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 .
Response to Arguments
Applicant's arguments filed on February 12, 2026 have been fully considered but they are not fully persuasive.
Regarding Applicant’s arguments, Applicant states that Chen does not teach generating a heatmap representation depicting spatially distributed clinical response intensities within the search space, and further argues that inherency cannot be used to supply a specific graphical representation technique that is neither disclosed nor present in the reference.
The examiner respectfully disagrees. According to ScienceInsights, a heatmap is “a data visualization that uses color to represent values, turning numbers into an intuitive visual pattern where darker or more intense colors indicate higher values and lighter colors indicate lower ones.” See ScienceInsight, Page 1.
As shown below, Chen does teach wherein the user interface displays a data visualization that uses color to represent values (dark and light colors) to indicate higher values and lighter colors to indicate lower ones.
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Therefore, Chen does satisfy the definition of a heatmap, due to graphically displaying the features required by the above definition. Furthermore, as shown above, Chen also teaches spatially distributed clinical response intensities within the search space.
In regard to applicant’s arguments stating that Chen does not teach identifying and displaying effect regions based on predicted clinical response indicator across the search space, this argument has been found to be persuasive. Therefore, the previous rejection(s) have been withdrawn. However, upon further search and consideration, a new ground(s) of rejection have been made in view of applicant’s amendments as can be further seen below.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 101 due to the claims being directed to a mental process without significantly more.
All of claims 1-20 are directed to a system that predicts one or more clinical effects and provides recommendations for providing electrostimulation to a patient, which could be performed by the human mind and/or by a human with a physical aid as with pen and paper.
Step 1:
Claim 1 recites a system (a product) and claim 9 recites a method (a process).
Step 2A, Prong 1:
Claims 1 and 9 recite the steps of:
Identifying a first set of base stimulation settings and a different second set of base stimulation settings, each base stimulation setting of the first and second sets comprising an electrode configuration and stimulation parameter values or value ranges selected from a search space of electrode configurations and parameter values for the lead with respect to the neural target.
For each base stimulation setting of the second set, without delivering electrostimulation, predict one or more clinical effects based at least on the detected clinical effects corresponding to the first set of base stimulation settings, and estimate a clinical response indicator using the predicted one or more clinical effects.
Automatically identify a positive effect region and a negative effect region within the search space.
Determine characteristic stimulation amplitudes for at least one electrode configuration in the search space.
A user interface configured to display (i) a first heatmap representing the positive effect region and a second heatmap representing the negative effect region.
Provide a recommendation for programming a stimulation setting within the positive effect region.
Providing a graphical representation of the characteristic stimulation amplitudes for at least one electrode configuration.
The steps above, under broadest reasonable interpretation, can be performed by mental process steps because they can be practically performed in the human mind. For instance, a clinician can identify a base stimulation setting to apply to a neural target of a patient, and based on the patient’s response, predict one or more clinical effects for the second set of base stimulation settings and automatically identify a positive effect region (region where no side effects are present) and a negative effect region (region where side effects are present) as a result of the applied electrostimulation.
Step 2A, Prong 2:
Claims 1 and 9 include the additional elements of:
An implantable stimulator configured to provide electrostimulation to a neural target of the patient via a lead comprising a plurality of electrodes. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
A programming device communicatively coupled to the implantable stimulator. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
A programming device including a controller. This is merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.04 (d).
A user interface. This is merely adds insignificant extra-solution activity to the judicial exception. See MPEP 2106.04 (d).
Linking the use of a judicial exception to another technological environment or field of use; generic computer implementation; and insignificant extra-solution activity do not provide integration into a practical application.
Step 2B:
Claims 1 and 9 include the additional elements of:
An implantable stimulator configured to provide electrostimulation to a neural target of the patient via a lead comprising a plurality of electrodes. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
A programming device communicatively coupled to the implantable stimulator. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
A programming device including a controller. This is merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.04 (d).
A user interface. This is merely adds insignificant extra-solution activity to the judicial exception. See MPEP 2106.04 (d).
These additional elements in claims 1 and 9 identified by the courts, either alone or in combination, have found not to be enough to qualify as “significantly more” than the abstract idea itself when recited in a claim with a judicial exception.
Dependent Claims:
Claims 3-4, 10-12, and 15 further define the mental process and abstract idea, therefore failing to amount to “significantly more” than the abstract ideas either alone or in combination as previously stated for the independent claims.
Claims 5-8, 13-14, and 16-20 merely adds insignificant extra-solution activity to the judicial exception.
To overcome the current rejection, the examiner suggests amending claims 1 and 9 to include the claim limitations of claim 2.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0104500 A1 to Blum et al. (hereinafter “Blum”) in view of US 2017/0080234 A1 to Gillespie et al. (hereinafter “Gillespie”), US 2019/0126032 A1 to Cheeran et al. (hereinafter “Cheeran”), US 2014/0200633 A1 to Moffitt (hereinafter “Moffitt”), WO 2014/144029 A3 to Chen et al. (hereinafter “Chen”), and US 2019/0015039 A1 to Blum et al. (hereinafter “Blum’039”).
