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 .
DETAILED ACTION
Claims 1-29 are pending in the instant application and are examined on the merits herein.
Priority
The application is a continuation-in-part of application 17/527685, filed on 11/16/2021, which is a divisional application of 15/762,180, filed on 3/22/2018, now US 11,207,414, which is the national stage application of PCT/US2016/053122 filed on 9/22/2016, which claims priority to provisional applications 62/363,808, filed on 7/18/2016, 62/245,928, filed on 10/23/2015 and 62/222,144, filed on 9/22/2015. 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. 112(a). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a), except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed applications fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application. Specifically, there is no disclosure in these documents describing or enabling a cannabinoid glycoside, bearing a primary glucose having further glucose substitution at the 4 and/or 6 sugar ring positions. Therefore, the instant claims are not granted priority to the documents in the ‘685 priority chain.
The application is a continuation-in-part of application 17/510817, filed on 10/26/2021, now abandoned, which is a continuation of the national stage application of PCT/US2020/19886 filed on 2/26/2020. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a), except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed applications fail to provide adequate enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application. Specifically, applications ‘817 and ‘886 do not provide sufficient disclosure to enable one of skill in the art to make the invention claimed. The ‘817 and ‘886 applications refer to “providing higher order cannabinoid glycosides” as the source of the starting material for the action of a hydrolase to generate the claimed compounds. However, there is no disclosure on how such “providing” is actually performed. Therefore, the instant claims are not granted priority to the documents in the ‘817 priority chain.
In view of the above discussion, the effective filing date for the instant application is 3/13/2023.
Information Disclosure Statement
The information disclosure statement (IDS) dated 7/14/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112(b)
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.
Claims 7-9, 14-16, 24 and 26 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 7 depends from claim 1 and recites “a compound”. Claim 8 depends from claim 1 and recites “a tetrahydrocannabinol glycoside”. Claim 9 depends from claim 7 and recites “a pharmaceutical composition”. It is unclear if the recitations of claims 7-9 are referring to limitations in their base claims or introducing new limitations.
Claim 14 depends from claim 12 and recites “a compound”. Claim 15 depends from claim 12 and recites “a cannabinol glycoside”. It is unclear if the recitations of claims 14 and 15 are referring to limitations in their base claims or introducing new limitations.
Claim 16 depends from claim 15 and recites “a pharmaceutical composition as defined in claim 15”. There is insufficient antecedent basis for this limitation in the claim.
Claims 24 and 26 are indefinite for reciting the trademark “Lallzyme Beta” or “Vinotaste Pro”. The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name.
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.
(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 1-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hardman et al. (WO 2021/173130, pub 9/2/2021, PTO-892).
Hardman et al. discloses a tetrahydrocannabinol glycoside prodrug compound having Formula (I):
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186
221
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(I)
wherein R1 is H, beta-D-glucopyranosyl, or 3-O-beta-D-glucopyranosyl-beta-D-glucopyranosyl; and R2 is H or beta-D-glucopyranosyl, with the proviso that R1 and R2 are not both H. (Claim 1)
Hardman et al. discloses a cannabinol glycoside prodrug compound having Formula(II):
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142
280
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wherein R3 and R4 are H or a moiety having the structure:
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219
201
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with the proviso that R3 and R4 are not both H. (Claim 14)
Hardman discloses compounds VB309, VB310, VB311, VB312, VB313, VB135, VB138 and pharmaceutical compositions thereof, which are identical to compounds in instant claims 2-7 and 14-16. (Claims 2-7, 14-16) Hardman discloses a method for the site-specific delivery of tetrahydrocannabinol to the intestinal lumen of a subject, comprising the step of orally or rectally administering a tetrahydrocannabinol glycoside prodrug, or pharmaceutical composition thereof, as defined in any one of claims 1 to 6 or 14-16, to a subject in need thereof. (Claims 8-11) Hardman discloses a process for the preparation of a purified cannabinoid glycoside prodrug comprising the steps of: (a) providing a mixture of higher order cannabinoid glycosides; (b) incubating the mixture of cannabinoid glycosides with at least one hydrolase enzyme for a period of time sufficient to hydrolyze at least a portion of the glycosidic bonds to form a refined mixture of cannabinoid glycosides; and (c) separating the purified cannabinoid glycoside prodrug from the refined mixture of cannabinoid glycosides, where the higher order cannabinoid glycosides comprise VB311 or VB135 and the purified cannabinoid glycoside is VB311 or VB135. (Claim 23-33)
Accordingly, the instant claims are anticipated by the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693