DETAILED ACTION
This action is a response to the filing on 4/23/2026. Examiner acknowledges the amendments made to claims 61-63, 64-68, 72-74, 76-78, 81-86, and 88.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/13/2026 is being considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 61-88 have been considered but are moot because the new ground of rejection does not rely on any reference or relies on a different combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 61, and 76 are objected to because of the following informalities:
In claim 61, lines 8-9, “a predefined operational conditions” should be –predefined operational conditions--.
In claim 76, line 8, “a predefined operational conditions” should be –predefined operational conditions--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 61, 65, 71, and 72 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0133717 (Ghiron et al., hereinafter Ghiron).
In regards to claim 61, Ghiron discloses a method and system for monitoring magnetic stimulation (see title and abstract; paragraphs 18-120). Ghiron discloses a device with the following components:
a first coil unit (magnetic stimulation unit – 150, stimulation unit can be multiple treatment coils; paragraph 28) configured to be positioned at the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field ();
a second coil unit (magnetic stimulation unit – 150, stimulation unit can be multiple treatment coils; paragraph 28) configured to be positioned at the human or animal body to stimulate the second nerve by applying an electric or electro-magnetic second field; and
a safety control device (controller(s) 120, 220; multiple controllers control both sensors and magnetic stimulation system where each controller can be used to individually control magnetic stimulation components; paragraphs 31-40, 46-52) configured to ensure compliance with predefined operational conditions during stimulation of the first nerve by means of the first coil unit and of the second nerve by means of the second coil unit,
wherein the safety control device comprises a measurement circuit (sensor 110; flux gate sensor would measure magnetic flux and can be considered a measurement circuit and generation of voltage that is measured would require a measurement circuit; paragraphs 7, 29, 30, 35, ) configured to measure a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit (multiple controllers control both sensors and magnetic stimulation system where each controller can be used to individually control magnetic stimulation components; paragraphs 31-40, 46-52; Note that the claim does not specify if what is measured is the combined fluxes or the fluxes of the individual coils and also does not state how the measurement relates to ensuring compliance).
In regards to claim 65, Ghiron discloses the limitations of claim 61. In addition, paragraphs 35-39 and 46-52 discloses the controller determining if a characteristic is outside of an acceptance window and pausing or shutting down the stimulation procedure if the detected parameter is outside the acceptance window and initiates stimulation if no failure is detected.
In regards to claim 71, Ghiron discloses the limitations of claim 61. Because the device is a magnetic stimulation device, the coil units would be configured to activate by supplying stimulation current to the first and second coil units and would have impulses generated by one current.
In regards to claim 72, Ghiron discloses the limitations of claim 61. In addition, because Ghiron is a magnetic stimulation device, the power source (power supply 140; paragraph 27) of the device could be interpreted as a stimulator configured to induce currents in the first and second coil units.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) as applied to claim 61 above, and further in view of US 2006/0094924 (Riehl).
In regards to claim 62, Ghiron discloses the limitations of claims 61 but does not state that the predefined operational conditions involve cancelling an electric or electro-magnetic field in a region offset the first and second nerve when the first coil and second units are applying magnetic fields. In a related area, Riehl discloses systems and methods to reduce discomfort using nerve stimulation (see title and abstract). Of note is paragraph 49 which discloses the use of another coil during stimulation that applies its own magnetic field to cancel a portion of the magnetic field made by the stimulation device in order to maintain magnetic strength at the region of therapy while diminishing magnetic field strength in areas that should not be stimulated. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Ghiron to include the step of cancelling magnetic fields as taught by Riehl in order to maintain magnetic strength at the region of therapy while diminishing magnetic field strength in areas that should not be stimulated.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) as applied to claim 61 above, and further in view of US 5,743,844 (Tepper et al., hereinafter Tepper).
In regards to claim 68, Ghiron discloses the limitations of claim 61 but does not disclose the presence of a monitoring circuit that detects faults. In a related area, Tepper discloses a pulsed electromagnetic field stimulation (PEMF) system and method (title and abstract) that uses circuitry (monitoring unit) to detect faults in the PEMF system circuits (column 8, lines 35-column 9, line 45) that determines if there are issues in the coil circuitry. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention, to modify the device of Ghiron to detect faults at the coils unit as taught by Tepper in order to determine if there are issues in the coil circuitry.
Claim(s) 69 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron), as applied to claim 61 above, and further in view of US 2012/0016280 (Aliverti).
