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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/9/25 has been entered.
Response to Arguments
With regards to the 112b rejection for the antecedent basis issue of the “supervisory device” the rejection is withdrawn in view of the amendments.
Applicant's arguments filed 9/9/25 have been fully considered but they are not persuasive.
Applicants’ discussion seems to be mainly an argument that there is support in their specification, while only stating that the references don’t show the new elements. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As discussed more below Applicants in their remarks seem to have argued the elements reference provide support for communicating a change in parameters back to the IND as well as the processing on the external device provides such determination. Examiner does not agree. Examiner notes that the specification does recite “programming session” is actually programming the device only receiving readings from the IND for review. Additionally, the specification only references “uploading” for uploading data to a server not uploading/adjusting etc. (see [0057] using PG Pub for paragraph numbers) elements on the IND. Figs. 14 and 18 are figures based on the display of gathered data (see [0084]-[0085], [0087], [0097]). See more discussion in the 112a rejection below for claim 25 and how it is being distinguished from the elements in claim 1.
The remaining arguments rely on those discussed above and are not persuasive for the same reasons.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 25 recites “wherein the supervisory device is further configured to adjust the stimulation settings based on the clinical data.” However, there does not appear to be support for this in the specification. The specification is in its majority directed to the movement, processing and display of data away from the implantable stimulator (IND).
The specification does recite closed loop stimulation on the implantable device 100 - [0054] "The stimulator 100 comprises a Closed Loop Stimulator (CLS), in that the recorded neural responses are used in a feedback arrangement to control stimulation settings on a continuous or ongoing basis.". However, it does not recite the external device performing the processing and determination which is sent back. The external device is discussed as including [0055] "a clinical programming application 410 of a clinic interface, which compiles a clinical data log file 412 which is manipulated and optimised and efficiently presented by a clinical data viewer 414, for field diagnosis by a clinician, field clinical engineer (FCE) or the like."; [0059] "The Clinical Data Viewer 414 is intended to be used in the field to diagnose patient issues and optimise therapy for the patient.". Based on these discussions (and taking into consideration what is understood in the art), while it may not be explicitly stated, there is an implication that the “a clinician, field clinical engineer (FCE) or the like." can manually enter updated (or adjustments) which are uploaded to the stimulator. Under this interpretation the changes can be manually entered into the external device and “communicated” to the IND.
Claim 25 differs from the broader use of “communicating” the adjustments, to specifically recite the supervisory device is the device which makes the adjustment (as opposed to the user). As such there is not support for claim 25.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 7, 15-16, 18, 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Annoni (Elizabeth Annoni et al., US 20180192943) hereinafter Ann in view of AU 2015349614 to Parker using Parker (John Parker et al., US 20180228391) hereinafter Park in further view of Kovach (Peter Kovach et al., US 20090082640) hereinafter Kov with evidentiary support from Math (MathisFun, Histograms, https://www.mathsisfun.com/data/histograms.html, viewed on 5/31/24) hereinafter Math. Kov incorporates by reference in its entirety US Patent Application 11/789,690 which later published as Gar (cited below). AU 2015349614 to Parker incorporates by reference in [0023] “International Patent Publication No. WO 2012/155188” using the respective US publication Laird (John Parker, James Laird et al., US 20140236257) hereinafter Lair for paragraph numbers.
Regarding claim 1, an interpretation of Ann discloses system for managing clinical data of an implanted neuromodulation device (see citations below), the system comprising:
a supervisory device ([0052]-[0053], [0064]-[0065], [0076] see also [0046], [0107]-[0108], [0110]); and
an implanted neuromodulation device ([0046]-[0047], [0070] see also [0006], [0045], [0107]-[0108]) configured to:
deliver electrical neurostimulation therapy comprising neural stimuli according to stimulation settings ([0046]-[0047], [0073]-[0074] see also [0006], [0045], [0070], [0079], [0115]),
capture recordings of neural responses to the electrical neurostimulation therapy ([0008], [0045], [0056]-[0058], [0070]), and
record clinical data including operational parameters, measured values and derived values/metrics of the measured values ([0053], [0063] including “The memory 230 may be configured to store . . .”, Figs. 2-3; discloses storing/recording data and derived metrics of the measured signals on the implantable), the clinical data comprising histogram of data ([0060], [0063]; Discloses storing data and derived metrics such as histograms etc.),
communicate recorded clinical data to ([0053], [0064]-[0065], [0076]; discloses the transmission of data to an external “supervisory” device) the supervisory device ([0052]-[0053], [0064]-[0065], [0076] see also [0046], [0110]); and
wherein the supervisory device configured to receive clinical data from the implanted neuromodulation device via the receiver ([0052]-[0053], [0064]-[0065], [0076] see also [0046], [0110]), and to present the clinical data for review by a reviewer ([0053], [0060], [0064]-[0065], [0076], [0099] see also [0115]; The data can be used to determine “statistical parameters” such as histograms. To the extent “to present . . . for review” is an intended use of the device the recited data gathering and display ae functionally capable of performing the function);
and communicate an adjustment to the stimulation settings to the implanted neuromodulation device, the adjustment being based on the clinical data ([0052] including “The external system 130 may program the IND 112 to deliver pain therapy in a closed-loop fashion based on the pain score.”, [0053] including “The transmitted data may include, for example, real-time physiological or functional signals acquired by and stored in the IND 112, . . .one or more programming instructions to the IND 112 which may include configurations for sensing physiologic signal or stimulation commands and stimulation parameters”, [0070], [0073]-[0074] including “The implantable neuromodulator 310 may receive the information about electrostimulation parameters and the electrode configuration from the external system”, [0076], [0101] see also [0046], [0110], [0115]; external device can receive sensed data from IND process it and then send updated/desired stimulation settings based on the processed data back to the IND for use. To the extent “the adjustment being based on . . .” is an intended use of the device the device is structurally capable of performing the intended use).
