DETAILED ACTION
Response to Amendment
This Office Action is in response to the amendment filed 05/18/2026. Claims 65-91 are acknowledged as pending with claims 65-66, 69, 71, 75, 77, 79-86, and 88-90 being currently amended and claim 68 being cancelled.
The drawing and claim objections, as well as the rejections under 35 U.S.C. 112(b), 102(a)(1), and 103 are withdrawn as having been overcome by the amendment. New rejections necessitated by the amendment are presented below.
Response to Arguments
Per the Applicant’s response, Applicant argues on page 18, para. 2 that the primary reference Simon et al. (US 2015/0165226) does not teach two separately positionable coil units for stimulating two separate nerves as recited in claim 65, the argument is found persuasive.
Applicant argues on page 20-22 that the combination of references used to reject claim 68 (previously presented) does not teach the splitter-based connector arrangement. After further consideration, the argument is found persuasive.
Applicant’s arguments, filed 05/18/2026, with respect to the rejection(s) of claim(s) 65-91 under 35 U.S.C. 102(a)(1) and 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art.
Claim Objections
Claims 71-72, 75-76, are objected to because of the following informalities:
In claim 71, line 2, “the first field” should read “the electric or electro-magnetic first field”
In claim 71, lines 2-3, “the second field” should read “the electric or electro-magnetic second field”
In claim 72, line 2, “the first field” should read “the electric or electro-magnetic first field”
In claim 72, line 3, “the second field” should read “the electric or electro-magnetic second field”
In claim 75, lines 6-7, “the first field” should read “the electric or electro-magnetic first field”
In claim 75, line 7, “the second field” should read “the electric or electro-magnetic second field”
In claim 76, line 2, “the first field” should read “the electric or electro-magnetic first field”
In claim 76, line 3, “the second field” should read “the electric or electro-magnetic second field”
In claim 79, line 9, “the stimulation” should read “the stimulation device”
In claim 83, line 2, “the first field” should read “the electric or electro-magnetic first field”
In claim 83, line 3, “the second field” should read “the electric or electro-magnetic second field”
In claim 90, line 18, “the first field” should read “the electric or electro-magnetic first field”
In claim 90, line 19, “the second field” should read “the electric or electro-magnetic second field”
Appropriate correction is required.
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(s) 65, 69-70, 73-74, 78, 84, and 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. (US 9180305) in view of Seymour (TW 200937791), citing to attached translation.
Regarding claim 65, Roth et al. teaches a stimulation device (Fig. 3, system 10; Col. 2, lines 22-42) to stimulate a first nerve and a second nerve in a human or animal body for activating a target tissue in the human or animal body (Col. 3, lines 7-22; Col. 7, lines 35-40), comprising:
a first coil unit (Fig. 3, first electromagnetic stimulating coil 12) configured to be positioned at the human (Fig. 3, subject 16) or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field (Col. 8, lines 16-27);
a second coil unit (Fig. 3, second electromagnetic stimulating coil 14) configured to be positioned at the human (Fig. 3, subject 16) or animal body to stimulate the second nerve by applying an electric or electro-magnetic second field (Col. 8, lines 16-27), wherein the first coil unit and the second coil unit are individually positionable at the human or animal body (Col. 2, lines 24-29 and lines 53-55; Col. 3, lines 7-15; Claim 1).
Roth et al., in the embodiment relied upon above, fails to teach a connector connecting the first coil unit and the second coil unit such that the connector, the first coil unit and the second coil unit are electrically connected in series with each other, wherein the connector comprises a splitter, a first electrical cable connecting the splitter with the first coil unit and a second electrical cable connecting the splitter with the second coil unit.
Roth et al., in a separate embodiment, teaches a connector (see Claim 11) connecting the first coil unit and the second coil unit such that the connector, the first coil unit and the second coil unit are electrically connected in series with each other (Col. 3, lines 23-25; Fig. 12, coils L1 and L2; Claim 11; Col. 12, lines 41-44).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device disclosed in the first embodiment of Roth et al. with the connector disclosed in the second embodiment of Roth et al. Electrically connecting the coils in series with each other via a connector increases the total inductance of the circuit (Roth et al., Col. 13, lines 1-2).
While Roth et al., in the separate embodiment relied upon above, teaches the connector, Roth et al., in the separate embodiment relied upon above, fails to teach wherein the connector comprises a splitter, a first electrical cable connecting the splitter with the first coil unit and a second electrical cable connecting the splitter with the second coil unit.
In the same field of endeavor, Seymour teaches wherein the connector comprises a splitter (Fig. 2, splitter 118), a first electrical cable (Fig. 2, wire 226) connecting the splitter with the first load (Fig. 2, first set of loads 232) and a second electrical cable (Fig. 2, wire 230) connecting the splitter with the second load (Fig. 2, second set of loads 234).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the stimulation device disclosed in the second embodiment of Roth et al. with the splitter of Seymour. The splitter may be configured to apply a second regulated DC voltage across a multitude of output terminals in response to a DC supply voltage (Seymour, page 3, “the phase splitter 118 is configured to apply a second regulated DC voltage 122 across the first output terminal 1 8 and the second output terminal 11 of the DC power supply unit 104 in response to the DC power supply voltage 120. Above, and applying a third regulated DC voltage 124 across the second output 110 and the third output 112 of the DC power supply”).
