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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-2, 7-10, and 15-20 in the reply filed on 2/12/2026 is acknowledged.
Claims 3-6 and 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/12/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: 38, 330a, 330b, 330c, 330d, 800, 1646, and 220. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “942” has been used to designate both potential signal waveforms and evoked potential signals. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 1446 and 2200. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph 0088, line 4, “simulation artifact 940” should read “stimulation artifact 940”
In paragraph 0098, lines 3-4, “sensed 1646 evoked response signals” should read “sensed evoked response signals 1646”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 recites the limitation "the neurostimulation target" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the number of repeated presentations" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the first neurostimulation" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the number of repeated presentations" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the first neurostimulation" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the stimulation lead" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the user interface" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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)(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, 9, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dinsmoor et al. (U.S. Patent No. 11,896,828).
Regarding claim 1, Dinsmoor teaches a computer-implemented (Col. 24, 52-53) method (Fig. 8, Col. 20, line 12) of operating a neurostimulation device (Fig. 1, Col. 5, lines 42-43) to deliver electrical neurostimulation (Col. 11, lines 42-43) when connected to an implantable stimulation lead (Col. 9, lines 23-24), the method comprising: delivering first neurostimulation (Col. 21, line 18) to a subject (Col. 9, line 23) that produces evoked potential signals (Col. 12, lines 46-48); delivering second neurostimulation (Col. 21, lines 23-24) that includes at least one of multiple presentations (Col. 8, line 54) of the first neurostimulation or a change in a parameter (Col. 16, lines 1-8) of the first neurostimulation; sensing the evoked potential signals resulting from the first neurostimulation and the second neurostimulation (Col. 12, lines 2-4); detecting changes in the sensed evoked potential signals between the first neurostimulation and the second neurostimulation (Col.15, lines 47-49); and producing an indication of proximity (Col. 19, lines 15-18) of the stimulation lead to a preferred lead location (Col. 20, line 32) according to the detected changes in the sensed evoked potential signals (Col. 20, lines 31-35).
Regarding claim 9, Dinsmoor teaches a neurostimulation system (Fig. 1, Col. 5, lines 41-45), the system comprising: a stimulation circuit (Fig. 2, Col. 11, line 7) configured to deliver electrical neurostimulation (Col. 11, lines 42-43) to a subject (Col. 9, line 23) when coupled to an implantable stimulation lead (Col. 9, lines 23-24); a sensing circuit (Fig. 2, Col. 11, line 8) configured to sense evoked potential signals (Col. 12, lines 2-4) when coupled to the stimulation lead (Col. 12, lines 4-6); a control circuit (Fig. 2, Col. 12, lines 39-46) operatively coupled to the stimulation circuit and the sensing circuit (Col. 11, lines 6-9), and configured to initiate delivery of neurostimulation to the subject that produces an evoked potential signal (Col. 12, lines 46-48), and record sensed evoked potential signals resulting from the neurostimulation (Col. 12, lines 56-60); and signal processing circuitry (Fig. 3, Col. 14, lines 55-56) configured to detect changes in the sensed evoked potential signals (Col.15, lines 47-49) in response to a change in at least one of the number of repeated presentations (Col. 8, line 54) of the neurostimulation or a change in a parameter (Col. 16, lines 1-8) of the first neurostimulation, and produce an indication of proximity (Col. 19, lines 15-18) of the stimulation lead to a preferred lead location (Col. 20, line 32) according to the detected changes in the evoked potential signals (Col. 20, lines 31-35).
Regarding claim 19, Dinsmoor teaches a non-transitory computer readable storage medium (Col. 14, lines 6-17 and Col. 24, line 55) including instructions (Col. 14, line 19) that when performed by (Col. 14, lines 19-20) processing circuitry (Fig. 2, Col. 12, lines 39-46) of a neurostimulation system (Fig. 1, Col. 5, lines 41-45), cause the neurostimulation system to perform actions including: initiate delivery of neurostimulation to produce an evoked potential signal (Col. 12, lines 46-48) in a subject (Col. 9, line 23); record sensed evoked potential signals resulting from the neurostimulation (Col. 12, lines 56-60); detect changes in the sensed evoked potential signals (Col.15, lines 47-49) in response to a change in at least one of the number of repeated presentations (Col. 8, line 54) of the neurostimulation or a change in a parameter (Col. 16, lines 1-8) of the first neurostimulation; and display (Col. 15, lines 44-51) an indication of proximity (Col. 19, lines 15-18) of the stimulation lead to a preferred lead location (Col. 20, line 32) according to the detected changes in the sensed evoked potential signals (Col. 20, lines 31-35).
