DETAILED ACTION
This Office Action is in response to Applicant’s Amendment filed on 10/23/2025.
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 .
Information Disclosure Statement
The listing of references in the specification such as in [0079] is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objection
Following claims are objected to because of the following informalities:
Claim 1 lines 5-7 “the magnetic shield having a circular shape and being aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield” needs to be corrected. A suggested correction is – the magnetic shield having a circular shape and being aligned vertically with the permanent magnet [[such]] in a manner that a vertical axis of the permanent magnet is aligned with a center the magnetic shield —to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” is even required or not required.
Claim 11 lines 5-7 “the magnetic shield having a circular shape and being aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield” needs to be corrected. A suggested correction is – the magnetic shield having a circular shape and being aligned vertically with the permanent magnet [[such]] in a manner that a vertical axis of the permanent magnet is aligned with a center the magnetic shield —to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” is even required or not required.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 9-10 and 19-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 9 line 3-9 recites “a secondary magnetic shield configured to shield a plurality of target regions from the magnetic field generated by the permanent magnet, wherein the secondary magnetic shield is positioned between the magnetic shield and at least one target region, wherein the magnetic shield is positioned between one end of the permanent magnet and the secondary magnetic shield” which renders this claim unclear. More specifically, if the secondary magnetic shield is positioned between the magnetic shield and at least one target region and the magnetic shield is positioned between one end of the permanent magnet and the secondary magnetic shield, it is unclear as how any magnetic stimulation of target region is even possible without the secondary shield also including a gap region that coaxially vertically aligns with gap region in the magnetic shield i.e. secondary shield as recited would completely block all magnetic field from reaching target region.
Claim 19 line 3-9 recites “shielding, by a secondary magnetic shield, a plurality of target regions from the magnetic field generated by the permanent magnet, wherein the secondary magnetic shield is positioned between the magnetic shield and at least one target region, wherein the magnetic shield is positioned between one end of the permanent magnet and the secondary magnetic shield” which renders this claim unclear. More specifically, if the secondary magnetic shield is positioned between the magnetic shield and at least one target region and the magnetic shield is positioned between one end of the permanent magnet and the secondary magnetic shield, it is unclear as how any magnetic stimulation of target region is even possible without the secondary shield also including a gap region that coaxially vertically aligns with gap region in the magnetic shield i.e. secondary shield as recited would completely block all magnetic field from reaching target region.
Dependent claims 10 and 20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112 (b) issue in their respective base claims. Consequently, dependent claims 10 and 20 are also rejected under 35 U.S.C. 112(b) based in their direct/indirect dependency on their respective base claims.
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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5-7, 11-12, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Helekar et al. (Pub. No.: US 20160193476 A1, hereinafter referred to as “Helekar”).
As per independent Claim 1, Helekar discloses a magnetic stimulation apparatus (Helekar in at least abstract, fig. 8-11, [0006], [0010-0055], [0074], [0093-0111] for example discloses relevant subject-matter. More specifically, Helekar in at least fig. 8-9, 11, [0010-0014], [0093] for example discloses magnetic stimulation apparatus. See at least Helekar [0010] “method and apparatus for providing Transcranial Magnetic Stimulation (TMS) to an individual”) comprising:
a permanent magnet configured to generate a magnetic field (Helekar in at least fig. 9, [0095], [0111] for example discloses a permanent magnet 50 configured to generate a magnetic field. See at least Helekar [0095] “invention's use of a plurality of small but powerful permanent magnets, each independently positionable and independently rotatable, enable the apparatus of the present invention to generate a magnetic field which is both time-varying (e.g., by varying the duration and timing of rapid rotation of the magnets) and spatially-varying (by selecting which magnets are rotated) and strength-varying (by selecting the speed of rotation of the magnets)”; [0111] “rapid stimulus delivery … with single magnet-shutter assemblies”),
the permanent magnet having a cylindrical shape (Helekar fig. 9, magnet 50 has cylindrical shape); and
a magnetic shield configured to shield at least one target region from the magnetic field generated by the permanent magnet (Helekar in at least fig. 9, 11, [0099], [0103] for example discloses a magnetic shield 105 configured to shield at least one target region from the magnetic field generated by the permanent magnet. See at least Helekar [0103] “each magnet assembly 15 is provided with an associated magnetic shield shutter mechanism for additionally tailoring the magnetic stimuli applied to the brain of the individual by that magnet assembly 15”),
the magnetic shield having a circular shape (Helekar fig. 9 , 105 is circular/disc shaped),
wherein the magnetic shield includes at least one gap region configured to expose the at least one target region to the magnetic field generated by the permanent magnet, and wherein the at least one gap region is moveable (Helekar in at least fig. 9, 11, [0104-0105], [0107] for example discloses wherein the magnetic shield 105 includes at least one gap region 110 configured to expose the at least one target region to the magnetic field generated by the permanent magnet, and wherein the at least one gap region is moveable. See at least Helekar [0104] “a magnet shield shutter mechanism 100 which comprises a disc 105 formed out of a magnetic shielding material… Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual. Disc 105 is mounted to the drive shaft 115 of a motor 120, such that motor 120 can be used to selectively (i) position the magnetic shielding material of disc 105 between stationary or moving magnet 50 and the brain of the individual, whereby to shield the brain of the individual from the magnetic field of the stationary or moving magnet 50, or (ii) position the at least one circular opening 110 between stationary or moving magnet 50 and the brain of the individual, whereby to expose the brain of the individual to the magnetic field of stationary or moving magnet 50, or (iii) sweep the at least one circular opening 110 of disc 105 by stationary or moving magnet 50 so as to modulate the magnetic field created by magnet 50”; [0107] “the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration.”).
