DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 27 August 2024 was filed before the mailing of an Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jaklenec et al. (US 2015/0164816 A1).
Regarding claim 1, Jaklenec et al. teach micronutrient fortified salts that are thermally stable and release the micronutrients at the desired location in the gastrointestinal tract ([0002], [0012]; Claims 1-2). The formulations provide particles of micronutrients and vitamins (“MNs”) formulated into a stabilizing matrix formed of materials such as sugars, which is then encapsulated within heat resistant pH-sensitive water-insoluble polymers ([0013]). The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills (Abstract; [0013]). Exemplary micronutrients include, but are not limited to, iron, cobalt, zinc, manganese, copper, iodine, selenium, molybdenum, chromium, vitamin A, beta carotene, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9 (folic acid), vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin K, pantothenic acid, biotin, and combinations thereof ([0050]). Vitamin C also enhances the absorption of iron ([0061]). See also Figures 1A-1G.
Jaklenec et al. teach that the matrix is coated or encapsulated with one or more pH-sensitive, thermally stable biocompatible polymers. The solubility of the polymer is pH-dependent such that a desired release point can be achieved by selecting the appropriate polymer. For example, if release is desired in the stomach, the pH-sensitive polymer ideally dissolves at a pH less than 3, preferably less than 2, such as 1-2. In other embodiments, release may be desired in the small intestine, wherein the polymer dissolves at the higher pH of the duodenum (pH 6-6.5) or the small intestine, such as 6-8, more preferably 7-8. For agricultural applications, such as mineral supplements to ruminants like cattle, sheep and goats, pH release between 5 and 6 is desirable to achieve release within the rumen ([0064], [0094]; Claim 7).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare encapsulated micronutrients according to Jaklenec et al. wherein the release of the micronutrients is controlled by selecting the appropriate biocompatible polymers. A person of ordinary skill in the art would have been motivated to select a combination of nutrients wherein the nutrients facilitate complementary uptake, such as vitamin C and iron, as reasonably suggested by Jaklenec et al.
Regarding claims 2-3, Jaklenec et al. teach that vitamin C also enhances the absorption of iron ([0061]).
Regarding claim 4, Jaklenec et al. teach that the solubility of the polymer is pH-dependent such that a desired release point can be achieved by selecting the appropriate polymer. For example, if release is desired in the stomach, the pH-sensitive polymer ideally dissolves at a pH less than 3, preferably less than 2, such as 1-2. In other embodiments, release may be desired in the small intestine, wherein the polymer dissolves at the higher pH of the duodenum (pH 6-6.5) or the small intestine, such as 6-8, more preferably 7-8. For agricultural applications, such as mineral supplements to ruminants like cattle, sheep and goats, pH release between 5 and 6 is desirable to achieve release within the rumen ([0064], [0094]; Claim 7).
Regarding claim 5, Jaklenec et al. teach that the term “microspheres” or “microcapsules” is art recognized, and includes substantially spherical solid or semi-solid structures, e.g., formed from biocompatible polymers such as subject compositions, having a size ranging from about one or greater up to about 1000 microns. The term “microparticles” is also art-recognized, and includes microspheres and microcapsules, as well as structures that may not be readily placed into either of the above two categories, all with dimensions on average of less than about 1000 microns ([0041], [0049], [0111]).
Regarding claim 6, Jaklenec et al. do not explicitly disclose the particles having a mass of approximately 0.5 g, as instantly claimed.
However, Jaklenec et al. teach microspheres and microcapsules having a size up to about 1 mm ([0041], [0049], [0111]). Jaklenec et al. also teach that the particles can be used to deliver daily-recommended dosages of micronutrients ([0013], [0044], [0050]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to determine through routine experimentation the optimum mass of the particles to prepare formulations comprising the recommended daily doses of nutrients and also having a particles size of up to about 1 mm.
Regarding claims 7 and 13, Jaklenec et al. teach formulations made up of particles distributed in a matrix which is coated or encapsulated with one or more pH-sensitive, water-insoluble, thermally stable materials, encapsulated in a salt, are used for simultaneous delivery of salts, vitamins and trace minerals, and optionally one or more therapeutic, prophylactic, and/or diagnostic agents. The pH-sensitive, water-insoluble, thermally stable materials help to stabilize the vitamins and trace minerals, particularly at high temperatures, such as during preparation and cooking, and effect release of the vitamins and micronutrients at the desired locations after ingestion (e.g., stomach, small intestine, etc.). The particles can be used to deliver daily-recommended dosages of micronutrients via salt, eliminating the need for vitamin pills, or other therapeutic and prophylactic agents ([0044]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare formulations comprising a first supplement bead comprising nutrient(s) encapsulated in a biocompatible polymer and a second supplement bead comprising nutrient(s) encapsulated in a biocompatible polymer in order to deliver daily-recommended dosages of multiple micronutrients, as reasonably suggested by Jaklenec et al.
Regarding claims 8-9 and 14-19, Jaklenec et al. teach exemplary micronutrients include, but are not limited to, iron, cobalt, zinc, manganese, copper, iodine, selenium, molybdenum, chromium, vitamin A, beta carotene, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9 (folic acid), vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin K, pantothenic acid, biotin, and combinations thereof ([0050]).
Regarding claim 10, Jaklenec et al. teach that the solubility of the polymer is pH-dependent such that a desired release point can be achieved by selecting the appropriate polymer. For example, if release is desired in the stomach, the pH-sensitive polymer ideally dissolves at a pH less than 3, preferably less than 2, such as 1-2. In other embodiments, release may be desired in the small intestine, wherein the polymer dissolves at the higher pH of the duodenum (pH 6-6.5) or the small intestine, such as 6-8, more preferably 7-8. For agricultural applications, such as mineral supplements to ruminants like cattle, sheep and goats, pH release between 5 and 6 is desirable to achieve release within the rumen ([0064], [0094]; Claim 7).
Regarding claims 11 and 20, Jaklenec et al. teach that the term “microspheres” or “microcapsules” is art recognized, and includes substantially spherical solid or semi-solid structures, e.g., formed from biocompatible polymers such as subject compositions, having a size ranging from about one or greater up to about 1000 microns. The term “microparticles” is also art-recognized, and includes microspheres and microcapsules, as well as structures that may not be readily placed into either of the above two categories, all with dimensions on average of less than about 1000 microns ([0041], [0049], [0111]).
Regarding claims 12 and 20, Jaklenec et al. do not explicitly disclose the particles having a mass of approximately 0.5 g, as instantly claimed.
However, Jaklenec et al. teach microspheres and microcapsules having a size up to about 1 mm ([0041], [0049], [0111]). Jaklenec et al. also teach that the particles can be used to deliver daily-recommended dosages of micronutrients ([0013], [0044], [0050]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to determine through routine experimentation the optimum mass of the particles to prepare formulations comprising the recommended daily doses of nutrients and also having a particle size of up to about 1 mm, as taught by Jaklenec et al.
Conclusion
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616