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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 04/13/2026 and the species of cannabigerolic acid, N-acyl ethanolamine for claim 1, palmitoylethanolamine for claim 4, beta hydroxy butyrate for claim 7, piperine for claim 9, CBGA for claim 10, inhalable for claim 12, limonene, beta caryophylline and myrcene for claim 13, N-acyl ethanolamine for claim 15, CBGA and N-acyl ethanolamine for claim 19, palmitoylethanolamine for claim 20 and CBGA and N-acyl ethanolamine for claim 21 is acknowledged. The applicant has not argued why they believe the species or groups are not distinct from each other and therefore their argument is not found valid.
Group III, is classified in A61K31/658.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-15 and 17-22 are being examined on the merits.
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 10 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 10 recites “wherein the at least one cannabinoid comprises a full spectrum extract from a botanical source comprising the at least one cannabinoid selected from the group consisting of” and it is unclear how a cannabinoid can comprise of a full spectrum extract because it would be a component which is extracted from a full spectrum extract but could not comprise of one. This limitation is confusing and indefinite.
Claim 18 recites wherein the at least one cannabinoid comprises an extract of Cannabis sativa L. var. Panakeia and it is unclear how a cannabinoid is to comprise of an extract of cannabis. This issue is the same as the issue with claim 10. Cannabinoids are extracts from cannabis not the other way around. This limitation is confusing and indefinite.
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 1-15 and 17-22 are rejected under 35 U.S.C. 101 because the claimed composition 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 and endogenous fatty acids (ie. cannabinoids, terpenes, n-acyl ethanolamine, palmitoyl ethanolamine etc.), 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 cannabinoids, terpenes, n-acyl ethanolamine, palmitoyl ethanolamine 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 such as cannabinoids and terpenes along with naturally synthesized fatty acids (PEA and NEA), steroid hormone dehydroepiandrosterone and fatty acid neurotransmitter anandamide. Plant and animal 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/animal 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 and animal extracts are purified by removing unwanted 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/animal 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/animals 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 applicant is merely claiming these judicial exceptions together in varying amounts and in inhalable formulations.
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)).
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 and animal extracts is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US20210015774A1, US20210015740, US20210015746, US20210015759, US20210015836.
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 10, 15, and 29-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Debra Kimless et. al. (US20210015774A1).
Regarding claims 1, 10, 15, 19 and 21 Kimless discloses a composition comprising n-acyl ethanolamine; at least one cannabinoid; and at least one terpene (see claim 1) and discloses wherein the cannabinoid includes cannabigerolic acid (see claim 4).
Regarding claim 2, Kimless discloses effective amounts per dose (see 0039, 0052, 0057).
Regarding claim 20, Kimless discloses wherein the n-acyl ethanolamine is palmitoylethanolamide (see claim 3).
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 1-4, 8, 10-15, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Debra Kimless et. al. (US20210015774A1).
Regarding claims 1, 10, 15, 17, 19 and 21 Kimless discloses a composition comprising n-acyl ethanolamine; at least one cannabinoid; and at least one terpene (see claim 1) and discloses wherein the cannabinoid includes cannabigerolic acid (see claim 4).
Regarding claim 2, Kimless discloses effective amounts per dose (see 0039, 0052, 0057).
Regarding claims 3-4 and 8, Kimless discloses wherein the cannabinoid is 10 mg (see 0050) and teaches “in general, however, the disclosed composition can include, by weight, 1 to 2000 parts of the n-acyl ethanolamine and 1 to 2000 parts of the cannabinoid or combined amount of cannabinoids. As an example, the unitary part by weight is 1 milligram. In further examples, the composition includes 10 to 1800 parts of the n-acyl ethanolamine and 1 to 100 parts of the cannabinoid or combined amount of cannabinoids. In one example, a tablet includes 10 milligrams of CBD, 100 milligrams of PEA, and 0.1 milligrams of terpenes (myrcene, linalool, B caryophylline, and humulene)” (see 0040).
Regarding claim 11, the same composition would be expected to have the same antimicrobial effects as they appear to be identical in nature, unless shown some evidence to the contrary.
