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 .
Priority
The present Application, filed October 7, 2022, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/US2021/026792, filed April 12, 2021, which claims priority to U.S. Provisional Patent Application No. 63/009,727, filed April 14, 2020.
Status of the Claims
In the amendment filed January 20, 2026, claims 1 and 8 are amended. Claims 1-4 and 6-20 are currently pending, with claims 14-17 being withdrawn.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
Claim Objections – Necessitated by Amendment
An objection is raised to claim 1 because of the following informalities: the word “arabic” is not capitalized in “gum arabic” but is capitalized in “modified gum Arabic.” It is preferable that this be consistent. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Necessitated by Amendment
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 1-4, 6-13, and 18-20 are indefinite:
Claims 1-4, 6-13, and 18-20 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.
Claim 1 is indefinite for reciting “wherein the solid composition is orally dissolvable,” because a person of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. While this phrase is comprehensible in general, qualitative terms, it is too qualitative to constitute a definite limitation. In particular, no dissolution conditions are given, nor is any degree or rate of dissolution, nor whether it meets the limitation if some components dissolve or is required that all components dissolve. In short, due to the absence of this variety of relevant dissolution factors, it would not be feasible for one to reasonably determine whether a given composition met this qualitative function requirement.
Claims 2-4, 6-13, and 18-20 are indefinite for depending from claim 1 without curing this indefiniteness. Because it is not feasible to ascertain what constitutes “orally dissolvable” in the context of claim 1, this will be understood as requiring that the composition be configured or intended for buccal or sublingual administration, which necessarily requires some degree of composition dissolution in the mouth.
Notes on claim interpretation:
Claim 1 is amended to recite that “the encapsulated CBD is prepared without an emulsifier used by microfluidizer technology, the emulsifier including at least purity gum, gum arabic, and modified gum Arabic.” While this phrasing is somewhat convoluted, it is understood to simply mean that the encapsulated CBD cannot include any of purity gum, gum arabic, and modified gum Arabic, but it can include any other emulsifier. Claim 1 further recites that “the solid composition is…configured for an extended oral residence time to deliver 5-30 mg of CBD through oral mucosa.” The claim does not describe what such configuration entails, and the only reference in the specification to delivery of 5-30 mg of CBD through oral mucosa states merely that the composition contains about 5-30 mg of CBD and that it should be retained in the mouth for an extended time so that the full amount (or majority) of CBD will be delivered (paragraph [0042]). As such, this limitation is understood simply to require that the composition contain about 5-30 mg of CBD.
Claim Rejections - 35 USC § 103 – Slightly Modified in view of Amendment, Substantially Maintained
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.
Claims 1-4, 6, 8-13 and 18-20 are unpatentable over Heller and Soni;
Claims 1-4, 6, 8-13, and 18-20 under 35 U.S.C. § 103 are unpatentable over U.S. Patent Application Publication No. 2020/0054702 to Heller (hereinafter, “Heller”), in view of the non-patent publication, Mutagenicity and genotoxicity of ClearTaste, Toxicol. Rep., 5, pgs. 196-206 (2018) by Soni et al. (hereinafter, “Soni”).
Applicant argues that Heller does not teach the features of claim 1 newly added via amendment, namely that the composition is “orally dissolvable” and that it is “configured for an extended oral residence time to deliver 5-30 mg of CBD through oral mucosa,” (pg. 6 of Applicant’s Response of January 20, 2026, final paragraph). As noted above, these elements are understood as requiring that the composition be formulated for buccal/sublingual administration (hence orally dissolvable) and that the composition contain about 5-30 mg of CBD (consistent with the specification’s description of an ability to deliver 5-30 mg of CBD when provided sufficient oral residence time). This argument has been fully considered, but is not found persuasive. As discussed in the reiterated rejection, Heller does teach these features.
In particular, as noted, Heller expressly teaches buccal/sublingual formations of the disclosed cannabinoid compositions (orally dissolvable), and also teaches cannabinoid concentrations that easily encompass the claimed CBD quantity of 5-30 mg.
Applicant further argues that the secondary and tertiary references fail to cure this alleged deficiency, and that all dependent claims (e.g. claim 18) are, like claim 1, patentable since the cited references allegedly fail to teach the features of claim 1 added via amendment. These arguments are undermined, however, by the fact that Heller teaches the elements added to claim 1 by amendment.
The rejections, slightly modified in view of amendment, are maintained.
Slightly modified, but substantially reiterated rejections:
Claim 1 recites a solid composition comprising encapsulated cannabidiol (CBD), mushroom mycelia, and flavor. Claim 1 further specifies, according to the claim construction described above, that the composition (or at least the encapsulated CBD portion of it) is prepared without the emulsifiers purity gum, gum Arabic, and modified gum Arabic; that the composition is configured for buccal or sublingual administration, and that the composition contains about 5-30 mg of CBD. The instant specification teaches that encapsulated CBD can be made by creating a CBD nanoemulsion (e.g. via microfluidization of aqueous CBD oil) and then dry spraying a mixture of the emulsion with a substrate such as maltodextrin (paragraphs [0014]-[0016]). The instant specification also states that an exemplary source of mushroom mycelia is ClearIQ™ bitter blocker from MycoTechnology (paragraph [0023]), and that an exemplary flavor for inclusion in the solid composition is stevia (paragraph [0026]). Thus, a particular embodiment of the solid composition of claim 1 comprises spray dried CBD emulsion/maltodextrin, ClearIQ™ bitter blocker, and stevia.
