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 01/05/2024 states that the instant application is a 371 of PCT/CA2020/051680, filed 12/07/2020.
The WO document received 06/06/2023 supports the instant claims. Therefore, the effective filing date is 12/07/2020.
Restriction/Species Election
Applicant’s election of Group I without traverse in the remarks filed 11/07/2025 was acknowledged. The applicant has amended the claims to narrow to the following:
-Lipophilic solvent is “a mixture of C8 and C10 triglycerides”.
-Additional antioxidant is “α-tocopherol”.
Claims 17-18 and 20-22 have been withdrawn from further consideration being drawn to a non-elected invention.
Withdrawn Rejections
In view of the terminal disclaimer filed, the non-statutory double patenting rejection made in the prior office action has been withdrawn.
Modified Rejections
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, 10-12, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biro (WO2018222923) in view of Sinai (CA2982250, published 2016), and Whittle (GB 2400320, published 2004).
Independent claim 1 is drawn to an oral cannabidiol composition comprising i) cannabidiol (CBD), a lipophilic carrier comprising β-caryophyllene (BCP), a mixture of C8-C10 triglycerides, and α-tocopherol (vitamin E). Claim 1 additionally requires that the CBD be a purified botanical isolate that is at least 98 wt.% pure and wherein the composition is substantially free of tetrahydrocannabinol (THC), other cannabinoids, other terpenes, other solvents, essential oils, surfactants, emulsifiers, alcohols, and other pharmaceutically active ingredients.
Dependent claims 4-6 are drawn to embodiments wherein the CBD is 98.5 – 99.5 wt% pure.
Dependent claim 7 is drawn to an embodiment wherein THC is not present or is present in an amount not exceeding 10 ppm, based on the total composition.
Claims 10 and 16 are drawn to embodiments wherein the ratio of BCP to mixture of C8 to C10 triglycerides is either 1:2 (claim 10) or is from about 55:45 to about 65:35 (claim 16).
Claims 11-12 are drawn to embodiments wherein the CBD is present in an amount from about 2% w/v to about 25% w/v (claim 11) or 9% w/v to about 23% w/v (claim 12). Similarly, claim 14 is drawn to an embodiment wherein the tocopherol is present in an amount from about 0.5% w/v to about 1.5% w/v.
Biro in para. [0021] contemplates a composition comprising a cannabinoid (cannabidiol) and beta-caryophyllene. Biro in para. [0055] points to Fig. 3A – Fig. 3B which teaches the combination of the cannabinoid CBD with beta-caryophyllene. Biro on p. 106 embodiment 19 contemplates compositions comprising CBD in a range of 1-10%.
Regarding beta-caryophyllene (BCP), Biro in para. [0237] teaches that “(E)-BCP is also a selective full agonist at the CB2 receptor, which make it the only phytocannabinoid found outside the cannabis genus. Recent studies have suggested BCP functionality in multiple physiological processes, including anti-inflammatory, analgesic, alcohol craving reduction, anti-cancer, anti-anxiety, and anti-depressant activities.” Biro cites to a Klauke where it states “Klauke et al. 2014 ‘The cannabinoid CB2-receptor-selective phytocannabinoid beta-caryophyllene exerts analgesic effects in mouse models of inflammatory and neuropathic pain”.
Sinai on p. 27 teaches compositions comprising cannabinoids as cannabis oil with the antioxidant tocopherol, shown below.
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Sinai on p. 6 also states “It is also an object of the present invention to provide a composition as mentioned above wherein the composition further comprises an additional lipophilic solvent or suspension carrier.” Sinai includes medium-chain triglycerides (6 to 12 carbon length) and short-chain triglycerides as possible lipophilic solvents and/or carriers. Therefore, Sinai contemplates medium chain glycerides (and mixtures of medium chain glycerides) within a lipophilic carrier.
Both Biro and Sinai are drawn to cannabinoid compositions. One of ordinary skill in the art would find it obvious to modify the components of one composition with components from the other. Specifically, one of ordinary skill in the art would find it obvious to modify the composition of Sinai to include the combination of CBD and BCP in order to include the properties of BCP into Sinai’s composition.
Neither Biro or Sinai discuss high CBC content extracts. However, botanical extracts high in CBD are known within the art as addressed by Whittle.
Whittle is drawn to a “cannabinoid rich extract that is substantially free of volatile terpenes…” (abstract).
Whittle on p. 36, Table 1 teaches an extract (example 4) that contains CBD at 98% with 1.5% THC, and 0.5% CBN.
Additionally, Whittle in p. 30-43, teaches a number methods of extracting cannabinoid isolates, including CBD isolates, resulting the in the extracts of Table 1.
Whittle therefore indicates that extracts containing high purity CBD as well as methods to perform these extractions are well known within the art. Whittle also details its methods sufficiently such that one of ordinary skill may optimize the extraction methods (see p. 37, example 5).
Whittle, Table 1
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While the critical difference between the Whittle reference and the instant claims is the amount of THC and cannabinol (CBN) within the Whittle extracts, one of ordinary skill would be enabled to optimize the extraction methods via the teachings of Whittle. Additionally, regarding the Whittle extracts and the weight by volume percentages (w/v%) in claims 1, 11, 12, and 14, 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.
Therefore, it would have bene prima facie obvious at the time of the effective filing date for one ordinary skill in the art to modify the composition of Sinai via the teachings of Biro to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill would be motivated to make the modifications in order to include the properties of BCP into the cannabinoid composition of Sinai.
Pertinent Art not cited
Friedman (US20190298683 A1) teaches similar compositions that excludes triglycerides and liposomes.
Conclusion
No claims allowed.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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