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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 01/07/2026 has been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set and Applicant’s remarks filed January 07, 2026 have been entered. Thus, 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Withdrawn Objections and Rejections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 non-final office action on October 07, 2025:
(I) The objection to the specification is withdrawn in view of Applicant’s amendment to the specification filed on January 07, 2026.
(II) The objection to claims 14-16 is withdrawn in view of Applicant’s amendment to said claims in the claim set filed January 07, 2026.
(III) The rejection of claims 1-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendment to claims 1, 3, 5-6 and 13 in the claim set filed January 07, 2026.
Response to Arguments
The rejection of claims 1-17 under 35 U.S.C. 103 is maintained.
Applicant argues:
(A) The cited references do not teach or suggest the claimed invention and the Examiner has failed to establish a prima facie case of obviousness, see Applicant’s remarks, pg. 7, 35 U.S.C. § 103, paragraph 4.
(B) The Examiner’s assertion of Goehart’s teaching of arabinogalactan combined with Futura’s teaching of water-soluble soybean polysaccharides renders obvious the “soluble soy polysaccharides” of claim 1 constitutes improper hindsight reconstruction, see Applicant’s remarks, pg. 8, paragraph 1.
(C) The Examiner’s motivation to combine references lacks proper foundation, as the references do not suggest using soluble soy polysaccharides (SSPS) as a replacement for insoluble soy fiber in a pediatric composition, as Applicant further argues FIBRIM 2000 is basically non-soluble fiber, see Applicant’s remarks, pg. 8, paragraph 2.
With respect to Applicant’s arguments (A)-(C), the Examiner respectfully notes Kokke teaches a dietary fiber mixture in the treatment of childhood constipation by administering a yoghurt drink containing a fibre mixture containing trans-galacto-oligosaccharides, inulin, soy fiber and resistant starch as discussed in the maintained 103 rejection below.
The Examiner respectfully notes Kokke exemplifies the soy fiber as “FIBRIM 2000”. However, the Examiner also respectfully notes a reasonable interpretation can be made that the recited phrase “soy fiber” as taught by Kokke above means any type of soy fiber, which may comprise insoluble fiber, soluble fiber or a mixture of insoluble and soluble fiber.
Additionally, the Examiner respectfully notes Goedhart teaches a liquid composition comprising a mixture of non-digestible carbohydrates, exemplifying a yoghurt drink as discussed within the 103 rejection below.
Goedhart teaches “FIRBRIM 2000” comprises 81% hemicellulose including insoluble arabinogalactan, see paragraph [0076].
The Examiner respectfully notes Goedhart explicitly teaches the composition further comprises a soluble non-digestible carbohydrate selected from the group consisting of and including arabinogalactan; where the composition comprises at least 1 wt% arabinogalactan; and further explicitly teaches arabinogalactan is advantageous for paediatric patients and/or (constipated) children since it results in an improved microbiota, increased water holding capacity and/or fermentation throughout the colon.
Moreover, Goedhart teaches a fibre mixture comprising both “FIBRIM 2000” and soluble arabinogalactan, see paragraph [0082].
Furthermore, as evidenced by Dupont Nutrition and Biosciences (Published 28 October 2020, “FIBRIM Soy Fiber”, pp. 1-2, IDS filed 06/06/2023), Dupont discloses FIBRIM soy fiber is a fiber source derived from the soy cotyledon (e.g. the inner cell wall of the soybean) and contains both soluble and insoluble fibers (between 62-70% insoluble and 5-9% soluble), see pg. 1, paragraph 3.
Finally, Futura teaches water soluble polysaccharides that had been extracted from soybean cotyledons consist of arabinogalactans and could be applied to food processing as discussed in the 103 rejection below.
Accordingly, the Examiner respectfully notes it would have been prima facie obvious to one of ordinary skill in the art to have replaced the exemplified soy fiber known as “FIBRIM 2000” within the yogurt drink as taught by Kokke above for the soluble non-digestible arabinogalactan as taught by Goedhart above in the form of water soluble polysaccharides as taught by Futura above as within the scope of the artisan as combining prior art elements according to known compositions to yield predictable results.
