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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/31/2026 has been entered.
Response to Amendment
This office action is in response to Applicant’s amendment filed 3/31/2026.
Claim 1 is amended.
Claims 11-12, 15, and 21-22 are cancelled.
Claims 1-10, 13-14, and 16-20 are pending. Claim 20 has been withdrawn.
Response to Arguments
Applicant's arguments filed 3/31/2026 have been fully considered but they are not persuasive.
Applicant has amended claim 1 to recite “the nanoemulsion further comprises a humectant in an amount from 5% to 25% by weight based on the total weight of the oral product” (p. 5). Applicant argues that Friedman fails to teach or suggest an oral product wherein the nanoemulsion comprises 5-25% by weight of humectant as recited in amended claim 1 (p. 6-7).
The Examiner respectfully disagrees. Upon further consideration, Friedman discloses a stable-oil-in-water submicron emulsion oral cannabinoid composition comprising about 1% to 40% of at least one taste-enhancing excipient (claim 1) wherein the at least one taste-enhancing excipient is selected from glycerin (claim 3), which is considered a humectant under Applicant’s invention (see instant specification at p. 26, ll. 26-31). Therefore, Friedman discloses a humectant present in the nanoemulsion in a range that overlaps the claimed invention.
Applicant’s also argues that Hovsepyan and Stahl do not disclose the claimed amount of humectant within an emulsion or nanoemulsion (see pp. 6, 8).
The Examiner has noted Applicant’s arguments but finds them unpersuasive because Friedman is now being relied upon for such a limitation.
Claim Rejections - 35 USC § 103
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.
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 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 1-3, 6-10, 13-14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 2020/0330378; of record).
Regarding claims 1-3 and 13-14, Friedman discloses an oral cannabinoid composition (abstract; “oral product”) comprising:
a stabilizing agent in the form of a high-molecular-weight polymer selected from a group consisting of cellulose derivatives such as microcrystalline cellulose ([0051]-[0052]; claim 13; “cellulose material” that is a “derivative of wood pulp fiber” and “microcrystalline cellulose”);
at least one cannabinoid ([0011] and [0086]; claim 1); and
an emulsion of a sub-micron type of or a nano-size type ([0059]; claim 1; “nanoemulsion”) of an oil-in-water type ([0011] and [0086]; “oil phase” and “aqueous phase”) having emulsifiers ([0011] and [0086]; claim 1; “one or more emulsifying agents”), wherein the at least one cannabinoid is emulsified ([0011]) and wherein at least 99% of the particle plurality in the stable emulsion are below a mean particle size of preferably 200 nm ([0025]) or a mean particle size of from 10 nm to about 200 nm ([0086]-[0088]), and further comprising a taste-enhancing excipient that may be glycerin ([0097]; claim 3; “humectant” and “taste modifier” in the form of “glycerine”) in an amount of about 1 to about 40% (claim 1; see also Table 12, using 20% glycerin).
Regarding the claim limitation “a humectant in an amount from 5% to 25% by weight, based on the total weight of the oral product,” Friedman discloses a range of 1-40%, which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 6-7, Friedman discloses the oral product as discussed above with respect to claim 1, wherein emulsion composition comprises from about 0.02% to about 10% w/w of at least one cannabinoid or mixture of cannabinoids ([0086]-[0087]; claim 1; overlapping the claimed range of “about 1% to about 30% by weight of the oral product” and “about 5% to about 15% by weight of the oral product”). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 8-9, Friedman discloses the cannabinoid is selected from the group consisting of cannabidiol (CBD) (see also [0056]), cannabidiolic acid (CBDA) tetrahydrocannabinol (THC), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabicyclol (CBL), cannabivarin (CBV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), and combinations thereof ([0016]).
Regarding claim 10, Friedman discloses the oral product is a day time composition comprising at least one cannabinoid derivative having a CBD:THC ratio of about 10 to about 200 ([0046]; overlaps the claimed range of “at least 98% by weight of a cannabinoid”). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 16, Friedman discloses the oral product as discussed above with respect to claim 1.
