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 June 11, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112 – Indefiniteness (New Rejection)
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.
Claims 1, 3 and 5-7 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation, “(a) at least one component selected from a group consisting of a saccharide, a sugar alcohol, an amino acid, a phosphate compound, a carbonate compound, and a calcium compound”, and the claim also recites “(a) as a sugar alcohol” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
Claims 1, 3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2003528127 (JP 127’) in view of Litkowski et al. (US 5735942) in further view of Donnet (WO 2018134446).
JP 127’ discloses powder spray for treating the gingival margin. The powders for cleaning the supragingival surface include amino acids, sugars, organic acids and their salts. A suitable powder mixture is, for example, a mixture of amino acids and sugars and/or organic acids, preferably a mixture of glycine and urea. It is also advantageous to further mix the powder with a substance present in a very finely divided form before it is used as a tooth surface cleaner. This has the effect that the resulting powder mixture can be transferred more effectively and faster with conventional powder jet equipment. Examples of very finely divided powders include boron oxide, silica gel, highly disperse silica that are preferably silanized with organosilanes, for example silica containing trimethylsilyl groups. The compositions may also comprise fluoride-donating substances such as sodium fluoride.
JP 127’ differs from the instant claims insofar as it does not disclose an ion-sustained-release glass.
Litkowski et al. disclose a silica based bioactive glass composition that can be used in conjunction with a delivery agent, such as a toothpaste, having a particle size which will form a rapid and continuous reaction with body fluids due to the immediate and long term ionic release of Ca and P from the core silica particles, to produce a stable crystalline hydroxy carbonate apatite layer deposited onto and into the dentin tubules for the immediate and long term reduction of dentin hypersensitivity (Abstract). Fluoride may be add to the glass and the addition of fluoride in the glass composition will enhance and strengthen the tooth structure to make it more resistant to a reoccurrence of hypersensitivity. The bioactive glass composition can also be applied in a saline or distilled water based medium (col. 7, lines 37-43).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added the bioactive glass comprising fluoride to the powders of JP 127’ motivated by the desire to use a fluoride providing component that can provide apatite to the dentin tubules for immediate and long term reduction of dentin hypersensitivity and can be applied in a water based medium.
JP 127’ in view of Litkowski et al. differs from the instant claims insofar as it does not disclose the sugar is a sugar alcohol.
Donnet disclose powders for cleaning an internal body part and/or implant by means of a powder jet device. The powder may comprise sodium bicarbonate, calcium carbonate, sugar alcohols such as erythritol and disaccharides, in particular trehalose or isomaltulose, depending on the intended use. These are compositions which are already used in the surface treatment of teeth. Particularly preferred are erythritol and/or glycine. Erythritol powder-water mixtures can be applied without problem at the gum line and at the pocket entrance. Erythritol powder is suitable for the removal of slight deposits and discolorations, for tooth polish and for biofilm removal, especially on sensitive implant surfaces. The powders are hygroscopic and are therefore mixed with amorphous silica (silicon dioxide) .As a result, moisture absorption of the powders during sterilization can be reduced or even completely prevented. The addition of amorphous silica leads to a hydrophobic coating of the powder particles and thus counteracts the moisture absorption of the powder particles during the sterilization process.
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 trehalose as the sugar or erythritol as the sugar in the glycine sugar combination of JP 127’ in view of Litkowski et al. because they are suitable for use and because erythritol can be applied without problem at the gum line and at the pocket entrance as well as it is suitable for the removal of slight deposits and discolorations, for tooth polish and for biofilm removal, as disclosed by Donnet.
Response to Arguments
The Examiner submits that although Litkowski et al. is mainly drawn to toothpaste, Litkowski et al. and JP 127’ are analogous art. JP 127’ discloses a composition for cleaning the teeth. These components are also used in toothpaste. Therefore, one of ordinary skill in the art would reasonably conclude that components used in toothpaste may be used in powders that are used to treat teeth. In regards to jet cleaning, JP 127’ discloses that fluoride delivering components may be added to the powders disclosed therein. Therefore, it would have been reasonable to conclude that not only does the powder remove deposits but also deliver actives to the teeth. If this was not the case, one would reasonably conclude that using fluoride would not be suggested. Further, in regards to Litkowski disclosing ion release, one would reasonably conclude that the powders remain on the wet surface of the teeth until rinsed off. This would also be the case for a toothpaste. A toothpaste is brushed onto the teeth and then rinsed off after mechanical brushing. Therefore if an ion releasing component is present after brushing, one would also reasonably conclude that it would remain on the teeth after spaying a powder onto the wet surface of the teeth. In regards to the interaction, the powder projected onto the teeth are applied to a wet surface. Therefore, one would reasonably conclude that there is a chemical interaction as in the case with a toothpaste. The powders of JP ‘127 may be used to carry active agents. Therefore one would reasonably conclude that the actives would also remain on the surface. One of ordinary skill in the art would look to Litkowski for suitable oral care actives because it discloses oral care compositions. In regards to the reasonable expectation of success, one would reasonably conclude that when a powder is sprayed on the teeth, the wet environment of the oral cavity would cause some of the powder to adhere to the teeth. Therefore, the actives in the powder would adhere to the teeth before they are rinsed with water. In regards to Donnet, Donnet was used to for its disclosure of suitable sugars used in jet powders. Although it may be used in composition that absorb moisture, it is not unsuitable for compositions that do not. Erythritol is a suitable sugar for powder jet compositions. One would not need to apply the teachings of Donnet to that of JP ‘127 because Donnet was used for its teaching of erythritol. In regards to erythritol’s hygroscopic property, this would not appear to stop one from using erythritol in a dry system for its therapeutic effects. Therefore, using erythritol would not appear to change the function of JP ‘127. Further, most sugars are hygroscopic and JP ‘127 disclose sugars are suitable components for the powder. This further supports that erythritol would not affect the function of the powders of JP’127. Therefore the rejection is maintained.
Conclusion
Claims 1, 3 and 5-7 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
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