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 .
Response to Amendment
Applicant's submission filed on 01/27/2026 has been entered. Accordingly, claims 1-13 and 15-20 remain pending, claims 1-, 5, 8-11, and xx-19 have been amended, and claim 14 has been canceled.
Response to Arguments
Drawing Objections
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
The specific drawing objections regarding the use of “502” twice in FIG. 5 and unlabeled step in FIG. 6 have been rendered moot by the amended drawings filed 01/27/2026 and these specific drawing objections have been withdrawn. However, the remaining drawing objections have not been remedied nor addressed by applicant’s amendments nor remarks as filed.
Applicant states in the second paragraph of page 6
“Applicant respectfully traverses the claim-feature related objections as Figures 1 and 3a already illustrate the device positioning relative to exemplary body parts, and claim features not shown, such as the specific body parts or positioning the apparatus near a particular body part is commonly understood to those of ordinary skill in the art and not essential to proper understanding of the claims. Moreover, exemplary electropermanent magnets and coils are in US 10908240 incorporated by reference in the disclosure.
Claim 14 has been rejected under 35 U.S.C. 112(a) as allegedly failing to comply with the written description requirement. Applicant maintains that the claim is fully supported and enabled insofar as using MRI and tissue modulation to diagnose and treat cancer and disease would be understood by those of ordinary skill, the claim as been cancelled to advance prosecution”.
In response, it is noted that the above referenced documents by the applicant as being incorporated by reference have not been properly cited on the previously filed IDS. Nonetheless, neither of the above documents describe all of the features of the claims outlined in the previous and withstanding drawing objections that have not been shown in the drawing. And it is noted that there is no corresponding structure shown in previously filed FIGS. 1 and 3a, nor in FIGS. 2, 3B-3D, nor 4, and applicant has not made remarks regarding the objections of these drawings.
It is also noted that the claim amendments filed 01/27/2026 have now limited the claims to be drawn to an apparatus and method relating to stimulation of nerves in the heart. Neither of the above documents cited by the applicant relate to stimulation of the heart, let alone nerves of the heart or any part. In the contrary, both US10908240 and US20170227617 both disclose that the systems disclosed therein as explicitly for not causing nerve stimulation (see column 6, lines 35-42 of US10908240 and [0041], [0043] of US20170227617).
Therefore, the drawings remain objected.
Rejections under 35 USC 112
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
In light of applicant’s amendments to the claims filed 01/27/2026 canceling claim 14, the specific rejection of claim 14 under 112(a) as been rendered moot and has been withdrawn.
Applicant argues in the fourth paragraph through the y paragraph of page 6
“Claims 1-20 have been rejected under 35 U.S.C. 112(b) as allegedly indefinite for containing the term "near." The term "near" is defined in the specification as less than 100 cm in distance in published application para. [0016]. It is further submitted that lines 6-8 are clearly including the assembly chick includes all of the plurality of magnetic modules and the preceding clause merely points out that magnetic modules are independently operable relative to others within the assembly during operation and control of the assembly. The remaining claims have been amended to clarify antecedence. Withdrawal of the rejection is respectfully request”.
In response, it is noted that lines 6-8 of amended claim 1 filed 01/27/2026 recites:
“…controller to be fired independently of another of the plurality of magnetic modules, wherein the assembly is controllable by the controller to induce electric fields at different frequencies at different locations in a body part, the body part comprising a heart, and…”.
