DETAILED ACTION
This Office Action is responsive to the Amendment filed 13 August 2025. Claims 1 – 2, 6 – 14, 16 – 19, and 21 – 27 are now pending. The Examiner acknowledges the amendments to claims 1, 19, 23 and 26.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 2, 6 – 14, 16 – 19, and 21 – 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 23, the limitation “… period of time are sequential and not overlapping such that” is unclear as it raises the question what “overlapping” entails, whether it refers to a duration of time such as implying one period being from 1 – 5 minutes and the next period being 6 – 10 minutes in which both period duration is five minutes long.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7, 11, 13 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al (US 20130289433 A1, hereinafter Jin) in view of Schneider et al (US 20100286470 A1, hereinafter Schneider).
Regarding claim 1, Jin teaches a pulsed electromagnetic field device (abstract; [0006]; Figure 4 phased array as shown in Figure 8) configured to direct pulsed electromagnetic fields ([0023]) toward a brain of a user (abstract, Figure 4), comprising:
a head covering (“cap”, [0014], Figure 4) having an internal surface configured to receive a head of the user ([0007]), wherein the head covering has a left side, a right side, a top side, a front side and a back side (see annotated Figure 4 below);
at least two planar flexible arrays ([0006] – [0007], Figure 8), wherein:
each of the at least two planar flexible arrays ([0006] – [0007], Figure 8) comprises at least one planar microcoil ([0022] – [0023]; emitters, 404, 405 being phased emitters; 801 showing the structure of the phased emitter) integrated into a flexible substrate ([0006] – [0007]);
a first of the at least two planar flexible arrays is coupled to at least one of the left side, the right side, the top side, the front side or the back side of the head covering; and
a second of the at least two planar flexible arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) is coupled to at least one of the left side, the right side (see annotated Figure 4 below), the top side, the front side or the back side ([0014]) and is not on a same side as the first of the at least two planar flexible arrays (see annotated Figure 4 below); and
a controller (“central processor” 802, [0053], Figure 8) configured to be electrically coupled to each of the at least two planar flexible arrays (see annotated Figure 4 below) and configured to generate an electrical current ([0006] – [0007], [0018]),
wherein each array of the at least two planar flexible arrays (see annotated Figure 4 below) is configured to receive the electrical current and generate separate pulsed electromagnetic fields ([0006] – [0007], [0018]),
wherein, during a treatment session ([0035]), the controller (802) is configured to direct the electrical current to the first of the at least two planar flexible arrays (see annotated Figure 4 below) for a first period of time ([0035]) and configured to direct the electrical current to the second of the at least two planar flexible arrays (see annotated Figure 4 below) for a second period of time ([0035]). Additionally, the coils Jin mentions are considered to be ''microcoils'' in that the coils are of a small size ([0023]).
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Jin does not teach the first period of time and the second period of time are sequential and not overlapping such that a first magnetic field is emitted for the first period of time and not the second period of time, and a second magnetic field is emitted for the second period of time and not the first period of time.
However, Schneider discloses “Transcranial Magnetic Simulation (TMS) systems and methods of using them for emitting focused, or shaped, magnetic fields for TMS” and teaches the first period of time and the second period of time are sequential (“the primary and secondary TMS electromagnets may be stimulated sequentially, but within a window of time to allow temporal summation of the magnetic fields on the tissue”, [0050];”By firing the front and back triad at separate times, mutual interference may be minimized”, [0059]) and not overlapping such that a first magnetic field is emitted for the first period of time and not the second period of time ([0050],”By firing the front and back triad at separate times, mutual interference may be minimized”, [0059]), and a second magnetic field is emitted for the second period of time and not the first period of time ([0050],”By firing the front and back triad at separate times, mutual interference may be minimized”, [0059]).
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 pulsed electromagnetic field device of Jin such that the first period of time and the second period of time are sequential, in light of paragraph [0050] that the controller is configured to direct emission for one time period and not the other, as taught by Schneider, for the benefit of prevent undesirable coil interference while stimulating a target (Schneider: [0059]).
