DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 05 September 2024 has been considered by the Examiner.
Claim Objections
3. Claims 27 and 37 are objected to because of the following informalities.
Claims 27 and 37 contain minor typographical errors.
- Claim 27, line 7: The Examiner suggests changing “an action” to “the action”.
- Claim 37, line 7: The Examiner suggests changing “an action” to “the action”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
4. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claims 21, 24, 30, 36, and 39-40 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Sawchuk (US 2009/0299421 A1).
Regarding claim 21, Sawchuk teaches a method ([abstract, 0010]) comprising:
receiving, by processing circuitry (the IMD 16 comprises the processor 80 [0012, 0072, 0075]), information indicative of one or more evoked compound action potential (ECAP) signals, the one or more ECAP signals sensed by at least one electrode carried by a medical lead (the IMD 16 comprises a plurality of leads 18, 20, and 22 having electrodes 40, 42, 46, 48, 50, 62, 64, and 66 that can sense evoked potential signals [abstract, 0031, 0043, 0051, 0120]);
determining, by processing circuitry and based two or more peaks of each ECAP signal of the one or more ECAP signals (the processor 80 of the IMD 16 is configured to monitor a trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0072, 0185-0186]), at least one characteristic value of the one or more ECAP signals (a characteristic value (e.g., mean peak amplitude) is determined from the trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0185-0186]);
receiving, by the processing circuitry, accelerometer data indicative of patient movement ([0069, 0082]); and
performing, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer, an action (the lead integrity may be evaluated in response to the mean peak amplitude of the evoked signals deviating from a threshold or baseline [0172, 0184-0187]. Furthermore, the lead integrity may be evaluated in response to the amplitude signals and the accelerometer signals [0081-0082, 0184, 0186]. Specifically, the lead integrity is evaluated to determine if the signals are indicative of a positive sensing integrity or a negative sensing integrity [0081-0082, 0172, 0184, 0186]. The Examiner respectfully submits that a negative sensing integrity may be referred to as a “sensing integrity condition” [0082, 0184-0186]).
Regarding claim 24, Sawchuk teaches comparing, by the processing circuitry, the at least one characteristic value of the one or more ECAP signals to at least one characteristic value of a baseline ECAP signal (as stated previously in claim 21, a characteristic value (e.g., mean peak amplitude) is determined from the trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0185-0186]. Specifically, the characteristic value (e.g., mean peak amplitude) is compared to a baseline ECAP threshold (e.g. absolute upper threshold or absolute lower threshold) to determine if a sensing integrity condition has occurred [0185-0188]); and
determining, by the processing circuitry, based on the comparison, that the at least one characteristic value of the one or more ECAP signals is outside of an expected range of the at least one characteristic value of the baseline ECAP signal (the characteristic value (e.g., mean peak amplitude) is compared to a baseline ECAP threshold (e.g. absolute upper threshold or absolute lower threshold) to determine if a sensing integrity condition has occurred [0185-0188]).
Regarding claim 30, Sawchuk teaches a medical device (system 10 [0041]) comprising:
stimulation generation circuitry configured to deliver a first stimulation pulse to a patient (the IMD 16 comprises a stimulation generator 84 that is configured to deliver electrical pulses to the patient [0036, 0041, 0044, 0072, 0075]);
sensing circuitry (sensing module 86 [0072, 0079]) configured to sense information indicative of one or more evoked compound action potential (ECAP) signals, where the sensing circuitry comprises at least one electrode carried by a medical lead (the sensing module 86 comprises the leads 18, 20, and 22 having respective electrodes 40, 42, 46, 48, 50, 58, 62, 64, and 66 that can sense evoked potential signals [0043, 0051, 0079, 0120]); and
processing circuitry (the IMD 16 comprises the processor 80 [0072]) configured to:
receive information indicative of the one or more ECAP signals ([0072, 0115-0116]);
determine, based on two or more peaks of each ECAP signal of the one or more ECAP signals (the processor 80 of the IMD 16 is configured to monitor a trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0072, 0185-0186]), at least one characteristic value of the one or more ECAP signals (a characteristic value (e.g., mean peak amplitude) is determined from the trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0185-0186]);
receive accelerometer data indicative of patient movement ([0069, 0082]); and
perform, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, an action (the lead integrity may be evaluated in response to the mean peak amplitude of the evoked signals deviating from a threshold or baseline [0172, 0184-0187]. Furthermore, the lead integrity may be evaluated in response to the amplitude signals and the accelerometer signals [0081-0082, 0184, 0186]. Specifically, the lead integrity is evaluated to determine if the signals are indicative of a positive sensing integrity or a negative sensing integrity [0081-0082, 0172, 0184, 0186]. The Examiner respectfully submits that a negative sensing integrity may be referred to as a “sensing integrity condition” [0082, 0184-0186]).
