DETAILED ACTION
This Office Action is responsive to the Amendment filed 31 July 2025. Claims 1 – 26 and 32 - 35 are now pending. The Examiner acknowledges the amendments to claims 1 - 2, 7, 9 – 15, 17 – 26, and as well as the cancellation of claims 27 – 31.
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 .
Claim Rejections - 35 USC § 103
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 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 1 - 2, 8 – 14, 18 - 20 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Sivo (US 20130261711 A1) in view of APPENDIX 3. ELECTRIC AND MAGNETIC FIELDS AND OTHER FIELD-RELATED CONCERNS (2004, NPL: U, hereinafter “APPENDIX 3”).
Regarding claim 1, Sivo teaches a device ([0028], Figure 7, [0039]) for generating pulsed electrical fields (“an electrotherapeutic system of employing electromagnetic field energies to a human or animal for the purpose of inducing growth arrest and cell death in cancer cells and cancerous tumors and/or foreign pathogens that reside in the body of animals or humans”, [0034]), comprising:
one or more toroid or cylinder structure(s) ([0028], Figure 7, [0039]),
a plurality of conducting windings (“embodiments of the present invention also contemplate the use of a stationary coil or set of coils that can be configured to have a patient moved into and about such coils. Such exemplary embodiments are depicted in FIGS. 7-10 where it is shown that the stationary table design types of coil assemblies can be used for application of electromagnetic energy to a patient in the clinical setting, where the patient is resting on the table during the electromagnetic field delivery. More particularly, embodiments of the present invention may be adapted to employ a clam-shell coil configuration (FIG. 7), a full coil configuration (FIG. 8), one or two opposing figure eight coils (FIG. 9), and/or a c-shaped coil (FIG. 10).”, [0039]) wrapped around each of the one or more toroid or cylinder structure ([0037]), and
a plurality of wires that supply electrical current to the conducting windings (“The magnetic field is adapted to induce an electric field, thus the electromagnetic field is produced. During treatment applications on a patient, and with a coil assembly as described above positioned on, about, or around the tissue area of choice”, [0041]; [0040]),
wherein the device is configured to deliver a uniform external electrical field over the entire body of a patient without contacting the patient ([0039] – [0040], “To optimize the uniformity of the electromagnetic field lines and induced voltage in the targeted cancer cells, cancerous tumor tissues, and/or cell/tissue sites of foreign pathogens it is recommended that the size of the coil that is used for treatment of the above be determined with consideration to the anatomical location and size of the treatment site being addressed.”, [0041], Figures 7 - 10).
Sivo does not teach an electrical field that comprises an amplitude less than 100 V/m.
However, APPENDIX 3 (2004) discloses “potential health effects from exposure to electric and magnetic fields” (page 3-1, paragraph 1) and teaches an electrical field that comprises an amplitude less than 100 V/m (Table 1 on page 3-4 and pasted below; Examiner interprets common household appliances induce an electrical field that comprises an amplitude less than 100 V/m, considering values of 0.03 – 0.09 kV/m from Table 1 translate to 30 – 90 V/m.). 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 amplitude of the device of Sivo such as the amplitude being less than 100 V/m, as taught by APPENDIX 3 (2004), considering the International Radiation Protection Association, in cooperation with the World Health Organization, recommends the limits are 4.2 kV/m for electric fields exposures (APPENDIX 3: page 3-7, paragraph 2) and generic medical devices would produce a small electrical field. It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” See MPEP 2144.05(I). Furthermore, applicant appears to have placed no criticality on the claimed range.
