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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 15, 2026 has been entered.
Claim Status
Claims 1-17 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the final office action on March 13, 2026:
The rejection of claims 1-17 under 35 U.S.C. 103 are withdrawn in view of Applicant’s amendment to claim 1.
Response to Arguments
The Examiner has reviewed and considered Applicant’s claim amendments and remarks which are found persuasive to overcome the 103-rejection written in the final rejection mailed March 13, 2026, as discussed above.
However, upon further consideration of the prior art, particularly the Huh and Feng references as evidenced by the Nakamura reference, the combination of Huh and Feng teach the newly added limitation recited in claim 1, lines 6-7.
Accordingly, the Examiner has written new 103 rejections which are discussed in further detail below.
Claim Rejections - 35 USC § 103
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.
(I) Claims 1-2, 4, 6-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kokke et al. (Published 01 November 2008, Journal of Pediatric Gastroenterology and Nutrition, Vol. 47, Issue 5, pp. 592-597, IDS filed 06/06/2023) in view of Feng (Published 24 March 2020, CN-110898099-A, English Machine Translation Used, PTO-892) as evidenced by Nakamura et al. (Published 01 January 2001, Bioscience, Biotechnology, and Biochemistry, Vol. 65, Issue 10, pp. 2249-2258, PTO-892).
Regarding claims 1-2, 4, 6-11, and 13-15, Kokke teaches a dietary fiber mixture in the treatment of childhood constipation (e.g. improving intestinal health, required in claims 9 and 13 and treating constipation, required in claims 10 and 14), see pg. 592, title.
Kokke teaches constipation is defined as infrequent, painful bowel movements, see pg. 592, left column, paragraph 1; and wherein the baseline characteristics of 26% of patients in the fiber mix group (n=42) experienced painful defecation, see pg. 594, Table 2.
Kokke teaches dietary fibers have water-retaining capacity and stimulate gastrointestinal motility by increasing feces volume, bacterial growth and bacterial degradation products that promote colonic propulsion, reduces transit time, and facilitates defecation, see pg. 593, left column, paragraph 1.
Kokke teaches patients received a yogurt drink (e.g. a young child formula, required in claim 7) with mixed dietary fibers (10g/125mL), wherein the fiber mixture contained 3.0 g trans-galacto-oligosaccharides (e.g. the beta-oligosaccharides, required in claim 1, line 2), 3.0 g inulin (e.g. the inulin, required in claim 1, line 3), 1.6 g soy fiber, and 0.33 g resistant starch 3 (Novelose 330) (e.g. the resistant starch, required in claim 1, line 4) per 100 mL, see pg. 593, left column, study products, paragraph 1.
Kokke teaches the age range of the patients administered the fiber mixture were 1-12 years (e.g. the age range, required in claims 13-15), see pg. 594, Table 2, age, y (median and range).
The Examiner respectfully notes the yogurt drink of Kokke contains 3.0 g trans-galacto-oligosaccharides, 3.0 g inulin, 1.6 g soy fiber, and 0.33 g resistant starch 3 per 100 mL; and consequently, when adding the gram amount of each ingredient contained in the fiber mixture, said yogurt drink of Kokke contains 7.9 grams of fiber per 100 mL (e.g. the fibre mixture amount in liquid form, required in claim 4).
Additionally, based on the total weight of the fiber mixture of Kokke which contained the trans-galacto-oligosaccharides, inulin, soy fiber and resistant starch, the Examiner notes:
the 3.0 grams of trans-galacto-oligosaccharides constitutes 38% of the fiber mixture based on weight (e.g. the percentage required in claim 1, line 2);
the 3.0 g of inulin constitutes 38% of the fiber mixture based on weight (e.g. the percentage required in claim 1, line 3);
the 0.33 g of resistant starch constitutes 4.2% of the fiber mixture based on weight (e.g. the percentage required in claim 1, line 3); and
the 1.6 g of soy fiber constitutes 20% of the fiber mixture based on weight (e.g. the percentage required in claim 1, line 4).
The Examiner further notes the percentages of trans-galacto-oligosaccharides, inulin, soy fiber and resistant starch as discussed above correspond to the weight ratios recited in claim 1, last two lines of the claim; and claim 2.
