DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 January 2026 has been entered.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1 line 11: “strength for each magnetic modules” should read –strength for each of the magnetic modules--.
Claim 11 lines 12-13: “to stimulate or otherwise modules” should read –stimulate or otherwise modulate--.
Claim 14: “11,wherein” should read --11, wherein--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 5, 7, 8, 10-16, 18, 19, 21, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 11 each recite the limitation “each of the at least two magnetic modules including a magnetizable material and a coil…the magnetizable material comprising electropermanent magnets” (emphasis added). Therefore, claim 1, as written, requires each module includes a coil and, separately, a plurality of electropermanent magnets. Applicant’s original specification discloses “each magnetic module may constitute an electropermanent magnet, containing a core…surrounded in part by one or more coils of electrically conductive material” ([0023]). Accordingly, applicant’s original specification does not provide adequate written description to support each magnetic module including a plurality of electropermanent magnets and a separate coil.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 5, 7, 8, 10-16, 18, 19, 21, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “to induce electric fields” in line 12. It is unclear whether applicant intends to refer to the same electric fields previously recited in the claim.
Claim 1 recites “each of the two magnetic module electropermanent magnets” in line 16, yet previously recites “at least two magnetic modules”. It is unclear whether applicant intends to reference two or at least two magnetic modules in line 16.
Claim 1 recites the limitation “the subject” in its last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “induce electric fields” in line 12. It is unclear whether applicant intends to refer to the same electric fields previously recited in the claim.
Claim 11 recites the limitation “the tissue body part” in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the subject” in its last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “a subject” in line 1. It is unclear whether applicant intends to reference the same subject as in claim 11.
Claim 14 recites “overlapping electric fields”. It is unclear whether the electric fields of claim 14 are the same as that of claim 13.
Claim 15 recites “one subject”. It is unclear whether the subject of claim 15 is intended to be the same or different from the subject of parent claim 13.
Claim 18 recites “applying electric fields”. It is unclear whether the electric fields of claim 18 are intended to be the same as that of parent claim 13.
Claim 21 recites “the electric field”, while parent claim 13 recites plural “electric fields”. It is unclear whether applicant intends to refer one of or the plurality of the same electric fields in claim 21.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 is dependent on cancelled claim 20, thus fails to further limit a parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 5, 7, 8, 10-16, 18, 19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0357935 (Ilmoniemi et al.) in view of U.S. Patent Application Publication No. 2012/0016177 (Mishelevich et al.) and U.S. Patent Application Publication No. 2019/0150741 (Weinberg).
Regarding claim 1, Ilmoniemi teaches an apparatus (abstract), comprising:
an assembly of at least two magnetic modules (coils, 82), wherein at least one of the modules may be fired independently of another module ([0054]; pulses staggered in each coil, [0076]; Figure 8), each of the at least two magnetic modules including a coil of electrically conductive material ([0054]; Figure 8), and
a control system configured to control timing of electric fields generated by the assembly to induce electric fields at different frequencies or waveforms at different locations in a body part and to thereby modulate tissue differently at different locations in the body part ([0075]-[0076]; controller and/or processor, [0082]). Ilmoniemi does not expressly teach the control system determines which of at least two magnetic modules to activate and at which actuation strength for each magnetic modules, the control system determines a sequence of actuations to induce electric fields to stimulate or otherwise modulate at least one deep section of the body part such that the modulation on the at least one deep section is more effective than modulation on at least one relatively superficial section of the body part.
