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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 16 June 2026 has been entered.
Priority
The application was filed on 21 July 2022 and claims domestic benefit to provisional application 63/224,750 filed on 22 July 2021. Therefore, the effective filing date of the application is 22 July 2021.
Examiner’s Note
Applicant's amendments and arguments filed 16 June 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
and not reiterated from previous Office Actions are hereby withdrawn. The
following rejections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application. Claim 1 has been amended, claim 23 has been canceled, and no new claims have been added. Support for the amendments can be found from the canceled claim. No new matter has been added.
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.
Claim(s) 1-8, 11, 13-22, 24-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crumrine (US 20210401746 A1, priority date of 26 June 2020), Jackowetz et al. (US 20210177013 A1, priority date of 18 November 2018), and persistencemarketresearch.com.
Regarding claim 1, Crumrine teaches a nanoemulsion (paras. 12, 64, 65, entire teaching) composition that may comprise 0.01-10% (para. 19) of cannabidiol (CBD) (abs), sunflower oil or canola oil (first oil) (para. 106) in an amount of 1-30% (para. 120), water (para. 8), lecithin (para. 18), PEG-8-glyceryl capylate/caprate (abs, paras. 34, 120), which is a PEG glyceryl fatty acid ester surfactant, as evidenced by the instant specification (pg. 18). The dispersed oil droplets may have a diameter of 100 nm or smaller (para. 9). Regarding 2-25% of PEG glyceryl fatty acid ester surfactant, the solubilizing agent (para. 95) to CBD may be in a 1:1 ratio (para. 100), which is interpreted as falling within the 2-25% range for PEG glyceryl fatty acid ester surfactant when the amount of CBD is 0.01-10%. Regarding 10-15% of lecithin, the amount of stabilizer (para. 18) may be used in excess or a 1:1 ratio or greater in relation to the CBD mixture (para. 122). Therefore, if the composition comprises 0.01-10% of CBD, it is interpreted that the amount of lecithin may fall within 10-15%.
Regarding claim 2, the composition may comprise 0.01-10% (para. 19) of cannabidiol (abs).
Regarding claim 3, the composition may comprise 0.01-10% (para. 19) of cannabidiol (abs).
Regarding claim 4, the composition may comprise cannabidiol (CBD) (abs).
Regarding claim 5, the composition may comprise cannabidiol (CBD) (abs).
Regarding claim 6, the composition may comprise cannabidiol (CBD) (abs).
Regarding claim 7, the composition may comprise catechins (para. 18).
Regarding claim 8, the composition may comprise sunflower oil (para. 106).
Regarding claim 11, the amount of stabilizer (para. 18) may be used in excess or a 1:1 ratio or greater in relation to the CBD mixture (para. 122). If the composition comprises 0.01-10% of CBD, it is interpreted that the amount of lecithin may fall within 10-15%. where it is Therefore, it is interpreted that it is possible for the second oil to be 1.5 times greater than the first oil.
Regarding claim 13, the composition may comprise polyoxyethylene stearate (para. 133).
Regarding claim 14, the composition may comprise xylitol (para. 15).
Regarding claim 15, the composition may comprise glycyrrhizin (para. 173), which is interpreted as synonymous with glycyrrhizic acid.
Regarding claim 18, the composition may comprise vitamin E as an antioxidant (para. 109).
Regarding claims 19-21, the composition may comprise propylene glycol.
Regarding claim 22, since ethanol and other mono-alcohols are optional ingredients, the composition is interpreted as free of mono-alcohols.
Regarding claim 24, the emulsion may be stable for at least 6 months or at least 12 months (para. 25).
Claims 25 and 26 are interpreted as intended use and are given minimal patentable weight. See MPEP 2111.02(II). Furthermore, the composition may be administered orally such as with a tablet (para. 130) or liquid preparations (para. 131) and may be diluted (para. 22).
Regarding claim 27, the composition may further include preservatives (para. 125).
Regarding claim 28, the emulsion may be stable for at least 6 months or at least 12 months (para. 25).
Regarding claim 29, the composition may comprise 0.01-10% (para. 19) of cannabidiol (abs).
Regarding claim 30, the amount of stabilizer (para. 18) may be used in excess or a 1:1 ratio or greater in relation to the CBD mixture (para. 122). If the composition comprises 0.01-10% of CBD, it is interpreted that the amount of lecithin may fall within 10-15%. where it is Therefore, it is interpreted that it is possible for the second oil to be 1.5 times greater than the first oil.
Crumrine does not teach an exact combination of cannabinoid, oils, PEG glyceryl fatty acid ester surfactant, and water in claim 1. Crumrine does not teach crude, unrefined lecithin in claim 1 or stevia in claim 15.
