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 .
Summary
Receipt of Applicant’s disclosures filed on 10/10/2024 is acknowledged. Claims 1-23 are pending and under examination in this application.
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP23202900.9, filed on 10/11/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/21/2026,12/08/2025, 09/10/2025 and 05/07/2025 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies have been attached to this office action.
Claim Objections
Claims 5 and 16 are objected to because of the following informalities: the claims depends from claim 1 and 12, respectively, and recite “the individual ligands”, which lacks clear antecedent basis. Claim 1 and 12 introduce “a monodentate ligand,” “a didentate ligand,” and “a tridentate ligand” individually, never “individual ligands” as a term. Appropriate correction is required, e.g., “each of the monodentate ligand, the didentate ligand and tridentate ligand.”
Claims 1 and 12 recite “molar ratio of stannous ions”, but the antecedent basis introduced is “a stannous ion source” (singular source), not “stannous ions” (plural ions). Appropriate correction is required, e.g., “the stannous ions delivered by the stannous ion source.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, in part: “i. a monodentate ligand…; and ii. a didentate ligand…; or iii. a tridentate ligand….” This mixed “and…or” construction does not unambiguously indicate whether element (i) is required in combination with either element (ii) or (iii) — i.e., i AND (ii OR iii) — or whether element (iii) alone, without element (i), satisfies the claim — i.e., (i AND ii) OR (iii alone). The metes and bounds of the claim cannot be determined with reasonable certainty. Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014).
This ambiguity is underscored by claim 12, which recites the same three elements using fully conjunctive language (“i…; and ii…; and iii…”), evidencing that Applicant is capable of clearly claiming all three elements as mandatory when so intended and confirming that claim 1’s differing connectors are not merely a stylistic variant.
Claims 2-11 depend from claim 1, do not resolve the ambiguity, and are rejected for the same reason.
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.
Claim(s) 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Glandorf et al., US 2021/0346255 A1 hereinafter (“Glandorf”) in view of Prencipe et al., US 5,578,293 hereinafter (“Prencipe”), and further in view of Ramji et al., US 10,123,953 B2 hereinafter (“Ramji”).
Glandorf discloses oral care (dentifrice/toothpaste) compositions comprising tin (stannous) ions, a monodentate ligand, and a polydentate ligand at an optimized molar ratio, formulated to maximize soluble, bioavailable stannous while avoiding over- or under-stabilization (¶[0001]-[0002]). Glandorf’s working Example 3 (Table 2) is a toothpaste containing stannous fluoride (SnF₂) and stannous chloride (SnCl₂) as the stannous/fluoride sources, sodium gluconate as the monodentate ligand, and sodium citrate as the polydentate (tridentate) ligand, at a Sn:monodentate:polydentate molar ratio of 1:1:1 — i.e., a 1:2 ratio of stannous ions to the combined mixture of dentate ligands, which is an exact numerical match to instant claim 1’s “about 1:2” ratio. Claim 1 is unpatentable over Glandorf substantially as set forth in the following claim chart:
Claim
Claim Limitation
Glandorf (US 2021/0346255 A1) Disclosure
1(pre)
An oral care composition comprising:
Glandorf discloses oral care compositions, including dentifrice/toothpaste compositions (Glandorf ¶¶[0044]-[0046]; Ex. 1-4, Table 2).
1(a)
an oral care active comprising a fluoride ion source and a stannous ion source
Ex. 3 (Table 2) uses SnF₂ (0.454%) and SnCl₂ (0.5619%) as the tin ion source; Glandorf expressly teaches “the fluoride ion source and the tin ion source can be the same compound, such as for example, stannous fluoride” (¶[0098]-[0100]).
1(b)(i)
a monodentate ligand — monocarboxylic acid (acetic, lactic, or gluconic acid or combination)
Ex. 3 uses sodium gluconate as the monodentate ligand (Table 2); Glandorf’s monodentate-ligand section expressly lists gluconate and lactate among suitable carboxylic-acid monodentate ligands (¶[0083]-[0087]).
