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 1-5, 8-10, 12, 13, 16-18 and 23-29.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 has been entered.
Applicants' arguments, filed 01/29/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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 1-5, 8-10, 12, 13, 16, 17, 23-26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Rajaiah et al. (US 2002/0187108, Dec. 12, 2002) (hereinafter Rajaiah) in view of Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand).
Rajaiah discloses an oral care composition comprising polybutene with a molecular weight of about 300 to about 3000, an oral care active, and an oral care carrier (abstract). The composition may contain one or more oral care actives to treat and prevent plaque, calculus, cavities, gingivitis, and mouth malodor (¶ [0031]). The composition may comprise at least one anti-calculus agent present at a level from about 0.001% to about 50%. Suitable anti-calculus agents include sodium tripolyphosphate, sodium hexametaphosphate, and mixtures thereof (¶ [0033]). The composition may include a stannous ion source. The stannous ions may be provided from stannous fluoride. Stannous fluoride has been found to help in the reduction of gingivitis, plaque, sensitivity, and in improved breath benefits. The stannous salt may typically be present in an amount of from about 0.1% to about 7% (¶ [0035]). Anti-pain or desensitizing agents can also be included in the composition. Such agents include potassium nitrate (¶ [0044]). Suitable oral care carriers include humectants, water, and mixtures thereof (¶ [0014]). Oral care carriers typically comprise from about 10% to about 99% by total weight of the oral composition (¶ [0051]). Water will generally comprise from about 5% to about 70% by weight of the oral care carrier component of the oral care composition (¶ [0055]). The humectant may comprise from about 0% to about 70% by weight of the oral care carrier component of the oral care composition (¶ [0060]). The oral care composition may be a single-phase oral care composition (¶ [0011]). The composition may be in the form of a mouth rinse (¶ [0071]). The composition may be contained in a jar or any other liquid holding or dispensing means (¶ [0069]). The composition may comprise phosphoric acids as an oral care carrier component. The oral care carrier component of the oral care composition may contain from about 0.01% to about 20% of the phosphoric acids (¶ [0057]). Oral care carriers typically comprise from about 10% to about 99% by total weight of the oral composition (¶ [0051]).
Rajaiah differs from the instant claims insofar as not disclosing the amount of potassium nitrate.
However, Strand discloses an oral composition comprising both tin(II) and zinc ions (¶ [0001]). The composition may comprise potassium nitrate as a dentinal desensitizing agent to control hypersensitivity (¶ [0047]). The composition may comprise 5 wt. % potassium nitrate (¶ [0054]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 5 wt. % potassium nitrate into the composition of Rajaiah since this is a known and effective amount of potassium nitrate for use as a desensitizing agent as taught by Strand.
In regards to instant claims 1 and 10 reciting wherein the composition comprises a molar ratio of the polyphosphate source comprising three of more phosphate moieties to the stannous ion source of about 1:1 to 5:1, Rajaiah discloses about 0.001% to about 50% sodium hexametaphosphate and 0.1 to 2% stannous fluoride. When converting the amounts of sodium hexametaphosphate and stannous fluoride 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 claim 1 reciting a molar ratio of the total amount of water-soluble nitrate salt to the total amount of stannous ions source of about 0.3:1 to about 20:1, Strand discloses 5 wt. % potassium nitrate and Rajaiah discloses 0.1 to 2% stannous fluoride. When converting the amounts of potassium nitrate and stannous fluoride 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 claim 24 reciting a closure which seals the compartment, Rajaiah discloses wherein the composition may be in a jar. A jar has a closure which seals the compartment. Also, Rajaiah discloses wherein the composition may be in the form of a mouth rinse. Thus, it would have been obvious to one of ordinary skill in the art that the composition is in a compartment of a container with a closure which seals the compartment since the composition is a liquid.
In regards to instant claim 26 reciting a method of stabilizing stannous ion comprising (1) providing an aqueous vehicle, (2) adding to the aqueous vehicle a stannous ion source, (3) adding to the aqueous vehicle a nitrate ion source, and (4) adding to the aqueous vehicle a polyphosphate ion source, wherein the final composition is a single-component composition comprising at least 10% water, as discussed above, Rajaiah discloses providing a composition comprising water, stannous fluoride, potassium nitrate, and sodium hexametaphosphate. Therefore, since Rajaiah teaches substantially the same method step as claimed, Rajaiah necessarily teaches stabilizing stannous ion.
2. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rajaiah et al. (US 2002/0187108, Dec. 12, 2002) (hereinafter Rajaiah) in view of Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand), and further in view of Lambert et al. (US 9,724,278, Aug. 8, 2017) (hereinafter Lambert).
The teachings of Rajaiah and Strand are discussed above. Rajaiah and Strand do not teach wherein the composition is a single component dual phase composition.
