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 09/03/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
1-15, 17-24 are pending and 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.
Claims 1-15, 17-24 are 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.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds for what is an appropriate amount for the term substantially are not known or described and is confusing as this has not been defined in the specifications. The term and claim are indefinite along with any claims that depend on the rejected claim.
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 different unit dose or metered dose formulations such as transdermal, transmucosal or inhalation administration.
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. Furthermore, when considered these components would exist together when a human consumes cannabinoids and these cannabinoids coexist with the endogenous endocannabinoids circulating within the human that has consumed those plant-based cannabinoids.
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.
Response to Arguments
Applicant's arguments filed 09/03/2026 have been fully considered but they are not persuasive. The applicant argues that the Office has improperly analyzed the set of claims because they believe that the claim as a whole was not looked at and the judicial exceptions being claimed are not properly compared to their closest natural counterparts. The applicant argues that since the composition comprises of cannabinoids and N-acyl ethanolamines or DHEA that this composition exists nowhere in nature and is not a composition of nature. The combining of judicial exceptions was taken into consideration when the analysis was done (see step 2B). The applicant also argues that the analysis to the natural counterpart should be to a full spectrum cannabis extract. This is not the proper analysis that needs to be considered. The applicant is not claiming a full spectrum cannabis extract. The applicant is merely claiming at least one cannabinoid derived from a botanical plant and at least one additional active “composition” selected from N-acyl ethanolamine, an N-alkylamide, gamma amino butyric acid (GABA), and dehydroepiandrosterone (DHEA). This is not a full spectrum cannabis extract as what is being argued and the naturally occurring counterparts are the cannabinoids being claimed and the additional N-acyl ethanolamine, an N-alkylamide, gamma amino butyric acid (GABA), and dehydroepiandrosterone (DHEA). The applicant argues that since the claims comprise components not found together in nature, they are not a composition of nature. The claimed components may indeed exist together after consumption of cannabinoids or botanical extracts containing cannabinoids. The components N-acyl ethanolamine, an N-alkylamide, gamma amino butyric acid (GABA), and dehydroepiandrosterone (DHEA) exist in human circulation systems and so would the cannabinoids if consumed. The applicant argues that there is an unexpected synergistic effect from their composition but does not show any evidence that this is the case. The applicant has not even tested their compositions to show any synergy described and so their arguments do not hold weight. The applicant argues that the Office ignores the structural transformation required by the negative limitations which require there to be no CBDA or TCHA in the composition. This is not a structural transformation as being argued. Claiming a composition to be without THCA or CBDA does not structurally transform the other claims cannabinoids in any way. The applicant misinterprets the comparison of the judicial exceptions to their closest naturally occurring counterparts. A full spectrum extract is not the proper comparison. The applicant argues that there are novel properties from the combination of claimed components, however, again does not show any evidence to this activity. The applicant merely recites a list of activities known to be exerted from cannabinoids in the presence of other cannabinoids or in their absence. The applicant discusses the entourage effect of CB1/CB2 interactions and CBG modulating endocannabinoid signaling pathways, however this is not what is being claimed. The applicant discusses how CBD can interfere with endocannabinoid interactions and may have opposing effects downstream of cellular targets, such as immune signaling. Again, this is not a showing of synergy and the applicant’s knowledge of cannabinoids and downstream molecular pathways is not the same as showing that their invention has some kind of synergistic effect.
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. These are new rejections based on the amendments filed on 09/03/2026.
Claims 1, 3-6, 8-9, 11-15, 17, and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Richard Postrel (WO2018118197A1).
Postrel teaches a composition for improving a non-human animal's well-being comprising an orally or subcutaneously administrable substance containing at least one dosage selected from the group consisting of: a mitochondrial booster, an androgen hormone and a prohormone, said dosage selected to optimize at least one physiologic function in a selected mammal (see claim 1).
Postrel teaches the composition to further comprise of a compound having or supporting cannabolic activity (see claim 2) and comprising an endocannabinoid (see claim 3), wherein the cannabinoid is selected from the group AEA, 2AG, PEA, OEA and LEA and resveratrol (see claim 8) and CBGA, CBGAM, CBG, CBGM; CBGVA and CBGV (see claim 11).
Postrel teaches the composition to also comprise compounds which are N-alkyalmides n-alkanes, N-acylethanolamines, flavonoids, curcuminoids (see claim 15).
