DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The listing of claims filed 10 October 2024, have been examined. Claims 1-20 are pending.
Claim Objections
Claims 9, 13, 15-17, and 20 are objected to because of the following informalities:
Claim 9 recites "individual ligands". One could argue which ligands is unclear (e.g., does "individual ligands" mean oxalic acid and lactic acid or oxalic acid, lactic acid and citric acid, or every ligand independently, particularly when the composition contains additional ligands beyond those specifically recited), thus does the claim intend each ligand individually (i.e., each of the first polydentate ligand and the monodentate ligand independently falls within the range), the total weight of all individual ligands combined or the total weight of the recited first polydentate ligand and monodentate ligand.
However, the examiner finds when read with claim 1, a person of ordinary skill in the art would probably understand that "individual ligands" refers to each ligand present in the ligand system. The applicant may consider elucidating "individual ligands” in the claim to improve clarity and eliminate any potential ambiguity associated with the phrase.
Claim 13 contains a punctuation errors, reciting, "...from about 0.2% to about 1%. by weight of the oral care composition. of the fluoride ion source." The periods after "1%" and after "composition" should be commas. The applicant is advised to make the following correction by amending the claim to state, "...from about 0.2% to about 1%, by weight of the oral care composition, of the fluoride ion source."
Claims 15 and 16 contain identical punctuation errors, "...from about 0.2% to about 1.0%. by weight of the oral care composition. of the stannous ion source." The applicant is advised to make the following correction by amending the claims to state, "...from about 0.2% to about 1.0%, by weight of the oral care composition, of the stannous ion source."
Claim 17 recites, "The oral care composition of anyone of claim 1..." and should read "The oral care composition of claim 1..." since only claim 1 is referenced.
Claim 20(c) "letting the oral care composition acting..." is grammatically incorrect and should read either "allowing the oral care composition to act..." or "letting the oral care composition act...".
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-19 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Glandorf et al. (US20210346255A1; published 11 November 2021, hereinafter “Glandorf”).
Glandorf teaches oral care compositions including stannous fluoride, a monodentate carboxylic acid ligand including the alpha hydroxy acid lactic acid, and a polydentate ligand including oxalic acid and/or citric acid with an optimized molar ratio of stannous fluoride to monodentate ligand to polydentate ligand of 1:0.5:0.5 to about 1:5:5 or 1:1:1 to about 1:5:5 (claims 1, 4, 6, 12, 14, 17, 20, and 21 and ¶[0044] and ¶[0056]), wherein the tin-chelant ratio and binding affinity must be carefully balanced to maximize the amount of available tin ions that are optimally bioavailable for the desired product benefit (¶[0004]). Summing the ligand components, this corresponds to a total tin-to-ligands ratio as broad as about 1:1 to 1:10, which encompasses the instant claimed 1:1 to 1:4 range. Exemplified ratios like 1:1:1 (Sn:total ligands = 1:2) and 1:2:1 (Sn:total ligands = 1:3) fall squarely within the claimed range (¶[0056]), confirming that the claimed sub‑range does no more than select a routine optimization from Glandorf’s expressed objective.
Glandorf demonstrates that a mixed monodentate/polydentate ligand system yields the desired ΔpH “Goldilocks” range (e.g., Table 8 shows Sn:Gluc:Oxalate (1:1:1) gives ΔpH 0.50). Glandorf further shows that lactate and gluconate are interchangeable monodentate ligands, wherein Sn:Lactate:Citrate (1:1:1) and Sn:Gluconate:Citrate (1:1:1) both produce a ΔpH of 0.64 (Table 6) to achieve a similar stabilizing effect. Thus, Glandorf explicitly places the skilled artisan in possession of a finite, known class of monodentate ligands (gluconate, lactate, etc.) and polydentate ligands (oxalate, citrate, etc.) that function interchangeably to achieve the same “Goldilocks” stabilization of stannous ions, providing itself the motivation to substitute lactate for gluconate when using oxalate as the polydentate ligand, because the data show the two monodentate ligands are functionally equivalent with respect to the desired tin stabilization.
A person of ordinary skill would have had a reasonable expectation of success that Sn:Lactate:Oxalate would perform analogously to Sn:Gluconate:Oxalate (ΔpH 0.50, Table 8). Nothing in the teachings of Glandorf discourages the use of oxalate with lactate, rather it identifies both as suitable and demonstrates that monodentate ligands can be swapped effectively. The prior art does not characterize any specific lactate/oxalate pairing as inoperative, and the general disclosure motivates optimizing the ligand mixture to balance tin bioavailability and fluoride uptake. Therefore, the instant claims are anticipated and rendered obvious by the Glandorf’s disclosure, particularly when considered together with the obvious substitution of lactate for other monodentate ligands like gluconate in the explicitly tested oxalate-containing systems.
The instant claims’ requirement of a mixture of dentate ligands including a first polydentate ligand being oxalic acid and a monodentate ligand being lactic acid is therefore described as an available combination within the prior art’s broad genus of ligands. Glandorf lists oxalic acid/salts as a polydentate ligand and lactic acid/salts as a monodentate ligand among a finite, recognizable class of acceptable choices. The selection of these specific, individually disclosed components from the broad genus is thus anticipated and obvious. Glandorf explicitly teaches mixed polydentate systems, including oxalate with citrate (Table 8; Sn:Gluc:Oxalate:Cit 1:1:2). Using the tricarboxylic acid citric acid as a second polydentate ligand alongside oxalate and lactate is therefore encompassed within the teachings of Glandorf, including wherein it is also obvious as certain combinations of polydentate ligands are taught by Glandorf to be beneficial.
The claimed composition is nothing more than a combination of known ingredients, each taught in the reference for the same purpose of optimizing tin bioavailability and fluoride uptake. Because Glandorf teaches that various monodentate/polydentate pairings (gluconate/citrate, lactate/citrate, gluconate/oxalate) all achieve the desired outcome, there is a clear motivation to combine the particular set of components recited, oxalate with lactate, and a reasonable expectation that they would perform in the predictable manner demonstrated by the data. Moreover, Glandorf explicitly suggests mixed polydentate systems, including oxalate with citrate (Table 8), providing further motivation to incorporate a second polydentate ligand such as citric acid.
The oral care composition taught by Glandorf comprises a tin ion source such as stannous fluoride from about 0.4% to about 1% by weight of the oral care composition (¶[0039] and ¶[0040]). The oral care composition taught by Glandorf can includes a monodentate ligand, such as lactic acid from about 0.01% to about 10%, or from about 1% to about 5%, by weight of the composition (¶[0044] and ¶[0047]). The oral care composition taught by Glandorf includes a polydentate ligand such as oxalic acid from about 0.01% to about 10% or from about 1% to about 5% by weight of the composition (¶[0054] and ¶[0055]) and can comprise two or more carboxylic acids including a tricarboxylic acid (¶[0051]). The oral care composition taught by Glandorf can comprise from about 0.01% to about 10% or from about 1% to about 5% by weight of the oral care composition, of tricarboxylic acid polydentate ligand citric acid or salts thereof (¶[0063]-[0066]).
The oral care composition taught by Glandorf can comprise fluoride, which can be provided by a fluoride ion source including stannous fluoride and sodium fluoride or mixtures thereof capable of providing from about 50-5000 ppm (preferably 500-3000 ppm) of free fluoride ions with the fluoride ion source present in the oral care composition at an amount of from about 0.2% to about 1% by weight of the oral care composition, wherein the fluoride ion source and the tin ion source can be the same compound, such as stannous fluoride, or separate compounds (¶[0071], ¶[0072], and ¶[0075]; e.g., tin ion source is stannous fluoride and the fluoride ion source is sodium fluoride).
Thus, Glandorf teaches compositions containing tin (stannous ion source) and fluoride (fluoride ion source), often together as stannous fluoride or separately as stannous fluoride and sodium fluoride. In addition, the pH of the oral care compositions taught by Glandorf can be from about 4 to about 7 or from about 4.5 to about 5.5 using from about 1% to about 10% by weight of the composition buffering agent citric acid (¶[0081] and ¶[0082]).
