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 of the Response and Amendment after Non-Final Office Action filed 12/22/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the specification/claims and/or persuasive remarks: (1) the objection to the specification and claims have been withdrawn; (2) the 35 U.S.C. 101 rejections of claims 7-9 and 17 have been withdrawn; and (3) the 35 U.S.C. 102(a)(1) rejections of claims 7 and 20 over Kashimura et al. have been withdrawn.
Claim “5(b)” has been canceled and will be effectively disregarded moving forward. The claim in any subsequent claim sets may be deleted. Examiner notes that the limitations of the claim were moved to claim 21. Claim “5(a)” will be referred to as claim 5.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-20
Withdrawn claims: None
Previously canceled claims: None
Newly canceled claims: 2 and 16
Amended claims: 1, 7, 12, 14, and 18
New claims: 21
Claims currently under consideration: 1, 3-15, and 17-21
Currently rejected claims: 1, 3-15, and 17-21
Allowed claims: None
Claim Rejections - 35 USC § 102
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 1, 3, 4, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kashimura et al. (U.S. 2004/0219141 A1) as evidenced by Markosyan (U.S. 2013/0040033 A1).
Regarding claim 1, Kashimura et al. discloses a method for inhibiting glucose absorption in a subject comprising the step of administering to the subject an effective amount of a plant extract that inhibits glucose transport in a mammalian cell ([0022], [0044], [0059], [0081]), wherein the plant extract contains a substance that is an isoprenoid (i.e., stevia sweetener, presumably unrefined) ([0069], [0111], Table 5). Markosyan discloses that stevia extract naturally comprises rubusoside ([0010]).
Regarding claim 3, Kashimura et al. discloses the method of claim 1. Markosyan discloses that stevia extract naturally comprises rubusoside ([0010]). The presence of rubusoside is adequate to anticipate the claimed limitation that the plant extract is a sweet tea extract, even though the rubusoside is presumed to be present in the stevia composition. Claim 1 is directed to a method but comprises a single step of administering a composition. The limitations that the composition is a “plant extract” (claim 1), and more specifically a “sweet tea extract” (claim 3) are essentially product-by-process limitations that do not serve to limit the actual composition in terms of its composition. MPEP 2113. The method of claim 1 does not require anything related to a process step of actually obtaining the plant extract.
As for claim 4, Markosyan discloses that stevia extract naturally comprises rubusoside ([0010]).
As for claim 21, Kashimura et al. discloses the plant extract is a stevia extract ([0069], [0111], Table 5).
Claims 7-12 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markosyan (U.S. 2013/0040033 A1).
Regarding claim 7, Markosyan discloses a composition comprising a high-intensity sweetener (HIS) (i.e., rebaudioside A) ([0045]-[0046], [0010]) and a glucose transport inhibitor that is not derived from the HIS that is rubusoside (which may be derived from Rubus suavissimus) ([0015], [0023]). MPEP 2112 I (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” It is unnecessary that the prior art characterize the rubusoside as a “glucose transport inhibitor”.) that is present in the composition in a final concentration in the range of 1-10,000 ppm (specifically, <0.2% in dried leaves of Stevia, [0010]; [0071], where use of purified rubusoside “as-is” or in combination with other sweeteners anticipates any concentration of rubusoside ranging from >0 to 100%).
As for claim 8, Markosyan discloses the glucose transport inhibitor is a plant extract comprising rubusoside ([0023], [0045]).
As for claim 9, Markosyan discloses the glucose transport inhibitor is a stevia extract ([0046], [0010]) and that the composition may further comprise a high-intensity sweetener from a different source (e.g., mogroside V) ([0047]).
As for claim 10, Markosyan discloses the glucose transport inhibitor is a non-SG substance (e.g., mogroside V) ([0047]).
As for claim 11, Markosyan discloses the glucose transport inhibitor is a monk fruit extract (e.g., mogroside V) ([0047]).
As for claim 12, Markosyan discloses the glucose transport inhibitor is a sweet tea extract (e.g., rubusoside) ([0015]).
As for claim 17, Markosyan discloses a beverage comprising the composition ([0069]).
