DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1 and 11 is objected to because of the following informalities:
Lines 17-18 of claim 1 currently recite “modify the neurostimulation programming model based on the weighted data, the neurostimulation programming model to generate updated programming parameters for the neurostimulation treatment”. Examiner suggests amending the claim to recite “modify the neurostimulation programming model based on the weighted data[[, the neurostimulation programming model]] to generate updated programming parameters for the neurostimulation treatment”.
Lines 11-12 of claim 11 currently recite “modifying the neurostimulation programming model based on the weighted data, the neurostimulation programming model to generate updated programming parameters for the neurostimulation treatment”. Examiner suggests amending the claim to recite “modifying the neurostimulation programming model based on the weighted data[[, the neurostimulation programming model]] to generate updated programming parameters for the neurostimulation treatment”.
Appropriate correction is respectfully requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 11-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of modifying a neurostimulation programming model) without significantly more.
Step 1
The claimed invention in claims 1-9 and 11-19 are directed to statutory subject matter as the claims recite a method/system for modifying a neurostimulation programming model.
Step 2A, Prong One
Regarding claims 1-9 and 11-19, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claims 1 and 11, the limitations of “identify one or more experiences…”, “determine weighted data…”, and “modify the neurostimulation programming model…” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation but for the recitation of generic computer components.
Step 2A, Prong Two
For claims 1-9 and 11-19, the judicial exception is not integrated into a practical application. For claims 1 and 11, the additional limitation of “at least one processor and at least one memory”, “event data processing circuitry”, and “neurostimulation programming circuitry” are recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitation of “obtain patient data observed during a prior time period…” amount to nothing more than the pre-solution activity of data gathering.
Step 2B
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitation of “obtain patient data observed during a prior time period…” is directed to nothing more than the pre-solution activity of data gathering, which does not amount to an inventive concept.
The recitation of the above-identified additional limitations of “identify one or more experiences…”, “determine weighted data…”, and “modify the neurostimulation programming model…” in claims 1 and 11 amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
Dependent claims 2-9 and 12-19 are further directed to the abstract idea. The above mentioned claims do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B. While claims 9 and 19 recite additional limitations of “…cause the use of the identified programming parameters” the term “programming parameters” is extremely broad and could encompass analysis parameters as well as stimulation parameters. Therefore as currently written, claims 9 and 19 do not require the delivery of updated stimulation parameters to the patient and amount to merely changing a value.
Dependent claims 10-20 recite additional limitations of “…pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes, for modulated energy provided with a plurality of leads of the neurostimulation device” which integrates the abstract idea into a practical application.
Claim Rejections - 35 USC § 112
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 5, 7, 15, and 17 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.
The term “data relevance” in claims 5, 7, 15, and 17 is a relative term which renders the claim indefinite. The term “data relevance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what a decrease in data relevance or maximum value of data relevance would be. In order to further advance prosecution, Examiner is interpreting data relevance to be data variance in the patient data resulting from an identified event.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 9-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al (US 2024/0001125) hereinafter Isaacson in view of Esteller et al (US 2022/0323764) hereinafter Esteller.
Regarding claim 1, Isaacson discloses a device for adapting a neurostimulation programming model used for neurostimulation treatment (Fig. 2), the device comprising:
at least one processor ([0077] processing circuitry 201) and at least one memory ([0063] storage device 212);
event data processing circuitry ([0063] processing circuitry 210), operably coupled with the processor and the memory (Fig. 2 shows processor 201 containing processing circuitry 210 and storage device 212 which are in communication with each other; [0067]), the event data processing circuitry configured to:
obtain patient data observed during a prior time period (sensed evoked response signal), the patient data for a human patient having a neurostimulation treatment delivered with a neurostimulation device (IMD 110; [0063] Examiner notes IMD 200 is an example of IMD 110) to treat a medical condition [0055-0056];
identify one or more events (noise/artifact interference) during the prior time period that cause variance in measurements of the patient data ([0025] Stimulation artifacts typically have amplitudes many times that of the evoked response signal; [0056] artifact or noise within the sensed evoked signal); and
determine weighted data by weighting the patient data observed during the one or more events ([0075] processing circuitry 210 may weight an area of the window having the artifact with a lower weight than the other areas of the window, processing circuitry 210 may reduce or remove the artifact from the sensed evoked response signal); and
neurostimulation programming circuitry ([0063] stimulation generation circuitry 202), operably coupled with the at least one processor and the at least one memory [0068], the neurostimulation programming circuitry configured to:
modify the neurostimulation programming model based on the weighted data, the neurostimulation programming model to generate updated programming parameters for the neurostimulation treatment ([0076] processing circuitry 210 may, in response to determining that the characteristic value of at least one of the artifact or the sensed evoked response signal is greater than the amplitude threshold, alternate the polarity of the stimulation electrodes; [0070] processing circuitry controls stimulation generation circuitry to apply stimulation to selected combinations of electrodes),
wherein the weighting of the patient data reduces effects of the patient data during the one or more events on the neurostimulation programming model ([0075] weighting an area of the window having the artifact with a lower weight than the other areas of the window).
