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 .
Response to Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on December 22, 2025 is acknowledged. The traversal is on the ground(s) that a search of one group would identify relevant references for both groups. Therefore, there is not serious burden to search all the claims. This is not found persuasive because Burden consists not only of specific searching of classes and subclasses, but also of searching multiple databases for foreign references and literature searches. Burden also resides in the examination of independent claim set for clarity, enablement and double patenting issues. Further, a reference that would anticipate the invention of one group would not necessarily anticipate or even make obvious another group. Finally, the consideration for patentability is different in each case. Thus, it would be an undue burden to examine all of the above inventions in one application and the restriction for examination purposes as indicated above is deemed proper.
The requirement is still deemed proper and is therefore made FINAL.
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 22, 2025.
Claims
Claim Rejections - 35 USC § 112 - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “short interval” in claim 14 is a relative term which renders the claim indefinite. The term “short interval” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how much time constitutes a short interval. Therefore the claim is indefinite.
Claim Rejections - 35 USC § 102 - Anticipation
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1,4-7, 12 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tashiro et al. (JP 2018002719).
Tashiro et al. disclose liquid oral compositions having low irritancy while having an anionic surfactant. The composition comprises at least an anionic surfactant, a polyoxyethylene hydrogenated castor oil and hyaluronic acid (Abstract). Preferred anionic surfactants include N-acyl amino acid salts including sodium lauroyl sarcosine and sodium lauroyl methyl taurine (sodium lauroyl methyl taurate). The liquid oral composition comprises an anionic surfactant from 0.05 to 0.5% by weight, polyethylene hydrogenated castor oil from 0.01 to 2% by weight and a polysaccharide, hyaluronic acid, from 0.001 to 0.5% by weight. Cationic fungicides may be used and include cetylpyridinium chloride and zinc salts such as zinc chloride. A mouth wash composition comprises 0.1% sodium hyaluronate, 0.05 cetylpyridinium chloride, 8% glycerin, 2% sucralose, 0.01% saccharin sodium, 0.1 fragrance (flavor), 0.25 of an anionic surfactant and 79.7% water (Example 3). Another mouthwash example comprises 10% sorbitol, 5% glycerin, 2% erythritol, 5% maltitol, 0.25 cocoyl (C12-C16) sodium sulfate, 0.2% citric acid, 0.1% sodium hyaluronate, 0.05% cetylpyridinium chloride, 0.01% saccharin sodium, 0.1 fragrance and water.
One would only need to replace the anionic surfactant with sodium lauroyl methyl taurine to arrive at the instant claims. Therefore Tashiro et al. anticipate the instant claims.
In regards to claim 14, the composition comprises sodium lauroyl methyl taurine, and therefore, when sodium lauroyl methyl taurine is used, it would have an enhanced delivery of CPC to the teeth.
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.
Claim Rejections - 35 USC § 103 - Obviousness
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 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.
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 amount of sodium methyl cocoyl taurate or 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 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.
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.
2) 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.
Claims 1-19 are rejected.
Claim 21 is withdrawn.
No claims allowed.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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