An interpretation of Ann may not explicitly disclose measure evoked compound action potential (ECAP) magnitudes from the recordings wherein the clinical data includes the measured ECAP magnitudes; control the delivery of subsequent neural stimuli using the measured ECAP magnitudes and a plurality of feedback target values in a feedback arrangement; the clinical data including the measured ECAP magnitudes further including feedback target values.
However, in the same field of endeavor (medical devices), Park teaches measure evoked compound action potential (ECAP) magnitudes from the recordings wherein the clinical data includes the measured ECAP magnitudes (Park [0002], [0030]-[0031], [0053], [0058], figs. 4a-4b see also [0005]-[0006], [0050], figs. 5a, 6a, 7a);
control the delivery of subsequent neural stimuli using the measured ECAP magnitudes and a plurality of feedback target values in a feedback arrangement (Park [0035], [0051], [0066]; Lair [0092], [0094]-[0095], Fig. 12 see also [0112], [0116]; recites closed loop feedback with a plurality of (or variable) feedback target values);
the clinical data including the measured ECAP magnitudes further including feedback target values (Park [0002], [0030]-[0031], [0053], [0058], figs. 4a-4b, 9a see also [0005]-[0006], [0050], figs. 5a, 6a, 7a; Lair [0072]-[0073], [0092], [0094]-[0095]; Records ECAP readings over time at multiple locations).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including further derived metrics such as histograms as recited by Ann to include to include accurately sensing ECAP magnitudes and their respective position along the nerve fiber and using the ECAP as a feedback element with a plurality of feedback target values in a loop feedback arrangement as recited by Park in order to better understand the effects of neural modulation, provide feedback and stimulation adjustment based on the feedback ([0007]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention because it is merely combining prior art elements according to known methods to yield predictable results; combining the disclosed elements of a nerve stimulator/sensor device for treatment, gathering multiple types of event (clinical) data including neural data related to an event as recited by Ann and combining this with disclosure of Park which discloses the particular parameters sensed namely ECAP magnitude and feedback variable targets being used for feedback the combination of which yields the predictable result of histograms for the ECAP magnitude and feedback variable targets to be used in logs as feedback for the stimulation procedure.
An interpretation of Ann may not explicitly disclose wherein recording clinical data includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data for respective time windows.
However, in the same field of endeavor (medical devices), Kov teaches includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data ([0007]-[0008] recites gathering various information in coordination with the occurrence of an even including various physiological parameters, [0009] including “may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time.”, [0043], [0076], [0108], [0158] including “Bar graphs or histograms may allow the concise and clear presentation of a variety of event information” see also [0010], [0068], [0117], Claim 1; discloses histograms for multiple parameters relevant to the event. Examiner notes as evidenced by Fun Histograms are well known to the extent they are presented on math websites designed for teaching k-12 concepts see MathisFun About page. Examiner notes that Ann reference includes the determination of histogram(s) in the implantable) for respective time windows ([0007]-[0008], [0009], [0043], [0076], [0108], [0132], [0158] see also [0010], [0068], [0117], Claim 1; recite gathering multiple types of event information relevant to the each event, which encompasses the plurality of histograms comprising a first histogram of a first parameter for a time window and a second histogram a second parameter for the time window, and each event being a “respective” time window. Furthermore, the cited portions also disclose selecting a respective time window for review).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including ECAP magnitudes, feedback targe values and further derived metrics such as histograms as recited by Ann in view of Park to include the recording of the clinical data as therapy logs comprising a plurality of histograms of clinical data for respective time windows as described by Kov because the data when transferred to the external device with the interface is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009], [0158]).
