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 .
DETAILED ACTION
Claim Status
Claims 1-16 are pending and under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, directed to a tooth gel with remineralization capability, in the reply filed on 29 Jan 2026 is acknowledged. Applicants also elected without traverse in an additional reply on 14 May 2026 that the raw material for preparing the active ingredient comprises SiO2, P2O5, Li2O, SrO, MgO, SnO, SrF2, SrCl2 and KCl in response to the species election requirement.
Claims 3, 4, 11, 12, 15, and 16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim 3 and 4 require calcium phosphate as the raw material for preparing the active ingredient and claims 11 and 12 require components for the raw material for preparing the active ingredient in addition to the elected species of components.
Claims 1, 2, 5-10, 13, and 14 are under consideration to the extent of the elected species, i.e., that the raw material for preparing the active ingredient comprises SiO2, P2O5, Li2O, SrO, MgO, SnO, SrF2, SrCl2 and KCl.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 09/28/2021. It is noted, however, that applicant has not filed a certified copy of the CHINA202111143027.2 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27, Mar 2024 and 01 Apr 2025 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the brief description of the figures has a description for “Fig. 2,” “Fig. 6,” and “Fig. 8” but the drawings include figures (a) and (b) for figures 2, 6, and 8. The applicant is required to write a brief description of (a) and (b) for figures 2, 6, and 8. See MPEP 608.01(f)
Appropriate correction is required.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 may be improved by removing “selected from” before the polyethylene glycol 400, acesulfame potassium and menthol as there is only one item present in each group and the limitation does not require a “selection” to be made. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13, the phrase "such as" in the line “the essence is selected from essence such as menthol” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 5-10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chopra et al. (US 2012/0021031, published 26 Jan 2012) in view of Sharma et al. (US 20090317339, published 24 Dec 2009, listed on IDS filed 01 Apr 2025), Hill et al. (US 2016/0051457, published 25 Feb 2016, listed on IDS filed 27 Mar 2024), Qingguang et al. (CN110302065A, published 08 Oct 2019, listed on IDS filed 27 Mar 2024), Sagel et al. (US 2016/0074290, published 17 Mar 2016), and Singh et al. (US 2015/0139919, published 21 May 2015) as evidenced by PubChem (Glycerol) and evidenced by InnoPharmChem (The Significance of Sodium Stannate as a Hydrogen Peroxide Stabilizer).
Chopra teaches combinations of bioactive glass composition and potassium salts that are useful in oral care compositions such as oral gels ([0001]). Chopra teaches the invention forms a rapid and continuous reaction with body fluids (e.g., saliva) to promote the immediate and long-term release of calcium and phosphorus ions to produce a stable crystalline layer deposited onto and into the dentin tubules for the immediate and long term reduction of dentin hypersensitivity and tooth surface remineralization ([0001]). Chopra teaches that the bioactive glass is present from 0.1 to 20 wt% ([0062]) and the potassium salt is from 0.1 to 10wt% ([0050]), rendering obvious the 1-35% of active ingredient in claim 1. Chopra teaches that the bioactive glass includes components such as 40-86 wt% SiO2 and 1-15 wt% P2O5 ([0080]) and 0-5 wt% MgO ([0081]). The 1-15 wt% P2O5 renders obvious the content of P2O5 at more than 2.0 mol% as in claims 5 and 7 and the more than 3.5 mol% of in claim 10 Chopra teaches the inclusion of one or more sources of fluoride ([0058]). Chopra teaches the composition is incorporated as a glycerin gel ([0055]) and that the glycerin is able to dissolve potassium chloride ([0141]) and provides examples where glycerin is about 60wt% (e.g. Table 2, 4), rendering obvious the solvent of claims 1 and 13. As evidenced by PubChem glycerin is also known as glycerol (page 1 synonyms). Chopra teaches the inclusion of other additives conventionally used in dentifrice formulations in any suitable amount or form, including surfactants, thickening agents, adhesion agents, pH modifying agents, sweeteners, and flavorants ([0104]). Chopra teaches the flavorants includes ingredients that provide fragrance or other sensory effect in the mouth such as menthol and may be from 0.01 to 5% ([0121]), rendering obvious the essence of claims 1 and 13. Chopra teaches the sweetener is from 0.005-5% ([0122), rendering obvious the sweetener of claim 1. Chopra teaches that the composition may further include whitening agents ([0104], [0115]).
