DETAILED ACTION
Applicants' arguments, filed 08/20/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 63/071,530 filed on 08/28/2020.
Claim Rejections - 35 USC § 112 New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim1-6 and 9-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 as amended recites “A dental care composition for treating or preventing a dental condition in the oral cavity of a subject, the composition comprising: spherical-shaped metal nanoparticles having a particle size and a particle size distribution and/or coral-shaped metal nanoparticles having a particle size and a particle size distribution, wherein the metal nanoparticles are uncoated; and a carrier in which the spherical-shaped metal nanoparticles are dispersed so as to form a single part dental care composition formulated to treat or prevent the dental condition; wherein the dental care composition is provided in the form of a dentifrice, tooth paste, tooth gel, mouth wash, mouth rinse, lozenge, chewable tablet, dental implement, or denture cleaning solution to bring the spherical-shaped metal nanoparticles and/or coral-shaped metal nanoparticles into contact with tooth surfaces, wherein the dental care composition is not a spray, and wherein the dental care composition is formulated so that application of the dental care composition to the tooth surfaces adjusts the pH level at tooth surface microenvironments to a target pH level in a range of about 6.5 to about 7.25.” (emphasis added), it is presently unclear where the limitation “and a carrier in which the spherical-shaped metal nanoparticles are dispersed so as to form a single part dental care composition formulated to treat or prevent the dental condition” is supported within the specification. The instant specification does not, to the best of the Examiners understanding, positively disclose a specifically single phase or single part dental care composition nor does it specifically exclude a multipart composition. Because it is unclear if the claim amendment is supported by the instant specification the amendment is currently considered new matter. As such the claims that are dependent on claim 1, 2-6 and 9-14 are also new matter.
Claim Rejections - 35 USC § 112 indefiniteness
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 1-6 and 9-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 as amended recites “A dental care composition for treating or preventing a dental condition in the oral cavity of a subject, the composition comprising: spherical-shaped metal nanoparticles having a particle size and a particle size distribution and/or coral-shaped metal nanoparticles having a particle size and a particle size distribution, wherein the metal nanoparticles are uncoated; and a carrier in which the spherical-shaped metal nanoparticles are dispersed so as to form a single part dental care composition formulated to treat or prevent the dental condition; wherein the dental care composition is provided in the form of a dentifrice, tooth paste, tooth gel, mouth wash, mouth rinse, lozenge, chewable tablet, dental implement, or denture cleaning solution to bring the spherical-shaped metal nanoparticles and/or coral-shaped metal nanoparticles into contact with tooth surfaces, wherein the dental care composition is not a spray, and wherein the dental care composition is formulated so that application of the dental care composition to the tooth surfaces adjusts the pH level at tooth surface microenvironments to a target pH level in a range of about 6.5 to about 7.25.” (emphasis added), it is presently unclear if the limitation “and a carrier in which the spherical-shaped metal nanoparticles are dispersed so as to form a single part dental care composition formulated to treat or prevent the dental condition” is present for only embodiments with spherical nanoparticles, or is present in embodiments with only coral shaped nanoparticles, or is present in embodiments with both spherical and coral nanoparticles. Because the metes and bounds of the limitation is unclear the claim is at present indefinite. As such the claims that are dependent on claim 1, 2-6 and 9-14 are also indefinite.
Claim Rejections - 35 USC § 103 - Obviousness
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 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.
Claims 1-6 and 9-22 remain rejected under 35 U.S.C. 103 as being unpatentable over O’Malley (US Patent Application Publication 20150030546A1) in view of Tarbet et al (U.S. Patent 9,839,652 B2).
O’Malley recites a two-part oral care system includes a first vessel containing an oxidative composition having a pH less than 7.5 and a second vessel containing a reductant composition having a pH greater than 7 (O’Malley at claim 1). O’Malley further recites wherein the reductant composition comprises a nanoparticle silver water comprising 0.1% to 10.0% per mass of the final composition (O’Malley at claim 9). O’Malley teaches that the invention concerns cleaning one's teeth and the general health of one's mouth as well as improving the feel good factor. One of the embodiments of the present invention is a toothpaste or other dental related product (O’Malley at [0022]). O’Malley further teaches that the formulation can be combined or integrated into toothpaste, mouthwash, lozenges, or gum (O’Malley at [0024]). O’Malley teaches that the user can dispense the final composition of the oxidative and reductant mixture for brushing. This will effectively clean the mouth. Then the user can use a probiotic lozenge to install the new and healthy bacteria that promote a clean mouth until the next cleaning(O’Malley at [0070]). O’Malley teaches the use of stabilizers including grapeseed oil (O’Malley at [0009]).