Regarding claim 2, an interpretation of Ann further discloses wherein the implanted neuromodulation device is configured to record the clinical data substantially continuously during device operation ([0053], [0056]-[0058], [0063]).
Regarding claim 4, an interpretation of Ann further discloses wherein the clinical data comprising user commands input to the implanted neuromodulation device ([0052]-[0053], [0071] including “The stimulation parameters may be provided by a system user.”, [0077] see also [0063], [0073], [0111]-[0113], [0116]).
Regarding claim 7 an interpretation of Ann further discloses wherein the supervisory device is configured to present statistics derived from the clinical data ([0060] including “The signal metrics may include statistical parameters extracted from the sensed signal, such as signal mean, median, or other central tendency measures or a histogram of the signal intensity, among others.”, [0064]-[0065], [0076], [0099] see also [0053]).
Regarding claim 15, an interpretation of Ann further discloses wherein the recorded clinical data includes device programming data ([0050], [0064], [0068], [0071]-[0072], [0075], [0077] including “the user interface 234 to allow a user to confirm, reject, or edit the stimulation parameters, sensing parameters, or other parameters controlling the operation of the implantable neuromodulator 210.”).
In the alternative if it is determined the clinical data includes device programming data is not disclosed by Ann then, an interpretation of Ann may not explicitly disclose wherein the recorded clinical data includes device programming data.
However, in the same field of endeavor (medical devices), Kov teaches wherein the recorded clinical data includes device programming data ([0005], [0043], [0009], [0088], [0158] see also [0076], [0108], [0117], [0160], Fig. 9C, Claim 1).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including ECAP magnitudes, feedback targe values and further derived metrics such as histograms as recited by Ann in view of Park to include the recording of the clinical data as therapy logs comprising a plurality of histograms of clinical data for respective time windows as described by Kov because the data when transferred to the external device with the interface is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009], [0158]).
Regarding claim 16, an interpretation of Ann in view of Park in further view of Kov discloses the above in claim 15, recorded clinical data is disclosed in claim 1 see the rejection above.
An interpretation of Ann may not explicitly disclose wherein the clinical data includes programming notes entered by a clinician during device programming.
However, in the same field of endeavor (medical devices), Kov teaches wherein the clinical data includes programming notes entered by a clinician during device programming ([0104], [0119] including “to enter any other notes deemed applicable to the therapy, event, or condition of patient 14”, [0145], [0148] see also [0005], [0046], [0111]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including stimulator elements and sensors, external control/monitoring device including a user interface, with data transfer between the between the internal and external devices including sensor data, operational status data and control data as recited by Ann to include the user interface to display therapy logs as described by Kov because the data is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009]).
Regarding claim 18, an interpretation of Ann discloses a method of managing clinical data of an implanted neuromodulation device (see citations below), the method comprising:
an implanted neuromodulation device delivering electrical neurostimulation therapy comprising neural stimuli according to stimulation settings ([0046]-[0047], [0073]-[0074] see also [0006], [0045], [0070], [0079] [0115]);
the implanted neuromodulation device capturing recordings of neural responses to the electrical neurostimulation therapy ([0045], [0056]-[0058], [0070]);
the implanted neuromodulation device recording clinical data including operational parameters, measured values and derived values/metrics of the measured values ([0053], [0063] including “The memory 230 may be configured to store . . .”, Figs. 2-3; discloses storing/recording data and derived metrics of the measured signals on the implantable);
the implanted neuromodulation device communicating the recorded clinical data ([0053], [0063]-[0065], [0076]) to a supervisory device ([0052]-[0053], [0064]-[0065], [0076] see also [0046], [0110]); and
receiving the clinical data from the implanted neuromodulation device ([0052]-[0053], [0064]-[0065], [0076] see also [0046], [0110]), and
presenting the clinical data for review by a reviewer ([0053], [0060], [0064]-[0065], [0076], [0099]; The data can be used to determine “statistical parameters” such as histograms); and
communicating an adjustment to the stimulation settings to the implanted neuromodulation device, the adjustment being based on the clinical data ([0052] including “The external system 130 may program the IND 112 to deliver pain therapy in a closed-loop fashion based on the pain score.”, [0053] including “The transmitted data may include, for example, real-time physiological or functional signals acquired by and stored in the IND 112, . . .one or more programming instructions to the IND 112 which may include configurations for sensing physiologic signal or stimulation commands and stimulation parameters”, [0070], [0073]-[0074] including “The implantable neuromodulator 310 may receive the information about electrostimulation parameters and the electrode configuration from the external system”, [0076], [0101] see also [0046], [0110], [0115]; external device can receive sensed data from IND process it and then send updated/desired stimulation settings based on the processed data back to the IND for use).
