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 .
Status of the Claims
Receipt of Remarks/Amendments filed on 05/22/2026 is acknowledged. Claims 4, 8 and 13-17 are cancelled. Claims 18 and 19 are new. Claims 1-3, 5-7, 9-12, and 18-19 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Rejections not reiterated from the previous Office Action are hereby withdrawn.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.
Modified Rejection As Necessitated by the Amendment Filed 05/22/2026
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, 11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rangavajla (Of record),and as evidenced by Ford et al. (Of record), Kaur et al. (Carbohydrate Polymer Technologies and Applications 1 (2020): 100011.), and Huber et al. (J Food Sci Technol (July 2016) 53(7):3043–3052).
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 symptoms are associated with IBS (Col. 2, lines 12-27), as evidenced by Ford et al. (pp. 2573-2576).
Regarding Claims 1, 11, and 19, 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).
Because Rangavajla teaches corn fiber, which contains 51.6% insoluble fraction as evidenced by Kaur et al. (Abstract), the claimed range of insoluble fraction of Poaceae plant fiber is rendered obvious. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Because Rangavajla teaches pea fiber, which contains 63.75% insoluble fraction as evidenced by Huber et al. (Table 3), the claimed range of insoluble fraction of Leguminoseae plant fiber is rendered obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05.
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.
Further regarding the recitation of “improves survival of Bifidobacterium probiotic in the gastrointestinal tract passage in a subject….” in Claims 1 and 11, because Rangavajla teaches the claimed Bifidobacterium and the pea and corn fibers, which the instant claim and specification notes to improve the survival, 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rangavajla, as applied to Claim 1 above, and in view of Garleb (Of record).
Regarding Claim 3, Rangavajla contemplates the mixture of insoluble fiber comprising pe fiber and corn fiber, but does not teach the amount of corn fiber in the mix.
Garleb also 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% dietary fiber which is both insoluble and non-fermentable, and wherein the insoluble and non-fermentable is selected from oat hull fiber and corn bran fiber (Claims 9-10).
Both Rangavajla and Garleb teaches oat hull fiber and corn fiber. It would also have been prima facie obvious to prepare the composition comprising pea fiber of Rangavajla with corn fiber in the amount taught by Garleb for insoluble fiber or corn fiber, and modify 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 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rangavajla, as applied to Claim 1 above, and in view of Roughead (Of record), as evidenced by Orikasa et al. (Of record).
Roughead also teaches administration of nutritional compositions comprising dietary fibers [0002]. Administering the composition to HIV, Intensive Care Unit ("ICU") and pediatric patients not only improved the patients’ gut health but improved their catch up weight [0134]. Roughead teaches administration of enteral formula containing its composition to patients, and resulted in positive balance of the microbiota composition in critically ill children (Examples 1 and 2). 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 et al. (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).
Claims 9 and 12 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. (Of record), hereinafter Chen.
Regarding Claims 9 and 12, Chen discloses 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).
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).
Allowable subject matter
Claim 2, which depend from Claim 1 respectively, is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 2 is allowable because while Rangavajla teaches corn fiber, which contains 51.6% insoluble fraction, there is no art and/or motivation to replace the corn fiber with another Poaceae plant fiber which has an insoluble fraction of between 70 to 80% (w/w).
Claims 10 and 18 are allowable because the prior art does not teach growing Bifidobacterium longum in a culture medium comprising a combination of Poaceae and Leguminoseae plant fibers. While Chen discloses producing Bifidobacterium in a culture medium comprising corn chaff powder, there is no reason to combine Leguminoseae plant fibers in the culture medium to grow Bifidobacterium longum.
Response to Arguments:
Applicant traversed the rejection over Rangavajla in view of Garleb, appearing to argue that Rangavajla does not teach the claimed survival effect, does not disclose any experiment, data, or teaching showing improved survival of an administered Bifidobacterium during upper-GI passage, nor does it compare administration with and without the claimed Poaceae fiber. Applicant also argues that Rangavajla does not suggest or disclose the claimed Leguminoseae plant fibers.
The Examiner has considered the argument and partially agree. Claim 10, drawn to a method of improving survival of Bifidobacterium longum comprising growing Bifidobacterium longum in a culture medium comprising a combination of Poaceae and Leguminoseae plant fibers is now allowable. However, the Examiner maintains the rejection of Claim 11, drawn to a composition comprising Bifidobacterium probiotic, Poaceae and Leguminoseae plant fibers, over Rangavajla which teaches or suggests all the claimed element. Additionally, the rejection of Claim 1, drawn to a “method for weight management and/or treating a condition…” comprising the administration of a composition comprising Bifidobacterium probiotic, Poaceae and Leguminoseae plant fibers is also maintained because the method claims are examined for steps, and the step of administering to the subject a composition comprising a Bifidobacterium probiotic, and Poaceae and Leguminoseae plant fibers in the claimed range is rendered obvious by Rangavajla. The recitation of “wherein the Poaceae plant fiber…. improves survival of the Bifidobacterium probiotic in a gastrointestinal tract passage” is not given patentable weight. "A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed._Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). Note MPEP 2111.04. In this case, Claim 1 uses the term "wherein", rather than "whereby", but it is concluded that the terms should be treated the same ... the wherein clause merely characterizes the results of the step of administering the composition and does not distinguish the instantly claimed application from the steps taught in the prior art.
