DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed October 14, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-4, 6-8, 10-12, 14-17, 19, 30, 38, 39, and 46 are pending.
Claim Objections
4. Claim 1 is objected to because of the following informalities: Claim 1 has unmarked changes to the claim. In line 6, “0 wt %” has been amended to read “0.1 wt%”. Additions to the claims must be underlined. This amendment to claim 1 now requires citrus pectin as an ingredient while it was optional in the previous claim set.
Claim Rejections - 35 USC § 112
5. Claims 1-4, 6-8, 10-12, 14-17, 19, 30, 38, 39, and 46 are 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 for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. As discussed in the previous Office action, the phrase “glycan equivalent” in the claims is indefinite. Applicant’s specification defines “glycan equivalent” as any fiber with a “substantially similar glycan content as the composition to which it is being compared…(paragraph 77).” It is unclear what would be encompassed by “substantially similar”. In addition, applicant states that the means in which an artisan must determine this “similarity” is to analyze each potential “equivalent” for the glycan content. This indicates that the limitation is not fully defined and would require substantial analysis on the part of the artisan to be able to determine which fibers would be encompassed by the claims. Thus, the metes and bounds of the claims are unclear.
In response applicant argues that paragraphs 77 and 84 of the specification provide clear definitions of what are considered to be “glycan equivalents” which is considered to be “substantially similar.” However, paragraphs 77 and 84 do not provide limiting definitions, rather than provide potential examples which are described as not limiting. Paragraph 77 specifically states ‘The term "compositional glycan equivalent" refers to a fiber preparation with a substantially similar glycan content as the composition to which it is being compared…A compositional glycan equivalent may be defined in terms of its monosaccharide content and optionally by an analysis of the glycosidic linkages…’. Paragraph 84 specifically states ‘The term "substantially similar" generally refers to a range of numerical values, for instance, ± 0.5-1%, ± 1-5% or ± 5-10% of the recited value, that one would consider equivalent to the recited value, for example, having the same function or result…’. The use of “may be defined,” “optionally,” “generally”, “for instance” and “for example” clearly indicate that the stated values are only examples and are not intended to be limiting definitions. Thus, “glycan equivalent” and “substantially similar” are still considered to have undefined metes and bounds.
As discussed in the previous Office action, the phrase “high molecular weight inulin” in the claims is a relative phrase which renders the claim indefinite. The phrase “high molecular weight inulin” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what molecular weights are encompassed by “high molecular weights.”
In response applicant argues that paragraph 130 of the published application defines high molecular weight inulin as “defined by AOAC method 999.03”. However, applicant has not provided a reference to show AOAC method 999.03. In addition, this appears to refer to inulin itself rather than what inulins are considered to be “high” molecular weight inulin. Thus, the metes and bounds of this limitation are still considered to be unclear.
As discussed in the previous Office action, claim 46 is indefinite because it is unclear what types of food must be present in order to be considered a “Western diet”. In addition, it is unclear what characteristics subjects must have in common in order to be considered “similar” subjects as set forth in lines 3-4 of the claim.
In response applicant argues that ‘Applicant clearly defines a "Western diet" at paragraph [0221]. Specifically, Applicant reports "a 'Western diet' refers to a diet high in red meat, dairy products, processed and artificially sweetened foods and/or drinks, and salt, with minimal intake of fruits, vegetables, fish, legumes, and whole grains" (see, [0221])…’. However, this definition is not considered to be a clear, limiting definition because it is unclear what amounts of red meat, dairy products, etc. are encompassed by “high” and what amount of fruits, vegetables, etc. are considered to be “minimal.” Thus, the metes and bounds of “Western diet” are not clearly defined.
In addition, applicant argues ‘For the sake of brevity, Applicant's previous arguments with respect to "substantially similar" and "similarity" are incorporated herein…’. However, the previous arguments were in regards to what are considered to be glycan equivalents. It is unclear how these arguments relate to definitions of subject population similarity. Thus, this claim limitation is still considered to be indefinite for the stated reasons.
Claim Rejections - 35 USC § 103
6. Claim(s) 1-4, 6-8, 10-12, 14-17, 19, 30, 38, 39, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wadsworth (US 6,254,913) in view of Cao (CN 108887688 A – English translation) with Metcalf (“Inulin” https://www.webmd.com/vitamins-and-supplements/inulin-uses-and-risks - accessed 7/2025) providing definitions.
Wadsworth teaches a fiber composition comprising citrus pulp, chicory root fiber (inulin as defined by Metcalf on page 1), pea fiber, and barley fiber (see Example 1). The reference states that the citrus pulp contains fiber. The reference teaches that the fiber ingredients can be present in amounts up to 30% by weight (see column 1, lines 58-62 and column 3, lines 21-33). In addition, the reference teaches incorporating the fiber into food compositions with additional ingredient such as sweeteners, flavors, minerals, vitamins (see column 3, line 33-column 4, line 32). The reference does not require citrus pectin and does not state that an orange is a source of the citrus pulp.
However, Cao teaches it was known in the art prior to the effective filing date to use orange fiber as a source of citrus fiber in fiber supplement blends. In addition, Cao teaches using pomelo (a type of citrus) pectin in the fiber blend. The reference teaches using the orange fiber and pectin in combination with fiber ingredients such as those taught by Wadsworth, i.e. pea, barley, and inulin (see the claims). Thus, the artisan of ordinary skill would reasonably expect that orange fiber and citrus pectin could be used as the type of citrus fiber in the composition taught by Wadsworth. This reasonable expectation of success would have motivated the artisan to modify Wadsworth to use orange fiber and citrus pectin in the composition.
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach that the concentrations of fiber in the composition can be varied. Thus, the artisan would reasonably expect to vary the amount of fibers in and around the amounts taught by the references during routine experimentation. Varying the concentration of the ingredients within the composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
The references do not specifically teach that the composition has the same effects as claimed by applicant in claims 38, 39, and 46. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
7. 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.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655