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 .
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.
3. Claims 1-3, 11-12, 14, 18-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, and 12-15 of U.S. Patent No. (12,161,876). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are anticipated by the claims of U.S. Patent No. (12,161,876) as shown below.
INSTANT APPLICATION (18/951176)
U.S. Patent No. (12,161,876)
Claim 1: A method of applying tumor treating fields to a subject’s body, the method comprising:
locating a first transducer at a first location on the subject’s body;
locating a second transducer at a second location on the subject’s body;
and inducing a modulated electric field between at least part of the first transducer and at least part of the second transducer to treat a tumor of the subject’s body.
Claim 2: The method of claim 1, wherein the modulated electric field is induced by applying an amplitude modulated AC voltage to the first and second transducers, and wherein the amplitude modulated AC voltage comprises a first frequency and a second frequency, and the first frequency is smaller than the second frequency, wherein the second frequency of the amplitude modulated AC voltage is at least 500 kHz and at most 10 GHz.
Claim 1: A method of applying tumor treating fields to a subject's body, the method comprising:
inducing a modulated electric field between a first transducer and a second transducer to treat a tumor of the subject's body,
wherein the first transducer is located at a first location of the subject's body, and
wherein the second transducer is located at a second
location of the subject's body,
wherein the modulated electric field comprises a first
frequency and a second frequency, the first frequency being a frequency to disrupt mitosis in the tumor of the subject's body, and the second frequency being a frequency to attenuate obstructive effects of frequency dependent electric tissue properties, wherein the modulated electric field is induced by applying an amplitude modulated AC voltage to the first and second transducers,
and wherein the amplitude modulated AC voltage comprises the first frequency and the second frequency, and the first frequency is smaller than the second frequency, wherein the second frequency of the amplitude modulated AC voltage is between 500 kHz and 10 GHz.
Claim 3: The method of claim 2, wherein the second frequency of the amplitude modulated AC voltage is at least 1 MHz and at most 10 GHz.
Claim 3: The method of claim 1, wherein the first frequency of the first electric field is between 100 kHz and 500 kHz, and wherein the second frequency of the second electric field is between 1 MHz and 5 MHz.
Claim 11: A method of applying tumor treating fields to a subject’s body, the method comprising:
inducing a modulated electric field between a first electric field generator and a second electric field generator to treat a tumor of the subject’s body, wherein the first electric field generator is situated at a first location on the subject’s body,
wherein the second electric field generator is situated at a second location on the subject’s body, and wherein the modulated electric field comprises a first signal having a first frequency and a second signal having a second frequency, the first frequency being at least 100 kHz and at most 500 kHz, the second frequency being at least 500 kHz and at most 10 GHz, and the first signal modulating the second signal.
Claim 12: A method of applying tumor treating fields to a subject's body, the method comprising:
inducing a modulated electric field between a first electric field generator and a second electric field generator,
wherein the first electric field generator is situated at a first location of the subject's body,
wherein the second electric field generator is situated at a second location of the subject's body, and wherein the modulated electric field comprises a first signal having a first frequency and a second signal having a second frequency, the first frequency being between 100 kHz and 500 kHz, the second frequency being between 500 kHz and 10 GHZ, and the first signal modulating the second signal, wherein the first frequency being a frequency to disrupt mitosis in the tumor of the subject's body, and the second frequency being a frequency to attenuate obstructive effects of frequency-dependent electric tissue properties.
Claim 12: The method of claim 11, wherein the second frequency is at least 1 MHz and at most 10 GHz.
Claim 13: The method of claim 12, wherein the second frequency is between 1 MHz and 10 GHz.
Claim 14: A method of applying tumor treating fields to a torso of a subject’s body, the method comprising:
generating an electric field between a first grouping of electrodes and a second grouping of electrodes, the electric field having two simultaneous frequencies, wherein the first grouping of electrodes is affixed at a first location on the subject’s body, and wherein the second grouping of electrodes is affixed at a second location on the subject’s body.
Claim 1: A method of applying tumor treating fields to a subject's body, the method comprising:
inducing a modulated electric field between a first transducer and a second transducer to treat a tumor of the subject's body,
wherein the first transducer is located at a first location of the subject's body, and
wherein the second transducer is located at a second location of the subject's body,
wherein the modulated electric field comprises a first frequency and a second frequency, the first frequency being a frequency to disrupt mitosis in the tumor of the subject's body, and the second frequency being a frequency to attenuate obstructive effects of frequency dependent electric tissue properties, wherein the modulated electric field is induced by applying an amplitude modulated AC voltage to the first and second transducers,
and wherein the amplitude modulated AC voltage comprises the first frequency and the second frequency, and the first frequency is smaller than the second frequency, wherein the second frequency of the amplitude modulated AC voltage is between 500 kHz and 10 GHz.
