DETAILED ACTION
This Office Action is in response to Applicant’s Amendment filed on 02/05/2026.
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 Objections
Following claims are objected to because of the following informalities:
“repetitive magnetic pulses" in each of claim 45 and claim 46 should read -- repetitive magnetic field pulses -- in order to maintain consistent terminology with its antecedent at lines 9-10 and lines 13-14 respectively of Claim 21. Appropriate correction is required.
Each of claim 45-46 lines 1-2 “the repetitive magnetic pulses and the repetitive magnetic pulses” needs to be corrected to distinguish the first instance of “the repetitive magnetic pulses” from the second instance of “the repetitive magnetic pulses”.
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 44-46 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 44 in line 1-2 recites “the repetitive magnetic field pulses” which renders this claim unclear. More specifically, it is unclear as to whether claim 44 lines 1-2 “the repetitive magnetic field pulses” is referencing claim 21 lines 9-10 “repetitive magnetic field pulses” and/or claim 21 lines 13-14 “repetitive magnetic field pulses” or both.
Claim 45 in lines 1-2 recites “the repetitive magnetic pulses” which renders this claim unclear. More specifically, it is unclear as to whether claim 45 lines 1-2 “the repetitive magnetic pulses” is referencing claim 21 lines 9-10 “repetitive magnetic field pulses” and/or claim 21 lines 13-14 “repetitive magnetic field pulses”. Additionally, it is unclear as to how the first instance of “the repetitive magnetic pulses” in claim 45 line 1 differs from the second instance of “the repetitive magnetic pulses” in claim 45 line 2 in the limitation “wherein the repetitive magnetic pulses and the repetitive magnetic pulses to the target location”.
Claim 46 in lines 1-2 recites “the repetitive magnetic pulses” which renders this claim unclear. More specifically, it is unclear as to whether claim 46 lines 1-2 “the repetitive magnetic pulses” is referencing claim 21 lines 9-10 “repetitive magnetic field pulses” and/or claim 21 lines 13-14 “repetitive magnetic field pulses”. Additionally, it is unclear as to how the first instance of “the repetitive magnetic pulses” in claim 46 line 1 differs from the second instance of “the repetitive magnetic pulses” in claim 46 line 2 in the limitation “wherein the repetitive magnetic pulses and the repetitive magnetic pulses to the target location”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Examined claims 21, 23 and 33-36, 38-39, 41-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,661,094 B2 (U.S. Patent Application No. 15/131616, hereinafter referred to as Jin-094).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the more generic or broader claims now pending (instant claims 21, 23 and 33-36, 38-39, 41-46 under examination). That is, the rationale of In re Goodman applies here in that once Applicant has received a patent for a species or a more specific embodiment, Applicant is not entitled to a patent for the generic or broader invention without maintaining common ownership and ensuring that the term of the latter issued patent will expire at the end of the original term of the earlier issued patent. More specifically:
As per Examined independent Claim 21, Examined Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 1 of Jin-094. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 21 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 1 (species) in the conflicting patent to Jin-094 and thus, examined claim 21 is anticipated by and unpatentable over patented claim 1 in the conflicting patent to Jin-094.
As per Examined independent Claim 23, Examined Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 1 of Jin-094 when patented claim 1 limitation “mount is either a wearable vest or a chair back” is broadly yet reasonably interpreted as reciting “mount is …wearable” option. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 23 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 1(species) in the conflicting patent to Jin-094 and thus, examined claim 23 is anticipated by and unpatentable over patented claim 1 in the conflicting patent to Jin-094.
As per Examined independent Claim 33, Examined Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 of Jin-094. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 33 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 11(species) in the conflicting patent to Jin-094 and thus, examined claim 33 is anticipated by and unpatentable over patented claim 11 in the conflicting patent to Jin-094.
As per Examined dependent Claim 34, Examined Claim 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 of Jin-094. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 34 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 11(species) in the conflicting patent to Jin-094 and thus, examined claim 34 is anticipated by and unpatentable over patented claim 11 in the conflicting patent to Jin-094.
As per Examined dependent Claim 36, Examined Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 1 of Jin-094. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 36 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 1(species) in the conflicting patent to Jin-094 and thus, examined claim 36 is anticipated by and unpatentable over patented claim 1 in the conflicting patent to Jin-094.
As per Examined dependent Claim 39, Examined Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 1 of Jin-094. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 39 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 1(species) in the conflicting patent to Jin-094 and thus, examined claim 39 is anticipated by and unpatentable over patented claim 1 in the conflicting patent to Jin-094.
As per Examined dependent Claims 35, 38, 41-44 each of Examined Claims 35, 38, 41-44 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 1 of Jin-094. Although each of the claims at issue are not identical, they are not patentably distinct from patented claim 1 because each of the examined claims 35, 38, 41, 42 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 1(species) in the conflicting patent to Jin-094 and thus, each of the examined claims 35, 38, 41-44 is anticipated by and unpatentable over patented claim 1 in the conflicting patent to Jin-094.
As per Examined dependent Claim 45, Examined Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 9 of Jin-094. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 45 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 9(species) in the conflicting patent to Jin-094 and thus, examined claim 45 is anticipated by and unpatentable over patented claim 9 in the conflicting patent to Jin-094.
As per Examined dependent Claim 46, Examined Claim 46 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 10 of Jin-094. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 46 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 10(species) in the conflicting patent to Jin-094 and thus, examined claim 46 is anticipated by and unpatentable over patented claim 10 in the conflicting patent to Jin-094.
Examined claims 37 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,661,094 B2 (U.S. Patent Application No. 15/131616, hereinafter referred to as Jin-094) in view of Simon; Bruce J. et al. (Pub. No.: US 20150165226 A1, hereinafter referred to as “Simon”).