The teachings of O’Malley differ from the instant claims insofar as they do not specifically teach the dimensions of the silver nanoparticles within the silver nanoparticle water. The teachings of Tarbet cure this deficit.
Tarbet recites a composition comprising: a first set of metal nanoparticles made by laser ablation so as to be nonionic and spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles are within ±3 nm of the mean particle size, wherein the first set of metal nanoparticles comprise ground state silver; a second set of metal nanoparticles that differ from the first set of metal nanoparticles by at least one of comprising a different metal, made by a different process, having a different particle size and particle size distribution, or having a different shape, wherein the second set of metal nanoparticles comprise ground state gold; and a stabilizing agent that prevents or reduces agglomeration of the metal nanoparticles as compared to a composition without the stabilizing agent (Tarbet at claim 1). Tarbet further recites wherein the second set of nanoparticles comprises coral-shaped metal nanoparticles made by laser ablation so that each is nonionic, has a non-uniform cross section, and has a globular structure with multiple non-linear strands joined together without right angles (Tarbet at claim 3). Tarbet further recites that the composition further comprises a solvent carrier comprised of one or more of water or alcohol (Tarbet at claim13). Tarbet recites wherein the spherical-shaped nanoparticles are included at a concentration of between 1 and 15 ppm, and wherein the coral-shaped metal nanoparticles are included in a concentration of between 1 and 10 ppm (Tarbet at claim 10). Tarbet recites a composition with a set of coral-shaped metal nanoparticles made by laser ablation so that each is nonionic, has a non-uniform cross section, and has a globular structure with multiple non-linear strands joined together without right angles, the coral-shaped metal nanoparticles having a mean length in a range of about 15 nm to about 100 nm, at least 99% of the coral-shaped metal nanoparticles having a length within 30% of the mean length (Tarbet at claim 14). Tarbet recites wherein at least 99% of the spherical-shaped nanoparticles have a diameter within ±1 nm of the mean particle size (Tarbet at claim 7). Tarbet recites wherein spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles are within ±3 nm of the mean particle size (Tarbet at claim 1). Tarbet teaches a composition which may be spayed into the mouth (Tarbet at column 14 at lines 38- 53), a mouth spray would include the teeth. Tarbet teaches that the composition may have a carrier that is an oil, alcohol, water, cream, and gels (Tarbet at Claim 19). Tarbet further teaches the use of stabilizing agents and carriers (Tarbet at columns 11-12).
Tarbet differs from the instant claims in this rejection insofar as it does not teach specifically teach the application of the composition to teeth. The teachings of O’Malley et al cure this deficit.
Generally, it is prima facie obvious to select a known material (e.g. the silver nanoparticles of Tarbet) for incorporation into a composition (that of O’Malley), based on its recognized suitability for its intended use (a personal care composition comprising nanosilver particles). See MPEP 2144.07.
It would have been prima facie obvious to have combined the silver nanoparticles of Tarbet with the silver nanoparticles of O’Malley for the predictable result of a personal care produce with silver nanoparticles. See MPEP 2144.06(I).
In the alternative it would have been prima facie obvious to have substituted the silver nanoparticles of Tarbet with the silver nanoparticles of O’Malley for the predictable result of a personal care produce with silver nanoparticles. See MPEP 2144.06(II). It would have been prima facie obvious to have substituted the more detailed silver nanoparticles of Tarbet for the general silver nanoparticle of O’Malley. See MPEP 2143(I)(B).
