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 February 26, 2026, have been fully considered but they are not persuasive.
Applicant’s argument states that Goetz’333 does not teach defining “locations outside of which the location cannot be moved.” The examiner respectfully disagrees.
As shown in fig. 2, 204-1 through 204-3, para 0014, para 0035, and para 0041, Goetz’333 does teach defining locations outside of which the location cannot be moved. Due to the stimulation zones being located on the grid line intersections (and can only be moved or placed at the grid-line intersections), one of ordinary skill in the art would understand that the pre-defined region defines both locations in which the stimulation can and cannot be moved (since the stimulation zones can only be placed at the intersections, and not on the plain white area adjacent to the grid-line intersections).
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 46-47, 49-52, 55, 61-65 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0046800 A1 to Doan et. al (hereinafter “Doan”) in view of US 2006/0155333 A1 to Goetz (hereinafter “Goetz’333”) and US 2007/0203541 A1 to Goetz et al. (hereinafter “Goetz’541”).
Regarding claim 46, Doan teaches an external controller for controlling sub-perception stimulation provided by an implantable stimulator device having an electrode array (para 0013-0014 and para 0182, and para 0184-0185), comprising:
control circuitry configured to render a graphical user interface (GUI) (para 0020, lines 4-18), a location at which the sub-perception stimulation is provided within the electrode (fig 6, para 0054 and para 0182), wherein the control circuitry is configured to receive one or more inputs to move the location of the sub-perception stimulation within the region (fig 5, para 0016 and para 0249), and wherein moving the location causes the control circuitry to send programming instructions to the implantable stimulator device to move the sub-perception stimulation to the moved location in the electrode array (para 0016 and para 0249), and a pre-defined region/stimulation zone(s) (see fig. 17 and para 0169, lines 1-8),
but does not explicitly disclose wherein the GUI comprises a two-dimensional representation of a pre-defined region drawn on the GUI, wherein the pre-defined region defines locations inside of which the locations can be moved and defines locations outside of which that the location cannot be moved, and wherein
the location of sub-perception stimulation can be moved inside of, wherein the pre-defined region includes positions to which the location can be moved that do not correspond to positions of the electrodes,
and wherein the pre-defined region is constrained to less than the entire electrode array,
wherein the control circuitry is configured to receive one or more first inputs to move the location of the sub-perception stimulation within the pre-defined region.
However, Goetz’333 teaches a programming user-interface device comprising multiple levels of abstraction for configuring program treatment settings (abstract, lines 1-2). The system (figs. 1-4) comprises a GUI/ display (see abstract: “These interfaces may include a display of a stimulatable area of the patient's body. The display may include a depiction of leads and/or the underlying physiology, such as a depiction of a portion of a spine.”), and wherein the GUI/display comprises a two-dimensional representation of a pre-defined region/grid line intersections (shown by the location of the stimulation zone(s)) drawn on the GUI (see fig. 2, 204-1 through 204-3, para 0014, para 0023, para 0035, and para 0041) , wherein the pre-defined region/grid line intersections (see fig. 2, 204-1 through 204-3, para 0014, and para 0041) defines locations inside of which the location can be moved and defines locations outside of which the location cannot be moved (see fig. 2, fig. 2, 204-1 through 204-3, para 0014, and para 0041). Due to the stimulation zones being located on the grid line intersections (and can only be moved or placed at the grid-line intersections), it is inherent that the pre-defined region defines both locations in which the stimulation can and cannot be moved (since the stimulation zones can only be placed at the intersections, and not on the plane white area adjacent to the grid-line intersections).
Furthermore, Goetz’333 teaches the location of sub-perception stimulation can be moved inside of, wherein the pre-defined region includes positions to which the location can be moved that do not correspond to positions of the electrodes (see annotated fig. 2 below and para 0038-0041; as noted in e.g. para 0041, stimulation zones may be placed at “locations substantially centrally located between an electrode on a first lead and an electrode on a second lead”),
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wherein the control circuitry is configured to receive one or more first inputs to move the location of the sub-perception stimulation within the pre-defined region (see fig. 2 above, 208-1, and para 0036).
