DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 May 2026 has been entered.
Claims 1 – 26, and 32 - 35 are pending in the instant application. The Examiner acknowledges the amendments to claims 1 – 19, 22 – 26 and 32
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.
Claim 25 is 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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Claim 25 is 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) in further view of Chu (US 6762666 B2).
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 a toroid or cylinder magnetic cores (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 toroid or cylinder magnetic cores ([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]).
The modified invention of Sivo, Piantelli and APPENDIX 3 does not teach multiple toroid or cylinder magnetic cores.
However, Chu discloses a “toroidal core for a toroid, including at least two toroidal ring” (abstract) and teaches multiple toroid or cylinder magnetic cores (“at least two toroidal rings that are stacked co-axially one upon another abstract; “three toroidal rings 20, 30 and 40 placed co-axially one upon another” column 2, line 19 – 20, Figure 3).
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, Piantelli and APPENDIX 3 to incorporate multiple toroid or cylinder magnetic cores, as taught by Chu, for the benefit of prevent[ing] “improper operation and/or overheating” (Chu: column 1, lines 11).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo in view of APPENDIX in further view of Chu (US 6762666 B2).
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 a toroid or cylinder magnetic cores ([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 toroid or cylinder magnetic cores ([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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The modified invention of Sivo and APPENDIX 3 does not teach multiple toroid or cylinder magnetic cores.
However, Chu discloses a “toroidal core for a toroid, including at least two toroidal ring” (abstract) and teaches multiple toroid or cylinder magnetic cores (“at least two toroidal rings that are stacked co-axially one upon another abstract; “three toroidal rings 20, 30 and 40 placed co-axially one upon another” column 2, line 19 – 20, Figure 3).
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, Piantelli and APPENDIX 3 to incorporate multiple toroid or cylinder magnetic cores, as taught by Chu, for the benefit of prevent[ing] “improper operation and/or overheating” (Chu: column 1, lines 11).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Sivo, APPENDIX 3 and Chu, as applied in claim 32, in view of Mangano et al (US 6589786 B1, hereinafter Mangano).
Regarding claim 33, Sivo, APPENDIX 3 and Chu teach all limitations of claim 32. The modified invention of Sivo APPENDIX 3 and Chu 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, APPENDIX 3 and Chu 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, APPENDIX 3 and Chu, as applied in claim 32, in view of Hulvershorn et al (US 20100036453 A1, hereinafter Hulvershorn).
Regarding claim 34, Sivo, APPENDIX 3 and Chu teach all limitations of claim 32. The modified invention of Sivo, APPENDIX 3 and Chu 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, APPENDIX 3 and Chu 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, APPENDIX 3 and Chu 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 35 is rejected under 35 U.S.C. 103 as being unpatentable over Siv, APPENDIX 3 and Chu, as applied in claim 32, in view of Rehan et al (US 20070203390 A1, hereinafter “Rehan”).
Regarding claim 35, Sivo APPENDIX 3 and Chu 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, APPENDIX 3 and Chu 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.
Allowable Subject Matter
Claimd 1 - 24 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, in light of applicant’s amendments, filed 15 May 2026 with respect to prior are allowable. The prior art of record, either singly or in combination does not teach and/or fairly suggest a device for generating pulsed electrical fields, comprising: multiple toroid or cylinder magnetic cores, a plurality of conducting windings wrapped around each toroid or cylinder magnetic core, a plurality of wires that supply electrical current to the conducting windings, wherein the multiple toroid or cylinder magnetic cores are arranged coaxially, at separations by a distance equal to the radius of the toroid or cylinder structure; and wherein the device is configured to deliver a uniform external electrical field that comprises an amplitude less than 100 V/m over the entire body of a patient without contacting the patient.
The inclusion of “the multiple toroid or cylinder magnetic cores are arranged coaxially, at separations by a distance equal to the radius of the toroid or cylinder structure” is what sets the application apart from prior art.
The closet prior art of record, [primary art in view of art…] in combination teach[es] the following:
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:
A toroid or cylinder magnetic cores ([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 the toroid or cylinder magnetic core ([0037]), and -3
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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The modified invention of Sivo and APPENDIX 3 does not teach multiple toroid or cylinder magnetic cores.
However, Chu discloses a “toroidal core for a toroid, including at least two toroidal ring” (abstract) and teaches multiple toroid or cylinder magnetic cores (“at least two toroidal rings that are stacked co-axially one upon another abstract; “three toroidal rings 20, 30 and 40 placed co-axially one upon another” column 2, line 19 – 20, Figure 3).
However, these references fail to disclose, either singly or in combination, a device for generating pulsed electrical fields, comprising multiple toroid or cylinder magnetic cores, wherein the multiple toroid or cylinder magnetic cores are arranged coaxially, at separations by a distance equal to the radius of the toroid or cylinder structure as claimed.
Claims 2 - 24 are dependent on claim 1.
Response to Arguments
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, pages 7 - 8, filed 15 May 2026, 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, examiner contends it is pertinent to the problem of the inventor since it is a known range for what is safe to apply to a human. Thus, 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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