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 .
Applicant’s arguments and amendments filed in the reply on 6/08/2026 were received and fully considered. Claims 1, 16, and 17 were amended. Please see below for more detail.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/08/2026 has been entered.
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “a processor configured to assess the neural recording to produce a measure of postsynaptic activation;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“at least one stimulation electrode configured to deliver an electrical stimulus to neural tissue in the spinal cord of a patient;”
“at least one measurement electrode configured to record a neural recording of a response of the neural tissue to the stimulus;”
“use the measure of postsynaptic activation to adjust a loop parameter for a feedback loop controlling delivery of stimuli; and
cause the at least one stimulation electrode to deliver a subsequent electrical stimulus according to the adjusted loop parameter.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, stimulation electrodes and measurement electrodes are general fields of use and processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of mentally evaluating received neural recording data and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 2-15 and 18-22 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 16, the claim(s) recites “assessing the neural recording to produce a measure of postsynaptic activation;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“delivering an electrical stimulus to neural tissue in the spinal cord of a patient using at least one stimulation electrode;”
“obtaining a neural recording of a response of the neural tissue to the stimulus using at least one measurement electrode;”
“using the measure of postsynaptic activation to adjust a loop parameter for a feedback loop controlling delivery of stimuli; and
delivering a subsequent electrical stimulus according to the adjusted loop parameter.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, stimulation electrodes and measurement electrodes are general fields of use.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of mentally evaluating received neural recording data and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Regarding Claim 17, the claim(s) recites “assessing the neural recording to produce a measure of postsynaptic activation” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“delivering an electrical stimulus to neural tissue in the spinal cord of a patient using at least one stimulation electrode;”
“obtaining a neural recording of a response of the neural tissue to the stimulus using at least one measurement electrode,”
“using the measure of postsynaptic activation to adjust a loop parameter for a feedback loop controlling delivery of stimuli; and
delivering a subsequent electrical stimulus according to the adjusted loop parameter.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, stimulation electrodes and measurement electrodes are general fields of use and non-transitory computer readable medium are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of mentally evaluating received neural recording data and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
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.
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.
Claim(s) 1-4, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey et al (US 2016/0082268) (“Hershey”) as evidenced by Marceglia et al (US 2020/0188675) (“Marceglia”) in view of Tass et al (US 2018/0169373) (“Tass”).
Regarding Claim 1, while Hershey teaches a neurostimulation system (Abstract) comprising
at least one stimulation electrode configured to deliver an electrical stimulus to neural tissue in the spinal cord of a patient (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102] steps 1865 and step 1972 deliver stimulation to neural tissue in the spinal cord of a patient);
at least one measurement sensor configured to record a neural recording of a response of the neural tissue to the stimulus (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102] steps 1867 and step 1974 sense one or more neurophysiological response to stimulation, [0086] example neural recording parameters); and
A processor configured to assess the neural recording to produce a measure of postsynaptic activation ([0088] programming interface 1656 assesses response parameters to generate programming signal for the modulation device 1512, [0080], [0086] where the modulation can be performed specifically on and monitored from the post-synaptic membrane. Examiner will note that the local field potential would be recognized as “a measure of postsynaptic activation” as it is known in the art as a summation of both pre- and post-synaptic activation as evidenced by Marceglia: [0026]);
Wherein the processor is further configured to:
Use the measure of postsynaptic activation to adjust a loop parameter for a feedback loop controlling delivery of stimuli (Figs. 18-19, [0092]-[0102] steps 1869-1870 and steps 1976-1977 use the provided measures to adjust the modulation parameter of the stimuli to set the response parameters in a target range); and
Cause the at least one stimulation electrode to deliver a subsequent electrical stimulus according to the adjusted loop parameter (Figs. 18-19, [0092]-[0102] steps 1869-1870 and steps 1976-1977 use the provided measures to adjust the modulation parameter of the stimuli to set the response parameters in a target range, where the nature of closed loop monitoring leads to the delivery a subsequent stimulus), Hershey fails to explicitly teach the at least measurement sensor being a measurement electrode.
However Tass teaches a neurostimulation system (Abstract) where a response to stimulation may be done by measuring a local field potential with an electrode ([0109]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to measure the local field potential of Hershey with an electrode as taught by Tass as Tass provides a specific hardware component to achieve the monitoring, which enables consistency across applications of the invention.