As the Examiner further respectfully notes Kokke and Goehart are both drawn to fiber mixtures containing soy fiber. Kokke exemplifies their soy fiber as FIBRIM 2000, which as evidenced by Dupont as discussed above is a mixture of insoluble and soluble soy fibers. The Examiner also respectfully notes Goedhart teaches a fibre mixture comprising both “FIBRIM 2000” and soluble arabinogalactan; and where Goehart further explicitly teaches within their fibre mixture the soluble arabinogalactan is present in at least 1 wt%.
Therefore, the Examiner respectfully notes a person having ordinary skill in the art (PHOSITA) would have been motivated to replace the exemplified soy fiber (e.g. FIBRIM 2000) as taught by Kokke above for the soluble arabinogalactan as taught by Goehart above in order to provide a fiber mixture that is advantageous for constipated children as taught Goehart; as the Examiner respectfully notes Goehart explicitly teaches said fibre mixture comprises at least 1 wt% arabinogalactan; and consequently it would have been within the scope of the PHOSITA through routine experimentation and optimization to optimize the soy fiber within the fibre mixture of Kokke above to contain only soluble soy polysaccharides (e.g. soluble arabinogalactan) in view of the combined teachings of Kokke and Goehart as discussed above.
Thus, the PHOSITA would have had a reasonable expectation of success to have made the substitution as discussed above as both Kokke and Goehart are drawn to fiber compositions containing soluble soy fiber for treating constipated children as discussed above.
Finally, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Thus, Applicant arguments (A)-(C) have been fully considered but are not found persuasive.
Applicant further argues:
(D) The specification demonstrates unexpected results showing the fiber mix with soluble soy polysaccharides results in significantly higher butyrate production and lower propionate production compared to mixtures containing insoluble soy polysaccharides. Particular attention is made to Table 1 from Example 1 of the specification. See Applicant’s arguments, pg. 8, last paragraph of the page.
(E) Table 1 shows the comparison of the prior art mixture of Kokke (MF4prior art) with the present inventive mixture (MF4new); wherein the difference in these mixtures is the replacement of the non-soluble fiber FIBRIM 2000 from Kokke with the soluble soy fiber ingredient as presently claimed, see Applicant’s arguments, pg. 8, last paragraph of the page.
(F) The results showed the unexpected effect of a statistically significant lower amount of propionate and a statistically significant higher amount of butyrate produced by the inventive mixture (MF4new) compared to the fibre mixture of Kokke (MF4 prior art), see Applicant’s remarks, pg. 8, last paragraph of the page.
With respect to Applicant’s arguments (D)-(F), the Examiner respectfully notes claim 1 is drawn to a fibre mixture consisting of beta-galactooligosaccahrides, inulin, resistant starch and soluble soy polysaccharides, wherein the weight ratio of said beta-galactooligosaccahrides: inulin: resistant starch: soluble soy polysaccharides within said fibre mixture is 1: 0.5-2: 0.05-0.2: 0.25-1.
However, the Examiner respectfully notes the fibre mixture as recited by Applicant within claim 1 and argued by Applicant having an unexpected result of decreased propionate and increased butyrate production when compared to the prior art is only demonstrated for a fibre mixture consisting of beta-galactooligosaccahrides, inulin, resistant starch and soluble soy polysaccharides, wherein the weight ratio of said beta-galactooligosaccahrides: inulin: resistant starch: soluble soy polysaccharides within the fibre mixture is 38: 38: 4: 20, and wherein said fiber mixture is at a concentration of 10mg/mL, see pg 16, example 1, line 25 – pg. 17, line 10.
Moreover, as evidenced by Ferguson et al. (Published 19 February 1996, Mutation Research - Fundamental and Molecular Mechanisms of Mutagenesis, Vol. 350, Issue 1, pp. 173-184, PTO-892), Ferguson discloses products of degradation of the dietary fibre polysaccharides are fermented by bacteria to produce short-chain fatty acids (SCFAs) (mainly acetic, butyric and propionic), wherein the proportions of SCFAs vary depending on the composition of the dietary fibre, see pp. 175, right column, 4.2 indirect mechanisms, paragraph 1 – pg. 176, left column, paragraph 1.
Additionally, claim 4 is drawn to a nutritional composition, either when present in liquid form comprising 0.4 -10 g of the fibre mixture of claim 1 per 100 ml; or when in solid form comprising 3-45 g of the fibre mixture of claim 1 per 100 g dry weight.