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 and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Glandorf et al. (US20210346255A1; published 11 November 2021, hereinafter “Glandorf”), in view of Drake et al. (US20220241165A1; published 04 August 2022, hereinafter “Drake”), in further view of Strand et al. (US20200390677A1; published 17 December 2020, hereinafter “Strand”).
Glandorf teaches the limitations of instant claim 1, as described above, from which instant claim 20 depends, however does not explicitly teach the specific limitations of instant claim 20.
Glandorf teaches that it is known in the art to include tin ions (from tin such as stannous fluoride, see claim 4) in oral care compositions, to counter oral bacteria and to prevent and treat conditions caused by bacteria in the oral cavity, such as formation of dental plaque and calculus. The formation of dental plaque and calculus and failure to stop their proliferation are the primary cause of dental caries, gingivitis, periodontal disease, and tooth loss. Additionally, tin ions can deposit on surfaces in the oral cavity to provide protective functions, such as anti-erosion, antibacterial, and/or anti-sensitivity benefits (¶[0002]). The oral care compositions taught by Glandorf comprise a dentifrice composition, a unit-dose oral care composition, an emulsion composition, a leave-on oral care composition, or combinations thereof (claim 28), wherein a leave-on oral care composition implies that the composition acting on the oral cavity surfaces for at least 2 minutes.
However, Glandorf does not explicitly teach the method for treating erosion, preventing erosion, treating caries, preventing caries, or a combination thereof comprising depositing on a toothbrush, brushing, leaving for at least two minutes, and expectorating and optionally rinsing. Although, the method steps of instant claim 20 are unquestionably the ordinary manner of using a toothpaste and fully obvious in view of the obviousness of the composition itself and the conventional nature of the recited method steps.
Nonetheless, Drake teaches oral care compositions comprising oxalic acid and pH buffering agent such as citric acid or salts thereof with a pKa of from about 4 to about 6.5 with an oral care composition pH from about 4-6 or 4-5.5 (Abstract; claims 27 and 28) and a method of preventing, treating, or mitigating sensitivity in an oral cavity of a user comprising applying the oral care composition to at least one tooth in the oral cavity for an application period of from about 30 seconds to about 2 minutes followed by expectoration of the oral care composition after the application period (claim 29).
Further, Strand teaches leave-on toothpaste and gel oral care compositions applied onto the intraoral tissue of the subject with an applicator comprising a handle and a head, and applying by brushing teeth and leaving the oral care composition on the intraoral tissue for a duration of time from about 1 to 1000 minutes (claims 1, and 10-15).
Given Glandorf teaches oral compositions containing stannous fluoride tin ions are known to provide anti-erosion, caries prevention, and/or antisensitivity benefits (¶[0002]), it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the method of preventing, treating, or mitigating sensitivity in an oral cavity taught by Drake and apply in to the oral compositions taught by Glandorf to arrive at the method of instant claim 20.
Glandorf teaches that the composition may be a dentifrice and that leave‑on compositions may be used (claim 28). Drake explicitly teaches the exact method for an oxalic‑acid‑containing composition (claim 29), and Strand confirms that leave‑on toothpaste applied with a brush for a duration of 1‑1000 minutes is known. The combination of these references merely applies the well‑known method of using a toothpaste (Drake) to the composition taught by Glandorf, in order to achieve the known benefits (anti‑erosion, anticaries) that Glandorf itself ascribes to stannous ions. This is a predictable use of a known composition according to a standard protocol (see In re Aller, 220 F.3d 1368, 1373 (Fed. Cir. 2000), wherein the prior art teaches the composition and the method is a conventional application, the claimed method is obvious). The selection of “at least 2 minutes” is a routine optimization of an application period already taught to be effective for leave‑on treatments (Strand’s 1‑1000 minutes). The sub‑range is not shown to be critical and is obvious (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003)).
In sum, when the teachings of Glandorf are combined with the background knowledge of a person of ordinary skill, the claimed composition and method would have been arrived at with a reasonable expectation of success, using no more than routine skill and the predictable results demonstrated by the prior art itself. The claimed invention is therefore obvious.
Claim Rejections – Nonstatutory 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).
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, 10, 11 of co-pending US Application No. 19/319,939 (published as US20260000588A1, hereinafter “’939”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claim 1 is directed to an oral care composition comprising an oral care active with a fluoride ion source and a stannous ion source, a mixture of dentate ligands: oxalic acid (first polydentate) and lactic acid (monodentate), and a molar ratio of stannous ions to the mixture of dentate ligands from about 1:1 to about 1:4.
The ’939 claim 1 recites “tin” that comprises stannous fluoride or stannous chloride. Stannous fluoride itself supplies both stannous ions and fluoride ions. The specification describes oral care compositions containing stannous fluoride as a dual source of tin and fluoride (¶[0020]). The ’939 application defines polydentate ligands as including dicarboxylic acids (claim 1(c)), and claim 10 specifically identifies oxalic acid as a dicarboxylic acid. Monodentate ligands include aliphatic carboxylic acids (claim 1(b)), and claims 4 and 6 specifically teach alpha hydroxy acids and lactate. Lactic acid is a species of the monodentate class. The ’939 claim 1 provides a three-way ratio of tin:monodentate:polydentate of 1:0.5:0.5 to 1:5:5. The sum of monodentate and polydentate relative to tin ranges from 1:1 to 1:10. The instant range of 1:1 to 1:4 is fully encompassed by this broad range, and constitutes a narrowing of the taught range. The specification of the ’939 application describes that particularly stable stannous complexes are formed when the total ligand amount is between about 1:1 and about 1:5 (¶[0065]). See also supporting ’939 specification ¶[0008]-[0025], and ¶[0050]-[0080].
The instant composition is merely a selection of two specifically disclosed ligands, oxalic acid and lactic acid, from the broad classes taught by the ’939 application, used together in the manner expressly contemplated (a mixture of polydentate and monodentate ligands) with a total ligand ratio that falls squarely within the taught range. The ’939 application explicitly teaches each of these ligands as suitable members of their respective classes and provides an explicit motivation to combine a polydentate dicarboxylic acid with a monodentate aliphatic carboxylic acid to chelate tin effectively. No unexpected results have been demonstrated that would render the selected species and subrange patentably distinct. A person of ordinary skill would have arrived at the claimed composition by simply selecting two preferred ligands and optimizing the total ligand amount within the taught range (see In re Aller, 220 F.2d 454 (CCPA 1955), wherein selection of a species from a disclosed genus is obvious absent evidence of unexpected properties). Therefore, instant claim 1 is not patentably distinct from the ’939 application.
Regarding instant claim 2 (ratio 1:1-1:3), a further narrowing of the already taught and obvious range. Selecting an optimum subrange is a routine optimization, the ’939 application suggests effective ratios in the lower portion of the range (¶[0065]). Regarding instant claim 3 (second polydentate ligand, tridentate), the ’939 claim 1(c) explicitly allows the polydentate ligand to include a tridentate ligand. Adding a second polydentate is an obvious extension of the disclosed ligand mixture, as the ’939 specification describes the use of multiple ligands (¶[0045]). Regarding instant claims 4-6 (second polydentate tricarboxylic acid as citric acid), tricarboxylic acids are recited as polydentate ligands in ’939 claim 1(c) and claim 11 (citric acid). Incorporating an additional known tridentate ligand is an obvious variation.
Regarding instant claims 7-10 (specific weight percentages), the ’939 specification provides general guidance on ligand concentrations in oral care compositions, typically from about 0.5% to 10% by weight (¶[0055]). The claimed ranges (1.0-7.5%, 1.7-4.0%) represent obvious, routine optimization amounts that would have been arrived at through standard formulation practice. Regarding instant claims 11-13 (fluoride ion source selections, amount, and concentration), stannous fluoride, sodium fluoride, sodium monofluorophosphate, and amine fluoride are conventional fluoride sources. The ’939 application’s tin sources inherently include stannous fluoride, which delivers fluoride. The specific amounts (≥1000 ppm fluoride ions, 0.2-1% fluoride ions) are standard in dentifrices and taught in the art, not imparting patentable distinction.
