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 .
Status of Claims
This office action is responsive to the amendment filed 10 June 2026.
Claims 1-3 and 8-10 are amended.
Claims 1-15 are presently pending in this application.
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.
Claims 1-5, 8-10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Flyash et al. (US Patent Publication No. 20180071065 A1), hereinafter Flyash, in view of Bacon et al. (US Patent Publication No. 20210370052 A1), hereinafter Bacon, in further view of Shalev (US Patent Publication No. 20030176892 A1), Leimkuehler et al. (US Patent Publication No. 20240408386 A1), hereinafter Leimkuehler, and Ivanoff et al. (US Patent Publication No. 20140162206 A1), hereinafter Ivanoff.
Regarding claim 1, Flyash discloses a device (Flyash: Fig. 1A, dental treatment apparatus 100) for electrokinetic delivery of a treatment agent into a hard dental tissue treatment site (electric current application; para. 0015), the device (100) comprising: a power source (Fig. 1A, power source 120) adapted to provide energy for delivery to a treatment electrode (Fig. 4, electrodes 140 and 140-1); the treatment electrode (140) adapted for placement proximate the hard dental tissue treatment site (electrodes 140 and 140-1 are placed near, but not touching, the teeth; para. 0087) and adapted to contact a treatment agent (active agent; para. 0047-0050) applied to the hard dental tissue treatment site (active agent is delivered to hard dental tissue treatment site; par. 0050); and a control system (Fig. 1A, portable unit 118) adapted to perform operations comprising: initiating a voltage application (through the DC current generator 124, a voltage is applied to the treatment site; para. 0086) over a predetermined time interval (dental treatment time; para 0065); if a predetermined condition is met, terminating voltage delivery (device is configured to stop treatment based on treatment parameters; para. 0075).
Flyash does not expressly disclose the treatment electrode is configured to deliver the treatment agent across or into the hard dental tissue treatment site via electrokinetic transport of the treatment agent.
Ivanoff teaches a treatment electrode (Ivanoff: IDE electrode; para. 0044) is configured to deliver a treatment agent (active agent is conductive fluoride ions; para. 0039, 0076, and 0083) across or into the hard dental tissue treatment site (enamel; para. 0041) via electrokinetic transport of the treatment agent (electroosmosis; para. 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash such that the treatment electrode is configured to deliver the treatment agent across or into the hard dental tissue treatment site via electrokinetic transport of the treatment agent as taught by Ivanoff in order to allow for increased uptake of the active agent (Ivanoff: para. 0044).
Flyash does not expressly disclose a return electrode.
Bacon teaches a return electrode (Bacon: Fig. 3(b), reference electrode 524; para. 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash to include a reference electrode as taught by Bacon in order to keep voltage and current from the treatment electrode at a constant value compared to the stable reference electrode (Bacon: para. 0029)
Flyash in view of Bacon does not expressly disclose initiating a voltage ramp from an initial voltage to a target treatment voltage over a predetermined time interval.
Shalev teaches initiating a voltage ramp (Shalev: voltage ramp up; para. 0153) from an initial voltage to a target treatment voltage (examiner interprets a voltage ramp to comprise an initial voltage and a target voltage, as a ramp must have a start and stop point in order to be considered a ramp) over a predetermined time interval (Fig. 5A, time T1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the operation of Flyash to include initiating a voltage ramp from an initial voltage to a target treatment voltage over a predetermined time interval as taught by Shalev in order to block neural activity in the affected tissue (para. 0144).
Flyash in view of Bacon and Shalev do not expressly disclose monitoring current delivered to the treatment electrode during the voltage ramp and a treatment period; and if the monitored current meets a predetermined condition, terminating voltage delivery.
Leimkuehler teaches monitoring current (Leimkuehler: controller 300 monitors delivery current; para. 0099) delivered to the treatment electrode (delivery electrode; para. 0100) during the voltage application and a treatment period (current and voltage delivery are monitored; para. 0132); and if the monitored current meets a predetermined condition, terminating voltage delivery (if the current detected is less the open circuit, or, if the current detected is more than the over current fault limit, stimulation will be stopped; para. 0102).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the operation of Flyash in view of Bacon and Shalev such that it included monitoring current delivered to the treatment electrode during the voltage ramp and a treatment period; and if the monitored current meets a predetermined condition, terminating voltage delivery as taught by Leimkuehler in order to prevent the stimulation from exceeding an overcurrent fault limit (Leimkuehler: para. 0099).
