DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-8, 10-17, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyden (US 2009/0018384) in view of Schneider (US 2013/0317281) in view of Young (5707334) further in view of Whelan (US 2004/0176805) further in view of Saitoh (US 2016/0346562).
Regarding claim 1, Boyden teaches a portable therapeutic device for repetitive transcranial magnetic stimulation (abstract “A portable, modular transcranial magnetic stimulation device”) comprising:
an energy storage device coupled to a power supply and configured to store energy received from the power supply (Energy storage device: Figure 1, element 120. Paragraph [0017] "A preferred embodiment comprises a battery, a flyback transformer that permits a DC voltage (e.g., battery) to charge a capacitor, a set of thyristors that optimally allow charging and discharging of the capacitor"),
the energy storage device being configured to operate during a predetermined number of charge-discharge cycles, wherein during a charge portion of each charge-discharge cycle, the energy storage device is configured to receive and store energy from the power supply, and during a discharge portion of each charge- discharge cycle, the energy storage device is configured to discharge stored energy (Energy Storage Device: Figure 1, element 120. Paragraph [0017] “A preferred embodiment comprises a battery, a flyback transformer that permits a DC voltage (e.g., battery) to charge a capacitor, a set of thyristors that optimally allow charging and discharging of the capacitor.” Paragraph [0020] “These batteries can fully recharge in as little as 5 minutes, making it simple to operate with rapid cycle times, e.g. on a number of patients, or if the protocol must be repeated several times.” The examiner is interpreting the battery as the power supply.)
a magnetic field generation device coupled to the energy storage device (Magnetic Field Generation Device: Figure 1, element 150. Paragraph [0029] "FIGS. 4A and 4B are circuit diagrams of exemplary embodiments of a multiphasic stimulator and a biphasic stimulator, respectively, according to one aspect of the present invention. In FIG. 4A, which is adapted for multiphasic stimulation, energy storage unit 410 (Cl) is charged to the appropriate level for the desired pulse strength via the power supply unit. Then the control unit disconnects the power supply unit and closes switch 420 (51). At this point, energy storage unit 410 and coil 425 (Ll) are connected in a LC circuit." The examiner is interpreting the coil unit as the magnetic field generation device.)
However, Boyden fails to teach that the device is configured to repeatedly generate a plurality of magnetic field pulses as a pulse train at a predetermined pulse repetition frequency during a predetermined period of time of at least 10 seconds, each magnetic field pulse being generated during the discharge portion of each charge-discharge cycle of the energy storage device.
Schneider teaches a TMS device that generates pulse trains during a discharge portion of a cycle. (paragraph [0006] “Repetitive transcranial magnetic stimulation (rTMS) involves placing an electromagnetic coil on the scalp while high-intensity current is rapidly turned on and off in the coil through the discharge of capacitors.” The examiner notes that each pulse is only generated during the discharge cycle in an rTMS device. Paragraph [0095] “Pulses may be delivered in sets called trains. The pulse train duration may refer to the amount of time required to deliver each set of pulses, such as <4 seconds within each 30 second period. Pulse train rest may refer to the amount of time between pulse trains, such as at least 26 seconds per 30 second period.” The examiner notes that the less than 4 seconds is the predetermined pulse repetition frequency and that 30 second period is the predetermined period of time of at least 10 seconds.)
It would prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the TMS system taught by Boyden to deliver the pulses in a pulse train as taught by Schneider. One of ordinary skill in the art would have been able to recognize that having the pulses in trains ensures delivery of the treatment at consistent timing and safely at a high frequency.
However, both Boyden and Schneider fail to teach that the pulse trains have a predetermined magnetic field strength greater than 100 mT.
However, Young teaches portable transcranial magnetic stimulation device wherein the
predetermined magnetic field strength is greater than 100 mT. (Claim 4: the magnetic field strength is
about 0.1 to about 4 Tesla)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify device taught in Boyden to be implemented using the magnetic field strength taught in Whelan. One of ordinary skill in the art would have been able to recognize this magnetic field strength is sufficient to treat subjects with a range of symptoms including mood changes (e.g., .... chronic and recurring depressions) (see column 1, line 20 of Young) which according to the applicant's specification is the purpose of the claimed device and magnetic field strength.
However, both Boyden, Schneider, and Young fail to teach the plurality of magnetic field pulses are configured to be applied to a subject from a predetermined distance in a range of approximately 1.5 cm to 2.5 cm from the magnetic field generation device.