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 7-8, 10, 15-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (U.S. Patent No. 11,896,828) in view of Kaula et al. (U.S. PGPub No. 2015/0134027).
Regarding claim 2, Dinsmoor teaches the method (Fig. 8, Col. 20, line 12) of claim 1, wherein the delivering the second neurostimulation (Col. 21, lines 23-24) includes delivering (Col. 12, lines 46-48) multiple neurostimulation pulses (Col. 14, lines 32-33); wherein the detecting changes in the sensed evoked potential signals (Col.15, lines 47-49) includes detecting a change in a signal feature (Col. 18, lines 1-25) of the sensed evoked potential signals between neurostimulation pulses (Fig. 4).
Dinsmoor does not teach that the producing the indication of proximity of the stimulation lead includes determining proximity of the stimulation lead according to a degree of saturation in the sensed evoked potential signals. Kaula, however, teaches a method for determining optimal placement for a pudendal nerve stimulation lead using patient feedback that produces an indication of proximity of the stimulation lead (Paragraph 0144, lines 4-7) according to a degree of saturation the sensed evoked potential signals (Paragraph 0143, lines 9-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Kuala to include that producing the indication of proximity of the stimulation lead includes determining proximity of the stimulation lead according to a degree of saturation in the sensed evoked potential signals. Doing so would allow a clinician to properly place the stimulation lead without verbal or voluntary physical feedback from the patient (Paragraph 0162), as recognized by Kaula.
Regarding claim 7, Dinsmoor teaches the method (Fig. 8, Col. 20, line 12) of claim 1, which includes producing the indication of proximity (Col. 19, lines 15-18) of the stimulation lead (Col. 9, lines 23-24). Dinsmoor does not teach that the method includes presenting an indication that the stimulation lead is close to the neurostimulation target according to a degree of saturation in the sensed evoked potential signals, presenting an indication that the stimulation lead is off of the preferred lead location according to a monotonical increase in amplitude of the sensed evoked potential signals, and presenting an indication that the stimulation lead is not close to the preferred lead location according to an amplitude of the sensed evoked potential signals that increases at first slower rate and then increases at second faster rate.
Kaula, however, teaches a method for determining optimal placement for a pudendal nerve stimulation lead using patient feedback that includes: producing an indication of proximity of the stimulation lead (Paragraph 0144, lines 4-7) according to a degree of saturation the sensed evoked potential signals (Paragraph 0143, lines 9-11); presenting an indication that the stimulation lead is off (Paragraph 0143, lines 9-13) of the preferred lead location according to a monotonical increase in amplitude (Fig. 13B, Paragraph 0142, lines 1-11) of the sensed evoked potential signals (Paragraph 0142, line 1); and presenting an indication that the stimulation lead is not close (Fig. 13B, Paragraph 0143, lines 1-4) to the preferred lead location according to an amplitude of the sensed evoked potential signals that increases at first slower rate (Fig. 13B, Paragraph 0142, lines 2-4) and then increases at second faster rate (Fig. 13B, Paragraph 0142, lines 4-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Kaula to include that producing the indication of proximity further includes: presenting an indication that the stimulation lead is close to the neurostimulation target according to a degree of saturation, presenting an indication that the stimulation lead is off of the preferred lead location according to a monotonical increase in amplitude, and presenting an indication that the stimulation lead is not close to the preferred lead location according to an amplitude of the sensed evoked potential signals that increases at first slower rate and then increases at second faster rate. Doing so would allow a clinician to properly place the stimulation lead without verbal or voluntary physical feedback from the patient (Paragraph 0162), as recognized by Kaula.
Regarding claim 8, Dinsmoor teaches the method (Fig. 8, Col. 20, line 12) of claim 1, which includes producing the indication of proximity (Col. 19, lines 15-18) of the stimulation lead (Col. 9, lines 23-24). Dinsmoor does not teach that this includes: presenting an indication that the stimulation lead is close to the preferred lead location when the sensed evoked potential signals saturate at a first signal amplitude at a first time relative to the neurostimulation; and presenting an indication that the stimulation lead is not close to the preferred lead location when the sensed evoked potential signals saturate at a second signal amplitude at a second time relative to the neurostimulation, wherein the second signal amplitude is larger than the first signal amplitude and the second time is later than the first time relative to the neurostimulation.
