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 . Claims included in the prosecution are claims 1, 3-17 and 19-24.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/20/2026 has been entered.
Applicants' arguments, filed 05/20/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
1. Claims 1, 3-14, 17 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Greenspan et al. (US 2007/0264291, Nov. 15, 2007) (hereinafter Greenspan) in view of Strand et al. (US 2016/0263007, Sep. 15, 2016) (hereinafter Strand), as evidenced by Pastero et al. (About the Genetic Mechanisms of Apatites: A Survey on the Methodological Approaches, Aug, 5, 2017) (hereinafter Pastero).
Greenspan discloses a bioactive glass composition which prevent or reduce plaque, plaque build-up and/or gingivitis though the use of low levels of small bioactive glass particles in amounts from about 0.25 to about 10% by weight in a non-aqueous formulation (abstract). The composition may be formulated as a non-aqueous dentifrice paste (¶ [0072]). The term “bioactive glass” means an inorganic glass material having an oxide of silicon as its major component and which is capable of bonding with growing tissue when reacted with physiological fluids (¶ [0033]). The bioactive glass may comprise between about 40 and about 86% by weight SiO2, between about 0 and about 35% by weight Na2O, between about 4 and about 46% by weight CaO, and between about 1 and about 15% by weight P2O5 (¶ [0035]). CaF2 may be included in the composition in addition to silicon, sodium, phosphorus, and calcium oxide, The preferred range for CaF2 is between about 0 and about 25% by weight (¶ [0036]). The average particle size of the bioactive glass is typically less than about 10 microns (¶ [0038]). Where a non-aqueous composition contains bioactive glass particles of an average particle size of less than about 10 microns, typically 90-95% of the particles will be less than about 20 microns (¶ [0032]). Components are admixed into the composition (¶ [0011]).
Greenspan differs from the instant claims insofar as not disclosing wherein the composition comprises calcium orthophosphate.
However, Strand discloses a composition comprising a water-insoluble calcium phosphate, wherein the water-insoluble calcium phosphate has a calcium to phosphorous molar ratio from 1:1 to 10:1 (¶ [0057]). The water-insoluble calcium phosphate can release and deliver small amounts of calcium and phosphate ions under physiological conditions for promoting remineralization of the tooth enamel and dentine (¶ [0058]). A specific calcium to phosphorous molar ratio range is important for tooth health and remineralization of the tooth enamel and dentine (¶ [0059]). Suitable water-insoluble calcium phosphates include tricalcium phosphate and fluorapatite (¶ [0060]). The water-insoluble calcium phosphate is present in an amount from 0.01%, 0.05%, 0.1%, 0.5%, 1%, or 2% to 3%, 5%, 10%, 20%, 50%, or 99%, by weight, of the composition (¶ [0064]). The water-insoluble calcium phosphate can be of any size which can deposit onto the tooth surface or into the tubules. The water-insoluble calcium phosphate may have a particle size from 0.01 to 5 microns (¶ [0062]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 0.01% to 20% 0.01 to 5 microns tricalcium phosphate or fluorapatite, wherein the calcium to phosphorous molar ratio is from 1:1 to 10:1, into the composition of Greenspan motivated by the desire to promote remineralization of tooth enamel and dentine as taught by Strand.
In regards to instant claims 3-5, Greenspan discloses a bioactive glass comprising between about 40 and about 86% by weight SiO2, between about 0 and about 35% by weight Na2O, between about 4 and about 46% by weight CaO, between about 1 and about 15% by weight P2O5, and between about 0 and about 25% by weight CaF2. Thus, the bioactive glass may comprise 70 wt. % SiO2, 5 wt. % Na2O, 5 wt. % CaO, 15 wt.% CaF2, and 5 wt. % P2O5. Such bioactive glass comprises 75 mol. % SiO2, 5 mol. % Na2O, 6 mol. % CaO, 12 mol. % CaF2, and 2 mol. % P2O5. Therefore, the claimed amount of fluoride would have been obvious.
In regards to instant claim 17 reciting a calcium deficient apatite that contains substantially no hydroxyl ions, fluorapatite contains no hydroxyl ions. As evidenced by Pastero, the Ca/P ratio for fluorapatite is 1.67 (Table 1). As discussed above, it would have been obvious to have incorporated fluorapatite with a Ca/P ratio as low as 1:1 into the composition of Greenspan. Therefore, the fluorapatite incorporated into Greenspan may be calcium deficient when the Ca/P ratio is 1:1.
In regards to instant claim 23 reciting for use in the treatment or prevention of dental caries, this is merely a recitation of the intended use of the claimed composition. Greenspan discloses wherein the composition prevents or reduces plaque. Since the composition prevents plaque and plaque causes dental caries, but preventing plaque one prevents dental caries too. As such, the composition of Greenspan is capable of preventing dental caries whether the prior art discloses such use or not.
