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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the preamble of the claims include a “computer-readable storage medium” and fails to state whether they are “non-transitory”. A “computer-readable storage medium” can be a compact disc or a carrier wave which covers a non-statutory embodiment and warrants a 101 rejection.
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.
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.
Claim(s) 1-4, 7, 8, 11, 13-15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shakour(WO 2017141257 A1) in view of Cosman(20170049513).
Regarding claim 1, Shakour discloses An electric field generating device, comprising: n electrodes, configured to surround a target biological tissue region in a set manner; wherein n is an integer not less than 3(In some embodiments, the control circuitry comprises a controller configured to analyze data indicative of the at least one desired target within the body region and determine a number n (n>l) and location of electrode elements in said electrodes' arrangement to define each of said pairs of first and second effective electrodes to be assigned in accordance with said desired target(see attached copy, page 5, paragraph 5)); an electrical signal generator, electrically connected to the n electrodes; and a control signal generator, electrically connected to the electrical signal generator, and configured to control the electrical signal generator to apply a first electrical signal to m electrodes of the n electrodes, and apply a second electrical signal to at least two electrodes of n-m electrodes, to generate an electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal(The system comprises an electrodes' arrangement configured to be placed in the vicinity of a body region to be stimulated; a signal generator configured to supply electric stimulation signals to the electrodes' arrangement; and a control circuitry connected to the signal generator and to the electrodes' arrangement; the electrodes' arrangement comprises a plurality of electrode elements arranged in a spaced-apart relationship and being connected to the signal generator, so as to define spatial resolution of stimulation; the control circuitry determines data indicative of a profile of a stimulating electric field to be produced by the electrodes' arrangement to stimulate at least one desired target in said body region, and selectively assign, for stimulating each target, at least one pair of first and second effective electrodes, each being formed by one or more of said electrode elements, and enable operation of each of said assigned effective electrodes by the signal generator to produce the stimulating electric field(see attached copy, abstract)). Shakour fails to disclose “configured to control the electrical signal generator to apply a first electrical signal to m electrodes of the n electrodes, and wherein a voltage of the second electrical signal is less than a voltage of the first electrical signal, 1≤m<n, and m is an integer”.
However, Cosman teaches “When controller 2027 switches to another set of bipolar electrodes, the voltage from unit 2011 can be changed to another value V2. That variation or change of the voltage output corresponding to different switch positions among the electrodes can be used to tailor the temperatures on the multiple electrodes so as to converge to a desired overall temperature distribution on the electrodes. [0080]. In another example of the present invention, a system for ablating tissue using a multiplexing system so that the output of a high frequency generator can be applied in a bipolar configuration across a first subgroup of n electrodes and a second subgroup of m electrodes that are subgroups of a total of N electrodes inserted into a patient's body, where N is an integer greater than two. A control system can vary the amplitude, time duration, and the distribution of n and m so that the respective temperatures of the N electrodes can each be held at a desired temperature[0023]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Shakour to include the voltage and integers of the electrode generator of Cosman. Doing so would specify the subgroup of electrodes as a part of the same larger group of electrodes for selective signaling and stimulation.
Regarding claim 2, Shakour in view of Cosman teaches the electric field generating device according to claim 1, wherein the electrical signal generator comprises: a first electrical signal generating circuit, electrically connected to the n electrodes, and configured to output the first electrical signal; and a second electrical signal generating circuit, electrically connected to the n electrodes and configured to output the second electrical signal(Shakour - Thus, according to a first broad aspect of the invention, there is provided an electric stimulation system, comprising: an electrodes' arrangement configured to be placed in the vicinity of a body region to be stimulated; a signal generator configured to supply electric stimulation signals to the electrodes' arrangement; and a control circuitry connected to the signal generator and to the electrodes' arrangement, wherein the electrodes' arrangement is configured for covering the body region and comprises a plurality of electrode elements arranged in a spaced-apart relationship and being connected to the signal generator, so as to define spatial resolution of stimulation; and the control circuitry is configured and operable to determine data indicative of a profile of a stimulating electric field to be produced by the electrodes' arrangement to stimulate at least one desired target in said body region, and selectively assign, for stimulating each target, at least one pair of first and second effective electrodes, each effective electrode being formed by one or more of said electrode elements of the electrodes' arrangement, and enable operation of each of said assigned effective electrodes by the signal generator to produce the stimulating electric field in accordance with said profile(see attached copy, page 5, paragraph 4)).
