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 .
Claim(s) 1-5, 7-9, 11, 14, 17, 19-20, 22-23, 28-29 and 32 are pending.
Election/Restrictions
Applicants’ election of Group I, claim(s) 1-5, 7-9, 11, 14, 17, 19-20, 22-23, 28-29 and 32 and applicants’ election of species for claim 2 (cannabinoids), claim 3 (cannabidiol (CBD)), claim 7 (menthol), claim 8 (WS-3), claim 11 (the encapsulation is by a molecular encapsulant, such as cyclodextrin), claim 14 (lecithin) and claim 20 (a terpene) in the reply filed on May 15, 2026 and August 31, 2026 is acknowledged. The traversal is on the ground(s) that “the noted species in each claim are related to a general inventive concept based on their similarity to the other species (as stated on pg. 3 of applicant remarks)…the examiner’s conclusory statements that the compounds in each claim have “different structures and different activities” does not demonstrate distinctness or a serious burden for search in the context of the claimed composition, where the compounds are substitutable for the same intended function within the composition” (as stated on pg. 4 of applicant remarks). This is not found persuasive because each of the species across claim(s) 2, 3, 7, 8, 11, 14 and 20 are distinct. For example, cannabinoids are very distinct from flavonoids as a result of origin and specific targets within the human body. Moreover, each of the species listed can be derived from different sources and can serve distinct functions and therefore having to search each and every species listed within the claim would pose a serious search burden to the examiner and therefore, election of species is necessary in this situation, thus, applicants’ traversal is not persuasive. The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 25 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-5, 7-9, 11, 14, 17, 19-20, 22-23, 28-29 and 32 are examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on January 17, 2024 and March 10, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Specification
The abstract of the disclosure is objected to because it is not a single paragraph preferably
within the range of 50 to 150 words in length. The abstract of the disclosure is roughly 31
words. A corrected abstract of the disclosure within the preferred ranges disclosed is required. See MPEP § 608.01(b).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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 broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) are: comprising a ““means for” solubilizing the one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment” in claim 9 and the ““means for” solubilizing the one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment encapsulates the one or more constituent, derivative or extract of cannabis, flavor or sensate” in claim 11.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to identify the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
The specification of the present invention does not give an adequate explanation of the “means for solubilizing the one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment” (as stated across claim(s) 9 and 11 of the present invention). For the sake of examination purposes, claim(s) 9 and 11 will use broadest reasonable interpretation based upon how the claims are presented because the applicant does not have a clear definition or structure for “solubilizing the one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 9 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim(s) 9 and 11 are rejected for failing to describe the genus of structures that are used for solubilizing the one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment as currently claimed.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. Claim(s) 9 and 11 are broadly generic to all possible solubilizing agents and any concentration of solubilizing agents of unknown constituents encompassed by the claims. The possible variations are enormous. Since the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure beyond those disclosed in the examples in the specification. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus since the specification does not provide any example of all of types of solubilizing agents known along with multiple concentrations of the solubilizing agents having the functional effects of solubilizing the one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment as currently claimed. Within claim(s) 9 and 11, the applicant of the invention has not shown possession of the claimed composition because the applicant has not shown that they have possession of a genus of solubilizing agents that is capable of solubilizing the one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment. The genus of agents is not described. There is no description of structure that is conveyed in the specification of the present invention that would allow one skilled in the art to understand what types of solubilizing agents are able to accomplish in terms of solubilizing one or more constituent, derivative or extract of cannabis, flavor or sensate in an aqueous environment.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 9, 11 and 19 and 20 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.
Within claim(s) 9 and 11, the claim limitation "means for" invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, claim(s) 9 and 11 fails to disclose the corresponding structure, material, or acts for performing the entire “means for” claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim(s) 19 and 20 are indefinite because it is unclear what is meant by “one of more components”; it is not clear of what components results in enhancing enterocyte intestinal absorption (claim 19) and increasing intestinal lymphatic transport (claim 20). The specification does not provide an explanation of the phrases. Thus, the metes and bounds of the claim are unclear.
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 Ormum, 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-opline/eterninal-disclaimor.
Claim(s) 1, 2, 5, 7, 17 and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 5, 22, 26 and 29 of U.S. Pending Application No. 18/580,361. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a pharmaceutical composition claimed in the copending reference '361 for example, each recite a pharmaceutical composition comprising:
A composition comprising one or more constituent, derivative or extract of cannabis in amorphous form and an additive capable of slowing or inhibiting crystallisation of the one or more constituent, derivative or extract of cannabis in an aqueous environment (claim 1 of ‘361);
A composition as claimed in claim 1, wherein the constituent, derivative or extract of cannabis is one or more compounds selected from: cannabinoids; terpenes; alkaloids; and flavonoids (claim 5 of ‘361);
A composition as claimed in claim 1, comprising: a further active agent; and/or a further flavour or sensate (claim 22 of ‘361);
An oral product for providing buccal delivery of one or more constituent, derivative or extract of cannabis, comprising a composition as claimed in claim 1 (claim 26 of ‘361);
An oral product as claimed in claim 26, comprising: a pouch containing the composition; and / or a dissolving strip comprising the composition, optionally the dissolving strip comprising a bioadhesive (claim 29 of ‘361).