In response, it is noted that even if the specification uses the same term of degree as in the claim, the rejection is proper if the scope is not understood when in light of the specification, see MPEP §2173.05(b). Accordingly, as it is unclear what the scope is of the claimed apparatus and the assembly thereof, and also the claimed method using said assembly for selectively modulating neural tissue in a body part, which the applicant seeks protection, the use of the term “near” it is unclear. Applicant has not clearly defined the structure of the apparatus and said assembly thereof in the claims. While it is noted that applicant has defined the term “near” to be “meant less than 100 cm in distance” in [0016], in the same paragraph, applicant also discloses that the assembly “may surround… a body part”. In [0015] applicant describes FIG. 1 as illustrating the “assembly is shown near or surrounding a body part 130” and that “magnetic modules 100 and 110 are shown as examples of modules, and in [0018], applicant describes FIG. As illustrating assembly 120 being near to or partially surrounding party part 240 where a set of modules is magnetized differently with respect to the rest of the assembly, in which actuation configuration to 10 a different set of modules is magnetized with respect to the rest of the assembly and a graph to 20 showing “the electrical field as a function of time near the surface the body part and deep in the body part 230 as the magnetic configurations are changed from 202 to 10 as a function of time”. It is noted that in the in FIG. 1 the magnetic modules 100 and 110 are indicated as pointing to the same item in figure and that the “set of modules” in actuation configuration 200 are indistinguishable from the actuation configuration 210. And that all modules indicated in the figures as being 100, 200, 210 are pictorially indistinguishable from one another, e.g., if any of these modules are meant to be of “different shapes, sizes, or configurations” (as described in [0015]), they are not distinguishable as presently illustrated in the figures. For example, as it is known in the anatomical arts that the distance between the error surface of the chest wall to the left ventricle of the heart is approximately less than 9 cm, as described in page 3 of Hedman et al. (Impact of the distance from the chest wall to the heart on surface ECG voltage in athletes, see attached) and that magnetic modules for stimulating the heart are known to be placed directly on the exterior surface of the chest wall, as described in page 1, FIG. 1 of Graessl et al. (Design, evaluation and application of a modular 32 channel transmit/receive surface coil array for cardiac MRI at 7T, see attached). Therefore as it is well-known that magnetic modules restimulation of the heart may be located within 9 cm of the heart, applicant’s disclosure that that applicant modules may be located near to the heart and near being within 100 cm of the heart or partially surrounding the heart, does not aid in determining the scope of structure of the claimed assembly by applicant. As noted in MPEP § 2173.05(b), the “adequacy of the disclosure of a standard is of greater criticality” when “relative terms are used in claims wherein the improvement over the prior art” may rest “entirely upon size or weight of an element in a combination of elements”. Accordingly, the provided disclosure in the specification does not adequately resolve the indefiniteness of the term and its use of within the associated claimed limitation as presently recited.
Further in response, it is noted that from the above portion of claim 1 referred by the applicant, it is unclear what applicant refers to as “…clearly including the assembly chick includes all of the plurality of magnetic modules…” and that “…the preceding clause merely points out that magnetic modules are independently operable relative to others within the assembly during operation and control of the assembly”.
It is noted that the preceding clause of the stanzas either partially or entirely standing lines 6-8 of amended claim 1 recites “a controller to control the plurality of magnetic modules” – which does not clearly, directly, or indirectly, point out that the magnetic modules are “independently operable relative to others within the assembly during operation and control of the assembly”. And the context of the indefinite is rejection outlines that it is unclear if the assembly in the above limitation (i.e., “…the assembly is controllable by the controller to induce electric fields at different frequencies at different locations in a body part, the body part comprising a heart,…” (Emphasis added)) is meant to be interpreted as being inclusive of or exclusive of (i.e., not including) the least one of the plurality of magnetic modules that is controllable by the controller the earlier recited to be fired independently of another of the plurality of magnetic modules, which is the recited earlier in the claim.
It is also noted that the features upon which applicant relies (i.e., “magnetic modules are independently operable relative to others within the assembly during operation and control of the assembly”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
It is also noted that applicant’s amendments to the claims filed 01/27/2026, have not remedied the outstanding rejections added further issues regarding clarity to the claims. Please see the updated and new rejections below.
Therefore, the applications remain rejected and the rejections have been made final.