Helekar does not necessarily require the magnetic shield be aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield at all times.
However, Helekar discloses alternate configurations in embodiments that disclose the magnetic shield magnetic shield being aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield (Helekar in at least fig. 9, 11, [0104-0105], [0107] for example discloses magnetic shield magnetic shield being aligned parallelly vertically with the permanent magnet such that a vertical axis of the permanent magnet is parallelly aligned with a center the magnetic shield as shown in fig. 9 wherein the magnet and center of disc shaped field assume parallel vertically aligned configurations. See at least Helekar [0104] “a magnet shield shutter mechanism 100 which comprises a disc 105 formed out of a magnetic shielding material… Disc 105 is disposed between … moving magnet 50 of a magnet assembly 15 and the brain of the individual. Disc 105 is mounted to the drive shaft 115 of a motor 120, such that motor 120 can be used to selectively (i) position the magnetic shielding material of disc 105 between … moving magnet 50 and the brain of the individual, whereby to shield the brain of the individual from the magnetic field of the … moving magnet 50, or (ii) position the at least one circular opening 110 between …moving magnet 50 and the brain of the individual, whereby to expose the brain of the individual to the magnetic field of … moving magnet 50, or (iii) sweep the at least one circular opening 110 of disc 105 by … moving magnet 50 so as to modulate the magnetic field created by magnet 50”; [0107] “the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the magnetic shield and permanent magnet alignment used by the magnetic stimulation apparatus as taught by Helekar, in a manner that the magnetic shield is aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield, as also taught by Helekar. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of modulating the magnetic field created by magnet in a manner that the spatial, strength and temporal characteristics of the magnetic field generated by the magnetic apparatus are custom tailored for each individual, to provide individual-specific therapy( Helekar, [0010], [0104]).
As per dependent Claim 2, Helekar as a whole further discloses magnetic stimulation apparatus wherein the at least one target region is situated on or inside a user of the magnetic stimulation apparatus (Helekar at least fig. 8, [0094]), and the at least one gap region is moveable based on a predetermined speed(Helekar in at least [0099], [0101], [0104] for example discloses the at least one gap region 110 is moveable based on a predetermined speed. See at least Helekar [0099] “rapid unshielding and shielding of the magnetic fields of the permanent magnets using a magnetic shield shutter mechanism…formed …by using high-speed shutters formed out of a special magnetic shielding material”; [0104] “a magnet shield shutter mechanism 100 which comprises a disc 105 formed out of a magnetic shielding material… Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual. Disc 105 is mounted to the drive shaft 115 of a motor 120, such that motor 120 can be used to selectively (i) position the magnetic shielding material of disc 105 between stationary or moving magnet 50 and the brain of the individual… or (ii) position the at least one circular opening 110 between stationary or moving magnet 50 and the brain of the individual… or (iii) sweep the at least one circular opening 110 of disc 105 by stationary or moving magnet 50 … Motor 120 is used to appropriately positioning a desired portion of disc 105 between stationary or moving magnet 50 and the brain of the individual. Preferably motor 120 is controlled by the same computerized controller 25 which drives magnet assemblies 15.”).