Regarding instant claim 1, O’Malley recites a two-part oral care system includes a first vessel containing an oxidative composition having a pH less than 7.5 and a second vessel containing a reductant composition having a pH greater than 7 (O’Malley at claim 1). O’Malley further recites wherein the reductant composition comprises a nanoparticle silver water comprising 0.1% to 10.0% per mass of the final composition (O’Malley at claim 9). O’Malley teaches that the invention concerns cleaning one's teeth and the general health of one's mouth as well as improving the feel good factor. One of the embodiments of the present invention is a toothpaste or other dental related product (O’Malley at [0022]). O’Malley further teaches that the formulation can be combined or integrated into toothpaste, mouthwash, lozenges, or gum (O’Malley at [0024]). Tarbet teaches a composition which may be applied to the mouth (Tarbet at column 14 at lines 38- 53) in order to fight an infection, a mouth application would include the teeth. Tarbet teaches that the composition may have a carrier that is an oil, alcohol, water, cream, and gels (Tarbet at Claim 19). Tarbet further teaches the use of stabilizing agents and carriers (Tarbet at columns 11-12). Tarbet recites composition comprising: a first set of metal nanoparticles made by laser ablation so as to be nonionic and spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles are within ±3 nm of the mean particle size, wherein the first set of metal nanoparticles comprise ground state silver; a second set of metal nanoparticles that differ from the first set of metal nanoparticles by at least one of comprising a different metal, made by a different process, having a different particle size and particle size distribution, or having a different shape, wherein the second set of metal nanoparticles comprise ground state gold; and a stabilizing agent that prevents or reduces agglomeration of the metal nanoparticles as compared to a composition without the stabilizing agent (Tarbet at claim 1). Tarbet teaches methods of treatment which comprise administering the composition to the area of affected tissue (Tarbet at column 14 line 12- Column 16 line 12). The application of an antimicrobial alcohol-based solution, like that of Tarbet, would change the pH level of the tooth surface and environment. The target range for pH is interpreted as an intended use of the claimed composition.
Regarding instant claim 2, O’Malley further recites wherein the reductant composition comprises a nanoparticle silver water comprising 0.1% to 10.0% per mass of the final composition (O’Malley at claim 9). Tarbet recites that the composition further comprises a solvent carrier comprised of one or more of water or alcohol (Tarbet at claim13).
Regarding instant claim 3, Tarbet recites wherein the spherical-shaped nanoparticles are included at a concentration of between 1 and 15 ppm, and wherein the coral-shaped metal nanoparticles are included in a concentration of between 1 and 10 ppm (Tarbet at claim 10). These ranges overlap with the instantly claimed ranges of at least 1ppm for spherical shaped nanoparticles and at least 0.5 ppm for coral shaped nanoparticles. 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 claims 4-5, the target range is interpreted as an intended use of the claimed composition. O’Malley recites a two-part oral care system includes a first vessel containing an oxidative composition having a pH less than 7.5 and a second vessel containing a reductant composition having a pH greater than 7 (O’Malley at claim 1). This combination of basic and acidic compositions would be able to provide a neutral pH.
Regarding instant claim 6, O’Malley teaches that the invention concerns cleaning one's teeth and the general health of one's mouth as well as improving the feel good factor (O’Malley at [0022]). O’Malley teaches the cleaning of the mouth which would prevent dental caries. O’Malley further teaches the use of probiotics in the composition to treat periodontal disease, gingivitis, periodontitis (O’Malley [0042]). Tarbet teaches the treatment of an infection within the mouth (Tarbet at column 14 at lines 38- 53). Tarbet further teaches that the composition is antimicrobial (Tarbet whole document), antimicrobial compositions kill bacteria which impacts periodontal disease and caries.
Regarding instant claim 9, Tarbet recites wherein the spherical-shaped nanoparticles are included at a concentration of between 1 and 15 ppm (Tarbet at claim 10). These ranges overlap with the instantly claimed range of between 1 and 15 ppm. 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 10, Tarbet recites wherein at least 99% of the spherical-shaped nanoparticles have a diameter within ±1 nm of the mean particle size (Tarbet at claim 7) and wherein the mean particle size in a range of about 1 nm to about 20 nm (Tarbet at claim 1). A mean particle size of 3.4 to 20nm with at least 99% of the particles have a diameter of plus or minus 1nm of the mean particle would have at least 99% of the particles within 30% of the mean diameter.