Regarding instant claims 14-16 (stannous ion source and amounts), stannous fluoride and stannous chloride are the tin sources of ’939 claim 1(a). The claimed weight percentages of stannous ion source are within the ranges ordinarily used and are obvious to try. Regarding instant claim 17 (fluoride and stannous source both from stannous fluoride), the ’939 application expressly includes stannous fluoride as a tin source that also provides fluoride. Thus, there is no patentable distinction. Regarding instant claims 18-19 (pH ranges 4-6, 4.5-5.5), the ’939 specification discloses that the oral care composition can be formulated at a pH of about 3.5 to 7, with a preferred range of about 4 to 6 (¶[0075]). The recited pH ranges are obvious optimizations. Each dependent claim merely adds a well-known or expressly taught feature and do not render the claimed invention patentably distinct.
Instant claim 20 recites a method of treating/preventing erosion or caries by applying the composition of claim 1 to the oral cavity with a toothbrush for at least 2 minutes, followed by expectorating. The ’939 application describes oral care methods comprising applying the oral care composition to the oral cavity to treat conditions including erosion and caries (¶[0006]-[0008]). The steps of brushing, surface contact time, and expectorating are inherent to the ordinary use of a dentifrice. Because the underlying composition is obvious, the method using that composition in a conventional manner is likewise obvious.
In summary, claims 1-20 of the instant application are not patentably distinct from the invention claimed in co-pending application ‘939. The instant claims define an obvious species and obvious variants of the broad genus already claimed. Accordingly, a provisional nonstatutory obviousness-type double patenting rejection is entered.
To overcome this rejection, applicant may present evidence or argument demonstrating that the claims are patentably distinct, or file a terminal disclaimer under 37 C.F.R. § 1.321 that disclaims the terminal part of any patent granted on the instant application beyond the expiration date of any patent issuing from the ’939 application. Upon filing of an appropriate terminal disclaimer, this rejection will be withdrawn.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, 10, and 11 of co-pending US Application No. 18/886,244 (published as US20250009616A1, hereinafter “’244”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 is directed to an oral care composition comprising an oral care active with a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands from about 1:1 to about 1:4. This combination is clearly and specifically taught by the ’244 application.
The ’244 claim 1 recites “tin” that comprises stannous fluoride. Stannous fluoride provides both stannous ions and fluoride ions, satisfying the “fluoride ion source and stannous ion source” of the instant claim. The specification explains that stannous fluoride is a preferred tin source for this purpose (¶[0020]). The ’244 application defines polydentate ligands to include dicarboxylic acids, and claim 10 expressly names oxalic acid as a dicarboxylic acid. It defines monodentate ligands to include aliphatic carboxylic acids, including alpha hydroxy acids (claim 4), and claim 6 specifies that the alpha hydroxy acid can be lactate (i.e., lactic acid). Thus, the specific combination of oxalic acid and lactic acid is a combination of two explicitly recited species from the claimed genera.
The ’244 claim 1 sets out a three-way ratio of tin:monodentate:polydentate. The possible total-ligand-to-tin ratios from those disclosed ranges include 1:1 to 1:10 (e.g., 1:0.5:0.5 yields total ligands:tin = 1:1; 1:5:5 yields 10:1). The instant range of 1:1 to 1:4 (total ligands:tin) is entirely encompassed by that disclosure. The specification indicates that total ligand:tin ratios of about 1:1 to about 1:5 are particularly effective (¶[0055]). See also supporting ’244 specification ¶[0030]-[0060].
Thus, the instant composition is nothing more than a selection of two specifically identified, preferred ligands, oxalic acid (a dicarboxylic acid) and lactic acid (an alpha hydroxy acid), from the broad classes taught by the ’244 application, used together in the precise manner taught (a mixture of polydentate and monodentate ligands) and within a total-ligand ratio that is expressly contemplated as optimal. The ’244 specification explicitly motivates combining a bidentate dicarboxylic acid and an alpha hydroxy acid monodentate ligand to chelate stannous, and exemplifies both. No unexpected results are shown to distinguish the selected combination from the broader disclosure. A person of ordinary skill in the art would have arrived at the claimed composition by simply choosing two named ligands and operating within the taught ratio range (see In re Aller, 220 F.2d 454 (CCPA 1955)). Therefore, instant claim 1 is not patentably distinct.
Regarding instant claim 2 (ratio 1:1 to 1:3), this is a further narrowing of a known range. Selecting an optimal sub-range is a matter of routine optimization; the ’244 specification suggests preferred ratios in the lower part of the range, making this obvious. Regarding instant claim 3 (second polydentate ligand, tridentate), the ’244 claim 1(c) explicitly states the polydentate ligand can be a tridentate ligand. Adding a second, tridentate polydentate ligand is an obvious modification taught in the ’244 application (¶[0045]). Regarding instant claims 4-6 (tridentate tricarboxylic acid as citric acid), tricarboxylic acids, including citric acid, are recited as polydentate ligands in ’244 claim 1(c) and claim 11. Incorporation of citric acid as a second polydentate is obvious.
Regarding instant claims 7-10 (specific weight percentages), the ’244 specification guides that the ligands are typically present in amounts of about 0.5% to 10% by weight (¶[0050]). The claimed ranges (1.0-7.5%, 1.7-4.0%) are routine formulation optimizations and not patentably distinct. Regarding instant claims 11-13 (fluoride ion source, amounts), stannous fluoride, sodium fluoride, sodium monofluorophosphate, and amine fluoride are conventional. The specific concentrations (≥1000 ppm fluoride ions, 0.2–1% fluoride ions) are standard in the art and would have been obvious to employ. The ’244 application inherently provides fluoride through stannous fluoride.
Regarding instant claims 14-16 (stannous ion source and amounts), stannous fluoride and stannous chloride are the exact tin sources of ’244 claim 1(a). The particular weight percentages fall within typical ranges and represent obvious choices. Regarding instant claim 17 (both ions from stannous fluoride), the limitation is explicitly taught, the ’244 application uses stannous fluoride as the dual source. Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’244 specification describes a pH range of about 3.5 to 7, with preferred pH around 4 to 6 (¶[0070]). The recited pH ranges are obvious optimizations.
Instant claim 20 recites a method of treating or preventing erosion or caries by brushing with the composition of claim 1 for at least 2 minutes, then expectorating. The ’244 application describes oral care methods that include applying the composition to teeth to treat or prevent conditions including erosion and caries (¶[0006]). The specific brushing and timing steps are inherent to conventional dentifrice use. Because the underlying composition is not patentably distinct, the method of using it in an ordinary manner is similarly obvious (see In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).
In summary, claims 1-20 of the instant application are not patentably distinct from the invention claimed in co-pending application ‘244. The instant claims define a specific combination of oxalic acid and lactic acid as dentate ligands, a combination explicitly taught by the ’244 application, with a total ligand ratio fully encompassed by the ’244 application’s disclosure. No patentable distinction arises from the routine selection of species, sub-ranges, or conventional formulation details.
To overcome this rejection, the applicant may file a terminal disclaimer under 37 C.F.R. § 1.321, disclaiming any patent term that extends beyond that of a patent issuing from the ’244 application, or present evidence or arguments demonstrating that the instant claims are patentably distinct (e.g., unexpected results attributable to the specific combination as a whole). Failure to respond to this rejection will result in a final rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10, and 11 of co-pending US Application No. 18/936,549 (published as US20250057743A1, hereinafter “’549”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 is directed to an oral care composition comprising an oral care active with a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands from about 1:1 to about 1:4. This composition is merely a specific embodiment of the compositions taught and claimed by the ’549 application, arrived at by routine selection from the disclosed classes.