Regarding claim 3, Shakiur in view of Cosman teaches the electric field generating device according to claim 2, further comprising: a first switch assembly and a second switch assembly; wherein the first electrical signal generating circuit is electrically connected to the n electrodes through the first switch assembly, and the control signal generator is electrically connected to the first switch assembly; the second electrical signal generating circuit is electrically connected to the n electrodes through the second switch assembly, and the control signal generator is electrically connected to the second switch assembly; and the control signal generator is configured to control the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and control the second switch assembly to transmit the second electrical signal to at least two electrodes of n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal(Shakour - Reference is made to Fig. 2b, which illustrates another specific but not limiting example of the configuration and operation of a switching mechanism 201 implemented by a switching assembly 221 and connected to a stimulation driver 211, the controller 22 and electrode's arrangement via connection assembly 231. As exemplified, the switching assembly 221 includes a switches' arrangement 223 formed by a plurality of a first set of switches 223a-223c configured to be connected to a first set of electrodes via connection links 231a-231c respectively to controllably connect/disconnect the associated electrodes with port 225 to emulate a first effective electrode position and characteristics, while a second set of switches 223d-223f is configured to be connected to a second set of electrodes via links 231d-231f respectively to controllably connect/disconnect the associated electrodes with port 227 to emulate a second effective electrode position and characteristics. As shown, ports 225 and 227 are configured to be connected to the signal generator/driver 211 for obtaining an electric signal for stimulation, while being controlled by the controller 22(see attached copy, page 10, paragraph 4)).
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Regarding claim 4, Shakour in view of Cosman teaches the electric field generating device according to claim 3, wherein the first switch assembly comprises n first switch units; the second switch assembly comprises n second switch units; the n first switch units are electrically connected to the n electrodes respectively, and electrically connected to the first electrical signal generating circuit and the control signal generator; and the n second switch units are electrically connected to the n electrodes respectively, and electrically connected to the second electrical signal generating circuit and the control signal generator(Shakour - Reference is now made to Fig. 2a, which illustrates a specific but not limiting example of the configuration and operation of a switching mechanism 200. The switching mechanism is implemented by a switching assembly / circuitry 220 (24 in Fig. 1 A) which is connected to the signal generator / driver 210, and is also connected to the electrodes' arrangement (not shown here) via connection assembly 230. As exemplified in the figure, the switching assembly 220 includes a switches' arrangement 222 formed by a plurality of switches 222a-222d which are configured to be connected to a plurality of associated electrodes via links 230a-230d respectively. Each of the switches 222a-222d is controllably shifted (by the controller 22 of the control circuitry) between its operative positions and an inoperative position, such that the switch in its operative positions connects the associated electrode element to a first port 224 or a second port 226 of the signal generator / driver, and in the inoperative position disconnects the electrode from any of the driver ports. Ports 224 and 226 are configured to be connected to driver / signal generator 210 for obtaining (while being controlled by the control circuitry) an electric signal for stimulation(see attached copy, page 10, paragraph 2)).
Regarding claim 7, Shakour in view of Cosman teaches a control method for the electric field generating device according to claim 1, but Shakour fails to explicitly state comprising: controlling the electrical signal generator to apply a first electrical signal to m electrodes of the n electrodes, and apply a second electrical signal to at least two electrodes of n-m electrodes, to generate an electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal; wherein n is an integer not less than 3, 1≤m<n, m is an integer; wherein the electric field generating device comprises the electrical signal generator and the n electrodes that are electrically connected to each other; a voltage of the second electrical signal is less than a voltage of the first electrical signal.
However, Cosman teaches “In another example, referring to FIG. 1, the signal output from the generator 2011 can be chosen according to clinical needs and can be varied in coordination with the switching process controlled by 2027 to achieve a desired thermal distribution around the electrodes in accordance with clinical objectives. In one example, as the switched connections to the electrodes are being made, the voltage +V and −V from the output jacks + and − on unit 2011 can be adjusted to increase or decrease the heating on the connected electrodes so as to have the thermal distribution converge on a desired objective, and that objective can be to achieve a desired size of lesion volume or to modify, alter the shape of, enlarge, or modify the lesion volume. For example, as the unit 2027 switches to one set or combination of bipolar electrodes, the voltage output can be V1. When controller 2027 switches to another set of bipolar electrodes, the voltage from unit 2011 can be changed to another value V2. That variation or change of the voltage output corresponding to different switch positions among the electrodes can be used to tailor the temperatures on the multiple electrodes so as to converge to a desired overall temperature distribution on the electrodes. [0080]. In another example of the present invention, a system for ablating tissue using a multiplexing system so that the output of a high frequency generator can be applied in a bipolar configuration across a first subgroup of n electrodes and a second subgroup of m electrodes that are subgroups of a total of N electrodes inserted into a patient's body, where N is an integer greater than two. A control system can vary the amplitude, time duration, and the distribution of n and m so that the respective temperatures of the N electrodes can each be held at a desired temperature[0023]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Shakour to include the voltage and integers of the electrode generator of Cosman. Doing so would specify the subgroup of electrodes as a part of the same larger group of electrodes for selective signaling and stimulation.
