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 .
Status of Claims
Claims 1-28 are currently pending and are under examination. As per the amendments filed on 05/21/2026, claims 1, 7-8, and 11 are amended.
Priority
The instant application (filed on 06/21/2024) is a national stage of PCT/AU2022/051556 (filed on 12/22/2022), filed under 35 USC 371. Acknowledgment is made of Applicant's claim to foreign priority based on application AU2021904237 filed on 12/23/2021. Amended instant claims 1-28 are adequately supported in the certified foreign priority disclosure. Therefore, instant claims 1-28 will receive an effective filing date of 12/23/2021 and all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant's arguments, see Remarks page 8 (Rejections under 35 U.S.C. § 112), filed 05/21/2026, with respect to the rejections of claims 1-28 under 35 USC § 112(b) have been fully considered. The arguments regarding the rejections specifically of claims 1, 7-8, and 11 are persuasive and the rejections of claims 1-28 are withdrawn.
Applicant's arguments, see Remarks pages 8-12 (Rejections under 35 U.S.C. § 102), filed 05/21/2026, with respect to the rejections of Claims 1-5 and 7-28 under 35 USC § 102 been fully considered. Regarding independent claim 1, Applicant argues:
The Office Action at pages 4-5 rejected independent claim 1 under 35 U.S.C. § 102 as being anticipated by Yoo. In doing so, the Office Action asserted that Yoo discloses every feature of that claim. Applicant respectfully disagrees, because Yoo fails to disclose a stimulation control as recited in claim 1. In particular, claim 1 as amended recites a neurostimulation system including: (see Claim 1 language listed in response)
In other words, the recited system includes an external device that renders a stimulation control on a display. The external device both ramps and ceases ramping the value of the stimulus intensity parameter in response to respective activation and de-deactivation of that same stimulation control by the user. This use of the same stimulation control provides advantages as described in Applicant's Specification, for example by taking advantage of the human withdrawal reflex as described in paragraph [0093] of Applicant's Specification. Applicant submits that Yoo fails to disclose at least those features of independent claim 1.
In particular, Yoo fails to disclose ramping on receiving an activation of a stimulation control and ceasing ramping on receiving a de-activation of that stimulation control. Applicant submits that Yoo appears to disclose a wearable stimulator device 12a that communicates with a user device 32 having a processor and a display. See, e.g., Yoo at fig. 5. The device 12a has buttons (e.g., button controls 124, 128) that affect the delivery of stimuli. See [0076][0080]. The device 12a itself has a display 120 on which virtual controls may be displayed, [0076], and by inference such virtual controls appear to include virtual buttons emulating the operation of buttons 124, 128. The user device 32 (separate from the stimulator device 12a) may also display virtual controls, id [0073], which by inference also appear to emulate the virtual buttons displayable on screen 120 of the wearable device 12a.
As disclosed by Yoo, button 122 turns the device on and off Id [0076]. Button 124 can increase stimulus intensity when pressed (a one-off increase per press). Id [0077]. Button 128 switches operation to a pre-programmed mode such as a "ramp" mode #1 that ramps stimulation intensity to a selected intensity and keeps it there for 60 minutes. Id [0079]. Button 122 operates as a pause and restart stimulation toggle button when double-pressed.[0076]. Accordingly, none of those physical buttons disclosed by Yoo (and thus no "virtual controls" emulation those buttons) disclose a single stimulation control that causes ramping when activated by the user and ceases ramping which de-activated by the user as recited in claim 1 as amended.
Yoo at Fig. 10a further illustrates an "assessment protocol" that uses a "ramping stimulation intensity function 500," and allows the user to provide input indicating when various thresholds are met during the upward ramp, including discomfort threshold 502c. See [0180]. For example, Yoo discloses that user input may be provided by pressing a button on the device 12 to indicate discomfort. Id. [0180]. However, Yoo appears to disclose that ramping according to the function 500 ceases "when the user indicates a pain threshold has been reached 502d," id. ,i [0180], and not on "de-activation of the stimulation control" as claimed. Accordingly, Yoo appears to disclose at most activating one virtual control on a display to turn on the assessment protocol to ramp stimulation as per Fig. 1 0a, and then that the user can, by a separate operation of a different control, pause or cease the ramp. Accordingly, Yoo does not reach a ramp that is started and ceases by activation and de-activation by the user of the same stimulation control as recited in claim 1 as amended. (05/21/2026 Remarks, pages 8-11)
This argument is not persuasive. The relevant limitations from instant claim 1 are:
• the external computing device comprising
•a display and
•a processor configured to:
initialise the stimulus intensity parameter;
render a stimulation control on the display;
ramp, on receiving an activation of the stimulation control by a user, a value of the stimulus intensity parameter while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the ramping value of the stimulus intensity parameter; and
cease, upon receiving a de-activation of the stimulation control by the user, ramping the value of the stimulus intensity parameter.
