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 claims
Claims 1-134 are canceled by the applicant. Claims 135-138, 141, 143, 145, 148, 150-152 are currently amended. Claims 139-140, 142, 144, 146-147, 149, and 153-154 are previously presented. Claims 135-154 are pending and under examination.
Priority
This application is a 371 of PCT/US2022/051563, filed on 12/01/2022. The application is claiming priority to U.S provisional Application No. 63/284,921 filed on 12/01/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/25/2026 and 07/23/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Rejections/Objections withdrawn
All objections imposed in the previous correspondence are hereby withdrawn due to applicant’s amendments.
All 35 USC § 112 (b) rejections imposed in the previous correspondence that are not reiterated in this action are hereby withdrawn due to applicant’s amendments. All arguments toward them are moot.
All 35 USC § 102 rejections imposed in the previous correspondence are hereby withdrawn due to applicant’s amendments. All arguments toward the withdrawn rejections are moot.
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.
Rejections maintained due to applicant’s failure to properly amend:
Claim 135-147 and 150-154, 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 135 recites “a first lipophilic component comprising cannabidiol (CBD) and/or Ddefr-9- tetrahydrocannabinol (D9-THC), a surfactant component comprising sorbitan monooleate, polysorbate 80, D-a-tocopherol polyethylene glycol 1000 succinate (TPGS), or a combination thereof”, and “wherein a ratio of the first lipophilic component to the surfactant component is at least 1:1 (% w/w)”. Because the claim uses open-ended transitional phrase “comprising/comprises”, it is unclear what ingredients must be included in calculating the claimed ratio. Specifically, it is unclear whether the ‘first lipophilic component” for the purposes of the ratio is limited to CBD and/or D9-THC or instead includes additional lipophilic materials that may also be present within that component. Likewise, it is unclear whether the “surfactant component” for purposes of the ratio refers to one listed surfactant, all listed surfactant present, or a broader surfactant component including additional materials. As a result, the scope of this claim is unclear regarding what to use in determining the ratio, and thus indefinite. For the purpose of compact prosecution, the examiner will consider the ratios with the species of ingredients listed noting that tables in the specification with formulations have the ratios based on the particular actives and surfactants in the table, which are also those species in the claim. Applicant may close the groups with “selected from the group consisting of” language to overcome the indefiniteness, however, applicant should consider the prior art as well.
Claims 136-147 are rejected as being dependent on an indefinite claim.
Claim 150 recites “a first lipophilic component comprising a lipophilic vitamin”, “a surfactant component comprising sorbitan monooleate and TPGS”, and “wherein a ratio of the first lipophilic component to the surfactant within the beverage is at least 1:1 (% w/w)”. because the claim uses the open-ended phrase “comprising” for these ingredients, it is unclear whether the “first lipophilic component” for purposes of the claimed ratio is limited to the recited lipophilic vitamin or includes additional lipophilic materials. It is likewise unclear whether the “surfactant component” for purposes of the ratio refers only to sorbitan monooleate and TPGS or to a broader surfactant component that may include other ingredients. Accordingly, the ratio limitation does not provide a reasonably certain claim scope, and is thus indefinite. For the purpose of compact prosecution, the examiner will consider the ratios with the species of ingredients listed noting that tables in the specification with formulations have the ratios based on the particular actives and surfactants in the table, which are also those species in the claim. Applicant may close the groups with “selected from the group consisting of” language to overcome the indefiniteness, however, applicant should consider the prior art as well.
Claims 151-154 are rejected as being dependent on an indefinite claim.
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.
Rejections maintained in view of applicant’s amendments: prior art unchanged, prior art mapping unchanged, obviousness statement unchanged.
Claims 135-154 are rejected under 35 U.S.C. 103 as being unpatentable over Faraci et al. (US20200037638A1).
