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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/2025 has been entered.
Status of the Claims
Receipt of Remarks/Amendments filed on 11/17/2026 is acknowledged. Claims 8 and 14-17 are cancelled. Claims 1-7 and 9-13 are presented for examination on the merits for patentability.
Rejections not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
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.
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.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Rangavajla et al. (US 10,015,978 B2; Of record), hereinafter Rangavajla, in view of Garleb et al. (CA 2100972 C), hereinafter Garleb, and as evidenced by Ford et al. (N Engl J Med 376;26 June 29, 2017. 2566-2576).
Rangavajla discloses an invention directed to a novel method for improving the stool characteristics of a formula-fed infant, comprising administering to the infant at least one prebiotic and hydrolyzed pectin, and one or more insoluble fibers, and additionally comprises at least one probiotic (Claims 1 and 11). Rangavajla relates that while administration of prebiotics to formula-fed infants may beneficially affect the population of beneficial bacteria in the gut, the fermentation process often produces excess gas, abdominal distension, bloating, and diarrhea; diarrhea and loose stools can severely compromise infant health due to depletion of fluids, electrolytes and nutrients (Col. 2, lines 12-27). These symptoms are also associated with IBS. People with IBS experience symptoms that include abdominal pain and cramps, frequent diarrhea, constipation or both, but which can be managed by diet, drugs and probiotics etc. as evidenced by Ford et al. (pp. 2573-2576).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to administer to an infant patient having IBS symptoms at least one prebiotic and hydrolyzed pectin, and one or more insoluble fibers, and additionally comprises at least one probiotic according to the method of Rangavajla in order to alleviate the abdominal pain and cramps, frequent diarrhea, constipation or both.
Rangavajla teaches that the probiotic is selected from the group consisting of Bifidobacteria spp. and Lactobacillus spp., and that the one or more insoluble fibers consists of oat hull fiber, soy fiber, pea fiber, beet fiber, cellulose and corn fiber, and a mixture thereof (Claims 12-14). Rangavajla relates that in its embodiments, the "insoluble fiber" refers to a dietary fiber in which at least 60 weight% of the total dietary fiber is insoluble dietary fiber (Col. 4, lines 11-22).
Regarding Claim 1, Rangavajla does not expressly teach the amount of Poaceae insoluble fraction.
Garleb teaches a blend of dietary fibers for use as a component of a nutritional product (Claim 1). Garleb teaches a fiber system comprises 45-85% oat hull fiber (Claim 2). Garleb teaches that for a liquid nutritional product, a fiber system comprising oat hull at 70% to 75% and 7.5%-10% sodium carboxymethylcellulose exhibited good physical stability, but that the formulation may be varied (p. 26, 1st paragraph). Garleb also teaches that the insoluble and non-fermentable fiber is selected from oat hull fiber and corn bran fiber (Claim 10).
Both Rangavajla and Garleb teaches oat hull fiber and corn fiber. It would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the same amount exemplified by Garleb in the composition of Rangavajla, modifying as needed. All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). As such, the amounts in instant Claims 2-3 are also obvious.
Claims 4-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Rangavajla in view of Garleb, as applied to Claim 1 above, and further in view of Roughead et al. (WO 2011/060123 A1), hereinafter Roughead, and as evidenced by Orikasa et al. (Bioscience of Microbiota, Food and Health Vol. 35 (3), 141–145, 2016), hereinafter Orikasa.
Regarding Claim 4, Rangavajla teaches pea fiber, but does not expressly teach the amount of insoluble fraction (Claims 13-14).
