DETAILED ACTION
Response to Arguments
Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive.
Applicant argues the data provided in the specification and declaration demonstrates the unexpected results of the claimed stabilizing components. The Examiner disagrees. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In this case, the evidence provided by Applicant is not commensurate in scope with the claims for many reasons. Claim 1 recites tert-butylhydroquinone in an amount of at least 400 ppm, whereas the data provided in the declaration only includes 1 example with tert-butylhydroquinone in an amount of 4100 ppm. Claim 1 recites propyl-gallate in an amount of at least 5200 ppm, whereas the data provided in the declaration only includes 1 example with propyl-gallate in an amount of 500 ppm. Claim 1 recites a wide range of different cannabinoids, whereas the examples in the declaration and Table 3 of the present application only include CBD. The carrier of claim 1 is open to unlimited different carriers, whereas the examples in the declaration and Table 3 of the present application only include a specific combination of propylene glycol and glycerol. The Examiner also disagrees that Table 3 demonstrates unexpected results of the combination of ascorbic acid and sodium ascorbate compared to ascorbic acid alone. Ascorbic acid on its own when measured at 84 days reduced CBDHQ formation more the combination of ascorbic acid and sodium ascorbate, indicating variance in the results depending on when the measurement takes place.
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 [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].
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]. Although Vangara does not specifically teach a combination of ascorbic acid and sodium ascorbate in this embodiment, Vangara does teach suggest 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).
Regarding claims 7-9, Vangara teaches further including cannabinol [0029].
Regarding claims 16-19, Vangara teaches an amount of 0.01% to 1% of the antioxidant (stabilizing component) [0055], or 100 ppm to 10,000 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]. 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 ascorbic acid and sodium ascorbate are included as a pH modifier [0045] and antioxidant [0056]. 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 achieve predictable results, e.g. a stable formulation, and it further would have been obvious to include ascorbic acid and sodium ascorbate to help achieve this desired pH and inhibit oxidation as suggested by Vangara.
Regarding claims 16-19, modified Miller teaches 0.01% to 1% of the antioxidant (stabilizing component) [Vangara 0055], or 100 ppm to 10,000 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
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 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