As per examined claims 37 and 40, each of examined claims 37 and 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Jin-125 in view of Simon. Although each of the examined claim 37 and 40 and patented claim 1 at issue are not identical, they are not patentably distinct from each other because each of examined claim 37 and 40 as recited encompasses patented claim 1 recited limitations i.e. examined claim 37 recitation (i.e. genus claim) and examined claim 40 recitation (i.e. genus claim) when broadly yet reasonably interpreted can be seen as encompassing the species disclosed in patented claim 1 of Jin-125 except for the figure-8 coil feature which explicitly disclosed and made obvious by Simon which is an analogous prior art in the magnetic field based neuromodulation therapy field of endeavor (Simon, fig. 4E, [0031], [0100]). 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 coil used in device to treat spasticity in a subject of patented claim 1 such that the coil is a figure-8 coil as taught by Simon. A person of ordinary skill would have been motivated to do so as a matter of simple substitution of one known equivalent for another, with a reasonable expectation of success, for the advantage of providing energy to the stimulator coil in order to deliver the stimulating, blocking and/or modulating impulse customized to a target nerve as desired (Simon, [0054], [0061]).
Examined claims 21, 23, 33-38, 42-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent No. 11,511,125 B2 (U.S. Patent Application No. 16/855993, hereinafter referred to as Jin-125) to Jin in view of Simon.
As per examined independent claims 21, although examined claim 21 and patented claim 1 at issue are not identical, they are not patentably distinct from each other because examined claim 21 as recited encompasses patented claim 1 recited limitations i.e. examined claim 21 recitation (i.e. genus claim) when broadly yet reasonably interpreted can be seen as encompassing the species disclosed in patented claim 1 of Jin-125 except for [a] the power source feature of claim 21 which although made implicitly obvious in Jin-125 but is not explicitly recited in claim 1, is nonetheless explicitly disclosed and made obvious by Simon which is an analogous prior art in the magnetic field based neuromodulation therapy field of endeavor (Simon in at least fig. 1, [0054-0058], [0060-0062], [0103], for example discloses a power source 320 configured via control unit 330 to energize the magnetic field generator 340 in order to generate a repetitive pulsed magnetic field outside a subject. See at least Simon [0054] “device 300 may include an impulse generator 310; a power source 320 coupled to the impulse generator 310; a control unit 330 in communication with the impulse generator 310 and coupled to the power source 320; and a magnetic stimulator coil 340 coupled via wires to impulse generator coil 310”); [b] adjustable strap of claim 35 which is disclosed in Simon in at least [012]; [c] coil is connected to the power source by a cable of claim 36 which is disclosed in Simon [0054], [0123]; [d] figure-8 coil of claim 37 which is disclosed in Simon fig. 4, [0031], [0100]; [e] the position of the strap is configured to be adjustable to move the magnetic field generator to a different target location of claim 38 which is disclosed by Simon in [0123]; [f] the position of the mount is configured to be adjustable to move the magnetic field generator to a different target location which is disclosed in Simon in at least [0123].
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 device to treat spasticity in a subject of patented claim 1 in a manner that a power source energizes the magnetic field generator as taught by Simon to derive the subject-matter of examined claim 1. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing energy to the stimulator coil in order to deliver the stimulating, blocking and/or modulating impulse to the target nerve (Simon, [0054], [0061]).
As per Examined dependent Claim 23, Examined Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 2 of Jin-125 in view of Simon as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 23 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 2 (species) in the conflicting patent to Jin-125 and thus, examined claim 23 is obvious and unpatentable the combination of patented claim 2 of Jin-125 in view of Simon as a whole.
As per Examined dependent Claim 33-34, each of Examined Claim 33-34 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 8 of Jin-125 in view of Simon as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because each of examined claim 33-34 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 8 (species) in the conflicting patent to Jin-125 and thus, each of examined claim 33-34 is obvious and unpatentable the combination of patented claim 8 of Jin-125 in view of Simon as a whole.
As per Examiner dependent Claims 35-38, 42, 46, each of Examiner dependent Claims 35-38, 42, 46 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 1 of Jin-125 in view of Simon as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because each of examined claim 35-38, 42, 46 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 1 (species) in the conflicting patent to Jin-125 and thus, each of examined claim 35-38, 42, 46 is obvious and unpatentable the combination of patented claim 1 of Jin-125 in view of Simon as a whole.
As per Examiner dependent Claim 43, Examiner dependent Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 6 of Jin-125 in view of Simon as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 43 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 6 (species) in the conflicting patent to Jin-125 and thus, examined claim 43 is obvious and unpatentable the combination of patented claim 6 of Jin-125 in view of Simon as a whole.
As per Examiner dependent Claim 45, Examiner dependent Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 7 of Jin-125 in view of Simon as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 45 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 7 (species) in the conflicting patent to Jin-125 and thus, examined claim 45 is obvious and unpatentable the combination of patented claim 7 of Jin-125 in view of Simon as a whole.
Examined claims 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent No. 11,511,125 B2 (U.S. Patent Application No. 16/855993, hereinafter referred to as Jin-125) to Jin in view of Simon and further in view of Burnett Daniel R (Pub. No.: US 20120302821 A1, hereinafter referred to as “Burnett”).
As per Examined dependent Claim 39, Examined Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 2 of Jin-125 in view of Simon and further in view of Burnett as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 39 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 2 (species) in the conflicting patent to Jin-125 with the battery feature of examined base claim 21 being disclosed by Simon. However, the combination of patented claim 2 of Jin-125 and Simon as a whole does not explicitly disclose the mount is a vest which is disclosed by Burnett in at least fig. 41 for example discloses [0217-0218], and thus, examined claim 39 is obvious and unpatentable the combination of patented claim 2 of Jin-125, Simon and Burnett as a whole.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify coil including wearable of the device to treat spasticity in a subject of patented claim 2 as modified by Simon such that the coil including wearable is a vest as taught by Burnett to derive the subject-matter of examined claim 39. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of allowing for placement of the applicator onto or around a desired targeted body part or anatomy (Burnett, [0218]).
