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 .
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.
Priority
The instant application, filed 05/20/2022, claims priority to U.S. Provisional Patent Application No. 63/209,373, filed 06/10/2021.
Status of Application and Claims
No preliminary amendment was submitted at the time of filing. Claims 1-18 are pending and are examined on the merits herein.
Claim Rejections - 35 USC § 103
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.
All of the following prior art references are cited in the PTO-892 accompanying this office action.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over McPartland, J.; Shiekh, Z. (2018). “A review of Cannabis sativa-based insecticides, Miticides, and repellents.” J. Entomol. Zool. Stud., 6, 1288-1299 in view of US 2016/0279073 A1 (Donsky, M.; Winnicki, R.) published 09/29/2016.
McPartland teaches the use of Cannabis sativa as a plant-based insecticide with five types of application: companion planting, the use of harvested plant material without any extraction, aqueous extracts, essential oil (EO) extracts, and solvent extracts (Abstract). McPartland teaches that Cannabis synthesizes the phytocannabinoids tetrahydrocannabinol acid (THCA) and cannabidiolic acid (CBDA), which decarboxylate to the well-studied tetrahydrocannabinol (THC) and cannabidiol (CBD) (“1. Introduction,” paragraph 3). McPartland teaches that the cannabinoid THC is toxic to insects (Abstract). McPartland teaches that terpenoids from Cannabis have insecticidal properties, and these terpenoids constitute the plant’s EO (“1. Introduction,” paragraph 4). McPartland teaches that phytocannabinoids are extracted using nonpolar solvents, such as supercritical CO2, or polar solvents, such as ethanol, and that crude extracts from solvent extraction contain phytocannabinoids as well as EOs (“2.5 Solvent extracts with phytocannabinoids”). This reads on the extracting oil component of instant claim 1.
McPartland teaches testing Cannabis extracts against phytophagous arthropods known to feed on Cannabis, such as Tetranychus urticae and Gryllotalpa gryllotalpa (“3. Results and Discussion”). McPartland teaches that spraying cucumber leaves colonized by spider mite T. urticae with an emulsion of Cannabis extract EO resulted in nymph and adult mortality after 14 days (Table 2, row 4). McPartland teaches solvent extraction from Cannabis flower with EtOH, sonication, evaporation, and generation of a 1% emulsion; the resulting emulsion was used to successfully kill T. urticae spider mites on bean leaves after seven days (Table 3, row 15). Therefore, McPartland reads on foliar spraying of Cannabis extracts onto the leaves of plants for treatment against pests, particularly T. urticae, which feeds on Cannabis.
McPartland differs from the instant invention in that it fails to teach a method for increasing cannabinoid production in growing Cannabis plants, comprising forming a solution of the extracted oil in a mix of ethanol and water having a chosen concentration of the extracted oil, and applying the solution to growing Cannabis plants during plant growth, as recited in claim 1. McPartland fails to teach that the foliar spraying is specifically onto Cannabis plants, as recited in instant claim 5.
US’073 teaches a method to produce a stable formulation of hemp oil and cannabinoids for drug delivery that includes the steps of: (a) dissolving cannabinoid oil in ethanol to obtain an ethanol-cannabinoid solution; (b) injecting the ethanol-cannabinoid solution in distilled water to obtain an ethanol-cannabinoid emulsion; (d) adding a carbohydrate, such as glycerol, to the ethanol-cannabinoid emulsion and blending this mixture to obtain ethanol-cannabinoid-carbohydrate solution; (e) adding lecithin with terpenes and hemp oil to the above mixture and blending to obtain a stable cannabinoid-terpene-hemp oil formulation ([0030]). US’073 further teaches preparation of a stable emulsion by dissolving cannabinoids into ethanol, then using a syringe to inject the cannabinoid-ethanol solution into water, before blending and injecting glycerin, lecithin and terpenes; the mixture is homogenized using a blender to create a homogenous emulsion ([0080]). Thus, US’073 reads on the solution of Cannabis extracted oil in a mixture of ethanol and water recited in claim 1.
