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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 September 2025 has been entered.
Response to Amendment
This office action is responsive to the documents filed on 29 September 2025. As directed by the amendment: none of the claims have been amended. Thus claims 16, 18-23, and 38-42 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 29 September 2025, with respect to the rejection(s) of independent claim 16 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Levine (US 2012/0183919 A1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16, 18-23, 38-40, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Nemeh et al. (US 2014/0093832 A1) in view of Levine (US 2012/0183919 A1) and Davidovitch et al. (US 2015/0343208 A1).
Regarding claim 16, Nemeh et al. discloses a device comprising: a mouthpiece (860 Fig 13) sized and configured to fit into a mouth of a human, the mouthpiece including first and second opposing U-shaped channels (See the channels in Fig 12B which are filled by mold pieces 830A and 830B) configured to receive one or more teeth of the human; and a plurality of electrodes (the portions of the wires 780A-780D Fig 9 that extend into the vertical walls of the channels Fig 12B in addition to the conductive elastomer at the tips, shown by the darkened portion of Fig 12B) being electrically coupled to a controller (the embodiment shown in Figs 7-13 would use the controller 112 shown in Fig 1) and being supported by the mouthpiece (As shown in Fig 12B the electrodes are molded into the mouthpiece), each electrode comprising one of an anodic electrode and a cathodic electrode (140, 150 Fig 1), at least a first electrode (780B Fig 9) disposed on a first surface (the buccal surface, 800B Fig 12A) of one of the U-shaped channels and a second electrode (780A Fig 9) being disposed on (the lingual surface, 800A Fig 12A) of the same U-shaped channel (the upper channel defined by 800A and 800B Fig 12A), the first surface and second surface being separated by a width of a top surface or a bottom surface of a bite plane (As shown in Fig 12A the surfaces of 800A and 800B are separated by the bite plane); wherein the mouthpiece comprises an encapsulant (the “non-conductive material” [0018], [0019]) encasing a flexible circuit ([0019] “The plurality of wires 780A,780B, 780C,780D are now encapsulated by the non-conductive material.”, when the non-conductive material is “a thermoplastic elastomer” as described in [0018], the circuit is made of the wires and would flex with the elastomeric encapsulant); wherein each electrode has a distal end coated with an electrically conductive polymer (the top and bottom surfaces shown darkened in Fig 12B and formed by the steps shown in Figs 12A-12B, [0121] “A conductive material is then inserted into each of the fill ports 760. The cavities are filled when material is coming out of all vents 770 in the second mold 810. The conductive material is preferably a thermosetting elastomer, but may also be a thermoplastic, a thermoplastic elastomer, or other polymer.”) and is electrically coupled to a connector through the flexible circuit ([0067] “Electrical conductors then connect these electrodes to an adjustable power supply”, the wires extending out of the mouthpiece would be electrically coupled to the power supply 110); and wherein each electrode is selectively programmable as an anode or a cathode by the controller ([0078] “Microcontroller 112 is also able to reverse the polarity of the cathodic electrodes 140 and anodic electrodes 150 by controlling the output of power source 116. This allows for dynamic changing of electrode polarity during treatment.”).
However, Nemeh et al. fails to disclose the flexible circuit is a flex circuit, and wherein each electrode is selectively programmable as an anode or a cathode by the controller separate and apart from any other electrode on the mouthpiece.
Levine teaches the circuit (22 Fig 2) is a flex circuit ([0033] “a flexible circuit board 22”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the circuit of Nemeh et al. to be a flex circuit as taught by Levine as it “may be bent by the user to adjust the orientation of the mouthpiece 10 to set the arch for comfort in the user's mouth” [0033], further a flex circuit allows components to be specifically positioned such as shown in Fig 2 before encapsulation to prevent the components from moving out of place during the manufacturing process.
Davidovitch et al. teaches each electrode is selectively programmable as an anode or a cathode by the controller separate and apart from any other electrode on the mouthpiece ([0049] “control circuitry 20 is arranged to select for each lingual electrode 40 and buccal electrode 50 to which voltage terminal of power source 30 to be coupled to”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Nemeh et al. to include the limitations as taught by Davidovitch et al. so the user will have more control over each electrode and the direction of current generated ([0058] “As a result, for each lingual electrode 40 and buccal electrode 50, control circuitry 20 will control whether a parallel current or an orthogonal current will be generated thereat and whether the particular electrode will act as an anode, i.e. outputting the current, or as a cathode, i.e. receiving the current.”).
Regarding claim 18, modified Nemeh et al. teaches the device according to claim 16. Modified Nemeh et al. further teaches wherein all electrodes disposed on the first surface of each U-shaped channel are selectively activatable to the same polarity (Nemeh et al.- [0065] “The electrodes on each side (lingual or buccal) of the gingiva are of the same polarity. […] The polarization of these electrodes may be reversed during treatment or in between treatments.”; further, in view of the modification with Davidovitch et al. the electrodes on the buccal surfaces of 800B and 800D are selectively activatable to either polarity including the same polarity).
Regarding claim 19, modified Nemeh et al. teaches the device according to claim 18. Modified Nemeh et al. further teaches wherein all electrodes disposed on the first surface of both U-shaped channels are selectively activatable to the same polarity (Nemeh et al.- [0065] “The electrodes on each side (lingual or buccal) of the gingiva are of the same polarity. […] The polarization of these electrodes may be reversed during treatment or in between treatments.”; further, in view of the modification with Davidovitch et al. the electrodes on the buccal surfaces of 800B and 800D are selectively activatable to either polarity including the same polarity).
