Prosecution Insights
Last updated: April 19, 2026
Application No. 18/546,826

SYSTEMS AND METHODS FOR EVALUATION OF TRANSCRANIAL MAGNETIC STIMULATION INDUCED ELECTRIC FIELDS

Non-Final OA §101
Filed
Nov 29, 2023
Examiner
LE, JOHN H
Art Unit
2857
Tech Center
2800 — Semiconductors & Electrical Systems
Assignee
The General Hospital Corporation
OA Round
1 (Non-Final)
88%
Grant Probability
Favorable
1-2
OA Rounds
2y 8m
To Grant
95%
With Interview

Examiner Intelligence

Grants 88% — above average
88%
Career Allow Rate
1286 granted / 1464 resolved
+19.8% vs TC avg
Moderate +7% lift
Without
With
+7.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
53 currently pending
Career history
1517
Total Applications
across all art units

Statute-Specific Performance

§101
28.6%
-11.4% vs TC avg
§103
26.2%
-13.8% vs TC avg
§102
20.5%
-19.5% vs TC avg
§112
15.4%
-24.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1464 resolved cases

Office Action

§101
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. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1- 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Step 1: According to the first part of the analysis, in the instant case, claims 1- 1 0 are directed to a system , claim s 1 1 - 20 are directed to a method, and claim 21 is directed to a system . Thus, each of the claims falls within one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). Regarding claim 1 1 : A method for E-field determination for an electromagnetic coil positioned about a subject having one or more conductivity boundaries, the method comprising: (a) retrieving, from a memory: a predetermined electromagnetic coil E-field map; a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; and a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles; (b) receiving, using a processor, a location information of the electromagnetic coil; (c) aligning, using the processor and based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map; (d) determining, using the processor, the incident E-field (E i nc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model; (e) determining, using the processor, basis function coefficients ( m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ and ( g ) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest. Step 2A Prong 1 : “ (a) retrieving, from a memory: a predetermined electromagnetic coil E-field map; a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; and a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles ” is directed to mental step of data gathering. “(b) receiving, using a processor, a location information of the electromagnetic coil” is directed to mental step of data gathering. “ (c) aligning, using the processor and based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map ” is directed to math because aligning a boundary model with an E-field map requires mathematical transformations translations and rotations to align the coordinate systems based on received positioning data. The E-field map is generated using mathematical techniques like the Finite Element Method (FEM) . “ (d) determining, using the processor, the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model ” is directed to math because the electric field is a vector quantity requiring vector field calculations. The “predetermined electromagnetic coil E-field map” and “boundary model” are digital representations, likely generated using numerical techniques such as the Finite Element Method (FEM). Aligning the coil map to the boundary model involves mathematical transformations (rotation and translation matrices) to ensure accurate spatial mapping . “(e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest” is directed to math because this process to applied mathematics, specifically numerical electromagnetics and linear algebra. It involves using a processor to solve for coefficients (m ^ ) in a boundary condition equation that matches a predetermined incident E-field (A inc ) to a coils’s E-field (E inc ) at a specific surface. “ (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ “ is directed to math because calculating an approximation (E d tot ) of the total E-field of the electromagnetic coil is an algorithmic process that maps physical laws into numerical data using mathematical tools. Each limitation recites in the claim is a process that, under BRI covers performance of the limitation in the mind but for the recitation of a generic “ calculation and measurement” which is a mere indication of the field of use. Nothing in the claim elements precludes the steps from practically being performed in the mind. Thus, the claim recites a mental process. Further, the claim recites the step of " (c) aligning, using the processor and based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map; (d) determining, using the processor, the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model; (e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ ” which as drafted, under BRI recites a mathematical calculation. The grouping of "mathematical concepts” in the 2019 PED includes "mathematical calculations" as an exemplar of an abstract idea. 2019 PEG Section |, 84 Fed. Reg. at 52. Thus, the recited limitation falls into the "mathematical concept" grouping of abstract ideas. This limitation also falls into the “mental process” group of abstract ideas, because the recited mathematical calculation is simple enough that it can be practically performed in the human mind, e.g., scientists and engineers have been solving the Arrhenius equation in their minds since it was first proposed in 1889. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. See October Update at Section I(C)(i) and (iii). Additional Elements: Step 2A Prong 2 : “A method for E-field determination for an electromagnetic coil positioned about a subject having one or more conductivity boundaries, the method comprising” recited in the preamble does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(a) retrieving, from a memory: a predetermined electromagnetic coil E-field map; a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; and a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles ” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(b) receiving, using a processor, a location information of the electromagnetic coil” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(c) aligning, using the processor and based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(d) determining, using the processor, the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ “ does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “ (g) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest ” is directed to insignificant activity and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g) . The claim is merely selecting data, manipulating or analyzing the data using math and mental process, and displaying the results. This is similar to electric power : MPEP 2106.05(h) vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A ., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). In contrast, a claim that purports to improve computer capabilities or to improve an existing technology may integrate a judicial exception into a practical application or provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). See MPEP §§ 2106.04(d)(1) and 2106.05(a) for a discussion of improvements to the functioning of a computer or to another technology or technical field. The claim as a whole does not meet any of the following criteria to integrate the judicial exception into a practical application: An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim; an additional element effects a transformation or reduction of a particular article to a different state or thing; and an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Step 2B : “A method for E-field determination for an electromagnetic coil positioned about a subject having one or more conductivity boundaries, the method comprising” recited in the preamble does not amount to significantly more than the judicial exception in the claim . This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(a) retrieving, from a memory: a predetermined electromagnetic coil E-field map; a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; and a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles ” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(b) receiving, using a processor, a location information of the electromagnetic coil” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(c) aligning, using the processor and based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(d) determining, using the processor, the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “(f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ “ does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). “ (g) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest ” is directed to insignificant activity and does not amount to significantly more than the judicial exception in the claim. See MPEP 2106.05(g) and 2106.05(d)(ii), third list, (iv). T he claim is therefore ineligible under 35 USC 101. Claim 1 is similar to claim 1 1 but recites a n E-field determination system for an electromagnetic coil positioned about a subject having one or more conductivity boundaries, the system comprising: a memory configure and a processor communicatively coupled with the memory and configured . These additional elements fail to integrate the abstract idea into a practical application. These limitations are recited at a high level of generality and do not add significantly more to the judicial exception. These elements are generic computing devices that perform generic functions. Using generic computer elements to perform an abstract idea does not integrate an abstract idea into a practical application. See 2019 Guidance, 84 Fed. Reg. at 55. Moreover, “the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.” Alice, 573 U.S. at 223; see also FairWarninglP, LLCv. latric SysInc., 839 F.3d 1089, 1096 (Fed. Cir. 2016) (citation omitted) (“[T]he use of generic computer elements like a microprocessor or user interface do not alone transform an otherwise abstract idea into patent-eligible subject matter”). On the record before us, we are not persuaded that the hardware of claim 1 integrates the abstract idea into a practical application. Nor are we persuaded that the additional elements are anything more than well-understood, routine, and conventional so as to impart subject matter eligibility to claim 1. Claim 2 1 is similar to claim 1 1 but recites a system for positioning an electromagnetic coil about a subject, the system comprising: a memory having stored therein and a processor communicatively coupled with the memory and configured . These additional elements fail to integrate the abstract idea into a practical application. These limitations are recited at a high level of generality and do not add significantly more to the judicial exception. These elements are generic computing devices that perform generic functions. Using generic computer elements to perform an abstract idea does not integrate an abstract idea into a practical