DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 08 August 2024 has been considered by the Examiner.
Claim Rejections - 35 USC § 103
3. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 1-2, 4, 7, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al. (US 2020/0338346 A1) in view of Shamir et al. (US 2022/0305277 A1).
Regarding claim 1, Schmidt teaches an implantable system for cancer treatment (the implanted medical device 500 is configured to treat a cancerous tumor [0044, 0057, 0059, FIG. 5]) comprising:
a therapy output circuit (the implanted medical device 500 comprises an electric field generating circuit [abstract, 0057]), wherein the therapy output circuit is configured to generate an electrical output for one or more electrodes to create one or more electric fields (the electric field generating circuit is configured to generate an electrical output for the electrodes 108 to create one or more electric fields [abstract, 0051, 0057, 0059]);
control circuitry (the implanted medical device 500 comprises a control circuitry [abstract, 0057, 0059]), wherein the control circuitry causes the therapy output circuit to generate the one or more electric fields at frequencies selected from a range of between 10 kHz to 1 MHz within a bodily tissue ([abstract, 0057, 0101]), wherein the one or more electric fields are effective to prevent and/or disrupt cellular mitosis in a cell ([0102]); and
a therapy zone temperature sensor (the implanted medical device 500 may comprise one or more temperature sensors 518 that are configured to measure the temperature of tissue at the site of the tumor 110 which is treated by the electric field [abstract, 0060-0062]);
wherein the implantable system is configured to measure temperature and/or record temperature data of a patient over time (the one or more temperature sensors 518 are configured to monitor the temperature of the tissue [0060-0062]. Furthermore, the one or more temperature sensors 518 may monitor the changes in temperature of the tissue throughout the duration of the treatment [0060-0062]); and
the temperature data comprising tissue temperatures (the temperature sensors 518 are configured to record the changes in the temperature of the tissue throughout the duration of the treatment [0060-0061, 0072]).
Although teaches the use of time stamps ([0093]) Schmidt does not explicitly teach the temperature data to include time stamps.
The prior art by Shamir is analogous to Schmidt, as they both teach the application of electric fields to region of interest (e.g., tumor) within the patient’s body [0070, 0074-0075]).
Shamir teaches the temperature data to include time stamps (the patient’s vital or physiological parameters (e.g., temperature) are recorded during a treatment session of inducing an electric field (e.g., tumor treating field) in the subject’s body [0074-0075]. Specifically, the patient’s vital or physiological parameters (e.g., temperature) are recorded over time and stored with time stamps [0032, 0040, 0074-0075]. Furthermore, the patient’s vital or physiological parameters (e.g., temperature) may be collected at regular time intervals (e.g., every second, five seconds, thirty seconds, one minute, five minutes, ten minutes, thirty minutes, an hour, two hours, four hours, etc.) [0074-0075]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Schmidt’s temperature data to include time stamps, as taught by Shamir. This modification is beneficial, as the time stamps will allow for tracking the exact time at which the temperature of the tissue changed during the treatment (see paragraphs [0032, 0040, 0074-0075]).
Regarding claim 2, Schmidt teaches wherein the control circuitry is configured to process the temperature data and modulate a therapy parameter based on the temperature data (the control circuitry receives the temperature data from the temperature sensors 518 to further modulate or adjust the frequencies of the electric fields ([0005, 0043, 0060]. Specifically, the control circuitry monitors the temperature data and modulates the parameters (e.g., frequency) of the electric field to prevent thermal destruction of the tissue [0005, 0043]).
Regarding claim 4, Schmidt teaches the therapy parameter comprising at least one selected from the group consisting of a field strength ([0108-0109]) and a therapy vector ([0059, 0084]).
Regarding claim 7, Schmidt teaches wherein the implantable system is configured to index the temperature data based on one or more of direct or indirect measurement (the temperature sensor 518 can be configured to measure the temperature of the tissue at the site of the tumor 110 [0060]).
