Prosecution Insights
Last updated: April 19, 2026
Application No. 18/050,168

TOOTH-WHITENING GEL COMPRISING MODIFIED NIOBIUM COMPOUNDS, METHOD AND USE

Final Rejection §103§112
Filed
Oct 27, 2022
Examiner
PETRITSCH, AMANDA MICHELLE
Art Unit
1612
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Odonto Tech Pesquisa E Inovacao Ltda
OA Round
2 (Final)
61%
Grant Probability
Moderate
3-4
OA Rounds
3y 1m
To Grant
92%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
54 granted / 89 resolved
+0.7% vs TC avg
Strong +31% interview lift
Without
With
+31.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
55 currently pending
Career history
144
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
48.2%
+8.2% vs TC avg
§102
8.6%
-31.4% vs TC avg
§112
17.0%
-23.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 89 resolved cases

Office Action

§103 §112
DETAILED ACTION Applicants' arguments, filed 09/30/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 . Election/Restrictions Applicant's election with traverse of Group 1, claims 1-8 and 15-16 in the reply filed on 05/16/2025 is acknowledged. Applicant’s election of species niobium modified by peroxide within claims 1-2, 4-8, and 15-16 in reply 05/16/2025 is acknowledged. Applicant’s election is applied to claims 1-2, 4-7, 16, 18-20 in the reply filed 09/30/2025. Priority The instant application claims foreign priority to BR1020200153676 filed 07/28/2020 and BR1320210238053 filed 11/25/2021. The instant application is a CIP of PCT/IB2021/056144 filed 07/08/2021. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 6 recites the limitation "wherein the cations are" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 4 from which claim 6 depends upon has been amended and no longer discloses cations. As such, there is insufficient antecedent basis for the limitation of claim 6 and it is therefore currently indefinite. 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. Claims 1-2, 4-7,16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Galley et al (US Patent 5688492A). Galley recites an oral composition suitable for use in oral hygiene or dental treatment comprising an effective amount of an antimicrobial agent in the form of a particulate, non-ion-exchanging, zeolite-free, inert metal oxide, a sparingly soluble metal salt providing antimicrobial metal ions in use and a further material selected from the group consisting of humectants, gelling agents, abrasives, fluoride sources, desensitizing agents, flavorings, colorings, sweeteners, preservatives, structuring agents, bactericides, anti-tartar agents and anti-plaque agents (Galley at claim 1). Galley recites wherein the metal oxide is selected from the group consisting of titanium dioxide, aluminum oxide, zirconium oxide, hafnium oxide, niobium oxide, tantalum oxide, calcium hydroxyapatite, barium sulphate, and magnesium oxide (Galley at claim 3). Galley recites wherein the metal oxide has an average particle size of less than about 25 micrometers (Galley at claim 9). Galley recites wherein the antimicrobial agent is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15). Galley recites a method of cleaning a mouth of an individual for cosmetic purposes, comprising applying to the mouth an oral hygiene composition comprising an effective amount of an antimicrobial agent comprising a particulate, non-ion-exchanging, zeolite-free, inert metal oxide and a sparingly soluble metal salt providing antimicrobial metal ions in use (Galley at claim 16). Galley recites a method of treating or preventing dental caries or gingivitis, comprising applying to a mouth of an individual an oral hygiene composition comprising an effective amount of an antimicrobial agent comprising a particulate, non-ion-exchanging, zeolite-free, inert metal oxide and a sparingly soluble metal salt providing antimicrobial metal ions in use (Galley at claim 17). Galley recites wherein the composition is selected from the group consisting of a dentifrice, mouthwash, tooth powder, chewing gum, lozenge, mouth spray, denture cleansing formulation, tooth paint and glass ionomer cement (Galley at claim 20). Galley teaches that the composition is a toothpaste (Galley at column 5 lines 55-56). Galley teaches the use of xanthan gum (Galley at column 4 lines 19-31). Galley teaches the use of cationic surfactants (Galley at columns 3-4). Galley teaches the use of hydrogen peroxide as an antimicrobial agent (Galley at column 5 at columns 25-50). Galley differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Galley teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each 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 Galley to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I). Regarding instant claim 1, Galley recites the use of niobium oxide as an antimicrobial agent (Galley at claim 3). Galley teaches the use of hydrogen peroxide as an antimicrobial agent (Galley at column 5 at columns 25-50). Galley recites wherein the antimicrobial agent, including niobium oxide and hydrogen peroxide, is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15). Galley teaches the use of xanthan gum, a thickener, in a range of 0 to 5% or 0 to 3% by weight of the composition(Galley at column 4 lines 19-31). Niobium oxide, hydrogen peroxide, and xanthan gum would be able to produce the ratio of between 1 and 50% by mass of the niobium to thickener. It would be prima facie obvious to have optimized the amount of antimicrobial agent and thickener in order to produce an oral care agent that was effective at providing a antimicrobial benefit and the desired thickness for application in the oral cavity. 