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 Claims
Acknowledgement is made of the response filed on February 9, 2026. In that response, claim 1 was and claim 23 was cancelled. Claims 1, 2, 4-16, and 18-22 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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, 2, 4-16, and 18-22 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 “sub-therapeutic” in claim 1 is a relative term which renders the claim indefinite. The term “sub-therapeutic” 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. Claim 1 recites a method comprising orally administering to a subject an oral dissolvable film. However claim 1 does not recite the purpose therefor, i.e., why the dissolvable film is administered. Since the claim does not recite what therapeutic effect the method is achieving, the therapeutic dose is undefined. As a result what amount is “sub-therapeutic”, i.e., below the therapeutic dose, is also unknown.
Dependent claim 2 recites “boosting physical energy level, increasing performance on problem-solving tasks, …, or any combination thereof”. This phrase might be the intended purpose of orally administering the recited oral dissolvable film in claim 1. However claim 2 is not written as such, e.g., “method of claim 1, wherein the method if for boosting physical energy level, increasing performance on problem-solving tasks, …, or any combination thereof”. Instead claim 2 recites “comprising boosting physical energy level, increasing performance on problem-solving tasks, …, or any combination thereof”, meaning another step comprising the method of claim 1 given that claim 1 recites a “method comprising…”.
Assuming arguendo that claim 2 clearly recites “boosting physical energy level, increasing performance on problem-solving tasks, …, or any combination thereof” as a purpose for administering the oral dissolvable film of claim 1, it is noted that neither the claims nor the Specification sets forth some measure of determining the requisite degree of “therapeutic” (and thereby what amount is “sub-therapeutic”) with respect to any of “boosting physical energy level, increasing performance on problem-solving tasks, …, or any combination thereof”. Determining therapeutic efficacy for each of the “purposes” or desired outcomes in claim 2 requires some means of testing and quantification. Notably each of the outcomes in claim 2 are not amenable to one objective testing, e.g., detecting an analyte in a chemical sample. To the contrary methods of quantifying a therapeutic dose for “treating addiction” for example in claim 2, would vary depending on the addictive substance, target demographic, and assessment scale, among other factors. Here neither the claims nor the Specification sets forth any measure of determining the requisite degree of “therapeutic” or “sub-therapeutic”, for any of the putative purposes or outcomes in claim 2.
Furthermore It is noted that predictably and repeatably quantifying the effects of psilocybin-containing mushrooms, which is the present Specification does not disclose, is not established in prior art. A concept similar to the “sub-therapeutic dose” is “microdosing”. As evidenced by Johnstad (Johnstad, P.G., Powerful substances in tiny amounts: An interview study of psychedelic microdosing, Nordic Studies on Alcohol and Drugs 2018, Vol. 35(1) 39–51) the “most commonly used psychedelics for microdosing were psilocybin-containing ‘magic mushrooms’”, at 0.1-0.3 g (p.43 rt. col, p.44 left col..; see title; abstract) which represent “about a tenth of a full dose” (p.44 left & rt. cols). There is also a range called “mini-dose”, lesser than the full dose,, which “might have serious negative consequences for users who combine microdosing with work, driving a car, and other activities not compatible with drug intoxication” (p.48 left-rt.col.). Also individual response differs based on the dose and concomitant situation as exemplified by a user two used 0.25 g and 0.25-0.35 g (p.46 right col.). Claim 1 here recites a much broader range, 0.01 to 5 mg. Therefore “at a sub-therapeutic dose” in claim 1 renders the claims indefinite.
None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
For the purposes of examination now this claim term is construed as an amount.
Response to Arguments
Applicant's arguments filed February 9, 2026 have been fully considered but they are not persuasive. Applicant referred to the following disclosure (Specification, page 33 second para.) as clearly defining “sub-therapeutic dose”. (Remarks, 7, Feb. 9, 2026).
