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 08/06/2025 states that the instant application is a 371 of PCT/US2021/030671, filed 05/04/2021, which claims benefit of provisional applications 63/025,663, filed 05/15/2020 and 63/019,840 filed 05/04/2020.
The ‘840 provisional application supports non-elected claims. The ‘663 application, however, supports claims 15-19. Therefore, the instant application has an effective filing date of 05/15/2020.
Information Disclosure Statement
The information disclosure statement (IDS) received 02/17/2023 has been considered.
Restriction/Species Election
Applicant’s election of Group IV without traverse in the remarks submitted 12/12/2025 is acknowledged. Applicant’s election of the species cannabidiol, caryophyllene, and further comprising cannabigerol is acknowledged.
Claims 1-20 are pending and claims 15-19 are under examination. Claims 1-14 and 20 are withdrawn from further consideration being drawn to non-elected subject matter.
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 Rationale
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) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeze (US20200085959), in view of Dorman (J. Essential Oil Res., 12, 241-248, 2000), Klumpers (Journal of AOAC Intl. Vol. 102, No. 2, 2019), and Karelis (AU2017305103).
Claim 15 is drawn to an anti-inflammatory cannabinoid composition comprising at least two of but less than five of the species selected from cannabidiol, cannabidiolic acid, caryophyllene, pinene, and combinations thereof.
Dependent claim 16 specifies the selection of one cannabinoid from the group consisting of cannabidiol and cannabidiolic acid and the selection of one terpene from the group consisting of caryophyllene, pinene, and humulene.
Dependent claim 17 further comprises cannabigerol.
Dependent claims 18 and 19 are drawn to forms of the composition. Claim 18 specifies forms which are a tincture, an injectable solution, or a suppository. Claim 19 claims a dry powder form suitable for administration via nebulizer.
Regarding claims 15-17, Freeze in claim 9 claims a terpene infused topical cream composition comprising a terpene blend, cannabidiol, and further comprising cannabigerol. Freeze in para. [0023] contemplates a composition comprising i) an isolated terpene selected from the group consisting of geraniol, citronellol, geranial, citronellal, linalool, menthone, rose oxide, alpha-terpineol, ii) cannabidiol or a combination of cannabinoids which includes cannabidiol and cannabigerol.
Freeze in para. [0009] also states that the composition of its invention is “useful for treatment of inflammatory skin disorders and conditions.”
Freeze does not contemplate caryophyllene. Freeze is drawn to an antioxidant topical cream and does not explicitly discuss other forms of its composition. This is addressed by the combination of Dorman, Klumpers, and Karelis.
Dorman is drawn to the In vitro Antioxidant Activity of Plant Essential Oils and Phytoconstituents (title). Dorman on p. 247, Table II lists the antioxidant activity of phytoconstituents caryophyllene, citronellal, linalool, menthone, and (+)-Terpinene-4-ol (closest molecule to alpha-terpineol, structures shown below).
Alpha-Terpineol and Terpinene-4-ol
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218
314
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178
124
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The antioxidant potential of caryophyllene (7.77±0.98 mmol/L) is less than the antioxidant potential compared to citronellal (22.50±5.67 mmol/L), linalool 14.29±0.10 mmol/L), and menthone (13.09±2.32 mmol/L), but is similar to that of Terpinene-4-ol (7.62±1.14 mmol/L) and other constituents similar to terpineol. Additionally, caryophyllene is a known terpene (specifically, sesquiterpene) compound as are citronellal, linalool, menthone, and alpha-terpineol. One of ordinary skill in the art would find it obvious to modify the composition of Freeze to instead use caryophyllene because a) caryophyllene would be considered an alternative species and b) the antioxidant potential of caryophyllene would be similar to alpha-terpineol.
Regarding claim 18, Klumpers is drawn to the historic use of the cannabis plant as a medicine. Klumpers on p. 412, para. 1 states “Cannabis originated in Central Asia, and it is one of the oldest plants used for medicinal purposes. In almost every ancient handbook on plant medicine, it is references, most commonly in the form of a tincture or a tea”. Klumpers on p. 413, sec. Cannabinoids and Terpenes then shows that the cannabis plant contains compounds cannabidiol, cannabigerol, and β-caryophyllene. Together, this teaching at least implies that tinctures of the compounds cannabidiol, cannabigerol, and β-caryophyllene are well known within the art and one of ordinary skill would know how to make tincture forms of the compounds by themselves or in combination with each other.
Karelis is drawn to pharmaceutical compositions comprising cannabinoids including cannabidiol and/or cannabigerol and terpenes including caryophyllene. Karelis in para. [0020] teaches compositions comprising the either of the following:
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290
356
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Karelis in para. [0021] contemplates a terpene fraction comprising
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132
574
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While Karelis does not teach combinations of the CBD, CBG, and caryophyllene, Karelis on p. 19, para. [0079] at least contemplates dry powder forms formulated for administration via an inhaler. Karelis in this paragraph teaches that “the active ingredients may be provided in the form of a dry powder, for example a powder mix of the compound in a suitable powder base such as lactose starch, starch derivatives such as hydroxypropylmethyl cellulose [HMPC] and polyvinylpyrrolidone (PVP).” Therefore, one of ordinary skill in the art is enabled to formulate dry powder compositions for administration via nebulization.
Freeze teaches a topical composition comprising at least cannabidiol, cannabigerol, and a terpene. Dorman teaches the antioxidant capabilities of caryophyllene compared to other terpenes. While Dorman indicates that caryophyllene is has weaker antioxidant properties, the reference shows that it would not be unreasonable to modify the composition of Freeze to include caryophyllene in place of the other terpenes as caryophyllene has antioxidant properties and it is known as an alternative species of terpenes. Tinctures of cannabis extracts are well known within the art, as taught by Klumpers, and one of ordinary skill would find a combined tincture of cannabidiol, cannabigerol, and caryophyllene obvious. Similarly, Karelis teaches how to formulate cannabis compounds, such as cannabigerol and cannabidiol, and terpene compounds, such as caryophyllene, into a dry powder formulation for nebulizers. The art teaches the elements of the claims and also teaches how to formulate said elements into tincture forms and dry powder forms. Motivations to make the modifications is outlined in the KSR rationale above and are A) combining prior art elements according to known methods to yield predictable results and (B) simple substitution of one known element for another to obtain predictable results
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 modified the composition of Freeze via the teachings of Dorman, Klumpers, and Karelis to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill in the art would find motivation to make the modifications as the art teaches predictable results of combining the teachings.
Examiner’s Comments
The anti-inflammatory properties of cannabidiol and cannabigerol are discussed in Atalay (Antioxidants, 2020, 9, 21, published 2019) and Dahham (Molecules and Medicinal Chemistry, 2015; 1).
Conclusion
No claims allowed.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624