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 Arguments
Applicant's arguments filed on 02/17/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC 101
Regarding the pending 101 rejection, Applicant argues that the human mind is incapable of delivering stimulations to the brain, collecting data related to the excitation from the stimulations, estimating properties based on the collected excitation data, and/or forming a conduction map of the stimulation neighborhood of the brain. Examiner respectfully disagrees as estimating properties and/or forming a conduction map based off of gathered data could be reasonably performed by the human mind using observation, evaluation, and judgement. Delivering the stimulations and collecting the resulting data amounts to nothing more than the pre-solution activity of data gathering (MPEP 2106.05(g)).
Applicant further argues that the recited implanted electrode is not an abstract idea and is instead a specific technical implementation. Examiner respectfully disagrees as the electrode is generally recited and the use of an implantable electrode to deliver stimulation is considered to be well-known, routine, and conventional in the art. For examples see Moffitt et al (US 2015/0134031) [0001], Dinsmoor et al (US 2019/0388693) [0042], and Lee (US 2014/0031908) [0004].
Applicant further argues that the highly specialized computing device for forming conduction maps integrates the abstract idea into a practical application. Examiner respectfully disagrees as the “computing device” comprising “a memory” and “a processor” is very generally recited and amounts to nothing more than a generic computer component. Forming the conduction map based off of the gathered data is part of the abstract idea and as discussed above can be performed by the human mind. Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675 (MPEP 2106.04(a)(2)(III)).
Applicant further argues that the “ability to precisely map neurons based on properties related to excitation is a significant improvement in the fields of brain stimulation treatments”. Examiner respectfully disagrees as the claims omit any details as to how the “computing device” solves a technical problem, and instead recites only the idea of a solution or outcome. Also, the claim invokes a generic computing device comprising a memory and a processor merely as a tool for analyzing gathered data rather than purporting to improve the technology or a computer. See MPEP 2106.05(f). Therefore, the limitation represents no more than mere instructions to apply the judicial exception on a computer. It can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of computers.
Lastly, Applicant argues that the claims set forth a unique mechanism for forming conduction maps with a unique stimulation, conduction, and estimation paradigm that have not been previously known or utilized in the field. Examiner respectfully disagrees and maintains that the generally recited implantable electrode for delivering stimulation and the generally recited computing device used to analyze the resulting data are considered to be well-known, routine, and conventional in the art.
Prior Art Rejections
Applicant argues that Moffitt is silent regarding at least the use of multiple types of stimulation parameters and refractory periods to determine properties of neural elements in a same stimulation neighborhood. Examiner respectfully disagrees and notes that Moffitt discloses the use of multiple types of stimulation parameters to determine properties of neural elements in a same stimulation neighborhood ([0027] using a plurality of neuromodulation settings to responsively map activated tissue regions). Examiner notes that Moffitt is not being relied upon to disclose the use of refractory periods. However, Examiner further notes that as the claim is currently written, the second stimulation is configured to be delivered after the first group of neural elements has entered a refractory period, which could be anytime after an action potential has been sensed as supported by [0029] of the instant disclosure. Therefore, any art that discloses delivering a second stimulus after a first stimulus evoked potential has been sensed would read on delivering a second stimulus after a first group of neural elements has entered a refractory period.
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 1-9 and 11-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of estimating properties of neural constituents and forming conduction maps) without significantly more.
Step 1
The claimed invention in claims 1-9 and 11-25 are directed to statutory subject matter as the claims recite a method/system for estimating properties of neural constituents and forming conduction maps.
Step 2A, Prong One
Regarding claims 1-9 and 11-25, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claims 1 and 20, the limitations of “estimating, by the system, at least one property of constituent elements of the first group of neural elements and at least one property of constituent elements of the second group of neural elements…” and “forming…a conduction map of the stimulation neighborhood….” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation but for the recitation of generic computer components.
Step 2A, Prong Two
For claims 1-9 and 11-25, the judicial exception is not integrated into a practical application. For claims 1 and 20, the additional limitation of “a computing device”, “a memory”, and “a processor” are recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitations of sending stimulation to an electrode to excite a first and second group of neural elements and collecting the data relating to excitation of the first and second neural groups amount to nothing more than the pre-solution activity of data gathering (MPEP 2106.05(g)).