Regarding claim 2, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above, wherein the hard dental tissue treatment site comprises at least one of enamel, dentin, cementum, gingiva, or mucosa (Flyash: enamel; para. 0023).
Regarding claim 3, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above, wherein the treatment electrode (Flyash: 140) is adapted to contact a conductive agent (electrodes contact fluid or gel with suitable electrical conductivity; para. 0087) of the treatment agent (para. 0050) applied to the treatment site (the conductive agent is applied to the teeth; para. 0025).
Flyash in view of Bacon, Shalev, and Leimkuehler does not expressly disclose facilitating transport of the conductive agent across or into the hard dental tissue treatment site via at least one of electrophoresis and electroosmosis.
Ivanoff teaches facilitating transport of the conductive agent (active agent is conductive fluoride ions; para. 0039, 0076, and 0083) across or into the hard dental tissue treatment site (Ivanoff: enamel; para. 0041) via at least one of electrophoresis and electroosmosis (electroosmosis; para. 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash in view of Bacon, Shalev, and Leimkuehler such that it facilitates transport of the conductive agent across or into the hard dental tissue treatment site via at least one of electrophoresis and electroosmosis as taught by Ivanoff in order to allow for increased uptake of the active agent (Ivanoff: para. 0044).
Regarding claim 4, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above, wherein the conductive agent (Flyash: para. 0087) comprises a gel-formulated agent (conductive agent is a gel; para. 0087).
Regarding claim 5, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above, wherein the conductive agent (Flyash: para. 0087) is a tooth whitening agent (conductive agent is a tooth whitening agent; para. 0025).
Regarding claim 8, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, and Ivanoff does not expressly disclose further comprising an electrically insulating barrier adapted to be applied to a region adjacent the hard dental tissue treatment site.
Leimkuehler teaches an electrically insulating barrier (Leimkuehler: electrically insulative silicone; para. 0079) adapted to be applied to a region adjacent the hard dental tissue treatment site (the electrically conductive skeleton of the mouthpiece 100 is adjacent to the teeth; para. 0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash in view of Bacon, Shalev, and Ivanoff such that it included an electrically insulating barrier adapted to be applied to a region adjacent the treatment site as taught by Leimkuehler in order to electrically insulate electrodes from the user and other parts of the device (Leimkuehler: para. 0079).
Regarding claim 9, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above, wherein the region adjacent the hard dental tissue treatment site comprises gingival tissue (Flyash: treatment is applied to the dental arcade, which is adjacent to the gingival tissue; para. 0045).
Regarding claim 10, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, and Ivanoff does not expressly disclose the electrically insulating barrier is light-curable and adapted to conform to the region adjacent the treatment site.
Leimkuehler teaches an electrically insulating barrier (Leimkuehler: electrically insulative silicone; para. 0079) is light-curable (silicone as material is known to be light curable) and adapted to conform to the region adjacent the treatment site (Fig. 3, mouthpiece 100 is shaped to be received within a mouth of a user, which includes gingival tissue; para. 0078 and 0121).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash in view of Bacon, Shalev, and Ivanoff such that the electrically insulating barrier is light-curable and adapted to conform to the region adjacent the treatment site as taught by Leimkuehler in order to receive any teeth of a human (Leimkuehler: para. 0078) and to electrically insulate electrodes from the user and other parts of the device (Leimkuehler: para. 0079).
Regarding claim 15, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff discloses the device above.
Flyash in view of Bacon, Shalev, and Ivanoff does not expressly disclose the control system operations further comprise generating an alert indicating a treatment status or fault condition.
Leimkuehler teaches a control system operation comprising generating an alert indicating a fault condition (a stimulation or treatment status 314 is capable of a variety of colors to indicate various treatment conditions; para. 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash in view of Bacon, Shalev, and Ivanoff such that the control system operations further comprise generating an alert indicating a treatment status or fault condition as taught by Leimkuehler in order to provide the user with feedback on the status of the treatment (Leimkuehler: para. 0083).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff, in further view of Corn et al. (US Patent Publication No. 20230173263 A1), hereinafter Corn.
Regarding claim 6, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff does not expressly disclose the conductive agent is a remineralizing or desensitizing agent, which is selected from the group consisting of fluoride salts, zinc salts, calcium phosphate compounds, and potassium nitrate.