However, Mishelevich teaches an apparatus (abstract), comprising: an assembly of at least two magnetic modules (array, 4 includes coils 130, 140, 150), wherein at least one of the modules may be fired independently of another module ([0057]; [0059]; [0060]; each coil may not have same stimulation parameters, [0090]; Figures 1A-1B), and a control system (6) configured to control timing of electric fields generated by the assembly to induce electric fields in different locations in a body part and to thereby modulate tissue differently at different locations in the body part, wherein the control system determines which of at least two magnetic modules to activate and at which actuation strength for each magnetic modules, the control system determines a sequence of actuations to induce electric fields to stimulate or otherwise modulate at least one deep section of the body part such that the modulation on the at least one deep section is more effective than modulation on at least one relatively superficial section of the body part ([0037]-[0039]; [0054]; [0057]; “direct a higher magnetic field at deep target structures…than at superficial positions”, [0063]; “stimulation parameters (e.g., pulse rate, pulse width and power) are determined based on the stimulation dose needed at the target”, [0088]; [0090]-[0091]). 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 apparatus of Ilmoniemi such that the control system determines which of the magnetic modules to activate, the strength at which to activate them, and a sequence of actuations to induce electric fields to stimulate or otherwise modulate at least one deep section of the body part such that the modulation on the at least one deep section is more effective than modulation on at least one relatively superficial section of the body part as taught by Mishelevich, in order to produce a result wherein “the net magnetic stimulation at the target at depth is greater than at superficial locations” in order to avoid “undesirable effects such a seizures” and “excitotoxicity” ([0039]; [0054]).
Ilmoniemi and Mishelevich do not teach each of the at least two magnetic modules further includes magnetizable material comprising electropermanent magnets, wherein the control system is configured to control each of the two magnetic module electropermanent magnets to form an image of the tissue in the subject and each of the at least two magnetic module coils to modulate the tissue, without moving the subject.
However, Weinberg teaches an apparatus comprising: an assembly of at least two magnetic modules (110, 140), each of the at least two magnetic modules including electropermanent magnets and a coil of electrically conductive material; a control system, wherein the control system is configured to control each of the two magnetic module electromagnetic magnets to form an image of the tissue in the subject and each of the at least two magnetic module coils to modulate the tissue, without moving the subject ([0028]-[0031]; Figure 1). 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 modules to further include electropermanent magnets, wherein the control system is configured to control each of the electropermanent magnets to form an image of the tissue in the subject and each of the coils to modulate the tissue without moving the subject, in light of the teachings of Weinberg, in order to guide treatment during its delivery ([0028]; [0030]). Note: The limitations “without moving the subject” is functional language. Since Weinberg teaches the electropermanent magnets and the coils are controlled by a computer to provide therapeutic stimulation “at one time” and perform imaging “at another time” during the course of treatment in order to facilitate image-guided therapy ([0030]), the apparatus is capable of performing the claimed function.
Regarding claim 4, Ilmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 1. Ilmoniemi teaches the at least two electromagnetic modules (82) are configured to generate overlapping fields in the tissue ([0054]-[0055]; Figure 8).
Regarding claim 5, Ilmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 1. Ilmoniemi teaches the control system is configured to control the timing of the electric fields to modulate a barrier in the tissue of the body part, wherein the modulation caused by the size, frequency, magnitude, or direction of the electric fields is different than the modulation caused by each of the at least two modules separately (The limitation “to control the timing of the electric fields to modulate a barrier in the tissue of the body part” is intended use. Since the control system controls the timing of the electric fields by modulating size, frequency, magnitude and/or direction of the electric fields, the system of capable of performing the claimed function. See at least [0075]-[0076]).
Regarding claims 7 and 8, Ilmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 1. Ilmoniemi teaches the control system is configured to activate a second module of the at least two modules subsequent to activation of a first module of the at least to modules (staggering coils, [0076]); wherein the first module and the second module are configured to generate overlapping electric fields in the tissue ([0054]-[0055]; Figure 8).
Regarding claim 10, Ilmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 1. Ilmoniemi, as modified, does not teach the apparatus is configured to deliver a payload to tissue that causes production of desired substances in the tissue or will cause regeneration of cells in the tissue.
However, Weinberg further teaches the apparatus is configured to deliver a payload to tissue that causes production of desired substances in the tissue or will cause regeneration of cells in the tissue (The limitation “to deliver a payload to tissue that causes production of desired substances in the tissue or will cause regeneration of cells in the tissue” are functional limitations. Since Weinberg teaches the apparatus is configured to deliver a therapeutic payload for medical treatment, the apparatus is capable of performing the claimed function, [0006]-[0007] and [0033].). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Ilmoniemi as modified to be configured to deliver a payload to tissue that causes production of desired substances in the tissue or will cause regeneration of cells in the tissue as taught by Weinberg in order to improve the therapeutic efficacy of the treatment.
