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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 11/30/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/30/2023 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products cannabinoid solutions in a mixture of sesame oil, amaranth oil and squalene, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the claims are only directed to a composition with different formulations and nothing more. Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
The Markush grouping of claim 8, recites sublingual sprays, ready-made solutions and solutions to be reconstituted and these formulations, when so broadly claimed would still exist the natural judicial exceptions but just in solutions which could be water. These formulations do not help to overcome the 101 rejections because these judicial exceptions can be found existing in solutions comprising water.
Since the naturally-occurring components as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring plant extracts is well-understood, routine practice in the art and has been conducted for centuries. Admixing plant oils together to help create stable compositions is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US 20250381238 A1, US 20070167514 A1, US 20160346339 A1, US 20180007924 A9 and US 20180125980 A1.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4-7 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).
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 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).
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.
Claims 2-3 and 8 are 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) as applied to claimz 1 and 4-7 above, and further in view of Ke Zhang et. al. (US10301242B2).
Vietta and Raiciu teach the cannabinoid solutions in a mixture of sesame oil, aramanth oil and squalene, however are silent on the composition comprising a cannabidiol or cannabigerol.
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 before the effective filing date to use the hydro-ethanol extraction of hemp to extract and concentrate cannabidiol in the method taught by Zhang to create a solution comprising a hydro-ethanolic extract of Cannabis sativa free of delta-9-tetrahydrocannabinol with a cannabidiol titre of 75-85% in the composition taught by Vietta. 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.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655