Claim 9: The method of claim 1, wherein the modulated electric field is induced in a head of the subject's body of the subject's body or in a torso of the subject's body of the subject's body.
Claim 18: An apparatus to apply tumor treating fields to a subject’s body, the apparatus comprising:
an AC voltage generator adapted to be coupled to a first transducer and a second transducer and capable of providing AC voltage to the first transducer and the second transducer;
and a controller adapted to be coupled to the AC voltage generator, the controller comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the controller to: induce a modulated electric field between at least part of the first transducer and at least part of the second transducer to treat a tumor of the subject’s body.
Claim 19: The apparatus of claim 18, wherein the modulated electric field is induced by applying an amplitude modulated AC voltage to the first transducer and the second transducer, wherein the amplitude modulated AC voltage comprises a first frequency and a second frequency, and the first frequency is smaller than the second frequency, and wherein the second frequency of the amplitude modulated AC voltage is at least 500 kHz and at most 10 GHz
Claim 14: An apparatus to apply tumor treating fields to a torso a subject's body, the apparatus comprising:
a first transducer adapted to be located at a first location of the subject's body;
a second transducer adapted to be located at a second location of the subject's body;
a voltage generator adapted to be coupled to the first transducer and the second transducer to be capable of providing voltage to the first transducer and the second transducer; and a controller coupled to the voltage generator, the controller comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the controller to:
instruct the voltage generator to generate a voltage signal for the first transducer and the second transducer to induce a modulated electric field in the subject's body, the voltage signal comprising a message signal at a first frequency and a carrier signal at a second frequency, the first frequency being a frequency to treat a tumor in the subject's body, the message signal modulating the carrier signal, and the second frequency being a frequency to attenuate obstructive effects of frequency dependent electric tissue properties, wherein the second frequency is between 500 kHz and 10 GHz.
Claim 21: The apparatus of claim 18, wherein the first frequency of the amplitude modulated AC voltage is at least 100 kHz and at most 500 kHz.
Claim 15: The apparatus of claim 14, wherein the first frequency is between 100 kHz and 500 kHz.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-5, 8, 10, 18, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giladi et al. (US Pub.: 2017/0281934 A1, – Applicant Cited).
Regarding claim 1, Giladi discloses a method of applying tumor treating
fields to a subject’s body, the method comprising:
locating a first transducer (e.g. Fig. 7 – transducer array 41) at a first location on the subject’s body (e.g. paragraphs 0045, 0048);
locating a second transducer (e.g. Fig. 7 – transducer array 42) at a second location on the subject’s body (e.g. paragraphs 0045, 0048, – “positioned in contact with the patient's skin in the vicinity of a tumor”);
and inducing a modulated electric field between at least part of the first transducer (41) and at least part of the second transducer (42) to treat a tumor of the subject’s body (e.g. paragraphs 0045, 0060).
Regarding claim 4, Giladi discloses the method of claim 1 as discussed
above, and Giladi further teaches wherein the first transducer (41) and the second transducers (42) are capacitively coupled (e.g. paragraph 0015).
Regarding claim 5, Giladi discloses the method of claim 1 as discussed
above, and Giladi further teaches wherein the first transducer (41) comprises a first array of substantially electrode elements (e.g. paragraph 0045), and the second transducer (42) comprises a second array of substantially electrode elements (e.g. paragraph 0045).
Regarding claim 8, Giladi discloses the method of claim 1 as discussed
above, and Giladi further teaches wherein the first transducer (41) and the second transducer (42) are non-conductive (e.g. paragraph 0031, – insulated by a high dielectric constant ceramic).
Regarding claim 10, Giladi discloses the method of claim 1 as discussed
above, and Giladi further teaches wherein a first pair of transducers includes the first transducer (41) and the second transducer (42) (e.g. paragraphs 0045, 0047), the method comprising:
locating a third transducer (e.g. Fig. 7 – transducer array 43) at a third location on the subject’s body (e.g. paragraphs 0045, 0048);
locating a fourth transducer at a fourth location (e.g. Fig. 7 – transducer array 44) on the subject’s body (e.g. paragraphs 0045, 0048),
wherein a second pair of transducers includes the third transducer (43) and the fourth transducer (44) (e.g. paragraphs 0045, 0047); alternately generating the modulated electric field with the first pair of transducers for a first time period and a second modulated electric field with the second pair of transducers for a second time period (e.g. paragraphs 0045-0047).