From the above instant limitations, the stimulation control is defined broadly and lacks the specificity to suggest a single engageable feature on the display of the stimulation control must be engaged to cause or cease ramping. The limitation only essentially requires that a stimulation control is rendered on the displayed and that the stimulation control is activated and deactivated by the user. While the Applicant may have a specific architecture of the stimulation control in mind with a single feature on a display to be engaged when controlling the ramping signal, the current limitations lack the specificity to support this narrow interpretation. The stimulation control is currently only rendered on the display and is not necessarily even a reference to an engageable feature on the display which is held down/released as the receiving function. Currently, Yoo displays a stimulation control in the form of virtual controls (Fig. 5, [0073]). The controls are used to activate a stimulation signal, such as a ramping signal ([0079], [0198]), and deactivate the signal ([0180] – user indicates a pain threshold is reached, [0065] – could simply be a button push on the controls).
Applicant additionally argues:
The Office Action asserted that Yoo discloses ceasing, upon receiving a de-activation of the stimulation control, ramping the value of the stimulus intensity parameter, and cited paragraph [0065], stating "this limitation could simply be pushing the 'off' button." Applicant respectfully disagrees. As discussed above, Yoo discloses separate physical buttons 122, 128 for turning the device on or off and initiating the ramp mode, respectively. Accordingly, simply pushing the off button would not reach de-activation by the user of the same stimulation control activated to initiate the ramp as recited in claim 1. Further, with respect to the assessment protocol shown in fig. 10A, Yoo discloses that the user provides "user input indicating when the thresholds are met," and may provide multiple such inputs. Id. [0180]. This disclosure of the user providing potentially multiple specific user inputs is not consistent with the user powering off the device in the middle of the assessment protocol, and further does not reach de-activation by the user of the same stimulation control activated to initiate the ramp as recited in claim 1. (05/21/2026 Remarks, pages 10-11)
This argument is not persuasive. The claim language does not reach the specificity required to make it so the stimulation control cannot be interpreted as containing multiple control features, such as buttons. Additionally, the claim only requires the signal to cease ramping after receiving a deactivation signal, which could be alternatively fulfilled by either the user indicating the pain threshold is reached to stop the ramp up or turning off the stimulation entirely with an off button. Therefore, the rejection of independent claim 1 is maintained.
Regarding independent claim 11, Applicant argues:
The Office Action rejected independent claim 11 under a similar rationale as that set forth for the rejection of claim 1. Accordingly, Applicant respectfully disagrees for all of the same reasons presented above with regard to amended claim 1. For at least those reasons, Applicant submits that Yoo does not teach all of the features of independent claim 11. As such, Applicant respectfully requests withdrawal of the Section 102 rejection of independent claim 11. (05/21/2026 Remarks, page 12)
This argument is not persuasive. Claim 11 mirrors claim 1 where the same arguments in claim 1 are suggested as being applicable to claim 11. However, the rejection of claim 1 was maintained, meaning the rejection to claim 11 is similarly maintained.
Regarding dependent claims, Applicant additionally argues:
Each of claims 1-5 and 7-10 includes independent claim 1 as a base claim; and each of claims 12-28 includes independent claim 11 as a base claim. As such, notwithstanding its own patentability, all of the arguments presented above with regard to independent claims 1 and 11 apply with equal force to dependent claims 1-5, 7-10, and 12-28. Accordingly, the Section 102 rejections of claims 1-5, 7-10, and 12-28 should be withdrawn and such action is respectfully requested. Any arguments specific to the dependent claim are maintained without prejudice or admission to any assertion made in the Office Action with regard to that claim. (05/21/2026 Remarks, page 12)
This argument is not persuasive. Applicant argues the dependent claims 1-5. 7-10, and 12-28 receive the arguments provided in independent claims 1 and 11. However, the rejections of claims 1 and 11 were maintained, meaning the rejections of dependent claims 1-5. 7-10, and 12-28 are similarly maintained.