As per Examined dependent Claim 40, Examined Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 2 of Jin-125 in view of Simon and Burnett as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 40 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 2 (species) in the conflicting patent to Jin-125 with battery features being disclosed in Simon and vest features being disclosed by Burnett (see claim 40 analysis below) and thus, examined claim 40 is obvious and unpatentable the combination of patented claim 2 of Jin-125 in view of Simon and Burnett as a whole.
As per Examined dependent Claim 41, Examined Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over the combination of patented claim 1 of Jin-125 in view of Simon and Burnett as a whole. Although the claims at issue are not identical, they are not patentably distinct from each other because examined claim 41 when broadly yet reasonably interpreted is generic (genus) to and fully encompasses patented claim 1 (species) in the conflicting patent to Jin-125 with battery features being disclosed in Simon and vest features being disclosed by Burnett (see claim 41 analysis below) and thus, examined claim 41 is obvious and unpatentable the combination of patented claim 1 of Jin-125 in view of Simon and Burnett as a whole.
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 21, 23, 33-43, 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Burnett
As per independent Claim 21, Simon discloses a device to treat spasticity in a subject (Here, the term “spasticity” is being interpreted in light of instant application specification page 1. Simon in at least abstract, fig. 1-5, [0002], [0006], [0012], [0015-0016], [0023-0025], [0029-0031], [0033-0036], [0053-0062], [0097], [0103], [0123], [0197] discloses relevant subject-matter. More specifically, Simon in at least abstract, fig. 1, [0023-0025], [0029], [0054-0058], [0062], [0103], [0123], [0182] for example discloses a nerve stimulating device 300 to treat a subject which is disclosed in [0002], [0036], [0053], [0197] as applicable to treat spasticity diseases. See at least Simon [0023] “devices and methods for the non-invasive treatment of medical conditions, utilizing an energy source that transmits energy non-invasively to bodily tissue. In particular, the device can transmit energy to, or in close proximity to, one or more selected nerves to temporarily … block and/or modulate electrophysiological signals in the selected nerves”;[0061] “a suitable electrical voltage/current profile 400 for the blocking and/or modulating impulse 410 to the portion or portions of a nerve may be achieved using pulse generator 310” and [0197] “the low-current toroidal magnetic stimulation device that is disclosed herein may also be used for all other applications… Spinal nerve roots, Motor Neurone Disease, Movement Disorders… Parkinson's Disease, Tremor…Multiple Sclerosis… Relief of Spasticity”; [0182] “more than one stimulation device may be used simultaneously”;) comprising:
a. a first magnetic field generator (Simon in at least fig. 1, [0024-0025], [0054-0058], [0182] for example discloses a magnetic field generator 340. See at least Simon [0025] “first and second coils configured to generate first and second time-varying magnetic fields; each coil being housed within an enclosure configured to substantially confine the magnetic field therein”; [0055] “the coil may also comprise two or more distinct coils”; [0182] “more than one stimulation device may be used simultaneously”;); and
b. a power source configured to energize the first magnetic field generator in a manner as to generate a repetitive pulsed magnetic field outside the subject (Simon in at least fig. 1, [0054-0058], [0060-0061], [0103], for example discloses a power source 320 configured via control unit 330 to energize the magnetic field generator 340 in order to generate a repetitive pulsed magnetic field outside a subject. See at least Simon [0061] “the pulse generator 310 may be implemented using a power source 320 and a control unit 330 having, for instance… to produce a pulse train 420 to the stimulator coils(s) 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve. Nerve stimulating/modulating device 300 may be externally powered and/or recharged may have its own power source 320.”); and
c. a first mount that is configured to position the first magnetic field generator above a first target location on or near a nerve 1/2 to 4 inches away from a spine of the subject (Examiner notes that the Applicant’s in at least instant application specification as-filed page 1 disclose mapping that allows one to determine the spinal nerve or nerves that communicate with a specific region of the body” as well-known prior art. (See instant application specification as-filed page 1 “Spasticity is often localized to a particular muscle or muscles in the body. Specific locations in the body communicate with the brain through at least one spinal nerve. 31 pairs of spinal nerves exist in the body, with each one connecting to the spine via its nerve root. Mapping has been performed and published, which allows one to determine the spinal nerve or nerves that communicate with a specific region of the body”). Simon in at least fig. 1, [0027], [0029], [0054-0058], [0123], claims 2-3 for example discloses a first mount (e.g. Straps, harnesses, or frames) that is configured to position the first magnetic field generator above a first target location on or near a nerve 1/2 to 4 inches away from a spine of the subject. See at least Simon [0027] “selectively applying energy to a target region within a patient…generating a time-varying magnetic field that is located essentially entirely outside of the patient and shaping an electric field induced by the magnetic field. An electric current from the electric field is conducted through an outer skin surface of the patient to the target region to modulate a nerve at the target region. The target region is preferably at least approximately 1-2 cm below the outer skin surface … about 2-5 cm below the outer skin surface”; “the target region is a nerve at least 1 cm below the outer skin surface”);
wherein the first magnetic field generator is configured to transmit repetitive magnetic field pulses in a manner that the magnetic field induces an electric current or voltage potential in the first target location on or near the nerve that connects a spasticity treatment location to the spine (Simon in at least fig. 1, fig. 3, [0023], [0057], [0060-0062], [0123], [0182], [0197] for example discloses wherein the first magnetic field generator 340 is configured to transmit repetitive magnetic field pulses in a manner that the magnetic field induces an electric current or voltage potential in the first target location on or near the nerve that treats spasticity. See at least Simon [0023] “devices and methods for the non-invasive treatment of medical conditions, utilizing an energy source that transmits energy non-invasively to bodily tissue… the device can transmit energy to, or in close proximity to, one or more selected nerves to temporarily … block and/or modulate electrophysiological signals in the selected nerves”;[0061] “a suitable electrical voltage/current profile 400 for the blocking and/or modulating impulse 410 to the portion or portions of a nerve may be achieved using pulse generator 310… the pulse generator 310 may be implemented using a power source 320 and a control unit 330 … to produce a pulse train 420 to the stimulator coils(s) 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve” ;[0182] “more than one stimulation device may be used simultaneously”; [0197] “the low-current toroidal magnetic stimulation device that is disclosed herein may also be used for all other applications… Spinal nerve roots, Motor Neurone Disease, Movement Disorders… Parkinson's Disease, Tremor…Multiple Sclerosis… Relief of Spasticity”); and
