DETAILED ACTION
Background
The amendment dated October 20, 2025 (amendment) amending claims 1 and 6, adding new claims 11-12 and canceling claims 2-5 and 7-10 has been entered. Claims 1, 6 and 11-12 as filed with the amendment have been examined. In view of the amendment, all outstanding claim objections have been withdrawn and all outstanding rejections of canceled claims 2-5 and 7-10 have been withdrawn.
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 Objections
Claims 1 and 6 are objected to because of the following informalities:
In claim 1, at line 14, after “activity range of” insert -- the--, and after “xylitol particles” replace [[that does]] with --is such that the particles do not--;
at line 15, after “calcium aspartate particles” insert --, and--; and,
at line 16, after “correlated with” replace [[a]] with --the--; and,
In claim 6, at line 15 after “xylitol particles” replace [[that does]] with --is such that the particles do not--; and,
at line 17, after “particles” insert --, and--, and, after “correlated with” replace [[a]] with --the--.
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.
Claims 1, 6 and 11-12 are 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.
Regarding instant claims 1 and 6, claim 1 recites the limitation "range of 0.36 to 0.66" in line 20 referring to the water activity of the xylitol particles. Further, claim 6 recites the limitation "range of 0.40 to 0.67" in line 23 referring to the water activity of the xylitol particles. There is insufficient antecedent basis for these limitations in the claims. Is the last stanza in each of claims 1 and 6 a test of the recited composition, or does it involve addition of a quantity of maltitol particles to a composition after further adjusting the water activity of the xylitol particles to a newly recited range of water activity?
Claims 11-12 are rejected as depending from a rejected base claim.
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 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over CN113317428 A to Qin et al. (Qin) in view of JP08196300 A to Sugitani et al. (Sugitani), both of record, and US2013/0323390 A1 to Kawamura et al (Kawamura).
All references to Qin and Sugitani refer to the Clarivate machine translation, a copy of which was included in a prior Office action.
Unless otherwise disclosed, all percents (%) disclosed without units are interpreted as weight %s (wt%) and wt% is interpreted as interchangeable with mass %.
The Office considers the adjusting of the water activity of the calcium aspartate particles and the xylitol particles in the instant claims to include adjusting water activity of those materials at any time before their mixture, if even for a transitory period of time.
Regarding instant claims 1 and 6, Qin at Abstract on page 2 discloses a solid preparation and preparation method thereof comprising calcium aspartic (“calcium aspartate”) as a calcium source, a zinc source, an iron source, xylitol and sugar. Qin at page 4, 4th and 5th paragraph discloses a method comprising mixing and grinding the calcium source and the iron and zinc sources; further discloses (at page 7, 7th full paragraph) adding water as adhesive and mixing the calcium compound and xylitol (“mixing calcium aspartate particles with xylitol particles to obtain a mixture of xylitol and calcium aspartate”) and then granulating and drying the mixture. Further, Qin at page 3, 5th full paragraph (starting with “The invention is”) discloses use as a food.
Qin does not disclose adjusting and measuring the water activities of xylitol particles and calcium aspartate particles, wherein the water activities of the xylitol particles and the calcium aspartate particles are adjusted by drying, and mixing calcium aspartate particles with a water activity of from 0.50 to 0.52 and xylitol particles with a water activity in a range of 0.48 to 0.56 to obtain a mixture of xylitol and calcium aspartate. Further, Qin does not disclose adding maltitol particles in a weight ratio of 5%-20% (5 to 20 wt%) relative to a total mass of the xylitol particles and the maltitol particles to the mixture of the xylitol and the calcium aspartate. And, although it discloses granules generally, Qin does not disclose xylitol particles having a size in a range of 10 to 80 mesh.
The Office considers the calcium aspartate particles disclosed in Qin at page 4, 4th and 5th paragraph that are ground and the calcium aspartate particles of the claimed invention to be substantially the same thing. Accordingly, absent a clear showing as to how the water activity of the calcium aspartate particles of Qin differ from that of the calcium aspartate particles as claimed, the Office considers the calcium aspartate particles of Qin to have a water activity in the range of from 0.50 to 0.52 as in claim 1 and of from 0.52 to 0.58 as in claim 6. See MPEP 2112.01.I.
Kawamura at Abstract discloses xylitol as a water activity reducing agent for use in food. Further, Kawamura at [0005] discloses that microorganisms cannot proliferate in a condition with a water activity (Aw) of less than 0.6. In addition, Kawamura discloses independently preparing the xylitol [0081] and other carbohydrate water activity reducers as a powder or a paste before adding them to a food product. Still further, at Table 1 on page 10 Kawamura discloses solid contents and water activities for mixtures of sorbitol and xylitol and shows that drying the mixtures reduces their water activity.
