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 1-30 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 claim 1 , line 9, “the subject’s brain” lacks antecedent basis.
Regarding claim 16 , line 13, “the subject’s brain” lacks antecedent basis.
Regarding claims 8 and 23 “the rotating magnetic field vector is substantially constant” is unclear as to the intended meets and bounds of the limitation substantially constant and the specifications does not provide clarification is to the intended scope.
Regarding claims 10 and 25 “the phase offset between the first magnetic field and the second magnetic field is substantially the same as the phase offset between the second magnetic field and the third magnetic field” is unclear as to the intended meets and bounds of the limitation substantially the same and the specifications does not provide clarification is to the intended scope.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moses et al.( WO 2010100643) hereinafter Moses et al .
Moses et al. teaches methods and tools for the design of efficient magnetic stimulators. Such stimulators can excite neuronal networks that were not sensitive to stimulation until now. Stimulation can be carried out both in-vitro and in-vivo. Novel systems and techniques of this invention will enable both treatment and diagnostics by stimulating regions of the brain or neuronal assemblies that were previously unaffected by TMS. [009] comprising subjecting one or more neurons to a rotating electric field, thereby exciting said neuron or said neurons. In one embodiment, the rotating electric field is the resultant sum of at least two time-dependent electric fields. [0010] In one embodiment, the at least two time-dependent electric fields are induced by at least two time-dependent magnetic fields. In one embodiment, the at least two time-dependent magnetic fields are induced by passing currents through at least two separate and independent coils. [0015] In one embodiment, the currents passed through the at least two coils comprise: a first current passed through a first coil and a second current passed through a second coil such that said first current has a phase with respect to said second current. In one embodiment, the phase of the first current with respect to the second current is a 90 degree phase.
Regarding claims 1 ,11, and 15 Moses et al. teaches positioning a plurality of magnetic sources in proximity to a head of the subject, each magnetic source being configured to provide a magnetic field;
selecting a phase offset between a first magnetic field provided by a first magnetic source of the plurality of magnetic sources and a second magnetic field provided by a second magnetic source of the plurality of magnetic sources; operating the plurality of magnetic sources with the selected phase offset; and applying the magnetic fields provided by the plurality of magnetic sources to the head of the subject to provide a therapeutic treatment within a target area of the subject’s brain, wherein the magnetic fields combine to produce a rotating magnetic field vector in proximity to the target area of the subject’s brain. Note figures 1 and 3, the abstract, and paragraphs [009] and [0015].
Regarding claim 2, Moses et al. teaches wherein the plurality of magnetic sources are stationary magnetic sources. The coils in Moses et al. are fixed electromagnetic coils not rotating permanent magnets. [00174] the devices, tools, apparatuses or systems of this invention further comprises stands, supports and/or other accessories for holding the coils or the electrode assembly in desired positions with respect to the subject, the animal or the culture being probed. In one embodiment, the coils, the electrodes, the devices, tools, apparatuses or systems of this invention further comprises moving parts for helping in positioning the coils or the electrodes with respect to the area under examination or the area treated. In one embodiment, the moving parts are controlled by a computerized system.
Regarding claim 3, Moses et al. teaches wherein each magnetic source of the plurality of magnetic sources is an electromagnetic coil. Note figures 1 and 3 and paragraphs [009] and [0015].
Regarding claim 4, Moses et al. teaches wherein applying the magnetic fields provided by the plurality of magnetic sources to the head of the subject includes inducing electric fields in the subject’s brain, wherein the electric fields combine to produce a rotating electric field vector within the target area of the subject’s brain. Note figures 1 and 3 and paragraphs [009], [0015], and [0020].
Regarding claims 5 and 6, Moses et al. teaches wherein the magnetic field vector rotates in a first direction and the electric field vector rotates in a second direction and wherein the second direction is opposite from the first direction. Note figures 1 and 3 and paragraphs [009], [0015], and [0020] and [00200] teaches rfTMS A different kind of implementation of rfTMS to the human head is the cloverleaf design (see Methods and Materials), which achieves a focused scanning field capability while using the equivalent of the well-known figure-eight coil. This configuration is expected to be more agreeable for clinical use than the crossed coil one. The use of rfTMS on human subjects will eventually enable the excitation of currently inaccessible cortical regions, whose random axonal orientation is not amenable to excitation with a fixed-direction, non-rotating field. It is well understood that in rfTMS, the coil design and current modulation create a rotating magnetic field in the plane of the coil. The induced rotating electric field in the brain is also in the same plane, but rotates in the opposite sense to the magnetic field rotation. This is because the electric field is the time derivative of the magnetic field, and the sign in Faraday’s law flips the rotational direction.