Applicant argues that Garleb's core claims are framed at the level of the fiber system as a whole, not at the level of an individual Poaceae fiber ingredient, and therefore Garleb does not teach the Poaceae plant fiber having an insoluble fraction of between 40 to 80%.
The Examiner has considered the explanation, and the rejection supra now only relies on Garleb to teach the amount of plant fiber mix because the primary art Rangavajla teaches the claimed features as evidenced by Kaur et al. and Huber et al.
Applicant argues that while Roughead reports a statistically significant increase in Bifidobacteria test group, the administered Bifidobacterium longum NCC 3001 strain was identified in only 18% of the patients, and that the increase in Bifidobacteria should not be solely attributed to the administered Bifidobacterium strain but also to the bifidogenic effect of the prebiotic blend. Applicant argues that the Bifidobacteria may not therefore have survived GI tract transit in any meaningful way, i.e. Roughead itself attributed at least part of the increase to the prebiotic blend rather than to the administered strain, and therefore cannot equate "bifidogenic effect" with "improves survival of the administered probiotic in GI tract passage.
The Examiner considered the argument but was not persuaded. It is insufficient to rely solely on Applicant's opinion of the reference without addressing the totality of evidence in the reference or in the record as a whole, which, in the instant case, clearly provides a teaching of the increase in Bifidobacteria. Stating that Bifidobacteria may not therefore have survived GI tract transit in any meaningful way, needs to be supported. While the Bifidobacterium longum NCC 3001 strain was identified in only 18%, it remains that the strain in fact survived. Furthermore, Roughead’s other strain that was tested, Lactobacillus paracasei NCC 2461 survived at 84%. There are many factors for consideration with regards to the data, and Roughead did not see the 18% as being a decline. Indeed, Roughead concluded that its prebiotic supplement is “effective in promoting not only the reduction of bacterial groups comprising known pathogens…(Enterobacteria, Clostridia), but also the increase of microbial groups of reputed beneficial effects (Bifidobacteria)...” (p. 44, Conclusion). Also, “Bifidobacteria diminished in the control group whereas they augmented in the test group reaching a statistical significance difference at day 14” [0210]. It appears that Applicant is applying a standard of absolute predictability in order to find obviousness, which is not required. Rather, to find obviousness, only a reasonable expectation of success is required, which is provided supra. Additionally, Rangavajla is the primary art, which teaches the pea fiber and Bifidobacteria and the other features of Claim 1. In the modified rejection supra, Roughead is only relied on to teach the outer pea fiber, and the strain of the Bifidobacteria, i.e. Bifidobacterium longum NCC 3001, in the dependent claims. As indicated above, because Rangavajla teaches the claimed Bifidobacterium and the pea and corn fibers, which the instant claim and specification notes to improve the survival, 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.
Applicant argues that even if the same SHIME platform is used, Roughead uses SHIME to study the prebiotic properties using a continuous in vitro setup representing the GI tract, stating that administration of prebiotic blends caused significantly increased Bifidobacteria in colon compartments, but that this does not indicate the survival of administered Bifidobacterium in the upper GI passage; Roughead uses SHIME to evaluate only prebiotic properties and changes in microbial populations but not the survival of the administered Bifidobacterium.
This argument have been addressed above.
Applicant traversed the inherency rationale for the rejection of Claim 11, appearing to argue that the missing limitation must be necessarily present, or be the natural result of, the prior-art combination.
The Examiner reviewed the argument and the prior art, and found that Rangavajla in fact teaches all the claimed limitations. If Applicant believes that Rangavajla teaches a different composition and/or different method step for Claim 11, which only requires the step of administering the composition, the burden is on the Applicant to show the difference by comparing the closest prior art, Rangavajla with the instant claims.
Applicant and traverses the Office’s stand that the alleged unexpected result in Figs. 3-5 is in fact expected over Rangavajla because Rangavajla does not address the claimed GI tract survival effect. Applicant argues that the claims are not directed merely to a composition that includes both a probiotic and corn fiber, but also to the improved survival of the administered probiotic during GI passage.
First, as indicated in above, a “wherein” clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim, and in the case of Claim 1 only characterizes the results of the step of administering the composition and does not distinguish the instantly claimed application from the prior art.
Second, 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, pea fiber, 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.
Lastly, the Examiner notes that Figs. 3-5 only shows data for NCC3001 with corn fiber mix and with pea fiber separately, but does not show any data wherein the composition comprises the bifidobacterium and corn fiber, further comprising Leguminoseae. As such, if Applicant is claiming unexpected results from the combination, as the amended claims recite, there is no data showing synergistic effect.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brassart et al. (US 5,972,415).
Claims 2, 10, and 18 are allowable.
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 JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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