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 .
Response to Amendment
The Amendment filed November 25, 2025 has been entered. Claims 1-9 and 21-26 remain pending in the application.
Response to Arguments
Applicant's arguments filed November 25, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments, see Remarks pages 9-11, filed November 25, 2025, with respect to the section 101 rejections have been fully considered and are persuasive. The section 101 rejection has been withdrawn. Claim 6 recites, “an apparatus for…” and the apparatus is configured for applying the current across the body and is not claiming the human body. Thus, the arguments are persuasive. The amendments to the claims have additionally addresses the section 112 rejections and the rejections have been withdrawn.
With respect to the arguments regarding the section 103 rejections, the arguments are not persuasive. In response to applicant's argument that Paulus is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the claims are directed towards an apparatus for applying alternating current between electrode elements configured to be on the body. The primary reference Wasserman and the secondary reference Paulus are both directed towards the same. Thus, the arguments are not persuasive.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wasserman et al. (US 2020/0155835 A1) (“Wasserman”) in view of Paulus et al. (US 2013/0345774 A1) (“Paulus”).
Regarding claim 6, Wasserman discloses An apparatus for applying alternating current between at least four first electrode elements positioned on a first side of a body and at least four second electrode elements positioned on a second side of the body, the apparatus comprising (Abstract and entire document, see at least FIG. 3 and associated paragraphs, see [0040], “Each of the transducer assemblies 31, 32 includes a plurality of electrode elements 52.” The left side 31 and right side 32 each have at least four electrode elements):
an AC signal generator that generates an AC output signal (FIG. 3 and [0039], “The AC signal generator 30 generates an AC signal”);
at least four first switches, each of which is configured to selectively apply the AC output signal to a respective one of the first electrode elements depending on a state of a respective control signal (FIG. 3 and [0040], “an electrically controlled switch (S) 56 is wired in series with each electrode element (E) 52” there are the same amount of switches as electrode elements and are each respectively coupled. [0040], “Each of the switches 56 is configured to switch on or off independently of other switches based on a state of a respective control input that arrives from the digital output of the respective controller 85.” Each switch is configured to selectively apply the AC output signal based on a control signal from the controller 85);
at least four second switches, each of which is configured to selectively apply the AC output signal to a respective one of the second electrode elements depending on a state of a respective control signal (each of the left half 31 and right half 32 have the electrode elements and switches and controller, see limitation above); and
a controller configured to control the plurality of first switches and the plurality of second switches so that (FIG. 3 and [0040], “Each of the switches 56 is configured to switch on or off independently of other switches based on a state of a respective control input that arrives from the digital output of the respective controller 85.” Each switch is configured to selectively apply the AC output signal based on a control signal from the controller 85)
in a first mode, the controller issues control signals that cause a majority of the first switches to apply the AC output signal to corresponding first electrode elements and that cause a majority of the second switches to apply the AC output signal to corresponding second electrode elements (FIG. 3 and [0049], “Assume, in the FIG. 3 embodiment, that the left and right transducer assemblies 31, 32 are positioned on the left and right sides of a subject's head, respectively; that all of the switches 56 in the transducer assemblies 31, 32 are in the ON state with a 100% duty cycle; and that the AC signal generator 30 is initially outputting 500 mA of current into the conductors 51.” All of the first switches and second switches apply the AC output signal), and
in a second mode, the controller issues control signals that (a) cause the second switches to apply the AC output signal to corresponding second electrode elements (FIG. 3 and [0049], “Assume, in the FIG. 3 embodiment, that the left and right transducer assemblies 31, 32 are positioned on the left and right sides of a subject's head, respectively; that all of the switches 56 in the transducer assemblies 31, 32 are in the ON state with a 100% duty cycle; and that the AC signal generator 30 is initially outputting 500 mA of current into the conductors 51.” the second switches apply the AC output signal to the electrode elements)
wherein in the first mode the AC output signal has a frequency between 100 and 500 kHz (FIG. 3 and [0039], “The AC signal generator 30 generates an AC signal (e.g. a 200 kHz sine wave) between the two terminals of each of those outputs in an alternating sequence (e.g., activating OUT1 for 1 sec., then activating OUT2 for one sec., in an alternating sequence).”)and
Wasserman fails to disclose (b) sequentially cause different ones or subsets of the first switches to apply the AC output signal to corresponding first electrode elements, and
(c) sequentially receive impedance measurements corresponding to respective combinations of the first electrode elements and second electrode elements,
in the second mode the AC output signal has a frequency below 20 kHz.