While Isaacson discloses identifying one or more events (noise/artifact) during the prior time period that cause variance in the measurements of the patient data [0056] as discussed above, Issacson does not explicitly disclose identifying one or more events experienced by the human patient since it is unclear if the patient would necessarily experience the artifact/noise in the evoked signal. However, Esteller discloses identifying one or more events experienced by the human patient (posture/activity) during the prior time period that cause variance in measurements of the patient data using a sensed artifact feature ([0061] stimulation artifact features as sensed can be used to determine a posture or activity of the patient). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Isaacson with identifying one or more events experienced by the human patient during the prior time period that cause variance in measurements of the patient data as taught by Esteller. Such a modification would provide the predictable results of adjusting a therapy based on a detected posture/activity (Esteller, [0071]).
Regarding claims 2 and 12, Isaacson discloses wherein the one or more events include an intervention event (stimulus pulse) that is related to treatment of the medical condition of the human patient ([0056] artifact resulting from stimulus pulse), and
wherein to determine the weighted data for the intervention event includes to calculate a weight that reduces the effects of the patient data throughout a duration of the intervention event ([0075] weighting an area of the window having the artifact with a lower weight than the other areas of the window).
Regarding claims 3 and 13, Isaacson discloses wherein the one or more events include a confounding event (Noise interference) that is not related to treatment of the medical condition of the human patient ([0056] noise within the sensed evoked response signal), and wherein to determine the weighted data for the confounding event includes to calculate a weight that reduces the effects of the patient data throughout a duration of the confounding event ([0056] IMD 110 may ignore that outlier signal or assign the outlier signal with a weight of 0).
Regarding claims 4 and 14, Isaacson discloses calculate weights for the patient data throughout the prior time period for respective measurements of the patient data ([0056] IMD 110 may weight temporal data within the window), wherein the calculation of the weights uses a discount that reduces effects of the respective measurements on the neurostimulation programming model, based on an amount of time elapsed ([0056] MD 110 may weight temporal data within the window and/or may weight calculated features (e.g., within the morphology of the temporal data) of the temporal data within the window. In some examples, the weighting may be different for different portions of the window).
Regarding claims 5 and 15, the modified Isaacson discloses the method/system of claims 4 and 14 as discussed above, but fails to disclose wherein to calculate the weights for the patient data throughout the prior time period for the respective measurements of the patient data, includes to calculate the weights for the patient data based on a rate of decrease in data relevance and a maximum value of the data relevance. However, Isaacson further discloses the weighting may be configured to emphasize the evoked response or the artifact and that IMD 110 may dynamically adjust averaging of the weighted temporal data and/or the weighting of the calculated features of the temporal data based on the artifact or noise within the sensed evoked response signal. Therefore it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to calculate the weights for the patient data based on a rate of decrease in data relevance within the sensed evoked response signal and a maximum value of the data relevance within the sensed evoked response signal in order to dynamically adjust the averaging of the weighted temporal data. Examiner notes that an averaging of the data would incorporate both a decrease in data relevance and a maximum value of the data relevance. Such a modification would provide the predictable results of adjusting stimulation parameters based on the weighted data [0056-0057].
Regarding claims 6 and 16, Isaacson discloses wherein to determine the weighted data corresponding to a respective event of the one or more events, includes to calculate a weight based on a duration for the respective event ([0075] By weighting an area of the window having the artifact (this would require determining the duration of the artifact) with a lower weight than the other areas of the window, processing circuitry 210 may reduce or remove the artifact from the sensed evoked response signal).
Regarding claims 7 and 17, Isaacson discloses wherein to determine the weighted data corresponding to a respective event of the one or more events, includes to calculate a weight based on an estimated impact of the respective event on data relevance ([0075] By weighting an area of the window having the artifact with a lower weight than the other areas of the window), and wherein the estimated impact differs based on a type or severity of the respective event ([0025] Stimulation artifacts typically have amplitudes many times that of the evoked response signal; [0075]).
