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 .
Election/Restrictions
Applicant’s election without traverse of claims 14-20 in the reply filed on July 8, 2025 was acknowledged. Claims 1-13 are withdrawn.
Information Disclosure Statement
The information disclosure statement(s) filed June 10, 2024 and October 30, 2024 has/have been considered by the Examiner.
Response to Arguments
Claims 15-20 are pending.
Double Patenting
The applicant’s request that the double patenting rejection to be held in abeyance until later when claims are subject to allowance are acknowledged. However, to provide clarity, the double patenting rejection is presented again in this office action.
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to claim(s) 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the reference as taught by Buysse (US-20060079887-A1) is used as a tertiary reference to teach the limitation, wherein the adjusting of the duty cycles is configured to keep the temperature at each of the electrode elements below 41° C, as stated in the rejection below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,395,916 B2, and claims 1-20 of U.S. Patent No. 12,029,898 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 15-20 of U.S. application 18/738,457, and claims 1-20 of both U.S. Patent No. 11,395,916 B2 and U.S. Patent No. 12,029,898 B2 pertain to apparatuses for applying alternating electric fields to a subject’s body comprising a plurality of electrode elements, support configured to hold the electrodes against the subject, a plurality of temperature sensors, an electrical conductor, a plurality of electrically controlled switches, and a controller configured to control the state of the control input of each of the switches, as detailed in the comparison table below.
18/738,457
US Patent 11,395,916 B2
US Patent 12,029,898 B2
An apparatus for applying an alternating electric field to a subject's body, the apparatus comprising:
a plurality of electrode elements;
a support configured to hold the plurality of electrode elements against the subject's body;
and a plurality of temperature sensors, wherein each of the temperature sensors is positioned to sense a temperature at a respective one of the electrode elements and generate a respective signal indicative of the sensed temperature;
an electrical conductor;
a plurality of electrically controlled switches, wherein each of the switches is configured to, depending on a state of a respective control input, either (a) allow current to flow between the electrical conductor and a respective electrode element or (b) prevent current from flowing between the electrical conductor and the respective electrode element;
and a controller configured to control the state of the control input of each of the switches so as to individually adjust a duty cycle of an AC signal that is applied to each of the electrode elements, respectively, based on respective sensed temperatures, wherein the adjusting of the duty cycles prevents the electrode elements from overheating.
The apparatus of claim 14, wherein each of the electrode elements is a capacitively coupled electrode element having a dielectric layer.
An apparatus for applying an alternating electric field to a subject's body, the apparatus comprising:
a plurality of capacitively coupled electrode elements, each of the electrode elements having a dielectric layer;
a support configured to hold the plurality of electrode elements against the subject's body with the dielectric layer of the electrode elements facing the subject's body;
a plurality of temperature sensors, wherein each of the temperature sensors is positioned to sense a temperature at a respective electrode element and generate a respective signal indicative of the sensed temperature;
an electrical conductor;
a plurality of electrically controlled switches, wherein each of the switches is configured to, depending on a state of a respective control input, either (a) allow current to flow between the electrical conductor and a respective electrode element or (b) prevent current from flowing between the electrical conductor and the respective electrode element;
and a controller configured to control the state of the control input of each of the switches.
An apparatus for applying an alternating electric field to a subject's body, the apparatus comprising:
a plurality of sets of at least two electrode elements, wherein all of the electrode elements within any given set of electrode elements are adjacent to each other;
a support configured to hold the plurality of sets of electrode elements against the subject's body;
and a plurality of temperature sensors, wherein each of the temperature sensors is positioned to sense a temperature at a respective one of the sets of electrode elements and generate a respective signal indicative of the sensed temperature.
5. The apparatus of claim 1, further comprising:
an electrical conductor;
a plurality of electrically controlled switches, wherein each of the switches is configured to, depending on a state of a respective control input, either (a) allow current to flow between the electrical conductor and a respective electrode element or (b) prevent current from flowing between the electrical conductor and the respective electrode element;
and a controller configured to control the state of the control input of each of the switches.