Regarding claim 8, Shakour in view of Cosman teaches the control method for the electric field generating device according to claim 7, wherein controlling the electrical signal generator to apply the first electrical signal to m electrodes of the n electrodes, and apply the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling a first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling a second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal; wherein the electrical signal generator comprises a first electrical signal generating circuit and a second electrical signal generating circuit; wherein the electric field generating device further comprises the first switch assembly and the second switch assembly; the first switch assembly is electrically connected to the first electrical signal generating circuit, the control signal generator and n electrodes; the second switch assembly is electrically connected to the second electrical signal generating circuit, the control signal generator and n electrodes(Shakour - Reference is now made to Fig. 2a, which illustrates a specific but not limiting example of the configuration and operation of a switching mechanism 200. The switching mechanism is implemented by a switching assembly / circuitry 220 (24 in Fig. 1 A) which is connected to the signal generator / driver 210, and is also connected to the electrodes' arrangement (not shown here) via connection assembly 230. As exemplified in the figure, the switching assembly 220 includes a switches' arrangement 222 formed by a plurality of switches 222a-222d which are configured to be connected to a plurality of associated electrodes via links 230a-230d respectively. Each of the switches 222a-222d is controllably shifted (by the controller 22 of the control circuitry) between its operative positions and an inoperative position, such that the switch in its operative positions connects the associated electrode element to a first port 224 or a second port 226 of the signal generator / driver, and in the inoperative position disconnects the electrode from any of the driver ports. Ports 224 and 226 are configured to be connected to driver / signal generator 210 for obtaining (while being controlled by the control circuitry) an electric signal for stimulation( see attached copy, page 10, paragraph 2)).
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Regarding claim 11, Shakour in view of Cosman teaches the control method for the electric field generating device according to claim 8, but Shakour fails to explicitly disclose wherein m is 1, and controlling the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling the second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling n first switch units to be turned on sequentially according to a set order, to enable n electrodes to receive the first electrical signal sequentially according to the set order, synchronously controlling n second switch units to be turned off sequentially according to the set order, and synchronously controlling second switch units combinations to be turned on sequentially according to the set order, to enable electrode combinations corresponding to the second switch units combinations to receive the second electrical signal sequentially according to the set order; wherein each second switch units combination comprises at least two second switch units of n-1 second switch units that are not turned off; each electrode combination comprises at least two electrodes that do not receive the first electrical signal; wherein the first switch assembly comprises the n first switch units, and the second switch assembly comprises the n second switch units.
However, Cosman teaches “Electrodes E1, E2, E3, and E4 can be connected in a controlled way to the jacks + and − through the control unit 2027. Unit 2027 comprises switches designated S11, S12, S21, S22, S31, S32, S41, and S42 that enable the signal output to be switched among the electrodes. The control unit 2027 insures that the switches S11 and S12 are not closed at the same time to prevent shorting out of the outputs + and −. The same is true for the other switch pairs S21 and S22, S31 and S32, and S41 and S42. The unit 2027 can switch any combination of bipolar pairs of electrodes across the outputs + and − according to a control algorithm or electronic sequence control in unit 2027. For example, closing S11 and S22 will put output + on E1 and − on E2. Or, for example, closing S11 and S21 and closing S32 and S42 will put the + output on E1 and E2 and the − output on E3 and E4. In this way, the bipolar output + and − from generator 2011 can be put across any combination of pairs of the electrodes E1, E2, E3, E4[0076]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Shakour to include the sequential switches of the electrode generator of Cosman. Doing so would specify the signaling to the switching circuits at a specific rate to target certain areas of tissue.
Regarding claim 13, Shakour in view of Cosman teaches the control method for the electric field generating device according to claim 7, but Shakour fails to disclose wherein the first electrical signal applied by the electrical signal generator to m electrodes of n electrodes is a high voltage signal, and the second electrical signal applied by the electrical signal generator to at least two electrodes of n-m electrodes is controlled to be a low voltage signal.