Regarding instant claim 11, Tarbet recites wherein spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles are within ±3 nm of the mean particle size (Tarbet at claim 1). These ranges overlap with the instantly claimed range of within plus or minus 3nm of the mean diameter. 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 12, Tarbet recites a composition with a set of coral-shaped metal nanoparticles made by laser ablation so that each is nonionic, has a non-uniform cross section, and has a globular structure with multiple non-linear strands joined together without right angles, the coral-shaped metal nanoparticles having a mean length in a range of about 15 nm to about 100 nm, at least 99% of the coral-shaped metal nanoparticles having a length within 30% of the mean length (Tarbet at claim 14). These ranges overlap with the instantly claimed range of within 30% of the mean length. 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 13, Tarbet recites wherein the coral-shaped metal nanoparticles are included in a concentration of between 1 and 10 ppm (Tarbet at claim 10). These ranges overlap with the instantly claimed range of between 1 and 10 ppm. 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 14, Tarbet recites a composition comprising: a first set of metal nanoparticles wherein the first set of metal nanoparticles comprise ground state silver; a second set of metal nanoparticles that differ from the first set of metal nanoparticles wherein the second set of metal nanoparticles comprise ground state gold (Tarbet at claim 1).
Regarding instant claim 15, O’Malley recites a two-part oral care system includes a first vessel containing an oxidative composition having a pH less than 7.5 and a second vessel containing a reductant composition having a pH greater than 7 (O’Malley at claim 1). O’Malley further recites wherein the reductant composition comprises a nano particle silver water comprising 0.1% to 10.0% per mass of the final composition (O’Malley at claim 9). Tarbet teaches a composition which may be applied to the mouth (Tarbet at column 14 at lines 38- 53) in order to fight an infection, a mouth application would include the teeth. Tarbet teaches that the composition may have a carrier that is an oil, alcohol, water, cream, and gels (Tarbet at Claim 19). O’Malley teaches the use of stabilizers including grapeseed oil (O’Malley at [0009]). Tarbet further teaches the use of stabilizing agents and carriers (Tarbet at columns 11-12). O’Malley teaches that the invention concerns cleaning one's teeth and the general health of one's mouth as well as improving the feel good factor(O’Malley at [0022]). O’Malley teaches that the user can dispense the final composition of the oxidative and reductant mixture for brushing. This will effectively clean the mouth. Then the user can use a probiotic lozenge to install the new and healthy bacteria that promote a clean mouth until the next cleaning(O’Malley at [0070]). Tarbet recites composition comprising: a first set of metal nanoparticles made by laser ablation so as to be nonionic and spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles are within ±3 nm of the mean particle size, wherein the first set of metal nanoparticles comprise ground state silver; a second set of metal nanoparticles that differ from the first set of metal nanoparticles by at least one of comprising a different metal, made by a different process, having a different particle size and particle size distribution, or having a different shape, wherein the second set of metal nanoparticles comprise ground state gold; and a stabilizing agent that prevents or reduces agglomeration of the metal nanoparticles as compared to a composition without the stabilizing agent (Tarbet at claim 1). O’Malley further teaches that the formulation can be combined or integrated into toothpaste, mouthwash, lozenges, or gum (O’Malley at [0024]). Tarbet teaches methods of treatment which comprise administering the composition to the area of affected tissue (Tarbet at column 14 line 12- Column 16 line 12). O’Malley recites a two-part oral care system includes a first vessel containing an oxidative composition having a pH less than 7.5 and a second vessel containing a reductant composition having a pH greater than 7 (O’Malley at claim 1). This combination of basic and acidic compositions would be able to provide a neutral pH. The application of an antimicrobial alcohol-based solution, like that of Tarbet, would change the pH level of the tooth surface and environment. The target range for pH is interpreted as an intended use of the claimed composition.