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). Galley further teaches that the composition is produced by stirring components together (Galley at Examples) as such Galley teaches the combination of niobium oxide, hydrogen peroxide, and xanthan gum. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113(I). Regarding instant claim 2, Galley teaches the use of hydrogen peroxide as an antimicrobial agent (Galley at column 5 at columns 25-50). Galley recites wherein the antimicrobial agent is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15), which overlaps the instantly claimed range of 1.0 to 10% w/v. 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 4, Galley recites the use of niobium oxide (Galley at claim 3). Galley recites wherein the antimicrobial agent, including niobium oxide, is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15), which overlaps the instantly claimed range of 0.1 to 30% m/m. 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 5, Galley teaches the use of calcium carbonate (Galley at column 4 lines 32-55). Regarding instant claim 6, Galley teaches the use of cationic surfactants (Galley at columns 3-4). Galley teaches potassium fluoride which provides a potassium ion source and a fluoride ion source (Galley at column 4 lines 56-62). Galley teaches the use of calcium carbonate (Galley at column 4 lines 32-55). Regarding instant claim 7, Galley teaches the use of xanthan gum (Galley at column 4 lines 19-31). Regarding instant claim 16, Galley teaches that the composition is a toothpaste (Galley at column 5 lines 55-56). Regarding instant claim 18, Galley recites the use of niobium oxide as an antimicrobial agent (Galley at claim 3). Galley teaches the use of hydrogen peroxide as an antimicrobial agent (Galley at column 5 at columns 25-50). Galley recites wherein the antimicrobial agent, including niobium oxide and hydrogen peroxide, is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15). Galley teaches the use of xanthan gum, a thickener, in a range of 0 to 5% or 0 to 3% by weight of the composition. Niobium oxide, hydrogen peroxide, and xanthan gum would be able to produce the ratio of between 1 and 50% by mass of the niobium to thickener. It would be prima facie obvious to have optimized the amount of antimicrobial agent and thickener in order to produce an oral care agent that was effective at providing a antimicrobial benefit and the desired thickness for application in the oral cavity. 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). Galley teaches the use of cationic surfactants (Galley at columns 3-4). Galley teaches potassium fluoride which provides a potassium ion source and a fluoride ion source (Galley at column 4 lines 56-62). Galley teaches the use of calcium carbonate (Galley at column 4 lines 32-55). Galley further teaches that the composition is produced by stirring components together (Galley at Examples) as such Galley teaches the combination of niobium oxide, hydrogen peroxide, potassium fluoride, calcium carbonate and xanthan gum. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113(I). Regarding instant claim 19, Galley recites the use of niobium oxide (Galley at claim 3). Galley recites wherein the antimicrobial agent, including niobium oxide, is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15), which overlaps the instantly claimed range of 0.1 to 30% m/m. 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). Galley teaches the use of cationic surfactants (Galley at columns 3-4). Galley teaches potassium fluoride which provides a potassium ion source and a fluoride ion source (Galley at column 4 lines 56-62). Galley teaches the use of calcium carbonate (Galley at column 4 lines 32-55). Regarding instant claim 20, Galley teaches that the composition is a toothpaste (Galley at column 5 lines 55-56). With regards to the unelected species niobium modified with acid the additional rejection is included below for the purpose of compact prosecution and to provide the applicant with the most relevant prior art. Claims 1-2, 4-7,16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Galley et al (US Patent 5688492A) in view of Karlinsey (US Patent Application Publication 20090104242A1). The teachings of Galley are discussed above. The teachings of Galley differ from the instant claims insofar as they do not specifically teach the use of hydrofluoric acid. The teachings of Karlinsey cure this deficit. Karlinsey recites a nanostructure, comprising: a niobium oxide having a