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 .
Priority
The instant application claims domestic priority to PRO 62/727,377 filed 09/05/2018 and PRO 62/847,807 filed 05/14/2019. The instant application is a 371 of PCT/CA2019/051237 filed 09/04/2019. The instant application is a CON of 17/273,661 filed 03/04/2021.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Please see Specification paragraph [0092].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
A) Claims 88-90 are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. (WO 2011085092 A1).
Jung et al teaches a borate-based glass reproduced below (Jung at [0054]). Jung recites a glass comprising from about 40% to about 80% B2O3, one or more alkaline earth oxides including Na2O and one or more alkaline earth oxides including MgO, SrO, and CaO (Jung at claim 4).
Jung further teaches that the fluoride can be in the form of CaF2 in an amount from about 5wt% to 40wt% (Jung at [0071]).
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Jung differs from instant claim 88 insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation.
Given the prior art disclosure of each instantly recited component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Jung to have selected and combined prior art components for their established functions with predictable results. MPEP §2143 and §2144.06(I). More specifically, it would be prima facie obvious to one of ordinary skill in the art prior following the teachings of Jung to have combined at least 3 components of paragraph 54 to yield the predictable result of forming a bioactive glass having improved bone growth (Jung at [0039]) as taught by Jung.
With regard to the ranges instantly claimed, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP §2144.05(I).
Regarding instant claim 88, Jung teaches that the glass may comprise; 40 to 80 wt% B2O3, 0 to 25 wt% Na2O, 0 to 40 wt% CaO, and 0 to 25% MgO which means that the composition of Jung is able to overlap with the instant range of about 90 mol% to about 95 mol% (Jung at [0054]). With regard to the ranges instantly claimed, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP §2144.05(I). Jung further teaches that the composition may contain four or more components which would produce at least a quaternary system (Jung at [0054]). Jung recites a glass comprising from about 40% to about 80% B2O3, one or more alkaline earth oxides including Na2O and one or more alkaline earth oxides including MgO, SrO, and CaO (Jung at claim 4). Jung teaches that the glass may comprise 5 to 40 wt% CaF2 (Jung at [0071]),which overlaps the instantly claimed range of about 5 mol% to about 10 mol%. With regard to the ranges instantly claimed, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP §2144.05(I). Jung teaches that the glass may comprise; 40 to 80 wt% B2O3, 0 to 25 wt% Na2O, 0 to 40 wt% CaO, , 0 to 25% MgO and 5 to 40 wt% CaF2. This combination of components is capable of producing the ratio of elements described in the instant invention. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 89, Jung teaches that the glass may comprise; 40 to 80 wt% B2O3 which means that the composition of Jung is able to overlap with the instant range of about 50mol%, 0 to 25 wt% Na2O which means that the composition of Jung is able to overlap with the instant range of about 15 mol%, 0 to 40 wt% CaO which means that the composition of Jung is able to overlap with the instant range of about 10 mol%, 0 to 25 wt% MgO which means that the composition of Jung is able to overlap with the instant range of about 20 mol% (Jung at [0054]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Jung teaches that the glass may comprise 5 to 40 wt% CaF2 (Jung at [0071]), which overlaps the instantly claimed range of about 5 mol%. With regard to the ranges instantly claimed, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP §2144.05(I).
Regarding instant claim 90, Jung teaches that the glass may comprise 5 to 40 wt% CaF2 (Jung at [0071]), which overlaps the instantly claimed range of about 5 mol%. With regard to the ranges instantly claimed, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP §2144.05(I).
B) Claims 91 and 93-96 are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. (WO 2011085092 A1) in view of Kuromitsu et al (JP 2000264677A).
The teachings of Jung are discussed above.
The teaching of Jung differs from claim 93 insofar as Jung does not teach a size for the glass particles. The teachings of Kuromitsu cure this deficit.