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Regarding claim 32, Sivo teaches a method for therapeutic treatment of cancer, comprising generating pulsed electrical fields (a “method of using electromagnetic field energies to reduce or arrest the growth rate and proliferation of cancer cells, and induce apoptosis in cancer cells, and reduce or arrest the growth and survival of foreign pathogens”, abstract) by
a toroid or cylinder device comprising one or more toroid or cylinder structure(s) ([0028], Figure 7, [0039]),
conducting windings (“embodiments of the present invention also contemplate the use of a stationary coil or set of coils that can be configured to have a patient moved into and about such coils. Such exemplary embodiments are depicted in FIGS. 7-10 where it is shown that the stationary table design types of coil assemblies can be used for application of electromagnetic energy to a patient in the clinical setting, where the patient is resting on the table during the electromagnetic field delivery. More particularly, embodiments of the present invention may be adapted to employ a clam-shell coil configuration (FIG. 7), a full coil configuration (FIG. 8), one or two opposing figure eight coils (FIG. 9), and/or a c-shaped coil (FIG. 10).”, [0039]) wrapped around each of the one or more toroid or cylinder structure(s) ([0037]), and
wires that supply electrical current to the conducting windings (“The magnetic field is adapted to induce an electric field, thus the electromagnetic field is produced. During treatment applications on a patient, and with a coil assembly as described above positioned on, about, or around the tissue area of choice”, [0041]; [0040]),
wherein the device is configured to deliver a uniform external electrical field over the entire body of a patient without contacting the patient ([0039] – [0040], “To optimize the uniformity of the electromagnetic field lines and induced voltage in the targeted cancer cells, cancerous tumor tissues, and/or cell/tissue sites of foreign pathogens it is recommended that the size of the coil that is used for treatment of the above be determined with consideration to the anatomical location and size of the treatment site being addressed.”, [0041], Figures 7 - 10).
Sivo does not teach an electrical field that comprises an amplitude less than 100 V/m.
However, APPENDIX 3 (2004) discloses “potential health effects from exposure to electric and magnetic fields” (page 3-1, paragraph 1) and teaches an electrical field that comprises an amplitude less than 100 V/m (Table 1 on page 3-4 and pasted below; Examiner interprets common household appliances induce an electrical field that comprises an amplitude less than 100 V/m, considering values of 0.03 – 0.09 kV/m from Table 1 translate to 30 – 90 V/m.).
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 amplitude of the device of Sivo such as the amplitude being less than 100 V/m, as taught by APPENDIX 3 (2004), considering the International Radiation Protection Association, in cooperation with the World Health Organization, recommends the limits are 4.2 kV/m for electric fields exposures (APPENDIX 3: page 3-7, paragraph 2) and generic medical devices would produce a small electrical field. It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” See MPEP 2144.05(I). Furthermore, applicant appears to have placed no criticality on the claimed range.
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Regarding claim 2, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teaches the one or more toroid or cylinder structure(s) is made of a magnetic material with high relative magnetic permeability (Sivo: “a coil which can be made of various electric conducting materials (e.g., steel, copper, aluminum, gold, silver, etc.)”, [0040]).
Regarding claim 8, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teaches a magnetic field inside a magnetic material is generated when the electrical current is ramped through the conducting windings (Sivo: “An electromagnetic transducer(s) e.g. coil(s) of any design or configuration that is (are) capable of producing said electromagnetic field energy may be employed as the tool for delivery of the electromagnetic field energy to the treatment site of interest. Any of a variety of electrical signal generators can be used to provide alternating (e.g., sinusoidal, square, sawtooth, etc.) current that can be amplified to the desired radio-frequency power levels and modulated to give the desired signal characteristics such as envelope shapes and repetition rates. This signal is used to drive electromagnetic coils with a current that will generate a time varying magnetic field, B. The magnetic field penetrates the biologic tissue and induces an electric field in the tissue.”, [0012]).
Regarding claim 9, Sivo and APPENDIX 3 teach all limitations of claim 8. The modified invention of Sivo and APPENDIX 3 teaches the magnetic field increase or decrease as the current in the conducting windings increases or decreases to create an electrical field (Sivo: “a signal comprising modulated-bursts of a sine wave (or similar type of wave), and this electromagnetic energy is delivered to the area of cancer and/or foreign pathogen growth at a pre-determined amplitude range. The amplitude of the electromagnetic wave is set by controlling the current output from the current source to the amplifier. In the context of cancer, the electromagnetic signal parameters found to be effective in reducing cancer cell proliferation and inducing cancer cell apoptosis are within a particular range.”, [0042]; “The variation of electromagnetic field signal properties within the electromagnetic field signal parameter range that are necessary to address the above histological and biologic factors includes, but is not limited to, waveform type, carrier frequency, burst duration and width, duty cycle, burst repetition rate, rise and/or fall time, and peak amplitude.”, [0043]).
