DETAILED ACTION
Amendments made September 12, 2025 have been entered.
Claims 1-5, 7, and 10-15 are pending.
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 .
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.
Claim Objections
The objections to claims 1-5, 7, and 10-15 have been withdrawn in light of applicant’s amendments made September 12, 2025.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The previous rejections of claims 1-5, 7, and 10-15 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inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention have been withdrawn in light of applicant’s amendments made September 12, 2025.
Claim 15 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 15 recites “amino acids thereof”. It is unclear as to what “thereof” is in relation to. For example, it is unclear as to if it is related to a specific component recited in the composition, or if it is related to any amino acid form.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 does not further limit the subject matter of the claim upon which it depends because claim 5 recites that the at least one HMO is present from 0.1-60% of the total weight of the gelled confection, which is already required in claim 1 step iii, from which claim 5 depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. It is noted that the rejection was not previously made as claim 1 previously recited in the percentage as by weight of an unknown formulation and not the confection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nieto (WO 2019/168594 A1) in view of Vargas et al (WO 2016/029113 A1).
Regarding claims 1, 3-5, and 7, Nieto teaches of a gummy food product, i.e. a gelled confection, (abstract and paragraph 34) comprising:
About 15-60% of a first prebiotic, including gum Arabic which is a gelling substance and hydrocolloid (paragraphs 24 and 25)
About 5-40% water, i.e. having a moisture content of 5-40% (paragraphs 33 and 44); and
About 10-35% of a second prebiotic, including oligosaccharides (paragraphs 0006 and 26-27). Also see claims 1, 3-5, 8-14, 16-18, and 20.
Nieto is silent to the oligosaccharide as at least one Human Milk Oligosaccharide (HMO) as recited in claim 1, preferably one chosen from the group listed in claim 4.
Vargas et al (Vargas) teaches nutritional prebiotic compositions which can be in the form of candies, gels, and gelatin (abstract, page 6 lines 9, page 10 line 19, and page 11 lines 22 and 25-26). Vargas teaches that the prebiotic is selected from one or more of a group including HMOs, including 6’SL, LNnT, 3’SL, and 2’FL (abstract and page 4 lines 19-22), and that HMOs in addition to being prebiotics have a variety of other important biological effects including antimicrobial effects, immunomodulatory functions, positive effects in learning and memory, and neuroprotective effects (page 1 line 25 through page 2 line 5).
Regarding the oligosaccharide as at least one Human Milk Oligosaccharide (HMO) as recited in claim 1, preferably one chosen from the group listed in claim 4, it would have been obvious for the prebiotic oligosaccharide of Nieto to be a HMO (human milk oligosaccharide), including 6’SL, LNnT, 3’SL, and 2’FL, as Vargas teaches said HMOs were prebiotic oligosaccharides that provided additional biological benefits. To add a known prebiotic and oligosaccharide, wherein one was disclosed would have been obvious and well within the purview of one of ordinary skill in the art. Thus, the composition of Nieto in view of Vargas would comprising about 10-35% of at least one HMO selected from 6’SL, LNnT, 3’SL, and 2’FL.
Regarding the composition as having no added non-HMO sugars or sugar alcohols, such that it is essentially free of them as recited in claim 1, as discussed above, it would have been obvious for the second probiotic of Nieto to be an HMO. Furthermore, as Nieto teaches that the composition may be “sugar free” or with reduced sugar (paragraph 21 and claim 11) and does not require sugar alcohols (all) the teachings of Nieto would encompass, or at least make obvious the composition as claimed. To form the product of the prior art as disclosed, with the named ingredients and without additional ingredients would have been obvious to one of ordinary skill in the art.
Regarding the composition as free of sialic acid as recited in claim 2, as Nieto does not require the use of sialic acid (all), the teachings of Nieto would encompass, or at least make obvious the composition as claimed. To form the product of the prior art as disclosed, and without additional ingredients would have been obvious to one of ordinary skill in the art.
Regarding the composition as comprising citric or other acid as recited in claim 10, preferably 0.1-10% as recited in claim 11, Nieto teaches that the composition may comprises about 0.001-10% additives, including acids and specifically citric acid (paragraphs 29 and 31 and claim 9). Additionally, Nieto exemplifies the prebiotic gummy as comprising 1% citric acid (page 12, Sample 1, page 13 Sample 3, and page 14 Sample 4), 0.75% citric acid (page 13 Table 12), and 1.5% citric acid (page 14 Sample 5). Thus, to use an acid in the gummy confection within the claimed range is considered encompassed, or at least obvious over Nieto.
Regarding the confection as comprising at least one flavor ingredient as recited in claim 12, Nieto teaches that the confection may comprise a flavorant (paragraphs 29, 31, and 34 and claim 9). It would have been specifically obvious to one of ordinary skill in the art to include the flavorant to impart the desired flavor.
Regarding the confection as comprising at least one coloring agent ingredient as recited in claim 13, preferably from 0.01-1% as recited in claim 14, Nieto teaches that the confection may comprise additives from about 0.001-10% (paragraph 31), and that coloring can be an additive (paragraph 29 and claim 9). It would have been specifically obvious to one of ordinary skill in the art to include the coloring within the disclosed range to impart the desired color.
Regarding the confection as comprising an active ingredient as recited in claim 15, Nieto teaches that the confection may comprise nutrients, vitamins and minerals (paragraphs 29 and 31 and claim 9). It would have been specifically obvious to one of ordinary skill in the art to include the vitamins and/or minerals for their known benefits, including their nutritional effect.
Nieto discloses overlapping ranges of the claimed components. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Response to Arguments
Applicant's arguments filed September 12, 2025 have been fully considered but they are not persuasive.
Applicant argues that a combination of Nieto and Vargas is inapproportae as Nieto teaches a gummy with at least two prebiotics without conventional gelling agents and Vargas does not teach of sugar free compositions. This argument is not convincing as Nieto teaches the first probiotic as gum Arabic which is a gelling substance and hydrocolloid, as well as a sugar free composition. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Furthermore, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). As discussed above, it would have been obvious for the prebiotic oligosaccharide of Nieto to be a HMO (human milk oligosaccharide), including 6’SL, LNnT, 3’SL, and 2’FL, as Vargas teaches said HMOs were prebiotic oligosaccharides that provided additional biological benefits. To add a known prebiotic and oligosaccharide, wherein one was disclosed would have been obvious and well within the purview of one of ordinary skill in the art. Thus, the composition of Nieto in view of Vargas would comprising about 10-35% of at least one HMO selected from 6’SL, LNnT, 3’SL, and 2’FL.
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 KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
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/KELLY J BEKKER/Primary Patent Examiner,
Art Unit 1792