Regarding claim 12, Kimless teaches that the active chemicals in medicinal cannabis can be delivered into the body through inhalation, ingestion, or topical application (see 0002).
Regarding claim 13, Kimless teaches myrcene, limonene, caryophyllene (see claim 5).
Regarding claim 17, Kimless teaches the composition can comprise of both Cannabigerol and CBGA (see 0038)
Regarding claim 20, Kimless discloses wherein the n-acyl ethanolamine is palmitoylethanolamide (see claim 3).
Kimless does not specifically teach that the one cannabinoid which is at least 10 mg is CBGA however Kimless teaches cannabinoids in this amount and therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to optimize the cannabinoid CBGA in this range as it is an optimization well within the purview of any skilled artisan. 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 pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical 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 5, 9 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Debra Kimless et. al. (US20210015774A1) as applied to claims 1-4, 8, 10-15, 17, and 19-21 above, and further in view of Aharon Eyal and Nora Raz (WO2021033149A1) hereinafter Eyal.
Kimless teaches the instant composition however is silent on the composition comprising anandamide.
Eyal teaches compositions for the treatment of conditions characterized by anandamide deficiencies (see abstract).
Regarding claims 5, Eyal teaches pharmaceutical compositions comprising a carrier and a pharmaceutically effective amount of at least one modulator of an activity which is responsive to modulation by at least one selected from the group consisting of anadamide, N-Oleoylethanolamine (OEA), N-palmitoylethanolamind (PEA) and seretonine (see abstract or claim 1).
Eyal teaches “Anandamide (IV-arachidonoylethanolamine or AEA)— C22H37NO2— is an endocannabinoid which acts as a neurotransmitter and has a structure very similar to that of tetrahydrocannabinol (THC), the active constituent of cannabis. Anandamide affects the endocannabinoid system, which comprises the endocannabinoids, their producing enzymes, their degrading enzymes and their receptors. Anandamide is a component of the endocannabinoid system. The endocannabinoid system comprises endocannabiniods, their producing enzymes, their degrading enzymes and their receptors. Endocannabinoid receptors include G protein-coupled receptors, e.g. CBi, CB2, GPCR119, GPCR55, transient receptor potential (TRP) channel, peroxisome proliferator-activated receptor (PPAR) and others. Modulating of these receptors by anadamide or by other endocannabionids affects the activity of the endocannabinoid system. Endocannabinoids and their receptors are found throughout the body: in the brain, lungs, digestive system, connective tissues, hormone releasing glands, skin/hair, bone, the immune system, and the reproductive organs. The effects of ananadamide can occur in either the central or peripheral nervous system, mediated primarily by CBi cannabinoid receptors in the central nervous system, and CB2 cannabinoid receptors in the periphery” (see 002).
Regarding claims 9 and 22, Eyal also teaches wherein one of the modulators can be piperine (see claim 20 and 0022) and teaches according to some such embodiments, said preparation comprises between 0.1 and 100 milligram modulator (see 0025).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to include piperine and anandamide in the cannabinoid pharmaceutical composition taught by Kimless because these are known modulators that can help treat diseases related to anandamide deficiencies. Optimizing the amount to be at 10 mg is well within the purview of any skilled artisan as this is within the effective range already disclosed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Debra Kimless et. al. (US20210015774A1) as applied to claims 1-4, 8, 10-15, 17, and 19-21 above, and further in view of Healthline (https://www.healthline.com/nutrition/dhea-supplements).
Kimless teaches the instant composition however is silent on the composition comprising dehydroepiandrosterone (DHEA).
Healthline teaches that DHEA or dehydroepiandrosterone is a is a hormone that’s produced by your body. Some of it is converted into the major male and female sex hormones testosterone and estrogen (1). Its effects can be driven by the actions of testosterone and estrogen after this conversion occurs, as well as by the DHEA molecule itself (2). Given that DHEA is produced naturally, some wonder why it’s consumed as a supplement. The main reason is that DHEA levels decrease as you age, and this decrease is associated with several diseases. In fact, it’s estimated that DHEA decreases by up to 80% throughout adulthood. This isn’t just relevant for older adults, as levels begin to decrease around age 30 (3, 4, 5 ). Lower DHEA levels have been associated with heart disease, depression and mortality (1, 2, 4, 6, 7). When you take this hormone as a supplement, its levels in your body increase. Some of it is also converted into testosterone and estrogen (1). Increased levels of these three hormones produce a variety of effects” (see article, 2nd page).