Kuromitsu et al teaches a glass composition comprises 0-40 mol.% of SiO2, 10-60 mol.% of B2O3, 10-50 mol.% of one or more kinds of alkaline earth metal oxides selected from the group consisting of MgO, CaO, SrO and BaO, 5-50 mol.% of one or more kinds of oxides selected from the group consisting of Li2O, Na2O and K2O and 0-10 mol.% of one or more kinds of fluorides selected from the group consisting of BaF2, CaF2, SrF2, MgF2 and AlF3 (Kuromitsu at overview). Kuromitsu teaches that the glass ranges in particle diameter from 0.1 micron to 30 microns (Kuromitsu at [0011]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Jung et al. disclose wherein the glass composition comprises a bioactive glass, but does not disclose a particle size. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the bioactive glass particles of Jung et al. to have a size within the range of 0.1 microns to 30 microns since that size is a known and effective size for bioactive glass particles used in bioactive glass compositions as taught by Kuromitsu.
With regards to claim 91, Jung teaches that where the biocompatible glass material is borate-based or phosphate-based, the trace element concentration is less than 5 wt%, and it may be higher and up to 10 wt% where the biocompatible material is silicate-based. The trace elements are selected from the group consisting of Ag, Cu, F, Fe, Mn, Mo, Ni, Sr, and Zn (Jung at [0040]). Kuromitsu teaches the use of NaF as a fluoride source used in an amount of 10 mol% (Kuromitsu at Table 3). It would have been prima facie obvious to have used the NaF as the fluoride source in Jung because Kuromitsu teaches it as a fluoride source in B2O3 glasses. One would have a reasonable expectation of success because the NaF is being used for its intended purpose as a fluoride source in a glass. See MPEP 2144.07. See MPEP 2144.06(I).
With regards to the ranges in claim 93, Kuromitsu teaches that the glass ranges in particle diameter from 0.1 micron to 30 microns (Kuromitsu at [0011]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Jung teaches a bioactive glass and Kuromitsu teaches a bioactive glass with a particle range between 0.1microns and 30 microns. Jung and Kuromitsu teach a composition comprising substantially the same compounds as the instantly claimed invention, in substantially the same amounts as the claimed invention, and with same size as the instantly claimed invention. Therefore, one of ordinary skill in the art would reasonably conclude that the composition of Jung and Kuromitsu has substantially the same properties, such as the one disclosed in instant claims 93, as the claimed invention. Where all of the recited structural limitations are met by the prior art there is a reasonable expectation that the functional properties would also be met.
Regarding instant claim 94-96, Kuromitsu teaches that the glass ranges in particle diameter from 0.1 micron to 30 microns (Kuromitsu at [0011]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
C) Claim 97 is rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. (WO 2011085092 A1) and Kuromitsu et al (JP 2000264677A), in view of Rokitowski et al. (U.S. Patent 8,715,625 B1).
The teachings of Jung and Kuromitsu are discussed above. Kuromitsu further teaches using this glass in a paste with a viscosity of 1000-500,000 cps (Kuromitsu at [0007]).
The combined teachings of Jung and Kuromitsu differ from claim 97 insofar as they fail to teach the glass composition used specifically in a dentin desensitizing composition. The teachings of Rokitowski et al. cure this deficit.
Rokitowski teaches an anhydrous toothpaste with a bioactive glass (Rokitowski at claim 1). Rokitowski teaches that bioactive glass chemically reacts with the surface of dentin and intimately bonds to a tooth's structure, creating a new mineral layer which leads to a significant reduction in the amount of sensitivity and significantly reducing the reopening of dentin tubules due to contact with oral fluids (Rokitowski at [0057]). Rokitowski further teaches the particulate bioactive and biocompatible glass with a particle size range less than about 5μm or alternatively less than about 2μm. An effective amount of bioactive glass includes compositions that are between 5-8 percent by weight bioactive glass (Rokitowski at [0061]). Rokitowski further teaches that the viscosity of the composition can be changed with thickening agents (Rokitowski at [0069]) and that the compositions have a viscosity between 100,000 to 350,000 cps @ 25°C (Rokitowski at claim 6). Rokitowski further teaches a method of cleaning, remineralizing and reducing plaque buildup by putting the toothpaste on teeth (Rokitowski at claims 12 and 13).
Regarding instant claim 97, Rokitowski teaches an anhydrous toothpaste (Rokitowski at claim 1) using bioactive and biocompatible glass (Rokitowski at [0061]), which is used in desensitizing (Rokitowski at [0057]), and a pharmaceutically acceptable carrier (Rokitowski at claim 1). Rokitowski further teaches the particulate bioactive and biocompatible glass have a particle size range of less than about 2 μm.
