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, 2, 9-11, 14-16, 18, 19, 21, 22, 27 and 28.
Applicants' arguments, filed 06/26/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 1, 2, 9-11, 14, 16, 19, 22 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Westenfelder et al. (WO 2004/041228, May 21, 2004) (IDS reference) (hereinafter Westenfelder) in view of Yoshida et al. (JP 2018043933 A, Mar. 22, 2018) (hereinafter Yoshida).
Westenfelder discloses the use of a polymer for improving the uptake and retention of water-soluble ascorbic acid derivatives from oral care compositions onto the surface of teeth and the surrounding dental tissue (abstract). In one embodiment, a toothpaste is disclosed comprising 0.01-5.0 wt. % sodium ascorbyl phosphate, sodium fluoride, hydrated silica (i.e., abrasive), sorbitol (i.e., humectant), and glycerol (i.e., humectant) (Example 2). Ascorbic acid derivatives such as sodium ascorbyl phosphate have teeth whitening effect (page 2, lines 13-15). As a result of the porous structure of the enamel layer, coffee, tea, or tobacco can permeate the enamel and change its surface to appear yellow or brownish in color (page 2, lines 1-6). A method of improving the bleaching and teeth-whitening activity of ascorbic acid derivatives in oral care composition comprises incorporating an effective amount of a polymer into an oral care composition which contains a water-soluble ascorbic acid derivative (claim 31). The composition may contain additional ingredients which are conventionally used in oral care compositions (page 4, lines 22-23). A dentifrice may contain surfactants (page 4, line 28), abrasives such as sodium and potassium pyrophosphates (page 4, lines 25-26) and metal salts such as stannous fluoride (page 4, lines 34-35).
Westenfelder differs from the instant claims insofar as not disclosing wherein the composition comprises sodium cocoyl glutamate, sodium cocoyl taurate, and a zwitterionic surfactant.
However, Yoshida discloses a composition for the oral cavity comprising an ascorbic acid ester or a salt thereof and at least one anionic surfactant (abstract). The one or more anionic surfactants improve the retention and absorbability of the ascorbic acid ester or a salt thereof. Suitable anionic surfactants include sodium cocoyl glutamate and sodium cocoyl taurate (page 3 of translation). The composition may comprise other surfactants as an additive component (page 4 of translation). Such surfactants include zwitterionic surfactants (page 5 of translation).
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. Westenfelder discloses wherein the composition improves the uptake and retention of water-soluble ascorbic acid derivatives and wherein the composition comprises surfactants. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated sodium cocoyl glutamate and sodium cocoyl taurate into the composition of Westenfelder since these are known and effective surfactants that may be used together for improving the retention and absorbability of ascorbic acid derivatives as taught by Yoshida.
Westenfelder also discloses wherein the composition comprises additional ingredients which are conventionally used in oral care compositions. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated a zwitterionic surfactant into the composition of Westenfelder since it is a known and effective additive for oral care compositions as taught by Yoshida.
In regards to instant claim 2 reciting wherein the amount of the ascorbic acid derivative is sufficient to increase ΔW of the enamel by at least 0.3 times greater or by 0.3-4 times greater relative to a reference oral care composition that does not comprise an ascorbic acid derivative, as noted by the instant specification in paragraph [00108], the ascorbic acid derivative is present in an amount from 1%-5%. Accordingly, since Westenfield discloses substantially the same amount of sodium ascorbyl phosphate as the claimed invention, the sodium ascobryl phosphate of Westenfield is sufficient to increase ΔW of the enamel by at least 0.3 times greater or by 0.3-4 times greater relative to a reference oral care composition that does not comprise an ascorbic acid derivative.
In regards to instant claim 22 reciting contacting the surface of the tooth with an oral care composition for a duration of time sufficient to whiten the surface of the tooth, Westenfield discloses a method of improving the bleaching and teeth-whitening activity of ascorbic acid derivatives in oral care composition, as such the composition bleaches and whitens teeth. Therefore, the composition is contacted with the surface of a tooth for a duration of time sufficient to whiten the surface of the tooth.
2. Claims 15, 18 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Westenfelder et al. (WO 2004/041228, May 21, 2004) (IDS reference) (hereinafter Westenfelder) in view of Yoshida et al. (JP 2018043933 A, Mar. 22, 2018) (hereinafter Yoshida), and further in view of Deisenroth et al. (US 2017/0143612, May 25, 2017) (hereinafter Deisenroth).
The teachings of Westenfelder and Yoshida are discussed above. Westenfelder and Yoshida do not teach wherein the composition comprises a basic amino acid, zinc oxide, and cocamidopropyl betaine.
However, Deisenroth discloses an oral care composition comprising ascorbyl palmitate and zinc oxide as an antioxidant (¶ [0251]). Amphoteric surfactants such as cocamidopropyl betaine may be included in the composition (¶ [0233]). Arginine may be incorporated as a desensitizing agent (¶ [0237]).
