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 Amendment
This Office Action is responsive to the amendment filed on 26 Jun 2026. As directed by the amendment: claims 1-2 and 5-9 have been amended, claims 14-20 have been canceled, and no claims have been added. Thus, claims 1-13 are presently pending in this application.
Response to Arguments
Claim Objections:
Applicant’s arguments, see Remarks, filed 26 Jun 2026, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
35 USC § 112 Rejections:
Applicant’s arguments, see Remarks, filed 26 Jun 2026, with respect to the rejections of claims 1-2, 6, and 13 under 35 U.S.C. 112 have been fully considered and are persuasive in light of the claim amendments. The rejections of claims 1-2, 6, and 13 under 35 U.S.C. 112 have been withdrawn.
The rejections of claims 9-10 is maintained because the claims have not been amended to obviate the rejection.
35 USC § 101 Rejections:
Applicant's arguments filed 26 Jun 2026 have been fully considered but they are not persuasive.
Applicant argues
The claimed invention does not merely recite mathematical manipulation of values but instead requires a user interface that operates in two distinct modes with different input paradigms and associated system behaviors. In the percentage-based programming mode, the system accepts and applies user-specified percentage values and total current, whereas in the current-based programming mode, the system accepts a direct current amplitude input and automatically derives a consistent set of device parameters, including a recalculated total current and updated percentage values for all electrodes. This mode-dependent functionality necessarily requires machine execution to interpret user input differently depending on the selected mode and to perform coordinated recalculations across multiple electrodes in a manner that maintains valid device constraints. Such operations cannot be practically or reliably performed mentally or with pen and paper, particularly in real-time while ensuring that all electrode parameters remain consistent and suitable for programming the IPG.
(Remarks, page 6)
Examiner respectfully disagrees. Claim 1 does not positively recite the GUI. Claim 1 only recites control circuitry configured to provide a GUI. Furthermore, the use of the GUI to receive user input is a pre-solution activity of data gathering. Therefore, the claimed GUI element does not integrate the judicial exception into a practical application.
Rejections Over the Prior Art:
Applicant’s arguments, see Remarks, filed 26 Jun 2026, with respect to the rejection of claim 1 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Young-Dixon et al. (US 20210154480 A1, previously cited), hereinafter Young-Dixon, in view of Kothandaraman et al. (US 20190329024 A1), hereinafter Kothandaraman, as explained in further detail below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “at least one of the non-selected electrodes” in line 3 and “that non-selected electrode” in line 4. There is insufficient antecedent basis for the limitation “that non-selected electrode” in the claim. For the purposes of examination, “that non-selected electrode” will be interpreted as “that at least one of the non-selected electrodes”.
Claim 10 recites the limitations “the non-elected electrodes” and “that non-elected electrode”. There is insufficient antecedent basis for this limitation in the claims. For the purposes of examination, “the non-elected electrodes” will be interpreted as “the non-selected electrodes”, and “that non-elected electrode” will be interpreted as “the at least one of the non-selected electrodes”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Determination as to whether a claim satisfies the criteria for subject matter eligibility is a stepwise process (MPEP 2016).
Step 1: Does the claim fall within a statutory category of invention?
Claims 1-13 recite a machine (system), which is within the four statutory categories. Therefore, claims 1-13 are directed to a statutory category of invention.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-13 are directed to an abstract idea.
