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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 112, 102, and 103 (or as subject to pre-AIA 35 U.S.C. 112, 102, and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art, relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application claims priority to U.S. Provisional application 63-455457 filed 29 March 2023. The Effective Filing Date of the instant invention is 29 March 2023.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted 2 April 2024, 24 April 2024, 10 June 2024, 8 October 2024, and 4 March 2025 have been considered by the Examiner.
Drawings
The original drawings received on 22 March 2024 are accepted by the Examiner.
Claim Comment
Claim 1 recites “wherein, when subjected to artificial saliva of Table 1A or Table 1B, the glass composition forms a bioactive crystalline phase”. This limitations reads only that the glass be capable of forming a bioactive crystalline phase and the bioactive crystalline phase need not be present in the glass composition.
Claim Objections
Claims 3 and 5 are objected to because of the following informalities: minor typographical errors.
Claims 3 and 5 are objected to since they do not end with a period(.). See MPEP 608.01(m).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or second paragraph
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.
Claims 1-20 are 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 pre-AIA the applicant regards as the invention.
Claims 1 and 8 recite "Table 1A or Table 1B". The information in Table 1A and Table 1B should be incorporated in the claim. See MPEP 2173.05(a) which states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
Claim 4 is recites the limitation “comprising Li2O+Na2O+K2O in an amount of 10 wt.% or less.” This renders the claim indefinite since it is not clear if the glass composition requires a non-zero amount of Li2O+Na2O+K2O. For the purposes of examination, the claim is read with the broadest reasonable interpretation, where the range 10 wt.% or less includes no or zero Li2O+Na2O+K2O.
Claim 11 recites “A matrix comprising the glass composition of claim 1, wherein: the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation.” This renders the claim indefinite since it is confusing. The claim reads that “A matrix” (1st instance) comprises the glass composition of claim 1, and the glass composition can be attached to the matrix (2nd instance) comprising the glass composition or the glass composition is mixed with the matrix (2nd instance) comprising the glass composition. The claim further defines the matrix (3rd instance) as including at least one of: toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation. Therefore, the claim is read such that the term “matrix” is used as 1) the resultant product of the combination of the components (1st instance) and also as 2) the frame work material that the glass is mixed or attached to (2nd and 3rd instances). The Examiner believes the claim is directed towards a matrix (1st instance) being 1) the resultant product of the combination of the components and “the matrix” (2nd and 3rd instances) being a carrier the glass is adhered to or mixed with. Accordingly, the claim is being examined as if claim 11 was written as “A matrix comprising the glass composition of claim 1 and a carrier, wherein the glass composition is attached to the carrier or mixed therein, and the carrier includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation.” See the instant specification, paragraphs [0009], [0086], and [00115] for the use of the term carrier.
Alternatively, in composite materials, a composite comprises a matrix material which holds smaller elements such as particles, fibers, or flakes together. See Matrix Materials – Definition, Types, Importance, Examples, Advantages by Dharmesh Kumar. Thus, using this definition, the claim would read: “A composite comprising the glass composition of claim 1 and a matrix, wherein the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation.” The claim is not examined in view of this alternative interpretation.
Claim 12 recites “The matrix of claim 11, wherein the matrix is substantially free of a fluoride ion source.” This renders the claim indefinite since it is confusing, specifically, in view of claim 11 as rejected above. The term “matrix” in claim 11 appears to describe both 1) the combined product (1st instance) and 2) the material the glass composition is adhered to or mixed with (as discussed above, where the matrix (2nd and 3rd instances) refers to a carrier which includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation.) Claim 12 is read in view of claims 11 and 1, and if “the matrix” is considered to be the combined product it would comprise the glass composition would include a fluoride ion source since the glass would release fluoride ions. It is believed that the claim intends to limit the 2nd and 3rd instances of “matrix” in claim 11, where the material the glass composition is adhered to or mixed with, is “the carrier”, which includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, from including a fluoride ion source. As such, the examiner believes the claim is intended to limit the second recitation of “the matrix” in claim 12, which correlates to the 2nd and 3rd instances of the “matrix” in claim 11. And the claim is being examined in view of the above rejection where the 2nd and 3rd instances of “matrix” in claim 11 are being interpretated as “the carrier” and therefore the carrier is substantially free of a fluoride ion source and not the first recitation of “the matrix” in claim 12 (the combined product). As such, claim 12 would read: “The matrix of claim 11, wherein the carrier is substantially free of a fluoride ion source.”
Claim 13 recites “the matrix of claim 11, wherein the matrix is a dentifrice composition.” This renders the claim indefinite since it is confusing, specifically, in view of claim 11 as rejected above. The term “matrix” in clam 11 appears to describe both 1) the combined product (1st instance) and 2) the material the glass composition is adhered to or mixed with (2nd and 3rd instances). This renders the claim indefinite since it is unclear if the “matrix” that is being further limited is 1) the combined product or 2) the material the glass composition is adhered to or mixed with (“the carrier” as discussed above). For the purposes of examination, it is believed that both recitations of “the matrix” in claim 13 are referring to 1) the combined product as the “matrix”.
Comment regarding claims 14 and 15, the claims are read with respect to the above rejections over claims 11-13, and for the purposes of examination, the first and second recitations of “the matrix” in claims 14 and 15 are read as the matrix (or combined product) as explained and interpreted in the above rejection over claim 11. In view of this, claims 14 and 15 would be read as:
“The matrix of claim 13, wherein the dentifrice composition comprises:
>0-20 wt% of the glass composition, based on total weight of the matrix,
insert either {water (claim 14)} or {glycerin (claim 15)}, and
one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof.”
The bolding was added by the examiner to indicate the selection of either water or glycerin depending which claim is being interpretated, claim 14 or claim 15.
Comment regarding claim 16, if the claim interpretation of claim 11 is adopted, claim 16 should be amended accordingly to recite “with the carrier”.
Claim 17 recites the limitation "the matrix of claim 1" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner believes the claim should depend from claim 11. Furthermore, the claim would be clearer if rewritten to read: “A method comprising applying the matrix of claim 11 to a tooth.”
Claims 2, 3, 5-7, 9, 10, 14-16, and 18-20 are rejected as indefinite since they depend either directly or indirectly from a claim rejected as indefinite without correcting the issue.
Claim Rejections - 35 USC § 112(d) or fourth paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites that the matrix of claim 11, wherein the matrix is substantially free of a fluoride ion source. This fails to further limit claim 11, from which it depends, since claim 11 requires the glass composition of claim 1 and the glass composition of claim 1 requires that there be >0-5 wt% of F-, which would provide a fluoride source to the matrix of claim 12.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 and 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-13 and 16-20 are rejected under 35 U.S.C. § 102(a)(1) and 35 U.S.C. § 102(a)(1) as being anticipated by Coon et al., U.S. Patent Application Publication, US 2002/0274866 A1.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Coon et al. disclose a glass composition in terms of wt.% comprising 15-65% of SiO2, 2.5-25% of MgO, 1-30% of P2O5, 15-50% of CaO, 0-5% of F-, 0-10% of ZrO2, 0-10% of Al2O3, 0-10% of SrO, 0-10% of ZnO, 15-50% of MgO+CaO+SrO+BaO+BeO, 0-30% of Li2O+Na2O+K2O+Rb2O+Cs2O, 0-5% of B2O3, 0-5% of Na2O+K2O. See Abstract and the entire specification, specifically, paragraphs [0005], [0022], [0024]-[0026], and [0028]-[0035]. Coon et al. disclose that the glass when immersed in simulated body fluid, it forms apatite crystals. See paragraph [0009]. Coon et al. disclose that the fluorine can combine with the CaO and P2O5 of the glass composition to form fluorapatite which improves the bioactivity of the composition and fluorapatite is an inorganic mineral in dental enamel and the ability to form fluorapatite can help regeneration of the enamel due to cavities. See paragraphs [0025], [0027], and [0030]. Coon et al. disclose the glass composition is melted at temperature from 1100°C to 1400°C and then cooled. See paragraph [0045]. Coon et al. disclose that the glass material is formed into a particle, bead, particulate, short fiber, long fiber, woolen mesh using traditional forming methods. See paragraphs [0009] and [0044]-[0047]. Coon et al. disclose that the glass materials can be combined with a matrix comprising at least one of: a toothpaste, mouthwash, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, wherein the glass composition is attached to or mixed in the matrix material. See paragraphs [0010] and [0044]. Coon et al. disclose that the compositions or matrices comprising the bioactive glass compositions are used to treat medical conditions including consumer and dental applications. See paragraphs [0044] and [0048]. The compositional ranges of Coon et al. are sufficiently specific to anticipate the composition as recited in claims 1-13 and 16-20. See MPEP 2131.03.
Specifically, as to claim 1, Coon et al. disclose Examples 2-6 and 9-11 (see Table 1). Furthermore, Coon et al. disclose that the glass when immersed in simulated body fluid, it forms apatite crystals (see paragraph [0009]) and Coon et al. disclose that the fluorine can combine with the CaO and P2O5 of the glass composition to form fluorapatite which improves the bioactivity of the composition and fluorapatite is an inorganic mineral in dental enamel and the ability to form fluorapatite can help regeneration of the enamel due to cavities (see paragraphs [0025], [0027], and [0030]), which reads on a glass in terms of weight percentages, comprising: 15-50% of SiO2, 25-60% of CaO, 3-30% of P2O5, 0.5-15% of ZrO2, and >0-5% of F-, wherein when subjected to artificial saliva of Table 1A or Table 1B, the glass composition forms a bioactive crystalline phase, as recited in instant claim 1.