US’073 teaches exemplary compounds for use in the invention include cannabidiol (CBD) and variations of THC ([0013]). US’073 teaches its inventive compositions can be stored for extended periods of time, for example, greater than 20 weeks at 25° C, and are believed to exhibit superior systemic delivery and biorelease of their payloads ([0060]).
It would have been prima facie obvious for a person having ordinary skill in the art to spray the leaves of growing Cannabis plants with an emulsion containing extracts of Cannabis sativa phytocannabinoids and EO terpenes in order to kill T. urticae that feed on the Cannabis plants, because McPartland teaches the success of both emulsions of EO extracts and emulsions of crude ethanol solvent extracts of Cannabis (containing phytocannabinoids and EOs) applied onto bean and cucumber plant leaves kills T. urticae present. An ordinarily skilled artisan would have been motivated to extend this application to Cannabis plant leaves because Cannabis is also prone to colonization by T. urticae. An ordinarily skilled artisan would have a predicted success in killing T. urticae by spraying Cannabis plant leaves with pesticidal Cannabis crude solvent extracts containing phytocannabinoids and EO terpenes, because McPartland teaches the success in killing T. urticae on cucumber leaves by spraying with Cannabis extract. Obviousness exists when some motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143 I(G)).
Furthermore, it would have been prima facie obvious for an ordinarily skilled artisan to choose to use the stable cannabinoid-terpene-hemp oil emulsion taught by US’073 to spray Cannabis leaves in the same way the emulsions containing Cannabis phytocannabinoid and EO terpenes were used in McPartland to treat plant leaves in order to kill T. urticae. It would have been obvious for an ordinarily skilled artisan to use the emulsion of US’073 because the emulsions taught by McPartland and US’073 are analogous and both contain Cannabis extracts (cannabinoids and oils). The emulsion of US’073 is desirable because it is stable and can be stored for extended periods of time, for example, greater than 20 weeks at 25° C. An ordinarily skilled artisan would have noted the shelf-life design incentive provided by the emulsion taught by US’073, and would have been motivated to use the emulsion in order to provide a pesticidal formulation with good long-term storage. An ordinarily skilled artisan would have predicted success in using the emulsion of US’073 as an insecticide when sprayed onto Cannabis leaves based on the fact that its main substituents (cannabinoids and essential oil terpenoids) are taught by McPartland to be active insecticidal ingredients, and show success when used in emulsion form to kill T. urticae. A case for obviousness exists when a known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art (see MPEP 2143 I(F)).
Regarding the instant method working toward increasing cannabinoid production in growing Cannabis plants, "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (MPEP 2112.01(II)). The contents of the emulsion of US’073 include cannabinoids CBD and THC, which McPartland teaches to be insecticidal. The instant specification discloses the cannabinoids of the instant invention include cannabinoids, particularly CBD, and the cannabinoids cause an increase in cannabinoid production in the glandular trichomes when applied to Cannabis plants via foliar spray and/or soil drench (see instant specification [0019]; [0023]). Therefore, the cannabinoids of McPartland and US’073, when applied to Cannabis plants in US’073’s taught emulsion form and with McPartland’s taught foliar spray method, would also inherently promote cannabinoid production in the glandular trichomes, as is taught in the instant specification. The situation is similar to the one in Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993), when the Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The inherent properties of cannabinoids taught by the instant specification also apply here.
Claims 2, 6-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over McPartland, J.; Shiekh, Z. (2018). “A review of Cannabis sativa-based insecticides, Miticides, and repellents.” J. Entomol. Zool. Stud., 6, 1288-1299 and US 2016/0279073 A1 (Donsky, M.; Winnicki, R.) published 09/29/2016 as applied to claims 1 and 5 above, and further in view of PlantwisePlus Knowledge Bank. (2019). “Gryllotalpa gryllotalpa (European mole cricket).” https://plantwiseplusknowledgebank.org/doi/full/10.1079/pwkb.species.26042.
