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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 31, 2026 is noted. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 15, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tessarotto (EP 1525857) in view of Johansson et al. (2017/0367943) as evidenced by Johansson (WO 2018/048393).
With respect to claim 1, Tessarotto teaches a process for electrochemically whitening a tooth, the process comprising: a) contacting the tooth with a whitening gel having a first pH, the whitening gel located in a dental device comprising a positive electrode 27a-f and a negative electrode 28a-f (see figs. 1-2, abstract, pars. 29-30, such that the tooth whitening composition/gel is placed in the trough and inserted into the mouth, the whitening gel inherently has a pH); b) flowing a current between the positive and negative electrode through the whitening gel to whiten the tooth such that the whitening gel transitions from the first pH to a second pH while the whitening gel is in contact with the tooth, wherein the transition from the first pH to the second pH occurs within the dental device while positioned in an oral cavity (such that the whitening gel undergoes a chemical reaction which changes the pH, see explanation below, abstract, par. 30); wherein the whitening gel comprises a peroxide source (see pars. 10, 45, 52, 62) and an electrolyte source (pars. 30, 42-43, 45), the peroxide source present in an amount ranging from about 0.05 wt% to about 15 wt% (pars. 52, 60 such that the peroxide is an active agent and the active agent is disclosed as having a concentration from about 0.001-20 wt%, such that the carrier), and wherein the second pH is greater than the first pH. Such that Tessarotto teaches electrolysis using a composition including sodium chloride. It is noted that the weight of the peroxide taught by Tessarotto does not clearly teach the weight percent being of the total composition, however, does teach different bleaching techniques where the wt% of peroxide is from 30% (see par. 25) to as low as 3-6% (par. 26) and further teaches the current method allows for the reduction in the concentration of the peroxide without compromising the performance of the whitening agent (see par. 10). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the peroxide concentration to be within the claimed ranges as taught by Tessarotto since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.04). Such that Tessarotto clearly teaches the whitening effect can be controlled by the concentration of the peroxide in the composition. It is noted that electrolysis of the solution including the sodium chloride causes the reaction to form NaOH which is a strong base, thereby increasing the pH of the composition as claimed. Further it is noted that the claimed process including the composition and applying the current is claimed, therefore, the outcome, i.e. the change in the pH, would be the same. It is noted that the applicant has not disclosed any additional steps of elements within the composition that causes the pH to change. As discussed in MPEP 2112.02, I; “When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process”. In this case the apparatus including the positive and negative electrodes are used to carry out the same process including applying a current to a whitening gel as claimed, therefore, the outcome, i.e. the change in the pH would inherently occur as a result of the chemical reaction due to the electrical current and the decomposition of the electrolyte. This chemical reaction is evidence by Johansson in which a conductive whitening gel including a peroxide is placed in a container with a positive and negative electrode and a current is applied and flowed between the electrodes through the gel which results in an increase of the pH of the composition (see pars. 4, 6, 30, 32, 35). Tessarotto teaches the invention as substantially claimed and discussed above, however, does not specifically teach the first pH ranges from about 5 to about 6.
Johansson teaches a process for electrochemically whitening a tooth, the process comprising a) contacting a tooth with a whitening gel having a first pH, the whitening gel located in a dental device comprising a positive electrode and a negative electrode (see pars. 18), flowing a current between the positive electrode and the negative electrode through the whitening gel to whiten the tooth such that the composition comprises a transition (i.e. a chemical reaction) and the transition occurs withing the dental device while positioned in an oral cavity (abstract, see pars. 12, 18), wherein the whitening gel comprises a peroxide (see par. 47) and an electrolyte (see pars. 37, 42) and wherein the first pH ranges from about 5 to about 6 (see par. 48). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the pH of the composition taught by Tessarotto to be within the claimed range taught by Johansson since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.04). Further it is noted that the amount of peroxide and pH of the whitening gel effects the speed and effectiveness of the whitening process. It is further noted that the applicant does not teach the claimed range provides any unexpected results or advantages. It teaches several different ranges, all of which are alternative embodiments. It is noted that the applicant teaches the pH shift provided by the electrical current provides the surprising discovery of boosting whitening performance which is taught by the prior art of Tessarotto.