Whelan teaches wherein the magnetic field pulses are being configured to be applied
to the subject from a predetermined distance and wherein the predetermined distance is
in a range of 1.5 cm to 2.5 cm. (Paragraph [0015] "In the methods described herein,
positioning a device adjacent a bodily tissue of an individua I refers to placing the device close to the skin of the individual (e.g., within 0.5, 1, 2, 3, 4, 5, or 6 inches of the skin) or in contact with the skin.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date
of the application to modify the device taught in Boyden to be implemented at the predetermined
distances as taught in Whelan. Boyden fails to disclose a range of the magnetic field pulses so it would
be obvious to one of ordinary skill in the art to use a well-known range for magnetic field pulse
application such as taught in Boyden. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions 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 USPQ233,
235 (CCPA 1955). MPEP 2144.05.11.
However, both Boyden, Schneider, Young, and Whelan fail to teach the plurality of magnetic field pulses being configured to cause generation of an electric field having a predetermined strength in a range of approximately 50 V/m to 120 V/m at the predetermined distance, thereby generating a desired repetitive transcranial magnetic stimulation therapeutic effect in the subject.
However, Saitoh teaches changing coil design parameters to acquire a desired induced electric
field intensity wherein the predetermined strength of the generated electric field falls in a range of
approximately 50 V/m to 120 V/m and thereby generating a desired repetitive transcranial magnetic stimulation therapeutic effect in the subject. (Fig 30. Shows testing various coil
designs which produce generated electric field strengths varying from 50 V/m to 150 V/m where one of
the coil designs produce approximately 65 V/m as seen on the graphs. The examiner is interpreting this
as there is an embodiment of this prior art that is capable of producing an electric field with strength of
65 V/m. Paragraph [0129] "The alternating current applied to the coil was set to the
frequency of 3.4 kHz.", "The electric conductivity of this brain model was set to 0.115/m from the
electric conductivity of the grey matter at 3.4 kHz.", the frequency is being set based on the desired area
to be treated, i.e. therapeutic effect.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date
of the application to modify the magnetic field taught in Boyden to have the predetermined strength of the electric field to generate the therapeutic effect as taught by Saitoh. Boyden fails to disclose an electric field strength and Saitoh teaches using max electric field strengths ranging from 56-121 V/m (Table 4) for transcranial magnetic stimulation, it would therefore be obvious to apply a field strength within that range such as 65 V/m. Additionally, Boyden teaches a transcranial magnetic
stimulation device that is modular so that one can change the properties of the machine ([0004]). It
would therefore be obvious to one of ordinary skill in the art to change a property of the machine such
as the magnetic field pulse frequency to target the desired area to be treated/the desired therapeutic
effect. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions 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 USPQ233, 235 (CCPA 1955). MPEP 2144.05.11.
Regarding claim 2, Boyden discloses wherein the energy storage device includes a capacitor.
(Paragraph [0022] “The energy storage unit of FIG. 3 comprises capacitor 310 (C1) that stores the energy
coming from the power supply unit until it is needed to generate a stimulation pulse and additional
circuitry to discharge it and measure its voltage.”)
Regarding claim 3, Boyden discloses wherein the magnetic field generation device includes an
inductive coil having a conductive wire, the conductive wire is configured to be wound. (Paragraph
[0036] “Optional features of the present invention include, but are not limited to, the capacity to
recharge the battery via remote power, such as, but not limited to, through an RF inductive coil,
including through the same coil used to do the stimulation, making the coil into an array of coils, each
individually actuatable, for more focal stimulation, and replacing the coils with a mesh electrode of copper wires that can go under the hair, for invisible and fashionable wearable brain stimulation. “, coil
used for stimulation is an inductive coil, which is a wound conductive wire.)