d. a second magnetic field generator configured to transmit repetitive transcranial magnetic field pulses to the subject at a second target location (Simon in at least fig. 1, 6, 10, [0025], [0055], [0057], [0065], [0183], [0123], [0197] for example disclose a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location as in fig. 6. See at least Simon [0025] “first and second coils configured to generate first and second time-varying magnetic fields; each coil being housed within an enclosure configured to substantially confine the magnetic field therein”; [0055] “the coil may also comprise two or more distinct coils”; [0057] “control unit 330 controls the impulse generator 310 to generate a signal for each of the device's magnetic stimulation coils. The signals are selected to be suitable for amelioration of a particular medical condition, when the signals are applied non-invasively to a target nerve or tissue via the magnetic stimulator coil 340.”; [0123] “magnetic stimulation device … 30 is initially positioned … Straps, harnesses, or frames are used to maintain the stimulator in position (not shown in FIG. 6 or 7). The stimulator signal may have a frequency and other parameters that are selected to influence the therapeutic result. … parameters of the stimulation may be varied in order to obtain a beneficial response”; [0182] “more than one stimulation device may be used simultaneously”; [0183] “position the stimulator to the desired location…by the example shown in FIG. 10…relates to stimulation of the brain (transcranial stimulation)”;).
Simon does not explicitly disclose spinal nerve features i.e. a first mount that is configured to position the first magnetic field generator above a first target location on or near a spinal nerve therapeutic distance away from a spine of the subject; wherein the first magnetic field generator is configured to transmit repetitive magnetic field pulses in a manner that the magnetic field induces an electric current or voltage potential in the first target location on or near the spinal nerve that connects a spasticity treatment location to the spine and a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location, wherein said second target location is connected to a different area of the spine through a spinal nerve.
However, in an analogous wearable magnetics field of endeavor, Burnett discloses a device to treat spasticity in a subject (Burnett in at least abstract, fig. 9C, fig. 32-35, fig. 41, [0020-0022], [0024], [0066], [0068-0069], [0070], [0112-0114], [0117], [0187], [0201], [0204 0208], [0217-0221], [0224-0225], [0228-0231] for example discloses relevant subject-matter. More specifically, Burnett in at least [0020], [0117], [0201], [0218-0221], [0225], [0204-0205], [0207-0208] for example discloses device to treat spasticity in a subject. See at least Burnett [0020] “systems for electromagnetic induction therapy may include one or more conductive coils disposed within or along an applicator. The coils may be configured to generate a magnetic field focused on a target nerve, muscle or other body tissues in proximity to the coil”; [0117] “Ailments that may be treated through the use of apparatus and methods as described herein include …restless leg syndrome… multiple sclerosis… muscle spasticity… nerve damage… restless legs, tremor”) comprising:
a first mount that is configured to position the first magnetic field generator above a first target location on or near a spinal nerve therapeutic distance away from a spine of the subject; wherein the first magnetic field generator is configured to transmit repetitive magnetic field pulses in a manner that the magnetic field induces an electric current or voltage potential in the first target location on or near the spinal nerve that connects a spasticity treatment location to the spine (Burnett in at least fig. 9C, fig. 31-35, fig. 41, [0086], [0020], [0022], [0112-0113] [0201], [0204-0208], [0218] for example discloses a first mount (see fig. 9C, fig. 32-35, fig. 41) that is configured to position the magnetic field generator/applicator above a first target location on the spine on or near a spinal nerve a therapeutic distance away from a spine of the subject, wherein the magnetic field generator is configured to transmit repetitive magnetic field pulses in a manner that the magnetic field induces an electric current or voltage potential in the first target location on or near the spinal nerve that connects a spasticity treatment location to the spine. See at least Burnett [0022] “electromagnetic induction therapy may include one or more of the following steps…an applicator may be positioned relative to or in proximity to a first portion of a patient's body, such that a target nerve… within the first portion of the body is in proximity to one or more conductive coils disposed within … the applicator. A current may be passed through a coil to generate a magnetic field focused on the target nerve… a muscular response caused by an electrical conduction through the target nerve or stimulation of a nerve…may be detected … along a second portion of the body”; [0086] “When multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field”; [0112] “non-limiting variations shaped as body worn ergonomic applicator garments…coils of any configurations may be used”; [0113] “a coil wrap shaped like a band 114, in which coils 116 are connected to a logic controller (not shown) by a connector 118. When this variation is employed, band 114 may be wrapped around a body portion … and be retained in place by a system known in the art, for example, a hook and loop system, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric or other material in another portion of band 114”; [0201] “electromagnetic or magnetic induction applicators designed or configured to stimulate various portions of a patient's body for treating various conditions are contemplated herein”; [0204] “back applicator 330 may be ergonomic or contoured to the back or to a specific area of the back to be positioned relative to or in proximity to the back to generate an electromagnetic or magnetic field focused on a target nerve…back applicator 330 may be aligned along the spine or positionable in proximity to the spine. The back applicator 330 may be utilized to stimulate nerve offshoots, dorsal ganglion, the spinal cord itself or any other nerve in the body, to treat various conditions”; [0205] “back applicator 330 may include several coils, which may be pulsed intermittently…to ensure stimulation of the proper dorsal root ganglion or vertebral body.”; [0207] “a system including a whole back applicator 350, a sensor 352 and a logic controller 354…applicators 350 may include multiple coils, which can be fired sequentially to stimulate the entire spine or chain of dorsal root ganglion … after suffering other nerve damaging conditions”; [0208]” a back applicator 360 which may be positioned in proximity to or aligned along a spine…applicator 360 may include several coils that are pulsed intermittently… the back applicator 360 or focused back applicator may me held on a patient by an ergonomic positioning element 361 (e.g., a belt) and may be fit such the cervical, thoracic, lumbar, sacral and/or lumbosacral curvatures hold the back applicator 360 in the optimal position. The applicator 360 may be located anywhere along the positioning element 361 depending on the individual and area to be stimulated.”).