However, in the same field of endeavor, Paulus teaches (b) sequentially cause different ones or subsets of the first switches to apply the AC output signal to corresponding first electrode elements ([0058], “A matrix switch 8 is arranged between the electrode arrangement 3 and function generators 2a, 2b and includes a matrix circuit with a total of twelve output terminals 14 which are each assigned and electrically connected to an electrode 3a-3p.” and [0059], “The choice of the electrode pairs, the assignment between the electrode pairs and the function generators 2a, 2b, . . . and the control of the matrix switch 8 is performed by a controller 9.” And [0060], “Depending on the therapeutic approach, for instance, different alternating current signals which are provided by different function generators may be applied alternately, or only one alternating current signal of a function generator may be applied via several selected electrode pairs at the same time.” The controller can sequentially cause the switches to apply the AC signal to an electrode or an electrode pair or several pairs. It appears that all combinations or only one are considered, depending on the therapeutic approach.), and
(c) sequentially receive impedance measurements corresponding to respective combinations of the first electrode elements and second electrode elements ([0062], “The Electrical Impedance Tomography (EIT) is a non-invasive imaging technique by means of which a tomographic image of the brain is obtained on the basis of the conductivity distribution in the brain. Advantageously, the electrode pairs 3a-3p placed on the head 4 may be used as sensor elements, wherein a measuring current is supplied at one electrode pair, e.g. 3a/3i, and an electrical potential distribution can be determined at the other electrode pairs 3b-3h & 3j-3p.”),
in the second mode the AC output signal has a frequency below 20 kHz ([0062], “Thus, the impedance tomography makes it possible to obtain knowledge about the morphology and the function. The measuring currents used are higher-frequency alternating currents in the frequency range of 10 to 100 kHz” which teaches using frequency below 20 kHz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman to include (b) sequentially cause different ones or subsets of the first switches to apply the AC output signal to corresponding first electrode elements, and (c) sequentially receive impedance measurements corresponding to respective combinations of the first electrode elements and second electrode elements, in the second mode the AC output signal has a frequency below 20 kHz as taught by Paulus to provide feedback and adapt to improve the stimulation ([0063], “According to an inventive approach it is possible to use the process of the impedance tomography as a feedback analysis of the inventive stimulation. This means that the alternating current stimulation is triggered, and the resistance is determined at the same time. The stimulation excites the nerve cells, causing the resistance to become smaller. The stimulation intensity and/or the frequency can then be adapted correspondingly.”).
Regarding claim 7, Wasserman as modified discloses The apparatus of claim 6, Wasserman further discloses wherein in the second mode the controller issues control signals that (a) cause the second switches to apply the AC output signal to corresponding second electrode elements (FIG. 3 and [0049], “Assume, in the FIG. 3 embodiment, that the left and right transducer assemblies 31, 32 are positioned on the left and right sides of a subject's head, respectively; that all of the switches 56 in the transducer assemblies 31, 32 are in the ON state with a 100% duty cycle; and that the AC signal generator 30 is initially outputting 500 mA of current into the conductors 51.” the second switches apply the AC output signal to the electrode elements)
Wasserman fails to disclose (b) sequentially cause each of the first switches in turn to apply the AC output signal to a corresponding individual first electrode element, and
(c) sequentially receive impedance measurements corresponding to respective combinations of individual first electrode elements and the second electrode elements.
