DETAILED ACTION
Applicant' s arguments, filed 06/03/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/06/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the current claims hereby under examination.
All references to Applicant’s Specification are made using the paragraph numbers assigned in the US publication of the present application (US 2023/0114613 A1).
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1 recites “a parameter adjuster configured to …” which is a generic placeholder coupled with functional language. However, the following limitations recite the necessary acts to entirely perform the recited function (that is the acts of delivering stimulation using a plurality of evoking and recording configurations and selecting those configurations which include the target response as the suitable evoking-recording configurations) and thus the limitation is not being interpreted under 35 USC 112(f).
It is noted that the various “circuitry” and “controller” components of claim 1 are not being interpreted under 112(f) as per MPEP 2181 (I)(A) which recites:
“The following are examples of structural terms that have been found not to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: "circuit," "detent mechanism," "digital detector," "reciprocating member," "connector assembly," "perforation," "sealingly connected joints," and "eyeglass hanger member." See Mass. Inst. of Tech., 462 F.3d at 1355-1356, 80 USPQ2d at 1332 (the court found the recitation of "aesthetic correction circuitry" sufficient to avoid pre-AIA 35 U.S.C. 112, paragraph 6, treatment because the term circuit, combined with a description of the function of the circuit, connoted sufficient structure to one of ordinary skill in the art.)”
Claim Objections
Claims 1, 11, and 20 are objected to because of the following informalities:
Claim 1 lines 26-27 it appears that “the difference recording configurations” should read “the different recording configurations”
Claim 11 line 15 it appears that “a sequence of text evoking-recording parameter sets” should read “the sequence of text evoking-recording parameter sets”
Claim 11 line 23 it appears that “the difference recording configurations” should read “the different recording configurations”
Claim 20 line 16 it appears that “a sequence of text evoking-recording parameter sets” should read “the sequence of text evoking-recording parameter sets”
Claim 20 line 24 it appears that “the difference recording configurations” should read “the different recording configurations”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 11, and 20 each recite “wherein the different evoking configurations and the difference recording configurations are each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes and spatially and temporally arranged in the sequence of test evoking-recording parameter sets to limit a time of the evaluating the sequence of test evoking-recording parameter sets” but it is unclear what this limitation is meant to convey. It would seem that each evoking configuration is associated with a respective recording configuration and thus the evoking/recording configurations are inherently a subset of all possible electrode configurations because no single evoking or recording configuration can include all the electrodes since that would not permit a corresponding recording/evoking configuration. It is unclear how the limitation “each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes” is intended to be interpreted. Additionally, it is unclear what “spatially” arranging the evoking and recording parameter sets entails since these parameter sets are not physical items which can be arranged in a space. The limitation and what it is intended to convey is unclear. For the purposes of this examination, the limitation is interpreted as the evoking-recording parameter sets being tested are a subset of all possible evoking-recording parameter sets and that the evoking-recording parameter sets are testing in an order that reduces the time required to perform the testing.
Claims 2-10 are rejected by virtue of their dependence on claim 1.
Claims 12-19 are rejected by virtue of their dependence on claim 11.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-9, 11, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker, and further in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson.
Regarding claim 1, Carcieri discloses a system for delivering neurostimulation to a patient using a plurality of electrodes (Abstract), comprising:
a stimulation output circuit configured to deliver the neurostimulation to evoke responses from the patient using an evoking configuration defining a stimulation electrode set including electrodes selected from the plurality of electrodes (Paragraphs 0047-0048: the stimulation output circuitry outputs stimulation pulses to the electrical terminals which correspond to the electrodes. The evoking configuration defining a stimulation electrode set includes the electrodes used to stimulate the patient ; Paragraph 0040: the stimulation parameters can include various electrode combinations and configurations);
a sensing input circuit configured to sense one or more signals including the evoked responses using a recording configuration defining a sensing electrode set including electrodes selected from the plurality of electrodes (Paragraphs 0049-0050: the monitoring circuitry monitors the therapeutic feedback using one or more sensors which may include the electrodes which can measure the evoked action potentials); and
a control circuit (Paragraph 0050: processing circuitry) including:
a stimulation controller configured to control the delivery of the neurostimulation using stimulation parameters including the evoking configuration (Paragraphs 0047-0050: the control logic and stimulation output circuitry control the parameters of the stimulation pulse; Paragraph 0040: the stimulation parameters can also include which electrodes are selected to stimulate);
a sensing controller configured to control the sensing of the evoked responses using sensing parameters including the recording configuration (Paragraphs 0049-0050: the monitoring circuitry monitors the therapeutic feedback using one or more sensors which may include the electrodes which can measure the evoked action potentials; Paragraph 0064: The stimulating electrodes or electrodes near the target tissue site may be utilized to record the evoked potential); and
a parameter adjuster configured to determine one or more suitable evoking-recording parameter sets by evaluating a sequence of test evoking-recording parameter sets, the evaluating including delivering the neurostimulation and sensing the one or more signals according to the sequence of test evoking-recording parameter sets, and selecting the one or more suitable evoking-recording parameter sets from the sequence of test evoking-recording parameter sets, the one or more suitable evoking-recording parameter sets each including a set of the stimulation parameters allowing the evoked response to include a target response by controlling the stimulation output circuit to deliver the neurostimulation and a set of the sensing parameters allowing the target response to be recorded using the sensed signals by controlling the sensing input circuit, the sequence of test evoking-recording parameter sets including different evoking configurations (Paragraphs 0067-0074: automatic stimulation parameters adjustment may be carried out in order to match the recorded evoked potential to the desired evoked potential. Any of the parameter sets that evoke the desired action potential, or evoked potential are considered “suitable” The system may alter various parameters of the stimulation pulse including the electrodes selected to deliver the pulse, or evoking configurations. Each iteration of stimulation parameters are considered “test” parameter sets, the parameter sets that evoke the desired action potential are considered “suitable” parameter sets. Paragraphs 0064: different electrodes can be used for recording such as the stimulating electrode or electrodes near the targeted tissue. There may be dedicated recording electrodes or the electrodes located on the already implanted leads may be utilized. Thus, Carcieri seems to at least suggest the selection of recording electrodes which are most appropriate to the location of the desired therapeutic effect).