As to claim 2, Coon et al. disclose Examples 3-5, 9, and 11 (see Table 1), which reads on a glass in terms of weight percentages, comprising: 25-45% of SiO2, 30-50% of CaO, 5-25% of P2O5, 2-10% of ZrO2, and 0.001-3% of F-, as recited in instant claim 2.
As to claim 3, Coon et al. disclose Examples 2-6 and 9-11 (see Table 1), which reads on a glass in terms of weight percentages, comprising at least one of: >0-25% of MgO, >0-5% of B2O3, >0-5% of Al2O3, >0-10% of Li2O, >0-10% of Na2O, >0-10% of K2O, >0-10% of sro2, and >0-10% of ZnO, as recited in instant claim 3.
As to claim 4, Coon et al. disclose Examples 2-6 and 9-11 (see Table 1), which reads on a glass in terms of weight percentages, comprising 0-10% of Li2O+Na2O+K2O, as recited in instant claim 4.
As to claim 5, Coon et al. disclose Examples 2-6 and 9-11 (see Table 1), which reads on a glass in terms of weight percentages, comprising at least one of: 5-30% of F-+P2O5, 30-70% of MgO+CaO, 40-70% of CaO+P2O5, as recited in instant claim 5.
As to claim 6, Coon et al. disclose that the glass comprises 0-5 wt.% of F- and 15-50 wt.% of CaO (see paragraphs [0026], [0030], and [0045]), which reads on a glass comprising F-, wherein the F- is derived from calcium fluoride, magnesium fluoride, sodium fluoride, potassium fluoride, stannous fluoride, sodium monofluorophosphate, sodium difluorophosphate, or any combination thereof, as recited in instant claim 6. Furthermore, claim 6 is considered to be a Product-by-Process claim. Claim 6 claims the glass composition based on the starting materials or source materials of the glass composition prior to melting. The source of a material, absent evidence to the contrary, does not materially change the nature of the product itself. In this case, the glass comprises CaO and F- no matter the source of the calcium and fluorine. See MPEP 2113(I) which states:
"[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
As to claim 7, Coon et al. disclose glass composition in Examples 2-6 and 9-11 (see Table 1), which reads on a glass composition is substantially free of a crystalline phase, as recited in instant claim 7.
As to claim 8, Coon et al. disclose that the glass when immersed in simulated body fluid, it forms apatite crystals (see paragraph [0009]), which reads on when the glass composition is subjected to artificial saliva of Table 1A or Table 1B, the bioactive crystalline phase comprises apatite, as recited in instant claim 8.
As to claim 9, Coon et al. disclose that the glass when immersed in simulated body fluid, it forms apatite crystals (see paragraph [0009]) and Coon et al. disclose that the fluorine can combine with the CaO and P2O5 of the glass composition to form fluorapatite which improves the bioactivity of the composition and fluorapatite is an inorganic mineral in dental enamel and the ability to form fluorapatite can help regeneration of the enamel due to cavities (see paragraphs [0025], [0027], and [0030]), which reads the glass composition forming an apatite crystal phase after being subjected to artificial saliva, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, as recited in instant claim 9.
As to claim 10, Coon et al. disclose that the glass material is formed into a particle, bead, particulate, short fiber, long fiber, woolen mesh using traditional forming methods (see paragraphs [0009] and [0044]-[0047]), which reads on the glass composition is in a form of particulates, microbeads, fibers or a combination thereof, as recited in instant claim 10.
As to claim 11, Coon et al. disclose that the glass materials can be combined with a matrix comprising at least one of: a toothpaste, mouthwash, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, which reads on a matrix comprising the glass composition of claim 1, wherein, the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, as recited in instant claim 11.
As to claim 12, Coon et al. is silent to the matrix material comprising a fluoride ion source, which reads on the matrix being substantially free of a fluoride ion source, as recited in instant claim 12.
As to claim 13, Coon et al. teaches that the biocompatible inorganic composition is used in dental applications which can help the regeneration of dental enamel due to cavities (see paragraphs [0030] and [0048]), which reads on the matrix is a dentifrice composition, as recited in instant claim 13.
As to claim 16, Coon et al. disclose that the glass materials can be combined with a matrix comprising at least one of: a toothpaste, mouthwash, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, wherein the glass composition is attached to or mixed in the matrix material (see paragraphs [0010] and [0044]), which reads on a method for making the matrix, comprising combining the glass composition with a carrier as recited in claim 16.
As to claim 17, Coon et al. disclose using the glass containing matrices to treat a medical condition can be simply like the use of the matrix as normally applied, Coon et al. teach that the matrix comprising the glass composition could include toothpastes, mouthwashes, etc. to help the regeneration of dental enamel due to cavities (see paragraphs [0010], [0030], and [0044]), which reads on a method comprising applying to a tooth the matrix, as recited in instant claim 17.
As to claim 18, Coon et al. disclose using the glass containing matrices to treat a medical condition can be simply like the use of the matrix as normally applied, Coon et al. teach that the matrix comprising the glass composition could include toothpastes, mouthwashes, etc. to help the regeneration of dental enamel due to cavities (see paragraphs [0010], [0030], and [0044]), which reads on a method which remineralizes enamel of the tooth, treats caries of the tooth, treats dentin hypersensitivity of the tooth, or any combination thereof, as recited in instant claim 18.
As to claim 19, Coon et al. disclose that the glass is made by combining the glass composition components, melting the glass composition components to form a melt at temperatures from 1100 °C to 1400 °C, and cooling the melt to form slabs (see paragraph [0045]), which reads on a method for making the glass composition comprising: combining each component of the glass composition to form a mixture, heating the mixture to a temperature of 1500 °C or less to form a melted mixture, and cooling the melted mixture to form a cooled mixture, as recited in instant claim 19.
As to claim 20, Coon et al. disclose a method of making a glass wherein the cooled glass can be ground into fine particles and that the glasses can be further processed into short fibers, beads, sheets, 3-D scaffolds, and continuous fibers using various methods (see paragraphs [0046] and [0047]), which reads on a method further comprising forming the cooled mixture into particulates, microbeads, fibers, or a combination thereof, as recited in claim 20.
Claims 1, 3-10, 19, and 20 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Mohri et al., U.S. Patent Publication, US 4,820,660.
Mohri et al. disclose a glass composition in terms of wt.% comprising 38-52% of SiO2, 4-16% of P2O5, 20-33% of MgO+CaO+SrO+BaO+ZnO, where CaO is at least 2/5 of MgO+CaO+SrO+BaO+ZnO, 6-18% of a trivalent metal oxide which includes at least one of Al2O3 and La2O3 and the Al2O3 is at least ½ of the trivalent metal oxide, 4-17% of a tetravalent metal oxide which is at least one of ZrO2 and TiO2 and ZrO2 is at least 1/3 of the tetravalent metal oxide, 0-0.5% of an alkali metal oxide which is at least one of Na2O, Li2O, and K2O, 0.1-1% of F2, and the molar ratio of P2O5 to the tetravalent metal oxide is not greater than 3:1. See Abstract and the entire specification, specifically, column 1, lines 44-64 and column 3, line 32 to column 4, line 68. Mohri et al. disclose that the source of the fluorine is calcium fluoride. See column 4, lines 17-24 and 54-62 and column 5, lines 27-60. Mohri et al. disclose that the glass can be made using conventional glass melting and forming methods. See column 3, lines 1-5. Mohri et al. disclose that the glass requires a heat treatment to form a glass-ceramic. See column 1, line 65 to column 2, line 16. Mohri et al. disclose that the glass material can be used as a biomaterial for artificial teeth and bones. See column 3, lines 11-12. Mohri et al. disclose the glass composition is melted at temperature from 1400°C to 1550°C and then cooled. See column 4, lines 54-68. Mohri et al. disclose that the molten glass can be cooled to obtain a solid glass mass and the solid glass mass can be pulverized to obtain a glass frit consisting of fairly fine particles. See column 5, lines 15-18. Mohri et al. disclose the batch materials were melted at temperatures of 1400 °C to 1550 °C and cast onto a steel plate to cool to form a glass. See column 5, line 67 to column 6, line 3. The compositional ranges of Mohri et al. are sufficiently specific to anticipate the composition as recited in claims 1, 3-10, 19, and 20. See MPEP 2131.03.
Specifically, as to claim 1, Mohri et al. disclose Examples 9-16 (see Table 1), which reads on a glass in terms of weight percentages, comprising: 15-50% of SiO2, 25-60% of CaO, 3-30% of P2O5, 0.5-15% of ZrO2, and >0-5% of F-, as recited in instant claim 1. As to the limitation of claim 1, wherein when subjected to artificial saliva of Table 1A or Table 1B, the glass composition forms a bioactive crystalline phase, this is an intended use limitation, and since the glass composition comprises the recited amounts of CaO, P2O5, and fluorine it stands that the composition of the reference is the same as those claimed herein and it follows that the glasses of Mohri et al. would inherently possess the formation of the bioactive crystalline phase if subjected to artificial saliva of Table 1A or Table 1B, as recited in claim 1. See MPEP 2112.
It is well settled that when a claimed composition appears to be substantially the same as a composition disclosed in the prior art, the burden is properly upon the applicant to prove by way of tangible evidence that the prior art composition does not necessarily possess characteristics attributed to the CLAIMED composition. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Circ. 1990); In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980); In re Swinehart, 439 F.2d 2109, 169 USPQ 226 (CCPA 1971).