Regarding Claim 2, Hershey, Marceglia, and Tass teach the system of claim 1, wherein the processor is further configured to assess both primary activation and postsynaptic activation (See Claim 1 Rejection, local field potentials of Hershey are combinations of pre-synaptic/primary activation and post-synaptic activation).
Regarding Claim 3, Hershey, Marceglia, and Tass teach the system of claim 1 wherein the processor is further configured to assess both axonal activation of postsynaptic fibres and synaptic activation of postsynaptic fibres (See Claim 1 Rejection, by measuring action potentials, the system of Hershey is configured to assess both axonal activation of postsynaptic fibres and synaptic activation of postsynaptic fibres).
Regarding Claim 4, Hershey, Marceglia, and Tass teach the system of claim 1, comprising an implantable neurostimulator (See Claim 1 Rejection, Hershey [0099]).
Regarding Claim 15, Hershey, Marceglia, and Tass teach the system of claim 1 wherein the processor is further configured to use the measure of postsynaptic activation to revise at least one stimulation parameter for a subsequent stimulus (See Claim 1 Rejection, [0083]-[0084]).
Regarding Claim 16, while Hershey teaches a method of neurostimulation (Abstract, Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102]), the method comprising:
delivering an electrical stimulus to neural tissue in the spinal cord of a patient using at least one stimulation electrode (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102] steps 1865 and step 1972 deliver stimulation to neural tissue in the spinal cord of a patient);
obtaining a neural recording of a response of the neural tissue to the stimulus using at least one measurement sensor (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102] steps 1867 and step 1974 sense one or more neurophysiological response to stimulation, [0086] example neural recording parameters); and
assessing the neural recording to produce a measure of postsynaptic activation (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102], steps 1867 and step 1974 derive one or more response parameters from the sensed response, [0080], [0086] where the modulation can be performed specifically on and monitored from the post-synaptic membrane. Examiner will note that the local field potential would be recognized as “a measure of postsynaptic activation” as it is known in the art as a summation of both pre- and post-synaptic activation as evidenced by Marceglia: [0026]);
using the measure of postsynaptic activation to adjust a loop parameter for a feedback loop control controlling delivery of stimuli (Figs. 18-19, [0092]-[0102] steps 1869-1870 and steps 1976-1977 use the provided measures to adjust the modulation parameter of the stimuli to set the response parameters in a target range);
delivering a subsequent electrical stimulus according to the adjusted loop parameter (Figs. 18-19, [0092]-[0102] steps 1869-1870 and steps 1976-1977 use the provided measures to adjust the modulation parameter of the stimuli to set the response parameters in a target range, where the nature of closed loop monitoring leads to the delivery a subsequent stimulus), Hershey fails to explicitly teach the at least measurement sensor being a measurement electrode.
However Tass teaches a neurostimulation system (Abstract) where a response to stimulation may be done by measuring a local field potential with an electrode ([0109]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to measure the local field potential of Hershey with an electrode as taught by Tass as Tass provides a specific hardware component to achieve the monitoring, which enables consistency across applications of the invention.
Regarding Claim 17, while Hershey teaches a non-transitory computer readable medium for neurostimulation, comprising instructions which, when executed by one or more processors (Abstract, Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102], [0065] clinician programmer can execute the instructions by way of a computer, where computers use non-transitory computer readable medium to receive instructions), causes performance of the:
delivering an electrical stimulus to neural tissue in the spinal cord of a patient using at least one stimulation electrode (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102] steps 1865 and step 1972 deliver stimulation to neural tissue in the spinal cord of a patient);
obtaining a neural recording of a response of the neural tissue to the stimulus using at least one measurement sensor (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102] steps 1867 and step 1974 sense one or more neurophysiological response to stimulation, [0086] example neural recording parameters); and
assessing the neural recording to produce a measure of postsynaptic activation (Figs. 15-16, 18-19, [0081]-[0088], [0092]-[0102], steps 1867 and step 1974 derive one or more response parameters from the sensed response, [0080], [0086] where the modulation can be performed specifically on and monitored from the post-synaptic membrane. Examiner will note that the local field potential would be recognized as “a measure of postsynaptic activation” as it is known in the art as a summation of both pre- and post-synaptic activation as evidenced by Marceglia: [0026]);
using the measure of postsynaptic activation to adjust a loop parameter for a feedback loop control controlling delivery of stimuli (Figs. 18-19, [0092]-[0102] steps 1869-1870 and steps 1976-1977 use the provided measures to adjust the modulation parameter of the stimuli to set the response parameters in a target range);
delivering a subsequent electrical stimulus according to the adjusted loop parameter (Figs. 18-19, [0092]-[0102] steps 1869-1870 and steps 1976-1977 use the provided measures to adjust the modulation parameter of the stimuli to set the response parameters in a target range, where the nature of closed loop monitoring leads to the delivery a subsequent stimulus), Hershey fails to explicitly teach the at least measurement sensor being a measurement electrode.
