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 .
Election/Restrictions
Applicant's election with traverse of Group II: claims 9-23 in the reply filed on 1/27/2026 is acknowledged.
The traversal is on the ground(s) that “product as claimed can be made by another process” is unsupported as “Neither independent claim 1 nor independent claim 9 indicates any sequence”. This is not found persuasive because the issue is not “sequence”. As stated in the restriction requirement, the proposed different method is different from method of claim 1 because it does not require that the "liquid fructooligosaccharide" have "a Brix of at least 25%". Thus, the method includes liquid fructo-oligosaccharides of any Brix, such as a Brix of 23%. Further, applicant may argue that the limitation "a Brix of at least 25%" is also required by the product, as product claim 8 depends from claim 1. However, noting that because claim 8 is product claim, any recitation of process steps therein does not carry patentable weight. Thus, although product claim 8 requires "according to the method of claim 1" and hence "a Brix of at least 25%" recited in claim 1, this makes claim 8 a product-by process claim. As "Brix of at least 25%" is not a property of the final product {as final product is a "chewable gummy), it incorporates details of a process step (because "a Brix of at least 25%" is a property that is applicable only when process steps are considered, product claimed is "a chewable gummy" to which "a Brix of at least 25%" does not apply).
The requirement is still deemed proper and is therefore made FINAL.
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 15 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.
Claim 15 requires “The chewable gummy of claim 9 comprising less than 250 mg sugar”. However, claim 15 depends from claim 9 and neither claim 9 nor claim 15 define quantity of “chewable gummy” or any relative quantity of it’s ingredients. Thus, it appears that whether the “chewable gummy” is 1 mg or 1 ton, it still must comprise “less than 250 mg sugar”, which appears to be in error. 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.
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 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over IDS reference to Watson (US 20120301588), hereinafter Watson, in view of Ludwig (US 20150132365), hereinafter Ludwig.
Regarding claims 9-14, Watson teaches (as recited in claim 9) a chewable gummy (para 10 discloses "chewable compositions" that are commonly referred to as "jelly, gummy or gummi candies") comprising:
first oligosaccharide (see "LBS /inulin" described in para 53 and TABLE 3; also see para 12-13 that describes inulin as "oligomer"; i.e. an oligosaccharide, with "fructooligosaccharide" being those oligosaccharides that have "smaller amounts of fructose unit"; i.e. lower degree of polymerization);
second oligosaccharide (any one of powdered inulins such as "F97 lnulin" described in para 42; also see 1st sentence of para 53);
pectin (para 18 describes gelling agent may be "pectin"); and
food acid (see "Citric Acid" in TABLE 3 on page 4; also see para 56), as recited in claim 9.
Watson also teaches the chewable gummy comprising (as recited in claim 13) from 10% by weight to 80% by weight of the first fructo-oligosaccharide, from 10% by weight to 80% by weight of the second fructo-oligosaccharide, and that gelling agent may be pectin (para 18), comprising from 1% to 15% of the chewable composition (para 19), which overlaps with the range "from 1% by weight to 5% by weight of the pectin"
Watson does not clearly disclose that the first oligosaccharide is a first "fructo-oligosaccharide" and that the second oligosaccharide is a second "fructo-oligosaccharide", with the first "fructo-oligosaccharide" differing from the second "fructo-oligosaccharide" based on a property selected form the group consisting of average degree of polymerization, mode degree of polymerization, mode molecular weight, and combinations thereof (as recited in claim 9), and further (as recited in claim 10) wherein the first "fructo-oligosaccharide" has "an average degree of polymerization no greater than 10", and the second "fructo-oligosaccharide" has "an average degree of polymerization no greater than 20"; OR that (as recited in claim 13) comprising "from 10% by weight to 80% by weight of the first fructo-oligosaccharide, from 10% by weight to 80% by weight of the second fructo-oligosaccharide, from 1% by weight to 5% by weight of the pectin" (as recited in claim 13).
Ludwig also teaches a food composition also comprising oligosaccharides (para 95) such as inulin (para 96), further teaching it is known to use a mixture of oligosaccharides which is a mixture of fructo-oligosaccharide with an average DP (i.e. degree of polymerization) below 10, and a fructo-oligosaccharide with an average DP preferably above 11 (para 105), which overlaps with the claimed range in claim 10.
Ludwig also teaches that weight ratio of the short chain fructo-oligosaccharide and long chain fructo-oligosaccharide may be in a weight ratio of from 1/19 to 19/1 (para 99), which overlaps the claimed "the ratio of the first fructo-oligosaccharide to the second fructo-oligosaccharide is from 50:50 to 65:35", as recited in claim 14.The above teachings also meet the requirements of claim 11 by exhibiting a bimodal degree of polymerization (i.e. one mode each for each of the two “degree of polymerization” ranges of claim 10) and also the requirements of claim 12 that requires “first fructo-oligosaccharide has a mode degree of polymerization that is greater than the mode degree of polymerization of the second fructo-oligosaccharide”.
Regarding the overlapping of ranges between the invention and prior art composition described above, it is noted that in the case where the claimed ranges "overlap or lie inside the ranges disclosed by the prior art" a prima facie case of obviousness exists (In re Wertheim, 541 F2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990)).
