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 .
International Search Report
No International Application was found corresponding to the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1,3,5-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Woelfel et al (US 2019/0015383).
Claims 1 and 13: Woelfel et al discloses compositions comprising a mixture of purified cannabinoid compounds (active ingredient), at least one carrier oil, and at least one water soluble agent (Abs, [0008], [0009]). In some embodiments , the composition is an aqueous emulsion, a film coating or particles ([0009], [0013]). In some embodiments, the mixture is applied to a substrate, such as a food product, as a film and dried ([0017], [0071], [0073]), therefore, adsorption to the exterior of the substrate would have been obvious to one of ordinary skill in the art. Exemplary substrates include tea leaves, including herbal teas such as mint, chamomile, etc. [0073], which include claimed botanical substrates. The emulsion may be dried to form a flowable powder ([0081]-[0082]).
When applied to the substrate, the film may provide a dose ranging from about 0.5 to about 50.0 or more mg cannabinoids per g substrate [0076], or from 0.05 to from 5 or more percent by mass, which significantly overlays the claimed range. In an example, the dried particles formed had an average diameter of 187.6 mm, or 0.1876 mm ([0149]-[0151], Example 6), which lies inside the claimed particle size range. The thin coating is assumed to add only a minor contribution to the particle size of the substrate, therefore one of ordinary skill in the art would have found it obvious to obtain a claimed particle size of the substrate.
Absent convincing evidence of unexpected results commensurate in scope with the claims, it would have been obvious to one of ordinary skill in the art to form a coated botanical substrate as claimed.
Claim 3: Suitable cannabinoids that can be provided in the compositions include D-9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerol, cannabichromene, cannabicyclol, cannabivarin, cannabielsoin, cannabicitran, cannabigerolicacid, cannabigerolicacidmonomethylether, cannabigerolmonomethylether, cannabigerovarinicacid, cannabigerovarin, cannabichromenicacid, cannabichromevarinicacid, cannabichromevarin, cannabidolicacid, cannabidiolmonomethylether, cannabidiol-C4, cannabidivarinicacid, cannabidiorcol, D-9-tetrahydrocannabinolic acid A, D-9-tetrahydrocannabinolic acid B, D-9-tetrahydrocannabinolicacid-C4, D-9-tetrahydrocannabivarinicacid, D-9-tetrahydrocannabivarin, D-9-tetrahydrocannabiorcolicacid, D-9-tetrahydrocannabiorcol, D -7-cis-isotetrahydrocannabivarin, delta-8-tetrahydrocannabiniolicacid, delta-8-tetrahydrocannabinol, cannabicyclolicacid, cannabicylovarin, cannabielsoicacid A, cannabielsoicacid B, cannabinolicacid, cannabinolmethylether, cannabinol-C4, cannabinol-C2, cannabiorcol, 10-ethoxy-9-hydroxy-delta-6a-tetrahydrocannabinol, 8, 9-dihydroxy-delta-6a-tetrahydrocannabinol, cannabitriolvarin, ethoxycannabitriolvarin, dehydrocannabifuran, cannabifuran, cannabichromanon, cannabicitran, 10-oxo-delta-6a-tetrahydrocannabinol, delta-9-cistetrahydrocannabinol, 3, 4, 5, 6-tetrahydro-7-hydroxy-alpha-alpha-2-trimethyl-9-npropyl-2, 6-methano-2H-1-benzoxocin-5-methanol-cannabiripsol, trihydroxy-delta-9-tetrahydrocannabinol, cannabinol, and derivative thereof [0025], which includes most of the claimed compounds.
Absent convincing evidence, selecting one or more of the claimed cannabinoids would have been obvious to one of ordinary skill in the art with a reasonable expectation of obtaining a suitable coated botanical composition.
Claim 5: Woelfel et al discloses that the purified cannabinoid mixture is distilled from a natural cannabis extract and comprises less than 5.0% by weight terpene compounds [0121]. Therefore, the active ingredient (cannabinoid) is a cannabis extract, distillate or isolate.
Claim 6: Woelfel et al discloses D-9-tetrahydrocannabinolic acid A, as a suitable cannabinoid. Absent convincing evidence of unexpected results commensurate in scope with the claims, selecting purified tetrahydrocannabinolic acid A as an active ingredient would have been obvious to one of ordinary skill in the art with a reasonable expectation of obtaining a suitable coated botanical composition.
Claim 7: Woelfel et al discloses that the purified cannabinoids comprise retained terpenes ([0033], [0036]), therefore are sources of terpenes.
Claim 8: The retained terpenes are cannabis-derived or botanically-derived since they are in the purified cannabinoids..
Claim 9: Woelfel et al discloses that the composition may comprise from about 0.5% to about 50.0% by weight, from about 1.0% to about 40.0% by weight of the purified cannabinoid mixture [0055]. The disclosed range subsume or lie within the claimed range. Therefore, it would have been obvious that to include at least one of the purified cannabinoids in an amount between 0.2 and 10 percent by mass.
Claim 10: Woelfel et al discloses that the composition can comprise at least one antioxidant, flavoring agent, sweetener, coloring agent, food preservative, or combination thereof [0011]. The antioxidant, flavoring agent, sweetener, coloring agent, food preservative, or combination comprise non-solvent like substances.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Woelfel et al as evidenced by Simiyu et al (Understanding Cannabis sativa L.: Current Status of Propagation, Use, Legalization, and Haploid-Inducer-Mediated Genetic Engineering).
Claim 2: Woelfel et al does not disclose that the botanical substrate is Cannabis sativa L. Simiyu et al teaches that Cannabis sativa L is hemp or marijuana (Introduction) and cannabis smoking has been in existence for thousands of years and is widely used today for recreation (p 9, last paragraph bridging to p 10).
Cannabis sativa L would have been an obvious to select for the substrate of Woelfel et al as a widely known smokable substrate material.
Claim 4: Woelfel et al discloses that the composition may comprise from about 0.5% to about 50.0% by weight, from about 1.0% to about 40.0% by weight of a purified cannabinoid mixture as described herein [0055]. The disclosed ranges subsume or lie within the claimed range.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Woelfel et al in view of Brunson (US 2021/0137156).
Woelfel et al does not disclose a smokable container comprising the composition. Brunson teaches what is widely known to those of ordinary skill in the art, Brunson teaches that Cannabis plant matter is often vaporized and inhaled through smoking. Typically, the Cannabis plant matter is wrapped and rolled into a smokable cylindrical roll (smokable container) similar to a cigarette and referred to as a joint, blunt, cigarette, spliff, or other terms.
The plant matter used as a filler in the cylindrical rolled joint/blunt may be from the Cannabis plant or a mixture of Cannabis plant matter and tobacco plant matter [0008].
It would have been obvious to one of ordinary skill in the art to include the composition of Woelfel et al in a smokable container for smoking as a common use for cannabis containing compositions.
Pre-rolled blunts and cones are commercially available products for smokers who wish to fill them with preferred fillers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS R CORDRAY whose telephone number is (571)272-8244. The examiner can normally be reached Monday-Friday 8 AM-5 PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abbas Rashid can be reached at (571) 270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS R CORDRAY/Primary Examiner, Art Unit 1748
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