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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/20/2022 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Response to Amendment
Applicant's amendment and argument filed 03/02/2026, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-6, 9-11, 15, 17-18 and 20-21 are pending of which claim 1 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/12/2025.
Claims 2-6, 9-11, 15, 17-18 and 20-21 are being examined on the merits.
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 11 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.
The term “about” in claim 11 is a relative term which renders the claim indefinite. The amount of mulberry component is not defined by the claim, 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. Paragraph [0067], states “As used herein, the term “about” when referring to a measurable value such as an amount is meant to encompass variations of ±20% or in some instances ±10%, or in some instances ±5%, or in some instances ±1%, or in some instances ±0.1% from the specified value, as such variations are appropriate to the disclosed composition.” It is unclear what amount of mulberry component is encompassed by about 5% to about 95%.
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 2-3, 5-6, 9-11, 15, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et. al. (CN108552525A) and Klosterbuer (JP6527522B2). This is a new rejection based on the amendments filed on 01/30/2026.
Qian’s general disclosure is to lowering blood-fat and reducing weight functional foods (see abstract).
Qian teaches “A functional food for reducing fat and reducing weight. The active ingredient of the functional food is mulberry leaf extract, and the mulberry leaf extract includes mulberry leaf dietary fiber and mulberry leaf polyphenol extract. Preferably, the mass ratio of the mulberry leaf dietary fiber to the polyphenol extract is 4:1” (see page 2 Contents of the invention). Qian teaches the composition as a powder (see claims 5 and 8).
Qian also teaches specifically “Dietary fiber and polyphenol extracts have a synergistic effect, especially when the two are compounded at a ratio of 4:1” (see page 2, right before example 1), this amount would also encompass the broadly claimed range of mulberry component at 5% to about 95%.
Qian does not specifically teach wherein the fiber is a combination of FOS, inulin, acacia gum and optionally PHGG.
Klosterbuer teaches nutritional compositions containing a fiber blend that includes soluble fibers that are fructo-oligosaccharide (FOS), acacia gum and inulin for treating C. difficile (see abstract and claim 1).
Regarding claims 9, 17, 18, Klosterbuer also teaches wherein the composition further comprises PHGG (see page 4, embodiment 39, page 5, embodiment 43, 0045, 0050).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to use a combination of FOS, inulin, acacia gum and optionally PHGG because as Klosterbuer teaches this combination can not only act as a fiber for beneficial gut bacteria, but can also be useful for treating C. difficile infections.
It would have also been obvious to optimize the amount of fiber to mulberry component to be within the instantly claimed amount as it is a matter of mere optimization to arrive within the instantly claimed range and one which any person having skill can do without undue experimentation. Optimizing the fiber and the mulberry extract and to be at 4:1 ratio would have also been obvious as Qian teaches wherein this ratio of fibers and mulberry leaf extract exert synergy for weight loss. This would have given any skilled person in the art enough reason to begin optimizing at this amount and to arrive at the instant invention in seeing that the same benefit can be noted with other fibers such as the ones taught by Klosterbuer.
There would have been a reasonable expectation of success in arriving at the instant invention given the prior art.
Claims 4 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et. al. (CN108552525A) and Klosterbuer (JP6527522B2) as applied to claims 2-3, 5-6, 9-11, 15, 17-18 and 20 above, and further in view of Chen Xie and Yinghu Zou (WO2011032502A1). This is a new rejection based on the amendments filed on 01/30/2026.
Qian and Klosterbuer teach the method for supporting weight loss in a subject however is silent on the mulberry component being Morus alba and wherein the method supports the maintenance of glycemia and/or management of blood glucose.
Xie’s general disclosure is to plant extracts from the leaves of mulberry for treating different ailments (see abstract).
Xie teaches wherein the plant extract can be form Morus alba L. (see claim 10) and teaches that the extract is to control blood glucose levels and glycemic index (see abstract and claim 24).
Xie also teaches wherein “DNJ is an active compound identified from Morus extract, as an or-glucosidase inhibitor andean reduce the activity of tyrosinase resulting in reduction of melanin in B-16 melanoma cell lines. Since the content of natural occurring DNJ in all plants is very low, it is impossible to use natural DNJ for a commercial purpose. But with Morus extract, although the DNJ content in Morus extract is as low as 2-5%, Morus extract still demonstrated a similar potency of activity to DNJ, which indicated that within Morus extract, DNJ may work synergistically with other active compounds to generate a strong anti- pigmentation effect” (see 00116).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to use Morus alba L. for the management of blood glucose and to support the maintenance of glycemia because that is exactly what Xie teaches it being used to treat. It would have also been obvious to include DNJ in the amount of 1 mg per dry weight because Xie teaches it as an active components for glucosidase and tyrosinase inhibitory activity and optimizing it to be at 1 mg of dry weight would have been an obvious and predictable optimization well within the purview of any skilled artisan.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive. The applicant argues against the teaching of Zengqiang for showing an incorrect ratio of fiber to mulberry leaf extract. The Office no longer relies upon this art in the new rejection. Qian does teach this ratio as can be appreciated from the above rejection.
The applicant argues that they have provided details showing discovered synergy between mulberry leaf extract and fibers and that the Office acknowledges this effect as a secondary consideration. The applicant argues that in view of the new amendments that the new limitations are in scope with the noted synergy noted between the mulberry and the fiber and that the scope of the claims should not be limited to the literal effects shown in the examples. The invention outside of the synergy noted from the particular specific components in those synergistic amounts are obvious to combine for the reasons just stated above. The art recognizes that synergy can be obtained from mulberry leaf extract and fiber in the ratio of 4:1.
The applicant’s synergy is to specific amounts as previously discussed. The synergy is noted for the effects of perineal fat mass and epididymal fat mass when the fiber is at 5g/kg and the mulberry leaf extract is at 0.2g/kg. Amending the claims to be at the correct amount and for those specific effects would overcome the current rejections as these are specific amounts and effects which were not disclosed or recognized in the prior art. The current range of 30:1 to 4:1 is merely an embodiment that the applicant has recited in the specifications and has support for but does not show that this range is synergistic. If the applicant continues to amend to different amounts than what the Office has determined to be synergistic then the applicant should articulate and point to the evidence to support the broader ratios which support their argued synergy. The current prior art recognizes already that when combining fiber and mulberry leaf extract in a ratio of 4:1 that there is synergy for weight loss and this is exactly what the applicant claims. As previously argued, the claims are not commensurate in scope with the noted synergy.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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