Carcieri fails to explicitly disclose the system wherein, the sequence of test evoking-recording parameter sets including different recording configurations and wherein the different evoking configurations and the difference recording configurations are each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes and spatially and temporally arranged in the sequence of test evoking-recording parameter sets to limit a time of the evaluating the sequence of test evoking-recording parameter sets.
Parker teaches an automated assessment of neural response recordings involving storing a set of basis functions comprising at least one compound action potential basis function and at least one artefact basis function. Neural recordings of electrical activity in neural tissue are obtained by application of stimuli, using a single configuration of stimulation and recording. Each neural recording is decomposed by determining at least one parameter which estimates at least one of a compound action potential and an artefact. The at least one parameter is/are determined for each respective one of the plurality of neural recordings, to yield a plurality of values. A spread of the plurality of values is determined. An indication that the neural response recordings are of higher quality is output if the spread is small. An indication that the neural response recordings are of lower quality is output if the spread is large (Abstract). Thus,. Parker falls within the same field of endeavor as Applicant’s invention.
Parker teaches a system where each possible combination of evoking configurations is tested with each possible combination of recording configuration. The various combinations of evoking and recording configurations are assessed to determine an evoked compound action potential (ECAP) quality score. The system may update the evoking and/or recording configuration to obtain an optimal ECAP score (Paragraph 0026). The ECAP score may be determined by comparing two or more recordings and normalizing the determined scores between the obtained recordings (Paragraphs 0032-0034 and 0036-0038). The score for each ECAP may be determined using signal quality indicators including signal-to-artifact (SNA) and signal-to-noise ratios (SNR) (Paragraphs 0124-0125, 0128-0132, and 0149).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the testing of all possible evoking and recording configurations as taught by Parker into the system of Carcieri because such a selection capability would allow the system of Carcieri to select not only select the most desirable stimulating electrodes, but also the most desirable sensing electrodes for each stimulation configuration based on the quality score of the recorded response. Implementing the testing of all evoking and recording configurations as taught by Parker would allow the system of modified Carcieri to select the most optimal evoking and sensing arrangement for each stimulation depending on what type of measurement is most desirable.
Carcieri in view of Parker fails to further teach the system wherein the different evoking configurations and the difference recording configurations are each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes and spatially and temporally arranged in the sequence of test evoking-recording parameter sets to limit a time of the evaluating the sequence of test evoking-recording parameter sets.
Torgerson teaches one or more efficacious electrode combinations for delivering electrical stimulation therapy to a patient may be selected based on the delivery of electrical stimulation to the patient via a predefined set of test electrode combinations in a predetermined order (Abstract). Thus, Torgerson falls within the same field of endeavor as Applicant’s invention.
Torgerson teaches that testing all possible combinations of electrode sets is time consuming (Col 7 lines 33-51). Thus it is desirable to test a predefined combination of electrode sets in a predefined order in order to save time in identifying a suitable electrode set for evoking a desired response (Col 8 lines 9-61). Torgerson further teaches that the predefined electrode sets may be tested in a particular order in order to reduce the time required to can through the predefined electrode sets. The order may be include ordering the electrode sets by ensuring that at least one shared anode or cathode is present between adjacent electrode sets to increase the speed of testing (Col 9 lines 13-34). The predefined set of electrode combinations may be determined a number of ways such as being set by the manufacturer, patterns that are potentially effective for a particular patient condition, patterns determined by a clinician, and other selection methods (Col 10 line 43 – Col 11 line 9).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the testing of only predetermined electrode sets and testing the sets in a particular order as taught by Torgerson into the system of Carcieri in view of Parker because Torgerson teaches that testing every possible combination of electrode sets is time consuming (Col 7 lines 33-51), and testing only the predetermined electrode sets in a predetermined order improves the speed and efficiency in determining a suitable electrode combination (Col 9 lines 13-34).
All dependent claims are rejected with the understanding that Carcieri in view of Parker further in view of Torgerson as presented above teaches that the selection of different evoking configurations of Carcieri further includes the selection of different recording parameters as taught by Parker and that testing involves testing a subset of evoking and recording configurations in a particular order as taught by Torgerson.
Regarding claim 6, Carcieri in view of Parker further in view of Torgerson teaches the system of claim 1. Modified Carcieri further teaches the system wherein the stimulation output circuit is configured to deliver pulses of the neurostimulation, and the stimulation controller is configured to control the delivery of the pulses using the stimulation parameters including the evoking configuration and waveform parameters defining waveform of the pulses (Paragraphs 0040 and 0067: the stimulation adjustment includes pulse rate, width, amplitude, and duty cycle; the stimulation parameters further includes electrode combinations).
Regarding claim 7, Carcieri in view of Parker further in view of Torgerson teaches the system of claim 1. Modified Carcieri further teaches the system, wherein the parameter adjuster is configured to select an optimal evoking-recording parameter set from the one or more suitable evoking-recording parameter sets based on a maximum value of a parameter of the recorded target response resulting from a specified intensity of the neurostimulation or a minimum intensity of the neurostimulation resulting in a value of the parameter of the recorded target response exceeding a specified threshold (Paragraph 0066-0068: the “suitable” stimulation settings are the stimulation settings that results in the desired evoked potential; Paragraphs 0070-0075: the system may continue to optimize stimulation settings after a desired template match is achieved in order to reduce power consumption. Thus, the “optimal” evoking-recording parameter set is the parameter set which evoked the target response and has the lowest power requirement).
Regarding claim 8, Carcieri in view of Parker in view of Torgerson teaches the system of claim 1. Modified Carcieri further teaches that the system may include a reference database for assisting the stimulation parameter adjustment (Paragraph 0067).
