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 .
Applicants' arguments, filed September 4, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejections)
1) Claims 1, 5, 10-12, 15-16, 19, 21-23 and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Colgate Palmolive Co. (Colgate, GB 1 562 979). The rejection is maintained and further applied to claim 34.
Colgate discloses oral care compositions containing at least one nitrogen-containing antibacterial plaque-preventing compound from the group consisting of the cationic antibacterial plaque-preventing compounds and long-chain amines having an alkyl radical of 12 to 18 carbon atoms (Abstract). The compositions may be formulated into gels and include gelling agents. Gelling agents include hydroxyethyl cellulose and comprise from 0.5% to 5% of the composition. Antibacterial agents include chlorhexidine salts and comprise 0.001 to 15% by weight. The compositions may comprise additional antibacterial agents and include cetylpyridinium chloride. A toothpaste may be prepared by forming a gel with humectant, gum or thickener such as hydroxyethyl cellulose, sweetener and adding thereto polishing agent, flavor, antibacterial agent, such as benzethonium chloride, cetyl pyridinium chloride or chlorhexidine, and additional water, followed by addition of a stain inhibiting agent. Color materials may also be added to the compositions. Water comprises 0 to 80% by weight of a toothpaste composition (page 6, lines 58-60). The pH may be adjusted by sodium hydroxide (see examples). A toothpaste comprises 16% glycerine, 6% sorbitol, 1.2% hydroxyethyl cellulose, chlorhexidine digluconate (20%), sodium saccharin, flavor and water (Example 16).
Colgate differs from the instant claims insofar as it does not exemplify a composition comprising a mixture of chlorhexidine and cetylpyridinium chloride.
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06,I. It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have used a combination of chlorhexidine and cetylpyridinium chloride in the compositions of Colgate because they are taught for the same function.
In regards to the amount of chlorhexidine, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See 2144.05. Colgate discloses the amount of antibacterial comprises 0.001 to 15% by weight and the range in the recited claims for chlorhexidine is 0.04 to 0.3 wt.% and cetyl pyridinium chloride is 0.01 to 0.1%. The instant ranges lie within the range of the reference and therefore it would have been obvious to have used 0.04 to .03% chlorhexidine and 0.01 to 0.1% cetylpyridinium chloride in the compositions of Colgate because the amounts lie within the range disclosed by Colgate.
In regards to the compositions not comprising an abrasive, the reference contemplates gels. It would have been obvious to omit a component where the function is not desired or required. See MPEP 2144.04, A. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have not added an abrasive to the oral composition of Colgate when making a gel to obtain a gel without abrasive properties.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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. The pH adjusting agent is a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of a pH adjusting agent such as sodium hydroxide to 0.0001% to 1.0% to make the composition the desired pH.
Response to Arguments
The Examiner submits that although the claims have been amended, it would have taken no more than the relative skill of one of ordinary skill in the art through routine experimentation have adjusted each component to arrive at an effective therapeutic amount for each of cetylpyridinium chloride and chlorhexidine. Further, it appears that the amount recited by the instant claims excludes the amount tested for chlorhexidine. Therefore it does not appear that the claims are in scope with the results. Further, it appears that only one amount for each component was tested in the instant specification. Therefore, it is not clear if the amounts of the instant claims or the different ratios of cetylpyridinium chloride to chlorhexidine encompassed by the instant claims would yield similar results. In regards to an abrasive, the claims do not exclude abrasives from being in added to the claimed composition.
In regard to claim 31, Colgate suggests using mixtures. It would have taken no more than the relative skill of one of ordinary skill in the art to arrive at the amounts of the instant claims through routine experimentation. Therefore the rejection is maintained. In regards to the water range, Colgate discloses 80%, which falls within the claimed range. Therefore the amount water recited by the instant claims is obvious over the range of Colgate. See 2144.05. In regards to the color and flavor, both are result effective variables. One provides the color to the composition and the flavor provides the taste. Therefore the desired color intensity and taste can be obtained through routine experimentation. See 2144.05. In regard to the composition being carefully optimized, this is for intended use. This would not exclude the gels from being used for other purposes and it does not appear that Applicant has pointed or provided evidence to the contrary.
2) Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Colgate Palmolive Co. (Colgate, GB 1 562 979) in view of Bush et al. (WO 2016/164903).
Colgate is discussed above and differs from the instant claims insofar as it does not disclose a delivery system comprising a syringe.
Bush et al. disclose aqueous gel systems comprising water (Abstract). The gel systems are delivered by syringe (page 10, line 27-28).
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. It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have used a syringe to deliver a gel composition of Colgate when making a gel because a syringe is suitable for delivering gel compositions.
Response to Arguments
The rejection over Colgate has been maintained. Bush cures the deficiencies of Colgate by disclosing a syringe. It would have been obvious to have used a syringe to deliver a gel composition of Colgate because a syringe is suitable for delivering gel compositions. Therefore, the rejection is maintained.
Conclusion
Claims 1, 5, 10-12, 15-16, 19, 21-23 and 27-34 are rejected.
No claims 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 LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached on 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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