In regards to claims 69 and 70, Ghiron discloses the limitations of claim 61 but does not show a connector that electrically connects the coil units and that the coil units are individually positionable on a human or animal body. In a related area, Aliverti discloses a magnetic stimulation device and its application in stimulating nerves (title and abstract; figures 1-3; paragraphs 31-79). Aliverti shows the following steps
positioning a first coil unit at the first nerve of the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field (figures 1-3, elements 10, 14 left side; paragraph 51); and
positioning a second coil unit at the second nerve of the human or animal body by applying an electric or electro-magnetic second field (figures 1-3, elements 11 14 right side; paragraph 51).
Aliverti states that this is done to stimulate abdominal muscles or stimulate the phrenic nerve to stimulate abdominal muscles and the diaphragm to pump blood (paragraphs 24-26 and 42-59). Aliverti also states that the coils are connected by cables (12 and 15) to electronic circuits. Aliverti states modifying positions of stimulators to accommodate differences in body size (paragraphs 21-54 and 78). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Ghiron to include connectors and making the coil units individually positionable on a human body as taught by Aliverti in order accommodate differences in body size to stimulate abdominal muscles or stimulate the phrenic nerve to stimulate abdominal muscles and the diaphragm to pump blood.
Claim(s) 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron), as applied to claim 61 above, and further in view of US 2018/0200503 (Ryaby et al., hereinafter Ryaby).
In regards to claim 74, Ghiron discloses the limitation of claim 61 but does not state the presence of a counter member that counts pulses for the first and second coils units. In a related area, Ryaby discloses a pulsed electromagnetic field device for stimulating musculoskeletal tissues (title and abstract). Paragraph 49 states the use of counter that counts the number of times a coil is energized against a threshold where the threshold is used to execute a different treatment regimen. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Ghiron to include a counter that counts pulses as taught by Ryaby in order to determine when to transition to different treatment regimens. Note that without knowing specifics about the predefined operational conditions, Ghiron and Ryaby would meet the limitations of the claim.
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron), as applied to claim 61 above, and further in view of US 2015/0360045 (Fischell et al., hereinafter Fischell).
In regards to claim 75, Ghiron discloses the limitations of claim 61 but does not state the presence of a button that operates the coils to induce pulses of their respective fields. In a related area, Fischell discloses an electrical pulse generator to create magnetic pulses for treatments (title and abstract). Of note is paragraphs 58-61 which details the operator of the device using a button to manually begin or stop treatment of the patient with the unique advantage of being readily adjustable to optimize treatment for different patients and treatment locations. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Ghiron to include a button that allows for manual operation as taught by Fischell in order to be readily adjustable to optimize treatment for different patients and treatment locations.
Claim(s) 76, 77, 83, and 88 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) in view of US 2012/0016280 (Aliverti).
In regards to claim 76 and 88, Ghiron discloses a method and system for monitoring magnetic stimulation (see title and abstract; paragraphs 18-120). Ghiron discloses a device with the following components:
a first coil unit (magnetic stimulation unit – 150, stimulation unit can be multiple treatment coils; paragraph 28) configured to be positioned at the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field ();
a second coil unit (magnetic stimulation unit – 150, stimulation unit can be multiple treatment coils; paragraph 28) configured to be positioned at the human or animal body to stimulate the second nerve by applying an electric or electro-magnetic second field; and
a safety control device (controller(s) 120, 220; multiple controllers control both sensors and magnetic stimulation system where each controller can be used to individually control magnetic stimulation components; paragraphs 31-40, 46-52) configured to ensure compliance with predefined operational conditions during stimulation of the first nerve by means of the first coil unit and of the second nerve by means of the second coil unit,
wherein the safety control device comprises a measurement circuit (sensor 110; flux gate sensor would measure magnetic flux and can be considered a measurement circuit and generation of voltage that is measured would require a measurement circuit; paragraphs 7, 29, 30, 35, ) configured to measure a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit (multiple controllers control both sensors and magnetic stimulation system where each controller can be used to individually control magnetic stimulation components; paragraphs 31-40, 46-52; Note that the claim does not specify if what is measured is the combined fluxes or the fluxes of the individual coils and also does not state how the measurement relates to ensuring compliance).
The controller units perform the ensuring compliance and measuring steps. However, Ghiron does not disclose the step of positioning coils. In a related area, Aliverti discloses a magnetic stimulation device and its application in stimulating nerves (title and abstract; figures 1-3; paragraphs 31-79). Aliverti shows the following steps
positioning a first coil unit at the first nerve of the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field (figures 1-3, elements 10, 14 left side; paragraph 51); and
positioning a second coil unit at the second nerve of the human or animal body by applying an electric or electro-magnetic second field (figures 1-3, elements 11 14 right side; paragraph 51).