With respect to claim 15, Tessarotto/Johansson teaches the invention as substantially claimed and discussed above, Tessarotto further teaches wherein the peroxide source is selected from the group consisting of hydrogen peroxide, urea peroxide, glyceryl peroxide, benzoyl peroxide (see par. 52).
With respect to claim 50, Tessarotto/Johansson teaches the invention as substantially claimed and discussed above, Tessarotto further teaches wherein the current applied to the whitening gel ranges from about 10 mA to about 40 mA (see par. 61, such that the current is 1 to 15 mA, which includes the claimed range of 10-15mA).
Claim(s) 5, 7, 9, 11, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tessarotto (EP 1525857) in view of Johansson et al. (2017/0367943) as evidenced by Johansson (WO 2018/048393) as applied to claim 1 above, and further in view of Ryles (5,902,568).
Tessarotto/Johansson teaches the invention as substantially claimed and discussed above including Tessarotto teaches a first pH, the whitening gel undergoing a chemical reaction to have a second, higher pH (see detailed explanation above), however, does not specifically teach wherein the peroxide source is present in an amount ranging from about 8.0 wt. % to about 10.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 8.0, wherein the peroxide source is present in an amount ranging from about 5.0 wt. % to about 7.0 wt. % based on the total weight of the whitening gel and the second pH is about 7.5, wherein the peroxide source is present in an amount ranging from about 2.0 wt. % to about 4.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 10.0, wherein the peroxide source is present in an amount ranging from about 0.5 wt. % to about 2.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 9.0 to about 10.0, wherein the peroxide source is present in an amount ranging from about 0.05 wt. % to about 0.2 wt. % based on the total weight of the whitening gel and the second pH ranges from about 8.0 to about 10.5.
Ryles teaches a whitening gel which has a first pH, the whitening gel undergoes a chemical reaction and has a second higher pH (see col. 1, II. 63-67, col. 2, II. 1-4, 31- 40, col. 3, II. 16-20, 56-56, col. 4, II. 1-5, such that the peroxide has a pH of 5-6 and when mixed it has a pH of 8-12).
Ryles further teaches with respect to claim 5, wherein the peroxide source is present in an amount ranging from about 8.0 wt. % to about 10.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 8.0 (see col. 3, II. 12-15, col. 4, II. 1-5).
Ryles further teaches with respect to claim 7, wherein the peroxide source is present in an amount ranging from about 5.0 wt. % to about 7.0 wt. % based on the total weight of the whitening gel and the second pH is about 7.5 (see col. 3, II. 12-15, col. 4, II. 1-5). It is noted that the applicant discloses "about" mean +/- 5%, therefore the pH of 8 taught by Ryles is "about" 7.5.
Ryles further teaches with respect to claim 9, wherein the peroxide source is present in an amount ranging from about 2.0 wt. % to about 4.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 10.0 (see col. 3, II. 12-15, col. 4, II. 1-5).
Ryles further teaches with respect to claim 11, wherein the peroxide source is present in an amount ranging from about 0.5 wt. % to about 2.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 9.0 to about 10.0 (see col. 3, II. 12-15, col. 4, II. 1-5).
Ryles further teaches with respect to claim 13, wherein the peroxide source is present in an amount ranging from about 0.05 wt. % to about 0.2 wt. % based on the total weight of the whitening gel and the second pH ranges from about 8.0 to about 10.5 (see col. 3, II. 12-15, col. 4, II. 1-5). 28.
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Tessarotto/Johansson with the claimed peroxide concentrations and second pH as taught by Ryles in order to provide the desired whitening effect of the teeth. Such that it is known that the amount of peroxide and pH of the whitening gel effects the speed and effectiveness of the whitening process. It is further noted that the applicant does not teach the claimed range provides any unexpected results or advantages. It teaches several different ranges, all of which are alternative embodiments. It is noted that the applicant teaches the pH shift provided by the electrical current provides the surprising discovery of boosting whitening performance which is taught by the prior art of Tessarotto and further Ryles teaches a pH shift to boost whitening performance.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tessarotto (EP 1525857) in view of Johansson et al. (2017/0367943) as evidenced by Johansson (WO 2018/048393) as applied to claim 1 above, further in view of Nguyen (2006/0127837).