Response to Arguments
Applicant argues that it is technically impossible to produce a melt derived glass with 86% by weight of SiO2 that was bioactive.
The Examiner does not find Applicant’s argument to be persuasive. The instant claims do not recite wherein the composition is a melt derived glass and do not recite an amount of SiO2 for the bioactive glass. Therefore, it is unclear how the teachings of Greenspan teach away from the claimed invention. Also, Applicant has not provided objective evidence supporting Applicant’s assertion. Therefore, it is unclear whether Applicant’s assertion is factual. Moreover, Greenspan discloses wherein the amount of SiO2 may be between about 40 and about 86%. Applicant has not shown wherein the other amounts of SiO2 would not be effective. Additionally, Greenspan discloses in paragraph [0039] wherein the glass composition may be prepared in other ways besides melting, such as by sol-gel and sintering. Applicant has not shown wherein these other methods would not be effective. As such, Applicant’s argument is unpersuasive.
Applicant argues that one having ordinary skill in the art will realize that it is not technically possible to incorporate CaF2 into a bioactive sol gel glass for at least the reasons that CaF2 is too water insoluble and remains crystallized within the sol gel glass. In addition, it is not technically possible to incorporate fluorine into a bioactive glass using NH4F or HF since the fluorine group would react with the silanol Si-OH to form HF and would be lost by volatilization during sol gel processing.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not provided objective evidence supporting Applicant’s assertion. Therefore, it is unclear whether Applicant’s assertion is factual.
Applicant argues that as shown in Table A, the calculated NC value for the compound (i.e., 3.89) far exceeds even a critical NC of 2.6, indicating that each of the glasses are inert and not bioactive.
The Examiner does not find Applicant’s argument to be persuasive. It is unclear what model Applicant used to determine the NC. Without such information and a mathematical showing, it is unclear whether the NC determined by Applicant is correct. Also, Greenspan specifically discloses wherein the glass is bioactive. Therefore, one of ordinary skill in the art would conclude that the glass of Greenspan is bioactive. Applicant has not shown with objective evidence where it is not. Table A is not objective evidence since the Examiner cannot verify the authenticity of the results. Additionally, Table A uses a very specific bioactive glass with specific amounts. Applicant has not shown wherein none of the glasses in Greenspan is bioactive such that none of the glasses would meet the instant claims. As such, for all these reasons, Applicant’s argument is unpersuasive.
Applicant argues that the calcium deficient apatite is not being incorporated into the glass.
The Examiner submits that the rejection does not state wherein the calcium deficient apatite is incorporated into the glass. The rejection states incorporating 0.01% to 20% 0.01 to 5 microns tricalcium phosphate or fluorapatite, wherein the calcium to phosphorous molar ratio is from 1:1 to 10:1, into the composition of Greenspan. The composition of Greenspan is not the glass but comprises the glass. As such, Applicant’s argument is unpersuasive.
Applicant argues that fluorapatite will not be calcium deficient as a result of hydroxyl ion deficiency.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, as evidenced by Pastero, the Ca/P ratio for fluorapatite is 1.67:1 (Table 1). Strand discloses a fluorapatite wherein the Ca/P molar ratio may be 1:1. Since the Ca/P molar ratio of the fluorapatite of Strand is lower than what is known, the fluorapatite of Strand may be considered calcium deficient. As such, Applicant’s argument is unpersuasive.
Applicant argues that fluorapatite is chemically more stable and more acid resistant than hydroxyapatite. Provision of paste with fluorapatite would not provide a significant benefit, as the native tooth enamel hydroxyapatite would dissolve before the fluorapatite can remineralize the tooth enamel whereas the presently claimed composition enables the formation of fluorapatite on the enamel surface thereby reducing the solution of teeth in acidic condition.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not provided objective evidence supporting Applicant’s assertion. Therefore, it is unclear whether Applicant’s assertion is factual.
Applicant argues that except at pHs <4.5, fluorapatite does not dissolve significantly to provide fluoride ions.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein fluorapatite would not be able to provide remineralization through the calcium ions and phosphate ions that it comprises. Also, Applicant has not shown wherein the pH of the mouth can never below 4.5 such that fluorapatite would never dissolve to provide fluoride ions to any subject. As such, one of ordinary skill in the art would still appreciate fluorapatite and Applicant’s argument is unpersuasive.
Applicant argues that in stark contrast to Applicant’s claimed subject matter, the Strand composition is designed for two sequential treatments. Furthermore, Strand teaches a water-based paste, whereas the presently claimed composition is anhydrous.