It would be prima facie obvious to substitute the glass taught by Jung and Kuromitsu for the bioactive glass used in Rokitowski’s toothpaste because the compositions have similar structures and perform the same function of a bioactive glass to yield the predictable result of a desensitizing toothpaste. See MPEP §2143(I)(B) and MPEP §2144.06(II).
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
I) Claims 88-91 and 93-97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,076,424 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires a water-free, orally compatible carrier in the independent claim which is not presently required in the independent claim of the instant application. The instant application recites a glass comprising: fluoride, which is provided as from about 5 mol% to about 10 mol% of CaF2, SnF2, NaF, KF, or any combination thereof; and from about 90 mol% to about 95 mol% of a combination of B2O3, Na2O, MgO, and CaO, wherein the boron, the magnesium, the combination of sodium and any potassium, and the combination of calcium and any tin in the glass composition are present in elemental ratios of about 20 : about 4 : about 6 : about 3, respectively.
The reference patent recites dentin-desensitizing composition comprising: (i) glass particles that are from about 1 to about 50 um in size; and (ii) a water-free, orally-compatible carrier; wherein: the glass particles lose at least 5 mass % within 24 hours when exposed to a buffered saline solution; the composition of the glass particles consists of: about 50 mol % B2O3, about 15 mol % Na2O, about 20 mol % MgO, about 10 mol % CaO, and about 5 mol % NaF, KF, CaF2, SnF2, or any combination thereof (‘424 at claim 1). The reference patent recites wherein the composition is a mouthwash, a toothpaste, a dental gel, a prophylaxis paste, a tooth varnish, or a bonding agent (‘424 at claim 2). The reference patent recites wherein the orally-compatible carrier is an orally-compatible viscous carrier that has a viscosity from about 100 cP at 30° C. to about 150,000 cp at 30° C (‘424 at claim 3). The reference patent recites a method of at least temporarily reducing, in an individual, pain associated with sensitive teeth, the method comprising applying the toothpaste, prophylaxis paste, or tooth varnish according to claim 2 to dentin in the individual (‘424 at claim 4). The reference patent recites wherein the fluoride is provided as about 5 mol % of CaF2 (‘424 at claim 5). The reference patent recites wherein at least 75%, at least 85%, or at least 95% of the particles are smaller than 50 μm in size, and/or wherein at least 5% of the particles are smaller than 7 μm in size (‘424 at claim 6). The reference patent recites wherein: a) at least 5% of the glass particles are smaller than 35 μm in size, at least 5% of the particles are smaller than 15 μm in size, and at least 5% of the particles are smaller than 7 μm in size; or b) at least 5% of the glass particles are from about 15 μm to about 35 μm in size, at least 5% of the particles are from about 6 μm to about 15 μm in size, and at least 5% of the particles are from about 3 μm to about 7 μm in size (‘424 at claim 7). The reference patent recites wherein: about 10% of the glass particles are smaller than 5 μm in size, about 50% of the glass particles are smaller than 15 μm in size, and about 90% of the glass particles are smaller than 30 μm in size (‘424 at claim 8).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
II) Claims 88-91 and 93-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40, 44, 47-52, 58, and 61 of copending Application No. 17/909,247 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application does not require a specific ratio of elements, which is presently required in the independent claim of the instant application. The instant application recites a glass comprising: fluoride, which is provided as from about 5 mol% to about 10 mol% of CaF2, SnF2, NaF, KF, or any combination thereof; and from about 90 mol% to about 95 mol% of a combination of B2O3, Na2O, MgO, and CaO, wherein the boron, the magnesium, the combination of sodium and any potassium, and the combination of calcium and any tin in the glass composition are present in elemental ratios of about 20 : about 4 : about 6 : about 3, respectively.
