DETAILED ACTION
Claims 1-22 are pending in the instant application.
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 .
Priority
The instant application claims priority to the U.S. Provisional Application Serial No. 63/578,464 filed August 24, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
Claim Objections
Claims 6 and 16 are objected to because of the following informalities: ‘topicithin’ is a typing error. Appropriate correction is required.
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.
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 6 and 16 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. Topicithin is not a word. Claims 6 and 16 contains the trademark/trade name topcithin. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe lecithin product from sunflower and, accordingly, the identification/description is indefinite.
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.
(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 1-3, 7, 9-111, 13, 16-17, 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jang et al. (US 2024/0066092 A1, priority 2021).
Jang discloses a curcumin nanoparticle complex (Abstract). The present invention is to provide a curcumin nanoparticle complex comprising curcumin and phospholipids (e.g., lecithin) and having a particle size of less than 1000 nm ([0012]). The nanoparticle complex can further comprise a cationic coating layer and an anionic coating layer ([0016]). Phospholipids can be natural lecithin obtainable from soy bean, sunflower or other sources ([0030]). The cationic material can be a polymer such as cellulose ([0034]). The anionic material can be hydrogel ([0039]). The composition can be formulated into an injection as well as tablets, capsules, pills ([0049]). Jang discloses curcumin-phospholipids complexes has been developed by mixing curcumin dissolved in ethanol with phospholipids ([0005]). Jang discloses lecithin being dissolved in ethanol as well ([0070]). Jang teaches that the enolic hydroxyl group of curcumin and the polar section of phospholipids form a hydrogen bond as a complex ([0005]). Jang teaches curcumin solubilized in ethanol and lecithin solubilized in ethanol. These are mixed. Then a cationic hydrogel, chitosan, was added to the curcumin complex solution ([0070-0073]).
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.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (US 2024/0066092 A1, CON of PCT/KR2022/014386 filed Sep 27, 2022), Nataraj et al. (Phospholipid Complex Technique for Superior Bioavailability of Phytoconstituents, Advanced Pharmaceutical Bulletin, 2017), Barani et al. (Phytosomes as innovative delivery systems for phytochemicals: A comprehensive review of literature, International Journal of Nanomedicine, 2021).
Jang discloses a curcumin nanoparticle complex (Abstract). The present invention is to provide a curcumin nanoparticle complex comprising curcumin and phospholipids (e.g., lecithin) and having a particle size of less than 1000 nm ([0012]). The nanoparticle complex can further comprise a cationic coating layer and an anionic coating layer ([0016]). Phospholipids can be natural lecithin obtainable from soy bean, sunflower or other sources ([0030]). The cationic material can be a polymer such as cellulose ([0034]). The anionic material can be hydrogel ([0039]). The composition can be formulated into an injection as well as tablets, capsules, pills ([0049]). Jang discloses curcumin-phospholipids complexes has been developed by mixing curcumin dissolved in ethanol with phospholipids ([0005]). Jang discloses lecithin being dissolved in ethanol as well ([0070]). Jang teaches that the enolic hydroxyl group of curcumin and the polar section of phospholipids form a hydrogen bond as a complex ([0005]).
Nataraj discloses that phytoconstituents have been utilized as medicine for thousands of years, yet their application is limited owing to major hurdles like deficit lipid solubility, large molecular size and degradation in the gastric environment. Phospholipid-complex technique addresses these by enhancing the solubilizing capacity, protecting the active herbal components (Abstract). Nataraj lists various phospholipid complexes (Table 2).
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Furthermore, Nataraj discloses that Abdelkader et al. formulated a novel phytosomal technology for ocular delivery of L-carnosine by combining hyaluronic acid (HA) hydrogel and phospholipid by using solvent evaporation preparation method (pg 39, left col, 1st paragraph).
Above references do not explicitly mention emodin or quercetin.
Barani discloses that phytosomes are the vesicular drug delivery system enhancing the absorption and bioavailability of low-soluble drugs. Phytosomes are complex phospholipids and natural active phytochemicals. Between all the phytochemicals, only those having an active hydrogen atom can be integrated into a phytosome structure (pg 6984). Barani discloses nanovesicle encapsulated herbal formulations including emodin, and capsaicin hydrogel (See Table 1). Barani teaches that quercetin (antioxidant flavonoids) is routinely incorporated into phytosomes or phospholipid-complex (pg 6990, left col, 2nd paragraph).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a composition comprising a hydrogel, the hydrogel comprising a phospholipid-complex of solubilized phospholipid and solubilized nutraceutical compound. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, hydrogen bond is taught above.
Regarding claim 3, nutraceutical compound or phytochemicals are discussed above.
Regarding claim 4, one of ordinary skill in the art would experiment with emodin within a phospholipid-complex as taught by Barani above.
Regarding claim 5, quercetin, emodin, or other phytochemicals would be considered by one of ordinary skill in the art to create a phospholipid-complex to increase delivery of these chemicals.
Regarding claim 6, Jang teaches that the lecithin can be sunflower-derived (brand name topcithin).
Regarding claims 7-8, cellulose is taught above. Jang discloses that the cationic polymer consists of cellulose but is not limited thereto ([0034]). One of ordinary skill in the art would routinely consider any and all cellulose derivatives when forming a hydrogel. Hydroxypropyl methylcellulose is a type of cellulose.
Regarding claims 9-10, formulations are taught above.
Regarding claim 11, Jang teaches curcumin solubilized in ethanol and lecithin solubilized in ethanol. These are mixed. Then a cationic hydrogel, chitosan, was added to the curcumin complex solution ([0070-0073]). The method for forming a hydrogel is taught by Jang.
Regarding claim 12, phospholipids inherently contain a polar phosphate group and Barani discloses that nutraceutical compounds with hydrogen bonding capability can be used to form a bond as taught above.
Regarding claims 13-15, nutraceutical compound is discussed above.
Regarding claim 16, topcithin, or a sunflower-derived lecithin is taught above.
Regarding claims 17-18, cellulose is taught above.
Regarding claims 19-20, formulations are taught above.
Regarding claims 21-22, one of ordinary skill in the art would routinely experiment with routinely used solubilizing agent to dissolve nutraceutical compound and phospholipids when creating phytosomes or hydrogels.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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