DETAILED ACTION
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 .
Election/Restrictions
Applicant’s response to the restriction/ election requirement from 5/4/2026 is acknowledged. Applicant has made the following election without traverse.
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The Examiner notes that claim 17 is a related claim, and has also been joined it. The Examiner also notes that according to claim 12, the dosage form of the composition is a capsule, which is not compatible with a tobacco filter, and hence this claim cannot be reading on the elected species. Accordingly, claims 12, 18-29 and 32 have been withdrawn from consideration as directed to a non-election invention and species. The restriction/ election requirement is hereby MADE FINAL. Claims 1, 11-12, and 15-17 are pending, and have been examined herewith to the extent of Applicant’s elected species.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al., β-Caryophyllene, a dietary terpenoid, inhibits nicotine taking and nicotine seeking in rodents, Br J Pharmacol, 2020 May;177(9):2058-2072 (“He”).
He discloses as a way of background and purpose that: “β-Caryophyllene (BCP) is a plant-derived terpenoid used as a food additive for many decades. Recent studies indicate that BCP is a cannabinoid CB2 receptor agonist with medical benefits for a number of human diseases. However, little is known about its therapeutic potential for drug abuse and addiction.” Per He, they systematically evaluate the effects of BCP on nicotine-taking and nicotine-seeking behaviour in animal models of drug self-administration, electrical, and optical brain-stimulation reward. He reports that: “Systemic administration of BCP dose-dependently inhibited nicotine self-administration and motivation for nicotine seeking in rats and mice. . . The present findings suggest that BCP has significant anti-nicotine effects via both CB2 and non-CB2 receptor mechanisms and, therefore, deserves further study as a potential new pharmacotherapy for cigarette smoking cessation.” (Abstract). He reports that BCP was dissolved in 5% Cremophor. (p. 2060, col. 2).
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.
Claims 11, 13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over He et al., β-Caryophyllene, a dietary terpenoid, inhibits nicotine taking and nicotine seeking in rodents, Br J Pharmacol, 2020 May;177(9):2058-2072 (“He”), as applied to claim 1 in the 35 U.S.C. 102(a)(1) rejection above, and further in view of WO 2019/183731 A1 to Daley (“Daley”, of record).
He is discussed in the 35 USC 102(a)(1) rejection above.
The findings of suggest that BCP has significant anti-nicotine effects via both CB2 and non-CB2 receptor mechanisms and, therefore, deserves further study as a potential new pharmacotherapy for cigarette smoking cessation. He does not, however, disclose additionally formulating the composition of CBP as a tobacco product/ filter.
Daley relates to “A device and a method of making a device that includes a mouthpiece, a filter containing terpenes, and a cigarette holder. The mouthpiece has a mouth opening and far opening connecting therewith. The filter fits within the mouthpiece's far opening. . . During inhalation, airflow from the cigarette's end portion is drawn through the holder's near opening and across the filter, thus releasing the terpenes released for inhalation, with smoke through the mouth opening.” (Abstract). The terpenes are selected from the group consisting of myrcene, limonene, linalool, caryophyllene, pinene, alpha-bisabolol, eucalyptol, trans-nerolidol, humulene, delta 3 carene, camphene, borneol, terpineol, valencene, and geraniol. (claim 3).
The device includes one or more terpenes. ([0022]). The additional terpenes are a fragrance. “[0008] Some of the distinctive fragrances and flavour in cannabis - and advantageous effects from terpenes - may be owing, at least in part, to the presence of one or more of the following terpenes (among others): myrcene; limonene; linalool; caryophyllene, including beta-caryophyllene; pinene, including alpha-pinene and beta-pinene; alpha-bisabolol, also known as levomenol and bisabolol; eucalyptol; trans-nerolidol; humulene; delta 3 carene; camphene; borneol; terpineol; valencene; and geraniol.”
Daley discloses[0011 ] Terpenes may alter the effect of the cannabinoids. Terpenes and cannabinoids may act together to create a combined effect which may be experienced with freshly-cured cannabis, but which may be lost with older dried plant material, concentrates, and/or oils. Research may suggest the effect of THC may be diminished at 25% terpene content, but may be restored when the terpene profile is returned to its original 100% concentration. [0012] It may be advantageous and/or desirable to use introduce and/or reintroduce terpenes, such as cannabis terpenes, when smoking a cigarette (e.g., a tobacco and/or cannabis cigarette). a number of benefits of smoking marijuana together with terpenes: “
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the disclosure of He and Daley in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to create a composition of CBP as a tobacco product/ filter, guided by the desire to create pharmacotherapy for smoking cessation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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