An interpretation of Ann may not explicitly disclose the implanted neuromodulation device measuring evoked compound action potential (ECAP) magnitudes from the recordings; the implanted neuromodulation device controlling the delivery of subsequent neural stimuli using the measured ECAP magnitudes and a plurality of feedback target values in a feedback arrangement; the clinical data including measured ECAP magnitudes further including feedback target values.
However, in the same field of endeavor (medical devices), Park teaches the implanted neuromodulation device measuring evoked compound action potential (ECAP) magnitudes from the recordings (Park [0002], [0030]-[0031], [0053], [0058], figs. 4a-4b see also [0005]-[0006], [0050], figs. 5a, 6a, 7a); the implanted neuromodulation device controlling the delivery of subsequent neural stimuli using the measured ECAP magnitudes and a plurality of feedback target values in a feedback arrangement (Park [0035], [0051], [0066]; Lair [0092], [0094]-[0095], Fig. 12 see also [0112], [0116]; recites closed loop feedback (stimulation control) based on ECAP readings with comparison to one of a plurality of (or variable) feedback target values); the clinical data including measured ECAP magnitudes further including feedback target values (Park [0002], [0030]-[0031], [0053], [0058], figs. 4a-4b see also [0005]-[0006], [0050], figs. 5a, 6a, 7a, 9a; Lair [0072]-[0073], [0092], [0094]-[0095]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including further derived metrics such as histograms as recited by Ann to include to include accurately sensing ECAP magnitudes and their respective position along the nerve fiber and using the ECAP as a feedback element with a plurality of feedback target values in a loop feedback arrangement as recited by Park in order to better understand the effects of neural modulation, provide feedback and stimulation adjustment based on the feedback ([0007]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention because it is merely combining prior art elements according to known methods to yield predictable results; combining the disclosed elements of a nerve stimulator/sensor device for treatment, gathering multiple types of event (clinical) data including neural data related to an event as recited by Ann and combining this with disclosure of Park which discloses the particular parameters sensed namely ECAP magnitude and feedback variable targets being used for feedback the combination of which yields the predictable result of histograms for the ECAP magnitude and feedback variable targets to be used in logs as feedback for the stimulation procedure.
An interpretation of Ann may not explicitly disclose wherein recording clinical data includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data for respective time windows.
However, in the same field of endeavor (medical devices), Kov teaches includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data ([0007]-[0008] recites gathering various information in coordination with the occurrence of an even including various physiological parameters, [0009] including “may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time.”, [0043], [0076], [0108], [0158] including “Bar graphs or histograms may allow the concise and clear presentation of a variety of event information” see also [0010], [0068], [0117], Claim 1; discloses histograms for multiple parameters relevant to the event. Examiner notes as evidenced by Fun Histograms are well known to the extent they are presented on math websites designed for teaching k-12 concepts see MathisFun About page. Examiner notes that Ann reference includes the determination of histogram(s) in the implantable) for respective time windows ([0007]-[0008], [0009], [0043], [0076], [0108], [0132], [0158] see also [0010], [0068], [0117], Claim 1; recite gathering multiple types of event information relevant to the each event, which encompasses the plurality of histograms comprising a first histogram of a first parameter for a time window and a second histogram a second parameter for the time window, and each event being a “respective” time window. Furthermore, the cited portions also disclose selecting a respective time window for review).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including ECAP magnitudes, feedback targe values and further derived metrics such as histograms as recited by Ann in view of Park to include the recording of the clinical data as therapy logs comprising a plurality of histograms of clinical data for respective time windows as described by Kov because the data when transferred to the external device with the interface is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009], [0158]).
Regarding Claim 22, an interpretation of Ann in view of Kov in further view of Park with the evidentiary support discloses the above in claim 1.
An interpretation of Ann may not explicitly disclose wherein the supervisory device is configured to display therapy logs from the clinical data.
However, in the same field of endeavor (medical devices), Kov teaches wherein the supervisory device is configured to display therapy logs from the clinical data ([0009] including “may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time.”, [0043], [0076], [0108] see also [0010], [0068], [0117], [0165], Claim 1; presents logs of current even and stores prior event logs for display),
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including ECAP magnitudes and further derived metrics such as histograms as recited by Ann in view of Park to include the user interface to display therapy logs which including histograms for multiple parameters (first and second parameters) based on sensed data as described by Kov because the data is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009], [0158]).
Regarding Claim 23, an interpretation of Ann further discloses wherein the recorded clinical data further comprises battery state ([0073] including “battery status”).
