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 § 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) 1-5 , 16, 20-24 and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phillips( US 20220096785) hereinafter Phillips.
Phillips teaches systems and methods of adjusting a vibrational energy source for influencing an intrinsic frequency of a specified EEG band of a subject toward a pre-selected or target intrinsic frequency of the specified band and applying the vibrational energy to the head of a subject. Other EEG based influences may also or alternatively be made. The vibrational energy may be created by rotating and/or translating weights. The weights may be magnetic and the vibrational energy is applied in conjunction with a magnetic and/or electric stimulation at a frequency. The frequency of the electric and/or magnetic stimulation may be approximately equal to, a harmonic of, and/or subharmonic of the frequency of the vibrational stimulation. [0045] The vibration system may be combined with other means of brain stimulation. For example, the vibration system may be combined with a coil-based rTMS system, resulting in additive benefit. The rTMS system may be programmed to provide stimulation with a pulse frequency that matches the vibration frequency. If rotating magnets are used to provide magnetic stimulation, the magnets could be mounted so that they produce vibration along with generation of the magnetic field.
Regarding claims 1 and 20, Phillips teaches a motor coupled to the first magnetic source; a second magnetic source positioned in proximity to the first magnetic source; at least one memory storing computer-executable instructions; and at least one processor for executing the instructions stored on the memory, wherein execution of the instructions causes the at least one processor to: when the second magnetic source is positioned in proximity to a head of the subject, operate the motor to rotate the first magnetic source causing the first magnetic source to produce a first magnetic field,
wherein the first magnetic field is applied to the second magnetic source and causes the second magnetic source to rotate and produce a second magnetic field that is applied to the head of the subject to provide a therapeutic treatment.
Note Fig. 2 and paragraph [0038], FIG. 2 shows an exemplary drawing of a vibration system 200 in which two diametrically magnetized cylindrical magnets 240 are rotated above a person's head. The magnets 240 could be mounted to a headset 210 that is worn by the person. The magnets could be rotated using a motor 250. It is also possible to rotate only one magnet 240 with the motor 250, and the other magnet 240 will rotate on its own due to the attraction and repulsion due to the magnetic fields generated by the magnets. If the magnets 240 are mounted on shafts, the shafts and motors 250 could be mounted to the headset 210 using a spring or other flexible material, which would allow the magnets 240 and motors 250 to shift during rotation, resulting in vibration. The system may also include controller 120 coupled to headset through a wired or wireless connection 130. [0049] the device including logic may be with a memory and processor for storing and executing the logic local to or within a housing of the machine. Exemplary embodiments of the device including logic may be with a memory and process or for storing and executing the logic local in wired and/or wireless communication with the machine. For example, logic may be on a remote server and/or handheld device of the user. Any combination of logic in different locations of the system are within the scope of the instant disclosure. It is understood that if the first magnet causes the second magnet to rotate both magnets will generate a magnetic field( thus a first and second magnetic field) and the claim does not require the magnetic fields to be different. If rotating magnets are used to provide magnetic stimulation, the magnets could be mounted so that they produce vibration along with generation of the magnetic field.
Regarding claims 2 and 21, Phillips teaches wherein the therapeutic treatment includes transcranial magnetic stimulation (TMS). Note [0045] The vibration system may be combined with other means of brain stimulation. For example, the vibration system may be combined with a coil-based rTMS system, resulting in additive benefit. The rTMS system may be programmed to provide stimulation with a pulse frequency that matches the vibration frequency.
Regarding claims 3 and 22, Phillips teaches wherein the first magnetic field and the second magnetic field are applied to the head of the subject to provide the therapeutic treatment. Note Fig. 2 and paragraph [0038] and [0049].
Regarding claims 4 and 23, Phillips teaches wherein the first magnetic source and the second magnetic source are permanent magnets. Note paragraph [0047], In some embodiments of at least one aspect described above, the magnetic vibrational energy is generated by movement of at least one permanent magnet. In some embodiment, the movement comprises rotation of at least one permanent magnet. The movement may comprise linear motion of at least one permanent magnet. In some embodiments, the movement may include curvilinear motion of at least on permanent magnet. The movement may comprise at least one of rotational motion, linear motion, and/or swing motion.
Regarding claims 5 and 24, Phillips teaches wherein the first magnetic source and the second magnetic source are each cylindrical magnets having a height and a diameter. Note Fig. 2 and paragraph [0038] and [0049]. FIG. 2 shows an exemplary drawing of a vibration system 200 in which two diametrically magnetized cylindrical magnets 240 are rotated above a person's head.