Rejections under 35 USC 102/103
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new grounds of rejection have been presented. Consequently, the arguments do not apply to new references or the new combination of the references being used in the current rejection.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the apparatus for selectively modulating neuronal tissue in a body; the assembly of a plurality of magnetic modules; the at least one of the plurality of magnetic modules that includes a magnetizable material and a coil of electrically conductive material; the plurality of magnetic modules are positioned around the body part, and the body part is the brain, nerve root, heart, inner ear, or gut of an animal; the sensors configured to detect electrical or magnetic activity in the body part; the apparatus is further configured to implement anesthesia by applying the electric fields to nerves in or near teeth; the electric fields that are applied to structures at selective locations in the body for diagnosis or treatment of cancers or other diseases – must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the results of the MRI performed 603 are analyzed to verify that the correct region has been selected according to plan 604 according to the calculation 601 in FIG. 6, and the MRI of the prior operation is analyzed to see if the plan has been executed correctly, and whether the planned number of repetitions has been executed 607. If so, the study is concluded in FIG. 6, as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "100" and "110" have both been used to designate the same pictorially indistinguishable magnetic modules and FIG. 1 as presently illustrated. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “100”, “110”, “200”, “210” have been used to designate both magnetic modules and an actuation configuration, while appearing, as presently illustrated to indicate the same structurally indistinguishable element(s) in the figure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because FIGS. 1-3 contain text that is not legible. FIGS. 1-3 also appear, although unclear, to be vector-color coded, but no petition to accept color drawings has been filed and it is unclear what the various shades of gray in each sub-image in each of the FIGS. 1-3 is representing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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 1-13 and 15-20 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.
The term “near” in claim 1 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The assembly being controllable by the controller to induce electric fields at different frequencies at different locations in a body part, the body part comprising a part, and the location thereof/positioning thereof of the body part/heart, with respect to/in relation with the assembly, has been rendered indefinite by the use of the “near”.
Further, claim 1 has been amended to recite “wherein the assembly is controllable by the controller to induce electric fields at different frequencies at different locations in a body part, the body part comprising the heart, and the body part being near or partially enclosed by the assembly” in lines 6-8, which renders the claim indefinite because it is unclear how the assembly comprising a plurality of magnetic modules, is structurally/spatially arranged with or in proximity to the heart when reciting that, the assembly as a whole, is able to induce electrical fields at different frequencies at different locations in the heart, and that the heart being near or partially enclosed by the assembly.
It is also unclear if the assembly in the above limitation is inclusive of or exclusive of (not including) the earlier recited the least one of the plurality of magnetic modules that is controllable by the controller to be fired independently of another of the plurality of magnetic modules.
Claim 10 is also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim 2 has been amended to recite “wherein the controller is configured to induce the electric fields at neural tissue in the body part at a neuronal tissue frequency-dependent threshold for stimulation so that deep sections of the body part may be stimulated or otherwise modulated to a different degree than superficial sections of the body part” in lines 1-5, which renders the claim indefinite because it is unclear if the neural tissue in the body part is meant to be inclusive of the nerves and conductive pathways in the heart recited in parent claim 1, on which claim 2 is dependent. It is also unclear if the deep sections of the body part and superficial sections of the body part are also meant to be inclusive of the nerves and conductive pathways in the heart recited in parent claim 1.
Claim 11 is also rejected for reciting the same and/or limitations outlined above.
Claim 5 has been amended to recite “wherein the electric fields induced in the body part are configured to cause temporary or permanent changes in electrical conduction or conductivity in the body part” in lines 1-3, which renders the claim indefinite because it is unclear if the temporary or permanent changes recited in the present claim are meant to refer to the temporary inhibition, or permanent ablation of nerves and conduction pathways in the heart, recited in parent claim 1, on which claim 5 is dependent.
Claims 16-17 are also rejected for reciting the same and/or limitations outlined above.
Claim 8 has been amended to recite “wherein the apparatus is further configured to implement anesthesia by controlling the controller to induce electric fields to nerves in or near teeth” in lines 1-3, which renders the claim indefinite because it is unclear if the electric fields and the nerves in the present claim are the same and meant to refer to the electric fields and the nerves recited in parent claim 1, on which claim 8 is dependent. It is also unclear how the controller in the presented claim is presently recited as being controlled to implement anesthesia by induc[ing] electric fields to nerves in or near teeth, as applicant has by present claim amendment, limited the body part to be the heart in parent claim 1. Therefore, it is unclear to what the teeth refer.
Claim 19 is also rejected for reciting the same and/or limitations outlined above.
Claim 13 recites “wherein the image collection comprises magnetic resonance imaging, and wherein the apparatus is configured to collect the image before and after selective modulation of the body part to depict the localization of the electric fields” in lines 1-4, which renders the claim indefinite because it is unclear how the image collection comprising magnetic resonance imaging is able to depict the localization of the electric fields if the apparatus is configured to collect the image before the selective modulation of the body part, as the image collection is recited in the alternate as being before or after the selective modulation of the body part.