Regarding claim 10, Sivo and APPENDIX 3 teach all limitations of claim 9. The modified invention of Sivo and APPENDIX 3 teaches the electric field is generated in an interior region of each of the one or more toroid or cylinder structure(s) (Sivo: [0028], Figure 7, [0039]) by changing the magnitude of the magnetic field with time (Sivo: “This signal is used to drive electromagnetic coils with a current that will generate a time varying magnetic field, B.”, [0012]; “embodiments of the present invention also contemplate the use of a stationary coil or set of coils that can be configured to have a patient moved into and about such coils. Such exemplary embodiments are depicted in FIGS. 7-10 where it is shown that the stationary table design types of coil assemblies can be used for application of electromagnetic energy to a patient in the clinical setting, where the patient is resting on the table during the electromagnetic field delivery. More particularly, embodiments of the present invention may be adapted to employ a clam-shell coil configuration (FIG. 7), a full coil configuration (FIG. 8), one or two opposing figure eight coils (FIG. 9), and/or a c-shaped coil (FIG. 10).”, [0039]).
Regarding claim 11, Sivo and APPENDIX 3 teach all limitations of claim 10. The modified invention of Sivo and APPENDIX 3 teaches the magnitude of the electrical field generated is directly proportional to the rate of change of the magnetic field inside a magnetic material of each of the one or more toroid or cylinder structure(s) (Sivo: [0028], Figure 7, [0039]) (Sivo: “An electromagnetic transducer(s) e.g. coil(s) of any design or configuration that is (are) capable of producing said electromagnetic field energy may be employed as the tool for delivery of the electromagnetic field energy to the treatment site of interest. Any of a variety of electrical signal generators can be used to provide alternating (e.g., sinusoidal, square, sawtooth, etc.) current that can be amplified to the desired radio-frequency power levels and modulated to give the desired signal characteristics such as envelope shapes and repetition rates. This signal is used to drive electromagnetic coils with a current that will generate a time varying magnetic field, B.”, [0012]).
Regarding claim 12, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teaches each of the one or more toroid or cylinder structure(s) (Sivo: [0028], Figure 7, [0039]) is in a circular shape ([0028], Figure 7, [0039]).
Regarding claim 13, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 does not teach each of the one or more toroid or cylinder structure(s) is in a non-circular shape.
However, another embodiment of Sivo teaches each of the one or more toroid or cylinder structure(s) is in a non-circular shape (Sivo: “one or two opposing figure eight coils”, [0039], [0030], Figure 9 depicts a figure-of-8 embodiment that is non-circular.).
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 device of Sivo and APPENDIX 3 such that each of the one or more toroid or cylinder structure(s) is in a non-circular shape, as taught by another embodiment of Sivo, for the benefit of having an embodiment better suited “reduce or arrest the growth rate and proliferation of cancer cells” (Sivo: abstract).
Regarding claim 14, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teach each of the one or more toroid or cylinder structure (Sivo: [0028], Figure 7, [0039]) is a closed structure(s) (Sivo: [0028], Figure 7, [0039]). Examiner interprets the structure is one structure and thus is closed.
Regarding claim 18, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teaches the device is further configured to position the patient along a central axis of the device (Sivo: Figure 7).
Regarding claim 19, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teaches the uniform external electrical field is created by a voltage applied across the conducting windings of each of the one or more toroid or cylinder structure(s) (Sivo: “The electromagnetic energy field generated by a coil and applied to a patient in accordance with at least some embodiments of the present invention is composed of current and voltage (i.e., is generated in a coil or similar conductor at a particular voltage and current level) to induce a particular magnetic field.”, [0040]; “To optimize the uniformity of the electromagnetic field lines and induced voltage in the targeted cancer cells, cancerous tumor tissues, and/or cell/tissue sites of foreign pathogens it is recommended that the size of the coil that is used for treatment of the above be determined with consideration to the anatomical location and size of the treatment site being addressed.”, [0041]).
Regarding claim 20, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teaches the amplitude is controlled in an 'open-loop' arrangement, in which an expected electrical field output is known from input voltage, currents created, and system resistances (Sivo: [0042] – [0044]). Examiner interprets the stimulation parameters are controlled by control mechanism (Sivo: “control mechanism”, [0042]) in order to produce a particular field amplitude; thus, input parameters of signal are necessarily known (voltage, current, resistances).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3 in view of Andalib et al (US 20150273233 A1, hereinafter Andalib), as evidenced by Nickel Iron Alloys & Soft Magnetics. Arnold Magnetic Technologies (NPL: U, page 3 of attached datasheet).
