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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
Status of the Claims
Claims 1, 3-17, 21-24, 26, 27, and 29 are pending and are subject to this office action. This office action is in response to Applicant’s amendment filed on 05/08/25.
Claim 1 is amended.
Claims 2, 18-20, 25, and 28 are canceled.
Claim 27 is withdrawn.
Response to Arguments
Applicant's arguments (filed 11/04/25) with respect to the rejection(s) of Claim 1 under 35 U.S.C. 103 as being unpatentable over Hovsepyan in view of Bruun have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Greenbaum (US 20190037909 A1).
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 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, 10, 11, 13, 15-17, 21-24, 26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Greenbaum (US 20190037909 A1).
Regarding Claim 1, Greenbaum discloses a pouched oral product (cannabis based moist snuff composition. [0007]) comprising:
a permeable pouch (The cannabis based moist snuff composition may be packaged in a plurality of individual mesh pouches. [0038]), and
a composition incorporated therein, the composition comprising: (i) a cannabinoid (The pouch comprises a moist casing component which may further comprise cannabinoids. [0007], [0015])
(ii) a filler (The pouch may comprise cannabis leaves and stems, which are fibrous organic materials. [0007], [0016]-[0018]. The presence of a fibrous material in the pouch acts as a filler material.)
(iii) water, wherein the water content of the oral product is from about 10% to about 30% by weight of the oral product ("Water may be present in a range of about 8-25% by weight of the casing component." [0020]), and
(iv) a humectant in an amount from 5% to 25% by weight of the oral product wherein the humectant is selected from the group consisting of glycerin, propylene glycol, and mixtures thereof ("Glycerin and propylene glycol may be present in the composition at a range of about 8-25% by weight of the casing component." [0020]).
Greenbaum does not explicitly disclose the water activity of the pouched oral product. However, given that the water activity of the oral product is dependent on its composition, specifically the compositional ratio of water, humectant, and fibrous material, it follows that Greenbaum, having an overlapping composition as the claimed oral product, would reasonably have a water activity no greater than 0.85 similarly as claimed, absent evidence to the contrary. See MPEP 2112(III).
Regarding Claim 10, Greenbaum discloses a pouched oral product wherein the cannabinoid is selected from the group consisting of tetrahydrocannabinol (THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCA), Cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabivarin (THCV), and cannabidivarin (CBDV) ([0012]).
Regarding Claim 11, Greenbaum discloses a pouched oral product wherein the cannabinoid comprises cannabidiol (The cannabinoid may comprise cannabidiol (CBD). [0012]).
Regarding Claim 13, Greenbaum discloses a pouched oral product wherein the oral product contains an emulsion comprising a continuous phase and a dispersed phase wherein the emulsion comprises at least one cannabinoid ("the cannabinoids will be a nanoemulsion of cannabinoid components and/or whole plant cannabis extracts. Nano emulsions can be formed using any nano emulsion methods known to those having skill in the art." [0031]).
Regarding Claim 15, Greenbaum discloses a pouched oral product containing an emulsion as discussed in regard to Claim 13 but does not explicitly disclose an oral product wherein the emulsion is in the form of a nanoemulsion in which nanoparticles of an oil phase are dispersed in an aqueous phase. However, given that a nanoemulsion of nanoparticles comprising of an oil phase dispersed in an aqueous phase is dependent on the composition of the oral product, specifically the emulsified mixture of water and the lipophilic cannabidiol as claimed in Claims 1 and 13, it follows that Greenbaum, having an overlapping composition as the claimed oral product, would reasonably have a nanoemulsion in which nanoparticles of an oil phase are dispersed in an aqueous phase as claimed, absent evidence to the contrary.
Regarding Claim 16, Greenbaum discloses a pouched oral product wherein the cannabinoid is present in the nanoparticles of the oil phase (The casing component may comprise ingredients that are liquid, semi-liquid, or solid. In the case of solid or powdered ingredients, they may be dissolved in the liquid ingredients prior to mixing with the cannabis leaf/stem component. [0019]).