a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location, wherein said second target location is connected to a different area of the spine through a spinal nerve (Here, the claim limitation is being interpreted broadly yet reasonably as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results. Burnett in at least [0086], [0201], fig. 41, [0217-0218], for example discloses a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location, wherein said second target location is at least indirectly connected to a different area of the spine through a spinal nerve. See at least Burnett [0086] “When multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field”; [0201] “electromagnetic or magnetic induction applicators designed or configured to stimulate various portions of a patient's body for treating various conditions are contemplated herein”; [0218] “applicators … ergonomic or contoured to the specific region of the body or anatomy to which the applicator will be delivering stimulation… applicators described herein may approximate the respective targeted body area or anatomy or the applicators may be designed such that the body region or targeted anatomy may approximate the applicator.”; [0217] “a system including a variation of an ergonomic back applicator 410 held on a patient's body by an ergonomic positioning element 411 in the form of a shoulder harness… applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment, or an ergonomic back-countered plate… one or more coils may be fixed on the applicator (requiring prior targeting by a healthcare provider or patient) or one or more coils may move freely within or along the applicator and may be locked into position when the desired or optimal position is located…system may be … have at least two components including a separate logic controller”).
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 wearable applicator targeting region used in the pulsed electromagnetic stimulation device as taught by Simon, in a manner that wearable applicator is localized to spinal region close to spinal roots, as taught by Burnett. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of ensuring focused stimulation of proper spinal area, nerve offshoots, dorsal ganglion, dorsal root ganglion, chain of dorsal root ganglion, the spinal cord itself or the entire spine to treat various conditions that response to such spinal peripheral nerve stimulation (Burnett, [0204-0205], [0207]).
As per dependent Claim 23, the combination of Simon and Burnett as a whole further discloses device wherein the first mount is configured to be attached to a body of the subject in a manner that the first magnetic field generator may be worn by the subject (Simon in at least [0123] for example discloses a first mount (e.g. Straps, harnesses…) is configured to be attached to a body of the subject in a manner that the magnetic field generator may be worn by the subject. See at least Simon [0123] “Straps, harnesses…are used to maintain the stimulator in position… The stimulator signal may have a frequency and other parameters that are selected to influence the therapeutic result”).
As per dependent Claim 33, the combination of Simon and Burnett as a whole further discloses device wherein the first magnetic field generator is a coil (Simon in at least fig. 1, fig. 4, [0043], [0054] for example discloses the magnetic field generator is a coil 340. See at least Simon [0054] “a magnetic stimulator coil 340 coupled via wires to impulse generator coil 310”).
As per dependent Claim 34, the combination of Simon and Burnett as a whole further discloses device wherein the coil is included inside a strap configured to encircle a torso of the subject (Simon in at least [0123] for example discloses a strap mount that includes the coil. Burnett in at least fig. 9C, fig. 35, fig. 41, [0069], [0113], [0208], [0217] for example discloses coil included inside a wrap or a band or a strap or upper torso garment or belt configured to encircle a torso of the subject. See at least Burnett [0113] “a coil wrap shaped like a band 114, in which coils 116 are connected to a logic controller (not shown) by a connector 118. … band 114 may be wrapped around a body portion … and be retained in place by a system known in the art, for example, a hook and loop system, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric or other material in another portion of band 114.”; [0208] “the back applicator 360 or focused back applicator … held on a patient by an ergonomic positioning element 361 (e.g., a belt) and may be fit such the cervical, thoracic, lumbar, sacral and/or lumbosacral curvatures hold the back applicator 360 in the optimal position”; [0217] “ergonomic back applicator 410 held on a patient's body by an ergonomic positioning element 411 in the form of a shoulder harness… The applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment, or an ergonomic back-countered plate”).
As per dependent Claim 35, the combination of Simon and Burnett as a whole further discloses device wherein the strap is adjustable (Simon in at least [0123] for example discloses a strap mount whose position and angular orientation on the patient body surface is adjustable. Burnett in at least fig. 9C, fig. 35, fig. 41, [0113], [0208], [0217-0218] for example discloses the strap is adjustable. See at least Simon [0123] “The toroidal magnetic stimulation device of the present invention 30 is initially positioned there…The position and angular orientation of the device are then adjusted about that location until the patient perceives stimulation when current is passed through the stimulator coils… Straps, harnesses, or frames are used to maintain the stimulator in position”; see at least Burnett [0113] “a coil wrap shaped like a band 114… may be wrapped around a body portion … and be retained in place by a system known in the art, for example, a hook and loop system, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric or other material in another portion of band 114.” and [0218] “applicators may be openable or adjustable … to allow for placement of the applicator onto or around the targeted body part or anatomy. The applicators may be flexible or ergonomic to accommodate nearly any type of body habitus”).