Regarding claim 36, Sawchuk teaches wherein the processing circuitry is configured to:
determine over a period of time the at least one characteristic value of the one or more ECAP signals is a variance of the one or more ECAP signals (the evoked signals for the sensing vectors may be variable which will indicate a potential trend deviation or unreliability of the lead [0147-0148, 0166-0168]. Specifically, the lead integrity is evaluated in response to variations in the evoked signals [0147-0148, 0166-0168]); and
responsive to the determination of the variance between the at least one characteristic value and the one or more ECAP signals, periodically compare the at least one characteristic value of the one or more ECAP signals against the at least one characteristic value of a baseline ECAP signal (the inconsistent or variable evoked signals for the sensing vectors may be compared against a universal baseline [0147-0148, 0166-0168]. This provides an accurate way to determine the reliability of the lead [0147-0148, 0166-0168]).
Regarding claim 39, Sawchuk teaches wherein the medical device is configured to be implanted within the patient ([0041]); and
the processing circuitry is configured to control the stimulation generation circuitry to deliver spinal cord stimulation to the patient ([0041, 0072, 0209]).
Regarding claim 40, Sawchuk teaches a computer-readable storage medium comprising instructions that, when executed, cause processing circuitry to ([0012, 0072]):
receive information indicative of one or more evoked compound action potential (ECAP) signals ([0072, 0115-0116]), the one or more ECAP signals sensed by at least one electrode carried by a medical lead (each of the leads 18, 20, and 22 have respective electrodes 40, 42, 46, 48, 50, 58, 62, 64, and 66 that can sense evoked potential signals [0043, 0051, 0079, 0120]):
determine, based on two or more peaks of each ECAP signal of the one or more ECAP signals (the processor 80 of the IMD 16 is configured to monitor a trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0072, 0185-0186]), at least one characteristic value of the one or more ECAP signals (a characteristic value (e.g., mean peak amplitude) is determined from the trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0185-0186]);
receive accelerometer data indicative of patient movement ([0069, 0082]); and
perform, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, an action (the lead integrity may be evaluated in response to the mean peak amplitude of the evoked signals deviating from a threshold or baseline [0172, 0184-0187]. Furthermore, the lead integrity may be evaluated in response to the amplitude signals and the accelerometer signals [0081-0082, 0184, 0186]. Specifically, the lead integrity is evaluated to determine if the signals are indicative of a positive sensing integrity or a negative sensing integrity [0081-0082, 0172, 0184, 0186]. The Examiner respectfully submits that a negative sensing integrity may be referred to as a “sensing integrity condition” [0082, 0184-0186]).
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 23 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Sawchuk in view of Krause et al. (US 2010/0114221 A1).
Regarding claim 23, Sawchuk teaches the method of claim 21, wherein the action comprises a lead integrity test (a lead integrity test may be issued when the evoked signals deviates from a threshold [0147-0149, 0185-0186]) and wherein performing the lead integrity test further comprises performing the lead integrity test by at least measuring an impedance for the at least one electrode carried by the medical lead (the lead integrity test comprises measuring the impedance of the sensing vectors (e.g., electrodes) that are associated with the leads 18, 20, and 22 [0033, 0157-0158]).
However, Sawchuk does not explicitly teach determining whether the measured impedance is within one or more thresholds defined by stored instructions.
The prior art by Krause is analogous to Sawchuk, as they both teach an implantable medical device that is configured to provide cardiac stimulation ([abstract, 0061]).
Krause teaches determining whether the measured impedance is within one or more thresholds defined by stored instructions (the lead integrity test may involve comparing the measured impedance to a threshold [0374-0375]. Specifically, the threshold is defined by instructions of the computer readable medium [0011, 0027, 0374-0375]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Sawchuk’s lead integrity test to determine if the impedance is within a threshold, as taught by Krause. This modification is beneficial, as the measured impedance is compared to a threshold to identify any significant changes in the impedance that may adversely affect the stimulation therapy and/or sensing that is provided by the electrodes (see paragraphs [0373-0375] by Krause).
