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 12/22/2025 were received and fully considered. Claims 1, 16, and 17 were amended. Please see below for more detail.
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 1-20 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;”
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.
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 18-20 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;”
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.
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,”
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.
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, 3-6, 8-9, 13, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent et al (“Measurement of Evoked Potentials During Thalamic Deep Brain Stimulation”) (“Kent”) in view of Edgerton et al (US 2016/0175586) (“Edgerton”) and further in view of Mahrous et al (“The Mechanistic Basis for Successful Spinal Cord Stimulation to Generate Steady Motor Outputs”) (“Mahrous”).
Regarding Claim 1, while 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), Kent fails to teach the system using a processor for assessing and delivering electrical stimulus to neural tissue in the spinal cord of a patient.
However Edgerton teaches a spinal neuromodulation system (Abstract, [0081], [0085], [0111]) comprising
at least one stimulation electrode configured to deliver an electrical stimulus to neural tissue in the spinal cord of a patient ([0107]-[0111] electrode arrays provide stimulation to spinal cord);
at least one measurement electrode configured to record a neural recording of a response of the neural tissue to the stimulus ([0107]-[0111] electrode arrays record evoked potentials from spinal cord); and
A processor configured to assess the neural recording to produce a measure of neural response ([0027] computing device assesses relationship between neural recording and stimulation to build a model of neural response).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the closed-loop evoked compound action potential testing of a brain taught by Kent as a closed-loop evoked potential testing of spinal tissue as taught in Edgerton as Kent teaches that the feedback control teachings are also applicable to spinal cord stimulation (p43, Col. 1). Furthermore, it was known in the neuromodulation art that electrical stimulation and measures of postsynaptic activation were applicable in optimizing stimulation protocols for spinal cord injury (Mahrous: Abstract). Finally, it would be obvious for the processor of Edgerton to be applied for the data processing of Kent as an example of a standardized system component enabling closed-loop evaluation of stimulation and measurement data.
Regarding Claim 3, Kent, Edgerton, and Mahrous 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 Kent is configured to assess both axonal activation of postsynaptic fibres and synaptic activation of postsynaptic fibres).
Regarding Claim 4, Kent, Edgerton, and Mahrous teach the system of claim 1, comprising an implantable neurostimulator (See Claim 1 Rejection, Edgerton [0080]).
Regarding Claim 5, Kent, Edgerton, and Mahrous teach the system of claim 1 and Kent teaches wherein the processor 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).
Regarding Claim 6, Kent, Edgerton, and Mahrous 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, Kent, Edgerton, and Mahrous teach the system of claim 6 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, this will also reflect a determination of the state of the intervening synapse).
Regarding Claim 9, Kent, Edgerton, and Mahrous teach the system of claim 1 and Edgerton teaches 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 electrodes in the system of 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 Kent.
Regarding Claim 13, Kent, Edgerton, and Mahrous teach the system of claim 9 and Kent teaches wherein the processor is further configured to compare a 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, this will also reflect a determination of the state of the intervening synapse).
Regarding Claim 15, Kent, Edgerton, and Mahrous 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).
Regarding Claim 18, while Kent, Edgerton, and Mahrous teach the system of claim 8, and Edgerton comprises 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]), where the state of the synapse is the state of the intervening synapse (See Claim 8 Rejection).
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 Kent as this facilitates the desired recovery from locomotion injury when judging spinal injury.
Regarding Claim 16, while Kent teaches a method of neurostimulation (Abstract, p43, Col. 1-2, Introduction, p44, Col. 1-2, Intraoperative experimental setup), the method comprising:
delivering an electrical stimulus to neural tissue using at least one stimulation electrode (p44, Col. 1-2, Intraoperative experimental setup¸ DBS lead);
obtaining a neural recording of a response of the neural tissue to the stimulus using at least one measurement electrode (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
assessing the neural recording to produce a measure of postsynaptic activation (p50, Neural origin of the ECAP response), Kent fails to teach delivering an electrical stimulus to neural tissue in the spinal cord of a patient.
However Edgerton teaches a spinal neuromodulation system (Abstract, [0081], [0085], [0111]) comprising
at least one stimulation electrode configured to deliver an electrical stimulus to neural tissue in the spinal cord of a patient ([0107]-[0111] electrode arrays provide stimulation to spinal cord); and
at least one measurement electrode configured to record a neural recording of a response of the neural tissue to the stimulus ([0107]-[0111] electrode arrays record evoked potentials from spinal cord).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the closed-loop evoked compound action potential testing of Kent to the closed-loop evoked potential testing of Edgerton as Kent teaches that the feedback control teachings are also applicable to spinal cord stimulation (p43, Col. 1). Furthermore, it was known in the neuromodulation art that electrical stimulation and measures of postsynaptic activation were applicable in optimizing stimulation protocols for spinal cord injury (Mahrous: Abstract).