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In response it is noted that this disclosure fails to resolve indefiniteness of claim 1 because it does not identify any “whole-body effects” or any “cellular response to be observed”. The relevant information would include what effect, e.g., analgesia, anxiety relief, etc., as well as which cells to assay for what biomarker of such effect. Particularly with respect to claim 2 it is unclear, without any relevant disclosure, how “increasing performance on problem-solving tasks” for example, could be measured not as a “whole-body effect” but through a “cellular response to be observed”.
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 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 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.
Claims 1, 2, 4-16 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US 7,025,983) in view of Johnstad (Johnstad, P.G., Powerful substances in tiny amounts: An interview study of psychedelic microdosing, Nordic Studies on Alcohol and Drugs 2018, Vol. 35(1) 39–51) and Bengs (US 6565640), as evidenced by Wypych (Wypych, A., Glyceryl monoacetate (Monoacetin), Databook of Plasticizers (Second Ed.), 2017, available at https://www.sciencedirect.com/topics/engineering/monoacetin accessed on April 5, 2024).
Regarding claims 1, 4-9, 13, 14, and 18-22, Leung teaches (title; abstract; col.3 ll.10-13, col.19 l.1-col.20 l.21; claims 1-11) rapidly dissolvable films comprising an active agent and the excipients in present claims 19 and 21 (col.5 ll.15-23, col.13 ll.53-59), specifically including the following:
“plasticizing agents” including but not limited to triacetin, monoacetin, and diacetin at up to about 20% (col.5 ll.54-57; col.13 ll. 53-55);
moisture, preferably at about 3 to about 8% (col.11 ll.21-27);
sweeteners at up to about 10% (col.6 l.21-col.7 l.5)
a flavoring, preferably at about 8 to about 10 % (col.7 ll.8-56);
a mixture of water soluble film-forming polymers such as pullulan and sodium alginate at about 30 to about 80% (col.4 l.66-col.5 l.14; claim 11);
colorants, preferably at under 1% (col.7 l.57-col.8 l.9);
a preservative, preferably sodium benzoate and potassium sorbate, preferably at about 0.01 % (col.14 ll.1-6); and
active agents including psychopharmacologicals at a suitable dose amount, e.g., 1-4 mg/dose (col.12 l.22-col.13 l.59, especially col.13 ll.22-25).
Regarding the plasticizer, Wypych evidences that the monoacetin that Leung teaches is also known as glyceryl or glycerol monoacetate, in claim 20.
Regarding the preservative, Leung teaches sodium benzoate and potassium sorbate. Thus the skilled person would appreciate sodium sorbate would be suitable. Furthermore Leung teaches ascorbic acid or vitamin C as a saliva stimulating agent that that can be added to the films (col.5 lines 42-48). A “chemical composition and its properties are inseparable”, MPEP § 2112.01(II), and therefore vitamin C would act as a preservative in Leung’s composition, whether the formulator intended it as a preservative or as a saliva stimulating agent.
The films dissolve within 30 seconds (col.9 ll.62-63). For the pharmaceutically active agent, 1-4 mg/dose is within the range in claim 1 and overlaps with those in claims 6-8, and includes that in claim 9, 13, and 14. For each excipient, Leung’s ranges overlap those in claim 21. In the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding “wherein … the oral dissolvable film exhibits high stability such that .. 3 months”, the following is noted:
Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect:
(A) statements of intended use or field of use, including statements of purpose or intended use in the preamble,
(B) "adapted to" or "adapted for" clauses,
(C) "wherein" or "whereby" clauses,
(D) contingent limitations,
(E) printed matter, or
(F) terms with associated functional language.
This list of examples is not intended to be exhaustive... For more information about these types of claim language and how to determine whether they have a limiting effect on claim scope, see MPEP §§ 2111.02 through 2111.05.
MPEP §2103(I)(C) (emphases added). Here the phrase “wherein … the oral dissolvable film exhibits high stability such that .. 3 months” does not require a particular structure, e.g., concentration of each component that is disclosed as obtaining the properties recited in the wherein clause. The disclosure contains the same phrase (along with several similar stability parameters, e.g., 95% of the psychedelic compounds remains in the film under the same accelerated stability conditions) but contains no comparative stability studies supporting such a result and/or any disclosure on how to actually attain the “high stability”. There is also no example film formulation disclosed that might attain the “high stability”. Thus the phrase does not limit the scope of the claim and is not afforded patentable weight.