Regarding claim 1, Blum teaches a system for providing electrostimulation to a patient (para 0002, lines 1-3), comprising:
an implantable stimulator (para 0006) configured to provide electrostimulation to a neural target of the patient via a lead comprising a plurality of electrodes (para 0004 and para 0008); and
a programming device (para 0070, lines 4-8) communicatively coupled to the implantable stimulator (para 0070, lines 4-8), the programming device including a controller (para 0070, lines 1-8 and para 0090, lines 1-7) configured to:
identify a first set of base stimulation settings/parameters (para 0017, lines 1-8) and a different second set of base stimulation settings/parameters (para 0005, lines 8-21 and para 0017, lines 1-17), each base stimulation setting of the first and second sets comprising an electrode configuration/electrode determination (para 0007 and para 0008, lines 1-3) and stimulation parameter values or value ranges (para 0005, lines 8-11) selected from a search space/parameter space of electrode configurations and parameter values for the lead with respect to the neural target (para 0067, para 0076, and para 0093, lines 1-5);
for each base stimulation setting of the first set, detect one or more clinical effects/ clinical response values in response to electrostimulation delivered according to the corresponding base stimulation setting (para 0005, lines 1-16), and evaluate a clinical response indicator/therapeutic response within a specified/designated threshold using the detected one or more clinical effects/clinical response values (para 0168, lines 1-8 and para 0182);
for each base stimulation setting of the second set, without delivering electrostimulation, predict one or more clinical effects/therapeutic response values based at least on the detected clinical effects/clinical response values corresponding to the first set of base stimulation settings (para 0005, lines 1-25, para 0012, and para 0024), and estimate a clinical response indicator/therapeutic response using the predicted one or more clinical effects (para 0017, lines 1-19). Furthermore, Blum discloses using the clinical response indicators/therapeutic response of the first and second base stimulation settings/parameters to generate improved stimulation parameter values and an electrode configuration/determination from the parameter search space (para 0005 and para 0076), wherein the clinical response indicators/therapeutic responses satisfying respective conditions/a stop condition or a therapeutic response within a designated tolerance (para 0005, lines 26-32 and para 0078, lines 13-17), and a user interface (fig. 6K and para 0039), but does not disclose wherein,
based on the clinical response indicators/therapeutic response of the first and second sets of base stimulation settings;
automatically identify a positive effect region and a negative effect region within the search space, the positive effect region determined based on and encompassing at least data points representing stimulation parameters and electrode configurations corresponding to electrostimulation without causing side effects,
the negative effect region determined based on and encompassing at least data points representing stimulation parameters and electrode configuration corresponding to electrostimulation causing side effects, and does not teach a user interface configured to display (i) a first heatmap representing the positive effect region and a second heatmap representing the negative effect region, each heatmap depicting spatially distributed clinical response intensities within the search space, wherein the first heatmap and the second heatmap are generated based at least in part on spatial interpolation of clinical response indicators for untested stimulation settings.
However, Chen teaches a system and method for clinical response mapping (abstract). The system (figs. 1 and 4) utilizes a processor, a storage component, and base stimulation program settings in order to elicit a therapeutic response in a patient (para 6, 15, 20, 31, and 33). After the therapeutic response is stored, the system automatically determines the positive effect region and a negative side effect region/adverse side effect region is identified within the search space/data store (para 17, para 33), wherein the positive effect region represents a first subspace of stimulation parameters (such as amplitude) and electrode configuration (leadwire position or electrode number) corresponding to electrostimulation without causing side effects (therapeutic) (see abstract, annotated fig. 1 below, and para 41-47), and the negative effect region (adverse side effect region) representing a second subspace of stimulation parameters and electrode corresponding to electrostimulation causing side effects (see abstract, annotated fig. 1 below, and para 41-47). Furthermore, the system (fig. 1) contains a user interface configured to display a first heatmap representing the positive effect region and a second heatmap representing the negative effect region, each heatmap depicting spatially distributed clinical response intensities within the search space (see explanation above regarding annotated fig. 1 below, as well as para 41 and 45), wherein the first heatmap and second heatmap are used to generate an overall interpolated score based on the therapeutic effect region and side effect region (see para [75]-[77]), where the negative effect region and positive effect region is determined based on and encompassing at least data points representing stimulation parameters and electrode configurations corresponding to electrostimulation causing side effects and without causing side effects (see explanation above regarding annotated fig. 1 below, as well as para 41 and 45).
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Chen does not explicitly disclose wherein the first heatmap and the second heatmap are generated based at least in part on spatial interpolation of clinical response indicators.
However, Blum’039 teaches systems and methods for generating a clinical effects map based on the received clinical response(s), where the clinical response(s) are associated with at least one therapeutic effect and/or side effect (see abstract). The system (figs. 1 and figs. 8-9) teach wherein a first region/therapeutic effect region and second region/side effect region (see fig. 5, 501 and 503 and para [0056]) are generated based at least in part on spatial interpolation of clinical response indicators (see para [0022], [0056], and para [0076]-[0080]). However, the combination of Blum, Chen, and Blum’039 does not explicitly disclose determining characteristic stimulation amplitudes for at least one electrode configuration/electrode determination in the search space/parameter space based on the clinical response indicators/therapeutic response of the first and second sets of base stimulation settings/parameters.
