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 .
CONTINUING DATA
This application is a 371 of PCT/EP2023/051730 01/25/2023
FOREIGN APPLICATIONS
LUXEMBOURG 501323 01/25/2022
Claims 1-23 and 25 are pending.
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 11-12, 14, and 17-18 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.
Claims 11-12, 14, and 17-18 each depend from claim 1 and recite that the solubility of the cannabinoid in water is a certain value. It is unclear whether the solubility of the cannabinoid pertains to the cannabinoid itself, or the complexed cannabinoid.
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.
Claim(s) 1-5, 7-12, 16-19, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gedo (WO 2020/021545 A1).
Gedo teaches a composition comprising glucosamine and CBD. The glucosamine is D-glucosamine [0030], which is glucosamine base. The ratio of CBD to glucosamine is 1:1, 1:2, 1:5, 1:1 to 1:5, or 1:25 w/w. Paragraph [0034]. The composition is in the form of a powder (isolated) [0086], or the composition includes aqueous solutions for parenteral administration [0060]. Placing the composition in water inherently reacts the glucosamine and CBD.
The D-glucosamine and CBD in water inherently form a complex, and the solubility is an inherent property of the complex at a given ratio. Gedo teaches ratios which are the same as, or encompass, the claimed ratios. The current specification acknowledges that the solubility of CBD in water is at least about 100 mg/L. Paragraph [0259].
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.
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gedo (WO 2020/021545 A1).
Gedo teaches as set forth above, a ratio of 1:1 to 1:5 or a ratio of 1:2.5. Gedo does not explicitly teach a ratio of 1:3.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare Gedo’s composition at a ratio of 1:3 because the claimed ratio 1:3 lies inside the range taught by Gedo (1:1 to 1:5). See MPEP 2144.05: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gedo (WO 2020/021545 A1) in view of Royal CBD (Cannabinoids: Differences Between CBD vs CBG, CBDA, CBN, CBC, and CBDV, internet article dated 2020, https://web.archive.org/web/20201031032810/https://royalcbd.com/cbg-cbda-cbn-cbc-cbdv/).
Gedo teaches a composition comprising CBD, as set forth above. Gedo does not teach compositions comprising CBDA or CBG.
Royal CBD teaches that CBD is the best-researched cannabinoid to date. Page 5. CBDA is a precursor to CBD, and CBD and CBDA have similar chemical structures and effects. Page 5. CBG is also a precursor to CBD. Page 7.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify Gedo’s composition to contain CBDA or CBG because they are precursors to CBD. Because CBDA and CBG transform into CBD, a composition comprising either of them would have been expected to function similarly to a composition containing CBD.
D-glucosamine and cannabinoids in water inherently form a complex, and the solubility is an inherent property at a given ratio. Gedo teaches ratios which are the same as, or encompass, the claimed ratios.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gedo (WO 2020/021545 A1) in view of Chopdekar (US 7622576B1, 2009).
Gedo teaches as set forth above but does not teach obtaining the glucosamine base by stripping off a counter ion from glucosamine in salt form.
Chopdekar teaches preparation of glucosamine base by reacting glucosamine hydrochloride with a lithium base. See abstract. Glucosamine is commercially available in the form of a halide salt and free glucosamine base is unstable, and a method for removing the halide is desirable for medicinal purposes. Column 2, lines 16-36.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare Gedo’s D-glucosamine by stripping off the halide counter ion from a glucosamine salt because glucosamine is commercially available as a salt and the glucosamine base form is desirable in certain applications.
Claim(s) 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gedo (WO 2020/021545 A1) in view of Belali (Indo J Pharm 3 (2019) 99-104).
Gedo teaches as set forth above. Gedo also teaches that the composition can be in the form of a capsule or tablet [0077]. Secondary considerations include taste [0076]. Gedo does not explicitly teach a preparation step which includes concentration or removal of solvent.
Belali teaches that solvent evaporation has been widely used for preparing tablets. See abstract. The drug to be encapsulated is dissolved in a solvent to form a suspension, emulsion or a solution, and then the solvent is evaporated. Pages 99-100, Section 2. Solvent evaporation is frequently used for taste masking. Pages 100-101, Section 5.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare Gedo’s tablet or capsule formulation by solvent evaporation because solvent evaporation is widely used for preparing oral dosage forms.
Claim(s) 1-12 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall (Exploring nuances of cannabinoid bioavailability: how water-soluble products can lead to greater absorption, internet article dated 2010, https://www.rdworldonline.com/exploring-nuances-of-cannabinoid-bioavailability-how-water-soluble-products-can-lead-to-greater-absorption/) in view of Al-Hamidi (Colloids and Surfaces B: Biointerfacces 76 (2010) 170-178, cited on IDS).
Hall teaches that cannabinoids are lipophilic and do not mix well with water, which results in restricted absorption in the body. Cannabinoids include CBD.
Hall does not teach complexation of cannabinoids with glucosamine.
Al-Hamidi teaches that the solid dispersion technique is the most effective method for improving the dissolution rate of poorly water-soluble drugs. The use of glucosamine-HCl in solid dispersion formulations significantly enhances the dissolution rate of poorly water-soluble drugs. See abstract. The ratios of drug to glucosamine were 1:1, 1:2, 1:4, 2:1, and 4:1. See Figure 1.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare a complex of a cannabinoid and glucosamine-HCl because cannabinoids are not water soluble and complexation with glucosamine HCl improves dissolution rates of poorly soluble drugs. Al-Hamadi teaches that the ratio of drug to glucosamine was 1:4 to 4:1, and the claimed ratio of 1:3 lies inside the prior art range. See MPEP 2144.05: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
The solubility of the complex is an inherent property of the complex.
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Al-Hamidi as applied to claims 1-12 and 16-19 above, and further in view of Royal CBD (Cannabinoids: Differences Between CBD vs CBG, CBDA, CBN, CBC, and CBDV, internet article dated 2020, https://web.archive.org/web/20201031032810/https://royalcbd.com/cbg-cbda-cbn-cbc-cbdv/).
Hall teaches cannabinoids generally and CBD specifically but does not mention CBDA and CBG.
Royal CBD teaches that CBD is the best-researched cannabinoid to date. Page 5. CBDA is a precursor to CBD, and CBD and CBDA have similar chemical structures and effects. Page 5. CBG is a precursor to CBD. Page 7.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the composition suggested by Hall in view of Al-Hamidi to contain CBDA or CBG because they are precursors to CBD. Because CBDA and CBG transform into CBD, a composition comprising either of them would have been expected to function similarly to a composition containing CBD.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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