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 September 29, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
It is noted that claims have incorrect modifiers. Appropriate action is requested.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (New Rejection)
1) Claims 27-31 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Tosun et al. (TR 201608805) in view of Samano-Valencia et al. (Journal or Nanomaterials, 2014) in further view of Tokura et al. (WO 2006067987).
Tosun et al. disclose oral care compositions to treat hypersensitivity comprising chitosan and sodium fluoride. The chitosan mixed with the fluoride enables fluoride to clog the dentin tubules and a higher rate. A mixture of basic chitosan gel and sodium fluoride, is better in reducing the number of open tubules by reducing the number of open tubules and the penetration depth is more effective. Chitosan comprises 2% (20000 ppm) of an encompassed gel and sodium fluoride comprises 5% (50,000 ppm, ~23000 fluoride ions). Chitosan is a linear aminopolysaccharide obtained by deacetylation of chitin (instant claim 34). The degree of deacetylation of the chitosan gels used in the content of the dental desensitizing agents of the application may be from 60 to 100%. The deacetylation degree of basic chitosan gel used in dentifrice composition containing basic chitosan gel was determined as 85%. The degree of deacetylation of the water-soluble chitosan gel used in the composition was determined to be 86%. The physicochemical properties of chitosan vary with the degree of deacetylation and molecular weight and consequently affect the properties of pharmaceutical formulations prepared with chitosan. Therefore, molecular weight and degree of deacetylation of chitosan, gel formation and active substance release.
Tosun et al. differ from the instant claims insofar as they do not disclose the chitosan has silver bound to it.
Samano-Valencia et al. disclose chitosan gels with silver and gold nanoparticles. The chitosan gels are coupled with silver or gold nanoparticles. Bactericide results show that these materials present and antibacterial activity against S. aureus, S. mutans and E. coli. The gels with silver and gold nanoparticles could be used to treat infections in oral or skin applications. Dental caries is one of the most common oral diseases all over the world and Streptococcus mutans is its main etiological agent (page 1, col. 2, lines 1-3). The silver nitrate has a concentration of 0.025 wt% (250 ppm), 0.1 wt% (1000 ppm) and 0.05 wt% (500 ppm) (page 2, col. 2, paragraph 6).
It would have been obvious to one of ordinary skill in the art prior to when the instant application was filed to have used chitosan-silver nanoparticles as the chitosan of Tosun motivated by the desire to use a chitosan that not only acts as a desensitizing agent but also has antibacterial properties against S. mutans, which is a bacteria found in dental caries.
Tosun et al. in view of Samano-Valencia et al. differ from the instant claims insofar as it does not disclose that the compositions are neutral.
However Tokura et al. disclose neutral chitosan hydrogels that can be stored stably for a long time at around room temperature. Acidic chitosan solutions have poor viscosity stability (molecular weight stability) at room temperature, so in order to perform the required functions, they must be stored as chitosan powder and dissolved immediately before use. In particular, when used as a cosmetic or hair styling agent, it is necessary to store the chitosan solution stably at around room temperature for a long time. In the acidic solution, the molecular weight of the chitosan is reduced with time even at room temperature, and the viscosity of the solution cannot be maintained (paragraph 004).
Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have neutralized the composition of Tosun et al. in view of Samano-Valencia motivated by the desire to insure the composition comprising chitosan-silver remains stable during storage.
In regards to the ratios of 29-30, as above, silver and fluoride are desensitizing agents. It would have taken no more than the relative skill of one of ordinary skill in the art by routine optimization to have adjusted the amounts of each of silver and fluoride to arrive at an effective ratio to desensitize the teeth. See MPEP 2144.05.
In regards to claim 31, the compositions comprise fluoride and therefore when entering the, one would reasonably conclude that they would form fluoroapatite when binding with a tooth, which comprises calcium and phosphate.
In regards to claim 36, the composition is a chitosan nanogel and therefore sodium fluoride is encompassed within the nanoparticle.
2) Claims 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tosun et al. (TR 201608805) in view of Samano-Valencia et al. (Journal or Nanomaterials, 2014) and Tokura et al. (WO 2006067987), in further view of Moradian-Oldak et al. (US 2017/0007737).
Tosun et al. in view of Samano-Valencia et al. and Tokura et al. is discussed and differs from the instant claims insofar as it does not disclose the molecular weight of the chitosan.
Moradian-Oldak et al. disclose composition for treating the oral cavity. The compositions are used to treat exposed dentinal tubules (paragraph 0050). Chitosan is used and has a molecular weight ranging from 150,000 to 400,000 Dalton.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art prior to when the Application was filed to have used a chitosan ranging from 150,000 to 200,000 in the compositions of Tosun et al. in view of Samano-Valencia et al. and Tokura et al. because it is an appropriate chitosan for treating dental tubules.
Conclusion
Claims 27-36 are rejected.
No claims 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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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612