The Examiner respectfully notes claim 4 recites “comprising” when referring to either form of the nutritional composition.
The Examiner also respectfully notes MPEP 2113.03(I) recites the transitional term "comprising" is synonymous with "including," "containing," or "characterized by," and therefore is inclusive or open-ended and does not exclude additional, unrecited elements.
The Examiner also respectfully notes claim 4 is completely silent about the presence or absence of other fibres within the nutritional composition of claim 4. Therefore, its reasonably interpreted by the Examiner that the nutritional composition recited within claim 4 may comprise other ingredients, for example any type of fiber, including both soluble and insoluble fiber which may or may not be a soy polysaccharide.
The Examiner further respectfully notes there is no disclosure within the specification with respect to the unexpected effect as recited by Applicant above attributable to the recited claim scope of the nutritional composition as recited within instant claim 4 discussed by the Examiner above.
Additionally, even if the Examiner were to interpret the nutritional composition of claim 4 which contains the fibre mixture as recited within claim 1 as the only fibres present within the composition, the Examiner reiterates the unexpected results as argued by Applicant within argument (F) above are only demonstrated by a fibre mixture consisting of beta-galactooligosaccahrides, inulin, resistant starch and soluble soy polysaccharides where the weight ratio of beta-galactooligosaccahrides: inulin: resistant starch: soluble soy polysaccharides within said fibre mixture is 38: 38: 4: 20, and wherein said fiber mixture is at a concentration of 10mg/mL as discussed above.
Moreover, the Examiner respectfully notes MPEP 716.02(d) states “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.”
Furthermore, the Examiner respectfully notes MPEP 716.02(d)(II) states “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range”.
Therefore, the Examiner reasonably interprets the scope of the fibre mixture recited within claim 1 and the nutritional composition recited within claim 4 is broader in scope then the evidence provided by Example 1, specifically the exemplary fibre mixture known as MF4new which demonstrates the unexpected results argued by Applicant within argument (F) as discussed above.
Accordingly, the Examiner reasonably interprets based on the recited fibre mixture of claim 1 and the nutritional composition recited within claim 4, Applicant’s evidence showing an unexpected result as detailed within Applicant’s argument (F) as discussed above is not commensurate in scope with either the fibre mixture recited within claim 1 or the nutritional composition recite within claim 4, particularly in view of Ferguson disclosing the proportions of SCFAs vary depending on the composition of the dietary fibre as discussed above.
Finally, the Examiner respectfully reminds the Applicant of the burden of explaining why the data are evidence of non-obviousness. In addition to being unexpected and non-obvious, the difference(s) must be of both statistical and practical significance and commensurate in scope with the claims which the evidence is offered to support. Therefore, Applicant’s evidence as a whole provided within the specification and argued within Applicant’s arguments (D)-(F) as discussed above do not meet this burden.
Thus, Applicant’s arguments (D)-(F) have been fully considered but are not found persuasive.
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.
Claims 1-17 remain 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 Goedhart et al. (Published 19 March 2015, US-20150080297-A1, PTO-892 mailed 10/07/2025) and Furuta et al. (Published Year 1998, Published Online 22 May 2014, Bioscience, Biotechnology and Biochemistry, Vol. 62, Issue 12, pp. 2300-2305, PTO-892 mailed 10/07/2025).
Regarding claims 1-17, Kokke teaches a dietary fiber mixture in the treatment of childhood constipation (e.g. improving intestinal health, required in claim 9 and treating constipation, required in claim 10), see pg. 592, title.
Kokke teaches patients received a yogurt drink (e.g. a young child formula, required 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 13-16), 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, 0.33 g resistant starch 3 per 100 mL. Thus, when adding the gram amount of each ingredient the fiber mixture contains 7.93 grams of the fiber mixture of Kokke per 100 mL (e.g. the fibre mixture amount in liquid form, required in claim 4).
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 11-12), see pg. 594, right column, paragraph 2.
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 also 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 claim 17), see paragraph [0053].
Although, Kokke does not teach (a) the soluble soy polysaccharides, required in claim 1, line 5; (b) the weight percentage and weight ratios of ingredients as recited in claim 1 or claim 2; (c) the degree of polymerization of inulin required in claim 3; (d) the lipid, protein and digestible carbohydrates, required in claim 5; (e) at least 80 wt% of the fibre mixture based on total fibres, required in claim 6; and (f) the powder, required in claim 8.
