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 .
Response to Amendment
Applicant's amendment and argument filed 05/04/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1 and 5-8 are being examined on the merits.
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 and 5-8 rejected under 35 U.S.C. 103 as being unpatentable over Luis Vietta and Sean Hall (US20190315704A1) and supporting evidence by Anca Daniela Raiciu et. al. (Therapeutic Applications of Vegetable Oils and GC-MS Evaluation of ω-3, ω-6 and ω-9 Amounts in Six Oleaginous Plants, Rev. Chem. (Bucharest):67, No. 12, 2016, 2449-2453) and Ke Zhang et. al. (US10301242B2). This is a new rejection due to the amendments filed on 05/04/2026.
Vietta teaches protecting plant extracts specifically cannabinoids and compounds from degradation (see abstract).
Vietta teaches “the compositions or delivery systems may further comprise at least one oil. In some embodiments the one or more cannabinoids, cannabis extract or hemp seed oil may be provided in the oil or in an oil/solvent mixture. The oil or oil mixture may act as a carrier or solvent for the one or more cannabinoids. The oil or oil mixture may increase the stability of the composition or delivery system” and teaches both sesame oil and amaranth oil as suitable oils (see 0056).
Vietta teaches “described herein are compositions and delivery systems comprising at least one non-ionic surfactant, at least one polyol, and one or more cannabinoids. In some embodiments the composition or delivery system further comprises at least one oil. In some embodiments, the present invention beneficially provides delivery of one or more cannabinoids in a stable, protected composition or delivery system via the oral and/or nasal transmucosal or transdermal route, thereby bypassing the gastrointestinal tract and avoiding the need to break the skin, as with, for example an injection, and ensuring rapid absorption by the bloodstream” (see 0046).
Vietta does not specifically teach the composition to comprise of squalene.
Raiciu is relied upon to show that amaranth oil contains squalene, a component being claimed in the instant composition.
Raiciu’s general disclosure is to different vegetable oils and the amounts of omega-fatty acids within those oils (see abstract).
Raiciu teaches “Amaranth was not only a basic food product, but also a remedy almost miraculous as reliever of haemorrhoidal pain, for treating colds, diarrhea, nerve and skin disorders, being also a great energizer. Since the ‘70s, amaranth was rediscovered as a plant
with great health benefits. It is a gluten-free, high value nutritious protein food, rich in lysine (an essential amino acid which cannot be produced by the body, only obtained from food, and necessary for protein synthesis), fibres, A, C, E, D vitamins, B complex, essential amino acids and
minerals (iron, magnesium, zinc, phosphorus, copper, manganese and especially calcium) [20]. Known also as a grain-drug, it showed beneficial effects in cardiovascular disease, hypertension, hypercholesterolemia, diabetes, cancer, inflammations, and contributes to immunity strengthen [21]” (see page 2450, right column, 1-2 para.).
“Amaranth seed oil was found to contain 8% polyunsaturated fatty acids (PUFA), a high level of squalene (10.8%) compared with shark liver oil (1-1.5%), vitamin E, and beta-sitosterol. Squalene, a steroid precursor and a powerful antioxidant, induces healing properties to amaranth seed oil, a positive influence on cell regeneration, and even significant anticancer characteristics” (see page 2452, right column, 2nd para.).
Raiciu also teaches that amaranth oil contains omega-3 fatty acids (see table 2 and Figure 7).
Zhang teaches that the main cannabinoids of Cannabis sativa plants are tetrahydrocannabinol (THC), cannabinol (CBN), cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), etc., among which the top three account for more than 90% of cannabinoids, whereas tetrahydrocannabinol is a toxic ingredient which may cause hallucinations (see background para. 2-3).
Zhang teaches methods for extracting cannabidiol from hemp through a 30-100% ethanol (V/V) ethanol to obtain an extracting solution and concentrating the eluate through column chromatography (see abstract), teaches specifically 80% ethanol (see at least examples 5-7), teaches there to be no THC (see table 1) and teaches creating ready-made solutions or solutions to be reconstituted (see different embodiments 2-4 in at least columns 9-10).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to combine a cannabinoid solution with sesame oil, amaranth oil and squalene because Vietta teaches combining cannabinoids with carrier oils such as both amaranth oil and sesame oil in order to increase stability of the composition and specifically to protect cannabinoids and as Raiciu teaches amaranth oil contains high levels of squalene which is also a useful antioxidant. It would have further been obvious to optimize the amounts of each component in the composition as this is well within the purview of any skilled artisan especially given that those components activities are previously described in the art for being useful for the same purpose being instantly described. As discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention. Furthermore it would have been obvious to create ready-made solutions or solutions to be reconstituted as Vietta describes solutions of cannabinoids which are ready-made and are indeed able to be reconstituted.
It would have also been obvious to select cannabidiol as Zhang teaches that this cannabinoid has many potential beneficial activities and teaches to exclude the toxic THC component during extraction and gives methods for concentrating the cannabinoid through chromatography. Persons having skill could easily titre the concentration to be within the instantly claimed range without any undue experimentation. This appears to be a matter of mere judicious selection well within the purview of any skilled artisan.
There would have been a reasonable expectation of success in arriving at the instant invention because Vietta teaches in creating cannabinoid solutions along with amaranth oil, sesame oil and squalene, and including cannabidiol, one of the most common cannabinoids would have been prima facie obvious especially given the prior art.
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive. The declaration under 37 CFR 1.132 filed 05/04/2026 is insufficient to overcome the rejection of claims 1, 5-8 based upon 35 U.S.C. 103 as set forth in the last Office action because: The activity from the combined ingredients is predictable and expected. The applicant argues Vietta is silent on the composition comprising squalene and that Raiciu’s teaching that amaranth oil is known to comprise of squalene is not enough to teach the instant invention because the applicant has shown some unexpected and unpredictable results. The applicant’s declaration provides evidence that combining carrier oils with cannabis extract will stabilize and make the extract more bioavailable. However these activities are indeed predictable as that is what the art teaches and what carrier oils are known for. Vietta specifically describes that cannabis extract, cannabinoids or hemp seed oil which can be provided in an oil/solvent mixture can act as a carrier for the cannabinoids and the oil or oil mixture may increase stability of the composition or delivery system. Carrier oils are known to do both of these activities and the applicant has indeed provided evidence that some may be better than others however does not show that their combination has some unpredictable or unexpected results. The applicant has not provided any evidence that synergy exists which would be needed to overcome the prior art, because the prior art already recognized the activities being claimed. For instance, the applicant would be better off showing that the combination of squalene, amaranth oil, sesame oil in the ratio being claimed is greater than the summation of those ingredients alone. The applicant has not shown any data for testing squalene by itself on its effects on cannabis extract. Increasing squalene within the composition of amaranth oil would have been obvious given that the art recognizes its potential as a strong antioxidant. The art recognizes the benefits of amaranth oil and squalene as carrier oil and as powerful antioxidants (which are known to stabilize and prolong shelf life) and to help with rapid and stable absorption of cannabinoids into the bloodstream. Optimizing these are well within the purview of the skilled artisan.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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