As per dependent Claim 5, Helekar as a whole further discloses magnetic stimulation apparatus wherein the magnetic shield includes a plurality of gap regions configured to expose the at least one target region to the magnetic field generated by the permanent magnet (Helekar in at least fig. 9, 11, [0104], [0107] for example discloses the magnetic shield 105 includes a plurality of gap regions 110 configured to expose the at least one target region to the magnetic field generated by the permanent magnet).
As per dependent Claim 6, Helekar as a whole further discloses magnetic stimulation apparatus wherein the permanent magnet includes a north pole and a south pole, and wherein the north pole and the south pole are positioned to generate a polarity of the magnetic field in a direction tangential with respect to the at least one target region (Helekar in at least fig. 8, 9, 11, [0074], [0094-0095], [0101], [0104] for example discloses wherein each independently controlled permanent magnet includes a north pole and a south pole, wherein the north pole and the south pole are positioned to generate a polarity of the magnetic field in a direction tangential with respect to the at least one target region via at least one or more independent controlled magnetic assemblies on the head mount. See at least Helekar [0094] “apparatus comprises a plurality of high strength … neodymium magnets … magnet assemblies are mounted in various locations on a EEG-type cap or head mount”; [0095] “use of a plurality of small but powerful permanent magnets, each independently positionable and independently rotatable, enable the apparatus of the present invention to generate a magnetic field which is both time-varying (e.g., by varying the duration and timing of rapid rotation of the magnets) and spatially-varying (by selecting which magnets are rotated) and strength-varying (by selecting the speed of rotation of the magnets).”;[0101] “the magnet assembly may comprise a stationary permanent magnet and the magnetic shield shutter mechanism may be used to provide the desired changing magnetic field…magnet assembly may comprise a moving permanent magnet to provide a changing magnetic field and the magnetic shield shutter mechanism may be used to modulate the changing magnetic field created by the moving magnet so as to provide a desired changing magnetic field at the anatomical location”; [0104] “Motor 120 is used to appropriately positioning a desired portion of disc 105 between stationary or moving magnet 50 and the brain of the individual. Preferably motor 120 is controlled by the same computerized controller 25 which drives magnet assemblies 15.” ).
As per dependent Claim 7, Helekar as a whole further discloses magnetic stimulation apparatus wherein the magnetic shield is rotatable (Helekar in fig. 9 and fig. 11 discloses wherein the magnetic shield 105 is rotatable).
As per independent Claim 11, Helekar discloses a magnetic stimulation method (Helekar in at least abstract, fig. 8-11, [0006], [0010-0055], [0074], [0093-0111] for example discloses relevant subject-matter. More specifically, Helekar in at least fig. 8-9, 11, [0010-0014], [0093] for example discloses magnetic stimulation method. See at least Helekar [0010] “method and apparatus for providing Transcranial Magnetic Stimulation (TMS) to an individual”;[0093] “method and apparatus for providing transcranial magnetic stimulation (TMS) to the brain of an individual so as to induce, modulate and/or disrupt neural activity in the brain of the individual”) comprising:
generating a magnetic field by a permanent magnet (Helekar in at least [0095], [0111] for example discloses generating a magnetic field by a permanent magnet. See at least Helekar [0095] “invention's use of a plurality of small but powerful permanent magnets, each independently positionable and independently rotatable, enable the apparatus of the present invention to generate a magnetic field which is both time-varying (e.g., by varying the duration and timing of rapid rotation of the magnets) and spatially-varying (by selecting which magnets are rotated) and strength-varying (by selecting the speed of rotation of the magnets)”; [0111] “rapid stimulus delivery … with single magnet-shutter assemblies”),
the permanent magnet having a cylindrical shape (Helekar fig. 9, magnet 50 has cylindrical shape); and
shielding, by a magnetic shield, at least one target region from the magnetic field generated by the permanent magnet (Helekar in at least fig. 9, 11, [0099], [0103] for example discloses shielding, by a magnetic shield 105, at least one target region from the magnetic field generated by the permanent magnet. See at least Helekar [0103] “each magnet assembly 15 is provided with an associated magnetic shield shutter mechanism for additionally tailoring the magnetic stimuli applied to the brain of the individual by that magnet assembly 15”),
the magnetic shield having a circular shape (Helekar fig. 9 , 105 is circular/disc shaped)
wherein the magnetic shield includes at least one gap region configured to expose the at least one target region to the magnetic field generated by the permanent magnet, and wherein the at least one gap region is moveable based on a predetermined speed (Helekar in at least fig. 8-9, 11, [0099], [0101], [0104-0105], [0107] for example discloses wherein the magnetic shield 105 includes at least one gap region 110 configured to expose the at least one target region to the magnetic field generated by the permanent magnet, and wherein the at least one gap region 110 is moveable based on a predetermined speed. See at least Helekar [0099] “rapid unshielding and shielding of the magnetic fields of the permanent magnets using a magnetic shield shutter mechanism…formed …by using high-speed shutters formed out of a special magnetic shielding material”; [0104] “a magnet shield shutter mechanism 100 which comprises a disc 105 formed out of a magnetic shielding material… Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual. Disc 105 is mounted to the drive shaft 115 of a motor 120, such that motor 120 can be used to selectively (i) position the magnetic shielding material of disc 105 between stationary or moving magnet 50 and the brain of the individual… or (ii) position the at least one circular opening 110 between stationary or moving magnet 50 and the brain of the individual… or (iii) sweep the at least one circular opening 110 of disc 105 by stationary or moving magnet 50 … Motor 120 is used to appropriately positioning a desired portion of disc 105 between stationary or moving magnet 50 and the brain of the individual. Preferably motor 120 is controlled by the same computerized controller 25 which drives magnet assemblies 15.”; [0107] “the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration.”).