However, Lambert discloses a single compartment dual phase mouth wash composition (claim 1). One of the benefits of a dual phase mouth wash composition is that the hydrophobic phase generally resides above the hydrophilic phase as the hydrophilic phase is generally more dense than the hydrophobic phase. Such a configuration is beneficial to the stability of actives that reside in the hydrophilic phase, as actives are commonly degraded by oxidation, e.g., when exposed to air. The separation of the hydrophobic phase on top of the hydrophilic phase essentially prevents or inhibits the oxidation of such actives. Thus, in compositions where the hydrophobic and hydrophilic phases do not completely separate, e.g., emulsion remains after allowing the composition to remain at rest, the actives in the hydrophilic phase are subject to degradation by oxidation (col. 1, lines 34-47).
The composition of Rajaiah may be a mouth rinse and comprise actives. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composition of Rajaiah as a single compartment dual phase mouth wash composition since such configuration is beneficial to the stability of actives in the composition as taught by Lambert.
3. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Rajaiah et al. (US 2002/0187108, Dec. 12, 2002) (hereinafter Rajaiah) in view of Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand), and further in view of Cummins (US 2009/0087501, Apr. 2, 2009).
The teachings of Rajaiah and Strand are discussed above. Rajaiah and Strand do not teach wherein the composition comprises sodium trimetaphosphate.
However, Cummins discloses wherein sodium trimetaphosphate is a useful tartar control agent in oral compositions (¶ [0072]).
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. Rajaiah discloses wherein the composition comprises at least one anti-calculus agent. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated sodium trimetaphosphate into the composition of Rajaiah since it is a known and effective anti-calculus agent as taught by Cummins.
4. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Rajaiah et al. (US 2002/0187108, Dec. 12, 2002) (hereinafter Rajaiah) in view of Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand), and further in view of Fujisawa (US 2004/0146465, Jul. 29, 2004).
The teachings of Rajaiah and Strand are discussed above. Rajaiah and Strand do not teach wherein the composition comprises sodium tetrametaphosphate.
However, Fujisawa discloses an oral composition (abstract). The composition may comprise soluble inorganic phosphoric acid compounds represented by formula (3) (¶ [0062]). Examples of compounds represented by formula (3) include sodium tetrametaphosphate (¶ [0067]).
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. Rajaiah discloses wherein the composition comprises phosphoric acids. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated sodium tetrametaphosphate into the composition of Rajaiah since it is a known and effective phosphoric acid compound in oral compositions as taught by Fujisawa.
In regards to instant claim 1 reciting about 0.8 to about 5 wt. % sodium tetrametaphosphate, the claimed amount would have been obvious from Rajaiah disclosing about 0.01% to about 20% of the phosphoric acids in the oral care carrier and about 10% to about 99% oral care carrier in the oral composition (¶ [0051]).
In regards to instant claim 1 reciting wherein the composition comprises a molar ratio of the polyphosphate source comprising three of more phosphate moieties to the stannous ion source of about 1:1 to 5:1, Rajaiah discloses 0.1 to 2% stannous fluoride. Rajaiah also discloses about 0.01% to about 20% of the phosphoric acids in the oral care carrier and about 10% to about 99% oral care carrier in the oral composition. Thus, one of ordinary skill in the art would have arrived at an amount of phosphoric acids. When converting the amounts of phosphoric acids and stannous fluoride 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 although Rajaiah may mention sodium hexametaphosphate, it does not exemplify or teach a composition comprising sodium hexametaphosphate. In fact, Rajaiah does not exemplify a composition using any of sodium trimetaphosphate, potassium trimetaphosphate, sodium tetrametaphosphate, potassium tetrametaphosphate, sodium hexametaphosphate, or potassium hexametaphosphate.
The Examiner does not find Applicant’s argument to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to working examples. As such. Applicant’s argument is unpersuasive.
Applicant argues that to arrive at the presently claimed ratio, one of ordinary skill in the art would have had to take the exceeding large range of about 0.001% to about 50% of at least one anti-calculus agent and the range of stannous salts of 0.1% to 7% and then arbitrarily choose certain sub-ranges to compare to each other and then construct a ratio using these sub-ranges. Then the skilled artisan would have needed to choose one of a select few recited polyphosphate from the very large number of anti-calculus agents to arrive at the recreated ratio of sodium hexametaphosphate to stannous ion source.
