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 .
DETAILED ACTION
Claims 1-2, 4-5, 7-8, 10, 12-16, 18, 20-23, and 26-28 are pending.
Election/Restrictions
Applicant's election with traverse of sugar alcohols, cannabidiol (CBD), croscarmellose, lecithin, polyvinylpyrrolidone, a flavor in the reply filed on 5/14/2026 is acknowledged. The traversal is on the ground(s) that there is no undue burden to examine all the different species. This is not found persuasive because a search of one group is not coextensive with the search of the other groups. Thus, it would be burdensome to search the entire claims.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/17/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-2, 4-5, 7-8, 10, 12-16, 18, 20-23, and 26-28 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.
Claims 1, 5, 7, 13-15, 20-22, and 26-28 are indefinite because it is not clear what is exactly encompassed by “derivative” of cannabis. Page 2 of Applicant’s Specification gives a list of cannabis derivatives. Since applicant’s definition of “derivative” is opened ended, what is encompassed by “derivative” cannot be definitely determined. Numerous compounds could possibly be derived from cannabis including simple elements like carbon and hydrogen. It is not clear what compounds would still be considered “derivatives” in keeping with this limitation in the claims and what is taught in applicant’s specification.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See 4th line from top of claim 2.
Claims 7, 12, and 18 use the term “about” to describe numerical values, but it is unclear what the permissible deviation encompasses.
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 1-2, 4-5, 7, 10, 12-14, 16, 18, 20-22, and 26-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1 is directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims cannabis extract within a water soluble matrix, which would be a plant extract in a pectin or gel. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, in claim 1-2, the plant extracts form the ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. As for Claims 10 and 16 with lecithins and flavors, respectively, these ingredients can derive from product of nature, such as plant fibers and fruit flavors. Mixing together various natural molecules doesn’t change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
In this case, claims 27, the form of a matrix-forming material and a solvent are combined and spray dried to form the composition does not have markedly different characteristic. A cannabidiol within a gel in a dried form is a process by the sun and wind that can occur in nature.
Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application.
The homogenized composition of the different plants and vegetables together are non-natural. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the amounts of Claims 4 and 12 are amounts of cannabidiol and lecithin that can be found in plants. The mixing of homogenized plants are well understood, routine, and conventional method of making a product (see reference below). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 4-5, 7-8, 10, 12-16, 18, 20-23, and 26-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stinchcomb et al. (ES2534900 T3).
Stinchcomb et al. teaches a cannabidiol (CBD) in a gel formulation with 40% aqueous PEG-400 receptor fluid (Fig. 15). Pharmaceutically acceptable excipients such as solvents, thickeners, penetration enhancers, wetting agents, lubricants, emollients, binders, flavor enhancers, disintegrants, substances added to mask or counteract an unpleasant odor, fragrances or flavors, and substances added to improve the appearance or texture of the composition (page 6, last paragraph). The gelling agents in a total amount by weight of about 0.1-15% (page 12, paragraphs 5-7). The composition can include emollient including lecithin (page 14, last paragraph). The composition can include binders such as mannitol, sorbitol, maltitol, xylitol, erythriol, polyvinylpyrrolidone (page 16, lines 1 and 4). The compositions described herein may contain disintegrants, such as croscarmellose (page 16, paragraph 2). The cannabidiol is in a total of between 0.1-95% weight (page 16, paragraph 6). The composition may be administered in patches, ointments, creams, suspensions, lotions, pastes, sprays, foams or oils (page 18, paragraph 1). The compositions described herein are suitable for oral administration including formulations in which the prodrug of cannabidiol is administered in tablets, capsules, suspensions, syrups or liquids (page 18, paragraph 2). The composition can be gels, pastes, dissolvable tablets or dissolvable strips (page 18, paragraph 4), which would require cannabis in a matrix-forming material and spray dried; therefore, Claims 26-28 are met). The composition would inherently release when exposed to water because the material is the same; therefore, the limitations of Claims 13-14 are met. Topical administration, drug administration would be based on a localized administration compared to a systemic administration. Therefore, follicular administration can be chosen as a target for administration with or without microparticle formulations (page 37, paragraph 9). A pouch does not change the structure of the claims.