Regarding claim 69, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. fails to teach wherein the stimulation device is configured to provide a first voltage from the splitter to the first coil unit, a second voltage from the first coil unit to the splitter, the second voltage from the splitter to the second coil unit and a third voltage from the second coil unit to the splitter.
Seymour further teaches wherein the stimulation device is configured to provide a first voltage from the splitter to the first load, a second voltage from the first load to the splitter, the second voltage from the splitter to the second load and a third voltage from the second load to the splitter (see Annotated Figure 2).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Roth et al. in view of Seymour with the regulated voltages of Seymour. Doing so supplies regulated voltages at different levels; therefore, if the coils have a fixed resistance, increasing/reducing the voltage also proportionally increases/reduces the current flowing through each respective coil unit (Seymour, Abstract; Claim 1).
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Annotated Figure 2
Regarding claim 70, Roth et al. in view of Seymour teaches the stimulation device according to claim 69 as stated above wherein the second voltage is about half of the first voltage (page 3, “Both the second and third regulated voltages are less than the DC supply voltage. Therefore, two reduced and regulated DC voltages are generated instead of using a step-down transformer before rectification”; since the regulated voltages are less than the power supply’s voltage, the circuit is structurally capable of variably reducing the output voltages) and/or the third voltage is about zero.
Regarding claim 73, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above wherein the first coil unit and the second coil unit are substantially axially arranged (Roth et al., Col. 2, lines 24-29 and 53-55; Col. 3, lines 7-15; Col. 7, lines 26-40, wherein the electromagnetic stimulating coils are configured to be positioned at various body parts/peripheral nerves or the same body part/peripheral nerve, therefore, the coils are configured to be operable along the same anatomical axis).
Regarding claim 74, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above wherein in an axial view a stimulation current flows through the first winding and the second winding in opposite directions (Roth et al., Col. 9, lines 36-38).
Regarding claim 78, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above wherein the stimulation device is configured to activate the first coil unit and the second coil unit by supplying a stimulation current to the first coil unit and the second coil unit (Roth et al., Col. 8, lines 4-7, lines 16-18, and lines 41-48).
Regarding claim 84, Roth et al. teaches a method of stimulating first and second nerves in a human or animal body for activating a target tissue in the human or animal body (Claim 1; Col. 2, lines 1-9; Col. 3, lines 12-22; Col. 6, lines 3-11), comprising the steps of:
individually 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 (Claim 1; Col. 2, lines 24-29 and lines 53-55; Col. 3, lines 7-15; Col. 8, lines 16-27);
individually positioning a second coil unit at the second nerve of the human or animal body by applying an electric or electro-magnetic second field (Claim 1; Col. 2, lines 24-29 and lines 53-55; Col. 3, lines 7-15; Col. 8, lines 16-27).
Roth et al., in the embodiment relied upon above, fails to teach the first coil unit and the second coil unit being electrically connected in series by means of a connector, wherein the connector comprises a splitter, a first electrical cable connecting the splitter with the first coil unit and a second electrical cable connecting the splitter with the second coil unit; and supplying a stimulation current to the first coil unit and the second coil unit via the connector.
Roth et al., in a separate embodiment, teaches wherein the first coil unit and the second coil unit being electrically connected in series by means of a connector (see Claim 11; Col. 3, lines 23-25; Col. 12, lines 41-44); and supplying a stimulation current to the first coil unit and the second coil unit via the connector (Fig. 13; Col. 12, lines 64-67 and Col. 13, lines 1-5; Col. 7, lines 46-49; Col. 8, lines 4-7 and lines 16-18).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method disclosed in the first embodiment of Roth et al. with the connector disclosed in the second embodiment of Roth et al. Electrically connecting the coils in series with each other via a connector increases the total inductance of the circuit (Roth et al., Col. 13, lines 1-2).
While Roth et al., in the separate embodiment relied upon above, teaches the connector, Roth et al., in the separate embodiment relied upon above, fails to teach wherein the connector comprises a splitter, a first electrical cable connecting the splitter with the first coil unit and a second electrical cable connecting the splitter with the second coil unit.
In the same field of endeavor, Seymour teaches wherein the connector comprises a splitter (Fig. 2, splitter 118), a first electrical cable (Fig. 2, wire 226) connecting the splitter with the first load (Fig. 2, first set of loads 232) and a second electrical cable (Fig. 2, wire 230) connecting the splitter with the second load (Fig. 2, second set of loads 234).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the stimulation device disclosed in the second embodiment of Roth et al. with the splitter of Seymour. The splitter may be configured to apply a second regulated DC voltage across a multitude of output terminals in response to a DC supply voltage (Seymour, page 3, “the phase splitter 118 is configured to apply a second regulated DC voltage 122 across the first output terminal 1 8 and the second output terminal 11 of the DC power supply unit 104 in response to the DC power supply voltage 120. Above, and applying a third regulated DC voltage 124 across the second output 110 and the third output 112 of the DC power supply”).