However, in the same field of endeavor, Paulus teaches (b) sequentially cause each of the first switches in turn to apply the AC output signal to a corresponding individual first electrode element ([0058], “A matrix switch 8 is arranged between the electrode arrangement 3 and function generators 2a, 2b and includes a matrix circuit with a total of twelve output terminals 14 which are each assigned and electrically connected to an electrode 3a-3p.” and [0059], “The choice of the electrode pairs, the assignment between the electrode pairs and the function generators 2a, 2b, . . . and the control of the matrix switch 8 is performed by a controller 9.” And [0060], “Depending on the therapeutic approach, for instance, different alternating current signals which are provided by different function generators may be applied alternately, or only one alternating current signal of a function generator may be applied via several selected electrode pairs at the same time.” The controller can sequentially cause the switches to apply the AC signal to an electrode or an electrode pair or several pairs. It appears that all combinations or only one are considered, depending on the therapeutic approach.), and
(c) sequentially receive impedance measurements corresponding to respective combinations of individual first electrode elements and the second electrode elements ([0062], “The Electrical Impedance Tomography (EIT) is a non-invasive imaging technique by means of which a tomographic image of the brain is obtained on the basis of the conductivity distribution in the brain. Advantageously, the electrode pairs 3a-3p placed on the head 4 may be used as sensor elements, wherein a measuring current is supplied at one electrode pair, e.g. 3a/3i, and an electrical potential distribution can be determined at the other electrode pairs 3b-3h & 3j-3p.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman to include (b) sequentially cause each of the first switches in turn to apply the AC output signal to a corresponding individual first electrode element, and (c) sequentially receive impedance measurements corresponding to respective combinations of individual first electrode elements and the second electrode elements as taught by Paulus to provide feedback and adapt to improve the stimulation ([0063], “According to an inventive approach it is possible to use the process of the impedance tomography as a feedback analysis of the inventive stimulation. This means that the alternating current stimulation is triggered, and the resistance is determined at the same time. The stimulation excites the nerve cells, causing the resistance to become smaller. The stimulation intensity and/or the frequency can then be adapted correspondingly.”).
Regarding claim 8, Wasserman as modified discloses The apparatus of claim 7, Wasserman further discloses wherein the controller is further configured to control the plurality of first switches and the plurality of second switches so that in a third mode, the controller issues control signals that (a) cause the first switches to apply the AC output signal to corresponding first electrode elements (FIG. 3 and [0049], “Assume, in the FIG. 3 embodiment, that the left and right transducer assemblies 31, 32 are positioned on the left and right sides of a subject's head, respectively; that all of the switches 56 in the transducer assemblies 31, 32 are in the ON state with a 100% duty cycle; and that the AC signal generator 30 is initially outputting 500 mA of current into the conductors 51.” the first switches apply the AC output signal to the electrode elements)
Wasserman fails to disclose (b) sequentially cause each of the second switches in turn to apply the AC output signal to a corresponding individual second electrode element, and
(c) sequentially receive impedance measurements corresponding to respective combinations of individual second electrode elements and the first electrode elements.