Modified Carcieri fails to further teach the system wherein the parameter adjuster is configured to reduce a number of the evoking-recording parameter sets in the sequence of evoking-recording parameter sets using prior information including information about the patient obtained prior to the evaluating the sequence of test evoking-recording parameter sets.
Torgerson teaches system wherein the parameter adjuster is configured to reduce a number of the evoking-recording parameter sets in the sequence of evoking-recording parameter sets using prior information including information about the patient obtained prior to the evaluating the sequence of test evoking-recording parameter sets (Col 10 lines 43-56: the predetermined group of electrode sets may be determined by a clinician based on what is effective for a particular patient condition or one or more symptoms based on historical data)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the selection of a subset of electrode configurations to test based on historical data and information about the patient such as symptoms, conditions, and user experiences as taught by Torgerson into the system of modified Carcieri because selecting electrode sets based on patient data may allow the system to determine suitable electrode configurations faster by reducing the number of sets to be tested based on what sets are predicted to be effective and what sets are not predicted to be effective.
Regarding claim 9, Carcieri in view of Parker in view of Torgerson teaches the system of claim 8. Modified Carcieri further discloses the system, wherein the parameter adjuster is configured to reduce a number of changes in the recording configuration in the sequence of test evoking-recording parameter sets (Paragraphs 0077 and 0081: the adjustment step sizes can be increased or decreased based on the desired resolution of matching and may be dynamically adjusted to allow for “quick adjustment” where larger changes can be made quickly to better match the desired evoked action potential)
Modified Carcieri fails to further disclose the reduction in a number of changes is accomplished by arranging the test evoking-recording parameter sets for evaluating all of the test evoking-recording parameter sets sharing one recording configuration before evaluating all of the test evoking-recording parameter sets having a different recording configuration.
An obvious variation of modified Carcieri would be to arrange the test evoking-recording parameter sets for evaluating all of the test evoking-recording parameter sets sharing one recording configuration before evaluating all of the test evoking-recording parameter sets having a different recording configuration. Such a variation would be obvious because Torgerson teaches that it is desirable to order the testing of electrode configurations such that they share at least one electrode in common with the adjacent configurations in order to reduce the time required to perform the testing (Col 9 lines 13-45) and thus Torgerson teaches that it is desirable to order the tested electrode sets according to shared electrode usage. An obvious variation of this ordering would be to order the electrode sets such that all configurations sharing one recording configuration are tested before testing the evoking configurations on a different recording configuration. Such a variation is obvious because the specific order of testing is considered to be a matter of routine optimization and experimentation that does not produce a surprising technical effect. Torgerson teaches that it is advantageous to order the electrode configurations such that they share at least one electrode to reduce the time taken to perform the testing (Col 9 lines 13-45). Thus, altering the particular order in which the electrode sets are tested is considered a matter of routine optimization and experimentation that is adjusted according to the particular electrode sets being tested, the patient requirements, and the clinician’s judgment. It is known from the teachings of Torgerson that specific order may allow for faster testing so an increase in testing speed for a particular order is not considered a surprising technical effect.
Regarding claim 11, Carcieri discloses a method for delivering neurostimulation to a patient using a plurality of electrodes (Abstract), comprising:
delivering the neurostimulation to evoke responses from the patient using a stimulation output circuit and an evoking configuration defining a stimulation electrode set including electrodes selected from the plurality of electrodes (Paragraphs 0047-0048: the stimulation output circuitry outputs stimulation pulses to the electrical terminals which correspond to the electrodes. The evoking configuration defining a stimulation electrode set includes the electrodes used to stimulate the patient ; Paragraph 0040: the stimulation parameters can include various electrode combinations and configurations);
sensing one or more signals including the evoked responses using a sensing input circuit and a recording configuration defining a sensing electrode set including electrodes selected from the plurality of electrodes (Paragraphs 0049-0050: the monitoring circuitry monitors the therapeutic feedback using one or more sensors which may include the electrodes which can measure the evoked action potentials);
controlling the delivery of the neurostimulation using stimulation parameters including the evoking configuration (Paragraphs 0047-0050: the control logic and stimulation output circuitry control the parameters of the stimulation pulse; Paragraph 0040: the stimulation parameters can also include which electrodes are selected to stimulate);
controlling the sensing of the one or more signals including the evoked responses using sensing parameters including the recording configuration (Paragraphs 0049-0050: the monitoring circuitry monitors the therapeutic feedback using one or more sensors which may include the electrodes which can measure the evoked action potentials; Paragraph 0064: The stimulating electrodes or electrodes near the target tissue site may be utilized to record the evoked potential); and
determining one or more suitable evoking-recording parameter sets by evaluating a sequence of test evoking-recording parameter sets, the evaluating including delivering the neurostimulation and sensing the one or more signals according to a sequence of test evoking-recording parameter sets, and selecting the one or more suitable evoking-recording parameter sets from the sequence of test evoking-recording parameter sets, the one or more suitable evoking-recording parameter sets each including a set of the stimulation parameters allowing the evoked responses to include a target response by controlling the delivery of the neurostimulation and a set of the sensing parameters allowing the target response to be recorded using the sensed one or more signals by controlling the sensing of the one or more signals, the sequence of test evoking-recording parameter sets including different evoking configurations (Paragraphs 0067-0074: automatic stimulation parameters adjustment may be carried out in order to match the recorded evoked potential to the desired evoked potential. Any of the parameter sets that evoke the desired action potential, or evoked potential are considered “suitable” The system may alter various parameters of the stimulation pulse including the electrodes selected to deliver the pulse, or evoking configurations. Each iteration of stimulation parameters are considered “test” parameter sets, the parameter sets that evoke the desired action potential are considered “suitable” parameter sets. Paragraphs 0064: different electrodes can be used for recording such as the stimulating electrode or electrodes near the targeted tissue. There may be dedicated recording electrodes or the electrodes located on the already implanted leads may be utilized. Thus, Carcieri seems to at least suggest the selection of recording electrodes which are most appropriate to the location of the desired therapeutic effect).
