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 Claims 1-13 are withdrawn.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
Claim 14 is canceled. Claims 15-20 are amended. Claims 15-20 are pending.
Specification
Applicant’s arguments, filed 01/28/2026, with respect to the abstract objection have been fully considered and are persuasive in view of the abstract amendment. The abstract objection of 07/29/2025 has been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s arguments, filed 01/28/2026, with respect to the 112(b) rejection of claim 18 have been fully considered and are persuasive in view of the claim 18 amendment. The 112(b) rejection of claim 18 of 07/29/2025 has been withdrawn.
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 filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant arguments regarding claim 15’s limitation, “…wherein the adjusting of the duty cycles is configured to keep the temperature at each of the electrode elements below 41° C”, specifically to the combination of Schroeppel (US 20090024075 A1 – hereinafter Schroeppel) in view of Cosman, Sr. (US 9008793 B1 – hereinafter Cosman, Sr.), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Schroeppel is relied upon to teach an apparatus for applying an alternating electric field to a subject's body, including duty cycle adjustment (Schroeppel 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”) as stated in the claim 15 rejection below. Cosman, Sr. is then relied upon to teach a similar stimulation system for treating cancerous tumors which comprise a plurality of temperature sensors, positioned to sense a temperature at a respective one of the electrode elements, and duty cycle adjustment based on electrode 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”). Although the combined invention, specifically Cosman, Sr. does not expressly teach setting the temperature at each of the electrode elements to keep at below 41° C, the set temperature knob 614 of Cosman, Sr. would allow a user to configure the electrode temperature to be set below 41° C to keep electrode temperatures below 41° C. Both Schroeppel and Cosman, Sr. also teach systems which allow a user to adjust duty cycles as desired. It is reminded that 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, see MPEP 2114 Apparatus and Article Claims — Functional Language. Therefore, since the temperature knob allows user control to set a desired electrode temperature to read temperatures to say below 41° C, the combination of Schroeppel and Cosman, Sr. would allow adjustment of duty cycles (as per Schroeppel and Cosman, Sr.) to keep electrode temperatures to temperatures below 41° C (as capable per Cosman, Sr.), and therefore the claim language of “…wherein the adjusting of the duty cycles is configured [indicating intended use] to keep the temperature at each of the electrode elements below 41° C” would therefore be satisfied by the combination of Schroeppel and Cosman, Sr.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 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 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.
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
The term(s) “for” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. 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. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
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.) [all previously cited].
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);
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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);
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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”);
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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”);
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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”).
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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 AND wherein the adjusting of the duty cycles is configured to keep the temperature at each of the electrode elements below 41° C.
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).
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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.
Cosman, Sr. further teaches wherein the adjusting of the duty cycles is configured to keep the temperature at each of the electrode elements below 41° C (Cosman, Sr. column 13, lines 40-48: “In one example, the Set Temp user interface can comprise a knob 614, however there are other implementations of this control that are possible, such as up/down switches, slide controls, and so on. Element 620 indicates the set temperature. Displays 624 can indicate the temperature readout values from the electrodes' temperature sensors…”, where the element 620 allows the user to set the target electrode temperatures, where figure 10 shows the set target temperature to be 80° C). Furthermore, it is reminded that "[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) (emphasis in original). 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, see MPEP 2114. II. Although Cosman, Sr. of the combined invention does not expressly teach setting the temperature at each of the electrode elements to keep at below 41° C, the set temperature knob 614 would allow the user to configure the electrode temperature to be set below 41° C.
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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.
Re. claim 16, 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”).
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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”).
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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”).
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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 in further view of Palti (US 20110137229 A1 – hereinafter Palti) [all previously cited].
Re. claim 20, the combined invention teaches the claimed invention 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) … “).
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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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796