DETAILED ACTION
Election Acknowledged/ Status of Application
Applicants’ election without traverse the invention of Group I encompassing claims 1-15 and 26 is acknowledged. The restriction is made final without traverse.
It is noted that the claims lack a “claim 9” and an objection to this deficiency is made below. For purposes of examination, claims will be examined according to how they are presently presented.
Claim Objections
Claims 10-26 are objected to because of the following informalities: they are not appropriately numbered as the claim listing fails to include a claim 9. Claim 10 should read as claim 9 and later claims should be similarly corrected. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 10-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Macleman et al. (US 2021/0290552).
Macleman describes a formulation comprising at least one cannabinoid in an amount of between 5-10 wt% (see [0088]), 5-10 wt% of at least one emulsifier (see [0093]), about 2% of a solvent (see [0091]) and a filler/binder in an amount of 50-60 wt% (see [0095]) (see instant claim 1). It is observed that the wt% of cannabinoids and emulsifier encompasses ratios of 2:1 to 1:2 (10:5 to 5:10) (see instant claim 12). See MPEP 2131.03 regarding the anticipation of ranges.
The cannabinoids may be extracted from Cannabis (i.e. exogenous cannabinoid) (see [0004, 0057]) (see instant claims 2 and 3) or a cannabinoid such as 2-arachidonoylglycerol (i.e. endogenous cannabinoid) (see [0010]) (see instant claims 2 and 4). The composition may be in the form of a liquid and this would require the cannabinoid be similarly in such a state (see [0004, 0056]) (see instant claim 5). Alternatively, Macleman also teaches that the composition may be in the form of tablets and powders (see [0027]) (see instant claim 10).
Additional cannabinoids include cannabidiol (CBD), cannabichromene and delta 9-tetrahydrocannabinol (see [0010, 0012]) (see instant claims 6 and 7). The CBD of Macleman is expected to overlap with the forms described under instant claim 7, e.g. isolate, broad-spectrum, full-spectrum, as the CBD of Macleman is identical to the CBD of the claims.
Claim 11 provides that the composition ‘is capable of forming a stable emulsion’ when mixed with water. This is an intended use limitation as it provides an outcome for when the composition is used in a specific way. See MPEP 2111.02(II). Moreover, because the composition described by Macleman is identical to that claimed, the property of being suitable to forming a stable emulsion would be inherent. See MPEP 2112.01.
The composition is to exhibit improved bioavailability of cannabinoids upon administration. Regarding instant claim 13, this is an outcome of an intended use (ingestion) and not a property of the composition itself and does not structurally limit the composition itself. See MPEP 2111.02(II) regarding intended use limitations. Claim 14 is similarly an intend use claim as it provides an outcome of a potential method of use but does not limit the composition itself.
Regarding instant claim 15, the outcome of having “75% by weight of the one or more cannabinoids present in the composition are transferred into the water and can be recovered therefrom.”, this is ultimately an intended use limitation as the outcome requires the process step of “dispersing and/or solubilizing” a quantity of the composition in water. The identified outcome is tied to the intended use of the composition. Moreover, because the composition described by Macleman is identical to that claimed, the property claimed would be overlapping. See MPEP 2112.01.
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 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 1-8, 10-15 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macleman et al. (US 2021/0290552; of record) in view of Murty et al. (US 2007/0104741).
Macleman is relied upon for disclosure described in the rejection of claims 1-7 and 10-15 under 35 U.S.C. 102(a)(2).
Macleman fails to teach the emulsifier as being a surfactant having an HLB of 6-20 and a solvent as being polyethylene glycol (PEG) and derivatives thereof, propylene glycol, glycerin, and so on.
Murty, like Macleman, is directed to a self-emulsifying cannabinoid composition. The composition comprises 1-80% a cannabinoid, 5-50 wt% a solvent and 10-80 wt% a surfactant (i.e. emulsifier) (see [0046]). The surfactant is to have an HLB of between 11-12 which is described providing optimal performance to the composition (see [0177]) (see instant claim 8). Exemplified solvents useful in Murty’s self-emulsifying composition include dimethylacetamide, polyethylene glycol and propylene glycol (see [0074]) (see instant claim 26). It would have been obvious to modify Macleman’s formulation such that the emulsifier employed had an HLB of 11-12 so as to provide optimal performance and the solvent include that of dimethylacetamide, polyethylene glycol and/or propylene glycol with a reasonable expectation for success in producing a self-emulsifying cannabinoid composition. See MPEP 2143(I)(A) which states that combining prior art elements according to known methods to yield predictable results is supportive of obviousness.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611