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
Claim Status
Claims 5, 7, 13-15, 17, 18, 22, and 30-32 are cancelled.
Claims 25 and 28 have been amended.
Claims 1-4, 6, 8-12, 16, 19-21, and 23-29 are pending and under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 6, 8-10, 25-27 and 29, in the reply filed on 27 Oct 2025 is acknowledged. Applicants also elected that the cannabinoid is cannabidiol and the composition type is a pharmaceutical in response to the species election requirement.
During a telephone conversation with Colin Dean on 30 Oct 2025 the election for the compositional form was requested to be changed to a nutraceutical form. The examiner agreed to the change and a provisional election was made without traverse to prosecute the invention of the compositional form as a nutraceutical.
Affirmation of this election must be made by applicant in replying to this Office action.
Claims 11, 12, 16, 19-21, 23, 24, and 26-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-4, 6, 8-10, and 25 are under consideration to the extent of the elected species, i.e., that the cannabinoid is cannabidiol and the compositional form is a nutraceutical.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 Jan 2024 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner. Non-patent literature document citation 10 was not considered as a copy was not provided.
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 2, 3, 4, 6 and 10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation of a pH range from 4 to 7.8, and the claim also recites pH preferably from 4.5 to 5.2 which is the narrower statement of the range/limitation. Claim 3, recites the broad recitation of a weight ratio from 10:1 to 1:10, and the claim also recites a weight ratio preferably from 5:1 to 1:5 which is the narrower statement of the range/limitation. Claim 4, recites the broad recitation of a cannabinoid as a phytocannabinoid, and the claim also recites a cannabinoid preferably of cannabidiol, cannabigerol or a mixture thereof which is the narrower statement of the range/limitation. Claim 6, recites the broad recitation of a hyaluronic acid salt, and the claim also recites a hyaluronic acid preferably as sodium hyaluronate which is the narrower statement of the range/limitation. Claim 10, recites the broad recitation of a PDI from 0.25 to 0.9, and the claim also recites a PDI preferably from 0.35 to 0.5 which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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 1-4 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Turcsanyi et al. (International Journal of Biological Macromolecules 148, 01 Apr 2020, 218–225, listed in IDS filed 18 Jan 2024) in view of Winnicki (US 8,808,734, published 19 Aug 2014).
Turcsanyi teaches chitosan modified hyaluronic acid based nanosized drug carriers (title). Turcsanyi teaches that hyaluronic acid is negatively charged and forms complexes with components such as cationic polysaccharide chitosan and the complex is efficient in drug loading (page 218 paragraph 1). Turcsanyi teaches mixing of the polysaccharides using appropriate mass or molar ratios and mostly polymer concentrations results in the formation of possible colloidal drug carriers (page 222 left column). Turcsanyi teaches preparation of the carriers with chitosan, hyaluronic acid and water and the pH of the solution was 4.40-4.70 (page 219 section 2.2.1). Turcsanyi teaches the effect of chitosan to HyA mass ratio on the carrier and teaches that particles containing more chitosan than required for charge compensation that the particle size increased and teaches carriers with ratios from 20:1 to 1:1 chitosan:HyA where the size increased form 195 nm to 864 nm (page 223 left column). Thus, Turcansyi renders obvious the claimed ratio and size of 2.6:1 to 3.8:1 and 600-750 nm. Turcsanyi teaches loading vitamins as model hydrophobic drugs for the carriers (page 223 section 3.2.2). Turcsanyi teaches the example carriers with vitamins had 15 and 66% drug per polymer, rendering obvious the 100:1 to 1:100 ratio of claim 1 and 5:1 to 1:5 of claim 3. Turcsanyi teaches the hyaluronic acid as the sodium salt form (page 218 section 2.1).
Turcsanyi does not teach the inclusion of cannabinoids in the particles. This deficiency is made up for in the teachings of Winnicki.
Winnicki teaches cannabinoid formulations (title) and that cannabinoids have a hydrophobic nature which leads them to be poorly absorbed systemically from oral dosage forms because of the poor dissolution of cannabinoids in the aqueous environment of the gastrointestinal tract (col 1 lines 32-37) and teaches there is a need for oral formulations of cannabinoids with improved dissolution, taste and enhanced bioavailability and absorption (col 2 lines 17-21). Winnicki teaches incorporating the cannabinoids into micelle particle suspensions (col 2 lines 25-33) for use as nutraceuticals (col 1 lines 10-12, col 4 lines 42-52). Winnicki teaches the incorporation of cannabinoids such as cannabidiol (col 2 lines 40-42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have incorporated cannabinoids such as cannabidiol into the hyaluronic acid-chitosan polyelectrolyte complex taught by Turcsanyi as part of a nutraceutical formulation. Compositions comprising water and polyelectrolyte complexes of hyaluronic acid and chitosan which load hydrophobic drugs such as vitamins are known from Turcsanyi. As taught by Winnicki, cannabinoids such as cannabidiol are known to be useful as nutraceutical compositions but their use in oral formulations is limited due to the hydrophibic nature of cannabinoids. Cannabinoids can be incorporated into particles such as micelles which allows for their use in oral formulations, as known form Winnicki. Thus, it would be obvious to one of ordinary skill to incorporate cannabinoids such as cannabidiol into the polyelectrolyte complex of Turcsanyi as an alternative means of drug loading for nutraceutical use. One would have a reasonable expectation of success as the polyelectrolyte complexes are known to serve as drug carriers for hydrophobic compounds such as vitamins and cannabinoids are hydrophobic compounds known to perform better when incorporated into carriers for delivery. Overall, the polyelectrolyte complex of the instant claims is known and its use as a hydrophobic drug carrier and it is also known that oral delivery of cannabinoids is improved by incorporating into carriers due to their hydrophobic nature and one of ordinary skill would recognize the utility of the polyelectrolyte complexes as carriers for hydrophobic cannabinoids. Regarding the limitation of claim 1 that the cannabinoids are arranged in hydrophobic patches formed between the positive charged polymer and the negative charged polymer chains, this would be a necessary feature of incorporating the cannabinoids into the drug carrier. The same polyelectrolyte complexes of the instant claims are known and incorporating hydrophobic cannabinoids would necessarily be incorporated into the hydrophobic patches of the complexes.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Turcsanyi et al. (International Journal of Biological Macromolecules 148, 01 Apr 2020, 218–225, listed in IDS filed 18 Jan 2024) in view of Winnicki (US 8,808,734, published 19 Aug 2014) as applied to claims 1-4 and 25 above and further in view of Manero et al. (WO1999047130, published 23 Sep 1999).