Sugitani at the Abstract on page 1 discloses a pulverized mixture of from 70 to 97 parts by weight (%) xylitol and from 3 to 30%, based on the total weight of the mixture, of reduced maltose (maltitol) that is resistant to agglomeration and provides improved taste as a sweetener; and, further discloses milling the product to produce a ground product. The claimed 5 to 20 wt% by mass of maltitol particles, based on the total mass of xylitol particles and maltitol particles lies within the Sugitani discloses 3 to 30 wt% maltitol particles, based on the total mass of xylitol particles and maltitol particles. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Kawamura for Qin to adjust the water activity of its xylitol before mixing them with its calcium aspartate particles by drying them to form a powder as well as to measure water activity of independently prepared materials and food or materials with which xylitol is mixed. Both references disclose xylitol compositions in dry form for use in food. Because Kawamura discloses forming xylitol independently as a powder before mixing it with other materials such as the calcium aspartate particles of Qin, the ordinary skilled artisan in Qin as modified by Kawamura would have found it obvious to form xylitol particles and adjust their water activity by drying them independently as in Kawamura before mixing with calcium aspartate particles or other materials. The ordinary skilled artisan in Qin would have desired to measure and adjust the water activity of the calcium aspartate particles and the xylitol particles independently to form a powder and to adjust the water activity of its xylitol to below 0.6, within which range the claimed water activity for xylitol of 0.48 to 0.56 in claim 1 and of 0.50 to 0.60 in claim 6 lies. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05.I. Kawamura discloses the claimed water activity as desirable for use in water activity reducers and for avoiding microbial contamination. In addition, the ordinary skilled artisan in Qin as modified by Kawamura would have found it obvious to determine if there is a need to avoid microbial contamination in materials before mixing them by measuring their water activity.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Sugitani for Qin to add the claimed 5 to 20% by mass, based on the total mass of xylitol particles and maltitol particles to its composition of xylitol particles and calcium aspartate particles and to grind the composition of xylitol particles to a size range of 10 mesh to 80 mesh. Both references disclose flowable solid particle compositions comprising xylitol particles as a sweetener. The ordinary skilled artisan in Qin would have desired to include the claimed amount of maltitol particles in its sweetened powder as in Sugitani to give an improved sweet flavor and enhance its resistance to agglomeration and to lower the water activity of the xylitol particles and calcium aspartate particles by absorbing water; and, further, the ordinary skilled artisan in Qin would have desired to mill the xylitol particles as in Sugitani to give a smaller particle size for easy dissolving.
Response to Arguments
In view of the amendment dated October 20, 2025, the following rejection is withdrawn as moot:
The rejections of Claims 1- under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in regard to the term “or” in each of claim 1, at line 5 and claim 6, at line 6.
The positions taken in the remarks accompanying the amendment dated October 20, 2025 (Reply) have been fully considered but they are not found persuasive for the following reasons:
Regarding the position taken in the Reply that Qin does not teach or suggest measuring any physical properties (let alone water activity) of xylitol or calcium aspartate prior to mixing the materials, and that Qin's "drying" step is a post-treatment step, whose purpose is to remove the additional liquid water previously added for granulation, respectfully the Office does not rely on Qin for the recited measuring water activity or for drying the calcium aspartate particles and xylitol particles prior to mixing them; it relies instead on Kawamura.
Regarding the position taken in the Reply that the claims recite measuring water activity as an active and pre-positioned quality control step and drying as a pre-treatment step, the position is restated: “In contrast, as recited in amended claim 1, measuring the water activities of xylitol particles and calcium aspartate particles is performed prior to mixing respectfully the Office relies not on Qin for this but on Kawamura.
Regarding the position taken in the Reply that the basis for the proportion of maltitol particles and xylitol particles differs in Sugitani and in the instant claims, the Office respectfully disagrees. Sugitani clearly discloses at “Constitution” mixing reduced xylose (xylitol) and 3 to 30 weight parts reduced maltose (maltitol) based on the total weight (mass) of the xylitol particles and maltitol particles, which is as claimed.
Regarding the position taken in the Reply that the data in the instant specification establish unexpected results, respectfully the comparative data in the instant specification allow a comparative composition to sit for 4 weeks before processing it whereas Qin dries its composition right after granulating. Accordingly, the comparison does not properly address Qin. Rather, a proper comparison to address the art mixes particles first, then dries them and stores them for 4 weeks and compares that to drying particles first and then mixing them before storing for 4 weeks.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Calcium Aspartate - Aprofood, downloaded from “https://www.aprofood.com/calcium-aspartate-item-895.html at page 2 discloses that calcium aspartate generally comprises a fine powder having a moisture content of less than or equal to 6.0%.
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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/A.E.M./Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791