Regarding Claim 17, while Kent teaches a performance (Abstract, p43, Col. 1-2, Introduction, p44, Col. 1-2, Intraoperative experimental setup) of the following:
delivering an electrical stimulus to neural tissue using at least one stimulation electrode (p44, Col. 1-2, Intraoperative experimental setup¸ DBS lead);
obtaining a neural recording of a response of the neural tissue to the stimulus using at least one measurement electrode (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
assessing the neural recording to produce a measure of postsynaptic activation (p50, Neural origin of the ECAP response),.
Kent fails to teach a non-transitory computer readable medium for neurostimulation, comprising instructions which, when executed by one or more processors, causes performance of the above steps; and
Delivering an electrical stimulus to neural tissue in the spinal cord of a patient.
However Edgerton teaches a spinal neuromodulation system (Abstract, [0081], [0085], [0111]) comprising
at least one stimulation electrode configured to deliver an electrical stimulus to neural tissue in the spinal cord of a patient ([0107]-[0111] electrode arrays provide stimulation to spinal cord);
at least one measurement electrode configured to record a neural recording of a response of the neural tissue to the stimulus ([0107]-[0111] electrode arrays record evoked potentials from spinal cord); and
A processor configured to assess the neural recording to produce a measure of neural response ([0027] computing device assesses relationship between neural recording and stimulation to build a model of neural response).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the closed-loop evoked compound action potential testing of Kent to the closed-loop evoked potential testing of Edgerton as Kent teaches that the feedback control teachings are also applicable to spinal cord stimulation (p43, Col. 1). Furthermore, it was known in the neuromodulation art that electrical stimulation and measures of postsynaptic activation were applicable in optimizing stimulation protocols for spinal cord injury (Mahrous: Abstract). Finally, it would be obvious for the processor of Edgerton to be applied for the data processing of Kent as an example of a standardized system component enabling closed-loop evaluation of stimulation and measurement data.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent in view of Edgerton and further in view of Mahrous and further in view of Kudela et al (“Computational Modeling of Subdural Cortical Stimulation: A Quantitative Spatiotemporal Analysis of Action Potential Initiation in a High-Density Multicompartment Model”) (“Kudela”).
Regarding Claim 2, while Kent, Edgerton, and Mahrous teach the system of claim 1, wherein the processor is further configured to assess postsynaptic activation (See Claim 1 Rejection), their combined efforts fail to teach wherein the processor is further configured to assess both primary activation and postsynaptic activation.
However Kudela teaches an analysis of presynaptic activation (Abstract) and notes that presynaptic activation’s stimulation effect is dependent on neuron orientation and the stimulation current parameters (p451, Discussion, “Figures 2 and 4 show that the repertoire of axonal activation varies depending on the neuron orientation and the stimulating current parameters…In this case, the applied stimulation does not only result in the spatial activation of neurons in the network but also produces more complex temporal responses in the post synaptic neurons.”).
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 complexities of primary activation from Kudela in the analysis of Kent as this may improve the computational model of Kent which uses pre-synaptic activation as an parameter in the model (p46, Computational model of ECAP recording during thalamic DBS, “Transmembrane potentials were measured over time at the TC initial segment or proximal node of Ranvier in pre-synaptic inputs to detect neural activation, and transmembrane currents were measured in all neural compartments within the population to calculate the ECAP signal in the third stage of the model.”).
Claim(s) 7, 12, 14, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent in view of Edgerton and further in view of Mahrous and further in view of Bharmi et al (US 2014/0288551) (“Bharmi”).
Regarding Claim 7, while Kent, Edgerton, and Mahrous 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 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 12, while Kent, Edgerton, and Mahrous 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 14, Kent, Edgerton, Mahrous, and Bharmi teach the system of claim 7, and Edgerton comprises 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]), where the state of the synapse is the state of the intervening synapse (See Claim 7 Rejection).
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 Kent as this facilitates the desired recovery from locomotion injury when judging spinal injury.
Regarding Claim 19, Kent, Edgerton, Mahrous, 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 utilize multiple electrodes in the system of 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 Kent by indicating whether a patient will benefit from neuromodulation.