Regarding Claim 24, an interpretation of Ann in view of Park in further view of Kov discloses the above in claim 1. While the rejection of claim 1 disclosed a plurality of feedback target values and the therapy logs with clinical data including derived metrics such as a plurality of histograms based on data such as ECAP magnitudes.
An interpretation of Ann may not explicitly disclose the clinical data including feedback target values
an interpretation of Park further discloses the clinical data including feedback target values (Park [0002], [0030]-[0031], [0053], [0058], figs. 4a-4b, 9a see also [0005]-[0006], [0050], figs. 5a, 6a, 7a; Lair [0072]-[0073], [0092], [0094]-[0095]; Records ECAP readings over time at multiple locations).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including further derived metrics such as histograms as recited by Ann to include to include accurately sensing ECAP magnitudes and their respective position along the nerve fiber and using the ECAP as a feedback element with a plurality of feedback target values in a loop feedback arrangement as recited by Park in order to better understand the effects of neural modulation, provide feedback and stimulation adjustment based on the feedback ([0007]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention because it is merely combining prior art elements according to known methods to yield predictable results; combining the disclosed elements of a nerve stimulator/sensor device for treatment, gathering multiple types of event (clinical) data including neural data related to an event as recited by Ann and combining this with disclosure of Park which discloses the particular parameters sensed namely ECAP magnitude and feedback variable targets being used for feedback the combination of which yields the predictable result of histograms for the ECAP magnitude and feedback variable targets to be used in logs as feedback for the stimulation procedure.
An interpretation of Ann may not explicitly disclose wherein recording clinical data includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data for respective time windows.
However, in the same field of endeavor (medical devices), Kov teaches includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data ([0007]-[0008] recites gathering various information in coordination with the occurrence of an even including various physiological parameters, [0009] including “may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time.”, [0043], [0076], [0108], [0158] including “Bar graphs or histograms may allow the concise and clear presentation of a variety of event information” see also [0010], [0068], [0117], Claim 1; discloses histograms for multiple parameters relevant to the event. Examiner notes as evidenced by Fun Histograms are well known to the extent they are presented on math websites designed for teaching k-12 concepts see MathisFun About page. Examiner notes that Ann reference includes the determination of histogram(s) in the implantable) for respective time windows ([0007]-[0008], [0009], [0043], [0076], [0108], [0132], [0158] see also [0010], [0068], [0117], Claim 1; recite gathering multiple types of event information relevant to the each event, which encompasses the plurality of histograms comprising a first histogram of a first parameter for a time window and a second histogram a second parameter for the time window, and each event being a “respective” time window. Furthermore, the cited portions also disclose selecting a respective time window for review).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including ECAP magnitudes, feedback targe values and further derived metrics such as histograms as recited by Ann in view of Park to include the recording of the clinical data as therapy logs comprising a plurality of histograms of clinical data for respective time windows as described by Kov because the data when transferred to the external device with the interface is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009], [0158]).
Regarding Claim 25, an interpretation of Ann further discloses wherein the supervisory device is further configured to adjust the stimulation settings based on the clinical data ([0052] including “The external system 130 may program the IND 112 to deliver pain therapy in a closed-loop fashion based on the pain score.”, [0053] including “The transmitted data may include, for example, real-time physiological or functional signals acquired by and stored in the IND 112, . . .one or more programming instructions to the IND 112 which may include configurations for sensing physiologic signal or stimulation commands and stimulation parameters”, [0070], [0073]-[0074] including “The implantable neuromodulator 310 may receive the information about electrostimulation parameters and the electrode configuration from the external system”, [0076], [0101] see also [0046], [0110], [0115]; external device can receive sensed data from IND process it and then send updated/desired stimulation settings based on the processed data back to the IND for use).
Regarding Claim 26, interpretation of Ann discloses the above in claim 1.
An interpretation of Ann may not explicitly disclose measure evoked compound action potential (ECAP) magnitudes from the recordings wherein the clinical data includes the measured ECAP magnitudes; the clinical data including the measured ECAP magnitudes further including feedback target values.
