DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed on 1/20/2026 have been fully considered but they are not persuasive. Regarding newly amended claim 1, Applicant argues that Srivastava fails to disclose the steps that tie adjusting parameters of therapy delivered during a second time period based on a therapy response score determined based on physiological-inputs measured during a previous, first time period. Examiner respectfully disagrees and notes that Srivastava teaches delivering therapy in response to a pain score that was generated based on physiological inputs. Specifically, Srivastava discloses a first time period in which a signal is sensed and a pain score is generated [0076-0077] and a subsequent second interval in which a therapy is delivered according to the generated pain score [0079]. Examiner further notes that in order for the therapy to be delivered according to the pain score, it would have to be delivered during a second time period after the initial first time period in which the pain score is generated.
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11, lines 17-18 recite the limitation, “…neuromodulation therapy with the at least one first adjustment for the one or more parameters”. Examiner suggests adding a semicolon (“…parameters;”) to help separate the claim limitations. Appropriate correction is respectfully requested.
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.
Claim(s) 1, 3-7, 9-10, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srivastava et al (US Publication 2021/0060343) hereinafter Srivastava.
Regarding claim 1, Srivastava discloses a system for neuromodulation therapy (Fig. 3), the system comprising:
a processor ([0076] controller circuit 240); and
a memory storing data for processing by the processor ([0076] memory circuit 370), the data, when processed, causes the processor to:
receive one or more first physiological-based inputs of a user measured during a first time period ([0077] signals sensed by the sensor circuits 210 and 220);
determine a first therapy response score based on the one or more first physiological-based inputs ([0068] pain score generator 232 may generate a pain score using the signal metrics generated from sensed signals; [0076] pain scores generated by the pain score generator 232);
generate at least one first adjustment for one or more parameters of neuromodulation therapy based on the first therapy response score ([0079] adaptively adjusting one or more stimulation parameters or stimulation electrode configuration based on the pain score); and
cause, during a second time period after the first time period, a therapy system ([0075] pain management system 300) to deliver to the user the neuromodulation therapy having the at least one first adjustment for the one or more parameters ([0079] generation and delivery of electrostimulation in a closed-loop fashion by adaptively adjusting one or more stimulation parameters).
Regarding claim 3, Srivastava discloses herein the memory stores further data for processing by the processor that, when processed, causes the processor to:
receive information (battery status) about a state of the therapy system ([0078] parameters associated with operation of the therapy circuit 260, such as battery status may be transmitted to the external system 320); and
generate a notification based on at least one of the state of the therapy system, the first therapy response score, or the one or more first physiological-based inputs ([0071] the output circuit may generate alerts, alarms, emergency calls, or other means of warnings to signal the system user about the detected pain score).
Regarding claim 4, Srivastava discloses wherein the one or more parameters comprises at least one of increasing or decreasing a stimulation amplitude of a signal, increasing or decreasing a pulse width of a signal, increasing or decreasing a frequency of a signal, increasing or decreasing a number of electrode contacts, changing the electrode contacts that provide stimulation, starting or stopping the neuromodulation therapy, increasing or decreasing a cycling of the neuromodulation therapy, increasing or decreasing the cycling of high frequency components of the neuromodulation therapy independently of low frequency components of the neuromodulation therapy, adjustment of charge balancing strategy, or changing an on/off cycling time while maintaining a cycling ratio ([0074] controller circuit 240 may configure the therapy circuit 260 to deliver electrostimulation pulses via a set of electrodes selected from the plurality of electrodes).
Regarding claim 5, Srivastava discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to receive one or more additional inputs and the first therapy response score may be further based on the one or more additional inputs ([0070] input circuit may enable a system user to program the parameters used for sensing the physiological signals, generating signal metrics, or generating the pain score),
wherein the one or more additional inputs comprises at least one of user feedback or an environmental signal ([0070] input circuit may enable a user to confirm, reject, or edit the programming of the therapy circuit 260).
Regarding claim 6, Srivastava discloses wherein the one or more first physiological-based inputs comprises at least one of an activity or accelerometer signal, a cardiac-derived metric, a sleep score, a pain score, CMAP, EMG, respiration, an eCAP signal, posture, and/or other autonomic measures including organ sensing respiration ([0059] functional signal may include patient posture, gait, balance, physical activity signals, frequency or duration of sleep position switch, sleep incline, or other indicators of sleep quality; Fig. 4: motion sensors 410).