The reference application recites a glass composition comprising: from 45 mol% to about 95 mol% of B203;from about 3 mol% to about 60 mol% of one or more glass components selected from the group consisting of: K20, Na20, CaO, and MgO; and from about 2 mol% to about 45 mol%, of CaF2, SnF2, NaF, KF, Na2PO3F, or a combination thereof; wherein the glass composition comprises B203 and MgO; and wherein the glass composition comprises: substantially no CuO; less than 0.1 mol% of Li2O;less than 0.1 mol% of Rb20;less than 0.1 mol% of BaO; less than 0.1 mol% of P205;less than 0.1 mol% SiO2;less than 30 mol% of MgO; less than 30 mol% of CaF2 or SnF2; and less than 30 mol% of a combination of CaF2 and SnF2 (‘247 recites at claim 1). The reference application recites wherein the glass composition comprises B203, MgO, and CaO (‘247 recites at claim 2). The reference application recites wherein the glass composition comprises (a) B203, (b) MgO and optionally CaO, and (c) one or more of Na2O and K20 (‘247 recites at claim 3). The reference application recites wherein the glass composition comprises B203, MgO, CaO, and one or more of Na2O and K20 (‘247 recites at claim 4). The reference application recites wherein the glass composition comprises one or more of: NaF, KF, and CaF2 (‘247 recites at claim 5). The reference application recites wherein the glass composition comprises from 45 mol% to about 55 mol% B203 (‘247 recites at claim 6). The reference application recites wherein the glass composition comprises from about 5 mol% to about 15 mol% K20 (‘247 recites at claim 7). The reference application recites wherein the glass composition comprises from about 5 mol% to about 15 mol% Na20 (‘247 recites at claim 8). The reference application recites wherein the glass composition comprises from about 10 mol% to about 20 mol% CaO (‘247 recites at claim 9). The reference application recites wherein the glass composition comprises from 1 mol% to about 30 mol% MgO (‘247 recites at claim 10). The reference application recites wherein the glass composition comprises from about 10 mol% to about 25 mol% MgO (‘247 recites at claim 11). The reference application recites wherein the glass composition comprises less than 0.1 mol% of ZnO, and less than 0.1 mol% of SrO (‘247 recites at claim 12). The reference application recites wherein the glass composition comprises substantially no CuO, substantially no Li20, substantially no Rb20, substantially no BaO, and substantially no P205 (‘247 recites at claim 13). The reference application recites wherein the composition does not include: from about 5 mol% to about 10 mol% of CaF2, SnF2, NaF, KF, Na2PO3F, or a combination thereof, and from about 90 mol% to about 95 mol% of a combination of B203, Na20, MgO, and CaO, where the boron, the magnesium, the combination of sodium and any potassium, and the Ca in the glass composition are present in elemental ratios of about 20: about 4: about 6: about 3, respectively (‘247 recites at claim 14). The reference application recites wherein the composition does not include about 50 mol% B203; about 15 mol% Na2O; about 20 mol% MgO; about 10 mol% CaO; and about 5 mol% NaF, KF, CaF2, SnF2, or any combination thereof (‘247 recites at claim 15). The reference application recites comprising: from about 5 mol% to about 10 mol% of CaF2, SnF2, NaF, KF, or a combination thereof; and from about 90 mol% to about 95 mol% of a combination of B203, Na2O, MgO, and CaO; wherein the boron, the magnesium, the combination of sodium and any potassium, and the Ca in the glass composition are present in elemental ratios of about 20: about 4:about 6: about 3, respectively (‘247 recites at claim 16). The reference application recites comprising: about 50 mol% B203, about 15 mol% Na2O, about 20 mol% MgO, about 10 mol% CaO, and about 5 mol% NaF, KF, CaF2, SnF2, or any combination thereof (‘247 recites at claim 17). The reference application recites comprising: about 50 mol% B203, about 15 mol% Na2O, about 20 mol% MgO, about 10 mol% CaO, and about 5 mol% CaF2 (‘247 recites at claim 18). The reference application recites comprising: about 48 mol% B203, about 9 mol% Na2O, about 19 mol% MgO, about 14 mol% CaO, and about 10 mol% NaF (‘247 recites at claim 19). The reference application recites wherein the glass composition is a particulate material that comprises particles that are from about 1 to about 50 pm in size (‘247 recites at claim 20). The reference application recites wherein at least 75% of the particles are smaller than 50 pm in size (‘247 recites at claim 21). The reference application recites wherein at least 85% of the particles are smaller than 50 pm in size (‘247 recites at claim 22). The reference application recites wherein at least 95% of the particles are smaller than 50 pm in size (‘247 recites at claim 23). The reference application recites wherein at least 5% of the particles are smaller than 7 pm in size (‘247 recites at claim 24). The reference application recites wherein: at least 5% of the particles are smaller than 35 pm in size, at least 5% of the particles are smaller than 15 pm in size, and at least 5% of the particles are smaller than 7 pm in size (‘247 recites at claim 25). The reference application recites wherein: at least 5% of the particles are from about 15 pm to about 35 pm in size, at least 5% of the particles are from about 6 pm to about 15 pm in size, and at least 5% of the particles are from about 3 pm to about 7 pm in size (‘247 recites at claim 26). The reference application recites about 10% of the particles are smaller than 5 pm in size, about 50% of the particles are smaller than 15 pm in size, and about 90% of the particles are smaller than 30 pm in size (‘247 recites at claim 27). The reference application recites wherein the glass composition loses at least 5 mass% within 24 hours when exposed to a buffered saline solution (‘247 recites at claim 28). The reference application recites wherein the glass composition loses at least 20 mass% within 24 hours when exposed to a buffered saline solution (‘247 recites at claim 29). The reference application recites wherein the glass composition loses at least 40 mass% within 24 hours when exposed to a buffered saline solution (‘247 recites at claim 30). The reference application recites wherein the glass composition loses at least 60 mass% within 24 hours when exposed to a buffered saline solution (‘247 recites at claim 31). The reference application recites wherein the glass composition loses at least 80 mass% within 24 hours when exposed to a buffered saline solution (‘247 recites at claim 32). The reference application recites a toothpaste comprising the glass composition according to claim 20 (‘247 recites at claim 33). The reference application recites a toothpaste comprising the glass composition according to claim 20, wherein the toothpaste includes a sufficient amount of the glass composition to result in about 500 ppm (m/m) to about 1,500 ppm (m/m) of the fluoride (‘247 recites at claim 34). The reference application recites wherein the toothpaste further comprises glycerin; sodium lauryl sulphate; silica; Carbopol 940; and a flavoring agent (‘247 recites at claim 35). The reference application recites wherein the toothpaste comprises about 85 mass% glycerol, about 1.2 mass% sodium lauryl sulphate, about 7.5 mass% silica, about 0.5 mass% Carbopol 940, about 1.0 mass% flavoring agent, and about 5.0 mass% of the glass composition (‘247 recites at claim 36). The reference application recites a prophylaxis paste comprising the glass composition according to claim 20 (‘247 recites at claim 37). The reference application recites wherein the toothpaste includes a sufficient amount of the glass composition to result in about 1,000 ppm (m/m) to about 1,500 ppm (m/m) of the fluoride (‘247 recites at claim 38). The reference application recites a tooth varnish comprising the glass composition according to claim 20 (‘247 recites at claim 39). The reference application recites wherein the toothpaste includes a sufficient amount of the glass composition to result in about 1,000 ppm (m/m) to about 5000 ppm (m/m) of the fluoride (‘247 recites at claim 40). The reference application recites a method of at least temporarily reducing, in an individual, pain associated with sensitive teeth, the method comprising applying: the toothpaste according to claim 33, to dentin in the individual (‘247 recites at claim 44). The reference application recites a dentin-desensitizing composition comprising:(i) the glass composition according to claim 20; and(ii) a water-free, orally-compatible carrier (‘247 recites at claim 47). The reference application recites wherein the orally-compatible carrier is a mouthwash (‘247 recites at claim 48). The reference application recites wherein the orally-compatible carrier is formulated to mix with a mouthwash (‘247 recites at claim 49). The reference application recites wherein the orally-compatible carrier is an orally-compatible viscous carrier (‘247 recites at claim 50). The reference application recites wherein the orally-compatible viscous carrier has a viscosity from about 100 cP at 30°C to about 150,000 cp at 30°C (‘247 recites at claim 51). The reference application recites wherein the orally-compatible viscous carrier is a toothpaste, a dental gel, a prophylaxis paste, a tooth varnish, or a bonding agent (‘247 recites at claim 52). The reference application recites a method to increase surface enamel microhardness, the method comprising applying the toothpaste according to claim 33 to enamel in the individual (‘247 recites at claim 55). The reference application recites a method to at least partially remineralize surface enamel, the method comprising applying the toothpaste according to claim 33 to enamel in the individual (‘247 recites at claim 58). The reference application recites a method to at least partially occlude one or more dentin tubules, the method comprising applying the toothpaste according to claim 33 to the dentin tubules in an individual (‘247 recites at claim 61).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
III) Claims 88-91 and 93-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-10,12-47, 51-52, 54-60, 62, 65, 68, and 70 of copending Application No.17/910,296 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application does not require a specific ratio of elements, which is presently required in the independent claim of the instant application. The instant application recites a glass comprising: fluoride, which is provided as from about 5 mol% to about 10 mol% of CaF2, SnF2, NaF, KF, or any combination thereof; and from about 90 mol% to about 95 mol% of a combination of B2O3, Na2O, MgO, and CaO, wherein the boron, the magnesium, the combination of sodium and any potassium, and the combination of calcium and any tin in the glass composition are present in elemental ratios of about 20 : about 4 : about 6 : about 3, respectively.
The reference application recites a glass composition comprising: from about 20 mol% to 45 mol% of B203;from about 10 mol% to about 80 mol% of one or more glass components selected from the group consisting of CaO and MgO; optionally one or more glass components selected from the group consisting of Na20, K20, and a phosphate source; and optionally up to about 45 mol% of CaF2, SnF2, NaF, KF, Na2PO3F, or a combination thereof; wherein the composition comprises less than 0.1 mol% CdO, and less than 0.1 mol% phosphate (‘296 at claim 1). The reference application recites wherein the glass composition comprises:a) from about 10 mol% to about 80 mol% of CaO;b) from about 10 mol% to about 80 mol% of MgO;c) from about 10 mol% to about 80 mol% of a combination of CaO and MgO;d) from about 10 mol% to about 80 mol% of a combination of (i) CaO, and (ii) Na2O or K20 or both;e) from about 10 mol% to about 80 mol% of a combination of (i) MgO, and (ii) Na2O or K20 or both; or f) from about 10 mol% to about 80 mol% of a combination of (i) CaO, (ii) MgO, and (iii) Na2O or K20 or both (‘296 at claim 4). The reference application recites wherein the glass composition comprises Na2O, CaO, and MgO in a molar ratio of 1.0 to 0.5-2.5 to 0.5- 2.5 (Na2O : CaO : MgO) (‘296 at claim 5). The reference application recites wherein the glass composition comprises:a) from about 16 mol% to about 22 mol% Na2O, from about 11 mol% to about 17 mol% CaO, and from about 16 mol% to about 22 mol% MgO;b) from about 14 mol% to about 20 mol% Na2O, from about 14 mol% to about 20 mol% CaO, and from about 16 mol% to about 22 mol% MgO;c) from about 11 mol% to about 17 mol% Na2O, from about 16 mol% to about 22 mol% CaO, and from about 16 mol% to about 22 mol% MgO; or d) from about 13 mol% to about 19 mol% Na2O, from about 18 mol% to about 24 mol% CaO, and from about 18 mol% to about 24 mol% MgO (‘296 at claim 6). The reference application recites wherein the molar ratio of (B203 + MgO) : (CaO + Na2O + K20) is greater than 1.0, such as greater than 1.15 or greater than 1.30 (‘296 at claim 7). The reference application recites wherein the glass composition comprises at least 54 mol%, such as at least 57 mol%, of a combination of B203 and MgO (‘296 at claim 8). The reference application recites wherein the glass composition comprises at least 33 mol%, such as at least 40 mol% or at least 50 mol%, of a combination of CaO and MgO (‘296 at claim 9). The reference application recites wherein the glass composition comprises at least 7 mol%, such as at least 15 mol% or at least 30 mol%, of a combination of N20 and K20 (‘296 at claim 10). The reference application recites wherein the glass composition consists essentially of B203, one or both of Na2O and K20, and one or both of CaO and MgO (‘296 at claim 12). The reference application recites wherein the glass composition comprises B203, one or both of Na2O and K20, and one or both of CaO and MgO in amounts according to any one of the compositions listed in the following table:
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(‘296 at claim 13). The reference application recites wherein the glass composition comprises less than 30 mol% of CaF2 or SnF2; and less than 30 mol% of a combination of CaF2 and SnF2 (‘296 at claim 14). The reference application recites wherein the glass composition comprises from about 2 mol% to about 15 mol% of CaF2, SnF2, NaF, KF, Na2PO3F, or a combination thereof, such as from about 5 mol% to about 15 mol% of CaF2, NaF, KF or a combination thereof (‘296 at claim 15). The reference application recites comprising: about 43 mol% of B203, about 21 mol% MgO, about 21 mol% CaO, and about 15 mol% Na2O; such as comprising 43.0 mol% of B203, 20.7 mol% MgO, 20.7 mol% CaO, and 15.6 mol% Na2O (‘296 at claim 16). The reference application recites comprising: from about 25 mol% to about 45 mol%, such as from about 41 mol% to about 45 mol%, of B203; from about 10 mol% to about 23 mol%, such as from about 13 mol% to about 23 mol%, of CaO; from about 10 mol% to about 30 mol%, such as from about 18 mol% to about 23 mol%, of MgO; and from about 8 mol% to about 22 mol%, from about 13 mol% to about 22 mol%, of Na2O;and optionally from about 8 mol% to about 15 mol% of NaF, KF, CaF2, or any combination thereof. (‘296 at claim 17). The reference application recites