Kaula, however, teaches a method for determining optimal placement for a pudendal nerve stimulation lead using patient feedback that indicates a stimulation lead is close to the target lead location when the sensed evoked potential signals reach a threshold value (Fig. 13B, Paragraph 0142, lines 4-5) and then saturate (Fig. 13B, Paragraph 0142, lines 8-9) at a first signal amplitude at a first signal amplitude at a first time relative to the neurostimulation (Fig. 13B, Paragraph 0144, lines 7-11).
Furthermore, Kaula teaches that the stimulation lead is not close to the preferred lead location when the sensed evoked potential signals reach a threshold value and then saturate at a second signal amplitude at a second time relative to the neurostimulation, wherein the second signal amplitude is larger than the first signal amplitude (Fig. 13B, Paragraph 0144, lines 11-14) and the second time is later than the first time relative to the neurostimulation (Fig. 13B, Paragraph 0144, lines 4-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Kaula to include indicating if a stimulation lead is close or not close to the preferred lead location based on when the sensed signal saturates in correlation to signal amplitudes and time. Doing so would allow a clinician to know how well a stimulation lead is placed, and how the lead needs to be adjusted to achieve more optimal results (Paragraph 0161), as recognized by Kaula.
Regarding claim 10, Dinsmoor teaches the system (Fig. 1, Col. 5, lines 41-45) of claim 9, wherein the control circuit (Fig. 2, Col. 12, lines 39-46) is configured to initiate delivery (Col. 12, lines 46-48) of multiple neurostimulation pulses (Col. 14, lines 32-33) by the stimulation circuit (Fig. 2, Col. 11, line 7); wherein the signal processing circuit (Fig. 3, Col. 14, lines 55-56) is configured to: detect a change in a signal feature (Col. 18, lines 1-25) of the sensed evoked potential signals between neurostimulation pulses (Fig. 4). Dinsmoor does not teach that the signal processing circuit is configured to produce the indication of proximity of the stimulation lead according to a degree of saturation in the sensed evoked potential signals.
Kaula, however, teaches a system for determining optimal placement for a pudendal nerve stimulation lead using patient feedback that includes a signal processing circuit (Paragraph 0086, line 5). Furthermore, Kuala teaches that the signal processing circuit is used to produce an indication of proximity of the stimulation lead (Paragraph 0144, lines 4-7) according to a degree of saturation the sensed evoked potential signals (Paragraph 0143, lines 9-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Kuala to include that the signal processing circuit is configured to produce the indication of proximity of the stimulation lead according to a degree of saturation in the sensed evoked potential signals. Doing so would allow a clinician to properly place the stimulation lead without verbal or voluntary physical feedback from the patient (Paragraph 0162), as recognized by Kaula.
Regarding claim 15, Dinsmoor teaches the system (Fig. 1, Col. 5, lines 41-45) of claim 9, including: a user interface (Fig. 3, Col. 14, line 57) operatively coupled to (Fig. 3, Col. 14, lines 55-57) the signal processing circuit (Fig. 3, Col. 14, lines 55-56) that provides an indication on the user interface that the stimulation lead is close to, off, or not close to the preferred lead location (Col. 15, lines 65-67 and Col. 16, lines 1-10).
Dinsmoor does not teach that the system is configured to: detect saturation of a feature in a sensed evoked potential signal and present an indication that the stimulation lead is close to the preferred lead location according to a degree of saturation detected in the sensed evoked potential signals; detect when a magnitude of the sensed evoked potential signal increases monotonically with the neurostimulation and present an indication that the stimulation lead is off the preferred lead location when detecting the monotonical increase in the sensed evoked potential signal; and detect when a rate of increase in the magnitude of the feature in the sensed evoked potential signal changes and present an indication that the stimulation lead is not close to the preferred lead location according to the detected change in rate of increase in the magnitude of the feature.
Kaula, however, teaches a system for determining optimal placement for a pudendal nerve stimulation lead using patient feedback that: detects saturation of a feature in a sensed evoked potential signal (Paragraph 0143, lines 9-11); detects when a magnitude of the sensed evoked potential signal increases monotonically with the neurostimulation (Fig. 13B, Paragraph 0142, lines 1-11); and detects when a rate of increase in the magnitude of the feature in the sensed evoked potential signal changes (Fig. 13B, Paragraph 0142, lines 2-8).