Claim 16 recites “wherein the electric fields are applied to electrically-sensitive tissues at selective locations in the body to temporarily alter properties of electrical conduction or conductivity” in lines 1-3, which renders the claim indefinite because it is unclear if the “electrically-sensitive tissues” and “at selective locations in the body” are meant to refer to the nerves and conductive pathways and the heart, respectively, as nerves recited in parent claim 10, on which claim 16 is dependent.
Claim 17 is also rejected for reciting the same and/or limitations outlined above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 6, 9-10, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weinberg et al. (US20170227617, hereafter “Weinberg 7617”), in view of Weinberg (US20190391217, hereafter “Weinberg 1217”), further in view of Borsody (US20140343349).
Regarding claims 1 and 10, Weinberg 7617 discloses an apparatus and a method for selectively modulating neuronal tissue in a body (see preambles in claims 1 and 10) comprising:
an assembly of a plurality of magnetic modules (claim1: one or more arrays of magnetizable components),
a controller to control the plurality of magnetic modules (claim 1: a controller), and
wherein the at least one of the plurality of magnetic modules is configured to collect an image of the body part ([0016] images are collected using magnetic resonance imaging of nuclei), but does not explicitly disclose wherein at least one of the plurality of magnetic modules is controllable by the controller to be fired independently of another of the plurality of magnetic modules nor wherein the assembly is controllable by the controller to induce electric fields at different frequencies at different locations in a body part, the body part being* near by the assembly.
However, in the same field of endeavor, Weinberg 1217 teaches wherein at least one of the plurality of magnetic modules is controllable by the controller to be fired independently of another of the plurality of magnetic modules ([0034], FIG. 6 selected modules are magnetized/fired independently of another of the plurality of magnetic modules), and
wherein the assembly is controllable by the controller to induce electric fields at different frequencies at different locations in a body part ([0039] by selecting frequencies of excitation with radiofrequency energy or with alterations of the magnetic gradient profile or both, the FOV may vary along the pulse sequence), the body part being*, ** near by the assembly ([0022] the two-dimensional array 220 of electropermanent magnets 210 adjacent to a field-of-view 230 containing protons or other magnetizable particles of interest, and the FOV corresponds to the body part as the particles may be incorporated into tissues (living or otherwise)).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the at least one of the plurality of magnetic modules is controllable by the controller to be fired independently of another of the plurality of magnetic modules and the assembly is controllable by the controller to induce electric fields at different frequencies at different locations in a body part, the body part being near or partially or totally enclosed by the assembly as taught by Weinberg 1217 in order to improve uniformity or other desirable attributes of B0. ([0035] of Weinberg 1217).
While Weinberg 7617 does not explicitly disclose the body part comprising a heart, nor wherein the assembly is controllable to apply*** cardiac stimulation of nerves and conduction pathways in the heart.
However, in the same field of endeavor, Borsody teaches the body part comprising a heart ([0010], FIG. 1, the body part is the heart), and
wherein the assembly is controllable to apply*** cardiac stimulation of nerves and conduction pathways in the heart ([0020]-[0023], the device comprising magnetic modules is configured to deliver electrical stimulation to the heart and its tissues, the heart tissues include electrically-conductive tissues that control the heart including: sinoatrial or atrioventricular nodes, internodal pathways, bundle branches/nerves, Purkinje cells).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the body part comprising a heart and the assembly being controllable to apply cardiac stimulation of nerves and conduction pathways in the heart as taught by Borsody order to provide a therapeutic dose of electrical energy to the heart sufficient to depolarize or hyperpolarize a critical mass of the heart muscle, terminate a dysrhythmia, and/or allow normal sinus rhythm to be reestablished by the body's natural pacemaker (the sinoatrial node of the heary) ([0026] of Borsody).
*The limitation is interpreted in the alternative, requiring the body part being near by the assembly; or requiring the body part being partially enclosed by the assembly; or requiring the body part being totally enclosed by the assembly.
**The term has been interpreted under the broadest reasonable interpretation to mean any distance within any type of vicinity of the assembly as known in the art, including but not limited to, such as being positioned adjacent thereto, etc.