1(b)(iii)
a tridentate ligand comprising tricarboxylic acid (citric, isocitric, aconitic, propane-1,2,3-tricarboxylic, trimesic acid, salt, or combination)
Ex. 3 uses sodium citrate as the polydentate ligand (Table 2); Glandorf’s tricarboxylic-acid disclosure recites the identical list — “citric acid, isocitric acid, aconitic acid, propane-1,2,3-tricarboxylic acid, trimesic acid… salts thereof” (¶[0117]-[0119]).
1(wherein)
molar ratio of stannous ions to the mixture of dentate ligands is about 1:2
Ex. 3 is prepared at a Sn:monodentate:polydentate molar ratio of 1:1:1 (Table 2, Table 3), i.e., stannous ions to the combined (monodentate + polydentate) ligand mixture of 1:2 — an exact numerical match to the claimed ratio.
1(wherein)
pH of the composition is in a range of from about 4 to about 5
Glandorf teaches, for compositions of this same ligand system, a pH “from about 4 to about 7, from about 4.5 to about 6.5, or from about 4.5 to about 5.5” (¶[0154]), which overlaps and substantially subsumes the claimed 4-to-5 window. Selecting a pH within the disclosed and overlapping range would have been obvious as routine optimization. In re Aller, 220 F.2d 454 (CCPA 1955); MPEP §2144.05(I).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to formulate Glandorf’s Example 3 composition (or any composition falling within Glandorf’s disclosed Sn:monodentate:polydentate ratio range of about 1:0.5:0.5 to about 1:5:5) at a pH within Glandorf’s own disclosed and preferred pH windows (about 4 to about 7; about 4.5 to about 5.5), because (i) Glandorf itself identifies these pH ranges as suitable for the identical ligand-stabilized stannous chemistry, (ii) the claimed 4-to-5 range is fully subsumed within and overlaps Glandorf’s disclosed ranges, and (iii) selecting a workable or optimum pH value within a range already taught by the prior art is no more than routine optimization absent a showing of unexpected results. In re Aller, 220 F.2d 454, 456 (CCPA 1955); MPEP §2144.05(I)-(II).
Regarding claims 2-11, Glandorf's further discloses the claims limitations in chart below:
Claim
Claim Limitation
Glandorf (US 2021/0346255 A1) Disclosure
2
monocarboxylic acid comprises gluconic acid, lactic acid, salt, or combination
Ex. 3’s monodentate ligand is sodium gluconate (a salt of gluconic acid). Glandorf ¶[0083]-[0087].
3
dicarboxylic acid comprises oxalic acid, salt, or combination (didentate branch)
Glandorf treats bidentate and tridentate carboxylic-acid ligands as interchangeable species of the same “polydentate ligand” genus, expressly listing “oxalic acid… salts thereof, or combinations thereof” alongside citric acid (¶[0113]-[0119]). Substituting Glandorf’s own listed dicarboxylic acid (oxalic acid) for the exemplified tricarboxylic acid (citrate) is obvious substitution of art-recognized equivalents within the same genus. MPEP §2144.06.
4
tricarboxylic acid is citric acid, salt, or combination
Ex. 3’s polydentate ligand is sodium citrate. Glandorf ¶[0117]-[0119].
5
1.5% to 5.0 wt% of the individual ligands
Glandorf discloses “from about 0.01% to about 10%, … from about 1% to about 5%…” by weight for both the monodentate and the polydentate ligand (¶[0087], ¶[0122]) — a range that overlaps and nearly duplicates the claimed 1.5-5.0% window.
6
pH is about 4.5
Falls within Glandorf’s expressly preferred “about 4.5 to about 5.5” window (¶[0154]); 4.5 is in fact the lower boundary of that preferred range.