Faraci et al. discloses cannabinoid formulations, including self-emulsifying formulations and micellar dispersions, as well as methods of making and using the same (abstract). the invention provides for a beverage additive product comprising a composition of the present invention (¶151), which can be added to any beverage suitable for human consumption (¶153). Faraci et al. teaches that the composition may include at least one or more active ingredient such as cannabinoids and terpenes (¶101), which include Delta-9-tetrahydrocannabinol (Δ9-THC) (¶4) and Cannabidiol (CBD) (¶5).Faraci et al. teaches that the composition may include surfactants (¶62) such as sorbitan monooleate, polysorbate 80, and D-α-Tocopherol polyethylene glycol 1000 succinate (TPGS), or a combination thereof (¶71 and ¶72). ). Faraci et al. specifically teaches that multiple surfactants can be used in the composition [¶122]. Faraci et al. teaches that the beverage additive can be added to aqueous beverages such as water and orange juice (¶154). Faraci et al. teaches that the composition may additionally contain a flavoring agent (¶151). Faraci et al. teaches that the composition may comprise preservatives such as methyl parabens and propyl parabens, and combinations thereof (¶186). Faraci et al. teaches that the composition may include emulsion stabilizers (¶145). Faraci et al. teaches that the composition may also include D-α-tocopherol (¶104) and alpha-bisabolol (¶67) as active ingredients. Faraci et al. teaches that the composition may include ascorbyl palmitate as a cytochrome P450 inhibitor (¶175 and ¶177). Faraci et al. teaches that the composition may comprise ethylenediaminetetraacetic acid (EDTA) as a chelating agent (¶181). Faraci et al. teaches that the composition may additionally include coenzyme Q10 as an active ingredient (¶58). Faraci et al. teaches that the composition may further comprise preservatives including potassium sorbate and sodium benzoate (termed sodium benzonate), and combinations thereof (¶186). Faraci et al. teaches that the composition may comprise nutraceutical active ingredients such as lipophilic vitamins A, D, E, and K, or a combination thereof (¶58). Faraci et al. teaches that the composition may further comprise a citric acid as a pH adjuster or a chelator (¶182 and ¶183). Faraci et al. teaches that the composition may include viscosity modifying agents such as carnauba wax (¶175-¶176). Faraci et al. teaches that the above surfactants can be present in the composition at concentrations ranging from 0% to 97% w/w, and even more specifically, from 0% to 10% (¶77). Faraci et al. teaches that the composition may comprise from 1% to 15% w/w or greater of the one or more of the above active ingredients, and even more specifically, from 10% to 15% w/w (¶117). The above concentrations hence overlap with all of the concentration (by weight) ratios stated in the present claims. In multiple examples (¶113, table 1, compositions 1-106), Faraci et al. teaches many formulations comprising active ingredients, surfactants, and co-surfactants, all ranging within various concentrations. In other examples (¶260, table 4, formulations A2 and A3), Faraci et al. teaches additional formulations that comprise THC (10% w/w) combined with TPGS (9% w/w). Faraci et al. also teaches beverage formulations with flavorants included (¶283-¶285, tables 8-9). All of the above examples thus provide multiple points of reference for modifying such compositions.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate the beverage compositions of claims 135-154 using the ingredients, components, and their respective concentrations taught by Faraci et al. This is because Faraci et al. discloses cannabinoid formulations including self-emulsifying and micellar systems suitable for incorporation into aqueous beverages. Faraci et al. further teaches that the composition may include all of the ingredients listed in the present claims for the purpose of incorporating active ingredients, surfactants, preservatives, stabilizers, flavorants, cytochrome P450 inhibitors, pH adjusters, viscosity modifiers, chelating agents, with the applicable components being present at concentration ratios overlapping with all of those in the present claims. A person of ordinary skill in the art would have thus been motivated to select and combine these known components into a single beverage formulation in order to obtain their established effects and benefits as stated above. Furthermore, Faraci et al. teaches concentration ranges for active ingredients and surfactants that encompass broad overlapping weight percentage ranges, and determining the relative ratios between lipophilic actives and surfactants within these disclosed ranges would have constituted routine formulation optimalization and design choice of result-effective variables––well within the ordinary skill of a formulator seeking to achieve desirable characteristics such as stability and efficacy. Because the selection of such particular actives, preservatives, stabilizers, surfactants, and the other optional components listed above expressly disclosed by Faraci et al. involves nothing more than the predictable use of known elements for performing their established functions in beverage and emulsion formulations, a person of ordinary skill in the art would have had a reasonable expectation of success in preparing the claimed beverage compositions using only the teachings of Faraci et al., rendering all claimed subject matter obvious.
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive.
Regarding the 35 USC 112 (b) rejections maintained above:
Applicant’s amendment does not overcome the rejection of claim 135. As presently drafted, the first lipophilic component may comprise CBD and/or THC together with additional ingredients, and the surfactant may likewise comprise one or more of the recited surfactants together with additional ingredients. Accordingly, the calculated ratio depends upon which additional ingredients are considered part of each component, and the claim does not define these boundaries. If the intended ratio is between specifically recited ingredients, the claim should expressly identify those ingredients as the numerator and denominator of the ratio.
Likewise, with respect to claims 150, the first lipophilic component may comprise the recited vitamin together with additional ingredients, while the surfactant component may compromise sorbitan monooleate and TPGS together with additional ingredients. Thus, the calculated ratio depends on which materials are included within each component, rather than a specifically defined ingredient-to-ingredient ratio.