Claim 1 is directed to a system for programming an implantable pulse generator (IPG), wherein the IPG is configurable to connect to a plurality of electrodes, the system comprising: control circuitry configured to: provide a graphical user interface (GUI) displaying an indication of an initial total current to be delivered by the plurality of electrodes and, for each electrode of the plurality of electrodes, an initial percentage value indicating an initial percentage of the initial total current assigned to that electrode, wherein each initial percentage value defines an initial amplitude of current assigned to that electrode; wherein the GUI is configured to, upon user selection, switch between a percentage-based programming mode and a current-based programming mode; wherein in the percentage-based programming mode the GUI is configured to accept user input to adjust the initial total current to be delivered by the plurality of electrodes and user input to adjust the initial percentage value for one or more of the plurality of electrodes; wherein in the current-based programming mode the GUI is configured to accept a user selection of a selected electrode and a user input to adjust the initial amplitude of current assigned to the selected electrode; receive, via the GUI operating in the current-based programming mode, an instruction to adjust the initial amplitude of current assigned to the selected one of the electrodes to an adjusted amplitude of current while maintaining the initial amplitudes of current for each of the non-selected electrodes; calculate an adjusted total current and adjusted percentage values for each of the plurality of electrodes in accordance with the instruction, and use the adjusted total current and the adjusted percentage values to program the IPG.
The limitations of adjusting and maintaining amplitude values, calculating an adjusted total current and adjusted percentage values, as drafted, under their broadest reasonable interpretations, are merely mental processes, because these steps are akin to having a doctor or other human actor performing these operations with pen and paper. For example, “calculat[ing] an adjusted total current for the plurality of electrodes” encompasses nothing more than a human actor mentally evaluating the values according to the received instructions.
The limitation of displaying an indication of an initial total current and initial percentage values encompasses nothing more than a human actor writing or drawing out values on a piece of paper.
Therefore, claim 1 recites an abstract idea.
Claims 2-13 depend on claim 1. These dependent claims only recite additional features of the analysis described in claim 1, which may also be performed by a human actor mentally and using a pen and paper. For example, claim 3 recites displaying graphical representations of each of the plurality of electrodes, which encompasses nothing more than a human actor drawing out the plurality of electrodes. Claim 6 recites calculating adjusted percentage values, which encompasses nothing more than a human actor mentally evaluating given current values.
Therefore, claims 1-13 recite an abstract idea.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application.
Claim 1 recites the additional limitation “control circuitry”. This additional element is recited at a high level of generality (i.e. most generic computers would be known to have this component). Paragraph [0022] of the specification describes the control circuitry at a high level of generality. This limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore the control circuitry of claim 1 does not integrate the judicial exception into a practical application.
The limitations of displaying graphical representations, values, warnings, or GUI elements are post-solution activities that do not add meaningful limitations to practicing the abstract ideas. The limitation of programming the IPG is also an insignificant extra-solution activity.
Thus, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea. As described above, dependent claims 2-13 only recite other limitations of displaying values or performing calculations, which may be done mentally by a human actor and/or with a pen and paper.
Step 2B: Does the claim include additional elements that are sufficient to amount to significantly more than the judicial exception?
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As explained above with respect to the integration of the judicial exception into a practical application (Step 2A, Prong 2), the additional elements of using computer components to perform the process steps amounts to no more than mere instructions to apply the judicial exception using generic computer elements. Claim 1 recites the additional limitation “control circuitry”. This additional element is recited at a high level of generality (i.e. most generic computers would be known to have this component). Paragraph [0022] of the specification describes the control circuitry at a high level of generality, and only provides conventional, well-known computing functions that do not add meaningful limits to practicing the abstract idea.
The limitations of displaying graphical representations, values, warnings, or GUI elements are post-solution activities that do not add meaningful limitations to practicing the abstract ideas. The limitation of programming the IPG is also an insignificant extra-solution activity.
Therefore, claims 1-13 are not patent-eligible under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 7-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Young-Dixon et al. (US 20210154480 A1, previously cited), hereinafter Young-Dixon, in view of Kothandaraman et al. (US 20190329024 A1), hereinafter Kothandaraman.