The ’549 claim 1 permits the fluoride ion source to be stannous fluoride. Claim 4 explicitly adds a tin ion source (stannous fluoride, stannous chloride). Thus, a composition falling within the scope of claim 1 as amended by claims 4 comprises both a fluoride ion source and a stannous ion source, satisfied in a single compound (stannous fluoride) or by separate compounds. The ’549 claim 1 mandates oxalic acid or a salt (a dicarboxylic acid, i.e., a polydentate ligand). Claim 10 adds a monodentate ligand, a polydentate ligand, or both. The specification teaches that a monodentate ligand can be an aliphatic carboxylic acid, and specifically names alpha hydroxy acids, including lactic acid, as suitable (¶[0042]). Selecting lactic acid as the monodentate ligand to use with the mandatory oxalic acid polydentate is therefore a specific choice from the taught class.
The ’549 claim 11 sets a three-way tin:monodentate:polydentate ratio of 1:0.5:0.5 to 1:5:5. The sum of monodentate and polydentate relative to tin thus spans 1:1 (at 1:0.5:0.5) to 1:10 (at 1:5:5). The instant range of 1:1 to 1:4 (total ligands:tin) is a subrange wholly within that broad range. The specification indicates that total ligand:tin ratios in the lower portion, particularly between about 1:1 and about 1:5, are advantageous for bioavailability (¶[0055]). See also supporting ’549 specification ¶[0038]–[0045], and ¶[0052]–[0060].
One of ordinary skill in the art, desiring to prepare an oral care composition with stannous and fluoride for anti-caries/anti-erosion benefits, would have started with the ’549 composition, oxalic acid as the required polydentate and a stannous fluoride source (as per claims 1 and 4). Recognizing from the specification that a monodentate ligand can further enhance tin stabilization, one of ordinary skill in the art would have selected lactic acid, a well-known, food-grade alpha hydroxy acid monodentate chelator taught in the ’549 application. One of ordinary skill in the art would then optimize the total ligand amount to fall within the disclosed preferred subrange, arriving at a stannous:total ligand ratio of 1:1 to 1:4. No unexpected results have been demonstrated that would confer patentable distinction upon this specific combination and ratio (see In re Aller, 220 F.2d 454 (CCPA 1955), wherein selection of a species from a disclosed genus is obvious absent evidence of unexpected properties). Therefore, instant claim 1 is not patentably distinct from the ’549 application.
Each dependent claim adds a limitation that is either taught by the ’549 application or represents a routine optimization. Regarding instant claim 2 (ratio 1:1 to 1:3), a narrower subrange of the known ratio, selecting an optimum within a taught range is obvious. Regarding instant claim 3 (second polydentate ligand, tridentate), the ’549 application already includes a polydentate ligand (oxalic acid), and claim 10 permits an additional polydentate ligand. The specification explains that tridentate ligands such as citric acid may be included (¶[0065]). Regarding instant claims 4-6 (second polydentate is tricarboxylic acid, as citric acid), the ’549 specification describes tricarboxylic acids as suitable additional polydentate ligands (¶[0065]-[0068]).
Regarding instant claims 7-10 (weight percentages of ligands), the ’549 application broadly teaches that the dicarboxylic acid (oxalic acid) is used at 1-5% by weight (claim 1), and the specification indicates that additional ligands are typically added in similar amounts of about 0.5% to 10% (¶[0048]). The claimed ranges represent obvious formulation adjustments. Regarding instant claims 11-13 (fluoride ion source, ppm, amount), the ’549 claim 1 lists the same fluoride ion sources, the claimed amounts and concentration are conventional and taught in the art.
Regarding instant claims 14-16 (stannous ion source and amounts), claim 4 of the ’549 application names stannous fluoride and stannous chloride, the weight ranges are standard and would have been obvious optimizations. Regarding instant claim 17 (both ions from stannous fluoride), explicitly taught by the ’549 application, where stannous fluoride may serve as the fluoride source and tin source (claims 1 and 4). Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’549 claim 1 defines pH 4.5-7, and the specification describes preferred pH ranges of 4.5-6 (¶[0072]). The recited subranges are obvious.
Instant claim 20 recites a method of treating or preventing erosion or caries by brushing with the composition of claim 1 for at least 2 minutes, then expectorating. The ’549 application is directed to dentifrice compositions that reduce calcium loss (i.e., treat/prevent erosion) and necessarily involve brushing for normal use. The specification describes methods of reducing dental erosion and caries using the composition (¶[0008]-[0012]). The specific steps of brushing and expectorating are conventional. As the composition itself is obvious, the method of using it in a known manner is similarly obvious (see In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).
In summary, claims 1-20 of the instant application define obvious variants of the composition and method already claimed in the ’549 application. The instant claims therefore constitute an improper attempt to prolong the patent term for the same inventive concept. A provisional nonstatutory obviousness-type double patenting rejection is entered.
To overcome this rejection, applicant may present evidence or argument establishing that the claims are patentably distinct (e.g., demonstrating unexpected results attributable to the specific combination as a whole), or file a terminal disclaimer pursuant to 37 C.F.R. § 1.321 disclaiming the terminal part of any patent granted on this application beyond the expiration date of any patent issuing from the ’549 application. Upon filing of an appropriate terminal disclaimer, this rejection will be withdrawn.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 9, and 13 of co-pending US Application No. 18/911,374 (published as US20250120891A1, hereinafter “’374”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 is directed to an oral care composition comprising an oral care active with a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands from about 1:1 to about 1:4.
Although the ’374 claim 1 does not literally list oxalic acid as the mandatory first polydentate ligand, the specification and dependent claims make clear that oxalic acid is a suitable bidentate dicarboxylic acid for stannous chelation. Claim 6 explicitly includes oxalic acid as a second polydentate ligand. The choice of oxalic acid as the polydentate partner for a monodentate ligand, in place of the specifically listed first polydentate acids, would have been obvious because of known functional equivalence, explicit suggestion of combination with monodentate, and obvious optimization.
The ’374 specification teaches that the polydentate ligand functions to chelate stannous ions through its two carboxylic acid groups. Oxalic acid is the simplest dicarboxylic acid and is well known in the art for its metal-chelating ability. The ’374 application acknowledges that oxalic acid can serve as a polydentate ligand in the same manner as malonic, malic, or tartaric acid, merely distinguishing it as a “second” polydentate for combination benefits, not as a less effective chelator.
Claim 9 of the ’374 application provides that when the mixture includes a monodentate ligand (rather than a second polydentate), that monodentate can be lactic acid. The specification describes compositions that pair a polydentate dicarboxylic acid with a monodentate monocarboxylic acid such as lactic acid to achieve good stannous stability (¶[0028]). While the exemplified polydentate in the claims is from the restricted list, a person of ordinary skill would have immediately recognized that substituting oxalic acid, a known bidentate ligand taught as suitable in the same application, would predictably retain the same chelation function.
In addition, the specific combination of oxalic acid and lactic acid represents nothing more than the selection of one known polydentate and one known monodentate from the genera disclosed in the ’374 application. No unexpected results or criticality are shown (see In re Aller, 220 F.2d 454 (CCPA 1955)).
Regarding the molar ratio, the instant ratio of stannous to total ligands (1:1 to 1:4) is identical to that claimed in the ’374 application and is taught as the preferred range (¶[0032]). See also supporting ’374 specification ¶[0018]-[0035]. Therefore, instant claim 1 merely defines an obvious combination of a polydentate and a monodentate ligand, both of which are explicitly taught as suitable components in the ’374 application, within the very same molar ratio range. The claim is not patentably distinct from the invention of the ’374 application.