Leung does not specifically teach psilocybin, psilocin, baeocystin, or combinations thereof or the plasticizing agent, d-Glucono-1,5-lactone in claims 1, 2, and 4.
Johnstad teaches that the “most commonly used psychedelics for microdosing were psilocybin-containing ‘magic mushrooms’”, at 0.1-0.3 g (p.43 rt. col, p.44 left col.; see title; abstract) which represent “about a tenth of a full dose” (p.44 left & rt. cols). Johnstad’s microdose of 0.1-0.3 g is within the range in claim 1. Johnstad states that users reported “relief from depression and social anxiety”, “manic bipolar depression and suicidal ideations”, (p.44 rt.col.-p.45 left col.), “success in pain management” (p.45 left col.), and other benefits (p.46 left col.-rt.col.). Baeocystin was reported beneficial for pain management (p.45 left col.).
Bengs teaches thermoplastic films made from edible starches from tubers such as potatoes, seeds such as wheat, etc. (col.3 lines 24-) and d-glucono-1,5-lactone (Examples and Tables I-IV). The thermoplastic is used for “shaped articles which are biodegradable and physiologically nonhazardous…[and] may be used as … casing for food or drink or pharmaceutical products, or also for the controlled release of active substances, or else for producing temporary protective coatings” (abstract (emphases added)) including “packaging for pharmaceutical products, a shaped articles for the controlled release of active substances” (col.3 lines 11-13 (emphases added)). “For the purposes of the present invention, preference is also given to the use of the thermoplastic mixture as a short-lived protective film for technical consumer articles.” (Col.6 lines 22-24). “Casing for food or drink or pharmaceutical products”, “release of active substances”, and “short-lived protective film” all indicate dissolution of the film.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Leung, Johnstad, and Bengs and use Leung’s rapidly dissolving dosage forms to include psilocybin in amounts that Johnstad teaches, and use d-Glucono-1,5-lactone that Bengs teaches. The skilled person would have been motivated to do so because (i) all references are drawn to orally-administered pharmaceutical compositions, (ii) Leung teaches that the rapidly dissolving film dosage forms are “adequately tolerated without causing undue negative side effects” (col.12 ll.29-30) for benefits such as improved patient compliance (col.1 ll.23-25) and teaches using various plasticizing agents, (iii) Johnstad teaches that “micro-dose” oral psilocybin and baeocystin have been reported to relieve psychiatric distress, depression, and pain, among others and (iv) Bengs teaches that gluconolactone in combination with starch and/or modified starch can form compositions which “can be prepared simply and cost-effectively, have good homogeneity, and even in a mixture with other polymers, …, are very homogeneous, and have good thermoplastic processability, are physiologically nonhazardous and biodegradable, and can advantageously be processed to give shaped articles which are useful in industry, and have good homogeneity and good mechanical properties, such as excellent flexibility, and in which the plasticizer has little or no tendency to migrate” (col 2 lines 32-43).
Regarding the two different plasticizers and/or preservatives (one each from the groups in claims 1 and 20), it is noted that it is “prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted). In other words some unexpected result from using two rather than a single one would overcome prima facie obviousness; however merely reciting more than one does not.
Regarding claim 2 which recites “comprising boosting physical energy level, …treating addiction, or any combination thereof” it is noted that those results are not steps are not performed actively, i.e., as a step comprising the method claimed. Rather it would occur as an effect of the administering step in claim 1. Thus the clause raises a question as to the limiting effect of the claim language. Such a clause “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”, as in the instant claim. MPEP § 2111.04 (I) (citations omitted). As discussed above, Johnstad discusses prior art on using micro-dose psilocybin for these indications.
