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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al.(CN 110975153) hereinafter Xu et al. in view of Fang et al.(CN 115887932) hereinafter Fang et al.
Regarding claim 1, Xu et al. teaches an upper computer control software,
a system main control module, a stimulation coil excitation power module, and
a deep stimulation coil module; wherein an output end of the upper computer control software is connected to an input end of the system main control module, an output end of the system main control module is connected to a control end of the stimulation coil excitation power module, and an output end of the stimulation coil excitation power module is connected to an input end of the deep stimulation coil module;
the upper computer control software is configured to send a stimulation instruction to the system main control module according to predetermined parameter data, wherein the predetermined parameter data comprises a target region, excitation time, and an excitation current;
the system main control module is configured to send a control enable signal to the stimulation coil excitation power module when receiving the stimulation instruction;
the stimulation coil excitation power module is configured to provide a current to the deep stimulation coil module according to the control enable signal;
the deep stimulation coil module is configured to generate a superimposed magnetic field and transmit the superimposed magnetic field to the target region;
the deep stimulation coil module comprises a plurality of coil groups; each coil group comprises two coils; there is an overlapping part among magnetic fields of the plurality of coil groups, the overlapping part corresponds to a predetermined target region, and a current flowing through each coil group has same magnitude and direction, the plurality of coil groups are placed in different orientations on a brain;
a position and an angle of each coil group are adjusted according to the target region, such that electromagnetic fields generated by respective coil groups are superimposed in the target region;
by generating a superimposed electromagnetic field, a non-invasive transcranial magnetic field is able to accurately reach a deep brain region, and the plurality of coil groups are added for greater intensity of regulatory stimulation.
Note figure 3 and the corresponding description in the specification. Xu et al. teaches a method and system for deep brain stimulation, an electronic device, and a storage medium, and specifically discloses the following technical characteristics (see paragraphs 5-54 of the specification of Reference Document 1): S1, obtaining data, and establishing a three-dimensional model by scanning a target head, the three-dimensional model including coordinates of a target region to be stimulated; S2, forming stimulation channels, and configuring multiple coils to a set position of the target head according to the three-dimensional model, where the coils are correspondingly connected to a control unit to form the stimulation channels, the multiple stimulation channels are configured through instructions sent by a main control board, the main control board sends the instructions to the multiple control units so that the coils receive pulse signals and act on the target region, the instructions sent by the main control board to the stimulation channels are different, and the multiple stimulation channels send out different pulse signals under the regulation of the main control board and perform superposition compensation at the target region to obtain required stimulation values for deep stimulation; and S3, performing depth stimulation, configuring output pulse signals of the multiple stimulation channels to perform superposition compensation at the coordinates of the target region to obtain required stimulation values for depth brain stimulation. The coils are coils, which are distributed above the target region. The types of coils may include various conventional transcranial magnetic stimulation coils, such as round coils, splayed coils, and four-leaf coils. Frequency signals control corresponding control pulses to turn on a switch to control the functions of charging and discharging circuits. The discharging circuit is connected to an excitation coil to realize the function of inducing a magnetic field by the excitation coil. The main control board is connected with a handheld terminal, and the handheld terminal is configured to send instructions to the main control board. In one embodiment, the control process of the main control board is customized by keys of a wired handle, i.e. the handheld terminal, and the frequency and phase of pulses of the channels are set at the handheld terminal. The method independently adjusts the frequency and phase signals of the pulse signals of the multiple stimulation channels by the main control board, so that the electromagnetic fields between the multiple channels are superimposed and synthesized to realize the function of precise stimulation of a deep brain region. To realize the superposition of carrier pulse signals of the two stimulation channels, the coils in the stimulation channels need to cooperate, and the position of the coils can be regulated by the main control board to cooperate with the superposition compensation of the pulse signals of the two stimulation channels to achieve the best stimulation effect.
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Xu et al. does not specifically teach wherein the deep brain region is a brain region with a depth greater than 6 cm.
Fang et al. teaches a tangential encircling space array and system for deep non-invasive focus stimulation of craniocerebral, relating to the technical field of craniocerebral electromagnetic stimulation. The spatial array includes a plurality of tangential coils arranged transversely around the head of the human body and having the same geometric parameter; when the space array is working, a plurality of corresponding stimulation currents are input to the plurality of tangential coils, the plurality of stimulation currents are used for passing through the plurality of tangential coils, a plurality of first induction electric field vectors with similar amplitude and small included angle are generated at the deep part of the craniocerebral, multiple second induction electric field vectors with large amplitude difference and large included angle are generated in the scalp shallow layer, which is good for enhancing the overlapping effect of the induction electric field in the deep craniocerebral region, effectively improving the stimulation depth, realizing the purpose of space selective stimulation and improving the stimulation focusing. In addition, it can obtain the best stimulation current parameter in the array to realize the global optimization of the space array. Fang et al. also teaches a coil spatial array design solution for non-invasive focus stimulation of deep craniocerebral portion is provided, that is, comprising a plurality of tangential coils for being arranged transversely around the head of the human body and having the same geometric parameter, wherein the tangential coil is a coil structure capable of being tangential to the scalp surface of the human head. It effectively improves the stimulation depth, realizes the purpose of space selective stimulation and improves the focusing of the stimulation, so as to be good for stimulating the biological tissue under the scalp more than 4 cm depth, satisfying the need of the craniocerebral stimulation to the stimulation depth. As can be seen from FIG. 6, the induced electric field generated by the tangential surrounding spatial array can form a significant focal region 59 at the deep portion of the craniocerebral; and through finite element numerical analysis to obtain the tangential surrounding space array in the stimulation depth depth=10cm.