Regarding claim 7, Jin and Schneider teach all limitations of claim 1. Jin teaches the controller (“central processor” 802, [0053], Figure 8) is configured to direct the electrical current to each of the at least two planar flexible arrays ([0006] – [0007], Figure 8) such that, over the treatment session (“…stimulating two or more regions in the brain of a patient treated with such a device when rTMS is required to generate synchronous TMS pulses that affect multiple regions of the brain ... " [0005]; examples of sessions for treating various disorders, [0044 - 0047]), a same volume of the user's brain (“... the [magnetic] lobes can effectively be focused to a targeted area [same volume of the user's brain] of the scalp and underlying brain structures ... ", [0035]) is exposed to the separate pulsed electromagnetic fields, wherein the separate pulsed electromagnetic fields change direction ([0036]) depending on which of the at least two planar flexible arrays is receiving the electrical current ([0036] – [0037]). Since each type of Jin's emitters/coils are identical around the surface of the cap, Jin's emitters/coils target the same amount of volume directed towards the targeted area (paragraph [0035]) and the direction of stimulation changes depending on where the arrays are located on a user's head in order for electromagnetic fields to penetrate the skull (paragraph [0036]).
Regarding claim 11, Jin and Schneider teach all limitations of claim 1. Jin teaches each of the at least two planar flexible arrays ([0006] – [0007], Figure 8) comprises at least 4 spiral-shaped (Figure 8) planar microcoils ([0022 - 0023]; emitters, 404, 405 being phased emitters; 801 showing the structure of the phased emitter) that are each embedded into the flexible substrate ([0006] – [0007]).
Regarding claim 13, Jin and Schneider teach all limitations of claim 1. Jin teaches a third of the at least two planar flexible arrays (see annotated Figure 4 below), wherein the third of the at least two planar flexible arrays is coupled to at least one of the left side (see annotated Figure 4 below), the right side, the top side, the front side or the back side and is not on the same side as the first of the at least two planar flexible arrays or on a same side as the second of the at least two planar flexible arrays (see annotated Figure 4 below).
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Regarding claim 23, Jin teaches a pulsed electromagnetic field device (abstract; [0006]; Figure 4 phased array as shown in Figure 8) configured to direct pulsed electromagnetic fields ([0023]) toward a brain of a user (abstract, Figure 4), comprising:
a hat defined by a crown (“cap”, [0014], Figure 4) having an internal surface configured to receive a head of the user (abstract, Figure 4), wherein the crown has a left side, a right side, a top side, a front side and a back side (see annotated Figure 4 above);
at least three planar arrays (see annotated Figure 4 above), wherein:
each of the at least three planar arrays ([0006] – [0007], Figure 8) comprises at least two planar microcoils ([0022] – [0023]; emitters, 404, 405 being phased emitters; 801 showing the structure of the phased emitter) integrated into a substrate ([0006] – [0007]);
a first of the at least three planar arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) is coupled to at least one of the left side, the right side, the top side, the front side (see annotated Figure 4 above) or the back side of the crown;
a second of the at least three planar arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) is coupled to at least one of the left side, the right side (see annotated Figure 4 above), the top side, the front side or the back side and is not on a same side as the first of the at least three planar arrays; and
a third of the at least three planar arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) is coupled to at least one of the left side (see annotated Figure 4 above), the right side, the top side, the front side or the back side and is not on the same side as the first of the at least three planar arrays or on a same side as the second of the at least three planar arrays; and
a controller (“central processor” 802, [0053], Figure 8) configured to be electrically coupled to each of the at least three planar arrays and configured to generate an electrical current ([0006] – [0007], [0018]), wherein each array of the at least three planar arrays (see annotated Figure 4 above) is configured to receive the electrical current and generate separate pulsed electromagnetic fields ([0006] – [0007], [0018]), wherein, during a treatment session ([0035]), the controller (802) is configured to direct the electrical current to the first of the at least three planar arrays (see annotated Figure 4 above) for a first period of time ([0035]), configured to direct the electrical current to the second of the at least three planar arrays (see annotated Figure 4 above) for a second period of time ([0035]), and configured to direct the electrical current to the third of the at least third planar flexible arrays (see annotated Figure 4 above) for a third period of time ([0035]).