Regarding claim 91, a modified Roth et al. in view of Seymour teaches the method according to claim 84 as stated above wherein a stimulation device (Roth et al., in the first embodiment: Fig. 3) is used to perform the method, the stimulation device comprising:
a first coil unit configured to be positioned at the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field (Roth et al., in the first embodiment relied upon: Claim 1; Col. 8, lines 16-27);
a second coil unit configured to be positioned at the human or animal body to stimulate the second nerve by applying an electric or electro-magnetic second field (Roth et al., in the first embodiment relied upon: Claim 1; Col. 8, lines 16-27), wherein the first coil unit and the second coil unit are individually positionable at the human or animal body (Roth et al., in the first embodiment relied upon: Col. 2, lines 24-29 and lines 53-55; Col. 3, lines 7-15; Claim 1); and
a connector (Roth et al., in the separate embodiment relied upon: see Claim 11) connecting the first coil unit and the second coil unit such that the connector, the first coil unit and the second coil unit are electrically connected in series with each other (Roth et al., in the separate embodiment relied upon: Col. 3, lines 23-25; Fig. 12, coils L1 and L2; Claim 11; Col. 12, lines 41-44).
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, further in view of Schneider (US 2015/0099921).
Regarding claim 66, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. in view of Seymour fails to teach a bracket structure holding the first coil unit and the second coil unit, wherein the bracket structure is configured such that a position of the first coil unit relative to the second coil unit is adjustable, and/or wherein the first coil unit and the second coil unit are mechanically connected with each other only by the bracket structure.
Schneider teaches an analogous stimulation device further comprising a bracket structure (Figs. 2-3, frame 210 and 260) holding the first coil unit and the second coil unit (paras. 0025 and 0039-0040),
wherein the bracket structure is configured such that a position of the first coil unit relative to the second coil unit is adjustable (paras. 0015 and 0039), and/or
wherein the first coil unit and the second coil unit are mechanically connected with each other only by the bracket structure.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Roth et al. in view of Seymour with the bracket structure of Schneider. Incorporating a mechanical frame that supports the TMS coils may enable rough and fine positioning of said TMS coils around a patient’s skull for precise and focal treatment (Schneider, para. 0039).
Claim(s) 67, 72, and 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, further in view of Zangen et al. (WO 2019/150378).
Regarding claim 67, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. in view of Seymour fails to specifically teach wherein the connector comprises an electrical conduct directly connecting the first coil unit and the second coil unit.
Zangen et al. teaches an analogous stimulation device wherein the connector comprises an electrical conduct (Zangen et al., Figs. 1 and 6, wire segment 11-12) directly connecting the first coil unit and the second coil unit (Zangen et al., Figs. 1 and 6, wire segment 11-12; page 6, lines 7-12; page 20, lines 25-28).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Roth et al. in view of Seymour with the electrical conduct of Zangen et al. The electrical conduct may electrically connect the innermost winding/loop of one of the coils with an outermost winding of the other coil in serial fashion (Zangen et al., page 20, lines 6-11).
Regarding claim 72, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. in view of Seymour fails to teach wherein the first coil unit comprises a first coil winding for generating the first field and the second coil unit comprises a second coil winding for generating the second field, wherein the first coil winding of the first coil unit and the second coil winding of the second coil unit are wound axially in opposite directions.
Zangen et al. teaches an analogous stimulation device wherein the first coil unit comprises a first coil winding (Figs. 5-6, wound wing/lobe 11; page 22, lines 27-33 and page 23, lines 1-9) for generating the first field (page 21, lines 15-18) and the second coil unit comprises a second coil winding (Figs. 5-6, wound wing/lobe 12; page 22, lines 27-33 and page 23, lines 1-9) for generating the second field (page 21, lines 15-18), wherein the first coil winding of the first coil unit and the second coil winding of the second coil unit are wound axially in opposite directions (page 5, lines 10-19).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Roth et al. in view of Seymour with the opposite coil windings of Zangen et al. Winding the coils in opposite directions and arranging the stimulating coils relative to each other may induce an additive electromagnetic field near the stimulation site (Zangen et al., page 5, lines 15-19).
Regarding claim 86, Roth et al. in view of Seymour teaches the method according to claim 84 as stated above. Roth et al. further teaches substantially axially arranging the first coil unit and the second coil unit, wherein an angle between an axis of the first coil unit and an axis of the second coil unit is ten degrees or less, or five degrees or less (Col. 3, lines 7-22; Col. 7, lines 26-40, wherein the location of the electromagnetic stimulation coils are configured to be positionable on the same body part, different body parts, or different regions of the same body part; therefore, the electromagnetic stimulation coils are structurally and functionally capable of being oriented along the same anatomical axis with an angle of 10 degrees or less between each other). Roth et al. in view of Seymour fails to teach wherein the first coil unit comprises a first winding wound in a first direction, the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction.