.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-5, 7-8, 10, 12-16, 18, 20-23, and 26-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 20240325415 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts are not the same.
Application No. 20240325415 A1:
1. A composition comprising a first active agent formulated for buccal delivery and a second active agent formulated for gastric delivery, the composition comprising one or more constituent, derivative or extract of cannabis and a further physiologically active agent selected from the group consisting of nutraceuticals, nootropics and psychoactives.
2. A composition as claimed in claim 1, wherein the first active agent, second active agent and or further physiologically active agent are independently selected from the group consisting of constituents, derivatives or extracts of cannabis, nicotine, caffeine, taurine, theine, vitamins such as B6 or B12 or C, melatonin, gamma-aminobutyric acid (GABA), theanine, a botanical or combinations thereof.
3. A composition as claimed in claim 1 or claim 2, wherein the first active agent formulated for buccal delivery comprises one or more constituent, derivative or extract of cannabis.
4. A composition as claimed in any one of claims 1 to 3, wherein the second active agent formulated for gastric delivery comprises one or more constituent, derivative or extract of cannabis.
5. A composition as claimed in any one of claims 1 to 4, wherein the constituent, derivative or extract of cannabis is one or more compounds selected from: cannabinoids; terpenes; alkaloids; and flavonoids.
6. A composition as claimed in any one of claims 1 to 5, wherein the constituent, derivative or extract of cannabis is selected from the group consisting of: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A).
7. A composition as claimed in any one of claims 1 to 6, wherein the constituent, derivative or extract of cannabis is present in an amount of from about 0.1 to about 30% by weight, based on the total weight of the composition.
8. A composition as claimed in any one of claims 1 to 7, comprising a means for solubilising the one or more constituent, derivative or extract in an aqueous environment.
9. A composition as claimed in claim 8, the means for solubilising the one or more constituent, derivative or extract in an aqueous environment comprising a solvent in which the one or more constituent, derivative or extract is at least partially dissolved.
10. A composition as claimed in claim 8 or claim 9, wherein the means for solubilising the one or more constituent, derivative or extract in an aqueous environment encapsulates the one or more constituent, derivative or extract.
11. A composition as claimed in claim 10, wherein the encapsulation is by a molecular encapsulant, such as a cyclodextrin.
12. A composition as claimed in claim 10, wherein the encapsulation is by a micelle comprising a surfactant.
13. A composition as claimed in any one of claims 1 to 12, comprising a surfactant, optionally wherein the surfactant is selected from the group consisting of: glyceryl monooleate; and sodium lauryl sulfate (sodium dodecyl sulfate, SLS, or SDS), docusate sodium, lecithins, polyoxyethylene sorbitan fatty acid esters (Polysorbate, Tween®), polyoxyethylene 15 hydroxy stearate (Macrogol 15 hydroxy stearate, Solutol HS15®), polyoxyethylene castor oil derivatives (Cremophor® EL, ELP, RH 40), polyoxyethylene stearates (Myrj®), sorbitan fatty acid esters (Span®), polyoxyethylene alkyl ethers (Brij®), polyoxyethylene nonylphenol ether (Nonoxynol®) and sugar esters.
14. A composition as claimed in claim 13, wherein the surfactant is selected from the group consisting of long chain triglycerides (such as C16-C18 triglycerides).
15. A composition as claimed in claim 13 or claim 14, wherein the composition comprises the surfactant in an amount of from about 0.5 to about 10% by weight, based on the total weight of the composition.
16. A composition as claimed in any one of claims 1 to 15, comprising an additive which slows or inhibits crystallisation of the one or more constituent, derivative or extract of cannabis in an aqueous environment.
17. A composition as claimed in claim 16, wherein the additive is selected from the group consisting of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC) and mixtures thereof.
18. A composition as claimed in any one of claims 1 to 17, comprising one of more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative or extract of cannabis.
19. A composition as claimed in any one of claims 1 to 18, comprising one of more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis.
20. A composition as claimed in claim 19, comprising a terpene, a grapefruit extract or a black pepper extract.
21. A composition as claimed in any one of claims 1 to 20, comprising a flavour or sensate.
22. A composition as claimed in any one of claims 1 to 21, comprising a buffering agent.
23. A composition as claimed in any one of claims 1 to 22, in the form of a solid unit dosage form, a powder or granules.