But does not explicitly disclose wherein the pre-defined region is constrained to less than the entire electrode array.
However, Goetz’541 teaches a programming implantable stimulation used to deliver electrical stimulation energy to a patient via one or more leads using complex electrode array geometries (see abstract, lines 1-4). The system (figs. 1 and 11) comprise a GUI/User interface (see fig. 11, 172 and para 0127), and comprises a representation of a location at which the sub-perception stimulation (stimulation provided based on general tissue characteristics stored in the programmer) is provided within the electrode array (see annotated fig. 9 below and para 0122-0123).
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Furthermore, Goetz’541 teaches wherein the GUI comprises a representation in which the pre-defined region is constrained to less than the entire electrode array (since the electrodes marked with an “X” prevent a user from selecting these electrodes, the pre-defined region is constrained to less than the entire electrode array).
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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 teachings of Doan with the teachings of Goetz’333 and Goetz’541 to arrive at the claimed invention. Such combination would yield predictable results, since implementing a zone/constraint within the electrode array and the pre-defined region/zone and stimulation location of Goetz’333 would ensure stimulation parameters are only sent to electrodes that are in close proximity to the patient’s pain site, ensure more accurate and safe stimulation therapy for the patient.
Regarding claim 47, Doan as modified teaches the external controller (para 0013-0014) of claim 46, wherein the control circuitry is configured to receive the one or more inputs to move the location from a patient via the GUI (para 0087 and para 0185), but does not explicitly disclose receiving the one or more first inputs to move the location from a patient via the GUI.
However, Goetz’333 teaches receiving the one or more first inputs to move the location/zone of stimulation from a patient via the GUI/display (see fig. 2 above, 208-1, and para 0036).
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 modified teachings of Doan with the teachings of Goetz’333 to arrive at the claimed invention. Such modification would improve the system by ensuring the location of stimulation is properly targeting the proper anatomical region of the patient (in the case when the stimulation therapy does not provide proper sub-perception stimulation), ultimately ensuring more accurate and safe stimulation therapy for the patient.
Regarding claim 49, Doan as modified teaches the external controller (para 0013-0014) of claim 46, wherein the sub-perception stimulation is associated with a perception threshold stored in the control circuitry, wherein an amplitude of the sub-perception stimulation is less than or equal to the perception threshold (para 0215).
Regarding claim 50, Doan as modified teaches the external controller (para 0013-0014) of claim 49, wherein moving the location causes the control circuitry to send the programming instructions to the implantable stimulator device to set the amplitude of the sub-perception stimulation relative to the perception threshold (para 0249-0251). It is assumed that in the context of this paragraph that the amplitude threshold is used interchangeably with the perception threshold.
Regarding claim 51, Doan as modified teaches the external controller (para 0013-0014) of claim 50, wherein setting the amplitude of the sub-perception stimulation relative to the perception threshold comprises setting the amplitude of the sub-perception stimulation to a percentage of the perception threshold (para 0251). It is assumed that in the context of this paragraph that the amplitude threshold is used interchangeably with the perception threshold.
Regarding claim 52, Doan as modified teaches the external controller (para 0013-0014) of claim 49, wherein the control circuitry is configured to render on the GUI an option to allow the amplitude to be adjusted to less than or equal to the perception threshold (para 0215 and para 0216, lines 1-5).
Regarding claim 55, Doan as modified teaches the external controller (para 0013-0014) of claim 46, wherein the control circuitry is configured to render on the GUI at least a portion of the electrode array (see fig. 5, para 0020, para 0022 lines 1-15, and para 0024).