Products of identical composition may not have mutually exclusive properties. In re Spada 15 USPQ2d 1655,1658 (Fed. Circ. 1990).
As to claim 3, Mohri et al. disclose Examples 9-15 (see Table 1), which reads on a glass in terms of weight percentages, comprising at least one of: >0-25% of MgO, >0-5% of B2O3, >0-5% of Al2O3, >0-10% of Li2O, >0-10% of Na2O, >0-10% of K2O, >0-10% of sro2, and >0-10% of ZnO, as recited in instant claim 3.
As to claim 4, Mohri et al. disclose Examples 9-16 (see Table 1), which reads on a glass in terms of weight percentages, comprising 0-10% of Li2O+Na2O+K2O, as recited in instant claim 4.
As to claim 5, Mohri et al. disclose Examples 9-16 (see Table 1), which reads on a glass in terms of weight percentages, comprising at least one of: 5-30% of F-+P2O5, 30-70% of MgO+CaO, 40-70% of CaO+P2O5, as recited in instant claim 5.
As to claim 6, Mohri et al. disclose that the source of the fluorine is calcium fluoride (see column 4, lines 17-24 and 54-62 and column 5, lines 27-60), which reads on a glass comprising F-, wherein the F- is derived from calcium fluoride, magnesium fluoride, sodium fluoride, potassium fluoride, stannous fluoride, sodium monofluorophosphate, sodium difluorophosphate, or any combination thereof, as recited in instant claim 6. Furthermore, claim 6 is considered to be a Product-by-Process claim. Claim 6 claims the glass composition based on the starting materials or source materials of the glass composition prior to melting. The source of a material, absent evidence to the contrary, does not materially change the nature of the product itself. In this case, the glass comprises CaO and F- no matter the source of the calcium and fluorine. See MPEP 2113(I) which states:
"[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
As to claim 7, Mohri et al. disclose Examples 9-16 (see Table 1) which have not been heat treated to form crystals, which reads on a glass composition is substantially free of a crystalline phase, as recited in instant claim 7.
As to claim 8, wherein when the glass is subjected to artificial saliva of Table 1A or Table 1B, the glass composition forms a bioactive crystalline phase comprises apatite, this is an intended use limitation, and since the glass composition comprises the recited amounts of CaO, P2O5, and fluorine it stands that the composition of the reference is the same as those claimed herein and it follows that the glasses of Mohri et al. would inherently possess the formation of the bioactive crystalline phase comprising apatite, if subjected to artificial saliva of Table 1A or Table 1B, as recited in claim 8. See MPEP 2112.
As to claim 9, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, this is an intended use limitation, and since the glass composition comprises the recited amounts of CaO, P2O5, and fluorine it stands that the composition of the reference is the same as those claimed herein and it follows that the glasses of Mohri et al. would inherently possess the formation of the bioactive crystalline phase comprising apatite, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, as recited in instant claim 9. See MPEP 2112.
As to claim 10, Mohri et al. disclose that the molten glass can be cooled to obtain a solid glass mass and the solid glass mass can be pulverized to obtain a glass frit consisting of fairly fine particles (see column 5, lines 15-18), which reads on the glass composition is in a form of particulates, microbeads, fibers or a combination thereof, as recited in instant claim 10.
As to claim 19, Mohri et al. disclose the glass composition is melted at temperature from 1400°C to 1550°C and then cooled. Mohri et al. disclose the batch materials were melted at temperatures of 1400 °C to 1550 °C and cast onto a steel plate to cool to form a glass (see column 4, lines 54-68 and column 5, line 67 to column 6, line 3), which reads on a method for making the glass composition comprising: combining each component of the glass composition to form a mixture, heating the mixture to a temperature of 1500 °C or less to form a melted mixture, and cooling the melted mixture to form a cooled mixture, as recited in instant claim 19.
As to claim 20, Mohri et al. disclose that the molten glass can be cooled to obtain a solid glass mass and the solid glass mass can be pulverized to obtain a glass frit consisting of fairly fine particles (see column 5, lines 15-18), which reads on a method further comprising forming the cooled mixture into particulates, microbeads, fibers, or a combination thereof, as recited in claim 20.
Claim 2 is rejected under 35 U.S.C. § 103 as being unpatentable over Mohri et al., U.S. Patent Publication, US 4,820,660.
Mohri et al. teach a glass composition in terms of wt.% comprising 38-52% of SiO2, 4-16% of P2O5, 20-33% of MgO+CaO+SrO+BaO+ZnO, where CaO is at least 2/5 of MgO+CaO+SrO+BaO+ZnO, 6-18% of a trivalent metal oxide which includes at least one of Al2O3 and La2O3 and the Al2O3 is at least ½ of the trivalent metal oxide, 4-17% of a tetravalent metal oxide which is at least one of ZrO2 and TiO2 and ZrO2 is at least 1/3 of the tetravalent metal oxide, 0-0.5% of an alkali metal oxide which is at least one of Na2O, Li2O, and K2O, 0.1-1% of F2, and the molar ratio of P2O5 to the tetravalent metal oxide is not greater than 3:1. See Abstract and the entire specification, specifically, column 1, lines 44-64 and column 3, line 32 to column 4, line 68. Mohri et al. teach that the source of the fluorine is calcium fluoride. See column 4, lines 17-24 and 54-62 and column 5, lines 27-60. Mohri et al. teach that the glass can be made using conventional glass melting and forming methods. See column 3, lines 1-5. Mohri et al. teach that the glass requires a heat treatment to form a glass-ceramic. See column 1, line 65 to column 2, line 16. Mohri et al. teach that the glass material can be used as a biomaterial for artificial teeth and bones. See column 3, lines 11-12. Mohri et al. teach the glass composition is melted at temperature from 1400°C to 1550°C and then cooled. See column 4, lines 54-68. Mohri et al. teach that the molten glass can be cooled to obtain a solid glass mass and the solid glass mass can be pulverized to obtain a glass frit consisting of fairly fine particles. See column 5, lines 15-18. Mohri et al. teach the batch materials were melted at temperatures of 1400 °C to 1550 °C and cast onto a steel plate to cool to form a glass. See column 5, line 67 to column 6, line 3.
Mohri et al. fail to teach any examples or compositional ranges that are sufficiently specific to anticipate the compositional limitations of claim 2. However, the weight percent ranges taught by Mohri et al. have overlapping compositional ranges with instant claim 2. See column 1, lines 44-64 and column 3, line 32 to column 4, line 68. Overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have selected from the overlapping portion of the ranges disclosed by Mohri et al. because overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05.
One of ordinary skill in the art before the effective filing date would have considered the invention to have been obvious because the compositional ranges taught by Mohri et al. overlap the instantly claimed ranges and therefore are considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, particularly in view of the fact that;
“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages”, In re Peterson 65 USPQ2d 1379 (CAFC 2003).
Also, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976); In re Malagari, 182 USPQ 549, 553 (CCPA 1974) and MPEP 2144.05.
As to claim 2, Mohri et al. teach a glass composition in terms of wt.% comprising 38-52% of SiO2, 4-16% of P2O5, 20-33% of MgO+CaO+SrO+BaO+ZnO, where CaO is at least 2/5 of MgO+CaO+SrO+BaO+ZnO, 6-18% of a trivalent metal oxide which includes at least one of Al2O3 and La2O3 and the Al2O3 is at least ½ of the trivalent metal oxide, 4-17% of a tetravalent metal oxide which is at least one of ZrO2 and TiO2 and ZrO2 is at least 1/3 of the tetravalent metal oxide, 0-0.5% of an alkali metal oxide which is at least one of Na2O, Li2O, and K2O, 0.1-1% of F2, and the molar ratio of P2O5 to the tetravalent metal oxide is not greater than 3:1 (see column 1, lines 44-64 and column 3, line 32 to column 4, line 68), which reads on a glass in terms of weight percentages, comprising: 25-45% of SiO2, 30-50% of CaO, 5-25% of P2O5, 2-10% of ZrO2, and 0.001-3% of F-, as recited in instant claim 2.
Claims 1-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Gibson et al., U.S. Patent Application Publication, US 2011/0244430 A1.
