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, 4, 6, 7, 9-12, 14-16, 18, 19, 21, 22, 27 and 28.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/02/2026 has been entered.
Applicants' arguments, filed 12/03/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 fails to further limit claim 1 since claim 12 recites wherein the composition comprises an anionic surfactant and this recitation is already recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4, 6, 9-12, 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 7, 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 ascorbyl 6-palmitate, 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 ascorbyl palmitate (i.e., ascorbyl 6-palmitate), 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 inclusion of sodium cocoyl glutamate produces unexpected results in the form of improved color stability (i.e., less yellowing) of the ascorbic acid composition.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has compared 4 samples. Sample 1 does not contain any surfactants or sodium ascorbyl phosphate and has a b* value of 0.1 (essentially white). Sample 2 contains 1.5 wt. % sodium ascorbyl phosphate (SAP) and has a b* value of 15.9 (severe yellowing). Sample 6 contains 2.5 wt. % sodium cocoyl glutamate (Plantapon) and 1 wt. % sodium lauryl isethionate and has a b* value of 1.5. Sample 11 contains 2.5 wt. % sodium cocoyl glutamate and 1.5 % sodium ascorbyl phosphate and has a b* value of 11.1. Applicant found that addition of sodium cocoyl glutamate to sodium ascorbyl phosphate did not increase yellowing (i.e., a b* value greater than 15.9).
The Examiner does not find Applicant’s showing to be unexpected. 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. See MPEP 716.02. In the instant case, since each sample is compositionally different, one of ordinary skill in the art would reasonably expect each sample to have a different b* value. Although Sample 2 has a b* value of 15.9 and Sample 11 has a b* value of 11.1, it is unclear how this difference in value is to the extent that shows that Sample 11 is unexpected over Sample 2. In other words, it is unclear whether the difference in yellowing between the two samples is to the extent that one of ordinary skill in the art would even notice a difference between the two samples with the naked eye. Also, Sample 2 (SAP only) has a whitening value L* of 80.6 and Sample 11 (SAP + Plantapon) has a whitening value L* of 82.8. The difference in whitening is so small that the difference does not appear to be to the extent that the difference is really unexpected.
Furthermore, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP 716.02(a)(I). SAP and Plantapon are not pigments; therefore, one of ordinary skill in the art would not reasonably expect for there to be a cumulative increase in yellowing when combining the two. Even if one were to expect a cumulative increase in yellowing, Sample 6 contains 1 wt. % sodium lauryl isethionate. Thus, one of ordinary skill in the art would not reasonably expect a cumulative increase in yellowing to be shown in Sample 11 (SAP + Plantapon) by adding Sample 2 (SAP only) and Sample 6 (Plantapon + sodium lauryl isethionate) since Sample 11 does not comprise sodium lauryl isethionate. As discussed above, Applicant has not shown wherein the difference in b* is to an unobvious extent that the results are of a significant, practical advantage. For at least these reasons, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 2, 4, 6, 7, 9-12, 14-16, 18, 19, 21, 22, 27 and 28 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614