Jin does not teach the first period of time, the second period of time, and the third period of time are sequential and not overlapping such that the first of the at least three planar arrays emits a first magnetic field for the first period of time and not the second period of time or the third period of time, the second of the at least three planar arrays emits a second magnetic field for the second period of time and not the first period of time or the third period of time, and the third of the at least three planar arrays emits a third magnetic field for the third period of time and not the first period of time or the second period of time.
However, Schneider discloses “Transcranial Magnetic Simulation (TMS) systems and methods of using them for emitting focused, or shaped, magnetic fields for TMS” and teaches the first period of time, the second period of time, and the third period of time are sequential and not overlapping (“one or more (e.g., two, three, four, etc.)”, [0013]; “some variations the systems or devices include three secondary TMS electromagnets”, [0029]; “the primary and secondary TMS electromagnets may be stimulated sequentially, but within a window of time to allow temporal summation of the magnetic fields on the tissue”, [0050];”By firing the front and back triad at separate times, mutual interference may be minimized”, [0059]),
such that the first of the at least three planar arrays emits a first magnetic field for the first period of time and not the second period of time or the third period of time ([0050],”By firing the front and back triad at separate times, mutual interference may be minimized”, [0059]),
the second of the at least three planar arrays emits a second magnetic field for the second period of time and not the first period of time or the third period of time ([0050],”By firing the front and back triad at separate times, mutual interference may be minimized”, [0059]).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to include a third of the at least three planar arrays, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04.VI.B.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 pulsed electromagnetic field device of Jin such that the first period of time, the second period of time, and the third period of time are sequential and not overlapping such that the first of the at least three planar arrays emits a first magnetic field for the first period of time and not the second period of time or the third period of time, the second of the at least three planar arrays emits a second magnetic field for the second period of time and not the first period of time or the third period of time, and the third of the at least three planar arrays emits a third magnetic field for the third period of time and not the first period of time or the second period of time, in light of paragraph [0050] that the controller is configured to direct emission for one time period and not the other, as taught by Schneider, for the benefit of prevent undesirable coil interference while stimulating a target (Schneider: [0059]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 1, in view of Schneider et al (US 20150099921 A1, hereinafter Schneider ‘921).
Regarding claim 2, Jin and Schneider teach all limitations of claim 1. Jin teaches the first period of time and the second period of time ([0035]) but does not teach each of the first period of time and the second period of time is less than five minutes.
However, Schneider ‘921 discloses “[m]ethods and systems for transcranial magnetic stimulation applied to the posterior cingulate” and teaches the first period of time and the second period of time is between thirty seconds and 3 hours (“applying a rapid TMS pulse pattern (e.g., of greater than 10 Hz) from each of the plurality of TMS coils (either separately/independently or jointly) to increase metabolic activity (e.g., by driving stimulation, inducing action potentials, etc.) of the patient's posterior cingulate for between about thirty seconds and 3 hour”, [0008]). 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 the first period of time and second period of time of the pulsed electromagnetic field device of Jin such as a range of thirty seconds to 5 minutes, as taught by Schneider ‘921, for the benefit of “treating Alzheimer's by non-invasively stimulating brain areas involved in Alzheimer's disease pathology, and particularly the posterior cingulate nerve fiber bundle” (Schneider ‘921: [0008]). 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 1, in view of Hancock et al (WO 2020141165 A1).
Regarding claim 6, Jin and Schneider teach all limitations of claim 1. Jin does not teach the single treatment session is less than 6 contiguous hours.
However, Hancock discloses that the time is selected based on the person and the target tissue (“…deliver a required electromagnetic field dosage treatment programme to a specific tissue region at a specific body portion of the human or animal subject…”, page 26, paragraph [0108]), making it a results effective variable. The term “dosage treatment programme” includes various period of operation time (page 61, paragraph [0237]). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Jin by modifying the treatment time to be less than 6 contiguous hours as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 8 - 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 1, in view of Abraham (WO 2010067336 A2).
Regarding claims 8 and 9, Jin and Schneider teach all limitations of claim 1, and Jin, Schneider and Abraham teach all limitations of claim 8. Jin does not teach the electrical current is defined by an electrical pulse train having a frequency in a range of 0.1 Hz to 60 Hz and wherein pulses of the electrical pulse train have a substantially rectangular shape and said pulses have different peak levels of current and wherein the different peak levels are in a range of 5 mA to 500 mA.