Gibson et al. teach a glass composition in terms of wt.% comprising 1-60% of SiO2, 0-5% of Al2O3, 1-80% of P2O5, 10-70% of CaO, 0-25% of fluoride, 0.5-60% of MgO+SrO+BaO+ZnO, 0-40% of rare earth metal oxides, 0-45% of Li2O+Na2O+K2O, 0-40% of B2O3, 0-15% of ZrO2. See Abstract and the entire specification, specifically, paragraphs [0044]-[0052]. Gibson et al. teach that the bioactive glass comprises calcium fluoride. See paragraph [0041]. Gibson et al. teach that the bioactive glass is made by traditional glass melting processes. See paragraph [0041]. Gibson et al. teach that the bioactive glasses may be amorphous. See paragraph [0042]. Gibson et al. teach that the glass is a bioactive glass and used for tooth remineralization. See paragraphs [0001] and [0013]-[0024]. Gibson et al. teach that bioactive glasses alone or incorporated into oral care compositions can be applied to the teeth and can remineralize teeth by rebuilding the hydroxy apatite structure. See paragraphs [0004]-[0007]. Gibson et al. teach that the bioactive glass can be in the form of particles, fibers, or platelets. See paragraph [0057]. Gibson et al. teach that when the bioactive glass is in contact with physiological fluids, such as saliva, the glass particles release calcium and phosphate ions to form hydroxy carbonate apatite. See paragraph [0030]. Gibson et al. teach that the bioactive glass is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024]. Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material. See paragraphs [0069]-[0074]. Gibson et al. teach that the film comprises the bioactive glass, wherein the particulate glass comprises 1-60% of the wight of the film, notably 8-16% by weight of the film. See paragraph [0033]. Gibson et al. teach that the bioactive glass can be mixed with other materials such as sweeteners, flavorings, antimicrobial agents, plasticizing agents, coloring agents, saliva stimulating agents, cooling agents, surfactants, stabilizing agents, emulsifying agents, thickening agents, preservative, bulking agents, humectants, vitamins, minerals, fluorides, and fillers. See paragraph [0060]. Gibson et al. teach that the film maybe in the form of a strip which intended to swell in dissolve in the oral cavity by the action of the saliva to release the remineralization composition. See paragraphs [0062]-[0064] and [0068]. Gibson et al. teach that the film is incorporated into products such as dentifrices and toothpastes. See paragraph [0066]. Gibson et al. teach that the film composition may include sweeteners comprising methyl esters of L-aspartyl-L-phenylglycerin. See paragraph [0083]. Gibson et al. teach that the film is made by dispersing the bioactive glass in a polymer solution comprising all other ingredients. See paragraph [0087]. Gibson et al. teach that the dental composition comprises a water soluble polymer film former, a bioactive glass, and the dental composition may be in the form of a strip (film), toothpaste, and/or some other form of dentifrice. See paragraphs [0097]-[0111]. Gibson et al. disclose that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass. See paragraphs [0112]-[0117]. Gibson et al. further disclose the method of making the water soluble polymeric film composition comprising mixing the water soluble polymeric film former and the bioactive glass may also have plasticizers, humectants, flavors, emulsifiers, fillers, sweeteners, and colors mixed in. See paragraph [0118]. Gibson et al. teach a method of treating teeth by providing tooth remineralization using the film comprising the bioactive glass. See paragraphs [0097]-[0117], [0128], [0140] and [0141].
Gibson et al. fail to teach any examples or compositional ranges that are sufficiently specific to anticipate the compositional limitations of claims 1-20. However, the weight percent ranges taught by Gibson et al. have overlapping compositional ranges with instant claim 1. See paragraphs [0044]-[0052]. Overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have selected from the overlapping portion of the ranges disclosed by Gibson et al. because overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05.
One of ordinary skill in the art before the effective filing date would have considered the invention to have been obvious because the compositional ranges taught by Gibson et al. overlap the instantly claimed ranges and therefore are considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, particularly in view of the fact that;
“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages”, In re Peterson 65 USPQ2d 1379 (CAFC 2003).
Also, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976); In re Malagari, 182 USPQ 549, 553 (CCPA 1974) and MPEP 2144.05.
Specifically, as to claim 1, Gibson et al. teach a glass composition in terms of wt.% comprising 1-60% of SiO2, 0-5% of Al2O3, 1-80% of P2O5, 10-70% of CaO, 0-25% of fluoride, 0.5-60% of MgO+SrO+BaO+ZnO, 0-40% of rare earth metal oxides, 0-45% of Li2O+Na2O+K2O, 0-40% of B2O3, 0-15% of ZrO2 (see paragraphs [0044]-[0052]). Furthermore, Gibson et al. teach that when the bioactive glass is in contact with physiological fluids, such as saliva, the glass particles release calcium and phosphate ions to form hydroxy carbonate apatite (see paragraph [0030]), which reads on a glass in terms of weight percentages, comprising: 15-50% of SiO2, 25-60% of CaO, 3-30% of P2O5, 0.5-15% of ZrO2, and >0-5% of F-, wherein when subjected to artificial saliva of Table 1A or Table 1B, the glass composition forms a bioactive crystalline phase, as recited in instant claim 1.
As to claim 2, Gibson et al. teach a glass composition in terms of wt.% comprising 1-60% of SiO2, 0-5% of Al2O3, 1-80% of P2O5, 10-70% of CaO, 0-25% of fluoride, 0.5-60% of MgO+SrO+BaO+ZnO, 0-40% of rare earth metal oxides, 0-45% of Li2O+Na2O+K2O, 0-40% of B2O3, 0-15% of ZrO2 (see paragraphs [0044]-[0052]), which reads on a glass in terms of weight percentages, comprising: 25-45% of SiO2, 30-50% of CaO, 5-25% of P2O5, 2-10% of ZrO2, and 0.001-3% of F-, as recited in instant claim 2.
As to claim 3, Gibson et al. teach a glass composition in terms of wt.% comprising 1-60% of SiO2, 0-5% of Al2O3, 1-80% of P2O5, 10-70% of CaO, 0-25% of fluoride, 0.5-60% of MgO+SrO+BaO+ZnO, 0-40% of rare earth metal oxides, 0-45% of Li2O+Na2O+K2O, 0-40% of B2O3, 0-15% of ZrO2 (see paragraphs [0044]-[0052]), which reads on a glass in terms of weight percentages, comprising at least one of: >0-25% of MgO, >0-5% of B2O3, >0-5% of Al2O3, >0-10% of Li2O, >0-10% of Na2O, >0-10% of K2O, >0-10% of sro2, and >0-10% of ZnO, as recited in instant claim 3.
As to claim 4, Gibson et al. teach a glass composition in terms of wt.% comprising 1-60% of SiO2, 0-5% of Al2O3, 1-80% of P2O5, 10-70% of CaO, 0-25% of fluoride, 0.5-60% of MgO+SrO+BaO+ZnO, 0-40% of rare earth metal oxides, 0-45% of Li2O+Na2O+K2O, 0-40% of B2O3, 0-15% of ZrO2 (see paragraphs [0044]-[0052]), which reads on a glass in terms of weight percentages, comprising 0-10% of Li2O+Na2O+K2O, as recited in instant claim 4.
As to claim 5, Gibson et al. teach a glass composition in terms of wt.% comprising 1-60% of SiO2, 0-5% of Al2O3, 1-80% of P2O5, 10-70% of CaO, 0-25% of fluoride, 0.5-60% of MgO+SrO+BaO+ZnO, 0-40% of rare earth metal oxides, 0-45% of Li2O+Na2O+K2O, 0-40% of B2O3, 0-15% of ZrO2 (see paragraphs [0044]-[0052]), which reads on a glass in terms of weight percentages, comprising at least one of: 5-30% of F-+P2O5, 30-70% of MgO+CaO, 40-70% of CaO+P2O5, as recited in instant claim 5.
As to claim 6, Gibson et al. teach that the bioactive glass comprises calcium fluoride (see paragraph [0041]), which reads on a glass comprising F-, wherein the F- is derived from calcium fluoride, magnesium fluoride, sodium fluoride, potassium fluoride, stannous fluoride, sodium monofluorophosphate, sodium difluorophosphate, or any combination thereof, as recited in instant claim 6. Furthermore, claim 6 is considered to be a Product-by-Process claim. Claim 6 claims the glass composition based on the starting materials or source materials of the glass composition prior to melting. The source of a material, absent evidence to the contrary, does not materially change the nature of the product itself. In this case, the glass comprises CaO and F- no matter the source of the calcium and fluorine. See MPEP 2113(I) which states:
"[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
As to claim 7, Gibson et al. teach that the bioactive glasses may be amorphous (see paragraph [0042]), which reads on a glass composition is substantially free of a crystalline phase, as recited in instant claim 7.
As to claim 8, Gibson et al. teach that when the bioactive glass is in contact with physiological fluids, such as saliva, the glass particles release calcium and phosphate ions to form hydroxy carbonate apatite (see paragraph [0030]), which reads on when the glass composition is subjected to artificial saliva of Table 1A or Table 1B, the bioactive crystalline phase comprises apatite, as recited in instant claim 8.
As to claim 9, Gibson et al. teach that when the bioactive glass is in contact with physiological fluids, such as saliva, the glass particles release calcium and phosphate ions to form hydroxy carbonate apatite (see paragraph [0030]), which reads the glass composition forming an apatite crystal phase after being subjected to artificial saliva, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, as recited in instant claim 9.
As to claim 10, Gibson et al. teach that the bioactive glass can be in the form of particles, fibers, or platelets (see paragraph [0057]), which reads on the glass composition is in a form of particulates, microbeads, fibers or a combination thereof, as recited in instant claim 10.
As to claim 11, Gibson et al. teach that the bioactive glass is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024]. Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material (see paragraphs [0069]-[0074]), which reads on a matrix comprising a glass composition, wherein, the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, as recited in instant claim 11.
As to claim 12, Gibson et al. is silent to the water soluble polymeric film former comprising a fluoride ion source, which reads on the matrix being substantially free of a fluoride ion source, as recited in instant claim 12.
As to claim 13, Gibson et al. disclose that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass (see paragraphs [0112]-[0117]) and Gibson et al. teach that the film is incorporated into products such as dentifrices and toothpastes (see paragraph [0066]), which reads on the matrix is a dentifrice composition, as recited in instant claim 13.
