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 .
Restriction/Election
Applicant’s election without traverse of Group I, claims 40 and 50-55 in the reply filed on 05/20/26 is acknowledged.
Claims 41-53 and 55-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/20/26.
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.
Claim(s) 40 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Kleidon et al. (WO2016/094810).
Kleidon teaches cannabinoid compositions that can be a or topical treatment or encapsulated and administered to a subject through oral consumption (abstract). This reference teaches specifically that the composition comprises (a) at least one cannabinoid compound and (b) at least one terpene compound present in an amount of at least about one microgram [0006]. Kleidon further teaches that the cannabinoid compositions that comprise β-Caryophyllene as the terpenoid, which acts as an essential oil, anti-inflammatory agent, an anti-tumor agent, and an analgesic, in amounts of up to 50 mcg in a capsule, 500 mg in a food product or at least 50% by weight [0092, 0054, 0070, Claim 12]. This reference further teaches that the cannabinoid compositions add pregnenolone for its anti-inflammatory and analgesic effects, as well as protect subjects from cannabis intoxication, where the compositions comprises between about 1 mg and 50 mg of pregnenolone [0025, 0134, example 7, claims 53-54]. This reference teaches that the cannabidiol compositions are used to treat various conditions, including inflammation, pain, sleep disorders and anxiety. Among others [0096].
The difference between the prior art and the instant claims is that the prior art does not reduce to practice an embodiment having both pregnenolone and β-caryophyllene together.
However, it would have been obvious to one of ordinary skill in the art the filing date of the invention to have combined pregnenolone with β-caryophyllene in a cannabinoid composition because Kleidon teaches that pregnenolone protects from intoxication and β-caryophyllene treats inflammation and acts as an analgesic. One would be motivated to combine the two components because Kleidon teaches that β-caryophyllene is also useful in encapsulated compositions that treat inflammation and pain, while pregnenolone also reduces the intoxication associated with the therapeutic effects of β-caryophyllene and other cannabinoids. As such, there is a reasonable expectation of success that the β-caryophyllene and pregnenolone composition taught by Kleidon will effectively treat inflammation and pain when administered in a composition together.
This meets the limitations of claim 40 and 55 by teaching a pharmaceutical composition comprising pregnenolone and β-caryophyllene together in a composition. As to the limitation “CB2 receptor agonist,” this is inherent to β-caryophyllene. The MPEP states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id.
As such, the CB2 receptor agonist activity of β-caryophyllene is inherent to the terpene itself, and the art is not required to teach its specific mechanism of action on the CB2 receptor.
Other Relevant Prior Art
Ceccarelli et al. teach that b-caryophyllene (BCP), an ancient remedy to treat pain, is a sesquiterpene found in large amounts in the essential oils of various spice and food plants that binds to the CB2 receptor, acting as a full agonist to decrease pain behaviors in a model of repeated inflammatory pain. (Frontiers in Neuroscience. August 2020, Volume 14 , Article 850).
Alberti et al. teach that β-caryophyllene (BCP), a cannabinoid receptor type 2 (CB2)-selective phytocannabinoid, has been shown to exhibit both anti-inflammatory and analgesic effects in mouse models of inflammatory and neuropathic pain. (Int J Mol Sci. 2017 Apr 1;18(4):691).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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