DETAILED ACTION
This Office Action is in response to the communication dated 15 April 2026 concerning Application No. 17/206,007 filed on 18 March 2021.
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 .
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 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.
Status of Claims
Claims 1-23 are pending and currently under consideration for patentability; claims 1, 11, 22, and 23 have been amended.
Information Disclosure Statement
The Information Disclosure Statements dated 30 December 2025 and 15 April 2026 have been considered by the Examiner.
Response to Arguments
Applicant’s arguments dated 15 April 2026 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended independent claims 1 and 11 to recite wherein the motoric function compresses activation of one or more muscles that produces movement of a body part, and wherein the one or more anatomical structures comprise a portion of the spinal cord associated with producing the movement of the body part. Applicant has amended independent claims 22 and 23 to recite a user gesture input that directly modifies one of a plurality of graphical objects. The Examiner has addressed the amended limitations in the updated text below.
Regarding the George reference, in relation to the amended limitations, Applicant argues that George fails to disclose or suggest stimulation patterns corresponding to a motoric function which comprises activation of a muscle that produces movement of a body part. Applicant further argues that George does not provide stimulation to a portion of the spinal cord associated with producing the movement of the body part. The Examiner respectfully disagrees and directs Applicant to George’s paragraph [0440], which describes a coordinated therapy scheme including providing stimulation to a portion of the spinal cord associated with a muscle that produces movement of a body part. The Examiner has provided a more detailed analysis of this section of George in the rejection below.
Regarding claims 23 and 24, Applicant argues against the Examiner’s interpretation of Wechter’s pulse composition area as well as directly manipulating a graphical object. Although the Examiner respectfully disagrees with Applicant’s characterizations, the Examiner has introduced the Er reference herein, which more directly reads on the amended limitations. The Examiner respectfully submits that Applicant’s arguments regarding Wechter’s teachings in reference to amended independent claims 23 and 24 have been rendered moot.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 7-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wechter et al. (US 2019/0381328 A1) in view of George et al. (US 2020/0121544 A1).
Regarding claims 1 and 11, Wechter describes a neuromodulation system ([0006]) and a non-transitory computer-readable storage medium storing one or more programs, that, when executed by one or more processors, cause the one or more processors to perform a method for neuromodulation ([0079], claims 18-20), comprising
a user interface device ([0069]) configured to
display graphical information on a screen ([0089]), the graphical information comprising a plurality of graphical objects representing a time sequence of a plurality of stimulation patterns along a timeline (figure 9, [0097], the display of the waveform building blocks, the preview pane of the waveform building blocks), each of the plurality of stimulation patterns comprising a plurality of stimulation pulses ([0069], “the present system provides for patterns of neurostimulation pulses…accommodating need for customization of neurostimulation pulse patterns as well as need for new types of neurostimulation pulse patterns”; [0089], the user interface “allows the user to define the pattern of neurostimulation pulses”, emphasis added by Examiner)
change a shape or a position of at least one of the plurality of graphical objects along the timeline in response to a user input ([0089]: “user interface 610 includes a GUI that has an interactive screen for displaying a graphical representation of a waveform building block and allows the user to adjust the waveform building block by graphically editing the waveform building block”; [0090]: “interface control circuit 640 controls the operation of user interface 610 including responding to various inputs received by user input device 644 and defining the one or more stimulation waveforms”; the Examiner respectfully submits that Wechter’s waveform composer performs this feature, as described throughout the text of Wechter’s disclosure, the citations above being just two examples of where Wechter describes these features) directly manipulating the at least one of the plurality of graphical objects while it is displayed along the timeline ([0127], figure 23)
update the display of the plurality of graphical objects on the screen ([0078], graphical editing of the waveforms with the waveform composer, as described, would generate updated displays of the waveform on the screen)
generate a first updated time sequence of the stimulation patterns corresponding to the updated display of the plurality of graphical objects ([0089] - [0090], for example, at the end of the waveform composition, the final displayed waveform is the updated display of the graphical objects as claimed, with the stimulation parameters programmed by the user corresponding to the updated time sequence of the stimulation patterns as claimed)