However, in the same field of endeavor, Paulus teaches (b) sequentially cause each of the second switches in turn to apply the AC output signal to a corresponding individual second electrode element ([0058], “A matrix switch 8 is arranged between the electrode arrangement 3 and function generators 2a, 2b and includes a matrix circuit with a total of twelve output terminals 14 which are each assigned and electrically connected to an electrode 3a-3p.” and [0059], “The choice of the electrode pairs, the assignment between the electrode pairs and the function generators 2a, 2b, . . . and the control of the matrix switch 8 is performed by a controller 9.” And [0060], “Depending on the therapeutic approach, for instance, different alternating current signals which are provided by different function generators may be applied alternately, or only one alternating current signal of a function generator may be applied via several selected electrode pairs at the same time.” The controller can sequentially cause the switches to apply the AC signal to an electrode or an electrode pair or several pairs. It appears that all combinations or only one are considered, depending on the therapeutic approach.), and
(c) sequentially receive impedance measurements corresponding to respective combinations of individual second electrode elements and the first electrode elements ([0062], “The Electrical Impedance Tomography (EIT) is a non-invasive imaging technique by means of which a tomographic image of the brain is obtained on the basis of the conductivity distribution in the brain. Advantageously, the electrode pairs 3a-3p placed on the head 4 may be used as sensor elements, wherein a measuring current is supplied at one electrode pair, e.g. 3a/3i, and an electrical potential distribution can be determined at the other electrode pairs 3b-3h & 3j-3p.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman to include (b) sequentially cause each of the second switches in turn to apply the AC output signal to a corresponding individual second electrode element, and (c) sequentially receive impedance measurements corresponding to respective combinations of individual second electrode elements and the first electrode elements as taught by Paulus to provide feedback and adapt to improve the stimulation ([0063], “According to an inventive approach it is possible to use the process of the impedance tomography as a feedback analysis of the inventive stimulation. This means that the alternating current stimulation is triggered, and the resistance is determined at the same time. The stimulation excites the nerve cells, causing the resistance to become smaller. The stimulation intensity and/or the frequency can then be adapted correspondingly.”).
Regarding claim 9, Wasserman as modified discloses The apparatus of claim 6, Wasserman fails to disclose wherein in the first mode and based on the received impedance measurements, the controller is configured to issue a control signal to cause a reduction in current at one or more of the first electrode elements.
However, in the same field of endeavor, Paulus teaches wherein in the first mode and based on the received impedance measurements, the controller is configured to issue a control signal to cause a reduction in current at one or more of the first electrode elements ([0063], “According to an inventive approach it is possible to use the process of the impedance tomography as a feedback analysis of the inventive stimulation. This means that the alternating current stimulation is triggered, and the resistance is determined at the same time. The stimulation excites the nerve cells, causing the resistance to become smaller. The stimulation intensity and/or the frequency can then be adapted correspondingly.” Intensity or frequency or current can be increased or reduced based on the feedback analysis of the received impedance measurements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman to include wherein in the first mode and based on the received impedance measurements, the controller is configured to issue a control signal to cause a reduction in current at one or more of the first electrode elements as taught by Paulus to provide feedback and adapt to improve the stimulation ([0063], “According to an inventive approach it is possible to use the process of the impedance tomography as a feedback analysis of the inventive stimulation. This means that the alternating current stimulation is triggered, and the resistance is determined at the same time. The stimulation excites the nerve cells, causing the resistance to become smaller. The stimulation intensity and/or the frequency can then be adapted correspondingly.”).
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wasserman et al. (US 2020/0155835 A1) (“Wasserman”) in view of Paulus et al. (US 2013/0345774 A1) (“Paulus”) in further view of Ferree et al. (US 2014/0296935 A1) (“Ferree”).
Regarding claim 21, Wasserman as modified discloses The apparatus of claim 6, Wasserman as modified fails to disclose wherein the controller is further configured to compare the received impedance measurements to criteria, and to determine a condition of corresponding electrode elements based on the comparing.
However, in the same field of endeavor, Ferree teaches wherein the controller is further configured to compare the received impedance measurements to criteria, and to determine a condition of corresponding electrode elements based on the comparing ([0098], “For these reasons, electrode-skin contact monitor 184 monitors the electrode-skin impedance (obtained by dividing the anode-cathode voltage difference by the stimulation current, where the anode-cathode voltage difference is measured via means 188 in FIG. 1C and the stimulation current is measured by means 186 in FIG. 1C).” and [0103], “Electrode-skin contact detector 184 detects any "trip" condition (i.e., increased impedance) that is indicative of the degradation of the electrode-skin contact integrity due to electrode peeling (block 612).” The condition of the electrode is determined based on a comparison of the measured impedance to a criteria (interpreted as comparing to any criteria such as the impedance increasing)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman as modified to include wherein the controller is further configured to compare the received impedance measurements to criteria, and to determine a condition of corresponding electrode elements based on the comparing as taught by Ferree to ensure efficacy ([0015], “If the electrode-skin impedance becomes too high, the maximum current deliverable by the TENS stimulator may be lower than the desired therapeutic current intensity. To ensure therapeutic efficacy of the TENS device, the TENS device should measure and monitor the actual current delivered to the user in real-time”).