As for claim 18, Markosyan discloses a dairy product comprising the composition ([0069]).
As for claim 19, Markosyan discloses a food product comprising the composition ([0069]).
As for claim 20, Markosyan discloses a method comprising administering to the subject an effective amount of the composition of claim 7 ([0022], [0044], [0064]). MPEP 2111.02 II states: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” The statement that the method is “for inhibiting glucose absorption in a subject” is considered a statement of intended use that does not materially limit the claimed method.
Claim Rejections - 35 USC § 103
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kashimura et al. (U.S. 2004/0219141 A1) in view of Markosyan (U.S. 2013/0040033 A1).
Regarding claim 5, Kashimura et al. discloses the method of claim 1.
Kashimura et al. does not disclose the composition as containing a monk fruit extract.
However, Markosyan discloses mogroside V for use as a sweetener ([0047]), where mogroside V is a monk fruit extract.
It would have been obvious to one having ordinary skill in the art to combine a monk fruit extract (i.e., mogroside V) with the composition of Kashimura et al. Since Kashimura et al. discloses that a high intensity sweetener may be added to modulate the sweetness of the composition ([0069]), the addition of mogroside V to the composition of Kashimura et al. as a sweetener would be obvious to a skilled practitioner.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kashimura et al. (U.S. 2004/0219141 A1) in view of Eidenberger (U.S. 2008/0293644 A1).
Regarding claim 6, Kashimura et al. discloses the method of claim 1.
Kashimura et al. does not disclose the composition as containing a guava fruit extract.
However, Eidenberger discloses a guava fruit extract that exhibit DP-IV inhibitory activity ([0012], [0037]), which was presumed to lower blood glucose ([0010]).
It would have been obvious to one having ordinary skill in the art to combine a guava fruit extract with the composition of Kashimura et al. MPEP 2144.06 I states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Since Eidenberger discloses guava fruit extract as contributing to lower blood glucose ([0012], [0010]) and Kashimura et al. discloses the composition as also reducing blood glucose levels ([0011]), the addition of guava fruit extract to the composition of Kashimura et al. would be obvious to a skilled practitioner.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Markosyan (U.S. 2013/0040033 A1).
Regarding claim 13, Markosyan discloses the composition of claim 12, including that it may comprise rubusoside ([0015]). Markosyan et al. further discloses that a purified composition may have a concentration of 82.3% ([0076]), which is sufficiently close to 85% to render the use of RU85 obvious. MPEP 2144.05 I (“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Markosyan (U.S. 2013/0040033 A1) in view of Eidenberger (U.S. 2008/0293644 A1).
Regarding claim 14, Markosyan discloses the composition of claim 7.
Markosyan does not disclose the composition as containing a guava fruit extract.
However, Eidenberger discloses a guava fruit extract that exhibit DP-IV inhibitory activity ([0012], [0037]), which was presumed to lower blood glucose ([0010]).
It would have been obvious to one having ordinary skill in the art to combine a guava fruit extract with the composition of Markosyan. Since Markosyan discloses the rubusoside may be combined “with other sweeteners, flavors and food ingredients” ([0071]-[0072]) and Eidenberger discloses the guava extract may be incorporated into various foods/drinks ([0097]-[0100]), the addition of guava fruit extract to the composition of Markosyan would be obvious to a skilled practitioner.
As for claim 15, Eidenberger discloses that the guava extract has antioxidant activities ([0078]).
Double Patenting
Claims 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,154,079 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of the ‘079 patent claims a composition comprising sweet tea extracts, rubusoside, and mogrosides, which would fall within the scope of the noted present claims.
Response to Arguments
Specification Objection: Applicant has overcome the objection to the specification based on amendment of the abstract. Accordingly, the objection has been withdrawn.
Claim Objections: Applicant has overcome the objections of claims 2, “5(b)”, 12, and 18 based on amendments to the claims and/or cancellation. Accordingly, the claim objections have been withdrawn.