Heller teaches compositions and methods of forming a particulate material derived from a cannabis plant (Abstract). Heller teaches forming a cannabinoid emulsion via microfluidic homogenization (paragraphs [0233]-[0234]). Heller further teaches formation of encapsulated cannabinoid solid by combining the cannabinoid emulsion with aqueous maltodextrin (paragraph [0241]) and spray drying the cannabinoid emulsion/maltodextrin mixture directly into a free flowing powder (i.e. formation of encapsulated cannabinoid; paragraphs [0243] and [0245]). Heller teaches that the active ingredient/cannabinoid can be CBD, such that the encapsulated cannabinoid formed would be encapsulated CBD (paragraph [0012]).
With respect to the limitation of instant claim 1 that the composition is prepared without purity gum, gum Arabic, and modified gum Arabic, Heller teaches that whey protein isolate is an example of an emulsifier that can be used to create the encapsulated cannabinoids (paragraph [0129]. Heller further teaches an example (Example 8, paragraphs [0223]-[0231] that uses whey protein isolate as an emulsifier and is free of the recited emulsifiers, thus meeting the limitation understood as excluding purity gum, gum Arabic, and modified gum Arabic from the encapsulated CBD.
With respect to the limitation that the composition is configured to deliver (contains) 5-30 mg of CBD, Heller teaches various cannabinoid concentrations, such as 1-200 mg/g for powder formulas intended for sublingual/buccal absorption (paragraphs [037]-[0374]). While, given cannabinoid density, the mass of CBD contained in the administered composition would of course depend on the mass of composition administered, but given a typical buccal/sublingual powder mass of about one hundred to several hundred mg, this easily encompasses the recited range of about 5-30 mg of CBD. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, particularly when there is no showing that the claimed range is critical. In re Wertheim, 541 F.2d 257, (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990)
Heller further teaches that cannabis oils can have bitter and harsh flavors (e.g. paragraph [0105], stating that certain emulsifiers can subdue the characteristic bitter and harsh flavors). Heller also teaches that additives, such as sugar, stevioside (stevia), essential oil, or other flavorants, can be included in the emulsion system or the polymer matrix to improve the flavor (paragraph [0361]). Heller thus teaches a solid composition comprising encapsulated CBD and flavor, that is free of the recited emulsifiers, and that is orally dissolvable and contains about 5-30 mg of CBD, but Heller does not explicitly teach inclusion of mushroom mycelia in the solid composition. It would have been obvious to one of ordinary skill in the art to include mushroom mycelia in the solid composition of Heller, because mushroom mycelia was known in the art as a suppressor of bitterness and unpleasant flavors. See, for example, Soni.
Soni teaches that ClearTaste™ is a taste modulating powder made through the culturing of Cordyceps sinensis (Introduction, first paragraph), and that ClearTaste™ is a bitter blocker that can, at concentrations less than 50 ppm, also mitigate sour, metallic and lingering off tastes (Introduction, second paragraph). It therefore would have been obvious to incorporate the ClearTaste™ of Soni into the encapsulated CBD with flavorant (solid composition) of Heller in order to mitigate the bitter and strong flavors of the CBD oil contained therein.
Further, the non-patent publication, ClearIQ™ Absolute Flavor, Safety Data Sheet, by MycoTechnology (hereinafter, “Myco”), available online at the time of this writing at the url: assets.website-files.com/5f57196756ffac822737c502/63e40c6f34aa7659e1f824d2_SDS%20-%20ClearIQ%20Absolute%20Flavor%20-%20Issued%2011.25.20.pdf, states that the trademarks ClearIQ™ and ClearTaste™ refer to the same product (Section 1.1). While Myco shows a date of compilation of 11/25/2020, Myco is not cited as prior art, but is cited instead as evidence that the ClearTaste™ product referenced by Soni is inherently the same as the ClearIQ™ bitter blocker of paragraph [0023] of the instant specification, and is therefore a source of mushroom mycelia of instant claim 1. As such, Heller, modified by Soni, teaches a particulate material (solid composition) comprising spray dried CBD emulsion/maltodextrin (encapsulated CBD), ClearTaste™/ClearIQ™ (mushroom mycelia), and flavor, and that is free of purity gum, gum Arabic, modified gum Arabic, and oily surfactants, that is orally dissolvable and that contains about 5-30 mg of CBD.
