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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 12-20 in the reply filed on 07/07/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/30/2025 is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12, 13 and 17 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Carlson (EP 4061477 B1) herein referred to as “Carlson” (see Foreign reference attached from IDS filed 07/30/2025).
Regarding claim 12, Carlson discloses a system (apparatus 10, Figure 1), comprising: an electric field generator operable to generate an alternating current (AC) electrical signal having a frequency in a range from 50 kHz to 1 MHz (the signal generator 18 can be configured to generate an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz), Paragraph [0020]); one or more pair of transducer arrays configured to be electrically connected to the electric field generator and operable to generate an electric field based on the AC electrical signal (the apparatus 10 can comprise an electric field generator 12 and one or more electrode (e.g., transducer) arrays 104, each comprising a plurality of electrodes 106, The apparatus 10 can be configured to generate tumor treating fields (TTFields) (e.g., at 150 kHz) via the electric field generator 12 and deliver the TTFields to an area of the body through the one or more electrode arrays 104, Paragraph [0018], Figure 1); and a probe having a probe tip sized and dimensioned for insertion into a patient's body (an implantable device 100 can be positioned within a patient proximate to a target site, Paragraph [0027], at least one electrode 200 can be positioned so that an imaginary line between the implantable device and the at least one electrode 200 extends through the target site, and a second pair of electrodes that are skew or orthogonal to the imaginary line between the internal electrodes through the target region to the at least one electrode 200 can be desirable for applying the electric field from a different direction. Thus, modeling can be performed for generic tumor locations, for example, in different quadrants of the tissue. In further aspects, image scans for a given patient can be used to tailor individualized optimal field shaping (e.g., different directional paths of TTFields through the target site) by the various electrodes, Paragraph [0029]).
Regarding claim 13, Carlson discloses the system of claim 12, wherein the one or more pair of transducer arrays includes a first pair of transducer arrays and a second pair of transducer arrays (the apparatus 10 can comprise an electric field generator 12 and one or more electrode (e.g., transducer) arrays 104, each comprising a plurality of electrodes 106, Figure 1, Paragraph [0018]).
Regarding claim 17, Carlson discloses a kit (apparatus 10, Figure 1), comprising: an electric field generator operable to generate an alternating current (AC) electrical signal having a frequency in a range from 50 kHz to 1 MHz (the signal generator 18 can be configured to generate an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz), Paragraph [0020]); a pair of transducer arrays configured to be electrically connected to the electric field generator and operable to generate an electric field based on the AC electrical signal (the apparatus 10 can comprise an electric field generator 12 and one or more electrode (e.g., transducer) arrays 104, each comprising a plurality of electrodes 106, The apparatus 10 can be configured to generate tumor treating fields (TTFields) (e.g., at 150 kHz) via the electric field generator 12 and deliver the TTFields to an area of the body through the one or more electrode arrays 104, Paragraph [0018], Figure 1); and a probe having a probe tip operable to generate heat when disposed within the electric field (an implantable device 100 can be positioned within a patient proximate to a target site, Paragraph [0027], at least one electrode 200 can be positioned so that an imaginary line between the implantable device and the at least one electrode 200 extends through the target site, and a second pair of electrodes that are skew or orthogonal to the imaginary line between the internal electrodes through the target region to the at least one electrode 200 can be desirable for applying the electric field from a different direction. Thus, modeling can be performed for generic tumor locations, for example, in different quadrants of the tissue. In further aspects, image scans for a given patient can be used to tailor individualized optimal field shaping (e.g., different directional paths of TTFields through the target site) by the various electrodes, Paragraph [0029]).
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) 14-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Wallace (US 20170215936 A1) herein referred to as “Wallace”.
Regarding claim 14, Carlson discloses the system of claim 12.
Carlson discloses wherein the probe can comprises a thermistor (Optionally, the implantable device can comprise a temperature sensor (e.g., a thermocouple or thermistor), Paragraph [0050]).
However Carlson does not explicitly disclose wherein the thermistor is adjacent to the probe tip, wherein the thermistor is a variable resistor having a resistance that varies based on temperature.
Wallace discloses an electrosurgical device comprising a probe (Abstract) wherein the probe comprises a thermistor adjacent to the probe tip (thermistor 605, Paragraph [0073], Figure 6), wherein the thermistor is a variable resistor having a resistance that varies based on temperature (to monitor the temperature of the probe tip based on the resistor element, Paragraph [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Carlson to incorporate
the teachings of Wallace by including wherein the probe comprises a thermistor adjacent to the probe tip, wherein the thermistor is a variable resistor having a resistance that varies based on temperature. The motivation to do so being to monitor the temperature of the probe tip (Wallace, Paragraph [0073]).