Regarding instant claim 16, Tarbet recites wherein the spherical-shaped nanoparticles are included at a concentration of between 1 and 15 ppm, and wherein the coral-shaped metal nanoparticles are included in a concentration of between 1 and 10 ppm (Tarbet at claim 10). These ranges overlap with the instantly claimed range of about 10 ppm to about 60 ppm for spherical shaped nanoparticles and about 10 to about 120 ppm for coral shaped nanoparticles. 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 17, O’Malley further recites wherein the reductant composition comprises a nano particle silver water. Tarbet recites that the composition further comprises a solvent carrier comprised of one or more of water or alcohol (Tarbet at claim13). Tarbet recites wherein the spherical-shaped nanoparticles are included at a concentration of between 1 and 15 ppm, and wherein the coral-shaped metal nanoparticles are included in a concentration of between 1 and 10 ppm (Tarbet at claim 10). These ranges overlap with the instantly claimed range of 10ppm or more. 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 18, Tarbet teaches the use of stabilizing agents include alcohols generally (e.g., ethanol, propanol, butanol, etc.), as alcohols have been observed to effectively maintain nanoparticles of different sizes and different shapes within a given solution (Tarbet at column 11). Tarbet recites wherein the spherical-shaped nanoparticles are included at a concentration of between 1 and 15 ppm, and wherein the coral-shaped metal nanoparticles are included in a concentration of between 1 and 10 ppm (Tarbet at claim 10). Tarbet recites that the composition further comprises a solvent carrier comprised of one or more of water or alcohol (Tarbet at claim13). These ranges overlap with the instantly claimed range of 10ppm or more. 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 19, O’Malley further recites wherein the reductant composition comprises a nano particle silver water comprising 0.1% to 10.0% per mass of the final composition (O’Malley at claim 9). O’Malley teaches that the invention concerns cleaning one's teeth and the general health of one's mouth as well as improving the feel good factor (O’Malley at [0022]). O’Malley further teaches that the formulation can be combined or integrated into toothpaste, mouthwash, lozenges, or gum (O’Malley at [0024]). Tarbet teaches methods of treatment which comprise administering the composition to the area of affected tissue (Tarbet at column 14 line 12- Column 16 line 12). O’Malley recites a two-part oral care system includes a first vessel containing an oxidative composition having a pH less than 7.5 and a second vessel containing a reductant composition having a pH greater than 7 (O’Malley at claim 1). The application of an antimicrobial alcohol-based solution, like that of Tarbet, would change the pH level of the tooth surface and environment. The target range for pH is interpreted as an intended use of the claimed composition.
Regarding instant claim 20, O’Malley recites a two-part oral care system includes a first vessel containing an oxidative composition having a pH less than 7.5 and a second vessel containing a reductant composition having a pH greater than 7 (O’Malley at claim 1). This combination of basic and acidic compositions would be able to provide a neutral pH. Tarbet teaches the use of an alcohol carrier (Tarbet at columns 11-12) which would increase the pH of the mouth bringing it closer to the pH of alcohols. The target range for pH is interpreted as an intended use of the claimed composition. Purely en arguendo, the mouth has a pH of between 6-7 with bacteria causing the pH to lower as it produces acid which is part of the reason bacteria are bad for teeth. Alcohols have a pH of around 7 to 7.3, they are more basic than the mouth and the acid produced by bacteria. Therefore, the treatment of a base to an acidic environment will increase the pH bringing it closer to neutral a pH of 7, which would fall within the range of about 6.5 to about 6.9. 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 21, O’Malley teaches that the user can dispense the final composition of the oxidative and reductant mixture for brushing. This will effectively clean the mouth. Then the user can use a probiotic lozenge to install the new and healthy bacteria that promote a clean mouth until the next cleaning (O’Malley at [0070]). Tarbet teaches a composition which may be applied to the mouth (Tarbet at column 14 at lines 38- 53) in order to fight an infection, a mouth application would include the teeth. Tarbet teaches that the composition may have a carrier that is an oil, alcohol, water, cream, and gels (Tarbet at Claim 19). Tarbet further teaches the use of stabilizing agents and carriers (Tarbet at columns 11-12). Tarbet recites composition comprising: a first set of metal nanoparticles made by laser ablation so as to be nonionic and spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles are within ±3 nm of the mean particle size, wherein the first set of metal nanoparticles comprise ground state silver; a second set of metal nanoparticles that differ from the first set of metal nanoparticles by at least one of comprising a different metal, made by a different process, having a different particle size and particle size distribution, or having a different shape, wherein the second set of metal nanoparticles comprise ground state gold; and a stabilizing agent that prevents or reduces agglomeration of the metal nanoparticles as compared to a composition without the stabilizing agent (Tarbet at claim 1). Tarbet teaches methods of treatment which comprise administering the composition to the area of affected tissue (Tarbet at column 14 line 12- Column 16 line 12). The application of an antimicrobial alcohol-based solution, like that of Tarbet, would change the pH level of the tooth surface and environment. The target range for pH is interpreted as an intended use of the claimed composition.
