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
Filing Receipt and Priority
The filing receipt mailed 06/01/2023 states that the instant application claims benefit of provisional application 63/331,610, filed 04/15/2022. The instant application finds support in the provisional application. Therefore, the effective filing date is 04/15/2022.
Information Disclosure Statement
As of the date of this action, no information disclosure statement has been submitted.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Species Election
The election without traverse of the following species in the remarks submitted 10/08/2025 is acknowledged.
The elected species are other cannabinoids. Applicant has canceled claims 5 and 6 and has also amended claim 7 to one singular additional cannabinoid which is tetrahydrocannabinolic acid (THCA).
Status of Claims
Claims currently pending and under examination are claims 1-4, 7, and 9-18.
Claim Objections
Claims 1 and 11 are objected to for the following minor informality: “tetrahydrocannaphorol” should be “tetrahydrocannabiphorol”. Emphasis added by examiner.
Claims 1 and 11 are also missing a “,’ after “tetrahydrocannaphorol (THCP) and “first THC homologue” in said claims.
Claim 1 states “THC homologues” without first spelling out “THC” which would be “tetrahydrocannabinol”. It is typically best practice to first spell out a word before using its shorthand. Applicant does this appropriately regarding tetrahydrocannabiphorol and tetrahydrocannabutol.
In bullets (ii) of both claims 1 and 11, the comma should come before “and” before continuing to bullet (iii). Additionally, the “(iii)” is not needed before the wherein clause. See 112(b) rejection below.
Claim 11 states “a first THC homologue” without specifying a second THC homologue. THCP and THCB are considered THC homologues and, therefore, would technically be a second THC homologue, but with the current claim language, the use of “first” is unnecessary.
Rejections
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, 7, 11, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring composition without significantly more.
Claim 1 recites “A cannabinoid composition of at least two THC homologues comprising: (i) [tetrahydrocannabiphorol], (ii) tetrahydrocannabutol and, (iii) wherein the THCP and the THCB combination create a cannabinoid composition capable of a capped and biphasic effect.”.
Claim 11 recites “A cannabinoid composition of at least two THC homologues comprising: (i) a first THC homologue, (ii) tetrahydrocannabutol (THCB) or tetrahydrocannabiphorol (THCP), and (iii) wherein the composition exhibits a capped or biphasic effect.”
The above cannabinoid compositions are not integrated into a practical application as discussed and as evidenced by Sampson (J. Nat. Prod. 2021, 84, 142-160) and as evidenced by Linciano (J. Nat. Prod. 2020, 83, 88-98).
Sampson on p. 155 and 156, sec. Δ9-Tetrahydrocannabutol and Cannabidibutol and Δ9-Tetrahydrocannabiphorol and Cannabidiphorol teaches that both THCB and THCP are minor components of C. sativa. Sampson on p. 155 states “Analogues of both CBD and Δ9-THC that carry a four-carbon butyl side chain have been reported as minor component of C. sativa.” Sampson on p. 156 states “Most naturally occurring phytocannabinoids present in C. sativa contain side chain units of five or few carbons. Recently, naturally occurring phytocannabinoids carrying a seven-carbon side chain were identified. The two new phytocannabinoids were isolated and the structures confirmed by stereoselective synthesis. They were found to be direct structural analogues Δ9-THC and CBD and subsequently named Δ9-tetrahydrocannabiphorol…”.
Regarding claim 11, Sampson on p. 146 also teaches that another THC homologue, tetrahydrocannabivarin (THCV), is another component of C. sativa where it states “Tetrahydrocannabivarin…is an analogue of [THC] carrying an n-propyl (C3) side chain. The cannabinoid was isolated by column chromatography from a tincture of C. sativa in 1970.”
Regarding the “biphasic effect” limitations of claims 1 and 11, Linciano on p. 93 states “The possible involvement of other receptors such as the transient receptors potential channels family (TRPs) might also explain, at least in part, the biphasic effect of Δ9-THCB at different doses.”