However, in the same field of endeavor of dietary compositions, with respect to limitations (a)-(f), 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 (i) at least 5 wt% beta-galactooligosaccharides; (ii) at least 4 wt% fructan; and (iii) at least 0.5 wt% non-digestible alpha-glucan, 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.
Goedhart teaches the composition further comprises a soluble non-digestible carbohydrate selected from the group consisting of and including arabinogalactan, see paragraph [0038].
Goedhart teaches the composition preferably comprises at least 1 wt% arabinogalactan and wherein a sufficient amount of arabinogalactan is advantageous for paediatric patients and/or (constipated) children since it results in an improved microbiota, increased water holding capacity and/or fermentation throughout the colon, see paragraph [0068].
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].
Goedhart teaches the invention also relates to a packaged powder composition, wherein said package is provided with instructions to admix the powder with a suitable amount of liquid, thereby resulting in a liquid composition, (e.g. the powder, required in claim 8), see paragraph [0027], pg. 3, paragraph 1.
Additionally, Furuta teaches extraction of water-soluble soybean polysaccharides under acidic conditions, see pg. 2300, title. Furuta investigated the gelation and sugar composition of water soluble polysaccharides that had been extracted from soybean cotyledons under acidic conditions (e.g. water-soluble soybean polysaccharides, SSPS) (e.g. soluble soy polysaccharides, required in claim 1, line 5); wherein water-soluble soybean polysaccharides where found to consist of arabinogalactans which were easily hydrolyzed under acidic conditions, see pg. 2300, abstract.
Furuta teaches most of the SSPS solutions remained fluid after neutralization and storage at 5°C, some underwent gelation, wherein gelation occurred in those samples that had been extracted below pH 3 and below 100°C, see pg. 2305, left column, paragraph 2.
Furuta teaches four characteristic types of SSPS which included heat reversible gelation and fluidity even at 5°C and where these characteristics could well be applied for food processing, see pg. 2305, left column, paragraph 3.
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 in view of the teachings of the combination of Kokke, Goedhart and Furuta which teach the fiber mixture as recited in claim 1; and further in view of the teachings of Goedhart which teaches a packaged powder composition which can be reconstituted in liquid to form the liquid composition as taught by Goedhart above. Thus, the physical limitation of claim 6 will be met as the combined teachings of Kokke, Goedhart and Furuta teach a fiber mixture of claim 1 in powder form that would constitute up to 100% of the fibre mixture of the nutritional composition of claim 4 based on total fibers.
It would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filing date to have (a) substituted the soy fiber taught by Kokke for the arabinogalactan as taught by Goedhart in the form of soluble soybean polysaccharides (SSPS) as taught by Furuta as within the scope of the artisan as simple substitutions according to known compositions to yield predictable results and (b) to arrive at the weight percentages and weight ratios as recited in claims 1 and 2 above through routine experimentation and optimization as Goedhart teaches percentages of beta-galactooligosaccharides, inulin, resistant starch, and arabinogalactan in the form of soluble soy polysaccharides as taught by Furuta at weight percentages encompassing the weight percentages of beta-galactooligosaccharides, inulin, resistant starch and soluble soy polysaccharides as recited and required in claim 1.
One of ordinary skill in the art would have been motivated to include limitations (a)-(b) into the yogurt drink of Kokke as Goedhart teaches a sufficient amount of arabinogalactan is advantageous for paediatric patients and/or (constipated) children since it results in an improved microbiota, increased water holding capacity and/or fermentation throughout the colon as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated limitations (a)-(b) into the yogurt drink of Kokke, as both Kokke and Goedhart are drawn to yogurt drinks comprising beta-galactooligosaccharides, inulin, resistant starch and soy fiber to treat constipation in children, and Furuta teaches SSPS contain arabinogalactans wherein SSPS could well be applied for food processing as discussed above.
Thus, 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)-(f) as discussed above into the yogurt drink as taught by Kokke above as combining prior art elements according to known compositions 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 incorporate limitations (a)-(f) into the yogurt drink of Kokke, as both Kokke and Goedhart are drawn to yogurt drinks comprising beta-galactooligosaccharides, inulin, resistant starch and soy fiber to treat constipation in children.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
THIS ACTION IS MADE FINAL. 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 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