Regarding claims 4 and 5, Boyden discloses wherein the inductive coil is configured to include a
predetermined shape (of claim 4) and wherein the predetermined shape includes at least one of the
following: a circular shape, a figure-8 shape, an oval shape, an elliptical shape, a butterfly shape, a
double butterfly shape, a triple butterfly shape, an H-coil shape, a regular shape, an irregular shape, and
any combination thereof (of claim 5). (Paragraph [0035] “The best designs appear to have a FIG. 8 or
similar shape, such as rectangular (where the two loops are rectangular instead of circular). ..Many other coil geometries exist, and any coils with the same inductance can be interchanged with one another without alteration of any other part of the circuit, making this also a modular aspect of the circuit. ”)
Regarding claim 6, Boyden discloses wherein the wherein the inductive coil includes at least one
of the following parameters: a predetermined length, a predetermined number of winding turns of the
conductive wire, a predetermined radius of one or more winding turns of the conductive wire, a
thickness of the conductive wire, and any combination thereof. (paragraph [0035] “Two model coil
designs implemented as prototypes to test the present invention were made of 10-gauge copper
magnet wire, insulated with heavy amidester coating, and had two 2.5-15 cm diameter coils arranged in
a figure-8.” The examiner is noting that the 10-gauge copper wire has a thickness of approximately 2.5
mm (a “predetermined” thickness) and that the radius of the coil would be 1.5 cm – 7.5 cm (a “predetermined” radius of turns).)
Regarding claim 7, Boyden teaches wherein the predetermined magnetic field strength is
determined using at least one of the inductive coil parameters. (Paragraph [0035] “A smaller coil has less
flux, and thus requires a higher current to drive; a larger coil requires less current.” The coil parameters
inherently dictate the magnetic field strength as noted in paragraph [0040] in the applicant’s disclosed
specification where magnetic field strength is calculated using coil parameters such as coil radius in Biot-Savart’s Law. Therefore, the predetermined magnetic field strength is determined using at least
one of the inductive coil parameters.)
Regarding claim 8, Boyden, Schneider, Young, and Whelan teach the portable therapeutic device according to claim 1 fails to teach wherein the predetermined length is in a range of approximately 50 mm to 150 mm.
However, Saitoh teaches a coil device for transcranial magnetic stimulation treatment wherein
the coil has a predetermined length in a range of approximately 50 mm to 150 mm. (Paragraph [0042]
“Based on the model of FIG. 16 determined as the most effective coil in the analysis with the simplified
model, a 20-turn dome-type coil was modeled to have the horizontal length of 112 mm, the vertical
length of 39 mm, and the coil width of 97 mm as shown in FIG. 20.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the coil unit taught in Boyden to have the predetermined length taught in Saitoh. Boyden teaches various coil geometries/parameters can be used ([0035]) and Saitoh teaches a coil in the same field of endeavor so it would have been obvious to one skilled in the art before the effective filing date of the claimed invention was filed to substituted the coil of Boyden with the coil of Saitoh as a matter of simple substitution yielding the predictable result of providing transcranial magnetic stimulation. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions 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). MPEP 2144.05.II.
Regarding claims 10, Boyden, Schneider, Young, Whelan and Saitoh teach the portable therapeutic device according to claim 1 but fails to teach wherein the predetermined strength of the generated electric field is approximately 65 V/m.
Saitoh further teaches changing coil design parameters to acquire a desired induced electric field intensity wherein the predetermined strength of the generated electric field can be approximately 65 V/m. (Fig 30. Shows testing various coil designs which produce generated electric field strengths varying from 50 V/m to 150 V/m where one of the coil designs produces approximately 65 V/m as seen on the graphs. The examiner is interpreting this as there is an embodiment of this prior art that is capable of producing an electric field with strength of 65 V/m.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the magnetic field taught in Boyden to have the predetermined strength of approximately 65 V/m as taught by Saitoh. Boyden fails to disclose an electric field strength and Saitoh teaches using max electric field strengths ranging from 56-121 V/m (Table 4) for transcranial magnetic stimulation, it would therefore be obvious to apply a field strength within that range such as 65 V/m. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions 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). MPEP 2144.05.II.
Regarding claim 11, Boyden teaches wherein the power supply is rechargeable. (Paragraph [0020] “These batteries can fully recharge”.)
Regarding claims 12 and 13, Boyden, Schneider, Young, Whelan, and Saitoh teach the portable therapeutic device according to claim 1, and Boyden further teaches wherein the magnetic field generation device is configured to generated the plurality of magnetic field pulses as a result of a predetermined current received from the energy storage device (of claim 12) and wherein the predetermined current being in a range of approximately 800 A to 2500 A (of claim 13). (Paragraph [0020] “For example, one suitable battery configuration is a set of super-high capacity lithium ion batteries that contain storage electrodes comprising sub-100 nanometer active material particles, and can produce 2.3 Amp-hours at 3.3V, in a 70-gram package (e.g., the ANR26650M1 from A123 Systems in the present implementation). These specific batteries can store >20.000 J, enough so that five such batteries can generate O(100) full TMS pulses (100 microseconds, 1000V, 10000 A) even if all the energy is dissipated as heat (and even more if some of the energy is recovered).”)