substantially conical nanostructure having a tip and a base wherein the tip is substantially thinner than the base (Karlinsey at claim 1). Karlinsey recites a bioactive material, comprising: substantially pure niobium oxide, wherein of said niobium oxide is formed by anodizing niobium metal in the presence of hydrofluoric acid and at least one salt (Karlinsey at claim 12). Karlinsey recites wherein the level of hydrofluoric acid present in the electrolyte at the start of the anodization step is between about 0.2 wt. percent to about 15 wt. percent (Karlinsey at claim 22). Karlinsey recites a method of forming bioactive crystalline niobium oxide, comprising the steps of: providing a portion of niobium metal; and anodizing said portion of niobium metal in the presence of an electrolyte wherein said electrolyte includes hydrofluoric acid (aq.) and at least one salt (Karlinsey at claim 15). Karlinsey teaches self-organized niobium oxide nanocones with nano-sized tips are prepared by anodization of niobium in the presence of an electrolyte such as hydrofluoric acid (HF) (aq.). Dimensions and integrity of the bulk nanostructures formed are strongly dependent on potential, temperature, electrolyte composition, and anodization times. Accordingly, the morphology, topology, uniformity and bioactivity of the niobium oxide nanostructures formed can be readily adjusted by adjusting these anodization parameters. A bioactive form of crystalline niobium oxide is formed by anodizing niobium metal in the presence of an electrolyte that includes HF and at least one salt such as Na2SO4 or NaF. One property of bioactive niobium oxide formed by anodizing niobium metal in the presence of HF (aq.) is its ability to interact with hydroxylapatite (Karlinsey at abstract). Karlinsey teaches that the niobium oxide nanostructures can be admixed with suitable surfactants such as aliphatic alcohols and or polyethylene glycol or biocompatible polymers such as polycaprolacton in various dentifrices for delivery of the oxide to various HAP rich components in the oral cavity (Karlinsey at [0023]). Karlinsey teaches that the choice of a carrier to be used is generally determined by the way the composition is to be S introduced into the oral cavity. If a tooth paste (including tooth gels, etc.) is to be used, then a “toothpaste carrier” is chosen and may include for, example, abrasive materials, sudsing agents, binders, humectants, flavoring and sweetening agents and the like as disclosed in, for example, U.S. Pat. No. 3,988,433, to Benedict, issued on Oct. 25, 1976, which is incorporated herein by reference (Karlinsey at [0102]). Karlinsey teaches that the preferred compositions for use in various embodiments may be in the form of dentifrices, such as toothpastes, tooth gels, tooth polishes and tooth powders. Components of such toothpaste and tooth gels generally include one or more of a dental abrasive (from about 10% to about 50%), a surfactant (from about 0.5% to about 10%), a thickening agent (from about 0.1% to about 5%), a humectant (from about 10% to about 55%), a flavoring agent (from about 0.04% to about 2%), a sweetening agent (from about 0.1% to about 3%), a coloring agent (from about 0.01% to about 0.5%) and water (from about 2% to about 45%). Such toothpaste or tooth gel may also include one or more of an additional anticaries agent (from about 0.05% to about 10% additional anticaries agent), and an anticalculus agent (from about 0.1% to about 13%). Tooth powders, of course, contain substantially all non-liquid components. Karlinsey teaches that toothpastes and gels typically include a thickening agent added to the compound to create a desirable consistency, to provide desirable release characteristics when used, to increase shelf stability, and to increase the overall stability of the composition, etc. Preferred thickening agents that may be used in various embodiments include, but are not limited to, carboxyvinyl polymers, carrageenan, hydroxyethyl cellulose, laponite and water soluble salts of cellulose ethers such as sodium carboxymethylcellulose and sodium carboxymethyl hydroxyethyl cellulose. Natural gums such as gum karaya, xanthan gum, gum arabic, and gum tragacanth can also be used. Colloidal magnesium aluminum silicate or finely divided silica may be added to further improve the texture of the composition (Karlinsey at [0118]). Karlinsey teaches that thickening agents in an amount from about 0.1% to about 15%, or from about 0.2% to about 6%, in another embodiment from about 0.4% to about 5%, by weight of the total toothpaste or gel composition, can be used (Karlinsey at [0122]). Karlinsey teaches the use of calcium carbonate as an abrasive (Karlinsey at [0108]). The teachings of Karlinsey differ from the instant application insofar as they do not teach the amount of niobium oxide in the toothpaste. The teachings of Galley cure this deficit. It would have been prima facie obvious to have combined the niobium oxide of Galley with the bioactive niobium oxide of Karlinsey for the predictable result of a toothpaste with niobium oxide. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). With regards to the end product niobium modified with peroxide the additional rejection is included below for the purpose of compact prosecution and to provide the applicant with the most relevant prior art. Claims 1-2, 4-7,16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Galley et al (US Patent 5688492A) in view of Yao (US Patent Application Publication 20040134873A1). The teachings of Galley are discussed above. The teachings of Galley differ from the instant claims insofar as they do not specifically teach the use of niobium hydroxides and/or oxide hydroxides. The teachings of Yao cure this deficit. Yao teaches the use of niobium hydroxides and/or oxide hydroxides as non-abrasive additives in polishing compositions (Yao at [0178]). Yao teaches that the non-abrasive additive can be used in an amount of about 0.1% to about 25% (Yao at [0192]). The teachings of Yao differ from the instant application insofar as they do not teach the use of a thickener. The teachings of Galley cure this deficit. It would have been prima facie obvious to have combined the niobium oxide of Galley with the niobium oxide and niobium oxide hydroxide of Yao for the predictable result of a composition with niobium oxides. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). It would have been prima facie obvious to have used the niobium oxide hydroxide and niobium hydroxide of Yao as the niobium oxide and hydrogen peroxide of Galley based on its use in another field of for the combination of the niobium oxide and hydrogen peroxide to use one product for two components saving time and money. See MPEP2143(I)(F). Response to Arguments and Affidavit Applicant's arguments and affidavit filed 09/30/2025 have been fully considered but they are not persuasive. Applicant argues that the prior art does not teach the amended claims. As such the obviousness rejection should be withdrawn. The Examiner does not agree. Claim limitation of the instant application is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. One of ordinary skill who practices the method of making the toothpastes would necessarily obtain the product by combining the ingredients or the composition of Galley. Yao teaches the end product of a niobium oxide hydroxide. Karlinsey teaches a method of modifying niobium oxide with acid to create a nanostructured complex. Therefore, if the method of making the product is obvious, the product obtained by practicing the method is rendered obvious. More specifically, Galley recites the use of niobium oxide as an antimicrobial agent (Galley at claim 3). Galley teaches the use of hydrogen peroxide as an antimicrobial agent (Galley at column 5 at columns 25-50). Galley recites wherein the antimicrobial agent, including niobium oxide and hydrogen peroxide, is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15). Galley teaches the use of xanthan gum, a thickener, in a range of 0 to 5% or 0 to 3% by weight of the composition (Galley at column 4 lines 19-31). Galley further teaches that the composition is produced by stirring components together (Galley at Examples) as such Galley teaches the combination of niobium oxide, hydrogen peroxide, potassium fluoride, calcium carbonate and xanthan gum. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113(I). More specifically, Karlinsey recites a nanostructure, comprising: a niobium oxide having a substantially conical nanostructure having a tip and a base wherein the tip is substantially thinner than the base (Karlinsey at claim 1). Karlinsey recites a bioactive material, comprising: substantially pure niobium oxide, wherein of said niobium oxide is formed by anodizing niobium metal in the presence of hydrofluoric acid and at least one salt (Karlinsey at claim 12). Karlinsey recites wherein the level of hydrofluoric acid present in the electrolyte at the start of the anodization step is between about 0.2 wt. percent to about 15 wt. percent (Karlinsey at claim 22). Karlinsey recites a method of forming bioactive crystalline niobium oxide, comprising the steps of: providing a portion of niobium metal; and anodizing said portion of niobium metal in the presence of an electrolyte wherein said electrolyte includes hydrofluoric acid (aq.) and at least one salt (Karlinsey at claim 15). Karlinsey teaches self-organized niobium oxide nanocones with nano-sized tips are prepared by anodization of niobium in the presence of an electrolyte such as hydrofluoric acid (HF) (aq.). Dimensions and integrity of the bulk nanostructures formed are strongly dependent on potential, temperature, electrolyte composition, and anodization times. Accordingly, the morphology, topology, uniformity and bioactivity of the niobium oxide nanostructures formed can be readily adjusted by adjusting these anodization parameters. A bioactive form of crystalline niobium oxide is formed by anodizing niobium metal in the presence of an electrolyte that includes HF and at least one salt such as Na2SO4 or NaF. One property of bioactive niobium oxide formed by anodizing niobium metal in the presence of HF (aq.) is its ability to interact with hydroxylapatite (Karlinsey at abstract). Karlinsey teaches that thickening agents in an amount from about 0.1% to about 15%, or from about 0.2% to about 6%, in another embodiment from about 0.4% to about 5%, by weight of the total toothpaste or gel composition, can be used (Karlinsey at [0122]). Karlinsey teaches the use of calcium carbonate as an abrasive (Karlinsey at [0108]). Therefore Karlinsey teaches a method of making a modified niobium acid complex. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113(I). The Applicant is responsible for describing the nonobvious difference between the prior art and the instant composition. "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP2113(II). As such, Applicant’s arguments are not persuasive and the obviousness rejection stands. Applicant argues the niobium oxide and hydrogen peroxide is used for antimicrobial purposes rather than for whitening. As such the obviousness rejection should be withdrawn. The Examiner does not agree. With regards to the niobium complex providing a whitening effect, the prior art does not need to solve the same problem as the instant invention and can use the same component to solve a different problem entirely. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP2144(IV). As such, Applicant’s arguments are not persuasive and the obviousness rejection stands. Applicant argues recites the use radiation and further of high-wavelength low-energy radiation with the composition has a special effect. As such the obviousness rejection should be withdrawn. The Examiner does not agree. With regards to the use of radiation, to the best of the Examiner’s understanding radiation is not discussed in the instant claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., radiation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, the Applicant’s argument is not persuasive and the obviousness rejection stands. With regards to the Affidavit filed 09/30/2025, Affidavit recites a niobium-peroxide complex which is produced by combining niobium compounds with peroxide compounds and then adding a thickener. Affidavit further recites that the whitening effect comes from the compound rather than free hydrogen peroxide. Affidavit recites the use radiation and further of high-wavelength low-energy radiation. As such the obviousness rejection should be withdrawn. The Examiner does not agree. Galley recites the use of niobium oxide as an antimicrobial agent (Galley at claim 3). Galley teaches the use of hydrogen peroxide as an antimicrobial agent (Galley at column 5 at columns 25-50). Galley recites wherein the antimicrobial agent, including niobium oxide and hydrogen peroxide, is included in the composition in an amount of from about 0.01% to 3% by weight (Galley at claim 15). Galley teaches the use of xanthan gum, a thickener, in a range of 0 to 5% or 0 to 3% by weight of the composition(Galley at column 4 lines 19-31). Galley further teaches that the composition is produced by stirring components together (Galley at Examples) as such Galley teaches the combination of niobium oxide, hydrogen peroxide, potassium fluoride, calcium carbonate and xanthan gum. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113(I). The Applicant is responsible for describing the nonobvious difference between the prior art and the instant composition. "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP2113(II). With regards to the niobium complex providing a whitening effect, the prior art does not need to solve the same problem as the instant invention and can use the same component to solve a different problem entirely. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP2144(IV). With regards to the lack of free hydrogen peroxide in the composition, to the best of the Examiner’s understanding, a negative limitation with regards to hydrogen peroxide is not discussed in the instant claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., negative limitations of hydrogen peroxide) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). With regards to the use of radiation, to the best of the Examiner’s understanding radiation is not discussed in the instant claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., radiation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, the Affidavit is not persuasive and the obviousness rejection stands. Conclusion No claims are presently allowable. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612 /SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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Prosecution Timeline

Oct 27, 2022
Application Filed
Jun 26, 2025
Non-Final Rejection — §103, §112
Sep 30, 2025
Response Filed
Jan 10, 2026
Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
61%
Grant Probability
92%
With Interview (+31.3%)
3y 1m
Median Time to Grant
Moderate
PTA Risk
Based on 89 resolved cases by this examiner. Grant probability derived from career allow rate.

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