Healthline discusses how DHEA may be able to increase bone density (see page 3), fight depression (see page 5), improve sexual libido (see page 7) and may help with certain adrenal issues (see page 8) and teaches of dosages of 10-500 mg have been reported (see dosages and side effects, page 8).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to include DHEA in the composition taught by Kimless because it can potentially improve depression, sexual libido, bone density and because many peoples DHEA levels begin decreasing by 80% throughout adulthood. Including it in the composition would create a composition which can treat diseases and assist in human overall health. Optimizing the amount to be at 10 mg is well within the purview of any skilled artisan as this is within the effective range already disclosed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Debra Kimless et. al. (US20210015774A1) as applied to claims 1-4, 8, 10-15, 17, and 19-21 above, and further in view of Gary Millet (US10512615B1).
Kimless teaches the instant composition however is silent on the composition comprising beta hydroxy butyrate.
Millet teaches of compositions comprising of a ketone body component; a a cannabidiol (CBD) component, wherein the CBD component includes a CBD compound having at least one beta-hydroxybutyrate (BHB) or acetoacetate attached to the CBD compound via an ester bond; and a pharmaceutically or dietetically acceptable carrier.
Millet teaches that “Ketone bodies can be used by cells of the body as a fuel in addition or instead of glucose to satisfy the body's energy needs, including the brain and heart. During prolonged fasting, for example, blood ketone levels can increase to 2-3 mmol/L or more. It is conventionally understood that when blood ketones rise above 0.5 mmol/L, the heart, brain and peripheral tissues are using ketone bodies (e.g., beta-hydroxybutyrate and acetoacetate) as the primary fuel source. This condition is referred to as ketosis. Between 1.0 mmol/L and 3.0 mmol/L the condition is called “nutritional ketosis.”(see 2nd para. of background).
Millet teaches “The “therapeutically effective amount” is that amount necessary to promote a therapeutically effective result in vivo. In accordance with the present disclosure, a suitable single dose size is a dose that is capable of preventing or alleviating (reducing or eliminating) a symptom in a patient when administered one or more times over a suitable time period (e.g., a daily dose)” (see column 22, lines 28-38).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to include beta hydroxy butyrate because the body can use this as an energy source and would create a product which could fuel the body and treat disease. It would have also been obvious to optimize the amount to at least 0.5 uMoles because Millet teaches optimizing to find therapeutically effective amounts for creating suitable doses for preventing or alleviating symptoms in patients. Furthermore the amount does not appear to be critical to the invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Debra Kimless et. al. (US20210015774A1) as applied to claims 1-4, 8, 10-15, 17, and 19-21 above, and further in view Brian Maclver (https://www.cannabisbusinesstimes.com/business-issues-benchmarks/hemp-research/news/15691569/hemp-tradings-panakeia-cbg-variety-hits-canadian-market#:~:text=Panakeia%20will%20be%20the%20first,health%20benefits%2C%E2%80%9D%20Ghosseing%20continued.).
Kimless teaches the instant composition however is silent on the composition comprising extracts of cannabinoids from Cannabis sativa L, var. Panakeia.
Malcver teaches that “the partnership, officially announced on June 25, will make Ottawa-based Cannabis Orchards the first Canadian company to bring to the hemp market a genetic that is THC-free, has a high CBG content (testing reports from Hemp Trading show Panakeia testing at 18% CBG) and that also is feminized”. “With an advertised cannabinoid content of 18% CBG and 0.00% THC, “Panakeia will be groundbreaking for the majority of cannabis users seeking health benefits,” (see article).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use Cannabis sativa L. var. Panakeia because it is THC-free and has a high cannabinoid content which cannabis users are seeking for health benefits.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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