Regarding claim 11, Ilmoniemi teaches a method of selectively modulating tissue in a body part comprising: selectively actuating at least two magnetic modules (82) in an assembly near to or enclosing the body part, each of the magnetic modules including a coil of electrically conducive material ([0054]; Figure 8),
wherein the selective actuation creates electric fields at different frequencies or waveforms at different locations in said body part to selectively modulate tissues at different locations in said body part ([0054]-[0055]; [0074]-[0076]; Figure 8). Ilmoniemi does not expressly teach determining which of the at least two modules to activate, and at which actuation strength for each of the at least two magnetic modules, determining a sequence of actuations to induce electric fields to stimulate or otherwise modulate at least one deep section of the body part such that the deep modulation is more effective than modulation on at least one relatively superficial section of the body part.
However, Mishelevich teaches a method (abstract), comprising: selectively actuating at least two magnetic modules (130, 140, 150) in an assembly near to or enclosing the body part, wherein the selective actuation creates electric fields at different frequencies or waveforms at different locations in said body part to selectively modulate tissues at different locations in said body part ([0057]; [0059]; [0060]; each coil may not have same stimulation parameters, [0090]; Figures 1A-1B), and determining which of the at least two modules to activate, and at which actuation strength for each of the at least two magnetic modules, determining a sequence of actuations to induce electric fields to stimulate or otherwise modulate at least one deep section of the body part such that the deep modulation is more effective than modulation on at least one relatively superficial section of the body part ([0037]-[0039]; [0054]; [0057]; “direct a higher magnetic field at deep target structures…than at superficial positions”, [0063]; “stimulation parameters (e.g., pulse rate, pulse width and power) are determined based on the stimulation dose needed at the target”, [0088]; [0090]-[0091]; stimulation “computed algorithmically”, [0083] and [0088]). 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 method of Ilmoniemi to include determining which of the magnetic modules to activate, the strength at which to activate them, and a sequence of actuations to induce electric fields to stimulate or otherwise modulate at least one deep section of the body part such that the modulation on the at least one deep section is more effective than modulation on at least one relatively superficial section of the body part as taught by Mishelevich, in order to produce a result wherein “the net magnetic stimulation at the target at depth is greater than at superficial locations” in order to avoid “undesirable effects such a seizures” and “excitotoxicity” ([0039]; [0054]).
Ilmoniemi and Mishelevich do not teach each of the at least two magnetic modules further includes magnetizable material comprising electropermanent magnets, wherein the method includes imaging the body part using the same at least two magnetic modules in the assembly, wherein each of the two magnetic module electropermanent magnets are controllable to form the image of the tissue body part and each of the at least two magnetic module coils are controllable to modulate the tissue, without moving the subject.
However, Weinberg teaches a method of selectively modulating tissue in a body part ([0028]-[0031]; [0033]; [0037]), comprising: selectively actuating at least two magnetic modules (110, 140), each of the at least two magnetic modules including electropermanent magnets and a coil of electrically conductive material, and imaging the body part using the same at least two magnetic modules in the assembly, wherein each of the magnetic module electropermanent magnets are controllable to form the image of the tissue body part and each of the at least two magnetic module coils are controllable to modulate the tissue, without moving the subject ([0028]-[0031]; [0033]; [0037]; Figures 1-3). 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 modules to further include electropermanent magnets, wherein the method includes imaging the body part using the magnetic modules in the assembly and wherein each of the electropermanent magnets are controllable to form the image and each of the coils are controllable to modulate the tissue without moving the subject, in light of the teachings of Weinberg, in order to guide treatment during its delivery ([0028]; [0030]; [0037]). (Note: The limitations “controllable…without moving the subject”, emphasis added, is functional language. Since Weinberg teaches the electropermanent magnets and the coils are controlled by a computer to provide therapeutic stimulation “at one time” and perform imaging “at another time” during the course of treatment in order to facilitate image-guided therapy ([0030]), the apparatus is capable of performing the claimed function.)
