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 .
Claim Status
Applicants’ amendments and arguments filed 01/30/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-26 and 29-31 are canceled.
Claim 27 is amended.
Claims 27-28 and 32-41 is examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/09/2026 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 now recites “wherein the composition is administered for a time sufficient to increase gastrointestinal microbiota diversity in the individual”. However, the instant specification and application as a whole fails to define “time sufficient”, thus rendering the claim indefinite. For example is “time sufficient” 3 times a day for a week or is it once a week for a year.
For the purpose of moving prosecution forward, the examiner broadly interprets this to mean any time.
Maintained Rejections Updated for Claim Amendments
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 following rejections are maintained:
Claims 27, 28, and 33-41 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hara (WO 2015/067936, cited by Applicant in IDS filed 14 January 2020) optionally in view of Gorsek (US Patent 6,565,847, previously cited).
Regarding claim 27, O’Hara teaches compositions for weight management (i.e., promoting or maintaining weight loss) comprising a microbiome modifying component; a satiety modifying component; and a metabolic modifying component (e.g., abstract). The microbiome modifying component may comprise a prebiotic; the satiety modifying component may comprise dietary fibre, preferably glucomannan; and the metabolic modifying component may comprise chromium (e.g., page 4, lines 13-15; page 5, line 3). O’Hara specifically names a combination of glucomannan, FOS (fructooligosaccharides), and chromium (e.g., page 5, line 20). Regarding the limitation “increasing gastrointestinal microbiota diversity in an individual”, O’Hara further teaches the microbial strains which are already present in the individual can be manipulated by encouraging or inhibiting growth, to allow the desired microbial population to be selected so as to provide their associated health benefits (e.g., page 7, lines 18-22). Therefore, the skilled artisan would reasonably expect the composition may be used for increasing gastrointestinal microbiota diversity, absent a teaching otherwise. Further, it regards to “time sufficient”, O’Hara teaches the supplement taken 3 times a day (page 13, lines 23-25).
While O’Hara does not specifically exemplify chromium in the form of chromium picolinate in its compositions, O’Hara teaches chromium picolinate is already a known form of chromium for use in compositions having the purpose of promoting or maintaining weight loss. O’Hara teaches that prior studies demonstrate the use of chromium picolinate and weight loss, and report a weighted mean difference of 1.1 kg in favor of chromium picolinate over placebo (e.g., page 11, lines 3-5). Optionally additionally, Gorsek is in the field of compositions for weight management (e.g., abstract), and also having the components glucomannan and chromium (e.g., col. 1, line 36). Gorsek teaches chromium, in the form of chromium picolinate, helps insulin to metabolize fat, turns protein into muscle and converts sugar into energy (e.g., col. 2, lines 12-15). Suitable amounts are 40-4,000 µg (e.g., col. 2, lines 14-15).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to include chromium in the form of chromium picolinate in the composition of O’Hara; thus arriving at the claimed invention. One skilled in the art would be motivated to do so, with a reasonable expectation of success, because chromium picolinate is already known to be a suitable form of chromium in weight loss compositions, and provides the benefits of improved weight loss as cited by O’Hara, as well as helping insulin to metabolize fat, turning protein into muscle and converting sugar into energy, as taught by Gorsek.
Regarding amounts of each component administered (claim 27 and claim 35), O’Hara teaches the composition may comprise the dietary fibre (preferably glucomannan) in a dose of the range of 0.5 to 5g per day; chromium in a dose in the range of 50 to 1000 µg per day; and prebiotic in a dose of 3 to 30 g per day (e.g., page 8, lines 10-18). These amounts overlap those instantly claimed, and/or are sufficiently close as to render them 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. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (for example, “about 2.5 g” and “about 2 g” is sufficiently close to “3 g”). See MPEP 2144.05 I. In this case, it would be within the purview of the skilled artisan to select amounts from within the ranges taught by O’Hara, including the amounts instantly claimed, with a reasonable expectation of success. Also note that, since O’Hara teaches the compositions may be blended with, or consumed along foods/drinks, the skilled artisan would reasonably expect the dose per day may be divided amongst the food(s)/drink(s) consumed. "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." See MPEP 2144.01.
Regarding claim 28, it is noted that, since O’Hara teaches the compositions may be blended with, or consumed alongside foods/drinks (which are normally divided into up to 3 meals a day) (e.g., page 6, lines 2-5), the skilled artisan would reasonably expect the composition may be administered up to 4 times a day, absent evidence to the contrary.