Roughead also teaches administration of nutritional compositions comprising dietary fibers [0002]. Roughead teaches an embodiment wherein the nutritional composition comprises insoluble outer pea fiber in an amount of 5-10 g/L (Claim 7, [0114]). The addition of 4 g/d pea hull fiber to the diet of elderly institutionalized residents significantly increased bowel frequency and decreased need for laxative us, has been shown to increase stool weight in humans and animals, and also found to reduce postprandial serum cholesterol levels [0114]. Roughead teaches an adult and pediatric formula comprising 7.5 g of outer pea fiber, which is 50% of the total fiber (Table 1). The composition is safe for use in infants (pp. 44-45, Example 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Roughead with Rangavajla and use pea outer fiber starting at the amount taught by Roughead, and modifying as needed. All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding Claim 5, Roughead teaches the “outer pea fiber” comprises cellulose, hemicellulose, and pectic, which are found on the cell wall, and thereby reads on the pea cell wall fiber ([00114]-[00115; Table 1).
Regarding Claims 6-7, Rangavajla teaches Bifidobacteria, but not as specifically claimed (Claim 12). Roughead recognizes that bifidobacteria is a beneficial bacteria (Claim 35). Roughead teaches enteral feeding of a composition comprising Bifidobacterium longum NCC 3001 (BB536) (Example 1), which appears to be a synonym of required BAA-999 strain, as evidenced by Orikasa (p. 143, L. Col., bottom paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Roughead with Rangavajla and use Bifidobacterium longum ssp. Longum, specifically the BB536/BAA-999 strain used in the infant formula study of Roughead in the method of Rangavajla, because Roughead showed that enteral feeding with the supplement comprising the fibers and Bifidobacterium longum ssp. Longum, specifically the BB536/BAA-999 strain has beneficial effects in sick children and is safe for use (Example 1).
Regarding Claim 11, Rangavajla teaches an embodiment where the prebiotic composition comprising the plant fiber is blended with probiotic and then administered to pediatric patients (Col. 2, lines 32-43; Col. 6, lines 26-32). Because Bifidobacterium is in the gut, providing the nutritional composition comprising the plant fiber in the gut would necessarily affect the growing environment of the probiotic, enhancing its survival and growth.
Because Rangavajla teaches the claimed Bifidobacterium and Leguminoseae fiber, which the instant claim and specification notes to improve metabolic activity, metabolite production, and/or bifidogenic effect of a Bifidobacterium probiotic during gastrointestinal passage in a subject, Rangavajla therefore renders the claims obvious as it is an inherent property. Because the prior art composition is the identical composition claimed, the composition must necessarily have the characteristics claimed in Claims 1 and 11. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Further regarding the limitation of improvement of the survival of the Bifidobacterium probiotic in a gastrointestinal tract passage, Roughead teaches the increase in Bifidobacteria in studies simulating human intestinal microbial ecosystem (SHIME) with the prebiotic (Example 3), which is the same method used in the instant application to look at improvement of B. longum survival . The blends were administered to the models as part of the liquid nutritional medium which enters the stomach compartments [0215]. The art teaches that the products are bifidogenic, and increased the number of Bifidobacteria (Figs. 18A and B).
Claims 9-10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rangavajla in view of Garleb and Roughead, as applies to Claims 1 and 11 above, and further in view of Chen et al. (CN 108070542 A, machine translation from IP.com; Of record), hereinafter Chen.
Rangavajla does not expressly teach growing the Bifidobacterium in a culture medium prior to administration to a subject.
Regarding Claims 9-10 and 12, Chen cures the deficiency by disclosing a process of fermenting and producing Bifidobacterium with water-insoluble meals fiber, which improves resistance, activity, and survival rate (p. 3). Chen teaches the growth and fermentation of Bifidobacterium in a culture medium comprising water insoluble dietary fibers, including corn chaff powder (p. 8; p. 17, Claim 3). Chen expressly teaches preparation of by Bifidobacterium mycoderm fermentation medium, the fermentation process, and collection, followed by spray-drying. Objectives include preparing a bacterium powder for incorporation in food, and while improving its survival (p. 7, bottom half of page). Chen teaches that its method produces Bifidobacteria powder with high activity and strong resistance, which can significantly improve the spray drying survival rate and gastrointestinal tract tolerance (p. 6).
