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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
Claims contain subject matter not disclosed in provisional application 63/353,422. Claims include limitations directed towards a comminuted cannabis plant material and heating the cannabis extract to a temperature of between about 60C and about 120C. These limitations are not supported in the previously filed provisional application. The effective filing date of the claims in the current application is that of the PCT 6/16/2023.
Claim Objections
Claims 30, 32, and 35 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, 7, 11, 15-16, 26-32, 35, 43, 47-51, and 55 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "substantially liquid or flowable state" renders the claim indefinite. It is unclear what material state would read on this limitation. The specification at par. 115 includes a discussion of what “may” constitute the meaning of such a limitation but the scope of the claim remains unclear. It is unclear if the limitations “substantially liquid” and “flowable state” are intended to encompass the same meaning or if “flowable state” includes materials that are solid/powdered or in vapor form. Further, it is unclear at what state something would read on “substantially liquid”. What amount of liquid would need to be present to be considered substantially liquid? Does it just need to have some amount of liquid or does it just need to flow when heated to be considered substantially liquid.
Regarding claims 26 and 29, the phrase "the step of mixing" renders the claim indefinite as it does not have proper antecedent basis in claim 1. Claim 1 refers to simultaneous mixing and continued mixing but it is unclear which mixing is being referred to.
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 (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 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)(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, 3-4, 7, 11, 15-16, 29-32, 35, 43, 47, 51, and 55 are rejected under 35 U.S.C. 102(a2) as being anticipated by Fletcher et al. (WO2023/115215A1).
Regarding claim 1, Fletcher teaches a method for preparing a homogeneous extract-infused cannabis biomass (abstract) , the method comprising: providing a cannabis extract having a predefined concentration of at least one extract-derived cannabinoid, at least one extract-derived terpene, or any combination thereof, wherein the cannabis extract is a distillate (par. 57-80: CBD Distillate is sprayed onto the dryed cannabis material.); providing a cannabis plant material having a predefined concentration of at least one plant-derived cannabinoid, at least one plant-derived terpene, or any combination thereof, wherein the cannabis plant material is a milled or comminuted cannabis plant material (par. 61: Dried cannabis can be cut/trimmed/milled prior to application of extract.); in sequence: i. heating the cannabis extract at a temperature of between about 60° C. and about 120° C. to provide a heated cannabis extract, wherein the heated cannabis extract is in a substantially liquid or flowable state (par. 73-75: Extract can be heated to about 60C as well as other ranges that anticipate the claim in order to control the viscosity of the extract for preparation of spraying.); ii. applying the heated cannabis extract, while in its heated state, to the cannabis plant material using a predefined ratio of the cannabis plant material to the heated cannabis extract to provide an extract-applied plant material, wherein the predefined ratio provides a target amount of at least one biomass cannabinoid, at least one biomass terpene, or any combination thereof within the extract-applied plant material (par. 57-80: Extract is applied to cannabis material in order to form a biomass with a desired composition.), wherein the applying is by pouring, sprinkling or showering the heated cannabis extract onto the cannabis plant material with simultaneous mixing of the cannabis plant material (par. 67: Mixing is performed while spraying/showering or dropping/sprinkling the extract onto cannabis material.); and iii. continuing to mix the extract-applied plant material to provide a homogeneous extract-infused cannabis biomass, wherein there is less than a 15% variability in a target concentration of the at least one biomass cannabinoid, the at least one biomass terpene, or any combination thereof throughout a prepared batch and/or between alternate batches of the homogeneous extract-infused cannabis biomass. (par. 57-80, and claim 1: Mixing and application of extract is completed in order to form homogenous end product. Further, When the claimed and prior art products are identical or substantially identical are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01.)
Regarding claims 3, 4, and 7, Fletcher teaches mixing and application of extract is completed in order to form homogenous end product. (par. 57-80 and claim 1) Further, When the claimed and prior art products are identical or substantially identical are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01.
