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 and 15-19.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/23/2026 has been entered.
Applicants' arguments, filed 05/26/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 1 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (WO 2021/062607 A1, Filing date: Sep. 30, 2019) (hereinafter Shi).
Shi discloses an oral care composition comprising hops beta acid and from about 0.01% to about 10% of a basic amino acid (claim 1). Suitable amino acids include arginine (page 10, line 20). The oral care composition can comprise a zinc ion source. The zinc ion source can comprise one or more zinc containing compounds, such as zinc oxide and zinc citrate (page 17, lines 6-9). The zinc ion source may be present in the oral care composition at an amount of from about 0.01% to about 10% (page 17, lines, 12-13). The oral care composition can comprise one or more surfactants (page 19, line 12). Suitable surfactants include lauryl glucoside (page 22, line 8) and sodium cocoyl glutamate (page 22, line 7). The oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15% (page 22, lines 23-24). The oral care composition can comprise a fluoride ion source (page 11, line 1). The oral care composition can comprise one or more thickening agents (page 22, line 28). Suitable thickening agents include xanthan gum (page 23, line 3) and carboxymethyl cellulose (page 23, line 5). The oral care composition can comprise a non-calcium abrasive such as precipitated silica (page 15, line 19). The oral care composition can comprise from about 5% to about 70% of the non-calcium abrasive (page 15, line 25). Examples of oral care compositions include toothpaste (page 3, line 6).
The prior art discloses an oral care composition (claim 1) comprising arginine (page 10, line 20), zinc oxide, zinc citrate (page 17, lines 6-9), lauryl glucoside (page 22, line 8), and sodium cocoyl glutamate (page 22, line 7) Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to instant claim 1 reciting lauryl glucoside and sodium cocoyl glutamate as the sole surfactant system, Shi discloses wherein the composition comprises one or more surfactants, such as lauryl glucoside and sodium cocoyl glutamate. Thus, one may select lauryl glucoside and sodium cocoyl glutamate as the one or more surfactants such that lauryl glucoside and sodium cocoyl glutamate is the sole surfactant system.
In regards to instant claim 1 reciting wherein the composition is free of sodium lauryl sulfate, Shi does not disclose wherein one or more surfactants have to include sodium lauryl sulfate. Thus, a composition free of sodium lauryl sulfate would have been obvious.
In regards to instant claim 1 reciting wherein the composition exhibits a stabilized rheological equilibrium such that that total loss of viscosity is limited to less than 33% after 4 weeks of storage at 49°C or after 90 days of storage at 40°C, Tables 2 and 3 and paragraph [0058] of the instant specification discloses wherein this viscosity profile is obtained from a composition comprising lauryl glucoside and sodium cocoyl glutamate as the surfactants. Therefore, since Shi discloses a composition comprising lauryl glucoside and sodium cocoyl glutamate as the surfactants, the composition of Shi necessarily exhibits a stabilized rheological equilibrium like the claimed invention.
In regards to instant claim 15 reciting from 0.5% to 2% zinc oxide and from 0.1% to 1% zinc citrate, Shi discloses wherein the zinc ion source may be present in the oral care composition at an amount of from about 0.01% to about 10% and wherein suitable zinc ion sources include zinc oxide and zinc citrate. Thus, the claimed amount of zinc oxide and zinc citrate would have been obvious to one of ordinary skill in the art from selecting an amount of each from the range disclosed by Shi.
Response to Arguments
Applicant argues that as documented in Tables 1 and 3 of the present specification, a standard comparative oral care composition utilizing standard sodium lauryl sulfate (SLS) loses a highly damaging 33% to 36% of its viscosity over time when exposed to the zinc and arginine electrolyte matrix. Conversely, Applicant’s Compositions I and II utilizing the alternative closed surfactant loops of Claim 1 either show a drastically minimized viscosity loss or unexpectedly build and reinforce their viscosity over time under identical storage conditions.
The Examiner does not find Applicant’s argument to be persuasive. The claim subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). In the instant case, Applicant’s comparative example with SLS as the surfactant is not the closest prior art. Biocare Toothpaste (IDS reference) comprises substantially the same surfactants as claimed (e.g., sodium cocoyl glutamate and lauryl glucoside) and comprises zinc oxide and arginine, and does not comprise SLS. Thus, Biocare Toothpaste appears to be the closest prior art. Since Applicant has not compared the claimed invention with Biocare Toothpaste and shown wherein the claimed invention is unexpected over Biocare Toothpaste, Applicant has not effectively rebutted a prima facie case of obviousness. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1 and 15-19 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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