Abraham discloses a magnetic stimulation device and thus is analogous art (see abstract). Abraham teaches that the current supplied to the TMS coil induces an electric field proportional to the time derivative of the current ([0003]), and further that it is known to alter the electrical field pulse to produce a physiological effect on a neuronal structure in the internal body organ ([0031]). The external control unit 24 of Abraham controls the current supplied to the TMS coil which further allows for control of the timing of each turning on/off, amplitude of the initial voltage on the energy storage device (20), frequency of discharging of current of energy storage device (20), time intervals between pulses or combinations of pulses, pulse widths, pulse shapes, duration of pulse trains or pulses or pulse combinations, time intervals between pulse trains, relative polarities of current directions in coils 12 and 14 at different periods of operation, direction of current flow in coils 12 and 14, numbers of each type of pulse, and any other parameters ([0033]). Thus, the frequency, peak levels and shape of the pulses within the pulse train are a results effective variable.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Jin to produce an electrical pulse train which comprises a frequency in a range of 0.1 Hz to 60 Hz, wherein pulses of the electrical pulse train have a substantially rectangular shape and said pulses have different peak levels of current and wherein the different peak levels are in a range of 5 mA to 500 mA as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further, as discussed above, the prior art has recognized problem in the art. The current supplied to the TMS coil induces an electric field proportional to the time derivative of the current (Abraham: [0003]), and further that it is known to alter the electrical field pulse to produce a physiological effect on a neuronal structure in the internal body organ. Altering the electrical field pulse can be accomplished by changing the timing of each turning on/off, amplitude of the initial voltage on the energy storage device 20, frequency of discharging of current of energy storage device 20, time intervals between pulses or combinations of pulses, pulse widths, pulse shapes, duration of pulse trains or pulses or pulse combinations, time intervals between pulse trains, relative polarities of current
directions in coils 12 and 14 at different periods of operation, direction of current flow in coils 12 and 14, numbers of each type of pulse, and any other parameters (Abraham: [0033]). There is a finite number of identified, predictable solutions of altering the electrical field for a therapeutic effect and thus it would have been obvious to one of ordinary skill in the art to have modified Jin to produce an electrical pulse train which comprises a frequency in a range of 0.1 Hz to 60 Hz, wherein pulses of the electrical pulse train have a substantially rectangular shape and said pulses have different peak levels of current and wherein the different peak levels are in a range of 5 mA to 500 mA. "A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under§ 103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Regarding claim 10, Jin and Schneider teach all limitations of claim 1. Jin teaches a pulsed electromagnetic field device (abstract; paragraph [0006]; Figure 4 phased array as shown in figure 8) and first period and second period ([0035]) but does not teach the electrical current is defined by an electrical pulse train, wherein, during the first period of time, the electrical pulse train comprises at least two pulses having different current amplitudes, and wherein, during the second period of time, the electrical pulse train also comprises at least two pulses having different current amplitudes.
However, Abraham discloses a magnetic stimulation device and thus is analogous art (see abstract). Abraham teaches that the current supplied to the TMS coil induces an electric field proportional to the time derivative of the current ([0003]), and further that it is known to alter the electrical field pulse to produce a physiological effect on a neuronal structure in the internal body organ ([0031]). The external control unit 24 of Abraham controls the current supplied to the TMS coil which further allows for control of the timing of each turning on/off, amplitude of the initial voltage on the energy storage device (20), frequency of discharging of current of energy storage device (20), time intervals between pulses or combinations of pulses, pulse widths, duration of pulse trains or pulses or pulse combinations, time intervals between pulse trains, relative polarities of current directions in coils 12 and 14 at different periods of operation, direction of current flow in coils 12 and 14, numbers of each type of pulse, and any other parameters ([0033]). Thus, the frequency, peak levels of the pulses within the pulse train are a results effective variable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Jin to produce an electrical current is defined by an electrical pulse train, wherein, during the first period of time, the electrical pulse train comprises at least two pulses having different current amplitudes, and wherein, during the second period of time, the electrical pulse train also comprises at least two pulses having different current amplitudes, as taught by Abraham, for the benefit of causing “a physiological effect on a neuronal structure in the [targeted] internal body organ” (Abraham: [0031]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 11, in view of Burnett (US 20030158583 A1).
