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 .
Applicant’s election of Group I, claims 1-10 and 12-14, in the reply filed on 11/26/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/2025.
Claims 1-10 and 12-15 are pending. Claim 15 is withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: in the third line of component (iii), “and” should be removed. Appropriate correction is required.
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.
Claim 6 is 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 6 recites the limitation "are present in the powderous mixture in a 1:1 mixture" in line 3. Claim 6 depends from claim 1 where there is no limitation of a mixture. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be interpreted as “are present in the powderous composition in a 1:1 mixture.”
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 1-10 and 12-14, 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 of 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; GO2 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 powderous composition further comprises at least 1 wt% of at least one water-soluble dietary fiber.
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 use 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 the water-soluble dietary fiber of claims 1, 9, and 10, 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 wheat dextrins, fructo-oligosaccharides, beta glycan, or the preferred inulin, as taught by MacDonald.
Regarding the amount of dietary fiber of claim 1, it would have been obvious to include known amounts of water-soluble fiber 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 claims 7 and 8, it would have been obvious to select from starch sodium octenyl succinate as the modified polysaccharide, as taught by Bulbarello.
Regarding claim 12, it would have been obvious to select maltodextrin as the GO1 having a DE of <18, as taught by Bulbarello.
Regarding claim 13, it would have been obvious to select maltodextrin as the GO2 having a DE of >18, 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 12-14, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/262,078 (reference application), hereinafter ‘078, in view of Bulbarello et al (WO 2019206984 A1, hereinafter “Bulbarello,” cited on IDS dated 07/19/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘078 disclose a powderous composition comprising up to 70 wt% of at least one fat soluble vitamin, 5-30 wt% of at least one D-glycose oligomer (preferably maltodextrin) (GO1) having a DE of < 18, 5-30 wt% of at least one D-glycose oligomer (preferably maltodextrin) (GO2) having a DE >18, 5-70 wt% of at least one modified polysaccharide, and at least 1 wt% of at least one water-soluble dietary fiber (claim 1). The GO1 has a DE of less than 15 and the GO2 has a DE of more than 20 (claims 5, 6). The GO1 and GO2 are in a 1:1 mixture (claim 7). The modified polysaccharide is modified starch, wherein the modified starch is starch sodium octenyl succinate (claims 8, 9). 1-20 wt% of the water-soluble fiber is used, wherein the water-soluble fiber is chosen from beta-glucans, psyllium, inulin, wheat dextrin and oligosaccharides (claims 10, 11).
The claims of ‘078 do not disclose up to 70 wt% of at least one carotenoid and/or one carotenoid derivative.
It would have been obvious to modify ‘078 by substituting the fat soluble vitamins with the carotenoids of Bulbarello, where both are active components suitable for powderous compositions comprising 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 >18, 5-70 wt% of at least one modified polysaccharide, and at least 1 wt% of at least one water-soluble dietary fiber.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following is also rejected in view of Bulbarello for the same reasons:
Copending Application No. 18/261,590: The claims of ‘590 differ from the instant claims insofar as they recite at least one polyunsaturated fatty acid as the first component. It would have been obvious to modify ‘590 by substituting the polyunsaturated fatty acid with the carotenoids of Bulbarello, for the same reasons discussed above.
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
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600