DETAILED ACTION
Applicants' arguments, filed 02/02/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 .
Priority
The application claims domestic priority to PRO 63/084,020 filed on 9/28/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 03/02/2026 and 10/10/2025 both comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 24 recites “wherein the oral care composition exhibits a synergistic antibacterial effect with respect to Porphyromonas gingivals due to the combination of the prenylated flavonoid and the metal ion”. The term synergistic or synergy is not to the best of the Examiner’s understanding used in the Instant Specification or the Instant claims prior to this amendment. To the best of the Examiner’s understanding the Instant Specification recites a Table 1 with MIC values for a variety of flavonoids but there is no data present in the Instant Specification for MIC values of flavonoids with a metal ion. The Applicants remarks filed 02/02/2026 recite “New claim 24 is added. Support for this amendment is found in claim 1 and page.” and the Examiner had not found support for this limitation in the previous Instant Claims or the Instant Specification. As such, claim 24 is presently rejected for new matter.
Claim Rejections - 35 USC § 103 - Obviousness
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
A) Claims 1-6, 9, 11, 13-15, 18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al (U.S. Patent App. Pub. 20060018867 A1).
Kawasaki et al teaches a mouth wash, tooth wash, or toothpaste (Kawasaki at [0051]). Kawasaki teaches the use of mulberrin, aka Kuwanon C a prenylated flavonoid with two prenyl functional group (Kawasaki at [0091]), in an amount of from 0.0001% to 50% (Kawasaki at [0087-88]). Kawasaki teaches the use of zinc oxide (Kawasaki [0102], [0099]), in an amount of from 0.0001% to 50% (Kawasaki at [0087-88]). Kawasaki teaches the use of Cannabis extract (Kawasaki at [0101]). Kawasaki teaches the use of humulus extract (Kawasaki at [0102], [0094], [0090]).
Kawasaki differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Kawasaki teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Kawasaki to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1, Kawasaki et al teaches a mouth wash, tooth wash, or toothpaste (Kawasaki at [0051]). Kawasaki teaches the use of mulberrin, aka Kuwanon C a prenylated flavonoid with two prenyl functional group (Kawasaki at [0091]), in an amount of from 0.0001% to 50% (Kawasaki at [0087-88]), which overlaps with the instantly claimed range of at least about 0.05%. Kawasaki teaches the use of zinc oxide (Kawasaki [0102], [0099]), in an amount of from 0.0001% to 50% (Kawasaki at [0087-88]), which overlaps with the instantly claimed range of about 1% to about 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 2, Kawasaki et al teaches a mouth wash, tooth wash, or toothpaste (Kawasaki at [0051]). Kawasaki teaches the use of mulberrin, aka Kuwanon C a prenylated flavonoid with two prenyl functional group (Kawasaki at [0091]), in an amount of from 0.0001% to 50% (Kawasaki at [0087-88]), which overlaps the instantly claimed range about 0.05% to about 10%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 3, Kawasaki teaches the use of mulberrin, aka Kuwanon C a prenylated flavonoid with two prenyl functional group (Kawasaki at [0091]).
Regarding instant claim 4, Kawasaki teaches the use of Cannabis extract (Kawasaki at [0101]). Kawasaki teaches the use of humulus extract (Kawasaki at [0102], [0094], [0090]).
Regarding instant claim 5, Kawasaki teaches the use of Cannabis extract (Kawasaki at [0101]). Kawasaki teaches the use of humulus extract (Kawasaki at [0102], [0094], [0090]).
Regarding instant claim 6, Kawasaki teaches the use of Cannabis extract (Kawasaki at [0101]). Kawasaki teaches the use of humulus extract (Kawasaki at [0102], [0094], [0090]).
Regarding instant claim 9, Kawasaki teaches the use of mulberrin, aka Kuwanon C a prenylated flavonoid with two prenyl functional group (Kawasaki at [0091]).
Regarding instant claim 11, Kawasaki teaches the use of calcium (Kawasaki at [0123]).
Regarding instant claim 13, Kawasaki teaches the use of zinc oxide (Kawasaki [0102], [0099]).
Regarding instant claim 14, Kawasaki et al teaches a mouth wash, tooth wash, or toothpaste (Kawasaki at [0051]).
Regarding instant claim 15, Kawasaki does not require the use of fluoride.
Regarding instant claim 18, Kawasaki teaches the use of mulberrin, aka Kuwanon C a prenylated flavonoid with two prenyl functional group (Kawasaki at [0091]).
Regarding instant claim 24, Kawasaki et al teaches a mouth wash, tooth wash, or toothpaste (Kawasaki at [0051]). Kawasaki teaches the use of mulberrin, aka Kuwanon C a prenylated flavonoid with two prenyl functional group (Kawasaki at [0091]), in an amount of from 0.0001% to 50% (Kawasaki at [0087-88]), which overlaps with the instantly claimed range of at least about 0.05%. Kawasaki teaches the use of zinc oxide (Kawasaki [0102], [0099]), in an amount of from 0.0001% to 50% (Kawasaki at [0087-88]), which overlaps with the instantly claimed range of about 1% to about 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). With regards to the limitation “wherein the oral care composition exhibits a synergistic antibacterial effect with respect to Porphyromonas gingivals due to the combination of the prenylated flavonoid and the metal ion”, see the 112 a New Matter rejection above, this obviousness rejection is given for compact prosecution and to provide the Applicant with the relevant prior art.