Regarding the capped effect, the instant specification in para. [0008] teaches that THCP exhibits a capped effect at low doses. This indicates that the capped effect is a property of THCP.
Regarding claims 7 and 15, Sampson on p. 145, sec. Phytocannabinoid Origins teaches that “The biosynthetic pathways for a number of phytocannabinoids have been elucidated and many begin from geranyl diphosphate (GPP), a common biosynthetic precursor of terpenoid and sesquiterpenoids, as shown in Scheme 1” (Scheme 1 shown below). Sampson in the same section continues “The ‘THC-like’ class of phytocannabinoids is produced through oxidative cyclization of 16a and 16b catalyzed by THCA synthase to the tricyclic moieties Δ9-tetrahydrocannabivaric acid…and Δ9-tetrahydrocannabinolic acid…”
Sampson Scheme 1
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Considering the teachings above, the current claim language does not sufficiently make the instant composition distinct from naturally occurring C. sativa.
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, 7, 11, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sampson (J. Nat. Prod. 2021, 84, 142-160) and as evidenced by Linciano (J. Nat. Prod. 2020, 83, 88-98).
The discussion regarding the components of C. sativa, the biphasic effect of THCB, and the capped effect of THCP from the 101 rejection above are incorporated here.
Considering the above, Sampson’s tincture of C. sativa includes within its components at least THCP, THCB, THCA, and some other THC homologue including THCV. Linciano teaches the biphasic effect of THCB. The instant specification discloses that THCP exhibits a capped effect.
Therefore, a tincture of C. sativa would embrace claims 1, 7, 11, and 15.
Claim Rejections - 35 USC § 112(b)
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 1-4, 7, and 9-18 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.
Claim 1 states “A cannabinoid composition of at least two THC homologues comprising: (i) [tetrahydrocannabiphorol], (ii) tetrahydrocannabutol and, (iii) wherein the THCP and the THCB combination create a cannabinoid composition capable of a capped and biphasic effect.”
The first use of “A cannabinoid composition of at least two THC homologues” becomes unclear with the use of “the THCP and the THCB combination create a cannabinoid composition” because it implies that the first cannabinoid composition does not contain the two THC homologues. The second instance of “cannabinoid composition” is redundant.
Examiner suggests moving “and” between “(i) tetrahydrocannabiphorol” and “(ii) tetrahydrocannabutol”. Additionally, the “(iii)” before the wherein clause is not needed.
Claim 18 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.
Claim 18 states “The cannabinoid composition of claim 11 for use in treating sever pain that minimizes the anxiety or incapacitation that would otherwise occur from utilizing delta-9 THC alone.”
The limitation “anxiety or incapacitation that would otherwise occur from utilizing delta-9 THC alone” is indefinite.
THC-induced anxiety is a well-known effect within the art as discussed in Raymundi (BMC Psychiatry, 2020, 20:420). Raymundi on p. 7-8, Table 2 teaches a number of studies that examined the effect of administering doses of THC and whether the dose led to anxiety. Among these, certain studies indicated a dose of 10mg or higher increased anxiety. See below.
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Another study indicated that a dose of 5 mg THC also increased anxiety.
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However, one study that also examined administering THC at 5 mg showed a decreased level of anxiety in patients with PTSD.
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Therefore, there are doses that can lead to increased anxiety but there are also that lead to lowered anxiety. The anxiety effect is inconsistent and is not tied to a specific dose of THC. Without a way to determine which doses of THC will and will not lead to anxiety in a patient, one of ordinary skill in the art would not be able to determine which amounts do or do not read on the claims.
Considering the above, one of ordinary skill in the art would not know the metes and bounds of the claim.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-4, 7, and 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuan (US2021/0299081) in view of Sampson (J. Nat. Prod. 2021, 84, 142-160) and Palomares (Biochemical Pharmacology, 171, 2020, 113693) and as evidenced by AbbVie (Marinol Label Information Sheet, 2017) and Linciano (J. Nat. Prod. 2020, 83, 88-98).