Regarding claim 3, Sivo and APPENDIX 3 teach all limitations of claim 2. The modified invention of Sivo and APPENDIX 3 does not teach the high relative magnetic permeability of the magnetic material is 1,000 or higher.
However, Andalib discloses “[d]evices and methods for directing a magnetic field into a body party of a subject” (abstract) and teaches the high relative magnetic permeability of the magnetic material is 1,000 or higher (“the ferromagnetic yoke may contain a silicon steel (e.g., permalloy or permendur), a metallic glass (i.e., an amorphous, non-crystalline metal, such as an alloy containing boron, silicon, phosphorus, zirconium, palladium, iron, cobalt, nickel, titanium, copper, or magnesium), a ferrite (e.g., manganese zinc ferrite, nickel zinc ferrite), or carbonyl iron. The ferromagnetic yoke may contain iron, nickel, or cobalt.”, [0049]). Examiner interprets permendur as a magnetic material with a relative magnetic permeability of 5000 (page 3 of previously attached datasheet).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo, as applied in claim 2, in view of Murakami et al (US 5496419 A).
Regarding claim 4, Sivo and APPENDIX 3 teach all limitations of claim 2. The modified invention of Sivo and APPENDIX 3 does not explicitly teach the magnetic material is selected from the group consisting of silicon steel, powdered iron, nickel-iron alloys, ferrite ceramics, nanocrystalline alloys of iron, boron, and silicon.
However, Murakami discloses “an excellent wear-resistant high permeability magnetic alloy” (column 1, lines 17 - 18) and teaches the magnetic material is selected from the group consisting of silicon steel, powdered iron, nickel-iron alloys, ferrite ceramics, nanocrystalline alloys of iron, boron, and silicon (“a wear resistant high permeability magnetic alloy Ni, Nb, N, O and Fe as main components”, abstract; “having more than 3000 of an effective permeability”, column 2, lines 45 - 46). 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 device of Sivo and APPENDIX 3 such that the magnetic material is selected from the group consisting of silicon steel, powdered iron, nickel-iron alloys, ferrite ceramics, nanocrystalline alloys of iron, boron, and silicon, as taught by Murakami, for the benefit of having “good wear resistance having easy forgeability, a large effective permeability, more than 4000 G of a saturated flux density and a recrystallization texture” (Murakami: abstract).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo, as applied in claim 1, in view of Neuman et al (WO 2013164824 A1).
Regarding claim 5, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 does not explicitly teach the conducting windings are made of a material selected from the group consisting of aluminum, silver, tin, galvanized steel, phosphor bronze, lead, or gold.
However, Neuman discloses a device for producing a magnetic field in a patient (“the magnetic field produced by a coil within the implant”, abstract) and teaches a conducting winding is made of a material selected from the group consisting of aluminum, silver, tin, galvanized steel, phosphor bronze, lead, or gold (“electrically conductive materials, for example, copper, silver, aluminum, gold”, page 31, lines 21 - 26). 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 device of Sivo and APPENDIX 3 such that the conducting windings are made of a material selected from the group consisting of aluminum, silver, tin, galvanized steel, phosphor bronze, lead, or gold, as taught by Neuman, for the benefit of ensuring the production of a magnetic field through conductive wires for treatment (Neuman: abstract).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo, as applied in claim 1, in view of Fischell et al (US 9849302 B1, hereinafter Fischell).
Regarding claim 6, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 does not teach the conducting windings are made of copper wire in the range of 10-28 AWG.
However, Fischell discloses a “magnetic coil system for the treatment of foot pain which has an electrical pulse generator” (abstract) and teaches a conducting winding is made of copper wire in the range of 6 - 12 AWG (column 7, lines 59 - 60). 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 conducting windings in the device of Sivo and APPENDIX 3 to be made of copper wire, as taught by Fischell, for the benefit of being a good conductor of electricity. Furthermore, 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 gauge of the conducting winding in the device of Sivo and APPENDIX 3 to be in a range of 10 - 12 AWG, as taught by Fischell, for the benefit of having a suitable size for the maintenance of a reasonable coil temperature when using the high levels of electrical current as required for effective treatment (Fischell: column 5, lines 42 - 45). It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” See MPEP 2144.05(I). Furthermore, applicant appears to have placed no criticality on the claimed range.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3, as applied in claim 1, in view of Davidson (US 6235251 B1).