Carcieri fails to explicitly disclose the method wherein, the sequence of test evoking-recording parameter sets including different recording configurations and wherein the different evoking configurations and the difference recording configurations are each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes and spatially and temporally arranged in the sequence of test evoking-recording parameter sets to limit a time of the evaluating the sequence of test evoking-recording parameter sets.
Parker teaches a system where each possible combination of evoking configurations is tested with each possible combination of recording configuration. The various combinations of evoking and recording configurations are assessed to determine an evoked compound action potential (ECAP) quality score. The system may update the evoking and/or recording configuration to obtain an optimal ECAP score (Paragraph 0026). The ECAP score may be determined by comparing two or more recordings and normalizing the determined scores between the obtained recordings (Paragraphs 0032-0034 and 0036-0038). The score for each ECAP may be determined using signal quality indicators including signal-to-artifact (SNA) and signal-to-noise ratios (SNR) (Paragraphs 0124-0125, 0128-0132, and 0149).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the testing of all possible evoking and recording configurations as taught by Parker into the method of Carcieri because such a selection capability would allow the method of Carcieri to select not only select the most desirable stimulating electrodes, but also the most desirable sensing electrodes for each stimulation configuration based on the quality score of the recorded response. Implementing the testing of all evoking and recording configurations as taught by Parker would allow the system of modified Carcieri to select the most optimal evoking and sensing arrangement for each stimulation depending on what type of measurement is most desirable.
Carcieri in view of Parker fails to further teach the system wherein the different evoking configurations and the difference recording configurations are each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes and spatially and temporally arranged in the sequence of test evoking-recording parameter sets to limit a time of the evaluating the sequence of test evoking-recording parameter sets.
Torgerson teaches that testing all possible combinations of electrode sets is time consuming (Col 7 lines 33-51). Thus it is desirable to test a predefined combination of electrode sets in a predefined order in order to save time in identifying a suitable electrode set for evoking a desired response (Col 8 lines 9-61). Torgerson further teaches that the predefined electrode sets may be tested in a particular order in order to reduce the time required to can through the predefined electrode sets. The order may be include ordering the electrode sets by ensuring that at least one shared anode or cathode is present between adjacent electrode sets to increase the speed of testing (Col 9 lines 13-34). The predefined set of electrode combinations may be determined a number of ways such as being set by the manufacturer, patterns that are potentially effective for a particular patient condition, patterns determined by a clinician, and other selection methods (Col 10 line 43 – Col 11 line 9).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the testing of only predetermined electrode sets and testing the sets in a particular order as taught by Torgerson into the method of Carcieri in view of Parker because Torgerson teaches that testing every possible combination of electrode sets is time consuming (Col 7 lines 33-51), and testing only the predetermined electrode sets in a predetermined order improves the speed and efficiency in determining a suitable electrode combination (Col 9 lines 13-34).
All dependent claims are rejected with the understanding that Carcieri in view of Parker further in view of Torgerson as presented above teaches that the selection of different evoking configurations of Carcieri further includes the selection of different recording parameters as taught by Parker and that testing involves testing a subset of evoking and recording configurations in a particular order as taught by Torgerson.
Regarding claim 17, Carcieri in view of Parker further in view of Torgerson teaches the method of claim 11. Modified Carcieri further teaches the method further comprising selecting an optimal evoking-recording parameter set for evoking and recording the target response from the one or more suitable evoking-recording parameter set based on a maximum value of a parameter of the recorded target response resulting from a specified intensity of the neurostimulation or a minimum intensity of the neurostimulation resulting in a value of the parameter of the recorded target response exceeding a specified threshold (Paragraph 0066-0068: the “suitable” stimulation settings are the stimulation settings that results in the desired evoked potential; Paragraphs 0070-0075: the system may continue to optimize stimulation settings after a desired template match is achieved in order to reduce power consumption. Thus, the “optimal” stimulation parameter set is the parameter set which evokes the desired response and has the lowest power requirement)
Regarding claim 18, Carcieri in view of Parker further in view of Torgerson teaches the method of claim 11. Modified Carcieri further teaches the method wherein the one or more suitable evoking-recording parameter sets each define a stimulation electrode set allowing the target response to be evoked by delivering the neurostimulation, a sensing electrode set allowing the target response to be recorded, and a stimulation waveform allowing the target response to be evoked by delivering the neurostimulation (Paragraphs 0066-0073: the automatic adjustment process evaluates a sequence of stimulation parameters to determine which stimulation parameters generate the desired evoked potentials; Paragraphs 0074-0076: the optimization of the stimulation parameter. It is noted that the “suitable” stimulation parameters found by Carcieri implicitly include a stimulation and sensing electrode set which are suitable for carrying out their function and a stimulation waveform for evoking the target neural response. Such configurations are inherently taught by the stimulation being delivered through the electrode and the resultant neural response being recorded and determined to match the desired neural response.), and the sequence of test evoking-recording parameter sets comprises a sequence of evoking-recording configurations and a sequence of stimulation waveform parameter sets for each evoking-recording configuration of the sequence of evoking-recording configurations (Paragraphs 0040-0043: The stimulation parameters include configurations of stimulating electrodes; Paragraphs 0064: different electrodes can be used for recording such as the stimulating electrode or electrodes near the targeted tissue. There may be dedicated recording electrodes or the electrodes located on the already implanted leads may be utilized. The selection of various recording configurations is taught by Carcieri in view of Parker as presented above).
