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 04 September 2025 has been considered by the Examiner.
Double Patenting
3. 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.
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4. Claims 8-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-10, and 16-17 of U.S. Patent No. 12,285,605 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite tumor treating fields that are applied to a subject’s body. Specifically, both sets of claims recite a plurality of electrode elements, a plurality of temperature sensors, and a circuit that is implanted within the subject’s body. Furthermore, both sets of claims recite wherein the circuit reduces a number of conductors that are required to obtain temperature measurements from the plurality of temperature sensors.
Although not exhaustive, a brief matching of the pending claims to those of US Patent No. 12,285,605 B2 is provided below.
Application No. 19/093,702
U.S. Patent No. 12,285,605 B2
8
1, 4
9
2
10
3
11
17
12
5, 6
13
7
14
7, 9
16
7, 9, 10
17
1, 4, 17
18
3
19
5, 6
20
7
21
7, 9
23
16, 17
24
1, 4, 5, 6
25
2
26
3
27
16, 17
Regarding claims 15 and 22, U.S. Patent No. 12,285,605 B2 teaches wherein controlling the current applied to each individual electrode element to ensure that the electrode element do not overheat comprises proactively setting a duty cycle at each electrode element to control the temperature of the electrodes ([claim 7, claim 10]).
However, U.S. Patent No. 12,285,605 B2 does not explicitly teach setting the duty cycle at each electrode element to equalize and maintain an equal temperature across all of the electrode elements. However, the Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to try to set a duty cycle at each electrode element to equalize the temperature across all of the electrode elements (MPEP 2143). The advantage of such modification will prevent all of the electrodes from overheating during the treatment (see [claim 7, claim 10] by U.S. Patent No. 12,285,605 B2).
Allowable Subject Matter
5. Claims 8-27 are not in condition for allowance, as claims 8-27 have been rejected under nonstatutory double patenting. However, claims 8-27 would be allowable if the nonstatutory double patenting rejections were overcome.
6. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not explicitly teach a method and an apparatus for deliver tumor treating fields comprising a plurality of electrode elements, a plurality of temperature sensors, and at least one circuit similar to those recited in the pending claims. Specifically, the prior art of record does not explicitly teach wherein the at least one circuit reduces a number of conductors that are required to obtain temperature measurements from the plurality of temperature sensors. The following description demonstrates how the prior art of record fails to suggest the recited limitation.
Regarding claim 8, Wasserman (US 2018/0050200 A1) teaches a method of applying tumor treating fields to a subject's body ([abstract]) comprising:
a plurality of electrode elements (the electrode elements 52 [abstract, 0038, FIG. 1]);
a plurality of temperature sensors, wherein each of the temperature sensors is positioned to measure a temperature of a respective one of the electrode elements (the temperature sensors 54 are positioned to detect the temperature at each of the electrode elements 52 [abstract, 0038, FIG. 1]); and
at least one circuit, wherein the at least one circuit reduces a number of conductors that are required to obtain temperature measurements from the plurality of temperature sensors (the distal circuits 40 are configured to reduce the number of wires or conductors that are required to interface with each transducer array 50 [0041]. The Examiner respectfully submits that the transducer array 50 is configured to obtain the temperature readings from each temperature sensor 54 [0038-0039, 0041]).
Wasserman does not explicitly teach implanting the plurality of electrode elements within the subject’s body;
implanting the plurality of temperature sensors within the subject’s body; and
wherein the at least one circuit is configured to be implanted within subject’s body while reducing the number of conductors that are required to obtain temperature measurements from the plurality of temperature sensors.
Cosman, Jr. (US 2017/0049513 A1) teaches applying tumor treating fields to the subject body (the electric field is configured to treat a cancerous tumor [0036, 0107]) comprising:
implanting the plurality of electrode elements within the subject’s body (the electrodes are inserted within the body of the patient [0048, 0091, 0098-0100]);
implanting the temperature sensors within the subject’s body (the temperature sensors are coupled to the implantable electrodes to measure the temperature of the tissue [0098-0099]); and
implanting the at least one circuit within the subject’s body (figures 10-12 illustrate the implantable electrodes comprising a circuit [0049-0051, FIGS. 10-12]).