Regarding claim 7, Srivastava discloses wherein the one or more physiological-based inputs are received from at least one of a wearable device, a user device, or the therapy system ([0089] one or more of the motion sensors 410 may be incorporated in a mobile device, such as a smart phone, a wearable device, a fitness band, a portable health monitor, a tablet, a laptop computer, among other portable computerized device).
Regarding claim 9, Srivastava discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to map the one or more first physiological-based inputs to one or more events ([0109] alerts, alarms, emergency calls, or other forms of warnings may be generated to signal the system user about occurrence of a pain episode or aggravation of pain as indicated by the pain score).
Regarding claim 10, Srivastava discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to generate a notification when at least one of the one or more events is determined to be a risk to the user ([0109] alerts, alarms, emergency calls, or other forms of warnings may be generated to signal the system user about occurrence of a pain episode or aggravation of pain as indicated by the pain score).
Regarding claim 17, Srivastava discloses a system for neuromodulation therapy (Fig. 3), the system comprising:
a processor ([0076] controller circuit 240); and
a memory storing data for processing by the processor ([0076] memory circuit 370), the data, when processed, causes the processor to:
track one or more first physiological-based parameters of a user during a first time period ([0077] signals sensed by the sensor circuits 210 and 220);
determine a first therapy response score based on the one or more first physiological-based parameters ([0068] pain score generator 232 may generate a pain score using the signal metrics generated from sensed signals; [0076] pain scores generated by the pain score generator 232); and
cause, during a second time period after the first time period, a therapy system to deliver the neuromodulation therapy to the user based on the first therapy response score ([0079] generation and delivery of electrostimulation by adaptively adjusting one or more stimulation parameters or stimulation electrode configuration based on the pain score).
Claim(s) 11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dinsmoor et al (US 2016/0303376) hereinafter Dinsmoor.
Regarding claim 11, Dinsmoor discloses a system for neuromodulation therapy, the system comprising:
a processor ([0073] processor 80); and
a memory storing data for processing by the processor ([0073] memory 82), the data, when processed, causes the processor to:
receive one or more first physiological-based inputs of a user measured during a first time period ([0129] IMD 14 then detects an eCMAP biomarker (226));
determine a first therapy response score based on the one or more first physiological-based inputs ([0129] processor 80 determines if the eCMAP biomarker corresponds to a desired outcome (230));
generate at least one first adjustment for one or more parameters of neuromodulation therapy based on the first therapy response score ([0130] If the eCMAP biomarker does not correspond to the desired outcome, processor 80 adjusts at least one stimulation therapy parameter within the therapy program (232));
cause, during a second time period after the first time period, a therapy system to deliver to the user the neuromodulation therapy having the at least one first adjustment for the one or more parameters ([0130] Stimulation generator 84 provides stimulation according to the updated therapy program (224));
track, during the second time period, one or more second physiological-based inputs of the user measured while the user is receiving the neuromodulation therapy with the at least one first adjustment for the one or more parameters ([0129] IMD 14 then detects an eCMAP biomarker (226));
determine one or more physiological responses based on a difference between the one or more first physiological-based inputs and the one or more second physiological-based inputs ([0129] Processor 80 analyzes the detected eCMAP biomarker (228)); and
determine if a physiological event has occurred based on the one or more physiological responses ([0129] processor 80 determines if the eCMAP biomarker corresponds to a desired outcome (230)).
Regarding claim 13, Dinsmoor discloses a pulse generator (IMD 14) configured to generate an electrical signal ([0036] MD 14 is an implantable electrical stimulator configured for spinal cord stimulation (SCS)); and
a lead (leads 16) in communication with the pulse generator and configured to transmit the electrical signal to an anatomical element ([0036] energy is delivered from IMD 14 to spinal cord 18 of patient 12 via one or more electrodes disposed on implantable leads 16A and 16B).
Regarding claim 14, Dinsmoor discloses wherein the one or more second physiological-based inputs are tracked with at least one of stimulation or without stimulation ([0130] Stimulation generator 84 provides stimulation according to the updated therapy program (224). The process of providing stimulation (224), detecting an eCMAP biomarker (226), analyzing the eCMAP biomarker (228), and determining if the eCMAP biomarker corresponds to the desired outcome (230) is repeated until the eCMAP biomarker corresponds to the desired outcome).
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.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Srivastava (US 2021/0060343) in view of Kelley (US 2014/0179986).