As per dependent Claim 36, the combination of Simon and Burnett as a whole further discloses device wherein the coil is connected to the power source by a cable (Simon in at least [0054], [0123] for example discloses coil 340 is connected to the power source 320 by a cable as shown in figure 1. Also see Burnett fig. 9C, 33-35, 41, [0206], [0208]. See at least Simon [0054] “a nerve stimulating/modulating device 300 for delivering impulses of energy to nerves for the treatment of medical conditions… include …a magnetic stimulator coil 340 coupled via wires to impulse generator coil 310.”; [0123] “it is understood that the device 30 is connected via wires or cables (not shown) to an impulse generator 310 as in FIG. 1. ”; see Burnett [0206] “corded back applicator”; [0208] “a coil power line 365 for supplying power or current from the logic controller 364 to coils positioned in the applicator 360”).
As per dependent Claim 37, the combination of Simon and Burnett as a whole further discloses device wherein the coil is a figure-8 magnetic coil (Simon in at least fig. 4E, [0031], [0100] for example discloses coil is a figure-8 magnetic coil. See at least [0031] “device comprises two toroidal cores that lie side-by-side one another, around which coils are wound”; Also see Burnett [0112] “non-limiting variations shaped as body worn ergonomic applicator garments…coils of any configurations may be used”).
As per dependent Claim 38, the combination of Simon and Burnett as a whole further discloses device wherein the position of the strap is configured to be adjustable to move the first magnetic field generator to a different target location (Simon in at least [0123] for example discloses the position of the strap mount is configured to be adjustable to move the first magnetic field generator 340 to a different target location. See at least Simon [0123] “The toroidal magnetic stimulation device of the present invention 30 is initially positioned there…The position and angular orientation of the device are then adjusted about that location until the patient perceives stimulation when current is passed through the stimulator coils… Straps, harnesses… are used to maintain the stimulator in position”; Also see Burnett at least [0113] “a coil wrap shaped like a band 114… may be wrapped around a body portion … and be retained in place by a system known in the art, for example, a hook and loop system, a strap and buckle system, or simply a hook disposed at one end of band 114 for engaging fabric or other material in another portion of band 114.” and [0218] “applicators may be openable or adjustable … to allow for placement of the applicator onto or around the targeted body part or anatomy. The applicators may be flexible or ergonomic to accommodate nearly any type of body habitus”).
As per dependent Claim 39, the combination of Simon and Burnett as a whole further discloses device wherein the first mount is a vest (Burnett in at least fig. 35, fig. 41, [0217] for example discloses mount is a torso garment which reads on recited vest. [0217] “ergonomic back applicator 410 held on a patient's body by an ergonomic positioning element 411 in the form of a shoulder harness… The applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment, or an ergonomic back-countered plate”).
As per dependent Claim 40 the combination of Simon and Burnett as a whole further discloses device wherein the first magnetic field generator is a figure-8 magnetic coil that is included in the vest (Simon in at least fig. 4E, [0031], [0100] for example discloses wherein the magnetic field generator 340 is a figure-8 magnetic coil. Also see Burnett [0112] “non-limiting variations shaped as body worn ergonomic applicator garments…coils of any configurations may be used”).
As per dependent Claim 41, the combination of Simon and Burnett as a whole further discloses device wherein the position of the vest is configured to be adjustable to move the first magnetic field generator to a different target location (Burnett in at least fig. 41 for example discloses [0217-0218] for example discloses the position of the upper torso wearable/vest is configured to be adjustable to move the first magnetic field generator to a different target location. Also, Simon in at least [0123] for example discloses the position of the wearable mount is configured to be adjustable to move the magnetic field generator 340 to a different target location. See at least Simon [0123] “The toroidal magnetic stimulation device of the present invention 30 is initially positioned there…The position and angular orientation of the device are then adjusted about that location until the patient perceives stimulation when current is passed through the stimulator coils… Straps, harnesses… are used to maintain the stimulator in position”; Also see Burnett at least [0217] “an ergonomic back applicator 410 held on a patient's body by an ergonomic positioning element 411 …The applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment”; [0218] “applicators may be openable or adjustable … to allow for placement of the applicator onto or around the targeted body part or anatomy. The applicators may be flexible or ergonomic to accommodate nearly any type of body habitus”).
As per dependent Claim 42, the combination of Simon and Burnett as a whole further discloses device wherein the position of the first mount is configured to be adjustable to move the first magnetic field generator to a different target location (Simon in at least [0123] for example discloses the position of the first mount such as straps, harnesses… is configured to be adjustable to move the magnetic field generator 340 to a different target location. See at least Simon [0123] “The toroidal magnetic stimulation device of the present invention 30 is initially positioned there…The position and angular orientation of the device are then adjusted about that location until the patient perceives stimulation when current is passed through the stimulator coils… Straps, harnesses, or frames are used to maintain the stimulator in position”).
As per dependent Claim 43, the combination of Simon and Burnett as a whole further discloses device further comprising a second mount configured to hold the second magnetic field generator in position (Simon in fig. 10, [0183] discloses mount configured to hold the second magnetic field generator in position. See Simon [0183] “applications in which it is necessary to position the stimulator accurately…a method may be employed to position the stimulator to the desired location…by the example shown in FIG. 10…relates to stimulation of the brain (transcranial stimulation)”. Also see Burnett fig. 38, fig. 43, [0218] “applicators … ergonomic or contoured to the specific region of the body or anatomy to which the applicator will be delivering stimulation… applicators described herein may approximate the respective targeted body area or anatomy or the applicators may be designed such that the body region or targeted anatomy may approximate the applicator.”;[0244] “an ergonomic fixture or applicator 430 (e.g., a helmet) may be worn and a coil 432 positioned on the applicator may slide or move from its targeting position to its therapeutic position”).
