DETAILED ACTION
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 .
Status of the Application
Claims 1-12 filed on 1/10/2024 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/10/2024 was filed before the first 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 § 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 1 and dependent claims 2-12, 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.
Claim 1 and 3 recite “its derivatives”. The scope of “its” is unclear.
Claim 4 recites the broad recitation “gums” and the narrower “gum acacia”, “guar” “xanthan gum.” 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, 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 4 recites “gelatin-like modified starch” which is undefined. For examination purposes, pregelatinized starch is considered.
Claim 6 recites “vegetable oils like” followed by a listing. The phrase " like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 12 recites “keeping homogenization using homogenizer” in step ii. This phrase is unclear. Additionally it is unclear when the gel in (iii) is added to the mixture. Claim 12 further recites “pretreated starch.” Pretreatment is undefined. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites “fat-soluble vitamin composition is present in an amorphous form” which is recited in independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (CN112999206A) in view of Musaeus et al. (WO2021/165288A1) cited in an IDS and further in view of Hahnlein et al (US6,531,157B1).
Regarding claim 1 -3, Xu (abstract and translated summary) discloses fat-soluble vitamin composition in powder form comprising fat soluble vitamins including vitamins A,D,E,K; considered to include commonly used Vitamin A acetate and palmitate forms as in claim 3; an oil phase including soybean oil, MCT in which the fat soluble vitamin is dissolved, thereby functioning as solubilizer; an emulsifier and co-emulsifier system used to form a stable emulsion, an encapsulating agent (auxiliary emulsion) comprising pregelatinized starch, sucrose and corn starch, and colloidal silica as emulsifier.
Xu does not specifically disclose an amorphous form.
Musaeus discloses powder formulations comprising a fat-soluble-vitamin or a carotenoid, a hydrocolloid, a starch hydrolysate, tocopherol and sodium ascorbate prepared by a starch catch process wherein a stable emulsion of the vitamin is sprayed on starch to form particles (Example 1).
Both Xu and Musaeus disclose drying the composition. The excipients and formulation techniques disclosed in the references are compatible and routinely used together in formulating fat-soluble vitamin products. Hahnlein discloses a fat soluble vitamin composition in powder form comprising 3-40% by weight of a mixture of vitamin A, vitamin D, vitamin E and/or vitamin K and/or an inert oil, 5-40% by weight of a protective colloid, 0-30% by weight of a sugar and/or sugar alcohol, 0-70% by weight of a coating material and, where appropriate, 0-25% by weight of other additives. The term "inert oil" means sesame oil, corn oil, cottonseed oil, coconut oil, soybean oil or peanut oil, and esters of medium chain-length vegetable fatty acids. Examples of protective colloids (encapsulating agent) which are used are gelatin, fish gelatin, starch, dextrin, vegetable proteins, pectin, gum arabic, casein, caseinate or mixtures thereof, polyvinyl alcohol, polyvinyl pyrrolidone, methylcellulose, carboxymethylcellulose, hydroxypropylcellulose and alginates. To increase the mechanical stability of the final product, a plasticizer to a colloid, such as sugars or sugar alcohols, for example sucrose, glucose, fructose, lactose, invert sugar, sorbitol, mannitol, maltodextrin or glycerol. Other additives which can be added to increase the stability of the agents to oxidative degradation are stabilizers ascorbic acid. They are preferably emulsified together with the vitamins and, where appropriate, additional emulsifiers into the aqueous protective colloid solution. Examples of emulsifiers which can be used are ascorbyl palmitate, polyglycerol fatty acid esters, sorbitan fatty acid esters, propylene glycol fatty acid esters or lecithin. Coating materials are starch and/or starch derivatives, and silica and/or silica derivatives, (column 5 lines 16-60).
Regarding the amorphous form of the dry composition, the claimed amorphous character is inherent in the formed particles entrapped in a hydrocolloid/starch matrix as a dried sprayed emulsion, and in the powder in Xu which is dried with an encapsulating agent.
Regarding claim 4, Xu discloses an encapsulating agent (auxiliary emulsion) comprising pregelatinized starch (gelatin-like modified starch) , sucrose and corn starch. Musaeus discloses a hydrocolloid - gum acacia, starch, starch derivatives, dextrins, maltodextrin; gelatinized starch. Hahnlein discloses these materials as protective colloid.
Regarding claim 5, the auxiliary emulsion (encapsulating agent) in Xu is added at a level of 5-60 parts overlapping a content of encapsulating agent in claim 5 (40% to 99%).
Regarding claim 6 Xu discloses soybean oil and MCT as solubilizer.
Regarding claim 7, Xu discloses a fat-soluble vitamin composition comprising: 0.05-5 parts of fat-soluble vitamins; 5-80 parts of oil phase encompassing the claimed amount (5% to 40%).
Regarding claim 8, Xu discloses a stabilizer including antioxidants to inhibit oxidative degradation of fat soluble vitamins including tocopherols, ascorbic acid, sodium ascorbate.
Regarding claim 9, Xu discloses 0.1-10 parts of antioxidant overlapping the claimed content.
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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 10 and 11, Xu does not disclose conventional emulsifiers as in claim 10, but prefers a colloidal silica for the purpose. It would have been obvious to one of ordinary skill in the art to add conventional emulsifiers as needed in amounts as in claim 11, to make a stable emulsion. Their addition is considered an obvious modification based on generally used methods in the art and selection of a specific emulsifier or a blend is within the skill level of one of ordinary skill in the art. Hahnlein discloses emulsifiers as claimed in making fat soluble vitamin compositions as explained above.
Regarding claim 12, Xu discloses mixing the fat-soluble vitamin and oil phase to obtain the first mixture; mixing the antioxidant, auxiliary emulsion, emulsifying agent and water to obtain the second mixture; mixing the first mixture and the second mixture, and then drying and sieving to obtain the fat soluble vitamin composition.
In another embodiment step 2 specifically comprises: using a homogenizer to homogenize the first mixture and the second mixture, then drying and sieving to obtain the fat-soluble vitamin composition.
Musaeus discloses examples wherein an emulsion if fat soluble vitamins is prepared, and sprayed onto starch to produce particles (Example 1)
The excipients and formulation techniques disclosed in the references are compatible and routinely used together in formulating fat-soluble vitamin products.
Regarding the limitation “spherical particles in the form of beadlets” the spraying the encapsulated emulsion on starch is expected to produce beadlets.
Regarding the amorphous form of the dry composition, the claimed amorphous character is inherent in the formed particles entrapped in a hydrocolloid/starch matrix as a dried sprayed emulsion.
Claims 1-12 are therefore prima facie obvious in view of the art.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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/SUBBALAKSHMI PRAKASH/ Primary Examiner, Art Unit 1793