Regarding claims 16 and 35, Phillips teaches wherein the motor is configured to rotate the first magnetic source at a first frequency. [0011] In an exemplary embodiment, the vibrational energy is applied in conjunction with a magnetic and/or electric stimulation at a frequency. The frequency of the electric and/or magnetic stimulation may be approximately equal to, a harmonic of, and/or subharmonic of the frequency of the vibrational stimulation.
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) 1-9,11-14,16-28,30-33, and 35-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charles et al.( US 9962555) hereinafter Charles et al. in view of Phillips( US 20220096785) hereinafter Phillips.
Charles et al. teaches Helmets for applying a magnetic field to the head of a subject, comprising: a housing comprising a concave surface configured to receive a portion of the head of the subject; a motor coupled to one or more of: a first permanent magnet via a first axle along a first axis of rotation, wherein the first axle drives movement of the first magnet; a second magnet via a second axle along a second axis of rotation wherein the second axle drives movement of the second magnet; and a third magnet via a third axle along the third axis of rotation wherein the third axle drives movement of the third magnet, wherein the axes are parallel; and a fit mechanism comprising a adjuster coupled to the first magnet, wherein movement of the adjustor moves the first magnet independently of the second or the third magnet.
Regarding claims 1,9, 28, and 20, Charles et al. teaches a motor coupled to the first magnetic source; a second magnetic source positioned in proximity to the first magnetic source; at least one memory storing computer-executable instructions; and at least one processor for executing the instructions stored on the memory, wherein execution of the instructions causes the at least one processor to: when the second magnetic source is positioned in proximity to a head of the subject, operate the motor to rotate the first magnetic source causing the first magnetic source to produce a first magnetic field, and cause the second magnetic source to rotate and produce a second magnetic field that is applied to the head of the subject to provide a therapeutic treatment.
Charles et al. does teach a first motor coupled to one or more of: a first permanent magnet via a first axle along a first axis of rotation, wherein the first axle is configured to drive movement of the first permanent magnet but does not specifically teach wherein the first magnetic field is applied to the second magnetic source to cause the second magnetic source to rotate.
Phillips teaches, Note Fig. 2 and paragraph [0038], FIG. 2 shows an exemplary drawing of a vibration system 200 in which two diametrically magnetized cylindrical magnets 240 are rotated above a person's head. The magnets 240 could be mounted to a headset 210 that is worn by the person. The magnets could be rotated using a motor 250. It is also possible to rotate only one magnet 240 with the motor 250, and the other magnet 240 will rotate on its own due to the attraction and repulsion due to the magnetic fields generated by the magnets. Thus using the motor to drive only the first magnet and allowing the magnetic field generated by the first magnet to drive the second permanent magnet as an optional way to drive and rotate first and subsequent magnets.
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 Charles et al. to operate the motor to rotate the first magnetic source causing the first magnetic source to produce a first magnetic field, wherein the first magnetic field is applied to the second magnetic source and causes the second magnetic source to rotate as taught by Philips as a simple substitution of one known way to drive the magnets for another.
Regarding claims 2 and 21, Charles et al. teaches herein the therapeutic treatment includes transcranial magnetic stimulation as a helmet for applying a magnetic field to a head of a subject. Note paragraphs (24)-(25).
Regarding claims 3 and 22, Charles et al. teaches wherein the first magnetic field and the second magnetic field are applied to the head of the subject to provide the therapeutic treatment. Note paragraphs (24)-(25).
Regarding claims 4 and 23, Charles et al. teaches wherein the first magnetic source and the second magnetic source are permanent magnets. (3) Provided herein is a device comprising a helmet for applying a magnetic field to a head of a subject, comprising: a housing comprising a concave surface configured to receive at least a portion of the head of the subject; a magnet assembly within said housing comprising: a first motor coupled to one or more of: a first permanent magnet via a first axle along a first axis of rotation, wherein the first axle is configured to drive movement of the first permanent magnet; a second permanent magnet via a second axle along a second axis of rotation wherein the second axle is configured to drive movement of the second permanent magnet; and a third permanent magnet via a third axle along a third axis of rotation wherein the third axle is configured to drive movement of the third permanent magnet, wherein the first axis, the second axis, and the third axis are substantially parallel to each other.
Regarding claims 5 and 24, Charles et al. teaches wherein the first magnetic source and the second magnetic source are each cylindrical magnets having a height and a diameter. Note (41) Referring to FIGS. 3-4, in a particular embodiment, each assembly includes three magnets, optionally cylindrical.
Regarding claims 6 and 25, Charles et al. teaches wherein the motor is configured to rotate the first magnetic source in a first direction about an axis parallel to the height of the first magnetic source. Note paragraph (3), the first and the third permanent magnet rotate in a first direction, and wherein the second permanent magnet rotates in an opposite direction from the first rotation direction. Paragraphs (24)-(25), magnets that rotate in opposite directions in order to optimize and customize the magnetic field generated thereby to generate magnetic field with a larger dynamic range in variability.