The claim(s) of ‘361 do overlap with claim(s) 1, 2, 5, 7, 17 and 28-29 of the present invention because the claim(s) of pending app ‘361 describes a composition that contains an extract of Cannabis (that has one or more compounds derived from cannabinoids, terpenes, alkaloids and flavonoids), an additive (such as hydroxypropyl cellulose (HPC) or polyvinylpyrrolidone (PVP)), a flavour or sensate in which the composition can also be present within an oral form for buccal delivery that can be present within a pouch or a dissolvable strip. Thus, claim(s) 1, 5, 22, 26 and 29 of pending app ‘361 effectively reads on claim(s) 1, 2, 5, 7, 17 and 28-29 of the present invention and are therefore anticipatory and not patentably distinct.
Claim(s) 1-3, 5, 7, 14, 17 and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 4, 11, 17-18, 22 and 25 of U.S. Pending Application No. 18/580,066. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a pharmaceutical composition claimed in the copending reference '066 for example, each recite a pharmaceutical composition comprising:
A composition comprising one or more constituent, derivative or extract of cannabis in solution or in a solubilised form and a carrier material (claim 1 of ‘066);
A composition as claimed in claim 1, wherein the constituent, derivative or extract of cannabis is one or more compounds selected from: cannabinoids; terpenes; alkaloids; flavonoids; and 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) (claim 4 of ‘066);
A composition as claimed in claim 1, further comprising an effervescent agent or combination of agents, and/or further comprising a surfactant (claim 11 of ‘066);
A composition as claimed in claim 1, comprising an additive which slows or inhibits crystallisation of the one or more constituent, derivative or extract of cannabis in an aqueous environment, optionally wherein the additive is selected from the group consisting of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC) and carboxymethyl cellulose (CMC) (claim 17 of ‘066);
A composition as claimed in claim 1, comprising a further active agent, flavour and/or sensate (claim 18 of ‘066);
An oral product for providing buccal delivery of one or more constituent, derivative or extract of cannabis, comprising a composition as claimed in claim 1 (claim 22 of ‘066);
An oral product as claimed in claim 22, comprising a pouch containing the composition, or comprising a dissolving strip comprising the composition, optionally wherein the dissolving strip comprising a bioadhesive (claim 25 of ‘066).
The claim(s) of ‘066 do overlap with claim(s) 1-3, 5, 7, 14, 17 and 28-29 of the present invention because the claim(s) of pending app ‘066 describes a composition that contains an extract of Cannabis (that has one or more compounds derived from cannabinoids, terpenes, alkaloids and flavonoids) and a carrier material, a surfactant, an additive (such as hydroxypropyl cellulose (HPC) or polyvinylpyrrolidone (PVP)), a flavour and/or sensate in which the composition can also be present in an oral form for buccal delivery that can be present within a pouch or a dissolvable strip. Thus, claim(s) 1, 4, 11, 17-18, 22 and 25 of pending app ‘066 effectively reads on claim(s) 1-3, 5, 7, 14, 17 and 28-29 of the present invention and are therefore anticipatory and not patentably distinct.
Claim(s) 1, 3, 5, 7-8, 14, 17 and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2, 5, 10, 16, 20 and 23 of U.S. Pending Application No. 18/579,985. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a pharmaceutical composition claimed in the copending reference '985 for example, each recite a pharmaceutical composition comprising:
A composition comprising one or more constituent, derivative or extract of cannabis distributed within a water soluble matrix (claim 1 of ‘985);
The composition as claimed in claim 1, wherein the water soluble matrix comprises one or more matrix-forming material selected from the group consisting of: sugar alcohols; disaccharides; polysaccharides, such as cellulose, starch and their derivatives; dextrins; dextrates; natural gums; and polymers and copolymers, such as cellulosics, optionally wherein the water soluble material is selected from the group consisting of: mannitol, sorbitol, xylitol, isomalt, erythritol, arabitol, ribitol, maltitol, dulcitol, iditol and lactitol guar gum, acacia gum (also known as gum arabic), xanthan gum, locust bean gum, gellan gum, alginates and sodium alginates, hydroxypropyl methylcellulose (HPMC), hydroxypropyl methylcellulose acetate succinate (HPMCAS), polyvinyIpyrrolidone (PVP), polyethylene glycol (PEG), polyethylene oxide (PEO). Macrogol 15 Hydroxystearate (Solutol HS 150). and Vitamin E Polyethylene Glycol Succinate (Vit E TPGS) (claim 2 of ‘985);
The composition as claimed in claim 1, wherein the constituent, derivative or extract of cannabis is one or more compounds selected from: cannabinoids; terpenes; alkaloids; and flavonoids, or 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) (claim 5 of ‘985);
The composition as claimed in claim 1, further 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, lecithin, 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®), sugar esters and lecithins (claim 10 of ‘985);
The composition as claimed in claim 1, comprising one or more of: a further active agent, a flavor, and a sensate (claim 16 of ‘985);
An oral product for providing buccal delivery of one or more constituent, derivative or extract of cannabis, comprising a composition as claimed in claim 1 (claim 20 of ‘985);
The oral product as claimed in claim 20, comprising a pouch containing the composition and/or comprising a dissolving strip comprising the composition, optionally wherein the dissolving strip comprises a bioadhesive (claim 23 of ‘985).