application. See 2019 Guidance, 84 Fed. Reg. at 55. Moreover, “the mere recitation of a generic computer cannot transform a patent- ineligible abstract idea into a patent-eligible invention.” Alice, 573 U.S. at 223; see also FairWarninglP, LLCv. latric SysInc., 839 F.3d 1089, 1096 (Fed. Cir. 2016) (citation omitted) (“[T]he use of generic computer elements like a microprocessor or user interface do not alone transform an otherwise abstract idea into patent-eligible subject matter”). On the record before us, we are not persuaded that the hardware of claim 2 1 integrates the abstract idea into a practical application. Nor are we persuaded that the additional elements are anything more than well-understood, routine, and conventional so as to impart subject matter eligibility to claim 2 1. Regarding claims 2 and 12, “ repeating (c) to (f) for changing location information at least five times in a second ” does not integrate the judicial exception into a practical application. It does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)). Regarding claims 3 and 13, “ wherein the predetermined electromagnetic coil E-field map comprises an interpolating function (F inc g ); and determining the incident E-field (E inc ) of the electromagnetic coil at the first conductivity surface of interest using the interpolating function ( F inc g ) on the first surface of interest ” is directed to math . Regarding claims 4 and 14, “ wherein: aligning the predetermined boundary model with the predetermined electromagnetic coil E-field map comprises performing transform TJ1 on the boundary model, wherein: , wherein R c comprises the three-dimensional rotation matrix and T 0 comprises the translation vector from a previous location of the electromagnetic coil to a current location of the electromagnetic coil according to the received location information ” is directed to math. Regarding claims 5 and 15, “ wherein determining the basis function coefficients (n) comprises , wherein λ is a regularization parameter ” is directed to math . Regarding claims 6 and 16 , “ wherein the surface of interest comprises a conductivity boundary ” does not integrate the judicial exception into a practical application. It does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)) . Regarding claims 7 and 17, “ wherein the basis set of magnetic dipoles comprises a plurality of sets of three orthogonal magnetic dipoles located on a second surface around the model of the surface of the first conductivity boundary ” does not integrate the judicial exception into a practical application. It does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)) . Regarding claims 8 and 18, “ wherein the predetermined total E-field at the first surface of interest (A to t ) caused by the basis set of magnetic dipoles comprises the summation of the predetermined incident E-field at the first surface of interest (A inc ) caused by the basis set of magnetic dipoles and a predetermined secondary E-field at the first surface of interest (As) caused by a charge accumulation ” does not integrate the judicial exception into a practical application. It does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)) . Regarding claims 9 and 19 , wherein the predetermined secondary E-field at the first surface of interest (As) is determined according to a Boundary Element Method utilizing Fast Multilevel Multipole (BEM-FMM) ” does not integrate the judicial exception into a practical application. It does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)) . Regarding claims 10 and 20 , “ wherein the MSP comprises:the incident E-field at a plurality of surfaces of interest (A - inc ) caused by the basis set of magnetic dipoles, wherein A - inc is a subset of A inc ; and the total E-field at a plurality of surface of interest (A - tot ) caused by the basis set of magnetic dipoles, wherein A tot is a subset of A - tot “ does not integrate the judicial exception into a practical application. It does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)) . Hence the claims 1- 21 are treated as ineligible subject matter under 35 U.S.C. § 101. Allowable Subject Matter Claim s 1-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action. The following is a statement of reasons for the indication of allowable subject matter: Regarding claim s 1 and 11 , none of the prior art of record teaches or suggests a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles; and (a) receive a location information of the electromagnetic coil; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map;(c) determine the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model ; (d) determine basis function coefficients (m) that match the incident E-field (A inc ) of the basis set of magnetic dipoles to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ ; and (g) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest . It is these limitations as they are claimed in the combination with other limitations of claim, which have not been found, taught or suggested in the prior art of record, that make these claims allowable over the prior art. Regarding claim 21 , none of the prior art of record teaches or suggests a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; a predetermined Magnetic Stimulation Profile (MSP) associated with the subject; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map ; (c) determine an incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model; (d) determine an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface using the MSP and the incident E-field; and (e) generate