Regarding claim 12, Jin and Schneider teach all limitations of claim 11. Jin teaches the controller (“central processor” 802, [0053], Figure 8) is adapted to direct the electrical current to each of the at least 4 planar microcoils ([0022 - 0023]; emitters, 404, 405 being phased emitters; 801 showing the structure of the phased emitter; Figure 8) in the first of the at least two planar flexible arrays (see annotated Figure 4 above) during the first period of time ([0035]) and to each of the at least 4 planar microcoils in the second of the at least two planar flexible arrays during the second period of time ([0035]). The modified Jin does not teach directing the electrical current to microcoils concurrently.
However, Burnett discloses an “electromagnetic stimulation device which is comprised of a plurality of overlapping coils which are able to be independently energized in a predetermined sequence such that each coil will generate its own independent electromagnetic field and significantly increase the adjacent field” (abstract) and teaches the controller (“logic controller” 20, [0045]) is adapted to generate an electrical pulse train that is currently delivered to microcoils concurrently (“allowing stimulation of multiple coils in sequence or simultaneously”, [0045]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pulsed electromagnetic field device, wherein the controller is adapted to generate an electrical pulse train that is currently delivered to microcoils concurrently, as taught by Burnett, for the benefit of each coil will generate its own independent electromagnetic field and significantly increase the adjacent field to treat various medical conditions (Burnett: abstract).
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 1, in view of Burnett (US 20030158583 A1).
Regarding claim 16, Jin and Schneider teach all limitations of claim 1. Jin teaches the head covering (Figure 4), the first of the at least two planar flexible arrays and the second of the at least two planar flexible arrays (see annotated Figure 4 above) but does not teach the head covering comprising two or more layers of material and wherein the first of the at least two planar flexible arrays and the second of the at least two planar flexible arrays are positioned between the two or more layers of material.
However, Burnett discloses a “electromagnetic stimulation device which is comprised of a plurality of overlapping coils which are able to be independently energized in a predetermined sequence such that each coil will generate its own independent electromagnetic field and significantly increase the adjacent field” and teaches a pulsed electromagnetic field device (abstract comprising two or more layers of material (“a thin layer of conducting mesh 102”, “layer of non-conducting material 103”, [0062], Figure 9) and wherein at least two planar flexible arrays (“One or more arrays of coils 32”, [0045]) are positioned between the two or more layers of material (102, 103, Figure 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention wherein the head covering comprises two or more layers of material and wherein the first of the at least two planar flexible arrays and the second of the at least two planar flexible arrays are positioned between the two or more layers of material, as taught by Burnett, for the benefit of the layers to trap the current ([0062]) and blow an internal fuse disabling all current so as to protect the patient and/or caregiver and be a safeguard to help ensure that the patient and/or caregiver is not exposed to a shock from a short circuit ([0062]).
Regarding claim 19, Jin and Schneider teach all limitations of claim 1. Jin teaches the first of the at least two planar flexible arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) and the second of the at least two planar flexible arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) each comprise at least two planar microcoils ([0022] – [0023]; emitters, 404, 405 being phased emitters; 801 showing the structure of the phased emitter).
Jin does not teach each array having an input terminal configured to receive the electrical current from the controller and direct the electrical current to the at least two planar flexible arrays, an output terminal configured to receive the electrical current from the at least two planar flexible arrays, and traces that electrically connect each of the at least two planar microcoils to the respective input terminal and the respective output terminal.