Regarding claim 20, modified Nemeh et al. teaches the device according to claim 16. Modified Nemeh et al. further teaches wherein all electrodes disposed on the second surface of each U-shaped channel are selectively activatable to the same polarity (Nemeh et al.- [0065] “The electrodes on each side (lingual or buccal) of the gingiva are of the same polarity. […] The polarization of these electrodes may be reversed during treatment or in between treatments.”; further, in view of the modification with Davidovitch et al. the electrodes on the lingual surfaces of 800B and 800D are selectively activatable to either polarity including the same polarity).
Regarding claim 21, modified Nemeh et al. teaches the device according to claim 20. Modified Nemeh et al. further teaches wherein all electrodes disposed on the second surface of both U-shaped channels are selectively activatable to the same polarity (Nemeh et al.- [0065] “The electrodes on each side (lingual or buccal) of the gingiva are of the same polarity. […] The polarization of these electrodes may be reversed during treatment or in between treatments.”; further, in view of the modification with Davidovitch et al. the electrodes on the lingual surfaces of 800B and 800D are selectively activatable to either polarity including the same polarity).
Regarding claim 22, modified Nemeh et al. teaches the device according to claim 16. However, modified Nemeh et al. fails to teach wherein the plurality comprises at least eight electrodes.
Another embodiment of Nemeh et al. (Fig 4) teaches a plurality of electrodes comprises at least eight electrodes (4102 and 4202 Fig 4). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the plurality of electrodes of modified Nemeh et al. to comprise at least eight electrodes as taught by the alternate embodiment of Nemeh et al. as this “allows for multiple, discrete points of electrical contact within the mouth.” [0081]
Regarding claim 23, modified Nemeh et al. teaches the device according to claim 22. Modified Nemeh et al. further teaches wherein the at least eight electrodes comprise four pairs of electrodes disposed along surfaces of each U-shaped channel (As shown in Fig 4, eight of the electrodes 4102 and 4202 can be categorized into four pairs).
Regarding claim 38, modified Nemeh et al. teaches the device according to claim 16. Modified Nemeh et al. further teaches wherein the first and second U-shaped channels are at least partially defined by and separated by the bite plane (Nemeh et al.- As shown in Fig 12B, the bite plane defines the bottom of the top U shaped channel and the top of the bottom U shaped channel, it is what separates the two opposing channels).
Regarding claim 39, modified Nemeh et al. teaches the device according to claim 16. However, modified Nemeh et al. fails to teach wherein each electrode is further selectively programmable to a high-impedance mode.
Nemeh et al. teaches in an alternate embodiment wherein each electrode is further selectively programmable to a high-impedance mode ([0128] “electrical current intensity adjustment (e.g., based on sensed impedance between a cathode 940 and an anode 942”, while it is not referred to as a high-impedance mode, the sensed impedance resulting in a current intensity adjustment could be interpreted as comparatively higher and lower impedance and the resulting adjustment would include a comparatively high impedance mode). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Nemeh et al. to include the limitations as taught by the alternate embodiment of Nemeh et al. to “control the amount of electrical current delivered by the treatment device to provide a relatively constant current power source” [0126].
Regarding claim 40, modified Nemeh et al. teaches the device according to claim 16. Modified Nemeh et al. further teaches wherein the electrically conductive polymer comprises an electrically conductive silicone ([0064] “The electrodes may be fashioned out of any electrically-conductive material, including […] electrically-conductive silicone”).
Regarding claim 42, modified Nemeh et al. teaches the device according to claim 16. Modified Nemeh et al. further teaches wherein the first and second electrodes are selectively, simultaneously activatable in opposing polarities to establish a treatment zone (the electrodes on the buccal surfaces are selectively activatable simultaneously with the lingual electrodes, [0065] “Electrodes on opposite sides of the gingiva are of the opposite polarity. This allows the current to flow across the teeth and gums to the electrodes positioned on the transverse gingiva to complete the electrical circuit.”, the modification in view of Davidovitch et al. would result in each electrode being selectively activatable to the polarity).
Claim 41 are rejected under 35 U.S.C. 103 as being unpatentable over Nemeh et al. (US 2014/0093832 A1) in view of Levine (US 2012/0183919 A1), Davidovitch et al. (US 2015/0343208 A1), and Brawn et al. (US 9730780 B2).
Regarding claim 41, modified Nemeh et al. teaches the device according to claim 40. Modified Nemeh et al. further teaches further comprising: a strain relief portion extending outward from a center portion of an outside surface of the encapsulant (See the strain relief portion in annotated Fig 12B below).
However, modified Nemeh et al. fails to teach a plurality of cutouts extending through the encapsulant to allow air passage therethrough.
Brawn et al. teaches a plurality of cutouts extending through the encapsulant (3531, 3533, 3530 Fig 109) to allow air passage therethrough (the cutouts are fully capable of allowing air passage therethrough). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Nemeh et al. to include the limitations as taught by Brawn et al. to increase the flexibility of the outer flanges to better fit the user’s mouth (Col 77 lines 17-20).
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Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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