However, Cosman teaches “In another example, referring to FIG. 1, the signal output from the generator 2011 can be chosen according to clinical needs and can be varied in coordination with the switching process controlled by 2027 to achieve a desired thermal distribution around the electrodes in accordance with clinical objectives. In one example, as the switched connections to the electrodes are being made, the voltage +V and −V from the output jacks + and − on unit 2011 can be adjusted to increase or decrease the heating on the connected electrodes so as to have the thermal distribution converge on a desired objective, and that objective can be to achieve a desired size of lesion volume or to modify, alter the shape of, enlarge, or modify the lesion volume. For example, as the unit 2027 switches to one set or combination of bipolar electrodes, the voltage output can be V1. When controller 2027 switches to another set of bipolar electrodes, the voltage from unit 2011 can be changed to another value V2. That variation or change of the voltage output corresponding to different switch positions among the electrodes can be used to tailor the temperatures on the multiple electrodes so as to converge to a desired overall temperature distribution on the electrodes[0080]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Shakour to include the voltage values electrode generator of Cosman. Doing so would specify the different voltage values of the first and second signal to ensure effective stimulation treatment.
Regarding claim 14, Shakour discloses a computer-readable storage medium having a computer program stored thereon, the computer program implementing, when executed by a processor, following steps of a control method for an electric field generating device: controlling the electrical signal generator to apply a first electrical signal to m electrodes of the n electrodes, and apply a second electrical signal to at least two electrodes of n-m electrodes, to generate an electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal(In some embodiments, the control circuitry comprises a controller configured to analyze data indicative of the at least one desired target within the body region and determine a number n (n>l) and location of electrode elements in said electrodes' arrangement to define each of said pairs of first and second effective electrodes to be assigned in accordance with said desired target( see attached copy, page 5, paragraph 5). The system comprises an electrodes' arrangement configured to be placed in the vicinity of a body region to be stimulated; a signal generator configured to supply electric stimulation signals to the electrodes' arrangement; and a control circuitry connected to the signal generator and to the electrodes' arrangement; the electrodes' arrangement comprises a plurality of electrode elements arranged in a spaced-apart relationship and being connected to the signal generator, so as to define spatial resolution of stimulation; the control circuitry determines data indicative of a profile of a stimulating electric field to be produced by the electrodes' arrangement to stimulate at least one desired target in said body region, and selectively assign, for stimulating each target, at least one pair of first and second effective electrodes, each being formed by one or more of said electrode elements, and enable operation of each of said assigned effective electrodes by the signal generator to produce the stimulating electric field(see attached copy, abstract);but fails to disclose wherein n is an integer not less than 3, 1≤m<n, m is an integer; wherein the electric field generating device comprises the electrical signal generator and the n electrodes that are electrically connected to each other; a voltage of the second electrical signal is less than a voltage of the first electrical signal.
However, Cosman teaches “In another example, referring to FIG. 1, the signal output from the generator 2011 can be chosen according to clinical needs and can be varied in coordination with the switching process controlled by 2027 to achieve a desired thermal distribution around the electrodes in accordance with clinical objectives. In one example, as the switched connections to the electrodes are being made, the voltage +V and −V from the output jacks + and − on unit 2011 can be adjusted to increase or decrease the heating on the connected electrodes so as to have the thermal distribution converge on a desired objective, and that objective can be to achieve a desired size of lesion volume or to modify, alter the shape of, enlarge, or modify the lesion volume. For example, as the unit 2027 switches to one set or combination of bipolar electrodes, the voltage output can be V1. When controller 2027 switches to another set of bipolar electrodes, the voltage from unit 2011 can be changed to another value V2. That variation or change of the voltage output corresponding to different switch positions among the electrodes can be used to tailor the temperatures on the multiple electrodes so as to converge to a desired overall temperature distribution on the electrodes. [0080]. In another example of the present invention, a system for ablating tissue using a multiplexing system so that the output of a high frequency generator can be applied in a bipolar configuration across a first subgroup of n electrodes and a second subgroup of m electrodes that are subgroups of a total of N electrodes inserted into a patient's body, where N is an integer greater than two. A control system can vary the amplitude, time duration, and the distribution of n and m so that the respective temperatures of the N electrodes can each be held at a desired temperature.[0023]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Shakour to include the voltage and integers of the electrode generator of Cosman. Doing so would specify the subgroup of electrodes as a part of the same larger group of electrodes for selective signaling and stimulation.