Regarding claim 15, Carlson in view of Wallace discloses the system of claim 14.
Carlson further discloses wherein the system comprises a controller configured to communicate with the electric field generator and the thermistor (electric field generator 12 can comprise a processor 16 in communication with the signal generator 18, Paragraph [0019]), the controller having a processor and a non-transitory processor-readable medium storing processor-executable instructions that when executed by the processor (the electric field generator 12 can comprise control software 20 configured for controlling the performance of the processor 16 and the signal generator 18, Paragraph [0019]) cause the processor to: activate the electric field generator to supply the AC electrical signal to the one or more pair of transducer arrays (One or more outputs 24 of the electric field generator 12 can be coupled to one or more conductive leads 22 that are attached at one end thereof to the signal generator 18. The opposite ends of the conductive leads 22 are connected to the one or more electrode arrays 104 that are activated by the electric signals (e.g., waveforms), Paragraph [0021]), thereby generating an electric field between the one or more pair of transducer arrays such that the probe tip is disposed within the electric field for a period of time (The one or more outputs 24 can be operated sequentially. Output parameters of the signal generator 18 can comprise, for example, an intensity of the field, a frequency of the waves (e.g., treatment frequency), a maximum allowable temperature of the one or more electrode arrays 104, and/or combinations thereof. In some aspects, a temperature sensor 107 can be associated with each electrode array 104. Once a temperature sensor measures a temperature above a threshold, current to the electrode array associated with said temperature sensor can be stopped until a second, lower threshold temperature is sensed. The output parameters can be set and/or determined by the control software 20 in conjunction with the processor 16. After determining a desired (e.g., optimal) treatment frequency, the control software 20 can cause the processor 16 to send a control signal to the signal generator 18 that causes the signal generator 18 to output the desired treatment frequency to the one or more electrode arrays 104, Paragraph [0021], at least one electrode 200 can be positioned so that an imaginary line between the implantable device and the at least one electrode 200 extends through the target site, and a second pair of electrodes that are skew or orthogonal to the imaginary line between the internal electrodes through the target region to the at least one electrode 200 can be desirable for applying the electric field from a different direction. Thus, modeling can be performed for generic tumor locations, for example, in different quadrants of the tissue. In further aspects, image scans for a given patient can be used to tailor individualized optimal field shaping (e.g., different directional paths of TTFields through the target site) by the various electrodes, Paragraph [0029]).
Carlson does disclose wherein the processor receives a temperature reading to control the output of the electric field generator (Paragraph [0021]). However Carlson does not explicitly disclose wherein the processor receives a resistance reading indicative of the resistance of the thermistor in the probe tip.
Wallace discloses wherein the processor receives a resistance reading indicative of the resistance of the thermistor (similarly the probe tip 601 could include a standard resistive element 603, such as a Nichrome wire or a thick film, screened resistive ceramic element with a resistance of 3 ohms as an example, with a 10 volt D.C. power supply from the power supply, giving 33 watts of power. A feedback control circuit connects a thermistor 605 between the probe tip and the heating element's on-off switch 607, to monitor temperature of the probe tip and turn on and off the voltage of the resistor element in the probe tip so to maintain the probe tip as a desired temperature, such as at 120 degrees C, Paragraph [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Carlson to incorporate
the teachings of Wallace by including wherein the processor receives a resistance reading indicative of the resistance of the thermistor. The motivation to do so being to monitor the temperature of the probe tip so to maintain the probe tip at a desired temperature (Wallace, Paragraph [0073]).
Regarding claim 16, Carlson in view of Wallace discloses the system of claim 15.
Carlson discloses measuring a temperature above a threshold and deactivate the electric field generator to cease supplying the AC electrical signal to the one or more pair of transducer arrays (Paragraph [0021]). However Carlson does not explicitly disclose wherein the processor-executable instructions when executed by the processor further cause the processor to: determine whether a temperature at the probe tip is above a predetermined threshold based on the resistance reading; and responsive to a determination that the temperature at the probe tip is above the predetermined threshold, deactivate the electric field generator to cease supplying the AC electrical signal to the one or more pair of transducer arrays.