Chopra does not teach the further elected components of bioactive glass of Li2O, SrO, SnO, SrF2, SrCl2 and KCl. Chopra does not teach a network connectivity of 1.5-3.2 (claims 5 and 7) or a connectivity of 1.5-2.4 (claims 9 and 10). Chopra does not teach thickening agent, solid dispersant, and amount of pH regulator as in claim 1. Chopra does not teach the high temperature melting cold quenching preparation method. Chopra does not teach the three layer tooth strip as in claim 14. These deficiencies are made up for in the teachings of Sharma, Hill, Qingguang, Sagel and Singh.
Sharma teaches an oral care device configures to contact teeth where the device includes bioactive glass in an amount to mineralize teeth and a tooth-bleaching agent in an amount effective to whiten teeth (abstract). Sharma teaches that the bioactive glass includes components of SiO2, P2O5, MgO, as well as 0-10% Li2O, 0-10% SnO, and 0-10% SrO ([0017]). The 0-10% SnO renders obvious the functional metal oxide less than 5.0 mol% as in claims 9 and 10. Sharma teaches that the oral care device is in the form of a strip ([0022]) that is adherent to the teeth ([0038]).
Hill teaches chlorine containing silicate glasses and glass ceramics ([0001]) and that it is attractive to incorporate chlorine into silicate glasses such as bioactive glasses ([0004]) and teaches dental applications such as toothpaste and the glass dissolving in the mouth to release ions and form apatite on the tooth surface to re-mineralize the tooth surface and incipient caries lesions ([0012]). Hill teaches that for many applications such as toothpastes that it is preferable that the glass should release fluoride and form fluorapatite which aids in prevention of dental caries and aids apatite formation and stimulates the cell division of osteoblasts and thus fluoride is incorporated into bioactive glasses ([0007]). Hill teaches that chlorine is likely to behave like fluorine within the glass structure and confer similar properties on the glass ([0003]) and teaches that chlorine does not have the disadvantage of fluoride in bioactive glasses of forming fluorite or the equivalent chloride when its concentration is above 5 mol% and it does not cause fluorosis and it is not classified as a drug and chloride ions are found naturally in the body in significant concentrations ([0009]). Hill teaches the chlorine containing glass comprises SiO2, MgO, SrO and at least 0.5 mole percent metal chloride ([0021]). Hill teaches alkaline earth chloride and fluoride and alkali metal chlorides in the compositions ([0040], [0056]), rendering obvious salts including SrF2, SrCl2, and KCl. Hill teaches examples with fluoride salts ranging from 1-12.25 (Table 1) and teaches 2-12 percent MgF2 may be included ([0042]), rendering obvious the metal fluoride less than 9.3mol% as in claim 5 and less than 6.0 mol% as in claims 9 and 10. Hill teaches forming the glass by heating in a crucible to a melt and then quenching rapidly in demineralized water ([0055]), rendering obvious the preparation by “high-temperature melting-cold quenching method” of claims 5 and 7.
Regarding the network connectivity of claims 5, 7, 9, and 10, Hill teaches network connectivity is defined as the average number of non-bridging oxygens per silicon and that for silicate glasses which contain little or no Al2O3 that chlorine volatization is markedly suppressed where the glass has a network connectivity of two and that attempt to make chlorine-containing glasses with a network connectivity of three or more resulted in marked chlorine loss, and little or no retention of chlorine in the glass one it has been melted, and accordingly, silicate glasses containing less than 1 mole percent Al2O3 preferably have a network connectivity in the range of 2 to 3 ([0025]-[0026]).
