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
Response to amendments
The amendments made to the specifications 07/28/2026 have been entered.
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 solvent comprising β-caryophyllene (BCP), a mixture of C8-C10 triglycerides, and α-tocopherol (vitamin E) from about 0.1 % w/v to about 5% w/v. 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.
Response to Arguments
Applicant points to the parent PCT application which states “Surprisingly, the inventors have found that β-caryophyllene (BCP) is effective to both solubilize and stabilize CBD in a composition according to the present invention such that an acceptable shelf-life can be obtained with very few other ingredients.”
This is not sufficiently persuasive because the only discussion within the instant specification regarding “shelf life” is drawn to embodiments of the instant composition.
Para. [0011] states the quoted text above.
Para. [0062] states “Surprisingly, the inventors have found that BCP is a highly effective solvent and stabilizer for CBD when used in combination with at least one additional lipophilic solvent in the amounts described herein. For example, at least 300 mg of CBD can be dissolved in 1 mL of BCP. The enhanced stability of the CBD provides a composition with an acceptable shelf life and which can provide consistency in dosing and enhanced safety.”
Para. [0085] contemplates an embodiment and “The choice and amount of the excipient(s) can be readily determined by one skilled in the art and will depend on the other ingredients in the composition, the desired properties of the final composition, oral route of administration, and need for a stable final product with the desired shelf-life.”
The last remaining mention of shelf life is found on p. 28 in regards to the shelf life of medium chain triglyceride.
There is no direct comparison of the instant composition to similar compositions with other emulsifiers known within the art.
Applicant then argues that “The cited art does not teach or suggest the claimed lipophilic solvent, its recited ratio, and compositions substantially free of emulsifiers, surfactants, other cannabinoids, and other terpenes.”
Applicant argues that “Biro employs BCP as a pharmacologically active agent” and therefore, does not disclose BCP as a solvent or a vehicle. Additionally, applicant argues that Biro is silent on the ratio of BCP to a solvent or carrier.
Regarding Sinai, applicant argues that “in Sinai, medium chain triglycerides are only one option among a lengthy menu of alternative options for optional and optional lipophilic solvents/carriers” and that “Sinai does not pair MCTs or other lipophilic solvents with BCP or recite any BCP to MCTs ratio.”
Applicant further argues that “modifying the composition of Sinai to include the combination of CBD and BCP would lead to compositions that are outside of the scope of the instant claim 1. Applicant points to the examples provided in Sinai which require a phospholipid. Applicant states “To reach the claimed composition, the person skilled in the art would have to remove the emulsifier/surfactant (phospholipid) that define Sinai’s invention. A proposed modification that strips a reference of its essential features and would render it unsatisfactory for its intended purpose, or that changes its principle of operation, is evidence of non-obviousness” and that “Sinai accordingly teaches away from the claimed surfactant- and emulsifier-free composition.”
While the core of Sinai requires the phospholipid emulsifier, it does not necessarily teach away from removing the phospholipid portion. The crux of applicant’s argument relies on attacking the references individually. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection uses Sinai to show that the ingredient α-tocopherol is commonly used within the art as well as medium chain triglycerides. Additionally, the rejection contemplates not only addition of Biro to Sinai, but Sinai to Biro where it states “One of ordinary skill in the art would find it obvious to modify the components of one composition with components from the other.” Although the rejection states that one of ordinary skill would modify the composition of Sinai to include the combination of CBD and BCP, one of ordinary skill could alternatively add the tocopherol and triglycerides of Sinai to Biro.
The role of medium chain triglycerides is known within the art as discussed in Marangoni (Current Opinion in Food Science, 2019, 28:1-6). Marangoni on p. 3 states “The usual procedure for emulsion based encapsulation involves the dissolution of the cannabis oil in a suitable carrier oil. There are several choices, including the commercial vegetable oils or medium-chain triglycerides. Upon heating the cannabis oil will form a single phase in the oil and remain soluble.”
Similarly, Sinai teaches the use of α-tocopherol as an antioxidant within compositions.
The separate components and their use are known within the art and, as stated in the rejection, it would be obvious to combine them together to arrive at the instant claims.
Regarding applicant’s assertion that “the routine-optimization rationale is legally unavailable because the recited ratios are not disclosed, result-effective variables”, the applicant has not shown how the claimed ratio confers any properties that would distinguish the claimed invention as distinct from what would be known within the art. The claimed weight by volume percentages and the claimed ratios are arbitrary amounts that one of ordinary skill could easily arrive at via simple modifications. The rejection cannot be overcome by stating that the art is silent to a ratio or % w/v that imparts no distinguishing features that separate the claimed invention from what is known within the art.
The rejection is maintained.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