Regarding claim 61, Doan as teaches a method (abstract, line 1) for controlling sub-perception stimulation provided by an implantable stimulator device having an electrode array (para 0013-0014 and para 0182, and para 0184-0185), comprising:
rendering on an external controller a graphical user interface (GUI) (para 0020, lines 4-18),
a location at which the sub-perception stimulation is provided within the electrode array (fig 6, para 0054 and para 0182),
wherein the control circuitry is configured to receive one or more inputs to move the location of the sub-perception stimulation within the region (fig 5, para 0016 and para 0249);
and in response to moving the location, sending programming instructions from the external controller to the implantable stimulator device to move the sub-perception stimulation to the moved location in the electrode array (para 0016 and para 0249),
but does not explicitly disclose wherein the GUI comprises a two-dimensional representation of a pre-defined region drawn on the GUI, wherein the pre-defined region defines locations inside of which the locations can be moved and defines locations outside of which that the location cannot be moved, and wherein
the location of sub-perception stimulation can be moved inside of, wherein the pre-defined region includes positions to which the location can be moved that do not correspond to positions of the electrodes,
and wherein the pre-defined region is constrained to less than the entire electrode array,
wherein the control circuitry is configured to receive one or more first inputs to move the location of the sub-perception stimulation within the pre-defined region.
However, Goetz’333 teaches a programming user-interface device comprising multiple levels of abstraction for configuring program treatment settings (abstract, lines 1-2). The system (figs. 1-4) comprises a GUI/ display (see abstract: “These interfaces may include a display of a stimulatable area of the patient's body. The display may include a depiction of leads and/or the underlying physiology, such as a depiction of a portion of a spine.”), and wherein the GUI/display comprises a two-dimensional representation of a pre-defined region/grid line intersections (shown by the location of the stimulation zone(s)) drawn on the GUI (see fig. 2, 204-1 through 204-3, para 0014, para 0023, para 0035, and para 0041) , wherein the pre-defined region/grid line intersections (see fig. 2, 204-1 through 204-3, para 0014, and para 0041) defines locations inside of which the location can be moved and defines locations outside of which the location cannot be moved (see fig. 2, fig. 2, 204-1 through 204-3, para 0014, and para 0041). Due to the stimulation zones being located on the grid line intersections (and can only be moved or placed at the grid-line intersections), it is inherent that the pre-defined region defines both locations in which the stimulation can and cannot be moved (since the stimulation zones can only be placed at the intersections, and not on the plane white area adjacent to the grid-line intersections).
Furthermore, Goetz’333 teaches the location of sub-perception stimulation can be moved inside of, wherein the pre-defined region includes positions to which the location can be moved that do not correspond to positions of the electrodes (see annotated fig. 2 below and para 0038-0041; as noted in e.g. para 0041, stimulation zones may be placed at “locations substantially centrally located between an electrode on a first lead and an electrode on a second lead”),
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wherein the control circuitry is configured to receive one or more first inputs to move the location of the sub-perception stimulation within the pre-defined region (see fig. 2 above, 208-1, and para 0036).
But does not explicitly disclose wherein the pre-defined region is constrained to less than the entire electrode array.
However, Goetz’541 teaches a programming implantable stimulation used to deliver electrical stimulation energy to a patient via one or more leads using complex electrode array geometries (see abstract, lines 1-4). The system (figs. 1 and 11) comprise a GUI/User interface (see fig. 11, 172 and para 0127) comprising a representation of a location at which the sub-perception stimulation (stimulation provided based on general tissue characteristics stored in the programmer) is provided within the electrode array (see annotated fig. 9 below and para 0122-0123).
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Furthermore, Goetz’541 teaches wherein the GUI comprises a representation in which the pre-defined region is constrained to less than the entire electrode array (since the electrodes marked with an “X” prevent a user from selecting these electrodes, the pre-defined region is constrained to less than the entire electrode array).
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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 teachings of Doan with the teachings of Goetz’333 and Goetz’541 to arrive at the claimed invention. Such combination would yield predictable results, since implementing a zone/constraint within the electrode array and the pre-defined region/zone and stimulation location of Goetz’333 would ensure stimulation parameters are only sent to electrodes that are in close proximity to the patient’s pain site, ensure more accurate and safe stimulation therapy for the patient.