It would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Watson so that that the first oligosaccharide is a first "fructo-oligosaccharide" and that the second oligosaccharide is a second "fructo-oligosaccharide", with the first "fructo-oligosaccharide" differing from the second "fructo-oligosaccharide" based on a property selected form the group consisting of average degree [AltContent: ]of polymerization, mode degree of polymerization, mode molecular weight, and combinations thereof (as recited in claim 9), and further (as recited in claim 10) wherein the first "fructo-oligosaccharide" has "an average degree of polymerization no greater than 10", and the second "fructo-oligosaccharide" has "an average degree of polymerization no greater than 20", as well as the missing limitations of claims 11-13 (as described above). The ordinary artisan would have been motivated to modify Watson for at least the purpose of using an oligosaccharide mixture that is known to synergistically reduces colonic protein fermentation and proteolytic activity (para 105 of Ludwig), which is advantageous for gastrointestinal health (para 2 of Ludwig),
Regarding claims 15 and 20, Watson teaches the chewable gummy of claim 9 comprising a sugar selected from the group consisting of monosaccharides, disaccharides, and combinations thereof (para 20), but does not specify that the quantity of sugar is “less than 250 mg” (as required by claim 15) or that (as required by claim 20) wherein “the chewable gummy is sugar free”. However, it is known in the art that sugar can add calories and that sweetness may be adjusted by not only sugars but also artificial sweeteners. It would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Watson so that that sugar is used in a limited quantity, such as the quantity of sugar is “less than 250 mg” or not at all. The ordinary artisan would have been motivated to modify Watson for at least the purpose of providing natural sweet taste but without exceeding target calorific value of the chewable gummy, or alternatively, making the chewable gummy sugar free, which may be more suitable for people with diabetes.
Regarding claim 16, it follows from the rejection of claim 13 above as the combined range of weight of the two fructo-oligosaccharides in claim 13 overlaps with the claimed range of “from 50% by weight to 90% by weight fructo-oligosaccharides” in claim 16 and the claimed “from 1% by weight to 5% by weight pectin” is same as that in claim 13.
Regarding claim 17, it follows from the rejection of claim 13 above as the combined range of weight of the two fructo-oligosaccharides in claim 13 overlaps with the claimed range of “from 75% by weight to 90% by weight fructo-oligosaccharides” in claim 17
Regarding claims 18-19, Watson teaches the chewable gummy of claim 9, wherein the first and second fructo-oligosaccharides (inulins are described for claim 9; see Table 2 which shows all inulin variations contribute 53% + of dietary fiber per batch) contribute at least 20% by weight dietary fiber to the chewable gummy (because the first and second fructo-oligosaccharides may be up to 90% by weight fructo-oligosaccharides, as explained for claim 16, and as explained above, they contribute 53% + of dietary fiber per batch). From the above, it also follows (as recited in claim 19) that “the chewable gummy comprises greater than 20% by weight dietary fiber”.
Regarding claim 21, Watson teaches the chewable gummy of claim 9, wherein the total fructo-oligosaccharides present in the chewable gummy have an average degree of polymerization no greater than 20 (similar to claim 10 which recites “average degree of polymerization” of “no greater than 10” and “no greater than 20” – see rejection of claim 10) and a mode degree of polymerization no greater than 20 (as neither of the two modes of degree of polymerization explained above is greater than 20 – see rejection of claim 10), the fructo-oligo saccharides contributing at least 20% by weight dietary fiber to the chewable gummy (which is substantially similar to limitations of claim 18 - see rejection of claim 18).
Regarding claim 22, when the first fructo-oligosaccharide is 60% by weight and the second fructo-oligosaccharide is 20% by weight (which is an example in the range of claim 13 that recites “comprising from 10% by weight to 80% by weight of the first fructo-oligosaccharide, from 10% by weight to 80% by weight of the second fructo-oligosaccharide”) and the first fructo-oligosaccharide has an average degree of polymerization of 5, and the second fructo-oligosaccharide has an average degree of polymerization of 11 (which is an example in the range of claim 10 that recites “the first fructo-oligosaccharide has an average degree of polymerization no greater than 10, and the second fructo-oligosaccharide has an average degree of polymerization no greater than 20”), for the above example, the total fructo-oligosaccharides present in the chewable gummy have an average degree of polymerization of [(60% x 5)+ (20% x 11)], which is an average degree of polymerization of 5.2 with modes of degree of polymerization at 5 and 11, and which reads on the range recited in claim 22; i.e. “the total fructo-oligosaccharides present in the chewable gummy have an average degree of polymerization no greater than 11 and a mode degree of polymerization no greater than 11”. Thus, the limitations of claim 22 are simply a special case of claims 13 and 10.
Regarding claim 23, is also taught by Watson, as all limitations are addressed in claim 9, except the limitation “at least 20% by weight dietary fiber contributed by the first and second fructo-oligosaccharides”, which is addressed in claim 18; and the limitation “gelling agent and water” which is taught by para 18 of Watson which describes “gelling agent” a substance such as “pectin” which forms a gel by dissolving “in water”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI CHAWLA whose telephone number is (571)272-8212. The examiner can normally be reached M-F 9:30- 5:30.
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/JYOTI CHAWLA/Primary Examiner, Art Unit 1791
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