Regarding claim 1, Young-Dixon discloses a system for programming (Fig. 1, paragraph [0028], programmer 40) an implantable pulse generator (IPG) (Fig. 1, paragraph [0021], electrical stimulator 4), wherein the IPG is configurable to connect to a plurality of electrodes (Fig. 1, paragraph [0024], electrodes 11), the system comprising:
control circuitry (Fig. 2, paragraph [0043], processing circuitry 53) configured to:
provide a graphical user interface (GUI) (Fig. 2, paragraph [0043], user interface 59) displaying:
an indication of an initial total current to be delivered by the plurality of electrodes (Fig. 3, paragraph [0054], "display windows 210 and 212 indicating information regarding a master electrical current amplitude and/or a maximum current amplitude") and
for each electrode of the plurality of electrodes, an initial percentage value indicating an initial percentage of the initial total current assigned to that electrode (paragraph [0040], "a user interface of programmer 40 may display the electrical current amplitude corresponding to each electrode ... the user interface of programmer 40 may also display the fractional amount associated with each electrical current amplitude for one or more electrodes"; paragraph [0111], "display window 240 of FIG. 10 may include...percentage values indicating contribution levels");
wherein the GUI is configured to accept user input to adjust the initial total current to be delivered by the plurality of electrodes (paragraph [0037], "processing circuitry of electrical stimulator 4, or processing circuitry of a stimulation generator, may perform various adjustments, such as...by adjusting master electrical current amplitudes, to achieve the desired electrical current amplitude") and user input to adjust the initial percentage value for one or more of the plurality of electrodes (paragraph [0039], "The clinician may set a contribution for a particular electrode on a scale of 0.0 (0%) to 1.0 (100%), where the percentages or decimal values indicate a fraction of a total number of current regulator branches the stimulation generator is to use to implement a current regulator associated with the particular electrode");
wherein the GUI is configured to accept a user selection of a selected electrode and a user input to adjust the initial amplitude of current assigned to the selected electrode (paragraph [0037], "processing circuitry of programmer 40 may receive user input via a user interface that allows a user (e.g., clinician, physician, patient, etc.) to input electrical current amplitude values defining desired current amplitudes for electrical stimulation pulses delivered to one or more electrodes 11. In an illustrative example, the user interface may accept as input ‘1.2’ milliamps (mA; also, milliamperes) with respect to a first electrode 11");
receive, via the GUI, an instruction to adjust the initial amplitude assigned to a selected electrode of the plurality of electrodes to an adjusted amplitude value (paragraph [0048], "User interface 59 may receive, as user input, a desired electrical current amplitude for a first electrode") while maintaining the initial amplitude for each non-selected electrode (paragraph [0050], "maintain the electrical current amplitude of other electrodes not targeted for adjustment");
calculate an adjusted total current for the plurality of electrodes (paragraph [0041], "The master amplitude may be adjusted upward or downward as needed") and an adjusted percentage value for each electrode of the plurality of electrodes in accordance with the instruction (paragraph [0050], "When adjustments cause changes in the master electrical current amplitude, in order to maintain the electrical current amplitude of other electrodes not targeted for adjustment, the fraction of the other electrodes may need to be adjusted relative to the change in the master electrical current amplitude"), and
use the adjusted total current and the adjusted percentage values to program the IPG (paragraph [0048], "Processing circuitry 53 may receive the user input comprising the desired electrical current amplitude for a particular electrode of a multiple electrode system and may transmit instructions (e.g., adjustment instructions) to electrical stimulator 4 to implement adjustments to the electrical stimulator 4 to deliver electrical stimulation in accordance with the desired electrical current amplitude"; paragraph [0080], "Programmer 40 may then transmit the determined adjustments to electrical stimulator 4, where electrical stimulator 4 may implement the adjustments").
Young-Dixon does not explicitly disclose that the GUI is configured to, upon user selection, switch between a percentage-based programming mode and a current-based programming mode.
