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 December 26, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims
Claim Rejections - 35 USC § 103 - Obviousness
1) Claims 1-3, 5-6, 8-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over JP 5973585 (JP 585’) in view of Okada et al. (Dental Materials Journal, 2016).
JP 585’ discloses dental care products containing a biomimetic carbonate-substituted hydroxyapatite having a protein-functionalized surface. The hydroxyapatite is a biomimetic carbonate-substituted strontium hydroxyapatite. Hydroxyapatite with higher crystallinity is more resistant to plaque formation and the action of food and acidic beverages. Mature enamel, considered the most durable and tough material in the biological world, is composed of hydroxyapatite carbonate (CHA) (95-97 wt%) and less than about 1 wt% organic matter. Unlike other biomineralized tissues such as bone and dentin, mature enamel does contain cells and therefore cannot regenerate itself and therefore cannot be biologically reconstituted. As a result, enamel regeneration cannot occur in vivo. There is no biological process that can repair degraded or damaged enamel, which indicates the need for a synthetic enamel biocompatible material that can repair caries. The carbonate substituted strontium hydroxide has the formula Ca(10-x) Srx (PO4)(6-y) (CO3)y (OH)2 wherein x is a number included in the range of 0.0010 to 0.015; y is a number included in the range of 0.0010 to 0.010 (Embodiment 1). The would meet the carbonate percentage of the instant claims. The composition may be formulated into solutions, suspensions, oils, gels, pastes, dentifrices or Related to other solid products. A toothpaste comprises 10% of the substituted hydroxyapatite.
JP 585’ differs from the instant claims insofar as it does not disclose a germicide added to the hydroxyapatite.
Okada et al. disclose nanohydroxyapatite modified with cetylpyridinium chloride. The compositions have potential applications as nanoparticulate enamel repair agents with antibacterial properties (Abstract). Direct restorative materials with antibacterial properties have been developed to avoid secondary caries resulting from plaque formation on the restorative materials. The antibacterial modified hydroxyapatite with different CPC release profiles show potential application as enamel repair agents for damaged enamel (page 657, col. 1, paragraph 2).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have modified the carbonated hydroxyapatite of JP 585’ with cetylpyridinium chloride motivated by the desire to treat the teeth with a hydroxyapatite with antibacterial properties that would lead to the inhibition of plaque formation for an extended period of time.
In regards to the amount of germicide, the germicide is a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of germicide to obtain the desire antimicrobial effect. See MPEP 2144.05.
In regards to the compositions being for the skin, JP 585’ disclose hydroxyapatite, cetylpyridinium chloride and zinc, which are suitable for use on skin. Therefore the compositions of JP 585’ in view of Okada et al. would be suitable for use on skin.
In regards to claims 13-14, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." The functionalized carbonate-hydroxyapatite of the combination of references appears to be the same as that of the instant claims. Therefore, the hydroxyapatite of the combination meet the limitations of the instant claims, even if the synthesis is not the same.
Response to Arguments
The Examiner submits Sugimoto discloses carbonate hydroxyapatite. One would look to Okada because it discloses hydroxyapatite and would reasonably conclude that modifying a carbonate hydroxyapatite would be similar to modifying hydroxyapatite. Even if this was not the case, one would be motivated to modify carbonate hydroxyapatite to have the additional advantage of obtaining a carbonate hydroxyapatite with antibacterial properties. Further, one would not remove the strontium substitutions of Sugimoto. One would only add a germicide to the hydroxyapatite of Sugimoto for its germicidal properties. In regards to no reasonable expectation of success, one of ordinary skill in the art would reasonably conclude that the hydroxyapatite of Sugimoto would have a slightly different absorption of a germicide. The absorptions of cetylpyridinium chloride (CPC) on the hydroxyapatites of Okada varied with shape and surface area. However, absorption did occur for each of the structures. Therefore one of ordinary skill in the art would reasonably conclude that CPC would also absorb onto the carbonated hydroxyapatites of Sugimoto with a difference in the amount of absorption. Even if this was not the case, one would be motivated to try to obtain the antibacterial properties of CPC or another germicide by absorbing the CPC on the carbonated hydroxyapatite of Sugimoto.
2) Claims 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gazzaniga et al. (US 8,367,043) in view of Okada et al. (Dental Materials Journal, 2016).