Aliverti states that this is done to stimulate abdominal muscles or stimulate the phrenic nerve to stimulate abdominal muscles and the diaphragm to pump blood (paragraphs 24-26 and 42-59). Aliverti states modifying positions of stimulators to accommodate differences in body size (paragraphs 21-54 and 78). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Ghiron to include the steps of positioning coil units on different nerves as taught by Aliverti in order to accommodate differences in body size to stimulate abdominal muscles or stimulate the phrenic nerve to stimulate abdominal muscles and the diaphragm to pump blood.
In regards to claim 77, Ghiron and Aliverti disclose the limitations of claim 76. In addition, Aliverti discloses adjusting stimulator positions to accommodate different body sizes (paragraph 78). Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the method of Ghiron and Aliverti to include the step of adjusting a position of the coil units as taught by Aliverti in order to accommodate different body sizes.
In regards to claim 83, Ghiron and Aliverti disclose the limitations of claim 76. In addition, Ghiron shows in paragraphs 35-39 and 46-52 the controller determining if a characteristic is outside of an acceptance window and pausing or shutting down the stimulation procedure if the detected parameter is outside the acceptance window and initiates stimulation if no failure is detected.
Claim(s) 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) and US 2012/0016280 (Aliverti) as applied to claim 76 above, and further in view of US 2006/0094924 (Riehl).
In regards to claim 78, Ghiron and Aliverti disclose the limitations of claims 76 but do not state that the predefined operational conditions involve cancelling an electric or electro-magnetic field in a region offset the first and second nerve when the first coil and second units are applying magnetic fields. In a related area, Riehl discloses systems and methods to reduce discomfort using nerve stimulation (see title and abstract). Of note is paragraph 49 which discloses the use of another coil during stimulation that applies its own magnetic field to cancel a portion of the magnetic field made by the stimulation device in order to maintain magnetic strength at the region of therapy while diminishing magnetic field strength in areas that should not be stimulated. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Ghiron and Aliverti to include the step of cancelling magnetic fields as taught by Riehl in order to maintain magnetic strength at the region of therapy while diminishing magnetic field strength in areas that should not be stimulated.
Claim(s) 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) and US 2012/0016280 (Aliverti) as applied to claim 76 above, and further in view of US 5,743,844 (Tepper et al., hereinafter Tepper).
In regards to claim 83, Ghiron and Aliverti disclose the limitations of claim 76 but does not disclose the presence of a monitoring circuit that detects faults. In a related area, Tepper discloses a pulsed electromagnetic field stimulation (PEMF) system and method (title and abstract) that uses circuitry (monitoring unit) to detect faults in the PEMF system circuits (column 8, lines 35-column 9, line 45) that determines if there are issues in the coil circuitry. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention, to modify the method of Ghiron and Aliverti to detect faults at the coils unit as taught by Tepper in order to determine if there are issues in the coil circuitry.
Claim(s) 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) and US 2012/0016280 (Aliverti), as applied to claim 76 above, and further in view of US 2001/0018547 (Mechlenburg et al., hereinafter Mechlenburg).
In regards to claim 84 Ghiron and Aliverti disclose the limitations of claim 76. Aliverti also shows the individual positioning of the coil units in figures 1-3 and the rejection of claim 76. However, they do not state the sensing of temperatures at the coil units. In a related area, Mechlenburg discloses a muscle stimulating device using magnetic stimulation (title and abstract; paragraphs 11-113). Of note are paragraphs 13, 37, 51, 93, and 98 which disclose the use of a temperature sensor to monitor coil temperatures so that excessive heat is not generated at the coil by shutting off the coil when temperatures exceed a certain temperature (predefined operational conditions below a threshold temperature). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Ghiron and Aliverti to include sensing temperature of the coils as taught by Mechlenburg in order to ensure that excessive heat is not generated at the coil.
Claim(s) 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) and US 2012/0016280 (Aliverti), as applied to claim 76 above, and further in view of US 2018/0200503 (Ryaby et al., hereinafter Ryaby).
In regards to claim 86, Ghiron and Aliverti disclose the limitation of claim 76 but does not state the presence of a counter member that counts pulses for the first and second coils units. In a related area, Ryaby discloses a pulsed electromagnetic field device for stimulating musculoskeletal tissues (title and abstract). Paragraph 49 states the use of counter that counts the number of times a coil is energized against a threshold where the threshold is used to execute a different treatment regimen. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Ghiron and Aliverti to include a counter that counts pulses as taught by Ryaby in order to determine when to transition to different treatment regimens. Note that without knowing specifics about the predefined operational conditions, Ghiron, Aliverti, and Ryaby would meet the limitations of the claim.