Qingguang teaches a whitening tooth patch comprising nano titanium dioxide and bioactive glass (abstract). Qingguang teaches forming the composition into a roll shape which can be cut when in use to a desired shape for local whitening as needed and can be used by one or more people and can be packaged in a reusable self-sealing zipper bag to reduce packaging costs and be more environmentally friendly (page 3 lines 30-35). Qingguang teaches that the titanium dioxide and bioactive glass can be evenly dispersed in the gel substrate to achieve an even whitening effect (page 3 lines 27-30) and Qingguang teaches the inclusion of a gelling agent from 45-85% (page 1 lines 56-58) such as carbomer (page 2 lines 40-41), rendering obvious the carbomer thickening agent of claim 13. Qingguang teaches including a humectant such as polyethylene glycol (page 1 line 58, page 2 line 43). Qingguang teaches that the thickness of the whitening gel on the patch is 100-300 μm (page 7 line 17), rendering obvious the 100-300 μm gel layer thickness of claim 14. Qingguang renders obvious the high temperature melting cold quenching preparation method of claims 5 and 7 by teaching preparing the glass by melting the glass components and then quenching (page 2 lines 35-38).
Sagel teaches a strip for the delivery of an oral care active (title). Sagel teaches that whitening strips were developed to provide a low cost commercial oral care delivery system that is comfortable to wear and can deliver a sufficient amount of an oral care substance and does not require extensive user placement manipulations for optimal delivery and permits the wearer to use the system during social discourse and provides a containment means that protects the oral care substance from erosion from contact with other oral surfaces ([0004-0005]). Sagel further teaches the need for a delivery system customizable in length and can be stretched to fit the desired number of teeth and that provides a secure fit for strip-like delivery systems ([0005]). Sagel teaches a stretchable tooth treatment product that includes a backing layer and an oral care composition disposed on the backing layer and teaches a release liner ([0008], [0036], [0066], Fig 1). As shown in Figure 20 of Sagel, the oral care composition (adhesive composition) is between the backing layer and the release liner (Figure 20, [0036])). The backing layer of Sagel is understood to correspond to the “anti-sticking liner” of claim 14 and the release layer of Sagel is understood to correspond to and render obvious a “peel-off backing layer” as in claim 14. The oral care composition (adhesive composition) between the backing layer and release liner of Sagel is understood to render obvious a three-layer structure with an anti-sticking liner adhered to one side of the dental gel layer and the other side of the dental gel layer is adhered to a peel-off backing layer, as in claim 14. Sagel teaches that the backing layer may be comprised of polymeric materials ([0121]), rendering obvious the ‘polymer” for the “anti-sticking liner” of claim 14. Sagel teaches that the release liner may comprise paper ([0160]), rendering obvious the “paper sheet” for the peel-off backing layer of claim 14. Sagel teaches that the release liner may be coated with non-stick type materials ([0160]).
Sagel teaches that the adhesive is a composition, compound, or mixture capable of influencing or effecting a desired change in appearance and/or structure of the surface it contacts, such as whitening, and the adhesive composition includes one or more oral care actives ([0128]). Sagel teaches that the adhesive composition may be in the form of a gel ([0130]) and may be coated on the strip of material and the amount applied to the backing layer depends on the size and capacity of the piece of material, concentration of the active and the desired benefit ([0129]). Sagel teaches the inclusion of a pH adjusting agent which is added to optimize the storage stability of the gel and to make the substance safe for oral tissue and teaches pH adjusting agents such as sodium bicarbonate and sodium hydroxide and sodium stannate and combination thereof in amounts from about 0.01-15% ([0135]). As evidenced by InnoPharmChem, sodium stannate is a stabilizer of hydrogen peroxide (title, page 1). Thus, the obviousness of including sodium stannate meets the limitation of a stabilizer as in claim 2. Sagel teaches the gel adhesive compositions include a humectant such as polyethylene glycol from 10-95% ([0137]) and specifically teaches PEG 400 ([0169], [0172]).