24. A composition as claimed in claim 23, in the form of particles having a volume mean diameter of 100 to 2000 μm.
The reference does not specifically teach adding the ingredients in the amounts claimed by applicant. However, the reference does teach the composition for cannabis extract in a water soluble matrix. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-5, 7-8, 10, 12-16, 18, 20-23, and 26-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 20210177044 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts are not the same.
Application No. 20210177044 A1 teaches:
1. An oral product comprising: (i) a cannabinoid; (ii) a filler; and (iii) water; wherein the water content of the oral product is at least about 10% by weight of the oral product, and wherein the water activity of the oral product is no greater than about 0.85.
2. An oral product according to claim 1, wherein the water content of the oral product is from about 10% to about 30% by weight of the oral product.
3. An oral product according to claim 1, wherein the filler comprises a cellulose material selected from the group consisting of maize fiber, oat fiber, barley fiber, rye fiber, buckwheat fiber, sugar beet fiber, bran fiber, bamboo fiber, wood pulp fiber, cotton fiber, citrus pulp fiber, grass fiber, willow fiber, poplar fiber, cocoa fiber, derivatives thereof, and combinations thereof.
4. An oral product according to claim 3, wherein the cellulose material is a derivative of wood pulp fiber.
5. An oral product according to claim 4, wherein the cellulose material is microcrystalline cellulose.
6. An oral product according to claim 1, wherein the filler is present in an amount of at least about 50% by weight of the oral product.
7. An oral product according to claim 1, wherein the filler is present in an amount of from about 55% to about 95% by weight of the oral product.
8. An oral product according to claim 1, wherein the cannabinoid is present in an amount of from about 1% to about 30% by weight of the oral product.
9. An oral product according to claim 1, wherein the cannabinoid is present in an amount of from about 5% to about 15% by weight of the oral product.
10. An oral product according to claim 1, wherein the cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), Cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), tetrahydrocannabivarinic acid (THCV A), and mixtures thereof.
11. An oral product according to claim 1, wherein the cannabinoid comprises cannabidiol.
12. An oral product according to claim 11, wherein the cannabinoid comprises cannabidiol in an amount of at least 98% by weight of the cannabinoid.
13. An oral product according to claim 1, wherein the oral product contains an emulsion comprising a continuous phase and a dispersed phase, wherein the emulsion comprises at least one cannabinoid.
14. An oral product according to claim 13, wherein the oral product further comprises one or more emulsifying agents.
15. An oral product according to claim 13, wherein the emulsion is in the form of a nanoemulsion in which nanoparticles of an oil phase are dispersed in an aqueous phase.
16. An oral product according to claim 15, wherein the cannabinoid is present in the nanoparticles of the oil phase.
17. An oral product according to claim 1, wherein the oral product further comprises at least one additive selected from the group consisting of a flavoring agent, a taste modifier, a preservative, a humectant, a sweetener, a binder, a buffering agent, salt and mixtures thereof.
18. An oral product according to claim 17, wherein the oral product comprises at least one humectant.
19. An oral product according to claim 18, wherein the humectant is selected from the group consisting of glycerine, 1,2-propanediol, 1,3-propanediol, dipropylene glycol, sorbitol, xylitol, maltitol, and mixtures thereof.
20. An oral product according to claim 18, wherein the humectant is present in an amount of from about 0.1% to about 20% by weight of the oral product.
21. An oral product according to claim 1, wherein the oral product comprises salt.
22. An oral product according to claim 1, wherein the oral product is chemically and physically stable for a period of at least 6 months.
23. An oral product according to claim 1, wherein at least 50 wt % of the cannabinoid is released within at most about 60 minutes when placed in the oral cavity of a user.
24. An oral product according to claim 23, wherein at least 30 wt % of the released cannabinoid is absorbed into the oral mucosa within at most about 60 minutes.
25. A pouched oral product comprising a saliva permeable pouch and the oral product of claim 1 incorporated within the pouch, wherein the water activity of the oral product is no greater than about 0.85.
