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 July 13, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claims 1-2, 4-7, 9-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Toda et al. (JP 2019011300).
Toda et al. disclose an oral composition containing quaternary ammonium salt and hyaluronic acid and/or salt thereof and water. The quaternary ammonium salt may be cetylpyridinium chloride and comprises 0.01 to 1% by weight of the composition. The hyaluronic acid has an average molecular of 1,000 to 700,000 and comprises 0.001 to 5% by weight of the composition. The water is the base of the composition and comprises 1 to 95% by weight of the composition. Thickeners may be used and include other polysaccharides such as pullulan, and hydroxypropyl methyl cellulose. Surfactants may be used and include sodium methyl-N-acyl taurate and nonionic surfactants such as stearate, polyoxyethylene higher alcohol ether and polyoxyethylene polyoxypropylene copolymer. The pH ranges from 4-9. A pH adjuster is used and includes sodium benzoate. Dyes may also be used in the compositions. Plaque inhibitors may be used and include zinc salts. Antibacterials also comprise benzoic acid and sorbic acid. Flavors include menthol and peppermint oil (also cooling agents)
A composition comprises glycerin, 0.04% stannous fluoride, 0.01% sodium hyaluronate (MW 128000), 0.04% cetylpyridinium chloride, 2% sodium lauroyl methyl taurine, fragrance (flavor), polyoxyethylene hardened castor oil (nonionic surfactant) and water (about greater than 80%) (Table 10). The composition appears to be a solution and therefore may be used as a mouthwash.
A mouthwash composition comprises glycerin, ethanol, 0.05% sodium fluoride, 0.1% sodium hyaluronate (MW 1080), 0.05% cetylpyridinium chloride, 0.1 fragrance (flavor), 0.05 sodium saccharin and water (about greater than 80%) (Table 12).
The mouthwash is not anticipatory insofar as it does not disclose an exemplified example comprising all the essential elements. However, it would have been obvious to one of ordinary skill in the art prior to filing the instant claims to have combined a sodium methyl cocoyl taurate with hyaluronic acid and cetylpyridinium chloride because this combination is suggested by Toda et al.
In regards to claim 15, the composition of Toda et al. comprise substantially the same components and therefore should have the property of not forming a cetylpyridinium hyaluronate precipitate.
In regards to claim 16, the claim recites and/or. Therefore it appears these components may be present, but can’t be added all together. Therefore the reference meets the instant claim.
The composition comprises a combination of hyaluronic acid, cetylpyridinium chloride and sodium lauroyl methyl taurine and therefore should have the property wherein the formation of a cetylpyridinium hyaluronate precipitate is inhibited when the mouthwash composition is subjected to freeze-thaw cycling from -30°C to 30°C, even if the composition comprises HA having high average molecular weight of about 1 MDa.
Response to Arguments
The Examiner submits that a composition is disclosed where a taurate surfactant is used in a composition with cetylpyridinium chloride and a high molecular weight hyaluronic acid. Therefore, the functional language of claim 1, would be met. In regards to the alleged unexpected results, the reference discloses sodium lauroyl methyl taurine, which is encompassed by the formula of the instant claims. Therefore, one would reasonably conclude that the composition would yield the same results as disclosed in the instant specification. Therefore, the results are not persuasive and the rejection is maintained.
2) Claims 1-10 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Toda et al. (JP 2019011300) in view of Baig et al. (US 20100135933).
Toda et al. are discussed above and disclose a mouthwash composition comprises glycerin, ethanol, 0.05% sodium fluoride, 0.1% sodium hyaluronate (MW 1080), 0.05% cetylpyridinium chloride, 0.1 fragrance (flavor), 0.05 sodium saccharin and water (about greater than 80%) (Table 12).
Toda et al. differ from the instant claims insofar they do not disclose that the taurate surfactant is sodium methyl cocoyl taurate or the amount recited in the specific formula of 17-18.