Regarding instant claim 22, O’Malley further teaches that the formulation can be combined or integrated into toothpaste, mouthwash, lozenges, or gum (O’Malley at [0024]). O’Malley teaches that the user can dispense the final composition of the oxidative and reductant mixture for brushing. This will effectively clean the mouth. Then the user can use a probiotic lozenge to install the new and healthy bacteria that promote a clean mouth until the next cleaning (O’Malley at [0070]). Tarbet teaches methods of treatment which comprise administering the composition to the area of affected tissue (Tarbet at column 14 line 12- Column 16 line 12). The application of an antimicrobial alcohol-based solution, like that of Tarbet, would change the pH level of the tooth surface and environment. The target range for pH is interpreted as an intended use of the claimed composition.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims are amended to teach a single-phase oral care composition and therefore O’Malley now teaches away from the instant application.
The Examiner does not agree. See the above new matter and indefiniteness rejections. Secondly, O’Malley teaches a composition in two parts used as a singular whole product, see figure reproduced below.
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Similarly, the instant claims in claim 15 describe a nanoparticle additive that is separate from the carrier and then combined with a carrier and then applied to the oral cavity which is very similar to the teachings of O’Malley. It is in part the reason why the art of O’Malley was deemed the closest prior art over Bujard et al. O’Malley teaches a composition wherein the nanoparticle is in the reductant chamber and a carrier oil is in the oxidative chamber which than are pumped to combine to produce a singular oral care composition that is then applied to the mouth. Thirdly, purely en arguendo even if the two chamber into one product of O’Malley is not applicable O’Malley further teaches that the formulation can be combined or integrated into toothpaste, mouthwash, lozenges, or gum (O’Malley at [0024]) which could be considered single phase oral care compositions. As such the Applicants arguments are not persuasive and the obviousness rejection is maintained.
Relevant Prior Art
Niedemeyer et al (U.S. Patent 9,434,006 B2) recites a nanoparticle composition comprising: a plurality of spherical-shaped nanoparticles; and a plurality of coral-shaped metal nanoparticles, each coral-shaped metal nanoparticle having a non-uniform cross section and a globular structure formed by multiple, non-linear strands joined together without right angles (Niedemeyer at claim 1). Niedemeyer further recites wherein the spherical-shaped nanoparticles have a diameter of about 40 nm or less (Niedemeyer at claim 4). Niedemeyer further recites wherein the spherical-shaped nanoparticles have a mean diameter and wherein at least 99% of the spherical-shaped nanoparticles have a diameter within about 30% of the mean diameter (Niedemeyer at claim 5). Niedemeyer further recites wherein the spherical-shaped nanoparticles have a mean diameter and wherein at least 99% of the spherical-shaped nanoparticles have a diameter within ±3 nm of the mean diameter. (Niedemeyer at claim 6). Niedemeyer further recites wherein the coral-shaped metal nanoparticles have a length in a range of about 15 nm to about 100 nm (Niedemeyer at claim 8). Niedemeyer further recites wherein the coral-shaped metal nanoparticles have a mean length and wherein at least 99% of the coral-shaped metal nanoparticles have a length within about 30% of the mean length (Niedemeyer at claim 9). Niedemeyer further recites wherein the nanoparticle composition has a concentration of spherical-shaped nanoparticles in a range of about 10 ppb to about 500 ppm and a concentration of coral-shaped nanoparticles in a range of about 10 ppb to about 500 ppm (Niedemeyer at claim 11). Niedemeyer further recites wherein the spherical-shaped nanoparticles and the coral-shaped nanoparticles independently comprise at least one metal selected from the group consisting of gold, platinum, silver, palladium, rhodium, osmium, ruthenium, rhodium, rhenium, molybdenum, copper, iron, nickel, tin, beryllium, cobalt, antimony, chromium, manganese, zirconium, tin, zinc, tungsten, titanium, vanadium, lanthanum, cerium, heterogeneous mixtures thereof, and alloys thereof (Niedemeyer at claim 12). Niedemeyer further recites a method of using a nanoparticle composition, comprising applying a nanoparticle composition to a substrate, the nanoparticle composition including: a plurality of spherical-shaped nanoparticles; and a plurality of coral-shaped metal nanoparticles, each coral-shaped metal nanoparticle having a non-uniform cross section and a globular structure formed by multiple, non-linear strands joined together without right angles (Niedemeyer at claim 14) wherein the substrate is a living organism (Niedemeyer at claim 16).