In the same field of endeavor, Zangen et al. teaches wherein the first coil unit comprises a first winding wound in a first direction, and the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction (Zangen et al., page 5, lines 10-19).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Roth et al. in view of Seymour with the opposite coil windings of Zangen et al. Winding the coils in opposite directions and arranging the stimulating coils relative to each other may induce an additive electromagnetic field near the stimulation target (Zangen et al., page 5, lines 15-19).
Claim(s) 71 and 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, further in view of Schwarz et al. (US 10,709,895).
Regarding claim 71, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. in view of Seymour fails to specifically teach wherein the first coil unit is configured to generate the first field independent from the second coil unit generating the second field.
Schwarz et al. teaches an analogous stimulation device wherein the first coil unit is configured to generate the first field independent from the second coil unit generating the second field (Schwarz et al., Col. 4, lines 6-11; Claim 1, “the first magnetic field generating coil to generate a first time-varying magnetic field having a magnetic flux density in a range of 0.5 Tesla to 7 Tesla… the second magnetic field generating coil to generate a second time-varying magnetic field having a magnetic flux density in a range of 0.5 Tesla to 7 Tesla”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Roth et al. in view of Seymour with the varying electromagnetic/magnetic fields of Schwarz et al. Two independent electromagnetic/magnetic fields may be configured to generate a plurality of magnetic impulses at different intervals (Schwarz et al., Claim 1; Col. 20, lines 7-16).
Regarding claim 83, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. in view of Seymour fails to teach a button configured to, when activated, operate the first coil unit to induce a pulse of the first field and operate the second coil unit to induce a pulse of the second field, and/or wherein the first coil unit and the second coil unit are in at least five degrees of freedom individually positionable at the human or animal body.
Schwarz et al. teaches an analogous stimulation device further comprising a button (Fig. 31, switching devices 3118-3123; Col. 9, lines 46-52) configured to, when activated (Col. 15, lines 50-57, wherein the user may regulate the switch/energy source through the HMI), operate the first coil unit to induce a pulse of the first field and operate the second coil unit to induce a pulse of the second field (Col. 107, lines 1-20), and/or wherein the first coil unit and the second coil unit are in at least five degrees of freedom individually positionable at the human or animal body.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Roth et al. in view of Seymour with the switches of Schwarz et al. The switches enable the magnetic field generating device to generate either synchronized or independently timed impulses (Schwarz et al., Col. 107, lines 5-20).
Claim(s) 76 and 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, further in view of Schneider et al. (US 2016/0023015).
Regarding claim 76, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. in view of Seymour fails to teach wherein the first coil unit and the second coil unit are arranged such that a sum of the first field generated by the first coil unit and the second field generated by the second coil unit is about zero.
Schneider et al. teaches an analogous stimulation device wherein the first coil unit and the second coil unit are arranged such that a sum of the first field generated by the first coil unit and the second field generated by the second coil unit is about zero (paras. 0050-0051 and 0056).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Roth et al. in view of Seymour with the first and second coil arrangement generating a cancelled magnetic field of Schneider et al. The magnetic fields may be manipulated/shaped by arranging an TMS electromagnet with a positive polarity opposite to an TMS electromagnetic with a negative polarity. This particular electromagnet configuration may cancel the adjacent magnetic fields in a portion of the overlap zone (Schneider et al., paras. 0050-0051 and 0056).
Regarding claim 87, Roth et al. in view of Seymour teaches the method according to claim 84 as stated above. Roth et al. in view of Seymour fails to teach the first coil unit and the second coil unit are arranged such that a sum of the first field generated by the first coil unit and the second field generated by the second coil unit is about zero.
Schneider et al. teaches an analogous method wherein the first coil unit and the second coil unit are arranged such that a sum of the first field generated by the first coil unit and the second field generated by the second coil unit is about zero (paras. 0050-0051 and 0056).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Roth et al. in view of Seymour with the first and second coil arrangement generating a cancelled magnetic field of Schneider et al. The magnetic fields may be manipulated/shaped by arranging an TMS electromagnet with a positive polarity opposite to an TMS electromagnetic with a negative polarity. This particular electromagnet configuration may cancel the adjacent magnetic fields in a portion of the overlap zone (Schneider et al., paras. 0050-0051 and 0056).
Claim(s) 75, 77, 80, 82, 85, and 88 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, further in view of Savage (WO 2008/051790) and Casse et al. (US 2017/0225004).
Regarding claim 75, Roth et al. in view of Seymour teaches the stimulation device according to claim 65 as stated above. Roth et al. in view of Seymour fails to teach a safety control device configured to ensure compliance with a security policy 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 security policy comprises cancelling an electric or electro-magnetic field in a region offset the first and second nerves when the first coil unit and the second coil unit are applying the first field and the second field, and/or 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 wound in a first direction, the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction, wherein 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 100 or less, or 50 or less.
