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 .
Claim Status
Applicant’s remarks and amendments, filed 27 January 2026 in response to the non-final rejection mailed 19 November 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 27 January 2026 replaces all prior versions and listings of the claims.
Claims 1-18 and 21 are pending. Claim 21 is newly added. Claims 11-18 remain withdrawn. Claims 1 and 11 are amended. Claims 1-10 and 21 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to the specification have overcome the specification objection in regards to minor informalities. The objection to the specification has thus been withdrawn.
Applicant’s arguments and amendments, on pages 9-11 of the reply filed 27 January 2026 with respect to the rejection of Claims 1-10 under 35 USC § 112(b) have been fully considered. The rejections of Claims 1-10 are withdrawn due to amendment of the claims.
Applicant’s arguments and amendments, on pages 11-13 of the reply filed 27 January 2026 with respect to the rejection of Claims 1, 2, and 6-10 under 35 USC § 102(a)(1) or alternatively 35 USC § 103 have been fully considered. The rejections of Claims 1, 2, and 6-10 are withdrawn due to amendment of the claims.
Applicant’s arguments and amendments, on pages 13-15 of the reply filed 27 January 2026 with respect to the rejection of Claims 1, 2, 5, 9, and 10 under 35 USC § 102(a)(1) or alternatively 35 USC § 103 have been fully considered. The rejections of Claims 1, 2, 5, 9, and 10 are withdrawn due to amendment of the claims.
Applicant’s arguments and amendments, on pages 15-17 of the reply filed 27 January 2026 with respect to the rejection of Claims 1, 2, 6, 7, 9, and 10 under 35 USC § 102(a)(1) or alternatively 35 USC § 103 have been fully considered. The rejections of Claims 1, 2, 6, 7, 9, and 10 are withdrawn due to amendment of the claims.
Applicant’s arguments and amendments, on pages 17-18 of the reply filed 27 January 2026 with respect to the rejection of Claims 1-3 and 6-10 under 35 USC § 103 have been fully considered. The rejections of Claims 1-3 and 6-10 are withdrawn due to amendment of the claims.
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 1-10 and 21 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.
Regarding Claim 1, the limitation “followed by static treatment” is indefinite because it is unclear what is meant by “static treatment.” There is no definition of this limitation within the specification, nor is it a generally known term in the art. Additionally, the specification at [0050] describes how the pretreated gelling wall material is obtained and only discusses preparing an aqueous solution by mixing the wall material and the carbohydrate, stirring, and dispersing the aqueous solution. It is therefore unclear whether “static” refers to a lack of movement or progression, being fixed in place, radio static, or stationary electric charges. Appropriate clarification is necessary.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(b) for the reasons set forth above.
Response to Arguments
Applicant’s arguments and amendments, see pages 10-19 of the reply filed 27 January 2026, with respect to the rejections of Claims 1-10 have been fully considered and are persuasive. The rejections of Claims 1-10 under 35 USC § 102/103 have been withdrawn.
The instant claims are as of record, drawn to a carotenoid preparation obtained by mixing pretreated carotenoid with pretreated gelling wall material, emulsifying, and granulating, wherein the pretreated gelling wall material is 40-80 weight% and the raw material of the pretreated gelling wall material comprises wall material and carbohydrate. The pretreated carotenoid is obtained by mixing and stirring a solution of carotenoid and ethanol, pretreating the mixture by high-speed shear dispersion, and solvent removal. The pretreated gelling wall material is obtained by mixing, heating, and stirring the wall material and the carbohydrate.
Estrella et al. (WO 2017/168005 A1) teach a solid formulation comprising a milled (pretreated) carotenoid (carotenoid preparation) wherein the carotenoid is selected from lutein, zeaxanthin, or a mixture thereof, modified food starches, glucose syrup, sucrose, and a water soluble antioxidant (Estrella et al., Abstract). The solid formulation is prepared by providing an aqueous solution of the ingredients (mixing), forming a suspension which is then milled to obtain particles, and finally spray-granulating the suspension. The modified food starch (wall material) is starch sodium octenyl succinate and is present in the composition in a range of 10-50 weight% (Estrella et al., pages 6-7). The glucose syrup is present in a range of 5-40 weight% and the sucrose is present in a range of 0.1-40 weight% (carbohydrate). The total amount of modified food starch (wall material) and glucose syrup and sucrose (carbohydrate) is therefore 15.1-113 weight% of the composition, wherein the ingredients are the raw material of the pretreated gelling wall material and their combination is equivalent to the pretreated gelling wall material. The range of the prior art therefore overlaps the pretreated gelling wall material range of 40-80 weight%. Additionally, the weight ratio of wall material to carbohydrate is therefore (10-50):(5.1-80), or (1-5):(0.51-8), which encompasses the claimed weight ratios of (1-5):1 and 1:(1-5).
Zheng & Lin (CN 101032683 A) lutein (pretreated carotenoid) microcapsules (preparation) comprising microporous or crosslinking starch (starch), hydroxyethyl cellulose, carboxymethyl cellulose, or hydroxypropyl cellulose, (cellulose derivative; wall material), sugars including sucrose and glucose (carbohydrate; Zheng & Lin, page 2). The microcapsules are prepared by uniformly mixing lutein, starch, sugar, and cellulose and an aqueous solution of plant gum or protein using a colloid mill, high speed cutting emulsifying stirrer, high pressure homogenizer, or ultrasonic crusher to obtain a uniform colloid (emulsifying; e.g., Zheng & Lin, page 4, para. 4), and spray drying to obtain microcapsules (granulating; Zheng & Lin, page 2). In the examples, 25 g of starch and 35 g of carboxymethyl cellulose (wall material) is combined with 6 g of sucrose (carbohydrate) in a composition totaling 136.1 g (Zheng & Lin, first embodiment, pages 3-4). The pretreated wall material is therefore 66/136.1 g or 48.5% of the composition. Additionally, the ratio of starch:cellulose derivative is 25:35 or 5:7 or 1:1.4.
Li et al. (CN 108185424 A) teach a carotenoid particle preparation (pretreated carotenoid; carotenoid preparation) and preparation method thereof wherein the raw materials are mixed, emulsified, and granulated (Li et al., page 2). The carotenoid is selected from lutein, zeaxanthin, lycopene, alpha carotene, beta carotene, canthaxanthin, lutein ester (lutein fatty acid ester), astaxanthin, or mixtures thereof (Li et al., page 3). The gelling wall mixture (pretreated gelling wall material) comprises starch and carbohydrates in a mass ratio of 1:(1-5) wherein the starch is preferably sodium octenyl succinate and the carbohydrate is selected from sucrose, glucose, glucose syrup, xylose, fructooligosaccharide, corn syrup solid, or mixtures thereof (Li et al., pages 2-3). The gelling wall material is present in the final composition (weight of the preparation) at a dose of 30-65% (Li et al., page 3).
While the prior art teaches various carotenoid compositions comprising an emulsion of carotenoid, wall material, and carbohydrate, it does not reasonably teach or suggest pretreatment of the carotenoid wherein the carotenoid is mixed with an ethanol solution, pretreated via high-speed shear dispersion, and the solvent removed to obtain the pretreated carotenoid.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655