The claim(s) of ‘985 do overlap with claim(s) 1, 3, 5, 7-8, 14, 17 and 28-29 of the present invention because the claim(s) of pending app ‘985 describes a composition that contains an extract of Cannabis (that has one or more compounds derived from cannabinoids, terpenes, alkaloids and flavonoids) within a water soluble matrix such as polyvinylpyrrolidone (PVP), a cannabinoid, a surfactant (i.e. lecithin), a flavor and a sensate in which the composition can also be present in an oral form for buccal delivery that can be present within a pouch or a dissolvable strip. Thus, claim(s) 1, 2, 5, 10, 16, 20 and 23 of pending app ‘985 effectively reads on claim(s) 1, 3, 5, 7-8, 14, 17 and 28-29 of the present invention and are therefore anticipatory and not patentably distinct.
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.
Claim(s) 1-5, 7, 9, 11, 14, 19-20, 22, 23, 28, 29 and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. An oral composition or a composition for buccal delivery comprising an extract from Cannabis and one or more flavor or sensate of claim(s) 1-5, 7, 9, 11, 14, 19-20, 22, 23, 28, 29 and 32 encompasses naturally occurring substances.
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.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claim(s) 1-5, 7, 9, 11, 14, 19-20, 22, 23, 28, 29 and 32 are drawn to a composition that comprises an extract from Cannabis and one or more flavor or sensate. In addition, applicants' claims further recite the combination of an extract from Cannabis, one or more flavor (i.e. menthol) or sensate, cannabidiol (CBD), cyclodextrin, lecithin’s, a terpene (i.e. limonene) and acetic acid. Cannabis and a terpene (i.e. limonene) are from naturally occurring plants, menthol, cannabidiol (CBD), cyclodextrin, lecithin’s and acetic acid are also naturally occurring. 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, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or "man-made." Thus, the extract in turn is a mixture of the naturally occurring compounds found in the particular plant. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. In addition, the closest naturally occurring counterpart for each ingredient is the ingredient itself. There is no indication that mixing the following ingredients together such as an extract from Cannabis, one or more flavor (i.e. menthol) or sensate, cannabidiol (CBD), cyclodextrin, lecithin’s, a terpene (i.e. limonene) and acetic acid as commensurate in scope with the stated claims changes the structure, function, or other properties of the components in any marked way in comparison with the closest naturally occurring counterpart. Thus, the claims are drawn directly to a product of nature. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. 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. In this case, applicants' claims are directed to a composition with the intended use of a composition for gastric and buccal delivery and as an oral product. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prophylaxis' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must 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." However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. In this case, the additional element is the mixing of the claimed ingredients and the mixture of the claimed ingredients within a pouch. Mixing an extract from Cannabis, one or more flavor (i.e. menthol) or sensate, cannabidiol (CBD), cyclodextrin, lecithin’s, a terpene (i.e. limonene) and acetic acid and placing all of the claimed ingredients within a pouch does not amount to significantly more than a combination of judicial exception because mixing compounds and packaging them within a pouch is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter. In addition, applicants' intended use of a composition for gastric and buccal delivery and as an oral product is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Note* Claim 8 was not included because of the elected species WS-3, but would otherwise have a 35 USC 101 rejection based on the presence of naturally occurring vanillyl ethyl ether, capsaicin, or eucolyptol. If species are rejoined, then applicant should be aware of potential 35 USC 101 patentability issues.
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) 1-3, 5, 9, 11, 19-20, 22-23, 28 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wimalaratne (WO 2020168421 A1).