Wasserman and Cosman, Jr. do not explicitly teach wherein the at least one circuit is configured to be implanted within subject’s body while reducing the number of conductors that are required to obtain temperature measurements from the plurality of temperature sensors. As stated previously above, Wasserman teaches a circuit 40 that is configured to reduce the number of conductors that are required to obtain the temperature measurements and forward the obtained temperature measurements to the output ([0041-0042]). However, Wasserman’s circuit 40 is not designed to be implanted within the subject’s body (the circuit 40 is coupled to the external transducer assembly 50 consisting of the electrodes 52 and the temperature sensors 54 [0007, 0041, 0062, 0067-0068]). Furthermore, Cosman, Jr.’s implanted circuit is not configured to reduce the number of conductors that are required to obtain temperature measurements from the plurality of temperature sensors. Based on this deficiency, a person having ordinary skill in the art would not find it obvious to combine Wasserman and Cosman, Jr. to arrive at the claimed limitation.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. 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 9-16 are considered to contain allowable subject matter, as claims 9-16 depend upon claim 8.
Regarding claim 17, A method of preventing a plurality of implanted electrode elements from overheating, the method comprising: applying an AC voltage across the plurality of implanted electrode elements; using a plurality of implanted temperature sensors to measure respective temperatures at each of the implanted electrode elements; and transmitting data from the plurality of implanted temperature sensors to a destination using a plurality of cables, wherein each of the plurality of cables terminates at a respective assembly that includes (a) at least one of the implanted electrode elements and (b) at least four of the plurality of implanted temperature sensors, wherein, for each of the plurality of cables, the number of conductors contained within the cable is less than the number of implanted temperature sensors within the respective assembly.
Regarding claim 17, Wasserman teaches a method of preventing a plurality of electrode elements from overheating (the transducer arrays 50 includes a plurality of electrode elements 52 and a plurality of temperature sensors 54 [0038-0039]. Specifically, the temperature sensors 54 are configured to monitor the temperature of the electrodes 52 [0018, 0038]. Furthermore, the AC field generator 20 can determine based on the temperature readings, if the current to the electrodes 52 of the transducer arrays 50 has to be adjusted [0007, 0038-0039]), the method comprising:
applying an AC voltage across the plurality of electrode elements (the AC field generator 20 is configured to apply alternating current to the electrodes 52 of the transducer arrays 50 [0007, 0038-0039]);
using a plurality of temperature sensors to measure respective temperatures at each of the electrode elements (the temperature sensors 54 are configured to monitor the temperature at the respective electrodes 52 [0018, 0038]); and
transmitting data from the plurality of temperature sensors to a destination using a plurality of cables, wherein each of the plurality of cables terminates at a respective assembly that includes (a) at least one of the electrode elements and (b) at least four of the plurality of temperature sensors, wherein, for each of the plurality of cables, the number of conductors contained within the cable is less than the number of temperature sensors within the respective assembly (the distal circuits 40 are configured to reduce the number of wires or conductors in each of the cables 35 that are required to interface with each of the temperature sensors 54 of the transducer array 50 [0038-0039, 0041, 0070-0071]. Specifically, only 4 conductors are required and figure 6A illustrates the transducer arrays 50 having at least 8 temperature sensors 54 [0038-0039, 0041, 0070-0071, FIG. 6A]).
Wasserman does not explicitly teach the plurality of electrode elements to be implanted;
the plurality of temperature sensors to be implanted; and
for each of the plurality of cables, the number of conductors contained within the cable is less than the number of implanted temperature sensors within the respective assembly.
Cosman, Jr. teaches the plurality of electrode elements to be implanted (the electrodes are inserted within the body of the patient [0048, 0091, 0098-0100]);
the plurality of temperature sensors to be implanted (the temperature sensors are coupled to the implantable electrodes to measure the temperature of the tissue [0098-0099]).
However, Wasserman and Cosman, Jr. do not explicitly teach for each of the plurality of cables, the number of conductors contained within the cable is less than the number of implanted temperature sensors within the respective assembly. As stated previously above, Wasserman teaches a circuit 40 that is configured to reduce the number of conductors in each of the cables 35 that are required to interface with each of the temperature sensors 54 of the transducer array 50 ([0038-0039, 0041, 0070-0071]) However, Wasserman’s circuit 40, temperature sensors 54, and cables 35 are not designed to be implanted within the subject’s body (the circuit 40 includes cables 35 that are coupled to the external transducer assembly 50 consisting of the electrodes 52 and the temperature sensors 54 [0007, 0041, 0062, 0067-0068]). Based on this deficiency, a person having ordinary skill in the art would not find it obvious to combine Wasserman and Cosman, Jr. to arrive at the claimed limitation.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. 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 18-23 are considered to contain allowable subject matter, as claims 18-23 depend upon claim 17.