Independent claim 1 claims a cannabinoid composition comprising THCP and THCB, wherein the composition has a capped and biphasic effect.
Independent claim 9 claims a method of creating a general cannabinoid composition comprising admixing THCP and THCB withing a carrier.
Independent claim 11 claims a cannabinoid composition comprising a first THC homologue, either THCP or THCB, and wherein the composition exhibits a capped or biphasic effect.
Dependent claims 2-4 specify embodiments of claim 1 wherein the cannabinoid composition further comprises a pharmaceutically acceptable carrier (claim 2), is formulated for administration in various manners (claim 3), and specify specific ratios of THCP to THCB (claim 4).
Dependent claim 7 specifies an embodiment of claim 1 further comprising tetrahydrocannabinolic acid (THCA).
Dependent claim 10 specifies embodiments of claim 9 wherein the carrier is sesame oil, glycerin, or medium-chain triglycerides.
Dependent claims 12-14 specify embodiments of claim 11 wherein the composition further comprises a pharmaceutically acceptable carrier (claim 12), the composition is formulated for administration in various methods (claim 13), and the composition has a range of ratios regarding the first THC homologue to THCB or THCP.
Dependent claim 15 specifies an embodiment of claim 11 further comprising tetrahydrocannabinolic acid (THCA).
Dependent claims 16-18 are drawn to embodiments wherein the cannabinoid composition is used for treating pain associated with sunburn or sunstroke (claim 16), associated with frostbite or exposure (claim 17), or in treating severe pain that minimizes anxiety or incapacitation that would otherwise occur from using THC alone (claim 18).
Regarding claims 1, 3, 7, 9-13, and 15, Yuan in para. [0008]-]0010] teaches a composition of a “solid, self-emulsifying composition for oral administration”. Said composition comprises a population of particles wherein each particle comprises at least one of a cannabinoid and a terpene, at least one surfactant, and a carrier.
Yuan in para. [0015]-[0021] teaches methods of making said composition comprising dissolving the cannabinoid or the terpene in a solvent mixture to form a first solution, mixing the solid carrier with the first solution, evaporating the solvent, and collecting the particles.
Yuan in para. [0048] defines “cannabinoid” to encompass both a single cannabinoid and a combination of two or more cannabinoids. Yuan in para. [0037] contemplates several cannabinoids as components of its invention including cannabidiol (CBD), Δ9-THC, Δ8-THC, cannabigerol (CBG), THCV, cannabinol (CBN), cannabichromene (CBC) and cannabidivarin (CBV) or combinations thereof. Yuan in para. [0002] teaches a list of cannabinoids including those above and further including THCA, THCB, and THCP. Yuan in para. [0078] lists a number of preferred cannabinoids including THCB, THCP, and THCA.
Regarding claims 2, 10, and 12, Yuan in para. [0080] contemplates the addition of sesame oil and medium-chain triglyceride (MCT) oil.
Regarding claims 4 and 14, Yuan in para. [0079] contemplates dose amounts of cannabinoid ranging between 0.01 w/w to 20% w/w. Yuan in the same section also contemplates a total cannabinoid concentration between 0.1 mg/g to about 200 mg/g. While claims 4 and 14 are drawn to a range of ratios of THCP to THCB (claim 4) and a first homologue to either THCP or THCB (claim 14), the modification of effective doses is well within the skillset of one of ordinary skill.
The MPEP, section 2144.05, subsection II states:
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. 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). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Yuan in para. [0002], Table 1 teaches a number of cannabinoid compositions commercially available that include at least one cannabinoid in a carrier. Yuan in Table 1 teaches a product by AbbVie called “MARINOL” that comprises a cannabinoid and sesame oil as a carrier. AbbVie on p. 11 teaches that the active ingredient of MARINOL is Dronabinol, which is synthetic Δ9-THC.