As to claim 14, Gibson et al. teach that the glass is a bioactive glass and used for tooth remineralization. See paragraphs [0001] and [0013]-[0024]. Gibson et al. teach that the bioactive glass is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024]. Gibson et al. teach that the film comprises the bioactive glass, wherein the particulate glass comprises 1-60% of the wight of the film, notably 8-16% by weight of the film. See paragraph [0033]. Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material. See paragraphs [0069]-[0074]. Gibson et al. teach that the bioactive glass can be mixed with other materials such as sweeteners, flavorings, antimicrobial agents, plasticizing agents, coloring agents, saliva stimulating agents, cooling agents, surfactants, stabilizing agents, emulsifying agents, thickening agents, preservative, bulking agents, humectants, vitamins, minerals, fluorides, and fillers. See paragraph [0060]. Gibson et al. teach that the film is produced from an aqueous mixture of its components. See paragraph [0087]. Gibson et al. teach that the film is made by dispersing the bioactive glass in a polymer solution comprising all other ingredients. See paragraph [0087]. Gibson et al. teach that the dental composition comprises a water soluble polymer film former, a bioactive glass, and the dental composition may be in the form of a strip (film), toothpaste, and/or some other form of dentifrice. See paragraphs [0097]-[0111]. Gibson et al. teach that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass. See paragraphs [0112]-[0117]. Gibson et al. further disclose the method of making the water soluble polymeric film composition comprising mixing the water soluble polymeric film former and the bioactive glass may also have plasticizers, humectants, flavors, emulsifiers, fillers, sweeteners, and colors mixed in. See paragraph [0118]. The dental composition of Gibson et al. as taught above reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, water, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 14.
As to claim 15, Gibson et al. teach that the glass is a bioactive glass and used for tooth remineralization. See paragraphs [0001] and [0013]-[0024]. Gibson et al. teach that the bioactive glass is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024]. Gibson et al. teach that the film comprises the bioactive glass, wherein the particulate glass comprises 1-60% of the wight of the film, notably 8-16% by weight of the film. See paragraph [0033]. Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material. See paragraphs [0069]-[0074]. Gibson et al. teach that the bioactive glass can be mixed with other materials such as sweeteners, flavorings, antimicrobial agents, plasticizing agents, coloring agents, saliva stimulating agents, cooling agents, surfactants, stabilizing agents, emulsifying agents, thickening agents, preservative, bulking agents, humectants, vitamins, minerals, fluorides, and fillers. See paragraph [0060]. Gibson et al. teach that the film composition may include sweeteners comprising glycerin in the form of methyl esters of L-aspartyl-L-phenylglycerin. See paragraph [0083]. Gibson et al. teach that the film is made by dispersing the bioactive glass in a polymer solution comprising all other ingredients. See paragraph [0087]. Gibson et al. teach that the dental composition comprises a water soluble polymer film former, a bioactive glass, and the dental composition may be in the form of a strip (film), toothpaste, and/or some other form of dentifrice. See paragraphs [0097]-[0111]. Gibson et al. teach that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass. See paragraphs [0112]-[0117]. Gibson et al. further disclose the method of making the water soluble polymeric film composition comprising mixing the water soluble polymeric film former and the bioactive glass may also have plasticizers, humectants, flavors, emulsifiers, fillers, sweeteners, and colors mixed in. See paragraph [0118]. The dental composition of Gibson et al. as taught above reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, glycerin, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 15.
As to claim 16, Gibson et al. disclose that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass (see paragraphs [0112]-[0117]), which reads on a method for making the matrix, comprising combining the glass composition with a carrier as recited in claim 16.
As to claim 17, Gibson et al. teach a method of treating teeth by providing tooth remineralization using the film comprising the bioactive glass (see paragraphs [0097]-[0117], [0128], [0140] and [0141]), which reads on a method comprising applying to a tooth the matrix, as recited in instant claim 17.
As to claim 18, Gibson et al. teach a method of treating teeth by providing tooth remineralization using the film comprising the bioactive glass (see paragraphs [0097]-[0117], [0128], [0140] and [0141]), which reads on a method which remineralizes enamel of the tooth, treats caries of the tooth, treats dentin hypersensitivity of the tooth, or any combination thereof, as recited in instant claim 18.
As to claim 19, Gibson et al. teach that the bioactive glass is made by traditional glass melting processes (see paragraph [0041]), which reads on a method for making the glass composition comprising: combining each component of the glass composition to form a mixture, heating the mixture to a temperature of 1500 °C or less to form a melted mixture, and cooling the melted mixture to form a cooled mixture, as recited in instant claim 19.
As to claim 20, Gibson et al. teach that the bioactive glass can be in the form of particles, fibers, or platelets (see paragraph [0057]), which reads on a method further comprising forming the cooled mixture into particulates, microbeads, fibers, or a combination thereof, as recited in claim 20.
Claims 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mohri et al., U.S. Patent Publication, US 4,820,660 in view of Gibson et al., U.S. Patent Application Publication, US 2011/0244430 A1.
Mohri et al. teach a glass composition in terms of wt.% comprising 38-52% of SiO2, 4-16% of P2O5, 20-33% of MgO+CaO+SrO+BaO+ZnO, where CaO is at least 2/5 of MgO+CaO+SrO+BaO+ZnO, 6-18% of a trivalent metal oxide which includes at least one of Al2O3 and La2O3 and the Al2O3 is at least ½ of the trivalent metal oxide, 4-17% of a tetravalent metal oxide which is at least one of ZrO2 and TiO2 and ZrO2 is at least 1/3 of the tetravalent metal oxide, 0-0.5% of an alkali metal oxide which is at least one of Na2O, Li2O, and K2O, 0.1-1% of F2, and the molar ratio of P2O5 to the tetravalent metal oxide is not greater than 3:1. See Abstract and the entire specification, specifically, column 1, lines 44-64 and column 3, line 32 to column 4, line 68. Mohri et al. teach that the source of the fluorine is calcium fluoride. See column 4, lines 17-24 and 54-62 and column 5, lines 27-60. Mohri et al. teach that the glass can be made using conventional glass melting and forming methods. Cee column 3, lines 1-5. Mohri et al. teach that the glass requires a heat treatment to form a glass-ceramic. See column 1, line 65 to column 2, line 16. Mohri et al. teach that the glass material can be used as a biomaterial for artificial teeth and bones. See column 3, lines 11-12. Mohri et al. teach the glass composition is melted at temperature from 1400°C to 1550°C and then cooled. See column 4, lines 54-68. Mohri et al. teach that the molten glass can be cooled to obtain a solid glass mass and the solid glass mass can be pulverized to obtain a glass frit consisting of fairly fine particles. See column 5, lines 15-18. Mohri et al. teach the batch materials were melted at temperatures of 1400 °C to 1550 °C and cast onto a steel plate to cool to form a glass. See column 5, line 67 to column 6, line 3.
Mohri et al. fail to teach that the glass composition is combined with a matrix material as recited in claim 11-18.
Gibson et al. teach a similar glass composition in terms of wt.% comprising 1-60% of SiO2, 0-5% of Al2O3, 1-80% of P2O5, 10-70% of CaO, 0-25% of fluoride, 0.5-60% of MgO+SrO+BaO+ZnO, 0-40% of rare earth metal oxides, 0-45% of Li2O+Na2O+K2O, 0-40% of B2O3, 0-15% of ZrO2. See Abstract and the entire specification, specifically, paragraphs [0044]-[0052]. Gibson et al. teach that the bioactive glass comprises calcium fluoride. See paragraph [0041]. Gibson et al. teach that the bioactive glass is made by traditional glass melting processes. See paragraph [0041]. Gibson et al. teach that the bioactive glasses may be amorphous. See paragraph [0042]. Gibson et al. teach that the glass is a bioactive glass and used for tooth remineralization. See paragraphs [0001] and [0013]-[0024]. Gibson et al. teach that bioactive glasses alone or incorporated into oral care compositions can be applied to the teeth and can remineralize teeth by rebuilding the hydroxy apatite structure. See paragraphs [0004]-[0007]. Gibson et al. teach that the bioactive glass can be in the form of particles, fibers, or platelets. See paragraph [0057]. Gibson et al. teach that when the bioactive glass is in contact with physiological fluids, such as saliva, the glass particles release calcium and phosphate ions to form hydroxy carbonate apatite. See paragraph [0030]. Gibson et al. teach that the bioactive glass is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024]. Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material. See paragraphs [0069]-[0074]. Gibson et al. teach that the film comprises the bioactive glass, wherein the particulate glass comprises 1-60% of the wight of the film, notably 8-16% by weight of the film. See paragraph [0033]. Gibson et al. teach that the bioactive glass can be mixed with other materials such as sweeteners, flavorings, antimicrobial agents, plasticizing agents, coloring agents, saliva stimulating agents, cooling agents, surfactants, stabilizing agents, emulsifying agents, thickening agents, preservative, bulking agents, humectants, vitamins, minerals, fluorides, and fillers. See paragraph [0060]. Gibson et al. teach that the film maybe in the form of a strip which intended to swell in dissolve in the oral cavity by the action of the saliva to release the remineralization composition. See paragraphs [0062]-[0064] and [0068]. Gibson et al. teach that the film is incorporated into products such as dentifrices and toothpastes. See paragraph [0066]. Gibson et al. teach that the film composition may include sweeteners comprising methyl esters of L-aspartyl-L-phenylglycerin. See paragraph [0083]. Gibson et al. teach that the film is made by dispersing the bioactive glass in a polymer solution comprising all other ingredients. See paragraph [0087]. Gibson et al. teach that the dental composition comprises a water soluble polymer film former, a bioactive glass, and the dental composition may be in the form of a strip (film), toothpaste, and/or some other form of dentifrice. See paragraphs [0097]-[0111]. Gibson et al. disclose that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass. See paragraphs [0112]-[0117]. Gibson et al. further disclose the method of making the water soluble polymeric film composition comprising mixing the water soluble polymeric film former and the bioactive glass may also have plasticizers, humectants, flavors, emulsifiers, fillers, sweeteners, and colors mixed in. See paragraph [0118]. Gibson et al. teach a method of treating teeth by providing tooth remineralization using the film comprising the bioactive glass. See paragraphs [0097]-[0117], [0128], [0140] and [0141].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have a bioactive glass composition of Mohri et al. as suggested by Gibson et al. because the resultant matrix composition comprising the bioactive glass of Mohri et al. would have the superior bioactive properties of the glass composition while having the matrix properties of the dental film comprising the water soluble polymeric film former of Gibson et al.