Regarding claims 7 and 8 , Moses et al. teaches adjusting an amplitude of each magnetic field provided by the plurality of magnetic sources to control an amplitude of the rotating magnetic field vector and wherein the amplitude of each magnetic field is adjusted such that the amplitude of the rotating magnetic field vector is “substantially” constant. [0075] Theory - increasing rise time of magnetic stimulation without decreasing the induced electric field. Dendritic stimulation require pulse widths of the order of 1 ms. In order to obtain a given amplitude of induced electric field for a longer period of time, one needs to scale the magnetic field linearly with the pulse duration. This is because the induced electric field depends linearly on the time slope of the magnetic field, which decreases as the pulses get wider. [0092] In one embodiment, the first current is pulsed and the second current is pulsed. In one embodiment, the pulses of the first current and of the second current are of the same pulse rate. In one embodiment, the pulses of the first current and of the second current are of the same wave pattern. In one embodiment, the pulses of the first current and of the second current are of the same peak amplitude. Note also [00122], [00167].
Regarding claims 9 and 10, Moses et al. teaches selecting a phase offset between the second magnetic field provided by the second magnetic source of the plurality of magnetic sources and a third magnetic field provided by a third magnetic source of the plurality of magnetic sources and wherein the phase offset between the first magnetic field and the second magnetic field is substantially the same as the phase offset between the second magnetic field and the third magnetic field. [0027] In one embodiment, the currents passed through the at least two coils comprise: a first current passed through a first coil and a second current passed through a second coil such that the first current has a phase with respect to the second current. In one embodiment, the phase of the first current with respect to the second current is a 90 degree phase. [00167] In one embodiment, the coil is spherical. In one embodiment, the coil has a figure 8 shape. In one embodiment the coil is of a clover-leaf shape. In one embodiment, the coil is of a butterfly shape. In one embodiment, two coils are employed. In one embodiment, three or four coils are employed, hi one embodiment, five or six coils are used. In one embodiment, the number of coils ranges between two and ten coils. In one embodiment, the number of coils ranges between three and five coils. In one embodiment, the number of coils ranges between six and 20 coils. In one embodiment, each coil plane is perpendicular to all other coil planes. In one embodiment, all coil planes lie in the same plane. In one embodiment, there is an angle other than 90 degrees between the planes of at least two coils. In one embodiment, a multitude of protocols may be used to extend the rotating fields. Any combination of two separate coil systems can be combined to create some variation of a rotating electric field, for example an elliptical rotation instead of perfect circular one. The amplitude of both coils need not be the same, and so doesn't the cycle time and the relative orientation between the two coils.
Regarding claims 12 and 13 , Moses et al. teaches wherein positioning a plurality of magnetic sources in proximity to the head of the subject includes arranging the plurality of magnetic sources based on the target area of the subject’s brain. [0073] Rotating magnetic fields methods of this invention require the induction of a rotating field. It will be shown herein below how the induction of a rotating field is achieved, and that improved stimulating pulses of this invention target a larger number of neurons for excitation, both in the culture dish and in the live brain. Note also [0085], [00180] – [00187] teach using MRI and other diagnostic techniques along with the TMS.
Regarding claim 14, Moses et al. teaches wherein each magnetic field provided by the plurality of magnetic sources has a sinusoidal waveform. Note paragraphs [0049] and [00201].
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) 16-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moses et al.( WO 2010100643) hereinafter Moses et al. in view of SOEKADAR et al.( EP 3995176) hereinafter SOEKADAR et al.
Regarding claims 16, 26, and 30 Moses et al. teaches the claimed invention as set forth above including 00174] The devices, tools, apparatuses or systems of this invention further comprises stands, supports and/or other accessories for holding the coils or the electrode assembly in desired positions with respect to the subject, the animal or the culture being probed. In one embodiment, the coils, the electrodes, the devices, tools, apparatuses or systems of this invention further comprises moving parts for helping in positioning the coils or the electrodes with respect to the area under examination or the area treated. In one embodiment, the moving parts are controlled by a computerized system. Note figures 1 and 3, the abstract, and paragraphs [009] and [0015].