Helekar does not necessarily require the magnetic shield be aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield at all times.
However, Helekar discloses alternate configurations in embodiments that disclose the magnetic shield being aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield (Helekar in at least fig. 9, 11, [0104-0105], [0107] for example discloses magnetic shield being aligned parallelly vertically with the permanent magnet such that a vertical axis of the permanent magnet is parallelly aligned with a center the magnetic shield as shown in fig. 9 and fig. 11 wherein the magnet and center of disc shaped field assume parallel vertically aligned configurations. See at least Helekar [0104] “a magnet shield shutter mechanism 100 which comprises a disc 105 formed out of a magnetic shielding material… Disc 105 is disposed between … moving magnet 50 of a magnet assembly 15 and the brain of the individual. Disc 105 is mounted to the drive shaft 115 of a motor 120, such that motor 120 can be used to selectively (i) position the magnetic shielding material of disc 105 between … moving magnet 50 and the brain of the individual, whereby to shield the brain of the individual from the magnetic field of the … moving magnet 50, or (ii) position the at least one circular opening 110 between …moving magnet 50 and the brain of the individual, whereby to expose the brain of the individual to the magnetic field of … moving magnet 50, or (iii) sweep the at least one circular opening 110 of disc 105 by … moving magnet 50 so as to modulate the magnetic field created by magnet 50”; [0107] “the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the magnetic shield and permanent magnet alignment used by the magnetic stimulation method as taught by Helekar, in a manner that the magnetic shield is aligned vertically with the permanent magnet such that a vertical axis of the permanent magnet is aligned with a center the magnetic shield, as also taught by Helekar. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of modulating the magnetic field created by magnet in a manner that the spatial, strength and temporal characteristics of the magnetic field generated by the magnetic apparatus are custom tailored for each individual, to provide individual-specific therapy( Helekar, [0010], [0104]).
As per dependent Claim 12, Helekar as a whole further discloses magnetic stimulation method wherein the at least one target region is situated on a user (Helekar at least fig. 8, [0094]).
As per dependent Claim 15, Helekar as a whole further discloses magnetic stimulation method wherein the magnetic shield includes a plurality of gap regions configured to expose the at least one target region to the magnetic field generated by the permanent magnet (Helekar in at least fig. 9, 11, [0104], [0107] for example discloses the magnetic shield 105 includes a plurality of gap regions 110 configured to expose the at least one target region to the magnetic field generated by the permanent magnet).