Regarding claim 15, Shakour in view of Cosman teaches the computer-readable storage medium according to claim 14, wherein controlling the electrical signal generator to apply the first electrical signal to m electrodes of the n electrodes, and apply the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling a first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling a second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal; wherein the electrical signal generator comprises a first electrical signal generating circuit and a second electrical signal generating circuit; wherein the electric field generating device further comprises the first switch assembly and the second switch assembly; the first switch assembly is electrically connected to the first electrical signal generating circuit, the control signal generator and n electrodes; the second switch assembly is electrically connected to the second electrical signal generating circuit, the control signal generator and n electrodes(Shakour - Reference is now made to Fig. 2a, which illustrates a specific but not limiting example of the configuration and operation of a switching mechanism 200. The switching mechanism is implemented by a switching assembly / circuitry 220 (24 in Fig. 1 A) which is connected to the signal generator / driver 210, and is also connected to the electrodes' arrangement (not shown here) via connection assembly 230. As exemplified in the figure, the switching assembly 220 includes a switches' arrangement 222 formed by a plurality of switches 222a-222d which are configured to be connected to a plurality of associated electrodes via links 230a-230d respectively. Each of the switches 222a-222d is controllably shifted (by the controller 22 of the control circuitry) between its operative positions and an inoperative position, such that the switch in its operative positions connects the associated electrode element to a first port 224 or a second port 226 of the signal generator / driver, and in the inoperative position disconnects the electrode from any of the driver ports. Ports 224 and 226 are configured to be connected to driver / signal generator 210 for obtaining (while being controlled by the control circuitry) an electric signal for stimulation.( see attached copy, page 10, paragraph 2)).
Regarding claim 18, Shakour in view of Cosman teaches the computer-readable storage medium according to claim 15, but Shakour fails to teach wherein m is 1, and controlling the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling the second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling n first switch units to be turned on sequentially according to a set order, to enable n electrodes to receive the first electrical signal sequentially according to the set order, synchronously controlling n second switch units to be turned off sequentially according to the set order, and synchronously controlling second switch units combinations to be turned on sequentially according to the set order, to enable electrode combinations corresponding to the second switch units combinations to receive the second electrical signal sequentially according to the set order; wherein each second switch units combination comprises at least two second switch units of n-1 second switch units that are not turned off; each electrode combination comprises at least two electrodes that do not receive the first electrical signal; wherein the first switch assembly comprises the n first switch units, and the second switch assembly comprises the n second switch units.
However, Cosman teaches the computer-readable storage medium according to claim 15, wherein m is 1, and controlling the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling the second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling n first switch units to be turned on sequentially according to a set order, to enable n electrodes to receive the first electrical signal sequentially according to the set order, synchronously controlling n second switch units to be turned off sequentially according to the set order, and synchronously controlling second switch units combinations to be turned on sequentially according to the set order, to enable electrode combinations corresponding to the second switch units combinations to receive the second electrical signal sequentially according to the set order; wherein each second switch units combination comprises at least two second switch units of n-1 second switch units that are not turned off; each electrode combination comprises at least two electrodes that do not receive the first electrical signal; wherein the first switch assembly comprises the n first switch units, and the second switch assembly comprises the n second switch units(Electrodes E1, E2, E3, and E4 can be connected in a controlled way to the jacks + and − through the control unit 2027. Unit 2027 comprises switches designated S11, S12, S21, S22, S31, S32, S41, and S42 that enable the signal output to be switched among the electrodes. The control unit 2027 insures that the switches S11 and S12 are not closed at the same time to prevent shorting out of the outputs + and −. The same is true for the other switch pairs S21 and S22, S31 and S32, and S41 and S42. The unit 2027 can switch any combination of bipolar pairs of electrodes across the outputs + and − according to a control algorithm or electronic sequence control in unit 2027. For example, closing S11 and S22 will put output + on E1 and − on E2. Or, for example, closing S11 and S21 and closing S32 and S42 will put the + output on E1 and E2 and the − output on E3 and E4. In this way, the bipolar output + and − from generator 2011 can be put across any combination of pairs of the electrodes E1, E2, E3, E4[0076]).
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Shakour to include the sequential switches of the electrode generator of Cosman. Doing so would specify the signaling to the switching circuits at a specific rate to target certain areas of tissue.
Regarding claim 20, Shakour in view of Cosman teaches the computer-readable storage medium according to claim 14, but Shakour fails to disclose wherein the first electrical signal applied by the electrical signal generator to m electrodes of n electrodes is a high voltage signal, and the second electrical signal applied by the electrical signal generator to at least two electrodes of n-m electrodes is controlled to be a low voltage signal.