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. Westenfelder discloses wherein the composition comprises additional ingredients which are conventionally used in oral care compositions. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated zinc oxide and arginine (i.e., basic amino acid) into the composition of Westenfelder since they are known and effective additional ingredients conventionally used in oral care compositions, which provide desirable properties such antioxidation or desensitization, as taught by Deisenroth.
Additionally, as discussed above, it would have been obvious to one of ordinary skill in the art to have incorporated a zwitterionic surfactant. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated cocamidopropyl betaine in to the composition of Westenfelder since it is a known and effective zwitterionic surfactant as taught by Deisenroth.
3. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Westenfelder et al. (WO 2004/041228, May 21, 2004) (IDS reference) (hereinafter Westenfelder) in view of Yoshida et al. (JP 2018043933 A, Mar. 22, 2018) (hereinafter Yoshida), and further in view of Luo et al. (US 2001/0043907, Nov. 22, 2001) (hereinafter Luo).
The teachings of Westenfelder and Yoshida are discussed above. Westenfelder and Yoshida do not teach wherein the composition comprises 0.1-4% sodium stearate.
However, Luo discloses a composition comprising a stain removing agent selected from anionic and non-ionic surfactants for removing stains from dental materials including teeth (abstract). Suitable stain removing surfactants include sodium salts of stearate (¶ [0047]). A preferred amount of sodium stearate is about 0.5% (¶ [0048]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 0.5% sodium stearate into the composition of Westenfelder motivated by the desire to have the composition remove stains from teeth as taught by Luo.
Response to Arguments
Applicant argues that the targeted range of 1 wt. % - 3 wt. % is patentably distinct and non-obvious because it defines a critical boundary layer characterized by highly, unexpected, non-linear performance anomalies. As documented in Table 8, an oral care composition comprising 1.5 wt. % sodium ascorbyl phosphate delivers an extraordinary enamel-whitening result that is significantly greater than the whiteninf performance achieved by a composition formulation with a much higher concentration of 3.0 wt. % of the exact same active.
The Examiner does not find Applicant’s argument to be persuasive. Instant claim 1 recites 1-3 wt. % sodium ascorbyl phosphate. Thus, Applicant showing wherein 1.5% is more effective then 3% is not persuasive since both amounts are encompassed by the claim. As such, Applicant’s argument is unpersuasive.
Applicant argues that as shown in Table 11, a formulation comprising 2.75 wt. % of sodium ascorbyl phosphate demonstrates a substantially higher tooth-whitening response than an identical composition configured with a maximum concentration of 5.0 wt. % sodium ascorbyl phosphate.
The Examiner does not find Applicant’s argument to be persuasive. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02. Table 11 shows wherein the formulation comprising 2.75 wt. % sodium ascorbyl phosphate has a higher ΔW value than the formulation comprising 5.0% sodium ascorbyl phosphate. Since the two formulations have different amounts of sodium ascorbyl phosphate, one of ordinary skill in the art would reasonably expect the two formulations to have different ΔW values. Applicant has not shown wherein the difference is of statistical significance. It is unclear whether the formulation comprising 2.75 wt. % sodium ascorbyl phosphate has a whitening effect that is noticeable to a user when compared to the formulation comprising 5.0 wt. % sodium ascorbyl phosphate. As such, Applicant’s argument is unpersuasive.
Applicant argues that when Table 8 and Table 11 are reviewed together, they establish that the relationship between sodium ascorbyl phosphate concentration and enamel-whitening capability is highly non-linear and unpredictable.
The Examiner does not find Applicant’s argument to be persuasive. Table 8 shows wherein a formulation comprising 5.0% sodium ascorbyl phosphate has higher ΔW values compared with a formulation comprising 1.0 wt. % sodium ascorbyl phosphate and a formulation comprising 3.0 wt. % sodium ascorbyl phosphate. Instant claim 1 recites 1-3 wt. % sodium ascorbyl phosphate. Thus, Applicant has not shown wherein the claimed range is unexpected. As such, Applicant’s argument is unpersuasive.
Applicant argues that this trend reversal – where increasing the concentration of the active whitening agent beyond the 3 wt. % threshold actually diminishes the physical whitening outcome – constitutes a clear difference in kind.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Table 8 shows wherein 5 wt. % has higher ΔW values compared to 3 wt. %. Therefore, Applicant’s argument that beyond the 3 wt. % threshold diminishes the physical whitening outcome is unpersuasive. Also, MPEP 716.02 states wherein a difference in kind is if the range produces a new property dissimilar to the known property. Applicant has not shown wherein the claimed range produces a new property compared to values outside of the range. As such, Applicant’s argument of a difference in kind is unpersuasive.
Conclusion
Claims 1, 2, 9-11, 14-16, 18, 19, 21, 22, 27 and 28 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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