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 timely traversed the restriction (election) requirement in the reply filed on March 3rd, 2026. Applicant's election with traverse of Group I (claims 1-3, 5, 7-13, 15, 18, 19-21, and 25) in the reply filed on March 3rd, 2026 is acknowledged. The traversal is on the grounds that, according to the applicant, there should be no undue burden in examining all claims in the present applicatio. This is not found persuasive because the
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 19, 20, and the aqueous solution limitation of claim 21, are withdrawn as being drawn to non-elected species. The applicant’s election with traverse of Group II (claims 3, 5, and 7) and Group V (claim 21 – a colloidal dispersion) in the reply filed on March 3rd, 2026 is acknowledged. The traversal is on the grounds that, according to the applicant, there is no undue burden in examining all claims in the present application. This is not found persuasive because the election requirement stands on a lack of unity of invention (PCT Rule 13.1) regardless of search burden. Claims 22, 23, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1, 3, 5, 7-13, 15, 18, 21, and 25 are pending and were examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 18th, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the meaning of the term "PVA" (page 37. Appropriate correction is required.
The disclosure is objected to because of the following informalities: if the applicant intends to use the term . Appropriate correction is suggested.
The use of the terms ICN, Amberlite, Purolite, and Carbopol, each of which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1 objected to because of the following informalities: t. Appropriate correction is suggested.
Claims 11 is objected to because of the following informalities: the term . Appropriate correction is suggested.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The phrase “solubilising … in an aqueous environment” (independent claim 1 and dependent claim 3) is interpreted as encompassing the solubilization of molecular complexes comprising an encapsulant, in an aqueous environment (instant specification, page 1 lines 24-35, page 2 lines 1-5). Likewise, the phrase “the composition is water soluble” in dependent claim 18 is interpreted as encompassing water soluble molecular complexes comprising an encapsulant. Therefore, the composition as claimed in claims 1, 3, and 18, is interpreted as encompassing colloidal dispersions and emulsions. The examiner notes that this interpretation implies an understanding of the terms “solubilise” and “soluble”, that is broader than the strict understanding of these terms as referring to enabling or able to form a homogeneous mixture with another compound, but still this understanding is still consistent with their use in the art. The term “gastric delivery” (claim 25) is interpreted by the examiner to encompass enteral delivery, i.e. delivery through the intestines (instant specification, page 4, lines 33-35). Given the applicant’s explicit use of “gastric” in place of “enteral” in the instant specification (instant specification, page 4, lines 33-35), the term “gastric system” in instant claim 11 is interpreted to recite “gastrointestinal system”. The term “encapsulation” recited in claims 3 and 5 is interpreted as encompassing emulsification. The term “surfactant” recited in claims 5 and 7 is interpreted to encompass emulsifiers. The “one or more constituent, derivative or extract of cannabis” (claims 1, 3, 9, 10, 12, 13, and 25) is considered a drug.
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 3, 5, 7, and 10 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.
Regarding claims 3 and 5, 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).
The term “about” in claims 7 and 10 is a relative term which renders the claim indefinite. The amounts are 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. What amount is within the range of about an amount?
Claim 5 contains the trademark/trade name in parenthesis. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe surfactants and, accordingly, the identification/description is indefinite.
All claims that depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, 7-11, 15, 18, 21, and 25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Heller (US 20200054702 A1).
Heller summarizes his invention: “According to one aspect, the subject application involves a composition and a method of making a composition for powdered cannabinoids, terpene, essential oils, and the like, having a self-emulsifying property. For example, encapsulated cannabinoid emulsions can be cast or embedded in an aqueous polymeric solution or other polymeric solution … According to another aspect, the subject application involves a method of forming a particulate material derived from a cannabis plant. The method includes introducing a component comprising at least one of: (i) a cannabinoid, and (ii) a terpene, to a polymer to produce a polymeric mixture” (paragraphs [0004] and [0006]; instant claims 1, 3, and 5).
Heller recites a colloidal cannabinoid formulation: “The present disclosure involves a cannabinoid formulation that comprises encapsulated cannabinoids entrapped in a polymer matrix. The cannabinoid embedded polymer matrix can be in a gel or colloidal solution (e.g., “sol”) state or can be dehydrated to make a millable free flowing powder. The polymer matrix can be readily dissolvable in aqueous environments upon which the encapsulated cannabinoids can be released into the aqueous medium creating a substantially homogenous and substantially-perpetual stable emulsion” (paragraph [0010]; instant claims 1, 3, 5, 18, and 21).