Applicant's arguments, see Remarks pages 12-13 (Rejections under 35 U.S.C. § 103), filed 05/21/2026, with respect to the rejection of claim 6 under 35 USC § 103 have been fully considered. Applicant argues:
Claim 6 stands rejected under U.S. C § 103 as allegedly being unpatentable over Yoo (US PG Pub 2019/0001135 Al, hereinafter "Yoo") in view of Thacker (US 9,295,840 Al, hereinafter "Thacker"). Claim 6 includes independent claim 1 as a base claim. As described above in connection with independent claim 1, Yoo does not disclose all of the elements of independent claim 1 as amended. Applicant submits that the addition of Thacker fails to provide the elements that are not disclosed in Yoo. As such, the rejection of claim 6 should be withdrawn for the reasons hereinbefore discussed.
Additionally, Applicant submits that the proposed combination of Yoo and Thacker fails to reach all of the features recited in dependent claim 6. The Office Action concedes that Yoo fails to disclose a stimulation control configured to remain activated as long as the user continues to interact with the stimulation control, and to become de-activated as soon as the user ceases to interact with the stimulation control. To remedy those shortcomings in Yoo, the Office Action relies on Thacker. However, Thacker also fails to disclose at least those features of claim 6. For example, Thacker appears to disclose the holding and release of a button to turn stimulation on and off See Thacker at col. 10, 11. 46-54. However, this disclosed stimulation is not related to an intensity ramp; instead, the device "cycles through the [unspecified] amplitudes/frequency/pulse width as needed for each location." Id [0040]. Accordingly, the combination of Yoo and Thacker fails to reach ceasing a ramp in response to activation and deactivation of the stimulation control as the beginning and end of user interaction with the stimulation control as recited in dependent claim 6. For at least those reasons, Applicant submits that the proposed combination of references fail to render claim 6 obvious. Therefore, Applicant respectfully requests that the Section 103 rejection of claim 6 be withdrawn. (05/21/2026 Remarks, pages 12-13)
This argument is not persuasive. Claim 6 still has the same issue, as previously described with respect to claim 1, of Applicant using a more specific interpretation of the stimulation control than the claim language allows. However, the Examiner agrees that Yoo discloses button pushes to control the stimulation signal and does not disclose the stimulation signal is active only while the user interacts with the stimulation control. The Examiner determined the incorporation of the mechanism in Thacker would have been obvious to try given the same problem of how to control a sensation/tolerance test with button pushes for an implantable nerve stimulator. The limited options for manipulating a button control (pushing to start/stop vs. activated when in contact with a button) would make this combination obvious. The intensity ramp is provided by Yoo, while both Yoo and Thacker involve pain or sensation tolerance tests. Therefore, the rejection of claim 6 is maintained.
Summary: The prior art rejections of claims 1-28 are maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 7-28 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Yoo (US 2019/0001135 A1).