Wallace discloses wherein the processor-executable instructions when executed by the processor further cause the processor to: determine whether a temperature at the probe tip is above a predetermined threshold based on the resistance reading (similarly the probe tip 601 could include a standard resistive element 603, such as a Nichrome wire or a thick film, screened resistive ceramic element with a resistance of 3 ohms as an example, with a 10 volt D.C. power supply from the power supply, giving 33 watts of power. A feedback control circuit connects a thermistor 605 between the probe tip and the heating element's on-off switch 607, to monitor temperature of the probe tip and turn on and off the voltage of the resistor element in the probe tip so to maintain the probe tip as a desired temperature, such as at 120 degrees C, Paragraph [0073]); and responsive to a determination that the temperature at the probe tip is above the predetermined threshold (such as at 120 degrees C, Paragraph [0073]), deactivate the electric field generator to cease supplying the signal of the generator (A feedback control circuit connects a thermistor 605 between the probe tip and the heating element's on-off switch 607, to monitor temperature of the probe tip and turn on and off the voltage of the resistor element in the probe tip so to maintain the probe tip as a desired temperature, such as at 120 degrees C, Paragraph [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carlson to incorporate
the teachings of Wallace by including wherein the processor-executable instructions when executed by the processor further cause the processor to: determine whether a temperature at the probe tip is above a predetermined threshold based on the resistance reading; and responsive to a determination that the temperature at the probe tip is above the predetermined threshold, deactivate the electric field generator to cease supplying the AC electrical signal to the one or more pair of transducer arrays. The motivation to do so being to monitor the temperature of the probe tip so to maintain the probe tip at a desired temperature (Wallace, Paragraph [0073]).
Regarding claim 18, Carlson discloses the kit of claim 17.
Carlson discloses wherein the probe can comprise a thermistor (Optionally, the implantable device can comprise a temperature sensor (e.g., a thermocouple or thermistor), Paragraph [0050]).
However Carlson does not explicitly disclose wherein the probe further comprises a thermistor adjacent to the probe tip, wherein the thermistor is a variable resistor having a resistance that varies based on temperature.
Wallace discloses an electrosurgical device comprising a probe (Abstract) wherein the probe comprises a thermistor adjacent to the probe tip (thermistor 605, Paragraph [0073], Figure 6), wherein the thermistor is a variable resistor having a resistance that varies based on temperature (to monitor the temperature of the probe tip based on the resistor element, Paragraph [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Carlson to incorporate
the teachings of Wallace by including wherein the probe comprises a thermistor adjacent to the probe tip, wherein the thermistor is a variable resistor having a resistance that varies based on temperature. The motivation to do so being to monitor the temperature of the probe tip (Wallace, Paragraph [0073]).
Regarding claim 19, Carlson in view of Wallace discloses the kit of claim 18.
Carlson further discloses wherein the system comprises a controller configured to communicate with the electric field generator and the thermistor (electric field generator 12 can comprise a processor 16 in communication with the signal generator 18, Paragraph [0019]), the controller having a processor and a non-transitory processor-readable medium storing processor-executable instructions that when executed by the processor (the electric field generator 12 can comprise control software 20 configured for controlling the performance of the processor 16 and the signal generator 18, Paragraph [0019]) cause the processor to: activate the electric field generator to supply the AC electrical signal to the one or more pair of transducer arrays (One or more outputs 24 of the electric field generator 12 can be coupled to one or more conductive leads 22 that are attached at one end thereof to the signal generator 18. The opposite ends of the conductive leads 22 are connected to the one or more electrode arrays 104 that are activated by the electric signals (e.g., waveforms), Paragraph [0021]), thereby generating an electric field between the one or more pair of transducer arrays such that the probe tip is disposed within the electric field for a period of time (The one or more outputs 24 can be operated sequentially. Output parameters of the signal generator 18 can comprise, for example, an intensity of the field, a frequency of the waves (e.g., treatment frequency), a maximum allowable temperature of the one or more electrode arrays 104, and/or combinations thereof. In some aspects, a temperature sensor 107 can be associated with each electrode array 104. Once a temperature sensor measures a temperature above a threshold, current to the electrode array associated with said temperature sensor can be stopped until a second, lower threshold temperature is sensed. The output parameters can be set and/or determined by the control software 20 in conjunction with the processor 16. After determining a desired (e.g., optimal) treatment frequency, the control software 20 can cause the processor 16 to send a control signal to the signal generator 18 that causes the signal generator 18 to output the desired treatment frequency to the one or more electrode arrays 104, Paragraph [0021], at least one electrode 200 can be positioned so that an imaginary line between the implantable device and the at least one electrode 200 extends through the target site, and a second pair of electrodes that are skew or orthogonal to the imaginary line between the internal electrodes through the target region to the at least one electrode 200 can be desirable for applying the electric field from a different direction. Thus, modeling can be performed for generic tumor locations, for example, in different quadrants of the tissue. In further aspects, image scans for a given patient can be used to tailor individualized optimal field shaping (e.g., different directional paths of TTFields through the target site) by the various electrodes, Paragraph [0029]).
Carlson does disclose wherein the processor receives a temperature reading to control the output of the electric field generator (Paragraph [0021]). However Carlson does not explicitly disclose wherein the processor receives a resistance reading indicative of the resistance of the thermistor.
Wallace discloses wherein the processor receives a resistance reading indicative of the resistance of the thermistor (similarly the probe tip 601 could include a standard resistive element 603, such as a Nichrome wire or a thick film, screened resistive ceramic element with a resistance of 3 ohms as an example, with a 10 volt D.C. power supply from the power supply, giving 33 watts of power. A feedback control circuit connects a thermistor 605 between the probe tip and the heating element's on-off switch 607, to monitor temperature of the probe tip and turn on and off the voltage of the resistor element in the probe tip so to maintain the probe tip as a desired temperature, such as at 120 degrees C, Paragraph [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Carlson to incorporate
the teachings of Wallace by including wherein the processor receives a resistance reading indicative of the resistance of the thermistor. The motivation to do so being to monitor the temperature of the probe tip so to maintain the probe tip at a desired temperature (Wallace, Paragraph [0073]).
Regarding claim 20, Carlson in view of Wallace discloses the kit of claim 19. Carlson discloses measuring a temperature above a threshold and deactivate the electric field generator to cease supplying the AC electrical signal to the one or more pair of transducer arrays (Paragraph [0021]). However Carlson does not explicitly disclose wherein the processor-executable instructions when executed by the processor further cause the processor to: determine whether a temperature at the probe tip is above a predetermined threshold based on the resistance reading; and responsive to a determination that the temperature at the probe tip is above the predetermined threshold, deactivate the electric field generator to cease supplying the AC electrical signal to the one or more pair of transducer arrays.
Wallace discloses wherein the processor-executable instructions when executed by the processor further cause the processor to: determine whether a temperature at the probe tip is above a predetermined threshold based on the resistance reading (similarly the probe tip 601 could include a standard resistive element 603, such as a Nichrome wire or a thick film, screened resistive ceramic element with a resistance of 3 ohms as an example, with a 10 volt D.C. power supply from the power supply, giving 33 watts of power. A feedback control circuit connects a thermistor 605 between the probe tip and the heating element's on-off switch 607, to monitor temperature of the probe tip and turn on and off the voltage of the resistor element in the probe tip so to maintain the probe tip as a desired temperature, such as at 120 degrees C, Paragraph [0073]); and responsive to a determination that the temperature at the probe tip is above the predetermined threshold (such as at 120 degrees C, Paragraph [0073]), deactivate the electric field generator to cease supplying the signal of the generator (A feedback control circuit connects a thermistor 605 between the probe tip and the heating element's on-off switch 607, to monitor temperature of the probe tip and turn on and off the voltage of the resistor element in the probe tip so to maintain the probe tip as a desired temperature, such as at 120 degrees C, Paragraph [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carlson to incorporate
the teachings of Wallace by including wherein the processor-executable instructions when executed by the processor further cause the processor to: determine whether a temperature at the probe tip is above a predetermined threshold based on the resistance reading; and responsive to a determination that the temperature at the probe tip is above the predetermined threshold, deactivate the electric field generator to cease supplying the AC electrical signal to the one or more pair of transducer arrays. The motivation to do so being to monitor the temperature of the probe tip so to maintain the probe tip at a desired temperature (Wallace, Paragraph [0073]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cosman, JR. et al. (US 20150320481 A1) discloses an ablation device comprising a computer graphic control system and an automatic controller for control the signal output from the generator, and adapted to display on a real time graphic display a measured parameter related to the ablation process and visually monitor the variation of the parameter of the signal output that is controlled by the controller during the ablation process, Carlson et al . (US 20210196967 A1) discloses methods, systems, and apparatuses for managing temperatures induced by alternating electric fields, and Carlson et al. (US 20240299742 A1) discloses an implantable device to be positioned proximate to the target tissue site, wherein electric fields are generated with the implantable device.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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