Regarding claim 16, Schmidt teaches wherein the implantable system comprises a stimulation lead (the implantable medical device 500 comprises a plurality of electrodes 108 that are disposed on the stimulation leads 106 [0057-0059]), the stimulation lead comprising an electrode (the plurality of electrodes 108 are disposed on the stimulation leads 106 [0057-0059]); and
wherein the therapy zone temperature sensor is configured to measure a temperature at a site offset from a surface of the electrode (figure 5 illustrates the temperature sensor 518 being offset from the electrodes 108 [0060, 0063, FIG. 5]. Specifically, this allows the temperature sensor 518 to measure the temperature of a target tissue site which is near or offset from the electrodes 108 [0063, FIG. 5]).
Regarding claim 17, Schmidt teaches wherein the implantable system compensates for the offset in measuring or estimating tissue temperatures (as stated previously in claim 16, figure 5 illustrates the temperature sensor 518 being offset from the electrodes 108 [0060, 0063, FIG. 5]. Specifically, this allows the temperature sensor 518 to measure the temperature of a target tissue site which is near or offset from the electrodes 108 [0063, FIG. 5]).
5. Claim 3 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al. in view of Shamir et al., further in view of Wasserman et al. (US 2020/0269043 A1).
Regarding claim 3, Schmidt in view of Shamir suggests the implantable system of claim 2. Schmidt and Shamir do not explicitly teach wherein the implantable system is configured to use activity state data of the one or more electrodes and/or operational history of the one or more electrodes when processing temperature data from the therapy zone temperature sensor.
The prior art by Wasserman is analogous to Schmidt, as they both teach an implantable system that is configured to deliver an electric field to treat cancerous tumor ([abstract, 0045, 0067]).
Wasserman teaches wherein the implantable system is configured to use activity state data of the one or more electrodes when processing temperature data from the therapy zone temperature sensor (the implanted transducer assemblies 31-32 includes a plurality of electrodes 52 that are electrically connected to the respective switches 56 [0054, 0063, 0066, FIG. 7]. Specifically, the switches 56 control the activity state (e.g., ON or OFF state) of the respective electrodes 52 [0054, 0063, 0066]. Furthermore, the controller 85 may receive the activity state data of electrodes 52 from the switches 56 (e.g., ON or OFF state) and the temperature data from the temperature sensors 54 [0054, 0063, 0070]. Lastly, the controller 85 may monitor temperature data to determine if the electrodes are overheating and further adjust the activity state of the electrodes 52 via the switches 56 (e.g., switching from the ON to OFF state or switching between the ON and OFF state at a lower duty cycle) [0063, 0065-0066, 0070]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the implantable system to use the activity state data of one or more electrodes when processing temperature data from the therapy zone temperature sensor, as taught Wasserman. The advantage of such modification will allow for controlling the activity state of electrodes (e.g., switching from the ON to OFF state or switching between the ON and OFF state at a lower duty cycle) based on the measured temperatures to prevent overheating (see paragraphs [0063, 0065-0066, 0070] by Wasserman).
6. Claims 5-6, 11-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al. in view of Shamir et al., further in view of Hendrick et al. (WO 2023/039091 A1, with citations to corresponding US Publication No. 2024/0399154 A1).
Regarding claim 5, Schmidt in view of Shamir suggests the implantable system of claim 1. Schmidt and Shamir do not explicitly teach wherein the control circuitry is configured to process the temperature data and modulate a therapy parameter based on the temperature data as part of a closed loop control system.
The prior art by Hendrick is analogous to Schmidt, as they both teach an implantable system that is configured to deliver electrical fields to treat a cancerous tissue ([0069]).
Hendrick teaches wherein the control circuitry is configured to process the temperature data and modulate a therapy parameter based on the temperature data as part of a closed loop control system (the circuitry of the IMD operates in a closed loop manner to adjust the electric field parameters based on feedback variables (e.g., sensed temperature) [abstract, 0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the control circuitry suggested by Schmidt in view of Shamir to modulate a therapy parameter based on the temperature data as part of a closed loop control system, as taught by Hendrick. The advantage of such modification will allow the system to adjust the electric field parameters based on one or more feedback variables (e.g., sensed temperature) to increase therapy efficacy (see the [abstract] and paragraphs [0069, 0201] by Hendrick).
Regarding claim 6, Hendrick teaches the therapy parameter comprising a closed loop thermal setpoint value (as stated previously in claim 5, the circuitry of the IMD operates in a closed-loop manner to adjust the electric field parameters based on feedback variables (e.g., sensed temperature) [0069, 0095]. Specifically, the feedback variables may consist of a sensed temperature which is compared to a threshold temperature or thermal setpoint value [0095, 0247, 0250]. Furthermore, the circuitry of IMD may control or adjust the electrical field parameters when the sensed temperature exceeds a threshold temperature [0069, 0095, 0247, 0250]).
Regarding claim 11, Hendrick teaches wherein the implantable system is configured to increase an intensity of the therapy at times when a core body temperature or a reference body temperature is lower than a threshold temperature (the IMD 106 may increase the voltage and/or amplitude of the electric fields which causes the patient’s tissue temperature to reach a critical temperature threshold [0069, 0250]. However, the IMD 106 may reduce the amplitude of the electric field if the patient’s tissue temperature exceeds the critical temperature threshold [0250]. The Examiner respectfully submits that decreasing the stimulation amplitude would inherently affect the intensity of the treatment [0250]).
Regarding claim 12, Hendrick teaches wherein the implantable system is configured to increase an intensity of a therapy parameter at times when the patient is asleep (the IMD 106 is configured to detect when the patient is sleeping and can adjust (e.g., increase or decrease) a therapy parameter to treat the cancerous cell [0097, 0123, 0234]. Specifically, the various therapy parameters can be selected from the therapy program 214 that is stored in the memory of the IMD 106 [0108-0109]. For example, the IMD 106 may adjust (e.g., increase) the stimulation frequency or amplitude which would inherently affect the intensity of the treatment [0097, 0108-0109, 0123, 0234]).
Regarding claim 13, Hendrick teaches wherein the implantable system is configured to decrease an intensity of a therapy parameter at times when the patient has an elevated core body temperature or reference body temperature (the IMD 106 may reduce the amplitude of the electric fields to reduce tissue heating when the patient’s tissue temperature exceeds a critical temperature threshold [0069, 0250]. Specifically, this reducing the amplitude of the electric field allows the patient’s tissue temperature to cool down to an acceptable temperature [0250]. The Examiner respectfully submits that decreasing the stimulation amplitude would inherently affect the intensity of the treatment [0250]).
Regarding claim 14, Hendrick teaches wherein the implantable system is configured to decrease an intensity of a therapy parameter at times when the patient has a fever (the IMD 106 may reduce the amplitude of the electric fields to reduce tissue heating when the patient’s tissue temperature exceeds a critical temperature threshold [0069, 0250]. Specifically, the critical temperature threshold may be any specific temperature that is set or defined for the treatment [0250]. For example, the critical temperature may be set to a temperature that is below a fever (e.g., 37 degrees Celsius) [0250]. In this case, the IMD 106 will reduce the amplitude of the electric fields to reduce tissue heating if the patient’s temperature exceeds the critical temperature threshold leading to a fever [0250]. This will allow the patient’s temperature to cool down to an acceptable temperature [0250]. The Examiner respectfully submits that decreasing the stimulation amplitude would inherently affect the intensity of the treatment [0250]).
Regarding claim 15, Hendrick teaches wherein the therapy zone temperature sensor is configured to measure or estimate a core body temperature or a reference body temperature when therapy is turned off or paused (the processing circuitry 210 may pause or cancel the electric field therapy if the temperature of tissue is greater than a threshold temperature [0248-0249]. Furthermore, the processing circuitry 210 may continue to monitor the temperature data and withhold the electric field therapy until the temperature drops back down below the temperature threshold. Specifically, the processing circuitry 210 receives the temperature data from a temperature sensor [0249]).
Regarding claim 18, Hendrick teaches wherein the implantable system comprises accelerometer (the IMD 106 comprises a sensor 212 may consist of an accelerometer [0107, 0123]);
wherein the implantable system is configured to estimate physical activity based on a signal from the accelerometer and modulate a therapy parameter based on the same (the IMD 106 is configured to receive and utilize the movement signals from the accelerometer as feedback to control or modulate the delivery of electric field therapy [0123]).
Claim Rejections - 35 USC § 102
7. 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.
8. Claim 20 is rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Schmidt et al.
Regarding claim 20, Schmidt teaches an implantable system for cancer treatment (the implanted medical device 500 is configured to treat a cancerous tumor [0044, 0057, 0059, FIG. 5]) comprising:
a housing (the implanted medical device 500 comprises a housing 102 [0057]);
a therapy output circuit (the implanted medical device 500 comprises an electric field generating circuit [abstract, 0057]), wherein the therapy output circuit is configured to generate one or more electric fields (the electric field generating circuit is configured to generate an electrical output for the electrodes 108 to create one or more electric fields [abstract, 0051, 0057, 0059]);
a control circuitry (the implanted medical device 500 comprises a control circuitry [abstract, 0057, 0059]), wherein the control circuitry causes the therapy output circuit to generate the one or more electric fields at frequencies selected from a range of between 10 kHz to 1 MHz within a bodily tissue ([abstract, 0057, 0101]), wherein the one or more electric fields are effective to prevent and/or disrupt cellular mitosis in a cell ([0102]);
wherein the control circuitry and the therapy output circuit are disposed within the housing (the electric field generating circuit and the control circuitry are disposed within the housing 102 of the implanted medical device 500 [0057]);
a first temperature sensor, wherein the first temperature sensor is configured to measure a temperature of tissue at a site of therapy (the implanted medical device 500 comprises a plurality of temperature sensors 518 that are configured to measure a temperature of the tissue at the site of the tumor 518 [0060-0062, FIG. 5]);
a stimulation lead (the implanted medical device 500 comprises stimulation leads 106 [0058, FIG. 5]);
stimulation electrodes (the plurality of stimulation electrodes 108 are disposed on the stimulation leads 106 [0057-0059]);
wherein the stimulation electrodes are disposed on the stimulation lead (the plurality of stimulation electrodes 108 are disposed on the stimulation leads 106 [0057-0059]);
wherein the stimulation electrodes are in electrical communication with the therapy output circuit (the electric field generating circuit is configured to generate an electrical output for the electrodes 108 to create one or more electric fields [abstract, 0051, 0057, 0059]); and
a second temperature sensor (the temperature sensor 519 [0060]), wherein the second temperature sensor is configured to measure a core temperature or reference temperature of a patient (the temperature sensor 519 is disposed within the patient’s body at a site that is remote from the treatment region [0060, FIG. 5]. Specifically, the temperature sensor 519 can be used along with the temperature sensors 518 to determine changes in the core temperature that are a result of the therapy [0060]).
Allowable Subject Matter
9. Claims 8-10 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims
Regarding claim 8, Schmidt in view of Shamir suggests the implantable system of claim 1. Schmidt teaches wherein implantable system is configured to track that tissue is exposed to temperatures above a threshold level ([0044]).
However, Schmidt and Shamir do not explicitly teach wherein the implantable system is configured to track the amount of time that tissue is exposed to temperatures above the threshold level.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 9-10 are considered to contain allowable subject matter, as claims 9-10 depend upon claim 8.
Regarding claim 19, Schmidt in view of Shamir and Hendrick suggests the implantable system of claim 18. Hendrick teaches wherein the implantable system is configured to modulate the therapy parameter based on the estimated physical activity and the measured temperature changes (the IMD 106 comprises a sensor 212 may consist of accelerometers and temperature sensors [0107, 0123]. Furthermore, the IMD 106 is configured to utilize the accelerometer signals (e.g., movement) and temperature signals from the sensor 212 as feedback to control or modulate the delivery of electric field therapy [0123]).
Schmidt, Shamir, and Hendrick do not explicitly teach the implantable system to modulate the therapy parameter based on estimated physical activity in advance of measured temperature changes.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Statement on Communication via Internet
10. Communications via Internet email are at the discretion of the applicant. All Internet communications between USPTO employees and applicants must be made using USPTO tools.
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792