Regarding claim 32, Sawchuk teaches the medical device of claim 30, wherein the action comprises a lead integrity test (a lead integrity test may be issued when the evoked signals deviates from a threshold [0147-0149, 0185-0186]), and wherein the processing circuitry is configured to perform the lead integrity test by at least performing the lead integrity test by at least measuring an impedance for the at least one electrode carried by the medical lead (the lead integrity test comprises measuring the impedance of the sensing vectors (e.g., electrodes) that are associated with the leads 18, 20, and 22 [0033, 0072, 0157-0158]).
Sawchuk does not explicitly teach determining whether the measured impedance is within one or more thresholds defined by stored instructions.
The prior art by Krause is analogous to Sawchuk, as they both teach an implantable medical device that is configured to provide cardiac stimulation ([abstract, 0061]).
Krause teaches determining whether the measured impedance is within one or more thresholds defined by stored instructions (the lead integrity test may involve comparing the measured impedance to a threshold [0374-0375]. Specifically, the threshold is defined by instructions of the computer readable medium [0011, 0027, 0374-0375]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Sawchuk’s lead integrity test to determine if the impedance is within a threshold, as taught by Krause. This modification is beneficial, as the measured impedance is compared to a threshold to identify any significant changes in the impedance that may adversely affect the stimulation therapy and/or sensing that is provided by the electrodes (see paragraphs [0373-0375] by Krause).
8. Claims 27-29 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Sawchuk in view of Torgerson (US 2019/0099601 A1).
Regarding claim 27, Sawchuk teaches the method of claim 21. Sawchuk does not explicitly teach wherein performing, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, the action comprises at least:
determining, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals exceeds a threshold; and
responsive to determining that the at least one characteristic value of the one or more ECAP signals exceeds the threshold, performing, by the processing circuitry, an action.
The prior art by Torgerson is analogous to Sawchuk, as they both teach implantable devices that are configured to detect evoked signals ([abstract, 0064, 0067]).
Torgerson teaches wherein performing, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, the action comprises at least:
determining, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals exceeds a threshold (the processor 210 is configured to control an accelerometer to measure ECAP signals in the target tissue of the patient [0046-0047, 0061, 0068-0069]. Furthermore, the measured ECAP signals are compared to an expected range or ECAP threshold [0046-0047, 0061, 0068-0069]. Specifically, this comparison allows the user to determine if the measured ECAP signals are outside of the ECAP threshold [0044, 0046-0047, 0068-0069]); and
responsive to determining that the at least one characteristic value of the one or more ECAP signals exceeds the threshold, performing, by the processing circuitry, the action (the processor 210 is configured to adjust the electrical stimulation parameters in response to determining that ECAP signals are outside of the ECAP threshold [0044, 0046-0047, 0068-0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Sawchuk’s processing circuitry to perform an action in response to determining that the ECAP signals are outside of an expected range based on the accelerometer data, as taught by Torgerson. The advantage of such modification will allow for measuring the physiological effect of the compound action potential (see paragraph [0046] by Torgerson). Furthermore, this modification will allow for adjusting the electrical stimulation parameters to provide an efficacious therapy (see paragraphs [0068-0069, 0071] by Torgerson).
Regarding claim 28, Torgerson teaches wherein performing the action comprises suspending closed-loop adjustment of one or more parameters that define electrical stimulation therapy delivered to a patient (the sensors 212 utilizes feedback to control the delivery of the electrical stimulation therapy [0061]. Furthermore, the electrical stimulation may be briefly suspended to detect the presence of an ECAP signal [0067-0068]).
Regarding claim 29, Torgerson teaches wherein performing the action comprises reconfiguring a stimulation electrode combination (the processor 210 is configured to adjust the electrical stimulation parameters in response to determining that ECAP signals are outside of the ECAP threshold [0064, 0066]. For example, the processor 210 may control the IMD 102 to selectively activate two or more different electrode combinations for stimulation [0066]).
Regarding claim 37, Sawchuk teaches the medical device of claim 30. Sawchuk does not explicitly teach wherein the processing circuitry is configured to perform, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, the action by at least:
determining, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals exceeds a threshold; and
responsive to determining that the at least one characteristic value of the one or more ECAP signals exceeds the threshold, performing, by the processing circuitry, the action.
The prior art by Torgerson is analogous to Sawchuk, as they both teach implantable devices that are configured to detect evoked signals ([abstract, 0064, 0067]).