7
fluoride ion source: stannous fluoride, sodium fluoride, sodium MFP, amine fluoride, or combinations
Glandorf’s fluoride-source list recites “stannous fluoride, sodium fluoride, potassium fluoride, amine fluoride, sodium monofluorophosphate, zinc fluoride, and/or mixtures thereof” (¶[0155]) — fully encompasses the claimed list.
8
soluble fluoride ions of at least about 1000 ppm
Glandorf discloses a fluoride ion source providing “from about 50 ppm to about 5000 ppm, and preferably from about 500 ppm to about 3000 ppm of free fluoride ions” (¶[0157]) — a range that encompasses and overlaps the claimed ≥ 1000 ppm.
9
stannous ion source: stannous fluoride, stannous chloride, or combination
Ex. 3 uses SnF₂ and SnCl₂ together (Table 2).
10
0.2% to 1.0 wt% of stannous ion source
Glandorf discloses “from about 0.0025% to about 5%, … from about 0.2% to about 1%, from about 0.4% to about 1%…” by weight of tin ion source (¶[0148]) — the “0.2% to about 1%” sub-range is identical to the claimed range.
11
fluoride ion source and the stannous ion source comprise stannous fluoride
Ex. 3’s SnF₂ simultaneously supplies both the claimed fluoride ion source and (in part) the claimed stannous ion source; Glandorf confirms this dual role expressly (¶[0098]).
Regarding claim 12, the claim differs from claim 1 in that it requires a monodentate ligand, a didentate (dicarboxylic acid) ligand, AND a tridentate (tricarboxylic acid) ligand simultaneously present (fully conjunctive), rather than a monodentate ligand together with either a didentate or a tridentate ligand. Glandorf’s Example 3 alone (relied upon for claim 1) does not include all three ligand classes simultaneously and does not by itself satisfy claim 12.
Glandorf nonetheless expressly contemplates such multi-component ligand systems, teaching that “more complicated systems of multiple monodentate ligands and multiple polydentate ligands were also beneficial if properly balanced” and separately exemplifying a four-component mixed-ligand system (Sn:Gluconate:Lactate:Citrate at 1:1:1:1) achieving a ΔpH within its optimum stannous-stabilization window. Glandorf further treats dicarboxylic acid species (e.g., oxalic acid) and tricarboxylic acid species (e.g., citric acid) as interchangeable members of the same “polydentate ligand” genus (¶[0113]-[0119]).
This teaching is independently corroborated by two additional, unrelated references spanning nearly three decades. Prencipe discloses stannous fluoride/chloride oral care compositions stabilized with an “organic acid compound,” expressly defining that genus to include, as functionally interchangeable species, gluconic acid and lactic acid (monocarboxylic), tartaric acid, succinic acid, malic acid, and fumaric acid (dicarboxylic), and citric acid (tricarboxylic), used individually or, per Prencipe’s claims 10-14 and Table I (combining sodium citrate dihydrate with free citric acid alongside SnF₂/SnCl₂ at pH 5.3), in combination. Ramji, from an unrelated P&G application team, likewise lists “gluconic acid, tartaric acid, citric acid and pharmaceutically-acceptable salts thereof” together as a single class of chelating agents/sequestrants suitable for stabilizing stannous and other metal ions in oral care compositions.
It would have been obvious to a person having ordinary skill in the art to select, from Glandorf’s disclosed monodentate genus, a monocarboxylic acid (e.g., gluconate), and from Glandorf’s disclosed polydentate genus, both a dicarboxylic species (e.g., oxalic or malic acid) and a tricarboxylic species (e.g., citric acid), for simultaneous use in a single composition. This combination is motivated by Glandorf’s own teaching that multi-ligand systems are beneficial when properly balanced, and is independently corroborated by Prencipe and Ramji, each of which treats acids spanning the monocarboxylic, dicarboxylic, and tricarboxylic classes as art-recognized functional equivalents routinely selected and combined for the identical purpose of stabilizing stannous ions in oral care compositions. A reasonable expectation of success follows from each species’ independently confirmed chelating function across all three references. In re Kerkhoven, 626 F.2d 846 (CCPA 1980) (combining prior art elements each performing the same function they perform separately is prima facie obvious). The claimed “about 1:2” molar ratio and “about 4 to about 5” pH limitations of claim 12 are met for the same reasons discussed for claim 1, above, the combined weight of the three ligand species falling within Glandorf’s disclosed ratio and pH ranges.