As per dependent Claim 45, the combination of Simon and Burnett as a whole further discloses device wherein the repetitive magnetic pulses and the repetitive magnetic pulses to the target location are administered concurrently (Simon in at least fig. 1, 6, 10, [0025], [0055], [0057], [0065], [0182-0183], [0194], [0197] for example discloses use of multiple coils to transmit repetitive magnetic field pulses to a target location at therapeutic frequencies to the target location are administered concurrently. Burnett in at least [0086], [0201], fig. 41, [0217-0218], [0244] for example discloses for example discloses the repetitive magnetic pulses and the repetitive magnetic pulses to the target location are administered concurrently. See at least Burnett [0086] “When multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field”; [0201] “electromagnetic or magnetic induction applicators designed or configured to stimulate various portions of a patient's body for treating various conditions are contemplated herein”; [0217] “a system including a variation of an ergonomic back applicator 410 held on a patient's body by an ergonomic positioning element 411 in the form of a shoulder harness… applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment, or an ergonomic back-countered plate… one or more coils may be fixed on the applicator (requiring prior targeting by a healthcare provider or patient) or one or more coils may move freely within or along the applicator and may be locked into position when the desired or optimal position is located…system may be … have at least two components including a separate logic controller”; [0244] “an ergonomic fixture or applicator 430 (e.g., a helmet) may be worn and a coil 432 positioned on the applicator may slide or move from its targeting position to its therapeutic position”).
As per dependent Claim 46, the combination of Simon and Burnett as a whole further discloses device wherein the repetitive transcranial magnetic pulses and the repetitive magnetic pulses to the target location are administered non-concurrently (Simon in at least fig. 1, 6, 10, [0025], [0055], [0057], [0065], [0182-0183], [0194], [0197] for example discloses use of multiple coils to transmit repetitive magnetic field pulses to a target location at therapeutic frequencies to the target location are administered non-concurrently. Burnett in at least [0086], [0201], fig. 41, [0217-0218], [0244] for example discloses for example discloses the repetitive magnetic pulses and the repetitive magnetic pulses to the target location are administered concurrently. See at least Burnett [0086] “When multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field”; [0201] “electromagnetic or magnetic induction applicators designed or configured to stimulate various portions of a patient's body for treating various conditions are contemplated herein”; [0217] “a system including a variation of an ergonomic back applicator 410 held on a patient's body by an ergonomic positioning element 411 in the form of a shoulder harness… applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment, or an ergonomic back-countered plate… one or more coils may be fixed on the applicator (requiring prior targeting by a healthcare provider or patient) or one or more coils may move freely within or along the applicator and may be locked into position when the desired or optimal position is located…system may be … have at least two components including a separate logic controller”; [0244] “an ergonomic fixture or applicator 430 (e.g., a helmet) may be worn and a coil 432 positioned on the applicator may slide or move from its targeting position to its therapeutic position”).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Burnett and further in view of Jin Yi (Pub. No.: US 20130267760 A1, hereinafter referred to as “Jin”).
As per dependent Claim 44, the combination of Simon and Burnett as a whole discloses device of Claim 21 (see claim 21)
The combination of Simon and Burnett as a whole does not explicitly disclose the repetitive magnetic field pulses are transmitted at a frequency of a biological metric, or a harmonic or sub-harmonic of the biological metric.
However, in an analogous transcranial magnetic therapeutic field of endeavor, Jin discloses a magnetic therapy device (Jin in at least abstract, [0002], [0004-0006], [0011], [0014] for example discloses magnetic therapy device. See at least Jin [0004] “the brain activity of a mammal is modulated by subjecting the mammal to repetitive transcranial magnetic stimulation (rTMS) at a frequency of a biological metric, or a harmonic (including sub-harmonics) of the biological metric for a time sufficient to modulate the brain activity of the mammal”; [0005] “By modulating the brain activity of a mammal, improvements in physical conditions, psychological conditions, and neuropsychiatric conditions are improved in a non-invasive manner and usually without the need for medications”) wherein the repetitive magnetic pulses and the repetitive magnetic pulses to the target location are administered non-concurrently (Jin in at least abstract, [0002], [0004-0005] for example discloses the repetitive magnetic pulses and the repetitive magnetic pulses to the target location are administered non-concurrently. See at least Jin [0004] “the brain activity of a mammal is modulated by subjecting the mammal to repetitive transcranial magnetic stimulation (rTMS) at a frequency of a biological metric, or a harmonic (including sub-harmonics) of the biological metric for a time sufficient to modulate the brain activity of the mammal… biological metric can be any biological metric including but not limited to heart rate, respiratory rate, gastrointestinal movement rate, or an EEG frequency… beta band .. gamma band … or the Mu band (8-13 Hz).”).
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 frequency of the repetitive magnetic field pulses transmitted by the pulsed electromagnetic stimulation device of Simon, as modified with Burnett, in a manner that the repetitive magnetic field pulses are transmitted at a frequency of a biological metric, or a harmonic or sub-harmonic of the biological metric Jin. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of increasing frequency coupling among different organs (e.g., heart, brain, breathing, and gastrointestinal movement) through rhythmic entrainment to increase healthy state generating coherence (Jin, abstract, [0011], [0014])
Response to Amendment
According to the Amendment, filed 02/05/2026, the status of the claims is as follows:
Claims 21, 44-46 are currently amended;
Claims 23, 33-43 are previously presented; and
Claims 1-20, 22 and 24-32 are cancelled.
By the current amendment, as a result, claims 21, 23, 33-46 are now pending in this application and are being examined on the merits as being drawn to elected invention/species.
Response to Arguments
Issues Raised and Arguments/Remarks to Double Patenting Rejections presented on Page 5 of Applicant’s Amendment dated 02/05/2026 where Applicant’s’ remarks inter alia that:
Double Patenting[i] Without addressing the propriety of the Office's rejections, and specifically the Office's interpretation of what the cited references teach or suggest, Applicant respectfully and properly defers addressing the present double patenting rejections until there is otherwise allowable subject matter in the present application. Accordingly, Applicant respectfully requests that the rejections be held in abeyance until claims are allowable in the present application.