However, in the same field of endeavor (medical devices), Park teaches measure evoked compound action potential (ECAP) magnitudes from the recordings wherein the clinical data includes the measured ECAP magnitudes (Park [0002], [0030]-[0031], [0053], [0058], figs. 4a-4b see also [0005]-[0006], [0050], figs. 5a, 6a, 7a);
the clinical data including the measured ECAP magnitudes further including feedback target values (Park [0002], [0030]-[0031], [0053], [0058], figs. 4a-4b, 9a see also [0005]-[0006], [0050], figs. 5a, 6a, 7a; Lair [0072]-[0073], [0092], [0094]-[0095]; Records ECAP readings over time at multiple locations).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including further derived metrics such as histograms as recited by Ann to include to include accurately sensing ECAP magnitudes and their respective position along the nerve fiber and using the ECAP as a feedback element with a plurality of feedback target values in a loop feedback arrangement as recited by Park in order to better understand the effects of neural modulation, provide feedback and stimulation adjustment based on the feedback ([0007]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention because it is merely combining prior art elements according to known methods to yield predictable results; combining the disclosed elements of a nerve stimulator/sensor device for treatment, gathering multiple types of event (clinical) data including neural data related to an event as recited by Ann and combining this with disclosure of Park which discloses the particular parameters sensed namely ECAP magnitude and feedback variable targets being used for feedback the combination of which yields the predictable result of histograms for the ECAP magnitude and feedback variable targets to be used in logs as feedback for the stimulation procedure.
An interpretation of Ann may not explicitly disclose wherein recording clinical data includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data for respective time windows.
However, in the same field of endeavor (medical devices), Kov teaches includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data ([0007]-[0008] recites gathering various information in coordination with the occurrence of an even including various physiological parameters, [0009] including “may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time.”, [0043], [0076], [0108], [0158] including “Bar graphs or histograms may allow the concise and clear presentation of a variety of event information” see also [0010], [0068], [0117], Claim 1; discloses histograms for multiple parameters relevant to the event. Examiner notes as evidenced by Fun Histograms are well known to the extent they are presented on math websites designed for teaching k-12 concepts see MathisFun About page. Examiner notes that Ann reference includes the determination of histogram(s) in the implantable) for respective time windows ([0007]-[0008], [0009], [0043], [0076], [0108], [0132], [0158] see also [0010], [0068], [0117], Claim 1; recite gathering multiple types of event information relevant to the each event, which encompasses the plurality of histograms comprising a first histogram of a first parameter for a time window and a second histogram a second parameter for the time window, and each event being a “respective” time window. Furthermore, the cited portions also disclose selecting a respective time window for review).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including ECAP magnitudes, feedback targe values and further derived metrics such as histograms as recited by Ann in view of Park to include the recording of the clinical data as therapy logs comprising a plurality of histograms of clinical data for respective time windows as described by Kov because the data when transferred to the external device with the interface is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009], [0158]).
Claim Rejections - 35 USC § 103
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ann in view of Park in further view of Kov in further view of Simms (Howard Simms, US 20060136014) hereinafter Sim with evidentiary support from Math.
Regarding claim 3, an interpretation of Ann further discloses wherein the implanted neuromodulation device is configured to communicate all recorded clinical data to the supervisory device via a non-implanted receiver ([0052]-[0053], [0064]-[0065], [0076] see also [0046], [0110]).
An interpretation of Ann may not explicitly disclose communicating whenever implanted device is within wireless communications range of the non- implanted receiver. Examiner notes that it is not possible to transfer data when it is out of range without adjusting the operation or hardware.
However, in the same field of endeavor (medical devices), Sim teaches communicating whenever the implantable device is within wireless communications range of the non- implanted receiver ([0025] including “the wireless device 133, such as a transceiver, may receive web content transmitted from the implantable medical device 102, whenever the IMD 102 is within a range of the wireless device 133.”).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including stimulator elements and sensors, external control/monitoring device including a user interface, with data transfer between the between the internal and external devices including sensor data, operational status data and control data as recited by Ann to include transferring data when the device comes in range as recited by Sim is merely applying a known technique (transferring data upon determining it is within range) to a known device (implant and external reader) ready for improvement to yield predictable results, data will be transferred when the device comes within range.
Claim Rejections - 35 USC § 103
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ann in view of Park in further view of Kov with evidentiary support from Math or, in the alternative, under 35 U.S.C. 103 over Ann in view of Park in further view of Kov in further view of Garg (Chaya Garg et al., US 20080270188) hereinafter Gar. Gar incorporates by reference in their entirety several Provisional Applications in [0056] including, but not limited to: 62/445,075, 62/445,053 and 62/445,061.
Regarding claim 5, an interpretation of Ann in view of Kov in further view of Park discloses a plurality of clinical data such as measured values (ECAP etc.), other parameters (target feedback values etc.) etc. see the citations above in claim 1. Ann further discloses wherein the clinical data further comprising at least one of stimulus current ([0060], [0073] see also [0049]; the stimulus current is one of the stored parameters in the stimulation configuration).
An interpretation of Ann may not explicitly disclose wherein recording clinical data includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data for respective time windows.