As per dependent Claim 16, Helekar as a whole further discloses magnetic stimulation method wherein the permanent magnet includes a north pole and a south pole, and wherein the north pole and the south pole are positioned to generate a polarity of the magnetic field in a direction tangential with respect to the at least one target region (Helekar in at least fig. 8, 9, 11, [0074], [0094-0095], [0101], [0104] for example discloses wherein each independently controlled permanent magnet includes a north pole and a south pole, wherein the north pole and the south pole are positioned to generate a polarity of the magnetic field in a direction tangential with respect to the at least one target region via at least one or more independent controlled magnetic assemblies on the head mount. See at least Helekar [0094] “apparatus comprises a plurality of high strength … neodymium magnets … magnet assemblies are mounted in various locations on a EEG-type cap or head mount”; [0095] “use of a plurality of small but powerful permanent magnets, each independently positionable and independently rotatable, enable the apparatus of the present invention to generate a magnetic field which is both time-varying (e.g., by varying the duration and timing of rapid rotation of the magnets) and spatially-varying (by selecting which magnets are rotated) and strength-varying (by selecting the speed of rotation of the magnets).”;[0101] “the magnet assembly may comprise a stationary permanent magnet and the magnetic shield shutter mechanism may be used to provide the desired changing magnetic field…magnet assembly may comprise a moving permanent magnet to provide a changing magnetic field and the magnetic shield shutter mechanism may be used to modulate the changing magnetic field created by the moving magnet so as to provide a desired changing magnetic field at the anatomical location”; [0104] “Motor 120 is used to appropriately positioning a desired portion of disc 105 between stationary or moving magnet 50 and the brain of the individual. Preferably motor 120 is controlled by the same computerized controller 25 which drives magnet assemblies 15.” ).
As per dependent Claim 17, Helekar as a whole further discloses magnetic stimulation method wherein the magnetic shield is rotatable (Helekar in fig. 9 and fig. 11 discloses the permanent magnet 50 is relatively cylindrical, and wherein the magnetic shield 105 is rotatable).
Claims 3, 4, 8-9 and 13, 14, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Helekar in view of Phillips et al. (Pub. No.: US 20110112427 A1, hereinafter referred to as “Phillips”).
As per dependent Claim 3, Helekar discloses magnetic stimulation apparatus according to claim 1 (see claim 1 analysis),
Helekar does not necessarily require or explicitly disclose axial magnetization feature.
However, in an analogous magnetic stimulation apparatus field of endeavor, Phillips discloses magnetic stimulation apparatus (Phillips in at least fig. 1, fig. 9-10, fig. 13-16, fig. 21-22, fig. 24-25, fig. 28, [0129-0131], [0271] for example discloses magnetic stimulation apparatus. See at least Phillips [0129] “devices comprising, …(a) at least one permanent magnet; and …(b) a subunit coupled to the magnet; wherein the subunit enables movement of at least one said magnet at a frequency”; [0271] “methods and devices that provide low frequency sinusoidal or near-sinusoidal transcranial magnetic stimulation therapy by rotating one or more permanent magnets in close proximity to the subject's head”)
wherein the permanent magnet is configured to be axially magnetized(This well-known concept is disclosed in Phillips in at least fig. 13, [0565]. See at least Phillips [0565] “a disc shaped magnet that is axially magnetized (the poles are on the top and bottom faces) can be cut in half, one half turned over (aligning N of one half with S of the other half) and placed together. This disc can be spun about the center of the disc to get a magnetic field that is uniform over a large area”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the magnetization of the magnet used in the magnetic stimulation apparatus as taught by Helekar, such that the permanent magnet is configured to be axially magnetized, as taught by Phillips. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing tailored magnetic stimulation to the brain, with the magnetic stimulation being tailored to create the desired changing magnetic field and deliver the desired magnetic stimuli to the brain to treat various neuropsychiatric conditions such as depression, stroke rehabilitation, chronic pain and neurodegenerative diseases (Helekar,[0094], [0098], [0100-0102], [0104]) and/or to get a magnetic field that is uniform over a large area (Phillips, [0565]).
As per dependent Claim 4, Helekar discloses magnetic stimulation apparatus according to claim 1(see claim 1 analysis),
Helekar does not necessarily require or explicitly disclose diametrically magnetized feature.
However, in an analogous magnetic stimulation apparatus field of endeavor, Phillips discloses magnetic stimulation apparatus (Phillips in at least fig. 1, fig. 9-10, fig. 13-16, fig. 21-22, fig. 24-25, fig. 28, [0129] for example discloses magnetic stimulation apparatus)
wherein the permanent magnet is configured to be diametrically magnetized (This well-known concept is disclosed in Phillips in at least fig. 22, [0548]. See at least Phillips [0548] “magnet that is diametrically magnetized (pole on the left and right sides of the cylinder) spins about the cylinder axis. The magnet can be placed anywhere around the patient's head, and locations can be chosen based on the desire for a more focal therapy at a particular location”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the magnetization of the magnet used in the magnetic stimulation apparatus as taught by Helekar, such that the permanent magnet is configured to be diametrically magnetized, as taught by Phillips. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing tailored magnetic stimulation to the brain, with the magnetic stimulation being tailored to create the desired changing magnetic field and deliver the desired magnetic stimuli to the brain to treat various neuropsychiatric conditions such as depression, stroke rehabilitation, chronic pain and neurodegenerative diseases (Helekar,[0094], [0098], [0100-0102], [0104]) and/or to get a magnetic field that is uniform over a large area (Phillips, [0565]).