However Tass teaches a neurostimulation system (Abstract) where a response to stimulation may be done by measuring a local field potential with an electrode ([0109]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to measure the local field potential of Hershey with an electrode as taught by Tass as Tass provides a specific hardware component to achieve the monitoring, which enables consistency across applications of the invention.
Claim(s) 5-6, 8, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey as evidenced by Marceglia in view of Tass and further in view of Kent et al (“Measurement of Evoked Potentials During Thalamic Deep Brain Stimulation”) (“Kent”).
Regarding Claim 5, while Hershey, Marceglia, and Tass teach the system of claim 1, their combined efforts fail to teach wherein the processor is further configured to assess the neural recording for additional lobes.
However Kent teaches a neurostimulation system (Abstract, p43, Col. 1-2, Introduction, p44, Col. 1-2, Intraoperative experimental setup) comprising:
at least one stimulation electrode configured to deliver an electrical stimulus to neural tissue (p44, Col. 1-2, Intraoperative experimental setup¸ DBS lead);
at least one measurement electrode configured to record a neural recording of a response of the neural tissue to the stimulus (p44, Col. 1-2, Intraoperative experimental setup, “ECAPs were recorded differentially between two non-stimulating contacts using three series AC-coupled amplifier stages(A1,A2,andA3) and additional circuit components to reduce the stimulus artifact”); and
the system configured to assess the neural recording to produce a measure of postsynaptic activation (p50, Neural origin of the ECAP response),
wherein the system is further configured to assess the neural recording for additional lobes (p52, Discussion, N2, an additional lobe, is assessed as part of the measured evoked compound action potential).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to assess the neural recording for additional lobes as taught by Kent for the evoked compound action potential of Hershey as Kent teaches this as a way to identify differences between pre-synaptic and post-synaptic activation (p50, Neural origin of the ECAP response) and this characteristic of ECAP makes it a suitable feedback control signal for a neurostimulation system (p52-53, Relationship between ECAP and clinical effectiveness). Consequently, Hershey would want to find additional lobes to be able to fully make use of the ECAP as a feedback control signal for the dorsal closed loop stimulation.
Regarding Claim 6, Hershey, Marceglia, Tass, and Kent teach the system of claim 5 wherein the processor is further configured to use a presence or strength of additional lobes as a measure of the presence or strength of synaptic activation of postsynaptic fibres (See Claim 5 Rejection, p52, Discussion “Decreasing DBS frequency from 130 Hz to 10 Hz increased the magnitude of N2 and/or P2, and our previous study suggested that the increased post-synaptic synchronization of TC cells at low frequencies increased the magnitude of secondary phases.”).
Regarding Claim 8, Hershey, Marceglia, Tass, and Kent teach the system of claim 6 and Hershey teaches considering measures of an evoked compound action potential ([0086] such as latency, amplitudes, width, etc.) and Kent teaches wherein the processor is further configured to compare the measure of the presence or strength of synaptic activation of postsynaptic fibres to a presence or strength of primary activation, to determine a state of an intervening synapse (Fig. 3, prestimulation time considered for the ECAP to evaluate results of stimulation, p50, Neural origin of the ECAP response, temporal pattern of neural activation was considered with certain characteristics being reflective of monitoring locations, p50, Correlation between tremor and ECAP characteristics, where an abnormality in activation, i.e., could be analyzed for a subject to determine a state of intervening synapse).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform a comparison of the measure of the presence or strength of synaptic activation of postsynaptic fibres to a presence or strength of primary activation as taught by Kent for the ECAP of Hershey as a way to set an equivalent analysis of specific pain characteristics for Hershey as Kent did for tremors.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey as evidenced by Marceglia in view of Tass and further in view of Kent and further in view of Bharmi et al (US 2014/0288551) (“Bharmi”).
Regarding Claim 7, while Hershey, Marceglia, Tass, and Kent teach the system of claim 6 their combined efforts fail to teach wherein the processor is further configured to compare the measure of the presence or strength of synaptic activation of postsynaptic fibres to the electrical stimulus, to determine a state of an intervening synapse
However Bharmi teaches an analysis of electrical stimulation (Abstract) and notes that baseline synaptic activation may be measured to consider abnormal action potentials ([0217]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to consider the baseline synaptic activation of nerves in Hershey and Kent as taught by Bharmi to identify to nerve communication is reflective of an abnormal condition, i.e. nerve condition leading to inflammation.
