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 .
Response to Amendment
Applicant's amendment and argument filed 09/03/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-6, 10-11, 15, 17-18, 20-25 are pending of which claim 1 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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, 10-11, 15, 17-18 and 20-25 are being examined on the merits.
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, 10-11, 15, 17-18 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et. al. (CN108552525A) and Klosterbuer (JP6527522B2). This rejection is maintained with slight modifications based on the amendments filed on 09/03/2026.
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 17 and 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. It would have also been obvious to optimize the mulberry component and the fiber to be in within the instantly claimed ratios wherein the mulberry component is 0.5% to 50% and the fiber is 50% to 90% because the compositions are taught as being useful for the same purpose and having the same activities and optimizing the active components in a composition is well within the purview of any skilled artisan especially given that their activities are known.
There would have been a reasonable expectation of success in arriving at the instant invention given the prior art.
Claims 4 and 20-23 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, 10-11, 15, 17-18, and 24-25 above, and further in view of Chen Xie and Yinghu Zou (WO2011032502A1). This rejection is maintained with slight modifications based on the amendments filed on 09/03/2026.
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 at least 1 mg or 6 mg per dry weight because Xie teaches it as an active component for glucosidase and tyrosinase inhibitory activity and optimizing it to be at least 1 mg or 6 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 09/03/2026 have been fully considered but they are not persuasive. The applicant argues that Qian teaches adding mulberry leaf dietary fiber and does not teach the use of dietary fiber in general being in the claimed ratio of 4:1 to mulberry component. Mulberry leaf fiber is also dietary fiber and persons having ordinary skill in the art would be motivated to in the least optimize other fiber content added in the composition to this synergistic amount. The applicant argues that one would only be motivated to add the mulberry leaf fiber in the 4:1 ratio and not the other fibers being claimed. This is an obvious starting point for optimization as it is already described as being synergistic. Even if one were to not use this ratio as a starting point it would have been arrived at through standard optimization practice which is common and conventionally done in the art. The effects of weight loss are already noted from a synergistic mulberry leaf fiber to polyphenol amount at 4:1 and optimizing the additional fiber components (FOS, inulin, acacia gum and optionally PHGG), known for being beneficial to commensal bacteria and which can treat C. difficile infections to be in the same synergistic ratio of fiber content is prima facie obvious. Combining the additional fiber components would have been obvious for the benefit to a human commensal bacterium. A person having ordinary skill would not have to combine the fibers for the same reasons that the instant applicant has or is not limited in combining those fibers into the composition for merely reducing weight as the composition is already taught for having weight loss activity.
Conclusion
Currently 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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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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