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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 18 November 2025 has been entered.
Status of Claims
Claims 1-23 are pending and currently under consideration for patentability; claims 1, 2, 11, and 12 have been amended; claims 22 and 23 have been added as new claims.
Information Disclosure Statement
The Information Disclosure Statements submitted on 18 November 2025 (4) have been acknowledged and considered by the Examiner.
Applicant should note that the large number of references in the attached IDS have been considered by the Examiner in the same manner as other documents in Office search files are considered while conducting a search of prior art. See MPEP 609.05(b). Applicant is requested to direct the Examiner to any references in the IDS which may be of particular relevance to the presently claimed invention in response to this Office Action.
Response to Arguments
Applicant’s arguments dated 18 November 2025 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 the independent claims to recite stimulation patterns corresponding to a motoric function, arguing that since “George is merely directed to treating pain or neurological disorders associated with the head or neck,” George does not “disclose stimulation patterns corresponding to a motoric function, such as sitting down, standing up, walking, running, swimming, cycling, or rowing, that involves 'muscular activations' as described” in the Specification (Arguments, p.14).
The Examiner respectfully submits that that the features upon which applicant relies (i.e., sitting down, standing up, walking, running, etc.) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, the Examiner respectfully submits that the functions described in the Specification are not an exhaustive list of every action that may be considered a “motoric function.” For example, George describes that the treatments described therein may be used to treat movement disorders, balance disorders, tremors, dystonia, cerebellar disease, and other central nervous system disorders ([0259], [0325]), all of which may have significant motoric function contributions. Therefore, the Examiner respectfully maintains that George suggests the use of stimulation parameters corresponding to motoric functions.
Applicant has added new claims 22 and 23, arguing that in its decision affirming the Office’s previous rejections, the Patent Trial and Appeal Board found that Wechter’s editing of the waveform while it is displayed along the timeline on the screen discloses directly manipulating the stimulation patterns. Applicant argues that “these editors of Wechter only allow the user to edit the waveform by 'select[ing] options for editing each of the characteristics' of the burst, train, and sequence by interacting with editing menus, not the displayed graphics of the burst, train, sequence on the timeline that are mapped to the claimed 'graphical objects representing a time sequence of a plurality of stimulation patterns'” (Arguments, p. 17).
The Examiner has addressed the new claims in the text of the rejection below. Briefly, the Examiner respectfully submits that, in “directly manipulating” a graphical object (even via a burst editor, train editor, and sequence editor as described by Wechter), the user interacts with the object. Therefore, a broad reasonable interpretation of Wechter includes the user interacting with the graphical objects displayed on the screen.
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 17-23 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)
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. However, George also describes a neuromodulation system ([0003]), including selecting stimulation patterns corresponding to motor functions ([0093], [0259], [0325]). 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).
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’s interaction with the at 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.
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]).
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
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 3796