Torgerson teaches wherein the processing circuitry is configured to perform, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, the action by at least:
determining, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals exceeds a threshold (the processor 210 is configured to control an accelerometer to measure ECAP signals in the target tissue of the patient [0046-0047, 0061, 0068-0069]. Furthermore, the measured ECAP signals are compared to an expected range or ECAP threshold [0046-0047, 0061, 0068-0069]. Specifically, this comparison allows the user to determine if the measured ECAP signals are outside of the ECAP threshold [0044, 0046-0047, 0068-0069]); and
responsive to determining that the at least one characteristic value of the one or more ECAP signals exceeds the threshold, performing, by the processing circuitry, the action (the processor 210 is configured to adjust the electrical stimulation parameters in response to determining that ECAP signals are outside of the ECAP threshold [0044, 0046-0047, 0068-0069])
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Sawchuk’s processing circuitry to perform an action in response to determining that the ECAP signals are outside of an expected range based on the accelerometer data, as taught by Torgerson. The advantage of such modification will allow for measuring the physiological effect of the compound action potential (see paragraph [0046] by Torgerson). Furthermore, this modification will allow for adjusting the electrical stimulation parameters to provide an efficacious therapy (see paragraphs [0068-0069, 0071] by Torgerson).
Regarding claim 38, Torgerson teaches wherein the processing circuitry is configured to perform the action by at least one of:
suspending closed-loop adjustment of one or more parameters that define electrical stimulation therapy delivered to a patient (the sensors 212 utilizes feedback to control the delivery of the electrical stimulation therapy [0061]. Furthermore, the electrical stimulation may be briefly suspended to detect the presence of an ECAP signal [0067-0068]); or
reconfiguring a stimulation electrode combination (the processor 210 is configured to adjust the electrical stimulation parameters in response to determining that ECAP signals are outside of the ECAP threshold [0064, 0066]. For example, the processor 210 may control the IMD 102 to selectively activate two or more different electrode combinations for stimulation [0066]).
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,048,848 B2 in view of Sawchuk.
Regarding claim 21, U.S. Patent No. 12,048,848 B2 teaches a method ([claim 1]) comprising:
receiving, by processing circuitry, information indicative of one or more evoked compound action potential (ECAP) signals, the one or more ECAP signals sensed by at least one electrode carried by a medical lead ([claim 1]);
determining, by the processing circuitry, at least one characteristic value of the one or more ECAP signals ([claim 1]);
receiving, by the processing circuitry, accelerometer data indicative of patient movement ([claim 1);
and performing, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, an action ([claim 1]).
U.S. Patent No. 12,048,848 B2 does not explicitly teach determining, by the processing circuitry and based on two or more peaks of each ECAP signal of the one or more ECAP signals, the at least one characteristic value of the one or more ECAP signals.
The prior art by Sawchuk is analogous to U.S. Patent No. 12,048,848 B2, as they both teach a medical device that is configured to detect evoked signals ([abstract]).
Sawchuk teaches determining, by the processing circuitry and based on two or more peaks of each ECAP signal of the one or more ECAP signals (the processor 80 of the IMD 16 is configured to monitor a trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0072, 0185-0186]), the at least one characteristic value of the one or more ECAP signals (a characteristic value (e.g., mean peak amplitude) is determined from the trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0185-0186]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify U.S. Patent No. 12,048,848 B2’s processing circuitry to determine the at least one characteristic value of the ECAP signals based on two or more peaks of each ECAP signal, as taught by Sawchuk. The advantage of such modification will allow for determining a “mean peak amplitude” from a trend of ECAP signals (e.g., peak amplitudes) over a period of time (see paragraphs [0031, 0072, 0185-0186] by Sawchuk).
Regarding claim 22, U.S. Patent No. 12,048,848 B2 teaches determining, by the processing circuitry and based on the accelerometer data, that a circadian rhythm of a patient is within a normal circadian rhythm range ([claim 2]); and
determining, by the processing circuitry, that the at least one characteristic value of the one or more ECAP signals is below an expected range ([claim 2]), wherein performing the action comprises responsive to determining that the circadian rhythm is within the normal circadian rhythm range and the at least one characteristic value of the one or more ECAP signals is below the expected range, performing the action ([claim 2]).
Regarding claim 23, U.S. Patent No. 12,048,848 B2 teaches wherein the action comprises a lead integrity test, and wherein performing the lead integrity test further comprises performing the lead integrity test by at least measuring an impedance for the at least one electrode carried by the medical lead and determining whether the measured impedance is within one or more thresholds defined by stored instructions ([claim 3]).
