Prosecution Insights
Last updated: July 17, 2026
Application No. 18/258,267

Oral Care Compositions and Methods

Non-Final OA §103§112§DOUBLEPATENT
Filed
Jun 19, 2023
Priority
Dec 21, 2020 — provisional 63/128,678 +1 more
Examiner
LIU, TRACY
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Colgate-Palmolive Company
OA Round
3 (Non-Final)
55%
Grant Probability
Moderate
3-4
OA Rounds
1m
Est. Remaining
83%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allowance Rate
366 granted / 669 resolved
-5.3% vs TC avg
Strong +28% interview lift
Without
With
+28.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
75 currently pending
Career history
774
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
63.9%
+23.9% vs TC avg
§102
0.8%
-39.2% vs TC avg
§112
0.8%
-39.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 669 resolved cases

Office Action

§103 §112 §DOUBLEPATENT
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 . Claims included in the prosecution are claims 1-11, 14-19, 24, 27 and 28. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/20/2026 has been entered. Applicants' arguments, filed 02/20/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. Claim Objections Claim 27 is objected to because of the following informalities: “1:1 to 1.5” should be recited as --- 1.1 to 1.5:1 ---. Appropriate correction is required. Claim 28 is objected to because of the following informalities: “1:1 to 1.3” should be recited as --- 1.1 to 1.3:1 ---. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 27 and 28 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 27 recites the limitation "the water-soluble alkali metal polyphosphate." There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the water-soluble alkali metal polyphosphate is referring to tetrasodium pyrophosphate or to an additional water-soluble alkali metal polyphosphate present in the composition. Claim 28 recites the limitation "the nitric acid, the water-soluble nitrate salt, or the combination thereof." There is insufficient antecedent basis for this limitation in the claim. The claim does not recite wherein the composition comprises nitric acid. Therefore, the scope of nitric acid is unclear. Also, it is unclear whether the water-soluble nitrate salt is referring to potassium nitrate or to an additional water-soluble nitrate salt present in the composition. Claim 28 recites the limitation "the water-soluble alkali metal polyphosphate." There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the water-soluble alkali metal polyphosphate is referring to sodium tripolyphosphate or to an additional water-soluble alkali metal polyphosphate present in the composition. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 1. Claims 1-11, 14-16, 19 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam). Strand discloses an aqueous oral composition comprises a) from 0.2% to 3% divalent metal ions comprising: i. from 0.1% to 1.5% of zinc ions and ii. from 0.1% to 2% of tin(II) ions; b) a source of fluoride ions; c) a silica dental abrasive; d) one or more chelants having a MW of less than 1000 and capable of forming water-soluble complexes with the zinc ions; and e) an orally acceptable carrier comprising at least 20% total water (abstract). The tin(II) ions are provided by stannous chloride, stannous fluoride, or mixtures thereof (claim 8). The composition may comprise potassium nitrate (i.e., water-soluble nitrate salt) as a dentinal desensitizing agent to control hypersensitivity (¶ [0047]). The composition may comprise 5 wt. % potassium nitrate (¶ [0054]). The chelant is capable of solubilizing at least 80% of the total zinc ions within the oral composition. Suitable chelants include amino acids, such as glycine and tripolyphosphates (¶ [0027]). The molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1 (¶ [0031]). The composition is a dentifrice and may comprise from 20% to 65% total water (¶ [0038]). The composition may also comprise from 5% to 70% of a humectant (¶ [0041]). The composition is preferably single phase, by which is meant that all of the ingredients of the composition are containable within a single compartment of a container and no further mixing is required before use (¶ [0038]). The composition does not compromise stannous stability (¶ [0007]). The composition may comprise teeth whitening agents (¶ [0038]). Strand differs from the instant claims insofar as not disclosing wherein the composition comprises tetrasodium pyrophosphate. However, Shanmugam discloses a dentifrice composition comprising a polyphosphate. The polyphosphate may help in increasing a zinc ion source-copolymer complex formation (which in turn help facilitate the solubility of the zinc ion) (¶ [0019]). Suitable polyphosphates include tetrasodium pyrophosphate. The presence of polyphosphate ostensibly increases the amount of soluble zinc ion in the dentifrice composition (¶ [0020]). 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. Strand discloses wherein the composition comprises a polyphosphate capable of solubilizing zinc ions as a chelant. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated tetrasodium pyrophosphate into the composition of Strand as a chelant since it is a known and effective polyphosphate capable of solubilizing zinc ions as taught by Shanmugam. In regards to instant claims 1 and 8 reciting a molar ratio of water-soluble alkali metal polyphosphate to the stannous ion source of 1:1 to 1.5:1 and 1:1 to 1.3:1, respectively, Strand discloses wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1. The divalent metal ions comprises tin(II) ions. Thus, the claimed range overlaps with the range in the prior art. 