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 November 14, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejection
Claims 1, 3 and 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).
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.
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 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. One of ordinary skill in the art would also conclude that both references are the same “technical” art. In regards to the purpose of 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. Therefore it would have been obvious to have added other oral care actives to the composition of JP 127’, such as the glass of Litkowski et al. Additionally, a toothpaste would also remove deposits. Therefore both the powders of JP 127’ and the toothpaste of Litkowski et al. have similar purposes.
New Rejection
Claims 1 and 3-7 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.
Conclusion
Claims 1 and 3-7 are rejected.
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612