As per dependent Claim 8, the combination of Helekar and Phillips as a whole further discloses magnetic stimulation apparatus wherein the magnetic shield is positioned between one end of the permanent magnet and a plurality of target regions, and wherein the at least one gap region of the magnetic shield is wedge-shaped (Helekar in fig. 11, [0099], [0104], [0107] discloses the magnetic shield 105 is positioned between one end of the permanent magnet 50 and a plurality of target regions, and wherein the at least one gap region 110 of the magnetic shield is wedge-shaped. See at least Helekar [0099] “magnetic shield shutter mechanism is preferably formed …by using high-speed shutters formed out of a special magnetic shielding material … wherein the high-speed shutters … is interposed between permanent magnets and the brain of the individual.”; [0104] “Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual.”; [0107] “If desired… the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration.”).
As per dependent Claim 9, the combination of Helekar and Phillips as a whole further discloses magnetic stimulation apparatus further comprising: a secondary magnetic shield configured to shield a plurality of target regions from the magnetic field generated by the permanent magnet, wherein the secondary magnetic shield is positioned between the magnetic shield and at least one target region (Helekar in at least fig. 8, 9, [0101], [0103], [0104] for example discloses head mount with plurality of magnetic assemblies 15 with each magnet assembly 15 provided with an associated magnetic shield shutter mechanism for additionally tailoring the magnetic stimuli applied to the brain of the individual by that magnet assembly 15 and each magnet-shutter assembly being independently positionable to generate a desired changing magnetic field at the anatomical location with each magnetic shield disc 105 disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual which reads on the limitation as now explicitly, positively and specifically recited by the Applicants i.e. a secondary magnetic shield of spatially adjacent neighboring magnetic assembly on the head mount configured to shield a plurality of target regions from the magnetic field generated by the permanent magnet of a neighboring magnetic assembly on the head mount, wherein the secondary magnetic shield in such as configuration and arrangement would be positioned between the magnetic shield and at least one target region. See at least Helekar [0101] “the magnet assembly may comprise a stationary permanent magnet and the magnetic shield shutter mechanism may be used to provide the desired changing magnetic field…magnet assembly may comprise a moving permanent magnet to provide a changing magnetic field and the magnetic shield shutter mechanism may be used to modulate the changing magnetic field created by the moving magnet so as to provide a desired changing magnetic field at the anatomical location”; [0103] “each magnet assembly 15 is provided with an associated magnetic shield shutter mechanism for additionally tailoring the magnetic stimuli applied to the brain of the individual by that magnet assembly 15. And in one preferred form of the present invention, each magnet assembly 15 and its associated magnetic shield shutter mechanism are configured as a unit, such that when that magnet assembly 15 is mounted to head mount 10, its associated magnetic shield shutter mechanism is also mounted to head mount 10.”; [0104] “Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual….Motor 120 is used to appropriately positioning a desired portion of disc 105 between stationary or moving magnet 50 and the brain of the individual. Preferably motor 120 is controlled by the same computerized controller 25 which drives magnet assemblies 15.”),
wherein the magnetic shield is positioned between one end of the permanent magnet and the secondary magnetic shield, and wherein the at least one gap region of the magnetic shield is wedge-shaped (Helekar in fig. 11, [0099], [0104], [0107] discloses wherein the magnetic shield 105 is positioned between one end of the permanent magnet 50 and the secondary magnetic shield, and wherein the at least one gap region 110 of the magnetic shield is wedge-shaped. See at least Helekar [0099] “magnetic shield shutter mechanism is preferably formed …by using high-speed shutters formed out of a special magnetic shielding material … wherein the high-speed shutters … is interposed between permanent magnets and the brain of the individual.”; [0104] “Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual.”; [0107] “If desired… the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration.” ).
As per dependent Claim 13, Helekar discloses magnetic stimulation method according to claim 11 (see claim 11 analysis)
Helekar does not necessarily require or explicitly disclose axial magnetization feature.