Step 2B
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations sending stimulation and collecting excitation data are directed to nothing more than insignificant extra-solution activities which do not amount to an inventive concept. In addition, “at least one implantable electrode” is recited at a high level of generality and considered to be well known, routine, and conventional in the art. For examples see Moffitt et al (US 2015/0134031) [0001], Dinsmoor et al (US 2019/0388693) [0042], and Lee (US 2014/0031908) [0004].
Dependent claims 7-9, 11, 17, and 21-22 are further directed to the abstract idea and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claims 2-6, 12-16, 18-19, and 23-25 are further directed to extra-solution activities and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9, 11, 13, 16-17, and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al (US 2019/0388692) hereinafter Dinsmoor in view of Moffitt et al (US 2015/0134031) hereinafter Moffitt.
Regarding claim 1, Dinsmoor discloses a method comprising:
configuring, by a system (Fig. 1: system 100) comprising a processor ([0065] processing circuitry 214),
a first stimulation comprising a first parameter set ([0131] Processing circuitry 214 of IMD 200 may control stimulation generator 211 to deliver a control pulse to a patient) to be delivered to a first location in a stimulation neighborhood of a brain to excite a first group of neural elements at the first location in the stimulation neighborhood ([0049] system 100 may be configured to provide therapy taking the form of deep brain stimulation (DBS));
sending, by the system, the first stimulation to at least one implantable electrode positioned at or proximal the stimulation neighborhood ([0132] control pulse 1016 is delivered to the patient via electrode combination 1024),
wherein application of the first stimulation excites the first group of neural elements ([0131] ECAP signal elicited by the control pulse);
after the first stimulation is applied, collecting, by the system, data related to an excitation of the first group of neural elements ([0131] characteristic of the ECAP signal);
configuring, by the system, a second stimulation comprising a second parameter set ([0133] next control pulse), different from the first parameter set, to be delivered to a second location in the stimulation neighborhood of the brain after the first group of neural elements has entered a refractory state from the first stimulation to excite a second group of neural elements at the second location in the stimulation neighborhood of the brain ([0133] preliminary differential value is added to the ECAP pulse amplitude (e.g., the control pulse amplitude) to generate the new, or adjusted, ECAP pulse amplitude that at least partially defines the next control pulse 1016);
sending, by the system, the second stimulation to the at least one implantable electrode positioned at or proximal the stimulation neighborhood ([0132] a control pulse 1016 is delivered to the patient via electrode combination 1024),
wherein application of the second stimulation excites the second group of neural elements ([0132] resulting ECAP is sensed by the two electrodes at the opposing end of the lead of electrode combination 1028; Examiner notes that if the control pulse parameters have been adjusted, this would excite a second group of neural elements);
after the second stimulation is applied, collecting, by the system, data related to an excitation of the second group of neural elements ([1032] or each sensed ECAP, processing circuitry 214 may measure an amplitude of a portion of the ECAP signal); and
estimating, by the system, at least one property of constituent elements of the first group of neural elements and at least one property of constituent elements of the second group of neural elements based on the data related to the excitation of the first group of neural elements and the data related to the excitation of the second group of neural elements ([0147] measured ECAP amplitude varies as the sheep moves because the electrode-to-neuron distance is changing).
Dinsmoor fails to disclose forming, by the system, a conduction map of the stimulation neighborhood of the brain based on the estimates of the at least one property of the constituent elements of the first group of neural elements and the at least one property of the constituent elements of the second group of neural elements, wherein the conduction map contrasts how the first parameter set and the second parameter set interact with the first group of neural elements and the second group of neural elements.