Claims 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Glandorf in view of Prencipe and Ramji, for the reasons set forth for claim 12 above, further in view of the following claim-specific disclosures:
Claim
Claim Limitation
Disclosure (Glandorf, further in view of Prencipe/Ramji where noted)
13
monocarboxylic acid comprises gluconic acid, lactic acid, salt, or combination
Same as claim 2 — Glandorf ¶[0083]-[0087].
14
dicarboxylic acid comprises oxalic acid, salt, or combination
Same as claim 3 — Glandorf ¶[0113]-[0119], further in view of Prencipe/Ramji as discussed for claim 12.
15
tricarboxylic acid is citric acid, salt, or combination
Same as claim 4 — Glandorf ¶[0117]-[0119].
16
1.5% to 5.0 wt% of the individual ligands
Same as claim 5 — Glandorf ¶[0087], ¶[0122].
17
molar ratio of stannous ions to mixture of dentate ligands is about 1:1 to about 1:3
Encompassed by and overlapping Glandorf’s disclosed 1:0.5:0.5 to 1:5:5 Sn:mono:poly ratio range, which subsumes stannous:total-ligand ratios across and beyond 1:1–1:3 (¶[0126]).
18
second polydentate ligand is oxalic, malic, maleic, malonic, methylmalonic, tartaric, or maleic acid, salt, or combination
Glandorf’s dicarboxylic-acid list recites the identical species — “oxalic acid, malonic acid, succinic acid, glutaric acid… malic acid, tartaric acid… salts thereof” (¶[0113]).
19
second polydentate is oxalic acid and first polydentate is malonic acid
Both oxalic acid and malonic acid are individually listed in Glandorf’s dicarboxylic-acid genus (¶[0113]); combining two named genus members is an obvious routine selection under the same rationale as claim 12.
20
second polydentate ligand is citric, isocitric, aconitic, propane-1,2,3-tricarboxylic, trimesic acid, salt, or combination
Same as claim 4/15 — Glandorf ¶[0117]-[0119].
21
monocarboxylic acid comprises acetic, lactic, gluconic acid, salt, or combination
Same as claims 2/13 — Glandorf ¶[0083]-[0087] (acetic acid within the generically disclosed carboxylic-acid monodentate genus, ¶[0086]).
22
fluoride ion source and stannous ion source both comprise stannous fluoride
Same as claim 11 — Glandorf ¶[0098].
Regarding claim 23, the claim recites a method comprising depositing the claim 1 composition onto a toothbrush, applying it to oral cavity surfaces by brushing, allowing it to act for at least 2 minutes, and removing it by expectorating and optionally rinsing. Glandorf discloses that its stannous/ligand compositions are formulated as dentifrice and toothpaste compositions intended for oral cavity application (Glandorf ¶[0044]-[0046]) and are tested via a simulated brushing protocol using dentifrice slurries (Glandorf's Fluoride Uptake and HAP Dissolution methods, e.g., ¶[0187]-[0200]). It would have been obvious to a person of ordinary skill to apply Glandorf's toothpaste composition to the oral cavity via the universally conventional method of toothbrushing — depositing the composition on a toothbrush, brushing, and expectorating — since this is the only ordinary and customary manner of using a dentifrice product, and since brushing durations of “at least two minutes” are an art-recognized, ADA-endorsed standard duration with no evidence of record that this particular duration produces an unexpected result over any other conventional brushing duration. MPEP §2144.03; In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (combining known elements according to known methods to yield predictable results).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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