a stimulation pattern programming device ([0073] - [0074], programming device 102, for example) configured to
receive the first updated time sequence of the stimulation patterns ([0078] describes that the waveform composer allows the user to generate the stimulation patterns; [0074] describes that the stimulation patterns are received by the programming device)
provide, to a stimulation device, instructions to stimulate, using a first plurality of electrodes, one or more anatomical structures based on the first updated time sequence of the stimulation patterns ([0073] - [0074] describe that the programming device, using the user interface, allows a user to set and/or adjust the stimulation parameters, the programming device being connected to the stimulation device and electrodes for delivering the programmed stimulation to the user), wherein the one or more anatomical structures comprise a portion of the spinal cord ([0072])
Regarding claims 1 and 11, although Wechter describes that the neuromodulation system may be used to provide a variety of neurostimulation therapies ([0072], deep brain stimulation, spinal cord stimulation, peripheral nerve stimulation, vagus nerve stimulation), and further that “the present subject matter may apply to any therapy that employs stimulation pulses of electrical or other form of energy” ([0072], emphasis added by Examiner), Wechter does not explicitly disclose wherein the plurality of stimulation patterns correspond to a motoric function, wherein the motoric function comprises activation of one or more muscles that produces movement of a body part, and wherein the portion of the spinal cord that is stimulated corresponds with producing the movement of the body part. However, George also describes a neuromodulation system ([0003]), including selecting stimulation patterns corresponding to motor functions ([0093], [0259], [0325]), wherein the motoric function comprises activation of one or more muscles that produces movement of a body part ([0440], the stimulation modality can be configured to cause limb muscle contraction), and wherein stimulation is provided to a portion of the spinal cord corresponding with producing movement of the body part ([0440], the secondary stimulation target may be “adjacent a joint, nerve, or muscle (e.g., a shoulder, knee, cervical spine, thoracic spine, lumbosacral spine, elbow, hip, foot, ankle, or other site)”). As George is also directed towards neuromodulation systems and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the system described by Wechter in order to treat motor functions, as described by George, as doing so advantageously allows the resulting system to treat a larger number of neurologic conditions.
Regarding claims 2 and 12, George further describes wherein the user interface device is further configured to display an illustration of at least a portion of a human body representing the one or more anatomical structures (figures 5-8 illustrate user interfaces for identifying locations, symptoms, and intensities of pain felt by the patient, with the locations being used for treatment), the stimulation of the one or more anatomical structures evoking the motoric function (figure 10 illustrates the method for selecting treatment).
Regarding claims 3 and 13, Wechter further describes wherein the stimulation pattern programming device is further configured to receive feedback information from at least one sensor ([0083]), the feedback information comprising a physiological measurement of a patient ([0083]).
Regarding claims 4 and 14, although Wechter does not explicitly disclose wherein the stimulation pattern programming device is further configured to generate a second updated time sequence of the stimulation patterns based on at least in part on the feedback information, the Examiner respectfully submits that this would be the natural consequence, or the natural next action, after using the feedback control of neurostimulation as described by Wechter in paragraph [0083]. Wechter’s figure 5 further embodies that the sensing circuit 530 is connected to the stimulation control circuit 514 and the stimulation output circuit 212, with the stimulation output circuit 212, in turn, connected to leads 424 and electrodes 406. Therefore, the Examiner respectfully submits that Wechter provides both the structural framework (in figure 5) and the motivation (in paragraph [0083]) to obviate the claimed limitation of generating an updated stimulation pattern based on the patient feedback. Wechter further suggests providing, to the stimulation device, instructions to stimulate, using a second plurality of electrodes, the one or more anatomical structures based on the second updated time sequence of the stimulation patterns ([0073]: “the delivery of the neurostimulation is controlled by using a plurality of stimulation parameters, such as stimulation parameters specifying a pattern of the electrical pulses and a selection of electrodes through which each of the electrical pulses is delivered”; [0083]: “stimulation output circuit 212 is electrically connected to electrodes 406 through lead 424, and delivers each of the neurostimulation pulses through a set of electrodes selected from electrodes 406,” emphasis added by Examiner).