Corn teaches a conductive agent (Corn: polarizable agent; para. 0007) that is a remineralizing agent, which is a fluoride salt (Table of Agents & Indications, remineralization ions such as fluoride ions).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the conductive agent of Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff such that the conductive agent is a remineralizing or desensitizing agent, which is selected from the group consisting of fluoride salts, zinc salts, calcium phosphate compounds, and potassium nitrate as taught by Corn in order to remineralize the teeth during treatment (Corn: Table of Agents & Indications).
Regarding claim 7, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff does not expressly disclose the conductive agent is an antimicrobial or antibiotic agent, which is selected from the group consisting of chlorhexidine, triclosan, and a tetracycline-class compound.
Corn teaches a conductive agent (Corn: polarizable agent; para. 0007) that is an antibiotic agent, which is chlorhexidine (Table of Agents & Indications, antibiotics such as chlorhexidine).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the conductive agent of Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff such that the conductive agent is an antimicrobial or antibiotic agent, which is selected from the group consisting of chlorhexidine, triclosan, and a tetracycline-class compound as taught by Corn in order to reduce bacteria levels associated with periodontal disease (Corn: Table of Agents & Indications).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff, in further view of Waldstreicher et al. (US Patent Publication No. 20210236815 A1), hereinafter Waldstreicher, and Henley et al. (US Patent Publication No. 20030199808 A1), hereinafter Henley.
Regarding claim 11, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff does not expressly disclose confirming that the complete circuit is established comprises applying a low test voltage.
Waldstreicher teaches confirming that a complete circuit is established (Waldstreicher: indicate good or poor electrical contact; para. 0310) comprising applying a low test voltage (test pulse uses lower voltage than therapeutic delivery; para. 0310).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify operation of Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff such that confirming that the complete circuit is established comprises applying a low test voltage as taught by Waldstreicher in order to reduce deviations in tissue impedance response (Waldstreicher: para. 0310)
Flyash in view of Bacon, Shalev, Leimkuehler, Ivanoff, and Waldstreicher does not expressly disclose detecting that a resulting current exceeds a test threshold value.
Henley teaches detecting that a resulting current exceeds a test threshold value (Henley: after a self-diagnostic test, the device 300 monitors the current applied to the electrodes and checks if the current is measured above zero; para. 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the operation of Flyash in view of Bacon, Shalev, Leimkuehler, Ivanoff, and Waldstreicher such that it included detecting that a resulting current exceeds a test threshold value as taught by Henley in order to determine if the user is actively using the device and, if not, set device to an off state (Henley: para. 0062).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff, in further view of Henley.
Regarding claim 12, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff does not expressly disclose a current-limiting element adapted to limit an amount of current delivered to the treatment electrode.
Henley teaches a current-limiting element (Henley: Fig. 4, current limiter 416) adapted to limit an amount of current delivered to a treatment electrode (current limiter 416 provides safe upper limit for treatment current; para. 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff to include a current-limiting element adapted to limit an amount of current delivered to the treatment electrode as taught by Henley in order to prevent current leakage into the user (Henley: para. 0006).
Regarding claim 13, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff does not expressly disclose wherein the current-limiting element is selected from the group consisting of: a fixed resistor, a fuse, and a diode.
Henley teaches a current-limiting element (Henley: 416) is a resistor (current limiter 416 is a resistor; para. 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff such that the current-limiting element is selected from the group consisting of: a fixed resistor, a fuse, and a diode as taught by Henley in order to prevent current leakage into the user (Henley: para. 0006).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff, in further view of Babbage et al. (US Patent Publication No. 20240157070 A1), hereinafter Babbage.
Regarding claim 14, Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff disclose the device above.
Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff does not expressly disclose the device is adapted to interface only with components including an encoded connector, thereby restricting use to approved treatment conditions.
Babbage teaches a device (Babbage: Fig. 2A, base unit 50) that is adapted to interface only with components including an encoded connector (base unit 50 will only work with specific cables which have an encoded connection; para. 0967).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff such that the device is adapted to interface only with components including an encoded connector, thereby restricting use to approved treatment conditions as taught by Babbage in order to prevent unapproved third party devices to connect (para. 0967).
Response to Arguments
Applicant’s arguments, see page 8-9, filed 10 June 2026, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments, see page 9-11, filed 10 June 2026, with respect to the rejection of claims 1-15 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made to claim 1 in view of Flyash in view of Bacon, Shalev, Leimkuehler, and Ivanoff as cited above.
Conclusion
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 LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
Prosecution Insights