However, Gillespie teaches systems, devices, and methods for delivering neurostimulation to a patient (para 0002). The system (fig. 3) uses clinical response indicators (fig. 15, 1506) from a first and second set of base stimulation settings/inputs (fig. 13 and fig. 15, 1504) to determine characteristic stimulation amplitudes/fractionalized current distribution to electrodes for at least one electrode configuration in the search space/ranges (para 0062 and para 0079).
Gillespie does not disclose a recommendation for programming a stimulation setting within the positive effect region and,
a user interface configured to display (ii) a graphical representation of the characteristic stimulation amplitudes for the at least one electrode configuration.
Yet, Moffitt teaches a system and method for graphically identifying candidate electrodes of a leadwire used for stimulation a target anatomy of a patient (abstract). The system (figs. 3A-3B, and 5-6), teaches,
displaying graphical representations of the positive effect region/parameter recommendation marking (fig. 6, 602 and para 0073) and the negative effect region/region marking (figs. 5-6, 206 and 206a, and para 0073), and a recommendation for programming a stimulation setting (such as an ideal amplitude value between 2-3 mA) within the positive effect region/recommendation marking (see fig. 3A-3B, 5, annotated fig. 6 below, para 0071, and para 0073).
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Moffitt does not explicitly teach a user interface configured to display (ii) a graphical representation of the characteristic stimulation amplitudes for the at least one electrode configuration.
Nevertheless, Cheeran discloses methods for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) uses a user interface configured display a graphical representation of the characteristic stimulation amplitudes for at least one electrode configuration (figs 3 and 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Blum with the teachings of Chen, Blum’039, Moffitt, Gillespie, and Cheeran to arrive at the claimed invention. Such modification would improve the system’s accuracy by providing the clinician with a visual representation of the optimal stimulation configuration and amplitudes as well as the optimal stimulation settings in the positive effect region when stimulation is applied to the patient, ultimately providing safer stimulation that will prevent adverse side effect while enhancing the therapeutic benefit of the stimulation system.
Regarding claim 2, Blum as modified teaches the system of claim 1 above, wherein the programming device is configured to generate a control signal/stimulation and/or carrier wave signal to the implantable stimulator to deliver electrostimulation (para 0070, lines 1-8, para 0087, lines 1-11, and para 0089), but does not disclose wherein the control signal is based on the characteristic stimulation amplitudes for the at least one electrode configuration.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) uses stimulation amplitudes and different electrode configurations/combinations to apply electrostimulation signals to a patient (fig. 3, para 0035-0036).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Blum the electrode configuration and stimulation amplitudes of Cheeran to arrive at the claimed invention. Such modification would enhance the system’s accuracy by providing the clinician to visualize different stimulation configurations and amplitudes that result in different patient responses, ultimately allowing for more accurate and safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 3, Blum as modified teaches the system of claim 1 above, wherein a first amplitude corresponds to a clinical response indicator/therapeutic response(s) indicating an improvement in patient symptoms from a baseline (or within a designated tolerance and/or threshold) (fig. 7, para 0074 and para 0078, lines 1-15). Furthermore, Blum teaches a clinical response score/clinical response value computed as a weighted combination of one or more clinical effects (para 0091), but does not disclose wherein the characteristic stimulation amplitudes include one or more of a second stimulation amplitude corresponding to a clinical response score/percentage exceeding a threshold. Furthermore, Blum does not disclose a third stimulation amplitude corresponding to a clinical response indicator representing a side effect or a loss of improvement of patient symptom from the baseline.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) discloses using a second stimulation amplitude which corresponds to a clinical response score/window percentage exceeding a threshold (para 0055, lines 1-15). Moreover, Cheeran discloses using another stimulation amplitude/third stimulation amplitude that corresponds to a clinical response indicator/window percentage representing a side effect or a loss of improvement of patient symptom from a baseline/threshold (para 0047, and para 0055, lines 1-18).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Blum with the second amplitude, third amplitude, and the clinical response score/window percentage and threshold/baseline of Cheeran to arrive at the claimed invention. Such modification would enhance system’s accuracy by providing the clinician with the optimal stimulation configuration and amplitudes to provide safer stimulation that will prevent adverse side effect while enhancing the therapeutic benefit of the stimulation system.
Regarding claim 4, Blum as modified teaches the system of claim 3 above, wherein at least one of the first, the second, or the third stimulation amplitude is a minimum stimulation amplitude, within a specific amplitude range, (para 0146, lines 1-8) with a corresponding clinical response indicator/ therapeutic response satisfying a specific condition (para 0182, lines 1-5 and para 0150).
Regarding claim 5, Blum as modified teaches the system of claim 1 above wherein the controller is configured to predict the one or more clinical effects/clinical response values for each of the second set of base stimulation settings by applying the detected clinical effects/ clinical response values for the first set of base stimulation settings/parameters (para 0005, lines 1-19) to a trained machine-learning models/engines (para 0005, lines 1-19, para 0016, para 0017, and para 0090, lines 1-29).