Singh teaches hydrogel compositions for tooth whitening (title) where the composition is extruded onto a suitable substrate such as a backing layer or a releasable liner ([0112]). Singh teaches that it is desired to have a tacky layer positioned directly on the teeth and a non-tacky layer, e.g. the outer layer that is positioned nearest the lips ([0115]). Singh teaches that the material used for the substrate should permit the device to follow the contours of the teeth and be worn comfortably in the mouth without rubbing or otherwise irritating the lips or tongue ([0117]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included Li2O, SrO, 0-10% SnO, SrF2, SrCl2 and KCl in the bioactive glass gel composition of Chopra and to have the network connectivity between 2-3 and to further include 45-85% carbomer (i.e. a thickening agent), 10-95% PEG400 (i.e. a solid dispersant), and 0.01-15% pH regulator such as sodium bicarbonate, sodium hydroxide and sodium stannate (which is a stabilizer) and to form the bioactive glass gel by melting and quenching and to use the bioactive glass gel as part of a strip with an oral care (adhesive) layer, a backing layer and a release liner and to have the gel layer from 100-300 μm. Oral gels with 0.1 to 20 wt% bioactive glass and 0.1 to 10wt% potassium salt and comprising components including SiO2, 1-15 wt% P2O5, and MgO in the bioactive glass and which provide tooth surface remineralization and may include whitening agents are known from Chopra. It is further known from Chopra that the gel may be a glycerin gel with about 60% glycerin (i.e. a solvent) and include other components such as surfactants, thickening agents, adhesion agents, pH modifying agents, 0.005-5% sweeteners, and 0.01-5% flavorants (such as menthol). Bioactive glasses may also comprise oxide compounds such as Li2O 0-10% SnO, and SrO, as known from Sharma, and it is known form Hill that bioactive glasses may comprise alkaline earth chloride and fluoride and alkali metal chlorides, rendering obvious the inclusion of salts including SrF2, SrCl2, and KCl. One of ordinary skill would have a reasonable expectation of success in including these components in the bioactive glass as they are known to be used in bioactive glass formulations and are known to be associated with mineralizing teeth and aid apatite formation and preventing dental caries. Thus, this combination of oxides, chlorides and fluorides merely represents the use of known prior art elements for their known use in bioactive glass. It would be obvious to have the network connectivity of the glass between 2 to 3 as this is known from Hill as an appropriate range for including chlorides so as not to lose chlorine from volatization or during melting as the glass is formed. The inclusion of 45-85% carbomer (i.e. a thickening agent) is obvious as Chopra teaches including additional agents such as thickening agents and carbomer is known form Qingguang as a gelling agent used in bioactive glass gels for tooth patch whitening compositions. Bioactive glass gels used with teeth are known from Chopra and Qingguang and carbomer is a known gelling agent for such compositions, rendering it an obvious component for one of ordinary skill to include in such gels. Similarly, the inclusion of 10-95% humectants, such as PEG400 is known for use in oral whitening gels from Qingguang and Sagel and it would be obvious to one of ordinary skill to include the PEG400 for its humectant properties and it is known as suitable for such compositions. Additionally, it is known from Chopra to include pH regulators and sodium bicarbonate, sodium hydroxide and sodium stannate (which is a stabilizer) are known from Sagel to pH regulators to optimize the storage stability of oral gels and to make the substance safe for oral tissue and may be used in amounts from about 0.01-15% rendering these components and amounts as obvious to one of ordinary skill. The process of melting and quenching are process steps known from Hill and Qingguang for forming bioactive glass, thus rendering these an obvious means of forming the bioactive glass. Incorporating oral gels into strips or tooth patches is known from Qingguang and Sagel and offer a delivery means that can be cut to a desired shape and is comfortable