As to claim 11, Mohri et al. in view of Gibson et al. teach that a bioactive glass (see column 1, lines 44-64 and column 4, lines 17-24 and Examples 9-16 of Table 1 of Mohri et al.) is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024] of Gibson et al. Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material (see paragraphs [0069]-[0074]), which reads on a matrix comprising a glass composition, wherein, the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, as recited in instant claim 11.
As to claim 12, Mohri et al. in view of Gibson et al. is silent to the water soluble polymeric film former comprising a fluoride ion source, which reads on the matrix being substantially free of a fluoride ion source, as recited in instant claim 12.
As to claim 13, Mohri et al. in view of Gibson et al. disclose that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass (see paragraphs [0112]-[0117] of Gibson et al.) and Mohri et al. in view of Gibson et al. teach that the film is incorporated into products such as dentifrices and toothpastes (see paragraph [0066] of Gibson et al.), which reads on the matrix is a dentifrice composition, as recited in instant claim 13.
As to claim 14, Mohri et al. in view of Gibson et al. teach that the glass is a bioactive glass and used for tooth remineralization. See paragraphs [0001] and [0013]-[0024] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the bioactive glass is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film comprises the bioactive glass, wherein the particulate glass comprises 1-60% of the wight of the film, notably 8-16% by weight of the film. See paragraph [0033] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material. See paragraphs [0069]-[0074] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the bioactive glass can be mixed with other materials such as sweeteners, flavorings, antimicrobial agents, plasticizing agents, coloring agents, saliva stimulating agents, cooling agents, surfactants, stabilizing agents, emulsifying agents, thickening agents, preservative, bulking agents, humectants, vitamins, minerals, fluorides, and fillers. See paragraph [0060] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film is produced from an aqueous mixture of its components. See paragraph [0087] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film is made by dispersing the bioactive glass in a polymer solution comprising all other ingredients. See paragraph [0087] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the dental composition comprises a water soluble polymer film former, a bioactive glass, and the dental composition may be in the form of a strip (film), toothpaste, and/or some other form of dentifrice. See paragraphs [0097]-[0111] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass. See paragraphs [0112]-[0117] of Gibson et al. Mohri et al. in view of Gibson et al. further disclose the method of making the water soluble polymeric film composition comprising mixing the water soluble polymeric film former and the bioactive glass may also have plasticizers, humectants, flavors, emulsifiers, fillers, sweeteners, and colors mixed in. See paragraph [0118] of Gibson et al. The dental composition of Mohri et al. in view of Gibson et al. as taught above reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, water, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 14.
As to claim 15, Mohri et al. in view of Gibson et al. teach that the glass is a bioactive glass and used for tooth remineralization. See paragraphs [0001] and [0013]-[0024] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the bioactive glass is mixed with a water soluble polymer film former. See paragraphs [0013]-[0024] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film comprises the bioactive glass, wherein the particulate glass comprises 1-60% of the wight of the film, notably 8-16% by weight of the film. See paragraph [0033] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film or water soluble polymeric film forming is formed from an edible material. See paragraphs [0069]-[0074] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the bioactive glass can be mixed with other materials such as sweeteners, flavorings, antimicrobial agents, plasticizing agents, coloring agents, saliva stimulating agents, cooling agents, surfactants, stabilizing agents, emulsifying agents, thickening agents, preservative, bulking agents, humectants, vitamins, minerals, fluorides, and fillers. See paragraph [0060] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film composition may include sweeteners comprising glycerin in the form of methyl esters of L-aspartyl-L-phenylglycerin. See paragraph [0083] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film is made by dispersing the bioactive glass in a polymer solution comprising all other ingredients. See paragraph [0087] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the dental composition comprises a water soluble polymer film former, a bioactive glass, and the dental composition may be in the form of a strip (film), toothpaste, and/or some other form of dentifrice. See paragraphs [0097]-[0111] of Gibson et al. Mohri et al. in view of Gibson et al. teach that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass. See paragraphs [0112]-[0117] of Gibson et al. Mohri et al. in view of Gibson et al. further disclose the method of making the water soluble polymeric film composition comprising mixing the water soluble polymeric film former and the bioactive glass may also have plasticizers, humectants, flavors, emulsifiers, fillers, sweeteners, and colors mixed in. See paragraph [0118] of Gibson et al. The dental composition of Mohri et al. in view of Gibson et al. as taught above reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, glycerin, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 15.
As to claim 16, Mohri et al. in view of Gibson et al. disclose that the film for use in the oral cavity for the remineralization of a tooth comprises mixing a water soluble polymeric film former with a bioactive glass (see paragraphs [0112]-[0117] of Gibson et al.), which reads on a method for making the matrix, comprising combining the glass composition with a carrier as recited in claim 16.
As to claim 17, Mohri et al. Gibson et al. teach a method of treating teeth by providing tooth remineralization using the film comprising the bioactive glass (see paragraphs [0097]-[0117], [0128], [0140] and [0141] of Gibson et al.), which reads on a method comprising applying to a tooth the matrix, as recited in instant claim 17.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-18, and 20 of copending Application No. 18/613,825. Although the claims at issue are not identical, they are not patentably distinct from each other because the compositional ranges overlap. Overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Specifically, as to claim 1, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O, which reads on a glass in terms of weight percentages, comprising: 15-50% of SiO2, 25-60% of CaO, 3-30% of P2O5, 0.5-15% of ZrO2, and >0-5% of F-, as recited in instant claim 1. Also see copending Application No. 18/613,825, claims 8-10. As to the limitation of instant claim 1, wherein when subjected to artificial saliva of Table 1A or Table 1B, the glass composition forms a bioactive crystalline phase, this is an intended use limitation, and since the glass composition comprises the recited amounts of CaO, P2O5, and fluorine it stands that the composition of the reference is the same as those claimed herein and it follows that the glasses of copending Application No. 18/613,825 would inherently possess the formation of the bioactive crystalline phase if subjected to artificial saliva of Table 1A or Table 1B, as recited in instant claim 1. See MPEP 2112.
It is well settled that when a claimed composition appears to be substantially the same as a composition disclosed in the prior art, the burden is properly upon the applicant to prove by way of tangible evidence that the prior art composition does not necessarily possess characteristics attributed to the CLAIMED composition. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Circ. 1990); In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980); In re Swinehart, 439 F.2d 2109, 169 USPQ 226 (CCPA 1971).
Products of identical composition may not have mutually exclusive properties. In re Spada 15 USPQ2d 1655,1658 (Fed. Circ. 1990).
As to claim 2, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O, which reads on a glass in terms of weight percentages, comprising: 25-45% of SiO2, 30-50% of CaO, 5-25% of P2O5, 2-10% of ZrO2, and 0.001-3% of F-, as recited in instant claim 2. Also see copending Application No. 18/613,825, claims 8-10.
As to claim 3, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O, which reads on a glass in terms of weight percentages, comprising at least one of: >0-25% of MgO, >0-5% of B2O3, >0-5% of Al2O3, >0-10% of Li2O, >0-10% of Na2O, >0-10% of K2O, >0-10% of sro2, and >0-10% of ZnO, as recited in instant claim 3. Also see copending Application No. 18/613,825, claims 8-10.
As to claim 4, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O which reads on a glass in terms of weight percentages, comprising 0-10% of Li2O+Na2O+K2O, as recited in instant claim 4. Also see copending Application No. 18/613,825, claims 8-10.
As to claim 5, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O, which reads on a glass in terms of weight percentages, comprising at least one of: 5-30% of F-+P2O5, 30-70% of MgO+CaO, 40-70% of CaO+P2O5, as recited in instant claim 5. Also see copending Application No. 18/613,825, claims 8-10.
As to claim 6, copending Application No. 18/613,825, claim 7 recites a glass composition wherein the F- is derived from calcium fluoride, magnesium fluoride, sodium fluoride, potassium fluoride, stannous fluoride, sodium monofluorophosphate, sodium difluorophosphate, or any combination thereof, which reads on a glass comprising F-, wherein the F- is derived from calcium fluoride, magnesium fluoride, sodium fluoride, potassium fluoride, stannous fluoride, sodium monofluorophosphate, sodium difluorophosphate, or any combination thereof, as recited in instant claim 6. Furthermore, claim 6 is considered to be a Product-by-Process claim. Claim 6 claims the glass composition based on the starting materials or source materials of the glass composition prior to melting. The source of a material, absent evidence to the contrary, does not materially change the nature of the product itself. In this case, the glass comprises CaO and F- no matter the source of the calcium and fluorine. See MPEP 2113(I) which states:
"[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
As to claim 7, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O, which reads on a glass composition is substantially free of a crystalline phase, as recited in instant claim 7. Also see copending Application No. 18/613,825, claims 8-10 and 20.
