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 .
Applicants' arguments, filed 09/04/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103—New by Amendment
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.
1) Claim(s) 1-3, 5-8, 11, 13-14, 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al., (US 4,592,487, cited in IDS) in view of Nordstrom et al., (Caries Research 2010), and further in view of Vazquez et al., (KR-20090116803).
Simon et al. teaches, “Dentifrices comprising two components each of which comprises ingredients usually present in toothpastes or toothpowders, one component containing an iodophor as a source of derived iodine . . . “ (Abstract). As a dentifrice, method of use would have included applying the composition to the oral cavity of a human, as per claims 18-19.
The reference teaches a specific embodiment of a dentifrice comprising 10% “PVP-I” (polyvinyl pyrrolidone iodine) and 0.76% “Sodium monofluorophosphate” in a single phase:
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(see col. 12, claim 16). The 10% I2 suggests 1% iodine provided by the complex, as per claim 3. Calcium pyrophosphate suffices as the abrasive agent.
Other suitable sources of fluoride include “sodium fluoride” (col. 1, line 50), as per claims 5 and 8.
Other suitable sources of abrasive include “calcium carbonate” (col. 7, lines 64-65), as per claim 13.
Simon et al. does not teach a fluoride content greater than 4500 ppm.
Nordstrom et al. teaches, “Adolescents using 5000 ppm F toothpaste had significantly lower progression of caries compared to those using 1,450 ppm F toothpaste . . . . This may indicate that 5,000 ppm F toothpaste has a greater impact on individuals who do not use toothpaste regularly or do not brush twice a day. Thus 5,000 ppm F toothpaste appears to be an important vehicle for cries prevention and treatment of adolescents with a high caries risk” (Abstract).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide greater than 4500 ppm fluoride in the dentifrice formulations of Simon et al. for the advantage of treating caries in patients who do not use toothpaste regularly or do not brush twice a day, as taught by Nordstrom et al.
The combination of Simon et al. and Nordstrom et al. differs from the instant claims insofar as it does no teach wherein the dentifrice is thixotropic.
Vasquez et al. teaches oral care implements, i.e. toothbrushes, for enhanced cleaning of the teeth and soft tissues of the oral cavity (Abstract), where the toothbrushes utilize “toothpaste, which is easily dispensed from a tube (having beneficial yield stress and shear peeling) and cleansed after being applied to the toothbrush (with known stringiness). It is made of a viscoelastic material that is sensitive to shear forces that are blocked and is still recovering its composition in the toothbrush, for example ‘stand up’ (known as thixotropic). Common known toothpastes are, for example, cream toothpastes. Preferably, the tooth paste is of a rheological profile that facilitates dissolution and dispersal, and the rheological profile is a shear rate according to brushing in the oral cavity, which facilitates rapid disintegration and mixing with saliva. It has a sensitive reactivity. Typical toothpaste products have a viscosity of 100-1000 Pa.s at low shear rates, but when mixed with saliva in a ratio of 1:1 to 1:4 (toothpaste:salt), the viscosity drops to 0.01-1.0 Pa.s. The improvement of dissolution and dissemination of toothpaste or other active agent 101 in the oral cavity is such that the viscosity rate is reached faster and more consistently during oral care” (see p. 4 of translation, 2nd paragraph).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide that the dentifrice of Simon et al. is thixotropic for the advantage of improvement of dissolution and dissemination of the dentifrice in the oral cavity is such that the viscosity rate is reached faster and more consistently during oral care, as taught by Vasquez et al.
2) Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al., (US 4,592,487, cited in IDS) in view of Nordstrom et al., (Caries Research 2010) and Vazquez et al., (KR-20090116803) as applied to claim 1 above, and further in view of Mourya et al., (Soft Nanoscience, 2016).
The combination of Simon et al., Nordstrom et al., and Vazquez et al., which is taught above, differs from claims 9-10 insofar as they do not teach a particles size for their fluoride compounds.
Mourya et al. teaches, “The action of sodium fluoride is mainly used in dental preparations for delivering fluoride ion to the tooth enamel for that nano-particle size is required” (Abstract)
Sodium fluoride is characterized has having a particle size of 800 to 1000 nm (see Results and Discussion at p. 5).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use sodium fluoride having a particle size of less than 50 micrometers or less than 20±2 microns, since 800 to 1000 nm is suitable for treating the enamel, as taught by Mourya et al.
Response to Arguments
Applicant argues that the claims are overcome by the addition of “thixopic” to the instant claims. Applicant posits that the advantage of being thixotropic, i.e., uniformity, flowability, stability/breakability, are not taught by Simon et al.
However, the idea or concept of being thixotropic is not a novel one in the dental arts, as evidenced by Vasquez et al., above. It is a property the art values, which enables the dentifrice to “stand up” on the bristles of the tooth brush. The ability of the dentifrice to behave in a non-Newtonian way serves as advantageous for the improvement of dissolution and dissemination of the dentifrice in the oral cavity is such that the viscosity rate is reached faster and more consistently during oral care use.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick F. Krass can be reached (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612