B) Claims 1-7, 9, 11-18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al (U.S. Patent App. Pub. 20060018867 A1) in view of Cummins et al (U.S. Patent App. Pub. 2009/0087501 A1).
The teachings of Kawasaki are discussed above. Kawasaki teaches the use of antimicrobial agents (Kawasaki at [0102]), anti-inflammatory agents (Kawasaki at [0087]), astringents (Kawasaki at [0087]).
The teachings of Kawasaki differ from the instant claims insofar as it does not specifically teach the use of stannous chloride or stannous fluoride. The teachings of Cummins cure this deficit.
Cummins recites an oral composition (Cummins at claim 24) comprising at least two botanical active ingredients is about 0.001 to about 5% by weight of the total oral composition (Cummins at claim 26) wherein at least one of the botanical active ingredients is derived from Sophora flavescens and comprises kurarinone (Cummins at claim 19). Cummins further recites that the oral composition further comprises a source of stannous ions (Cummins at claim 20). Cummins teaches that the composition comprises an orally acceptable stannous ion source useful, for example, in helping reduce gingivitis, plaque, calculus, caries or sensitivity. Cummins further teaches that the stannous ions are used in a range of 0.01% to about 10% (Cummins at [0069]). Cummins further recites that the oral composition further comprises a source of copper as an antibacterial agent (Cummins at [0056]). Cummins teaches the use of stannous chloride and stannous fluoride (Cummins at [0069]). Cummins teaches the use of zinc citrate, zinc acetate, zinc gluconate, zinc sulfate and zinc oxide (Cummins at [0056]).
One would have been motivated to have added the stannous sources of Cummins with the toothpaste of Kawasaki for the benefit of in helping reduce gingivitis, plaque, calculus, caries or sensitivity.
It would have been prima facie obviousness to have combined the stannous sources of Cummins with the toothpaste of Kawasaki for the benefit of in helping reduce gingivitis, plaque, calculus, caries or sensitivity. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP 2144.07. The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). See MPEP 2144(II).
Regarding instant claim 7, Cummins recites an oral composition (Cummins at claim 24) comprising at least two botanical active ingredients is about 0.001 to about 5% by weight of the total oral composition (Cummins at claim 26) wherein at least one of the botanical active ingredients is derived from Sophora flavescens and comprises kurarinone (Cummins at claim 19).
Regarding instant claim 12, Cummins teaches the use of stannous chloride and stannous fluoride (Cummins at [0069]).
Regarding instant claim 16, Cummins teaches the use of stannous chloride and stannous fluoride (Cummins at [0069]).
Regarding instant claim 17, Cummins teaches the use of stannous chloride and stannous fluoride (Cummins at [0069]).
C) Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al (U.S. Patent App. Pub. 20060018867 A1) and Cummins et al (U.S. Patent App. Pub. 2009/0087501 A1) as applied to claims 1-7, 9, 11-18 and 24 above, and further in view of Zhang et al.
The teachings of Kawasaki and Cummins are discussed above.
The teachings of Kawasaki and Cummins differ from the instant claim 23 insofar as they teach the flavonoid extract of Sophora flavescens includes kurarinone but does not specifically teach the other flavonoids extracted from Sophora flavescens. The teachings of Zhang cure this deficit.
Zhange teaches a method coupling high-performance liquid chromatography (HPLC) with diode-array detector (DAD) and electrospray ionization mass spectrometry (ESI) was established for the separation and characterization of flavonoids in Sophora flavescens Ait. Based on the chromatographic separation of most flavonoids present in S. flavescens Ait., a total of 24 flavonoids were identified. Fourteen compounds were unambiguously identified comparing experimental data for retention time (tR), UV and MS spectra with those of the authentic compounds: 3′,7-dihydroxy-4′-methoxy-isoflavone (13), trifolirhizin (14), kurarinol (18), formononetin (19), 7,4′-dihydroxy-5-methoxy-8-(γ,γ-dimethylallyl)-flavanone (22), maackiain (21), isoxanthohumol (23), kuraridine (26), kuraridinol (27), sophoraflavanone G (30), xanthohumol (31), isokurarinone (33), kurarinone (35) and kushenol D (38), and additional 10 compounds were tentatively identified as kushenol O (10), trifolirhizin-6′′-malonate (15), sophoraisoflavanone A (20), norkurarinol/kosamol Q (24), kushenol I/N (25), kushenol C (28), 2′-methoxykurarinone (29), kosamol R (32), kushecarpin A (34) and kushenol A (37) by comparing experimental data for UV and MS spectra with those of literature. Furthermore, fragmentation pathways in positive ions mode of 24 flavonoid compounds of types of flavanone, flavanonol, flavonol, chalcone, isoflavone, isoflavanone and ptercocarpane were summarized (Zhang at abstract). Zhang further teaches that Sophorae Radix (Kushen in Chinese), the dried root of Sophora flavescens Ait. (Leguminosae), is a well known TCM widely spread in China, Japan and Korea. It has been applied frequently in traditional medicines as an antipyretic, diuretic, anthelmintic and atomachic and for the treatment of diarrhea, gastrointestinal hemorrhage and eczema. Phytochemical studies revealed that it mainly contains quinolizidine alkaloids and prenylated flavonoids. During the past work, pharmacological and clinical research was focused on its alkaloids. Nevertheless, it has been proved that the existence of lavandulyl radical could intensify the biologic activity of flavonoids. Prenylated flavonoids from the roots of S. flavescens have a variety of biological and chemical activities, and have the meaning of the comprehensive evaluation of its quality. Thus, in order to more precise control the quality of S. flavescens, on the basis of its quantitative and qualitative analysis, a reliable method for identification of the major constituents in S. flavescens is indispensable. In our previous paper, we applied two chromatographic conditions to establish chromatographic fingerprints of alkaloids and flavonoids constituents of S. flavescens, respectively, and main alkaloids were identified by comparing their retention time (tR) values with those of authentic standards (Zhang at introduction).