However, in an analogous magnetic stimulation method field of endeavor, Phillips discloses magnetic stimulation method (Phillips in at least fig. 1, fig. 9-10, fig. 13-16, fig. 21-22, fig. 24-25, fig. 28, [0271] for example discloses magnetic stimulation method. See at least [0271] “methods and devices that provide low frequency sinusoidal or near-sinusoidal transcranial magnetic stimulation therapy by rotating one or more permanent magnets in close proximity to the subject's head”).
wherein the permanent magnet is configured to be axially magnetized(This well-known concept is disclosed in Phillips in at least fig. 13, [0565]. See at least Phillips [0565] “a disc shaped magnet that is axially magnetized (the poles are on the top and bottom faces) can be cut in half, one half turned over (aligning N of one half with S of the other half) and placed together. This disc can be spun about the center of the disc to get a magnetic field that is uniform over a large area”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the magnetization of the magnet used in the magnetic stimulation method as taught by Helekar, such that the permanent magnet is configured to be axially magnetized, as taught by Phillips. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing tailored magnetic stimulation to the brain, with the magnetic stimulation being tailored to create the desired changing magnetic field and deliver the desired magnetic stimuli to the brain to treat various neuropsychiatric conditions such as depression, stroke rehabilitation, chronic pain and neurodegenerative diseases (Helekar,[0094], [0098], [0100-0102], [0104]) and/or to get a magnetic field that is uniform over a large area (Phillips, [0565]).
As per dependent Claim 14, Helekar discloses magnetic stimulation method according to claim 11(see claim 11 analysis),
Helekar does not necessarily require or explicitly disclose diametrically magnetized feature.
However, in an analogous magnetic stimulation method field of endeavor, Phillips discloses magnetic stimulation method (Phillips in at least fig. 1, fig. 9-10, fig. 13-16, fig. 21-22, fig. 24-25, fig. 28, [0271] for example discloses magnetic stimulation method. See at least [0271] “methods and devices that provide low frequency sinusoidal or near-sinusoidal transcranial magnetic stimulation therapy by rotating one or more permanent magnets in close proximity to the subject's head”),
wherein the permanent magnet is configured to be diametrically magnetized(This well-known concept is disclosed in Phillips in at least fig. 22, [0548]. See at least Phillips [0548] “magnet that is diametrically magnetized (pole on the left and right sides of the cylinder) spins about the cylinder axis. The magnet can be placed anywhere around the patient's head, and locations can be chosen based on the desire for a more focal therapy at a particular location”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the magnetization of the magnet used in the magnetic stimulation method as taught by Helekar, such that the permanent magnet is configured to be diametrically magnetized, as taught by Phillips. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing tailored magnetic stimulation to the brain, with the magnetic stimulation being tailored to create the desired changing magnetic field and deliver the desired magnetic stimuli to the brain to treat various neuropsychiatric conditions such as depression, stroke rehabilitation, chronic pain and neurodegenerative diseases (Helekar,[0094], [0098], [0100-0102], [0104]) and/or to get a magnetic field that is uniform over a large area (Phillips, [0565]).
As per dependent Claim 18, the combination of Helekar and Phillips as a whole further discloses magnetic stimulation method wherein the magnetic shield is positioned between one end of the permanent magnet and a plurality of target regions, and wherein the at least one gap region of the magnetic shield is wedge-shaped (Helekar in fig. 11, [0099], [0104], [0107] discloses the magnetic shield 105 is positioned between one end of the permanent magnet 50 and a plurality of target regions, and wherein the at least one gap region 110 of the magnetic shield is wedge-shaped. See at least Helekar [0099] “magnetic shield shutter mechanism is preferably formed …by using high-speed shutters formed out of a special magnetic shielding material … wherein the high-speed shutters … is interposed between permanent magnets and the brain of the individual.”; [0104] “Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual.”; [0107] “If desired… the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration.”).