However, Burnett discloses a pulsed electromagnetic device (abstract), and teaches an input terminal configured to receive the electrical current from the controller and direct the electrical current to the at least two planar flexible arrays ("each coil will be its own circuit" "conducting mesh 102 ... placed on both sides of the coils ... controller with be disabled immediately if a short circuit occurs ... if any current escapes the coil insulation ... the mesh 102 will trap the current and blow an internal fuse", [0061] - [0062]),
an output terminal configured to receive the electrical current from the at least two planar flexible arrays ("each coil ... may have its own internal switching mechanism to allow firing of the coil ... “, [0055]), and at traces that electrically connect each of the at least two planar microcoils ("each coil consists of insulated wire ... wrapped multiple times", [0060]; [0045]) to the respective input terminal and the respective output terminal. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the first of the at least two planar flexible arrays and the second of the at least two planar flexible arrays each comprise at least two planar microcoils, an input terminal configured to receive the electrical current from the controller and direct the electrical current to the at least two planar flexible arrays, an output terminal configured to receive the electrical current from the at least two planar flexible arrays, and at traces that electrically connect each of the at least two planar microcoils to the respective input terminal and the respective output terminal, as taught by Burnett, for the benefit of controlling one or more arrays of coils for the allowance of stimulation of multiple coils in sequence or simultaneously (Burnett: [0045]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 13, in view of Boveja et al (US 20060129205 Al, hereinafter Boveja) in further view of Burnett (US 20030158583 A1).
Regarding claim 14, Jin and Schneider teach all limitations of claim 13. Jin teaches a pulsed electromagnetic field device (abstract; paragraph [0006]; Figure 4 phased array as shown in figure 8) but does not teach the electrical current is defined by an electrical pulse train wherein each of the first, second, and third of the at least two planar flexible arrays receives the electrical pulse train at a frequency in a range of 1 Hz to 100 Hz and wherein the controller is configured to sequentially deliver the electrical pulse train to each of the first, second, and third of the at least two planar flexible arrays.
However, Boveja discloses a “method and system for providing rectangular and/or complex electrical pulses to cortical tissues of a patient for at least one of, providing therapy or alleviating symptoms of neurological disorders” and teaches the controller (" ... microcontroller/microprocessor of the implanted pulse generator (IPG) ... ", [0213]) is adapted to generate an electrical pulse train having a frequency in a range of 5 Hz to 200 Hz ([0097]) but does not explicitly teach a frequency in a range of 1 Hz to 100 Hz. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the frequency range of 5 Hz to 200 Hz ([0097]) to between 5 Hz to 100 Hz since 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)." Further, applicant appears to have placed no criticality on the claimed range (see page 7, line 6 - 8, indicating the frequency to be "optionally"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention wherein the controller is adapted to generate an electrical pulse train having a frequency within a similar range of 5 Hz to 100 Hz, as taught by Boveja, for the benefit of low frequencies are generally not suitable because of energy requirements for longer wavelengths, whereas higher frequencies are absorbed by the tissues and are converted to heat, which again results in power losses ([0231]) and creating the desired wave form and frequency suitable for an alternative medical care (" ... specific therapy to the individual patient ... “, [0251]).
The modified Jin does not teach the controller is configured to sequentially deliver the electrical pulse train to each of the first, second, and third of the at least two planar flexible arrays.
However, Burnett discloses a “electromagnetic stimulation device which is comprised of a plurality of overlapping coils which are able to be independently energized in a predetermined sequence such that each coil will generate its own independent electromagnetic field and significantly increase the adjacent field” and teaches the controller (logic controller 20) is configured to sequentially ("in sequence ... ", [0045]) deliver the electrical pulse train to each of the first, second, and third of the at least two planar flexible arrays (shown to be planar in Figure 9, "Three or more arrays of coils 32 ... " [0045] from Burnett). the controller (logic controller 20) is able to stimulate multiple coils sequentially ("in sequence ... ", [0045]) and deliver to each of the at least 5 planar flexible arrays (shown to be planar in Figure 9, "Three or more arrays of coils 32 ... " [0045] from Burnett). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pulsed electromagnetic field device, as taught by Jin, wherein the controller is adapted to generate an electrical pulse train having a frequency in a range of 5 Hz to 100 Hz, as taught by Boveja, and is configured to sequentially deliver the electrical pulse train to each of the first, second, and third of the at least two planar flexible arrays, as taught by Burnett, for the benefit of targeted placement of the device for the stimulation of key nerves, muscles, and/or body tissues (Burnett: [0005]).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, Boveja and Burnett, as applied to claim 14, in view of Abraham (WO 2010067336 A2).
