DETAILED ACTION
Response to Arguments
Applicant's arguments filed 6/3/2026 have been fully considered but they are not persuasive.
Applicant argues “Amended claim 1 requires that the formulation does not comprise medium chain triglycerides (MCT) or tocopherol acetate. Vangara teaches a pharmaceutical formulation requiring lipid, including medium-chain triglycerides, and describes using alpha-tocopherol as an antioxidant. Since Vangara describes using components that are expressly excluded from the composition of amended claim 1, Vangara does not teach each and every element of amended claim 1 and thus cannot anticipate claim 1. In the lipid formulations of Vangara, antioxidants are described as optional, with some formulations having 0% antioxidant. Vangara at [0086]. This suggests that Vangara relies primarily on the lipid as the source of stability, especially since the formulation requires about 10 to about 95% lipid. Where antioxidants are included in Vangara's formulations, alpha-tocopherol (Vitamin E) or ascorbyl palmitate are primarily used in combination with caprylic/capric triglyceride. Amended claim 1 excludes both medium chain triglycerides and tocopherol acetate, which are types of components that Vangara identifies as central to achieving stability.”
The Examiner disagrees. Vangara teaches a specific example that does not contain any medium chain triglyceride or tocopherol acetate [0181-0183]. This embodiment of “alcohol-free formulations”, as described in [0181-0183] and [0027-0049], does not use components that are excluded from claim 1. It is also noted that the optional antioxidant alpha-tocopherol in this embodiment is not the same as tocopherol acetate and not excluded from claim 1.
Applicant argues “Miller and Vangara are directed to fundamentally different types of formulations with different delivery routes and stability considerations. Miller is directed to a non-nicotine pre-vapor formulation for use in an e-vaping device-a formulation that is vaporized by a heating element and delivered to the consumer via inhalation. In contrast, Vangara, is directed to stable pharmaceutical formulations for oral administration comprising cannabinoid and lipid. The stability considerations between these types of formulations are different, as evidenced by the requirement in Vangara for stabilizing components, such as lipids, to be present. A person having ordinary skill in the art reading Miller-a vaping formulation reference-would have had no motivation to look to Vangara-an oral pharmaceutical formulation reference-to address stability concerns in an inhaled product. The Office's allegation that the combination would achieve "predictable results" of stability is unsupported by either reference as their formulation and stability considerations differ.”
This argument is contradicted by the fact that Vangara teaches the formulation is suitable for inhalation [0049]. As noted by Applicant, Miller is directed to a formulation for inhalation, and thus a person having ordinary skill in the art reading Miller would have motivation to look to Vangara which discloses a formulation suitable for inhalation. In any case, even if the eventual use of the formulation of Miller was different from that of Vangara, the stability concerns during storage, prior to use, would be the same for both formulations. A person having ordinary skill in the art reading the cannabinoid formulation of Miller would have motivation to look to the cannabinoid formulation of Vangara to improve stability during storage as suggested by Vangara [0181-0185].
Claim Rejections - 35 USC § 102
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-9, 16-27, 30, 34-35, 38-41, and 46-47 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Vangara (US 2015/0342902).
Regarding claims 1, 3-6, 20-24, 26, Vangara teaches a formulation comprising cannabidiol [0029], a combination of ascorbic acid and sodium ascorbate, or propyl gallate, in an amount of 0.02 to about 0.5% (200 to 5,000 ppm) [0033], 59% to 73% w/w carrier (preferred 25-30% polyethylene glycol, 30-35% propylene glycol, and 4-8% water) [0036-0038], and a pH of 6-7 [0039]. The formulation does not comprise MCT or tocopherol acetate.
In the alternative, Vangara teaches an example embodiment formulation comprising: cannabidiol, sodium ascorbate, and one or more carrier constituents (propylene glycol, polyethylene glycol, and water), wherein the total amount of the one or more carrier constituents is 68% based on the total weight of the formulation, wherein said formulation has a pH of 6.4 [0181-0183, Table 1, #AF3]. The formulation does not comprise MCT or tocopherol acetate. Although Vangara does not specifically teach propyl gallate or a combination of ascorbic acid and sodium ascorbate in this embodiment, Vangara does teach suggest propyl gallate or a combination of ascorbic acid and sodium ascorbate [0033]. "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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It is similarly prima facie obvious to substitute art recognized equivalents known for the same purpose, see MPEP 2144.06.
Regarding claims 7-9, Vangara teaches further including cannabinol [0029].
Regarding claims 16-19, Vangara teaches an amount of 0.02% to 0.5% of the antioxidant (stabilizing component) [0032], or 200 ppm to 5,000 ppm. 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 25, as cited above, Vangara teaches 68% by weight of the carrier constituents. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). One of ordinary skill in the art would have expected a content of 68% to be close enough to 70% to result in the same properties.