Regarding Claim 17, Greenbaum discloses a pouched oral product wherein the oral product further comprises at least one additive selected from the group consisting of a flavoring agent, a taste modifier, a preservative, a humectant, a sweetener, a binder, a buffering agent, salt and mixtures thereof ("Various flavoring compositions may be included in the casing component" [0022])
Regarding Claim 21, Greenbaum discloses a pouched oral product wherein the oral product comprises a salt ("sodium chloride (NaCl) is added both to improve/enhance flavor, as a preservative and/or to induce salivation." [0023]).
Regarding Claim 22, Greenbaum discloses a pouched oral product according to Claim 1 as discussed above but does not explicitly disclose an oral product wherein the oral product is chemically and physically stable for a period of at least 6 months. However, given that the chemical and physical stability of an oral product is dependent on the composition, specifically the compositional ratio of water to filler, humectant, and cannabinoid, it follows that Greenbaum, having an overlapping composition as the claimed oral product, would reasonably be chemically and physically stable for a period of at least 6 months as claimed, absent evidence to the contrary.
Regarding Claim 23, Greenbaum discloses a pouched oral product according to Claim 1 as discussed above but does not explicitly disclose an oral product wherein at least 50 wt% of the cannabinoid is released within at most about 60 minutes when placed in the oral cavity of a user. However, given that the rate of cannabinoid release of an oral product is dependent on the composition of the oral product, specifically the composition of filler and cannabinoid, it follows that Greenbaum, having an overlapping composition as the claimed oral product, would reasonably release at least 50 wt% of the cannabinoid within at most about 60 minutes when placed in the oral cavity of a user as claimed, absent evidence to the contrary.
Regarding Claim 24, Greenbaum discloses a pouched oral product according to Claim 23 but does not explicitly disclose an oral product wherein at least 30 wt% of the released cannabinoid is absorbed into the oral mucosa within at most about 60 minutes. However, given that the oral mucosa absorption of the cannabinoid is dependent on the composition of the oral product, specifically the overall quantity of the cannabinoid in the product, it follows that Greenbaum, having an overlapping composition as the claimed oral product, would reasonably have at least 30 wt% of the cannabinoid be absorbed into an oral mucosa within at most about 60 minutes when placed in the oral cavity of a user as claimed, absent evidence to the contrary.
Regarding Claim 26, Greenbaum discloses a package containing the pouched oral product according to Claim 1 ("The resulting cannabis based moist snuff composition may be packaged in any suitable container, such as in a tin, in a plurality of individual mesh pouches, such as for example those employed by Skoal in their “bandits” product, snus, or Copenhagen pouches, or any other package known in the art." [0038]).
Regarding Claim 29, Greenbaum discloses a pouched oral product comprising from about 1% to about 7.5% of an alkali metal salt by weight of the pouched oral product (“Sodium bicarbonate may be present in about 0.5-4% by weight of the casing.” [0024]. A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05(I)).
Claims 3-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Greenbaum (US 20190037909 A1) in view of Hovsepyan (EP 3756649 A1)
Regarding Claim 3, Greenbaum discloses a pouched oral product wherein the product comprises the fibrous components of cannabis leaves and stems ([0016]-[0018]), but does not explicitly disclose the use of other fibrous materials as a filler component.
However, Hovsepyan discloses a pouched oral product wherein the filler comprises a cellulose material selected from the group consisting of maize fiber, oat fiber, barley fiber, rye fiber, buckwheat fiber, sugar beet fiber, bran fiber, bamboo fiber, wood pulp fiber, cotton fiber, citrus pulp fiber, grass fiber, willow fiber, poplar fiber, cocoa fiber, derivatives thereof, and combinations thereof ("The carrier material may be a cellulose carrier material for example selected from the group consisting of... water insoluble plant fibers... Suitable plant fibers include bamboo fibers, oat fibers, maize fibers, cocoa fibers, tomato fibers, apple fibers and similar. " [0024]).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the fibrous component of Greenbaum with a non-cannabis derived fibrous component such as the fibrous components taught by Hovsepyan because Greenbaum and Hovsepyan are both directed to pouched oral products, Hovsepyan teaches the use of various fibrous materials as the fibrous filler material for a pouched oral product comprising a cannabinoid, and this merely involves applying a known fibrous component to a similar pouched oral product to yield predictable results.