Wimalaratne teaches [a] cyclodextrin inclusion [composition] comprising: a host comprising a cyclodextrin, and a cannabis extract. The cannabis extract may comprise a cannabinoid extract from cannabis (par. 0009). Wimalaratne teaches [that the composition can include] cannabidiol (CBD) (par. 0023). Wimalaratne teaches [that the composition can include] cannabis terpenes (par. 0001). Wimalaratne teaches [that] the cannabis terpenes [can be] limonene (par. 0024). Wimalaratne teaches [that] the cyclodextrin inclusion complexes may be used to deliver hydrophobic compounds of the cannabis extract, cannabinoids or cannabis terpenes to a subject via buccal or gastrointestinal pathways (par. 0022). Wimalaratne teaches [that] acetic acid can be used as an organic solvent ([acetic acid is known to serve as a buffer and as an extraction solvent]) (par. 0031). Wimalaratne teaches [that] the cyclodextrin inclusion complexes may be used or formulated as a solid or liquid for consumption by a subject (par. 0048). Wimalaratne teaches [that] the cyclodextrin inclusion complexes may be used or formulated as a capsule, a tablet, a powder, a solution, a suspension, an emulsion, a syrup, a food product ([i.e. a chew or an edible gel]), a supplement, etc., as known to a person of ordinary skill in the art (par. 0048).
The Wimalaratne reference does not explicitly teach that the composition enhances intestinal absorption or increasing intestinal lymphatic transport (as stated across claim(s) 19-20 of the present invention). However, one skilled in the art does know that enterocytes are known cells that line the small and large intestines and serve the function of helping to absorb nutrients; thus, making this function inherent. In addition, given that the composition of the present invention does include a terpene (which is taught by Wimalaratne), that would mean that the Wimalaratne reference would inherently engage in increasing intestinal lymphatic transport because of the similar structures.
Similarly, if the prior art reference teaches the identical structure or acts but is silent about performing the claimed function, a reasonable presumption is that the prior art structure inherently performs the same function.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
"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. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
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.
Claim(s) 1, 4, 7-8, 14, 17 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wimalaratne (WO 2020168421 A1) in view of Noel (WO 2021092054 A1), Anderson (U.S. Pub. No 20190105283 A1) and Rhodes (U.S. Pub. No. 20200078427 A1).
The teachings of Wimalaratne is above.
Regarding claim(s) 4, 7-8, 14, 17 and 29, Wimalaratne does not teach 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 (as stated within claim 4 of the present invention). Wimalaratne does not teach that the composition includes a flavor such as menthol (as stated within claim 7 of the present invention). Wimalaratne does not teach that the composition includes a cooling agent such as WS-3 (as stated within claim 8 of the present invention). Wimalaratne does not teach that the composition includes lecithin (as stated within claim 14 of the present invention). Wimalaratne does not teach that the composition includes an additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis in an aqueous environment, optionally wherein the additive is selected from the group consisting of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC) and mixtures thereof (as stated within claim 17 of the present invention). Wimalaratne does not teach that the composition comprises a pouch containing the composition or a dissolving strip comprising the composition, optionally wherein the dissolving strip comprises a bioadhesive (as stated within claim 29 of the present invention).
Noel teaches [a] composition [that] includes one or more cannabinoids [such as] cannabidiol (CBD) (par. 0114). Noel teaches [that] suitable penetration enhancers include menthol (par. 0261). Noel teaches [that] the composition may further comprise a hydrophilic component, e.g., comprising one or more water soluble agents. Exemplary water soluble agents include phospholipids (e.g., soy lecithin, egg lecithin, etc.) (par. 0216). Noel teaches [that] a binder is an excipient added to a composition [such as] hydroxypropyl cellulose ([HPC]), polyvinylpyrrolidone (PVP) (par. 0102). Noel teaches [that the] pharmaceutical compositions comprising embodiments [can be in the form of a] tablet (par. 0104).
Anderson teaches [a composition that can include] the extract of Cannabis sativa (par. 0129). Anderson teaches [that the composition can include] WS-3 (par. 0172).
Rhodes teaches [a] Cannabis sativa-derived formulation [that can be in the form of] orally dissolving strips (par. 0019). Rhodes teaches [that the formulation can be in the form of] gels, pastes, lozenges, gums, gummy candies, hard candies (par. 0019).
The composition as taught by Wimalaratne can be modified to include additional ingredients such as menthol (a flavor), soy lecithin (a surfactant), and HPC or PVP (an additive) as taught by Noel. Wimalaratne’s composition can further include WS-3 (a known cooling agent) as taught by Anderson and that Wimalaratne’s composition can be in the form of orally dissolvable strips as taught by Rhodes. One of ordinary skill in the art would reasonably expect to make the combination of the aforementioned references in order to create an optimal composition that includes an extract of Cannabis that can be formulated for gastric and buccal delivery.
Regarding claim 4, the combined aforementioned references does not teach the derivative or extract of Cannabis in the amounts as stated by the applicant within the claim of the present invention. However, 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 composition. Varying the concentration of ingredients within a 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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