Savage teaches an analogous magnetic field generator further comprising a safety control device (see Annotated Figure 1 below) configured to ensure compliance with a security policy (para. 0022, “The microcontroller 14 contains executable code which runs a routine 16”; paragraphs 0023-0024) during stimulation of the first nerve (Abstract, “living being”; Fig. 3, where the magnetic field generator can be incorporated into a headband, pendent, watch, or earrings which is positioned near nerves) by means of the first coil unit (para. 0045, “number of the coils”) and of the second nerve (Abstract, “living being”; Fig. 3, where the magnetic field generator can be incorporated into a headband, pendent, watch, or earrings which is positioned near nerves) by means of the second coil unit (para. 0045, “number of the coils”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the stimulation device of Roth et al. in view of Seymour with the safety control device configured to ensure compliance with a security policy of Savage. With a safety control device, the stimulation device may be able to perform autonomous operations, such as automatically modulating and supplying a current into a coil to generate a magnetic field. Furthermore, by implementing a security policy (executable code that runs the system’s routine), determinations may be executed based on feedback received from the coupled sensors and control devices. Ultimately, this combination may create an intuitive and safeguarded magnetic field generator capable of emulating specific therapeutic electromagnetic frequency ranges (Savage, paras. 0010, 0022, 0025-0026, and 0048-0052).
While Savage teaches the safety control device configured to ensure compliance with a security policy, the combination of Roth et al., Seymour, and Savage fails to disclose wherein the security policy comprises cancelling an electric or electro-magnetic field in a region offset the first and second nerves when the first coil unit and the second coil unit are applying the first field and the second field, and/or
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 wound in a first direction, the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction, wherein 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 10° or less, or 5° or less.
Casse et al. teaches an analogous magnetic stimulator wherein, the security policy (para. 0023, “smart algorithms to provide feedback control to optimize stimulation”) comprises cancelling an electric or electro-magnetic field in a region offset the first and second nerves when the first coil unit and the second coil unit are applying the first field and the second field (paras. 0024, 0037, and 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Roth et al. in view of Seymour and Savage with the security policy comprising cancelling an electric or electromagnetic field of Casse et al. Implementing a security policy, that has the ability to cancel electric or electromagnetic fields, facilitates tailored, localized stimulations that have the ability to target specific nerve fascicles. By the same token, a security policy that produces localized stimulations may be configured to concurrently limit the spread of electrical currents into off-target regions (Casse et al., paragraphs 0023-0024 0061).
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Regarding claim 77, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the stimulation device according to claim 75 as stated above. Roth et al. in view of Seymour fails to teach wherein the safety control device comprises a controller, wherein, the controller of the safety control device is configured to detect a non-compliance with the security policy and to prevent activation of the first coil unit and the second coil unit when the non-compliance is detected, and/or the controller is configured to activate the first coil unit and the second coil unit in case the security policy is met.
Savage further teaches wherein the safety control device comprises a controller (Fig. 1, microcontroller 14), wherein,
the controller of the safety control device is configured to detect a non-compliance (Fig. 2a, step 32, wherein motion not detected is being construed as “non-compliance”) with the security policy (para. 0022; Fig. 2a) and to prevent activation of the first coil unit and the second coil unit when the non-compliance is detected (paras. 0026 and 0037), and/or
the controller is configured to activate the first coil unit and the second coil unit in case the security policy is met (para. 0036).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the safety control device comprising the controller of Savage. Because the controller is configured to receive feedback indicative of a patient’s motion and make determinations based on the received feedback, the stimulation device is designed to be inoperable when the device is not contacting/near a patient. This programmed deactivation fashions a system with integrated safety measures (Savage, paras. 0025-0026 and 0036-0037).
Regarding claim 80, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the stimulation device according to claim 75 as stated above. Roth et al. in view of Seymour fails to teach wherein the safety control device comprises a monitoring circuit configured to detect a fault of the first coil unit and/or the second coil unit, wherein the security policy comprises the monitoring unit not detecting the fault of the first coil unit and/or the second coil unit.
Savage further teaches wherein the safety control device comprises a monitoring circuit (Fig. 1, current sense circuit 90) configured to detect a fault of the first coil unit and/or the second coil unit (paras. 0074-0081; specifically, para. 0078, “failure of a component within the magnetic field generator 10”), wherein the security policy comprises the monitoring unit not detecting the fault of the first coil unit and/or the second coil unit (Fig. 6; para. 0078, “performs steps 194, 196, 198, and 200”; para. 0081).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the monitoring unit of Savage. The monitoring unit monitors and produces an analog voltage relative to the level of power source charging current, the circulating current is a good indicator that the coils are operating according to the system’s routine. Therefore, if an inapt amount of current is detected, the system may terminate the charging process; the termination functions as a safety precaution to avoid overcharging (Savage, paras. 0030, 0078, and 0081).