Each dependent claim adds a feature that is either expressly taught by the ’374 application or represents a routine design choice. Regarding instant claim 2 (narrower ratio 1:1-1:3), a subrange fully within the taught 1:1-1:4 ratio, thus, is obvious as routine optimization. The ’374 specification indicates that lower ratios within this range may be particularly effective (¶[0033]). Regarding instant claim 3 (second polydentate ligand, tridentate), the ’374 claim 1(ii) already teaches that the mixture may include a second polydentate ligand, which can be a tridentate ligand. Regarding instant claims 4-6 (second polydentate tricarboxylic acid as citric acid), citric acid is explicitly listed as a tridentate ligand in the ’374 application (see claim 8, reciting citric acid as a second polydentate). Thus, adding citric acid as an additional ligand is obvious.
Regarding instant claims 7-10 (weight percentages of ligands), the ’374 application broadly describes that individual ligands may be present in amounts ranging from 0.5% to 10% by weight (¶[0040]). The recited amounts (1.0-7.5%, 1.7-4.0%) are routine concentration selections and do not patentably distinguish. Regarding instant claims 11-13 (fluoride ion source, ppm, amount), the ’374 claim 1 already requires a fluoride ion source, and claim 11 recites the same list. The minimum 1000 ppm fluoride and 0.2-1% fluoride source are standard, well-known dentifrice parameters taught in the art.
Regarding instant claims 14-16 (stannous ion source, amounts), the ’374 claim 1 requires a stannous ion source, claim 23 specifies stannous fluoride and stannous chloride. The claimed weight percentages are within conventional ranges. Regarding instant claim 17 (both ions from stannous fluoride), the ’374 application expressly contemplates stannous fluoride as a dual source (claim 11, reciting stannous fluoride as a fluoride source, and the inherent supply of stannous ions). Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’374 application teaches a preferred pH range of about 4 to 6 (claim 10), making the recited narrower ranges obvious.
Instant claim 20 recites a method for treating/preventing erosion or caries by brushing with the composition of claim 1 for at least 2 minutes and expectorating. The ’374 application describes identical methods (claim 25) using its oral care composition for the same therapeutic purposes, including the steps of brushing and expectorating. Since the underlying composition is obvious, the method of using it in a conventional manner is similarly obvious (see In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).
In summary, claims 1-20 of the instant application are not patentably distinct from the invention claimed in co-pending application ‘374. The instant claims define an obvious substitution of oxalic acid for the specifically recited first polydentate ligand, in combination with the known monodentate lactic acid, within the same molar ratio range taught by the ’374 application. No unexpected results have been presented, and the claims thus constitute an obvious variant that would improperly extend the patent term for the same inventive concept.
To overcome this rejection, the applicant may present evidence or argument demonstrating that the claims are patentably distinct (e.g., showing unexpected results specifically attributable to the oxalic acid/lactic acid combination that are not shared by the combinations in the ’374 application), or file a terminal disclaimer pursuant to 37 C.F.R. § 1.321, disclaiming any patent term that extends beyond that of any patent issuing from the ’374 application. Failure to respond may result in the rejection being made final.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12, and 23 of co-pending US Application No. 18/911,383 (published as US20250120892A1, hereinafter “’383”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 is directed to an oral care composition comprising an oral care active with a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands from about 1:1 to about 1:4.
The ’383 claim 1 explicitly provides the same oral care active (fluoride + stannous), a mixture that must include a monodentate from the group consisting of acetic acid, lactic acid, gluconic acid (or salts), and either a didentate from a group that specifically includes oxalic acid, or a tridentate, a molar ratio of stannous to the mixture of dentate ligands of about 1:2, and a pH of about 4 to 5.
The instant claim 1 selects lactic acid (a monodentate) and oxalic acid (a didentate) from the very groups recited in the ’383 claim 1. A composition containing lactic acid, oxalic acid, a fluoride ion source, and a stannous ion source in a stannous-to-total-ligands ratio of 1:2 falls squarely within the literal scope of the ’383 claim 1 with pH between 4 and 5. The instant claim 1 is broader in two respects the ratio is 1:1 to 1:4 rather than about 1:2, and it does not explicitly recite a pH limitation. The broadening of the ratio and the omission of the pH limitation do not render the claim patentably distinct.
The ’383 application teaches that a ratio of about 1:2 provides good stannous stabilization and bioavailability (¶[0030]). Varying the ratio slightly above or below 1:2 to a range of 1:1 to 1:4 would have been an obvious routine optimization to a person of ordinary skill in the art, particularly in the absence of any showing of unexpected results. The art generally recognized that total ligand-to-metal ratios in this vicinity are suitable for chelation. No inventive effort is required to expand the single value to a modest range that brackets it.
Instant claim 1 does not include a pH limitation, thereby covering compositions at any pH, including those outside the ’383 range of 4-5. Omitting a known feature, especially one that is conventional (the pH of dentifrices is routinely adjusted), is an obvious way to broaden a claim. The ’383 application itself describes that pH can vary (¶[0035]), thus, removing the pH limitation would have been an obvious modification.
Further, the instant claim encompasses the ’383 species. At least one composition falling within the instant claim (lactic acid + oxalic acid, ratio 1:2, pH 4-5) is covered by the ’383 claims. When a later claim reads on subject matter already claimed in a co-pending application, the later claim is not patentably distinct (see In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985)). For these reasons, the instant claim 1 is not patentably distinct from the invention claimed in the ’383 application.
Regarding instant claim 2 (ratio 1:1-1:3), a subrange of the already obvious 1:1-1:4 range, thus is not a patentable distinction. Regarding instant claim 3 (second polydentate, tridentate), the ’383 application already provides for the inclusion of a tridentate ligand (claim 1, option iii). Adding citric acid or another tridentate alongside oxalic acid is merely selecting a combination of ligands taught as alternatives. Regarding instant claims 4-6 (tridentate tricarboxylic acid as citric acid), citric acid is explicitly named as a tridentate ligand in the ’383 claims. Selection is obvious.
Regarding instant claims 7-10 (weight percentages), the ’383 specification describes ligand amounts generally in the range of about 0.5% to 10% (¶[0042]). The recited ranges represent obvious formulation choices, not patentably distinct. Regarding instant claims 11-13 (fluoride ion source, amounts), the same fluoride sources are listed in ’383 claim 7. The specific amounts are conventional.
Regarding instant claims 14-16 (stannous ion source, amounts), stannous fluoride and stannous chloride are named in ’383 claim 9. Amounts are standard. Regarding instant claim 17 (both ions from stannous fluoride), the limitation is taught by the ’383 application, where stannous fluoride serves as both sources (claims 1 and 11). Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’383 claim 1 recites pH 4-5. Expanding the range to 4-6 or 4.5-5.5 would have been an obvious optimization, especially where the specification teaches that a pH of about 4.5 is preferred (claim 6). The claimed ranges encompass the ’383 range and are not patentably distinct.
Instant claim 20 is directed to a method of treating/preventing erosion or caries by brushing with the composition of claim 1, with a dwell time of at least 2 minutes and expectoration. The ’383 application claims the identical method (claim 23) using its own composition. Because the underlying composition is not patentably distinct, the method of using it in the same way is likewise obvious (see In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).
In summary, claims 1-20 of the instant application are not patentably distinct from the invention claimed in co-pending application ‘383. The instant claims cover a composition that is a species within the ’383 application’s genus, and the modest variations in ratio and pH represent obvious design choices. Accordingly, a provisional nonstatutory obviousness-type double patenting rejection is entered.
To overcome this rejection, applicant may file a terminal disclaimer under 37 C.F.R. § 1.321, disclaiming any terminal part of a patent granted on this application beyond the expiration date of any patent issuing from the ’383 application, or present evidence or argument demonstrating that the instant claims are patentably distinct (e.g., unexpected results uniquely attributable to the claimed range or the specific combination of features not shared by the ’383 application’s disclosure). Failure to respond may result in a final rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-9, and 21 of co-pending US Application No. 18/911,401 (published as US20250120894A1, hereinafter “’401”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 is directed to an oral care composition comprising an oral care active with a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands from about 1:1 to about 1:4. The ’401 claim 1 ((i)+(ii)), recites the identical composition except that the monodentate ligand is gluconic acid instead of lactic acid. The instant claim therefore differs only in the selection of the monodentate.