Regarding claim 6, Blum as modified teaches the system of claim 1 above, wherein the at least one electrode configuration includes one or more monopolar configurations/monopolar review each involving respective ring electrodes at different longitudinal positions on the lead (fig. 3A-3D, para 0036, and para 0078), but does not disclose
wherein the controller/Implantable pulse generator is configured to, for each of the one or more monopolar configurations/ monopolar review, involving a corresponding ring electrode, determine respective characteristic stimulation amplitudes. Furthermore, Blum does not disclose graphically representing the respective characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the corresponding ring electrode.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) contains an implantable pulse generator (IPG)/controller configured to determine respective characteristic stimulation amplitudes for one or more monopolar configurations/monopolar reviews (which involves corresponding ring electrodes) (para 0035-0036, para 0045, lines 1-10, and para 0050). Cheeran does not explicitly disclose graphically representing the respective characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the corresponding ring electrode.
However, Chen discloses a system and method for clinical response mapping of stored data following electrical stimulation of anatomical tissue (abstract, lines 1-2). The system (fig. 1) graphically represents stimulation amplitudes using markers linearly arranged in a direction with respect to the longitudinal position corresponding to a lead wire/ stimulation electrodes (fig. 1, 108, para 35, para 42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of claim 1 with the IPG, monopolar review, and stimulation amplitudes of Cheeran and the GUI and marker display system and method of Chen to arrive at the claimed invention. Such modification would improve the system and enhance system accuracy by providing the clinician with a visual representation of the optimal stimulation configuration and amplitudes when stimulation is applied to the patient, ultimately providing safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 7, Blum teaches the system as modified for claim 1 above, wherein the at least one electrode configuration includes a monopolar configuration/monopolar review involving a set of segmented electrodes around a circumference of the lead at a longitudinal position (see first two sentences of para 0052, fig. 2, fig. 3A-3D; 330, para 0036, and para 0078), wherein the set of segmented electrodes is configured to deliver ring mode stimulation (fig. 3A-3D; 330 and para 0177), but does not disclose wherein the controller is configured to, for the monopolar configuration involving the set of segmented electrodes configured to deliver ring mode stimulation, determine respective characteristic stimulation amplitudes. Furthermore, Blum does not disclose graphically represent the characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the set of segmented electrodes on the lead (fig. 1, 108, para 35, para 42).
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) discloses a controller/IPG configured to determine stimulation amplitudes/characteristic stimulation amplitudes for the monopolar configuration/monopolar review involving the set of segmented electrodes configured to deliver ring mode stimulation (para 0035-0036, para 0045, lines 1-10, and para 0050). Cheeran does not explicitly disclose graphically represent the characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the set of segmented electrodes on the lead.
However, Chen discloses a system and method for clinical response mapping of stored data following electrical stimulation of anatomical tissue (abstract, lines 1-2). The system (fig. 1) graphically represents stimulation amplitudes using markers linearly arranged in a direction with respect to the longitudinal position corresponding to a lead wire/ stimulation electrodes (fig. 1, 108, para 35, para 42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of claim 1 with the IPG, monopolar review, and stimulation amplitudes of Cheeran and the GUI and marker display system and method of Chen to arrive at the claimed invention. Such modification would improve the system’s stimulation accuracy by allowing for more precise control when apply stimulation current to selective tissue, ultimately providing safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 8, Blum as modified teaches the system of claim 1, wherein the at least one electrode configuration includes one or more monopolar configurations/monopolar review each involving respective segmented electrodes at different angular positions around a circumference of the lead (fig. 3A-3D; 330, para 0036, para 0055 and para 0078), but does not explicitly disclose wherein the controller configured to, for each of the one or more monopolar configurations involving a corresponding segmented electrode, determine respective characteristic stimulation amplitudes and graphically represent the respective characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the angular position of the corresponding segmented electrode (para 0053 of Cheeran).