a report indicating (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest . It is these limitations as they are claimed in the combination with other limitations of claim, which have not been found, taught or suggested in the prior art of record, that make these claims allowable over the prior art. Pascual- Leone ( US 2010/0113959 A1 ) discloses an E-field system for an electromagnetic coil positioned about a subject having one or more conductivity boundaries ([abstract]- a portable transcranial magnetic stimulation (TMS) device...The portable TMS device comprises at least one coil that, when energized, generates electromagnetic energy; para (0062]- the distribution of one or more dielectric properties (e.g., conductivity, permittivity, permeability, etc.) in a portion of the brain to facilitate accurate positioning of one or more TMS coils). the system comprising: a memory configured to store (para (0494]- a computer-readable medium or multiple computer-readable media (e.g., a computer memory. one or more floppy disks, compact disks, optical disks, magnetic tapes, etc.) encoded with one or more programs that, when executed, on one or more computers or other processors, perform methods that implement the various embodiments of the invention discussed above) therein: a predetermined electromagnetic coil E-field map (Fig. 6; para (0087]- In step 610, a dielectric property map of a subject's brain, or portion of the subject's brain is obtained...a dielectric property map may be information that associates brain locations with one or more values of dielectric properties at the corresponding location); a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject (para (0062]- Applicant has developed methods for guiding the placement of coils by considering characteristics of the tissue within the brain...the distribution of one or more dielectric properties (e.g.. conductivity, permittivity, permeability, etc.) in a portion of the brain to facilitate accurate positioning of one or more TMS coils); and a processor communicatively coupled with the memory and configured (para (0494]- a computer-readable medium or multiple computer-readable media (e.g., a computer memory, one or more floppy disks. compact disks, optical disks, magnetic tapes, etc.) encoded with one or more programs that, when executed, on one or more computers or other processors, perform methods that implement the various embodiments of the invention discussed above) to: receive a location information of the electromagnetic coil (para (0061]- identification of the brain area to be targeted as a result of a particular coil placement is often based on a concentric sphere model of the field of distribution of the induced magnetic fields and resulting current fields); and align, based on the received location information (see Fig. 1D; para (0071]- A physician or trained operator may determine the location on the head that the coil should be placed to carry out the intended treatment. The coil may then be fastened into place by engaging one or more (preferably two or more fasteners to prevent rotation) of the fasteners located on the coil and the fasteners located on the skeleton). However, Pascual- Leone does not disclose a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles; and (a) receive a location information of the electromagnetic coil; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map;(c) determine the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model ; (d) determine basis function coefficients (m) that match the incident E-field (A inc ) of the basis set of magnetic dipoles to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ ; and (g) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claims 1 and 11 . Pascual- Leon also does not disclose a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; a predetermined Magnetic Stimulation Profile (MSP) associated with the subject; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map ; (c) determine an incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model; (d) determine an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface using the MSP and the incident E-field; and (e) generate a report indicating (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claim 21. Raij et al. (WO 2019/232125 A1) discloses an E-field determination system for an electromagnetic coil positioned about a subject ([abstract]- A method for generating a transcranial magnetic stimulation (TMS) treatment atlas includes computing (or measuring) an electric field (E-field) intensity induced by TMS of a location of a cortex of each of a plurality of patients), the system comprising: a memory (604) configured to store therein (Fig. 6; para (0074)- The computing device 600 also includes computer-readable medium 604 (e.g., one or more types of non-transitory memory, such as flash memory, magnetic memory, or dynamic random access memory)...The computer-readable medium 604 may be or include a non-transitory computer- readable medium having stored thereon computer executable instructions for carrying out any of the methods described herein): a predetermined electromagnetic coil E-field map (para (0017] Treatment atlases are computed from data of patients that have already received brain stimulation where the following two items were recorded (or can be estimated): the spatial distribution of brain stimulation (i.e., the stimulation intensity for each brain location), and the treatment outcome in each patient; (0018] To create an atlas. such data are taken from several patients. First. the TMS- induced electric