As to claim 8, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O, which reads on when the glass composition is subjected to artificial saliva of Table 1A or Table 1B, the bioactive crystalline phase comprises apatite, as recited in instant claim 8. Also see copending Application No. 18/613,825, claims 8-10. As to the limitation of instant claim 8, wherein when the glass composition is subjected to artificial saliva of Table 1A or Table 1B, the bioactive crystalline phase comprises apatite, this is an intended use limitation, and since the glass composition comprises the recited amounts of CaO, P2O5, and fluorine it stands that the composition of the reference is the same as those claimed herein and it follows that the glasses of copending Application No. 18/613,825 would inherently possess the formation of the bioactive crystalline phase comprising apatite if subjected to artificial saliva of Table 1A or Table 1B, as recited in instant claim 8. See MPEP 2112.
As to claim 9, copending Application No. 18/613,825, claim 1 recites a glass composition in terms of weight percent comprising 15-45% of SiO2, 10-30% of P2O5, 30-60% of CaO, 0.5-15% of ZrO2, 0.1-10% of F-, 0-25% of MgO, 0-5% of B2O3, 0-5% of Al2O3, 0-10% of Li2O, 0-10% of Na2O, 0-10% of K2O, 0-10% of SrO, 0-10% of ZnO, and 0-10% of Li2O+Na2O+K2O, which reads the glass composition forming an apatite crystal phase after being subjected to artificial saliva, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, as recited in instant claim 9. Also see copending Application No. 18/613,825, claims 8-10. As to the limitation of instant claim 9, wherein the glass composition forming an apatite crystal phase after being subjected to artificial saliva, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, this is an intended use limitation, and since the glass composition comprises the recited amounts of CaO, P2O5, and fluorine it stands that the composition of the reference is the same as those claimed herein and it follows that the glasses of copending Application No. 18/613,825 would inherently possess the formation of the bioactive crystalline phase comprising apatite wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, if subjected to artificial saliva of Table 1A or Table 1B, as recited in instant claim 9. See MPEP 2112.
As to claim 10, copending Application No. 18/613,825, claim 11 recites a glass composition, wherein the glass composition is in a form of particulates, microbeads, fibers, or a combination thereof, which reads on the glass composition is in a form of particulates, microbeads, fibers or a combination thereof, as recited in instant claim 10.
As to claim 11, copending Application No. 18/613,825, claim 12 recites a matrix comprising a glass composition, wherein: the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, which reads on a matrix comprising a glass composition, wherein, the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, as recited in instant claim 11.
As to claim 12, copending Application No. 18/613,825, claim 12 recites a matrix comprising a glass composition, wherein: the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, which reads on the matrix being substantially free of a fluoride ion source, as recited in instant claim 12.
As to claim 13, copending Application No. 18/613,825, claim 13 recites a matrix, wherein the matrix is a dentifrice composition, which reads on the matrix is a dentifrice composition, as recited in instant claim 13.
As to claim 14, copending Application No. 18/613,825, claim 14 recites a matrix, wherein the dentifrice composition comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, solvent, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof and paragraph [0075] of copending application No. 18/613,825 which states that the solvent comprises water, which reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, water, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 14.
As to claim 15, copending Application No. 18/613,825, claim 14 recites a matrix, wherein the dentifrice composition comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, solvent, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof and paragraph [0075] of copending application No. 18/613,825 which states that the solvent comprises glycerin, which reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, glycerin, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 15.
As to claim 16, copending Application No. 18/613,825, claim 15 recites a method for making the matrix comprising combining a carrier with the glass composition, which reads on a method for making the matrix, comprising combining the glass composition with a carrier as recited in claim 16.
As to claim 17, copending Application No. 18/613,825, claim 16 recites a method comprising applying to a tooth the dentifrice composition, which reads on a method comprising applying to a tooth the matrix, as recited in instant claim 17.
As to claim 18, copending Application No. 18/613,825, claim 17 recites a method wherein the method remineralizes enamel of a tooth, treats caries of a tooth, treats dentin hypersensitivity of the tooth, or any combination thereof, which reads on a method which remineralizes enamel of the tooth, treats caries of the tooth, treats dentin hypersensitivity of the tooth, or any combination thereof, as recited in instant claim 18.
As to claim 19, copending Application No. 18/613,825, claim 18 recites a method for making the glass composition comprising: combining each component of the glass composition to form a mixture; heating the mixture to a temperature of 1500 °C or less to form a melted mixture; and cooling the melted mixture to form a cooled mixture, which reads on a method for making the glass composition comprising: combining each component of the glass composition to form a mixture, heating the mixture to a temperature of 1500 °C or less to form a melted mixture, and cooling the melted mixture to form a cooled mixture, as recited in instant claim 19.
As to claim 20, copending Application No. 18/613,825, claim 18 recites a method for making the glass composition comprising: combining each component of the glass composition to form a mixture; heating the mixture to a temperature of 1500 °C or less to form a melted mixture; and cooling the melted mixture to form a cooled mixture and copending Application No. 18/613,825, claim 11 recites a glass composition, wherein the glass composition is in a form of particulates, microbeads, fibers, or a combination thereof, which reads on a method further comprising forming the cooled mixture into particulates, microbeads, fibers, or a combination thereof, as recited in claim 20.
Claims 1-9 and 11-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10-15, and 19 of copending Application No. 18/613,904. Although the claims at issue are not identical, they are not patentably distinct from each other because the compositional ranges overlap. Overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Specifically, as to claim 1, copending Application No. 18/613,904, claim 1 recites a bioactive glass composition in terms of weight percent comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P205, wherein, when the glass is subjected to an artificial saliva at 37 C, a bioactive crystalline phase is formed within 7 days, wherein the artificial saliva consists of 0.119 wt.% potassium chloride, 0.024 wt.% ammonium chloride, 0.054 wt.% potassium dihydrogen phosphate, 0.004 wt.% magnesium chloride hexahydrate, 0.011 wt.% calcium chloride, 0.477 wt.% HEPES buffer, 0.02 wt.% sodium azide, 0.012 wt.% sodium hydroxide, and a balance of water and copending Application No. 18/613,904, claim 6 recites the bioactive glass comprises at least one of: >0-25 wt.% MgO, based on total weight of the bioactive glass; >0-5 wt.% F-, based on total weight of the bioactive glass; and 0-5 wt.% Na20+K20+Li2O, based on total weight of the bioactive glass, which reads on a glass in terms of weight percentages, comprising: 15-50% of SiO2, 25-60% of CaO, 3-30% of P2O5, 0.5-15% of ZrO2, and >0-5% of F-, wherein, when subjected to artificial saliva of Table 1A or Table 1B, the glass composition forms a bioactive crystalline phase, as recited in instant claim 1. Also see copending Application No. 18/613,904, claim 5.
As to claim 2, copending Application No. 18/613,904, claim 1 recites a bioactive glass composition in terms of weight percent comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P205, wherein, when the glass is subjected to an artificial saliva at 37 C, a bioactive crystalline phase is formed within 7 days, wherein the artificial saliva consists of 0.119 wt.% potassium chloride, 0.024 wt.% ammonium chloride, 0.054 wt.% potassium dihydrogen phosphate, 0.004 wt.% magnesium chloride hexahydrate, 0.011 wt.% calcium chloride, 0.477 wt.% HEPES buffer, 0.02 wt.% sodium azide, 0.012 wt.% sodium hydroxide, and a balance of water and copending Application No. 18/613,904, claim 6 recites the bioactive glass comprises at least one of: >0-25 wt.% MgO, based on total weight of the bioactive glass; >0-5 wt.% F-, based on total weight of the bioactive glass; and 0-5 wt.% Na20+K20+Li2O, based on total weight of the bioactive glass, which reads on a glass in terms of weight percentages, comprising: 25-45% of SiO2, 30-50% of CaO, 5-25% of P2O5, 2-10% of ZrO2, and 0.001-3% of F-, as recited in instant claim 2. Also see copending Application No. 18/613,904, claim 5.
As to claim 3, copending Application No. 18/613,904, claim 1 recites a bioactive glass composition in terms of weight percent comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P205, wherein, when the glass is subjected to an artificial saliva at 37 C, a bioactive crystalline phase is formed within 7 days, wherein the artificial saliva consists of 0.119 wt.% potassium chloride, 0.024 wt.% ammonium chloride, 0.054 wt.% potassium dihydrogen phosphate, 0.004 wt.% magnesium chloride hexahydrate, 0.011 wt.% calcium chloride, 0.477 wt.% HEPES buffer, 0.02 wt.% sodium azide, 0.012 wt.% sodium hydroxide, and a balance of water and copending Application No. 18/613,904, claim 6 recites the bioactive glass comprises at least one of: >0-25 wt.% MgO, based on total weight of the bioactive glass; >0-5 wt.% F-, based on total weight of the bioactive glass; and 0-5 wt.% Na20+K20+Li2O, based on total weight of the bioactive glass, which reads on a glass in terms of weight percentages, comprising at least one of: >0-25% of MgO, >0-5% of B2O3, >0-5% of Al2O3, >0-10% of Li2O, >0-10% of Na2O, >0-10% of K2O, >0-10% of SrO, and >0-10% of ZnO, as recited in instant claim 3. Also see copending Application No. 18/613,904, claim 5.