Regarding claim 62, Doan as modified teaches the method (abstract, line 1) of claim 61, configured to receive the one or more inputs to move the location from a patient via the GUI (para 0087 and para 0185), but does not explicitly disclose receiving the one or more first inputs to move the location from a patient via the GUI.
However, Goetz’333 teaches receiving the one or more first inputs to move the location/zone of stimulation from a patient via the GUI/display (see fig. 2 above, 208-1, and para 0036).
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 modified teachings of Doan with the teachings of Goetz’333 to arrive at the claimed invention. Such modification would improve the system by ensuring the location of stimulation is properly targeting the proper anatomical region of the patient (in the case when the stimulation therapy does not provide proper sub-perception stimulation), ultimately ensuring more accurate and safe stimulation therapy for the patient.
Regarding claim 63, Doan as modified teaches the method (abstract, line 1) of claim 61, wherein the sub-perception stimulation is associated with a perception threshold stored in control circuitry of the external controller, wherein an amplitude of the sub-perception stimulation is less than or equal to the perception threshold (para 0016 and para 0215).
Regarding claim 64, Doan as modified teaches the method (abstract, line 1) of claim 63, wherein moving the location causes the control circuitry to send the programming instructions to the implantable stimulator device to set the amplitude of the sub-perception stimulation relative to the perception threshold (para 0249-0251). It is assumed that in the context of this paragraph that the amplitude threshold is used interchangeably with the perception threshold.
Regarding claim 65, Doan teaches a non-transitory computer-readable medium comprising instructions (para 0126, lines 1-5), wherein the instructions when executed in an external controller for an implantable stimulator device having an electrode array (para 0013-0014 and para 0182, and para 0184-0185) are configured to render on the external controller a graphical user interface (GUI) (para 0016 and para 0020, lines 4-18), including a location at which sub-perception stimulation is provided within the electrode array (fig 6, para 0054 and para 0182), and receive, at the external controller, one or more inputs to move the location of the sub-perception stimulation within the region (fig 5, para 0016 and para 0249);
and in response to moving the location, send programming instructions from the external controller to the implantable stimulator device to move the sub-perception stimulation to the moved location in the electrode array (para 0016 and para 0249),
but does not explicitly disclose wherein the GUI comprises a two-dimensional representation of a pre-defined region drawn on the GUI, wherein the pre-defined region defines locations inside of which the locations can be moved and defines locations outside of which that the location cannot be moved, and wherein
the location of sub-perception stimulation can be moved inside of, wherein the pre-defined region includes positions to which the location can be moved that do not correspond to positions of the electrodes,
and wherein the pre-defined region is constrained to less than the entire electrode array,
wherein the control circuitry is configured to receive one or more first inputs to move the location of the sub-perception stimulation within the pre-defined region.
However, Goetz’333 teaches a programming user-interface device comprising multiple levels of abstraction for configuring program treatment settings (abstract, lines 1-2). The system (figs. 1-4) comprises a GUI/ display (see abstract: “These interfaces may include a display of a stimulatable area of the patient's body. The display may include a depiction of leads and/or the underlying physiology, such as a depiction of a portion of a spine.”), and wherein the GUI/display comprises a two-dimensional representation of a pre-defined region/grid line intersections (shown by the location of the stimulation zone(s)) drawn on the GUI (see fig. 2, 204-1 through 204-3, para 0014, para 0023, para 0035, and para 0041) , wherein the pre-defined region/grid line intersections (see fig. 2, 204-1 through 204-3, para 0014, and para 0041) defines locations inside of which the location can be moved and defines locations outside of which the location cannot be moved (see fig. 2, fig. 2, 204-1 through 204-3, para 0014, and para 0041). Due to the stimulation zones being located on the grid line intersections (and can only be moved or placed at the grid-line intersections), it is inherent that the pre-defined region defines both locations in which the stimulation can and cannot be moved (since the stimulation zones can only be placed at the intersections, and not on the plane white area adjacent to the grid-line intersections).