Regarding claim 17 and 18, Jin, Schneider, Boveja, and Burnett teach all limitations of claim 14. Jin does not teach the electrical pulse train comprises at least a first pulse having a first amplitude, a second pulse having a second amplitude, and a third pulse having a third amplitude, wherein the first amplitude is less than the second amplitude and the second amplitude is less than the third amplitude, and each of the first pulse, the second pulse, and the third pulse has a substantially rectangular shape.
Abraham discloses a magnetic stimulation device and thus is analogous art (see abstract). Abraham teaches that the current supplied to the TMS coil induces an electric field proportional to the time derivative of the current ([0003]), and further that it is known to alter the electrical field pulse to produce a physiological effect on a neuronal structure in the internal body organ ([0031]). The external control unit 24 of Abraham controls the current supplied to the TMS coil which further allows for control of the timing of each turning on/off, amplitude of the initial voltage on the energy storage device (20), frequency of discharging of current of energy storage device (20), time intervals between pulses or combinations of pulses, pulse widths, pulse shapes, duration of pulse trains or pulses or pulse combinations, time intervals between pulse trains, relative polarities of current directions in coils 12 and 14 at different periods of operation, direction of current flow in coils 12 and 14, numbers of each type of pulse, and any other parameters [0033]. Thus, the amplitude and shape of the pulses within the pulse train are a results effective variable.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Jin to produce a pulse train which comprises a first pulse having a first amplitude, a second pulse having a second amplitude, and a third pulse having a third amplitude, wherein the first amplitude is less than the second amplitude and the second amplitude is less than
the third amplitude and wherein each of the first pulse, second pulse and third pulse have a substantially rectangular shape as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further, as discussed above, the prior art has recognized problem in the art. The current supplied to the TMS coil induces an electric field proportional to the time derivative of the current (Abraham: [0003]), and further that it is known to alter the electrical field pulse to produce a physiological effect on a neuronal structure in the internal body organ. Altering the electrical field pulse can be accomplished by changing the timing of each turning on/off, amplitude of the initial voltage on the energy storage device 20, frequency of discharging of current of energy storage device 20, time intervals between pulses or combinations of pulses, pulse widths, pulse shapes, duration of pulse trains or pulses or pulse combinations, time intervals between pulse trains, relative polarities of current
directions in coils 12 and 14 at different periods of operation, direction of current flow in coils 12 and 14, numbers of each type of pulse, and any other parameters (Abraham: [0033]). There is a finite number of identified, predictable solutions of altering the electrical field for a therapeutic effect and thus it would have been obvious to one of ordinary skill in the art to have modified Jin to produce a pulse train which comprises a first pulse having a first amplitude, a second pulse having a second amplitude, and a third pulse having a third amplitude, wherein the first amplitude is less than the second amplitude and the second amplitude is less than the third amplitude and wherein each of the first pulse, second pulse and third pulse have a substantially rectangular shape as it would have been obvious to try. "A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under§ 103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied in claim 1, in view of Dimino et al (US 9320913 B2, hereinafter Dimino).
Regarding claim 21, Jin and Schneider teach all limitations of claim 1. Jin teaches the head covering (“cap”, [0014], Figure 4) comprises a crown defined by the left side, the right side, the top side, the front side and the back side (see annotated Figure 4 above from claim 1) but does not teach a brim attached to said crown.
However, Dimino discloses “pulsed electromagnetic field (PEMF) apparatuses and methods of making and using them” and teaches a brim (“brim of the cap, hat, etc”, column 10, line 55) attached to said crown (Figure 6). 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 Jin and Schneider to incorporate a brim attached to a crown, as taught by Dimino, for the benefit of preventing the user from misplacing the product, considering it being a self-contained, lightweight, small, compact (e.g., in some variations, wearable) (abstract).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 1, in view of Mishelevich (US 20070260107 A1).
Regarding claim 22, Jin and Schneider teach all limitations of claim 1. Jin teaches during the first period of time ([0035]), the first of the at least two planar flexible arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) generates a first magnetic field defined by a first vector extending in a first direction ([0035] – [0036]), wherein, during the second period of time ([0035]), the second of the at least two planar flexible arrays (Figure 4 shows the indirect coupling of each array to the internal surface of the crown) generates a second magnetic field defined by a second vector extending in a second direction ([0035] – [0036]). Jin does not teach if the first vector and the second vector were to intersect each other, the first vector and the second vector would form an angle having a value greater than 15 degrees.
