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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/20/2025 has been entered.
Election/Restrictions
Applicant’s submission (see reply filed 10/20/2025 page 1) of new claim 20 as a withdrawn claim depending from previously withdrawn claim 15 is acknowledged. Claim 20 is withdrawn from consideration.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 6 the term “carragheenan” should be amended to “carrageenan”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Greif et al. (US 3,394,983) in view of Matthews et al. (US 4,816,259 A), Stangl et al. (US 2014/0272031 A1), and Liniger et al. (US 2008/0032011 A1).
Regarding claim 1, Greif et al. teaches a method of dyeing gelatin capsules (abstract), the capsules comprising a hydrogel matrix formed from gelatin as is known in the art, and therefore construed to read on “hydrogel-based materials”, comprising applying an aqueous colorant composition comprising water and a colorant material to an external surface of the capsules (column 2 lines 10-11, 19, and 23-24), mixing the aqueous colorant composition and the plurality of capsules to obtain colored capsules, (column 3 lines 33-35), and drying the colored capsules to remove at least a portion of the water absorbed into the hydrogel matrix thereby leaving the colorant therein (column 3 lines 39-46; column 4 lines 25-26, 48-49, and 63-74).
Regarding the plurality of hydrogel-based materials comprising one or more active ingredients, gel capsules are known in the art to hold “active ingredients” for delivery after ingestion. Greif et al. teaches the capsules are filled and can have indicia for drug identification or dosage levels (column 1 lines 41-42 and 60-61), which indicates use of “one or more active ingredients”.
Regarding “substantially all of the aqueous colorant composition is absorbed into the hydrogel matrix”, the process of Greif et al. is construed to read on the claimed feature since step “a.” as claimed only requires the colorant composition to be applied “to an external surface of the plurality of hydrogel-based materials”. Thus, the colorant composition must be absorbed through the external surface of the hydrogel-based materials. In view of the above, the “applied” aqueous colorant composition is construed to encompass the amount that has been absorbed by the gel matrix. Greif et al. teaches agitating the capsules in a bath of the aqueous colorant composition “until the depth of color is as desired”, where the color is imparted by absorption of the dye into the gel matrix as cited above. During the agitation, the portion of the colorant composition that comes into contact with, and is absorbed into the capsules is construed to read on the “applied” aqueous colorant composition. Therefore, “substantially all” of the applied colorant composition of Greif et al. would have necessarily been absorbed into the capsule matrix.
Regarding “drying…at a temperature sufficient to remove at least a portion of the water absorbed”, the drying process of Greif et al. is construed to read on the claimed feature. Since the claim does not specify a particular method of water removal (e.g., evaporation), the limitation is interpreted to encompass any method of removal, and by extension “any temperature” at which the removal occurs. Greif et al. teaches drying comprises extracting moisture from the capsule shell by a solvent and drying in a low humidity room until a desired moisture content is reached (column 3 lines 39-41 and 43-46). The drying steps would have necessarily occurred at a “temperature sufficient to remove…water”.
Greif et al. does not teach the capsule includes a filler. The term “filler” is interpreted to encompass at least the substances disclosed by the specification (paragraph 40).
Matthews et al. teaches gelatin capsules comprising gelatin, glycerin, and water (column 2 lines 13-19), the capsules therefore comprising a hydrogel matrix based on gelatin, forming the gelatin mass into capsules as is known in the art (column 2 lines 34- 39), and filling the capsules with active ingredient (column 5 lines 19-22 and 25-26). Glycerin (glycerol) is construed to be a filler as disclosed in Applicant’s specification. Further, the glycerin provides the gelatin capsule shells with “permanent flexibility” (column 3 lines 53-55), and the capsules are disclosed to exhibit an improved mechanical strength that will not crack or undergo substantial deformation during manufacturing procedures (column 1 lines 64-67).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the capsules of Greif et al. to include a filler such as glycerin and an active ingredient since the prior art recognizes gelatine capsules to include glycerin in the shell, and therefore to similarly provide sufficient flexibility and improved mechanical strength as taught by Matthews et al.
Greif et al. does not teach the colorant is a “natural colorant” and the aqueous colorant composition comprising up to 5 vol% of an aqueous miscible co-solvent comprising a C1-C4 alcohol or a C3-C4 ketone. The limitation “natural colorant” is interpreted in view of the specification (paragraph 59), where phycocyanin is disclosed as an embodiment thereof. The limitation of C1-C4 alcohol or C3-C4 ketone is interpreted to include compounds disclosed in Applicant’s specification (paragraph 64). For the sake of examination, the alternative “C1-C4 alcohol” is chosen. The alternative “C3-C4 ketone” is construed to be not required.