As per dependent Claim 19, the combination of Helekar and Phillips as a whole further discloses magnetic stimulation method further comprising: shielding, by a secondary magnetic shield, a plurality of target regions from the magnetic field generated by the permanent magnet, wherein the secondary magnetic shield is positioned between the magnetic shield and at least one target region( Helekar in at least fig. 8, 9, [0101], [0103], [0104] for example discloses head mount with plurality of magnetic assemblies 15 with each magnet assembly 15 provided with an associated magnetic shield shutter mechanism for additionally tailoring the magnetic stimuli applied to the brain of the individual by that magnet assembly 15 and each magnet-shutter assembly being independently positionable to generate a desired changing magnetic field at the anatomical location with each magnetic shield disc 105 disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual which reads on the limitation as now explicitly, positively and specifically recited by the Applicants i.e. shielding, by a secondary magnetic shield of spatially adjacent neighboring magnetic assembly on the head mount, a plurality of target regions from the magnetic field generated by the permanent magnet of a neighboring magnetic assembly on the head mount, wherein the secondary magnetic shield in such a configuration and arrangement would be positioned between the magnetic shield and at least one target region. See at least Helekar [0101] “the magnet assembly may comprise a stationary permanent magnet and the magnetic shield shutter mechanism may be used to provide the desired changing magnetic field…magnet assembly may comprise a moving permanent magnet to provide a changing magnetic field and the magnetic shield shutter mechanism may be used to modulate the changing magnetic field created by the moving magnet so as to provide a desired changing magnetic field at the anatomical location”; [0103] “each magnet assembly 15 is provided with an associated magnetic shield shutter mechanism for additionally tailoring the magnetic stimuli applied to the brain of the individual by that magnet assembly 15. And in one preferred form of the present invention, each magnet assembly 15 and its associated magnetic shield shutter mechanism are configured as a unit, such that when that magnet assembly 15 is mounted to head mount 10, its associated magnetic shield shutter mechanism is also mounted to head mount 10.”; [0104] “Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual….Motor 120 is used to appropriately positioning a desired portion of disc 105 between stationary or moving magnet 50 and the brain of the individual. Preferably motor 120 is controlled by the same computerized controller 25 which drives magnet assemblies 15.”),
wherein the magnetic shield is positioned between one end of the permanent magnet and the secondary magnetic shield, and wherein the at least one gap region of the magnetic shield is wedge-shaped(Helekar in fig. 11, [0099], [0104], [0107] discloses wherein the magnetic shield 105 is positioned between one end of the permanent magnet 50 and the secondary magnetic shield, and wherein the at least one gap region 110 of the magnetic shield is wedge-shaped. See at least Helekar [0099] “magnetic shield shutter mechanism is preferably formed …by using high-speed shutters formed out of a special magnetic shielding material … wherein the high-speed shutters … is interposed between permanent magnets and the brain of the individual.”; [0104] “Disc 105 is disposed between stationary or moving magnet 50 of a magnet assembly 15 and the brain of the individual.”; [0107] “If desired… the at least one circular opening 110 may be replaced by at least one slot 110. Alternatively, the at least one circular opening 110 may be replaced by at least one opening of another configuration”).
Contingently Allowable Subject-Matter
As per dependent claims 10 and 20, dependent claims 10 and 20 would be contingently allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
Additionally, as per dependent claims 10 and 20, dependent claims 10 and 20 are being 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 in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per dependent Claim 10, none of the prior art discloses a magnetic stimulation apparatus comprising a permanent magnet configured to generate a magnetic field, …having a cylindrical shape; and a magnetic shield configured to shield at least one target region from the magnetic field generated by the permanent magnet, the magnetic shield having a circular shape and being aligned vertically with the permanent magnet … a vertical axis of the permanent magnet is aligned with a center the magnetic shield; wherein the magnetic shield includes at least one gap region configured to expose the at least one target region to the magnetic field generated by the permanent magnet, and wherein the at least one gap region is moveable… a secondary magnetic shield configured to shield a plurality of target regions from the magnetic field generated by the permanent magnet … wherein the at least one gap region of the magnetic shield is wedge-shaped …wherein the secondary magnetic shield is stationary including all of the limitations, features, combination and arrangement of features of their respective base claim and any intervening claims.
As per dependent Claim 20, none of the prior art discloses magnetic stimulation method comprising generating a magnetic field by … permanent magnet having a cylindrical shape; and shielding, by a magnetic shield, at least one target region from the magnetic field generated by the permanent magnet, the magnetic shield having a circular shape and being aligned vertically with the permanent magnet … a vertical axis of the permanent magnet is aligned with a center the magnetic shield; wherein the magnetic shield includes at least one gap region configured to expose the at least one target region to the magnetic field generated by the permanent magnet, and wherein the at least one gap region is moveable based on a predetermined speed … shielding, by a secondary magnetic shield, a plurality of target regions from the magnetic field generated by the permanent magnet … wherein the at least one gap region of the magnetic shield is wedge-shaped …wherein the secondary magnetic shield is stationary including all of the limitations, features, steps, combination and arrangement of features and steps of their respective base claim and any intervening claims.
Response to Amendment
According to the Amendment, filed 10/23/2025, the status of the claims is as follows:
Claims 1, 7-9, 11, 15, 17-19 are currently amended; and
Claims 2-6, 10, 12