Regarding claim 14, Boyden, Schneider, Young, Whelan, and Saitoh teach the device according to claim 1 but fails to teach wherein the plurality of magnetic field pulses are generated at the predetermined pulse repetition frequency, the predetermined frequency being determined based on the desired repetitive transcranial magnetic stimulation therapeutic effect.
Saitoh further teaches wherein the plurality of magnetic field pulses are generated at a predetermined pulse repetition frequency, the predetermined frequency being determined based on the desired therapeutic effect. (Paragraph [0129] “The alternating current applied to the coil was set to the frequency of 3.4 kHz.”, “The electric conductivity of this brain model was set to 0.11 S/m from the electric conductivity of the grey matter at 3.4 kHz.”. The examiner notes that the frequency is being set based on the desired area to be treated, i.e. therapeutic effect, and that in claim 1 Schneider teaches the use of rTMS at a predetermined pulse repetition frequency.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the magnetic field taught in Boyden to have a predetermined frequency based on a desired therapeutic effect as taught by Saitoh. Boyden teaches a transcranial magnetic stimulation device that is modular so that one can change the properties of the machine ([0004]). It would therefore be obvious to one of ordinary skill in the art to change a property of the machine such as the magnetic field pulse frequency to target the desired area to be treated/the desired therapeutic effect.
Regarding claim 15, Boyden, Schneider, Young, Whelan, and Saitoh teach the device according to claim 1, and Boyden further teaches that the device comprises a voltage step-up device coupled to the power supply and the energy storage device and configured to increase voltage being supplied by the power supply to the energy storage device. (Paragraph [0019] “FIG. 2 is a schematic of an exemplary embodiment of a power supply unit using a flyback transformer, according to one aspect of the present invention. This implementation employs flyback transformer 210 (e.g., the 28K074 transformer, which can create up to 4000V at 15 mA) to step up the voltage of a fast oscillating (e.g 15 to 50 kHz), low voltage (e.g. 5 to 25V), moderately high current (100s of mA) waveform 220 and is turned on and off by a microcontroller (PIC).” The examiner is interpreting the flyback transformer as a voltage step up device as it is used to step up the voltage of the power supply.)
Regarding claim 16, Boyden discloses wherein the voltage supplied to the energy storage device is greater than approximately 200 V. (Paragraph [0018] “The power supply unit comprises a controllable device able to generate high voltages in the range of at least 1-3 kV starting from a lower voltage power source, such as, but not limited to, a wall socket, solar panels, or batteries.”)
Regarding claim 17, Boyden, Schneider, Young, Whelan, and Saitoh teach the device of claim 1 but fails to teach further comprising a printed circuit board for positioning at least one of the power supply, the energy storage device, the magnetic field generation device, and any combination thereof.
However, Whelan further teaches a portable electromagnetic stimulation device further comprising a printed circuit board for positioning at least one of the power supply, the energy storage device, the magnetic field generation device, and any combination thereof. (Paragraph [0057] “FIG. 8 depicts an implementation of an enhanced antenna comprising wires 802 wound around an annular ring 804 mounted on a printed circuit board 810. The ring may be a ferrite or magnetic, electrically-insulating ring. The ring may be arranged to support a battery 806 around the periphery. The battery 806 may be held in place by a retaining clip 808 to retain the battery adjacent the printed circuit board 810. Conductors 812 on the printed circuit board may be arranged to function as a main antenna for the therapeutic electromagnetic device and may be coupled to an electromagnetic field generator (not shown) as described above.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the circuit diagrams taught in Boyden to be implemented using a printed circuit board as taught in Whelan. One of ordinary skill in the art would have been able to recognize this method is widely used in the state of electronics today. Additionally, both Boyden and Whelan teach a portable electromagnetic field generating device so modifying the Boyden’s device to use a PCB to position at least one of the components (power supply, conductor, etc.) would have improved the device in a similar way as taught in Whelan.