Regarding claim 82, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the stimulation device according to claim 75 as stated above. Roth et al. in view of Seymour fails to teach wherein the safety control device comprises a counter configured to count a number of pulses induced by the first coil unit and the second coil unit, wherein the security policy comprises the counted numbers of pulses being below a predefined threshold pulse number.
Savage further teaches wherein the safety control device comprises a counter (Fig. 1, microcontroller 14; paras. 0024-0025) configured to count a number of pulses induced by the first coil unit and the second coil unit (para. 0071 and 0077), wherein the security policy comprises the counted numbers of pulses being below a predefined threshold pulse number (para. 0072 and 0077).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the counter of Savage. A counter may meter the charge pulses and execute various system routine changes/modifications in response to the counted pulse frequencies being outside or within a predefined range (Savage, paras. 0071-0072).
Regarding claim 85, a modified Roth et al. in view of Seymour teaches the method according to claim 84 as stated above. Roth et al. further teaches adjusting the stimulation current supplied to the first coil unit and the second coil unit (Roth et al., in the first embodiment relied upon: Claim 4, Col. 8, lines 41-55; Col. 9, lines 30-38). Roth et al. in view of Seymour fails to teach ensuring compliance with a security policy during stimulation of the first and second nerves by means of the first coil unit and the second coil unit, wherein the security policy comprises cancelling an electric or electro-magnetic field in a region offset from the first and second nerves when the first coil unit and the second coil unit are applying the first and second fields.
Savage teaches an analogous method further comprising ensuring compliance with a security policy (para. 0022, “The microcontroller 14 contains executable code which runs a routine 16”; paragraphs 0023-0024) during stimulation of the first and second nerves (Abstract, “living being”; Fig. 3, where the magnetic field generator can be incorporated into a headband, pendent, watch, or earrings which is positioned near nerves) by means of the first coil unit and the second coil unit (para. 0045, “number of coils”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Roth et al. in view of Seymour with security policy compliance of Savage. By implementing a security policy (executable code that runs the system’s routine), determinations may be executed based on feedback received from the coupled sensors and control devices. Ultimately, this combination may create an intuitive and safeguarded magnetic field generator capable of emulating specific therapeutic electromagnetic frequency ranges (Savage, paras. 0010, 0022, 0025-0026, and 0048-0052).
While Savage teaches the security policy, the combination of Roth et al., Seymour, and Savage fails to disclose wherein the security policy comprises cancelling an electric or electro-magnetic field in a region offset from the first and second nerves when the first coil unit and the second coil unit are applying the first and second fields.
Casse et al. teaches an analogous method wherein the security policy (para. 0023, “smart algorithms to provide feedback control to optimize stimulation”) comprises cancelling an electric or electro-magnetic field in a region offset from the first and second nerves when the first coil unit and the second coil unit are applying the first and second fields (paragraphs 0024, 0037, and 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Roth et al. in view of Seymour and Savage with the security policy comprising cancelling an electric or electromagnetic field of Casse et al. Implementing a security policy, that has the ability to cancel electric or electromagnetic fields, facilitates tailored, localized stimulations that have the ability to target specific nerve fascicles. By the same token, a security policy that produces localized stimulations may be configured to concurrently limit the spread of electrical currents into off-target regions (Casse et al., paragraphs 0023-0024 0061).
Regarding claim 88, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the method according to claim 85 as stated above. Roth et al. in view of Seymour fails to teach detecting a non-compliance with the security policy and preventing activation of the first coil unit and the second coil unit when the non-compliance is detected, activating the first coil unit and the second coil unit in case the security policy is met, and/or determining positions of the first coil unit and the second coil unit relative to each other, wherein the security policy comprises the relative positions being within a predefined range.
Savage further teaches detecting a non-compliance (Fig. 2A, step 32, wherein motion not detected is being construed as non-compliance) with the security policy (para. 0022; Fig. 2A) and preventing activation of the first coil unit and the second coil unit when the non-compliance is detected (paras. 0026 and 0037),
activating the first coil unit and the second coil unit in case the security policy is met (para. 0036), and/or
determining positions of the first coil unit and the second coil unit relative to each other, wherein the security policy comprises the relative positions being within a predefined range.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the method of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the non-compliance detection of Savage. Incorporating a non-compliance detection step ensures the magnetic field generator is within proximity or near the patient before treatment is applied, thereby minimizing hazardous situations (Savage, paras. 0025-0026, 0031, and 0036-0037).
Claim(s) 79 and 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, Savage, and Casse et al., further in view of Niemi (US 4,548,208).
Regarding claim 79, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the stimulation device according to claim 75 as stated above. Savage further teaches wherein the safety control device comprises a sensor (Fig. 1, motion sensor 30) configured to determine positions of the first coil unit and the second coil unit relative to each other (paras. 0011, 0025, 0031-0032, and 0042-0045, wherein the magnetic field generator comprises a headband with a plurality of coils disposed within, and the microcontroller determines if the magnetic field generator is in proximity to the living being, therefore, the microcontroller is configured to determine the location of the coils), wherein the security policy comprises the relative positions being within a predefined range (paras. 0026, wherein the microcontroller, running the routine, determines if the magnetic field generator is in proximity to the living being).
