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 .
Priority
The instant application was filed 05 February 2024 and is the continuation-in-part of 17/070,047 filed 14 October 2020. The Applicant claims priority to provisional application 62/914,853 filed 14 October 2019. Therefore, the effective filing date of the instant application is 14 October 2019.
Election/Restrictions
Applicant’s election of “at least one phytocannabinoid” in the reply filed on 26 June 2026 is acknowledged. The Applicant’s response is interpreted as electing “cannabidiol” as the species for “at least one phytocannabinoid.” Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 5-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 June 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a plurality of lipophilic molecules including at least one saturated straight chain C18-C34 fatty alcohol…and ω-9 C18-C20 fatty acid.” Claim 11 depends from claim 1 and lists palmitic acid, linoleic acid, etc. as options for the plurality of lipophilic molecules. Therefore, it is unclear if claim 1 requires all of the fatty alcohol and fatty acids. The list of fatty alcohol and fatty acids in claim 1 is herein interpreted as options or alternatives.
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) 1-4, 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garito et al. (EP 3417846 A1) and Gabriele et al. (WO 2019075558 A1).
Regarding claim 1, Garito teaches a food or nutraceutical composition (abs, entire teaching) comprising at least one endocannabinoid (active ingredient), such as cannabidiol (para. 13), oleic acid (active ingredient and interpreted as plurality of lipophilic molecules) (claim 6), rutin (active ingredient and bioflavanoid) (claim 6). The endocannabinoid may be present in a percentage by weight of the composition of between 15-90% (para. 18). Additionally, the amount of active ingredients may be present in a percentage by weight with respect to the weight of the composition of between 0.1-80% (para. 19).
Regarding claim 2, the endocannabinoid may be present in a percentage by weight of the composition of between 15-90% (para. 18).
Regarding claim 3, Garito teaches a food or nutraceutical composition (abs, entire teaching) comprising at least one endocannabinoid (active ingredient), such as cannabidiol (para. 13).
Regarding claim 4, Garito teaches a food or nutraceutical composition (abs, entire teaching) comprising at least one endocannabinoid (active ingredient), such as cannabidiol (para. 13). The endocannabinoid may be present in a percentage by weight of the composition of between 15-90% (para. 18).
Regarding claim 11, Garito teaches a food or nutraceutical composition (abs, entire teaching) comprising oleic acid (active ingredient and interpreted as plurality of lipophilic molecules) (claim 6).
Regarding claim 12, Garito teaches a food or nutraceutical composition (abs, entire teaching) comprising rutin (active ingredient and bioflavanoid) (claim 6).
Regarding claim 13, Garito teaches a food or nutraceutical composition (abs, entire teaching) comprising at least one endocannabinoid (active ingredient), such as cannabidiol (para. 13), oleic acid (active ingredient and lipophilic molecule) (claim 6), rutin (active ingredient and bioflavanoid) (claim 6). The endocannabinoid may be present in a percentage by weight of the composition of between 15-90% (para. 18). Additionally, the amount of active ingredients may be present in a percentage by weight with respect to the weight of the composition of between 0.1-80% (para. 19). Other active ingredients include cannabidivarin, cannabigerol, cannabichromene, cannabinol, cannabidiolic acid, and THC (scientific name: delta-9-tetrahydrocannabinol) (para. 13).
Garito does not teach an exact combination of the components recited in claims 1 and 13. Garito also does not specifically teach the amounts of components in claims 1 and 13. Garito does not teach a C18-C34 fatty alcohol, an unsaturated ω-3 C18-C24 fatty acid, an ω-6 C18-C22 fatty acid, an ω-7 C18-C20 fatty acid, and an ω-9 C18-C20 fatty acid in claim 1.
Regarding claim 1, Gabriele teaches compositions intended for food (para. 167) comprising 0.1 to about 5% (para. 132) of cannabidiol (para. 53), 0.5-5% (para. 98) of rutin (para. 95), palmitic acid (para. 141) (saturated 16 carbon fatty acid), linoleic acid (para. 141) (unsaturated 18 carbon fatty acid), eicosapentaenoic acid (para. 141) (unsaturated ω-3 20 carbon fatty acid), oleic acid (para. 141) (unsaturated ω -9 18 carbon fatty acid), stearic acid (para. 141) (saturated 18 carbon fatty acid), stearyl alcohol (para. 73) (saturated 18 carbon fatty alcohol), and vaccenic acid (para. 141) (unsaturated ω-7 18 carbon fatty acid). The fatty acids and fatty alcohols can be an emulsifier in an amount of 1-10% (para. 74) or a polar in an amount of 25-50% (para. 150) to help solubilize and dilute the hydrophobic compounds (para. 141).
In regards to selecting the combination of phytocannabinoids, bioflavanoid, and lipophilic molecule, “[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 combinations 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.”
Garito teaches a food or nutraceutical composition (abs, entire teaching) comprising at least one endocannabinoid (active ingredient), such as cannabidiol (para. 13), oleic acid (active ingredient and lipophilic molecule) (claim 6), rutin (active ingredient and bioflavanoid) (claim 6), whereas the claimed invention is directed towards a phytocannabinoid formulation comprising at least one phytocannabinoid, a plurality of lipophilic molecules, and at least one bioflavonoid. Since Garito teaches the individual components of the claimed 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.
In regards to the amounts of components recited in claims 1 and 13, Garito teaches that the endocannabinoid in their composition may be present in a percentage by weight of the composition of between 15-90% (para. 18). Additionally, the amount of active ingredients may be present in a percentage by weight with respect to the weight of the composition of between 0.1-80% (para. 19). That being said and in lieu of objective evidence of unexpected results, the amounts can be viewed as a variable that achieves the recognized result of successfully making the food or nutraceutical composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Garito. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of components as nonobvious.
Since Garito does not teach a C18-C34 fatty alcohol, an unsaturated ω-3 C18-C24 fatty acid, an ω-6 C18-C22 fatty acid, an ω-7 C18-C20 fatty acid, and an ω-9 C18-C20 fatty acid in claim 1, one of ordinary skill in the art would have been motivated to use Gabriele’s teaching of palmitic acid (para. 141) (saturated 16 carbon fatty acid), linoleic acid (para. 141) (unsaturated 18 carbon fatty acid), eicosapentaenoic acid (para. 141) (unsaturated ω-3 20 carbon fatty acid), oleic acid (para. 141) (unsaturated ω -9 18 carbon fatty acid), stearic acid (para. 141) (saturated 18 carbon fatty acid), stearyl alcohol (para. 73) (saturated 18 carbon fatty alcohol), and vaccenic acid (para. 141) (unsaturated ω-7 18 carbon fatty acid) with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings since both Garito and Gabriele teach compositions comprising cannabinoids potentially for oral use. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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