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 Application
Receipt is acknowledged of the request for continued examination, amendment and response filed 6/24/2026. Claims 104,107,111 and 113-115 are pending in the application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/24/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/24/2026 was filed before close of prosecution in the application. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 104, 107,111 and 113-115 are rejected under 35 USC 103 as being unpatentable over Ke et al. (CN 106070848 A) in view of Gu et al. (US10,881,675 B2), Levine et al. (US 7,977,319 B1), and Ranganathan et al. (US20200054690 A1, cited in an IDS), and further in view of Adam et al. (Nutr Metab (Lond) 11, 36 (2014). https://doi.org/10.1186/1743-7075-11-36).
Regarding claim 104 and dependent claims, Ke discloses a tea composition comprising a polysaccharide, a probiotic bacteria species and a green tea extract for synergistic use in dietary prevention or management of a metabolic disease or disorder.
Gu however discloses managing gut health with a composition comprising oligosaccharides and green and yellow kiwi fruit extract to improve the gut microbiome and have beneficial effects in subjects having a disease or disorder. Gu discloses that an imbalance or alteration of gut microbiotic populations can lead to a variety of health issues, including poor immune response, allergies, digestive disorders, high cholesterol and cardiovascular abnormality poor bone health, and metabolic imbalances. Studies demonstrate that people who suffer from particular diseases have a different microbiota signature than healthy subjects. Healthy digestive function is closely associated with the microbiotic signature in the gut of an individual, therefore maintaining healthy gut microflora is pivotal to the health of individuals. Gu further discloses that probiotics need to be delivered to the intestinal tract alive to be effective. However, they are extremely delicate-sensitive to heat and stomach acid, which can destroy them long before they reach the large intestine to colonize. Recent studies also indicate that most probiotic strains do not colonize the gut, but elicit their benefits while passing through the gut, thus limiting their benefits. Prebiotics such as fructooligosaccharides that are metabolized by gut bacteria can modify microbiota by targeting bacteria that is already present in the large intestine. Gu discloses a combination of xylooligosaccharides with kiwi fruit extract with improved health benefits.
Ranganathan discloses a composition composed of xylooligosaccharide, arabinogalactan, inulin, Ganoderma lucidum beta glucan, insoluble yeast β (1, 3/1, 6)-glucan, soluble oat β (1,3/1, 4)-glucan, and insoluble dried Saccharomyces cerevisiae fermentate, with a Bacillus coagulans component, for use in improving or maintaining digestive health, weight and glucose balance and boosting immunity.
It would have been obvious to one of ordinary skill in the art to have combined the dietary fibers, probiotics, and kiwi fruit or green tea extract to produce a composition that in effective amounts produces targeted health benefits in a subject having a disease or disorder, with a reasonable expectation of success. One would be motivated to do so in view of substantial knowledge available in the art regarding mechanisms related to consumption of dietary fiber, phytonutrients and probiotics, namely, production of short-chain fatty acids in the digestive tract of a subject, increased expression of beneficial enzymes, and improved microecology in the subject’s gut, which in turn benefits health.
Both beta-glucan and resistant starch are dietary fiber, as reviewed in Adam et al. (see Table 3 and text below the table). A person having ordinary skill in the art would have been motivated to combine beta-glucan and resistant starch in a dietary supplement targeting metabolism and dysbiosis because both were well-known fermentable dietary fibers that reach the colon, where they are fermented by the colonic microbiotica to produce SCFA. Resistant starch is known stimulate butyrate production and support satiety, oat beta-glucan is known to produce butyrate, acetate, propionate, depending upon its source and microecology and other individual factors. One of ordinary skill in the art would view the complementary benefits of the fibers and would have been motivated to combine them to provide desired health benefits with a reasonable expectation of success.
As the claimed method is directed to “delivering to a subject a plurality of polysaccharides comprising beta-glucan and potato starch”, the claimed method is not limited to beta-glucan and potato starch delivery. The open ended transitional phrase “comprising” does not preclude additional polysaccharides.
Claims 104, 107,111 and 113-115 are therefore prima facie obvious in view of the art.
Response to Arguments
Applicant’s arguments in view of the amended claims have been considered but are not persuasive.
Absent evidence of unexpected results with a specific composition of fibers and extracts as claimed, the claims remain obvious over the art, in view of knowledge that was generally available to one of ordinary skill in the art at the time of the invention .
As the claimed method is directed to “delivering to a subject a plurality of polysaccharides comprising beta-glucan and potato starch”, the claimed method is not limited to beta-glucan and potato starch delivery. The open ended transitional phrase “comprising” does not preclude additional polysaccharides.
Both beta-glucan and resistant starch provide soluble dietary fiber. A person having ordinary skill in the art would have been motivated to combine beta-glucan and resistant starch in a dietary supplement targeting metabolism and dysbiosis because both were well-known fermentable dietary fibers that reach the colon, where they are fermented by the colonic microbiotica to produce SCFA. Resistant starch is known to stimulate butyrate production and support satiety, oat beta-glucan is known to produce butyrate, acetate, propionate, depending upon its source and microecology and other individual factors. One of ordinary skill in the art would view the complementary benefits of the fibers and would have been motivated to combine them to provide desired health benefits with a reasonable expectation of success.
For these reasons applicant’s arguments are not persuasive.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793
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