Jackowetz et al. teach an oral (para. 81) emulsion composition (para. 167) that may include CBD (para. 21), up to 10% (para. 18) of sunflower oil as a carrier oil (para. 143), up to 10% (para. 18) of canola lecithin (crude, unrefined lecithin, as evidenced by the instant specification (pg. 17)) as an emulsifier (paras. 154, 155), PEG-based surfactants (para. 188), yangonin (para. 119), stevia as a sweetener (para. 261), vitamin E as an antioxidant (para. 208), and xylitol (para. 261). Since the composition may have 5% sunflower oil and 10% canola lecithin, it is interpreted that the ratio of canola lecithin to sunflower oil is 2:1. Droplet sizes may be about 30-100 nm (para. 281), which is interpreted as nanometer sized emulsions. when mixed with an aqueous solution, the composition may be stable for 6 months or 1 year (para. 264). The composition may be administered orally as a tablet (para 325) or in a liquid formulation (para. 81).
In regards to selecting a combination of CBD, water, catechins, sunflower oil, lecithin, polyoxyethylene stearate, propylene glycol, xylitol, vitamin E, and glycyrrhizin in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Crumrine teaches an emulsion composition comprising CBD, water, catechins, sunflower oil and/or canola oil, lecithin, polyoxyethylene stearate, propylene glycol, xylitol, vitamin E, and glycyrrhizin. The claimed invention is directed towards a nanoemulsion composition comprising a cannabinoid, a first oil, a second oil, PEG glyceryl fatty acid ester surfactant, and water. Since Crumrine teaches the individual components of the composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Crumrine teaches a sweetener (para. 125) and lecithin generally, but does not teach specifically stevia or canola lecithin as components in their CBD emulsion composition for claims 1 and 15, one of ordinary skill in the art would have been motivated to use canola lecithin and stevia in a CBD emulsion composition from Jackowetz because canola lecithin has favorable emulsification and stabilizing properties that are preferred over other lecithins (persistencemarketresearch.com, pg. 3). One of ordinary skill in the art would have been motivated to look to these teachings, as both teach oral emulsion compositions comprising CBD to treat pain, anxiety, depression, etc. (para. 2 in Crumrine, para. 125 in Jackowetz).
Response to Arguments
Applicant's arguments filed 16 June 2026 have been fully considered but they are not persuasive.
The Applicant argues that amended claim 1 now recites specific amounts or ranges of the components and is therefore patentable over Crumrine in view of Jackowetz and Persistence (Remarks, pgs. 8-9).
Applicant’s argument is not found persuasive. Regarding claim 1, Crumrine teaches a nanoemulsion (paras. 12, 64, 65, entire teaching) composition that may comprise 0.01-10% (para. 19) of cannabidiol (CBD) (abs), sunflower oil or canola oil (first oil) (para. 106) in an amount of 1-30% (para. 120), water (para. 8), lecithin (para. 18), PEG-8-glyceryl capylate/caprate (abs, paras. 34, 120), which is a PEG glyceryl fatty acid ester surfactant, as evidenced by the instant specification (pg. 18). The dispersed oil droplets may have a diameter of 100 nm or smaller (para. 9). Regarding 2-25% of PEG glyceryl fatty acid ester surfactant, the solubilizing agent (para. 95) to CBD may be in a 1:1 ratio (para. 100), which is interpreted as falling within the 2-25% range for PEG glyceryl fatty acid ester surfactant when the amount of CBD is 0.01-10%. Regarding 10-15% of lecithin, the amount of stabilizer (para. 18) may be used in excess or a 1:1 ratio or greater in relation to the CBD mixture (para. 122). Therefore, if the composition comprises 0.01-10% of CBD, it is interpreted that the amount of lecithin may fall within 10-15%.
Since Crumrine teaches a sweetener (para. 125) and lecithin generally, but does not teach specifically canola lecithin as components in their CBD emulsion composition in claim 1, one of ordinary skill in the art would have been motivated to use canola lecithin and stevia in a CBD emulsion composition from Jackowetz because canola lecithin has favorable emulsification and stabilizing properties that are preferred over other lecithins (persistencemarketresearch.com, pg. 3). One of ordinary skill in the art would have been motivated to look to these teachings, as both teach oral emulsion compositions comprising CBD to treat pain, anxiety, depression, etc. (para. 2 in Crumrine, para. 125 in Jackowetz).
The Applicant argues that amended claim 1 is patentable in regards to the unique stability of the nanoemulsion (Remarks, pgs. 9-10).
Applicant’s argument is not found persuasive. The Applicant is encouraged to show unexpected results regarding the unique stability of the formulation. Instant claim 1 broadly recites a nanoemulsion composition comprising a cannabinoid in an amount of “about 1%” or greater, any first oil in an amount of “about 8-12%”, a second oil comprising crude, unrefined lecithin in an amount of “about 10-15%,” any PEG glyceryl fatty acid ester surfactant in an amount of “about 2% to about 25%,” and water. Furthermore, Crumrine and Jackowetz both teach formulations of stable emulsions (paras. 10, 12 in Crumrine and paras. 12, 14 in Jackowetz). Since the art teaches the formulation in the weight percentage ranges, the compositions taught by Crumrine are presumed to result in stable formulations.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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