Claim(s) 9, 13, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey as evidenced by Marceglia in view of Tass and further in view of Kent and further in view of Edgerton et al (US 2016/0175586) (“Edgerton”).
Regarding Claim 9, Hershey, Marceglia, Tass, and Kent teach the system of claim 1, their combined efforts fail to teach wherein the processor is further configured to obtain a plurality of neural recordings of a response of the neural tissue to the respective stimulus from a respective plurality of measurement electrodes positioned along a fibre tract of the neural tissue, and wherein the processor is further configured to determine from the plurality of neural recordings a conduction velocity of at least one component of the response of the neural tissue.
However Edgerton teaches a spinal neuromodulation system (Abstract, [0081], [0085], [0111]) wherein the processor is further configured to obtain a plurality of neural recordings of a response of the neural tissue to the respective stimulus from a respective plurality of measurement electrodes positioned along a fibre tract of the neural tissue, and wherein the processor is further configured to determine from the plurality of neural recordings a conduction velocity of at least one component of the response of the neural tissue ([0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize multiple measurement electrodes for the system of Hershey, Marceglia, Tass, and Kent and further find the conduction velocity of the nerve stimulation as taught by Edgerton as this may provide a datapoint for the health of the nerve, which Edgerton teaches can characterize whether a patient suffering locomotor injury is recovering. This would be a useful application of the data of Hershey and Kent.
Regarding Claim 13, Hershey, Marceglia, Tass, Kent, and Edgerton teach the system of claim 9 and Hershey teaches considering measures of an evoked compound action potential ([0086] such as latency, amplitudes, width, etc.) and Kent teaches wherein the processor is further configured to compare the measure of the presence or strength of synaptic activation of postsynaptic fibres to a presence or strength of primary activation, to determine a state of an intervening synapse (Fig. 3, prestimulation time considered for the ECAP to evaluate results of stimulation, p50, Neural origin of the ECAP response, temporal pattern of neural activation was considered with certain characteristics being reflective of monitoring locations, p50, Correlation between tremor and ECAP characteristics, where an abnormality in activation, i.e., could be analyzed for a subject to determine a state of intervening synapse).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform a comparison of the measure of the presence or strength of synaptic activation of postsynaptic fibres to a presence or strength of primary activation as taught by Kent for the ECAP of Hershey as a way to set an equivalent analysis of specific pain characteristics for Hershey as Kent did for tremors.
Regarding Claim 18, while Hershey, Marceglia, Tass, and Kent teach the system of claim 8, their combined efforts fail to teach the system further comprising a diagnostic module configured to receive an indicium of the intervening synapse and configured to produce therefrom a prediction as to whether the patient will benefit from neuromodulation.
However Edgerton teaches a spinal neuromodulation system (Abstract, [0081], [0085], [0111]) comprising a diagnostic module configured to receive an indicium of the synapses and configured to produce predictions as to whether the patient will benefit from neuromodulation ([0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide predictions on whether a subject will benefit from neuromodulation as taught by Edgerton with the data analysis of Hershey, Marceglia, Tass, and Kent as this facilitates the desired pain management.
Regarding Claim 20, while Hershey, Marceglia, Tass, and Kent teach the system of claim 13, their combined efforts fail to teach the system further comprising a diagnostic module configured to receive an indicium of the intervening synapse and configured to produce therefrom a prediction as to whether the patient will benefit from neuromodulation.
However Edgerton teaches a spinal neuromodulation system (Abstract, [0081], [0085], [0111]) comprising a diagnostic module configured to receive an indicium of the synapses and configured to produce predictions as to whether the patient will benefit from neuromodulation ([0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide predictions on whether a subject will benefit from neuromodulation as taught by Edgerton with the data analysis of Hershey, Marceglia, Tass, and Kent as this facilitates the desired pain management.
Claim(s) 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey as evidenced by Marceglia in view of Tass and further in view of Kent and further in view of Edgerton and further in view of Bharmi.
Regarding Claim 12, while Hershey, Marceglia, Tass, Kent, and Edgerton teach the system of claim 9, their combined efforts fail to teach wherein the processor is further configured to compare a presence or strength of synaptic activation of postsynaptic fibres to the electrical stimulus, to determine a state of an intervening synapse.