Stangl et al. teaches a method of forming edible, colored particles (abstract) comprising forming an aqueous colorant system by mixing only warm water and dyes (paragraph 28 and table 1), spraying the colorant on particles to form coated particles, and drying the particles (paragraph 29). The dye can be a natural colorant material such as spirulina (paragraph 17).
Liniger et al. teaches a method of imparting a food grade colored fluid including a food grade dye onto the surface of an edible substrate (abstract), the dye including natural dyes (paragraph 26) and the substrate being porous to facilitate absorption of the dye and including gel capsules (paragraphs 18 and 100), where the food grade dye includes no more than about 5 wt% of C1-C6 alcohols as surface tension modifiers (paragraph 88).
While Greif et al. recites using an alcohol-water solution for the colorant composition, the overall disclosure indicates to one of ordinary skill in the art that gelatin capsules can be colored by absorbing pigment in an aqueous carrier. The prior art recognizes a colorant composition consisting of a natural colorant material and water as the carrier, and further recognizes food grade dyes can include a small amount of C1-C4 alcohols.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Greif et al. such that the aqueous colorant composition consists of a natural colorant, water, and up to 5 vol% C1-C4 alcohols since the prior art recognizes such a composition for food grade dyes to be applied to a substrate, to include a known surface tension modifier, and thus to combine prior art elements according to known methods to yield predictable results and/or as a substitution of art recognized equivalents suitable for dying substrates, see MPEP 2143 I.(A) and 2144.06 II., since there is no evidence of criticality or unexpected results associated with the claimed values, and therefore since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as type of dye and desired characteristics such as surface tension.
Regarding claim 12, Greif et al. does not teach the mass ratio of the aqueous colorant composition to the plurality of hydrogel-based materials is within a range of about 1:1 to about 1:19.
However, the reference teaches immersing the capsules in the dye solution bath for a period of time to allow a desired amount of the dye solution to be absorbed by the capsules and obtain a desired “depth of color” (column 3 lines 33-35). The duration for immersing the capsules in the dye correlates to the amount of dye absorbed by the capsules (column 4 lines 38-48).
While the claimed range of ratios is not explicitly taught, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the claimed ratios since the prior art recognizes the amount of colorant composition applied and absorbed by the capsules correlates to the “depth of color”, since there is no evidence of criticality or unexpected results associated with the claimed feature, and therefore since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as a desired amount of dye absorbed into the gel matrix, and thus desired appearance or depth of color, and the particular dye used.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Greif et al. in view of Matthews et al., Stangl et al., and Liniger et al. as applied to claim 1 above, and further in view of Benczedi et al. (US 2007/0122398 A1).
Regarding claims 6 and 7, Greif et al. teaches the hydrogel-based materials are capsules formed by methods recognized by the art, but does not teach the capsules are seamless and the hydrogel shell surrounds an oil-based inner core (claim 6) comprising one or more flavor or fragrance ingredients (claim 7).
Matthews et al. teaches the capsules are “manufactured on standard commercial encapsulating equipment” to produce capsules which “exhibit no shell weak points either internally or externally” i.e., “seamless” (column 2 lines 34-39).
Benczedi et al. teaches capsule for encapsulating function ingredients such as flavors and fragrances (abstract), comprising a gelatin matrix (paragraph 36) surrounding an oil-based inner core which acts as a carrier for the functional ingredient (paragraphs 73-74). The flavors and fragrances can be chosen to obtain more desirable characteristics (paragraphs 41-42).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Greif et al. such that the hydrogel shell surrounds and oil-based inner core since the reference does not particularly limit the type of capsule used and its structure, where the prior art acknowledges seamless gelatine capsules and oil carriers for functional ingredients, since there is no evidence of criticality or unexpected results associated with the claimed feature, and therefore to combine prior art elements according to known methods to yield predictable results, and to similarly provide desirable characteristics to the capsule.
Regarding claims 8-9, the combination of claims 6-7 above is similarly applied and would have been obvious for the same reasons, but the combination does not include the one or more flavor or fragrance ingredients having a Log KO/W less than 2 (claim 8), and 10 wt% or more of the oil-based inner core comprises said one or more flavor ingredients (claim 9). It is noted that the limitation “Log KO/W” is interpreted to be the “octanol water partition coefficient” as is recognized by the art.
Benczedi et al. further teaches the functional ingredient includes substances having a coefficient less than 2 (paragraphs 34-37), where such substances include different “flavor functions” (paragraph 43 table1). The functional ingredient can be 10-40 wt% of the capsule (paragraph 78).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Greif et al. such that the functional ingredient has a coefficient less than 2 and comprises 10 wt% or more of the oil-based inner core for the same reasons applied to claims 6-7, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as the desired flavor and/or aroma profile and intensity.
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Greif et al. in view of Matthews et al., Stangl et al., and Liniger et al. as applied to claim 1 above, and further in view of McPherson et al. (US 2019/0059422 A1).
Regarding claims 11 and 19, the combination applied to claim 1 teaches a natural colorant material, but does not teach the material comprises blue phycocyanins (claim 11), where the phycocyanins are a “thermally unstable dye that undergoes a change in a color appearance parameter, when subjected to a temperature…between 40oC and 80oC” (claim 19).
McPherson et al. teaches a composition comprising gelatin and a colorant for use in foods (abstract), where phycocyanin such as spirulina is used as a blue colorant recognized to change color at elevated temperatures due to degradation of the protein (paragraph 16), where the degradation temperature threshold is about 80oC (paragraph 43).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Greif et al. such that the colorant material comprises thermally unstable phycocyanin having the claimed features since the reference is already directed to facilitating identification via coloring (column 1 lines 28-31), and therefore to provide indication of undesired handling/storage conditions (e.g., maintaining an excessively high temperature can lead to degradation of active components), since the prior art recognizes that thermally unstable dyes can be used to color food products, where known phycocyanin dyes such as spirulina are recognized to have a thermal degradation threshold of about 80oC, where one of ordinary skill understands that slight variances in the threshold temperature can exist and/or be obtained, since there is no evidence of criticality or unexpected results associated with the claimed colorant material and dye, and therefore as a matter of preference for the particular color of the capsules.
Response to Arguments
Applicant’s arguments against Nakamura have been fully considered, but the amendments to claim 1 necessitated new grounds of rejection. The reference is no longer relied upon.
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive.
Applicant argues Greif teaches the aqueous colorant composition comprises 40-90% water-miscible organic solvent-water solution of a dye, the solvent including lower alcohols, and therefore does not teach or suggest the aqueous colorant composition comprising “up to 5% (v/v)…C1-C4 alcohol or…ketone.
This is not persuasive since the combination applied to claim 1 replaces the solution of Greif with that of Stangl and Liniger i.e., a natural colorant, less than 5 wt% alcohol, and the balance water. The alcohol is used as a surface tension modifier, and therefore the amount would have been obvious based on the desired respective property of the aqueous colorant composition.
Applicant argues modification of Greif to eliminate or reduce water-miscible volatile organic solvent would destroy the principle of operation.
This is not persuasive since the reference recites a lower alkanol-water solution is “preferred” (column 2 line 11). While the preference for such a solution is recognized, the reference does not suggest to one of ordinary skill that a solution with up to 5 vol% C1-C4 alcohol would be incapable of applying dye for absorption (see whole document; see also MPEP 2123). To the contrary, the reference suggests reasons to minimize the organic solvent (toxicity, cost, etc.) and states “water is an excellent compromise between availability, cost, and operating convenience” (column 2 lines 10-22). The prior art teaches colorant compositions including only colorant, water, and less than 5 wt% alcohol stated for claim 1.
Applicant argues that Matthews is directed to a process for coating gelatin capsules and creating distinct layers which may or may not be colored using synthetic dyes with polyethylene glycol as a co-solvent, in contrast to the claimed invention where the object is to impart color to a hydrogel-based material by mixing the aqueous colorant composition and the hydrogel materials such that the colorant composition is absorbed by the hydrogel matrix.
This is not persuasive since Greif et al. teaches applying an aqueous colorant composition to gelatin capsules such that the composition is absorbed into the capsule matrix, and later removing the aqueous carrier by drying. Likewise, the combination applied to claim 1 modifies the aqueous colorant composition of Greif to include only natural colorant, less than 5 wt% alcohol, and the balance water. Matthews et al. is relied on only to show that compositions for the gelatin capsules include “filler” such as glycerin.
Applicant argues McPherson does not teach or suggest that its pelletized colorant is suitable for use in coloring hydrogel-based materials as claimed, and the same for Benczedi.
This is not persuasive since the combination of Greif with Matthews, Stangl and Liniger applied to claim 1 teaches the claimed process and aqueous colorant composition. McPherson is relied on to show that phycocyanin dyes include spirulina, which is recognized to be “thermally unstable” with a degradation temperature threshold of about 80oC. Benczedi is relied on to show that capsules having active ingredients comprising the claimed features are recognized by the prior art.
Applicant’s argument against the dependent claims is not persuasive for the same reasons stated above.
Conclusion
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/BRYAN KIM/Examiner, Art Unit 1792