Furthermore, Goetz’333 teaches the location of sub-perception stimulation can be moved inside of, wherein the pre-defined region includes positions to which the location can be moved that do not correspond to positions of the electrodes (see annotated fig. 2 below and para 0038-0041; as noted in e.g. para 0041, stimulation zones may be placed at “locations substantially centrally located between an electrode on a first lead and an electrode on a second lead”),
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wherein the control circuitry is configured to receive one or more first inputs to move the location of the sub-perception stimulation within the pre-defined region (see fig. 2 above, 208-1, and para 0036), but does not explicitly disclose wherein the pre-defined region is constrained to less than the entire electrode array.
However, Goetz’541 teaches a programming implantable stimulation used to deliver electrical stimulation energy to a patient via one or more leads using complex electrode array geometries (see abstract, lines 1-4). The system (figs. 1 and 11) comprise a GUI/User interface (see fig. 11, 172 and para 0127) comprising a representation of a location at which the sub-perception stimulation (stimulation provided based on general tissue characteristics stored in the programmer) is provided within the electrode array (see annotated fig. 9 below and para 0122-0123).
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Furthermore, Goetz’541 teaches wherein the GUI comprises a representation in which the pre-defined region is constrained to less than the entire electrode array (since the electrodes marked with an “X” prevent a user from selecting these electrodes, the pre-defined region is constrained to less than the entire electrode array).
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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 teachings of Doan with the teachings of Goetz’333 and Goetz’541 to arrive at the claimed invention. Such combination would yield predictable results, since implementing a zone/constraint within the electrode array and the pre-defined region/zone and stimulation location of Goetz’333 would ensure stimulation parameters are only sent to electrodes that are in close proximity to the patient’s pain site, ensure more accurate and safe stimulation therapy for the patient.
Claims 48, 53-54, 56-60 are rejected under 35 U.S.C. 103 as being unpatentable over Doan in view of Goetz’541, Goetz’333, and US 2011/0093030 A1 to Goetz et al. (hereinafter “Goetz’030”).
Regarding claim 48, Doan as modified teaches the external controller of claim 47 (para 0013-0014) that use one or more inputs and a pre-defined region/zone(s) (fig. 17 and para 0168), but does not disclose wherein the one or more first inputs is configured to move the location of the sub-perception stimulation in orthogonal X and Y directions in the pre-defined region.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (figs. 1 and figs. 17-20) can contain a user interface depicting a sequence of user inputs for allowing the user to create a zone, and an algorithm for zone placement logic and move vector, which is essentially a move trajectory calculation calculated between a starting centroid and an ending centroid for the move of a target location divided into equal sized steps. Once the move trajectory vector is formed, the system may restrict/limit the move direction parallel to leads (y-direction) or orthogonal to the leads (x-direction) in the zone/pre-defined region (fig. 20, para 0168, and para 0142).
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 Doan with the teachings of Goetz’030 to arrive at the claimed invention. By modifying the modified system of Doan with the longitudinal or transverse/orthogonal X or Y directions in the pre-defined region of Goetz’030, the present invention would have resulted in a reasonable expectation for success, since one of ordinary skill would conclude this movement to be the most effective when moving in a pre-defined region for targeting the pain site of a patient as disclosed in the prior art.
Regarding claim 53, Doan as modified teaches the external controller (para 0013-0014) of claim 46, but does not disclose wherein the GUI comprises one or more second inputs to set the pre-defined region/zone.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (fig. 1) contains a user interface incorporated on an external programmer to allow a user to select and/or create stimulation zone(s)/regions through the use of an icon/input buttons located on the external programmer (fig. 17, para 0169, lines 1-8).