Heller further recites dissolution in aqueous liquids, encapsulation of cannabinoids, and preventing crystallization (interpreted by the examiner as inhibition of crystallization): “ The dehydrated maltodextrin agglomeration embedded with encapsulated cannabinoids can then be milled … . Alternatively, the aqueous mixture of maltodextrin/emulsion can be spray dried directly into a free flowing powder resulting in similar powder particle sizes. The resulting powder does not clump and rapidly dissolves in both hot and cold aqueous liquids. … The degree of polymerization of maltodextrin is reported as dextrose equivalents (DE), where DE=100/degree polymerization. … Further, as the DE decreases the following characteristics increase: molecular weight, viscosity, solubility, cohesiveness, film-forming properties, prevention of crystallization (cryoprotection)” (paragraph [0246]; instant claims 1, 3, and 18). Heller further recites “a specific example of a process for embedding encapsulated cannabinoids in maltodextrin matrix” (paragraph [0249]) where emulsifier content is 0.25%-20% w/w (paragraph [0255]; instant claim 7).
Heller further recites the use of micelles to make emulsions: “Emulsifiers and surfactants are responsible for encapsulating the oily fraction and partitioning it from the aqueous phase. Depending on the type of emulsifier/surfactant used emulsions can be made from micelles or liposomes” (paragraph [0090]; instant claims 3 and 5).
Heller further recites particular emulsifiers and surfactants useful to make encapsulated emulsions: “Polymer based emulsifiers can be utilized to create encapsulated cannabinoid emulsions. However, it is possible to create cannabinoid emulsions using a wide variety and combination of different emulsifiers and surfactants. These include but are not limited to: Q-naturale (quillaja saponins), polysorbates (Tween 20, 60, 80), Span (20, 60, 80, 83, 85, 120), vegetable lecithins (phospholipids), polyethylene glycols (PEG 300, 400, 600) polyethylene glycol esters, polyethylene glycol ethers, polypropylene glycol ethers, polyol esters, poloxamers” (paragraph [0142]; instant claims 3, 5, and 8).
Heller further recites cannabinoid active ingredients: “The component, interchangeably referred to herein as the active ingredient, can include oils, resins and molecules derived from the cannabis plant or modeled after the components found in the cannabis plant. … These active ingredients include cannabinoids such as: delta-9-tetrahydrocannabinolic acid (THCa), delta-9-tetrahydrocannabinol (THC), cannabidiol acid (CBDa), cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), or combinations thereof” (paragraph [0012]; instant claims 1, 3, 9, 12, 13, and 25) .
Heller recites an embodiment with a cannabinoid concentration of 0.1-300 mg/g, i.e. 0.0001-0.3 g/g or 0.01-30% w/w (paragraph [0100]; instant claim 10).
Heller recites including flavoring additives in the emulsion system: “Additives can be included in the emulsion system or the polymer matrix to improve the flavor of the system. These flavoring additives include but are not limited to: sugar, sucrose, sorbitol, sucralose, saccharin sodium, sodium cyclamate, aspartame, neotame, acesulfame potassium, stevioside, sodium chloride, D-limonene, citric acid, essential oils, natural and artificial flavors” (paragraph [0361]; instant claim 15).
Heller recites emulsion particles penetrating throughout the sub-mucosal layers in the intestine (paragraph [0357]; instant claims 11 and 25), and beverages made with the cannabinoid emulsions of Heller’s invention (paragraph [0379]; instant claim 25).
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 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Heller (US 20200054702 A1) and further in view of Ahn and Park (Biomaterials Research 2016, 20 (1), s40824-016-0083-1), abbreviated below as "Ahn"
The anticipation of claims 1, 3, 5, 7-11, 15, 18, 21, and 25 over Heller is of record above.
Claims 12 and 13 depend on independent claim 1. Claim 12 recites “A composition as claimed in claim 1, comprising one or more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative or extract of cannabis”. Claim 13 recites “A composition as claimed claim 1, comprising one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis, optionally comprising a terpene, a grapefruit extract, piperine or a black pepper extract”.
As of record above, Heller recites emulsions made from liposomes (paragraph [0090]).
Although Heller does not explicitly recite enhancing intestinal enterocyte absorption, Ahn recites “Compared with other lipid-based nanoparticles, liposomes have the ability to encapsulate and protect drugs and to increase their absorption into enterocytes” (under heading: Liposomal formulations for lymphatic drug transport; instant claim 12). Ahn further recites liposomes engineered to increase efficiency of their uptake into enterocytes, through the incorporation of bile salts, and through making the liposomes elastic (Ahn, subheading: Improvement of liposome absorption into enterocytes; instant claim 12).
Although Heller does not explicitly recite increasing intestinal lymphatic transport, Ahn recites “Lipids of liposomes can also be utilized to stimulate the production of chylomicrons in enterocytes, thus enhancing drug transport into the lymphatic system” (under heading: Liposomal formulations for lymphatic drug transport; instant claim 13), where enterocytes are broadly understood in the art as cells comprising the intestines (instant claim 13).