Moses does not specifically teach at least one memory storing computer-executable instructions; and at least one processor for executing the instructions stored on the memory.
SOEKADAR et al. teaches a system for magnetic stimulation of biological tissue, comprising at least two magnetic field generating devices (D1-D4) for generating time-varying magnetic fields, wherein the magnetic field generating devices (D1-D4) are to be arranged relative to the tissue in such a way that their time-varying magnetic fields at least partially overlap in the tissue; and at least one controlling arrangement (50) for controlling the two magnetic field generating devices (D1-D4). According to the invention, the controlling arrangement (50) is configured to control at least one (D2, D4) of the two magnetic field generating devices (D1-D4) in such a way that the time-varying magnetic field generated by the device (D2, D4) is modulated. Furthermore, the controlling arrangement may be configured to adjust the ratio of the amplitudes of the time-varying magnetic fields generated by the two magnetic field generating devices. The extent of amplitude modulation in particular depends on the vector sum of the two magnetic and/or induced electric fields at each location in the tissue. The modulation may be maximal when the two fields have equal magnitudes, and minimal near each magnetic field generating device, where one of the two fields may dominate the other. The locus of maximum amplitude modulation and thus the locus of maximum stimulation may be steered by adjusting the relative amplitudes (i.e. the amplitude ratio) of the generated time-varying magnetic fields. A computer program product comprising program code having instructions which - when executed by a programmable unit of the controlling arrangement of the system of any of the preceding claims - will cause the controlling arrangement to control the two magnetic field generating devices of the system in such a way that each of them generates a time-varying magnetic field, wherein the time-varying magnetic field of at least one of the devices is modulated. The controlling arrangement of the system according to the invention may comprise a programmable unit, e.g. a microcontroller. The programmable unit may generate at least one control signal (driving signal) for controlling the time-varying magnetic fields generated by the two magnetic field generating devices. For example, the controlling arrangement comprises an amplifier circuit that receives the control signal and supplies the amplified control signal to the magnetic field generating devices. The control signal may determine both the time-varying magnetic field generated by the magnetic field generating device, i.e. the carrier magnetic signal, and the modulation of the time-varying magnetic field. In particular, the control signals set the waveform (including the frequency, amplitude and/or phase) of the modulated or unmodulated time-varying magnetic field. The corresponding control signal instead of being provided by the programmable unit may also be generated by analogue circuitry. It is well understood and obvious a computer including executable program code to control the operation of the coils would include a memory to store the program code.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Moses et al. at least one memory storing computer-executable instructions; and at least one processor for executing the instructions stored on the memory for controlling the tms system as taught by SOEKADAR et al. as an obvious matter of design choice and to efficiently and automatically operate the brain stimulation device.
Regarding claim 17, Moses et al. teaches wherein the plurality of magnetic sources are stationary magnetic sources. [00174] the devices, tools, apparatuses or systems of this invention further comprises stands, supports and/or other accessories for holding the coils or the electrode assembly in desired positions with respect to the subject, the animal or the culture being probed. In one embodiment, the coils, the electrodes, the devices, tools, apparatuses or systems of this invention further comprises moving parts for helping in positioning the coils or the electrodes with respect to the area under examination or the area treated. In one embodiment, the moving parts are controlled by a computerized system.
Regarding claim 18, Moses et al. teaches, wherein each magnetic source of the plurality of magnetic sources is an electromagnetic coil. Note figures 1 and 3 and paragraphs [009] and [0015].
Regarding claim 19, Moses et al. teaches, wherein the magnetic fields provided by the plurality of magnetic sources, when applied to the head of the subject, induce electric fields in the subject’s brain that combine to produce a rotating electric field vector within the target area of the subject’s brain. Note figures 1 and 3 and paragraphs [009], [0015], and [0020].
Regarding claims 20 and 21, Moses et al. teaches, wherein the magnetic field vector rotates in a first direction and the electric field vector rotates in a second direction and wherein the second direction is opposite from the first direction. Note figures 1 and 3 and paragraphs [009], [0015], and [0020] and [00200] teaches rfTMS A different kind of implementation of rfTMS to the human head is the cloverleaf design (see Methods and Materials), which achieves a focused scanning field capability while using the equivalent of the well-known figure-eight coil. This configuration is expected to be more agreeable for clinical use than the crossed coil one. The use of rfTMS on human subjects will eventually enable the excitation of currently inaccessible cortical regions, whose random axonal orientation is not amenable to excitation with a fixed-direction, non rotating field. It is well understood that in rfTMS, the coil design and current modulation create a rotating magnetic field in the plane of the coil. The induced rotating electric field in the brain is also in the same plane, but rotates in the opposite sense to the magnetic field rotation. This is because the electric field is the time derivative of the magnetic field, and the sign in Faraday’s law flips the rotational direction.
