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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7-20, and 22-27 have been considered but are 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.
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.
Claim(s) 1, 4, 8, 10-12, 15, 19-20, 22, 23, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baru et al. (U.S. Patent Application Publication No. 2017/0259065) hereinafter referred to as Baru.
Regarding claim 1, Baru teaches a method comprising:
delivering, via an electrical stimulation device, one or more electrical stimulation signals to a patient (¶[0010]);
sensing one or more stimulation-evoked signals that are evoked by stimulation of nerves or muscles of the patient due to the delivery of the one or more electrical stimulation signals (¶[0149] ECAP);
determining a quality of the one or more stimulation-evoked signals (¶[0150] deviation in latency),
wherein determining the quality of the one or more stimulation-evoked signals comprises determining whether the one or more stimulation-evoked signals is a reliable indicator of the nerve or muscle stimulation evoked by the one or more electrical stimulation signals based at least on an evaluation of a signal feature in the one or more stimulation-evoked signals (¶[0150-0151] ECAP latency changing abruptly from an initial latency value); and
outputting, based on the quality of the one or more sensed stimulation-evoked signals being below a quality threshold, one or more instructions to improve the quality of one or more subsequent stimulation-evoked signals (¶[0152] notify a physician of the migration so that a corrective action may be taken).
Regarding claim 4, Baru teaches the method of claim 1.
Baru further teaches wherein the patient is in a non-clinic location (¶[0010] device is implanted for continuous or ongoing use at home).
Regarding claim 8, Baru teaches the method of claim 1.
Baru further teaches wherein the one or more stimulation-evoked signals comprises at least one of an electromyographic (EMG) signal, an evoked compound action potential (ECAP) (¶[0149] ECAP), a neural network excitability, or a muscular network excitability.
Regarding claim 10, Baru teaches the method of claim 1.
Baru teaches further comprising:
determining, based on the quality of the one or more sensed stimulation-evoked signals, an efficacy of a stimulation therapy program (¶[0152], ¶[0157]); and
outputting the determined efficacy (¶[0152], ¶[0157]).
Regarding claim 11, Baru teaches the method of claim 1.
Baru further teaches wherein the one or more stimulation-evoked signals comprise a composite stimulation-evoked signal comprising two or more stimulation- evoked signals generated by one or more signal sources in response to the one or more electrical stimulation signals (¶[0023] ECAP).
Regarding claim 25, Baru teaches the method of claim 1.
Baru further teaches wherein the signal feature comprises at least one of: a strength of the signal, a noise characteristic in the signal, an artifact in the signal, an amplitude of the signal, an amount of the signal integrated over a period of time, a frequency component of the signal, a peak characteristic of the signal, a growth curve of the signal, a latency characteristic of the signal (¶[0150-0151]), an impedance characteristic of the signal, a standard deviation of the signal, or a power spectrum of the signal.
Regarding claims 12, 15, and 19/22 the claims are directed to a system comprising substantially the same subject matter as claims 1, 4, and 8 and are rejected under substantially the same sections of Baru.
Regarding claim 20, Baru teaches the system of claim 19.
Baru further teaches wherein the one or more instructions comprises at least one of directing the patient to be in a predetermined posture during delivery of electrical stimulation, directing at least one of the patient or a clinician to change an electrical stimulation parameter, directing an electrical stimulation device configured to control the at least one electrode to change an electrical stimulation parameter (¶[0152]), or waiting for a predetermined amount of time before subsequent delivery of electrical stimulation.
Regarding claim 23, Baru teaches the system of claim 22.
Baru further teaches wherein automatically changing the one or more electrical stimulation therapy parameters comprises causing a change in a voltage or current amplitude (¶[0034] steering, current weights ¶[0063-0066] which adjust relative amplitudes), a pulse width, or a pulse frequency.
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) 2-3 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baru as applied to claim 1 above, and further in view of Lund et al. (U.S. Patent Application Publication No. 2007/0265675) hereinafter referred to as Lund.
Regarding claim 2, Baru teaches the method of claim 1.
Baru teaches SCS broadly but does not explicitly teach specific therapies.
Attention is brought to the Lund reference, which teaches wherein delivering the one or more electrical stimulation signals to the patient comprises delivering the one or more electrical stimulation signals to the patient for at least one of a pelvic health disorder, bladder dysfunction, retention, overactive bladder, urgency, urgency frequency, urinary incontinence, bladder incontinence, fecal incontinence, stress urinary incontinence, urinary retention, sexual dysfunction, obesity, gastroparesis, intractable constipation, pelvic pain, chronic pain, bladder pain syndrome, irritable bowel syndrome, inflammatory bowel disease, interstitial cystitis, neurogenic bowel, neurogenic bladder, neurological disorders, tremor, Parkinson's disease, epilepsy, multiple sclerosis, stroke, spinal cord injury, or neuropathy (¶[0034]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Baru to apply IPG stimulation to additional or other nerves in a user’s body to assist in treatment of additional patient dysfunction, as taught in Lund.
Regarding claim 3, Baru teaches the method of claim 1.