Regarding claim 19, Carcieri in view of Parker further in view of Torgerson teaches the method of claim 18. Modified Carcieri further teaches the method wherein determining the one or more suitable evoking-recording parameter sets comprises: delivering a burst of pulses of the neurostimulation and sensing the one or more signals according to each evoking-recording parameter set of the sequence of test evoking-recording parameter sets; and selecting each suitable evoking-recording parameter set of the one or more suitable evoking-recording parameter sets from the sequence of test evoking-recording parameter sets (Paragraphs 0066-0073: the automatic stimulation adjustment involves delivering a sequence of stimulation pulses, receiving the evoked potential responses, and adjusting the stimulation based on the received response as compared to a desired response. Each parameter set that achieves the desired response is selected as a ”suitable” parameter set).
Regarding claim 20, Carcieri teaches a non-transitory computer-readable storage medium including instructions (Paragraph 0005: the storage for executing the program), which when executed by a system, cause the system to perform a method for delivering neurostimulation to a patient using a plurality of electrodes (Abstract), the method comprising:
delivering the neurostimulation to evoke responses from the patient using a stimulation output circuit and an evoking configuration defining a stimulation electrode set including electrodes selected from the plurality of electrodes (Paragraphs 0047-0048: the stimulation output circuitry outputs stimulation pulses to the electrical terminals which correspond to the electrodes. The evoking configuration defining a stimulation electrode set includes the electrodes used to stimulate the patient ; Paragraph 0040: the stimulation parameters can include various electrode combinations and configurations);
sensing one or more signals including the evoked responses using a sensing input circuit and a recording configuration defining a sensing electrode set including electrodes selected from the plurality of electrodes (Paragraphs 0049-0050: the monitoring circuitry monitors the therapeutic feedback using one or more sensors which may include the electrodes which can measure the evoked action potentials);
controlling the delivery of the neurostimulation using stimulation parameters including the evoking configuration (Paragraphs 0047-0050: the control logic and stimulation output circuitry control the parameters of the stimulation pulse; Paragraph 0040: the stimulation parameters can also include which electrodes are selected to stimulate);
controlling the sensing of the one or more signals including the evoked responses using sensing parameters including the recording configuration (Paragraphs 0049-0050: the monitoring circuitry monitors the therapeutic feedback using one or more sensors which may include the electrodes which can measure the evoked action potentials; Paragraph 0064: The stimulating electrodes or electrodes near the target tissue site may be utilized to record the evoked potential); and
determining one or more suitable evoking-recording parameter sets by evaluating a sequence of test evoking-recording parameter sets, the evaluating including delivering the neurostimulation and sensing the one or more signals according to a sequence of evoking-recording parameter sets, and selecting the one or more suitable evoking-recording parameter sets from the sequence of test evoking-recording parameter sets, the one or more suitable evoking-recording parameter sets each including a set of the stimulation parameters allowing the evoked responses to include a target response by controlling the delivery of the neurostimulation and a set of the sensing parameters allowing the target response to be recorded using the sensed one or more signals by controlling the sensing of the one or more signals, the sequence of test evoking-recording parameter sets including different evoking configurations (Paragraphs 0067-0074: automatic stimulation parameters adjustment may be carried out in order to match the recorded evoked potential to the desired evoked potential. Any of the parameter sets that evoke the desired action potential, or evoked potential are considered “suitable” The system may alter various parameters of the stimulation pulse including the electrodes selected to deliver the pulse, or evoking configurations. Each iteration of stimulation parameters are considered “test” parameter sets, the parameter sets that evoke the desired action potential are considered “suitable” parameter sets. Paragraphs 0064: different electrodes can be used for recording such as the stimulating electrode or electrodes near the targeted tissue. There may be dedicated recording electrodes or the electrodes located on the already implanted leads may be utilized. Thus, Carcieri seems to at least suggest the selection of recording electrodes which are most appropriate to the location of the desired therapeutic effect.).
Carcieri fails to explicitly disclose the system wherein, the sequence of test evoking-recording parameter sets including different recording configurations and wherein the different evoking configurations and the difference recording configurations are each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes and spatially and temporally arranged in the sequence of test evoking-recording parameter sets to limit a time of the evaluating the sequence of test evoking-recording parameter sets
Parker teaches a neurostimulator which may select each electrode as a sensing, stimulating, or inactive electrode. The neurostimulator may control which electrodes are selected for which purpose for each stimulation pathway, or configuration, and may switch the electrodes type depending on the desired stimulation pathway (Paragraphs 0017 and 0034)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the sensing and stimulating electrode selection taught by Parker into the system of Carcieri because such a selection capability would allow the system of Carcieri to select not only the most desirable stimulating electrodes, but also the most desirable sensing electrodes for each stimulation configuration. Implementing the sensing electrode selection taught by Parker would allow the system of modified Carcieri to select the most optimal sensing arrangement for each stimulation depending on what type of measurement is most desirable.
Carcieri in view of Parker fails to further teach the system wherein the different evoking configurations and the difference recording configurations are each a subset of all possible combinations of electrodes of the plurality of electrodes and are selected from the all possible combinations of electrodes and spatially and temporally arranged in the sequence of test evoking-recording parameter sets to limit a time of the evaluating the sequence of test evoking-recording parameter sets.
Torgerson teaches that testing all possible combinations of electrode sets is time consuming (Col 7 lines 33-51). Thus it is desirable to test a predefined combination of electrode sets in a predefined order in order to save time in identifying a suitable electrode set for evoking a desired response (Col 8 lines 9-61). Torgerson further teaches that the predefined electrode sets may be tested in a particular order in order to reduce the time required to can through the predefined electrode sets. The order may be include ordering the electrode sets by ensuring that at least one shared anode or cathode is present between adjacent electrode sets to increase the speed of testing (Col 9 lines 13-34). The predefined set of electrode combinations may be determined a number of ways such as being set by the manufacturer, patterns that are potentially effective for a particular patient condition, patterns determined by a clinician, and other selection methods (Col 10 line 43 – Col 11 line 9).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the testing of only predetermined electrode sets and testing the sets in a particular order as taught by Torgerson into the method of Carcieri in view of Parker because Torgerson teaches that testing every possible combination of electrode sets is time consuming (Col 7 lines 33-51), and testing only the predetermined electrode sets in a predetermined order improves the speed and efficiency in determining a suitable electrode combination (Col 9 lines 13-34).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker further in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson as applied to claim 1 above and further in view of Stypulkowski US Patent Application Publication Number US 2012/0191157 A1 hereinafter Stypulkowski.