Tessarotto/Johansson teaches the invention as substantially claimed and discussed above, however, does not specifically teach the process further comprises c) irradiating the tooth with light having a wavelength ranging from about 390 nm to about 430 nm, more specifically about 410 nm.
Nguyen teaches a process for electrochemically whitening a tooth, the process comprising: a) contacting the tooth with a whitening gel having a first pH, the whitening gel located in a dental device comprising an electrode (see abstract, pars. 21, 31, 35, 37); b) flowing a current between the positive electrode and the negative electrode through the whitening gel to whiten the tooth (pars. 21, 34, 35, 37).
With respect to claims 2-3, Nguyen further teaches the process further comprises irradiation the tooth with light having a wavelength ranging from about 390 nm to about 430 nm (pars. 42, 54-55) and the wavelength of the light is about 410 nm (see par. 42). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the process of Tessarotto/Johansson to include the application of light as taught by Nguyen in order to enhance the electrochemical process (see par. 19).
Claim(s) 18-19, 31 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tessarotto (EP 1525857) in view of Johansson et al. (2017/0367943) in view of Nguyen (2006/0127837) as evidenced by Johansson (WO 2018/048393).
With respect to claim 18, Tessarotto teaches a process of electrochemically boosting tooth whitening performance of a whitening gel (par. 10), the process comprising: a) contacting the tooth with a whitening gel comprising a peroxide source ((see pars. 10, 45, 52, 62) and an electrolyte source (pars. 30, 42-43, 45), the whitening gel having a first pH (the whitening gel inherently has a pH), b) flowing a current between a positive electrode and a negative electrode through the whitening gel such that the whitening gel electrochemically transitions from the first pH to a second pH while the whitening gel is in contact with the tooth, wherein the transition from the first pH to the second pH occurs within a dental device while positioned in an oral cavity, wherein the second Ph and the first pH are different (such that the whitening gel undergoes a chemical reaction which changes the pH, see explanation below, abstract, pars. 27-30). Such that Tessarotto teaches electrolysis using a composition including sodium chloride. It is noted that electrolysis of the solution including the sodium chloride causes the reaction to form NaOH which is a strong base, thereby increasing the pH of the composition as claimed (i.e. being different). Further it is noted that the claimed process including the composition and applying the current is claimed, therefore, the outcome, i.e. the change in the pH, would be the same. It is noted that the applicant has not disclosed any additional steps of elements within the composition that causes the pH to change. As discussed in MPEP 2112.02, I; “When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process”. In this case the apparatus including the positive and negative electrodes are used to carry out the same process including applying a current to a whitening gel as claimed, therefore, the outcome, i.e. the change in the pH would inherently occur as a result of the chemical reaction due to the electrical current and the decomposition of the electrolyte. This chemical reaction is evidenced by Johansson in which a conductive whitening gel including a peroxide is placed in a container with a positive and negative electrode and a current is applied and flowed between the electrodes through the gel which results in an increase of the pH of the composition (see pars. 4, 6, 30, 32, 35). Tessarotto teaches the invention as substantially claimed and discussed above, however, does not specifically teach the first pH ranges from about 5 to about 6 and c) irradiating the tooth with light from a light source having a wavelength ranging from about 390 nm to about 430 nm.