Regarding claims 33 and 34, O’Hara also teaches the prebiotic comprises one or more selected from inulin, FOS, galactooligosaccharides (GOS), α-gluco-oligosaccharides, a low gas producing prebiotic and combinations thereof (e.g., page 8, lines 6-9), and thus the skilled artisan would find it obvious to include an additional prebiotic such as inulin and/or GOS, with a reasonable expectation of success.
Regarding claims 36-38, O’Hara teaches the composition may be in the form of a food stuff or food additive, or could be used as a dietary supplement (e.g., page 6, lines 3-5). while O’Hara does not specifically name snack bar as a type of food stuff for its compositions, O’Hara refers to prior art which teaches compositions in the form of snack bars (e.g., granola bars, biscuits) comprising components of its compositions, such as glucomannan (e.g., page 12, lines 16-17) and thus the skilled artisan would reasonably expect the phrase “food stuff” to include snack bars, absent evidence to the contrary.
Regarding claim 39, O’Hara teaches the composition may further comprise one or more active ingredients selected from vitamins, minerals, phytochemicals, antioxidants, and combinations thereof (e.g., page 6, lines 6-7).
Regarding claims 40 and 41, it is noted that, since O’Hara teaches the composition is used for weight management (e.g., abstract), and that the compositions may be blended with, or consumed alongside foods/drinks (which are normally divided into up to 3 meals a day) (e.g., page 6, lines 2-5), the skilled artisan would reasonably expect the composition may be taken up to 4 times a day as part of a calorie-controlled diet regime, and/or may be taken during and/or after a reduced calorie intake diet regime, absent evidence to the contrary. "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." See MPEP 2144.01.
Claims 27, 28, and 32-41 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hara optionally in view of Gorsek as applied to claims 27, 28, and 33-41 above, and further in view of Ryan.
The inventions of O’Hara, and Gorsek are delineated above (see paragraph 4, above).
Specifically regarding claim 32 (and more generally regarding the remaining claims), the cite prior art does not specifically teach the limitation wherein the composition further comprises maltodextrin or dextran.
Ryan is in the field of glucomannan compositions for food and beverage products and teaches a glucomannan-maltodextrin complex to lower the viscosity of glucomannan provides a therapeutic effect in lowering blood glucose and cholesterol (e.g., abstract, pages 1-2). Therefore, it would have been obvious to person having ordinary skill in the art at the time the invention was filed to agglomerate the glucomannan with maltodextrin, since doing so provides the additional therapeutic benefit of lowering blood glucose and cholesterol (which would be desired in patients for weight loss) as taught by Ryan.
Response to Arguments and Declaration
Applicant's arguments and Declaration filed 01/30/2026 have been fully considered but they are not persuasive.
In regards to the 35 U.S.C. 103 over O’Hara optionally in view of Gorsek, Applicant again argues O’Hara does not teach the claimed composition used for increasing gastrointestinal microbiota diversity and references the updated Declaration filed on 01/30/2026. Specifically, Applicant references paragraph 14-18 of the Declaration demonstrating the consumption of “SlimBiome” showing statistical and definitive evidence that the total number of observed species increased from the study of the study to the end of the 4-week study. Further, Applicant argues they have sufficiently defined SlimBiome® and diversity.
As stated previously and reiterated here, Applicant’s Declarations and Application as a whole fail to completely define what constitutes SlimBiome® as suggested by the Examiner in the interview on 01/30/2026. In the Declaration filed on 01/30/2026, Applicant continues to state “each delivering 3g of the active ingredient (Slimbiome: agglomerated glucomannon, oligofructose and chromium picolinate)…” from the annex A (page 3, section 14 of the dec and page 3, paragraph 2.4 of the annex). Further it is noted that Applicant’s instant specification examples still contain other ingredients (page 8-9, example 1) which may not only affect the functionality of the composition, but also demonstrates a lack of definition for SlimBiome®. Further, it is still noted that Applicant’s specification contains additional ingredients, such as live probiotic bacterial cultures complex (page 20 lines 1-16). Thus, Applicant has still failed to define SlimBiome® as the given definition broadly references active ingredients only while the examples and data reference other/additional ingredients. Therefore, the data still fails to be commensurate in scope to the claims overall.
In summary, the examiner is not persuaded by Applicant’s amendments. The rejections are maintained and updated for claim amendments.
Conclusion
No claims are 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 ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/ Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611
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