Regarding Claim 1, Yoo discloses a neurostimulation system ([0002]) comprising:
• a neurostimulation device for controllably delivering neural stimuli ([0046]), the neurostimulation device comprising:
a stimulus source configured to deliver neural stimuli via selected electrodes of a plurality of implantable electrodes to a neural pathway of a patient ([0218-0220] – different embodiments of an implantable neurostimulation device (implantable electrodes) with a stimulation generator); and
a control unit configured to control the stimulus source to deliver each neural stimulus according to a stimulus intensity parameter (Fig. 2, [0065] – stimulation intensity: “The user interface module 44, provides at least one user control for allowing adjustment of therapy (e.g. turning therapy on/off or increasing/decreasing stimulation intensity”); and
• an external computing device in communication with the neurostimulation device ([0058] – remote computer 82, which includes a mobile app on a doctor-oriented user device), the external computing device comprising:
a display ([0065] – “The display/notification module 42 includes displays (e.g., LCD or LEDs, touchscreen) and associated circuitry for presenting text, image information, notification signals, and a graphical user interface for obtaining user input”) and a processor ([0065] – “The control module contains the circuitry needed to control the other modules including at least one processor, readable and writeable memory, timers, clocks, signal processing circuitry, and all circuitry that is typically included in a device such as smartphone”) configured to:
initialise the stimulus intensity parameter ([0076-0080] – interface controls used to set parameters and run device);
render a stimulation control on the display (Fig. 5, [0073] – “When the stimulator device 12a operates with the user device 32 then the user device 32 may display virtual controls and display information and communicate using wireless signals 86a);
ramp, on receiving an activation of the stimulation control by a user ([0065] – this limitation could simply be pushing the “on” button: “The user interface module 44, provides at least one user control for allowing adjustment of therapy ( e.g. turning therapy on/off or increasing/decreasing stimulation intensity”); [0079] – a ramping signal is also disclosed as being initiated in response to a button push/mode selection; [0198] – ramping protocol described), a value of the stimulus intensity parameter while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the ramping value of the stimulus intensity parameter (Fig. 10A, [0180] – ramping protocol to discover different thresholds of stimulation for producing sensation, recruitment, discomfort, and pain); and
cease, upon receiving a de-activation of the stimulation control by the user, ramping the value of the stimulus intensity parameter ([0180] – the up-ramping feature is stopped when reaching a pain threshold; can also include a ramp down, [0065] – this limitation could simply be pushing the “off” button).
Regarding Claim 2, Yoo anticipates the neurostimulation system according to Claim 1, as indicated hereinabove. Yoo further discloses wherein the processor is further configured to ramp down, upon receiving the de-activation, the value of the stimulus intensity parameter, while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter ([0180] – once a user-indicated pain threshold is met, a ramp down feature is implemented toward a sensation level: “stimulation intensity is then decreased. The user can then be asked to indicate thresholds as the intensity decreases from pain towards sensation, or patient input is only prompted for by the user device 32 on the upward slope”).
Regarding Claim 3, Yoo anticipates the neurostimulation system according to Claim 1, as indicated hereinabove. Yoo further discloses wherein the processor is further configured to instruct, upon receiving the de-activation, the stimulus source to cease delivering the neural stimuli [0065] – this limitation could simply be pushing the “off” button).
Regarding Claim 4, Yoo anticipates the neurostimulation system according to Claim 1, as indicated hereinabove. Yoo further discloses wherein the processor is further configured to record, upon receiving the de-activation, the value of the stimulus intensity parameter as a discomfort threshold for the selected electrodes ([0180] – a ramp up waveform is implemented where the user provides feedback via the interface to identify thresholds as the ramp increases). While reaching the pain threshold is given as an example of a trigger to implement the deactivation signal in [0180], the discomfort threshold could reasonably be used as the same trigger given Yoo considers both pain and discomfort undesirable upper limits ([0178] – “A therapeutic level used during an awake protocol should often be set between a minimum effective level (recruitment threshold) and a maximum level that is less than the level at which a subject experiences pain or discomfort”).
Regarding Claim 5, Yoo anticipates the neurostimulation system according to Claim 4, as indicated hereinabove. Yoo further discloses wherein the processor is further configured to program, using the recorded value of the stimulus intensity parameter, the neurostimulation device to deliver neural stimuli to the patient. ([0180] – threshold data captured via user input during the ramp-up function, [0181] – the stimulation waveform intensity is meant to operate between the user-defined discomfort and recruitment thresholds).
Regarding Claim 7, Yoo anticipates the neurostimulation system according to Claim 1, as indicated hereinabove. Yoo further discloses wherein the processor is configured to animate the rendering of the stimulation control on the display to indicate elapsed time since the activation of the control ([0076] – “The device may provide a timed stimulation session where the timer automatically starts counting down when the stimulation intensity is greater than zero, or exceeds a minimum defined amplitude. The timer value can be displayed on the display 120”).
Regarding Claim 8, Yoo anticipates the neurostimulation system according to Claim 7, as indicated hereinabove. Yoo further discloses wherein the processor is configured to animate the rendering of the stimulation control on the display ([0058] – graphs of stimulation control are a part of the display) to indicate that the stimulus intensity has reached a neural response threshold ([0186] – warnings are provided when an intensity reaches a neural response threshold: “During patient adjustment 518 due to user input 522, the system 8 will warn a patient if they decrease the intensity of stimulation below the level defined as recruitment threshold”).