Claim Rejections - 35 U.S.C. § 101: Applicant has overcome the 35 U.S.C. § 101 rejections of claims 7-9 and 17 based on amendments to the claims and/or persuasive remarks. Specifically, Applicant argued that the composition was obtained via extraneous supplementation of rubusoside in amounts that caused a “significant inhibitory effect on glucose transport” (Applicant’s Remarks, p. 7, ¶3-¶4), which was determined to constitute significantly more than a judicial exception. Accordingly, the 35 U.S.C. § 101 rejections have been withdrawn.
Claim Rejections - 35 U.S.C. § 102(a)(1) of claims 1, 5(b), 7, and 20 over Kashimura et al.; and claims 2-4 over Kashimura et al., as evidenced by Markosyan: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant argued that Kashimura et al. does not disclose “the administration of an effective amount of a plant extract capable of inhibiting glucose transport in a mammalian cell to a subject, thereby inhibiting glucose absorption in said subject” (Applicant’s Remarks, p. 8, ¶9 – p. 9, ¶1).
However, Examiner maintains that the disclosure of Kashimura et al. that palatinose ingestion causes a reduction in blood glucose level increase ([0081]) anticipates the claimed limitations that the method is “for inhibiting glucose absorption in a subject” and that the composition “inhibits glucose transport in a mammalian cell”. Even if it were determined that Kashimura et al. does not adequately disclose the claimed effect, which Examiner does not concede, the reference nonetheless discloses the claimed step of administering a composition that comprises isoprenoids and rubusosides, and MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.”
Applicant further asserted that Kashimura et al. discloses palatinose as an active ingredient but not the isoprenoids or rubusosides (Applicant’s Remarks, p. 9, ¶2).
However, claim 1 does not require any of the claimed components to cause the claimed effect. Only the overall plant extract composition is required to cause the claimed effect. Examiner thus maintains that the disclosed method anticipates the claimed method. Further, the indication in MPEP 2112 I that “[T]the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” would support a determination that the claimed effect were anticipated even if the isoprenoid/rubusoside were required to cause the claimed effect.
The rejections of claims 1, 3, and 4 have been maintained herein.
The § 102(a)(1) rejection of claim 7 in view of Kashimura et al. has been withdrawn due to amendment of the claim. Applicant’s arguments regarding the §102(a)(1) rejection of claim 7 in view of Kashimura et al. are thus moot.
Claim Rejections - 35 U.S.C. § 102(a)(1) of claims 7-12 and 16-19 over Markosyan: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant argued that Markosyan does not disclose the claimed concentration of glucose transport inhibitor (Applicant’s Remarks, p. 9, ¶5).
As noted in the claim rejection, though, the disclosure of Markosyan that rubusoside is found at <0.2% in dried leaves of Stevia ([0010]) (where the dried leaves per se may constitute a composition comprising a high intensity sweetener and a glucose transport inhibitor) and that use of purified rubusoside may be “as-is” or in combination with other sweeteners ([0071]) (such that rubusoside may be at any concentration ranging from >0 to 100%) is adequate to anticipate the claimed concentration.
Applicant also argued that Markosyan does not teach inhibition of glucose transport in intestinal cells or any “technical teaching regarding the control of the type and content of such the glucose transport inhibitor in the composition” (Applicant’s Remarks, p. 15, ¶5; p. 16, ¶1, ¶6 – p. 17, ¶2).
However, no such feature of glucose transport inhibition is claimed in claim 7, which renders the arguments moot. Characterization of a compound as a “glucose transport inhibitor” does not implicitly require such an effect, especially since the claim is directed merely to a composition that may not even be used in the manner envisioned by Applicant.
Applicant argued that the experimental data in the present specification demonstrate inhibitory effects on glucose transport by intestinal cells (Applicant’s Remarks, p. 17, ¶6 – p. 18, ¶1).
However, claim 7 is rejected under §102(a)(1), such that an assertion of unexpected results is insufficient to overcome the rejection. MPEP 2131.04.
The rejection of claims 7 and 20 has been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claim 5(a) over Kashimura et al. and Markosyan: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first reasserted arguments pertaining to Kashimura et al. (Applicant’s Remarks, p. 11, ¶2-¶3) that have been addressed previously herein.