Regarding claim 24, U.S. Patent No. 12,048,848 B2 teaches comparing, by the processing circuitry, the at least one characteristic value of the one or more ECAP signals to at least one characteristic value of a baseline ECAP signal ([claim 4]); and
determining, by the processing circuitry, based on the comparison, that the at least one characteristic value of the one or more ECAP signals is outside of an expected range of the at least one characteristic value of the baseline ECAP signal ([claim 4]).
Regarding claim 25, U.S. Patent No. 12,048,848 B2 teaches responsive to a determination that the at least one characteristic value is outside the expected range from the at least one characteristic value of the baseline ECAP signal, performing, as the action, a lead integrity test that comprises measuring an impedance for the at least one electrode carried by the medical lead ([claim 5]);
determining, by the processing circuitry and based on lead integrity test results, that the measured impedance of the at least one electrode is within one or more thresholds defined by stored instructions ([claim 5]); and
outputting, by the processing circuitry based on a successful lead integrity test, a request for a user to adjust a closed-loop stimulation algorithm that controls delivery of electrical stimulation based on the one or more ECAP signals ([claim 5]).
Regarding claim 26, U.S. Patent No. 12,048,848 B2 teaches wherein performing the action comprises responsive to determining that the at least one characteristic value of the one or more ECAP signals is outside the expected range of the at least one characteristic value of the baseline ECAP signal, performing, as the action, a lead integrity test ([claim 6]), and the method further comprising:
determining, by the processing circuitry and based on the lead integrity test, that impedance measured at the at least one electrode of the medical lead is outside one or more thresholds defined by stored instructions ([claim 6]); and
responsive to the at least one electrode of the medical lead failing the lead integrity test, requesting, by the processing circuitry, a user to adjust a closed-loop stimulation algorithm that controls delivery of electrical stimulation based on the ECAP signals ([claim 6]).
Regarding claim 27, U.S. Patent No. 12,048,848 B2 teaches performing, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, the action comprises at least:
determining, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals exceeds a threshold (the processing circuitry is configured to determine, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals is outside of an expected range or threshold [claim 1]); and
responsive to determining that the at least one characteristic value of the one or more ECAP signals exceeds the threshold, performing, by the processing circuitry, an action ([claim 1]).
Regarding claim 28, U.S. Patent No. 12,048,848 B2 teaches wherein performing the action comprises suspending closed-loop adjustment of one or more parameters that define electrical stimulation therapy delivered to a patient ([claim 9]).
Regarding claim 29, U.S. Patent No. 12,048,848 B2 teaches wherein performing the action comprises reconfiguring at least one of a stimulation electrode combination or a sensing electrode combination ([claim 10]).
Regarding claim 30, U.S. Patent No. 12,048,848 B2 teaches a medical device ([claim 11]) comprising:
stimulation generation circuitry configured to deliver a first stimulation pulse to a patient ([claim 11]);
sensing circuitry configured to sense information indicative of one or more evoked compound action potential (ECAP) signals, where the sensing circuitry comprises at least one electrode carried by a medical lead ([claim 11]); and
processing circuitry ([claim 11]) configured to:
receive information indicative of the one or more ECAP signals ([claim 11]);
determine at least one characteristic value of the one or more ECAP signals ([claim 11]);
receive accelerometer data indicative of patient movement ([claim 11]); and
perform, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, an action ([claim 11]).
U.S. Patent No. 12,048,848 B2 does not explicitly teach determine, based on two or more peaks of each ECAP signal of the one or more ECAP signals, the at least one characteristic value of the one or more ECAP signals.
The prior art by Sawchuk is analogous to U.S. Patent No. 12,048,848 B2, as they both teach a medical device that is configured to detect evoked signals ([abstract]).
Sawchuk teaches determining, based on two or more peaks of each ECAP signal of the one or more ECAP signals (the processor 80 of the IMD 16 is configured to monitor a trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0072, 0185-0186]), the at least one characteristic value of the one or more ECAP signals (a characteristic value (e.g., mean peak amplitude) is determined from the trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0185-0186]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify U.S. Patent No. 12,048,848 B2’s processing circuitry to determine the at least one characteristic value of the ECAP signals based on two or more peaks of each ECAP signal, as taught by Sawchuk. The advantage of such modification will allow for determining a “mean peak amplitude” from a trend of ECAP signals (e.g., peak amplitudes) over a period of time (see paragraphs [0031, 0072, 0185-0186] by Sawchuk).