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 A. In regards to instant claim 1 and 9 reciting a molar ratio of the total amount of water-soluble nitrate salt to the total amount of stannous ions source of 0.7:1 to 7:1 and about 1:1 to 5:1, respectively, Strand discloses 5 wt. % potassium nitrate and 0.1% to 2% tin(II) ions. When converting the amounts of potassium nitrate and tin(II) ions to mole amounts, one of ordinary skill in the art would have arrived at a ratio between the two compounds that overlaps with the claimed ratio. 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 A. In regards to instant claims 5 and 10 reciting about 0.1 to about 5 wt. % alkali metal polyphosphate salt, Strand discloses wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and up to 20:1 and wherein the composition comprises from 0.2% to 3% divalent metal ions. Accordingly, one of ordinary skill in the art would have arrived at an amount of chelants that overlaps with claimed range from these ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. 2. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam), and further in view of Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli). The teachings of Strand and Shanmugam are discussed above. Strand and Shanmugan do not teach wherein the composition comprises arginine. However, Kohli discloses an oral care composition comprising an effective amount of a basic amino acid in free or salt form (abstract). The basic amino acid may be arginine (¶ [0009]). Arginine is believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0003]). The basic amino acid is present in an amount of about 0.1 to about 20% of the total composition weight (¶ [0031]). 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. Strand discloses wherein the composition comprises amino acids. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 0.1 to about 20% arginine into the composition of Strand since it is a known and effective amino acid and it combats cavity formation and tooth sensitivity as taught by Kohli. 3. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam), and further in view of Price et al. (US 2019/0269606, Sep. 5, 2019) (hereinafter Price). The teachings of Strand and Shanmugam are discussed above. Strand and Shanmugan do not teach wherein the composition comprises charcoal. However, Price discloses a toothpaste composition having white activated coconut husk charcoal (¶ [0013]). Activated charcoal has been used for a number of years as a dentifrice and whitening agent for the teeth (¶ [0011]). The composition may comprise 0.05-2% activated coconut white charcoal (Table 1). 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. Strand discloses wherein the composition comprises teeth whitening agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 0.05-2% activated coconut white charcoal into the composition of Strand since it is a known and effective whitening agent for the teeth as taught by Price. 4. Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam), and further in view Kruse et al. (US 2022/0339228, Filed Jul. 29, 2019) (hereinafter Kruse). The teachings of Strand and Shanmugam are discussed above. Strand and Shanmugan do not teach wherein the composition is used for treating or reducing systemic blood pressure. However, Kruse discloses a composition having a concentration-promoting and/or stimulating effect, in particular for the simultaneous lowering of arterial blood pressure, wherein said composition contains as component (a) at least one nitrate source and/or nitrate and as component (b) at least one substance having stimulating and/or stimulating effect, preferably caffeine (abstract). The reduction in blood pressure is achieved by the nitrate contained in the composition. Topical application of nitrate in the oral cavity can significantly lower blood pressure (¶ [0038]). The composition may be in the form of a toothpaste (¶ [0045]). The nitrate may be potassium nitrate (¶ [0063]). Accordingly, since the composition of Strand comprises potassium nitrate and is a topical oral composition (e.g., dentifrice), it would have been prima facie obvious to one of ordinary skill in the art to have used the composition for lowering arterial blood pressure since nitrates in topical oral compositions reduces blood pressure as taught by Kruse. 5. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam), and further in view of An et al. (KR 2013061874 A, Jun. 12, 2013) (hereinafter An). The teachings of Strand and Shanmugam are discussed above. Strand and Shanmugam do not disclose wherein the composition comprises sodium tripolyphosphate. However, An discloses an oral care composition comprising a metal ion chelating agent. The metal ion chelating agent may be sodium tripolyphosphate (abstract). 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. Strand discloses wherein the chelating agent may be a tripolyphosphate. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sodium tripolyphosphate into the composition of Strand since it is a known and effective tripolyphosphate chelating agent as taught by An. In regards to instant claim 28 reciting a molar ratio of water-soluble alkali metal polyphosphate to the stannous ion source of 1:1 to 1.3:1, Strand discloses wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1. The divalent metal ions comprises tin(II) ions. Thus, the claimed range overlaps with the range in the prior art. 