Regarding claim 18, Giladi discloses an apparatus to apply tumor treating fields to a subject’s body (e.g. paragraph 0045), the apparatus comprising:
an AC voltage generator (e.g. paragraph 0045) adapted to be coupled to a first transducer (e.g. Fig. 7 – transducer array 41) and a second transducer (e.g. Fig. 7 – transducer array 42) and capable of providing AC voltage to the first transducer (41) and the second transducer (42);
and a controller (e.g. Fig. 7 – controller 25) adapted to be coupled to the AC voltage generator (e.g. paragraphs 0015, 0048), the controller (25) comprising one or more processors and memory accessible by the one or more processors (e.g. paragraph 0046, – the microcontroller contains a processor and memory), the memory storing instructions that when executed by the one or more processors (e.g. paragraph 0046, – “microcontroller-based controllers that are programmed to implement the sequences described herein”), cause the controller (25) to: induce a modulated electric field between at least part of the first transducer (41) and at least part of the second transducer (42) to treat a tumor of the subject’s body (e.g. paragraphs 0045, 0060).
Regarding claim 21, Giladi discloses the apparatus of claim 18 as discussed above, and Giladi further teaches wherein the first frequency of the amplitude modulated AC voltage is at least 100 kHz and at most 500 kHz (e.g. paragraphs 0007, 0049, 0052).
Regarding claim 22, Giladi discloses the apparatus of claim 18 as discussed above, and Giladi further teaches further comprising: the first transducer (41) adapted to be located at a first location on the subject’s body (e.g. paragraph 0045); and the second transducer (42) adapted to be located at a second location on the subject’s body (e.g. paragraph 0045).
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.
Claims 2-3, 9, 14-17, and 19-20 are rejected under 35 U.S.C 103 as being unpatentable over Giladi and further in view of Palti et al. (US Pub.: 2013/0178820 A1).
Regarding claim 2, Giladi discloses the method of claim 1 as discussed
above, and Giladi further teaches wherein the modulated electric field is induced by applying an amplitude modulated AC voltage (e.g. paragraphs 0054, 0060) to the first (41) and second transducers (42), and wherein the amplitude modulated AC voltage comprises a first frequency and a second frequency (e.g. paragraph 0049), and the first frequency is smaller than the second frequency (e.g. paragraph 0052).
However, Giladi does not explicitly teach wherein the second frequency of the amplitude modulated AC voltage is at least 500 kHz and at most 10 GHz.
Palti, in a same field of endeavor of electrical stimulation therapy methods, discloses wherein the second frequency of the amplitude modulated AC voltage is at least 500 kHz and at most 10 GHz (e.g. paragraph 0026 – 500 kHz).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Giladi to incorporate applying a second frequency of the amplitude modulated AC voltage that is at least 500 kHz and at most 10 GHz, as taught and suggested by Palti, in order to enhance the ability to disrupt cellular structures by breaking the bridge membranes of dividing cells (Palti, paragraph 0026).
Regarding claim 3, Giladi in view of Palti teaches the method of claim 2 as
discussed above, and Palti further teaches wherein the second frequency of the amplitude modulated AC voltage is at least 1 MHz and at most 10 GHz (e.g. paragraph 0030).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Giladi and Palti to incorporate applying a second frequency of the amplitude modulated AC voltage that is at least 1 MHz and at most 10 GHz, as taught and suggested by Palti, in order to further enhance electric field strength so that it is strong enough to damage a significant portion of bacteria during cell division (Palti, paragraph 0030).
Regarding claim 9, Giladi discloses the method of claim 1 as discussed
above. However, Giladi does not explicitly teach wherein the first transducer and the second transducer comprise non-ceramic dielectric materials.
Palti, in a same field of endeavor of electrical stimulation therapy methods, discloses wherein the first transducer and the second transducer comprise non-ceramic dielectric materials (e.g. paragraph 0101, – potassium tantalate, etc.).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Giladi to incorporate wherein the first transducer and the second transducer comprise non-ceramic dielectric materials (i.e. potassium tantalate, etc.), as taught and suggested by Palti, in order to enhance the insulation and dielectric properties of the transducers (Palti, paragraphs 0015 and 0101).