However, Mishelevich discloses “Stereotactic Transcranial Magnetic Stimulation (sTMS) at predetermined locations with the brain or spinal cord and incorporates an array of electromagnets arranged in a specified configuration where selected coils in the array are pulsed simultaneously” and teaches if the first vector (magnetic field of “[coil] 130”, [0067]) and the second vector (magnetic field of “coil 200”, [0067]) were to intersect each other, the first vector and the second vector would form an angle having a value greater than 15 degrees ([0067], Figure 4). Examiner interprets the “coil 200”/top coil ([0067]) and “coil 130”/side coil ([0067]) would form a 90 degree angle of with both magnetic field vectors. 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 Jin such that if the first vector and the second vector were to intersect each other, the first vector and the second vector would form an angle having a value greater than 15 degrees, as taught by Mishelevich, for the benefit of obtaining “magnetic vectors from an array of coils allows an arrangement of the coils to be selected such that the magnetic fields of the magnets will combine in a manner that intensifies some areas of the overall magnetic field and weakens others” (Mishelevich: [0052]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 23, in view of Schneider ‘921.
Regarding claim 24, Jin and Schneider teach all limitations of claim 23. The modified Jin teaches each of the first period of time, the second period of time, and the third period of time ([0035]) but does not teach each of the period is less than five minutes.
However, Schneider ‘921 discloses “[m]ethods and systems for transcranial magnetic stimulation applied to the posterior cingulate” and teaches each of the period is less than five minutes (“applying a rapid TMS pulse pattern (e.g., of greater than 10 Hz) from each of the plurality of TMS coils (either separately/independently or jointly) to increase metabolic activity (e.g., by driving stimulation, inducing action potentials, etc.) of the patient's posterior cingulate for between about thirty seconds and 3 hour”, [0008]). 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 the first period of time, the second period of time and the third period of time of the pulsed electromagnetic field device of Jin such as a range of thirty seconds to 5 minutes, as taught by Schneider ‘921, for the benefit of “treating Alzheimer's by non-invasively stimulating brain areas involved in Alzheimer's disease pathology, and particularly the posterior cingulate nerve fiber bundle” (Schneider ‘921: [0008]). 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 25 is rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Schneider, as applied to claim 23, in view of Abraham (WO 2010067336 A2).
Regarding claim 25, Jin and Schneider teach all limitations of claim 23. Jin does not teach the electrical current is defined by an electrical pulse train having a frequency in a range of 1 Hz to 60 Hz, wherein pulses of the electrical pulse train have a substantially rectangular shape, wherein said pulses of the electrical pulse train have different peak levels of current, and wherein the different peak levels are in a range of 5 mA to 500 mA.
Abraham discloses a magnetic stimulation device and thus is analogous art (see abstract). Abraham teaches that the current supplied to the TMS coil induces an electric field proportional to the time derivative of the current ([0003]), and further that it is known to alter the electrical field pulse to produce a physiological effect on a neuronal structure in the internal body organ ([0031]). The external control unit 24 of Abraham controls the current supplied to the TMS coil which further allows for control of the timing of each turning on/off, amplitude of the initial voltage on the energy storage device (20), frequency of discharging of current of energy storage device (20), time intervals between pulses or combinations of pulses, pulse widths, pulse shapes, duration of pulse trains or pulses or pulse combinations, time intervals between pulse trains, relative polarities of current directions in coils 12 and 14 at different periods of operation, direction of current flow in coils 12 and 14, numbers of each type of pulse, and any other parameters ([0033]). Thus, the frequency, peak levels and shape of the pulses within the pulse train are a results effective variable.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Jin to produce an electrical pulse train which comprises a frequency in a range of 1 Hz to 60 Hz, wherein pulses of the electrical pulse train have a substantially rectangular shape and said pulses have different peak levels of current and wherein the different peak levels are in a range of 5 mA to 500 mA