Regarding claims 7 and 26, Charles et al. teaches wherein the second magnetic source is positioned such that the first magnetic field causes the second magnetic source to rotate in a second direction, the second direction being opposite from the first direction. Note paragraph (3), the first and the third permanent magnet rotate in a first direction, and wherein the second permanent magnet rotates in an opposite direction from the first rotation direction. Paragraphs (24)-(25), magnets that rotate in opposite directions in order to optimize and customize the magnetic field generated thereby to generate magnetic field with a larger dynamic range in variability.
Regarding claims 8 and 27, Charles et al. teaches wherein the height of the second magnetic source is parallel to the height of the first magnetic source. Note Fig. 4 and paragraph (3) and Paragraphs (24)-(25).
Regarding claims 11 and 30, Charles et al. teaches a third magnetic source positioned in proximity to the second magnetic source, wherein the second magnetic field is applied to the third magnetic source and causes the third magnetic source to rotate and produce a third magnetic field. Note Fig. 4 and paragraph (3) and Paragraphs (24)-(25).
Regarding claims 12 and 31, Charles et al. teaches wherein the third magnetic source is positioned such that the second magnetic field causes the third magnetic source to rotate in the first direction. Note Fig. 4 and paragraph (3) and Paragraphs (24)-(25) and (41) Referring to FIGS. 3-4, in a particular embodiment, each assembly includes three magnets, optionally cylindrical.
Regarding claims 13 and 32, Charles et al. teaches wherein the third magnetic source is a cylindrical magnet having a height and a diameter. Note Fig. 4 and paragraph (3) and Paragraphs (24)-(25) and (41) Referring to FIGS. 3-4, in a particular embodiment, each assembly includes three magnets, optionally cylindrical.
Regarding claims 14 and 33, Charles et al. teaches wherein the height of the third magnetic source is parallel to the height of the second magnetic source. . Note Fig. 4 and paragraph (3) and Paragraphs (24)-(25) and (41) Referring to FIGS. 3-4, in a particular embodiment, each assembly includes three magnets, optionally cylindrical.
Regarding claims 16 and 35 Charles et al. teaches wherein the motor is configured to rotate the first magnetic source at a first frequency. Note Paragraph (36) In some embodiments, various parameters of the magnetic fields generated by the helmet described herein are manipulated. These parameters include but are not limited to: (a) the combined field strength at the treatment site, which is determined by the strength of the magnets used and the distance between the magnets and the subject's head; (b) the frequency of the magnetic field, or the rate of change of the magnetic field, which is determined by movement of one or more magnets (as a non-limiting example, by the rotational speed at which at least one magnet rotates relative to the treatment area); (c) the amplitude of the waveform (or the net change in magnetic flux) to which the treatment area is subjected to, and (d) the phase of the magnetic field between two (or more) magnets (i.e. the magnetic phase) when the magnetic field frequencies of the two (or more) magnets are the same (or substantially the same).
Regarding claims 17 and 36, Charles et al. teaches wherein the rotation of the first magnetic source at the first frequency causes the first magnetic field to have a second frequency. Note Paragraph (36) In some embodiments, various parameters of the magnetic fields generated by the helmet described herein are manipulated. These parameters include but are not limited to: (a) the combined field strength at the treatment site, which is determined by the strength of the magnets used and the distance between the magnets and the subject's head; (b) the frequency of the magnetic field, or the rate of change of the magnetic field, which is determined by movement of one or more magnets (as a non-limiting example, by the rotational speed at which at least one magnet rotates relative to the treatment area); (c) the amplitude of the waveform (or the net change in magnetic flux) to which the treatment area is subjected to, and (d) the phase of the magnetic field between two (or more) magnets (i.e. the magnetic phase) when the magnetic field frequencies of the two (or more) magnets are the same (or substantially the same).
Regarding claims 18 and 37, Charles et al. teaches wherein the first magnetic field, when applied to the second magnetic source, causes the second magnetic source to rotate at a third frequency. Note Paragraph (36) In some embodiments, various parameters of the magnetic fields generated by the helmet described herein are manipulated. These parameters include but are not limited to: (a) the combined field strength at the treatment site, which is determined by the strength of the magnets used and the distance between the magnets and the subject's head; (b) the frequency of the magnetic field, or the rate of change of the magnetic field, which is determined by movement of one or more magnets (as a non-limiting example, by the rotational speed at which at least one magnet rotates relative to the treatment area); (c) the amplitude of the waveform (or the net change in magnetic flux) to which the treatment area is subjected to, and (d) the phase of the magnetic field between two (or more) magnets (i.e. the magnetic phase) when the magnetic field frequencies of the two (or more) magnets are the same (or substantially the same).