It would have been prima facie obvious for one of ordinary skill in the art to have combined the xanthohumol with the kurarinone of Kawasaki and Cummins for the predictable outcome of a prenylated flavonoid derived from a Sophora flavescens in an oral care composition as Zhang teaches that xanthohumol is a prenylated flavonoid also derived from Sophora flavescens. See MPEP 2144.06(I). See MPEP 2144.06(II). See MPEP 2144.07.
Response to Arguments
Applicant's arguments filed02/02/2026 have been fully considered but they are not persuasive.
Applicant argues that the unexpected results provide secondary considerations that overcome the obviousness rejection based on the effect of octanol/water partition coefficient (log P) on the minimum inhibitory concentration (MIC) values for a given prenylated flavonoid. Applicants note that prenylated flavonoids have unexpectedly low MIC against gram positive and gram negative bacteria that can reduce plaque acids, help to protect the oral hard tissues from caries, and provide an antigingivitic effect.
The Examiner does not agree. In demonstrating unexpected results, Applicants have the burden to demonstrate using objective evidence and explaining the results which they believe to be unexpected. MPEP 716. Here, Applicants appear to rely on the mere possibility that prenylated flavonoids can improve oral health. Next, Applicants have the burden of placing the claims commensurate in scope with the data relied upon for unexpected results. Here, the claims are drawn to compositions containing “at least about 0.05%” of a prenylated flavonoid. Applicants have not explained how such a de minimis amount of prenylated flavonoid would be expected to result in a statistical and practical improvement in oral health, regardless of what the remaining about 99.95% of the composition is. The Applicant has not established unexpected results. The burden is on the Applicant to both show that the differences in results are in fact unexpected and non-obvious and of both statistical and practical significance. The burden is on Applicant to explain how and why the data is both unexpected and non-obvious. See MPEP §716.02. Applicant has not explained the data nor described its statistical and practical significance. There is not statistical data provided for Table 1. As such, Applicants have not met their burden of demonstrating and explaining unexpected results which are commensurate in scope with the present claims. Accordingly, the obviousness rejections are maintained.
Applicant argues that the prenylated flavonoids require specific Log P and MIC values that are not disclosed by the prior art and that these values are an unexpected result, and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. To the best of the Examiner’s understanding, Log P value and MIC value are inherent to flavonoid compounds. Thus, kurarinone and xanthohumol would have the same effect regardless of whether the prior art identified the specific Log P value of the component or not. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. The prior art does not need to teach the kurarinone and xanthohumol for the same purpose or to solve the same problem as the instant invention. See MPEP 2144(IV). Furthermore, the Applicant has not established unexpected results. The burden is on the Applicant to both show that the differences in results are in fact unexpected and non-obvious and of both statistical and practical significance. The burden is on Applicant to explain how and why the data is both unexpected and non-obvious. See MPEP §716.02. Applicant has not explained the data nor described its statistical and practical significance. There is not statistical data provided for Table 1. There are below range samples that provide MICs that are less than about 25 ppm such as 6-Prenylaringenin. These data points appears to contradict argument that the Log P values are tied directly to the MIC. The Log P and MIC of the flavones appears to be an inherent quality of the flavones. Products of identical chemical composition cannot have mutually exclusive properties. See MPEP 2112.01(II). 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. See MPEP2112(I). As such, Examiner has established a prima facie case of obviousness and Applicants have not met their burden of demonstrating unexpected results which overcome the obviousness. Thus, Applicant’s argument is unpersuasive.
Regarding instant claim 7, the obviousness rejection in view of Kawasaki is withdrawn, see the supra obviousness rejection of Kawasaki in view of Cummins.
Regarding new claims 23 and 24, see the supra 112a New Matter rejection and the new obviousness rejection of Kawasaki and Cummins in view of Zhang et al.
Conclusion
No claims are presently allowable.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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