Regarding claim 22 and 23, Moses et al. teaches, wherein execution of the instructions causes the at least one processor to: adjust an amplitude of each magnetic field provided by the plurality of magnetic sources to control an amplitude of the rotating magnetic field vector and wherein the amplitude of each magnetic field is adjusted such that the amplitude of the rotating magnetic field vector is “substantially” constant. [0075] Theory - increasing rise time of magnetic stimulation without decreasing the induced electric field. Dendritic stimulation require pulse widths of the order of 1 ms. In order to obtain a given amplitude of induced electric field for a longer period of time, one needs to scale the magnetic field linearly with the pulse duration. This is because the induced electric field depends linearly on the time slope of the magnetic field, which decreases as the pulses get wider. [0092] In one embodiment, the first current is pulsed and the second current is pulsed. In one embodiment, the pulses of the first current and of the second current are of the same pulse rate. In one embodiment, the pulses of the first current and of the second current are of the same wave pattern. In one embodiment, the pulses of the first current and of the second current are of the same peak amplitude. Note also [00122], [00167].
Regarding claims 24 and 25, Moses et al. teaches, wherein execution of the instructions causes the at least one processor to: select a phase offset between the second magnetic field provided by the second magnetic source of the plurality of magnetic sources and a third magnetic field provided by a third magnetic source of the plurality of magnetic sources and wherein the phase offset between the first magnetic field and the second magnetic field is substantially the same as the phase offset between the second magnetic field and the third magnetic field. . [0027] In one embodiment, the currents passed through the at least two coils comprise: a first current passed through a first coil and a second current passed through a second coil such that the first current has a phase with respect to the second current. In one embodiment, the phase of the first current with respect to the second current is a 90 degree phase. [00167] In one embodiment, the coil is spherical. In one embodiment, the coil has a figure 8 shape. In one embodiment the coil is of a clover-leaf shape. In one embodiment, the coil is of a butterfly shape. In one embodiment, two coils are employed. In one embodiment, three or four coils are employed, hi one embodiment, five or six coils are used. In one embodiment, the number of coils ranges between two and ten coils. In one embodiment, the number of coils ranges between three and five coils. In one embodiment, the number of coils ranges between six and 20 coils. In one embodiment, each coil plane is perpendicular to all other coil planes. In one embodiment, all coil planes lie in the same plane. In one embodiment, there is an angle other than 90 degrees between the planes of at least two coils. In one embodiment, a multitude of protocols may be used to extend the rotating fields. Any combination of two separate coil systems can be combined to create some variation of a rotating electric field, for example an elliptical rotation instead of perfect circular one. The amplitude of both coils need not be the same, and so doesn't the cycle time and the relative orientation between the two coils.
Regarding claim 27, Moses et al. teaches, wherein the plurality of magnetic sources are configured to be positioned in proximity to the head of the subject in an arrangement based on the target area of the subject’s brain and wherein the at least one processor is configured to receive an indication of the target area of the subject’s brain. [0073] Rotating magnetic fields methods of this invention require the induction of a rotating field. It will be shown herein below how the induction of a rotating field is achieved, and that improved stimulating pulses of this invention target a larger number of neurons for excitation, both in the culture dish and in the live brain. Note also [0085], [00180] – [00187] teach using MRI and other diagnostic techniques along with the TMS.
Regarding claim 29, Moses et al. teaches, wherein each magnetic field provided by the plurality of magnetic sources has a sinusoidal waveform. Note paragraphs [0049] and [00201].
Regarding claim 30, Moses et al. teaches, wherein the therapeutic treatment includes transcranial magnetic stimulation (TMS).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
John(US 12722022) teaches Systems and methods improving patient benefit from stimulation therapy including transcranial magnetic stimulation (TMS) are disclosed. Treatment may include a first and second type of stimulation treatment provided as simultaneous, interleaved, or sequential stimulation. Treatment sequence and treatment session characteristics for the first or second stimulation type may be set or adjusted based on a patient's characteristics or response to stimulation meeting a minimum selected criterion. Combination therapy with at least two therapy types may obviate the need for repeated clinic visits which use TMS devices and protocols with stronger fields or other technical requirements. Stimulation targeting at least one cranial nerve with magnetic stimulation is also disclosed.