However, Moffitt discloses estimating, by a system, at least one property of constituent elements of a first group of neural elements and at least one property of constituent elements of a second group of neural elements ([0027] neuromodulation effects) based on data related to an excitation of the first group of neural elements and data related to the excitation of a second group of neural elements ([0027] performing a plurality of neuromodulations at a respective plurality of sets of neuromodulation settings; and recording, for each of at least a subset of the neuromodulations, at least one neuromodulation effect occurring at a respective one or more anatomical regions); and
forming, by the system, a conduction map of the stimulation neighborhood of the brain based on the estimates of the at least one property of the constituent elements of the first group of neural elements and the at least one property of the constituent elements of the second group of neural elements ([0027] the one or more anatomical region being responsively mapped by the processor to a respective one or more stimulation regions of tissue),
wherein the conduction map contrasts how the first parameter set and the second parameter set interact with the first group of neural elements and the second group of neural elements ([0027] the one or more anatomical region being responsively mapped by the processor to a respective one or more stimulation regions of tissue estimated by the processor to have been activated by the respective neuromodulation; Examiner notes that for each of at least a subset of the neuromodulations, neuromodulation effects are recorded and anatomical regions are mapped, therefore, if one of the sets of neuromodulation settings activated a different tissue region, it would be mapped after the respective modulation).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with estimating, by the system, at least one property of constituent elements of the first group of neural elements and at least one property of constituent elements of the second group of neural elements based on the data related to the excitation of the first group of neural elements and the data related to the excitation of the second group of neural elements; and forming, by the system, a conduction map of the stimulation neighborhood of the brain based on the estimates of the at least one property of the constituent elements of the first group of neural elements and the at least one property of the constituent elements of the second group of neural elements, wherein the conduction map contrasts how the first parameter set and the second parameter set interact with the first group of neural elements and the second group of neural elements as taught by Moffitt. Such a modification would provide the predictable results of generating a patient-specific mapping that is specific to the patient and that is based on the response information indicating prior responses by the patient to previous neuromodulations (Moffitt, [0024]).
Regarding claim 2, Dinsmoor discloses wherein the first location and the second location are the same location ([0132] a control pulse 1016 is delivered to the patient via electrode combination 1024).
Regarding claim 3, Dinsmoor discloses wherein the first stimulation comprises a single pulse ([0132] a control pulse 1016 is delivered to the patient).
Regarding claim 4, Dinsmoor discloses wherein the second stimulation comprises a single pulse or a pulse doublet ([0133] next control pulse 1016).
Regarding claim 5, Dinsmoor discloses wherein the stimulation neighborhood is proximal to a deep brain stimulation (DBS) lead that delivers the first stimulation and the second stimulation ([0049] system 100 may be configured to provide therapy taking the form of deep brain stimulation; [0059] Electrical stimulation therapy delivery by leads 130 of IMD 110 may cause neurons within the target tissue to evoke a compound action potential that travels up and down the target tissue).
Regarding claim 6, Dinsmoor discloses wherein the DBS lead comprises at least two electrodes, each configured to deliver at least one of the first stimulation and the second stimulation ([0132] electrode combination 1024).
Regarding claim 7, the modified Dinsmoor discloses the method of claim 1 as discussed above, but fails to disclose wherein the estimate of the at least one property of constituents of the first group of neural elements and the at least one property of constituents of the second group of neural elements provide an estimate of different types of neural elements in the stimulation neighborhood. However, Moffitt discloses wherein the estimate of the at least one property of constituents of the first group of neural elements and the at least one property of constituents of the second group of neural elements provide an estimate of different types of neural elements in the stimulation neighborhood ([0064] a computation stimulation model is used to determine an electric field, activation thresholds, and therefore an immediate estimated activation region, and then the tractography model is applied to the computation stimulation model to determine which neural elements are in the immediate estimated activation region).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with the estimate of the at least one property of constituents of the first group of neural elements and the at least one property of constituents of the second group of neural elements provide an estimate of different types of neural elements in the stimulation neighborhood as taught by Moffitt. Such a modification would provide the predictable results of determining outlying sites which would be affected by those neural elements (Moffitt, [0064]).
Regarding claim 8, the modified Dinsmoor discloses the method of claim 7 as discussed above, but fails to disclose wherein the estimate of different types of neural elements is further based on known stimulation response differences of distinct neural elements. However, Moffitt discloses wherein the estimate of different types of neural elements is further based on known stimulation response differences of distinct neural elements ([0064] a computation stimulation model is used to determine an electric field, activation thresholds, and therefore an immediate estimated activation region, and then the tractography model is applied to the computation stimulation model to determine which neural elements are in the immediate estimated activation region).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with the estimate of different types of neural elements is further based on known stimulation response differences of distinct neural elements as taught by Moffitt. Such a modification would provide the predictable results of determining outlying sites which would be affected by those neural elements (Moffitt, [0064]).