Regarding claim 14, Giladi teaches a method of applying tumor treating fields to a portion of a subject’s body (e.g. paragraph 0045), the method comprising: generating an electric field between a first grouping of electrodes and a second grouping of electrodes (e.g. paragraph 0045, 0053), the electric field having two simultaneous frequencies (e.g. paragraph 0057), wherein the first grouping of electrodes is affixed at a first location on the subject’s body (e.g. paragraph 0045), and wherein the second grouping of electrodes is affixed at a second location on the subject’s body (e.g. paragraph 0045).
However, Giladi does not explicitly teach applying tumor treating fields to a torso of a subject’s body.
Palti, in a same field of endeavor of electrical stimulation therapy methods, discloses applying tumor treating fields to a torso of a subject’s body (e.g. see Fig. 11; paragraphs 0043, 0120).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Giladi to incorporate applying tumor treating fields to a torso of a subject’s body, as taught and suggested by Palti, in order to treat a tumor associated with lung cancer (Palti, paragraph 0043).
Regarding claim 15, Giladi in view of Palti teaches the method of claim 14 as discussed above, and Giladi further teaches wherein the two simultaneous frequencies (e.g. paragraph 0057) include a first frequency being at least 100 kHz and at most 500 kHz (e.g. paragraphs 0007, 0049, 0052) and a second frequency (e.g. paragraph 0049).
However, Giladi does not explicitly teach the second frequency being at least 500 kHz and at most 10 GHz.
Palti, in a same field of endeavor of electrical stimulation therapy methods, discloses wherein the second frequency is at least 500 kHz and at most 10 GHz (e.g. paragraph 0026 – 500 kHz).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Giladi to incorporate applying a second frequency that is at least 500 kHz and at most 10 GHz, as taught and suggested by Palti, in order to enhance the ability to disrupt cellular structures by breaking the bridge membranes of dividing cells (Palti, paragraph 0026).
Regarding claim 16, Giladi in view of Palti teaches the method of claim 14 as discussed above, and Giladi further teaches wherein the modulated electric field (e.g. paragraphs 0005, 0060) comprises a first frequency and a second frequency (e.g. paragraphs 0005, 0060), the first frequency being a frequency to disrupt mitosis in the tumor of the subject’s body (e.g. paragraph 0046), and the second frequency being a frequency to attenuate obstructive effects of frequency-dependent electric tissue properties (e.g. paragraph 0046).
Regarding claim 17, Giladi in view of Palti teaches the method of claim 14 (see rejection of claim 14 above). Additionally, Giladi further teaches an apparatus comprising:
a voltage generator (e.g. Fig. 7 – signal generator 20 and power stage 28) adapted to be coupled to the first grouping of electrodes and the second grouping of electrodes (e.g. paragraph 0045, 0053) and capable of providing voltage to the first grouping of electrodes and the second grouping of electrodes (e.g. paragraphs 0015, 0045); and a controller (e.g. Fig. 7 – controller 25) coupled to the voltage generator (e.g. paragraphs 0015, 0048), the controller (25) comprising one or more processors and memory accessible by the one or more processors (e.g. paragraph 0046, – the microcontroller contains a processor and memory), the memory storing instructions that when executed by the one or more processors (e.g. paragraph 0046, – “microcontroller-based controllers that are programmed to implement the sequences described herein”), cause the controller (25) to perform the method of claim 14 (see rejection of claim 14 above).
Regarding claim 19, Giladi discloses the apparatus of claim 18 as discussed above, and Giladi further teaches wherein the modulated electric field is induced by applying an amplitude modulated AC voltage (e.g. paragraphs 0054, 0060) to the first transducer (41) and the second transducer (42), wherein the amplitude modulated AC voltage comprises a first frequency and a second frequency (e.g. paragraph 0049), and the first frequency is smaller than the second frequency (e.g. paragraph 0052).
However, Giladi does not explicitly teach wherein the second frequency of the amplitude modulated AC voltage is at least 500 kHz and at most 10 GHz.
