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, 6-9 and 15-19.
Applicants' arguments, filed 03/05/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 7-9 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over BioCare Toothpaste (May 2018) (of record) in view of Robinson et al. (US 2015/0297500, Oct. 22, 2015) (hereinafter Robinson) and Swett et al. (US 2014/0161743, Jun. 12, 2014) (hereinafter Swett).
Biocare Toothpaste discloses a toothpaste comprising arginine, zinc oxide, lauryl glucoside, sodium cocoyl glutamate, and xanthan gum (i.e., thickening agent) (Ingredients).
Biocare Toothpaste differs from the instant claims insofar as not disclosing the amount of arginine and zinc oxide and wherein the composition comprises zinc citrate, a betaine zwitterionic surfactant, a non-ionic block copolymer, and a fluoride ion source.
However, Robinson discloses an oral care composition comprising an orally acceptable vehicle, a basic amino acid in free or salt form, particles of precipitated calcium carbonate, a source of zinc ions, and a surfactant system selected from at least one of a nonionic block polymer surfactant and a betaine zwitterionic surfactant or a mixture thereof (¶ [0003]). The oral care composition may be a toothpaste (¶ [0077]). The basic amino acid in free or salt form comprises arginine (¶ [0043]). The basic amino acid in free or salt form is present in an amount of from 5 to 15 wt. % (¶ [0044]). The oral care composition comprises a source of zinc ions as an anti-plaque/anti-gingivitis component. Zinc ions have an anti-bacterial efficacy when used in the oral cavity, which in turn can act to reduce plaque and/or gingivitis (¶ [0046]). The source of zinc ions may comprise a mixture of zinc citrate and zinc oxide (¶ [0049]). The zinc citrate is present in an amount of from 0.25 to 0.75 wt. % and zinc oxide is present in an amount of from 0.75 to 1.25 wt. % (claim 27). The surfactant system in combination with a source of metal ions as an anti-bacterial component can provide enhanced forming and/or metal ion uptake by the tooth surface of an oral care composition (¶ [0028]). The nonionic block copolymer surfactant is present in an amount of from 0.25 to 2 wt. % (claim 2). The betaine zwitterionic surfactant is present in an amount of from 0.25 to 2 wt. % (claim 8). The betaine zwitterionic surfactant comprises cocamidopropyl betaine (claim 12). The nonionic block copolymer surfactant has polyoxypropylene and polyoxyethylene (claim 5). The composition may comprise a fluoride compound for providing anti-cavity efficacy (¶ [0077]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 5 to 15 wt. % arginine into Biocare Toothpaste since this is a known and effective amount of arginine for a toothpaste as taught by Robinson.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated 0.25 to 0.75 wt. % zinc citrate and 0.75 to 1.25 wt. % zinc oxide into Biocare Toothpaste motivated by the desire to have the composition reduce plaque and/or gingivitis as taught by Robinson.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated the surfactant system of Robinson into Biocare Toothpaste since Biocare Toothpaste comprises a zinc ion source and the surfactant system in combination with zinc ion source can provide enhanced forming and/or metal ion uptake by the tooth surface of an oral care composition as taught by Robinson.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated a fluoride compound into Biocare Toothpaste motivated by the desire to provide an anti-cavity effect as taught by Robinson.
The combined teachings of Biocare Toothpaste and Robinson do not teach the amount of lauryl glucoside and sodium cocoyl glutamate and wherein the composition comprises silica abrasive.
However, Swett discloses a dentifrice composition comprising an orally acceptable vehicle, an abrasive particulate, and a surfactant system comprising an anionic surfactant comprising a C8-C16 fatty acid glutamate salt and a nonionic surfactant comprising a C8-C16 alkyl glucoside (abstract). The C8-C16 alkyl glucoside comprises a C10-C14 alkyl glucoside, in particular lauryl glucoside (¶ [0033]). The C8-C16 fatty acid glutamate salt comprises a cocoylglutamate salt, in particular sodium cocoyl glutamate (¶ [0031]). The dentifrice compositions having 2 wt. % (30% active) or 2.5 wt. % (30% active) of each of lauryl glucoside and sodium cocoyl glutamate exhibited the lowest irritation potential (¶ [0075]). It may be seen that when the amount of each of lauryl glucoside and sodium cocoyl glutamate in the dentifrice is within the range of 2 wt % (30% active) to 3 wt % (30% active), the foam properties are similar to dentifrice formulations incorporating typically commercially used amounts of sodium lauryl sulfate. In other words, by providing these amounts of lauryl glucoside and sodium cocoyl glutamate as a combination surfactant system in the dentifrice composition, sodium lauryl sulfate can be omitted, and these combined surfactants can replace sodium lauryl Sulfate without compromising foam quality as expected by a consumer familiar with typical commercial dentifrice compositions incorporating sodium lauryl sulfate (¶ [0080]). The abrasive particulate comprises silica (¶ [0017]). The abrasive particulate is present in an amount of from 15 to 35 wt. % based on the weight of the dentifrice composition (¶ [0018]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 2 wt. % or 2.5 wt. % of each of lauryl glucoside and sodium cocoyl glutamate into Biocare Toothpaste since this amount exhibited the lowest irritation potential as taught by Swett.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated 15 to 35 wt. % silica abrasive into Biocare Toothpaste motivated by the desire to provide the composition with an abrasive effect as taught by Swett.