Regarding claims 10-12, an example film in Leung was about 22mm x 32mm, about 0.0013 inches (0.03mm) thick, and weighed about 35 mg (col.10 ll.39-43). Furthermore Leung expressly teaches that once prepared to a desired thickness, the film can be cut to a desired dimension to achieve the desired dose (col.11 ll.22-24, col.14 ll.56-60, col.20 ll.34-36). Without more, it is not seen that the measurements render claims 10-12 patentable.
Regarding claims 15 and 16, Leung discusses casting a uniform mixture of the active agent and the carriers and excipients, and then drying and cutting the mixture (col.20 ll.34-36). Therefore there would be under 5% variance of the active agent per unit area and content uniformity across multiple films. Further regarding claim 15 and claim 16, these claims recite quality control of the finished oral dissolvable films. As the one of ordinary skill in the art is also a person of ordinary competence in the field of pharmaceutical delivery, desiring and providing for uniformity within a film or among multiple film samples would have required no explicit teaching in prior art.
Response to Arguments
Although new rejections are made above Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed February 9, 2026 been fully considered but they are not persuasive. Applicant argues that “Leung is directed at a dissolvable film” whereas “Bengs discloses shaped compositions that include a plasticizer that ‘...is even difficult to leach out from the shaped article using liquids…’”. Therefore the skilled artisan would not have combined Leung with Bengs to arrive at an orally dissolvable film that includes D-glucono-1,5-lactone because to do so “would render Leung useless as a dissolvable film”. (Remarks, 8, February 9, 2026.) Applicant also contends, “the function of D-glucono-1,5-lactone would not be retained in the shaped composition of Bengs if it were incorporated into a dissolvable film as in Leung” by reading “difficult to leach out” as not “suitable for use in an oral dissolvable film” (id.).
However it cannot be agreed that Bengs teaches “shaped compositions” which exclude dissolvable films such as in Leung, or that the plasticizers Bengs teaches, including D-glucono-1,5-lactone or gluconolactone, should be one that is ‘even difficult to leach out from the shaped article using liquids…’ in all usages. Bengs expressly teaches its compositions can form films:
Finally, the invention also includes the use of the thermoplastic mixtures for producing moldings or films… in the form of coatings …, especially films, …, and release-slowing materials for controlled release of active substances in general, in particular drugs, …, flavorings, etc. The release of the active substance here may take place from foils, films, tablets,… or other shaped articles. (Col.5 lines 50-64 (emphases added); see also, e.g., col.6 lines 8-24 “films for use in food or drink applications”; Examples 4, 10; Table I)
Regarding the “difficult to leach out” (col.5 lines 17-19), the full quote is shown below.
The plasticizer is physiologically nonhazardous and does
not tend to migrate, and is even difficult to leach out from the
shaped article using liquids, for example, which may emerge
from food or drink. (Col.5 lies 17-20 (emphasis added).)
As evident from the actual quote, Bengs is referring to the need for the plasticizer not to leach out from the shaped article upon contact with a liquid, e.g., food or drink, which its thermoplastic material is to package (see col.5 lines 13-16). The ”difficult to leach out from the shaped article using liquids”, e.g., food or drink, is irrelevant here, which focuses on films, not shaped articles for holding liquid.
Bengs expressly teaches forming films that release active substances for pharmaceutical use (see the first block quote above from col.5 lines 50-64) and that is why it is relied on here. Bengs’s thermoplastic is “biodegradable and physiologically non-hazardous” (abstract), meaning the composition does “dissolve” and degrade in a liquid such as in a biological environment, in time. How long that takes would depend on the concentration of the plasticizer, the other components of the composition, and thickness of the item, which the instant claims do not limit. Therefore it cannot be agreed that combination of Leung and Bengs would render Leung unsuitable for its intended purpose.
Applicant next contends that Leung does not disclose any of the active agents in claim 1 or their dosages. (Remarks, 9, February 9, 2026.)
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). Furthermore the 1-4 mg range that Leung teaches as an example range is relevant to the amount that could be held within reasonable dimensions of its oral films.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/ Primary Examiner, Art Unit 1614