However, Cosman teaches “In another example, referring to FIG. 1, the signal output from the generator 2011 can be chosen according to clinical needs and can be varied in coordination with the switching process controlled by 2027 to achieve a desired thermal distribution around the electrodes in accordance with clinical objectives. In one example, as the switched connections to the electrodes are being made, the voltage +V and −V from the output jacks + and − on unit 2011 can be adjusted to increase or decrease the heating on the connected electrodes so as to have the thermal distribution converge on a desired objective, and that objective can be to achieve a desired size of lesion volume or to modify, alter the shape of, enlarge, or modify the lesion volume. For example, as the unit 2027 switches to one set or combination of bipolar electrodes, the voltage output can be V1. When controller 2027 switches to another set of bipolar electrodes, the voltage from unit 2011 can be changed to another value V2. That variation or change of the voltage output corresponding to different switch positions among the electrodes can be used to tailor the temperatures on the multiple electrodes so as to converge to a desired overall temperature distribution on the electrodes[0080]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Shakour to include the voltage values electrode generator of Cosman. Doing so would specify the different voltage values of the first and second signal to ensure effective stimulation treatment.
Claim(s) 5-6, 9-10, 12, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shakour in view of Cosman, and further in view of Chang(CN 109432601 A).
Regarding claim 5, Shakour in view of Cosman teaches the electric field generating device according to claim 1, but fail to disclose further comprising at least one of the following: the first electrical signal comprising an Alternating Current (AC) voltage signal, a pulse voltage signal or a square wave voltage signal; the second electrical signal comprising a constant voltage signal or a fluctuating voltage signal; an absolute value of a voltage amplitude of the first electrical signal being not less than 0V and not greater than 500V; an absolute value of a voltage amplitude of the second electrical signal being not less than 0 V and not greater than 10V; an intensity of the electric field being not less than 0.1V/cm and not greater than 10V/cm; a frequency of the electric field being not less than 50 kilohertz and not greater than 500 kilohertz; and m being 1.
However, Chang teaches “the device configuration signal. the signal source can provide an electric field signal (alternating signal), for example, a sine wave signal, a square wave signal, a spike signal, wherein the sine wave signal in single frequency, amplitude modulation, frequency modulation, frequency hopping randomly(Summary of the Invention, paragraph 24). Wherein the output electric field signal is a sine wave signal, 2 an electric field signal with higher frequency and frequency close to every output electric field signal for 0.1~3 seconds, pause for 0.1~3 seconds. frequency, field strength electric field 45 to 550KHz 0.1 to 11V/cm.(Embodiment 5, paragraph 5)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the alternating current of the electric field treatment of Chang. Doing so would specify the parameters of the voltage and field intensity to ensure proper tissue stimulation.
Regarding claim 6, Shakour in view of Cosman teaches the electric field generating device according to claim 5, but fails to disclose wherein the absolute value of the voltage amplitude of the second electrical signal is 0V, 1V or 5V.
However, Chang teaches “The device according to claim 5, wherein the time of the electric field signal of each signal source to a pair of electric field electrode output each time is 0.1~1 seconds, the peak voltage is 2 to 180V(claim 6)”. The range of maximum peak voltage includes the values claimed in claim 6, therefore Chang encompasses the claimed material.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the voltage values of the electric field treatment of Chang. Doing so would specify the range of voltage values for the second signal in the system to ensure proper tissue stimulation.
Regarding claim 9, Shakour in view of Cosman teaches the control method for the electric field generating device according to claim 8, wherein controlling the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling the second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling a first one of first switch units to transmit the first electrical signal to a first electrode of n electrodes, and controlling a second one of the first switch units to a nth one of the first switch units to be turned off; simultaneously controlling a first one of second switch units that is electrically connected to the first electrode to be turned off, and controlling at least two second switch units among a second one of the second switch units to an nth one of the second switch units to transmit the second electrical signal to at least two electrodes of n electrodes except the first electrode; wherein the first switch assembly comprises n first switch units, and the second switch assembly comprises n second switch units; the n first switch units comprise the first one of the first switch units to the nth one of the first switch units; the n second switch units comprise the first one of the second switch units to the nth one of the second switch units; the n electrodes comprise the first electrode to an nth electrode.
However, Chang teaches “the device in this embodiment may include 2 signal source, the signal source a and signal source b, wherein electric field electrode pair A1, A1 electric field electrode A2 via a switch KA1 in a and b with the signal source connection. electric field electrode A2 via the switch KA2 and the signal source a and b connecting the electric field electrode the electric field electrodes B1 B1, B2 via the switch KB1 and the signal source a and b connecting the electric field electrode B2 connecting to the signal source a and b via the switch KB2; electric field electrode the electric field electrodes C1 C1, C2 via the switch KC1 and the signal source in a and b connecting the electric field electrode C2 via the switch KC2 and the signal source a and b connecting the electric field electrode pair D1, D1 electric field electrode D2 via the switch KD1 and the signal source in a and b connecting the electric field electrodes D2 via a switch KD2 a and b with the signal source connection. Thus, by a control device (not shown) controlling the conduction of said switch on and off, the signal source a and the signal source b can output electric field signal to any one of the electric field electrode. For example, control device selecting the electric field electrode needs to output electric field of the signal A1, A2, the switch KA1 and switch KA2 connects any one signal source, for example, can signal a and signal source b, and also can be respectively connected with signal source a or b, signal source is connected with signal source output electric field signal to the corresponding electric field electrode. Therefore, to make the electric field electrode pair A1, A2 generates an electric field. control device to switch on and off the pair of switches through any selected corresponding to the electric field electrode, so as to randomly selecting the electric field electrode pair to randomly generated electric field. wherein the processing of control device capable of processing the same with embodiment 1(embodiment 2)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the alternating current of the electric field treatment of Chang. Doing so would specify the parameters of the voltage and field intensity to ensure proper tissue stimulation.