The Examiner does not find Applicant’s argument to be persuasive. Because Rajaiah discloses wherein the composition may comprise anti-calculus agents and lists sodium hexametaphosphate as an anti-calculus agent, it would have been obvious to one of ordinary skill in the art to have formulated a composition with sodium hexametaphosphate. A reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Therefore, Rajaiah disclosing multiple anti-calculus agents does not make sodium hexametaphosphate less obvious. Next, since Rajaiah discloses wherein the amount of anti-calculus agents may be about 0.001% to about 50%, it would have been obvious to one of ordinary skill in the art to have selected any amount within that range for sodium hexametaphosphate. In cases involving overlapping ranges, even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 *Fed. Cir. 2003). Thus, a large range does not make any amount within that range nonobvious. Next, because Rajaiah discloses wherein the composition may comprise stannous salts of 0.1% to 7%, it would have been obvious to one of ordinary skill in the art to have incorporated an amount of stannous salts from that range. Next, since an amount of sodium hexametaphosphate and an amount of stannous ion source are taught, one of ordinary skill in the art may have formulated a ratio between the two. Since mass amounts can be easily converted to molar amounts, the amount of sodium hexametaphosphate and stannous ion source may be converted to molar amounts and a molar ratio may be obtained. Applicant has not explained why the claimed molar ratio is critical. Therefore, having a molar ratio between sodium hexametaphosphate and stannous ion source appears to be arbitrary. As such, since the claimed molar ratio may be obtained from the teachings of Rajaiah, the claimed molar ratio is obvious and Applicant’s argument is unpersuasive.
Applicant argues that the present application has discovered that polyphosphate sources comprising three of more phosphate moieties, when combined with a nitrate ion source and stannous ion source in the claimed molar ratios, provide enhanced stannous ion stability.
The Examiner does not find Applicant’s argument to be persuasive. Mere conclusory statements in the specification, unsupported by objective evidence, are entitled to little weight when the PTO questions the efficacy of those statements. In re Greenfield, 571 F.2d 1185, 197 U.S.P.Q. 227, 229 (C.C.P.A. 1978). As such, since Applicant has not provided objective evidence supporting their allegation, Applicant’s argument is unpersuasive.
Applicant argues that Rajaiah does not teach or suggest the presently claimed “from about 0.1 to about 5 wt. % nitric acid, a water-soluble nitrate salt, or a combination of two of more thereof.”
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. The claimed amount of water-soluble nitrate salt is taught by Strand as discussed in the rejection. As such, Applicant’s argument is unpersuasive.
Applicant argues that Strand does not teach or suggest the combination of a polyphosphate source comprising three or more phosphate moieties with a stannous ion source and a nitrate ion source for the purpose of stabilizing stannous ions.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, Rajaiah teaches the claimed polyphosphate source, stannous ion source, and nitrate source. Also, rationale different from Applicant’s is permissible. Therefore, it is not necessary for the prior art to disclose the combination for the same reason as Applicant. As such, Applicant’s argument is unpersuasive.
Applicant argues that Strand teaches away from the use of the recited concentration of from 0.8 to 5 wt. % polyphosphates.
The Examiner does not find Applicant’s argument to be persuasive. The composition being modified in the rejection is that of Rajaiah. Rajaiah teaches the claimed amount of polyphosphates. Just because the claimed concentration of polyphosphates did not work for Strand’s composition does not mean that it would not work for Rajaiah’s composition. Strand and Rajaiah disclose different compositions. As such, Applicant’s argument is unpersuasive.
Applicant argues that Lambert does not cure the deficiencies of Rajaiah.
The Examiner submits that arguments regarding Rajaiah are addressed above and are unpersuasive. Therefore, the rejection with Lambert is maintained.
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 1-5, 8-10, 12, 13, 16-18 and 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,918,580 and 11,723,846 in view of Rajaiah et al. (US 2002/0187108, Dec. 12, 2002) (hereinafter Rajaiah).
The pending claims differ from the patented claims insofar as reciting wherein the composition comprises a polyphosphate source comprising three or more phosphate moieties. However, Rajaiah discloses an oral care composition comprising at least one anti-calculus agent. Suitable anti-calculus agents include sodium tripolyphosphate, sodium hexametaphosphate, and mixtures thereof (¶ [0033]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sodium hexametaphosphate into the pending claims motivated by the desire to treat tartar as taught by Rajaiah.
Claims 1-5, 8-10, 12, 13, 16-18 and 23-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application Nos. 17/826,961, 18/366,067, 17/894,098, 18/258,251, 18/258,267, 17/950,735, and 18/517,201 in view of Rajaiah et al. (US 2002/0187108, Dec. 12, 2002) (hereinafter Rajaiah).
The pending claims differ from the copending claims insofar as reciting wherein the composition comprises a polyphosphate source comprising three or more phosphate moieties. However, Rajaiah discloses an oral care composition comprising at least one anti-calculus agent. Suitable anti-calculus agents include sodium tripolyphosphate, sodium hexametaphosphate, and mixtures thereof (¶ [0033]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sodium hexametaphosphate into the pending claims motivated by the desire to treat tartar as taught by Rajaiah.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1-5, 8-10, 12, 13, 16-18 and 23-29 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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