Kaula also teaches a system that produces an indication of proximity of the stimulation lead (Paragraph 0144, lines 4-7) which includes: producing an indication of proximity of the stimulation lead (Paragraph 0144, lines 4-7) according to a degree of saturation the sensed evoked potential signals (Paragraph 0143, lines 9-11); presenting an indication that the stimulation lead is off (Paragraph 0143, lines 9-13) of the preferred lead location according to a monotonical increase in the sensed evoked potential signal (Fig. 13B, Paragraph 0142, lines 1-11); and presenting an indication that the stimulation lead is not close (Fig. 13B, Paragraph 0143, lines 1-4) to the preferred lead location according to the change in rate of increase in the magnitude of the feature (Fig. 13B, Paragraph 0142, lines 2-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Kaula to include that system is able to detect saturation of a feature in a sensed evoked potential signal, detect when a magnitude of the sensed evoked potential signal increases monotonically, and detect when a rate of increase in the magnitude of the feature in the sensed evoked potential signal changes, and present an indication that the stimulation lead is close to, off, or not close to the preferred lead location based on the respective detected measurements. Doing so would allow a clinician to properly place the stimulation lead without verbal or voluntary physical feedback from the patient (Paragraph 0162), as recognized by Kaula.
Regarding claim 16, Dinsmoor teaches the system (Fig. 1, Col. 5, lines 41-45) of claim 9, including: a user interface (Fig. 3, Col. 14, line 57) operatively coupled to the signal processing circuit (Fig. 3, Col. 14, lines 55-56) that provides an indication on the user interface that the stimulation lead is close to or not close to the preferred lead location (Col. 15, lines 65-67 and Col. 16, lines 1-10). Dinsmoor does not teach that the system is configured to: detect when a sensed evoked potential signal saturates at a first signal amplitude at a first time relative to delivery of the neurostimulation; and detect when a sensed evoked potential signal saturates at a second signal amplitude larger than the first signal amplitude at a second time relative to the neurostimulation later than the first time.
Kaula, however, teaches a system for determining optimal placement for a pudendal nerve stimulation lead using patient feedback that indicates a stimulation lead is close to the target lead location when the sensed evoked potential signals reach a threshold value (Fig. 13B, Paragraph 0142, lines 4-5) and then saturate (Fig. 13B, Paragraph 0142, lines 8-9) at a first signal amplitude at a first signal amplitude at a first time relative to the neurostimulation (Fig. 13B, Paragraph 0144, lines 7-11).
Furthermore, Kaula teaches that the stimulation lead is not close to the preferred lead location when the sensed evoked potential signals reach a threshold value and then saturate at a second signal amplitude at a second time relative to the neurostimulation, wherein the second signal amplitude is larger than the first signal amplitude (Fig. 13B, Paragraph 0144, lines 11-14) and the second time is later than the first time relative to the neurostimulation (Fig. 13B, Paragraph 0144, lines 4-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Kaula to include indicating if a stimulation lead is close or not close to the preferred lead location based on when the sensed signal saturates in correlation to signal amplitudes and time. Doing so would allow a clinician to know how well a stimulation lead is placed, and how the lead needs to be adjusted to achieve more optimal results (Paragraph 0161), as recognized by Kaula.
Regarding claim 20, Dinsmoor teaches the non-transitory computer readable storage medium (Col. 14, lines 6-17 and Col. 24, line 55) of claim 19, including instructions (Col. 14, line 19) that cause the cause the neurostimulation system (Fig. 1, Col. 5, lines 41-45) to perform actions including: providing an indication on the user interface (Fig. 3, Col. 14, line 57) that the stimulation lead is close to, off, or not close to the preferred lead location (Col. 15, lines 65-67 and Col. 16, lines 1-10).
Dinsmoor does not teach that the system: detects saturation in a sensed evoked potential signal and indicates that the stimulation lead is close to the preferred lead location in response to detecting the saturation; detects when amplitude of a sensed evoked potential signal increases monotonically with the neurostimulation and indicates that the stimulation lead is off the preferred lead location in response to detecting the monotonical increase in the sensed evoked potential signal; and detects when a rate of increase in amplitude of a sensed evoked potential signal changes and indicates that the stimulation lead is not close to the preferred lead location in response to detecting the change in rate of increase in amplitude.
Kaula, however, teaches a system for determining optimal placement for a pudendal nerve stimulation lead using patient feedback that: detects saturation of a feature in a sensed evoked potential signal (Paragraph 0143, lines 9-11); detects when amplitude of the sensed evoked potential signal increases monotonically with the neurostimulation (Fig. 13B, Paragraph 0142, lines 1-11); and detects when a rate of increase in amplitude of the sensed evoked potential signal changes (Fig. 13B, Paragraph 0142, lines 2-8).
