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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 March 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicant’s election of Group I (claims 1-20) and species of 1) First Matrix -wax, 2) First Shell -Tocopherol Polyethylene Glycol Succinate, and 3) Second Matrix -protein in the reply filed on 11 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Application
3. The instant application was filed 9 August 2023. Claims 1-20 are currently pending. Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 March 2026. Claim 21 was cancelled. Claims 1-20 are examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b)
4. 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.
5. Claim 17 is 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.
6. Regarding instant claim 17, the claim recites “storage or shelf stability of at least about 12 months.” It is unclear what the lower limit of the range is. Does this mean “at least 12 months”, “at least 10 months”, “at least 5 months”, etc. The metes and bounds of the claim cannot be determined.
Claim Rejections – 35 U.S.C. 102
7. 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.
8. Claim(s) 1-11 and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moaseri (U.S. Patent No. 10,945,953).
Regarding instant claim 1, Moaseri discloses a population of particles, each particle including a core comprising an active ingredient, polymer and an aqueous solution, and a shell surrounding the core comprising a polymer, a plurality of lipophilic carriers, an active ingredient and emulsifying agents. The particles are within a dispersion medium comprising an aqueous solution, an active ingredient, a flavor agent and a polymer. See abstract.
Regarding instant claim 2, the lipophilic carrier may be vegetable oil. See claim 9.
Regarding instant claims 3-4, the particles may have multiple shells. See column 18, lines 39-40. Each shell may contain similar or different types of encapsulants and organic solvent or oil phases. The shell further comprises a wax. See claim 14.
Regarding instant claims 5 and 17, Moaseri teaches the same combination of ingredients and thus should behave in the same manner. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claim 6, the particles may comprise ethyl cellulose polymers. See column 71, lines 35-43. The aqueous phase may contain an encapsulant and an oil phase may contain a polymer or wax. See column 25, lines 1-16.
Regarding instant claims 7-10, the active ingredient can be Vitamin D3. See column 34, lines 16-67.
Regarding instant claim 11, the invention is directed to suspensions. See Title.
Regarding instant claim 13, which recites product-by-process limitations, the Examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding instant claim 14, the inner water phase may contain proteins in amounts of 1-80%. See column 14, lines 1-3.
Regarding instant claims 15-16, various food biopolymers can be used including gelatin, casein, whey protein, bean protein, etc. See column 14, lines 45-52.
Thus the instant claims are anticipated by Moaseri.
Claim Rejections – 35 U.S.C. 103
9. 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.
10. Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moaseri (U.S. Patent No. 10,945,953).
Regarding instant claim 1, Moaseri teaches a population of particles, each particle including a core comprising an active ingredient, polymer and an aqueous solution, and a shell surrounding the core comprising a polymer, a plurality of lipophilic carriers, an active ingredient and emulsifying agents. The particles are within a dispersion medium comprising an aqueous solution, an active ingredient, a flavor agent and a polymer. See abstract.
Regarding instant claim 2, the lipophilic carrier may be vegetable oil. See claim 9.
Regarding instant claims 3-4, the particles may have multiple shells. See column 18, lines 39-40. Each shell may contain similar or different types of encapsulants and organic solvent or oil phases. The shell further comprises a wax. See claim 14.
Regarding instant claims 5 and 17, Moaseri teaches the same combination of ingredients and thus should behave in the same manner. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claim 6, the particles may comprise ethyl cellulose polymers. See column 71, lines 35-43. The aqueous phase may contain an encapsulant and an oil phase may contain a polymer or wax. See column 25, lines 1-16.
Regarding instant claims 7-10, the active ingredient can be Vitamin D3. See column 34, lines 16-67.
Regarding instant claim 11, the invention is directed to suspensions. See Title.
Regarding instant claim 12, a plurality of antioxidants can be used such as polyethylene glycol, phospholipids, tocopherols, etc. See column 38, lines 31-41.
Regarding instant claim 13, which recites product-by-process limitations, the Examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding instant claim 14, the inner water phase may contain proteins in amounts of 1-80%. See column 14, lines 1-3.
Regarding instant claims 15-16, various food biopolymers can be used including gelatin, casein, whey protein, bean protein, etc. See column 14, lines 45-52.
The particles have a Z-average diameter of 0.5 to 5µm. See claim 7.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to provide a second matrix material such as casein or protein because Moaseri teaches various arrangements of polymers and additives in each layer that are effectively combined to formulate the particles. It would have been well within the purview of the skilled artisan to modify the amount of each ingredient and ratio of ingredients to optimize the formulation dependent on the property and effects desired. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to choose a vitamin D3 first active, a matrix of ethyl cellulose or wax, a first shell of emulsifying agents, and a second matrix of protein or casein based on the alternative embodiments of Moaseri wherein various ingredients can be effectively used in each phase. It would have been obvious to substitute tocopherol polyethylene glycol succinate for the antioxidants of Moaseri to yield predictable results since tocopherols and polyethylene glycols are effectively combined in the particles. In addition it would have been obvious to substitute one type of protein, i.e., pea protein for bean protein to yield predictable results. It would have been obvious to modify the particle size to achieve the optimal desired effect.
Conclusion
11. No claims are allowed at this time.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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