Regarding Claim 9, Yoo anticipates the neurostimulation system according to Claim 1, as indicated hereinabove. Yoo further discloses wherein the processor is further configured to cease ramping the value of the stimulus intensity parameter ([0180] – the up-ramping feature stops when reaching a pain threshold; [0065] – this limitation could simply be pushing the “off” button) upon expiry of a first timeout period since receipt of a communication from the neurostimulation device ([0180] – for one cycle, the timing of the ramping waveform is preprogrammed and would either stop ramping due to a user input or reaching the end of the waveform; [0198] – for the calibration process, if a user response is not received in a defined time period then an automatic protocol takes effect: “In step 528 the stimulus is presented to the user and in step 530 the response of the user is sensed or otherwise obtained. If the response is not detected the method returns to step 526 and the stimulus is adjusted according to the assessment protocol in the absence of a user response”).
Regarding Claim 10, Yoo anticipates the neurostimulation system according to Claim 9, as indicated hereinabove. Yoo further discloses wherein the processor is further configured to ramp down ([0180] – once a user-indicated pain threshold is met, a ramp down feature is implemented towards a sensation level: “stimulation intensity is then decreased. The user can then be asked to indicate thresholds as the intensity decreases from pain towards sensation, or patient input is only prompted for by the user device 32 on the upward slope”), upon expiry of a second timeout period since the expiry of the first timeout period without receiving a communication from the neurostimulation device, the value of the stimulus intensity parameter, while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter ([0180] – for one cycle, the timing of the ramping waveform is preprogrammed and would either down-ramp due to a user input or the programmed waveform; [0198] – for the calibration process, if a user response is not received in a defined time period then an automatic protocol takes effect: “In step 528 the stimulus is presented to the user and in step 530 the response of the user is sensed or otherwise obtained. If the response is not detected the method returns to step 526 and the stimulus is adjusted according to the assessment protocol in the absence of a user response”).
Regarding Claim 11, Yoo discloses an automated method of controlling (methods such as those in Figures 10B and 10C) a neurostimulation device ([0046]) to deliver neural stimuli (Fig. 2, [0065] - control feature) using an external computing device in communication with the neurostimulation device ([0058] – remote computer 82, which includes a mobile app on a doctor-oriented user device), the method comprising:
• rendering, by a processor of the external computing device, a stimulation control on a display of the external computing device (Fig. 5, [0073] – “When the stimulator device 12a operates with the user device 32 then the user device 32 may display virtual controls and display information and communicate using wireless signals 86a”);
• ramping, by the processor, on receiving an activation of the stimulation control by a user ([0065] – this limitation could simply be pushing the “on” button: “The user interface module 44, provides at least one user control for allowing adjustment of therapy ( e.g. turning therapy on/off or increasing/decreasing stimulation intensity”); [0079] – a ramping signal is also disclosed as being initiated in response to a button push/mode selection; [0198] – ramping protocol described), a value of a stimulus intensity parameter ([0065]), while instructing the neurostimulation device to deliver the neural stimuli according to the ramping value of the stimulus intensity parameter via selected electrodes of a plurality of implanted electrodes (Fig. 10A, [0180] – ramping protocol to discover different thresholds of stimulation for producing sensation, recruitment, discomfort, and pain); and
• ceasing, by the processor, upon receiving a de-activation of the stimulation control by the user, to ramp the value of the stimulus intensity parameter ([0180] – the up-ramping feature is stopped when reaching a pain threshold; can also include a ramp down, [0065] – this limitation could simply be pushing the “off” button).
Regarding Claim 12, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses ramping down, by the processor, upon receiving the de-activation, the value of the stimulus intensity parameter, while instructing the neurostimulation device to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter via the selected electrodes ([0180] – once a user-indicated pain threshold is met, a ramp down feature is implemented toward a sensation level: “stimulation intensity is then decreased. The user can then be asked to indicate thresholds as the intensity decreases from pain towards sensation, or patient input is only prompted for by the user device 32 on the upward slope”).