Regarding claim 7, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 teaches the conducting windings are wound into a coil arrangement on each of the one or more toroid or cylinder structure(s) ([0028], Figure 7, [0039]) but does not teach with 1 to 200 turns.
However, Davidson discloses “one wire of electrically conductive material is wrapped around the elliptically shaped ring of permanent magnets to form a coil” (column 2, lines 11 - 13), and teaches a conducting winding is wound into a coil arrangement with 1 to 200 turns (“the number of turns may be 100, 200”, column 2, lines 14 - 15). 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 device of Sivo and APPENDIX 3 such that the conducting windings are wound into a coil arrangement with 1 to 200 turns, as taught by Davidson, for the benefit of obtaining the desired application of the present system for treatment (Davidson: column 2, lines 12 - 16).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3, as applied in claim 1, in view of Terazawa (US 20120286842 A1).
Regarding claim 15, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 does not teach each of the one or more toroid or cylinder structure(s) is a non-closed structure.
However, Terazawa discloses “a pulse generator and a method of disposing the pulse generator” [0001] and teaches a toroid or cylinder structure(s) that is a non-closed structure (“It is desirable that the magnetic core 1048 should have an incomplete ring member”, [0091]).
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 device of Sivo and APPENDIX 3 such that each of the one or more toroid or cylinder structure(s) is a non-closed structure, as taught by Terazawa, for the benefit of allowing for a gap for adjusting the hysteresis of magnetization of the magnetic core, and providing a uniform pulse (Terazawa: [0091]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3, as applied in claim 1, in view of Stratton (US 2962679 A).
Regarding claim 16, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3does not teach at least two of the toroid or cylinder structures are arranged coaxially.
However, Stratton discloses “an improved inductive device” (column 1, lines 62 - 63) and teaches at least two of the toroid or cylinder structures are arranged coaxially (instead of placing the toroids side-by-side as in FIG. 3, a pair of toroids may be placed concentrically as shown in FIG. 4A. Instead of using two toroids, any number could be used, as illustrated by FIG. 4B that shows four concentrically positioned toroids, column 2, lines 55 -59; Figures 4A and 4B).
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 device of Sivo and APPENDIX 3 such that at least two of the toroid or cylinder structures are arranged coaxially, as taught by Stratton, for the benefit of optimizing low frequency response and primary inductance by providing a configuration capable of adjusting air gap length (Stratton: column 8, lines 40-55).
Regarding claim 17, Sivo, APPENDIX 3 and Stratton teach all limitations of claim 16. The modified invention of Sivo, APPENDIX 3 and Stratton does not teach the at least two of the toroid or cylinder structures are separated by a distance equal to the radius of each of the one or more toroid or cylinder structure(s).
However, Stratton discloses “an improved inductive device” (column 1, lines 62 - 63) and teaches at least two of the toroid or cylinder structures are separated by a distance equal to the radius of each of the one or more toroid or cylinder structure(s) (As compared with an "E" and "I" type core of the same cross-sectional area to obtain an equal air gap area in a coaxial type construction the length of the air gap need be only one-quarter the diameter of the core. To double the air gap area the air gap length need be lengthened only one-quarter of the core diameter [doubles to one half the diameter i.e. the radius], column, 8, lines 53-57).
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 device of Sivo, APPENDIX 3 and Stratton such that at least two of the toroid or cylinder structures are separated by a distance equal to the radius of each of the one or more toroid or cylinder structure(s), as taught by Stratton, for the benefit of optimizing low frequency response and primary inductance by adjusting air gap length (Stratton: column 8, lines 40-55).
Claims 21 - 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3, as applied in claim 1, in view of Grno (US 20170074907 A1).
Regarding claim 21, Sivo and APPENDIX 3 teach all limitations of claim 1. The modified invention of Sivo and APPENDIX 3 does not teach the device comprising an additional coil winding used for sensing an electrical field generated within the device.
However, Grno discloses an electric current sensor comprising “a fiber from soft magnetic material with uniform cross-sectional area and uniform magnetic properties along the whole length”, and teaches the device comprises an additional coil winding used for sensing an electrical field generated within the device (The sensing coil 3 is connected to the voltage transducer 7. The voltage transducer 7 produces the voltage signal u(t) corresponding to the induced voltage induced into the sensing coil 3 by the magnetic field [generated electric field]. The current signal i(t) and the voltage signal u(t) are led into the processor unit 8. [0036]; Figure 2).