***The limitation is interpreted in the alternative, requiring the assembly is controllable to apply cardiac stimulation of nerves and conduction pathways in the heart; or requiring the assembly is controllable to apply temporary inhibition of nerves and conduction pathways in the heart; requiring the assembly is controllable to apply permanent ablation of nerves and conduction pathways in the heart.
Regarding claim 3, Weinberg 7617, in view of Weinberg 1217, substantially discloses all the limitations of the claimed invention, specifically, Weinberg 1217 discloses wherein the at least one of the plurality of magnetic modules includes a magnetizable material and a coil of electrically conductive material ([0015]. FIG. 1, including coil 120 and magnetizable material 110).
Regarding claims 6 and 18, Weinberg 7617 substantially discloses all the limitations of the claimed invention, specifically, Weinberg 7617 discloses further comprising sensors configured to detect magnetic activity in the body part ([0045] the desired remanent magnetization level is measured by one or more sensors).
And Claim 18 further recites the following subject matter disclosed by Weinberg 7617, sensors that are located** in the modules and using the sensed magnetic fields to otherwise modify the image created by the modules ([0039], [0045], FIG. 3, the one or more sensors measures the magnetization and modifies the magnetic field by allowing the magnetization within the magnetic component to decrease to a desired remanent magnetization level)
*The limitation has been interpretation in the alternate, requiring the sensors configured to detect electrical activity in the body part; or requiring the sensors configured to detect magnetic activity in the body part.
**The limitation has been interpretation in the alternate, requiring the sensors that are located in the modules and using the sensed electric fields to bin the image created by the modules; or requiring the sensors that are located out of the modules and using the sensed electric fields to bin the image created by the modules; or requiring the sensors that are located in the modules and using the sensed magnetic fields to bin the image created by the modules; or requiring the sensors that are located out of the modules and using the sensed magnetic fields to bin the image created by the modules; or requiring the sensors that are located in the modules and using the sensed magnetic fields to otherwise modify the image created by the modules; or requiring the sensors that are located in the modules and using the sensed magnetic fields to otherwise modify the electrical fields created by the modules; or requiring the sensors that are located in the modules and using the sensed electric fields to otherwise modify the electrical fields created by the modules; or requiring the sensors that are located out of the modules and using the sensed magnetic fields to otherwise modify the electrical fields created by the modules; or requiring the sensors that are located in the modules and using the sensed electric fields to bin the electrical fields created by the modules; or requiring the sensors that are located out of the modules and using the sensed electric fields to bin the electrical fields created by the modules; or requiring the sensors that are located in the modules and using the sensed magnetic fields to bin the electrical fields created by the modules; or requiring the sensors that are located out of the modules and using the sensed magnetic fields to bin the electrical fields created by the modules; or requiring the sensors that are located out of the modules and using the sensed electric fields to otherwise modify the electrical fields created by the modules.
Regarding claim 9, Weinberg 7617, in view of Weinberg 1217, substantially discloses all the limitations of the claimed invention, specifically, Weinberg 7617 discloses wherein the apparatus is configured to collect the image before and after selective modulation of the body part to depict the localization of the electric fields ([0037], [0049] imaging is first performed to establish high uniformity of the magnetic field within the region of interest[before] and after selected modulation, the modules can be re-magnetized by application of current through the electrically conductive components to create a magnetic field in a region of interest that is suitable for imaging[after]), and specifically, Weinberg 1217 discloses wherein the image collection comprises magnetic resonance imaging ([0034], FIG. 6, he method may begin by initiating a pulse-sequence at 610, as is common practice in the MRI field), and wherein the apparatus is configured to collect the image before and after selective modulation of the body part to depict the localization of the electric fields ([0034], FIG. 6, the administering magnetic particles to the patient may follow the initiation of the pulse sequence).
Regarding claim 13, Weinberg 7617, in view of Weinberg 1217, substantially discloses all the limitations of the claimed invention, specifically, Weinberg 7617 discloses wherein the apparatus is configured to collect the image before and after selective modulation of the body part to depict the localization of the electric fields ([0037], [0049] imaging is first performed to establish high uniformity of the magnetic field within the region of interest[before] and after selected modulation, the modules can be re-magnetized by application of current through the electrically conductive components to create a magnetic field in a region of interest that is suitable for imaging[after]), and specifically, Weinberg 1217 discloses wherein the image collection comprises magnetic resonance imaging ([0034], FIG. 6, he method may begin by initiating a pulse-sequence at 610, as is common practice in the MRI field), and wherein the apparatus is configured to collect the image before or after selective modulation of the body part to depict the localization of the electric fields ([0034], FIG. 6, the administering magnetic particles to the patient may follow the initiation of the pulse sequence).