Regarding claims 7 and 17, Wechter further describes wherein changing the shape or the position of the at least one of the plurality of graphical objects comprises changing a width of at least one of the plurality of graphical objects ([0142] - [0144] describe the “pulse waveform preview,” “burst waveform preview,” and “train stimulation preview” features, all of which allow a user to change the width of the pulses, bursts, or trains; figures 35-37 provide embodiments of the graphical user interfaces for each of these features), and wherein generating the first updated time sequence of the stimulation patterns comprises updating a start time or stop time in response to changing a width of the at least one of the plurality of graphical objects (figures 35-37 show how the time courses, including start times and stop times, may change in response to the user changing the width of the pulses, bursts, or trains).
Regarding claims 8 and 18, George further describes an acoustic device operably connected to the user interface device and configured to provide acoustic information to a user or a patient concerning the start of the stimulation pattern ([0092], [0418] - [0419]).
Regarding claims 9 and 19, Wechter further describes wherein the user interface device is configured to display the plurality of graphical objects along the timeline in a plurality of rows (figure 13, for example, shows the composition of a sequence based on waveform building blocks, which are displayed in a plurality of rows), and change, in response to the user input, the position of at least one of the plurality of graphical objects along one row (figure 13, as the waveform building blocks are changed, or the order of the waveform building blocks are changed, or the duration of each of the waveform building blocks are changed, the overall composed sequence will also change).
Regarding claims 10 and 20, Wechter further describes wherein the user interface device is further configured to: change the position of at least one of the plurality of graphical objects to the end of one row along the timeline to cause the stimulation pattern represented by the at least one of the plurality of graphical objects to repeat ([0135], the graphical user interface has a pull-down menu with a “repeat” option, and the sequence composition area, in turn, displays the updated sequence with the repeat).
Claims 5, 6, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wechter in view of George, further in view of Wagner et al. (US 2020/0060602 A1).
Regarding claims 5 and 15, Wechter in view of George suggests the system of claim 1 and the medium of claim 11, but neither Wechter nor George explicitly disclose wherein the user interface device is further configured to receive patient locomotion data from a camera. However, Wagner also describes a neuromodulation system that may be used to target motor or autonomic functions ([0011], [0166]), including a user interface device configured to receive patient locomotion data from a camera ([0078], [0091). As Wagner is also directed towards targeting motor or autonomic functions and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a camera, similar to that described by Wagner, when using the system described by Wechter and George, as doing so advantageously allows the resulting system to better monitor a user’s progress and update the therapy parameters as needed.
Regarding claims 6 and 16, Wagner further describes wherein the patient locomotion data comprises recorded locomotion images for a patient ([0096]) and the user interface device is configured to display the recorded locomotion images for the patient together with reference locomotion images for the patient ([0091], [0095] - [0096]).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wechter in view of George, further in view of Er et al. (US 7,333,856 B1).