comprising: from about 25 mol% to about 43 mol% B203; from about 14 mol% to about 21 mol% CaO; from about 19 mol% to about 29 mol% MgO; from about 9 mol% to about 15 mol% Na20; and from about 9 mol% to about 15 mol% of NaF, KF, CaF2, or any combination thereof (‘296 at claim 18). The reference application recites comprising: from about 29 mol% to about 45 mol% of B203; from about 5 mol% to about 22 mol% of CaO; from about 1 mol% to about 22 mol% of MgO; from 0 mol% to about 15 mol% of K20; and from about 5 mol% to about 18 mol% of Na2O (‘296 at claim 19). The reference application recites wherein the glass composition comprises less than 0.1 mol% of ZnO, such as substantially no ZnO; less than 0.1 mol% of CuO; less than 0.1 mol% of Li2O; less than 0.1 mol% of Rb2O; less than 0.1 mol% of BaO; less than 0.1 mol% of SrO; less than 0.1 mol% of SiO2; or any combination thereof (‘296 at claim 20). The reference application recites wherein the glass composition is a particulate material that comprises particles that are from about 1 to about 50 pm in size (‘296 at claim 21). The reference application recites wherein at least 75% of the particles are smaller than 50 pm in size (‘296 at claim 22). The reference application recites wherein at least 85% of the particles are smaller than 50 pm in size (‘296 at claim 23). The reference application recites wherein at least 95% of the particles are smaller than 50 pm in size (‘296 at claim 24). The reference application recites wherein at least 5% of the particles are smaller than 7 pm in size (‘296 at claim 25). The reference application recites wherein: at least 5% of the particles are smaller than 35 pm in size, at least 5% of the particles are smaller than 15 pm in size, and at least 5% of the particles are smaller than 7 pm in size (‘296 at claim 26). The reference application recites wherein: at least 5% of the particles are from about 15 pm to about 35 pm in size, at least 5% of the particles are from about 6 pm to about 15 pm in size, and at least 5% of the particles are from about 3 pm to about 7 pm in size (‘296 at claim 27). The reference application recites wherein: about 10% of the particles are smaller than 5 pm in size, about 50% of the particles are smaller than 15 pm in size, and about 90% of the particles are smaller than 30 pm in size (‘296 at claim 28). The reference application recites wherein the glass composition loses at least 5 mass% within 24 hours when exposed to a buffered saline solution (‘296 at claim 29). The reference application recites wherein the glass composition loses at least 20 mass% within 24 hours when exposed to a buffered saline solution (‘296 at claim 30). The reference application recites wherein the glass composition loses at least 40 mass% within 24 hours when exposed to a buffered saline solution (‘296 at claim 31). The reference application recites wherein the glass composition loses at least 60 mass% within 24 hours when exposed to a buffered saline solution (‘296 at claim 32). The reference application recites wherein the glass composition loses at least 80 mass% within 24 hours when exposed to a buffered saline solution (‘296 at claim 33). The reference application recites a toothpaste comprising the glass composition according to claim 21 (‘296 at claim 34). The reference application recites wherein the glass composition comprises from about 2 mol% to about 15 mol% of CaF2, SnF2, NaF, KF, Na2PO3F, or a combination thereof, such as from about 5 mol% to about 15 mol% of CaF2, NaF, KF or a combination thereof, and wherein the toothpaste includes a sufficient amount of the glass composition to result in about 500 ppm to about 1,500 ppm of the fluoride, such as from about 750 ppm to about 1,500 ppm of the fluoride, or from about 1,000 ppm to about 1,500 ppm of the fluoride (‘296 at claim 35). The reference application recites wherein the glass composition lacks fluoride, and the toothpaste includes a sufficient amount of a fluoride source, such as sodium fluoride, to result in about 1000 ppm to about 1500 ppm fluoride (‘296 at claim 36). The reference application recites a toothpaste comprising: the glass composition according to claim 21; glycerin; sodium lauryl sulphate; silica; Carbopol 940; and a flavoring agent (‘296 at claim 37). The reference application recites wherein the