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 device of Sivo and APPENDIX 3 such that the device comprises an additional coil winding used for sensing an electrical field generated within the device, as taught by Grno, for the benefit of measuring the field with high accuracy without need for current circuit disconnection with a negligible space requirement (Grno: [0014] – [0015]).
Regarding claim 22, Sivo, APPENDIX 3 and Grno teach all limitations of claim 21. The modified invention of Sivo, APPENDIX 3 and Grno teaches the additional coil winding comprises a loop of wire encircling the cross section of each of the one or more toroid or cylinder structure(s) at least one turn for a higher sensitivity to the electrical field (Grno: The sensing coil 3 is connected to the voltage transducer 7. The voltage transducer 7 produces the voltage signal u(t) corresponding to the induced voltage induced into the sensing coil 3 by the magnetic field [generated electric field). The current signal i(t) and the voltage signal u(t) are led into the processor unit 8. [0036]; Figure 2).
Regarding claim 23, Sivo, APPENDIX 3 and Grno teach all limitations of claim 22. The modified invention of Sivo, APPENDIX 3 and Grno teaches the loop of wire induces a voltage which is equal in magnitude to a rate of change of magnetic flux through the cross section of each of the one or more toroid or cylinder structure(s) (Grno: The sensing coil 3 is connected to the voltage transducer 7. The voltage transducer 7 produces the voltage signal u(t) corresponding to the induced voltage induced into the sensing coil 3 by the magnetic field [based on rate of change of magnetic flux]. The current signal i(t) and the voltage signal u(t) are led into the processor unit 8. [0036]; Figure 2).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo, APPENDIX 3 and Grno, as applied in claim 22, in view of Blackwell (US 5997464 A).
Regarding claim 24, Sivo, APPENDIX 3 and Grno teach all limitations of claim 22. The modified invention of Sivo and Grno does not explicitly teach the loop of wire is closed at a high-impedance terminal for a measurement of the voltage.
However, Blackwell discloses “a coil for use in PEMF treatment which is deformable, flexible and pliant and easily adaptable for the application of an electromagnetic field to injuries at any location on a patient's body” (column 2, lines 21 - 25) and teaches the loop of wire is closed at a high-impedance terminal for the measurement of the voltage (column 4, lines 31 – 48, Figure 2A; column 4, lines 58 – 60, Figure 4B). Examiner interprets terminal as a connection between the loop of wire and another circuit.
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 Sivo, APPENDIX 3 and Grno such that the loop of wire is closed at a high-impedance terminal for a measurement of the voltage, as taught by Blackwell, for the benefit of measuring the magnetic field strength and using the information to adjust and apply the proper treatment for injuries in a patient (Blackwell: column 1, lines 11 - 12) without causing patient harm.
Claim 25is rejected under 35 U.S.C. 103 as being unpatentable over Sivo in view of Piantelli (WO 2010067180 A2, see attached) in further view APPENDIX 3 (2004).
Regarding claim 25, Sivo teaches a system for therapeutic treatments involving electric fields (“an electrotherapeutic system of employing electromagnetic field energies to a human or animal”, [0034]), comprising:
a toroid or cylinder device ([0028], Figure 7, [0039]) for generating pulsed electric fields ([0028], [0039]),
a driving and sensing circuitry ([0028], [0039], [0040]),
a plurality of cables connecting the device to the driving and sensing circuitry (“The electromagnetic field may be synthesized by one or multiple electrically energized electromagnetic coils that are connected via terminals and cables to an electric signal source.”, [0040]), and
a processor (processor in the “signal control unit”, [0045], Figure 11) for operating the device and the driving and sensing circuitry ([0028], [0039], [0040], [0045]),
wherein the device is configured to deliver a uniform external electrical field over the entire body of a patient without contacting the patient ([0039] – [0040], “To optimize the uniformity of the electromagnetic field lines and induced voltage in the targeted cancer cells, cancerous tumor tissues, and/or cell/tissue sites of foreign pathogens it is recommended that the size of the coil that is used for treatment of the above be determined with consideration to the anatomical location and size of the treatment site being addressed.”, [0041], Figures 7 - 10).
Sivo does not explicitly teach a microprocessor controlling a user interface and an electrical field that comprises an amplitude less than 100 V/m.