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) contains a controller/IPG configured to, for each of the one or more monopolar configurations involving a corresponding segmented electrode, determine respective characteristic stimulation amplitudes and graphically represent the respective characteristic stimulation amplitudes by markers/points linearly arranged in a direction with respect to the angular position of the corresponding segmented electrode (fig. 6; 603 and 632, para 0045, and para 0053).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of claim 1 with the controller, the display, the markers/points, and the characteristic stimulation amplitude method for the angular position of the segmented electrodes of Cheeran to arrive at the claimed invention. Such modification would improve the stimulation accuracy for each patient by allowing for more precise control and understanding of the stimulation effects when applying stimulation current to selective tissue, ultimately providing safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 9, Blum teaches a method of presenting electrostimulation data and patient clinical responses to electrostimulation (para 0002 and para 0017, lines 1-3), the method comprising:
identifying a first set of base stimulation settings/parameters (para 0017, lines 1-8) and a different second set of base stimulation settings/parameters (para 0005, lines 8-21 and para 0017, lines 1-17), each base stimulation setting of the first and second sets comprising an electrode configuration/electrode determination (para 0007 and para 0008, lines 1-3) and stimulation parameter values or value ranges (para 0005, lines 8-11) selected from a search space/parameter space of electrode configurations and parameter values for the lead with respect to the neural target (para 0067, para 0076, and para 0093, lines 1-5);
for each base stimulation setting of the first set, detect one or more clinical effects/ clinical response values in response to electrostimulation delivered according to the corresponding base stimulation setting (para 0005, lines 1-16), and evaluate a clinical response indicator/therapeutic response within a specified/designated threshold using the detected one or more clinical effects/clinical response values (para 0168, lines 1-8 and para 0182);
for each base stimulation setting of the second set, without delivering electrostimulation, predict one or more clinical effects/therapeutic response values based at least on the detected clinical effects/clinical response values corresponding to the first set of base stimulation settings (para 0005, lines 1-25, para 0012, and para 0024), and estimate a clinical response indicator/therapeutic response using the predicted one or more clinical effects (para 0017, lines 1-19). Furthermore, Blum discloses using the clinical response indicators/therapeutic response of the first and second base stimulation settings/parameters to generate improved stimulation parameter values and an electrode configuration/determination from the parameter search space (para 0005 and para 0076), wherein the clinical response indicators/therapeutic responses satisfying respective conditions/a stop condition or a therapeutic response within a designated tolerance (para 0005, lines 26-32 and para 0078, lines 13-17), and a user interface (fig. 6K and para 0039), but does not disclose wherein,
based on the clinical response indicators/therapeutic response of the first and second sets of base stimulation settings;
automatically identify a positive effect region and a negative effect region within the search space, the positive effect region determined based on and encompassing at least data points representing stimulation parameters and electrode configurations corresponding to electrostimulation without causing side effects,
the negative effect region determined based on and encompassing at least data points representing stimulation parameters and electrode configuration corresponding to electrostimulation causing side effects, and does not teach a user interface configured to display (i) a first heatmap representing the positive effect region and a second heatmap representing the negative effect region, each heatmap depicting spatially distributed clinical response intensities within the search space, wherein the first heatmap and the second heatmap are generated based at least in part on spatial interpolation of clinical response indicators for untested stimulation settings.
However, Chen teaches a system and method for clinical response mapping (abstract). The system (figs. 1 and 4) utilizes a processor, a storage component, and base stimulation program settings in order to elicit a therapeutic response in a patient (para 6, 15, 20, 31, and 33). After the therapeutic response is stored, the system automatically determines the positive effect region and a negative side effect region/adverse side effect region is identified within the search space/data store (para 17, para 33), wherein the positive effect region represents a first subspace of stimulation parameters (such as amplitude) and electrode configuration (leadwire position or electrode number) corresponding to electrostimulation without causing side effects (therapeutic) (see abstract, annotated fig. 1 below, and para 41-47), and the negative effect region (adverse side effect region) representing a second subspace of stimulation parameters and electrode corresponding to electrostimulation causing side effects (see abstract, annotated fig. 1 below, and para 41-47). Furthermore, the system (fig. 1) contains a user interface configured to display a first heatmap representing the positive effect region and a second heatmap representing the negative effect region, each heatmap depicting spatially distributed clinical response intensities within the search space (see explanation above regarding annotated fig. 1 below, as well as para 41 and 45), wherein the first heatmap and second heatmap are used to generate an overall interpolated score based on the therapeutic effect region and side effect region (see para [75]-[77]), where the negative effect region and positive effect region is determined based on and encompassing at least data points representing stimulation parameters and electrode configurations corresponding to electrostimulation causing side effects and without causing side effects (see explanation above regarding annotated fig. 1 below, as well as para 41 and 45).
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Chen does not explicitly disclose wherein the first heatmap and the second heatmap are generated based at least in part on spatial interpolation of clinical response indicators.
However, Blum’039 teaches systems and methods for generating a clinical effects map based on the received clinical response(s), where the clinical response(s) are associated with at least one therapeutic effect and/or side effect (see abstract). The system (figs. 1 and figs. 8-9) teach wherein a first region/therapeutic effect region and second region/side effect region (see fig. 5, 501 and 503 and para [0056]) are generated based at least in part on spatial interpolation of clinical response indicators (see para [0022], [0056], and para [0076]-[0080]). However, the combination of Blum, Chen, and Blum’039 does not explicitly disclose determining characteristic stimulation amplitudes for at least one electrode configuration/electrode determination in the search space/parameter space based on the clinical response indicators/therapeutic response of the first and second sets of base stimulation settings/parameters.
However, Gillespie teaches systems, devices, and methods for delivering neurostimulation to a patient (para 0002). The system (fig. 3) uses clinical response indicators (fig. 15, 1506) from a first and second set of base stimulation settings/inputs (fig. 13 and fig. 15, 1504) to determine characteristic stimulation amplitudes/fractionalized current distribution to electrodes for at least one electrode configuration in the search space/ranges (para 0062 and para 0079).
Gillespie does not disclose a recommendation for programming a stimulation setting within the positive effect region and,
a user interface configured to display (ii) a graphical representation of the characteristic stimulation amplitudes for the at least one electrode configuration.
Yet, Moffitt teaches a system and method for graphically identifying candidate electrodes of a leadwire used for stimulation a target anatomy of a patient (abstract). The system (figs. 3A-3B, and 5-6), teaches,
displaying graphical representations of the positive effect region/parameter recommendation marking (fig. 6, 602 and para 0073) and the negative effect region/region marking (figs. 5-6, 206 and 206a, and para 0073), and a recommendation for programming a stimulation setting (such as an ideal amplitude value between 2-3 mA) within the positive effect region/recommendation marking (see fig. 3A-3B, 5, annotated fig. 6 below, para 0071, and para 0073).