An apparatus for applying an alternating electric field to a subject's body, the apparatus comprising:
a plurality of electrode elements;
a support configured to hold the plurality of electrode elements against the subject's body;
and a plurality of temperature sensors, wherein each of the temperature sensors is positioned to sense a temperature at a respective one of the electrode elements and generate a respective signal indicative of the sensed temperature;
an electrical conductor;
a plurality of electrically controlled switches, wherein each of the switches is configured to, depending on a state of a respective control input, either (a) allow current to flow between the electrical conductor and a respective electrode element or (b) prevent current from flowing between the electrical conductor and the respective electrode element;
and a controller configured to control the state of the control input of each of the switches so as to individually adjust a duty cycle of an AC signal that is applied to each of the electrode elements, respectively, based on respective sensed temperatures, wherein the adjusting of the duty cycles prevents the electrode elements from overheating.
16. An apparatus for applying an alternating electric field to a subject's body, the apparatus comprising:
a plurality of first electrode elements;
a support configured to hold the plurality of first electrode elements against a subject's body;
a plurality of temperature sensors, wherein each of the temperature sensors is positioned to sense a temperature at a respective first electrode element and generate a respective signal indicative of the sensed temperature;
an electrical conductor;
a plurality of electrically controlled first switches, wherein each of the first switches is wired in series with a respective first electrode element in a circuit that begins at the electrical conductor and ends at the respective first electrode element, and wherein each of the first switches is configured to switch on or off independently of other first switches based on a state of a respective control input;
and a controller configured to generate an output that determines the state of the control input for each of the first switches.
An apparatus for applying an alternating electric field to a subject's body, the apparatus comprising:
a plurality of sets of at least two electrode elements, wherein all of the electrode elements within any given set of electrode elements are adjacent to each other;
a support configured to hold the plurality of sets of electrode elements against the subject's body;
and a plurality of temperature sensors, wherein each of the temperature sensors is positioned to sense a temperature at a respective one of the sets of electrode elements and generate a respective signal indicative of the sensed temperature;
an electrical conductor;
a plurality of electrically controlled switches, wherein each of the switches is configured to, depending on a state of a respective control input, either (a) allow current to flow between the electrical conductor and a respective electrode element or (b) prevent current from flowing between the electrical conductor and the respective electrode element;
and a controller configured to control the state of the control input of each of the switches so as to individually adjust a duty cycle of an AC signal that is applied to each of the electrode elements, respectively, based on respective sensed temperatures, wherein the adjusting of the duty cycles prevents the electrode elements from overheating.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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.
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeppel (US 20090024075 A1 – hereinafter Schroeppel) in view of Cosman, Sr. (US 9008793 B1 – hereinafter Cosman, Sr.) [both previously cited] and in further view of Buysse (US 20060079887 A1 – hereinafter Buysse, NEW).
Re. claim 15, Schroeppel teaches apparatus for applying an alternating electric field to a subject's body (paragraph 0102 – “The electrodes 31, 32, 33, 34, and 35 comprise an electrode array 310 that can be used to increase the effectiveness of electrical therapy by establishing an electric field pattern that encompasses all of the tumor volume”), the apparatus comprising:
a plurality of electrode elements (figures 3A-3C, electrodes 31-35);
PNG
media_image1.png
534
464
media_image1.png
Greyscale
a support configured to hold the plurality of electrode elements against the subject's body (figure 3A, insulated wire segment 30 and wire ring 1003 connects electrodes 31-35 and needles 36 for fixation);
PNG
media_image2.png
534
464
media_image2.png
Greyscale
an electrical conductor (figure 3A, wire bundle 29 which connects a generator to the electrodes for stimulation; paragraph 0101 – “A proximal end of the wire bundle 29 is coupled to a generator (such as in FIG. 1) which provides electrical therapy to the electrodes 31, 32, 33, 34, and 35”);
PNG
media_image3.png
534
464
media_image3.png
Greyscale
a plurality of electrically controlled switches, wherein each of the switches is configured to, depending on a state of a respective control input, either (a) allow current to flow between the electrical conductor and a respective electrode element or (b) prevent current from flowing between the electrical conductor and the respective electrode element (figures 2E-2F show H-bridge switches 240-245 open to prevent current flow; paragraph 0101 – “Current paths can be switched by the generator (not shown), such as by using circuitry similar to that depicted in FIG. 2E-2F, so that a current pulse can flow from the electrode 35 to the electrode 31, then from the electrode 34 to the electrode 31, then from the electrode 33 to the electrode 31, then from the electrode 32 to the electrode 31, and so on in any sequence by delivering pulses of current between successive pairs of the electrodes 31 and a remaining one of the electrodes 32, 33, 34, and 35”);
PNG
media_image4.png
422
626
media_image4.png
Greyscale
PNG
media_image5.png
430
246
media_image5.png
Greyscale
and a controller (figure 1, external instrument 5 and controller 84 act as controllers which couples to generator 1, which further supplies electrical therapy to electrodes 31-35 as per paragraph 0101 – “A proximal end of the wire bundle 29 is coupled to a generator (such as in FIG. 1) which provides electrical therapy to the electrodes 31, 32, 33, 34, and 35”; paragraph 0091 – “The external instrument 5 is operably coupled to the generator 1…The external instrument 5 may alter various parameters including rate, intensity, and duration of therapy”) configured to control the state of the control input of each of the switches so as to individually adjust a duty cycle of an AC signal that is applied to each of the electrode elements, respectively (paragraph 0101 – “Current paths can be switched by the generator (not shown), such as by using circuitry similar to that depicted in FIG. 2e-2f, so that a current pulse can flow from the electrode 35 to the electrode 31, then from the electrode 34 to the electrode 31, then from the electrode 33 to the electrode 31, then from the electrode 32 to the electrode 31, and so on in any sequence by delivering pulses of current between successive pairs of the electrodes 31 and a remaining one of the electrodes 32, 33, 34, and 35”; paragraph 0170 – “At step 111 the generator is programmed by telemetry. Many parameters can be programmed such as duration of therapy, duty cycle, pulse width, voltage, current, total coulombs delivered, anode/cathode switching, and the like”).
PNG
media_image6.png
404
504
media_image6.png
Greyscale
PNG
media_image7.png
332
496
media_image7.png
Greyscale
Schroeppel teaches the claimed invention as stated above, but does not explicitly teach a plurality of temperature sensors, wherein each of the temperature sensors is positioned to sense a temperature at a respective one of the electrode elements and generate a respective signal indicative of the sensed temperature; and adjusting duty cycle of each of the electrode elements based on respective sensed temperatures, wherein the adjusting of the duty cycles prevents the electrode elements from overheating.
Cosman, Sr. teaches a similar system for treating cancerous tumors (Cosman, Sr. column 6, lines 14-16: “In another example, the system and method can be applied to treat cancerous tumors or other functional disorders anywhere in the patient's body”). Cosman, Sr. further teaches the system of figure 3 comprises a high-frequency RF generator 180 connected to electrodes 145-147, with temperature sensors 161-163 attached to the electrodes (Cosman, Sr. figure 3).
PNG
media_image8.png
586
466
media_image8.png
Greyscale
The temperature sensors 161-163 measure the temperature of the respective electrodes 145-147 that they connect to (Cosman, Sr. column 9, lines 36-46: “Referring to FIG. 3, each of the electrodes has a temperature sensor built into them indicated by the elements 161, 162, and 163, corresponds to electrodes 145, 146, and 147, respectively. For example, the temperature sensors can be TC thermocouple sensors that are commonly used in RF electrodes. The temperature signal can be fed into the controllers by the connections 151, 152, and 153, respectively. In one example, there can be a set temperature control, illustrated by the elements 121, 122, and 123, whereby the user can set a temperature which the respective electrodes should lock onto during the procedure”).
Cosman, Sr. further details the temperature sensor 161 incorporated to sense the temperature specifically for electrode 145, comparing the temperature of electrode 145 to a set/target electrode temperature, and controlling the electrode 145 switch to remain closed to allow current to flow to the electrode 145 to reach the target temperature (Cosman, Sr. column 9, lines 57-64: “Temperature sensor 161 is incorporated into electrode 145 that reports the temperature at the tip electrode 145. The high frequency power connection 141 connects to the electrode 145 that in turn connects to the tissue around electrode 145 in the patient's body B. The high frequency power thus passing into the tissue heats the tissue, and, in turn, heats up the electrode 145 and the temperature sensor 161 within it. Temperature measured by 161 is reported via 151 to controller 131. Control 131 also has an input signal from set temperature control 121, and compares the set temperature to the measured temperature from 161 to determine how long switch S1 should be closed and when it should be opened during the allotted time slice for electrode 145. In this way, the electrode temperature can converge to the set temperature”).
Cosman, Sr. further teaches setting a set/target temperature for each electrode (Cosman, Sr. column 10, lines 63-64: “…the temperature of the electrode can be chosen at the set temperature”), and adjusting the duty cycle based on the sensed electrode temperature to steer the electrode to the set/target temperature (Cosman, Sr. column 11, lines 20-26: “During time slice T1, the duty time of the output can be controlled by the controller to be a fraction of the slice time T1, as illustrated by the time D1. Time duration D1 is controlled so that the temperature of the electrode 145 is steered back, by a feedback algorithm in the controller for electrode 145, to the set temperature value”).
Cosman, Sr. does not explicitly teach wherein the adjusting of the duty cycles prevents the electrode elements from overheating. However, since Cosman, Sr. teaches adjusting duty cycles based on the temperature sensed at the electrodes as stated above, AND Cosman, Sr. teaches adjusting the duty cycle to steer the electrode temperature back to the target temperature (Cosman, Sr. column 11, lines 20-26), Cosman, Sr. as stated above would meet all the positively recited steps of the claimed invention to prevent the electrodes from overheating.
Since Schroeppel and Cosman, Sr. are both within the field of systems for treating cancerous tumors with duty cycle adjustment, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Schroeppel to incorporate the electrode temperature sensors and duty cycle adjustment mechanisms based on the sensed electrode temperature as taught by Cosman, Sr. since such modification would predictably result in reducing treatment time, providing the patient with a shorter period of discomfort as well as not wasting valuable clinician and procedure-room time by regulating the temperatures of each electrode (Cosman, Sr. column 5, lines 9-11) or simply to prevent tissue damage to a patient by regulating electrode temperature.
The combined invention of Schroeppel and Cosman, Sr. (hereinafter the combined invention) teaches the claimed invention of claim 15 as stated above except wherein the adjusting of the duty cycles is configured to keep the temperature at each of the electrode elements below 41° C.
Buysse teaches a Radiofrequency ablation system (abstract – “A system and method for heat ablation of tissue in which energy is sequentially applied to at least two electrodes inserted into tissue. The system is comprised of a radiofrequency (RF) source for supplying RF energy, at least two electrodes configured to apply RF energy to tissue, at least one return electrode for returning the RF energy to the RF source, and a controller configured to sequentially apply the RF energy to each of the at least two electrodes”),
comprising a temperature sensor (paragraph 0051 – “The controller 217 will further include power supply 252 for supplying power to the various components of the controller 217; at least one temperature board 254 for determining a temperature at a tip of an electrode when the electrode includes a temperature sensor such as a thermocouple…”),
which allows duty cycle adjustment based on sensed temperature, or the set predetermined temperature limit (paragraph 0070 – “…the controller 217 will continuously monitor the temperature at the electrode tip 204 to ensure the temperature does not go below a predetermined limit, e.g., 65.degree. C. (step 514). If the temperature at the tip 204 goes above the predetermined limit, the controller 217 will adjust the duty cycle of the RF energy being applied to maintain the predetermined temperature limit (step 516), e.g., lower the duty cycle. If the temperature at the tip 204 goes below the predetermined temperature limit, the duty cycle will be increased…”; see also figure 5 flowchart).
PNG
media_image9.png
162
328
media_image9.png
Greyscale
Buysse further teaches that the predetermined temperature limits can range from 65-99° C (paragraph 0070 – “Optionally, the predetermined temperature limit may be a range of temperatures of about 60.degree. C. to about 99.degree. C.”), however, Buysse further teaches that the predetermined temperature limit is user selectable and can be set as low as 20° C (paragraph 0058 – “The ablation process will not begin until all selected electrodes are below a predetermined limit, e.g., 20.degree. C. This predetermined temperature limit may be user selectable or selected by the controller based on tissue type, procedure selected, etc..”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention of Schroeppel in view of Cosman, Sr., to try setting the lower predetermined temperature limit below 41° C (i.e. 20° C) as taught by Buysse as stated above, since such modification would still predictably result in preventing tissue damage to a patient by regulating electrode temperature.
Re. claim 16, the combined invention of Schroeppel, Cosman, Sr. and Buysse (hereinafter the combined invention) further teaches wherein the adjusting of the duty cycles only occurs when the temperature at a given electrode element begins to approach a set value (Cosman, Sr. column 11, lines 20-26: “During time slice T1, the duty time of the output can be controlled by the controller to be a fraction of the slice time T1, as illustrated by the time D1. Time duration D1 is controlled so that the temperature of the electrode 145 is steered back, by a feedback algorithm in the controller for electrode 145, to the set temperature value”). Furthermore, the set temperature knob 614 of Cosman, Sr. figure 10 would allow the user to configure the electrode temperature to be set at any desired temperature, and can increase signal output if the electrode temperature is less than the set temperature (Cosman, Sr. column 5, lines 53-55: “Similarly, if the electrode tip temperature is less than the set temperature, the high frequency signal output to that electrode can be increased by the system control electronics”).
Re. claim 17, the combined invention further teaches wherein the adjusting of the duty cycles is configured to proactively set the duty cycle at each of the electrode elements individually (Schroeppel teaches that duty cycle can be programmed by the generator for current flows to each electrode in paragraphs 0101 – “Current paths can be switched by the generator (not shown), such as by using circuitry similar to that depicted in FIG. 2e-2f, so that a current pulse can flow from the electrode 35 to the electrode 31, then from the electrode 34 to the electrode 31, then from the electrode 33 to the electrode 31, then from the electrode 32 to the electrode 31, and so on in any sequence by delivering pulses of current between successive pairs of the electrodes 31 and a remaining one of the electrodes 32, 33, 34, and 35” and paragraph 0170 – “At step 111 the generator is programmed by telemetry. Many parameters can be programmed such as duration of therapy, duty cycle, pulse width, voltage, current, total coulombs delivered, anode/cathode switching, and the like”),
so as to equalize the temperature across all the electrode elements (Cosman, Sr. figure 12, electrode temperature display 734 shows the electrode temperatures of four independent electrodes to be the same as the set electrode temperature via display 720; columns 11, lines 23-36: “Time duration D1 is controlled so that the temperature of the electrode 145 is steered back, by a feedback algorithm in the controller for electrode 145, to the set temperature value…The level that is maintained and applied at each group of time cycles, can be determined by the feedback algorithm so that each and all of the electrodes can get the sufficient power of signal output during its allotted time slice to achieve the temperature of the set temperature”).