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 A. In regards to instant claim 28 reciting a molar ratio of the total amount of water-soluble nitrate salt to the total amount of stannous ions source of 0.2:1 to 34:1, Strand discloses 5 wt. % potassium nitrate and 0.1% to 2% tin(II) ions. When converting the amounts of potassium nitrate and tin(II) ions to mole amounts, one of ordinary skill in the art would have arrived at a ratio between the two compounds that overlaps with the claimed ratio. 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 A. Response to Arguments Applicant argues that Strand does not disclose or teach the two claimed molar ratios. The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, the claimed molar ratio of water-soluble alkali metal polyphosphate to the stannous ion source is taught from Strand disclosing wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1. Water-soluble alkali metal polyphosphate is a chelant and the divalent metal ions comprises tin(II) ions. The claimed molar ratio of the total amount of water-soluble nitrate salt to the total amount of stannous ions source is taught from Strand disclosing 5 wt. % potassium nitrate and 0.1% to 2% tin(II) ions. When converting the amounts of potassium nitrate and tin(II) ions to mole amounts, one of ordinary skill in the art would have arrived at a ratio between the two compounds that overlaps with the claimed ratio. As such, Applicant’s argument is unpersuasive. Applicant argues that neither Strand nor the other applied references teach or provide guidance that would lead one of ordinary skill to find it obvious to make the 7 foregoing selections and modifications. The Examiner does not find Applicant’s argument to be persuasive. With regards to the molar ratio of water-soluble alkali metal polyphosphate to stannous ion source, one of ordinary skill in the art would not have had to make 7 selections and modifications because Strand specifically discloses wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1. With regards to the molar ratio of potassium nitrate to stannous ion source, Strand discloses an amount of potassium nitrate and an amount of stannous ion source. All amounts in mass may be converted into moles. When there are two compounds, one may formulate an amount ratio between the two. Applicant has not explained why a molar ratio is critical or why a ratio between potassium nitrate and stannous ion source is critical. As such, Applicant’s argument is unpersuasive. Applicant argues that one of ordinary skill would not have routinely optimized the molar ratios to achieve the claimed ranges for the two interlinked molar ratios. The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state wherein it would have been obvious to have optimized the claimed ratios. As such, Applicant’s argument is unpersuasive. Applicant argues that solutions containing stannous fluoride, potassium nitrate, and tetrasodium pyrophosphate had a significantly improved stannous stability. The Examiner does not find Applicant’s argument to be persuasive. Tetrasodium pyrophosphate is a polyphosphate. Although Applicant has shown wherein stannous compositions comprising TSPP appears to be superior over stannous compositions comprising citrate, gluconate, or arginine, compositions comprising stannous and a polyphosphate were already known. US 2019/0167543 discloses a composition comprising a stannous ion source and a polyphosphate (claim 1). The polyphosphate is a pyrophosphate (claim 20). Suitable pyrophosphates include tetrasodium pyrophosphate (¶ [0037]). As such, a composition comprising a stannous and a polyphosphate, such as TSPP is not unexpected. Furthermore, the inclusion of potassium nitrate to the composition does not appear to be unexpected. US 2013/0039867 discloses that it was unexpectedly found that when nitrates are combined in an aqueous solution with stannous ions, the stannous ions are stabilized against oxidation by atmospheric oxygen (¶ [0014]). Thus, incorporating nitrate to the composition to stabilize stannous ions does not appear to be unexpected. As such, the combination of stannous ions, nitrate, and a polyphosphate does not appear to be unexpected and Applicant’s argument is unpersuasive. Applicant argues that compositions having stannous fluoride and tetrasodium pyrophosphate but were free of potassium nitrate exhibited significantly inferior stannous stability than compositions having the combination of stannous fluoride, potassium nitrate, and one of tetrasodium pyrophosphate or sodium tripolyphosphate. The Examiner does not find Applicant’s argument to be persuasive. As discussed above, the inclusion of potassium nitrate to the composition does not appear to be unexpected. US 2013/0039867 discloses that it was unexpectedly found that when nitrates are combined in an aqueous solution with stannous ions, the stannous ions are stabilized against oxidation by atmospheric oxygen (¶ [0014]). Thus, incorporating nitrate to the composition to stabilize stannous ions does not appear to be unexpected. As such, Applicant’s argument is unpersuasive. Applicant argues that certain molar ratios unexpectedly achieved