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 Xu et al. where the coil groups are adjusted at a position and an angle according to the target region, such that electromagnetic fields generated by respective coil groups are superimposed in the target region to achieve a target depth of greater than 6cm as taught by Fang et al. to provide space selective stimulation and improving the stimulation focusing at greater depths.
Regarding claim 3, Xu et al. teaches a power fault detection module. The power
fault detection module is respectively connected to the system main control module and the
stimulation coil excitation power module. The power fault detection module is configured to collect
a working state of the stimulation coil excitation power module in real time and transmit the working
state to the system main control module. The system main control module controls the on and off of
the stimulation coil excitation power module according to the working state. The system main control module is further configured to transmit a closed state of the stimulation coil excitation power module to the upper computer control software when the stimulation coil excitation power module is controlled to be closed. The upper computer control software displays the closed state of the stimulation coil excitation power module and sends a stop instruction to the system main control module.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al.(CN 110975153) hereinafter Xu et al. in view of Fang et al.(CN 115887932) hereinafter Fang et al. and further in view of Wu et al.( CN 113559417) hereinafter Wu et al.
Regarding claim 2, Xu et al. as modified by Fang et al. teaches the claimed invention as set forth above, however does not specifically teach a coil temperature detection module; wherein the coil temperature detection module is connected to the system main control module, and the coil temperature detection module is located inside the deep stimulation coil module; the coil temperature detection module is configured to collect a temperature of the deep stimulation coil module in real time, and to transmit the temperature to the system main control module; the system main control module is configured to control on/off of the stimulation coil excitation power module according to the temperature; the system main control module transmits the temperature to the upper computer control software, and the upper computer control software is configured to send a stop instruction to the system main control module when the temperature is greater than a predetermined temperature threshold, and the upper computer control software displays temperature failure information.
Wu et al. teaches a transcranial magnetic stimulation coil for deep precision magnetic stimulation includes a coil fixing member 1 and a DO dual-coil fixed by the coil fixing member, and the DO dual-coil includes a D-shaped coil 2 and an O-shaped coil 3 arranged asymmetrically. Two ends of the D-shaped coil 2 and two ends of the O-shaped coil 3 respectively pass through the coil fixing member 1 and are connected to a current output apparatus. The D-shaped coil 2 is arranged inside the O-shaped coil 3, and the D-shaped coil 2 is closely attached to the upper part of the O-shaped coil 3 at a position
where the D-shaped coil 2 crosses the O-shaped coil 3, and the cross region constitutes a target
region 4. The current output apparatus outputs a reference current for the D-shaped coil 2, which is
used for providing the distribution intensity and direction of a reference magnetic field. The current
output apparatus provides a regulation current for the O-shaped coil 3, which is used for regulating the magnetic field distribution intensity and direction of the whole DO dual-coil. The magnetic stimulation helmet is mainly divided into three parts, where the second part is a circuit part, which connects an air duct of a cooling system and a power line generating magnetic pulses into the helmet, and collects a temperature feedback signal in real time to ensure the coils to work continuously at a suitable temperature. (Equivalent to: a coil temperature detection module. The coil temperature detection module is located inside the deep stimulation coil module. The coil temperature detection module is configured to collect the temperature of the deep stimulation coil module in real time, so as to ensure the coils to work continuously at a suitable temperature). In addition, the coil temperature detection module plays the same role in Wu et al. as it plays in solving the technical problems in the present invention, and is configured for the normal use of the apparatus for deep transcranial magnetic stimulation modulated therapy.
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 Xu et al. as modified by Fang et al. where a coil temperature detection module is connected to the system main control module and transmits the temperature to the system main control module, the system main control module controls the on and off of the stimulation coil excitation power module according to the temperature, the system main control module transmits the temperature to the upper computer control software, the upper computer control software is configured to send a stop instruction to the system main control module when the temperature is greater than a preset temperature threshold, and the upper computer control
software displays temperature fault information as taught by Wu et al. to ensure the stimulation intensity of the non-target area is small, and the target area is subjected to safe stimulation levels and at safe temperatures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Glover et al.(WO 2018136429) teaches method and device are disclosed for targeting deep brain structures. The method can include placing a transcranial magnetic stimulation device adjacent to a patient's scalp, wherein the transcranial magnetic stimulation device comprises a plurality of annular coils. The method can also include providing each of the plurality of annular coils with an amplitude and direction such that the magnetic field adjacent to the coil array is reduce and the magnetic field at greater depths survives. A device for targeting deep brain structures can include a plurality of transcranial magnetic stimulation coils, wherein each of the plurality of transcranial magnetic stimulation coils are configured to be annular to each of the other plurality of transcranial magnetic stimulation coils. The device can also include a plurality of power supplies configured to independently control each of the plurality of transcranial magnetic stimulation coils. [0015] To mitigate depth limitations of conventional technology, disclosed is a MRI-compatible array of TMS coils that can be configured to, for example, facilitate important studies of deep brain structures (e.g. up to 6 cm from the scalp).