The teachings of McPartland and US’073, as they apply to claims 1 and 5, are addressed supra. Furthermore, McPartland teaches successful killing of the mole cricket Gryllotalpa gryllotalpa, which feeds on Cannabis plants, by flooding underground nests with water suffused with hemp oil (“3.3 Aqueous extracts”).
The combined references fail to teach the treatment of Cannabis sativa plants specifically, as recited in claim 2. Furthermore, the references fail to teach drenching of the soil surrounding the Cannabis plant, as is recited in instant claims 6 and 7. Finally, the references fail to teach the method as written, including application to the soil, is for the purpose of reducing the hydrophobicity of plant soil, as recited in instant claim 12.
PlantwisePlus teaches that the plant Cannabis sativa is a main host for the European mole cricket Gryllotalpa gryllotalpa (“Host Plants and Other Plants Affected”). PlantwisePlus also teaches that mole crickets tunnelling through the soil around the plant's root system will desiccate the surrounding soil, and the plants will be water stressed and eventually die; the mole crickets that feed do so on the roots and during warm, wet nights they may feed on the stems and occasionally the leaves at the soil surface (“Symptoms”).
It would have been prima facie obvious for an ordinarily skilled artisan to use the combined teachings of McPartland and US’073 with those of PlantwisePlus to flood the soil surrounding Cannabis sativa plants afflicted by Gryllotalpa gryllotalpa with the emulsion taught by US’073 along with foliar spraying as taught by McPartland in an effort to treat plants afflicted by both species of pests, T. urticae and Gryllotalpa gryllotalpa, simultaneously. An ordinarily skilled artisan would have a reasonable expectation of success in killing both species of pests by using the emulsion of US’073 for both foliar spraying Cannabis sativa and flooding the soil surrounding it wherein Gryllotalpa gryllotalpa is tunneling, because US’073 contains Cannabis hemp oil, the active ingredient responsible for killing Gryllotalpa gryllotalpa in the flooding method taught in McPartland. A case for obviousness exists when combining prior art elements according to known methods to yield predictable results (MPEP 2143 I(A)). The inherent properties of the cannabinoids present in the emulsion, and their effect on cannabinoid production in Cannabis plants when both foliar spraying and soil drenching, have been addressed supra.
The inherent properties of cannabinoids applied to the soil also extend to the claimed decrease in soil hydrophobicity of claim 12. The instant specification discloses an observed decrease in water repellency after application of the instant composition to soil, with note that “the addition of cannabinoid extracts appears to chemically alter the soil. Additionally, despite being a non-polar compound, weak chemical bonding and interaction with soil aggregates is observed” (see instant specification [0026]). Because a chemical compound is not distinguishable from its properties, the cannabinoids present in the emulsion of US’073, when applied to soil surrounding Cannabis plants in order to kill Gryllotalpa gryllotalpa, would also inherently decrease soil water repellency based on the cannabinoids’ weak chemical bonding and interaction with soil aggregates taught in the instant specification.
Claims 3-4, 8-11 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over McPartland, J.; Shiekh, Z. (2018). “A review of Cannabis sativa-based insecticides, Miticides, and repellents.” J. Entomol. Zool. Stud., 6, 1288-1299, US 2016/0279073 A1 (Donsky, M.; Winnicki, R.) published 09/29/2016, and PlantwisePlus Knowledge Bank. (2019). “Gryllotalpa gryllotalpa (European mole cricket).” https://plantwiseplusknowledgebank.org/doi/full/10.1079/pwkb.species.26042 as applied to claims 1-2, 5-7 and 12 above, and further in view of US 2018/0296616 A1 (Rivas, J.) published 10/18/2018, as evidenced by Wang, M. et al. (2016). “Decarboxylation Study of Acidic Cannabinoids: A Novel Approach Using Ultra-High-Performance Supercritical Fluid Chromatography/Photodiode Array-Mass Spectrometry.” Cannabis Cannabinoid Res., 1, 262-271.