Regarding Claim 13, which depends from Claim 12, Chen teaches the use of insoluble fibers including soybean, oat bran, corn etc. (Claim 3). Rangavajla recognizes the same insoluble fibers, e.g. soy, pea etc. to be useful in its composition (Claim 13).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Chen to Rangavajla and use the process of Chen, i.e. growing the Bifidobacterium in a culture medium in the presence of Poaceae and Leguminoseae plant fiber taught by Rangavajla, and fermenting, and harvesting according to the method of Chen. One would have been motivated to do so because both references teach the same bacteria, and requires insoluble fiber fractions, recognizing the health advantages to compositions comprising the same. Hence, one with ordinary skill in the art would have applied the known technique of growing the Bifidobacteria in the said fiber prior to administration as taught by Chen. It can be expected that using this technique would lead to Bifidobacterium production with improved resistance, activity, and survival rate. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Response to Arguments:
Applicant traversed the rejection over Zamzam, stating that it is silent about the use of Poaceae fiber and does teach the amended claim features, and traverse the rejection over Zamzam in view of Makino.
The rejection supra no longer relies on Zamzam or Makino.
Applicant argues that Chen refers only to improved survival during spray drying, which would not be linked to survival in the GI tract. Applicant cites its Example 2, showing only insoluble fiber was able to support the survival of the probiotic.
The Examiner does not find this argument convincing. First, Chen clearly teaches the method of preparing Bifidobacterium mycoderm fermentation using insoluble fibers, and even teaches use of corn flour (Abstract; Claim 1 and 3; Embodiments 2-3). Second, Chen teaches that its method produces Bifidobacteria powder with high activity and strong resistance, which can significantly improve the spray drying survival rate and gastrointestinal tract tolerance (p. 6).
Applicant argues that Rangavajla does not disclose that the plant fiber is specifically Poaceae and/or Leguminoseae fiber having an insoluble fraction between 40 to 80% (w/w), and that it does not disclose anything regarding survival of probiotics in the GI tract. Rather, Rangavajla teaches a pre-biotic composition, and does not teach a composition comprising an effective amount of Poaceae plant fiber and a Bifidobacterium probiotic. Rangavajla does not teach the Bifidobacterium longum subsp. Longum in Claim 6.
The Examiner considered the argument but was not persuaded. Firstly, the rejection is one of obviousness and not anticipation, and the amount of insoluble corn/pea fibers are taught by the secondary references.
Second, contrary to Applicant’s allegation, Rangavajla expressly claims the probiotic is selected from the group consisting of Bifidobacteria spp. and Lactobacillus spp. (Claims 11-12). Roughead teaches Bifidobacterium longum NCC 3001 (Bb536).
Applicant cites its data in Figs. 3-5, claiming that corn fiber alone improves the survival of the Bifidobacterium probiotic in a gastrointestinal tract passage.
Applicant appears to be claiming unexpected results. However, the data fails to demonstrate that the results seen with were unexpectedly greater than what would have already been expected by one of ordinary skill in the art at the time of the invention in view of the teachings of Rangavajla, which already recognizes the combination of the Bifidobacterium probiotic and corn fiber. Please see MPEP §716.02(b)[R-2], which states, “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’ Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)”. Therefore, this property of improving the survival of the Bifidobacterium probiotic in a gastrointestinal tract passage when in the presence of corn fiber mix is comparable to what is already expected from the prior art. The establishment of a property that is also found in the prior art fails to provide a patentable distinction between the products and, therefore, is insufficient to rebut the evidence of obviousness. Please see MPEP §716.02(c)[R-2] (“Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. [n re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977).”) In other words, though Applicant asserts that the allegedly unexpected effect(s) of the instantly claimed compound was unpredictable from the disclosure of the prior art, it remains that the prior art acknowledges a clear expectation of this property, and this expectation of survival improvement of the probiotic is, thus, predicted by the skilled artisan.
Conclusion
No claims are allowed.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792