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Moffitt does not explicitly teach a user interface configured to display (ii) a graphical representation of the characteristic stimulation amplitudes for the at least one electrode configuration.
Nevertheless, Cheeran discloses methods for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) uses a user interface configured display a graphical representation of the characteristic stimulation amplitudes for at least one electrode configuration (figs 3 and 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Blum with the teachings of Chen, Blum’039, Moffitt, Gillespie, and Cheeran to arrive at the claimed invention. Such modification would improve the system’s accuracy by providing the clinician with a visual representation of the optimal stimulation configuration and amplitudes as well as the optimal stimulation settings in the positive effect region when stimulation is applied to the patient, ultimately providing safer stimulation that will prevent adverse side effect while enhancing the therapeutic benefit of the stimulation system.
Regarding claim 10, Blum as modified teaches the method of claim 9 above, containing first and second base stimulation settings/parameters (para 0005), but does not explicitly disclose wherein the characteristic stimulation amplitudes are determined for at least one of a monopolar electrode configuration/monopolar review in the first set of base stimulation settings, or a monopolar electrode configuration/monopolar review in the second set of base stimulation settings.
However, Cheeran discloses methods for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) teaches wherein the characteristic stimulation amplitudes are determined for at least one electrode configuration/monopolar review for various electrode combinations each with differing parameters/settings (para 0035-0036).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified system of Blum with the teachings of Cheeran to arrive at the claimed invention. Such combination would improve the stimulation method when applied to patients by allowing both the clinician and patient to see which electrode configuration and stimulation settings would provide the safest stimulation for the patient, ultimately preventing adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 11, Blum as modified teaches the method of claim 9 above, wherein a first amplitude corresponds to a clinical response indicator/therapeutic response(s) indicating an improvement in patient symptoms from a baseline (or within a designated tolerance and/or threshold) (fig. 7, para 0074 and para 0078, lines 1-15). Furthermore, Blum teaches a clinical response score/clinical response value computed as a weighted combination of one or more clinical effects (para 0091); but does not disclose wherein the characteristic stimulation amplitudes include one or more of a second stimulation amplitude corresponding to a clinical response score/percentage exceeding a threshold. Furthermore, Blum does not disclose a third stimulation amplitude corresponding to a clinical response indicator representing a side effect or a loss of improvement of patient symptom from the baseline.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) discloses using a second stimulation amplitude which corresponds to a clinical response score/window percentage exceeding a threshold (para 0055, lines 1-15). Moreover, Cheeran discloses using another stimulation amplitude/third stimulation amplitude that corresponds to a clinical response indicator/window percentage representing a side effect or a loss of improvement of patient symptom from a baseline/threshold (para 0047, and para 0055, lines 1-18).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method of Blum with the second amplitude, third amplitude, and the clinical response score/window percentage and threshold/baseline of Cheeran to arrive at the claimed invention. Such modification would enhance system’s accuracy by providing the clinician with the optimal stimulation configuration and amplitudes to provide safer stimulation that will prevent adverse side effect while enhancing the therapeutic benefit of the stimulation system.
Regarding claim 12, Blum as modified teaches the method of claim 11 above, wherein at least one of the first, the second, or the third stimulation amplitude is a minimum stimulation amplitude, within a specific amplitude range, (para 0146, lines 1-8) with a corresponding clinical response indicator/ therapeutic response satisfying a specific condition (para 0182, lines 1-5 and para 0150).
Regarding claim 13, Blum as modified teaches the method of claim 11, but does not disclose further comprising displaying a therapeutic window representing an amplitude range between the first characteristic stimulation amplitude and the third characteristic stimulation amplitude.
However, Cheeran discloses methods for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) comprises displaying a therapeutic window representing an amplitude range between the first characteristic stimulation amplitude/side-effect amplitude value and a third characteristic stimulation amplitude/benefit amplitude value (fig. 7, para 0054-0055).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method of Blum with the teachings of Cheeran to arrive at the claimed invention. Such modification would improve the stimulation system by providing a range of stimulation amplitudes that can be applied to an electrode/ electrode configuration without introducing unwanted side effects, which would provide safer and more accurate stimulation for each patient.
Regarding claim 15, Blum as modified teaches the method of claim 9, wherein the evaluated clinical response indicator/clinical response value includes a clinical response score computed using a weighted combination of the detected one or more clinical effects, and the estimated clinical response indicator/clinical response score includes a clinical response score computed using a weighted combination of the predicted one or more clinical effects (para 0192).
Regarding claim 16, Blum as modified teaches the method of claim 9 above, wherein the at least one electrode configuration includes one or more monopolar configurations/monopolar review each involving respective ring electrodes at different longitudinal positions on the lead (fig. 3A-3D, para 0036, and para 0078), but does not disclose
wherein the controller/Implantable pulse generator is configured to, for each of the one or more monopolar configurations/ monopolar review, involving a corresponding ring electrode, determine respective characteristic stimulation amplitudes. Furthermore, Blum does not disclose graphically representing the respective characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the corresponding ring electrode.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) contains an implantable pulse generator (IPG)/controller configured to determine respective characteristic stimulation amplitudes for one or more monopolar configurations/monopolar reviews (which involves corresponding ring electrodes) (para 0035-0036, para 0045, lines 1-10, and para 0050). Cheeran does not explicitly disclose graphically representing the respective characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the corresponding ring electrode.