Regarding claims 9 and 19, Isaacson discloses neurostimulation programming circuitry further configured to:
identify, with the use of the neurostimulation programming model, programming parameters for use with the neurostimulation device ([0077] processing circuitry 210 may change a pulse shape of the stimulation parameters in an attempt to improve the quality of the sensed evoked response signal); and
communicate, to the neurostimulation device, at least one command to cause the use of the identified programming parameters ([0070] Processing circuitry 210 also controls stimulation generation circuitry 202 to generate and apply the stimulation signals to selected combinations of electrodes 232, 234).
Regarding claims 10 and 20, Isaacson discloses wherein the identified programming parameters specify operation of a neurostimulation program including one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes, for modulated energy provided with a plurality of leads of the neurostimulation device ([0070] Processing circuitry 210 also controls stimulation generation circuitry 202 to generate and apply the stimulation signals to selected combinations of electrodes 232, 234; [0077] processing circuitry 210 may change a pulse shape of the stimulation parameters in an attempt to improve the quality of the sensed evoked response signal).
Regarding claim 11, Isaacson discloses a method for use to adapt a neurostimulation programming model used for neurostimulation treatment, the method comprising a plurality of operations executed with at least one processor of a computing device, the plurality of operations comprising:
obtaining patient data (sensed evoked response signal) observed during a prior time period (window), the patient data for a human patient having a neurostimulation treatment delivered with a neurostimulation device (IMD 110) to treat a medical condition [0055-0056];
identifying one or more events (noise/artifact interference) during the prior time period that cause variance in measurements of the patient data ([0025] Stimulation artifacts typically have amplitudes many times that of the evoked response signal; [0056] artifact or noise within the sensed evoked signal);
determining weighted data by weighting the patient data observed during the one or more events ([0075] processing circuitry 210 may weight an area of the window having the artifact with a lower weight than the other areas of the window, processing circuitry 210 may reduce or remove the artifact from the sensed evoked response signal); and
modifying the neurostimulation programming model based on the weighted data, the neurostimulation programming model to generate updated programming parameters for the neurostimulation treatment ([0076] processing circuitry 210 may, in response to determining that the characteristic value of at least one of the artifact or the sensed evoked response signal is greater than the amplitude threshold, alternate the polarity of the stimulation electrodes),
wherein the weighting of the patient data reduces effects of the patient data during the one or more events on the neurostimulation programming model ([0075] weighting an area of the window having the artifact with a lower weight than the other areas of the window).
Isaacson fails to expressly disclose identifying one or more events experienced by the human patient during the prior time period that cause variance in measurements of the patient data. However, Esteller discloses identifying one or more events (posture/activity) experienced by the human patient during the prior time period that cause variance in measurements of the patient data ([0061] stimulation artifact features as sensed can be used to determine a posture or activity of the patient). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Isaacson with identifying one or more events experienced by the human patient during the prior time period that cause variance in measurements of the patient data as taught by Esteller. Such a modification would provide the predictable results of adjusting a therapy based on a detected posture/activity (Esteller, [0071]).
Claim(s) 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 2024/0001125) in view of Esteller (US 2022/0323764) and further in view of Giuffrida et al (US 2014/0005743) hereinafter Giuffrida.
Regarding claims 8 and 18, the modified Isaacson discloses the system/method of claims 1 and 11 as discussed above, but fails to disclose wherein to modify the neurostimulation programming model includes to perform reinforcement or re-training of the neurostimulation programming model using the weighted data, and wherein the neurostimulation programming model is implemented as an artificial neural network or as a machine learning classifier.
However, Giuffrida discloses wherein to modify the neurostimulation programming model includes to perform reinforcement or re-training of the neurostimulation programming model using the weighted data ([0138] each network is preferably trained three times with randomized initial weights and biases), and wherein the neurostimulation programming model is implemented as an artificial neural network or as a machine learning classifier ([0135] artificial neural network 14 to output suggested stimulation parameters).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system/method as taught by Isaacson with reinforcement or re-training of the neurostimulation programming model using the weighted data, and wherein the neurostimulation programming model is implemented as an artificial neural network or as a machine learning classifier as taught by Giuffrida. Such a modification would provide the predictable results of minimizing program iterations to reduce surgical and outpatient tuning session time (Giuffrida, [0135]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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