The ’401 specification (¶[0024]-[0031]) broadly teaches that the monodentate ligand can be any suitable monocarboxylic acid capable of chelating tin. Specifically, the specification identifies a class of monodentate ligands that includes aliphatic monocarboxylic acids, and further states that alpha-hydroxy acids are particularly suitable. Lactic acid is an alpha-hydroxy acid and is explicitly named as an exemplary monodentate in the specification (¶[0027] reciting, “Exemplary monodentate ligands include … lactic acid, gluconic acid, … and salts thereof.”). Thus, the ’401 specification clearly teaches that lactic acid is functionally equivalent to gluconic acid in the claimed combination.
A person of ordinary skill in the art, reading the ’401 application, would have understood that the specific monodentate may be selected from a group that includes both gluconic acid and lactic acid without any change in the fundamental operation of the composition, stabilizing stannous ions through chelation. The substitution of one disclosed alpha-hydroxy acid for another would have been a matter of routine optimization, absent any showing of unexpected results (see In re Aller, 220 F.2d 454 (CCPA 1955)). Thus, the instant composition as a whole is nothing more than an obvious variant of the composition specifically claimed in the ’401 application. Therefore, instant claim 1 is not patentably distinct from the ’401 application.
Each dependent claim adds a limitation that is either expressly taught by the ’401 application or represents a routine design choice. Regarding instant claim 2 (narrower ratio 1:1-1:3), a subrange fully within the disclosed range of 1:1-1:4, which is shown in the ’401 application to be a preferred ratio (¶[0032]), thus, is obvious optimization. Regarding instant claim 3 (second polydentate ligand, tridentate), the ’401 claim 1 already provides for the inclusion of a tridentate ligand ((iii)). Adding such a second polydentate to the monodentate-containing composition is explicitly taught by claim 9 of the ’401 application and is an obvious modification.
Regarding instant claims 4-6 (tridentate tricarboxylic acid as citric acid), citric acid is explicitly listed as a tridentate ligand in the ’401 specification (¶[0035]) and in dependent claim 3. Its selection is obvious. Regarding instant claims 7-10 (weight percentages), the ’401 specification describes that individual ligands are typically present in amounts ranging from about 0.5% to 10% by weight (¶[0040]). The recited ranges represent obvious formulation choices, not patentably distinct. Regarding instant claims 11-13 (fluoride ion source, ppm, amount), the ’401 claim 5 lists the same fluoride sources, claim 6 requires at least 1000 ppm soluble fluoride, and the specification generally teaches 0.2-1% fluoride source. These are well-known parameters, not imparting patentable distinction.
Regarding instant claims 14-16 (stannous ion source, amounts), the ’401 claim 7 recites stannous fluoride and stannous chloride and a 0.2-1.0% weight range. The instant amounts are within this range and obvious. Regarding instant claim 17 (both ions from stannous fluoride), the ’401 application contemplates stannous fluoride as a dual source (claim 5 reciting stannous fluoride as a fluoride source, and claim 7 reciting it as a stannous source). Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’401 claim 8 recites a pH of about 4 to about 6. Narrowing to 4.5-5.5 is an obvious optimization, the specification suggests pH around 4.5 as preferred (¶[0045]).
Instant claim 20 is directed to a method of treating/preventing erosion or caries by brushing with the composition of claim 1, with a dwell time of at least 2 minutes, followed by expectoration. The ’401 application claims the identical method (claim 21) using its own composition. Because the underlying composition is an obvious variant, the method of using it in the same way is likewise obvious (see In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).
In summary, claims 1-20 of the instant application are not patentably distinct from the invention claimed in co-pending application ‘401. The sole substantive difference, the use of lactic acid as the monodentate in place of gluconic acid, is a selection from an explicitly taught group of equivalent monodentate ligands and would have been obvious to a person of ordinary skill in the art. No unexpected results have been demonstrated that would confer patentable distinction. Accordingly, a provisional nonstatutory obviousness-type double patenting rejection is entered.
To overcome this rejection, applicant may file a terminal disclaimer under 37 C.F.R. § 1.321, disclaiming the terminal part of any patent granted on this application beyond the expiration date of any patent issuing from the ’401 application, or present evidence or argument establishing that the claims are patentably distinct (e.g., unexpected results uniquely attributable to the substitution of lactic acid for gluconic acid, not shared by the compositions of the ’401 application). Failure to respond may result in the rejection being made final.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 11, 18, and 20 of co-pending US Application No. 18/911,823 (published as US20250032377A1, hereinafter “’377”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 is directed to an oral care composition comprising an oral care active with a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands from about 1:1 to about 1:4. This combination is a straightforward selection of components and a ratio already taught by the ’377 application for the same purpose of stannous stabilization.
The ’377 claim 18 explicitly provides a tin ion source (stannous fluoride or chloride, see claim 20) together with a dicarboxylic acid (which can be oxalic acid per claim 10) and soluble fluoride. Thus, a composition containing stannous, fluoride, and oxalic acid is squarely within the ’377 invention. The ’377 specification further teaches that a monodentate ligand may be added to the composition to enhance tin chelation, and names lactic acid as a suitable monodentate. Adding lactic acid to the stannous-containing composition of claim 18 would have been obvious, because the application explicitly suggests doing so (claim 11 and ¶[0040]).
The specific molar ratio of stannous ions to total dentate ligands of 1:1 to 1:4 is a sub-range of the broad ratio (1:0.5 to 1:5) disclosed in the specification as suitable for tin chelation, and is expressly identified as a preferred range for bioavailability (¶[0055]). Selecting that range is mere optimization, not invention. See also supporting ’377 specification ¶[0030]-[0045] and ¶[0050]-[0055].
Thus, a person of ordinary skill in the art would have arrived at the instant composition by taking the composition of ’377 claim 18 (stannous, oxalic acid, fluoride), adding a monodentate ligand as taught (lactic acid), and operating within the taught preferred molar ratio. No unexpected results are shown (see In re Aller, 220 F.2d 454 (CCPA 1955)). Thus, instant claim 1 is not patentably distinct.
Regarding instant claim 2 (ratio 1:1-1:3), narrower subrange of the known preferred range, thus, an obvious optimization. Regarding instant claim 3 (second polydentate, tridentate), the ’377 application describes the use of a tridentate ligand such as citric acid in addition to a dicarboxylic acid (¶[0035]). Adding a second polydentate is an obvious extension of the chelation system. Regarding instant claims 4-6 (tridentate tricarboxylic acid as citric acid), citric acid is explicitly mentioned as a suitable tricarboxylic acid in the specification, thus, an obvious selection.
Regarding instant claims 7-10 (weight percentages of ligands), the specification teaches that individual ligands are typically present in amounts of 0.5% to 10% by weight. The recited ranges are routine formulation choices. Regarding instant claims 11-13 (fluoride ion source, ppm, amount), standard fluoride sources are listed in claim 9 of the ’377 application, and the minimum 1000 ppm soluble fluoride and 0.2-1% fluoride source are conventional.
Regarding instant claims 14-16 (stannous ion source, amounts), stannous fluoride and chloride are in claim 20, and the weight percentages are within the broad teaching of 0.01-10% in claim 18. Thus impart no patentable distinction. Regarding instant claim 17 (both ions from stannous fluoride), the limitations are taught by the ’377 application where stannous fluoride serves as both the tin and fluoride source (claim 20). Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’377 claims require pH 4-5.5 (claims 1 and 18), the instant ranges overlap or are obvious extensions.
Instant claim 20 recites a method of treating/preventing erosion or caries by brushing with the composition of claim 1 for at least 2 minutes, then expectorating. The ’377 specification describes the compositions as useful for preventing caries and erosion (¶[0006]), and the method of brushing is conventional. Because the composition is obvious, the method of using it is likewise obvious (see In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).