Roth et al. in view of Seymour, further in view of Savage and Casse et al. fails to teach wherein, the safety control device comprises a measurement circuit configured to measure a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit, wherein the security policy comprises preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold, the stimulation 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.
Niemi teaches an analogous stimulation device wherein the safety control device comprises a measurement circuit (Col. 13, lines 60-67) configured to measure a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit (Abstract; Col. 3, lines 30-36; Col. 6, lines 22-25; Col. 4, lines 1-10), wherein the security policy comprises preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold (Col. 2, lines 44-58),
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 (Col. 2, lines 43-58; Col. 3, lines 30-36).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have combined the stimulation device of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the measurement circuit of Niemi. By measuring the current flowing through the coils, the system may be configured to sense a short in a coil, a faulty coil, or a faulty cable when an overcurrent mode is identified (Niemi, Col. 2, lines 48-58).
Regarding claim 89, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the method according to claim 85 as stated above. Roth et al. in view of Seymour, further in view of Savage and Casse et al. fails to teach measuring a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit, wherein, the security policy comprises 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.
Niemi teaches an analogous method further comprising measuring a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit (Abstract; Col. 3, lines 30-36; Col. 6, lines 22-25; Col. 4, lines 1-10), wherein, the security policy comprises preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold (Col. 2, lines 44-58), the first and second magnetic fluxes are measured by measuring a current flowing through the first coil unit and the second coil unit (Col. 13, lines 60-67), 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.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have combined the method of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the measurement step of Niemi. By measuring the current flowing through the coils, the system may be configured to sense a short in a coil, a faulty coil, or a faulty cable when an overcurrent mode is identified (Niemi, Col. 2, lines 48-58).
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, Savage, and Casse et al., further in view of Zangen et al. (WO 2019/150378).
Regarding claim 81, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the stimulation device according to claim 75 as stated above. Roth et al. in view of Seymour, further in view of Savage and Casse et al. fails to teach wherein the safety control device comprises a first temperature sensing structure and a second temperature sensing structure, and wherein the first coil unit comprises the first temperature sensing structure and the second coil unit comprises the second temperature sensing structure, wherein, the first temperature sensing structure comprises a first temperature sensor and a second temperature sensor, and wherein the second temperature sensing structure comprises a first temperature sensor and a second temperature sensor, wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing structure, of the second temperature sensor of the first temperature sensing structure, of the first temperature sensor of the second temperature sensing structure, and of the second temperature sensor of the second temperature sensing structure being within a predefined threshold range of current consumption, and/or the security policy comprises temperatures measured by the first temperature sensing structure and by the second temperature sensing structure being below a predefined threshold temperature.
In the same field of endeavor, Zangen et al. teaches a first temperature sensing structure and a second temperature sensing structure (Fig. 1, temperature sensors 14), and wherein the first coil unit comprises the first temperature sensing structure and the second coil unit comprises the second temperature sensing structure (Fig. 1, lobes 11 and 12; page 6, lines 26-30; page 15, lines 24-28; page 19, lines 28-33), wherein,
the first temperature sensing structure comprises a first temperature sensor and a second temperature sensor, and wherein the second temperature sensing structure comprises a first temperature sensor and a second temperature sensor, wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing structure, of the second temperature sensor of the first temperature sensing structure, of the first temperature sensor of the second temperature sensing structure, and of the second temperature sensor of the second temperature sensing structure being within a predefined threshold range of current consumption, and/or
the security policy comprises temperatures measured by the first temperature sensing structure and by the second temperature sensing structure being below a predefined threshold temperature (page 19, lines 28-33; page 10, lines 6-8).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have combined the stimulation device of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the temperature structures of Zangen et al. The temperature sensors may facilitate real-time monitoring of the coil units, thereby preventing the coil units from overheating and inducing adverse effects near the application site (Zangen et al., page 6, lines 26-30; page 15, lines 24-28; page 19, lines 28-33).
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. in view of Seymour, Savage, and Casse et al., further in view of Zangen et al. and Schwarz et al.
Regarding claim 90, Roth et al. in view of Seymour, further in view of Savage and Casse et al. teaches the method according to claim 85 as stated above. Roth et al. in view of Seymour fails to teach detecting a fault of the first coil unit and/or the second coil unit, wherein the security policy comprises not detecting the fault of the first coil unit and/or the second coil unit, sensing a temperature at the first coil unit and a temperature at the second coil unit, wherein the security policy comprises the sensed temperatures being below a predefined threshold temperature, providing the first coil unit with a first temperature sensor and a second temperature sensor of a first temperature sensing structure, and providing the second coil unit with a first temperature sensor and a second temperature sensor of a second temperature sensing structure, wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing structure, of the second temperature sensor of the first temperature sensing structure, of the first temperature sensor of the second temperature sensing structure, and of the second temperature sensor of the second temperature sensing structure being within a predefined threshold range current consumption, counting a number of pulses induced by the first coil unit and the second coil unit, wherein the security policy comprises the counted numbers of pulses being below a predefined threshold pulse number, manually operating the first coil unit to induce a pulse of the first field and the second coil unit to induce a pulse of the second field.