LUO et al.( CN 114028720) teaches a magnetic stimulation device, comprising a locating fixed connection device and an electromagnetic wave emitting device. The locating and fixing connecting device comprises a spherical fixing frame composed of two completely same semi-spherical frames. The electromagnetic wave emitting device comprises a first, a second and a third electromagnetic generating coil group, each electromagnetic generating coil group comprises two coils which are symmetrically arranged in the centre. the first, the second and the third electromagnetic generating coil groups respectively form a dual focusing type magnetic stimulation coil pair, emitting electromagnetic wave to the central point of the spherical fixing frame. Because the magnetic stimulation device comprises three groups of dual focusing type magnetic stimulation coil pair, so that the magnetic stimulation signal is focused, so that the stimulation depth of the transcranial magnetic stimulation can be controlled, stimulation focusing is controllable, stimulation range is more controllable, under the premise of greatly improving the treatment effect of transcranial magnetic stimulation, reducing the complications caused by magnetic stimulation.
FITZGERALD et al.( WO 2013173875) teaches a method of optimizing transcranial magnetic stimulation is described. An electrical signal is applied to a coil to generate one or more magnetic field pulses for transcranial magnetic stimulation of a target cortical region of a patient. The transcranial magnetic stimulation has stimulation parameters including orientation of the coil relative to the patient and intensity of the magnetic stimulation. At least the orientation of the coil relative to the patient is varied. At different orientations of the coil relative to the patient, neuron activation at the target cortical region is determined by monitoring changes in blood flow and/or blood oxygenation, e.g. using near infra-red spectroscopy. Based on information obtained during the monitoring, one or more optimal coil orientations for the transcranial magnetic stimulation are determined.
QI et al.( CN 114796875) teaches an electromagnetic stimulation method, device, device and readable storage medium. The method is applied to the technical field of medical treatment, the method can solve the problem that the current technology stimulates the target area by electrical stimulation or magnetic stimulation, the focusing property is poor. The method comprises: receiving the operation instruction input by the user; under the condition that the operation instruction is used for indicating the target area of the target object for deep stimulation, controlling the current direction of the TES device in the electromagnetic stimulation device in the target area, and the current direction of the TMS device in the target area is the same, under the condition that the operation instruction is used for indicating the shallow stimulation to the target area, controlling the current direction of the TES device in the target area, and the current direction of the TMS device in the target area is opposite, the current signal generated by the TES device and the TMS in the target area for electromagnetic stimulation of the target area . The invention can improve the space focusability of the electromagnetic stimulation in the target area.
ZHANG et al.( CN 114225223) teaches a transcranial magnetic stimulation device, transcranial magnetic stimulation system and method, comprising a stimulation drive control module and a magnetic signal generating component. the magnetic signal generating component is used for fixedly connecting with the head, and emitting electromagnetic wave to the target area, the magnetic signal generating component comprises a first and a second electromagnetic generating coil group, respectively two first coil and the second coil with the same structure, and respectively forming a pair focusing type magnetic stimulation coil pair, magnetic stimulation is performed in the target area. wherein the central axis of the two first coils and two second coils are overlapped, and the diameters of the first coil and the second coil are different. the stimulation drive control module according to the preset coil stimulation intensity and stimulation time sequence respectively the first coil or the second coil for driving the time sequence control of the current. Because the magnetic stimulation is accurately controlled by two groups of dual focusing type magnetic stimulation coil group, so that the transcranial magnetic stimulation is more accurate, stimulation depth and stimulation range is more controllable, greatly reducing the complications caused by magnetic stimulation.
SCHNEIDER et al.( US 20160023015) teaches Transcranial Magnetic Simulation (TMS) systems and methods of using them for emitting focused, or shaped, magnetic fields for TMS. In particular, described herein are arrays of TMS electromagnets comprising at least one primary (e.g., central) TMS electromagnet and a plurality of secondary (e.g., lateral or surrounding) TMS electromagnets. The secondary TMS electromagnets are arranged around the primary TMS electromagnet(s), and are typically configured to be synchronously fired with the primary TMS electromagnets. Secondary TMS electromagnets may be fired at a fraction of the power used to energize the primary TMS electromagnet to shape the resulting magnetic field. The secondary TMS electromagnets may be stimulated at opposite polarity to the primary TMS electromagnet(s). Focusing in this manner may prevent or reduce stimulation of adjacent non-target brain regions.
SOEKADAR et al.( EP 3995176) 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