Phillips et al.( US 20110137104) teaches methods of treating a subject, comprising: (a) adjusting output of a magnetic field for influencing an intrinsic frequency of a specified EEG band of the subject toward a pre-selected or target intrinsic frequency of the specified EEG band; and (b) applying said magnetic field close to a head of the subject. The magnetic field results from a first magnetic source and a second magnetic source. In some embodiments, the first magnetic source and the second magnetic source are out of phase relative to each other.
Sun et al.( US 20220040491) teaches Systems and methods for providing brain stimulation (e.g., deep brain stimulation) are provided. A brain stimulation method includes applying a first magnetic field at a first location external of a brain, the first magnetic field having a waveform of a first frequency. The method further includes applying a second magnetic field at a second location external of the brain, the second magnetic field having a waveform of a second frequency. The second frequency is different from the first frequency such that temporal interference is generated at a focal point internal to the brain.
Schneider et al.( US 20100185042) teaches devices and method for control and coordination of TMS electromagnets for modulation of deep brain targets. For example, described herein are methods and devices for stimulating neural structures within the brain using multi-coil arrays. Also described herein are devices and methods that relate generally to the focusing of magnetic fields generated by electromagnets used for Transcranial Magnetic Stimulation. Devices and methods relating generally to the focusing of magnetic fields generated by electromagnets used for Transcranial Magnetic Stimulation are also described, as well as devices and methods that relate generally to moving and positioning electromagnets generating magnetic fields used for Transcranial Magnetic Stimulation. Finally, also described are devices and methods that relate generally to control of moving, positioning, and activating electromagnets generating magnetic fields used for Transcranial Magnetic Stimulation.
HONG et al.( US 20180193658) teaches Methods and systems to control magnetic fields and magnetic field induced currents, and to provide stimulations within a patient's body, e.g.: deep brain stimulation, in a non-invasive manner and with greater focus and control than has been afforded by prior known methods and systems. An array of magnetic coils is provided and positionable about a portion of a patient's body, and are configured to create a small region of a magnetic hole, or configured to create a small region of concentrated magnetic field strength, or their combination, and at depths within the patient's body in a focused region and sparing the surrounding tissues of the focused region, that have previously not been receptive to non-invasive TMS methods, which are either focused but can affect only the surface and shadow areas, or that can reach certain depths but by doing so only through affecting large surface areas and deep tissue areas.
Rotem et al., Solving the Orientation Specific Constraints in Transcranial Magnetic Stimulation by Rotating Fields, PLOS ONE, February 2014 | Volume9 | Issue2 | e86794. In rfTMS, the coil design and current modulation create a rotating magnetic field in the plane of the coil. The induced rotating electric field in the brain is also in the same plane, but rotates in the opposite sense to the magnetic field rotation. This is because the electric field is the time derivative of the magnetic field, and the sign in Faraday’s law flips the rotational direction.
Roth et al., Revisiting the Rotational Field TMS Method for Neurostimulation, J. Clin. Med. 2023, 12, 983. https://doi.org/10.3390/jcm12030983. teaches TMS (rfTMS) Method 3. Rotational Field TMS (rfTMS) Method For this Perspectives article, we surveyed publications related to the rotating field For this Perspectives article, we surveyed publications related to the rotating field
TMS method, as well as all publications related to the roles of orientation in TMS. The basic idea in rfTMS is to place two coils perpendicular to each other, one on top of the other, over the head (Figure 3a), and to operate them not simultaneously, but with a phase lag of 90°, namely, ¼ of a cycle.
TMSmethod, as well as all publications related to the roles of orientation in TMS. The basic
idea in rfTMS is to place two coils perpendicular to each other, one on top of the other, over
the head (Figure 3a), and to operate them not simultaneously, but with a phase lag of 90◦,
namely, 1/4 of a cycle.
Gutierrez et al, Devices and Technology in Transcranial Magnetic Stimulation:
A Systematic Review, Brain Sci. 2022, 12, 1218. https://doi.org/10.3390/brainsci12091218. Teaches a review of methods and coil structures for TMS.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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