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 teachings of Doan with the teachings of Goetz’030 to arrive at the claimed invention. Combining the system of Doan with the GUI/user interface and inputs of Goetz’030 would yield predictable results, since using input buttons/icons to set the pre-defined region(s) is already a known method as disclosed by the prior art, which ultimately ensures more accurate and safe stimulation therapy for the patient.
Regarding claim 54, Doan as modified teaches the external controller (para 0013-0014) of claim 46, but does not disclose wherein the pre-defined region is set relative to the electrode array.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (fig. 1) contains a user interface located on an external programmer to allow a user to select and/or create stimulation zone(s) through the use of icons/input buttons located on the external programmer (fig. 17 and para 0169, lines 1-8). Furthermore, the system (fig. 1) allows the user to select a pre-defined electrode center region, which is set relative to specific electrode array(s) located within the achievable stimulation region (ASR-see fig. 17, reference number 504)( para 0095, line 1-3, fig. 17, and para 0169, lines 1-20 ).
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 teachings of Doan with the teachings of Goetz’030 to arrive at the claimed invention. Combining the modified system of Doan with the pre-defined electrode region (that is set relative to the electrode array) would yield predictable results, since this setting is needed to determine the most fitting stimulation zone in order to provide stimulation in a target region within the electrode array for patient treatment as shown by the prior art.
Regarding claim 56, Doan as modified teaches the external controller (para 0013-0014) of claim 46, containing control circuitry configured to receive inputs for sub-perception stimulation (para 0016 and para 0258, lines 1-8), but does not disclose wherein the control circuitry is further configured to receive a third input to mark and store the sub-perception stimulation at the moved location, or to store the sub-perception stimulation at the moved location as a stimulation program.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (fig. 1) contains both a display screen for displaying a marked/selected stimulation zone field(s) selected by a user for zone-based programming and an algorithm that compensates for stretching/zone changes due to the zone stretching/manipulation by a user (such as a clinician) (fig. 6, para 0101-0102, para 0104, para 0112, lines 1-6, and para 0128, lines 1-8). Prior to manipulating the zone, the original zone electrode points are stored in a list, and once the zone shape changes (as a result of stretching done by the user), the second points are stored in that same list, and the second electrodes are recruited (para 0129). Furthermore, the two sets of electrode recruitments and contributions can be merged (to form a third input) by adding electrode recruitments/contributions that increase the first set, or are new to the first set, ultimately creating a resulting shape drawn from the merged set as the user drags the zone. This process of creating new stimulation points, storing stimulation points, and merging stimulation points can be repeated in order to create electrode recruitment and contributions for a zone (para 0129-0130).
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 teachings of Doan with the teachings of Goetz’030 to arrive at the claimed invention. By combining the sub-perception stimulation of Doan with the marking and storing concept taught by Goetz’030, the claimed invention would have yielded predictable results, since one of ordinary skill would recognize that the previously disclosed technique could compensate for changes to the stimulation location/configuration along the electrode array while still considering the previously selected electrodes. This would ultimately improve the stimulation therapy for the patient.
Regarding claim 57, Doan as modified teaches the external controller (para 0013-0014) of claim 56 containing control circuitry to render sub-perception stimulation parameters on the GUI (fig 5, para 0164, and para 0217 lines 14-17 ), but does not disclose wherein the control circuitry is configured to render the marked sub-perception stimulation or the simulation program on the GUI at the moved location.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (fig. 1) contains both a display screen for displaying a marked/selected stimulation zone field(s) selected by a user for zone-based programming and an algorithm that displays and compensates for the stimulation zone changes due to the zone stretching/manipulation by a user (such as a clinician) (fig. 6, para 0101-0102, para 0104, para 0112, lines 1-6, and para 0128, lines 1-8).
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 Doan with the teachings of Goetz’030 to arrive at the present invention. By modifying the system of Doan to contain a system that renders the new marked stimulation location on the display as taught by Goetz’030, the modification would improve the overall system, since this feature would compensate for changes to the stimulation location/configuration along the electrode array, while also allowing for better precision when targeting the patient’s pain site. Furthermore, this feature allows clinicians/users to visually see changes in the stimulation patterns/regions.