With respect to claim 2, Heller teaches exemplary maltodextrin-encapsulated CBD having CBD concentration of 0.1 to 400 mg/g (i.e. 0.01 to 40 wt.% CBD, see paragraphs [0249]-[0251]). Heller also teaches a tablet (an example of a solid composition of claim 1) can have 0.5-10 mg of cannabinoid per tablet (paragraph [0393]). These concentrations can produce a tablet having the wt.% range of encapsulated CBD recited in claim 2. For example, a typical tablet may have a total mass of about 500 mg [see, for example, the non-patent publication, Compressed Tablets-Average Weight, J. Am Pharm. Assoc., 42, pgs. 690-691 (1953) by Arambulo et al. (hereinafter, “Arambulo”)]. A 500 mg tablet having 15-100 mg of encapsulated CBD that is 40 wt.% CBD (60 wt. % maltodextrin and/or other material) is within the ranges taught by Heller and has the 15-20 wt.% encapsulated CBD recited in claim 2. Stated briefly, the ranges of (i) CBD concentration in encapsulated CBD, and of (ii) CBD dose in a tablet taught by Heller, cover a broad range of encapsulated CBD wt.% in a tablet that includes the 15-20 wt.% recited in claim 2.
With respect to claim 3, as noted, Heller teaches that encapsulated CBD can be 0.01 to 40 wt.% CBD (e.g. paragraphs [0249]-[0251]), covering the recited 10 wt.%. With regard to claims 2 and 3, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 25.
With respect to claim 4, Heller teaches that the active ingredient/cannabinoid can be purified by distillation (paragraph [0014]). With respect to claim 6, as noted, Heller teaches the encapsulated cannabinoid can be formed by spray drying a CBD emulsion/maltodextrin mixture (paragraphs [0243] and [0245]). With respect to claim 8, the instant specification states that the ClearTaste™/ClearIQ™ of Soni is an exemplary source of Cordyceps sinensis mycelia (paragraph [0023]), and Soni teaches that ClearTaste is made through the culturing of Cordyceps sinensis (Introduction, paragraph 1).
With respect to claims 9 and 10, Heller teaches that the additive to improve flavor can be stevioside (paragraph [0361]). With respect to claim 11, Heller teaches that sugar or sucrose is an optional additive (e.g. paragraph [0361]), but it is not required, and that alternative sweeteners such as stevioside can be used. With respect to claim 12, Heller teaches oral dosage forms made from encapsulated cannabinoid powder (paragraph [0391]), including pressed tablets (paragraph [0393]). With respect to claim 13, Heller teaches encapsulated cannabinoid powder can be dissolvable and self-emulsifying when reintroduced into an aqueous environment (paragraph [0079]). Such a composition would therefore be orally dissolvable. Heller further teaches the powder can be incorporated into a dissolvable strip for sublingual or buccal absorption (paragraph [0372]).
Claim 18 recites a nutraceutical product comprising the solid composition of claim 1. The term “nutraceutical” is not compositionally defined in the claim language, nor in the specification, and there does not appear to be a precise definition of the term in the art [see, e.g. the non-patent publication Nutraceuticals: definition, applied nanoengineering in their production and applications, Int. J. Biosens. & Bioelect., 5, pgs. 56-61 (2019) by Alpizar-Vargas et al., which states that, “Nutraceuticals can be defined as nutritional components that provide therapeutic or physiological benefits beyond the basic nutritional needs…” (Abstract)]. In addition, the instant specification states that tablets of the present invention can be nutraceuticals (paragraph [0036]). As such, a nutraceutical of claim 18 is construed as being any composition or formulation for oral ingestion or buccal/sublingual absorption comprising a solid composition of claim 1. And because a tablet of the present invention can be a nutraceutical, claim 18 is obvious according to the rationale applied to claim 12, above.
With respect to claim 19, Heller teaches that a tablet (an example of a nutraceutical product of claim 18) can have 0.5-100 mg/tablet (paragraph [0393]). As noted above, a typical tablet may have a total mass of about 500 mg (see Arambulo, Table II). A 500 mg tablet having 7.5-10 mg CBD (within the range taught by Heller) would have 1.5 to 2.0 wt.% CBD.
With respect to claim 20, Heller teaches that the encapsulated cannabinoids can be used in a wide variety of edible products, including mints.
Claim 7 is unpatentable over Heller, Soni, and Gao:
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Heller, in view of Soni, further in view of International Patent Application Publication No. WO2015/051306 to Gao et al. (hereinafter, “Gao”).
Claim 7, depending from claim 6, recites that the maltodextrin, that acts as substrate in the solid compound of claim 1, is digestion resistant. Heller, as noted above in the rejection of claim 6, teaches maltodextrin as substrate for forming encapsulated CBD, but does not explicitly teach that the maltodextrin is digestion resistant. It would have been obvious to one of ordinary skill in the art to use digestion resistant maltodextrin because the use of digestion resistant maltodextrin as a substrate in tablets for oral ingestion was well known in the art. See, for example, Gao.
Gao teaches tablets that contain a solid solution of soluble fiber and sugar alcohol, with nicotine (Abstract). Gao teaches that the soluble fiber can be digestion-resistant maltodextrin which can slow digestion/absorption of the composition (pg. 5, second full paragraph). It would have been obvious to use the digestion-resistant maltodextrin of Gao as the maltodextrin of Heller, to slow digestion of the composition and absorption of the CBD.
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.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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