Savage further teaches detecting a fault of the first coil unit and/or the second coil unit (paras. 0074-0081; specifically, para. 0078, “failure of a component within the magnetic field generator 10”), wherein the security policy comprises not detecting the fault of the first coil unit and/or the second coil unit (Fig. 6; para. 0078, “performs steps 194, 196, 198, and 200”; para. 0081), and
counting a number of pulses induced by the first coil unit and the second coil unit (Fig. 1, microcontroller 14; paras. 0024, 0071, and 0077), wherein the security policy comprises the counted numbers of pulses being below a predefined threshold pulse number (paras. 0072 and 0077).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the method of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the fault detection and counting step of Savage. Monitoring the current and counting the pulses ensures the system’s routine is running according to the preprogrammed treatment parameters. Therefore, if the counted pulse frequencies are outside a predefined range or if the current is determined to over/under supplied, modifications to the routine can be made to either terminate or alter the parameters (Savage, paras. 0030, 0071-0073, 0078, and 0081).
While Savage teaches detecting a fault of the first and second coil unit and counting a number of pulses, the combination of Roth et al., Seymour, Savage, and Casse et al. fails to teach sensing a temperature at the first coil unit and a temperature at the second coil unit, wherein the security policy comprises the sensed temperatures being below a predefined threshold temperature, providing the first coil unit with a first temperature sensor and a second temperature sensor of a first temperature sensing structure, and providing the second coil unit with a first temperature sensor and a second temperature sensor of a second temperature sensing structure, wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing structure, of the second temperature sensor of the first temperature sensing structure, of the first temperature sensor of the second temperature sensing structure, and of the second temperature sensor of the second temperature sensing structure being within a predefined threshold range current consumption, and manually operating the first coil unit to induce a pulse of the first field and the second coil unit to induce a pulse of the second field.
In the same field of endeavor, Zangen et al. teaches sensing a temperature at the first coil unit and a temperature at the second coil unit (page 6, lines 26-30; Col. 11, lines 20-25; page 15, lines 24-29), wherein the security policy comprises the sensed temperatures being below a predefined threshold temperature (page 19, lines 28-33; page 10, lines 6-8),
providing the first coil unit with a first temperature sensor and a second temperature sensor of a first temperature sensing structure (Fig. 1, temperature sensors 14; page 11, lines 20-25, “one or more temperature sensor”), and providing the second coil unit with a first temperature sensor and a second temperature sensor of a second temperature sensing structure (Fig. 1, temperature sensors 14; page 11, lines 20-25, “one or more temperature sensor”), wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing structure, of the second temperature sensor of the first temperature sensing structure, of the first temperature sensor of the second temperature sensing structure, and of the second temperature sensor of the second temperature sensing structure being within a predefined threshold range current consumption (page 6, lines 26-30 “communicate signals generated by the temperature sensors to external devices (e.g., control unit)”; page 30, lines 5-32, where the control unit regulates the electric current supplied to the windings. The temperature sensor and control unit are in communication, the temperature sensors generate measurement data/signals indicative of the temperature of the coil windings. An increase in current directly relates to an increase in temperature; consequently, the temperature sensors act as a current consumption indicator).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the method of Roth et al. in view of Seymour, further in view of Savage and Casse et al. with the temperature structures of Zangen et al. The temperature sensors may facilitate real-time monitoring of the coil units, thereby preventing the coil units from overheating and inducing adverse effects near the application site (Zangen et al., page 6, lines 26-30; page 15, lines 24-28; page 19, lines 28-33).
While Roth et al. in view of Seymour, Savage, and Casse et al., further in view of Zangen et al. teaches the temperature sensing structures, the combination of Roth et al., Seymour, Savage, Casse et al., and Zangen et al. fails to teach manually operating the first coil unit to induce a pulse of the first field and the second coil unit to induce a pulse of the second field.
Schwarz et al. teaches an analogous method further comprising manually operating the first coil unit to induce a pulse of the first field and the second coil unit to induce a pulse of the second field (Fig. 31, switching devices 3118-3123; Col. 9, lines 46-52; Col. 15, lines 50-57, wherein the user may regulate the switch/energy source through the HM; Col. 107, lines 1-20).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further combined the method of Roth et al. in view of Seymour, Savage, Casse et al., further in view of Zangen et al. with the manual operating step of Schwarz et al. Manually operating the switches enables the magnetic field generating device to generate either synchronized or independently timed impulses (Schwarz et al., Col. 107, lines 5-20).
Conclusion
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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