However, Chen discloses a system and method for clinical response mapping of stored data following electrical stimulation of anatomical tissue (abstract, lines 1-2). The system (fig. 1) graphically represents stimulation amplitudes using markers linearly arranged in a direction with respect to the longitudinal position corresponding to a lead wire/ stimulation electrodes (fig. 1, 108, para 35, para 42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of claim 1 with the IPG, monopolar review, and stimulation amplitudes of Cheeran and the GUI and marker display system and method of Chen to arrive at the claimed invention. Such modification would improve the system and enhance system accuracy by providing the clinician with a visual representation of the optimal stimulation configuration and amplitudes when stimulation is applied to the patient, ultimately providing safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 17, Blum as modified teaches the method of claim 16, but does not explicitly disclose characteristic stimulation amplitudes that includes first characteristic stimulation amplitudes for a first monopolar configuration that includes a first ring electrode at a first longitudinal position on the lead and second characteristic stimulation amplitudes for a second monopolar configuration that includes a second ring electrode at a second longitudinal position different than the first longitudinal position on the lead. Furthermore, Blum as modified does not explicitly disclose wherein the graphical representation of the characteristic stimulation amplitudes includes first markers, representing the first characteristic stimulation amplitudes, that are linearly arranged along a first line projecting from the first longitudinal position, and second markers, representing the second characteristic stimulation amplitudes, that are linearly arranged along a second line projecting from the second longitudinal position and parallel to the first line.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) contains characteristic stimulation amplitudes that includes first and second characteristic stimulation amplitudes/different amplitudes for various monopolar configurations that includes ring electrodes at first and second longitudinal positions on the lead (fig. 1; 101 and 102, fig. 3, para 0035-0036, para 0045-0046, para 0048, and para 0050 (first 4 sentences)). Cheeran does not explicitly disclose wherein the graphical representation of the characteristic stimulation amplitudes includes first markers, representing the first characteristic stimulation amplitudes, that are linearly arranged along a first line projecting from the first longitudinal position of the lead, and second markers, representing the second characteristic stimulation amplitudes, that are linearly arranged along a second line projecting from the second longitudinal position and parallel to the first line.
Nevertheless, Chen discloses a system and method for clinical response mapping of stored data following electrical stimulation of anatomical tissue (abstract, lines 1-2). The system (fig. 1) graphically represents stimulation amplitudes including first markers, representing the first characteristic stimulation amplitudes, that are linearly arranged along a first line projecting from the first longitudinal position on the lead wire/electrode (fig. 1;108, para 35, and para 42), and second markers, representing the second characteristic stimulation amplitudes, that are linearly arranged along a second line projecting from the second longitudinal position and parallel to the first line (fig. 1;108 and line 4 along the y-axis, para 35, and para 42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified method of Blum with the GUI and amplitude marking method of Chen to arrive at the claimed invention. Such combination would improve the system by allowing the clinician to visualize which electrodes/electrode configuration and characteristic amplitudes are benefiting the patient or causing substantial and unwanted side effects, which will ultimately provide safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 18, Blum as modified teaches the method of claim 9 above, wherein the at least one electrode configuration includes a monopolar configuration involving a set of segmented electrodes around a circumference of the lead at a longitudinal position (see first two sentences of para 0052, fig. 2, fig. 3A-3D; 330, para 0036, and para 0078), wherein the set of segmented electrodes is configured to deliver ring mode stimulation (fig. 3A-3D; 330 and para 0177), but does not disclose wherein the controller is configured to, for the monopolar configuration involving the set of segmented electrodes configured to deliver ring mode stimulation, determine respective characteristic stimulation amplitudes . Furthermore, Blum does not disclose graphically represent the characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the set of segmented electrodes on the lead.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The system (fig. 2) discloses a controller/IPG configured to determine stimulation amplitudes/characteristic stimulation amplitudes for the monopolar configuration/monopolar review involving the set of segmented electrodes configured to deliver ring mode stimulation (para 0035-0036, para 0045, lines 1-10, and para 0050). Cheeran does not explicitly disclose graphically represent the characteristic stimulation amplitudes by markers linearly arranged in a direction with respect to the longitudinal position of the set of segmented electrodes on the lead.
However, Chen discloses a system and method for clinical response mapping of stored data following electrical stimulation of anatomical tissue (abstract, lines 1-2). The system (fig. 1) graphically represents stimulation amplitudes using markers linearly arranged in a direction with respect to the longitudinal position corresponding to a lead wire/ stimulation electrodes (fig. 1, 108, para 35, para 42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of claim 1 with the IPG, monopolar review, and stimulation amplitudes of Cheeran and the GUI and marker display system and method of Chen to arrive at the claimed invention. Such modification would improve the system’s stimulation accuracy by allowing for more precise control when apply stimulation current to selective tissue, ultimately providing safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 19, Blum as modified teaches the method of claim 9 above, wherein the at least one electrode configuration includes one or more monopolar configurations/monopolar reviews each involving respective segmented electrodes at different angular positions around a circumference of the lead (fig. 3A-3D; 330, para 0036, para 0055 and para 0078), but does not explicitly disclose wherein for each of the one or more monopolar configurations involving a corresponding segmented electrode, the characteristic stimulation amplitudes and graphically represented by markers linearly arranged in a direction with respect to the angular position of the corresponding segmented electrode (para 0053 of Cheeran).