Regarding claim 24, Wasserman (US 2018/0050200 A1) teaches an apparatus for delivering tumor treating fields to a subject's body ([abstract]) comprising:
a plurality of electrode elements (the electrode elements 52 [abstract, 0038, FIG. 1]);
a plurality of temperature sensors, wherein each of the temperature sensors is in thermal contact with a respective one of the electrode elements (the temperature sensors 54 are positioned to detect the temperature at each of the electrode elements 52 [abstract, 0038, FIG. 1]); and
at least one circuit, wherein the circuit is configured to accept data from the plurality of temperature sensors and output corresponding data (the distal circuits 40 are configured to reduce the number of wires or conductors in each of the cables 35 that are required to interface with each of the temperature sensors 54 of the transducer array 50 [0038-0039, 0041, 0070-0071]. Furthermore, the distal circuits 40 are configured to forward the temperature readings to the hub 30 via the cables 35 [0041-0042]);
a cable configured to carry data that is output by the circuit (the distal circuits 40 are configured to forward the temperature readings to the hub 30 via the cables 35 [0041-0042]), and wherein the number of conductors within the cable that are used to carry the data that is output by the circuit is less than the number of temperature sensors (the distal circuits 40 are configured to reduce the number of wires or conductors in each of the cables 35 that are required to interface with each of the temperature sensors 54 of the transducer array 50 [0038-0039, 0041, 0070-0071]. Furthermore, the distal circuits 40 are configured to forward the temperature readings to the hub 30 via the cables 35 [0041-0042]. Specifically, only 4 conductors are required for each of the cables 35 and figure 6A illustrates the transducer arrays 50 having at least 8 temperature sensors 54 [0038-0039, 0041, 0070-0071, FIG. 6A]).
Wasserman does not explicitly teach the plurality of electrode elements to be configured for implantation within the subject’s body;
the plurality of temperature sensors to be configured for implantation within the subject’s body;
the circuit to be configured for implantation within the subject’s body;
the cable configured for implantation within the subject’s body, and wherein the wherein the number of conductors within the cable that are used to carry the data that is output by the circuit is less than the number of temperature sensors.
Cosman, Jr. teaches the plurality of electrode elements to be configured for implantation within the subject’s body ([0048, 0091, 0098-0100]);
the plurality of temperature sensors to be configured for implantation within the subject’s body (the temperature sensors are coupled to the implantable electrodes to measure the temperature of the tissue [0098-0099]);
the circuit to be configured for implantation within the subject’s body (figures 10-12 illustrate the implantable electrodes comprising a circuit [0049-0051, FIGS. 10-12]).
However, Wasserman and Cosman, Jr. do not explicitly teach the cable configured for implantation within the subject’s body, and wherein the wherein the number of conductors within the cable that are used to carry the data that is output by the circuit is less than the number of temperature sensors. As stated previously above, Wasserman teaches a circuit 40 that is configured to reduce the number of conductors in each of the cables 35 that are required to interface with each of the temperature sensors 54 of the transducer array 50 ([0038-0039, 0041, 0070-0071]) However, Wasserman’s circuit 40, temperature sensors 54, and cables 35 are not designed to be implanted within the subject’s body (the circuit 40 includes cables 35 that are coupled to the external transducer assembly 50 consisting of the electrodes 52 and the temperature sensors 54 [0007, 0041, 0062, 0067-0068]). Based on this deficiency, a person having ordinary skill in the art would not find it obvious to combine Wasserman and Cosman, Jr. to arrive at the claimed limitation.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. 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 25-27 are considered to contain allowable subject matter, as claims 25-27 depend upon claim 24.
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. Specifically, Giladi (US 2017/0281934 A1) is pertinent to Applicant’s disclosure, as Giladi teaches tumor treating fields that are applied to a subject’s body ([0044-0045]).
8. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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