Regarding claim 2, Srivastava discloses wherein the one or more parameters are adjusted automatically or manually ([0074] electrodes may be automatically selected based on the pain score), but fails to disclose wherein the first time period corresponds to a period of higher activity for the user than the second time period. However, Kelley discloses wherein the first time period corresponds to a period of higher activity for the user than the second time period ([0164-0165] At 808 physiological data are acquired from one or more patient worn modules and are processed to generate data indicative of the patient's current pattern of wakefulness; At 812 data from the Sleep History data store 810 are processed to determine if the patient is experiencing a transition to sleep; At 814 the parameters of the repeating pattern of stimulation are optionally modified). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Srivastava with the first time period corresponds to a period of higher activity for the user than the second time period as taught by Kelley. Such a modification would provide the predictable results of initiating and/or accelerating the onset of sleep and maintaining the sleep state after the onset of sleep (Kelley, Abstract).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over by Dinsmoor (US 2016/0303376) in view of Kelley (US 2014/0179986) and further in view of Krause et al (US 2010/0114221) hereinafter Krause.
Regarding claim 12, Dinsmoor discloses the system of claim 11 as discussed above, but fails to disclose wherein the first time period corresponds to a period of higher activity for the user than the second time period, and
wherein the physiological event comprises a lead migration.
Kelley discloses wherein the first time period corresponds to a period of higher activity for the user than the second time period ([0164-0165] At 808 physiological data are acquired from one or more patient worn modules and are processed to generate data indicative of the patient's current pattern of wakefulness; At 812 data from the Sleep History data store 810 are processed to determine if the patient is experiencing a transition to sleep; At 814 the parameters of the repeating pattern of stimulation are optionally modified). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with the first time period corresponds to a period of higher activity for the user than the second time period as taught by Kelley. Such a modification would provide the predictable results of initiating and/or accelerating the onset of sleep and maintaining the sleep state after the onset of sleep (Kelley, Abstract).
Krause discloses wherein the physiological event comprises a lead migration ([0126] lead migration detection module 120 may control operation of neurostimulation therapy module 106 to determine whether lead 28 has migrated to the extent that there is loss of nerve capture by electrodes 80-83). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with the physiological event comprises a lead migration as taught by Skelton. Such a modification would provide the predictable results of detecting a loss of nerve capture due to lead migration [0136].
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over by Dinsmoor (US 2016/0303376) in view of Pepin et al (US 2021/0052900) hereinafter Pepin.
Regarding claim 21, Dinsmoor discloses the system of claim 11 as discussed above, but fails to disclose wherein the memory stores further data for processing by the processor that, when processed, causes the processor to send data collected during the tracking the one or more second physiological-based inputs to a therapy response model for training the therapy response model. However, Pepin discloses the memory stores further data for processing by the processor that, when processed, causes the processor to send data collected during the tracking the one or more second physiological-based inputs to a therapy response model for training the therapy response model ([0087] as the subject's therapy parameters are adjusted at each cycle of the loop in FIG. 5B, a machine-learning model may be trained on the previous inputs and their known outputs (e.g., resulting subject biomarkers).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with the memory stores further data for processing by the processor that, when processed, causes the processor to send data collected during the tracking the one or more second physiological-based inputs to a therapy response model for training the therapy response model as taught by Pepin. Such a modification would provide the predictable results of using the trained models to predict the subject state for various possible adjustments (Pepin, [0087]).
Allowable Subject Matter
Claims 8, 15, 18, 20, and 25-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: Examiner has not found any prior art that teaches or suggests the limitations recited in claims 8, 15, and 18. Specifically, Examiner has not found any art that teaches or suggests “wherein the first time period is while the user is awake and the second time period is while the user is asleep, and wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
receive one or more second physiological-based inputs of the user measured while the user is asleep during the second time period and also receiving the neuromodulation therapy with the at least one first adjustment for the one or more parameters, wherein at
least one of the one or more second physiological-based inputs is different than the one or more first physiological-based inputs;
determine a second therapy response score based on the one or more second physiological-based inputs;
generate at least one second adjustment for the one or more parameters of the neuromodulation therapy based on the second therapy response score; and
cause, during a third time period after the user awakes from being asleep during the second time period, the therapy system to deliver to the user the neuromodulation therapy having the at least one second adjustment for the one or more parameters”.
Both Srivastava and Dinsmoor teach receiving physiological inputs and adjusting stimulation based off of those inputs (see rejections above), but remain silent regarding wherein the first time period is while the user is awake and the second time period is while the user is asleep.
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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792