The relevant prior art is presented for completeness of the record and compact prosecution. In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03, third paragraph in section. The examiner takes the position that Niedemeyer et al. (US 9,434,006 B2) appears to be just as good as Tarbet et al (US Patent 9,839,652 B2). As such, no rejection over Niedemeyer et al. (US Patent 9,434,006 B2) has been written in view of the provisions of MPEP 904.03.
Bujard et al (US Patent application Publication 20090214606A1) recites and antimicrobial product comprising toothpaste or mouthwash (Bujard at claim 11). Bujard recites wherein the particles contain an antimicrobial metal salt or metal in an amount of 0.001 to 20.0 percent by weight (Bujard at claim 6). Bujard further recites that the metal can include gold and silver (Brujard at claim 5). Bujard teaches that in a preferred embodiment individual particle of the antimicrobial compounds, such as silver, having a particle size in the range of from 1 to 50 nm, especially 2 to 20 nm (Bujard at [0021]). Bujard teaches that silver has antimicrobial benefits (Bujard at [0061]). Bujard also teaches that antimicrobial silver ions are particularly useful for in vivo use due to the fact that they are not substantially absorbed into the body (Bujard at [0057]). Bjard further teaches that silver nanoparticles have extreme antiseptic efficacy; a wide antibacterial spectrum; high bactericidal effect, especially during contact with water; no toxicity and no irrigation (Bujard at [0067]). Bujard further teaches the use of alcohols as antimicrobial agents (Bujard at [0037]). Bujard teaches that the composition may use a vehicle that is a mixture of solvents and water (Bujard at [0095]).
The relevant prior art is presented for completeness of the record and compact prosecution. In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03, third paragraph in section. The examiner takes the position that Bujard appears to be just as good as O’Malley. As such, no rejection over Bujard has been written in view of the provisions of MPEP 904.03.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
A) Claims 1-6 and 9-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of Tarbet et al. (U.S. Patent No. 10,953,043 B2) in view of O’Malley (US Patent Application Publication 20150030546A1).
Tarbet recites a composition comprising a carrier, spherical nanoparticles that are made by laser ablation, are uncoated and nonionic with no external bond angles or edges, and have a mean diameter and particle size distribution such that at least 99% of the spherical nanoparticles have a diameter within 30% of the mean diameter and within ±3 nm of the mean diameter, coral-shaped metal nanoparticles each having a non-uniform cross section and a globular structure with multiple non-linear strands joined together without right angles, the coral-shaped nanoparticles consisting of particles that together provide a mean length and a size distribution where at least 99% of the particles have a length within 30% of the mean length, wherein the spherical nanoparticles and coral-shaped nanoparticles are each independently formed from at least one metal selected from the group consisting of gold, platinum, silver, palladium, rhodium, osmium, ruthenium, rhodium, rhenium, molybdenum, copper, iron, nickel, tin, beryllium, cobalt, antimony, chromium, manganese, zirconium, tin, zinc, tungsten, titanium, vanadium, lanthanum, cerium, heterogeneous mixtures thereof, and alloys thereof (Tarbet at Claim 1). Tarbet further recites wherein the composition is treats a sore by applying the composition (Tarbet at claim 2). Tarbet recites wherein the composition is treats a sore by applying the composition (Tarbet at claim 2).
