as introduced in claim 1, so that it refers to the introduced “one or more tryptamine-scaffold psychedelics”.
Claim 16 recites the limitation “the SNEDDS of the present invention" in the claim without a prior recitation of “a SNEDDS” in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 is indefinite for the limitation of “the SNEDDS of the present invention” as there are multiple SNEDDS that might be made with the teachings of the disclosure. Thus, it is unclear which invention is referred to as the present invention. Applicant may delete “of the present invention” from the claim.
Claim 16 is indefinite for having step (c) as optionally followed by step (d) as it makes it unclear if everything following step (c) is optional including step (d) or if step (c) is optional and step (d) is actually a required part of the claim. For the purpose of compact prosecution, the examiner will read everything from step c as optional but will point out teachings if they are present in the prior art references. Applicant may move the “optionally” limitation into a new dependent claim that provides for “The process according to claim 16, wherein cooling of the pre-emulsion product is done after step (b) and before diluting.” or something similar.
Claim 19 is indefinite as it provides “a hydrophilic surfactant” and “a second surfactant comprising…” with dependence to claim 18, which introduces “one or more surfactants”, which makes it unclear if these are truly additional surfactants, which are not part of the “one or more surfactants” previously introduced or if these are part of the “one or more surfactants”. If they are meant to be included in the “one or more surfactants”, then applicant may amend the claim to indicate “wherein the one or more surfactants comprise a hydrophilic surfactant and a second surfactant comprising polyethylene glycol 660 12-hydroxystearate and the composition further comprises a triglyceride.”
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 12-13 provide for “about 20-95 nm” or “about 30-95 nm” where use of “about” would allow 95 nm to extend to 100 nm or above. Claim 11, on which these claims depend note the upper range as “less than 100 nm”. Thus, claims 12-13 with use of “about” allow these claims to not further limit the range presented in claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more. The claim(s) recite(s) a non-aqueous, pre-emulsion composition (composition without water and before it forms an emulsion) that include a tryptamine-scaffold psychedelic drug and surfactants. Claim 20 adds vitamin E (a natural antioxidant). Claim 18 provides for “capable of self-emulsifying upon mixture with an aqueous solution”, which relates to an action that has not taken place in the claim, and thus, is not a feature of the claim (i.e. there is no water and the composition is not emulsified). This judicial exception is not integrated into a practical application because natural tryptamine scaffold psychedelic drugs like psilocybin or psilocin, natural surfactants like lecithin, other phospholipids, saponins, and glycolipids, and vitamin E antioxidant amount to natural products that are present for their natural activities. It is notable that natural psychedelic mushrooms contain all of these compounds. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim amounts to a combination of these natural products without the combination changing the natural form or natural activity of these compounds. Additionally, they appear to be present for their natural capabilities, psychedelic compounds act as psychedelics, surfactants can decrease surface tension and vitamin E is a natural antioxidant.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 18 rejected is under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kaufman US20220054402.
Kaufman teaches nano-dimensional compositions of psychedelic drugs formed from lipids, polymers, stabilizers, mucoadhesives, permeation enhancers, and chemical stabilizers for delivering stable dosage forms by intraoral, gastrointestinal, transdermal, and intranasal, routes of administration (abstract). Paragraph 82 provides self-emulsifying drug delivery systems and that when they are exposed to GI fluids, they form oil-in-water nanoemulsions. Paragraph 82 also teaches SNEDDS and provides that surfactants are part of them as well as dilutions (also see claims 1 and 7 of Kaufman). Kaufman teaches psilocybin and psilocin (claim 8 of Kaufman). Kaufman teaches lipid and oils encompass triglycerides for the systems (paragraphs 64-65). Example 3 teaches intranasal nanopsilocin with lecithins and medium chain triglycerides delivered by pump (paragraphs 195-196). Example 3 also provides for a portion with ethanol, water, psilocin extract, propylene glycol, pluronic F127 (nonionic surfactant), polysorbate 20 (hydrophilic and nonionic surfactant), and other ingredients (paragraph 195, also see examples 4-5). Example 8 provides for a nano-dimensional SEDDS formulation of Red Reishi Mushroom extract formulated by mixing ethyl linoleate and MCT as the oil phase, Cremophor EL as emulsifier, and ethyl alcohol as the co-emulsifier with water (paragraph 205). Example 8 also teaches dilution in water for the self-emulsification (paragraph 205). Kaufman teaches medicinal mushrooms also have tocopherols (paragraph 12). Example 6 of Kaufman teaches intranasal delivered 5-MeO-DMT (another tryptamine psychedelic) in a formulation prepared as in example 3 (paragraph 201). A pump is used to dispense the formulation intranasally (paragraph 201). Kaufman teaches nasal sprays (paragraph 97). Kaufman teaches “The term “self-emulsifying drug delivery systems (SEDDS)” in this disclosure refers to lipid-based formulations that encompass isotropic mixtures of natural or synthetic oils, solid or liquid surfactants, and co-surfactants.”, and thus, envisions formulations with these, but not water until the composition is exposed to aqueous media (paragraph 82).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kaufman US20220054402.