Palti, in a same field of endeavor of electrical stimulation therapy systems, discloses wherein the second frequency of the amplitude modulated AC voltage is at least 500 kHz and at most 10 GHz (e.g. paragraph 0026 – 500 kHz).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Giladi to incorporate applying a second frequency of the amplitude modulated AC voltage that is at least 500 kHz and at most 10 GHz, as taught and suggested by Palti, in order to enhance the ability to disrupt cellular structures by breaking the bridge membranes of dividing cells (Palti, paragraph 0026).
Regarding claim 20, Giladi discloses the apparatus of claim 18 as discussed above. However, Giladi does not explicitly teach wherein the second frequency of the amplitude modulated AC voltage is at least 1 MHz and at most 10 GHz.
Palti, in a same field of endeavor of electrical stimulation therapy systems, discloses wherein the second frequency of the amplitude modulated AC voltage is at least 1 MHz and at most 10 GHz (e.g. paragraph 0030).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Giladi to incorporate applying a second frequency of the amplitude modulated AC voltage that is at least 1 MHz and at most 10 GHz, as taught and suggested by Palti, in order to enhance electric field strength so that it is strong enough to damage a significant portion of bacteria during cell division (Palti, paragraph 0030).
Claim 6 is rejected under 35 U.S.C 103 as being unpatentable over Giladi and further in view of Palti et al. (US Pub.: 2013/0190847 A1) (hereinafter, “Palti 847”) and further in view of Naveh et al. (NPL reference, 3857 Heading – “Optimizing Transducer Array Layout for the Treatment of Pancreatic Cancer Using Tumor Treating Fields (TTFields) in the Phase 3 Panova-3 Trial”).
Regarding claim 6, Giladi teaches the method of claim 5 as discussed above. However, Giladi does not explicitly teach wherein the first array of substantially electrode elements comprises a first plurality of ceramic disks, each of the first plurality of ceramic disks is approximately 2 cm in diameter and approximately 1 mm in thickness, a number of the first plurality of ceramic disks is between 13 and 20; and wherein the second array of substantially electrode elements comprises a second plurality of ceramic disks, each of the second plurality of ceramic disks is approximately 2 cm in diameter and approximately 1 mm in thickness, a number of the second plurality of ceramic disks is between 13 and 20.
Palti ‘847, in a same field of endeavor of electrical stimulation therapy methods, discloses wherein the first array of substantially electrode elements comprises a first plurality of ceramic disks (Fig. 2 – ceramic elements 20), each of the first plurality of ceramic disks (20) is approximately 2 cm in diameter and approximately 1 mm in thickness (e.g. see Figure 3A; paragraph 0015) and wherein the second array of substantially electrode elements comprises a second plurality of ceramic disks (Fig. 2 – ceramic elements 20), each of the second plurality of ceramic disks (20) is approximately 2 cm in diameter and approximately 1 mm in thickness (e.g. see Figure 3A; paragraph 0015).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Giladi to incorporate a plurality of ceramic disks, each of the plurality of ceramic disks being approximately 2 cm in diameter and approximately 1 mm in thickness for the first array of substantially electrode elements and the second array of substantially electrode elements, as taught and suggested by Palti ‘847, in order to enhance the dielectric properties of the array and since it requires only routine skill to scale a system or apparatus. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). 531 F.2d at 1053, 189 USPQ at 148. In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) (MPEP 2144.04 (IV)).
However, Giladi in view of Palti ‘847 does not explicitly teach wherein the first array of substantially electrode elements comprises a number of the first plurality of ceramic disks is between 13 and 20 as well as wherein the second array of substantially electrode elements comprises a number of the second plurality of ceramic disks is between 13 and 20.
Naveh, in a same field of endeavor of electrical stimulation therapy methods, discloses transducer arrays comprising a number of ceramic disks between 13 and 20 (e.g. 3857 Heading – Materials/Methods Subheading, – arrays with 13 or 20 disks per array).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Giladi and Palti ‘847 to incorporate a number of ceramic disks between 13 and 20 into the transducer arrays, as taught and suggested by Naveh, in order to generate higher electric field intensities and to provide therapy on the abdominopelvic region (Naveh, 3857 Heading).
Claim 7 is rejected under 35 U.S.C 103 as being unpatentable over Giladi and further in view of Schwarz et al. (International Publication No.: WO 2021/224678 A1).
Regarding claim 7, Giladi teaches the method of claim 1 as discussed above, and Giladi further teaches wherein the first transducer (41) covers a surface area (e.g. paragraph 0045), and the second transducer (42) covers a surface area (e.g. paragraph 0045).