Thus, claims 1-20 of the instant application define obvious variants of the compositions and methods already disclosed and claimed in the ’377 application. The specific selection of oxalic acid and lactic acid as the ligand pair, in a preferred molar ratio, would have been obvious to a person of ordinary skill in the art in view of the ’377 disclosure. Thus, the instant claims are not patentably distinct, and a provisional nonstatutory obviousness-type double patenting rejection is entered.
To overcome this rejection, applicant may file a terminal disclaimer under 37 C.F.R. § 1.321, disclaiming any terminal part of a patent granted on this application beyond the expiration date of any patent issuing from the ’377 application, or present evidence or argument establishing that the claims are patentably distinct (e.g., unexpected results uniquely attributable to the claimed combination not shared by the ’377 disclosure). Failure to respond may result in a final rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9-11, 13, 17-19, 22, and 24-30 of co-pending US Application No. 17/308,086 (published as US20210346256A1, hereinafter “’086”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 recites an oral care composition comprising a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands of about 1:1 to about 1:4. The ’086 method claims require the use of a dentifrice composition containing tin, a monodentate ligand, and/or a polydentate ligand. The specification of the ’086 application provides explicit teachings that make the instant composition obvious (¶[0030]-[0060]). The tin source in the method may be stannous fluoride (claim 7), which inherently supplies both stannous and fluoride ions. Fluoride may also be present as sodium fluoride, etc. (claim 13). Thus, the claimed “fluoride ion source and stannous ion source” is satisfied.
The ’086 application identifies lactic acid as a monodentate alpha hydroxy acid (claims 22 and 24) and oxalic acid as a dicarboxylic acid polydentate (claim 30). Both are taught to be suitable ligands for chelating tin. The combination of these two specific ligands is merely a selection from the disclosed classes, choosing a preferred species from a disclosed group is prima facie obvious absent unexpected results (see In re Aller, 220 F.2d 454 (CCPA 1955)).
The ’086 claims a tin:monodentate:polydentate ratio of 1:0.5:0.5 to 1:5:5. The total ligand:tin ratio from that range spans 1:1 (at 1:0.5:0.5) to 1:10 (at 1:5:5). The instant ratio of 1:1 to 1:4 is wholly encompassed, and the specification indicates that ratios in that lower portion are particularly effective for stannous stabilization (¶[0050]). Narrowing a known range to a preferred sub-range is a routine optimization that does not confer patentable distinction.
Consequently, the instant composition is an obvious variant of the dentifrice composition already required by the ’086 method claims. A person of ordinary skill in the art, following the teachings of the ’086 application, would have arrived at the instant composition by selecting stannous fluoride as the tin source, oxalic acid and lactic acid as the ligands, and a total ligand ratio within the taught preferred range. No unexpected results are demonstrated. Therefore, instant claim 1 is not patentably distinct.
Each dependent claim adds a feature that is taught, suggested, or represents a routine design choice in view of the ’086 application. Regarding instant claim 2 (ratio 1:1-1:3), this is a sub-range of the already-obvious range and represents mere optimization. Regarding instant claim 3 (second polydentate, tridentate), the ’086 application teaches that the polydentate ligand can be a tridentate ligand (e.g., citric acid; claims 25-27, and 31). Adding a second, tridentate polydentate is an obvious extension of the chelation system.
Regarding instant claims 4-6 (tridentate tricarboxylic acid as citric acid), these are explicitly listed in claim 31 and thus, are an obvious selection. Regarding instant claims 7-10 (weight percentages), the specification describes ligands in amounts typically from 0.5% to 10% by weight, thus, the recited ranges are obvious formulation choices. Regarding instant claims 11-13 (fluoride source, ppm, amount), this is standard and disclosed in the ’086 application (e.g., claim 13).
Regarding instant claims 14-16 (stannous source, amounts), stannous fluoride/chloride are disclosed (claim 7), the amounts are conventional. Regarding instant claim 17 (both ions from stannous fluoride), this is taught by claim 7 and claim 13 of the ’086 application. Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’086 specification suggests pH ranges including about 4 to about 7, with preferred ranges around 4.5-6 (¶[0065]). Thus, the recited ranges are obvious.
Instant claim 20 recites a method of treating/preventing erosion or caries by brushing with the composition of claim 1. The ’086 application already claims a method of increasing tooth density using the same composition. The step of applying the dentifrice to the oral cavity and brushing is inherent. Substituting the condition treated (erosion/caries) for tooth density would have been an obvious alternative application, as stannous fluoride is well known for anti-caries and anti-erosion benefits. Moreover, the ’086 specification mentions anti-caries and anti-erosion as additional benefits of the composition (¶[0008]). Thus, the method is not patentably distinct.
In summary, claims 1-20 of the instant application are not patentably distinct from the invention claimed in co-pending application ‘086. The instant composition is an obvious species of the dentifrice required by the ’086 method, and the instant method is an obvious alternative use of the same composition. Accordingly, a provisional nonstatutory obviousness-type double patenting rejection is entered.
To overcome this rejection, applicant may file a terminal disclaimer under 37 C.F.R. § 1.321, disclaiming the terminal part of any patent granted on this application beyond the expiration date of any patent issuing from the ’086 application, or present evidence or argument demonstrating that the claims are patentably distinct (e.g., unexpected results uniquely attributable to the specific combination and ratio, not suggested by the ’086 disclosure). Failure to respond may result in a final rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9-12, 19 and 20 of co-pending US Application No. 17/308,078 (published as US20210346259A1 hereinafter “’078”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 1 recites an oral care active comprising a fluoride ion source and a stannous ion source, a mixture of dentate ligands consisting of oxalic acid or a salt (first polydentate) and lactic acid or a salt (monodentate), and a molar ratio of stannous ions to the total mixture of dentate ligands of about 1:1 to about 1:4. The ’078 application’s dependent claims and specification teach each of these features, either expressly or by obvious selection.
The ’078 application claims 9-10 teach tin (stannous fluoride/chloride). Claims 11-12 teach fluoride, including stannous fluoride. Selecting stannous fluoride as the tin source supplies both stannous and fluoride ions. The ’078 claims broadly require a dicarboxylic acid (claim 1), which can be oxalic acid (claim 4). Claim 19 adds a monodentate and/or polydentate ligand. The specification identifies lactic acid as a monodentate and oxalic acid as a dicarboxylic acid polydentate. The combination of these two specific ligands is taught as a preferred embodiment (¶[0045]).
Claim 20 sets a three-way ratio of tin:monodentate:polydentate of 1:0.5:0.5 to 1:5:5. The sum of monodentate and polydentate relative to tin ranges from 1:1 (1:0.5:0.5) to 1:10 (1:5:5). The instant range of 1:1 to 1:4 (total ligands:tin) is a subrange fully encompassed by that disclosure, and the specification indicates that total ligand ratios in this lower portion are optimal (¶[0050]; more broadly see also ¶[0030]-[0055]).
A person of ordinary skill in the art, desiring to formulate a stannous-containing oral care composition, would have been motivated by the ’078 application to select stannous fluoride as the tin/fluoride source, oxalic acid as the dicarboxylic acid, and lactic acid as an additional monodentate ligand, because the specification teaches that such a combination effectively chelates stannous.
The selection of a total ligand ratio within the taught preferred subrange is routine optimization. No unexpected results are shown. Thus, the instant composition is an obvious variant of the composition disclosed in the ’078 application (see In re Aller, 220 F.2d 454 (CCPA 1955)). The absence of a PCR limitation in the instant claims does not confer patentable distinction; it merely claims the obvious composition more broadly. Therefore, instant claim 1 is not patentably distinct.
Regarding instant claim 2 (ratio 1:1-1:3), a narrower subrange of the already obvious ratio is a matter of routine optimization. Regarding instant claim 3 (second polydentate, tridentate), the ’078 application already teaches the optional use of additional polydentate ligands and tridentate ligands such as citric acid are mentioned in the specification (¶[0035]). Thus, it is an obvious modification. Regarding instant claims 4-6 (tridentate tricarboxylic acid as citric acid), citric acid is a well-known tricarboxylic acid and the specification identifies it as a suitable polydentate. Thus, it is an obvious selection. Regarding instant claims 7-10 (weight percentages), the ’078 application specification broadly guides that ligands may be present in amounts from about 0.5% to 10% by weight. The claimed ranges represent obvious formulation choices.