Regarding Claim 13, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses ramping down, by the processor, upon the stimulus intensity parameter satisfying a predetermined condition, the value of the stimulus intensity parameter to zero, while instructing the neurostimulation device to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter via the selected electrodes ([0180] – once a user-indicated pain threshold is met, a ramp down feature is implemented toward a sensation level: “stimulation intensity is then decreased. The user can then be asked to indicate thresholds as the intensity decreases from pain towards sensation, or patient input is only prompted for by the user device 32 on the upward slope). Note the downward slope, particularly if linear ([0180]), would eventually reach zero after a particular time period.
Regarding Claim 14, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 13, as indicated hereinabove. Yoo further discloses wherein the predetermined condition comprises the stimulus intensity parameter reaching a hard ceiling ([0068] – a maximum value which cannot be exceeded is programmed into the system: “For example, only a doctor may be allowed permission to increase the maximum allowed amplitude of stimulation or the amount of stimulation provided within a specified amount of time).
Regarding Claim 15, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 12, as indicated hereinabove. Yoo further discloses wherein the down- ramping value of the stimulus intensity parameter follows a linear profile with a predetermined rate of decrease ([0180] – the downward slope would have the same features as the upward slope (linear, predetermined slopes)).
Regarding Claim 16, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 15, as indicated hereinabove. Yoo further discloses wherein a rate of the linear profile is chosen such that the stimulus intensity parameter reaches zero after a predetermined interval ([0180] – the downward slope, particularly if linear, would eventually reach zero after a particular time period).
Regarding Claim 17, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 12, as indicated hereinabove. Yoo further discloses wherein the down- ramping value of the stimulus intensity parameter follows a threshold ramp parametrised by an ECAP threshold (Figure 10A, [0180] – the linear ramp function demonstrates the ramp parameters change after reaching one of four thresholds 502a-d where the reverse process would occur for the down-ramping; [0179] – these four thresholds are sensation, recruitment, discomfort, and pain).
Regarding Claim 18, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses wherein the ramp is linear with time ([0180] – “the system operates to provide an assessment protocol that automatically adjusts stimulus intensity by using a ramping stimuli intensity function 500 (which is sinusoidal, but which can also be linear or exponential) … for example, intensity adjustment varies as a function of time”).
Regarding Claim 19, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 18, as indicated hereinabove. Yoo further discloses wherein a ramp rate of the linear ramp is predetermined ([0180] – the intensity waveform, including the linear ramp waveform, is automatically adjusted as part of a function which is interpreted as predetermined).
Regarding Claim 20, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses wherein the ramp is a threshold ramp parametrised by an ECAP threshold (Figure 10A, [0180] – the linear ramp function demonstrates the ramp parameters change after reaching one of four thresholds 502a-d; [0179] – these four thresholds are sensation, recruitment, discomfort, and pain).
Regarding Claim 21, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses instructing, by the processor, upon receiving the de-activation, the neurostimulation device to cease delivering the neural stimuli ([0065] – this limitation could simply be pushing the “off” button).
Regarding Claim 22, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses recording, upon receiving the de-activation, the value of the stimulus intensity parameter as a discomfort threshold for the selected electrodes of the plurality of implanted electrodes ([0180] – a ramp up waveform is implemented where the user provides feedback via the interface to identify thresholds). While reaching the pain threshold is given as an example of a trigger to implement the deactivation signal, the discomfort threshold could reasonably be used as the same trigger given Yoo considers both pain and discomfort undesirable upper limits ([0178] – “A therapeutic level used during an awake protocol should often be set between a minimum effective level (recruitment threshold) and a maximum level that is less than the level at which a subject experiences pain or discomfort”).
Regarding Claim 23, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses repeating, by the processor, the ramping and instructing and ceasing for further selected electrodes of the plurality of implanted electrodes ([0185] – different electrodes can be assessed using the procedure in [0179-0184]).
Regarding Claim 24, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses wherein the stimulus intensity parameter is an amplitude of a stimulus current pulse ([0181] – amplitude is used as a measure of intensity).
Regarding Claim 25, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses animating the stimulation control to indicate elapsed time since the activation of the control ([0076] – “The device may provide a timed stimulation session where the timer automatically starts counting down when the stimulation intensity is greater than zero, or exceeds a minimum defined amplitude. The timer value can be displayed on the display 120”).