Therefore, it would have been obvious to the person having ordinary skill in the art to manufacture a composition with liposomal components as disclosed by Ahn to enhance and increase enterocyte intestinal absorption and intestinal lymphatic transport, because Heller discloses liposomal compositions for intestinal transport.
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, 3, 5, 7-10, 12, 13, 15, 18, 21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, 8, 10, 13, 16, 18, 19, 21, 22, 28, and 32 of copending Application No. 18/580005 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following similarities.
Each claim mentioned in the rejection below is a dependent claim unless stated otherwise for that particular claim.
Both applications recite a composition comprising one or more constituent, derivative or extract of cannabis, a means for solubilising the one or more constituent, derivative or extract of cannabis in an aqueous environment, and an additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis (instant independent claim 1; reference claims 1 (independent), 8, and 16).
Both applications recite a composition wherein the means for solubilising the one or more constituent, derivative, or extract of cannabis in an aqueous environment comprises encapsulation of the one or more constituent, derivative or extract of cannabis, optionally wherein the encapsulation is by a molecular encapsulant, such as a cyclodextrin (instant claim 3; reference claim 10), or by a micelle comprising a surfactant (instant claim 5; reference claims 10 and 13), where the weight percent range of surfactant encompasses about 0.5-10% based on the total weight of the composition (instant claim 7; reference claim 13). It is within the knowledge of one of skill in the art that a composition comprising micelles is reasonably a colloidal dispersion (instant claim 21; reference claims 10 and 13).
Both applications recite the additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis in an aqueous environment wherein the additive is selected from the group consisting of at least polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC) and mixtures (or a combination) thereof (instant claim 8; reference claim 16).
Both applications recite a composition wherein the one or more 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) (instant claim 9; reference claim 5).
Both applications recite a composition 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 (instant claim 10; reference claim 7). Both applications recite a composition comprising one [or] more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative or extract of cannabis (instant claim 12; reference claim 18).
Both applications recite a composition comprising one [or] more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis, optionally comprising a terpene, a grapefruit extract, or a black pepper extract (instant claim 13; reference claim 19).
Both applications recite a composition comprising either a pH modifier or buffer (which reasonably overlap) and a flavor or sensate (instant claim 15; reference claims 21 and 22).
Both applications recite a composition that is at least partially soluble in an aqueous environment (instant claim 18; reference claim 8).
Both applications recite an invention encompassing a beverage for providing gastric delivery of one or more constituent, derivative or extract of cannabis (instant claim 25; reference claims 1 (independent), 4, 28, and 32).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 8-10, 12, 13, 15, 18, 21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 9, 11, 14, 16, 17, 19, 20, and 22 of copending Application No. 18/580022 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following similarities.
Each claim mentioned in the rejection below is a dependent claim unless stated otherwise for that particular claim.
Both applications recite a composition comprising one or more constituent, derivative, or extract of cannabis, a means for solubilising the one or more constituent, derivative or extract of cannabis in an aqueous environment, and an additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis (instant independent claim 1; reference claims 1 (independent), 9, and 16).
Both applications recite a composition wherein the means for solubilising the one or more constituent, derivative, or extract of cannabis in an aqueous environment comprises encapsulation of the one or more constituent, derivative or extract of cannabis, optionally wherein the encapsulation is by a molecular encapsulant, such as a cyclodextrin (instant claim 3; reference claim 11) or by a micelle comprising a surfactant (instant claim 5; reference claims 11 and 14). It is within the knowledge of one of skill in the art that a composition comprising micelles is reasonably a colloidal dispersion (instant claim 21; reference claims 11 and 14).
Both applications recite the additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis in an aqueous environment wherein the additive is (at least optionally) selected from the group consisting of at least polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC) and mixtures (or a combination) thereof (instant claim 8; reference claim 17).
Both applications recite a composition wherein a 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) (instant claim 9; reference claim 3).
Both applications recite a composition 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 (instant claim 10; reference claim 4).
Both applications recite a composition comprising one [or] more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative, or extract of cannabis (instant claim 12; reference claim 19).
Both applications recite a composition comprising one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis, optionally comprising a terpene, a grapefruit extract, or a black pepper extract (instant claim 13; reference claim 20).
Both applications recite a composition comprising either a pH modifier or buffer (which reasonably overlap) and a flavor or sensate (instant claim 15; reference claims 5, 7, and 22).
Both applications recite a composition that is at least partially soluble in an aqueous environment (instant claim 18; reference claim 9).
Both applications recite an invention encompassing a composition for providing gastric delivery of one or more constituent, derivative or extract of cannabis (instant claim 25; reference claim 1 (independent)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655