Regarding claim 9, the modified Dinsmoor discloses the method of claim 1 as discussed above, but fails to disclose repeating, by the system, each of the steps at another location in the stimulation neighborhood. However, Moffitt discloses repeating, by the system, each of the steps at another location in the stimulation neighborhood ([0027] performing a plurality of neuromodulations at a respective plurality of sets of neuromodulation settings; and recording, for each of at least a subset of the neuromodulations, at least one neuromodulation effect occurring at a respective one or more anatomical regions). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with repeating, by the system, each of the steps at another location in the stimulation neighborhood as taught by Moffitt. Such a modification would provide the predictable results of generating a patient-specific mapping that is specific to the patient and that is based on the response information indicating prior responses by the patient to previous neuromodulations (Moffitt, [0024]).
Regarding claim 11, the modified Dinsmoor discloses the method of claim 9 a discussed above, but fails to disclose estimating, by the system, at least one boundary of a neural structure in the stimulation neighborhood of the brain. However, Moffitt discloses estimating, by the system, at least one boundary of a neural structure in the stimulation neighborhood of the brain ([0019] the system further includes a module for visualizing (and/or outputting a listing of) areas and/or components of the neural system expected to be affected by stimulation at the one or more stimulation sites/ [0064] the system following the extension of such neural elements to determine outlying sites which would be affected by those neural elements).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with estimating, by the system, at least one boundary of a neural structure in the stimulation neighborhood of the brain as taught by Moffitt. Such a modification would yield the predictable results of providing visualization components which help the physician to estimate how stimulation at one site affects other sites (Moffitt, [0064]).
Regarding claim 13, Dinsmoor discloses herein the first stimulation and the second stimulation differ in at least one of a polarity, a field orientation, a pulse width, a frequency, a duty-cycle, an amplitude, a burst property, or a pulse shape due to at least one difference between the first parameter set and the second parameter set ([0133] new, or adjusted, ECAP pulse amplitude that at least partially defines the next control pulse 1016).
Regarding claim 16, Dinsmoor discloses recording the excitation of the first group of neural elements and the second group of neural elements at another location in the stimulation neighborhood remote from or distinct but overlapping the first location and/or the second location ([0132-0133] the resulting ECAP or averaged ECAP amplitudes are subtracted from the target ECAP amplitude to create a differential amplitude which is multiplied by a gain value and added to the control pulse amplitude; Examiner notes that if the control pulse amplitude is increased, then the stimulation would travel deeper through the tissue overlapping with the first group of neural elements, but exciting a second group of neural elements distinct from the first group).
Regarding claim 17, Dinsmoor discloses configuring, by the system, a third stimulation comprising the second parameter set ([0132] control pulse 1016) to be delivered to the stimulation neighborhood of the brain to excite a third group of neural elements in the stimulation neighborhood of the brain ([0132-0133] If the measured ECAP is target ECAP, then there will be no amplitude change in the next control pulse);
sending, by the system, the third stimulation to the at least one electrode positioned at and/or near the stimulation neighborhood of the brain ([0132] control pulse 1016 is delivered to the patient via electrode combination 1024),
wherein application of the third stimulation excites the third group of neural elements ([0131] ECAP signal elicited by the control pulse);
after the third stimulation is applied, collecting, by the system, data related to an excitation of the third group of neural elements ([0131] characteristic of the ECAP signal);
configuring, by the system, a fourth stimulation ([0133] next control pulse) comprising the first parameter set to be delivered to the stimulation neighborhood of the brain after the third group of neural elements has entered a refractory state from the third stimulation to excite a fourth group of neural elements at the stimulation neighborhood of the brain ([0133] preliminary differential value is added to the ECAP pulse amplitude (e.g., the control pulse amplitude) to generate the new, or adjusted, ECAP pulse amplitude that at least partially defines the next control pulse 1016);
sending, by the system, the fourth stimulation to the at least one electrode positioned at and/or near the stimulation neighborhood of the brain ([0132] a control pulse 1016 is delivered to the patient via electrode combination 1024),
wherein application of the fourth stimulation excites the fourth group of neural elements ([0132] resulting ECAP is sensed by the two electrodes at the opposing end of the lead of electrode combination 1028);
after the fourth stimulation is applied, collecting, by the system, data related to an excitation of the fourth group of neural elements ([1032] or each sensed ECAP, processing circuitry 214 may measure an amplitude of a portion of the ECAP signal); and
estimating properties of a response of the first group of neural elements and/or the second group of neural elements based on the data related to the excitation of the third and fourth groups of neural element ([0147] measured ECAP amplitude varies as the sheep moves because the electrode-to-neuron distance is changing).