26. A package containing the pouched oral product according to claim 25.
The reference does not specifically teach adding the ingredients in the amounts claimed by applicant. However, the reference does teach the composition for cannabis extract in a water soluble matrix. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
There are many applications that are similar 20240114949 A1, 20240324654 A1, 20230363441 A1, 20230363440 A1, 20240316076 A1, 20240251841 A1, 20240415913 A1, 20250089757 A1, 20240335415 A1, 20240325415 A1, 20230033276 A1, 20240251841 A1, 20210177037 A1, 20210169129 A1, 202400335415 A1, 20240325415 A1, 2024025184 A1.
Claims 1-2, 4-5, 7-8, 10, 12-16, 18, 20-23, and 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-16 of U.S. Patent No. 12370171 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of sugar alcohol is not the same.
U.S. Patent No. 12370171 B2 teaches:
1. A meltable composition configured for oral use, the composition comprising: a cannabinoid or cannabimimetic; a filler comprising at least one sugar alcohol; a first lipid comprising palm oil, partially hydrogenated palm oil, hydrogenated palm oil, palm kernel oil, partially hydrogenated palm kernel oil, hydrogenated palm kernel oil, soybean oil, partially hydrogenated soybean oil, hydrogenated soybean oil, sunflower oil, partially hydrogenated sunflower oil, hydrogenated sunflower oil, cottonseed oil partially hydrogenated cottonseed oil, hydrogenated cottonseed oil, coconut oil, partially hydrogenated coconut oil, hydrogenated coconut oil, or a combination thereof; a second lipid having a melting point of about 25° C. or lower; and water in an amount by weight from about 0.1 to about 1%, based on the total weight of the composition; wherein a total amount of the first and second lipid is from about 35 to about 58% by weight, based on the total weight of the composition.
2. The meltable composition of claim 1, wherein the first lipid comprises palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil, or a combination thereof.
3. The meltable composition of claim 1, wherein the first lipid comprises palm oil, palm kernel oil, or a mixture thereof.
4. The meltable composition of claim 1, wherein the second lipid is selected from the group consisting of acai oil, almond oil, amaranth oil, apricot oil, apple seed oil, argan oil, avocado oil, babassu oil, beech nut oil, ben oil, bitter gourd oil, black seed oil, blackcurrant seed oil, borage seed oil, borneo tallow nut oil, bottle gourd oil, brazil nut oil, buffalo gourd oil, butternut squash seed oil, cape chestnut oil, canola oil, carob cashew oil, cocklebur oil, coconut oil, corn oil, cothune oil, coriander seed oil, cottonseed oil, date seed oil, dika oil, egus seed oil, evening primrose oil, false flax oil, flaxseed oil, grape seed oil, grapefruit seed oil, hazelnut oil, hemp oil, kapok seed oil, kenaf seed oil, lallemantia oil, lemon oil, linseed oil, macadamia oil, mafura oil, manila oil, meadowfoam seed oil, mongongo nut oil, mustard oil, niger seed oil, okra seed oil, olive oil, orange oil, papaya seed oil, peanut oil, pecan oil, perilla seed oil, persimmon seed oil, pequi oil, pili nut oil, pine nut oil, pistachio oil, pomegranate seed oil, poppyseed oil, pracaxi oil, prune kernel oil, pumpkin seed oil, quinoa oil, ramtil oil, rapeseed oil, rice bran oil, royle oil, sacha inchi oil, safflower oil, sapote oil, seje oil, sesame oil, soybean oil, sunflower oil, taramira oil, tea seed oil, thistle oil, tigernut oil, tobacco seed oil, tomato seed oil, walnut oil, watermelon seed oil, wheat germ oil, and combinations thereof.
5. The meltable composition of claim 1, wherein the second lipid is present in an amount of from about 2 to about 6% by weight, based on the total weight of the composition.
6. The meltable composition of claim 1, comprising from about 38 to about 58% by weight of the at least one sugar alcohol, based on the total weight of the composition.
7. The meltable composition of claim 1, wherein the at least one sugar alcohol comprises isomalt, maltitol, a glucose-polysaccharide blend, erythritol, sorbitol, arabitol, ribitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof.