Regarding the claim limitation “a water activity of the oral product is no greater than 0.85,” the instant application describes that “water activity” is the partial vapor pressure of the water in the product divided by the standard state partial vapor pressure of water (p. 49). Thus, the partial pressure of water in Friedman’s oral product is a dependent on all of the other components in the oral product that would similarly exert partial pressures. However, since Friedman discloses a product having an identical structure and composition to the claimed invention (see claim 1 above), Friedman’s oral product is expected to exhibit the identically claimed property. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I).
Regarding claim 17, Friedman discloses the composition is stable at ambient room temperature of at least one year and for two years ([0048]).
Regarding claim 18, Friedman discloses the oral product as discussed above with respect to claim 1.
Regarding the claim limitation “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,” since Friedman discloses a product having an identical structure and composition to the claimed invention (see rejection of claim 1 above), Friedman’s oral product is expected to exhibit the identically claimed property. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I).
Claims 1-10, 13-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hovsepyan (US 2022/0362146; of record) in view of Friedman (US 2020/0330378; of record).
Regarding claims 1-3, 8-9 and 13-14¸ Hovsepyan discloses a dose unit for efficient transfer to the oral mucosa of a user (abstract; [0008]; “oral product”) comprising:
a water insoluble carrier ([0006]) wherein the water insoluble carrier may be a cellulose carrier material selected from a group consisting of microcrystalline cellulose, plant fibers including bamboo fibers, oat fibers, maize fibers, cocoa fibers, and similar ([0040]), wherein microcrystalline cellulose is preferred ([0040]);
cannabidiol (CBD) ([0006]; “cannabinoid”); and
wherein the CBD is provided as CBD oil ([0038]) and that all components of the formulation are homogeneously mixed ([0036]), wherein the formulation further includes water ([0006], [0009], [0060]) and glycerine or other non-ionic polyols ([0044]; glycerine is known as an “emulsifying agent”) and propylene glycol ([0045]; propylene glycol is known as an “emulsifying agent”).
However, Hovsepyan is silent as to a nanoemulsion comprising an oil phase, an aqueous phase, and one or more emulsifying agents, wherein the nanoemulsions comprises the cannabinoid, and wherein an average particle size of the nanoemulsion is from about 10 nm to about 200 nm, the nanoemulsion further comprising a humectant in an amount from 5% to 25% by weight based on the total weight of the oral product.
Friedman teaches an oral cannabinoid composition (abstract) relating to stable emulsion composition of oil-in-water type ([0002]), wherein emulsions are thermodynamically unstable compositions that tend to separate over time, wherein separation is governed by Stocks equation and is mainly a function of particle size and viscosity ([0009]), wherein the composition is an emulsion of a sub-micron type of or a nano-size type ([0059]; “nanoemulsion”) of an oil-in-water type ([0011] and [0086]; “oil phase” and “aqueous phase”) and emulsifiers ([0011] and [0086]; “one or more emulsifying agents”), wherein the at least one cannabinoid is emulsified ([0011]) and wherein at least 99% of the particle plurality in the stable emulsion are below a mean particle size of preferably 200 nm ([0025]) or a mean particle size of from 10 nm to about 200 nm ([0086]-[0088]), and a taste-enhancing excipient including glycerin ([0097]; claim 3), wherein glycerin is known to mask the unpleasant taste of low to moderately bitter or earthy taste of cannabis extract ([0097]), and the taste-enhancing excipient being present in an amount of 1-40% of the submicron emulsion (claim 1).