However, Kothandaraman teaches interfaces for configuring the parameters of anodic and cathodic stimulation that is provided by an implantable medical device (Abstract) comprising a GUI configured to, upon user selection, switch between a percentage-based programming mode and a current-based programming mode (paragraph [0053], "The units selector 718 enables the user to specify whether the allocation of stimulation current is depicted on the lead representation 710 and IPG representation 708 in terms of the percent of the total stimulation current or the actual amplitude of the current in milliamps").
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 Young-Dixon with the teachings of Kothandaraman so that the GUI is configured to, upon user selection, switch between a percentage-based programming mode and a current-based programming mode, because doing so provides the ability to configure the IPG to provide anodic or cathodic stimulation or some mixture of the different stimulation types, to transition between anodic and cathodic stimulation modes in user-customizable ways that provide the most effective therapy (Kothandaraman, paragraph [0051]).
Regarding claim 3, the system of claim 1 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon further discloses that the GUI displays graphical representations of each of the plurality of electrodes (Fig. 3, paragraph [0052], "the GUI displays graphical representations of each of the plurality of electrodes such that each of the graphical representations are selectable by a user ... lead 12 includes four electrodes, namely electrodes 48A-48D") such that each of the graphical representations are selectable by a user (paragraph [0047], "a user (e.g., a clinician or patient 6) may interact with user interface 59 in order to, for example, manually select, change or modify programs, adjust voltage or current amplitude of stimulation pulses delivered by specific electrodes or a plurality of electrodes"; paragraphs [0054]-[0055]).
Regarding claim 4, the system of claim 3 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon further discloses that the GUI displays GUI elements for adding and/or subtracting amplitude of current assigned to the selected electrode (paragraph [0040], "The user interface may provide fillable fields, or other adjustment input devices, such as increase or decrease input keys, that allow a user to input a desired electrical current amplitude for a given electrode 11 targeted for adjustment, or for multiple electrodes 11 targeted for adjustment, of electrical stimulator 4").
Regarding claim 7, the system of claim 1 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon further discloses that using the adjusted total current and the adjusted percentage values to program the IPG comprises:
determining whether the IPG is capable of producing the adjusted total current and the adjusted percentage values (paragraph [0086], "processing circuitry 50 may utilize the target adjustment to adjust the first current amplitude to achieve the desired electrical current amplitude, while maintaining the second stimulation pulses at the same or approximately the same amplitude. The approximation may be due to the finite resolution available with the particular number of current regulator branches. For example, the second fraction adjustment may result in an increase of the master amplitude and a decrease of the second fraction relative to the master amplitude increase, such that the second amplitude maintains as close to the original second amplitude as possible."); and
if the IPG is capable of producing the adjusted total current and the adjusted percentage values, transmitting the adjusted total current and the adjusted percentage values to the IPG (paragraph [0086], "while maintaining the second stimulation pulses at the same or approximately the same amplitude"), or
if the IPG is not capable of producing the adjusted total current and the adjusted percentage values, calculating a modified adjusted total current and modified adjusted percentage values (paragraph [0087], "the exact same amplitude may not be possible ... processing circuitry 50 may program the second fraction to be 35/64, which actually equals 1.09 mA, but 35/64 the fraction that will maintain the second electrical current amplitude as close to 1.1 mA as possible").
Regarding claim 8, the system of claim 7 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon further discloses that determining whether the IPG is capable of producing the adjusted total current and the adjusted percentage values comprises determining whether the adjusted total current and the adjusted percentage values are within resolution capabilities of digital-to-analog (DAC) circuitry of the IPG (paragraph [0072], "The number of current regulator branches defines the resolution for each current regulator"; paragraph [0086], "The approximation may be due to the finite resolution available with the particular number of current regulator branches"; paragraph [0099], "the second amplitudes may be the same or approximately the same, meaning within a range that is dependent on the resolution available from the stimulation generator or in other words, the total number of current regulator branches available").