Regarding claim 22, Wasserman as modified discloses The apparatus of claim 6, Wasserman as modified fails to disclose wherein the controller is further configured to compare the received impedance measurements to a constant, and to determine a condition of corresponding electrode elements based on the comparing.
However, in the same field of endeavor, Ferree teaches wherein the controller is further configured to compare the received impedance measurements to a constant, and to determine a condition of corresponding electrode elements based on the comparing ([0098], “For these reasons, electrode-skin contact monitor 184 monitors the electrode-skin impedance (obtained by dividing the anode-cathode voltage difference by the stimulation current, where the anode-cathode voltage difference is measured via means 188 in FIG. 1C and the stimulation current is measured by means 186 in FIG. 1C).” and [0103], “Electrode-skin contact detector 184 detects any "trip" condition (i.e., increased impedance) that is indicative of the degradation of the electrode-skin contact integrity due to electrode peeling (block 612).” The condition of the electrode is determined based on a comparison of the measured impedance to a constant (interpreted as comparing to any constant such as the impedance increasing, would need to be compared to a value)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman as modified to include wherein the controller is further configured to compare the received impedance measurements to a constant, and to determine a condition of corresponding electrode elements based on the comparing as taught by Ferree to ensure efficacy ([0015], “If the electrode-skin impedance becomes too high, the maximum current deliverable by the TENS stimulator may be lower than the desired therapeutic current intensity. To ensure therapeutic efficacy of the TENS device, the TENS device should measure and monitor the actual current delivered to the user in real-time”).
Regarding claim 23, Wasserman as modified discloses The apparatus of claim 6, Wasserman as modified fails to disclose wherein the controller is further configured to compare the received impedance measurements to previous measured impedances, and to determine a condition of corresponding electrode elements based on the comparing.
However, in the same field of endeavor, Ferree teaches wherein the controller is further configured to compare the received impedance measurements to previous measured impedances, and to determine a condition of corresponding electrode elements based on the comparing ([0098], “For these reasons, electrode-skin contact monitor 184 monitors the electrode-skin impedance (obtained by dividing the anode-cathode voltage difference by the stimulation current, where the anode-cathode voltage difference is measured via means 188 in FIG. 1C and the stimulation current is measured by means 186 in FIG. 1C).” and [0103], “Electrode-skin contact detector 184 detects any "trip" condition (i.e., increased impedance) that is indicative of the degradation of the electrode-skin contact integrity due to electrode peeling (block 612).” The condition of the electrode is determined based on a comparison of the measured impedance to a previous measurement (such as the impedance increasing as compared to a previous impedance)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman as modified to include wherein the controller is further configured to compare the received impedance measurements to previous measured impedances, and to determine a condition of corresponding electrode elements based on the comparing as taught by Ferree to ensure efficacy ([0015], “If the electrode-skin impedance becomes too high, the maximum current deliverable by the TENS stimulator may be lower than the desired therapeutic current intensity. To ensure therapeutic efficacy of the TENS device, the TENS device should measure and monitor the actual current delivered to the user in real-time”).
Regarding claim 24, Wasserman as modified discloses The apparatus of claim 6, Wasserman as modified fails to disclose wherein the controller is further configured to compare the received impedance measurements to criteria, and to determine a condition of corresponding regions of skin based on the comparing.