Yuan teaches commercially known cannabinoid compositions and contemplates cannabinoid compositions that would comprise THCB and THCP, but does not disclose a composition comprising THCP and THCB and also does not disclose a composition further comprising THCA. This is addressed the combination of Sampson and Palomares.
Sampson on p. 155 teaches THCB and on p. 156, teaches THCP (structures shown below).
Sampson THCB and THCP
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Sampson on p. 155, right col., para. 2 teaches that THCB “differs only in the reduced length of the aliphatic side chain” and that the “biological activity mimics closely Δ9-THC.” Sampson teaches that THCB has a binding affinity for CB1 and CB2 receptors that is 15 and 51 nM respectively. Sampson continues stating that the binding affinity for CB1 is similar to THC (Ki = 5-40nM) and that there is “no significant difference in binding affinity” to CB2.
Regarding THCP, Sampson on p. 156, left col., para. 3 teaches that THCP has a binding affinity for CB1 and CB2 that is 1.2 and 6.9 nM. Sampson further states in sec. Future Directions, para. 3 that “THCP and CBDP are promising Δ9-THC and CBD surrogates that may offer similar therapeutic benefit at lower doses.”
Regarding claim 11, which claims a “first THC homologue” that is not either THCP or THCB, Sampson on p. 145 teaches tetrahydrocannabivarin (THCV). Sampson teaches that the binding affinity of THCV for CB1 and CB2 is 12.7 μM and 0.098/0.038 μM. While this is lower, Sampson on p. 148, left col., para. 3 teaches that Δ9-THCV “has been shown to downregulate NO production” which is a pro-inflammatory response to infection. Essentially, THCV acts as an anti-inflammatory. This is further affirmed where Sampson in the same section states “In addition to a reduction in NO levels, Δ9-THCV was also shown to downregulate the levels of both the pro-inflammatory cytokine IL-1β and prostaglandin synthase COX-2.”
Regarding claims 7 and 15, Palomares on p. 8, left col. states that “THCA-A…successfully ameliorated adiposity and reversed the metabolic and inflammatory complications associated to diet-induced obesity.
The MPEP section 2144.06 states
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding the biphasic limitations of claims 1 and 11, Linciano on p. 93 states “The possible involvement of other receptors such as the transient receptors potential channels family (TRPs) might also explain, at least in part, the biphasic effect of Δ9-THCB at different doses.”
Regarding the capped effect of claim 1 and 11, the instant specification in para. [0008] teaches that THCP exhibits a capped effect at low doses. This indicates that the capped effect is a property of THCP.
Regarding claims 16-18, the claims are drawn to compositions of claim 11 for use in various purposes. The use of the composition does not alter the properties of the composition of claim 11. Where the art makes obvious the composition of claim 11, the art would also make obvious the composition for use in whatever method claimed.
Yuan teaches and contemplates cannabinoid compositions formulated for oral administration and in doses that can be modified by one of ordinary skill in the art. Yuan also teaches methods of making the composition comprising mixing the THCB and THCP in a carrier. Critically, Yuan contemplates THCB, THCP, THCV, and THCA as components of a cannabinoid composition. Sampson teaches the enhanced binding affinity of THCB and THCP along with teaching that THCV acts as an anti-inflammatory. Palomares teaches the anti-inflammatory properties of THCA. Linciano teaches that the biphasic property of THCB is known within the art and the instant specification indicates that THCP has a capped effect that is a property of THCP. Therefore, the art teaches a number of the instant claim limitations and those which the art does not teach are properties of the cannabinoid compounds.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have combined the teachings of Yuan, Sampson, Palomares, and Linciano to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill would find motivation to make the combination as the art teaches that THCB and THCP have similar and/or enhanced binding affinity to CB1 and CB2 and that THCV and THCA have anti-inflammatory properties.
Examiner’s Comment
A 101 rejection was considered over the teachings of Sampson and Linciano. However, it could not be determined if a capped and biphasic effect is a property of the naturally occurring C. sativa.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624