Regarding claim 58, Doan as modified teaches the external controller (para 0013-0014) of claim 56 containing control circuitry configured to receive input to rank the sub-perception stimulation (para 0016, para 0184-0185, and para 0184), but does not disclose wherein the control circuitry is further configured to receive a fourth input to store the marked sub-perception stimulation or the stimulation program.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (fig. 1) contains both a display screen for displaying a marked/selected stimulation zone field(s) selected by a user for zone-based programming and an algorithm that compensates for stretching/zone changes due to the zone stretching/manipulation by a user (such as a clinician) (fig. 6, para 0101-0102, para 0104, para 0112, lines 1-6, and para 0128, lines 1-8). Prior to manipulating the zone, the original zone electrode points are stored in a list, and once the zone shape changes (as a result of stretching done by the user), the second points are stored in that same list, and the second electrodes are recruited (para 0129). Furthermore, the two sets of electrode recruitments and contributions can be merged (to form a third input) by adding electrode recruitments/contributions that increase the first set, or are new to the first set, ultimately creating a resulting shape drawn from the merged set as the user drags the zone. This process of creating new stimulation points, storing stimulation points, and merging stimulation points can be repeated in order to create electrode recruitment and contributions for a zone (para 0129-0130).
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 Doan with the teachings of Goetz’030 to arrive at the present invention. Such combination would lead to a reasonable expectation for success, since the prior art shows that the modification would improve the stimulation accuracy when target the pain site of a patient.
Regarding claim 59, Doan as modified teaches the external controller (para 0013-0014) of claim 56, containing control circuitry used to store sub-perception stimulation parameters (para 0244), but does not disclose wherein the control circuitry is further configured to store stimulation parameters for the marked sub-perception stimulation or the stimulation program.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (fig. 1) contains a user interface which displays the graphical representation of a manipulated stimulation zone (fig. 20). After the zone has been stretched/manipulated, a new center dot/zone is displayed on the screen relative to the new stimulation zone (fig. 20, ref. number 830, and para 0176, lines 1-9). Furthermore, the therapy system/device (fig. 1, ref. number 2), contains a clinician programmer and patient programmer with circuitry configured to store stimulation parameters for the stimulation program (para 0068, para 0071, para 0076, para 0190, and para 0145-0146).
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 Doan with the system of Goetz’030 to arrive at the claimed invention. Such modification would improve the system by allowing the user/clinician to properly record and access therapeutic parameters that provide the desired therapeutic effect for the patient, ultimately improving stimulation treatment for the patient.
Regarding claim 60, Doan as modified teaches the external controller (para 0013-0014) of claim 56 for sub-perception stimulation containing a GUI (para 0185), but does not disclose wherein any marked sub-perception stimulation or the simulation program is selectable on the GUI.
However, Goetz’030 discloses a system for providing electrical stimulation therapy to a patient (fig. 1 and abstract lines 1-2). The system (fig. 1) contains a user interface which displays the graphical representation of a marked stimulation zone (fig. 20). After the zone has been stretched/manipulated, a new center dot/zone is marked and displayed on the screen relative to the new stimulation zone (fig 20, ref number 830 and para 0176, lines 1-9). Furthermore, a display is incorporated into a clinician programmer and/or patient programmer, which allows both a patient and clinician to select from a plurality of programs (such as a stimulation program) via the GUI/display.
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 Doan with the system of Goetz’030 to arrive at the claimed invention. Such modification would improve the system by enabling user control and interaction when selecting necessary stimulation while also making the system easy to use for the patient and/or clinician, allowing either the patient or clinician to have better control of the stimulation areas and/or programs.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thacker et. al (US 7,363079 B1) discloses a system and method for viewing and hearing power consumption during a spinal cord stimulation (SCS) system fitting procedure.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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