Regarding claim 2, Carcieri in view of Parker further in view of Torgerson teaches the system of claim 1. Modified Carcieri further discloses the system including independently controlled current sources for providing stimulation pulses of a specified and known amperage to or from the electrical terminals (Paragraph 0048).
Carcieri fails to explicitly disclose the system wherein the stimulation output circuit comprises multiple stimulation channels, and the evoking configuration defines a different stimulation electrode set for each channel of the multiple stimulation channels to allow for simultaneous delivery of the neurostimulation using different stimulation electrode sets.
Stypulkowski teaches a target therapy delivery site for treating a patient condition, a relatively high frequency electrical stimulation signal is delivered to at least two areas within a first region (e.g., an anterior nucleus of the thalamus) of a brain of a patient, and changes in brain activity (e.g., as indicated by bioelectrical brain signals) within a second region (e.g., a hippocampus) of the brain of the patient in response to the delivered stimulation are determined. The target therapy delivery site, an electrode combination, or both, may be selected based on the changes in brain activity (Abstract). Thus Stypulkowski falls within the same field of endeavor as Applicant’s invention.
Stypulkowski teaches a stimulation output circuit comprises multiple stimulation channels, and the evoking configuration defines a different stimulation electrode set for each channel of the multiple stimulation channels to allow for simultaneous delivery of the neurostimulation using different stimulation electrode sets (Paragraph 0073: the stimulation generator may be multi-channel and can supply multiple stimulation pulses at a given time to multiple different electrode combinations, or channels).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the multi-channel stimulus generator of Stypulkowski into the system of modified Carcieri because the multi-channel stimulus generator of Stypulkowski allows for the simultaneous delivery of multiple different therapies through multiple electrode configuration channels and may thus be more effective at delivering certain therapies than a single channel system.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson in view of Stypulkowski US Patent Application Publication Number US 2012/0191157 A1 hereinafter Stypulkowski as applied to claim 2 above and further in view of Greenburg US Patent Application Publication Number US 2015/0157862 A1 hereinafter Greenburg.
Regarding claim 3, Carcieri in view of Parker in view of Torgerson in view of Stypulkowski teaches the system of claim 2. Modified Carcieri fails to further disclose the system wherein the sensing input circuit comprises multiple sensing channels, and the recording configuration defines a different sensing electrode set for each channel of the multiple sensing channels to allow for simultaneous sensing of multiple signals using different sensing electrode sets.
Greenburg teaches an implantable device with at least one package that houses electronics that sends and receives data or signals, and optionally power, from an external system through at least one coil attached to at least one package and processes the data, including recordings of neural activity, and delivers electrical pulses to neural tissue through at least one array of multiple electrodes that are attached to the at least one package. The device is adapted to electrocorticographic (ECoG) and local field potential (LFP) signals. A brain stimulator, preferably a deep brain stimulator, stimulates the brain in response to neural recordings in a closed feedback loop. The device is advantageous in providing neuromodulation therapies for neurological disorders such as chronic pain, post-traumatic stress disorder (PTSD), major depression, or similar disorders. The invention and components thereof are intended to be installed in the head, or on or in the cranium or on the dura, or on or in the brain (Abstract). Thus Greenburg falls within the same field of endeavor as Applicant’s invention.
Greenburg teaches a system wherein the sensing input circuit comprises multiple sensing channels, and the recording configuration defines a different sensing electrode set for each channel of the multiple sensing channels (Paragraph 0154: the device includes 16 sensing channels, each channel may have include different electrode combinations and different data processing techniques such as different gains or sampling rates) to allow for simultaneous sensing of multiple signals using different sensing electrode sets (Paragraph 0209: the multiple channels allows for the simultaneous sensing and/or stimulation at multiple different sites)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the plurality of configurable sensing channels taught by Greenburg into the system of modified Carcieri teaches that having multiple different sensing and/or stimulating channels allows for stimulation and/or sensing to be performed at multiple different sites at once which results in better therapy and reduced power consumption (Greenburg: paragraph 0209).
Regarding claim 4, Carcieri in view of Parker in view of Torgerson in view of Stypulkowski further in view of Greenburg teaches the system of claim 3, Modified Carcieri fails to further disclose the system wherein the parameter adjuster is configured to evaluate multiple evoking-recording parameter sets of the sequence of evoking- recording parameter sets simultaneously using two or more sensing channels of the multiple sensing channels.
Greenburg teaches a system having a plurality of independent channels in order to accommodate sensing and stimulation occurring at a plurality of different sites simultaneously (Paragraph 0209).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the plurality of configurable sensing channels taught by Greenburg into the system of modified Carcieri such that the automatic stimulation parameters adjustment of Carcieri (Carcieri: paragraphs 0067-0074) is performed for multiple different sites at once because Greenburg teaches that having multiple different sensing and/or stimulating channels allows for stimulation and/or sensing to be performed at multiple different sites at once which results in better therapy and reduced power consumption (Greenburg: paragraph 0209) and performing the stimulation parameters adjustment at each of these different sites simultaneously may reduce the power consumption of the device when compared to performing the stimulation parameter adjustment for each site one at a time.
Claims 5 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson as applied to claims 1 and 11 above and further in view of Steinke US Patent Application Publication Number US 2019/0134403 A1 hereinafter Steinke.
Regarding claim 5, Carcieri in view of Parker in view of Torgerson teaches the system of claim 1. Modified Carcieri fails to further disclose the system wherein the evoking configuration further defines a fractionalization specifying a distribution of a current of the neurostimulation over the stimulation electrode set.