PNG
media_image10.png
392
410
media_image10.png
Greyscale
Re. claim 18, the combined invention further teaches wherein the adjusting of the duty cycles is configured to proactively set the duty cycle at each of the electrode elements individually (Schroeppel teaches that duty cycle can be programmed by the generator for current flows to each electrode in paragraphs 0101 – “Current paths can be switched by the generator (not shown), such as by using circuitry similar to that depicted in FIG. 2e-2f, so that a current pulse can flow from the electrode 35 to the electrode 31, then from the electrode 34 to the electrode 31, then from the electrode 33 to the electrode 31, then from the electrode 32 to the electrode 31, and so on in any sequence by delivering pulses of current between successive pairs of the electrodes 31 and a remaining one of the electrodes 32, 33, 34, and 35” and paragraph 0170 – “At step 111 the generator is programmed by telemetry. Many parameters can be programmed such as duration of therapy, duty cycle, pulse width, voltage, current, total coulombs delivered, anode/cathode switching, and the like”),
so that the temperature of each of the electrode elements is maintained at a set value (Cosman, Sr. figure 12, electrode temperature display 734 shows the electrode temperatures of four independent electrodes to be the same as the set electrode temperature via display 720; columns 11, lines 23-36: “Time duration D1 is controlled so that the temperature of the electrode 145 is steered back, by a feedback algorithm in the controller for electrode 145, to the set temperature value…The level that is maintained and applied at each group of time cycles, can be determined by the feedback algorithm so that each and all of the electrodes can get the sufficient power of signal output during its allotted time slice to achieve the temperature of the set temperature”).
PNG
media_image10.png
392
410
media_image10.png
Greyscale
Re. claim 19, the combined invention wherein the controller is mounted, either directly or through intervening components, to the support (Schroeppel in figure 22 teaches the controller 84 rests on the intervening generator 1, where the generator 1 connects to the electrode support [insulated wire segment 30 and wire ring 1003] via the wire bundle 29 and telemetrically coupled to the external device 5; paragraph 0101 – “A proximal end of the wire bundle 29 is coupled to a generator (such as in FIG. 1) which provides electrical therapy to the electrodes 31, 32, 33, 34, and 35”; paragraph 0144 – “Looking now at FIG. 22 a block diagram of a basic generator 1 of the present embodiment is depicted. Shown are the generator 1, a tumor 6, a power source 83, a controller 84, a driver 85, and lead electrodes 86”).
PNG
media_image2.png
534
464
media_image2.png
Greyscale
PNG
media_image11.png
404
504
media_image11.png
Greyscale
PNG
media_image7.png
332
496
media_image7.png
Greyscale
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeppel (US 20090024075 A1 – hereinafter Schroeppel) in view of Cosman, Sr. (US 9008793 B1 – hereinafter Cosman, Sr.) and Buysse (US 20060079887 A1 – hereinafter Buysse, NEW), and in further view of Palti (US 20110137229 A1 – hereinafter Palti) [previously cited].
Re. claim 20, the combined invention teaches the claimed invention of claim 15 as stated above, but does not explicitly teach wherein each of the electrode elements is a capacitively coupled electrode element having a dielectric layer.
Palti teaches a similar system for treating tumors with alternating electric fields (Palti abstract) and further teaches in figure 7, a skin patch 300 support comprising electrodes 230 with an insulating material 310 made of a dielectric material (Palti paragraph 0098 – “The patch 300 includes internal insulation 310 (formed of a dielectric material) … “).
PNG
media_image12.png
458
496
media_image12.png
Greyscale
Palti further teaches that the electrodes are arranged to be capacitively coupled so that the AC electric field is capacitively coupled into the target tumor region (Palti paragraph 0031 – “The AC voltage source and the electrodes are configured so that, when the electrodes are placed against the patient's body and the AC voltage source is activated, an AC electric field is capacitively coupled into the target region of the patient via the electrodes”).
Since the combined invention and Palti all teach within the field of systems for treating cancerous tumors, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode support of the combined invention to utilize the skin patch with the capacitively coupled electrodes and dielectric layer as taught by Palti since such modification would predictably result in lower power consumption, less heating of the treated regions, and improved patient safety (Palti paragraph 0080), while the therapeutically effective dose is present at the target region (Palti paragraph 0029).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID HAMAOUI can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANH-KHOA N DINH/Examiner, Art Unit 3796
Prosecution Insights