Regarding claim 11, Fletcher teaches wherein the target amount is of the at least one biomass cannabinoid, and the target amount is obtained by a combination of the at least one extract-derived cannabinoid and the at least one plant-derived cannabinoid. (par. 57-80)
Regarding claim 15, Fletcher teaches a step of providing at least one additive to the cannabis extract prior to the applying of the heated cannabis extract to the cannabis plant material. (par. 60)
Regarding claim 16, Fletcher teaches wherein the at least one additive comprises at least one additive terpene, at least one additive cannabinoid, or any combination thereof, wherein the at least one additive is added to the cannabis extract at a predefined amount. (par. 60)
Regarding claim 29, Fletcher teaches after the mixing, a step of screening the homogeneous extract-infused cannabis biomass to improve homogeneity. (par. 78)
Regarding claim 30, Fletcher teaches wherein the applying is by pouring, sprinkling or showering the heated cannabis extract onto the cannabis plant material. (par. 58)
Regarding claim 31, Fletcher teaches wherein the mixing is by rotational mixing, blending, stirring, beating, kneading, or any combination thereof of the extract-applied plant material, and is manual, machine operated and/or automated. (par. 64)
Regarding claim 32, Fletcher teaches wherein the applying and the mixing steps are performed simultaneously. (par. 57-80)
Regarding claim 35, Fletcher teaches wherein in the step of heating the cannabis extract, the temperature is between about 60° C. and about 120° C. (par. 73-75)
Regarding claim 43, Fletcher teache wherein the target amount of the biomass cannabinoid is of Δ9-THC, CBD, CBG, any neutral versions thereof, or any combination thereof. (par. 27)
Regarding claim 47, Fletcher teaches wherein the cannabis plant material is dried flower. (par. 61)
Regarding claim 50, Fletcher teaches forming a target concentration of the formed product. The combination of the extract and cannabis material would fit into the claimed equation. (par. 27, 58, and examples provided)
Regarding claim 55, Fletcher teaches wherein the variability in the target concentration of the at least one biomass cannabinoid, the at least one biomass terpene, or any combination thereof is throughout the prepared batch and between alternate batches. (par. 57-80 homogenous distribution)
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.
Claims 26-28 and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (WO2023/115215A1) in view of Yuri et al. (WO2018015886A1)
Regarding claims 26-28, Fletcher does not explicitly teach wherein the step of mixing the extract-applied plant material comprises a step of freezing or cooling the extract-applied plant material, which comprises freezing the extract-applied plant material at a temperature between about −30° C. to about −10° C. to produce a frozen extract-applied plant material, and further comprising mixing the frozen extract-applied plant material to provide the homogeneous extract-infused cannabis biomass.
However, Yuri teaches a similar method of producing a cannabis products. Yuri teaches that it is known in the art to freeze the cannabis plant material for temperatures including a range of less than -20C prior to homogenization/milling/sieving/mixing. (abstract, par. 59, 117, 121, and claim 42)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have applied the frozen processing of Yuri, to the method of Fletcher, in order to prolong preservation of the cannabis material during processing.
Regarding claims 48 and 49, Fletcher does not explicitly teach wherein the milled or comminuted cannabis plant material is of a particle size of less than or equal to 5.0 mm, and wherein the particle size is between about 100 μm and about 3.5 mm.
However, Yuri teaches a similar method of producing a cannabis products. Yuri teaches that it is known in the art to use plant material with a paritzle size of .3-4.2mm. (abstract)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have particle size of Yuri, to the method of Fletcher, as it would be simple substitution providing the known result of producing a similar cannabis product.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (WO2023/115215A1).
Regarding claim 51, Fletcher does not explicitly teach wherein a length of time for the heating of the cannabis extract is calculated using the claimed equation.
However, Fletcher teaches heating to reduce the viscosity of the extract. (par. 67)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have determined the appropriate amount of time to provide a heat in order to control the viscosity of the extract to optimize spraying. Further, calculation of heat transfer using the widely known heat transfer equation would also be known in order to calculate time necessary to change the temperature of the extract needed to achieve a temperature that achieves an appropriate viscosity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIME A ABRAHAM whose telephone number is (571)270-5569. The examiner can normally be reached 9AM-5PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marivelisse Santiago-Cordero can be reached at 571-272-7839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIME A ABRAHAM/Supervisory Patent Examiner, Art Unit 3761