However, in the same field of endeavor (medical devices), Kov teaches includes therapy logs of the parameters or metrics which are included in the clinical data and the therapy logs comprising a plurality of histograms of the parameters or metrics which are included in the clinical data ([0007]-[0008] recites gathering various information in coordination with the occurrence of an even including various physiological parameters, [0009] including “may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time.”, [0043], [0076], [0108], [0158] including “Bar graphs or histograms may allow the concise and clear presentation of a variety of event information” see also [0010], [0068], [0117], Claim 1; discloses histograms for multiple parameters relevant to the event. Examiner notes as evidenced by Fun Histograms are well known to the extent they are presented on math websites designed for teaching k-12 concepts see MathisFun About page. Examiner notes that Ann reference includes the determination of histogram(s) in the implantable) for respective time windows ([0007]-[0008], [0009], [0043], [0076], [0108], [0132], [0158] see also [0010], [0068], [0117], Claim 1; recite gathering multiple types of event information relevant to the each event, which encompasses the plurality of histograms comprising a first histogram of a first parameter for a time window and a second histogram a second parameter for the time window, and each event being a “respective” time window. Furthermore, the cited portions also disclose selecting a respective time window for review).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including structural elements including stimulator elements, sensors, data transfer between the between the internal and external devices for additional processing and/or display and the determination of clinical data within the implantable including ECAP magnitudes, feedback targe values and further derived metrics such as histograms as recited by Ann in view of Park to include the recording of the clinical data as therapy logs comprising a plurality of histograms of clinical data for respective time windows as described by Kov because the data when transferred to the external device with the interface is organized in a format for the user to review and quickly ascertain relevant data records, relationships between the different data records or trends in the data ([0009], [0158]).
If it is determined that the stimulus current as clinical data is not disclosed by Ann then, In the same field of endeavor (medical devices), Gar teaches wherein the clinical data further comprises a stimulus current value ([0002], [0011], [0045]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including stimulator elements and sensors, external control/monitoring device including a user interface, with data transfer between the between the internal and external devices including sensor data, operational status data and control data as recited by Ann to include the user interface elements of plurality of histograms of the data in the user interface as described by Gar because the data is organized in a format for the user to review and quickly ascertain relationships between different events and elements of the data including prior/previous sessions ([0058], [0078]-[0079]).
Claim Rejections - 35 USC § 103
Claim(s) 6, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ann in view of Park in further view of Kov in further view of Gar with evidentiary support from Math. Gar incorporates by reference in their entirety several Provisional Applications in [0056] including, but not limited to: 62/445,075, 62/445,053 and 62/445,061.
Regarding claim 6, an interpretation of Ann in view of Park in further view of Kov discloses the above in claim 1.
An interpretation of Ann may not explicitly disclose wherein the supervisory device is configured to present the clinical data for review by presenting a subset of the clinical data as selected by filtering by time range.
However, in the same field of endeavor (medical devices), Gar teaches wherein the supervisory device is configured to present the clinical data for review by presenting a subset of the clinical data as selected by filtering by time range ([0049]-[0050], [0053]-[0055] see also [0048], [0058]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including stimulator elements and sensors, external control/monitoring device including a user interface, with data transfer between the between the internal and external devices including sensor data, operational status data and control data as recited by Ann to include the user interface elements of presenting a subset of data based on filtered time frame as described by Gar because the data is organized in a format for the user to view and track the data, quickly ascertain trends in data, and determine relationships between different events without having to invest a substantial amount of time into organizing the patient data ([0058], [0078]).
Regarding claim 8, an interpretation of Ann in view of Park in further view of Kov discloses the above in claim 1, including recorded clinical data.
An interpretation of Ann may not explicitly disclose wherein the clinical data comprises logged events, wherein the supervisory device is configured to present events for review by an indicia, and wherein each such indicia may be clicked or tapped to reveal a summary or full detail of the respective logged event represented by that indicia.
However, in the same field of endeavor (medical devices), Gar teaches wherein the clinical data comprises logged events ([0078]-[0079] see also [0076]-[0077], [0080]-[0081], [0083], Figs. 4, 8; Discloses logging of events during sessions), wherein the supervisory device is configured to present events for review by an indicia ([0078]-[0079]), and wherein each such indicia may be clicked or tapped to reveal a summary or full detail of the respective logged event represented by that indicia ([0079] including “select the “View Event” selection button 162 in order to view more detailed information about the significant event or event matches.”, [0083] See also [0076]-[0078], Figs. 4, 8).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including stimulator elements and sensors, external control/monitoring device including a user interface, with data transfer between the between the internal and external devices including sensor data, operational status data and control data as recited by Ann to include the user interface elements of event information and selection in the user interface as described by Gar because the data is organized in a format for the user to review and quickly ascertain relationships between different events and elements of the data including sensed data including ascertaining more details of a specific event upon user selection ([0078]-[0079]).