The Examiner does not find Applicant’s argument to be persuasive. The rejection states wherein the composition being modified is that of Greenspan and not of Strand. Strand was used to provided motivation to incorporate calcium orthophosphate into the composition of Greenspan. Applicant has not shown wherein Greenspan teaches away from the claimed structure. Also, it should be noted that independent claim 1 does not limit the claimed composition to an anhydrous composition. As such, Applicant’s argument is unpersuasive.
Applicant argues that one having ordinary skill in the art is unlikely to modify the composition of Greenspan with the teachings of Strand given the technically misleading statements of Strand. For instance, the claims of Strand recite fluoride in the second composition. In contrast, the actual composition of Strand reveal the first composition has numerous examples with fluoride, while the second composition contains no fluoride at all.
The Examiner does not find Applicant’s argument to be persuasive. Strand does not have misleading statements. A prior art is evaluated for all that it reasonably suggests. Strand discloses in paragraph [0066] wherein the first composition and the second composition can each independently contain a fluoride ion source. As such, Applicant’s argument is unpersuasive.
Applicant argues that in reading the Strand disclosure, the skilled artisan would be unlikely to include a free source of fluoride ions with the apatites of the second composition in a water-based paste because the fluoride ions will react with the apatite to give a fluoridated apatite.
The Examiner does not find Applicant’s argument to be persuasive. Strand teaches fluorapatite. The rejection even states to incorporate the fluorapatite taught by Strand into the composition of Greenspan. Applicant has not shown wherein one of ordinary skill in the art would not have been motivated to do so. As such, Applicant’s argument is unpersuasive and the rejection is maintained.
2. Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Greenspan et al. (US 2007/0264291, Nov. 15, 2007) (hereinafter Greenspan) in view of Strand et al. (US 2016/0263007, Sep. 15, 2016) (hereinafter Strand), and further in view of Hill et al. (US 2009/0208428, Aug. 20, 2009) (hereinafter Hill).
The teachings of Greenspan and Strand are discussed above. Greenspan and Strand do not disclose wherein the bioactive glass contains substantially no phosphate and substantially no calcium oxide.
However, Hill discloses an aluminum-free bioactive glass comprising Sr and SiO2 (claim 1). The bioactive glass may comprise CaO at a molar percentage of 0% to 50% and P2O5 at a molar percentage of 0% to 14% (claim 46). The molar percentage of SiO2 is 30% to 60% (claim 49). A toothpaste may comprise the bioactive glass (claim 57). The bioactive glass prevents and/or treats damage to dental tissue (claims 61 and 62).
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. Greenspan discloses wherein “bioactive glass” means an inorganic glass material having an oxide of silicon as its major component and which is capable of bonding with growing tissue when reacted with physiological fluids. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated the bioactive glass of Hill, which may be free of phosphate and calcium oxide as the bioactive glass of Greenspan since it is a known and effective bioactive glass since it has an oxide of silicon as its major component and it treats damage dental tissue as taught by Hill.
Response to Arguments
Applicant argues that Hill fails to cure the above-discussed deficiencies of the Greenspan and Strand combination.
The Examiner submits that arguments regarding Greenspan and Strand are addressed above and are unpersuasive. Therefore, this rejection is maintained.
3. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Greenspan et al. (US 2007/0264291, Nov. 15, 2007) (hereinafter Greenspan) in view of Strand et al. (US 2016/0263007, Sep. 15, 2016) (hereinafter Strand), and further in view of Dong et al. (WO 2021189435 A1, Filing Date: Mar. 27, 2020) (hereinafter Dong).
The teachings of Greenspan and Strand are discussed above. Greenspan and Strand do not disclose wherein the tricalcium phosphate is amorphous.
However, Dong discloses a calcium phosphate composite active material useful as tooth remineralization materials for toothpaste. The calcium phosphate composite material comprises amorphous tricalcium phosphate (Derwent Abstract).
As discussed above, it would have been obvious to have incorporated tricalcium phosphate into the composition of Greenspan to promote remineralization of tooth enamel and dentine. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated amorphous tricalcium phosphate into the composition of Greenspan since this is a known and effective type of tricalcium phosphate suitable for tooth remineralization as taught by Dong.
Response to Arguments
Applicant argues that Dong fails to cure the above-discussed deficiencies of the Greenspan and Strand combination.
The Examiner submits that arguments regarding Greenspan and Strand are addressed above and are unpersuasive. Therefore, this rejection is maintained.
Conclusion
Claims 1, 3-17 and 19-24 are rejected.
No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/TRACY LIU/Primary Examiner, Art Unit 1614
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