However, Piantelli discloses a “device for treating inflammatory and/or painful states by a variable local magnetic field that is produced by an electric current flowing within at least one induction circuit” (abstract) and teaches a microprocessor (“microprocessor of a computer 4”page 10, line 2) controlling a user interface (“computer 4”page 10, line 2).
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 Sivo to incorporate a microprocessor controlling a user interface, as taught by Piantelli, for the benefit of controlling a treatment session program (Piantelli: page 10, line 1).
The modified invention of Sivo and Piantelli does not explicitly teach an electrical field that comprises an amplitude less than 100 V/m.
However, APPENDIX 3 (2004) discloses “potential health effects from exposure to electric and magnetic fields” (page 3-1, paragraph 1) and teaches an electrical field that comprises an amplitude less than 100 V/m (Table 1 on page 3-4 and pasted below; Examiner interprets common household appliances induce an electrical field that comprises an amplitude less than 100 V/m, considering values of 0.03 – 0.09 kV/m from Table 1 translate to 30 – 90 V/m.). 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 amplitude of the device of Sivo and Piantelli such as the amplitude being less than 100 V/m, as taught by APPENDIX 3. ELECTRIC AND MAGNETIC FIELDS AND OTHER FIELD-RELATED CONCERNS (2004), considering the International Radiation Protection Association, in cooperation with the World Health Organization, recommends the limits are 4.2 kV/m for electric fields exposures (APPENDIX 3: page 3-7, paragraph 2) and generic medical devices would produce a small electrical field. It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” See MPEP 2144.05(I). Furthermore, applicant appears to have placed no criticality on the claimed range.
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Regarding claim 26, Sivo, Piantelli and APPENDIX 3 teach all limitations of claim 25. The modified invention of Sivo, Piantelli and APPENDIX 3 teaches the toroid or cylinder device comprises one or more toroid or cylinder structure(s) (Sivo: [0028], Figure 7, [0039]),
conducting windings (Sivo: “embodiments of the present invention also contemplate the use of a stationary coil or set of coils that can be configured to have a patient moved into and about such coils. Such exemplary embodiments are depicted in FIGS. 7-10 where it is shown that the stationary table design types of coil assemblies can be used for application of electromagnetic energy to a patient in the clinical setting, where the patient is resting on the table during the electromagnetic field delivery. More particularly, embodiments of the present invention may be adapted to employ a clam-shell coil configuration (FIG. 7), a full coil configuration (FIG. 8), one or two opposing figure eight coils (FIG. 9), and/or a c-shaped coil (FIG. 10).”, [0039]) wrapped around the one or more toroid or cylinder structure(s) ([0037]), and
wires that supply electrical current to the conducting windings (Sivo: “The magnetic field is adapted to induce an electric field, thus the electromagnetic field is produced. During treatment applications on a patient, and with a coil assembly as described above positioned on, about, or around the tissue area of choice”, [0041]; [0040]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3, as applied in claim 32, in view of Mangano et al (US 6589786 B1, hereinafter Mangano).
Regarding claim 33, Sivo and APPENDIX 3 teach all limitations of claim 32. The modified invention of Sivo and APPENDIX 3 does not teach the method comprises using pharmacological agents for in Targeted Osmotic Lysis.
However, Mangano is in the field of using electric fields for cell separation (abstract) and teaches a method comprising using pharmacological agents in targeted osmotic lysis (column 20, lines 55 - 60). 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 method of Sivo such that the method comprises using pharmacological agents in targeted osmotic lysis, as taught by Mangano, for the benefit of preventing membrane repair or to accelerate colloidal osmotic lysis (column 20, lines 58 - 59).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3, as applied in claim 32, in view of Hulvershorn et al (US 20100036453 A1, hereinafter Hulvershorn).
Regarding claim 34, Sivo and APPENDIX 3 teach all limitations of claim 32. The modified invention of Sivo and APPENDIX 3 teaches the pulsed electric fields consist of a polarization (Sivo: “a 100 kHz to about 1 GHz bipolar sinusoidal waveform, or preferably a 1 MHz to 100 MHz bipolar sinusoidal waveform, or more preferably about a 27 MHz bipolar sinusoidal waveform”, [0045]).
The modified invention of Sivo and APPENDIX 3 does not teach a forward polarization of 1-50 milliseconds, followed by a reverse polarization of similar duration and amplitude to that of the forward polarization.