Regarding claim 19, the modified Dinsmoor discloses the method of claim 1 as discussed above, but fails to disclose wherein the data related to an excitation of the first group of neural elements and/or the data related to an excitation of the second group of neural elements is collected in a different neighborhood than the stimulation neighborhood. However, Moffitt discloses wherein the data related to an excitation of the first group of neural elements and/or the data related to an excitation of the second group of neural elements is collected in a different neighborhood than the stimulation neighborhood ([0063] the stimulation response can be programmed to occur in one or multiple places that can, but need not, coincide with the sensing site(s)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with the data related to an excitation of the first group of neural elements and/or the data related to an excitation of the second group of neural elements is collected in a different neighborhood than the stimulation neighborhood as taught by Moffitt. Such a modification would yield the predictable results of providing visualization components which help the physician to estimate how stimulation at one site affects other sites (Moffitt, [0064]).
Regarding claim 20, Dinsmoor discloses a system (Fig. 1) comprising:
at least one implantable electrode ([0044] one or more electrodes) configured to be implanted in and/or near a stimulation neighborhood of a brain and configured to apply electrical stimulation ([0044] one or more electrodes (not shown) of implantable leads 130); and
a computing device ([0065] IMD 200), coupled to the at least one implantable electrode (Fig. 2A; [0069]),
comprising a memory storing instructions ([0065] memory 215) and a processor ([0065] processing circuitry 214) to execute the instructions to at least:
configure a first stimulation comprising a first parameter set ([0131] Processing circuitry 214 of IMD 200 may control stimulation generator 211 to deliver a control pulse to a patient) to be delivered to a location in the stimulation neighborhood of the brain to excite a first group of neural elements at the location in the stimulation neighborhood of the brain ([0049] system 100 may be configured to provide therapy taking the form of deep brain stimulation (DBS));
send the first stimulation to the at least one implantable electrode to excite the first group of neural elements ([0132] control pulse 1016 is delivered to the patient via electrode combination 1024);
after the first stimulation is applied, collect data related to an excitation of the first group of neural elements ([0131] characteristic of the ECAP signal);
configure a second stimulation comprising a second parameter set to be delivered to the location in the stimulation neighborhood of the brain after the first group of neural elements has entered a refractory state from the first stimulation to excite a second group of neural elements at the location in the stimulation neighborhood of the brain;
send the second stimulation ([0133] next control pulse 1016) to the at least one implantable electrode to excite the second group of neural elements ([0132] a control pulse 1016 is delivered to the patient via electrode combination 1024);
after the second stimulation is applied, collect data related to an excitation of the second group of neural elements ([1032] or each sensed ECAP, processing circuitry 214 may measure an amplitude of a portion of the ECAP signal);
estimate properties of constituent elements of the first group of neural elements and at least one property constituent elements of the second group of neural elements based on the data related to the excitation of the first group of neural elements and the data related to the excitation of the second group of neural elements ([0147] measured ECAP amplitude varies as the sheep moves because the electrode-to-neuron distance is changing).
Dinsmoor fails to disclose a memory storing instructions and a processor to execute the instructions to at least form a conduction map of the stimulation neighborhood of the brain based on the estimates of the at least one property of the constituent elements of the first group of neural elements and the at least one property of the constituent elements of the second group of neural elements, wherein the conduction map contrasts how the first parameter set and the second parameter set interact with the first group of neural elements and the second group of neural elements.