Regarding claim 9, the system of claim 7 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon further discloses that the modified adjusted total current and modified adjusted percentage values are calculated to minimize a deviation between the initial amplitude of current assigned to at least one of the non-selected electrodes and an amplitude of current defined for the at least one of the non-selected electrodes by the modified adjusted total current and modified adjusted percentage values (paragraph [0086], "the second amplitude maintains as close to the original second amplitude as possible"; paragraph [0008], "processing circuitry of the electrical stimulator may cause an adjustment to a first electrical current amplitude, while maintaining the electrical current amplitudes of other electrodes as close to the original electrical current amplitude"; paragraph [0099], "This is because a single branch of the total number of branches may be implemented in full so as to increase or decrease a fraction according to a finite step size (e.g., 1/64), and as such, an approximation may be used to achieve an adjusted amplitude as close to the original amplitude as possible as a function of the master amplitude").
Regarding claim 10, Young-Dixon discloses the system of claim 9, as explained above. Young-Dixon further discloses that the GUI is configured to display an indication of the deviation between the initial amplitude of current assigned to the at least one of the non-selected electrodes and the amplitude of current defined for the at least one of the non-selected electrodes by the modified adjusted total current and modified adjusted percentage values (paragraph [0111], "processing circuitry 50 may also output, for display via user interface 59, fractional values corresponding to the adjustment to the first fraction or the adjustment to the second fraction, wherein the fractional values indicate a change in contribution of the first or second electrodes").
Regarding claim 13, the system of claim 1 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon further discloses that the GUI is configured to display the amplitude of current assigned to any of the plurality of electrodes (paragraph [0063], "Each field of the plurality of individually definable fields is defined by one or more electrodes of the plurality of electrodes through which a pulse of the neurostimulation pulses is delivered and a current distribution of the pulse over the one or more electrodes.").
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Young-Dixon et al. (US 20210154480 A1, previously cited), hereinafter Young-Dixon, in view of Kothandaraman et al. (US 20190329024 A1), hereinafter Kothandaraman, and further in view of Moffitt (US 20110106215 A1, previously cited).
Regarding claim 2, the system of claim 1 is obvious over Young-Dixon and Kothandaraman, as explained above. Although Young-Dixon further discloses that the initial percentage values are configured to provide stimulation at a virtual pole (paragraph [0063], "A program may be defined directly, by selecting parameters and electrodes, or by zone-based programming, in which parameters and electrodes are automatically determined by the programmer in response to manipulation or positioning of stimulation zones"), Young-Dixon does not explicitly disclose that the virtual pole is at a position that is not a position of any of the plurality of electrodes.
However, Moffitt teaches a method and system for stimulating tissue using a plurality of electrodes (Abstract) wherein a percentage value of each electrode are determined (paragraphs [0049], [0061], [0069]-[0070]) in order to provide stimulation at a virtual pole at a position that is not a position of any of the electrodes (Figs. 8A-B, paragraphs [0062]-[0063]).
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 Young-Dixon and Kothandaraman with the teachings of Moffitt so that the initial percentage values are configured to provide stimulation at a virtual pole at a position that is not a position of any of the electrodes, because doing so allows the stimulation region to be adjusted to an effective pain site without reoperating on the patient in order to reposition the electrode array if the position of the electrode array gradually or unexpectedly moves (Moffitt, paragraph [0010]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Young-Dixon et al. (US 20210154480 A1, previously cited), hereinafter Young-Dixon, in view of Kothandaraman et al. (US 20190329024 A1), hereinafter Kothandaraman, and further in view of Rao et al. (US 20140100631 A1, previously cited), hereinafter Rao.
Regarding claim 5, the system of claim 1 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon does not explicitly disclose that calculating an adjusted total current comprises adding the initial amplitudes of the non-selected electrodes and the adjusted amplitude of the selected electrode.