Kaufman teaches nano-dimensional compositions of psychedelic drugs formed from lipids, polymers, stabilizers, mucoadhesives, permeation enhancers, and chemical stabilizers for delivering stable dosage forms by intraoral, gastrointestinal, transdermal, and intranasal, routes of administration (abstract). Paragraph 82 provides self-emulsifying drug delivery systems and that when they are exposed to GI fluids, they form oil-in-water nanoemulsions. Paragraph 82 also teaches SNEDDS and provides that surfactants are part of them as well as dilutions (also see claims 1 and 7 of Kaufman). Kaufman teaches psilocybin and psilocin (claim 8 of Kaufman). Kaufman teaches lipid and oils encompass triglycerides for the systems (paragraphs 64-65). Example 3 teaches intranasal nanopsilocin with lecithins and medium chain triglycerides delivered by pump (paragraphs 195-196). Example 3 also provides for a portion with ethanol, water, psilocin extract, propylene glycol, pluronic F127 (nonionic surfactant), polysorbate 20 (hydrophilic and nonionic surfactant), and other ingredients (paragraph 195, also see examples 4-5). Kaufman teaches Tweens 20 and 80 for nonionic surfactants (paragraph 77). Tween 80 is Polyoxyethylene Sorbitan Monooleate. Example 8 provides for a nano-dimensional SEDDS formulation of Red Reishi Mushroom extract formulated by mixing ethyl linoleate and MCT as the oil phase, Cremophor EL as emulsifier, and ethyl alcohol as the co-emulsifier with water (paragraph 205). Example 8 also teaches dilution in water for the self-emulsification (paragraph 205). Kaufman teaches medicinal mushrooms also have tocopherols (paragraph 12). Example 6 of Kaufman teaches intranasal delivered 5-MeO-DMT (another tryptamine psychedelic) in a formulation prepared as in example 3 (paragraph 201). A pump is used to dispense the formulation intranasally (paragraph 201). Kaufman teaches nasal sprays (paragraph 97). Kaufman teaches the use of beakers which are containers (paragraph 195).
Kaufman does not teach the steps in claim 16 as first combining the ingredients as in step (a) and then (b) adding a lower chain alcohol to said container while mixing.
Kaufman does teach combining all the ingredients and includes the addition of ethanol in the combination. Kaufman does provide for mixing under cooling and then cooling following a sonication (paragraphs 195 and 198). Example 8 also teaches dilution in water for the self-emulsification (paragraph 205). Kaufman recognizes SNEDDS formulations (paragraph 82). Kaufman teaches adding ethanol as a permeation enhancer (paragraph 72).
One of ordinary skill in the art before the time of filing would have added the ingredients in different combinations while mixing and using a cooling step after the mixing with the expectation of forming the formulation to provide for the process of forming a SNEDDS containing tryptamine psychedelics based on the teachings of Kaufman and the level of one of ordinary skill in the art. Thus, there was a reasonable expectation of success in changing the order of adding and mixing ingredients and still obtaining such a SNEDDS formulation.
Claim 1-15, 17 and 19-20 in addition to claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman US20220054402 and Friedman US20210228534.
Kaufman teaches the claims as discussed above. Kaufman teaches bufotenine as a tryptamine psychedelic drug (paragraphs 57 and 62). Kaufman teaches 2.5 mg of psilocin per 100 ul in example 3 (equal to 25 mg/ml). Kaufman also teaches 25 mg of psilocin per 100 ul per pump (paragraph 196) (equal to 250 mg/ml). Example 8 provide for droplet sizes of 75 nm. Paragraph 55 provides for 1 to 500 nm size structures.
Kaufman does not teach polyethylene glycol 660 12-hydroxystearate or adding an antioxidant comprising vitamin E.
Friedman teaches self-emulsifying compositions (abstract). Friedman teaches nasal dosage forms (paragraph 138). Friedman teaches sucrose ester surfactants including polyethyleneglycol 660 12-hydroxystearate (solutol HS-15) (paragraph 92). Friedman teaches antioxidants including alpha-tocopherol for synergistic effects (paragraph 128). Friedman provides for forming the formulation after dilution with water (paragraphs 42, 44 and 46). Friedman also teaches triglycerides (paragraph 39). Friedman teaches “Emulsifier components are selected from the group consisting of poly-glycolized glycerides and polyoxyethylene glycerides of medium to long chain mono-, di-, and triglycerides, such as: almond oil PEG-6 esters, almond oil PEG-60 esters, apricot kernel oil PEG-6 esters” (paragraph 90). Friedman teaches polyglycolized derivatives such as polyglyceryl oleate and polyglycerol dioleate (paragraph 91). Friedman teaches polyethylene glycols as a retarding agent (paragraph 24) or a high molecular weight polymers (paragraph 120). Friedman teaches 5% to 25% by weight of an emulsifier or mixture of emulsifiers or 25% to 50% by weight thereof (paragraph 95). Friedman teaches 1% to 20% by weight of retarding agent (paragraph 117). Thus, Friedman allows for a higher proportion of emulsifier which includes the polyglycol mono and di-esters than retarding agent that includes the polyethylene glycol (would be free polyethylene glycol since not attached to another molecule).
One of ordinary skill in the prior art before the time of filing would have been capable of including additional surfactants such as polyethylene glycol 660 12-hydroxystearate for emulsification and tocopherol antioxidant as suitable ingredients for self-emulsifying drug delivery systems by the combined teachings of Kaufman and Friedman to produce suitable self-emulsifying drug compositions and the nanoemulsion thereof. Kaufman teaches tryptamine amounts and particle/droplet sizes of applicant’s claims. Thus, there was a reasonable expectation of success in producing the claimed compositions and methods of treatment by intranasal sprays by the combined teachings of the prior art.
Conclusions
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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