Baig et al. disclose oral care compositions comprising a silica abrasive (Abstract). The composition may comprise zinc salts and cationic antibacterial agents. (paragraph 0013) The antibacterials comprise 0.1% to about 5% by weight of the composition. Zinc salts used include zinc lactate (examples). The cationic active material may be cetylpyridinium chloride (paragraph 0013). Surfactants include taurate surfactants and comprise about 0.1% to about 2.5% by weight (paragraph 0181). A preferred anionic surfactant is methyl cocoyl taurate. Compositions with cationic antibacterial agents may be desired to have surfactant systems with cation compatible surfactants selected from non-ionic surfactants, cationic surfactants, betaine surfactants, amphoteric surfactants, and combinations thereof. The cation compatible surfactants may include poly(oxyethylene)-poly(oxypropylene)(poloxamer), cocoamidopropyl betaine, polyethylene oxide, polyoxyethylene sorbitan monolaurate and monooleate, alkyl polyglucoside, sodium methyl cocoyl taurate, and combinations thereof. The surfactant comprises 0.01 to about 15% (paragraph 0177). Sweeteners include sucralose and saccharin and may be used in amounts ranging from 0.005% to about 5% (paragraph 00164). Preservatives include sodium benzoate in an amount of less than 1%.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used sodium methyl cocoyl taurate as the sodium methyl-N-acyl taurate and added 0.1 to about 2.5% sodium methyl cocoyl taurate to the composition of Toda et al. because it is a suitable taurate and amount for oral care compositions.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used and added zinc lactate to the composition of Toda et al. in an amount of 0.1 to obtain its therapeutic effect in a therapeutically effective amount.
Response to Arguments
The Examiner submits that Baig cures the deficiencies by disclosing a suitable amount of sodium methyl cocoyl taurate suitable for oral care compositions. Therefore, when using sodium methyl cocoyl taurate in place of sodium lauroyl methyl taurine, it would have been obvious to have added 0.3% to 0.8% of sodium methyl cocoyl taurate to an oral care composition. In regards to Toda restricting taurate usage, the composition of Table 10 is mostly liquid. Therefore, one would reasonably conclude that taurate may be used for solutions as well as toothpaste. Further, Toda discloses using taurate surfactants. Therefore, it would have been obvious to use a taurate surfactant in a mouthwash. Further, Toda discloses using 2% sodium lauroyl methyl taurine. Therefore the amounts disclosed in Baig would not appear to collapse the micellar stability of the mouthwash of Toda and the amounts would not be entirely unsuitable for intended purpose.
3) Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Toda et al. (JP 2019011300) in view of Baig et al. (US 20100135933) and Deisenroth et al. (US 20170143612).
Toda et al. in view of Baig et al. is discussed above and differs from the instant claims insofar as it does not disclose the type of poloxamer and lactic acid.
Deisenroth et al. disclose oral composition. Poloxamers surfactants are used and include poloxamer 407 (paragraph 0230). Lactic acid is used as an antioxidant (paragraph 0251).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added 0.1 to about 2.5% sodium methyl cocoyl taurate to the composition of Toda et al. because it is a suitable amount for oral care compositions.
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 filing the instant application to have used and added zinc lactate to the composition of Toda et al. in an amount of 0.1% to obtain its therapeutic effect in a therapeutically effective amount. It would also have been obvious to have added sucralose in an amount of 0.005 to 0.2% and a sodium benzoate in less than 1% to obtain their therapeutic effects of a sweetener and preservative, respectively.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used Poloxamer 407 as the poloxamer in an amount of 0.3 to 0.5% in the composition of Toda et al. in view of Baig et al. because it is a suitable poloxamer for oral care compositions and the range falls within the range taught by Baig et al.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added lactic acid to the composition Toda et al. in view of Baig et al. to obtain its therapeutic function as an antioxidant.
In regards to the amount of antioxidant, it would have taken no more than the relative skill of one of ordinary skill in the art through routine optimization to arrive at an amount 0.04 to 0.06% to obtain the desired therapeutic effect.
Response to Arguments
The Examiner submits that Deisenroth cures the deficiencies of the instant claims. Toda and Baig disclose nonionic surfactants. Deisenroth disclose oral care composition and supports that Poloxamer 407 is suitable for oral care compositions. Therefore, the rejection is maintained.
Conclusion
Claims 1-19 are rejected.
Claim 21 is withdrawn.
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 at 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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