However, Moffitt discloses estimating, by a system, at least one property of constituent elements of a first group of neural elements and at least one property of constituent elements of a second group of neural elements ([0027] neuromodulation effects) based on data related to an excitation of the first group of neural elements and data related to the excitation of a second group of neural elements ([0027] performing a plurality of neuromodulations at a respective plurality of sets of neuromodulation settings; and recording, for each of at least a subset of the neuromodulations, at least one neuromodulation effect occurring at a respective one or more anatomical regions); and
forming, by the system, a conduction map of the stimulation neighborhood of the brain based on the estimates of the at least one property of the constituent elements of the first group of neural elements and the at least one property of the constituent elements of the second group of neural elements ([0027] the one or more anatomical region being responsively mapped by the processor to a respective one or more stimulation regions of tissue),
wherein the conduction map contrasts how the first parameter set and the second parameter set interact with the first group of neural elements and the second group of neural elements ([0027] the one or more anatomical region being responsively mapped by the processor to a respective one or more stimulation regions of tissue estimated by the processor to have been activated by the respective neuromodulation; Examiner notes that for each of at least a subset of the neuromodulations, neuromodulation effects are recorded and anatomical regions are mapped, therefore, if one of the sets of neuromodulation settings activated a different tissue region, it would be mapped after the respective modulation).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor to estimate properties of constituent elements of the first group of neural elements and at least one property constituent elements of the second group of neural elements based on the data related to the excitation of the first group of neural elements and the data related to the excitation of the second group of neural elements; and form a conduction map of the stimulation neighborhood of the brain based on the estimates of the at least one property of the constituent elements of the first group of neural elements and the at least one property of the constituent elements of the second group of neural elements, wherein the conduction map contrasts how the first parameter set and the second parameter set interact with the first group of neural elements and the second group of neural elements as taught by Moffitt. Such a modification would provide the predictable results of generating a patient-specific mapping that is specific to the patient and that is based on the response information indicating prior responses by the patient to previous neuromodulations (Moffitt, [0024]).
Regarding claim 21, the modified Dinsmoor discloses the system of claim 20 as discussed above, but fails to disclose wherein the processor executes the instructions to define the location, wherein the location extends for a distance around the at least one implantable electrode. However, Moffitt discloses wherein the processor executes the instructions to define the location, wherein the location extends for a distance around the at least one implantable electrode ([0064] determine which neural elements are in the immediate estimated activation region, the system following the extension of such neural elements to determine outlying sites which would be affected by those neural elements).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with the processor executes the instructions to define the location, wherein the location extends for a distance around the at least one implantable electrode as taught by Moffitt. Such a modification would yield the predictable results of providing visualization components which help the physician to estimate how stimulation at one site affects other sites (Moffitt, [0064]).
Regarding claim 22, the modified Dinsmoor discloses the system of claim 20 as discussed above, but fails to disclose wherein the processor executes the instructions to provide information about the location automatically. However Moffitt discloses wherein the processor executes the instructions to provide information about the location automatically ([0064] the system provides visualization components which help the physician to estimate how stimulation at one site affects other sites; the system following the extension of such neural elements to determine outlying sites which would be affected by those neural elements).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with the processor executes the instructions to provide information about the location automatically as taught by Moffitt. Such a modification would yield the predictable results of providing visualization components which help the physician to estimate how stimulation at one site affects other sites (Moffitt, [0064]).
Regarding claim 23, Dinsmoor discloses wherein the processor executes the instructions to modify the first stimulation and/or the second stimulation based on the data related to the excitation of the first group of neural elements and/or the data related to the excitation of the second group of neural elements ([0132-0133] the resulting ECAP or averaged ECAP amplitudes are subtracted from the target ECAP amplitude to create a differential amplitude which is multiplied by a gain value and added to the next control pulse amplitude).
Regarding claim 24, Dinsmoor discloses wherein the at least one implantable electrode comprises a deep brain stimulation (DBS) lead ([0069] leads 230) that delivers the first stimulation and the second stimulation ([0049] system 100 may be configured to provide therapy taking the form of deep brain stimulation (DBS)).