However, Giladi does not explicitly teach that the first transducer covers a surface area of approximately 140 to 250 cm2 and that the second transducer covers a surface area of approximately 140 to 250 cm2.
Schwarz, in a same field of endeavor of electrical stimulation therapy, discloses transducer arrays covering a surface area of approximately 140 to 250 cm2 (e.g. paragraph 0106 – 150 cm2)
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Giladi to incorporate transducer arrays covering a surface area of approximately 140 to 250 cm2, as taught and suggested by Schwarz, in order to provide the predictable results of allowing a clinician to target a specific area of a specific size for treatment.
Claims 11-13 are rejected under 35 U.S.C 103 as being unpatentable over Giladi and further in view of Palti and further in view of Grossman et al. (US Pub.: 2017/0216594 A1 – Applicant Cited).
Regarding claim 11, Giladi teaches a method of applying tumor treating fields to a subject’s body, the method comprising:
inducing a modulated electric field (e.g. paragraphs 0005, 0060) between a first electric field generator (e.g. Fig. 7 – transducer array 41) and a second electric field generator (e.g. Fig. 7 – transducer array 42) to treat a tumor of the subject’s body (e.g. paragraphs 0045, 0048, 0053), wherein the first electric field generator (41) is situated at a first location on the subject’s body (e.g. paragraphs 0045, 0048), wherein the second electric field generator (42) is situated at a second location on the subject’s body (e.g. paragraphs 0045, 0048), and wherein the modulated electric field comprises a first signal having a first frequency (e.g. paragraph 0049) and a second signal having a second frequency (e.g. paragraph 0049), the first frequency being at least 100 kHz and at most 500 kHz (e.g. paragraphs 0007, 0049, 0052).
However, Giladi does not explicitly teach the second frequency being at least 500 kHz and at most 10 GHz, and the first signal modulating the second signal.
Palti, in a same field of endeavor of electrical stimulation therapy methods, discloses wherein the second frequency is at least 500 kHz and at most 10 GHz (e.g. paragraph 0026 – 500 kHz).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Giladi to incorporate applying a second frequency that is at least 500 kHz and at most 10 GHz, as taught and suggested by Palti, in order to enhance the ability to disrupt cellular structures by breaking the bridge membranes of dividing cells (Palti, paragraph 0026).
However, Giladi in view of Palti does not explicitly teach and the first signal modulating the second signal.
Grossman, in a same field of endeavor of tissue stimulation methods, discloses and the first signal modulating the second signal (e.g. paragraphs 0077, 0209).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Giladi and Palti to include having the first signal modulating the second signal, as taught and suggested by Grossman, for the purpose of modifying an inferential setting to more clearly target desired tissue while avoiding damaging or affecting non-target tissue (Grossman, paragraphs 0001-0012).
Regarding claim 12, Giladi in view of Palti in view of Grossman teaches the method of claim 11 as discussed above, and Palti further teaches wherein the second frequency is at least 1 MHz and at most 10 GHz (e.g. paragraph 0030).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Giladi, Palti, and Grossman to incorporate applying a second frequency that is at least 1 MHz and at most 10 GHz, as taught and suggested by Palti, in order to further enhance electric field strength so that it is strong enough to damage a significant portion of bacteria during cell division (Palti, paragraph 0030).
Regarding claim 13, Giladi in view of Palti in view of Grossman teaches the method of claim 11 (see rejection of claim 11 above). Additionally, Giladi further teaches an apparatus comprising:
a voltage generator (e.g. Fig. 7 – signal generator 20 and power stage 28); paragraphs 0015, 0045) adapted to be coupled to the first electric field generator (e.g. Fig. 7 – transducer array 41) and the second electric field generator (e.g. Fig. 7 – transducer array 42) and capable of providing voltage to the first electric field generator (41) and the second electric field generator (42) (e.g. paragraphs 0015, 0045);
and a controller (e.g. Fig. 7 – controller 25) coupled to the voltage generator (e.g. paragraphs 0015, 0048), the controller (25) comprising one or more processors and memory accessible by the one or more processors (e.g. paragraph 0046, – the microcontroller contains a processor and memory), the memory storing instructions that when executed by the one or more processors (e.g. paragraph 0046, – “microcontroller-based controllers that are programmed to implement the sequences described herein”), cause the controller (25) to perform (e.g. paragraph 0046) the method of claim 11 (see rejection of claim 11 above).
Conclusion
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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