Regarding claim 22, Boyden teaches a method comprising:
Providing a portable therapeutic device for transcranial magnetic stimulation (abstract “A portable, modular transcranial magnetic stimulation device”) comprising:
an energy storage device coupled to a power supply and configured to store energy received from the power supply (Energy storage device: Figure 1, element 120. Paragraph [0017] "A preferred embodiment comprises a battery, a flyback transformer that permits a DC voltage (e.g., battery) to charge a capacitor, a set of thyristors that optimally allow charging and discharging of the capacitor"),
the energy storage device being configured to operate during a predetermined number of charge-discharge cycles, wherein during a charge portion of each charge-discharge cycle, the energy storage device is configured to receive and store energy from the power supply, and during a discharge portion of each charge- discharge cycle, the energy storage device is configured to discharge stored energy (Energy Storage Device: Figure 1, element 120. Paragraph [0017] “A preferred embodiment comprises a battery, a flyback transformer that permits a DC voltage (e.g., battery) to charge a capacitor, a set of thyristors that optimally allow charging and discharging of the capacitor.” Paragraph [0020] “These batteries can fully recharge in as little as 5 minutes, making it simple to operate with rapid cycle times, e.g. on a number of patients, or if the protocol must be repeated several times.” The examiner is interpreting the battery as the power supply.)
a magnetic field generation device coupled to the energy storage device (Magnetic Field Generation Device: Figure 1, element 150. Paragraph [0029] "FIGS. 4A and 4B are circuit diagrams of exemplary embodiments of a multiphasic stimulator and a biphasic stimulator, respectively, according to one aspect of the present invention. In FIG. 4A, which is adapted for multiphasic stimulation, energy storage unit 410 (Cl) is charged to the appropriate level for the desired pulse strength via the power supply unit. Then the control unit disconnects the power supply unit and closes switch 420 (51). At this point, energy storage unit 410 and coil 425 (Ll) are connected in a LC circuit." The examiner is interpreting the coil unit as the magnetic field generation device.)
However, Boyden fails to teach that the device is for repetitive transcranial magnetic stimulation and configured to repeatedly generate a plurality of magnetic field pulses as a pulse train at a predetermined pulse repetition frequency during a predetermined period of time of at least 10 seconds, each magnetic field pulse being generated during the discharge portion of each charge-discharge cycle of the energy storage device.
Schneider teaches a repetitive TMS device that generates pulse trains during a discharge portion of a cycle. (paragraph [0006] “Repetitive transcranial magnetic stimulation (rTMS) involves placing an electromagnetic coil on the scalp while high-intensity current is rapidly turned on and off in the coil through the discharge of capacitors.” The examiner notes that each pulse is only generated during the discharge cycle in an rTMS device. Paragraph [0095] “Pulses may be delivered in sets called trains. The pulse train duration may refer to the amount of time required to deliver each set of pulses, such as <4 seconds within each 30 second period. Pulse train rest may refer to the amount of time between pulse trains, such as at least 26 seconds per 30 second period.” The examiner notes that the less than 4 seconds is the predetermined pulse repetition frequency and that 30 second period is the predetermined period of time of at least 10 seconds.)
It would prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the TMS system taught by Boyden to deliver the pulses in a pulse train as taught by Schneider. One of ordinary skill in the art would have been able to recognize that having the pulses in trains ensures delivery of the treatment at consistent timing and safely at a high frequency.
However, both Boyden and Schneider fail to teach that the pulse trains have a predetermined magnetic field strength greater than 100 mT.
However, Young teaches portable transcranial magnetic stimulation device wherein the
predetermined magnetic field strength is greater than 100 mT. (Claim 4: the magnetic field strength is
about 0.1 to about 4 Tesla)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify device taught in Boyden to be implemented using the magnetic field strength taught in Whelan. One of ordinary skill in the art would have been able to recognize this magnetic field strength is sufficient to treat subjects with a range of symptoms including mood changes (e.g., .... chronic and recurring depressions) (see column 1, line 20 of Young) which according to the applicant's specification is the purpose of the claimed device and magnetic field strength.
However, both Boyden, Schneider, and Young fail to teach the plurality of magnetic field pulses are configured to be applied to a subject from a predetermined distance in a range of approximately 1.5 cm to 2.5 cm from the magnetic field generation device.
Whelan teaches wherein the magnetic field pulses are being configured to be applied
to the subject from a predetermined distance and wherein the predetermined distance is
in a range of 1.5 cm to 2.5 cm. (Paragraph [0015] "In the methods described herein,
positioning a device adjacent a bodily tissue of an individua I refers to placing the device close to the skin of the individual (e.g., within 0.5, 1, 2, 3, 4, 5, or 6 inches of the skin) or in contact with the skin.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date
of the application to modify the device taught in Boyden to be implemented at the predetermined
distances as taught in Whelan. Boyden fails to disclose a range of the magnetic field pulses so it would
be obvious to one of ordinary skill in the art to use a well-known range for magnetic field pulse
application such as taught in Boyden. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions 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 USPQ233,
235 (CCPA 1955). MPEP 2144.05.11.