Applicant further argued that the mechanism of glucose reduction differs between Kashimura et al. and the presently-claimed method (Applicant’s Remarks, p. 11, ¶5 – p. 12, ¶2). Applicant argued that “Kashimura does not disclose inhibiting the process of glucose transport in intestinal cells to inhibit glucose absorption” (Applicant’s Remarks, p. 12, ¶3).
However, claim 1, from which claim 5 depends, only requires that the method is “for inhibiting glucose absorption in a subject” and that the plant extract “inhibits glucose transport in a mammalian cell” but not that it inhibits “the process of glucose transport”, as Applicant asserts. A reduction of blood glucose level increase at taught in Kashimura et al. ([0081]) will necessarily inhibit glucose transport in a mammalian cell due to the downstream effects of a reduction in blood glucose level initially. The present claim does not require the inhibition of glucose transport to specifically be directly caused by the plant extract; any initial reduction in glucose may be seen as inhibiting glucose transport in a cell.
Regardless, the asserted distinction is inconsequential to the examination of the claim. The method practically comprises only the administration of a plant extract comprising an isoprenoid and a rubusoside, which is disclosed in Kashimura et al. MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” That Applicant may have identified an unrecognized effect of performing such a process does not render the process new.
Applicant then argued that palatinose does not fall within any of the claimed classes of compounds (Applicant’s Remarks, p. 12, ¶4).
The claim rejection does not rely on such an interpretation, though. The claim rejection relies on the presence of stevia sweetener as being (or containing) isoprenoids and rubusoside.
Applicant next argued that the “role of ‘stevia sweetener’ is merely that of a sweetener” in an example of Kashimura et al. (Applicant’s Remarks, p. 12, ¶5 – p. 13, ¶1).
However, the claim does not require the stevia extract or rubusoside to cause the glucose transport inhibition, which undermines Applicant’s argument. Even if it did, the effect would still merely constitute the recognition of an unrecognized property that would not render the claimed method novel. MPEP 2112 I.
The rejection of claim 5 has been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claims 6, 14, and 15 over Kashimura et al. and Eidenberger: Applicant’s arguments have been fully considered but they are not persuasive.
Regarding claim 6, Applicant argued that the guava extract of Eidenberger regulates blood glucose via a different mechanism than allegedly presently claimed in claim 6 (Applicant’s Remarks, p. 13, ¶2).
Examiner maintains that adequate motivation was detailed for incorporating guava extract into the method of Kashimura et al. The effect asserted by Applicant does not constitute anything more than the recognition of an unrecognized property that does not render the claimed method non-obvious. MPEP 2112 I.
Applicant further asserted experimental data purporting to show that guava and sweet tea material inhibited glucose transport (Applicant’s Remarks, p. 13, ¶3).
As before, though, MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” That Applicant may have identified an unrecognized effect of performing a process as described in Kashimura et al. as modified by Eidenberger does not render such a process non-obvious.
Regarding claim 14, Applicant argued that Eidenberger does not teach or suggest inhibition of glucose absorption via inhibition of glucose transport in intestinal cells (Applicant’s Remarks, p. 16, ¶2; p. 17, ¶3-¶6).
However, no such feature is claimed in claim 7 or 14, which renders the argument moot. Characterization of a compound as a “glucose transport inhibitor” does not implicitly require such an effect, especially since the claim is directed merely to a composition that may not even be used in the manner envisioned by Applicant. Examiner maintains that adequate motivation was detailed for incorporating guava extract into the composition of Markosyan.
The rejections of claims 6, 14, and 15 have been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claim 13 over Markosyan: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant reasserted arguments addressed previously herein (Applicant’s Remarks, p. 18, ¶2).
The rejection of claim 13 has been maintained herein.
Double patenting: Applicant noted the rejections and indicated an intent to address them upon an indication of allowable subject matter (Applicant’s Remarks, p. 18, ¶5).
The double patenting rejections have been maintained herein.
Conclusion
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.
Claims 1, 3-15, and 17-21 are rejected.
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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