Regarding claim 10, Shakour in view Cosman teaches the control method for the electric field generating device according to claim 8, but fails to specify wherein controlling the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling the second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling a first one of first switch units to transmit the first electrical signal to a first electrode of n electrodes, and controlling a second one of the first switch units to an nth one of the first switch units to be turned off; simultaneously controlling a first one of second switch units that is electrically connected to the first electrode to be turned off, and synchronously controlling at least two second switch units among a second one of the second switch units to an nth one of the second switch units to be turned on sequentially according to a set order, to transmit the second electrical signal to at least two electrodes of n electrodes except the first electrode according to the set order.
However, Chang teaches “electric field electrode E1 connecting via a switch KF2 with the signal source e and f via a switch KF1 to a signal source e and f connection, electric field electrode F2 through switch KE2 and signal source e and f connecting the electric field electrode F1 through switch KE1 and signal source e and f connecting the electric field electrode E2. electric field signal control device electric field signal output to any of a counter electric field electrode 2 based on preset mode control signal source e and f, in unit time to each electrode the electric field output predetermined times. Specifically, the control device through the on-off of the control switch KE1 and the switch KE2 to control signal source e and f-direction electric field electrode pair E1, E2 output electric field signal, and a control device to control signal source e and f output electric field signal to electric field electrode pair F1, F2 through the on-off of the control switch KF1 and the switch KF2. the fast growth of the signal source can produce an electric field applied to the brain of the patient in diseased tissue T when the output electric field signal the electric field electrode to electric field electrode, the electric field for destroying and inhibiting patient of diseased tissue. wherein, the unit time is 0.1~12 seconds/cycle, the predetermined times is 1(embodiment 5)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the switching units of the electric field treatment of Chang. Doing so would specify the order and parameters of the switching unit sequence to control which areas of tissue are being stimulated.
Regarding claim 12, Shakour in view of Cosman and further in view of Chang teach the control method for the electric field generating device according to claim 10, but Shakour fails to disclose wherein a time interval for the second switch units to be turned on or off sequentially according to the set order is not less than 20 milliseconds and not greater than 500 milliseconds.
However, Chang teaches “comprising: simultaneously output electric field signal to electric field electrode, keeping for 0.1~3 to 2 seconds for any pair of output electric field signal electric field of the electrodes to 2 based on preset mode, thus, generating 2 while applying an electric field with different direction of the lesion tissue, these 2 different directions of electric field intersect in order to generate instantaneous low frequency electric field at the intersection, stimulating disease tissue, inhibiting their growth, then pause for 0.1~3 seconds the output electric field signal, after repeating said step(embodiment 5, paragraph 4)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the timing of the electric field treatment of Chang. Doing so would specify the order and timing of the switching signals to control which areas of tissue are being stimulated.
Regarding claim 16, Shakour in view of Cosman teaches the computer-readable storage medium according to claim 15, but fails to specify wherein controlling the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling the second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling a first one of first switch units to transmit the first electrical signal to a first electrode of n electrodes, and controlling a second one of the first switch units to a nth one of the first switch units to be turned off; simultaneously controlling a first one of second switch units that is electrically connected to the first electrode to be turned off, and controlling at least two second switch units among a second one of the second switch units to an nth one of the second switch units to transmit the second electrical signal to at least two electrodes of n electrodes except the first electrode; wherein the first switch assembly comprises the n first switch units, and the second switch assembly comprises the n second switch units; the n first switch units comprise the first one of the first switch units to the nth one of the first switch units; the n second switch units comprise the first one of the second switch units to the nth one of the second switch units; the n electrodes comprise the first electrode to an nth electrode.