Regarding Claim 20, while Kent, Edgerton, Mahrous, and Bharmi teach the system of claim 13, and Edgerton comprises 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]), where the state of the synapse is the state of the intervening synapse (See Claim 8 Rejection).
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 Kent as this facilitates the desired recovery from locomotion injury when judging spinal injury.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent in view of Edgerton and further in view of Mahrous and further in view of Carr et al (US 2018/0236224) (“Carr”).
Regarding Claim 10, while Kent, Edgerton, and Mahrous teach the system of claim 9 their combined efforts fail to teach wherein the processor is further configured to determine whether the response of the neural tissue comprises at least two components conducting at different conduction velocities and originating simultaneously, and if so the processor being configured to output an indication that the neural response involved axonal activation of two different fibre types.
However Carr teaches a neuromodulation system involving the assessment of compound action potentials (Abstract, [0244]-[0260]), related to synapses ([0038]), and determine whether the response of the neural tissue comprises at least two components conducting at different conduction velocities and originating simultaneously, and recognizing this as an indication that the neural response involved axonal activation of two different fibre types ([0009]-[0010], [0048], [0260]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the conduction velocity analysis of Edgerton and further identify the characteristics of an axonal stimulation taught by Carr as this indicates a successful axonal stimulation of the subject.
Regarding Claim 11, while Kent, Edgerton, and Mahrous teach the system of claim 9 their combined efforts fail to teach wherein the processor is further configured to determine whether the response of the neural tissue comprises at least two components originating at distinct times consistent with synaptic delay, and if so the processor being configured to output an indication that the neural response involved synaptic activation of a postsynaptic fibre.
However Carr teaches a neuromodulation system involving the assessment of compound action potentials (Abstract, [0244]-[0260]), related to synapses ([0038]), and determine whether the response of the neural tissue comprises at least two components conducting at different conduction velocities and originating simultaneously, and recognizing this as an indication that the neural response involved axonal activation of two different fibre types ([0009]-[0010], [0048], [0260]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the conduction velocity analysis of Edgerton and further identify the characteristics of an axonal stimulation taught by Carr as this can indicate whether a successful axonal stimulation of the subject has occurred. If fibers are exhibiting characteristic delays of natural stimulation (synaptic activation) as opposed to the characteristic fiber conduction velocity waveform from a single stimulation (Carr), one can infer from the assessed data that the stimulation of Kent was not sufficient for postsynaptic activation.
Response to Arguments
Applicant’s amendments and arguments filed 12/22/2025 with respect to the 35 USC 101 rejections have been fully considered, but are not persuasive.
Applicant argues on page 8 of the Remarks dated 12/22/2025 that the claims overcome the 35 USC 101 rejection under step 2A, Prong One as the claims included limitations that can’t be performed in the human mind. Examiner respectfully disagrees. As stated by Applicant on page 6 of the Remarks, the two-step analysis is to identify if the claims are directed to a judicial exception, and then to evaluate if additional elements of the claims provide an inventive concept. Examiner analysis considers the stimulation electrode and delivered electrical stimulus to neural tissue as an additional element in the claim, outside of them mental steps. Thus, it is not a limitation that must be performed by a human mind.
Applicant argues on page 9 of the Remarks dated 12/22/2025 that the claims overcome the 35 USC 101 rejection under the Step 2A, Prong Two analysis because the claims recite a particular treatment or prophylaxis for a disease. Specifically, the system and method deliver electrical stimulus to neural tissue in the spinal cord of a patient, which is treatment for a disease or medical condition. Examiner respectfully disagrees. While the general concept of electrical stimulation includes treatment applications, that is not reflected in the current claim language. No limitation on frequency, amounts applied, voltage, or current have been applied to the electrical stimulation. On one hand, this could include stimulations that would harm a patient. On the other hand, without any limiting details, it is unclear if this will output a treatment. The claim language is not reflective of a particular treatment. Further, as written, the electrical stimulation is applied in a testing manner to judge patient response. The claims do not tie this stimulation to treating any disease. So it also is not a particular treatment for a disease.
Applicant argues on page 10 of the Remarks dated 12/22/2025 that the claims overcome the 35 USC 101 rejection under the Step 2B analysis for the reasons given above. Examiner respectfully disagrees for the reasons give above.
The rejection(s) stand.
Applicant’s amendments and arguments filed 12/22/2025 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 Kent, Edgerton, and Mahrous 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
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.
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
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights