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 in the Request for Continued Examination, filed December 3, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112 – Indefiniteness (New Rejection)
Claim 20 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 claim recites the limitation “the composition is compounded to be suitable for delivery through” then goes on to recite “soluble”. It is not clear what is meant by “soluble”. This does not appear to be a formulation.
The claim also recites “further comprising”. However, there appears to be no additional components incorporated into the composition of the instant claims.
Therefore the claim is indefinite.
Claim Rejections - 35 USC § 103 – Obviousness (Modified Rejection)
1) Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over CN 101176698. The rejection is maintained and further applied to claim 16.
CN 101176698 discloses compositions comprising magnesium salts. The compositions may be used to eliminate halitosis (page 4, paragraph eight). Magnesium salts include magnesium carbonate (insoluble), magnesium hydroxide and magnesium oxide (page 3). The magnesium salt has a particle size ranging reach nanometer level, 0.1 nm. The magnesium salt may have a particle size ranging from 0.1 to 0.15 nm and comprises 0.001 to 100% (page 4, second paragraph). The mouthwash comprises the magnesium salt and a proper thickening agent (instant claim 20). The product is made into uniform suspension with a thickener. Thickeners include sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, methyl cellulose, polyvinyl alcohol, gum Arabic, sodium carbomer, hydroxyethyl starch, sodium alginate, tragacanth, tara gum, ghatti gum, agar, and sodium starch glycolate (page 4, paragraph five) (meeting keratinophilic polymers).
CN 101176698 discloses the particle size of the magnesium salt and the amount of salt ranges from 0.1 to 0.15 nm and 0.001 to 100%, respectively, whereas the instant claims recite 1 to 1000 nm and 1 to 100 ppm, respectively. 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 MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap.
Response to Arguments
The Examiner submits that it does not appear Applicant has argued the merits of the rejection. However, the Examiner points out that the new claims 19-20 are encompasses by the reference. CN 101176698 discloses using an insoluble magnesium salt that is not an oxide or soluble. The salts may be used in combination with a polymer encompassed by keratinophilic polymers. Therefore the rejection is maintained.
2) Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Niedermeyer (WO 2022046977) in view of CN 101176698.
Niedermeyer discloses a nanoparticle composition for oral care including at least one of a first set of spherical nanoparticles or a second set of coral shaped nanoparticles, and a stabilizing agent. The nanoparticle composition is added to a carrier suitable for application to an oral cavity, including to teeth and surrounding oral tissues. The nanoparticle composition is configured to control the pH of the microenvironment to which it is applied, thereby preventing and/or treating a variety of oral conditions. The nanoparticle composition can be provided as a concentrated nanoparticle additive addable to a mouthwash, mouth rinse, dentifrice, mouth spray, oral gel, denture cleaning solution, or other carrier suitable for oral application (Abstract). The spherical nanoparticles include spherical metal nanoparticles. The spherical-shaped metal nanoparticles can have a diameter of about 40 nm or less (paragraph 0028). The metal nanoparticles, a metal, a mixture of metals, or a metal alloy, including at least one of silver, gold, tin, zinc, heterogeneous mixtures thereof, or alloys thereof. Preferred embodiments comprise silver and/or gold nanoparticles (paragraph 0037). A stabilizing agent is used and may itself be beneficial for use in oral care applications. Examples of stabilizing agents include alcohols generally (e.g., ethanol), as alcohols have been observed to effectively maintain nanoparticles of different sizes and different shapes within a given solution. Stabilizing agents can be dissolved into a carrier (e.g., water, alcohol, water alcohol combination, or any combination of other liquid phase materials readily applied to the oral cavity and/or to surrounding tissue of a person or animal) (paragraph 0049). The stabilizing agents have the capacity to hold the at least two differently sized and/or shaped nanoparticles in suspension and deliver these nanoparticles to the targeted area of a person or animal (e.g., the oral cavity or surrounding tissues) without diminishing the effectiveness of the nanoparticles (paragraph 0051). The nanoparticle composition may also include a carrier, or the stabilizing agent may itself function as a carrier. The carrier can be a liquid, gel, or solid. Carriers useful according the present disclosure can include a variety of additional ingredients. The concentration of the nanoparticle in an oral care composition is at least 0.5 to 1.5 ppm (paragraph 0079). The composition may further comprise at least one polymer. The polymer includes polysaccharides, polysaccharide gums, xanthan gum or combinations of polymers (paragraph 0063).
Niedermeyer differs from the instant claims insofar as it does not exemplify an aqueous composition comprising a mucoadhesive polymer. However, Niedermeyer does disclose that polymers may be added to the compositions.
CN 101176698 is discussed above and discloses xanthan gum maybe used in mouthwash compositions.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have formulated an oral rinse with xanthan gum and the nanoparticles of Niedermeyer because it is suggested by Niedermeyer and because xanthan gum is suitable to make oral rinses comprising particles as disclosed by CN 101176698.
In regards to agitating the composition to disperse, the composition of the prior art are suspensions. Therefore one would reasonably conclude that the composition should be agitated because they comprise particles.
In regards to tasteless, the compositions comprise a metal in an amount encompassed by the instant claims. Therefore, it would be reasonable to conclude that the compositions are tasteless.
Obvious-Type Double Patenting (Modified Rejection)
Claims 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,257,329.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they both recite an aqueous oral composition for controlling halitosis comprising a metal and a thickener. The instant claims differ from the patented claims insofar as the instant claims are genus claims reciting several metals whereas the patented claims recite a specific metal and thickener in the independent claims. Therefore the instant claims are obvious over the patented claims.
Response to Arguments
The Examiner argues that the patented claims are not distinct from the instant claims because they both recite the same subject matter of a metal and keratinophilic/mucoadhesive polymer for treating halitosis. Therefore, the rejection is maintained.
Conclusion
Claims 19-20 are rejected.
No claims allowed.
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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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612