Johansson teaches a process for electrochemically whitening a tooth, the process comprising a) contacting a tooth with a whitening gel having a first pH, the whitening gel located in a dental device comprising a positive electrode and a negative electrode (see pars. 18), flowing a current between the positive electrode and the negative electrode through the whitening gel to whiten the tooth such that the composition comprises a transition (i.e. a chemical reaction) and the transition occurs withing the dental device while positioned in an oral cavity (abstract, see pars. 12, 18), wherein the whitening gel comprises a peroxide (see par. 47) and an electrolyte (see pars. 37, 42) and wherein the first pH ranges from about 5 to about 6 (see par. 48). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the pH of the composition taught by Tessarotto to be within the claimed range taught by Johansson since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.04). Further it is noted that the amount of peroxide and pH of the whitening gel effects the speed and effectiveness of the whitening process. It is further noted that the applicant does not teach the claimed range provides any unexpected results or advantages. It teaches several different ranges, all of which are alternative embodiments. It is noted that the applicant teaches the pH shift provided by the electrical current provides the surprising discovery of boosting whitening performance which is taught by the prior art of Tessarotto. Tessarotto/Johansson teaches the invention as substantially claimed and discussed above, however, does not specifically teach c) irradiating the tooth with light from a light source having a wavelength ranging from about 390 nm to about 430 nm and wherein steps b) and c) at least partially overlap.
Nguyen teaches a process for electrochemically whitening a tooth, the process comprising: a) contacting the tooth with a whitening gel comprising a peroxide source, the whitening gel having a first pH (pars. 21, 34, 35, 37), b) flowing a current through the whitening gel to whiten the tooth (pars. 21, 34, 35, 37); and c) irradiating the tooth with light from a light source having a wavelength ranging from about 390 nm to about 430 nm and wherein steps b) and c) at least partially overlap (see pars. 42, 53-55, see fig. 7). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the process of Tessarotto/Johansson to include the application of light as taught by Nguyen in order to enhance the electrochemical process (see par. 19).
With respect to claim 19, Tessarotto/Johansson/Nguyen teaches the invention as substantially claimed and discussed above including Nguyen further teaching the wavelength of the light is about 410 nm (see par. 42).
With respect to claim 31, Tessarotto/Johansson/Nguyen teaches the invention as substantially claimed and discussed above, Tessarotto further teaches wherein the peroxide source is selected from the group consisting of hydrogen peroxide, urea peroxide, glyceryl peroxide, benzoyl peroxide (see par. 52).
With respect to claim 48, Tessarotto/Johansson/Nguyen teaches the invention as substantially claimed and discussed above, Tessarotto further teaches further comprising step b) for a plurality of treatment cycles, each treatment cycle comprising a treatment period spaced apart by a non-treatment period, and wherein the non-treatment period is greater than the treatment period (par. 12). It is noted that the combination of Tessarotto/Johansson/Nguyen would teach performing steps b) and c) for the plurality of treatment cycles.
Claim(s) 21, 23, 25, 27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tessarotto (EP 1525857) in view of Johansson et al. (2017/0367943) in view of Nguyen (2006/0127837) as evidenced by Johansson (WO 2018/048393) as applied to claim 18 above, and further in view of Ryles (5,902,568).
Tessarotto/Johansson/Nguyen teaches the invention as substantially claimed and discussed above including Tessarotto teaches a first pH, the whitening gel undergoing a chemical reaction to have a second, higher pH (see detailed explanation above), however, does not specifically teach wherein the peroxide source is present in an amount ranging from about 8.0 wt. % to about 10.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 8.0, wherein the peroxide source is present in an amount ranging from about 5.0 wt. % to about 7.0 wt. % based on the total weight of the whitening gel and the second pH is about 7.5, wherein the peroxide source is present in an amount ranging from about 2.0 wt. % to about 4.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 10.0, wherein the peroxide source is present in an amount ranging from about 0.5 wt. % to about 2.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 9.0 to about 10.0, wherein the peroxide source is present in an amount ranging from about 0.05 wt. % to about 0.2 wt. % based on the total weight of the whitening gel and the second pH ranges from about 8.0 to about 10.5.
Ryles teaches a whitening gel which has a first pH, the whitening gel undergoes a chemical reaction and has a second higher pH (see col. 1, II. 63-67, col. 2, II. 1-4, 31- 40, col. 3, II. 16-20, 56-56, col. 4, II. 1-5, such that the peroxide has a pH of 5-6 and when mixed it has a pH of 8-12).