The teachings of Turcsanyi and Winnicki are described supra.
Turcsanyi teaches variable weight of chitosan (190-375 kDa) and hyaluronic acid (1.5-1.8 106 Da) (page 219 section 2.1) but Turcsanyi and Winnicki do not teach the molecular weights of the hyaluronic acid and the chitosan as in claims 6 and 8. These deficiencies are made up for in the teachings of Manero.
Manero teaches polyelectrolyte complex nanoparticles of size 10-1000 nm that result from bringing together polyanions and polycations (page 4 lines 17-29). Manero teaches polycations for the complexes such as chitosan (page 5 lines 13-25). Manero teaches that the average molecular weight of the polyanions is preferably from 40,000 to 600,000 daltons (0.04-0.6 MDa) (page 5 lines 8-10) and that the average molecular weight of the polycations is preferably from 1,000 to 2,000,000 daltons (0.001-2 MDa) (page 5 lines 26-28).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the polyelectrolyte complexes with a polycation such as chitosan and a polyanion such as hyaluronic acid and that the weight of the polyanion may be from 40,000 to 600,000 daltons (0.04-0.6 MDa) and average molecular weight of the polycations may be from 1,000 to 2,000,000 daltons (0.001-2 MDa). Polyelectrolyte complexes with chitosan and hyaluronic acid are known from Turcsanyi and polyelectrolyte complexes of polycations such as chitosan and polyanions are similarly known from the teachings of Manero. It is known from Manero that the molecular weight of the polymer components for such complexes is variable where the polyanion may be from 40,000 to 600,000 daltons (0.04-0.6 MDa) and average molecular weight of the polycations may be from 1,000 to 2,000,000 daltons (0.001-2 MDa). Thus, one of ordinary skill would have a reasonable expectation of success in using chitosan and hyaluronic acid of variable weights as described above as polyelectrolyte complexes are known to be suitable with a variety of molecular weight polymers.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Turcsanyi et al. (International Journal of Biological Macromolecules 148, 01 Apr 2020, 218–225, listed in IDS filed 18 Jan 2024) in view of Winnicki (US 8,808,734, published 19 Aug 2014) as applied to claims 1-4 and 25 above and further in view of Nani et al. (Evidence-Based Complementary and Alternative Medicine Volume 2016, Article ID 6520475).
The teachings of Turcsanyi and Winnicki are described supra.
Turcsanyi and Winnicki do not teach that the water in the compositor is sea water. This deficiency is made up for in the teachings of Nani.
Nani teaches that deep sea water is a good source of water as it is known to offer a beneficial supply of minerals essential to health (page 1). Deep sea water has high purity, and is rich in nutrients (page 1) and is used for a variety of purposes such as for food products, cosmetics, aquaculture and agriculture (page 2). Deep sea water offers many benefits to health such as improving cholesterol profiles, treating fatigue and treating stomach ulcers (pages 2-7 section 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used deep sea water as the source of water for the polyelectrolyte composition. It is obvious to form the polyelectrolyte complex composition with cannabidiol for a nutraceutical use, as described supra, and it is known that deep sea water has health benefits over regular water due to the presence of various minerals. Thus, it would be obvious to use deep sea water as part of the nutraceutical formulation for the benefits that it is known to offer over the use of regular water.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Turcsanyi et al. (International Journal of Biological Macromolecules 148, 01 Apr 2020, 218–225, listed in IDS filed 18 Jan 2024) in view of Winnicki (US 8,808,734, published 19 Aug 2014) as applied to claims 1-4 and 25 above and further in view of Kleidon et al. (WO 2016/094810, published 16 June 2016).
The teachings of Turcsanyi and Winnicki are described supra.
Turcsanyi and Winnicki do not teach a polydispersity index of 0.25 to 0.9. This deficiency is made up for in the teachings of Kleidon.
Kleidon teaches microencapsulated cannabinoid compositions (title) and that cannabidiol is known to have a wide scope of medical applications ([0003]) and may be administered orally ([0015]). Kleidon teaches that the polydispersity index of the microcapsules is less than about 1.2 ([0025]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the polyelectrolyte complexes obvious over Tursanyi and Winnicki with a polydispersity index of less than about 1.2. Less than 1.2 renders obvious the claimed range of 0.25-09 as in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). It would be obvious to form the complexes with a polydispersity index of less than 1.2 as Turcsanyi and Winnicki do not specify a polydispersity index but it is known from Kleidon to have a polydispersity at less than 1.2 when used with encapsulated cannabinoids for health purposes, providing one of ordinary skill a reasonable expectation of success in having a polydispersity at less than 1.2.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600