Gazzaniga et al. disclose biologically active nanoparticles of a carbonate-substituted non-stoichiometric hydroxyapatite, having a crystallinity degree lower than 40%. The biologically active nanoparticles are used in oral or dental hygiene applications, as well as to compositions for oral or dental hygiene which include solutions, suspensions, oils, gels or other solid products. The nanoparticle may also be used in non-oral care compositions (Abstract). The hydroxyapatite nanoparticles comprise from 1 to 15% by weight based on the total weight of the nanoparticles of carbonate substituted into the hydroxyapatite structure (col. 5, lines 28-33). In one embodiment the carbonate substitution is at the phosphate site (B) of the hydroxyapatite and is greater than or equal to 65% by weight and, still more preferably, comprised between 90% and 100% by weight, of the total carbonate present in the hydroxyapatite (col. 5, lines 40-47). The nanoparticles may comprise from 0.1% to 20% by weight with respect of the total Ca content of an antibacterial metal M ion substituted into the hydroxyapatite structure. The antibacterial metal M is selected from Zn, Cu, Ag, and mixtures thereof. The aforementioned metal ions effectively have an antibacterial activity capable of preventing generation of carious tooth and periodontal diseases such as alveolar blennorrhoea and reducing halitosis. The nanoparticles of the invention can be represented for purely descriptive purposes by the following formula:
Ca10-xMx(PO4)6-y(CO3)y+z(OH)2-z
wherein x is a number comprised between 0.0055 and 0.6, y is a number comprised between 0.065 and 0.9 and z is a number comprised between 0 and 0.32. The antibacterial effect of the metal ions may be directly obtained in situ at the dentine and enamel surface during the resolubilization of the nanoparticles deposited thereon, thus achieving a prolonged release of metal ions, even after dentifrice removal (col. 6, lines 39-67). The compositions comprise 7.5% of the hydroxyapatite nanoparticles (Table 2).
Gazzaniga et al. differ from the instant claims insofar as they do not disclose the hydroxyapatites are functionalized with a germicide.
Okada et al. disclose nanohydroxyapatite modified with cetylpyridinium chloride. The compositions have potential applications as nanoparticulate enamel repair agents with antibacterial properties (Abstract). Direct restorative materials with antibacterial properties have been developed to avoid secondary caries resulting from plaque formation on the restorative materials. The antibacterial modified hydroxyapatite with different CPC release profiles show potential application as enamel repair agents for damaged enamel (page 657, col. 1, paragraph 2).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have modified the carbonated hydroxyapatite of Gazzaniga et al. with cetylpyridinium chloride motivated by the desire to treat the teeth with a hydroxyapatite with antibacterial properties that would lead to the inhibition of plaque formation for an extended period of time.
In regards to the amount of germicide, the germicide is a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of germicide to obtain the desire antimicrobial effect. See MPEP 2144.05.
In regards to the compositions being for the skin, Gazzaniga et al. disclose the hydroxyapatites disclosed therein may be used outside of oral care and disclose solutions. The components hydroxyapatite, cetylpyridinium chloride and zinc are suitable for use on skin. Therefore solutions of Gazzaniga et al. in view of Okada et al. would be suitable for use on skin.
Response to Arguments
The Examiner submits one would look to Okada because it discloses hydroxyapatite and would reasonably conclude that modifying a carbonate-substituted hydroxyapatite would be similar to modifying hydroxyapatite. Even if this was not the case, one would be motivated to modify carbonate-substituted hydroxyapatite to have the additional advantage of obtaining a carbonate hydroxyapatite with antibacterial properties. In regards to the references having different materials, both references disclose hydroxyapatites even though they have different properties. One of ordinary skill in the art would recognize that because the base of the materials of both references comprise hydroxyapatite, there would be a reasonable expectation that absorption of CPC onto the hydroxyapatite of Gazzaniga would occur successfully. In regards to the crystallinity of Gazzaniga, although amorphous hydroxyapatite has a lower absorption, absorption does occur. Further the hydroxyapatite of Gazzaniga has some crystallinity. Therefore one of ordinary skill in the art would reasonably conclude that it has a higher absorption than amorphous hydroxyapatite.
Conclusion
Claims 1-3 and 5-14 are rejected.
No claims allowed.
THIS ACTION IS MADE FINAL. 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