Claim(s) 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0133717 (Ghiron et al., hereinafter Ghiron) and US 2012/0016280 (Aliverti), as applied to claim 76 above, and further in view of US 2015/0360045 (Fischell et al., hereinafter Fischell).
In regards to claim 87, Ghiron and Aliverti disclose the limitations of claim 76 but do not state the presence of a button that operates the coils to induce pulses of their respective fields. In a related area, Fischell discloses an electrical pulse generator to create magnetic pulses for treatments (title and abstract). Of note is paragraphs 58-61 which details the operator of the device using a button to manually begin or stop treatment of the patient with the unique advantage of being readily adjustable to optimize treatment for different patients and treatment locations. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Ghiron and Aliverti to include a button that allows for manual operation as taught by Fischell in order to be readily adjustable to optimize treatment for different patients and treatment locations.
Allowable Subject Matter
Claims 63, 64, 66, 67, 73, 79-82, and 85 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claims 63 and 79, the prior art of record does not teach or suggest a device, as claimed by Applicant, where the safety control device comprises a support structure substantially axially arranging the first coil unit and the second coil unit, wherein the first coil unit comprises a first winding and the second coil unit comprises a second winding, and wherein in an axial view a stimulation current flows through the first winding and the second winding in opposite directions, wherein,
in the axial view the first winding is wound in a first direction and the second winding is wound in a second direction, and the first direction is opposite to the second direction, and/or
the first coil unit and the second coil unit are adjustable relative to the support structure such that an angle between an axis of the first coil unit and an axis of the second coil unit is 30° or less, or 20° or less, or 10° or less.
In regards to claim 64, the prior art of record does not teach or suggest a device, as claimed by Applicant, wherein the first coil unit and the second coil unit are arranged such that a sum of the first and second fields generated by the first coil unit and the second coil unit is about zero at a distance more than 30 or 45 cm.
In regards to claim 66, the prior art of record does not teach or suggest a device, as claimed by Applicant, wherein the safety control device comprises a sensor configured to determine positions of the coil units relative to each other wherein the predefined operational conditions comprise the relative positions being within a predefined range.
In regards to claim 67, the prior art of record does not teach or suggest a device, as claimed by Applicant, wherein the predefined operational conditions comprise preventing a sum of the first and second magnetic fluxes exceed a predefined threshold,
the stimulation device is configured to measure the first and second magnetic fluxes by measuring a current flowing through the first coil unit and the second coil unit, and/or
the stimulation device is configured to measure the first and second magnetic fluxes by using a first part of a plurality of consecutive waveforms of a stimulation current, wherein the safety control device is configured to deactivate stimulation when the sum of the first magnetic flux and the second magnetic flux exceeds the predefined threshold.
In regards to claim 73, the prior art of record does not teach or suggest a device, as claimed by Applicant, that includes a first and second sensing formation having two temperature sensors and the first coil units include the first sensing formation and the second coil unit includes the second sensing formation and where the predefined operational conditions comprise current consumptions of the sensors being within a predefined threshold range of current consumption.
In regards to claim 80, the prior art of record does not teach or suggest a device, as claimed by Applicant, wherein the first coil unit and the second coil unit are arranged such that a sum of the first and second fields generated by the first coil unit and the second coil unit is about zero at a distance more than 30 or 45 cm, and/or are connected in series.
In regards to claim 81, the prior art of record does not teach or suggest a device, as claimed by Applicant, that includes the step of determining positions of the first coil unit and the second coil unit relative to each other wherein the predefined operational conditions comprise relative positions being within a predetermined range.
In regards to claim 82, the prior art of record does not teach or suggest a device, as claimed by Applicant, wherein:
the predefined operational conditions comprise preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold,
the first and second magnetic fluxes are measured by measuring a current flowing through the first coil unit and the second coil unit, and/or
the method comprises measuring the first and second magnetic fluxes by using a first part of a plurality of consecutive waveforms of a stimulation current, and deactivating stimulation when the sum of the first magnetic flux and the second magnetic flux exceeds the predefined threshold.
In regards to claim 85, the prior art of record does not teach or suggest a method, as claimed by Applicant, that includes providing two temperature sensors each to the first coil unit and the second coil unit includes the second sensing formation and where the security policy comprises current consumptions of the sensors being within a predefined threshold range of current consumption.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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