In regards to instant claim 1 reciting a surfactant system consisting essentially of, absent a clear indication in the specification or claims of what the basic and novel characteristics of the claimed composition actually are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”. See MPEP 2111.03(III). In the instant case, the neither the specification or the claims describe what types of surfactants would be excluded from the surfactant system other than sodium lauryl sulfate. Therefore, since there is no clear indication of what the basic and novel characteristics are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”.
In regards to instant claim 1 reciting wherein the composition is free of sodium lauryl sulfate, sodium lauryl sulfate is not listed as an ingredient in Biocare Toothpaste.
Response to Arguments
Applicant argues that a person skilled in the art would readily infer that adding Robinson’s high-load electrolytes to the BioCare acrylate chassis could cause immediate viscosity collapse via charge neutralization and ion-induced precipitation, transforming the toothpaste into a low-viscosity liquid or a phase-separated “lumpy” mass. This would happen because the high concentration of cations Zn2+ and protonated arginine from Robinson’s actives can neutralize the negative charges on the acrylate polymer backbone, causing the expanded polymer chains to “shield” and coil back on themselves making Biocare’s composition unsuitable for its intended purpose.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not provided support for their assertion. Therefore, Applicant’s argument is merely speculative and holds no patentable weight. As such, Applicant’s argument is unpersuasive.
Applicant argues that for its specific composition (see Ex. 4 in Table 4 of Robinson), Robinson explicitly teaches that the use of standard anionic surfactants, such as sodium lauryl sulfate (SLS), is deleterious to the system’s performance.
The Examiner disagrees and does not find Applicant’s argument to be persuasive. Robinson does not disclose wherein anionic surfactants or SLS is deleterious to the system’s performance. Robinson discloses in paragraph [0126] wherein foam volume was increased as compared to Comparative Example 4 by changing the surfactant from SLS. Thus, Robinson discloses wherein using SLS does not produce as much foam volume as other surfactants. This is not mean that SLS is deleterious. As such, Applicant’s argument is unpersuasive.
Applicant argues that Robinson emphasizes that the preferred surfactant system for such compositions should be selected from non-ionic and/or zwitterionic surfactants because SLS yielded unacceptable results in the presence of the arginine and zinc mixture.
The Examiner does not find Applicant’s argument to be persuasive. A prior art is evaluated for all that it reasonably suggests and is not limited to preferred embodiments. Robinson does not teach away from incorporating an anionic surfactant into its surfactant system. Robinson discloses in paragraph [0058] wherein anionic surfactants may be optionally present in the composition. Robinson also discloses in paragraph [0017] wherein not including SLS or an anionic surfactant is optional. As such, Applicant’s argument is unpersuasive.
Applicant argues that a skilled person reading Robinson would be actively dissuaded from utilizing the Applicant’s surfactant class with Robinson’s composition (comprising Zn and arginine) or vice versa.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state to use Robinson’s composition. The rejection states to modify the composition of Biocare Toothpaste with the teachings of Robinson. Biocare Toothpaste discloses a composition comprising zinc, arginine, lauryl glucoside, and sodium cocoyl glutamate. Thus, it was known in the art that the claimed surfactants are compatible with zinc and arginine. Biocare Toothpaste does not disclose amounts. Therefore, it would have been obvious to one of ordinary skill in the art to have used the teachings of Robinson since Robinson discloses effective amounts. As discussed above, Robinson does not teach away since Robinson does not disclose wherein anionic surfactant should not be used. Robinson discloses in paragraph [0058] wherein the composition may comprise anionic surfactants. As such, Applicant’s argument is unpersuasive.
Applicant argues that Swett lacks a technical roadmap to revolve the incompatibility between the Robinson actives and the binder/thickening system.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Robinson does not disclose wherein anionic surfactants cannot be used. As such, Applicant’s argument is unpersuasive.