Kokke teaches in the fiber mix group a trend toward statistically significant softer stools was observed after 2 weeks of treatment and significantly softer stools were observed at the end of the intervention period (e.g. softening stool, required in claims 11 and 15), see pg. 594, right column, paragraph 2.
Although Kokke does not teach soluble soy polysaccharides as the soy fiber of Kokke, required in claim 1, line 5.
However, in the same field of endeavor of compositions for treating constipation, Feng teaches a formula composition for improving constipation and preparation method thereof, see pg. 1, title. Feng teaches within said composition comprises 0.1-20 parts of soluble soybean polysaccharide, see pg. 1, abstract (English), lines 1-2.
Feng teaches soluble soybean polysaccharides are a type of water-soluble dietary fiber which has the function of relaxing the bowels and has excellent emulsification characteristics which enable a water layer and an oil layer to be uniformly mixed and is more stable, see pg. 7, last paragraph.
Feng teaches the constipation relieving composition may be in the form of a powder (e.g. the powder, required in claim 8), see pg. 2, line 17.
Moreover, as evidenced by Nakamura, Nakamura discloses soybean soluble polysaccharides (SSPS) that are extracted from soybean cotyledons have a pectin-like structure, where the core polysaccharides after treatment contain approximately equal numbers of L-rhamnose and D-galacturonate residues, suggesting the presence of the rhamnogalacturonan (RG) I structure consisting of the diglycosyl repeating unit, -4)-α-D-GalpA-(1→2)-α-L-Rhap-(1-. The lengths of RG chains were calculated as approximately 15, 28, and 100 diglycosyl repeats. The RG components linked to each other by intervention of galacturonan (GN) chains, constituting the backbone of SSPS (e.g., the main backbone of the soluble soy polysaccharides, see claim 1, lines 6-7). See pg. 2249, abstract.
The Examiner further notes the structural disclosure of SSPS by Nakamura corresponds to the typical structure of soluble soy polysaccharides as disclosed by Applicant (see. pg. 5, lines 25-30).
With respect to the limitation wherein the nutritional composition comprises at least 80% of the fibre mixture according to claim 1, based on total fibres, as required in claim 6; the Examiner reasonably interprets this limitation as a physical limitation well within the scope of the artisan through routine experimentation and optimization in view of the teachings of the combination of Kokke and Feng which teach the fiber mixture as recited in claim 1; where dietary fiber facilitates defecation as taught by Kokke; and wherein said fiber mixture is incorporated into the yogurt drink of Kokke which corresponds to the nutritional composition as recited in claim 4.
Thus, the Examiner reasonably interprets the physical limitation of claim 6 will be met as the combined teachings of Kokke and Feng teach the fiber mixture of claim 1 that could constitute up to 100% of the fibre mixture in the yogurt drink of Kokke based on total fibers in order to facilitate defecation in constipated children as taught by the combination of Kokke and Feng.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have substituted the soy fiber taught by Kokke for the soluble soybean polysaccharides as taught by Feng in the compositions and methods as taught by Kokke, as Feng teaches soluble soybean polysaccharides are a type of water-soluble dietary fiber which has the function of relaxing the bowels and therefore is particularly useful in treating constipation as taught by Kokke, as Kokke teaches constipation is defined as infrequent, painful bowel movements as evidentiarily supported in Table 2 of Kokke; and said substitution as taught by Feng would further aid in dietary fibers’ function in facilitating defecation as taught by Kokke particularly in constipated children as taught by Kokke. Consequently, said substitution would have been well-within the scope of the artisan as combining prior art elements from the teachings of Kokke and Feng as discussed above according to known compositions and methods to yield predictable results.
One of ordinary skill in the art would have been motivated to have made the substitution as discussed above to treat constipation in children as taught by Kokke, because Feng uses soluble soybean polysaccharides within a constipation improving formula to relax the bowels; and thereby facilitate defecation in said patient population as taught by Kokke.
Finally, one of ordinary skill in the art would have had a reasonable expectation of success to have substituted the soy fiber taught by Kokke for the soluble soybean polysaccharides as taught by Feng in the compositions and methods of Kokke, because Kokke and Feng are drawn to compositions for improving constipation that contain soy fiber, Feng explicitly teaches soluble soybean polysaccharides have excellent emulsification characteristics which enable a water layer and an oil layer to be uniformly mixed and more stable as discussed above, and is particular useful in the administered yogurt drink of Kokke; as Feng teaches the soluble soybean polysaccharide can constitute 20 parts of the composition, and as the Examiner reasonably interprets 20 parts to correspond to 20% based on weight of the composition as Feng exemplifies the composition as a powder as discussed above.