Steinke teaches a system for delivering neurostimulation using a stimulation device and controlling the delivery of the neurostimulation may include a programming control circuit and a stimulation control circuit. The programming control circuit may be configured to program the stimulation device for delivering the neurostimulation according to a pattern of neurostimulation pulses defined by one or more stimulation waveforms. The stimulation control circuit may be configured to determine the pattern of neurostimulation pulses with the one or more stimulation waveforms constrained by one or more thresholds, and may include threshold circuitry that may be configured to receive one or more known values of the one or more thresholds and to determine needed values of the one or more thresholds by executing an algorithm allowing for prediction of the needed values of the one or more thresholds based on the one or more known values (Abstract). Thus, Steinke falls within the same field of endeavor as Applicant’s invention.
Steinke teaches a system wherein the evoking configuration further defines a fractionalization specifying a distribution of a current of the neurostimulation over the stimulation electrode set (Paragraph 0080: the stimulation is applied to selected fields which include a set of electrodes. The current of the stimulation is distributed by assigning a fraction of the overall pulse amplitude to each electrode of the set of electrodes which is referred to as fractionalization)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the fractionalization of the stimulation as taught by Steinke into the system of modified Carcieri because Carcieri teaches a number of pulse parameters that may be adjusted during the automatic stimulation parameters adjustment (Carcieri: paragraphs 0067-0068) and incorporating fractionalization into these parameters provides Carcieri with an additional metric with which to optimize the stimulation signal to result in the closest possible match of the desired evoked potential signal and lowest power consumption.
Regarding claim 15, Carcieri in view of Parker in view of Torgerson teaches the method of claim 11. Modified Carcieri further discloses the method further comprising selecting the stimulation electrode set from a reference electrode of the plurality of electrodes and lead electrodes of the plurality of electrodes, the lead electrodes each including one or more contacts and incorporated onto a lead configured to be coupled to the stimulation output circuit (Paragraphs 0040-0042: the stimulation parameters include electrode selection. The electrodes are selected from the lead electrodes and the outer case of the IPG, or a reference electrode; Fig. 2 references 26 and E1-16 illustrate the lead electrodes each comprising a plurality of contacts), and
Carcieri fails to further disclose the method wherein controlling the delivery of the neurostimulation comprises controlling an electrical current of the neurostimulation individually for each of the reference electrode and the contacts of the lead electrodes.
Steinke teaches a method wherein controlling the delivery of the neurostimulation comprises controlling an electrical current of the neurostimulation individually for each of the reference electrode and the contacts of the lead electrodes (Paragraph 0080: the stimulation is applied to selected fields which include a set of electrodes. The current of the stimulation is distributed by assigning a fraction of the overall pulse amplitude to each electrode of the set of electrodes which is referred to as fractionalization).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the fractionalization of the stimulation as taught by Steinke into the method of modified Carcieri because Carcieri teaches a number of pulse parameters that may be adjusted during the automatic stimulation parameters adjustment (Carcieri: paragraphs 0067-0068) and incorporating fractionalization into these parameters provides Carcieri with an additional metric with which to optimize the stimulation signal to result in the closest possible match of the desired evoked potential signal and lowest power consumption.
Regarding claim 16, Carcieri in view of Parker in view of Torgerson in view of Steinke teaches the method of claim 15. Modified Carcieri further discloses the method wherein selecting the stimulation electrode set comprises selecting one or more lead electrodes of the lead electrodes to function as a cathode for delivering the neurostimulation (Paragraphs 0040-0043: the electrodes may be selected as cathodes or anodes ).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson as applied to claim 1 above and further in view of Kent US Patent Number US 9492667 B1 hereinafter Kent.
Regarding claim 10, Carcieri in view of Parker in view of Torgerson teaches the system of claim 1. Modified Carcieri further discloses the system wherein the parameter adjuster is configured to evaluate each evoking-recording parameter set of the sequence of test evoking-recording parameter sets by causing the stimulation output circuit to deliver a burst of neurostimulation pulses and the sensing input circuit to sense the one or more signals using the each evoking-recording parameter set and satisfy one or more reliability criteria including at least one of exceeding a threshold amplitude or exceeding a threshold signal to noise ratio (Paragraphs 0067-0074: the stimulation is delivered as stimulation pulses and the evoked response is recorded so the stimulus can be adjusted to create the desired evoked response which includes the response being above a threshold amplitude to match the template)
Carcieri fails to further disclose the system configured to minimize a number of pulses in the burst of neurostimulation pulses while allowing for the target response to satisfy criteria including at least one of exceeding a threshold amplitude or exceeding a threshold signal to noise ratio.
Kent teaches systems and methods to control non-paresthesia stimulation of nerve tissue of a patient. The systems and methods deliver a non-paresthesia stimulation waveform to at least one electrode proximate to target nerve fibers, and define an analysis window that is positioned to occur at an intermediate point within at least one of a first burst or an inter-burst delay. Additionally, the systems and methods, during the analysis window, measure evoked potential (EP) signals from the target nerve fibers. The systems and methods also analyze the EP signals to obtain activity data for select nerve fiber components, and adjust at least one therapy parameter to change the non-paresthesia stimulation waveform based on the activity data (Abstract). Thus, Kent falls within the same field of endeavor as Applicant’s invention.
Kent teaches a system which minimize a number of pulses in the burst of neurostimulation pulses while allowing for the target response to satisfy criteria. (Col 20 lines 29-57: the minimum number of pulses in a burst required to sufficiently disrupt neuronal coherence).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the determination of the minimum number of pulses required to achieve the desired evoked potential as taught by Kent into the system of modified Carcieri because reducing the number of pulses delivered to the minimum required to achieve the desired evoked potential may reduce the power consumption of the device and may help delay or prevent the formation of scar tissue by reducing the damage to surrounding tissue.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson as applied to claim 11 above and further in view of Sinclair US Patent Application Publication Number US 2019/0143120 A1 hereinafter Sinclair.