However, Rao teaches an external control device for use with a neurostimulator coupled to a plurality of electrodes is provided (Abstract) wherein calculating an adjusted total current comprises adding the initial amplitudes of the non-selected electrodes and the adjusted amplitude of the selected electrode (paragraphs [0095]-[0096], "Consider an implementation having a total fractionalized cathodic current of -100 ... The user then assigns E1 a new value of -10. Upon that assignment, the CP 18 updates the fractionalized current values according to the RMR, employing the ONAM algorithm. Here, the New Total current available for distribution to the adjustment set is a fractionalized current value of -90. New Total=-100-New value of E1=-100-(-10)=-90").
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 Young-Dixon and Kothandaraman with the teachings of Rao so that calculating an adjusted total current comprises adding the initial amplitudes of the non-selected electrodes and the adjusted amplitude of the selected electrode, because doing so conserves fractionalized current values so that the sum of all fractionalized distributions equals 100% (Rao, paragraph [0093]).
Regarding claim 6, the system of claim 5 is obvious over Young-Dixon, Kothandaraman, and Rao, as explained above. Rao further teaches that calculating the adjusted percentage values for each of the plurality of electrodes comprises:
calculating an adjusted percentage value of the selected electrode by dividing the adjusted current for the selected electrode by the adjusted total current (paragraph [0100], "E1=E1/(E1+E5+E6) * 100=20/(20+20+40) * 100=25"), and
calculating adjusted percentage values for each of the non-selected electrodes by dividing the initial amplitude for each non-selected electrode by the adjusted total current (paragraph [0100], "E5=E5/(E1+E5+E6) * 100=20/(20+20+40) * 100=25 ... E6=E1/(E1+E5+E6) * 100=40/(20+20+40) * (100-10)=50").
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Young-Dixon et al. (US 20210154480 A1, previously cited), hereinafter Young-Dixon, in view of Kothandaraman et al. (US 20190329024 A1), hereinafter Kothandaraman, and further in view of Wechter et al. (US 20170080242 A1, previously cited), hereinafter Wechter.
Regarding claim 11, the system of claim 9 is obvious over Young-Dixon and Kothandaraman, as explained above. Young-Dixon does not explicitly disclose that the control circuitry is configured to compare the deviation to a predetermined threshold value for the deviation and issue a warning if the deviation exceeds the threshold value.
However, Wechter teaches a system for comparing neurostimulation waveforms (Abstract) comprising a GUI (Fig. 6, paragraph [0065], GUI 610) and control circuitry (Fig. 6, paragraph [0043], controller 650) configured to compare a deviation in stimulation amplitude to a predetermined threshold value for the deviation (paragraph [0087], "the comparator 652 can use a threshold, e.g., default or user-specified, when comparing the one or more received parameters of the customized neurostimulation waveform to the corresponding one or more parameters of the neurostimulation waveform(s)"; paragraph [0074], "the controller 650 can cause GUI 610 to display a percentage difference, e.g., 5% difference...between the amplitudes") and issue a warning if the deviation exceeds the threshold value (paragraph [0087], "the user may specify that if the percentage match of a corresponding compared parameter(s) is greater than 98%, the parameter can be displayed as a match, e.g. using GUI 610"; paragraph [0075], "differences between the waveform parameters can be displayed, e.g., highlighted, on the GUI 610").
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 Young-Dixon and Kothandaraman with the teachings of Wechter so that the control circuitry is configured to compare the deviation to a predetermined threshold value for the deviation and issue a warning if the deviation exceeds the threshold value, because doing so saves time and possible patient discomfort by allowing the user to determine whether the new waveform parameters will benefit the patient (Wechter, paragraph [0043]).
Regarding claim 12, the system of claim 11 is obvious over Young-Dixon, Kothandaraman, and Wechter, as explained above. Wechter further teaches that the GUI is configured to allow a user to set the predetermined threshold value (paragraph [0087], "the user can input the threshold using GUI 610") for any of the plurality of electrodes (paragraph [0041], "The user may also be allowed to define an electrode selection specific to each individually defined waveform.").
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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