However, both Boyden, Schneider, Young, and Whelan fail to teach the plurality of magnetic field pulses being configured to cause generation of an electric field having a predetermined strength in a range of approximately 50 V/m to 120 V/m at the predetermined distance, thereby generating a desired repetitive transcranial magnetic stimulation therapeutic effect in the subject.
However, Saitoh teaches changing coil design parameters to acquire a desired induced electric
field intensity wherein the predetermined strength of the generated electric field falls in a range of
approximately 50 V/m to 120 V/m and thereby generating a desired repetitive transcranial magnetic stimulation therapeutic effect in the subject. (Fig 30. Shows testing various coil
designs which produce generated electric field strengths varying from 50 V/m to 150 V/m where one of
the coil designs produce approximately 65 V/m as seen on the graphs. The examiner is interpreting this
as there is an embodiment of this prior art that is capable of producing an electric field with strength of
65 V/m. Paragraph [0129] "The alternating current applied to the coil was set to the
frequency of 3.4 kHz.", "The electric conductivity of this brain model was set to 0.115/m from the
electric conductivity of the grey matter at 3.4 kHz.", the frequency is being set based on the desired area
to be treated, i.e. therapeutic effect.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date
of the application to modify the magnetic field taught in Boyden to have the predetermined strength of the electric field to generate the therapeutic effect as taught by Saitoh. Boyden fails to disclose an electric field strength and Saitoh teaches using max electric field strengths ranging from 56-121 V/m (Table 4) for transcranial magnetic stimulation, it would therefore be obvious to apply a field strength within that range such as 65 V/m. Additionally, Boyden teaches a transcranial magnetic
stimulation device that is modular so that one can change the properties of the machine ([0004]). It
would therefore be obvious to one of ordinary skill in the art to change a property of the machine such
as the magnetic field pulse frequency to target the desired area to be treated/the desired therapeutic
effect. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions 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 USPQ233, 235 (CCPA 1955). MPEP 2144.05.11.
Response to Arguments
Claim Objections
Applicant’s arguments and amendments filed 5/29/26 with respect to claim 14 has been fully considered and are persuasive. The objection of claim 14 has been withdrawn.
35 U.S.C. 102
Applicant’s arguments and amendments filed 5/29/26 with respect to claims with respect to the rejection(s) of claim(s) 1-7, 11-13, 15 -16, 20, and 22 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Boyden, Schneider, Young, Whelan, and Saitoh.
Regarding claim 1, the examiner agrees that Boyden alone does not disclose generation of a plurality of magnetic field pulses as a pulse train at a predetermined pulse repetition frequency during a predetermined period of time of at least 10 seconds. However, a new rejection has been made in based on Boyden in combination with Schneider where when the device described in Boyden uses the pulse delivery taught in Schneider that a plurality of magnetic field pulses is delivered as a pulse train at a predetermined pulse repetition frequency during a predetermined time period. Further, the examiner asserted in the non-final rejection that an LC circuit is the hardware responsible for generating a magnetic field not a pulse train. However, as reiterated above when combined with Schneider a pulse train is created for rTMS. Further, when Boyden and Schneider are combined with Young (magnetic field strength greater than 100 mT), Whelan (predetermined distance), and Saitoh (generated electric field strength of 50 V/m to 120 V/m) the limitations of the amended claim 1 are met. Please see claim 1 rejection.
Regarding claims 2-7, 12, 13, 15 and 16, a new grounds of rejection of independent claim 1 and the dependent claims has been provided. Therefore, these dependent claims are found not to be allowable.
35 U.S.C. 103
Applicant's arguments filed 5/29/26 with respect to claims 8, 10, 14, 17-19 have been fully considered but they are not persuasive. Regarding claims, 8, 10, 14, and 17, a new grounds of rejection for independent claim 1 in view of Boyden, Schneider, Young, Whelan, and Saitoh has been made, that claim has not been found to be allowable, and therefore the rejections of those claims still hold.
Regarding claim 18-19, and 21, those claims have been cancelled and incorporated into independent claim 1. The rejections of these claims are moot. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning in in claim 21 rejection, the examiner notes in the non-final action dated 2/10/26 that column 1, line 20 of Young cites a reasoning for why the claimed magnetic field strength would be combined with Boyden. Further, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.L.D./
Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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