However, Hulvershorn discloses a “techniques for selecting signal delivery sites and other signal delivery parameters for treating depression and other neurological disorders, and associated systems and methods” (abstract) and teaches pulses of an electric field consisting of a forward polarization of 1-50 milliseconds, followed by a reverse polarization of similar duration and amplitude to that of the forward polarization (“electrical stimulation is provided in a unipolar or bipolar manner, signal polarity, and/or how stimulation signals are varied. In particular embodiments, the pulse system 260 can be used to control the polarity, frequency, duty cycle, amplitude, and/or spatial and/or topographical qualities of the stimulation. Representative signal parameter ranges include a frequency range of from about 0.5 Hz to about 125 Hz”, [0046]). Examiner interprets “0.5 Hz - 125 Hz” ([0046]) as 8 - 125 milliseconds and reads on “approximately 1 – 50 milliseconds”.
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 device of Sivo to incorporate a forward polarization, followed by a reverse polarization of similar duration and amplitude to that of the forward polarization, as taught by Hulvershorn, for the benefit of accounting for the anatomy surrounding the targeted area that is being stimulated. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify device of Sivo to incorporate a forward polarization, followed by a reverse polarization of similar duration and amplitude to that of the forward polarization, such as a range of 8 - 50, as taught by Hulvershorn, for the benefit of “target[ing] neural population to improve a patient function” (Hulvershorn: abstract). Furthermore, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” See MPEP 2144.05(I). Lastly, applicant appears to have placed no criticality on the claimed range.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo and APPENDIX 3, as applied in claim 32, in view of Rehan et al (US 20070203390 A1, hereinafter “Rehan”).
Regarding claim 35, Sivo and APPENDIX 3 teach all limitations of claim 32. The modified invention of Sivo and APPENDIX 3 does not teach each of the pulsed electrical fields is 5-50 milliseconds in duration.
However, Rehan discloses “magnetic stimulation techniques, and more particularly to neural stimulation using a magnetic field” ([0002]) and teaches each of the pulsed electrical fields is 0.1 - 10 milliseconds in duration (“the pulse duration can be from on the order of 0.1 milliseconds to 10 milliseconds”[0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify method of Sivo to incorporate each of the pulsed electrical fields is 0.1 - 10 milliseconds in duration, as taught by Rehan, for the benefit of “interact[ing] with neurons to cause cognitive effect (Rehan: abstract). Furthermore, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” See MPEP 2144.05(I). Lastly, applicant appears to have placed no criticality on the claimed range.
Response to Arguments
Applicant’s arguments, page 6, filed 31 July 2025, in respect to claim objections have been fully considered and are persuasive in light of the amendments. The claim objections for claims 1 - 2, 7, 9 - 15, 17, 19 – 24, 29 and 31 of 30 October 2025 have been withdrawn.
Applicant’s arguments, page 6, filed 31 July 2025, in respect to 35 U.S.C. 112(b) and 112(d) rejections have been fully considered and are persuasive in light of the amendments. The 35 U.S.C. 112(b) and 112(d) rejections for claims 10 – 11 and 18 - 33 of 30 October 2025 have been withdrawn.
Applicant’s arguments with respect to claim(s) 32 - 35 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejections above.
Applicant's arguments, page 6, filed 31 July 2025, have been fully considered but they are not persuasive. Applicant contends “APPENDIX 3 is non-analogous art with respect to the claimed invention. See MPEP 2401.01(a) ("In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention.”.
However, APPENDIX 3 is analogous as it is evidence of an appliance using an electric field on a human body and that this is a known range to be safe and acceptable to be used on the human body.
See, for example, Medtronic, Inc. v. Cardiac Pacemakers, 721 F.2d 1563, 220 USPQ 97 (Fed. Cir. 1983) (Patent claims were drawn to a cardiac pacemaker which comprised, among other components, a runaway inhibitor means for preventing a pacemaker malfunction from causing pulses to be applied at too high a frequency. Two references disclosed circuits used in high power, high frequency devices which inhibited the runaway of pulses from a pulse source. The court held that one of ordinary skill in the pacemaker designer art faced with a rate-limiting problem would look to the solutions of others faced with rate limiting problems, and therefore the references were in an analogous art.). Thus, the inclusion of Appendix 3 is simply teaching a known range of electric fields that are used safely with humans. That general knowledge would be applicable to Sivo in optimizing the appropriate usable range.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791