Claim Rejections - 35 USC § 103
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ann in view of Park in further view of Kov in further view of Tibshirani (Ryan Tibshirani, Histograms and Heatmaps, Statistical Computing, https://www.stat.cmu.edu/~ryantibs/statcomp-F16/lectures/histograms_heatmaps.html, Carnegie Mellon Statistical Computing Class, 9.21.2016, viewed on 8/26/23) hereinafter Tib with evidence from Fun and Grafana (Grafana Labs, Introduction to histograms and heatmaps, https://grafana.com/docs/grafana/latest/fundamentals/intro-histograms/, viewed on 8/25/23) hereinafter Grafana.
Regarding claim 11, an interpretation of Ann in view of Kov and Park discloses the above in claim 1 including Kov’s recitation of plotting using time as a variable for a histograms and for tracking trends of the data over time; as well as disclosing using three dimensional plots ([0009] including “may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time.”, [0158] including “three-dimensional may be useful including, for example, surface maps and the like.” See also the rejection of claim 10; Examiner notes a heat map is also known as a color map).
An interpretation of Ann may not explicitly disclose the use of a heat map representation.
However, in the same field of endeavor (data visualization), Tib teaches the use of a heat map to represent histogram (reference discloses the plotting and even code for displaying a histogram and a heatmap). Grafana provides evidence this can be used for a timescale, also as explained by Grafana instead of using bar height as a representation of frequency, a Heatmap uses cells, and colors the cell proportional to the number of values in the bucket (see the discussion of HeatMaps and the Figure).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including stimulator elements and sensors, external control/monitoring device including a user interface displaying log information including histograms over time, with data transfer between the between the internal and external devices including sensor data, operational status data and control data as recited by Ann in view of Kov to include the using a heat map to represent a histogram over time because it is the use of known technique displaying histograms over time as disclosed by Tib with evidence from Grafana to improve similar devices data visualization over time in the same way.
Claim Rejections - 35 USC § 103
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ann in view of Park in further view of Kov in further view of John (Michael John et al., US 20070208263) hereinafter John.
Regarding claim 17, an interpretation of Ann discloses the above in claim 1 including the display of histograms and statistical measures including mean etc. ([0060] see the rejection of claim 1).
An interpretation of Ann may not explicitly disclose wherein the presented clinical data includes quantitative analysis of one or more of the plurality of histograms.
However, in the same field of endeavor (medical devices), John teaches wherein the presented clinical data includes quantitative analysis of one or more of the plurality histograms ([0085] including “Analysis of histogram data can include a number of measures such as peak-bin, variance, skewness, or average, and can include algorithms to perform such methods as regression, smoothing, interpolation, and calculation of slope.”, [0088] see also [0003], [0012], [0086]-[0087], [0202]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the implanted stimulator including stimulator elements and sensors, external control/monitoring device including a user interface, with data transfer between the between the internal and external devices including sensor data, operational status data and control data as recited by Ann to include histogram analysis as described by John because the use of histogram data can be used for the detection of abnormalities, as well as the quantification, evaluation and classification of histogram data according to patient state values ([0012], [0088]) providing early detection and/or prediction of medical conditions and alarming the patient in response so action can be taken early ([0007], [0088]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jake VanderPlas, Python Data Science Handbook, Release date: November 2016, O'Reilly Media, Inc., ISBN: 9781491912058, viewed on 8/25/23
US 20140296737 (cited in IDS on 10/21/20) see abstract, Figs. 3, 5-7
Yun Guan et al.; Spinal Cord Stimulation-induced Analgesia: Electrical Stimulation of Dorsal Column and Dorsal Roots Attenuates Dorsal Horn Neuronal Excitability in Neuropathic Rats. Anesthesiology 2010; 113:1392–1405 doi: https://doi.org/10.1097/ALN.0b013e3181fcd95c
US 20170135624 (cited in IDS dated 9/5/23 and previously published as WO 2015143509) see [0058], [0060], Fig. 6 recites measuring ECAP and using a Histogram to represent data related to timings of ECAPs
US 20170173326 (cited in IDS dated 9/5/23) see [0106]-[0107]
Adam Hebb et al., Creating the feedback loop: closed-loop neurostimulation. Neurosurg Clin N Am. 2014 Jan;25(1):187-204. doi: 10.1016/j.nec.2013.08.006. Epub 2013 Oct 23. PMID: 24262909; PMCID: PMC4058859. Viewed on 10/18/24 – The concept of implanted closed loop electrical stimulation is well established in the art with cardiac pacemakers using closed loop pacing in about 1963 while neural based closed stimulation is more recent as disclosed by reference it also was generally known prior to the priority date
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/James Moss/ Examiner, Art Unit 3792