DETAILED ACTION
Response to Arguments
Applicant's arguments filed 9/16/2026 have been fully considered but they are not persuasive.
Applicant argues “Vangara does not identify these selections together as an aerosolizable formulation, nor does Vangara describe generating an aerosol from a formulation containing the stabilizing components required by claim 1.”
The Examiner disagrees. Vangara does need to identify its alcohol free formulation as aerosolizable in order to anticipate or render obvious the claimed aerosol formulation. The alcohol-free formulation taught by or suggested Vangara has the same composition of the claimed formulation and is inherently aerosolizable. Vangara teaches the same claimed carrier of propylene glycol which is aerosolizable as described in Applicant’s own specification [0052 of published application].
Applicant argues “The same deficiency identified in Stepan is present here. Vangara identifies numerous compounds generally as "suitable antioxidants," but does not provide a reason to select propyl gallate or the particular combination of ascorbic acid and sodium ascorbate for AF3, much less for an aerosolizable formulation as presently claimed. Vangara's alcohol-free examples test sodium ascorbate in AF3 and sodium ascorbate together with additional components in AF4. Vangara does not test propyl gallate, tert-butylhydroquinone, or the particular combination of ascorbic acid and sodium ascorbate in those formulations. See Vangara at " [0032]-[0033], [0181]-[0185], Tables 11-13. Nor does Vangara evaluate the effect of those stabilizing components on aerosol generation or their suitability under conditions associated with aerosolization. Thus, the fact that Vangara generally identifies these compounds among numerous possible antioxidants does not explain why a person of ordinary skill would have selected the particular stabilizing components required by claim 1 for use in the claimed aerosolizable formulation.”
The Examiner disagrees. Vangara teaches “In a preferred embodiment, the formulations contain alpha-tocopherol (Vitamin E), ascorbic acid, sodium ascorabte, ascobyl palminate or combinations thereof” [0033]. One of ordinary skill in the art would not have considered this preferred list a “long list” for the selection of the combination of ascorbic acid and sodium ascorbate. One of ordinary skill in the art also would not have considered the broader list of 16 suitable antioxidants too large for the selection of propyl gallate. See Applicant’s pending application 17/453,532 and the 2/3/2026 affirmed patent board decision: “The Appellant argues that a person of ordinary skill in the art would not have been motivated to select benzoic acid because the list of 16 acids disclosed by Rabinowitz is too broad…Those arguments are unpersuasive for reasons given by the Examiner, which we adopt as our own. We emphasize that a list of 16 acids is not exceptionally long…In this case, the reason for choosing benzoic acid is because it is a known suitable organic acid for controlling the sensory and organoleptic properties of a nicotine composition.” Similarly, in this case, the reason for selecting propyl gallate, or a combination of ascorbic acid and sodium ascorbate, as antioxidants in the formulation of Vangara is their know suitability for use as antioxidants as taught by Vangara. An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). As noted earlier, the formulation of Vangara is inherently aerosolizable and the mere mention in the claims that the formulation is aerosolizable has no bearing on the obviousness of the claimed formulation. Applicant’s argument that arriving at amended claim 1 from Vangara requires “employing the resulting formulation as an aerosolizable formulation” is blatantly incorrect. The claims are simply directed to a formulation. The claims are not directed to an aerosol-generating device comprising the formulation, nor are they directed to a method of generating aerosol from the formulation. Arriving at amended claim 1 from Vangara does not require “employing the resulting formulation as an aerosolizable formulation”.
Applicant’s arguments regarding criticality or unexpected results are unpersuasive for the reasons stated in the 2/4/2026 Office action.
Applicant argues “Vangara's AF2, AF3, and AF4 data do not establish that the antioxidants identified in paragraph [0033] are interchangeable or would predictably provide comparable stabilization. For example, at 25°C, AF2 maintained its assay value and total impurity level, whereas AF3 exhibited a reduced assay value and an increase in total impurities. Vangara at Tables 11-13. Thus, Vangara does not support the Office's apparent premise that its disclosed antioxidants could be transferred to Miller's aerosolizable formulation "to inhibit oxidation and optimal stability during storage of the formulation". The Examiner disagrees. As noted by Vangara, formulations # AF3 and # AF4, containing antioxidant(s) and pH modifiers, showed excellent stability for four weeks regardless of temperature and humidity conditions [0185]. Tables 2-9 demonstrate the significantly reduced total impurities resulting from the combination of antioxidants and pH modifiers. Applicant’s arguments regarding the selection of the claimed antioxidants are addressed above.
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
THIS ACTION IS MADE FINAL. 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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/ERIC YAARY/Examiner, Art Unit 1755