Regarding Claim 4, Hovsepyan further discloses a pouched oral product wherein the cellulose material is a derivative of wood pulp fiber ("The carrier material may be a cellulose carrier material for example selected from the group consisting of microcrystalline cellulose, powdered cellulose, or water insoluble plant fibers, or any combination thereof… In particular, microcrystalline cellulose is preferred." [0024]).
Regarding Claim 5, Hovsepyan further discloses a pouched oral product wherein the cellulose material is microcrystalline cellulose ("The carrier material may be a cellulose carrier material… In particular, microcrystalline cellulose is preferred." [0024]).
Regarding Claims 6 and 7, Greenbaum discloses the pouched oral product wherein the product comprises fibrous components ([0016]-[0018]), but does not explicitly disclose wherein the filler is present in an amount of at least about 50% by weight of the oral product and/or wherein the filler is present in an amount of from about 55% to about 95% by weight of the oral product.
However, Hovsepyan discloses a pouched oral product wherein the filler is present in an amount of at least about 50% by weight of the oral product, and wherein the filler is present in an amount of from about 55% to about 80% by weight of the oral product ("carrier material may be a cellulose carrier material… the formulation preferably comprises 45% to 60%" [0024]. A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05(I)).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the fibrous component of Greenbaum with a fibrous component in an amount of at least about 50%, and/or from about 55% to about 80%, by weight of the oral product as taught by Hovsepyan because Greenbaum and Hovsepyan are both directed to pouched oral products, Hovsepyan teaches preferred ranges of fibrous material as the filler for the pouched oral product, and this merely involves applying a known fibrous component to a similar pouched oral product to yield predictable results.
Regarding Claims 8 and 9, Greenbaum discloses the pouched oral product wherein the product comprises a cannabinoid ([0015]), but does not explicitly disclose wherein the cannabinoid is present in an amount of from about 1% to about 30% by weight of the oral product and/or wherein the cannabinoid is present in an amount of from about 5% to about 15% by weight of the oral product
However, Hovsepyan discloses a pouched oral product wherein the cannabinoid is present in an amount of from about 1% to about 30% by weight of the oral product, and wherein the cannabinoid is present in an amount of from about 5% to about 15% by weight of the oral product ("The amount of CBD in each pouch depends on the intended use… A useful proportion of CBD may be from 0.1% to 10%" [0022]. A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05(I)).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify quantity of the cannabinoid component of Greenbaum such that the cannabinoid is present in an amount of from about 1% to about 30% by weight of the oral product, and/or wherein the cannabinoid is present in an amount of from about 5% to about 15% by weight of the oral product as taught by Hovsepyan because Greenbaum and Hovsepyan are both directed to pouched oral products, Greenbaum is silent on the amount of cannabinoid component to utilize and Hovsepyan teaches a preferred quantity of cannabinoid in a similar product, and this merely involves applying a known quantity of cannabinoid component to a similar pouched oral product to yield predictable results.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Greenbaum (US 20190037909 A1) in view of Keller (US 20210068447 A1).
Regarding Claim 14, Greenbaum discloses a pouched oral product wherein the emulsion may be formed by known methods in the art ("Nano emulsions can be formed using any nano emulsion methods known to those having skill in the art." [0031]), but does not explicitly teach the use of emulsifying agents as the method to form a nano emulsion.
Keller teaches a similar pouched product comprising cannabinoid (The pouched mixture may include an active ingredient such as a cannabinoid. [0004], [0014]-[0017], [0129]) wherein the oral product further comprises one or more emulsifying agents (Additives may include emulsifiers. [0150]).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pouched composition of Greenbaum with the addition of an emulsifying agent as taught by Keller because Greenbaum and Keller are both directed to pouched oral products comprising a cannabinoid, Keller teaches the addition of an emulsifying agent in the pouched oral product, and this merely involves applying a known component to a similar pouched oral product to yield predictable results.
Conclusion
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/JEFFREY A. BUCKMAN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755