Therefore, Friedman suggests that the amount of glycerin present in the nanoemulsion is a result-effective variable that affects the degree of masking the bitter or earthy taste of cannabis extract.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hovsepyan’s CBD oil, water, glycerine and propylene glycol to be in the form of a nanoemulsion having an average particle size of 10 to 200 nm as in Friedman because (a) Hovsepyan suggests that these components are homogenously mixed, and Friedman’s nanoemulsion is an example of such a homogenous mixture; and (b) such a modification beneficially improves shelf life stability by extending the shelf life to two years and improved oral bioavailability of cannabinoids by at least 100% (Friedman; [0048]). Moreover, it would have been obvious to said skilled artisan to have modified the amount of glycerin in Hovsepyan’s nanoemulsion to be in the range of 1-40% as in Friedman in order to obtain the predictable result of masking the bitter and/or earthy taste of the CBD oil (Friedman; [0097]). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)(A).
Regarding claims 4-5, modified Hovsepyan discloses the formulation comprises preferably 45-60% of the carrier material, more preferably from 50-55%, most preferably 52-53% of the carrier material ([0040]).
Regarding the claim limitation “about 55% to about 95% by weight of the oral product,” the term “about” is being interpreted as including a margin of ±10%, meaning the claim limitation is being interpreted to include the range of 49.5-100% cellulose material. Thus, Hovsepyan’s disclosed range of 52-53% carrier material would be anticipate such a range.
Alternatively, if the claim limitation “about 55% to about 95% by weight of the oral product” is interpreted to be only include the range of 55-95% cellulose, then Hovsepyan’s disclosed range of 45-60 overlaps the claimed range and therefore renders such a range obvious. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 6-7, modified Hovsepyan discloses a useful proportion of CBD may be from 0.1% to 10%, wherein from 1% to 3% is preferred and from 1.8% to 2.4% is most preferred ([0038]).
Regarding the claim limitation “cannabinoid is present in an amount from about 5% to about 15% by weight of the oral product,” Hovsepyan’s disclosed range of 0.1-10% overlaps the claimed range and therefore renders such a range obvious. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 10, modified Hovsepyan discloses the CBD can be provided as CBD isolate with at least 98% purity ([0038]).
Regarding claim 13, modified Hovsepyan further discloses a flavoring agent ([0042]; also “taste modifier”), a binding agent ([0043]), and a preservative ([0045]).
Regarding claim 16, modified Hovsepyan discloses the oral product as discussed above with respect to claim 1, wherein the water content of the formulation is preferably from 30% to 40% ([0047]), that the moisture content of the formulation when packed is preferably at least 10% ([0048]) wherein moisture content refers to the total amount of oven volatile ingredients, such as for example water and ethanol, in the preparation ([0031]).
Regarding the claim limitation “a water activity of the oral product is no greater than 0.85,” the instant application describes that “water activity” is the partial vapor pressure of the water in the product divided by the standard state partial vapor pressure of water (p. 49). Thus, the partial pressure of water in modified Hovsepyan’s oral product is a dependent on all of the other components in the oral product that would similarly exert partial pressures. However, since modified Hovsepyan discloses a product having an identical structure and composition to the claimed invention (see claim 1 above), modified Hovsepyan’s oral product is expected to exhibit the identically claimed property. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I).
Regarding claim 17, modified Hovsepyan discloses the oral product as discussed above with respect to claim 1.
Regarding the claim limitation “the oral product is chemically and physically stable for a period of at least 6 months,” since modified Hovsepyan discloses a product having an identical structure and composition to the claimed invention (see rejection of claim 1 above), modified Hovsepyan’s oral product is expected to exhibit the identically claimed property. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I).
Regarding claim 18, modified Hovsepyan discloses the oral product as discussed above with respect to claim 1.
Regarding the claim limitation “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,” since modified Hovsepyan discloses a product having an identical structure and composition to the claimed invention (see rejection of claim 1 above), modified Hovsepyan’s oral product is expected to exhibit the identically claimed property. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I).
Regarding claim 19, modified Hovsepyan discloses a pouch (2) of packing material containing the moist formulation (3) ([0034]), wherein the packing material is saliva penetrable ([0035]).
Conclusion
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/SONNY V NGUYEN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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