*The limitation has been interpretation in the alternate, requiring the apparatus being configured to collect the image before selective modulation of the body part to depict the localization of the electric fields; the apparatus being configured to collect the image after selective modulation of the body part to depict the localization of the electric fields.
Claim(s) 2, 5, 11-12, 16-17 and are rejected under 35 U.S.C. 103 as being unpatentable over Weinberg 7617, in view of Weinberg 1217 and Borsody, as applied to claims 1 and 10 above, further in view of Simon et al. (US20150165226, hereafter “Simon”).
Regarding claims 2 and 11, Weinberg 7617 substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the controller is configured to induce the electric fields at neural tissue in the body part at a neuronal tissue frequency-dependent threshold for stimulation so that deep sections of the body part may be* stimulated or otherwise modulated to a different degree than other sections of the body part.
*The limitation is interpreted in the alternative, requiring the deep sections of the body part may be stimulated to a different degree than other sections of the body part; or requiring the deep sections of the body part may be otherwise modulated to a different degree than other sections of the body part.
Regarding claim 4, Weinberg 7617 substantially discloses all the limitations of the claimed invention, specifically, Weinberg 7617 discloses wherein the plurality of magnetic modules are positioned around the body part (FIG. 1, see magnetic modules 130 positioned around body part 140), but does not explicitly disclose the body part is the nerve root, heart, inner ear, or gut of an animal.
However, in the same field of endeavor, Simon teaches the body part* is the nerve root of an animal ([0105] the body part includes but is not limited to parasympathetic nerves, sympathetic nerves, spinal or cranial nerves).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the body part being the nerve root of an animal as taught by Simon in order to directly or indirectly stimulate or otherwise modulate nerves that innervate smooth or skeletal muscle, endocrine glands, and organs of the digestive system ([0105] of Simon).
*The limitation has been interpretation in the alternate, requiring the body part is the brain of an animal; or requiring the body part is the nerve root of an animal; or requiring the body part is the heart of an animal; or requiring the body part being inner ear of an animal; or requiring the body part being the gut of an animal.
Regarding claims 5 and 16, Weinberg 7617 substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the electric fields induced in the body part are configured to cause temporary or permanent changes in electrical conduction or conductivity in the body part.
However, in the same field of endeavor, Simon teaches wherein the electric fields induced in the body part are configured to cause* temporary changes in electrical conduction in the body part ([0023] the device can transmit energy to, or in close proximity to, one or more selected nerves to temporarily stimulate, block and/or modulate electrophysiological signals/ electrical conduction in the selected nerves/body part).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the wherein the electric fields induced in the body part are configured to cause temporary changes in electrical conduction in the body part as taught by Simon in order to provide an electrical stimulation signal of ant type desired stimulation to the desired target for the desired length in time ([0063] of Simon).
*The limitation has been interpretation in the alternate, requiring the electric fields induced in the body part are configured to cause temporary changes in electrical conduction in the body part; or requiring the electric fields induced in the body part are configured to cause permanent changes in electrical conduction in the body part; requiring the electric fields induced in the body part are configured to cause temporary changes in electrical conductivity in the body part; or requiring the electric fields induced in the body part are configured to cause permanent changes in electrical conductivity in the body part.
Regarding claim 12, Weinberg 7617 substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the selective actuation results in modulation of an arc or other pathway in the body part.
However, in the same field of endeavor, Simon teaches wherein the selective actuation results in* modulation of another pathway in the body part ([0121] electrical stimulation of the vagus nerve has also been shown to ameliorate postoperative ileus by inhibiting local intestinal inflammation by modulation/activating an anti-inflammatory pathway).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the selective actuation results in modulation of* another pathway** in the body part as taught by Simon in order to provide a magnetic field that induces an electric current at a nerve at the target region within the patient, the electric current being sufficient to modulate the nerve (claim 1 of Simon).
