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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 29 Apr 2026 has been entered.
Claims 1-4, 6, 8-12, 16, 19-21, and 23-29 remain pending in the application.
Claims 2-4, 6, 10, 11, and 24 are amended.
Claims 5, 7, 13-15, 17, 18, 22, and 30-32 are cancelled.
Claims 11, 12, 16, 19-21, 23, 24, and 26-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 Apr 2026 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.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 29 Dec 2025 are hereby withdrawn in light of applicant’s amendment of the claims.
Rejections Maintained
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 hydrophobic 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.
Response to Arguments
Applicant's arguments filed 29 Apr 2026 have been fully considered but they are not persuasive. Applicant argues that Turcsanyi cannot be properly combined Winnicki and that the rejection is based on impermissible hindsight reconstruction (page 9-10 of remarks). Applicant notes that Turcsanyi is directed to the field of polymer chemistry and characterizes different chitosan-hyaluronic acid polyelectrolyte complexes for delivering vitamins and that Winnicki is directed to formulation cannabinoids into well-established micelle/liposome delivery systems (page 10 of remarks). Applicant argues that the combination of Turcsanyi and Winnicki only appears logical with the benefit of the applicant’s disclosure which bridges these distinct technological fields (page 10 of remarks). Applicant argues that one of ordinary skill in the art starting from Winnicki would have been led toward micellar systems and not motivated to depart from that teaching to seek an alternative system as that of Turcsanyi (page 10 of remarks). Applicant argues that Winnicki teaches away from the present invention as one would be motivated to further optimize the micellar or liposomal systems of Winnicki rather than abandoning this technology in favor the polyelectrolyte system of Turcsanyi (page 11 of remarks).
The examiner is not persuaded by these arguments. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The examiner maintains that the combination of teachings from Turcsanyi and Winnicki render obvious the claimed composition. While Turcsanyi teaches chitosan modified hyaluronic acid complexes and Winnicki teaches liposomal/micelle formulations, both are directed to fields for carrying drugs. Specifically, the complexes of Turcsanyi are drug carriers useful for delivery with hydrophobic drugs as is made clear by the description of the vitamins as model hydrophobic drugs that were tested (page 219 left column, page 223 right column). It is further known from Winnicki that cannabinoids are used in nutraceutical formulations but their hydrophobic nature leads to challenges with normal oral dosage forms, which leads to the need for the specialized micelle/liposomal formulations. Thus, it is obvious from the prior art to use chitosan modified hyaluronic acid complexes as drug carriers for hydrophobic compounds and it is known that the hydrophobic nature of cannabinoids leads to the need for improved delivery methods for cannabinoids. Thus, it would be obvious to one of ordinary skill in the art to use the complexes of Turcsanyi with cannabinoids as the complexes would meet the need for improved delivery means of hydrophobic cannabinoids, as it obvious from Winnicki. Thus, contrary to the applicant’s assertion, the rejection does not rely upon the applicant’s disclosure and the teachings relied upon from Turcsanyi and Winnicki can be combined and would be obvious to one of ordinary skill in the art to combine. Further, the applicant’s argument regarding a teaching away from Winnicki is not persuasive as Winnicki does not in any way speak against the use of such chitosan-hyaluronic acid complexes. The fact that there may be more than one way of delivering hydrophobic cannabinoids, such as with micelles, would not lead one of ordinary skill in the art away from using an alternative means. The examiner notes that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). One of ordinary skill in the art would not see the micelles of Winnicki as the only possibility for delivery of the hydrophobic cannabinoids and would not feel constrained to not extend beyond the micelles but it would be obvious to one of ordinary skill in the art with ordinary creativity to extend the system of Turcsanyi known for use with hydrophobic compounds to alternative compounds such as the hydrophobic cannabinoids as known from Winnicki. Thus, the examiner maintains that the claims are obvious over the teachings of Turcsanyi and Winnicki.
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 composition 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.
Response to Arguments
Applicant's arguments filed 29 Apr 2026 have been fully considered but they are not persuasive. Applicant argues that one of ordinary skill in the art would not have expected seawater to work (page 12 of remarks). The applicant basis this argument on their specification which indicates that the present invention depends on a balance of electrical charges between the polymers and seawater is rich in salts and ions which would be expected to interfere with these interactions (page 12 of remarks). The applicant argues that the high ionic strength of seawater teaches away from its use in a system relying on delicate electrostatic interactions and a person of ordinary skill would not have had a reasonable expectation of success in such a combination (page 12 of remarks).
The examiner does not find this persuasive. As described in the rejection, sea water has health benefits over regular water due to the presence of various minerals and 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. The art relied upon does not in any way speak against the use of sea water and thus cannot be construed as teaching away. The applicant has noted various reasons why they think one would find it difficult to incorporate seawater but this is not sufficient to overcome the prima facie case of obviousness of using the seawater as presented in the prior art. One of ordinary skill would expect there to be challenges or difficulties that may arise when modifying a system, and noting the prospect of potential challenges is not in itself sufficient to overcome the obviousness of the combination. The applicant has not provided any evidence that one of ordinary skill would have, at the time, not pursued the use of seawater.
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 Turcsanyi 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.
Response to Arguments
Applicant's arguments filed 29 Apr 2026 have been fully considered but they are not persuasive. Applicant argues that polydispersity index values obtained by dynamic light scattering cannot be directly compared with values from laser diffraction measurements (page 13 of remarks). Applicant provided exhibits to indicate that the PDI calculation is different with DLS from laser diffraction.
The examiner does not find this persuasive. As a first matter, the examiner notes that, whether or not DLS and laser diffraction cannot be directly compared, the claims merely require a polydispersity index of 0.25 to 0.9 and thus the broadest reasonable interpretation of the claim includes the polydispersity obvious from the teachings of Kleidon. Secondly, while there may be differences between polydispersity results obtained from laser diffraction and DLS, the point remains that it is obvious to have a low polydispersity, e.g. less than 1.2. There is nothing to indicate that the polydispersity less than 1.2 taught by Kleidon, even if it is a different measurement technique from what the applicant used, would lead to a polydispersity outside the range of the claim. Thus, the examiner maintains that the claimed polydispersity is obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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
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