Regarding claims 19 and 38, Charles et al. teaches wherein the rotation of the second magnetic source at the third frequency causes the second magnetic field to have a fourth frequency. Note Paragraph (36) In some embodiments, various parameters of the magnetic fields generated by the helmet described herein are manipulated. These parameters include but are not limited to: (a) the combined field strength at the treatment site, which is determined by the strength of the magnets used and the distance between the magnets and the subject's head; (b) the frequency of the magnetic field, or the rate of change of the magnetic field, which is determined by movement of one or more magnets (as a non-limiting example, by the rotational speed at which at least one magnet rotates relative to the treatment area); (c) the amplitude of the waveform (or the net change in magnetic flux) to which the treatment area is subjected to, and (d) the phase of the magnetic field between two (or more) magnets (i.e. the magnetic phase) when the magnetic field frequencies of the two (or more) magnets are the same (or substantially the same).
Allowable Subject Matter
Claims 10,15,29, and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The prior art of record teaches the subject matter of the independent claims including applying magnetic field therapy to a user’s head by using a motor to rotate at least a first magnetic by which the magnetic field generated by the first magnet can be used to cause rotation of a second magnetic and a third magnet or more and the magnetics may each generate a magnetic field and rotate at a frequency and the magnets may be placed in parallel directions and rotation in opposite directions.
The prior art of record does not specifically teach the subject matter of the independent claims including the specific orientation of the magnets wherein an end of the second magnetic source faces an end of the first magnetic source, the end of the second magnetic source corresponding to a surface having the diameter of the second magnetic source and the end of the first magnetic source corresponding to a surface having the diameter of the first magnetic source or wherein an end of the third magnetic source faces an end of the second magnetic source, the end of the third magnetic source corresponding to a surface having the diameter of the third magnetic source and the end of the second magnetic source corresponding to a surface having the diameter of the second magnetic source.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Phillips et al.( US 20220096859) teaches a method of administering a simulation energy to the user. The stimulation energy may be any combination of electrical, magnetic, light, sound, or vibrational energy. The stimulation energy may be applied at a frequency. Exemplary embodiments may include any combination of interfaces, instructions, or controls for controlling the stimulation energy and/or providing information about the system described herein. For example, a mobile device may be used as a handheld controller that may communicate wireless to a head mountable device for administering stimulation energy. Exemplary embodiments of the head mountable device may also include electrodes for detective electrical activity of a user.
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.
Lowin(US 20210196971) teaches [0005] The present disclosure provides a method of stimulating or otherwise bioelectromagnetically affecting a biological, cellular or biochemical function or structure in a targeted subcortical location in a brain of a patient using a TRPMS apparatus provided on a head mount having a plurality of releasable magnetic assemblies with rotating permanent magnets operable to rotate for controlled durations and spin rates. The method comprises positioning two or more of the plurality of magnetic assemblies on locations of the head mount selected to affect the biological, cellular or biochemical function or structure at the targeted subcortical location in the brain of the patient, and activating the plurality of magnetic assemblies at the selected locations to generate magnetic fluxes of a selected strength, frequency and duration directed into the brain of the patient, wherein the magnetic flux directed into the brain of the patient from each of the assemblies is operative to generate induced electric field in regions of the brain.
Watterson(US 20140163305) teaches [0010] The present invention seeks to provide configurations of magnets, typically permanent magnets, which when rotated at high speed create high gradient of the electric field component along a nerve fibre for sufficient time to activate the nerve. The magnetic configurations disclosed herein generally employ several magnets positioned and aligned so that the electrical field gradients generated by the magnets all combine at a certain position (or positions) to create a sufficiently large sum to achieve nerve activation there. The electrical field gradient at the point oscillates sinusoidally in time and nerve activation occurs after a time interval of negative electric field gradient, sufficient to trigger the nerve action potential.
Souder(US 6001055) teaches a magnetic therapeutic device which subjects a treatment area such as an anatomical area or plant to a dynamic magnetic field having an amplitude of at least a half waveform. To subject the treatment area to such a dynamic magnetic field, the magnetic source may be rotated, oscillated, moved through a particular pattern, or otherwise moved relative to the treatment area. Each embodiment of the present invention includes at least one permanent magnet contained within a housing having an application surface which is adapted to engage a treatment area such as an anatomical area of a user's body. The application surface is positioned relative to the magnet so that the magnetic field extends around and/or through the application surface to the anatomical area to be treated. Each magnet has a north and south magnetic pole and a pole width equal to the width of the magnet at the poles. Means for moving the permanent magnet are provided in each embodiment, and are preferably positioned within the housing.
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
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