Thus, the claimed invention would have been prima facie obvious over the combined teachings of the prior art.
(II) Claims 3, 5, 12, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kokke et al. (Published 01 November 2008, Journal of Pediatric Gastroenterology and Nutrition, Vol. 47, Issue 5, pp. 592-597, IDS filed 06/06/2023) and Feng (Published 24 March 2020, CN-110898099-A, English Machine Translation Used, PTO-892) as evidenced by Nakamura et al. (Published 01 January 2001, Bioscience, Biotechnology, and Biochemistry, Vol. 65, Issue 10, pp. 2249-2258, PTO-892) as applied to claims 1-2, 4, 6-11, and 13-15 above, and further in view of Goedhart et al. (Published 19 March 2015, US-20150080297-A1, PTO-892 mailed 10/07/2025).
Kokke and Feng as evidenced by Nakamura address claims 1-2, 4, 6-11, and 13-15 as written above.
Although, Kokke and Feng do not teach (a) the degree of polymerization of inulin required in claim 3; (b) the lipid, protein and digestible carbohydrates, required in claim 5; and (c) the method for increasing intestinal butyrate levels, required in claims 12 and 16-17.
However, in the same field of endeavor of compositions for childhood constipation, with respect to limitations (a)-(c), Goedhart teaches providing nutrition to a child in need thereof, comprising administering to the child a liquid composition comprising a mixture of non-digestible carbohydrates, wherein the mixture of non-digestible carbohydrates comprises at least 4 wt% fructan, see pg. 9, right column, claim #1. Goedhart exemplifies a yogurt drink as a liquid composition in example 4, paragraph [0084].
Goedhart exemplifies fructan to include inulin and wherein the composition comprises long chain fructan with an average DP above 20 (e.g. the degree of polymerization of inulin, required in claim 3), see paragraph [0046].
Goedhart teaches the child suffers from constipation, see pg. 9, right column, claim #3; and the child is 1 to 14 years of age, see pg. 9, right column, claim #4. The Examiner notes the patient population of Goedhart encompasses the patient population of Kokke as discussed above.
Goedhart teaches the composition preferably comprises lipid, digestible carbohydrates and/or protein, paragraph [0028].
Goedhart teaches the composition preferably comprises 0 to 10 g lipid per 100 mL (e.g. the amount of lipid, required in claim 5, lines 2-3), see paragraph [0029].
Goedhart teaches the composition preferably comprises 0.5 to 8 g protein per 100 mL (e.g. the amount of protein, required in claim 5, line 3), see paragraph [0031].
Goedhart teaches the composition preferably comprises 5 to 37 g digestible carbohydrates per 100 mL (e.g. the amount of digestible carbohydrates, required in claim 5, lines 3-4), see paragraph [0033].
Additionally, as evidenced by Goedhart, Goedhart exemplifies resistant starch as a non-digestible alpha-glucan, see paragraph [0054]; and exemplifies a suitable source of resistant starch as Novelose 330, see paragraph [0051]. Goedhart further discloses the use of non-digestible alpha-glucan advantageously results in the formation of butyrate (e.g. increasing intestinal butyrate levels, required in claim 12 and claims 16-17), see paragraph [0053].
Moreover, the Examiner particularly notes Kokke exemplifies Novelose 330 as the resistance starch in their administered yogurt drink to treat constipation in children. Accordingly, the Examiner reasonably interprets the yogurt drink containing Novelose 330 as the resistant starch as taught by Kokke advantageously results in the formation of butyrate when administered and therefore meets the limitation of increased butyrate levels as required in claims 12 and 16-17 as discussed above.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated limitations (a)-(c) as taught by Goedhart into the yogurt drink as taught by Kokke as simple additions by combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to create a yogurt drink to treat constipation in children as taught by Kokke above. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated limitations (a)-(c) into the yogurt drink of Kokke, because Kokke and Goedhart are drawn to yogurt drinks comprising inulin to treat constipation in children.
Thus, the claimed invention would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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