Applicant’s request [i] above for abeyance of non-statutory obviousness-type double patenting is acknowledged. However, in the interest of clarity and thoroughness of the prosecution record, claims 21, 23, 33-46 rejection on the ground of nonstatutory double patenting as being unpatentable over claims of patented applications is being reiterated.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 5-6 of Applicant’s Amendment dated 02/05/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of the Amended Independent Claim 21
[A] Claim 21 is rejected under 35 U.S.C. § 103(a) as allegedly being obvious over Simon (US 20150165226) in view of Burnett (US 20120302821). Applicant respectfully disagrees.
[B] Neither Simon nor Burnett teach or suggest the claimed "second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location, wherein said second target location is connected to a different area of the spine through a spinal nerve."
[C] For at least these reasons, Applicant respectfully requests reconsideration and withdrawal of this rejection.
Applicant’s arguments [A-C] above with respect to the above claim limitation in Claim 21 have been considered but are not persuasive for the following reasons:
With respect to Applicant’s arguments [B-D] with respect to the recitation “a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location, wherein said second target location is connected to a different area of the spine through a spinal nerve” as now explicitly, positively and specifically recited by the Applicant, the combination of applied art as a whole discloses this limitation. More specifically, Simon in at least fig. 1, 6, 10, [0025], [0055], [0057], [0065], [0183], [0123], [0197] disclose a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location as in fig. 6 and fig. 10 (See at least Simon [0025] “first and second coils configured to generate first and second time-varying magnetic fields; each coil being housed within an enclosure configured to substantially confine the magnetic field therein”; [0055] “the coil may also comprise two or more distinct coils”; [0057] “control unit 330 controls the impulse generator 310 to generate a signal for each of the device's magnetic stimulation coils. The signals are selected to be suitable for amelioration of a particular medical condition, when the signals are applied non-invasively to a target nerve or tissue via the magnetic stimulator coil 340.”; [0123] “magnetic stimulation device … 30 is initially positioned … Straps, harnesses, or frames are used to maintain the stimulator in position (not shown in FIG. 6 or 7). The stimulator signal may have a frequency and other parameters that are selected to influence the therapeutic result. … parameters of the stimulation may be varied in order to obtain a beneficial response”; [0182] “more than one stimulation device may be used simultaneously”; [0183] “position the stimulator to the desired location…by the example shown in FIG. 10…relates to stimulation of the brain (transcranial stimulation)”) . Additionally, Burnett in at least [0086], [0201], fig. 41, [0217-0218], for example discloses a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location, wherein said second target location is at least indirectly connected to a different area of the spine through a spinal nerve (Here, the claim limitation is being interpreted broadly yet reasonably as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results. See at least Burnett [0086] “When multiple coils 26 are present, coils 26 may be activated simultaneously or differentially to generate the desired magnetic field”; [0201] “electromagnetic or magnetic induction applicators designed or configured to stimulate various portions of a patient's body for treating various conditions are contemplated herein”; [0218] “applicators … ergonomic or contoured to the specific region of the body or anatomy to which the applicator will be delivering stimulation… applicators described herein may approximate the respective targeted body area or anatomy or the applicators may be designed such that the body region or targeted anatomy may approximate the applicator.”; [0217] “a system including a variation of an ergonomic back applicator 410 held on a patient's body by an ergonomic positioning element 411 in the form of a shoulder harness… applicator 410 may include various positioning elements 411, e.g., a shoulder harness, an upper torso garment, or an ergonomic back-countered plate… one or more coils may be fixed on the applicator (requiring prior targeting by a healthcare provider or patient) or one or more coils may move freely within or along the applicator and may be locked into position when the desired or optimal position is located…system may be … have at least two components including a separate logic controller”). Thus, the combination of applied art as a whole discloses this limitation “a second magnetic field generator configured to transmit repetitive magnetic field pulses to the subject at a second target location, wherein said second target location is connected to a different area of the spine through a spinal nerve” as now explicitly, positively and specifically recited by the Applicant.
With respect to Applicant’s arguments [B] above, arguing against the references individually, Examiner notes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, claim 21 was rejected based on the combination of Simon and Burnett as a whole.
For the above reasons, claim 21 is still rejectable under 35 U.S.C. § 103 over the combination of Simon and Burnett as a whole and thus, claim 21 rejection under 35 U.S.C. § 103 over the combination of Simon and Burnett still applies. Please also cross-reference detailed claim 1interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 6-7 of Applicant’s Amendment dated 02/05/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of Dependent Claims 23, 33-46.
[a] Claims 23, and 33-43, and 45-46 are rejected under 35 U.S.C. § 103(a) as allegedly being obvious over Simon (US 20150165226) in view of Burnett (US 20120302821). Applicant respectfully disagrees.
[b] claims 23 and 33-46 depend from Claim 21, directly or indirectly, and include all its limitations, and therefore are also not prima face obvious over Simon in view of Burnett for the same reasons. For at least these reasons, Applicant respectfully requests reconsideration and withdrawal of this rejection.
[c] Claim 44 is rejected under 35 U.S.C. § 103(a) as allegedly being obvious over Simon in view of Burnett in view of Jin Yi (US 20130267760). Applicant respectfully disagrees.
As discussed supra, Simon and Burnett do not teach or suggest each element of the instant claims. Jin Yi does not rectify this shortcoming. Therefore, Applicant respectfully requests reconsideration and withdrawal of this rejection.
Applicant’s arguments [a-c] above with respect to dependent claims 23, 33-46 been considered but are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the dependent claims 23, 33-46 define a patentable invention based on their dependency on base claims without specifically pointing out how the language of the dependent claims patentably distinguishes them from the references.
For the above reasons, each of claims 23, 33-43, 45-46 is still rejectable under 35 U.S.C. § 103 over the combination of Simon and Burnett as a whole. Additionally, claims 44 is still rejectable under 35 U.S.C. § 103 over the combination of Simon, Burnett and Jin as a whole. Please also cross-reference detailed claims 23, 33-46 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above.
Conclusion
Applicant’s’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (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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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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