As to claim 4, copending Application No. 18/613,904, claim 1 recites a bioactive glass composition in terms of weight percent comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P205, wherein, when the glass is subjected to an artificial saliva at 37 C, a bioactive crystalline phase is formed within 7 days, wherein the artificial saliva consists of 0.119 wt.% potassium chloride, 0.024 wt.% ammonium chloride, 0.054 wt.% potassium dihydrogen phosphate, 0.004 wt.% magnesium chloride hexahydrate, 0.011 wt.% calcium chloride, 0.477 wt.% HEPES buffer, 0.02 wt.% sodium azide, 0.012 wt.% sodium hydroxide, and a balance of water and copending Application No. 18/613,904, claim 6 recites the bioactive glass comprises at least one of: >0-25 wt.% MgO, based on total weight of the bioactive glass; >0-5 wt.% F-, based on total weight of the bioactive glass; and 0-5 wt.% Na20+K20+Li2O, based on total weight of the bioactive glass, which reads on a glass in terms of weight percentages, comprising 0-10% of Li2O+Na2O+K2O, as recited in instant claim 4. Also see copending Application No. 18/613,904, claim 5.
As to claim 5, copending Application No. 18/613,904, claim 1 recites a bioactive glass composition in terms of weight percent comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P205, wherein, when the glass is subjected to an artificial saliva at 37 C, a bioactive crystalline phase is formed within 7 days, wherein the artificial saliva consists of 0.119 wt.% potassium chloride, 0.024 wt.% ammonium chloride, 0.054 wt.% potassium dihydrogen phosphate, 0.004 wt.% magnesium chloride hexahydrate, 0.011 wt.% calcium chloride, 0.477 wt.% HEPES buffer, 0.02 wt.% sodium azide, 0.012 wt.% sodium hydroxide, and a balance of water and copending Application No. 18/613,904, claim 6 recites the bioactive glass comprises at least one of: >0-25 wt.% MgO, based on total weight of the bioactive glass; >0-5 wt.% F-, based on total weight of the bioactive glass; and 0-5 wt.% Na20+K20+Li2O, based on total weight of the bioactive glass, which reads on a glass in terms of weight percentages, comprising at least one of: 5-30% of F-+P2O5, 30-70% of MgO+CaO, 40-70% of CaO+P2O5, as recited in instant claim 5. Also see copending Application No. 18/613,904, claim 5.
As to claim 6, copending Application No. 18/613,904, claim 1 recites a bioactive glass composition in terms of weight percent comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P205, wherein, when the glass is subjected to an artificial saliva at 37 C, a bioactive crystalline phase is formed within 7 days, wherein the artificial saliva consists of 0.119 wt.% potassium chloride, 0.024 wt.% ammonium chloride, 0.054 wt.% potassium dihydrogen phosphate, 0.004 wt.% magnesium chloride hexahydrate, 0.011 wt.% calcium chloride, 0.477 wt.% HEPES buffer, 0.02 wt.% sodium azide, 0.012 wt.% sodium hydroxide, and a balance of water and copending Application No. 18/613,904, claim 6 recites the bioactive glass comprises at least one of: >0-25 wt.% MgO, based on total weight of the bioactive glass; >0-5 wt.% F-, based on total weight of the bioactive glass; and 0-5 wt.% Na20+K20+Li2O, based on total weight of the bioactive glass, which reads on a glass comprising F-, wherein the F- is derived from calcium fluoride, magnesium fluoride, sodium fluoride, potassium fluoride, stannous fluoride, sodium monofluorophosphate, sodium difluorophosphate, or any combination thereof, as recited in instant claim 6. Furthermore, claim 6 is considered to be a Product-by-Process claim. Claim 6 claims the glass composition based on the starting materials or source materials of the glass composition prior to melting. The source of a material, absent evidence to the contrary, does not materially change the nature of the product itself. In this case, the glass comprises CaO and F- no matter the source of the calcium and fluorine. See MPEP 2113(I) which states:
"[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
As to claim 7, copending Application No. 18/613,904, claim 1 recites a bioactive glass composition in terms of weight percent comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P205, wherein, when the glass is subjected to an artificial saliva at 37 C, a bioactive crystalline phase is formed within 7 days, wherein the artificial saliva consists of 0.119 wt.% potassium chloride, 0.024 wt.% ammonium chloride, 0.054 wt.% potassium dihydrogen phosphate, 0.004 wt.% magnesium chloride hexahydrate, 0.011 wt.% calcium chloride, 0.477 wt.% HEPES buffer, 0.02 wt.% sodium azide, 0.012 wt.% sodium hydroxide, and a balance of water and copending Application No. 18/613,904, claim 6 recites the bioactive glass comprises at least one of: >0-25 wt.% MgO, based on total weight of the bioactive glass; >0-5 wt.% F-, based on total weight of the bioactive glass; and 0-5 wt.% Na20+K20+Li2O, based on total weight of the bioactive glass, which reads on a glass composition is substantially free of a crystalline phase, as recited in instant claim 7.
As to claim 8, copending Application No. 18/613,904, claim 3 recites a bioactive crystalline phase comprises apatite, brushite, or a combination thereof, which reads on when the glass composition is subjected to artificial saliva of Table 1A or Table 1B, the bioactive crystalline phase comprises apatite, as recited in instant claim 8.
As to claim 9, copending Application No. 18/613,904, claim 3 recites a bioactive crystalline phase comprises apatite, brushite, or a combination thereof, which reads the glass composition forming an apatite crystal phase after being subjected to artificial saliva, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, as recited in instant claim 9. As to the limitation of instant claim 9, wherein the glass composition forming an apatite crystal phase after being subjected to artificial saliva, wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, this is an intended use limitation, and since the glass composition comprises the recited amounts of CaO, P2O5, and fluorine it stands that the composition of the reference is the same as those claimed herein and it follows that the glasses of copending Application No. 18/613,904 would inherently possess the formation of the bioactive crystalline phase comprising apatite wherein the apatite comprises hydroxyapatite, fluorapatite, carbonated apatite, or any combination thereof, if subjected to artificial saliva of Table 1A or Table 1B, as recited in instant claim 9. See MPEP 2112.
As to claim 11, copending Application No. 18/613,904, claim 10 recites a composition is in a form of a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, transdermal formulation, or any combination thereof, which reads on a matrix comprising a glass composition, wherein, the glass composition is attached to the matrix or mixed therein, and the matrix includes at least one of: a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, or transdermal formulation, as recited in instant claim 11.
As to claim 12, copending Application No. 18/613,904, claim 10 recites a composition is in a form of a toothpaste, mouthwash, gel, varnish, rinse, spray, ointment, salve, cream, bandage, polymer film, oral formulation, pill, capsule, transdermal formulation, or any combination thereof, which reads on the matrix being substantially free of a fluoride ion source, as recited in instant claim 12.
As to claim 13, copending Application No. 18/613,904, claim 11 recites a composition, wherein the composition is a dentifrice composition or a skin care composition, which reads on the matrix is a dentifrice composition, as recited in instant claim 13.
As to claim 14, copending Application No. 18/613,904, claim 4 recites a composition, wherein the bioactive glass is present in an amount of >0-20 wt.%, based on total weight of the composition, copending Application No. 18/613,904, claim 11 recites a composition is a dentifrice composition, copending Application No. 18/613,904, claim 12 recites a composition comprises: water, glycerin, or both, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, a thickening agent, a pH modifier, a preservative, or any combination thereof, which reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, water, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 14.
As to claim 15, copending Application No. 18/613,904, claim 4 recites a composition, wherein the bioactive glass is present in an amount of >0-20 wt.%, based on total weight of the composition, copending Application No. 18/613,904, claim 11 recites a composition is a dentifrice composition, copending Application No. 18/613,904, claim 12 recites a composition comprises: water, glycerin, or both, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, a thickening agent, a pH modifier, a preservative, or any combination thereof, which reads on the matrix wherein the matrix is a dentifrice composition which comprises:>0-20 wt.% of the glass composition, based on total weight of the matrix, glycerin, and one or more of a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, or any combination thereof, as recited in instant claim 15.
As to claim 16, copending Application No. 18/613,904, claim 13 recites a method for making the composition comprising combining the amino acid, the bioactive glass, and optionally one or more of water, glycerin, a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a whitening agent, an abrasive, a thickening agent, a pH modifier, a preservative, or any combination thereof, which reads on a method for making the matrix, comprising combining the glass composition with a carrier as recited in claim 16.
As to claim 17, copending Application No. 18/613,904, claim 14 recites a method comprising applying to a tooth the composition, which reads on a method comprising applying to a tooth the matrix, as recited in instant claim 17.
As to claim 18, copending Application No. 18/613,904, claim 14 recites a method wherein the method remineralizes enamel of the tooth, treats caries of the tooth, treats dentin hypersensitivity of the tooth, or any combination thereof, which reads on a method which remineralizes enamel of the tooth, treats caries of the tooth, treats dentin hypersensitivity of the tooth, or any combination thereof, as recited in instant claim 18.
Conclusion
The additional references cited on the 892 have been cited as art of interest since they are considered to be cumulative to or less than the art relied upon in the rejections above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Elizabeth A. Bolden whose telephone number is (571)272-1363. The examiner can normally be reached 10:00 am to 6:30 pm M-F.
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, Amber R. Orlando can be reached at 571-270-3149. 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.
/Elizabeth A. Bolden/Primary Examiner, Art Unit 1731
EAB
16 July 2026
Prosecution Insights