Regarding claim 12, Carcieri in view of Parker in view of Torgerson teaches the method of claim 11. Modified Carcieri fails to further disclose the method wherein determining the one or more suitable evoking-recording parameter sets comprises determining the one or more suitable evoking-recording parameter sets for deep brain stimulation, including determining the one or more suitable evoking-recording parameter sets for recording evoked resonant neural activity (ERNA).
Sinclair teaches a method of monitoring neural activity responsive to a stimulus in a brain, the method comprising: applying the stimulus to one or more of at least one electrode implanted in a target neural structure of the brain; detecting a resonant response from the target neural structure evoked by the stimulus at one or more of the at least one electrode in or near the target neural structure of the brain; and determining one or more waveform characteristics of the detected resonant response (Abstract). Thus, Sinclair falls within the same field of endeavor as Applicant’s invention.
Sinclair teaches a deep brain stimulation device which records both an evoked compound action potential (ECAP) and also an evoked resonant neural activity (ERNA) for each stimulation. Sinclair teaches that the recording of the ERNA is useful for determining the patient’s natural state and can be induced without generating therapeutic effects and without causing sustained changes to the resonant neural circuit (Paragraphs 0122-0124).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of modified Carcieri for deep brain stimulation and the recording of evoked resonant neural activity (ERNA) as taught by Sinclair because modified Carcieri discloses that the method provided is suitable for deep brain stimulation (Carcieri: paragraph 0029) and recording ERNA responses provides the user with information regarding the patient’s natural neural state (Sinclair: paragraph 0123) which may be useful for diagnosing conditions or establishing a therapeutic threshold.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson as applied to claim 11 above and further in view of Greenburg US Patent Application Publication Number US 2015/0157862 A1 hereinafter Greenburg.
Regarding claim 13, Carcieri in view of Parker in view of Torgerson teaches the method of claim 11. Modified Carcieri fails to further disclose the method wherein sensing the one or more signals comprises sensing multiple signals simultaneously using multiple sensing channels of the sensing input circuit, the multiple sensing channels each associated with a recording configuration of the different recording configurations and each defining a sensing electrode set including electrodes selected from the plurality of electrodes.
Greenburg teaches a method wherein sensing the one or more signals comprises sensing multiple signals simultaneously using multiple sensing channels of the sensing input circuit, the multiple sensing channels each associated with a recording configuration of the different recording configurations and each defining a sensing electrode set including electrodes selected from the plurality of electrodes. (Paragraph 0154: the device includes 16 sensing channels, each channel may include different electrode combinations and different data processing techniques such as different gains or sampling rates) and evaluating the sequence of evoking-recording parameter sets comprises evaluating multiple evoking-recording parameter sets simultaneously using the multiple sensing channels of the sensing input circuit (Paragraph 0209: the multiple channels allows for the simultaneous sensing and/or stimulation at multiple different sites simultaneously)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the plurality of configurable sensing channels and simultaneous evaluations taught by Greenburg into the method of modified Carcieri because Greenburg teaches that having multiple different sensing and/or stimulating channels allows for stimulation and/or sensing to be performed at multiple different sites at once which results in better therapy and reduced power consumption (Greenburg: paragraph 0209) and may further reduce the time required to determine an optimal evoking-recording configuration by allowing multiple evoking and/or recording configurations to be evaluated simultaneously.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Carcieri US Patent Application Publication Number US 2014/0243926 A1 hereinafter Carcieri in view of Parker US Patent Application Publication Number US 2022/0249009 A1 hereinafter Parker in view of Torgerson US Patent Number US 8918184 B1 hereinafter Torgerson in view of Greenburg US Patent Application Publication Number US 2015/0157862 A1 hereinafter Greenburg as applied to claim 13 above and further in view of Stypulkowski US Patent Application Publication Number US 2012/0191157 A1 hereinafter Stypulkowski.
Regarding claim 14, Carcieri in view of Parker in view of Torgerson in view of Greenburg teaches the method of claim 13. Modified Carcieri fails to further disclose the method wherein delivering the neurostimulation comprises delivering the neurostimulation simultaneously using multiple stimulation channels of the stimulation output circuit, the multiple stimulation channels each associated with an evoking configuration of the different evoking configurations and each defining a stimulation electrode set including electrodes selected from the plurality of electrodes.
Stypulkowski teaches that neurostimulation comprises delivering the neurostimulation comprises delivering the neurostimulation simultaneously using multiple stimulation channels of the stimulation output circuit, the multiple stimulation channels each associated with an evoking configuration of the different evoking configurations and each defining a stimulation electrode set including electrodes selected from the plurality of electrodes (Paragraph 0073: the stimulation generator may be multi-channel and can supply multiple stimulation pulses at a given time to multiple different electrode combinations, or channels).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the multi-channel stimulus generator of Stypulkowski into the method of modified Carcieri because the multi-channel stimulus generator of Stypulkowski allows for the simultaneous delivery of multiple different therapies through multiple electrode configuration channels and may thus be more effective at delivering certain therapies than a single channel system. Furthermore, the implementation of the multi-channel stimulus generator into the method of modified Carcieri teaches “evaluating the sequence of test evoking-recording parameter sets comprises evaluating multiple test evoking-recording parameter sets simultaneously using the multiple channels of the sensing input circuit and the multiple stimulation channels of the stimulation output circuit” as modified Carcieri teaches the evaluation of multiple different sites at once as taught in the above rejection of claim 13 and it would be obvious to apply the multi-channel stimulator of Stypulkowski to the multiple simultaneous evaluations of different sites as taught by modified Carcieri because the simultaneous stimulation and sensing at multiple different sites can result in better therapy as taught by Greenburg (Greenburg: Paragraph 0209).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/RENE T TOWA/ Primary Examiner, Art Unit 3791
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