field ("E-field") maps showing the distribution of brain stimulation intensities are computed in each individual's brain (FIG. 2 first column)); a processor (602) communicatively coupled with the memory and configured (Fig. 6; para [0074]- The computing device, generally labelled 600, includes a processor 602 (e.g., a microprocessor, a controller, an application- specific integrated circuit ("ASIC"), a field-programmable gate array ("FPGA"), or a system on chip ("SoC")). The computing device 600 also includes computer-readable medium 604 (e.g., one or more types of non-transitory memory, such as flash memory, magnetic memory, or dynamic random access memory)...The computer-readable medium 604 may be or include a non-transitory computer- readable medium having stored thereon computer executable instructions for carrying out any of the methods described herein) to: (a) receive a location information of the electromagnetic coil (para [0052]- It is unknown where in it stimulation should be targeted for best therapeutic efficacy. To address this problem, a brain stimulation treatment atlas (BSTA) for CUD was developed. To do so, data from CUD patients treated with rTMS (N=20, total of 224 rTMS sessions, or 486,797 TMS pulses) aimed at different PFC targets across patients was analyzed, where individual MRls and recordings ofTMS coil locations). However, Raij et al. do not disclose a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles; and (a) receive a location information of the electromagnetic coil; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map;(c) determine the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model ; (d) determine basis function coefficients (m) that match the incident E-field (A inc ) of the basis set of magnetic dipoles to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ ; and (g) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claims 1 and 11 . Raij et al. also do not disclose a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; a predetermined Magnetic Stimulation Profile (MSP) associated with the subject; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map ; (c) determine an incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model; (d) determine an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface using the MSP and the incident E-field; and (e) generate a report indicating (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claim 21. F ox (US 2005/0113630 A1) discloses an E-field determination system for an electromagnetic coil positioned about a subject having one or more conductivity boundaries (para (0015]- algorithms for rapidly modeling the 3-D electric field created in the brain by a TMS coil at any external location; para (0067)- the brain's TMS-induced E field is subject to alterations from biological tissues, as follows. Following the TMS-induced E field, currents flow. At the interfaces of tissues whose conductivities differ), the system comprising: a memory configured to store (para (0124]- It is to be understood that the TMS treatment planning system described herein may be performed using a standard personal computer appropriately programmed, or it may be performed via specialized computers, such as a UNIX workstation or a mainframe computer) therein: a predetermined electromagnetic coil E-field map (Fig. 10, step 440; para (0124]- a 3-D E-field may be modeled for the chosen TMS stimulator design. Further, in an example embodiment, a 3-D induction model may be performed also. The 3-D induction_ model is derived from the scalar product of the E-field and the cortical column direction, and is the net volts/cm estimated for cortical columns); a processor communicatively coupled with the memory and configured (para (0124]- It is to be understood that the TMS treatment planning system described herein may be performed using a standard personal computer appropriately programmed, or it may be performed via specialized computers, such as a UNIX workstation or a mainframe computer) to: (a) receive a location information of the electromagnetic coil (10) (Fig. 1; para (0027]- The position and orientation of the TMS coil-surface relative to the conjoined functional/anatomical model may then be stored for subsequent use; para (0021]- FIG. 1 is a cross-sectional view of a subject's head 5 with a B-shaped coil 10 positioned thereabove); align, based on the received location information (para [0086)- a robot having six or more degrees of freedom may be used to appropriately position and orient the TMS coil in a precise location and orientation for most effective delivery of induced electric field). However, Fox does not disclose a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles; and (a) receive a location information of the electromagnetic coil; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map;(c) determine the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model ; (d) determine basis function coefficients (m) that match the incident E-field (A inc ) of the basis set of magnetic dipoles to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ ; and (g) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claims 1 and 11 . Fox also does not disclose a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; a predetermined Magnetic Stimulation Profile (MSP) associated with the subject; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map ; (c) determine an incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model; (d) determine an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface using the MSP and the incident E-field; and (e) generate