Ryles further teaches with respect to claim 21, wherein the peroxide source is present in an amount ranging from about 8.0 wt. % to about 10.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 8.0 (see col. 3, II. 12-15, col. 4, II. 1-5).
Ryles further teaches with respect to claim 23, wherein the peroxide source is present in an amount ranging from about 5.0 wt. % to about 7.0 wt. % based on the total weight of the whitening gel and the second pH is about 7.5 (see col. 3, II. 12-15, col. 4, II. 1-5). It is noted that the applicant discloses "about" mean +/- 5%, therefore the pH of 8 taught by Ryles is "about" 7.5.
Ryles further teaches with respect to claim 25, wherein the peroxide source is present in an amount ranging from about 2.0 wt. % to about 4.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 7.0 to about 10.0 (see col. 3, II. 12-15, col. 4, II. 1-5).
Ryles further teaches with respect to claim 27, wherein the peroxide source is present in an amount ranging from about 0.5 wt. % to about 2.0 wt. % based on the total weight of the whitening gel and the second pH ranges from about 9.0 to about 10.0 (see col. 3, II. 12-15, col. 4, II. 1-5).
Ryles further teaches with respect to claim 29, wherein the peroxide source is present in an amount ranging from about 0.05 wt. % to about 0.2 wt. % based on the total weight of the whitening gel and the second pH ranges from about 8.0 to about 10.5 (see col. 3, II. 12-15, col. 4, II. 1-5). 28.
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Tessarotto/Johansson with the claimed peroxide concentrations and second pH as taught by Ryles in order to provide the desired whitening effect of the teeth. Such that it is known that the amount of peroxide and pH of the whitening gel effects the speed and effectiveness of the whitening process. It is further noted that the applicant does not teach the claimed range provides any unexpected results or advantages. It teaches several different ranges, all of which are alternative embodiments. It is noted that the applicant teaches the pH shift provided by the electrical current provides the surprising discovery of boosting whitening performance which is taught by the prior art of Tessarotto and further Ryles teaches a pH shift to boost whitening performance.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Tessarotto (EP 1525857) in view of Johansson et al. (2017/0367943) as evidenced by Johansson (WO 2018/048393) as applied to claim 1 above, and further in view of Jimenez et al. (2007/0212665).
Tessarotto/Johansson teaches the invention as substantially claimed and discussed above including the whitening gel having an electrical conductivity, however, does not specifically teach the whitening gel has an electrical conductivity ranging from about 10 mS/cm to about 80 mS/cm.
Jimenez teaches a process for electrochemically whitening a tooth, the process comprising a) contacting the tooth with a whitening gel having a first pH, providing a dental device having a positive electrode and a negative electrode (see abstract, pars. 5, 29, 42, 45), b) flowing a current between the positive electrode and the negative electrode through the whitening gel to whiten the tooth (pars. 26, 45, fig. 5), wherein the whitening gel comprises a peroxide source and an electrolyte source (pars. 36, 40, 42, abstract).
With respect to claim 49, Jimenez further teaches wherein the whitening gel has an electrical conductivity ranging from about 10 mS/cm to about 80 mS/cm (see par. 33, such that .4-10 S/m is 4-100 mS/cm which includes the claimed range of 10-80). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the electrically conductivity of the whitening gel as taught by Tessarotto/Johansson to be within the claimed range as taught by Jimenez in order to provide the desired reaction to create the desired whitening result. Further it is noted that it would have been obvious to one having ordinary skill in the art to modify the electrical conductivity of the whitening taught by Tessarotto/Johansson since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.04).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed June 5, 2026 have been fully considered but they are not persuasive. The applicant argues unexpected results; however, the applicant has not submitted evidence showing the unexpected results. It is noted that the applicant would need to compare the closest prior art with the current invention to show the claimed current invention provides unexpected results over the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art of Khawaled has been cited to teach a method of electrochemically treating teeth using a whitening gel comprising a peroxide and electrolyte and the current being within the claimed range of 10-40 mA (see par. 87, such that it does not exceed 30 mA).
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.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 7/8/2026
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