Regarding claims 22 and 23, Wechter describes a neuromodulation system ([0006]) and a non-transitory computer-readable storage medium storing one or more programs, that, when executed by one or more processors, cause the one or more processors to perform a method for neuromodulation ([0079], claims 18-20), comprising
a user interface device ([0069]) configured to
display graphical information on a screen ([0089]), the graphical information comprising a plurality of graphical objects representing a time sequence of a plurality of stimulation patterns along a timeline (figure 9, [0097], the display of the waveform building blocks, the preview pane of the waveform building blocks), each of the plurality of stimulation patterns comprising a plurality of stimulation pulses ([0069], “the present system provides for patterns of neurostimulation pulses…accommodating need for customization of neurostimulation pulse patterns as well as need for new types of neurostimulation pulse patterns”; [0089], the user interface “allows the user to define the pattern of neurostimulation pulses”, emphasis added by Examiner)
change a shape or a position of at least one of the plurality of graphical objects along the timeline in response to a user gesture or input that modifies the least one of the plurality of graphical objects ([0089]: “user interface 610 includes a GUI that has an interactive screen for displaying a graphical representation of a waveform building block and allows the user to adjust the waveform building block by graphically editing the waveform building block”; [0090]: “interface control circuit 640 controls the operation of user interface 610 including responding to various inputs received by user input device 644 and defining the one or more stimulation waveforms”; the Examiner respectfully submits that Wechter’s waveform composer performs this feature, as described throughout the text of Wechter’s disclosure, the citations above being just two examples of where Wechter describes these features) while it is displayed along the timeline ([0127], figure 23)
update the display of the plurality of graphical objects on the screen ([0078], graphical editing of the waveforms with the waveform composer, as described, would generate updated displays of the waveform on the screen)
generate a first updated time sequence of the stimulation patterns corresponding to the updated display of the plurality of graphical objects ([0089] - [0090], for example, at the end of the waveform composition, the final displayed waveform is the updated display of the graphical objects as claimed, with the stimulation parameters programmed by the user corresponding to the updated time sequence of the stimulation patterns as claimed)
a stimulation pattern programming device ([0073] - [0074], programming device 102, for example) configured to
receive the first updated time sequence of the stimulation patterns ([0078] describes that the waveform composer allows the user to generate the stimulation patterns; [0074] describes that the stimulation patterns are received by the programming device)
provide, to a stimulation device, instructions to stimulate, using a first plurality of electrodes, one or more anatomical structures based on the first updated time sequence of the stimulation patterns ([0073] - [0074] describe that the programming device, using the user interface, allows a user to set and/or adjust the stimulation parameters, the programming device being connected to the stimulation device and electrodes for delivering the programmed stimulation to the user)
Regarding claims 22 and 23, although Wechter describes that the neuromodulation system may be used to provide a variety of neurostimulation therapies ([0072], deep brain stimulation, spinal cord stimulation, peripheral nerve stimulation, vagus nerve stimulation), and further that “the present subject matter may apply to any therapy that employs stimulation pulses of electrical or other form of energy” ([0072], emphasis added by Examiner), Wechter does not explicitly disclose wherein the plurality of stimulation patterns correspond to at least one of a motoric function or an autonomic function. However, George also describes a neuromodulation system ([0003]), including selecting stimulation patterns corresponding to motor or autonomic functions ([0093], [0135]). As George is also directed towards neuromodulation systems and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the system described by Wechter in order to treat autonomic or motor functions, as described by George, as doing so advantageously allows the resulting system to treat a larger number of neurologic conditions.
Regarding claims 22 and 23, although Wechter describes a user gesture or input that modifies one of a plurality of graphical objects ([0089]), Wechter does not explicitly disclose wherein the user gesture or input directly modifies the graphical object itself while it is displayed along the timeline on the screen. However, Er also describes a user interface configured to graphically display programming parameters and allow a user to modify stimulation parameters (col 3:21-36), including a user gesture or input that directly modifies at least one of a plurality of graphical objects itself while it is displayed along a timeline (col 7:61-8:20). As Er is also directed towards programming stimulation parameters and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a click-and-drag for similar direct manipulation capability similar to that described by Er when using the system described by Wechter and George, as doing so advantageously allows for a familiar in user interface that can be used more easily to control the stimulation parameters.
Allowable Subject Matter
Claim 21 is allowed.
The following is an Examiner’s statement of reasons for allowance.
The prior art of record does not disclose or suggest a neuromodulation system comprising a stimulation pattern programming device as claimed in addition to a user interface device configured to display a patient avatar on a screen, move one or more body parts of the patient avatar in response to user input, and generate a plurality of stimulation patterns based on the movement of the body part.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792
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