However, Chang teaches “the device in this embodiment may include 2 signal source, the signal source a and signal source b, wherein electric field electrode pair A1, A1 electric field electrode A2 via a switch KA1 in a and b with the signal source connection. electric field electrode A2 via the switch KA2 and the signal source a and b connecting the electric field electrode the electric field electrodes B1 B1, B2 via the switch KB1 and the signal source a and b connecting the electric field electrode B2 connecting to the signal source a and b via the switch KB2; electric field electrode the electric field electrodes C1 C1, C2 via the switch KC1 and the signal source in a and b connecting the electric field electrode C2 via the switch KC2 and the signal source a and b connecting the electric field electrode pair D1, D1 electric field electrode D2 via the switch KD1 and the signal source in a and b connecting the electric field electrodes D2 via a switch KD2 a and b with the signal source connection. Thus, by a control device (not shown) controlling the conduction of said switch on and off, the signal source a and the signal source b can output electric field signal to any one of the electric field electrode. For example, control device selecting the electric field electrode needs to output electric field of the signal A1, A2, the switch KA1 and switch KA2 connects any one signal source, for example, can signal a and signal source b, and also can be respectively connected with signal source a or b, signal source is connected with signal source output electric field signal to the corresponding electric field electrode. Therefore, to make the electric field electrode pair A1, A2 generates an electric field. control device to switch on and off the pair of switches through any selected corresponding to the electric field electrode, so as to randomly selecting the electric field electrode pair to randomly generated electric field. wherein the processing of control device capable of processing the same with embodiment 1(embodiment 2)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the alternating current of the electric field treatment of Chang. Doing so would specify the parameters of the voltage and field intensity to ensure proper tissue stimulation.
Regarding claim 17, Shakour in view of Cosman teaches the computer-readable storage medium according to claim 15, but fails to specify wherein controlling the first switch assembly to transmit the first electrical signal to m electrodes of the n electrodes, and controlling the second switch assembly to transmit the second electrical signal to at least two electrodes of the n-m electrodes, to generate the electric field between the electrodes with the first electrical signal and the electrodes with the second electrical signal comprises: controlling a first one of first switch units to transmit the first electrical signal to a first electrode of n electrodes, and controlling a second one of the first switch units to an nth one of the first switch units to be turned off; simultaneously controlling a first one of second switch units that is electrically connected to the first electrode to be turned off, and synchronously controlling at least two second switch units among a second one of the second switch units to an nth one of the second switch units to be turned on sequentially according to a set order, to transmit the second electrical signal to at least two electrodes of n electrodes except the first electrode according to the set order.
However, Chang teaches “electric field electrode E1 connecting via a switch KF2 with the signal source e and f via a switch KF1 to a signal source e and f connection, electric field electrode F2 through switch KE2 and signal source e and f connecting the electric field electrode F1 through switch KE1 and signal source e and f connecting the electric field electrode E2. electric field signal control device electric field signal output to any of a counter electric field electrode 2 based on preset mode control signal source e and f, in unit time to each electrode the electric field output predetermined times. Specifically, the control device through the on-off of the control switch KE1 and the switch KE2 to control signal source e and f-direction electric field electrode pair E1, E2 output electric field signal, and a control device to control signal source e and f output electric field signal to electric field electrode pair F1, F2 through the on-off of the control switch KF1 and the switch KF2. the fast growth of the signal source can produce an electric field applied to the brain of the patient in diseased tissue T when the output electric field signal the electric field electrode to electric field electrode, the electric field for destroying and inhibiting patient of diseased tissue. wherein, the unit time is 0.1~12 seconds/cycle, the predetermined times is 1(embodiment 5)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the switching units of the electric field treatment of Chang. Doing so would specify the order and parameters of the switching unit sequence to control which areas of tissue are being stimulated.
Regarding claim 19, Shakour in view of Cosman and further in view of Chang teaches the computer-readable storage medium according to claim 17, but Shakour fails to disclose wherein a time interval for the second switch units to be turned on or off sequentially according to the set order is not less than 20 milliseconds and not greater than 500 milliseconds.
However, Chang teaches “comprising: simultaneously output electric field signal to electric field electrode, keeping for 0.1~3 to 2 seconds for any pair of output electric field signal electric field of the electrodes to 2 based on preset mode, thus, generating 2 while applying an electric field with different direction of the lesion tissue, these 2 different directions of electric field intersect in order to generate instantaneous low frequency electric field at the intersection, stimulating disease tissue, inhibiting their growth, then pause for 0.1~3 seconds the output electric field signal, after repeating said step(embodiment 5, paragraph 4)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Shakour to include the timing of the electric field treatment of Chang. Doing so would specify the order and timing of the switching signals to control which areas of tissue are being stimulated.
Conclusion
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796