Kaula also teaches a system that produces an indication of proximity of the stimulation lead (Paragraph 0144, lines 4-7) which includes: producing an indication of proximity of the stimulation lead in response to the detected saturation (Paragraph 0143, lines 9-11); presenting an indication that the stimulation lead is off (Paragraph 0143, lines 9-13) of the preferred lead location in response to the detected monotonical increase in the sensed evoked potential signal (Fig. 13B, Paragraph 0142, lines 1-11); and presenting an indication that the stimulation lead is not close (Fig. 13B, Paragraph 0143, lines 1-4) to the preferred lead location in response to the detected change in rate of increase in amplitude (Fig. 13B, Paragraph 0142, lines 2-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Kaula to include that system is able to detect saturation in a sensed evoked potential signal, detect when amplitude of the sensed evoked potential signal increases monotonically, and detect when a rate of increase in amplitude of the sensed evoked potential signal changes, and present an indication that the stimulation lead is close to, off, or not close to the preferred lead location based on the respective detected measurements. Doing so would allow a clinician to properly place the stimulation lead without verbal or voluntary physical feedback from the patient (Paragraph 0162), as recognized by Kaula.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (U.S. Patent No. 11,896,828) in view of Moffit (U.S. PGPub No. 2022/0040486).
Regarding claim 17, Dinsmoor teaches the system (Fig. 1, Col. 5, lines 41-45) of claim 9, including: a communication circuit (Fig. 2, Col. 11, line 8) configured to communicate information (Col. 12, lines 17-18) with a separate device (Col. 12, lines 18-19). Dinsmoor does not teach that the stimulation circuit, sensing circuit, and communication circuit are included in an implantable pulse generator.
Moffit, however, teaches an electrical stimulation system that uses as implantable pulse generator (Fig. 1A, Paragraph 0035, line 2) to determine lead location with respect to a preferred lead location (Paragraph 0085, lines 1-4). Moffit further specifies that the IPG includes stimulation circuitry (Fig. 3, Paragraph 0043, lines 1-2), sensing circuitry (Fig. 3, Paragraph 0064, line 1), and communication circuitry (Fig. 3, Paragraph 0046, lines 8-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Moffit to include that the implantable medical device is an IPG that further includes a stimulation circuit, a sensing circuit, and a communication circuit. Using an IPG would allow estimation of the medication state of the patient, and whether more stimulation is needed (Paragraph 0101), as recognized by Moffit.
Regarding claim 18, Dinsmoor teaches the system (Fig. 1, Col. 5, lines 41-45) of claim 9, including: a user interface (Fig. 3, Col. 14, line 57) operatively coupled to (Fig. 3, Col. 14, lines 55-57) the signal processing circuit (Fig. 3, Col. 14, lines 55-56); wherein the sensing circuit (Fig. 2, Col. 11, line 8) is configured to sense an evoked potential signal (Col. 12, lines 2-4) for each electrode (Col. 11, lines 55-56) of multiple electrodes (Col. 6, lines 34-35) of the stimulation lead (Col. 12, lines 4-6); and wherein the signal processing circuit is configured to: detect the changes in the sensed evoked potential signals (Col.15, lines 47-49); and to operate a user interface (Col. 14, lines 55-57).
Dinsmoor does not teach that the signal processing circuit is configured to simultaneously present the changes of the sensed evoked potential signal for each electrode on the user interface. Moffit, however, teaches an electrical stimulation system that determines lead location with respect to a preferred lead location (Paragraph 0085, lines 1-4). Moffit further teaches a user interface (Paragraph 0080, line 1) that simultaneously presents the changes of the sensed evoked potential signal for each electrode (Paragraph 0080, lines 7-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor to incorporate the teachings of Moffit to include that the signal processing circuit is configured to simultaneously present the changes of the sensed evoked potential signal for each electrode on the user interface. Doing so would ensure that a healthcare provider is able to view changes of the sensed evoked potential signal for each electrode in real-time to improve accuracy of lead placement (Paragraph 0083), as recognized by Moffit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. PGPub No. 2020/0138324, WIPO Pub. No. 2011/159545, U.S. PGPub No. 2023/0173275, U.S. PGPub No. 2022/0401737, U.S. Patent No. 12,508,433, and U.S. PGPub No. 2018/0140843.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.A.H./Patent Examiner , Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796