DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims included in the prosecution are claims 1-5, 10-13, 15, 19 and 20.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2026 has been entered.
NOTE: As there are no arguments and/or claim amendments filed with the 03/03/2026 or 03/12/2026 RCE submissions or after RCE suspension of 3 months, the rejections of the previous office action are maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 1-5 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2010/0310614, Dec. 9, 2010) (hereinafter Strand) in view of Ladizinsky (US 2020/0397819, Dec. 24, 2020), Fischer et al. (US 2014/0294742, Oct. 2, 2014) (hereinafter Fischer), and Stiller et al. (WO 96/19189, Jun. 27, 1996) (hereinafter Stiller).
Strand discloses a particulate composition comprises a particulate source of stannous chloride and silicon dioxide. Strand also discloses a method for improving the flowability of particulate stannous chloride by admixing silica with it. The composition has been found to give improved flow properties to stannous chloride when compared to the absence of an anti-caking agent (abstract). Anti-caking agents function by absorbing excess moisture (¶ [0005]). Silica is used as an anti-caking agent (¶ [0006]). Stannous chloride has multiple benefits it can afford, including antimicrobial effects, control of breath malodor, control of dental plaque growth and metabolism, reduced gingivitis, decreased progression to periodontal disease, reductions in dentinal hypersensitivity, and reduced coronal and root dental caries and erosion (¶ [0002]). The source of stannous chloride is either stannous chloride dihydrate or stannous chloride anhydrous (claim 2). The composition may be manufactured into an oral composition which further comprises a dental abrasive, fluoride ions, and mixtures thereof (claim 7). The oral composition may be a toothpaste (claim 8). In preparing toothpaste, it is often necessary to add a thickening agent. Suitable thickening agent levels can range from 0.1 to 5% by weight (¶ [0027]). Table 4 discloses a toothpaste comprising 1.397 of a stannous chloride & silica blend 1%.
Strand differs from the instant claims insofar as not disclosing wherein the composition comprises calcium sulfate.
However, Ladizinsky discloses an oral or topical composition (abstract). Examples of anti-caking agents include calcium sulfate and silicon dioxide (¶ [0064]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have replaced the silicon dioxide of Strand with calcium sulfate since Strand discloses wherein silicon dioxide is used as an anti-caking agent and calcium sulfate is a suitable alternative anti-caking agent as taught by Ladizinsky.
The combined teachings of Strand and Ladizinsky do not teach wherein composition comprises fumed alumina.
However, Fischer discloses an anti-plaque dental treatment composition comprising at least one thickening agent (abstract). Suitable thickening agents include fumed alumina (¶ [0026]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Stand discloses wherein the oral composition comprises a thickening agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated fumed alumina into the oral composition of Strand since it is a known and effective thickening agent for oral compositions as taught by Fischer.
The combined teachings of Strand, Ladizinsky, and Fischer do not disclose wherein the fumed alumina has an average particle size of from about 0.4 microns to about 100 microns.
However, Stiller discloses dental hygiene product (abstract). The product comprises a thickening agent with an average particle size of 1 to 20 µm (page 6, lines 27-31).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the fumed alumina to have an average particle size of 1 to 20 µm since this is a known and effective particle size for thickening agents in oral compositions as taught by Stiller.
In regards to instant claim 1 reciting wherein the ratio of particulate stannous salt to alumina is from about 9:1 to 199:1, as discussed above, Strand discloses wherein the thickening agent may be 0.1% and wherein the toothpaste may comprise 1.397% stannous chloride & silica blend 1%. The particulate stannous salt (e.g., stannous chloride) to thickening agent (e.g., fumed alumina) ratio derived from these values overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
In regards to instant claim 1 reciting wherein the ratio of drying aid to alumina is from about 10:1 to 2:1, since improved flow properties to stannous chloride depend on the anti-caking agent and calcium sulfate is an anti-caking agent, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to arrive at an amount of calcium sulfate based on the amount needed to provide for the improved flow properties to stannous chloride.. Once such amount has been derived and knowing that Strand teaches 0.1 to 5% thickening agent (e.g., fumed alumina), one of ordinary skill in the art would have arrived at the claimed ratio and the claimed ratio would have been obvious. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
2. Claims 15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2010/0310614, Dec. 9, 2010) (hereinafter Strand) in view of Ladizinsky (US 2020/0397819, Dec. 24, 2020), Fischer et al. (US 2014/0294742, Oct. 2, 2014) (hereinafter Fischer), Stiller et al. (WO 96/19189, Jun. 27, 1996) (hereinafter Stiller), and further in view of Rajaiah et al. (US 2002/0187108, Dec. 12, 2002) (hereinafter Rajaiah).
The teachings of Strand, Ladizinsky, Fischer, and Stiller are discussed above. Strand, Ladizinsky, Fischer, and Stiller do not teach wherein the particulate source of a stannous salt has an average particle size of from about 0.4 microns to about 100 microns.
However, Rajaiah discloses an oral care composition comprising an oral care active (abstract). Where the oral care actives are in particulate form, a suitable particle size for use is from about 0.01 microns to about 1000 microns (¶ [0032]).
Strand discloses wherein stannous chloride is an oral care active. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the particulate source of stannous chloride be about 0.01 microns to about 1000 microns since Strand does not disclose a particle size for the particulate source and this is a known and effective particle size for oral care actives as taught by Rajaiah.
Response to Arguments
Applicant has not presented any arguments after filing the RCE. Therefore, the rejections are maintained.
Conclusion
Claims 1-5, 10-13, 15, 19 and 20 are rejected.
No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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