Regarding Claim 26, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 25, as indicated hereinabove. Yoo further discloses wherein the animating ([0058] – graphs of stimulation control are a part of the display) indicates that the stimulus intensity has reached a neural response threshold ([0186] – warnings are provided when an intensity reaches a neural response threshold: “During patient adjustment 518 due to user input 522, the system 8 will warn a patient if they decrease the intensity of stimulation below the level defined as recruitment threshold”).
Regarding Claim 27, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 11, as indicated hereinabove. Yoo further discloses ceasing ramping the value of the stimulus intensity parameter ([0180] – the up-ramping feature stops when reaching a pain threshold; [0065] – this limitation could simply be pushing the “off” button) upon expiry of a first timeout period since receipt of a communication from the neurostimulation device ([0180] – for one cycle, the timing of the ramping waveform is preprogrammed and would either stop ramping due to a user input or reaching the end of the waveform; [0198] – for the calibration process, if a user response is not received in a defined time period then an automatic protocol takes effect: “In step 528 the stimulus is presented to the user and in step 530 the response of the user is sensed or otherwise obtained. If the response is not detected the method returns to step 526 and the stimulus is adjusted according to the assessment protocol in the absence of a user response”).
Regarding Claim 28, Yoo anticipates the automated method of controlling a neurostimulation device according to Claim 27, as indicated hereinabove. Yoo further discloses ramping down ([0180] – once a user-indicated pain threshold is met, a ramp down feature is implemented toward a sensation level: “stimulation intensity is then decreased. The user can then be asked to indicate thresholds as the intensity decreases from pain towards sensation, or patient input is only prompted for by the user device 32 on the upward slope”), upon expiry of a second timeout period since the expiry of the first timeout period without receiving a communication from the neurostimulation device, the value of the stimulus intensity parameter, while instructing, by the processor, the neurostimulation device to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter ([0180] – for one cycle, the timing of the ramping waveform is preprogrammed and would either down-ramp due to a user input or the programmed waveform; [0198] – for the calibration process, if a user response is not received in a defined time period then an automatic protocol takes effect: “In step 528 the stimulus is presented to the user and in step 530 the response of the user is sensed or otherwise obtained. If the response is not detected the method returns to step 526 and the stimulus is adjusted according to the assessment protocol in the absence of a user response”).
Claim Rejections - 35 USC § 103
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim 6 is rejected under U.S.C 103 as being unpatentable over Yoo (US 2019/0001135 A1) in view of Thacker (US 9,295,840 A1).
Regarding Claim 6, Yoo anticipates the a neurostimulation system according to Claim 1, as indicated hereinabove. Yoo further discloses wherein the stimulation control is configured to:
• become activated upon the user interacting with the stimulation control ([0065] – this limitation could simply be pushing the “on” button). Yoo discloses a ramping protocol to discover different thresholds of stimulation for producing sensation, recruitment, discomfort, and pain as determined by the user with a button push where ramping stops when the user indicates a pain threshold is reached (Fig. 10A, [0180]). However, Yoo does not disclose remain activated as long as the user continues to interact with the stimulation control; and become de-activated as soon as the user ceases to interact with the stimulation control. Note the continued interaction is interpreted as a constant interaction (such as holding a button) necessary to prevent deactivation, such as discussed in the instant specification ([0088]).
Thacker, in the same field of endeavor of controlling an implantable electrical stimulation (Col 1, Lines 20-25), teaches a technique where the user holds a button until a sensation/tolerance is reached (Col 10, Lines 46-54: “In the clinic and/or during a trial period, many or all of the expected locations/ amplitudes to be used can be tested for sensation thresholds and patient tolerance. This can be done with an automated 50 system that is directed by the patient, where the patient holds a button to let the test proceed and then releases the button if they feel any sensation (stopping the test for that location). The test cycles through the amplitudes/frequency/pulse width as needed for each location”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yoo’s button push to signify a threshold has been reached with the button hold until a threshold is reached in Thacker. At the time, there would have been a recognized need to determine a sensation threshold based on user-supplied feedback via a button, such as that used in Yoo. Given the limited options for manipulating a button, the button hold until a threshold is reached in Thacker would have been a known calibration option and obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the button hold until reaching a threshold calibration in Thacker as part of the control mechanism in Yoo.
Conclusions
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