2. Claims 1, 6-9 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 2015/0297500, Oct. 22, 2015) (hereinafter Robinson) in view of Wenk et al. (US 2019/0307657, Oct. 10, 2019) (hereinafter Wenk) (of record).
Robinson discloses an oral care composition comprising an orally acceptable vehicle, a basic amino acid in free or salt form, particles of precipitated calcium carbonate, a source of zinc ions, and a surfactant system selected from at least one of a nonionic block polymer surfactant and a betaine zwitterionic surfactant or a mixture thereof (¶ [0003]). The oral care composition may be a toothpaste (¶ [0077]). The basic amino acid in free or salt form comprises arginine (¶ [0043]). The basic amino acid in free or salt form is present in an amount of from 5 to 15 wt. % (¶ [0044]). The oral care composition comprises a source of zinc ions as an anti-plaque/anti-gingivitis component. Zinc ions have an anti-bacterial efficacy when used in the oral cavity, which in turn can act to reduce plaque and/or gingivitis (¶ [0046]). The source of zinc ions may comprise a mixture of zinc citrate and zinc oxide (¶ [0049]). The zinc citrate is present in an amount of from 0.25 to 0.75 wt. % and zinc oxide is present in an amount of from 0.75 to 1.25 wt. % (claim 27). The nonionic block copolymer surfactant is present in an amount of from 0.25 to 2 wt. % (claim 2). The betaine zwitterionic surfactant is present in an amount of from 0.25 to 2 wt. % (claim 8). The betaine zwitterionic surfactant comprises cocamidopropyl betaine (claim 12). The nonionic block copolymer surfactant has polyoxypropylene and polyoxyethylene (claim 5). The composition may comprise a fluoride compound for providing anti-cavity efficacy (¶ [0077]). The orally acceptable vehicle may comprise thickening agents (¶ [0068]). The oral care composition does not comprise any sodium lauryl sulfate (claim 33). Other surfactants, which may be anionic, cationic, zwitterionic, amphoteric, or nonionic, and are known for use in oral care compositions, may optionally be present in the composition (¶ [0058]).
Robinson differs from the instant claims insofar as not disclosing wherein the composition comprises 3% to 7% rhamnolipid and about 15% to about 25% silica abrasive.
However, Wenk discloses an oral care composition comprising at least one biosurfactant and fluoride (abstract). Suitable biosurfactants include rhamnolipids (¶ [0026]). The biosurfactant is contained in an amount from 0.005 wt. % to 20 wt. % (¶ [0054]). The biosurfactant reduces staining of teeth (¶ [0080]). An abrasive polishing material may be included in the oral care composition. Typical abrasive polishing materials include silica gels (¶ [0060]). Silica dental abrasives of various types are preferred because of their unique benefits of exceptional dental cleaning and polishing performance without unduly abrading tooth enamel or dentine. The abrasive is generally present at a level of from about 6% to about 70% (¶ [0061]).
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. Robinson discloses wherein the composition comprises additional surfactants known for use in oral care compositions. Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated 0.005 wt. % to 20 wt. % rhamnolipid into the composition of Robinson since it is a known and effective oral care surfactant and amount thereof and it has the additional property of reducing staining of teeth as taught by Wenk.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated about 6% to about 70% silica abrasive into the composition of Robinson motivated by the desire to provide the composition with exceptional dental cleaning and polishing performance without unduly abrading tooth enamel or dentine as taught by Wenk.
In regards to instant claim 1 reciting a surfactant system consisting essentially of, absent a clear indication in the specification or claims of what the basic and novel characteristics of the claimed composition actually are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”. See MPEP 2111.03(III). In the instant case, the neither the specification or the claims describe what types of surfactants would be excluded from the surfactant system other than sodium lauryl sulfate. Therefore, since there is no clear indication of what the basic and novel characteristics are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”.
Response to Arguments
Applicant argues that there is no credible motivation in the prior art to replace a surfactant system that Robinson proves is functional with an anionic system that Robinson suggests will fail.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state wherein the surfactant system of Robinson would be replaced. As discussed in the rejection, Robinson discloses wherein the composition comprises additional surfactants known for use in oral care compositions. Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated 0.005 wt. % to 20 wt. % rhamnolipid into the composition of Robinson since it is a known and effective oral care surfactant and amount thereof and it has the additional property of reducing staining of teeth as taught by Wenk. Thus, the rejection states to additionally incorporate rhamnolipid as a surfactant. Also, as discussed above, Robinson discloses in paragraph [0058] wherein the composition may comprise anionic surfactants. Therefore, Robinson does not teach away from the incorporation of rhamnolipid. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 6-9 and 15-19 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.
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/TRACY LIU/Primary Examiner, Art Unit 1614