The teachings of McPartland, US’073, and PlantwisePlus, as they apply to claims 1-2, 5-7 and 12, are addressed supra.
The combined references fail to teach the method of decarboxylating the extracted oil after the extraction step, as recited in instant claims 3 and 13. They also fail to teach the method wherein the extracted oil used is decarboxylated extracted oil, as recited in instant claims 4 and 14. They fail to teach the method step of drying the hemp before extracting oil (instant claims 8 and 15), and they fail to further teach the extraction step contains contacting the hemp with liquid propane, ethanol, or supercritical CO2, as recited in instant claims 9-11 and 16-18.
US’616 teaches a process of maximizing yields of thermally-sensitive compounds such as terpenes and cannabinoids from low-temperature vacuum distillation of raw cannabis (Abstract). US’616 teaches that the method comprises steps that include (Claim 1):
distilling a terpene-rich essential oil from a water/raw cannabis mixture prepared by heating the raw cannabis/water mixture under gravity-assisted, vacuum conditions in a microwave oven at a predetermined power level for a predetermined period of time;
preparing a cannabinoid-rich crude extract from dried, decarboxylated cannabis resulting from A by exposing the dried, decarboxylated cannabis to a solvent and allowing a resulting extract to accumulate in a collection vessel as the solvent is purged; and
refining the crude extract to remove impurities, and preparing purified extract by distilling the refined extract.
US’616 teaches the solvent is chosen from propane, ethanol, and supercritical CO2 (claims 6 and 8). US’616 teaches the crude extract is an oil ([0065]). This method reads upon the extraction using the solvents listed in claims 9-11 and 16-18. Furthermore, claims 8 and 15 are addressed regarding the step of drying the cannabis before extracting oil. The decarboxylation and use of decarboxylated cannabis to generate crude extract is noted.
US’616 teaches many products result from its method; one product is a highly-purified, terpene-rich cannabis essential oil, a second product is a cannabis extract having a cannabinoid concentration that may exceed 99%, and many additional products may result from recombining the essential oil and cannabinoids in various proportions to produce extracts having a variety of medicinal effects ([0098]; claim 20).
It would have been prima facie obvious for a person having ordinary skill in the art to use both the essential oil (rich in terpenes) and extracted cannabinoids resulting from the method of US’616 in the method of preparing the emulsion as taught by US’073, to arrive at an emulsion rich in the cannabinoids and terpenes (compounds taught my McPartland to have insecticidal properties); thus, it would be subsequently obvious to use the emulsion as both a foliar spray and soil drench to treat Cannabis plants afflicted by T. urticae and Gryllotalpa gryllotalpa. An ordinarily skilled artisan would have been motivated to use the method of obtaining extracts taught by US’616 because the method achieves maximized yields of terpenes and cannabinoids, which are the insecticidal ingredients. An ordinarily skilled artisan would have a reasonable expectation of success incorporating the cannabinoids and essential oil into the emulsion of US’073 for subsequent foliar spray and soil drench because the active insecticidal ingredients, cannabinoids and terpenes, are collectively present in the cannabinoid extracts and essential oils produced via the method of US’616, and the same ingredients are used to make the emulsion of US’073. The inherent property of the cannabinoids present in the emulsion causing increased cannabinoid production when applied to Cannabis plants is addressed supra. Furthermore, the inherent property of the cannabinoids present in the emulsion resulting in reduced hydrophobicity of the soil upon soil drench is addressed supra.
Regarding the instant method’s decarboxylation step occurring after the oil extraction step, decarboxylation after solvent extraction of Cannabis plant material is established in the art, as evidenced by Wang (“Sample preparation and decarboxylation reactions of C. sativa extract”). The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (MPEP 2144.04). See In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Conclusion
No claims are allowed.
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/SOPHIA MARIE TAYLOR/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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