However, in the same field of endeavor, Ferree teaches wherein the controller is further configured to compare the received impedance measurements to criteria, and to determine a condition of corresponding regions of skin based on the comparing ([0098], “For these reasons, electrode-skin contact monitor 184 monitors the electrode-skin impedance (obtained by dividing the anode-cathode voltage difference by the stimulation current, where the anode-cathode voltage difference is measured via means 188 in FIG. 1C and the stimulation current is measured by means 186 in FIG. 1C).” and [0103], “Electrode-skin contact detector 184 detects any "trip" condition (i.e., increased impedance) that is indicative of the degradation of the electrode-skin contact integrity due to electrode peeling (block 612).” The condition of the electrode is determined based on a comparison of the measured impedance to a criteria (interpreted as comparing to any criteria such as the impedance increasing)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman as modified to include wherein the controller is further configured to compare the received impedance measurements to criteria, and to determine a condition of corresponding regions of skin based on the comparing as taught by Ferree to ensure efficacy ([0015], “If the electrode-skin impedance becomes too high, the maximum current deliverable by the TENS stimulator may be lower than the desired therapeutic current intensity. To ensure therapeutic efficacy of the TENS device, the TENS device should measure and monitor the actual current delivered to the user in real-time”).
Regarding claim 25, Wasserman as modified discloses The apparatus of claim 6, Wasserman as modified fails to disclose wherein the controller is further configured to compare the received impedance measurements to a constant, and to determine a condition of corresponding regions of skin based on the comparing.
However, in the same field of endeavor, Ferree teaches wherein the controller is further configured to compare the received impedance measurements to a constant, and to determine a condition of corresponding regions of skin based on the comparing ([0098], “For these reasons, electrode-skin contact monitor 184 monitors the electrode-skin impedance (obtained by dividing the anode-cathode voltage difference by the stimulation current, where the anode-cathode voltage difference is measured via means 188 in FIG. 1C and the stimulation current is measured by means 186 in FIG. 1C).” and [0103], “Electrode-skin contact detector 184 detects any "trip" condition (i.e., increased impedance) that is indicative of the degradation of the electrode-skin contact integrity due to electrode peeling (block 612).” The condition of the skin is determined based on a comparison of the measured impedance to a constant (interpreted as comparing to any constant such as the impedance increasing, would need to be compared to a value)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman as modified to include wherein the controller is further configured to compare the received impedance measurements to a constant, and to determine a condition of corresponding regions of skin based on the comparing as taught by Ferree to ensure efficacy ([0015], “If the electrode-skin impedance becomes too high, the maximum current deliverable by the TENS stimulator may be lower than the desired therapeutic current intensity. To ensure therapeutic efficacy of the TENS device, the TENS device should measure and monitor the actual current delivered to the user in real-time”).
Regarding claim 26, Wasserman as modified discloses The apparatus of claim 6, Wasserman as modified fails to disclose wherein the controller is further configured to compare the received impedance measurements to previous measured impedances, and to determine a condition of corresponding regions of skin based on the comparing.
However, in the same field of endeavor, Ferree teaches wherein the controller is further configured to compare the received impedance measurements to previous measured impedances, and to determine a condition of corresponding regions of skin based on the comparing ([0098], “For these reasons, electrode-skin contact monitor 184 monitors the electrode-skin impedance (obtained by dividing the anode-cathode voltage difference by the stimulation current, where the anode-cathode voltage difference is measured via means 188 in FIG. 1C and the stimulation current is measured by means 186 in FIG. 1C).” and [0103], “Electrode-skin contact detector 184 detects any "trip" condition (i.e., increased impedance) that is indicative of the degradation of the electrode-skin contact integrity due to electrode peeling (block 612).” The condition of the skin is determined based on a comparison of the measured impedance to a previous measurement (such as the impedance increasing as compared to a previous impedance)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus as taught by Wasserman as modified to include wherein the controller is further configured to compare the received impedance measurements to previous measured impedances, and to determine a condition of corresponding regions of skin based on the comparing as taught by Ferree to ensure efficacy ([0015], “If the electrode-skin impedance becomes too high, the maximum current deliverable by the TENS stimulator may be lower than the desired therapeutic current intensity. To ensure therapeutic efficacy of the TENS device, the TENS device should measure and monitor the actual current delivered to the user in real-time”).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.T./Examiner, Art Unit 3791
/TSE W CHEN/ Supervisory Patent Examiner, Art Unit 3791