glass composition is about 2.5 wt%to about 7.5 wt% of the toothpaste (‘296 at claim 38). The reference application recites wherein the toothpaste is substantially water-free (‘296 at claim 39). The reference application recites a prophylaxis paste comprising the glass composition according to claim 21 (‘296 at claim 40). The reference application recites wherein the glass composition comprises from about 2 mol% to about 15 mol% of CaF2, SnF2, NaF, KF, Na2PO3F, or a combination thereof, such as from about 5 mol% to about 15 mol% ofCaF2, NaF, KF or a combination thereof, and wherein the toothpaste includes a sufficient amount of the glass composition to result in about 1,000 ppm to about 1,500 ppm of the fluoride (‘296 at claim 41). The reference application recites wherein the glass composition lacks fluoride and the prophylaxis paste includes a sufficient amount of a fluoride source, such as sodium fluoride, to result in about 1000 ppm to about 1500 ppm fluoride (‘296 at claim 42). The reference application recites the prophylaxis paste according to claim 40, wherein the prophylaxis paste is substantially water-free (‘296 at claim 43). The reference application recites a tooth varnish comprising the glass composition according to claim 21 (‘296 at claim 44). The reference application recites wherein the glass composition comprises from about 2 mol% to about 15 mol% of CaF2, SnF2, NaF, KF, Na2PO3F, or a combination thereof, such as from about 5 mol% to about 15 mol% of CaF2, NaF, KF or a combination thereof, and wherein the tooth varnish includes a sufficient amount of the glass composition to result in about 1,000 ppm to about 5000 ppm of the fluoride (‘296 at claim 45). The reference application recites wherein the glass composition lacks fluoride and the tooth varnish includes a sufficient amount of a fluoride source, such as sodium fluoride, to result in about 1000 ppm to about 5000 ppm fluoride (‘296 at claim 46). The reference application recites wherein the tooth varnish is substantially water-free (‘296 at claim 47). The reference application recites a method of at least temporarily reducing, in an individual, pain associated with sensitive teeth, the method comprising applying: the toothpaste according to claim 34, to dentin in the individual (‘296 at claim 51). The reference application recites a glass composition according to claim 21 for desensitizing dentin (‘296 at claim 52). The reference application recites a dentin-desensitizing composition comprising:(i) the glass composition according to claim 21; and(ii) a water-free, orally-compatible carrier (‘296 at claim 54). The reference application recites wherein the orally- compatible carrier is a mouthwash (‘296 at claim 55). The reference application recites wherein the orally- compatible carrier is formulated to mix with a mouthwash (‘296 at claim 56). The reference application recites wherein the orally- compatible carrier is an orally-compatible viscous carrier (‘296 at claim 57). The reference application recites wherein the orally- compatible viscous carrier has a viscosity from about 100 cP at 30°C to about 150,000 cp at 30°C (‘296 at claim 58). The reference application recites wherein the orally- compatible viscous carrier is a toothpaste, a dental gel, a prophylaxis paste, a tooth varnish, or a bonding agent (‘296 at claim 59). The reference application recites wherein the glass is a bulk glass, for preparing a particulate glass composition (‘296 at claim 60). The reference application recites a method to increase surface enamel microhardness, the method comprising applying the toothpaste according to claim 34 to enamel in the individual (‘296 at claim 62). The reference application recites a method to at least partially remineralize surface enamel, the method comprising applying the toothpaste according to claim 34 to enamel in the individual (‘296 at claim 65). The reference application recites a method to at least partially occlude one or more dentin tubules, the method comprising applying the toothpaste according to claim 34 to the dentin tubules in an individual (‘296 at claim 68). The reference application recites wherein the glass composition comprises no ZrO2 (‘296 at claim 70).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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