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The method (para 0001, line 1) contains a controller/IPG configured to, for each of the one or more monopolar configurations involving a corresponding segmented electrode, determine respective characteristic stimulation amplitudes and graphically represent the respective characteristic stimulation amplitudes by markers/points linearly arranged in a direction with respect to the angular position of the corresponding segmented electrode (fig. 6; 603 and 632, para 0045, and para 0053).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system and method of claim 1 with the controller, the display, the markers/points, and the characteristic stimulation amplitude method for the angular position of the segmented electrodes of Cheeran to arrive at the claimed invention. Such modification would improve the stimulation accuracy for each patient by allowing for more precise control and understanding of the stimulation effects when applying stimulation current to selective tissue, ultimately providing safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Regarding claim 20, Blum as modified teaches the method of claim 19, containing segmented electrodes at various angular positions around the circumference (para 0055 and para 0061) as well as conducting a monopolar review/ testing monopolar configurations (para 0078) but does not explicitly disclose wherein the characteristic stimulation amplitudes includes first characteristic stimulation amplitudes for a first monopolar configuration that includes a first segmented electrode at a first angular position around the circumference, and second characteristic stimulation amplitudes for a second monopolar configuration that includes a second segmented electrode at a second angular position different than the first angular position around the circumference.
Furthermore, although Blum as modified discloses segmented electrodes at various angular positions (para 0055 and para 0061), they do not disclose wherein the graphical representation of the characteristic stimulation amplitudes includes first markers, representing the first characteristic stimulation amplitudes, that are linearly arranged along a first line projecting from the first angular position, and second markers, representing the second characteristic stimulation amplitudes, that are linearly arranged along a second line projecting from the second angular position.
However, Cheeran discloses methods and systems for programming a deep brain stimulation system and a clinician programmer device (para 0001). The method (para 0001, line 1) contains
characteristic stimulation amplitudes that includes first and second characteristic stimulation amplitudes/different amplitudes for various monopolar configurations that includes first and second sets of segmented electrodes (para 0006 (first 3 sentences), para 0013, last sentence, fig. 3, fig. 6, para 0035-0036, para 0045-0046, para 0048, and para 0050 (last 4 sentences)). Cheeran does not disclose wherein the graphical representation of the characteristic stimulation amplitudes includes first markers, representing the first characteristic stimulation amplitudes, that are linearly arranged along a first line projecting from the first angular position, and second markers, representing the second characteristic stimulation amplitudes, that are linearly arranged along a second line projecting from the second angular position.
Nevertheless, Chen discloses a system and method for clinical response mapping of stored data following electrical stimulation of anatomical tissue (abstract, lines 1-2). The system (fig. 1) graphically represents stimulation amplitudes including first markers, representing the first characteristic stimulation amplitudes, that are linearly arranged along a first line (fig. 1;108, para 35, and para 42), and second markers, representing the second characteristic stimulation amplitudes, that are linearly arranged along a second line (fig. 1;108 and line 4 along the y-axis, para 35, and para 42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine and modify the modified system of Blum with the stimulation amplitudes of Cheeran and the marking method of Chen to arrive at the claimed invention. Such modification would improve the stimulation accuracy for each patient by allowing for more precise control and visualization/ understanding of the stimulation effects when applying stimulation current to selective tissue, ultimately providing more precise and safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Blum in view of Chen, Blum’039, Moffitt, Gillespie, and Cheeran, and further in view of US 2019/0076645 A1 to Bower et al. (hereinafter “Bower”).
Regarding claim 14, Blum as modified teaches the method of claim 9, comprising first and second sets of base stimulation settings/parameters, clinical response indicators/therapeutic response values, visualize a parameter space, and a display method for the clinical effects for the stimulation settings/parameters (fig. 8; 802, para 0005, and para 0092), but does not disclose displaying graphically the search space as a heatmap representing intensities of the clinical response indicators or clinical effects for the first set of base stimulation settings and the second set of base stimulation settings.
However, Bower discloses techniques for sensing incorrect lead connections of an implantable stimulator device (para 0002). The method (fig. 7) discloses graphically displaying the electrode voltages search space as a heatmap representing intensities/magnitudes of the stimulation for more than one set of electrode stimulation settings (fig. 10-10D and para 0108).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Blum with the heatmap method teachings of Bower to arrive at the claimed invention. Such modification would enhance the system by allowing a clinician and/or patient to visualize the clinical effects corresponding to specific stimulation settings, ultimately providing safer stimulation that will prevent adverse side effect while enhancing therapeutic benefit of the stimulation system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mann et al. (US 6,393,325 B1) discloses a system and method for programming implantable electrode arrays.
Wood et. al (US 2005/0245987 A1) discloses a method for programming an implantable medical device.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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