However Bharmi teaches an analysis of electrical stimulation (Abstract) and notes that baseline synaptic activation may be measured to consider abnormal action potentials ([0217]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to consider the baseline synaptic activation of nerves in Kent as taught by Bharmi to identify to nerve communication is reflective of an abnormal condition, i.e. nerve condition leading to inflammation.
Regarding Claim 19, Hershey, Marceglia, Tass, Kent, Edgerton, and Bharmi teach the system of claim 12, and Edgerton teaches the system further comprising a diagnostic module configured to receive an indicium as to the state of the intervening synapse and configured to produce therefrom a prediction as to whether the patient will benefit from neuromodulation ([0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide predictions on whether a subject will benefit from neuromodulation as taught by Edgerton with the data analysis of Hershey, Marceglia, Tass, and Kent as this facilitates the desired pain management.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey as evidenced by Marceglia in view of Tass and further in view of Kent and further in view of Bharmi and further in view of Edgerton.
Regarding Claim 14, while Hershey, Marceglia, Tass, Kent, and Bharmi teach the system of claim 7, their combined efforts fail to teach the system further comprising a diagnostic module configured to receive an indicium of the intervening synapse and configured to produce therefrom a prediction as to whether the patient will benefit from neuromodulation.
However Edgerton teaches a spinal neuromodulation system (Abstract, [0081], [0085], [0111]) comprising a diagnostic module configured to receive an indicium of the synapses and configured to produce predictions as to whether the patient will benefit from neuromodulation ([0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide predictions on whether a subject will benefit from neuromodulation as taught by Edgerton with the data analysis of Hershey, Marceglia, Tass, and Kent as this facilitates the desired pain management.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hershey as evidenced by Marceglia in view of Tass and further in view of Rolston et al (WO 2010/025226) (“Rolston”).
Regarding Claim 21, while Hershey, Marceglia, and Tass teach the system of claim 1, their combined efforts fail to teach wherein the loop parameter is loop gain.
However Rolston teaches a neurostimulation system (Abstract) where in a closed feedback system of neurostimulation, a loop gain is a parameter used to adjust how rapidly feedback is adjusted ([0047] where a gain can be selected for rapid feedback and reduced overcompensation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the neuromodulation of Hershey modifiable by loop gain as taught by Rolston as a way to prioritize neurostimulation aspects such as rapid feedback for quicker pain relief.
Regarding Claim 22, Hershey, Marceglia, Tass, and Rolston teach the system of claim 21, wherein the processor is further configured to repeatedly:
cause the at least one stimulation electrode to deliver an electrical stimulus to the neural tissue;
cause the at least one measurement electrode to record a neural recording of a response of the neural tissue to the stimulus;
assess the neural recording to produce a measure of postsynaptic activation (See Claim 1 Rejection); and
use, if the measure of postsynaptic activation does not indicate higher therapeutic efficacy than the previous measure, the measure of postsynaptic activation to adjust the loop gain (See Claim 21 Rejection, adjusting the loop gain can change how quickly higher therapeutically effective values are found).
Response to Arguments
Applicant’s amendments and arguments filed 6/08/2026 with respect to the 35 USC 101 rejections have been fully considered, but are not persuasive.
Applicant argues on page 8-9 of the Remarks dated 6/08/2026 that the claims overcome the 35 USC 101 rejection under step 2A, Prong One as the amended claims now “effect a particular treatment or prophylaxis for a disease or medical condition.” Examiner respectfully disagrees. The broad nature of the adjusted stimulation fails to support that the output is a “particular treatment.” As of now, the measure of postsynaptic activation informs an adjustment of a loop parameter for controlling delivery stimuli. However, is the loop modified due to a static postsynaptic activation or a changing postsynaptic activation? Is there a particular disease that is treated by any change in postsynaptic activation? Applicant should amend the claim to limit how the postsynaptic activation informs an adjustment of the loop parameter, amend the claim to stimuli that would lead treatment to a particular condition, and explain how the new claim language reflects effecting “a particular treatment or prophylaxis for a disease or medical condition.”
The rejection(s) stand.
Applicant’s amendments and arguments filed 6/08/2026 with respect to the 35 USC 103 rejections have been fully considered, and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hershey, Marceglia, and Tass for Claims 1, 16, and 17. Correspondingly, claims 2-15 and 18-20 remain rejected due to their dependency on Claims 1, 16, and 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights