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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 1, 2026 has been entered.
In that response, claims 2, 4, 5, 9-16, and 18-22 were amended, claim 1 was cancelled, and claims 24-26 were added. Claims 2, 4, 5, 9-16, 18-22, and 24-26 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 § 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 2, 4, 5, 9-16, 18-22, and 24-26 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), Bengs (US 6565640), and Modi (US 2017/0252300) 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) and Johnson (Johnson, M.W., Griffiths, R.R., Potential Therapeutic Effects of Psilocybin, Neurotherapeutics (2017) 14:734–740).
Regarding claims 24, 4, 5, 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 oral 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 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.
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).
The films dissolve within 30 seconds (col.9 ll.62-63).
Leung does not specifically teach films comprising psilocybin, psilocin, baeocystin, or combinations thereof at total amount of 0.01 to 0.5 mg, or the plasticizing agent d-Glucono-1,5-lactone in claims 24, and encapsulation of the active agent in claims 25 and 26.
Johnstad teaches that the “most commonly used psychedelics for microdosing were psilocybin-containing ‘magic mushrooms’” (p.43 rt. col, p.44 left col.; see title; abstract) at represent “(about a tenth of a full dose) of LSD and psilocybin” (p.44 rt. col. (emphasis added); see left col.). The ‘magic mushrooms’ are free of cannabinoids. 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.). Johnson evidences that a “full dose” of psilocybin in prior clinical trials included, in patients suffering from cancer-related psychiatric distress, ~0.31 or 0.43 mg/kg of oral psilocybin, which resulted in “numerous improved clinical outcomes over the very-low-dose condition at 5 weeks (before the crossover)” as well as “large and persisting reductions at a 6-month follow-up” on the Hamilton Anxiety Rating Scale, the STAI, the Hamilton Depression Rating Scale, and the BDI (p.735 right col.; see also p.736 second col.). Inpatients of treatment-resistant depression, 10 mg oral psilocybin in a first session and 26 mg in a second session a week later resulted in improvement in depressive symptoms at week 1 and 3 months post-treatment. (p.736 left-rt. cols.). Similar doses were administered for treatment of tobacco addiction and alcohol dependence with promising results (p.737). A dose of about 0.3 mg/kg, with an adult weight of 60 kg, indicates a total daily dose of about 18 g. One-tenth of such doses would be achievable by administering a number oral films. The skilled person would have known to divide the total dose into one or more films of Leung as recited in claims 24 and 4 depending on desired dose increments and therapy targets. With result-effective variables 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).
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.
Modi is drawn to a rapidly dissolving orally administrable film formulation comprising active agent encapsulated in micelles (title; abstract; claim 1; see entire document including, e.g., paras.0018, 0023, 0070, 0074). The film formulation comprises excipients such as those in the present claims (see, e.g., claim 15). “The composition is not particularly restricted with respect to the pharmaceutical agent. “Suitable active agents are not particularly restricted” and specifically include psychopharmacological agents (para.0028). The active agent is included “in an amount between …, more preferably, in an amount between about 0.1 and 10 wt./wt. % of the total composition” (para.0056). “About 0.1” wt./wt.% is within the range in claim 24.
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, Bengs, and Modi, and use Leung’s rapidly dissolving dosage forms to include psilocybin in amounts that Johnstad teaches and concentrations that Modi 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, (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), and (v) Modi teaches, “pharmaceutical agent-containing micelles of the present composition can readily traverse since they are generally smaller than the pores of the [oral mucosal] membrane…absorption of the micelles in the present formulation into the oral mucosa enables rapid absorption into the blood stream, e.g. within about 5-7 minutes of taking the dose” (para.0070).
Regarding the total weight concentration of the psilocybin, psilocin, and/or baeocystin in the oral dissolvable film in claim 24 and the dose per square centimeter in claims 9, 13, and 14, the skilled person would recognize, as Leung states, the “amount of medicament that can be used in the rapidly dissolving films, according to the present invention, is dependent upon the dose needed to provide an effective amount of the medicament” (col. lines 26-29). Also the level of the excipients as well as the dimensions of the dissolvable film are within the control of the skilled person (see, e.g., col.6 lines 55-60, col.7 lines 48-56 and 57-59, col.11 lines 21-23, col.14 lines 57-61, col.20 lines 34-36). Modi teaches that typical weight concentration of an active agent in an oral dissolvable film is about 0.1 and 10% which overlaps the range in claim 24. 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).
Regarding the two different plasticizers and/or preservatives (one each from the groups in claims 24 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 24. 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 nonobvious.
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
Applicant's arguments filed July 1, 2026 been fully considered but they are not persuasive. Applicant argues that Leung is directed to dissolvable films comprising none of the recited active agents and the dosages are specific to the agents disclosed therein, and Johnstad’s dose range relates to the magic mushrooms rather than the compounds recited. (Remarks, 7-8, July 1, 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). Here Leung expressly teaches its dissolvable film is not particularly limited to specific pharmaceutical agents, and may include psychoactives. Johnstad teaches microdosing of psilocybin at as little as one-tenth of typical dose, which according to Johnson includes 10 mg or 18 mg depending on the condition being treated.
Applicant argues further that 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, July 1, 2026.)
However it cannot be agreed that Bengs teaches “shaped compositions” which exclude dissolvable films such as in Leung. “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments”. MPEP §2123 (citations omitted). Here while Bengs teaches the using D-glucono-1,5-lactone for packaging drinks, Bengs also 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)
As seen here Bengs expressly teaches forming films that release active substances for pharmaceutical use 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.
CONCLUSION
No claim is allowed.
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
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