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.
Applicants' arguments, filed 12/29/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103
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.
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 the instant claims require a bioactive glass composition containing fluorine, which is not taught or suggest by Greenspan.
The Examiner does not find Applicant’s argument to be persuasive. Greenspan discloses in paragraph [0035] wherein the bioactive glass with a composition comprising silicon dioxide, sodium oxide, phosphorous oxide, and calcium oxide. In paragraph [0036] Greenspan discloses wherein CaF2 may be included in the composition in addition to silicon, sodium, phosphorus and calcium oxides. Therefore, since CaF2 may be included with silicon, sodium, phosphorus and calcium oxides and silicon, sodium, phosphorus and calcium oxides are present in the bioactive glass composition, Greenspan discloses incorporating CaF2 into the bioactive glass composition. As such, Applicant’s argument is unpersuasive.
Applicant argues that even if the skilled artisan were to add CaF2 to the bioactive glass compositions of Greenspan, the resulting glass composition, when produced by the normal melt quench production route described in Greenspan, would not be bioactive in terms of being able to form an apatite.
The Examiner does not find Applicant’s argument to be persuasive. 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 methods would not be suitable with CaF2. As such, Applicant’s argument is unpersuasive.
Applicant argues that Greenspan teaches the formation of a stable crystalline carbonated hydroxyapatite. In contrast, the claimed composition comprising TCP and fluorine-containing bioactive glass forms a fluorapatite at lower pHs corresponding to caries challenge conditions.
The Examiner does not find Applicant’s argument to be persuasive. Greenspan does not need to teach a composition that forms fluorapatite at lower pHs corresponding to caries challenge conditions since this property is not recited in the claims. As such, Applicant’s argument is unpersuasive.
Applicant argues that the skilled artisan would not likely be motivated to combine the teachings of Greenspan and Strand for at lest the reason that Strand teaches a sequential application system that utilizes water based oral rinses, whereas Greenspan teaches incompatible non-aqueous glycerol-based toothpastes that are water free.
The Examiner does not find Applicant’s argument to be persuasive. The rejection states incorporating tricalcium phosphate or fluorapatite into the composition Greenspan based on the teachings of Strand. Just because Greenspan teaches non-aqueous compositions does not mean that tricalcium phosphate or fluorapatite would be unsuitable for the composition of Greenspan. Greenspan discloses in paragraph [0060] wherein the non-aqueous composition may additionally optionally contain other agents conventionally used in dentifrice formulation. Typically, these optional agents should not adversely affect the pH or reactivity of the overall non-aqueous composition. Strand discloses in paragraph [0038] wherein the composition comprising the water-insoluble calcium phosphates (i.e., second composition) may be a toothpaste. Therefore, since Greenspan does not disclose wherein the additional agents must be from conventionally used non-aqueous dentifrice formulation, and Strand discloses a dentifrice formulation, and Applicant has not shown wherein tricalcium phosphate or fluorapatite would adversely affect the pH or reactivity of the overall non-aqueous composition; one of ordinary skill in the art would have been motivated to have incorporated tricalcium phosphate or fluorapatite into the composition of Greenspan. As such, Applicant’s argument is unpersuasive.
Applicant argues that the claimed composition provides the technical advantage that fluorapatite is formed in the mouth, ideally within the tooth surface, and not within the paste itself.
The Examiner does not find Applicant’s argument to be persuasive. The claims as currently recited do not require fluorapatite to form in the mouth; therefore, the prior art is not required to teach this property. Also, Applicant has not explained how forming fluorapatite in the mouth is more advantageous than providing fluorapatite from a paste. As such, Applicant’s argument is unpersuasive.
Applicant argues that the skilled artisan would not incorporate fluorapatite into a toothpaste to promote fluorapatite formulation since it is more stable than the existing tooth mineral.
The Examiner does not find Applicant’s argument to be persuasive. This merely appears to be Applicant’s speculation since Applicant has not supported this assertion with objective evidence. Also, it is not clear why being more stable would mean that fluorapatite should not be incorporated into a toothpaste. As such, Applicant’s argument is unpersuasive.
Applicant argues that Strand mentions the addition of fluorapatite in its composition for the purpose of occluding tubules rather than to promote remineralization.
The Examiner does not find Applicant’s argument to be persuasive. Strand discloses in paragraph [0058] wherein water-insoluble calcium phosphate is used for promoting remineralization. Strand discloses in paragraph [0060] wherein suitable water-insoluble calcium phosphates include fluorapatite. As such, Strand does teach the addition of fluorapatite for promoting remineralization and Applicant’s argument is unpersuasive.
Applicant argues that a modification to a Ca/P ratio as low as 1:1 is not realistic technically.
The Examiner does not find Applicant’s argument to be persuasive. Strand specifically discloses a Ca/P ratio of 1:1 to 10:1. Applicant has not provided objective evidence supporting their assertion that a ratio as low as 1:1 is not realistic. Speculatory statements are not persuasive. Also, even if a ratio of 1:1 is unrealistic, Strand discloses a ratio of 1:1 to 10:1. A Ca/P ratio of less than 1.67 means calcium-deficiency. Applicant has not shown wherein all ratios less than 1.67 within Strand’s range are not realistic. As such, Applicant’s argument is unpersuasive.
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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614