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 .
Claim Status
Claims 1-17 are pending and being examined on the merits.
Information Disclosure Statement
The information disclosure statements do not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or do not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Specification
The incorporation of essential material in the specification by reference (at [0494]) to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because of the following informalities:
at [0143], line 10, the phrase “less diluted, and therefore, less potent” should instead read “more diluted, and therefore, less potent”; and
at [0494], line 6, a space is missing in the phrase “also incorporated”.
Appropriate correction is required.
Claim Objections
Claims 1-17 are objected to because “Cannabinoid Product” is not a proper noun and should be in lowercase. Additionally, “comprising” in dependent Claims 4, 6, 7, 12, and 13 should be rephrased as “further comprising”. Appropriate correction is required.
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 4, 6, 7, 12, and 13 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.
In Claim 4, the phrase “total non-cannabinoid solid ingredients” is indefinite because it is unclear what is meant by “total”: a specific type of non-cannabinoid solid ingredient, or the total amount of non-cannabinoid solid ingredients. It is recommended that the word “total” be removed to help clarify the claim meaning. Rephrasing the claim as follows, or in a similar manner commensurate in scope with the disclosure, would help clarify: “The solid cannabinoid product of claim 1 further comprising non-cannabinoid solid ingredients, wherein an amount of the non-cannabinoid solid ingredients is less than about 80% of the cannabinoid product by weight.”
Claims 6 and 12 recite the limitation “cyclodextrin.” Claims 7 and 13 recite the limitation “emulsifier.” There is insufficient antecedent basis for these limitations in the claims.
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 (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)(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.
Claims 1-7, 10-13, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vialpando et al. (WO 2020/222029 A1) as evidenced by Lee et al. (Biomaterials, 2011, 9434-9443).
The instant claims are as of record, drawn to a solid cannabinoid product comprising a non-crystalline cannabinoid oil loaded into colloidal silicon dioxide storage cavities wherein the ratio of non-crystalline cannabinoid oil to colloidal silicon dioxide is (0.5-3):1 by weight or wherein the non-crystalline cannabinoid oil is at least 30 w/w% of the colloidal silicon dioxide content, and a method of making thereof.
Vialpando et al., however, anticipate the claims by teaching a powder composition comprising a cannabinoid or cannabinoid mixture adsorbed onto at least one microporous silica ([008]). The mesoporous silica (e.g., colloidal silica, see e.g., Lee et al., Introduction, para. 3) comprises pores (internal storage cavities) and can be in particle form ([016]-[0018]; as required for instant Claims 1, 10, and 17). The cannabinoid comprises at least 80% cannabinoid by weight of the composition and the ratio of cannabinoid oil to mesoporous silica may be 14.3 wt% to 43 wt% (cannabinoid oil is 33.3% of the mesoporous silica content, or a 1:3 ratio; e.g., d9-THC of Example 2, Table 3 at [0141] is 85% purity; as required for instant Claims 2 and 10). Additionally, since the cannabinoid oil makes up 14.3% of the composition, the remaining ingredients are therefore 85.7% of the composition (about 80% ranges from 72-88%; see instant disclosure at [0034]; as required for instant Claim 4). The cannabinoid oil to mesoporous silica ratio may also be (2.6):1 by weight (e.g., Table 4, [0144]; as required for instant Claim 1), and the exemplary compositions do not comprise cyclodextrin or emulsifiers (e.g., less than 10%; as required for instant Claims 6, 7, 12, and 13).
The composition is made by heating the cannabinoid (e.g., non-crystalline cannabinoid oil, see instant disclosure [0194] and instant Claim 17) and mixing the cannabinoid and mesoporous silica such that the cannabinoid adsorbs the mesoporous silica (loaded onto; substantially loaded into; [023]; as required for instant Claims 1, 10, and 17). A surfactant may be added, however the cannabinoid (cannabinoid oil) is not dissolved in a non-cannabis solvent and can be heated in the absence of said surfactant, and no other solid material is present during loading ([0101], [0107]; as required for instant Claims 3, 5, and 11). The composition also comprises excipients such as lubricants, emulsifying agents ([0121]), and may be provided in solid dosage forms such as tablets or capsules ([0118]; as required for instant Claims 1, 10, and 17).
Claim Rejections - 35 USC § 102/103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Vialpando et al. (WO 2020/222029 A1) as evidenced by Lee et al. (Biomaterials, 2011, 9434-9443).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to a solid cannabinoid product comprising a non-crystalline cannabinoid oil loaded into colloidal silicon dioxide storage cavities wherein the ratio of non-crystalline cannabinoid oil to colloidal silicon dioxide is (0.5-3):1 by weight or wherein the non-crystalline cannabinoid oil is at least 30 w/w% of the colloidal silicon dioxide content, and a method of making thereof.
Vialpando et al. teach a powder composition comprising a cannabinoid or cannabinoid mixture adsorbed onto at least one microporous silica ([008]). The mesoporous silica (e.g., colloidal silica, see e.g., Lee et al., Introduction, para. 3) comprises pores (internal storage cavities) and can be in particle form ([016]-[0018]; as required for instant Claims 1, 10, and 17). The cannabinoid comprises at least 80% cannabinoid by weight of the composition and the ratio of cannabinoid oil to mesoporous silica may be 14.3 wt% to 43 wt% (cannabinoid oil is 33.3% of the mesoporous silica content, or a 1:3 ratio; e.g., d9-THC of Example 2, Table 3 at [0141] is 85% purity; as required for instant Claims 2 and 10). Additionally, since the cannabinoid oil makes up 14.3% of the composition, the remaining ingredients are therefore 85.7% of the composition (about 80% ranges from 72-88%; see instant disclosure at [0034]; as required for instant Claim 4). The cannabinoid oil to mesoporous silica ratio may also be (2.6):1 by weight (e.g., Table 4, [0144]; as required for instant Claim 1), and the exemplary compositions do not comprise cyclodextrin or emulsifiers (e.g., less than 10%; as required for instant Claims 6, 7, 12, and 13).
The composition is made by heating the cannabinoid (e.g., non-crystalline cannabinoid oil, see instant disclosure [0194] and instant Claim 17) and mixing the cannabinoid and mesoporous silica such that the cannabinoid adsorbs the mesoporous silica (loaded onto; substantially loaded into; [023]; as required for instant Claims 1, 10, and 17). A surfactant may be added, however the cannabinoid (cannabinoid oil) is not dissolved in a non-cannabis solvent and can be heated in the absence of said surfactant, and no other solid material is present during loading ([0101], [0107]; as required for instant Claims 3, 5, and 11). The composition also comprises excipients such as lubricants, emulsifying agents ([0121]), and may be provided in solid dosage forms such as tablets or capsules ([0118]; as required for instant Claims 1, 10, and 17).
Although Vialpando et al. teach the composition of the instant claims and method of making thereof, they are silent regarding the hardness (Claims 8 and 14), dissolution rates (Claims 9 and 16), and the amount of cannabinoid oil loaded into the silicon dioxide particles (Claim 15). Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the composition of the prior art and method of making thereof comprises the same properties of the instant invention. The method of making the composition and make-up thereof is the same as described above, and thus the properties of hardness, dissolution rate, and amount of cannabinoid oil loaded into the silicon dioxide particles are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the compositions are either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
Even if the composition not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and the same broad administration). Thus, the claimed process (and administered-composition effects intrinsic thereto) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Conclusion
No claims are currently allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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