Regarding instant claims 11-13 (fluoride ion source, ppm, amount), the same fluoride sources are listed in claim 12 of the ’078 application and the specific amounts and concentrations are standard in the art. Regarding instant claims 14-16 (stannous ion source, amounts), stannous fluoride/chloride are taught in claim 10 and the recited weight percentages are within the typical range disclosed. Regarding instant claim 17 (both ions from stannous fluoride), these limitations are expressly taught by the combination of claims 10 and 12 of the ’078 application. Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’078 claim 1 requires pH 4-6. The narrower 4.5-5.5 range is an obvious optimization; the specification indicates that a pH around 4.5-5 is preferred (¶[0060]).
Instant claim 20 recites a method of treating/preventing erosion or caries by brushing with the composition of claim 1 for at least 2 minutes and expectorating. The ’078 application describes the composition as suitable for oral care, including anti-caries benefits, and the method of brushing is conventional. Because the underlying composition is obvious, the method of using it in a standard way is similarly obvious (see In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).
In summary, claims 1-20 of the instant application are not patentably distinct from the invention claimed in co-pending application ‘078. The instant composition is a straightforward selection of specific ligands and a sub-range from the teaching of the ’078 application, and the method is a conventional use of the obvious composition. Accordingly, a provisional nonstatutory obviousness-type double patenting rejection is entered.
To overcome this rejection, applicant may file a terminal disclaimer under 37 C.F.R. § 1.321, disclaiming any terminal part of a patent granted on this application beyond the expiration date of any patent issuing from the ’078 application, or present evidence or argument demonstrating that the claims are patentably distinct (e.g., unexpected results uniquely attributable to the specific combination and ratio, not shared by the ’078 disclosure). Failure to respond may result in a final rejection.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 18, 22-24 and 30 of US Patent No. 12,427,097 B2 (hereinafter “’097”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below.
The instant application claim 1 claims an oral care composition comprising an oral care active, wherein the oral care active comprises a fluoride ion source and a stannous ion source, a mixture of dentate ligands comprising a first polydentate ligand, wherein the first polydentate ligand is oxalic acid or a salt thereof, or a combination thereof, and a monodentate ligand, wherein the monodentate ligand is lactic acid or a salt thereof, or a combination thereof, wherein a molar ratio of stannous ions to the mixture of dentate ligands is in a range of from about 1:1 to about 1:4.
The ’097 patent claims an oral care composition with a stannous ion source and a fluoride ion source, a dentate ligand mixture comprising a polydentate ligand that is oxalic acid or a salt, and at least one monodentate ligand selected from a group including lactic acid (claim 1). Dependent claim 15 specifically claims lactic acid as the monodentate ligand. Furthermore, the specification identifies lactic acid as a preferred monodentate ligand and discloses compositions comprising oxalic acid and lactic acid together (Example 3). The ’097 patent claims a molar ratio from about 1:0.5 to about 1:10 (claim 1) and more specifically from about 1:1 to about 1:5 (claim 18). The instant range of 1:1 to 1:4 is fully encompassed by and constitutes a narrow subrange within the patent’s generic and intermediate ranges. The specification further teaches that ratios between 1:1 and 1:4 is advantageous for stability.
Thus, the instant composition is a species of the genus claimed in the ’097 patent. The selection of lactic acid as the specific monodentate ligand from the disclosed group is an obvious choice, given that the ’097 specification expressly teaches compositions containing oxalic acid and lactic acid as a preferred combination. The selection of a subrange (1:1 to 1:4) from a broader range taught to be optimal is likewise an obvious optimization. No unexpected results have been demonstrated that would render the claimed species patentably distinct. Consequently, claim 1 is not patentably distinct from the claims of the ’097 patent.
The additional limitations in the dependent claims represent obvious variations of the subject matter claimed in the ’097 patent or are taught by the ’097 specification. The instant claim 2 (ratio 1:1 to 1:3) is a subrange of the 1:0.5-1:10 and 1:1-1:5 ranges disclosed and claimed in the ’097 patent. The specification indicates that ratios in this narrower range provide particularly favorable tin bioavailability, rendering this an obvious optimization.
Regarding instant claim 3 (second polydentate ligand, tridentate), the ’097 patent claims and describes compositions further comprising a second polydentate ligand that is a tridentate ligand (claim 22). Regarding instant claims 4-6 (tridentate tricarboxylic acid as citric acid), the ’097 patent specifically claims tricarboxylic acids as tridentate ligands, including citric acid (claims 23-24). Regarding instant claims 7-8 (weight percent of second polydentate), the recited amounts (about 1.0% to 7.5%, or 1.7% to 4.0%) fall within the ligand concentration ranges disclosed in the ’097 patent specification and represent routine formulation adjustments. Regarding claims 9-10 (weight percent of individual ligands), the same ranges taught in the ’097 specification (col. 10, ll. 5-20).
Regarding instant claim 11 (fluoride ion sources list), stannous fluoride, sodium fluoride, sodium monofluorophosphate, amine fluoride are all conventional fluoride sources listed in the ’097 patent (col. 5, ll. 10-28). Regarding instant claim 12 (soluble fluoride ≥1000 ppm), the ’097 patent describes compositions providing 1000-15000 ppm fluoride (col. 5, ll. 30-35). Regarding instant claim 13 (fluoride ion source amount 0.2%-1%), this is a conventional amount, disclosed in ’097 at col. 5, ll. 40-45. Regarding instant claim 14 (stannous ion source list), stannous fluoride and stannous chloride are the primary stannous sources in the ’097 patent (col. 4, ll. 55-65). Regarding instant claims 15-16 (stannous ion source amounts 0.2%-1.0% and 0.4%-1.0%), these ranges are disclosed in ’097 at col. 4, l. 66-col. 5, l. 5. Regarding instant claim 17 (fluoride and stannous from SnF₂), the ’097 patent teaches stannous fluoride as a single source supplying both ions (col. 4, l. 55-60; Example 1). Regarding instant claims 18-19 (pH 4-6, 4.5-5.5), the ’097 specification describes preferred pH ranges of 3.5 to 6.5, particularly 4.5 to 5.5 (col. 11, ll. 25-40). Thus, rendering the pH range an obvious selection.
Instant claim 20 recites a method of treating/preventing erosion or caries comprising applying the composition of claim 1 to the oral cavity by brushing, leaving it for at least 2 minutes, and expectorating. The ’097 patent claims an analogous method (claim 30) of treating or preventing dental erosion or caries comprising applying the composition of claim 1 to an oral cavity surface. The additional steps (depositing on a toothbrush, brushing, timing, expectorating) are inherent to the ordinary use of a dentifrice and are explicitly described in the ’097 patent as conventional application protocols (col. 14, ll. 50-65). Thus, the method claim merely invokes the obvious composition in a well-known manner and is not patentably distinct.
In summary, claims 1-20 of the instant application define either the same invention or obvious variants of the invention already claimed in the ’097 patent. The instant claims therefore constitute an improper attempt to extend the patent term for the same inventive concept, and thus are rejected as nonstatutory obviousness-type double patenting.
This rejection is a final rejection unless the applicant can show that the claims are patentably distinct. To overcome this rejection, the applicant may present arguments and/or evidence (e.g., of unexpected results) sufficient to establish that the claims are not obvious variants of the ’097 patent claims or file a terminal disclaimer in compliance with 37 C.F.R. § 1.321 and MPEP § 1490, thereby disclaiming any terminal part of the patent term of any patent granted on the instant application that extends beyond the term of the ’097 patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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, Robert A. Wax can be reached at (571) 272-0623. 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.
/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights