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 .
Priority
The present application is the national stage entry of PCT/EP2021/067674 filed 28 June 2021. Acknowledgement is made of the Applicant’s claim of foreign priority to application EP20183048.6 filed 30 June 2020.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11 August 2025 is acknowledged. The Applicant has canceled the non-elected claims.
Status of the Claims
Claims 1-10 and 16-21 are pending.
Claims 1-10 and 16-21 are rejected.
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 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Anfinsen et al. (WO 00/64277).
Anfinsen teaches a composition comprising vitamin-mineral granules of Example 3 and antioxidant granules of Example 4 in a 1:5 ratio (1 g to 5 g), which are taught as separate mixtures which are combined before use (pg 17, ln 18- pg 18, ln 28). The vitamin mineral granules comprise inulin, vitamin A, vitamin C, vitamin D, vitamin E, calcium, zinc, and other agents wherein 5 g of granules provides a recommended daily dose for adults over 50 years old (pg 17, lns 18-26). The antioxidant granules contain 100 mg of green tea extract, 100 mg of grape seed extract, and inulin (pg 18, lns 4-20). The first particle comprises at least three active agents and the second particle comprises less actives than the first wherein inulin (a macronutrient and a glycoside) is the only common agent among both particles. The first granule comprises the inulin in 26.5% (pg 22, lns 1-10). All the components of each granule are considered edible, so both components comprise 100% by weight of edible components. The antioxidant granules, or edible particles of a second variety, comprise 100 mg of green tea extract as well as other agents, therefore the composition necessarily comprises more than 25 mg of said particles. In a broader teaching, Anfinsen teaches that the granular composition can comprise vitamins such as vitamin E without specifying in which particle the vitamin is incorporated (pg 13, lns 16-22) and Anfinsen also teaches that the antioxidant particle can comprise vitamin E in 10-200 IU (pg 14, ln 29-pg 15, ln 5). It is further noted that the antioxidant particle can further comprise additional agents such as theanine (bitter masking agent) in amounts of 0.03% (pg 19, ln 6; pg 23, lns 10-15). It is noted that Anfinsen teaches the granules as individual entities such as a vitamin granule formulation (pg 22, lns 1-10) and an antioxidant nutrient formulation (pg 23, lns 9-16).
The granules of Anfinsen can be produced by a variety of processes including agglomerating using spray driers (pg 7, lns 5-15). The granules produced may comprise one or more ingredients and granules comprising only one ingredient may comprise inulin (pg 7, lns 18-21). Inulin is taught as being a carbohydrate that can improve lipid metabolism and serve as a carrier or granulating aid (pg 9, ln 30- pg 10, ln 6). Carbohydrates can be included in about 0.5% to about 100% by weight (pg 11, lns 20-21) and can be considered granulating aids that provide bulk to the granule and help in formation and binding (pg 15, lns 15-19).
It would have been prima facie obvious to prepare the edible particles of instant claim 1, and modify the composition of Anfinsen based on the disclosure to further include vitamin E in 10-200 IU, wherein the carbohydrate inulin is considered the matrix material due to its bulking ability. The range of amounts of vitamin E when converted to percentage overlaps with the 0.1-20 wt% of instant claim 10. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I). It is noted that although additional vitamins and supplements are taught as being included in the antioxidant formulation, the prior art does not require all active agents to be included and, based on the variety of examples, makes it clear that the skilled artisan can select the desired active agents from among the list of suitable vitamins and minerals. Moreover, Anfinsen provides for the granule to be up to 100% by weight of carbohydrate (inulin). Thus, it would have been obvious to prepare the second particle of Anfinsen either as a 100% inulin particle, as required in instant claim 17 or wherein the particle further comprises vitamin E, as required in instant claim 10. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Although it is taught that the antioxidant and the vitamin-mineral granules can be mixed into a single composition, each granule is taught individually in the art and thus it is obvious to package them individually prior to mixing and prior to use.
In an alternative formulation, the antioxidant particle can comprise an additional excipient for bitter taste masking taught as being present in 0.03%. The agent is known to provide bitter masking ability and thus it would have been obvious to the skilled artisan to adjust the amount present based on need. That being said and in lieu of objective evidence of unexpected results, the amount of excipient can be viewed as a variable which achieves the recognized result of successfully bitter masking the flavor of the granule. The optimum or workable range of excipient can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of excipient nonobvious.
Regarding instant claim 5, Anfinsen teaches that doses of 10-15 grams are too large to be conveniently taken, therefore it would have been obvious to prepare the formulation of the art in smaller, more user-friendly dosage forms such as wherein the first and/or second granule is 1000 mg in size.
Regarding claim 19, the composition can comprise all granules, or 100% granules, and can be made by spray drying.
The resulting compositions render obvious instant claims 1-10 and 16-21.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 7-8 of their remarks, that the compositions of Anfinsen comprise mixtures of the first and second ingredients and do not teach first and second single serving packs of each granule.
In response, the Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). While the art does teach combining the granules from Examples 3 and 4 into a single composition, the art also teaches the granules as distinct formulations, thus indicating suitable use thereof without mixing together. Because they are taught as distinct granule formulations as well as in a combined blend in a particular ratio for adults, it would have been obvious to package the vitamin-mineral granules in a pack separately from the antioxidant granules. Separate packaging provides for end-use mixing in any desired ratio and dosage for any age of person.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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