Regarding claim 12, Illmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 11. Illmoniemi as modified does not teach the method further comprises administering a payload to a subject with the body part, and applying the magnetic fields to modulate a barrier of tissue of the body part, wherein timing of the magnetic fields applied for modulation of the barrier of the tissue causes a different modulation than a modulation generated by applying a magnetic field of any individual module, and wherein the modulation of the barrier affects delivery of the payload to the tissue or of transport of a substance from the tissue.
However, Weinberg further teaches administering a payload to a subject with the body part, and applying the magnetic fields to modulate a barrier of tissue of the body part, wherein timing of the magnetic fields applied for modulation of the barrier of the tissue causes a different modulation than a modulation generated by applying a magnetic field of any individual module, and wherein the modulation of the barrier affects delivery of the payload to the tissue or of transport of a substance from the tissue (magnetic fields applied to navigate and deliver payload to target body tissue, [0006]-[0007]; [0028]-[0033]; [0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Ilmoniemi as modified to further include administering a payload to a subject with the body part, and applying the magnetic fields to modulate a barrier of tissue of the body part, wherein timing of the magnetic fields applied for modulation of the barrier of the tissue causes a different modulation than a modulation generated by applying a magnetic field of any individual module, and wherein the modulation of the barrier affects delivery of the payload to the tissue or of transport of a substance from the tissue as taught by Weinberg, in order to improve the therapeutic efficacy of the treatment.
Regarding claim 13, Ilmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 11. Ilmoniemi teaches activating the second magnetic module subsequent to activating the first magnetic module of the at least two modules (staggering coils, [0076]).
Regarding claim 14, Ilmoniemi in view of Mishelevich teaches all the limitations of claim 11. Ilmoniemi teaches the at least two modules generate overlapping electric fields ([0054]-[0055]; Figure 8).
Regarding claim 15, Ilmoniemi in view of Mishelevich teaches all the limitations of claim 11. Ilmoniemi teaches modulating one or more regions in one subject and then modulating one or more different regions in the same or a different subject ([0079]).
Regarding claim 16, Ilmoniemi in view of Mishelevich teaches all the limitations of claim 11. Ilmoniemi as modified teaches performing an MRI with the at least two magnetic modules to select an anatomic region for modulation (Ilmoniemi: MRI obtained, and MRI used for stimulation planning: [0086]; [0114]; [0119]; [0123]; Weinberg: [0028], [0037], claim 9).
Regarding claim 18, Ilmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 11. Ilmoniemi teaches applying electric fields to modulate neurons in the desired anatomic region (“mTMS”, [0054]; [0074]-[0075]).
Regarding claim 19, Ilmoniemi in view of Mishelevich and Weinberg teaches all the limitations of claim 11. Ilmoniemi as modified teaches magnetic resonance imaging is collected before or after the selective modulation to depict the localization of the electric fields ([0086]; Weinberg: [0028]).
Regarding claim 21, Ilmoneimi in view of in view of Mishelevich and Weinberg teaches all the limitations of claim 20 (see rejection under 35 U.S.C. 112(d) above). Ilmoniemi as modified teaches the waveform of the electric field is predominantly mono-phasic ([0077]).
Regarding claim 22, Ilmoneimi in view of in view of Mishelevich and Weinberg teaches all the limitations of claim 1. Ilmoniemi as modified teaches the stimulation and imaging comprise transcranial magnetic stimulation and magnetic resonance imaging (Ilmoniemi: TMS, [0027], and MRI, [0086]; Weinberg: MRI, [0028]).
Response to Arguments
Applicant’s arguments, see page 5, filed 12 January 2026, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments to the claims, except as noted above. The rejections of 6 November 2025 have been withdrawn.
Applicant’s arguments, see page 5, filed 12 January 2026, with respect to the rejections of claims 1, 11, and their dependents under 35 U.S.C. 103 have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ilmoniemi, Mishelevich, and Weinberg as these references in combination better teach and/or suggest applicant’s amendments to the claims.
Conclusion
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791