Postrel teaches “The compositions used in the present invention are preferably formulated and controllably administered to an animal to induce desired effects without also inducing undesired side effects, such as undesired anabolic or androgenic effects, in that animal. Dose will depend on the initial status of circulating hormone in the animal, on the active ingredient and its activity within the animal, on the size of the animal, the frequency of dosing and the rate at which an animal would metabolize the active ingredient(s) of the composition. Thus suitable unit doses may range from about: 0.01 mg to 500 mg, e.g., 0.01 mg, 0.05 mg,.0.07 mg„ 0.1 mg„ 0.15 mg, 0.2 mg.0.5 mg, 1.0 mg, 2 mg, 3 mg, 5 mg, 7 mg, 10 mg, 20 mg, 25 mg, 30 mg, 50 mg, 75 mg, 100 mg, 120 mg, 150 mg, 175 mg, 200 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, or 500 mg. Depending on the route of delivery, the animal's size, the animal's age, the animal's gender, the specific composition, etc. other ranges may be relevant, for example, 10 mg - 200 mg, 12.5 mg to 150 mg, 15 mg-100 mg, 20 mg-75 mg, 20 mg -50 mg, or 50 mg - 100 mg” (see page 66, 3rd para.).
Postrel teaches to add orally available compositions which comprise of dehydroepiandrosterone (DHEA) to supplement levels of androgens to achieve balance (see top of page 65).
Postrel teaches the composition to comprise limonene, pinene, (see claim 29) and teaches Myrcene is a major constituent of the essential oil of hops and appears to be related to opioid "high" possibly by agonizing opioid receptors or possibly by antagonizing opioid degradation. Plant sources are hops, verbana and cannabis. Myrcene is also found in lemongrass, thyme and mango. Echinacea contains multiple N-alkylamides that have
cannabinoid mimetic effects (see page 23, lines 14-18).
Postrel teaches “Beta-caryophyllene, a phytocannabinoid, and/or its oxides act as full agonists of the CB2 receptor where they exert anti-inflammatory and analgesic effects that are mediated through CB2, but not CB1” (see page 22, lines 7-9).
Postrel teaches “For example, they may be delivered orally, buccally, sublingually, nasally, vaginally, rectally, transdermally, ocularly, as a vapor” (see page 28, lines 17-19).
Postrel teaches Echinacea and Echinacea purpurea plant material being component of the invention (see claim 26).
Postrel does not particularly teach the composition to comprise of at least 1 mg of cannabinoid and at least 10 mg of at least one additional active component, however Postrel teaches wherein each can be administered in varying doses depending on the desired effect and to optimize the amount to control for undesired effects such as anabolic and androgenic effects and teaches suitable unit doses within the instantly claimed range.
Therefore, it would have been obvious to persons having ordinary skill in the art before the effective filing date to optimize the cannabinoid and additional active component to be in this range as it is an optimization well within the purview of any skilled artisan. It is also obvious in utilizing full spectrum extracts as these contain full spectrum of beneficial components of the extract.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Richard Postrel (WO2018118197A1) as applied to claims 1, 3-6, 8-9, 11-15, 17, and 19-24 above, and further in view of Gary Millet (US10512615B1).
Postrel teaches the instant composition, however, is silent on the composition comprising beta hydroxy butyrate.
Millet teaches compositions comprising of a ketone body component; 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 people 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 Richard Postrel (WO2018118197A1) as applied to claims 1, 3-6, 8-9, 11-15, 17, and 19-24 above, and further in view of 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.).
Postrel 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.
Response to Arguments
Applicant's arguments filed 09/03/2026 have been fully considered but they are not persuasive. The applicant arguments are made to the previously relied upon art and are moot as the Office brings in new art which teach the same compositions along with the new amended claim limitations. The applicant points out that a negative claim limitation specifically require there to be substantially no THC, CBDA or CBD in formulations. As can be appreciated from the above art, Postrel does not require these to be in formulation even if these components are selected among an option listed in a Markush group. For example, it would have been prima facie obvious to only select the cannabinoids CBGA, CBGAM, CBG, CBGM; CBGVA and CBGV as described in claim 11. Postrel does not require any of the instantly claimed negative limitations and therefore the limitation has been met.
The applicant argues Millet requires CBD in their invention, however the Office did not articulate including Millet’s entire invention to be combined with that of Postrel’s. Millet is relied upon for teaching beta hydroxy butyrate being used by the body as an energy source to create a product which could fuel the body and treat disease. Millet also teaches that other ketonnabidiol compositions can include other cannabinoids such as cannabigeriol CBG (see II. Ketonnabidiol Compositions) thus making obvious selecting compositions which include CBG and not CBD.
The applicant believes that the negative limitation must be strictly disclosed in the prior art for the negative limitation to be properly met, but this is not the case especially when relying on an obviousness 103 rejection and art does not require the specific cannabinoids in the composition.
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.
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