Regarding claim 27, Vangara teaches a propylene glycol content of up to 50% by weight [0037]. 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claims 30 and 34, Vangara teaches the one or more carrier constituents comprise glycerol and propylene glycol [0186].
Regarding claim 35, Vangara teaches the formulation comprises 89% (39/44) propylene glycol and 11% (5/44) glycerol based on the total amount of propylene glycol and glycerol [Table 15].
Regarding claims 38-41, Vangara does not specify the amount of cannabinoid in terms of mg/ml, but does teach the cannabinoid is used for medical purposes [0007]. One of ordinary skill in the art would have found it obvious to optimize the concentration of the cannabinoid as a matter of routine experimentation to achieve the desired effects.
Regarding claim 46, Vangara teaches the formulation is in the form of a liquid [0049], which is interpreted to be the case at room temperature, or about 25°C.
Regarding claim 47, as Vangara teaches the same formulation composition of the claimed invention, the formulation is expected to have the same stability as the claimed formulation such that the content of one or more specific cannabinoids is at least 80% of the initial content of the one or more specific cannabinoids based on a mg/ml basis of the formulation after 4 weeks at 40° C. and 75% Relative Humidity.
Claims 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over Vangara as applied to claim 1 above, and further in view of Khlystov (US 2020/0196679).
Vangara is silent to a terpene. Khlystov teaches an electronic smoking article formulation including limonene as a flavoring [0034]. It would have been obvious to one of ordinary skill in the art to include limonene (olfactory active constituent) with the formulation of Vangara, and to optimize the concentration thereof as a matter of routine experimentation, to achieve the desired level of flavoring.
Claims 1, 3-9, 16-41, 44, and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 2022/0015420) in view of Vangara (US 2015/0342902).
Regarding claims 1, 3-9, 20-22, Miller teaches a formulation comprising: one or more cannabinoids comprising CBD and cannabinol, and one or more vapor formers (carrier constituents), wherein the total amount of the one or more carrier constituents is 50% w/w or more based on the total weight of the formulation [0117-0118]. The formulation does not comprise MCT or tocopherol acetate. Miller is silent to a stabilizing component and the pH of the formulation. Vangara teaches a cannabinoid formulation wherein a most preferred pH is from 6.2 to 6.7 [0039] and propyl gallate, or ascorbic acid and sodium ascorbate, are included as an antioxidant [0033]. As a pH of 6.2 to 6.7 is a most preferred pH for a cannabinoid formulation known in the art, it would have been obvious to one of ordinary skill in the art to apply to the formulation of Miller to inhibit oxidation and optimal stability during storage of the formulation as suggested by Vangara [0185].
Regarding claims 16-19, modified Miller teaches 0.02% to 0.5% of the antioxidant (stabilizing component) [Vangara 0032], or 200 ppm to 5,000 ppm. 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 23-34, Miller teaches the carrier comprises glycerin (glycerol) and/or propylene glycol in an amount of 50% to 80% based on the total weight of the formulation [0114].
Regarding claims 35-37, Miller teaches a propylene glycol to glycerol ratio of about 3:2 [0114], or about 60% propylene glycol to about 40% glycerol. As “about” is interpreted to include a +/- range of 10% for both the disclosure of Miller and the claims, about 60% and about 40% are interpreted to overlap with about 70% and about 30%, or alternatively, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). In any case, Miller further teaches an upper limit of a 4:1 ratio, or 80% and 20%, further overlapping the claimed percentages.
Regarding claims 38-41, Miller teaches the cannabinoid is used for medicinal purposes [0117]. One of ordinary skill in the art would have found it obvious to optimize the concentration of the cannabinoid as a matter of routine experimentation to achieve the desired effects.
Regarding claim 44, Miller teaches the formulation further comprises a terpene (one or more active constituents in addition to the cannabinoid) [0111].
Regarding claim 46, Miller teaches the formulation is in the form of a liquid [0110], which is interpreted to be the case at room temperature, or about 25°C.
Regarding claim 47, as modified Miller teaches the same formulation composition of the claimed invention, the formulation is expected to have the same stability as the claimed formulation such that the content of one or more specific cannabinoids is at least 80% of the initial content of the one or more specific cannabinoids based on a mg/ml basis of the formulation after 4 weeks at 40° C. and 75% Relative Humidity.
Claims 42-43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Miller and Vangara as applied to claims 1 and 44 above, and further in view of Khlystov (US 2020/0196679).
Miller teaches a terpene [0111] but does not specify the type. Khlystov teaches an electronic smoking article formulation including limonene as a flavoring [0034]. It would have been obvious to one of ordinary skill in the art to include limonene (olfactory active constituent) with the formulation of modified Miller, and to optimize the concentration thereof as a matter of routine experimentation, to achieve the desired level of flavoring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC YAARY whose telephone number is (571)272-3273. The examiner can normally be reached M-F 9-5.
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/ERIC YAARY/Examiner, Art Unit 1755
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