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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/08/2026 has been entered.
Applicants' arguments, filed 09/08/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-6, 14, and 15, are pending.
Claim 15 is withdrawn.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract is less than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 4, and 5, are objected to because of the following informalities: the claims recite “DE”, and while understood to mean dextrose equivalent, the full name should be present the first time an acronym is used. 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 1-6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bulbarello et al (WO 2019206984 A1, hereinafter “Bulbarello,” cited on IDS dated 07/19/2023), in view Estrella et al (US 20190098924 A1, hereinafter “Estrella”), and MacDonald et al (US 20080311265 A1, hereinafter “MacDonald”).
Bulbarello discloses a powderous composition comprising up to 70 wt% of at least one carotenoid and/or one carotenoid derivative, 5-30 wt% of at least one D-glycose oligomer (GO1) having a DE of <18, 5-30 wt% of at least one D-glycose oligomer (GO2) having a DE of >18, and 5-70 wt% of at least one polysaccharide (pg 1 ln 24-32). The at least one carotenoid and/or carotenoid derivative are alpha- or beta-carotene, 8'-apo-beta-carotenal, 8'-apо-beta-carotenoic acid esters such as the ethyl ester, cantaxanthin, astaxanthin, astaxanthin esters, lycopene, lutein, zeaxanthin or crocetin and their derivatives (pg 1 ln 7-9). The formulation comprises 0.1-70 wt% of the at least one carotenoid and/or carotenoid derivative (pg 2 ln 17-18). GO1 has a DE of preferably less than 15 (pg 3 ln 27-30). GO2 has a DE of preferably more than 20 (pg 4 ln 12-14). GO1 and GO2 can be used in the same amounts (1:1 mixture) (pg 4 ln 26-27). Preferably the polysaccharide is a modified starch, preferably the modified polysaccharide is starch sodium octenyl succinate (pg 4 ln 32, pg 5 ln 16). GO1 is preferably maltodextrin (abs, pg 1 ln 24-32). Good flowability is desired for solid powderous formulations (pg 1 ln 11-13).
Bulbarello does not specifically teach wherein the D-glycose oligomer (GO2) is a dried glycose syrup, nor wherein the powderous composition further comprises at least 1 wt% of at least one water-soluble dietary fiber.
Estrella teaches solid formulations comprising a milled carotenoid and at least one hydrocolloid selected from modified food starches including starch sodium octenyl succinate, where it was known to include a dried glucose syrup having a DE above 20, and may be also combined with a low DE glycose syrup (abs, ¶¶ 37, 41-44). The solid formulation of the present invention has an excellent flowability and is in the form of a powder (¶¶ 101, 109). The amount of the dried glucose syrup is in the range of from 0.1 to 40 weight-%, preferably in the range of from 5 to 40 weight-%, more preferably in the range of from 10 to 30 weight-%, most preferably in the range of from 15 to 25 weight-%, based on the total weight of the formulation (¶ 45).
Estrella does not teach inulin.
MacDonald teaches powdered beverage compositions where it was known to include a water-soluble fiber to improve the flowability and cold-water solubility of the powdered compositions (abs, ¶ 6). The soluble fiber includes inulin, wheat dextrins, fructo-oligosaccharides, beta glycan and the like, etc., and mixtures thereof (¶ 15). The preferred soluble fiber is inulin (¶ 15). In embodiments, the soluble fiber is used in an amount of about 2-10 grams (¶¶ 5, 12).
Regarding claim 1, Bulbarello discloses a powderous composition comprising up to 70wt% of at least one carotenoid and/or one carotenoid derivative, 5-30 wt% of at least one D-glycose oligomer (GO1) having a DE of <18, 5-30 wt% of at least one D-glycose oligomer (GO2) having a DE of >18, and 5-70 wt% of at least one polysaccharide.
Regarding maltodextrin of claim 1, it would have been obvious to select maltodextrin as the GO1 having a DE of <18, as taught by Bulbarello.
Regarding dried glucose syrup of claim 1, where Bulbarello teaches a D-glycose oligomer (GO2) having a DE of >18, it would have been obvious to select from other known D-glycose oligomers suitable for powderous formulations that can be combined with a D-glycose oligomer with a lower DE, such as dried glucose syrup, as taught by Estrella. The skilled artisan would have a reasonable expectation of success where Bulbarello and Estrella are both directed to powderous formulations comprising a carotenoid, a D-glycose oligomer with a higher and lower DE, that may also be combined with starch sodium octenyl succinate.
Regarding starch sodium octenyl succinate of claim 1, it would have been obvious to select from starch sodium octenyl succinate as the modified polysaccharide, as taught by Bulbarello.
Regarding the inulin claim 1, where Bulbarello discloses powder formulations where good flowability is desired, it would have been obvious to further include a water-soluble fiber known to improve the flowability and water solubility of powdered compositions, such as inulin, as taught by MacDonald.
Regarding the amount of dietary fiber of claim 1, it would have been obvious to include known amounts of inulin that were known to be suitable for powdered compositions, such as from about 11 wt%, calculated the weight in grams of each component in paragraph [00012] of MacDonald. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of water-soluble fiber in order to achieve optimal powder flowability properties. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144(II)(A).
Regarding claim 2, it would have been obvious to include at least one carotenoid and/or one carotenoid derivative selected from the group consisting of alpha- or beta-carotene, 8'-apo-beta-carotenal, 8'-apо-beta-carotenoic acid esters such as the ethyl ester, cantaxanthin, astaxanthin, astaxanthin esters, lycopene, lutein, zeaxanthin or crocetin and their derivatives, as taught by Bulbarello.
Regarding claim 3, it would have been obvious to include 0.1-70 wt% of the at least one carotenoid and/or one carotenoid derivative, as taught by Bulbarello.
Regarding claim 4, it would have been obvious to include GO1 with a DE of less than 15, which is taught to be preferable by Bulbarello.
Regarding claim 5, it would have been obvious to include GO2 with a DE of more than 20, which is taught to be preferable by Bulbarello.
Regarding claim 6, it would have been obvious to formulate the powderous composition with a GO1 to GO2 mixing ratio of 1:1, as taught by Bulbarello.
Regarding claim 14, it would have been obvious to select an ethyl ester of 8’-apo-beta-carotenoic acid as the at least one carotenoid and/or one carotenoid derivative, as taught by Bulbarello.
Response to Arguments
First, Applicants again assert that Bulbarello does not direct the skilled artisan to a solution as to how flowability could further be improved, and MacDonald seems to present a solution to a problem that Bulbarello does not raise. Applicants assert MacDonald provides protein containing powderous beverage compositions that have improved flowability due to the use of inulin as a water-soluble dietary fiber. Applicants assert the skilled artisan would not have a reasonable expectation of success that any flowability problem associated with the Bulbarello compositions could be solved following the teachings of MacDonald, where Bulbarello teaches fat-soluble carotenoids and MacDonald teaches protein and fiber beverage compositions as different stabilizing systems/compounds that are required to make the compounds water-soluble.
Second, Applicants again assert that MacDonald requires anticaking and flow agents in addition to the soluble fiber in the compositions, which Applicants assert MacDonald acknowledges are needed to further improve flowability. Thus, Applicants assert MacDonald does not unambiguously disclose that inulin or any other soluble fiber would serve to improve flowability alone in the protein compositions of MacDonald, let alone the fat-soluble compositions disclosed by Bulbarello.
First, respectfully, this argument is not persuasive. The Examiner again responds with Bulbarello teaches it is desirable to formulate powderous compositions that have good flowability, as would also be recognized by the skilled artisan, such as for ease of processing, handling, etc. When formulating a powderous composition where good flow is desirable, the skilled artisan would then turn to MacDonald, teaching powderous compositions with good flow, where it is explicitly taught that “the incorporation of the soluble fiber improves the flowability… the preferred soluble fiber is inulin…” (see ¶ 15 of MacDonald). While MacDonald may be directed to compositions comprising proteins, the broader teaching is that soluble fibers, including inulin, were known to improve the flowability of powderous compositions generally that can be used for the same purpose. Obviousness requires only a reasonable expectation of success, not absolute expectation of success; at least some degree of predictability is all that is required. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See MPEP 2143.02. Following these teachings, the skilled artisan would have motivation to further include soluble fiber, including inulin, to the compositions of Bulbarello with the reasonable expectation that their inclusion would improve the flowability of other powderous compositions that can be used for the same purpose.
Second, respectfully, this argument is not persuasive. The Examiner again responds with Applicants assert MacDonald requires anticaking and flow agents in addition to the soluble fiber in the compositions, however, anticaking agents and flow agents appear to be taught as optional components, where the anticaking and flow agents can be included in the compositions in an amount of 0 grams (see claim 9 of MacDonald). As discussed above, MacDonald explicitly teaches that soluble fibers, including inulin, are responsible for the improved flowability of the powderous compositions. Purely arguendo, even if anticaking and flow agents were required, the instant claims use the open language “comprising,” which does not exclude additional unrecited elements.
Claims 1-6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bulbarello et al (WO 2019206984 A1, hereinafter “Bulbarello,” cited on IDS dated 07/19/2023), in view Estrella et al (US 20190098924 A1, hereinafter “Estrella”), MacDonald et al (US 20080311265 A1, hereinafter “MacDonald”), and Ahmed et al (US 20090197974 A1, hereinafter “Ahmed”, cited on IDS dated 07/19/2023).
Bulbarello, Estrella, and MacDonald are discussed above, and purely arguendo, if somehow it would not have been obvious to include inulin based on the teachings of MacDonald alone, Ahmed is cited for additional motivation.
Ahmed teaches compositions comprising lutein (carotenoid) (¶ 30, organic lutein), and teaches it was known to include inulin in powder formulations in order to enhance flowability (¶¶ 16, 29). The dietary fiber is used in tablet embodiments in an amount from about 5 wt% to about 50 wt% (¶ 25).
Where the inclusion of inulin is made obvious above by MacDonald, additional motivation is provided by Ahmed where it was known that inulin can be included to improve the flowability of carotenoid containing formulations. Accordingly, the skilled artisan would have been motivated, and would have had a reasonable expectation of success of including inulin in the powderous formulations made obvious above, where MacDonald teaches inulin improves flowability of powderous formulations, and Ahmad teaches inulin was known to be used in carotenoid containing formulations for the same purpose.
The additional limitations of claims 1-6 and 14 are rejected for the same reason above as applied to each and every claimed limitation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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