a report indicating (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claim 21. Saitoh et al. (US 2018/0071 545 A1) discloses an E-field determination system for an electromagnetic coil positioned about a subject having one or more conductivity boundaries ([abstract]- The magnetic body is provided for flowing a current therein by an induced electric field when the coil is driven, and for increasing the current flowing by the induced electric field in a magnetic stimulation-target region of the brain as compared with that with no magnetic body; para [0185]- The electric conductivity of the brain model 90 was 0.11 (Sim) (this was equivalent to that of the gray matter of the brain)), the system comprising: a predetermined electromagnetic coil (8) E-field map (Fig. 1; para [0121]- induced electric field intensities on a brain model surface were obtained by numerical analysis for each of the combinations of the coils and the magnetic bodies; para [0137)- The magnetic stimulation apparatus 4 includes a coil apparatus 5; para [0138]- The coil apparatus 5 includes a coil 8); (a) receive a location information of the electromagnetic coil (8) (Fig. 1; para [0149]- When the patient is to be treated by using the transcranial magnetic stimulation apparatus 1 having the above configuration, the position of the coil 8 with respect to the head of the patient is obtained based on the images taken by the camera 19); align, based on the received location information (para (0145]- The above described tomographic-image taking apparatus 16, the data receiving part 17, the stereoscopic-image-taking optical three-dimensional-position sensing camera 19, the data receiving part 20, etc. are one implementation aspect used for carrying out positioning of the coil apparatus 5 onto a head irradiation part). However, Saitoh et al. do not disclose a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles; and (a) receive a location information of the electromagnetic coil; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map;(c) determine the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model ; (d) determine basis function coefficients (m) that match the incident E-field (A inc ) of the basis set of magnetic dipoles to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (e) determining, using the processor, basis function coefficients (m ^ ) that match the predetermined incident E-field at the first surface of interest (A inc ) to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (f) determining, using the processor, an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest, wherein: E d tot = A tot m ^ ; and (g) outputting the approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claims 1 and 11 . Saitoh et al. also do not disclose a predetermined boundary model associated with the subject, wherein the boundary model comprises a model of a surface of a first conductivity boundary of the subject; a predetermined Magnetic Stimulation Profile (MSP) associated with the subject; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map ; (c) determine an incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model; (d) determine an approximation (E d tot ) of the total E-field of the electromagnetic coil at the first surface using the MSP and the incident E-field; and (e) generate a report indicating (E d tot ) of the total E-field of the electromagnetic coil at the first surface of interest as cited in claim 21. Pascual-Leone et al. (US 2010/0210894 A1) disclose a system for applying transcranial magnetic stimulation to a subject is disclosed. The system comprises an electromagnetic coil configured to deliver a fluctuating magnetic field to a subject's brain to induce an electric current therein. An interface is configured to position the electromagnetic coil in proximity to the brain of the subject. A controller controls operation of the electromagnetic coil according to an operating protocol. The operating protocol comprises delivering an initial fluctuating magnetic field having an intensity and a duration and delivering a subsequent fluctuating magnetic field after delivering the initial fluctuating magnetic field. At least one of intensity and duration of the subsequent fluctuating magnetic field is greater than the intensity and duration of the initial fluctuating magnetic field . However, Pascual-Leone et al. do not disclose a predetermined Magnetic Stimulation Profile (MSP) associated with the subject, wherein the MSP comprises: the incident E-field at a first surface of interest (A inc ) caused by a basis set of magnetic dipoles; and the total E-field at the first surface of interest (A tot ) caused by the basis set of magnetic dipoles; and (a) receive a location information of the electromagnetic coil; (b) align, based on the received location information, the predetermined boundary model with the predetermined electromagnetic coil E-field map;(c) determine the incident E-field (E inc ) of the electromagnetic coil at the first surface of interest based on the aligned predetermined electromagnetic coil E-field map and predetermined boundary model ; (d) determine basis function coefficients (m) that match the incident E-field (A inc ) of the basis set of magnetic dipoles to the determined incident E-field of the electromagnetic coil (E inc ) at the first surface of interest; (e) determining, using the processor, basi
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Prosecution Timeline

Nov 29, 2023
Application Filed
Mar 02, 2026
Non-Final Rejection — §101 (current)

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