Regarding applicant’s argument [p. 5, ¶¶4-5; p. 6, ¶¶1-3] that the complete group of lipophilic ingredients and surfactants present used to calculate the claimed ratio and that the amendment to the “surfactant component” resolves the indefiniteness:
This argument is not persuasive. claims continue to recite a “first lipophilic component comprising” a particular active agent while separately permitting additional lipophilic components, including the expressly recited “first lipophilic component comprising” a particular active while separately permitting additional lipophilic components, including an expressly recited “second lipophilic component” in claim 40. Indeed, claims 141, 143, and 145 separately recite ratios involving both the first and second lipophilic components, demonstrating that they are not necessarily equivalent. Applicant’s remarks therefore do not provide an objective boundary for determining whether an additional lipophilic material forms part of the “first lipophilic components” or a separate lipophilic component, and different reasonable assignments material affect the claimed numeral ratio.
Regarding applicant’s argument [p. 7, ¶¶6-8; p. 8, ¶1] that Faraci’s concentration ranges do not teach or suggest the claimed lipophilic component-to-surfactant ratios and that Faraci’s actual formulations are surfactant-dominant:
This argument is not persuasive. Faraci expressly discloses compositions having ranges of active ingredient, MCT/LCT, first surfactant, and second surfactant, identifies each table 1 composition as an individual embodiment, and expressly teaches cannabinoid actives including THC and CBD and TPGS as a surfactant. Under applicant’s own stated construction that all lipophilic ingredients present are included in calculating the lipophilic component, Applicant’s analysis is based solely on THC while excluding Faraci’s lipophilic/LCT is inconsistent with the proposed claim construction. Faraci’s disclosed concentration ranges encompass compositions satisfying the claimed ratios.
Regarding applicant’s argument [p. 8, ¶2] that Faraci teaches away from the claimed ratios because increasing surfactant concentration produces smaller particles and improved clarity and dilutability:
This argument is not persuasive. A preference for higher-surfactant formulations for particular properties does not constitute teaching away where Faraci also expressly discloses lower-surfactant embodiments and does not criticize, discredit, or discourage their use. Moreover, the pending claims do not require any particular particle size, clarity, or dilutability. A known composition does not become non-obvious merely because another disclosed composition may perform better for an unclaimed property.
Regarding applicant’s argument [p. 8, ¶¶3-4] that the specification established unexpected stability and improved palatability from use of less surfactant:
This argument is not persuasive. The cited statements do not provide comparative factual evidence establishing unexpected results relative to the closest prior art, and mere assertion of unexpected results are insufficient without supporting proof. Furthermore, the asserted results concern particle size, stability, and palatability, which are limitations that are not required by the pending claims. The showing is also not commensurate in scope with claims such as 135 and 150, which encompass ratios greater than 1:1, whereas applicant relies upon disclosure concerning ratios of at least 2:1.
Regarding applicant’s argument [p. 9, ¶1-3] that the claimed ratios would not have resulted from routine formulation optimization because Faraci allegedly provides no reason to reduce surfactant content:
This argument is not persuasive. Faraci expressly varies the relative concentration of active ingredients and surfactants and evaluates formulation properties affected by surfactant concentration, thereby establishing surfactant concentration as a recognized formulation variable. Moreover, the rejection does not rely solely upon routine optimization because Faraci itself expressly discloses concertation ranges encompassing compositions satisfying the claimed ratios. Optimization within disclosed ranges would have involved no more than routine formulation work, absent evidence of criticality or unexpected results.
Regarding applicant’s argument [p. 9, ¶¶4-6] that Faraci merely includes CoQ10 in a laundry list and does not specifically teach flavored beverage comprising CoQ10 and TPGS at a claimed ratio:
This argument is not persuasive. Faraci expressly identifies CoQ10 as a nutraceutical active ingredient, TPGS as a suitable surfactant, compositions having varied active/surfactant concentrations, and beverage formulations/additives that may contain flavoring and be incorporated into beverages. Faraci is not required to expressly exemplify the complete claimed formulation in a single worked example where the reference itself teaches the claimed components for their known functions and provides concentration teachings rendering their selection and formulation predictable.
Regarding applicant’s argument [p. 9, ¶¶7-8] that Faraci does not specifically teach a flavored beverage comprising a lipophilic vitamin with sorbitan monooleate and TPGS at the claimed ratio:
This argument is not persuasive. Faraci expressly teaches lipophilic vitamins as nutraceutical active ingredients, identifies both TPGS and sorbitan monooleate as suitable surfactants and permits combinations of surfactants, and teaches beverage compositions/additives and flavoring agents. Faraci further provides broad concentration teachings for active ingredients and surfactants. Selection of these expressly disclosed components for their established formulation functions and adjustments of their relative concentrations would have constituted the predictable use and routine optimization of known formulation components.
Conclusions
No claim is found to be allowed.
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 ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights