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 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) and Stangl et al. (US 2014/0272031 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 aqueous colorant composition consists of a natural colorant and water. The limitation “natural colorant” is interpreted in view of the specification to include spirulina (paragraph 59).
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 instead be a natural colorant material such as spirulina (paragraph 17).
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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Greif et al. such that the aqueous colorant composition consists of a natural colorant and water as a substitution of one known element for another and selection from known colorant compositions to obtain predictable results with a reasonable expectation of success, see MPEP 2143 I.(B) and (E), to impart a desired “depth of color”, and since the evidence of record does not indicate unexpected results associated with said composition.
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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed 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 depth of color.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Greif et al. in view of Matthews et al. and Stangl 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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. and Stangl 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 before the effective filing date of the claimed 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
The amendments to claim 1 necessitated new grounds of rejection since the “consisting of” language was not previously considered and since removal of the miscible co-solvent limitation changes the scope of the claim. Thus, Liniger et al. is no longer relied upon and Stangl et al. is cited to teach that the colorant composition can be made from only natural dye and water.
Applicant's arguments filed 5/4/2026 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, alcohol-water solutions are preferred, the organic solvent is necessary for the dye composition and is not an optional component, and eliminating the solvent would destroy the principal operation of Greif.
This is not persuasive since the alcohol-water solution is a preferred embodiment of Greif (column 2 line 11), see also MPEP 2123. The reference also teaches 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).
Further, Greif teaches the capsules comprise a hydrogel matrix, which one of ordinary skill would understand to absorb water after exposure. Since the prior art recognizes an edible colorant composition consisting of natural colorant material and water as taught by Stangl, it would have been reasonable to expect that replacing the colorant composition of Greif with that of Stangl would still result in absorption of the natural colorant along with water.
Applicant argues that Matthews is directed to a process for coating gelatin capsules and creating distinct layers which are 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. Applicant argues a skilled artisan interested in coloring hydrogel-based materials would not look to Matthews since the reference teaches coating the capsule, where the coating includes hydroxypropyl methyl cellulose and propylene glycol.
This is not persuasive since Matthews is not relied on to teach the argued features. Greif is relied on to teach applying an aqueous colorant composition to gelatin capsules such that the composition is absorbed into the capsule matrix, and the colorant composition is replaced with that of Stangl. The coating feature of Matthews is not incorporated into the combination. Rather, the reference teaches gelatin capsules are recognized to include “filler” material such as glycerin in order to provide flexibility and mechanical strength, which provides the motivation to modify the capsule of Greif to include such a material. Further, Matthews is considered analogous art since the reference is directed to a process of manufacturing/treating gelatin capsules, which is within Applicant’s field of endeavor.
Applicant argues Stangl teaches away from coloring other particles, such as conventional confectionary particles generally made with gums, gelatin, etc. that help adhere or dissolve a pigment.
This is not persuasive since the argued disclosure is directed to issues arising from the color particles being placed in deteriorating conditions, such as high humidity, which causes color bleed. While this may be an issue for edible color particles used in confections, such an issue would not be a concern in the process of Greif. The refence teaches batch coloring by absorbing the dye into the capsule gel matrix and subsequently removing the carrier water, so color bleed or loss of detail due to moisture would not be a concern. Thus, a skilled artisan would not have considered the argued disclosure to be a teaching away from modifying the process of Greif.
Applicant argues Benczedi and McPherson do not teach or suggest making colored hydrogel-based materials as claimed.
This is not persuasive for the same reasons stated above, and since the combination of Greif and Stangl already renders obvious coloring hydrogel-based materials through absorption of a colorant composition, said composition consisting of a natural color material and water. Benczedi is relied on to show that gelatin capsules contain an oil-based inner core that acts as a carrier for functional ingredients having the claimed property. McPherson is relied on to show that phycocyanin such as spirulina is recognized to be an edible colorant that has the advantage of changing color when exposed to temperature above a threshold.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bloom et al. (US 2021/0102228 A1) teaches a coloring composition such as spirulina suspended in tap water (paragraph 23).
Cavin et al. (US 2016/0021907 A1) teaches edible water-based inks, where the ink can be free of monohydric alcohols, diols, and triols based on user preference or dietary restriction, such as Muslim consumers who do not consume ethanol (paragraphs 47 and 49).
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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/B.K/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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