DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 09 June 2026 in which claims 1, 2, 7, 8 and 11 were canceled, and claim 3 was amended to change the scope and breadth of the claims.
Claims 3-6, 9, 10 and 13-18 are pending in the current application. Claims 6, 9, 10 and 13-18 remain withdrawn as being drawn to a non-elected invention. Claims 3-5 and 12 are examined on the merits herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The claims and specification have been amended to replace the recitation of “maltooligosaccharide” with “isomaltooligosaccharide”.
The priority date of the present claims is 19 May 2023.
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 .
Withdrawn Rejections
Applicants’ amendment, filed 09 June 2026, with respect to the rejection of claims 1, 7 and 8 under 35 U.S.C. § 102(a)(1), as being anticipated by Liu et al., has been fully considered and is persuasive because claims 1, 7 and 8 have been canceled. The rejection is hereby withdrawn.
Applicants’ amendment, filed 09 June 2026, with respect to the rejection of claims 2 and 11 under 35 U.S.C. § 103, as being unpatentable over Liu et al. in view of Madeiros et al. and Gonzalez-Sarrias et al., and further in view of Blahova et al., has been fully considered and is persuasive because claims 2 and 11 have been canceled. Furthermore, the claims have been amended to delete the recitation of “maltooligosaccharide”. The rejection is hereby withdrawn.
Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on , where the limitations in pending claim 3, the independent claim, as amended now have been changed. Therefore, rejections from the previous Office Action, dated 19 March 2026, have been modified and are listed below.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 3-5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO2019233202, cited in previous Office Action) in view of Medeiros et al. (Journal of Functional Foods, 2020, vol. 74, no. 104169, 11 pages, cited in previous Office Action) and Gonzalez-Sarrias et al. (Molecular Nutrition & Food Research, 2018, vol. 62, no. 11, p. 1800160, 10 pages, cited in previous Office Action).
Liu et al. teach a dietary fiber composition for reducing weight, promoting enterogastric peristalsis, preventing constipation, reducing blood lipid, reducing blood sugar, and absorbing/discharging heavy metals (abstract). The composition can function as a light healthy meal replacement (abstract). The composition comprises 0-1 parts xylooligosaccharide (XOS), 0-3 parts oligofructose (FOS) and 0-10 parts of isomaltooligosaccharide (isoMOS), (claim 1). Example 3 comprises 100 g XOS, 100 g FOS and 400 g isoMOS. Liu et al. teach the actual dietary fiber intake is 8-12 g/day, and the Chinese Nutrition Society recommends 25 g/day (para [0004]).
Liu et al. do not expressly disclose ellagic acid (present claim 3).
Medeiros et al. teach dietary fibers like fructooligosaccharide (FOS) are well recognized prebiotics (p.1, first para). Medeiros et al. found “strong evidence in preclinical studies that dietary polyphenols can stimulate both the growth of microorganisms identified as prebiotic targets and an increase in the production of SCFA” (abstract). Medeiros et al. specifically found clinical trials showed the consumption of ellagic acid and anthocyanins showed an increased abundance of Lactobacillus acidophilus, Bifidobacterium and Faecalibacterium spp., and a reduction in plasma lipopolysaccharide-binding protein (abstract). Medeiros et al. teach ellagic acid from a pomegranate extract was administered at doses of 0.45 g or 1.8 g to overweight-obese subjects. The patients showed an increase in Faecalibacterium, and a decrease in plasma lipopolysaccharide-binding protein (LBP), (Table 2, citation to Gonzalez-Sarrias et al, discussed below).
Gonzalez-Sarrias et al. administered pomegranate extract (PE) to overweight-obese individuals, and found high doses of the extract improved their gut microbiome (abstract). Gonzalez-Sarrias et al. teach each PE-containing capsule had 72.9 mg free ellagic acid (D1) or 450 mg free ellagic acid (D2) (p.2, section 2.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine ellagic acid with the dietary fiber composition of Liu et al.
According to MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, dietary fiber mixture comprising FOS, XOS and isomalto-oligosaacharide was observed to have a positive effect on reducing weight, promoting enterogastric peristalsis, preventing constipation, reducing blood lipid while a composition comprising ellagic acid was observed to increase Faecalibacterium, and decrease in plasma lipopolysaccharide-binding protein (LBP). Thus, the skilled artisan would have been motivated to combine the oligosaccharide fiber mixture with ellagic acid wherein they each produce similar effects as prebiotic agents, including reducing blood lipid and lipopolysaccharide-binding protein.
With respect to the amount, the ordinary artisan would have been motivated to use about 0.072 to 0.288 mg ellagic acid per 8-12 g dietary fiber, because Gonzalez-Sarrias et al. teach 0.072-0.288 g ellagic acid displayed a prebiotic effect, and Liu et al. teach most people consume 8-12 g dietary fiber per day. For a high dose of 0.288 g, the combination of active agents would result in a weight ratio of oligosaccharides to ellagic acid of (27.7-41.6):1 or (83.3-125.3):3. If the amount of fiber was increased to 25 g/day as recommended the Chinese Nutrition Society, the weight ratio could be as high as 86.8:1, or 260:3. These values encompass/overlap with the ratios recited in present claims 3, 4 and 12.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the claimed composition can be used “for promoting metabolism of EA into urolithin A”, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant contends the claimed combination of WSDF and ellagic acid produce a significant increase in the amount of urolithin A.
See MPEP 716.02(a), "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue."
See also MPEP 716.02(b), “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.”.
The data presented in Figures 1 and 2 have been reviewed, however, they do not appear to support a showing of unobviousness, because the amount of urolithin A does not appear to be statistically significant.
Figure 1 shows FOS, XOS and isomaltooligosaccharide each produce about 60 µg, 30 µg and 65 µg of urolithin A per gram of feces, respectively. Figure 2 shows ellagic acid produces about 25 µg urolithin A per gram of feces. Applicant argues the claimed combination produces 77.1 µg urolithin A per gram of feces. This amount does not appear to be significant compared to the oligosaccharides, because isomaltooligosaccharide alone resulted in about 65 µg of urolithin A per gram of feces. Furthermore, an amount of 77.1 µg/g does not appear to be significantly better than an additive effect from combining isomaltooligosaccharide and ellagic acid, let alone when all four are combined together. Thus, the data does not appear to demonstrate the claimed range is critical.
The rejection is hereby maintained.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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 BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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