The teachings of Tarbet differ from the instant invention insofar as it does not teach a mouthwash. The teachings of O’Malley cure this deficit.
The teachings of O’Malley are discussed supra.
The teachings of O’Malley differ from the instant invention insofar as they do not teach the specific shape of the silver nanoparticles. The teachings of Tarbet cure this deficit.
Generally, it is prima facie obvious to select a known material (e.g. the silver nanoparticles of Tarbet) for incorporation into a composition (that of O’Malley), based on its recognized suitability for its intended use (a personal care composition comprising nanosilver particles). See MPEP 2144.07.
It would have been prima facie obvious to have combined the silver nanoparticles of Tarbet with the silver nanoparticles of O’Malley for the predictable result of a personal care produce with silver nanoparticles. See MPEP 2144.06(I).
In the alternative it would have been prima facie obvious to have substituted the silver nanoparticles of Tarbet with the silver nanoparticles of O’Malley for the predictable result of a personal care produce with silver nanoparticles. See MPEP 2144.06(II). It would have been prima facie obvious to have substituted the more detailed silver nanoparticles of Tarbet for the general silver nanoparticle of O’Malley. See MPEP 2143(I)(B).
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
B) Claims 1-6 and 9-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of Tarbet (U.S. Patent No. 9,839,652 B2) in view of O’Malley (US Patent Application Publication 20150030546A1).
Tarbet recites a composition comprising: a first set of metal nanoparticles made by laser ablation so as to be nonionic and spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles are within ±3 nm of the mean particle size, wherein the first set of metal nanoparticles comprise ground state silver; a second set of metal nanoparticles that differ from the first set of metal nanoparticles by at least one of comprising a different metal, made by a different process, having a different particle size and particle size distribution, or having a different shape, wherein the second set of metal nanoparticles comprise ground state gold; and
a stabilizing agent that prevents or reduces agglomeration of the metal nanoparticles as compared to a composition without the stabilizing agent (Tarbet at claim 1). Tarbet further recites wherein the second set of nanoparticles comprises coral-shaped metal nanoparticles made by laser ablation so that each is nonionic, has a non-uniform cross section, and has a globular structure with multiple non-linear strands joined together without right angles (Tarbet at claim 3). Tarbet further recites that the composition further comprises a solvent carrier comprised of one or more of water or alcohol (Tarbet at claim13). Tarbet recites wherein the spherical-shaped nanoparticles are included at a concentration of between 1 and 15 ppm, and wherein the coral-shaped metal nanoparticles are included in a concentration of between 1 and 10 ppm (Tarbet at claim 10). Tarbet recites a composition with a set of coral-shaped metal nanoparticles made by laser ablation so that each is nonionic, has a non-uniform cross section, and has a globular structure with multiple non-linear strands joined together without right angles, the coral-shaped metal nanoparticles having a mean length in a range of about 15 nm to about 100 nm, at least 99% of the coral-shaped metal nanoparticles having a length within 30% of the mean length (Tarbet at claim 14). Tarbet recites wherein at least 99% of the spherical-shaped nanoparticles have a diameter within ±1 nm of the mean particle size (Tarbet at claim 7). Tarbet recites wherein spherical-shaped with no external bond angles or edges and so as to have solid metal cores, a mean particle size in a range of about 1 nm to about 20 nm, and a narrow particle size distribution in which at least about 99% of the spherical-shaped metal nanoparticles within ±3 nm of the mean particle size (claim 1).
The teachings of Tarbet differ from the instant invention insofar as it does not teach a mouthwash. The teachings of O’Malley cure this deficit.
The teachings of O’Malley are discussed supra.
The teachings of O’Malley differ from the instant invention insofar as they do not teach the specific dimensions of the silver nanoparticles. The teachings of Tarbet cure this deficit.
Generally, it is prima facie obvious to select a known material (e.g. the silver nanoparticles of Tarbet) for incorporation into a composition (that of O’Malley), based on its recognized suitability for its intended use (a personal care composition comprising nanosilver particles). See MPEP 2144.07.
It would have been prima facie obvious to have combine