*The limitation has been interpretation in the alternate, requiring the selective actuation results in modulation of an arc in the body part; or requiring the selective actuation results in modulation of another pathway in the body part.
**The term has been interpreted under the broadest reasonable interpretation to mean any type of pathway known in field of neuromodulation.
Regarding claim 17, Weinberg 7617 substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the electric fields are applied to electrically-sensitive tissues at selective locations in the body to temporarily alter properties of electrical conduction or conductivity.
However, in the same field of endeavor, Simon teaches wherein the electric fields are applied to electrically-sensitive tissues at selective locations in the body to temporarily alter properties of electrical* conduction ([0023] the device can transmit energy to, or in close proximity to, one or more selected nerves to temporarily stimulate, block and/or modulate electrophysiological signals/ electrical conduction in the selected nerves/body part).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the electric fields are applied to electrically-sensitive tissues at selective locations in the body to temporarily alter properties of electrical conduction as taught by Simon in order to provide an electrical stimulation signal of ant type desired stimulation to the desired target for the desired length in time ([0063] of Simon).
*The limitation has been interpretation in the alternate, requiring the electric fields are applied to electrically-sensitive tissues at selective locations in the body to temporarily alter properties of electrical conduction; or requiring the electric fields are applied to electrically-sensitive tissues at selective locations in the body to temporarily alter properties of electrical conductivity.
Claim(s) 7-8 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weinberg 7617, in view of Weinberg 1217 and Borsody, as applied to claims 1 and 10 above, further in view of Schneider et al. (US20100185042, hereafter “Schneider”).
Regarding claims 7 and 20, Weinberg 7617 substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the controller is further configured to control successively actuate different combinations of the plurality of magnetic modules in the assembly to rotate the electric fields in space as a function of time.
However, in the same field of endeavor, Schneider teaches wherein the controller is further configured to control successively actuate different combinations of the plurality of magnetic modules in the assembly ([0228] over successive firings, the electromagnetic coils of a TMS array are actuated) to rotate the electric fields in space as a function of time ([0146] the magnetic field is induced as a function of change in electrical current per unit time).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the controller is further configured to control successively actuate different combinations of the plurality of magnetic modules in the assembly to rotate the electric fields in space as a function of time as taught by Schneider in order to provide a means to optimize a therapeutic response to alleviate acute pain ([0266] Schneider).
Regarding claims 8 and 19, Weinberg 7617 substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the apparatus is further configured to implement anesthesia by controlling the controller to induce electric fields to nerves in or near teeth.
However, in the same field of endeavor, Schneider teaches wherein the apparatus is further configured to implement anesthesia by controlling the controller to induce electric fields to nerves in or near teeth ([0266] the patient was treated with TMS as the patient was also being treated for acute pain in conjunction with a dental procedure).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the apparatus and method disclosed by Weinberg 7617 with the apparatus is further configured to implement anesthesia by controlling the controller to induce electric fields to nerves in or near teeth as taught by Schneider in order to provide a means to optimize a therapeutic response to alleviate acute pain ([0266] Schneider).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Weinberg 7617, in view of Weinberg 1217 and Borsody, as applied to claim 10 above, further in view of Weinberg and Stepanov (US20130046169, hereafter “Stepanov”).
Regarding claim 15, Weinberg 7617 substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the electric fields are applied to administered materials at selective locations in the body, and wherein the administered materials are actuated for diagnosis or treatment of diseases.
However, in the same field of endeavor, Stepanov teaches wherein the electric fields are applied to structures administered materials at selective locations in the body (Abstract, direct nanoparticles/ administered materials in a body part under imaging guidance using at least one electromagnet), wherein the administered materials are actuated for* treatment of diseases (TITLE: “Mri-guided nanoparticle cancer therapy apparatus and methodology”).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Weinberg 7617 with the electric fields are applied to administered materials at selective locations in the body, and the administered materials are actuated for diagnosis or treatment of diseases as taught by Stepanov in order to provide methodologies for manipulating Magnetic NanoParticles (MNPs) in the body, as MRI can provide good contrast between the different soft tissues of the body ([0005], [0019] of Stepanov).
*The limitation has been interpretation in the alternate, requiring the administered materials are actuated for diagnosis of diseases; or requiring the administered materials are actuated for treatment of diseases.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798