to wear and can deliver a sufficient amount of an oral care substance and does not require extensive user placement manipulations for optimal delivery and permits the wearer to use the system during social discourse and provides a containment means that protects the oral care substance from erosion from contact with other oral surfaces, rendering this an obvious means of delivery of the bioactive gel composition. Having the gel layer from 100-300 μm is known from Qingguang, rendering this a suitable thickness for such layers on oral patch/strip delivery systems and thus obvious to one of ordinary skill. The use of three layers where an oral care composition (adhesive composition) is between a polymeric backing layer and a paper release liner is known from Sagel, rendering this an obvious means of forming oral strips. It further would be obvious to coat the side of the backing layer in a non-stick material as it is known from Singh that it is desired to have a tacky layer positioned directly on the teeth and a non-tacky layer positioned nearest the lips and that the substrate should permit the device to follow the contours of the teeth and be worn comfortably in the mouth without rubbing or otherwise irritating the lips or tongue. It is known from Sagel that liners may be coated with non-stick material and it thus would be obvious to coat the side of the backing layer that is next to the lips with a non-stick material to ensure that it doesn’t stick to the lips or cause any irritation to the lips or tongue.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chopra et al. (US 2012/0021031, published 26 Jan 2012) in view of Sharma et al. (US 20090317339, published 24 Dec 2009, listed on IDS filed 01 Apr 2025), Hill et al. (US 2016/0051457, published 25 Feb 2016, listed on IDS filed 27 Mar 2024), Qingguang et al. (CN110302065A, published 08 Oct 2019, listed on IDS filed 27 Mar 2024), Sagel et al. (US 2016/0074290, published 17 Mar 2016), and Singh et al. (US 2015/0139919, published 21 May 2015) as evidenced by PubChem (Glycerol) and evidenced by InnoPharmChem (The Significance of Sodium Stannate as a Hydrogen Peroxide Stabilizer) as applied to claims 1, 2, 5-10, and 14 above and further in view of Muscle et al. (US 2009/0324516, published 31 Dec 2009, listed on IDS filed 01 Apr 2025).
The teachings of Chopra, Sharma, Hill, Qingguang, Sagel, and Singh are described supra.
As described, it is obvious to form the bioactive glass gel composition with 0.1 to 20 wt% bioactive glass and 0.1 to 10wt% potassium salt and to include 45-85% carbomer (i.e. a thickening agent), about 60% glycerin (glycerol), 10-95% PEG400 (i.e. a solid dispersant), 0.01-5% flavorants such as menthol (i.e. an essence), 0.005-5% sweeteners, and 0.01-15% pH regulator such as sodium bicarbonate, sodium hydroxide and sodium stannate. Chopra, Sharma, Hill, Qingguang, Sagel, and Singh, however, do not teach the sweetener acesulfame potassium as in claim 13. This deficiency is made up for in the teachings of Muscle.
Muscle teaches contacting the tooth structure with an oral care composition comprising bioactive glass and fluoride (abstract). Muscle teaches the compositions for purposes such as remineralizing the tooth surface ([0025], [0068]). Muscle teaches the inclusion of sweeteners such as potassium acefulfame ([0012], [0015-0016]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included potassium acesulfame as the sweetener in bioactive gel composition rendered obvious over Chopra, Sharma, Hill, Qingguang, Sagel, and Singh. It is known that sweeteners may be included in the compositions from Chopra and it is known from Muscle that potassium acesulfame is a sweetener known for use with remineralizing oral compositions of bioactive glass. Thus, one of ordinary skill in the art would have a reasonable expectation of success in including potassium acesulfame in the composition as it is known to use sweeteners and potassium acesulfame is a sweetener known to be suitable for oral compositions with bioactive glass. The inclusion of potassium acesulfame thus merely represents using a known prior art element for its known purpose as a sweetener.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
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