8. The meltable composition of claim 1, wherein the at least one sugar alcohol comprises isomalt, maltitol, a glucose-polysaccharide blend, or a combination thereof.
9. The meltable composition of claim 1, further comprising lecithin in an amount of from about 0.5 to about 1.5% by weight, based on the total weight of the composition.
10. The meltable composition of claim 1, wherein the cannabinoid or cannabimimetic is present in an amount of from about 0.1 to about 20% by weight, based on the total weight of the composition.
11. The meltable composition of claim 1, wherein the cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarinic acid (THCV A), and combinations thereof.
12. The meltable composition of claim 1, wherein the cannabinoid is selected from the group consisting of tetrahydrocannabinol (THC), cannabidiol (CBD), and combinations thereof.
15. The meltable composition of claim 1, further comprising at least one additional component selected from sweeteners, salts, flavorants, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
16. The meltable composition of claim 1, wherein the composition is substantially free of nicotine.
The reference does not specifically teach adding the ingredients in the amounts claimed by applicant. However, the reference does teach the composition for cannabis extract in a water soluble matrix. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claims 1, 4-5, 7-8, 10, 12-16, 18, 20-23, and 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12318479 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of surfactant is not the same.
U.S. Patent No. 12318479 B2 teaches:
1. A nanoemulsion comprising at least one cannabinoid, wherein the nanoemulsion is obtained or obtainable by a process comprising: (a) providing an oil phase containing at least one cannabinoid; (b) providing a water phase and combining the water phase with a polyoxyethylene stearic acid ester, lecithin, and glycerin; (c) combining the oil phase and water phase to form a macroemulsion; and (d) treating the macroemulsion to form a nanoemulsion, wherein the polyoxyethylene stearic acid ester and lecithin are present in an amount from about 10% to about 25% by weight, based on the total weight of the nanoemulsion.
2. The nanoemulsion of claim 1, wherein a zeta potential of the nanoemulsion is less than about −10 mV as measured with a zeta analyzer.
3. The nanoemulsion of claim 1, wherein the nanoemulsion comprises droplets of the oil phase dispersed in the water phase, the droplets having an average diameter from about 1 nm to about 200 nm.
4. An oral product containing the nanoemulsion of claim 1.
5. The oral product of claim 4, further comprising a filler.
6. The oral product of claim 4, wherein a water activity of the oral product is no greater than about 0.85 as determined using a water activity meter having a tuneable diode laser.
7. A pouched oral product comprising a saliva permeable pouch and the oral product of claim 4 incorporated within the pouch.
8. A package containing at least one pouched oral product of claim 7.
9. A nanoemulsion comprising: (a) an oil phase containing at least one cannabinoid; and (b) a water phase; wherein the water phase comprises polyoxyethylene stearic acid ester, lecithin, and glycerin, wherein the polyoxyethylene stearic acid ester and lecithin are present in an amount from about 10% to about 25% by weight, based on the total weight of the nanoemulsion, and wherein a zeta potential of the nanoemulsion is less than about −10 mV as measured with a zeta analyzer.
10. The nanoemulsion of claim 9, comprising droplets of the oil phase dispersed in the water phase, the droplets having an average diameter from about 1 nm to about 200 nm.
11. The nanoemulsion of claim 9, wherein a weight ratio of the oil phase to the water phase is from about 2:1 to about 1:10.
12. The nanoemulsion of claim 9, wherein a weight ratio of the oil to the at least one cannabinoid is from about 1:1 to about 10:1.
13. The nanoemulsion of claim 9, wherein the oil phase comprises castor oil.
14. The nanoemulsion of claim 9, wherein the at least one cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), Cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), tetrahydrocannabivarinic acid (THCV A), and mixtures thereof.
15. The nanoemulsion of claim 9, wherein the at least one cannabinoid comprises cannabidiol.
The reference does not specifically teach adding the ingredients in the amounts claimed by applicant. However, the reference does teach the composition for cannabis extract in a water soluble matrix. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
There are many patents that are similar 12550928 B2, 12439949 B2, 12310959 B2, 1183527 B2, 11839602 B2, 10738268 B2, 1217798 B2, 11839602 B2, 123718479 B2, 12318479 B2.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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