enhanced stannous stability. The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein the claimed molar ratio range is unexpected. It is not clear from Applicant’s showing what is considered an unexpected amount of % stannous on Day 14 to show that the claimed molar ratio range is unexpected. For example, claim 1 recites a molar ratio of water-soluble nitrate salt to stannous ion source of 0.7:1 to 7:1 and a molar ratio of water-soluble alkali metal polyphosphate to stannous ion source of 1:1 to 1.5:1. All the embodiments in the showing meeting this limitation have a % Stannous on Day 14 of at least 85%. Claim 28 recites a molar ratio of water-soluble nitrate salt to stannous ion source of 0.2:1 to 34:1 and a molar ratio of water-soluble alkali metal polyphosphate to stannous ion source of 1:1 to 1.3:1. All the embodiments in the showing meeting this limitation have a % Stannous on Day 14 of at least 75%. An embodiment, which does not meet the claims, having a KNO3 to SnF2 molar ratio of 0.1:1 and a TSPP to SnF2 molar ratio of 1:1 have a % Stannous on Day 14 of 73%. It is unclear why a molar ratio producing 75% stannous on Day 14 would be considered unexpected and not a molar ratio producing 73% stannous on Day 14. Therefore, it is unclear how Applicant’s claimed molar ratios are unexpected. Also, the claimed KNO3 to SnF2 molar ratio do not appear to be unexpected since as discussed above it was known in the art that nitrates stabilize stannous ions. Thus, increasing the amount KNO3 to stannous ions would be expected to increase the % Stannous. Additionally, Applicant’s showing shows wherein a TSPP to SnF2 molar ratio of 1.3:1 produces 87% stannous on day 14, while a TSPP to SnF2 molar ratio of 2:1 produces 78% stannous on day 14. If Applicant’s molar ratio of water-soluble alkali metal polyphosphate to stannous ion source is unexpected because the upper molar ratio is before there is a drop in % stannous on day 14, Applicant’s argument would still be unpersuasive since claim 1 recites an upper limit of 1.5:1 and it is unclear whether there is a drop in % stannous on day 14 at 1.5:1. 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. Claims 1-11, 14-19, 24, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 7, 9-14, 27, 33 and 34 of copending Application No. 17/826,961 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional ingredients) and thus read on the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-11, 14-19, 24, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/894,098, 17/950,735, 18/258,248, 18/258,251, 18/366,067, and 18/517,201 in view of Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli). The pending claims differ from the copending claims insofar as reciting wherein the composition comprises a basic amino acid. However, Kohli discloses an oral care composition comprising an effective amount of a basic amino acid in free or salt form (abstract). The basic amino acid may be arginine (¶ [0009]). Arginine and other basic amino acids are believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0003]). Accordingly, it would have been obvious to have incorporated a basic amino acid into the pending claims since basic amino acids combat cavity formation and tooth sensitivity as taught by Kohli. This is a provisional nonstatutory double patenting rejection. Claims 1-11, 14-19, 24, 27 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over the of U.S. Patent Nos. 10,918,580 and 11,723,846 in view of Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli). The pending claims differ from the patented claims insofar as reciting wherein the composition comprises a basic amino acid. However, Kohli discloses an oral care composition comprising an effective amount of a basic amino acid in free or salt form (abstract). The basic amino acid may be arginine (¶ [0009]). Arginine and other basic amino acids are believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0003]). Accordingly, it would have been obvious to have incorporated a basic amino acid into the pending claims since basic amino acids combat cavity formation and tooth sensitivity as taught by Kohli. Response to Arguments Applicant has not addressed the double patenting rejections. Therefore, the double patenting rejections are maintained. Conclusion Claims 1-11, 14-19, 24, 27 and 28 are rejected. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm. 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, Ali Soroush can be reached at 571-272-9925. 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. /TRACY LIU/ Primary Examiner, Art Unit 1614
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Prosecution Timeline

Show 2 earlier events
Nov 05, 2025
Response Filed
Nov 21, 2025
Final Rejection mailed — §103, §112, §DOUBLEPATENT
Jan 12, 2026
Applicant Interview (Telephonic)
Jan 12, 2026
Examiner Interview Summary
Jan 21, 2026
Response after Non-Final Action
Feb 20, 2026
Request for Continued Examination
Feb 27, 2026
Response after Non-Final Action
Apr 22, 2026
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)

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Prosecution Projections

3-4
Expected OA Rounds
55%
Grant Probability
83%
With Interview (+28.3%)
3y 2m (~1m remaining)
Median Time to Grant
High
PTA Risk
Based on 669 resolved cases by this examiner. Grant probability derived from career allowance rate.

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