Baru does not teach wherein the one or more electrical stimulation doses are delivered to at least one of a sacral nerve, a tibial nerve, a saphenous nerve, a pudendal nerve, or a sciatic nerve
Attention is brought to the Lund reference, which teaches wherein one or more electrical stimulation doses are delivered to at least one of a sacral nerve, a tibial nerve, a saphenous nerve, a pudendal nerve, or a sciatic nerve (¶[0014]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Baru to apply IPG stimulation to additional or other nerves in a user’s body to assist in treatment of additional patient dysfunction, as taught in Lund.
Regarding claims 13-14 the claims are directed to a system comprising substantially the same subject matter as claims 2-3 and are rejected under substantially the same sections of Baru.
Claim(s) 5, 7, 9, 16-18, 24, and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baru as applied to claim 1 above, and further in view of Esteller et al. (U.S. Patent Application Publication No. 2022/0323764) hereinafter referred to as Esteller.
Regarding claim 5, Baru teaches the method of claim 1.
Baru does not teach wherein determining whether the one or more sensed stimulation-evoked signals is a reliable indicator is further based on determining that a posture of the patient is a predetermined posture at the time the one or more electrical stimulation signals are delivered and/or at the time the one or more stimulation- evoked signals are sensed.
Attention is drawn to the Esteller reference, which teaches wherein determining whether the one or more sensed stimulation-evoked signals is a reliable indicator is further based on determining that a posture of the patient is a predetermined posture at the time the one or more electrical stimulation signals are delivered and/or at the time the one or more stimulation- evoked signals are sensed (¶[0071], ¶[0073]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ECAP sensing of Baru to use stimulation artifact for optimizing stimulation, as taught by Esteller, because Esteller teaches that the stimulation artifact sensing and information is a specific improvement over the method of Baru alone (Esteller, ¶¶[0060-0061]).
Regarding claim 7, Baru as modified teaches the method of claim 5.
Esteller further teaches wherein the predetermined posture comprises at least one of a patient movement or a patient position, the patient position comprising one of sitting down, standing, or lying down (¶[0071], ¶[0076]).
Regarding claim 9, Baru as modified teaches the method of claim 7.
Esteller further teaches wherein the predetermined posture is a first predetermined posture (¶[0071], ¶[0076]), wherein the one or more instructions comprises at least one of directing the patient to be in a second predetermined posture different from the first predetermined posture during subsequent delivery of electrical stimulation (¶[0081]), directing at least one of the patient or a clinician to change an electrical stimulation parameter, directing the electrical stimulation device to change an electrical stimulation parameter, or waiting for a predetermined amount of time before subsequent delivery of electrical stimulation.
Regarding claim 24, Baru teaches the method of claim 1.
Baru does not teach wherein determining whether the one or more sensed stimulation-evoked signals is a reliable indicator is further based on determining a posture of the patient, wherein the posture of the patient comprises a position of the patient, a movement of the patient, or a state of the patient.
Attention is drawn to the Esteller reference, which teaches wherein determining whether the one or more sensed stimulation-evoked signals is a reliable indicator is further based on determining a posture of the patient, wherein the posture of the patient comprises a position of the patient, a movement of the patient, or a state of the patient (¶[0071], ¶[0073]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ECAP sensing of Baru to use stimulation artifact for optimizing stimulation, as taught by Esteller, because Esteller teaches that the stimulation artifact sensing and information is a specific improvement over the method of Baru alone (Esteller, ¶¶[0060-0061]).
Regarding claim 26, Baru teaches the method of claim 25.
Baru does not teach wherein an artifact in the signal includes at least one of a motion artifact, an electrical interference, a cardiac artifact, a bowel fullness, a bladder fullness, a spurious EMG, a standard deviation less than a threshold standard deviation, a variance less than a threshold variance, or a signal-to-noise ratio (SNR) greater than a threshold SNR.
Attention is drawn to the Esteller reference, which teaches wherein an artifact in the signal includes at least one of a motion artifact (¶[0081]), an electrical interference, a cardiac artifact, a bowel fullness, a bladder fullness, a spurious EMG, a standard deviation less than a threshold standard deviation, a variance less than a threshold variance, or a signal-to-noise ratio (SNR) greater than a threshold SNR.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ECAP sensing of Baru to use stimulation artifact for optimizing stimulation, as taught by Esteller, because Esteller teaches that the stimulation artifact sensing and information is a specific improvement over the method of Baru alone (Esteller, ¶¶[0060-0061]).
Regarding claim 27, Baru teaches the method of claim 1.
Baru does not teach wherein the signal feature comprises at least one of a SNR or an artifact in the signal.
Attention is brought to the Esteller reference, which teaches wherein the signal feature comprises at least one of a SNR or an artifact in the signal (¶[0081]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ECAP sensing of Baru to use stimulation artifact for optimizing stimulation, as taught by Esteller, because Esteller teaches that the stimulation artifact sensing and information is a specific improvement over the method of Baru alone (Esteller, ¶¶[0060-0061]).
Regarding claims 16-18, the claims are directed to a system comprising substantially the same subject matter as claims 6-9, 24, and 26-27 and are rejected under substantially the same sections of Baru and Esteller.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2021/0031042 to Davies et al. teaches a paresthesia threshold for electrical stimulation based specifically on patient posture.
U.S. Patent Application Publication No. 2014/0163639 to Zhu teaches a neurostimulation system that detects lead migration in postural change through features of a detected signal including impedance.
U.S. Patent Application Publication No. 2015/0032181 to Baynham et al. teaches compensating for lead migration due to postural changes
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