Regarding claim 25, Dinsmoor discloses wherein the DBS lead comprises at least two electrodes, each configured to deliver at least one of the first stimulation and the second stimulation ([0069] electrodes 232and 234; [0132] a control pulse 1016 is delivered to the patient via electrode combination 1024).
Claim(s) 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 2019/0388692) in view of Moffitt (US 2015/0134031) and further in view of Gliner (US 2003/0074032).
Regarding claim 12, the modified Dinsmoor discloses the method of claim 9 as discussed above, but fails to disclose wherein before the repeating, an amount of time elapses so that the first group of neural elements and the second group of neural elements return to a baseline neural activity level. However, Gliner discloses wherein before the repeating, an amount of time elapses so that the first group of neural elements and the second group of neural elements return to a baseline neural activity level ([0047] The time query 534 may provide a quiescent period during which the patient's neural activity becomes predominantly normal and/or representative of an acceptable baseline condition. If a minimum time interval has not elapsed, the process 500 remains at the time query 534; otherwise, the process 500 returns to the stimulation operation 502).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with before the repeating, an amount of time elapses so that the first group of neural elements and the second group of neural elements return to a baseline neural activity level as taught by Gliner. Such a modification would yield the predictable results of allowing the patient’s neural activity to return to an acceptable baseline condition (Gliner, [0047]).
Regarding claim 18, the modified Dinsmoor discloses the method of claim 17 as discussed above, but fails to disclose wherein the first and second groups of neural elements have returned to a baseline neural activity level before the third stimulation is delivered. However, Gliner discloses wherein the first and second groups of neural elements have returned to a baseline neural activity level before the third stimulation is delivered ([0047] The time query 534 may provide a quiescent period during which the patient's neural activity becomes predominantly normal and/or representative of an acceptable baseline condition. If a minimum time interval has not elapsed, the process 500 remains at the time query 534; otherwise, the process 500 returns to the stimulation operation 502).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with the first and second groups of neural elements have returned to a baseline neural activity level before the third stimulation is delivered as taught by Gliner. Such a modification would yield the predictable results of allowing the patient’s neural activity to return to an acceptable baseline condition (Gliner, [0047]).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 2019/0388692) in view of Moffitt (US 2015/0134031) and further in view of Dinsmoor et al (US 2022/0062638) hereinafter Dinsmoor2.
Regarding claim 14, the modified Dinsmoor discloses the method of claim 1 as discussed above, but fails to disclose wherein the first parameter set establishes a cathodic or anodic polarity for the first stimulation and the second parameter set establishes the opposite polarity for the second stimulation. However, Dinsmoor2 discloses the first parameter set establishes a cathodic or anodic polarity for the first stimulation and the second parameter set establishes the opposite polarity for the second stimulation ([0016] alternating polarity stimulus use a combination of electrodes, where one electrode is a cathode and the other electrode is an anode for a first stimulus (sometimes referred to as the “‘A’ Pulse”) and where the polarity of the two electrodes are switched for a second stimulus (sometimes referred to as the “‘B’ Pulse”)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with the first parameter set establishes a cathodic or anodic polarity for the first stimulation and the second parameter set establishes the opposite polarity for the second stimulation as taught by Dinsmoor2. Such a modification would yield the predictable results of canceling stimulation artifacts and/or improving signal amplitude (Dinsmoor2, [0016]).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 2019/0388692) in view of Moffitt (US 2015/0134031) and further in view of Parker et al (US 2021/0379386) hereinafter Parker.
Regarding claim 15, the modified Dinsmoor discloses the method of claim 1 as discussed above, but fails to disclose wherein the refractory state occurs during an absolute refractory period. However, Parker discloses wherein the refractory state occurs during an absolute refractory period ([0086] Both the first interphase gap and the second interphase gap should be maintained within the absolute refractory period). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with the refractory state occurs during an absolute refractory period as taught by Parker. Such a modification would yield the predictable results of avoiding overshoot in order to provide control over how rapidly the system responds to detected second cathode stimulation (Parker, [0086]).
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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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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