Regarding claim 31, U.S. Patent No. 12,048,848 B2 teaches wherein the processing circuitry is configured to:
determine, based on the accelerometer data, that a circadian rhythm of a patient is within a normal circadian rhythm range ([claim 12]);
determine the at least one characteristic value of the one or more ECAP signals is below an expected range ([claim 12]); and
responsive to determining that the circadian rhythm is within the normal circadian rhythm range and the at least one characteristic value of the one or more ECAP signals is below the expected range, perform the action ([claim 12]).
Regarding claim 32, U.S. Patent No. 12,048,848 B2 teaches wherein the action comprises a lead integrity test ([claim 13]), and wherein the processing circuitry is configured to perform the lead integrity test by at least performing the lead integrity test by at least measuring an impedance for the at least one electrode carried by the medical lead and determining whether the measured impedance is within one or more thresholds defined by stored instructions ([claim 13]).
Regarding claim 33, U.S. Patent No. 12,048,848 B2 teaches wherein the processing circuitry is configured to:
compare the at least one characteristic value of the one or more ECAP signals to at least one characteristic value of a baseline ECAP signal ([claim 15]); and
determine, based on the comparison, that the at least one characteristic value of the one or more ECAP signals is outside of an expected range of the at least one characteristic value of the baseline ECAP signal ([claim 15]).
Regarding claim 34, U.S. Patent No. 12,048,848 B2 teaches wherein the processing circuitry is configured to:
responsive to a determination the at least one characteristic value is outside the expected range from the at least one characteristic value of the baseline ECAP signal, perform, as the action, a lead integrity test that comprises measuring an impedance for the at least one electrode carried by the medical lead ([claim 16]);
determine, based on lead integrity test results, that the measured impedance of the at least one electrode is within one or more thresholds defined by stored instructions ([claim 16]); and
output, based on a successful lead integrity test, a request for a user to adjust a closed- loop stimulation algorithm that controls delivery of electrical stimulation based on the one or more ECAP signals ([claim 16]).
Regarding claim 35, U.S. Patent No. 12,048,848 B2 teaches wherein the processing circuitry is configured to:
responsive to determining that the at least one characteristic value of the one or more ECAP signals is outside the expected range of the at least one characteristic value of the baseline ECAP signal, perform, as the action, a lead integrity test ([claim 17]);
determine, based on the lead integrity test, that impedance measured at the at least one electrode of the medical lead is outside one or more thresholds defined by stored instructions ([claim 17]); and
responsive to the at least one electrode of the medical lead failing the lead integrity test, request a user to adjust a closed-loop stimulation algorithm that controls delivery of electrical stimulation based on the ECAP signals ([claim 17]).
Regarding claim 36, U.S. Patent No. 12,048,848 B2 teaches wherein the processing circuitry is configured to:
determine over a period of time the at least one characteristic value of the one or more ECAP signals is a variance of the one or more ECAP signals ([claim 7]); and
responsive to the determination of the variance between the at least one characteristic value and the one or more ECAP signals, periodically compare the at least one characteristic value of the one or more ECAP signals against the at least one characteristic value of a baseline ECAP signal ([claims 7-8]).
Regarding claim 37, U.S. Patent No. 12,048,848 B2 teaches wherein the processing circuitry is configured to perform, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, the action by at least:
determining, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals exceeds a threshold (the processing circuitry is configured to determine, based on the accelerometer data, that the at least one characteristic value of the one or more ECAP signals is outside of an expected range or threshold [claim 11]); and
responsive to determining that the at least one characteristic value of the one or more ECAP signals exceeds the threshold, performing, by the processing circuitry, an action ([claim 11]).
Regarding claim 38, U.S. Patent No. 12,048,848 B2 teaches wherein the processing circuitry is configured to perform the action by at least one of:
suspending closed-loop adjustment of one or more parameters that define electrical stimulation therapy delivered to a patient ([claim 18]); or
reconfiguring at least one of a stimulation electrode combination or a sensing electrode combination ([claim 19]).
Regarding claim 39, U.S. Patent No. 12,048,848 B2 teaches wherein the medical device is configured to be implanted within the patient ([claim 14]). Furthermore, Sawchuk teaches wherein the processing circuitry is configured to control the stimulation generation circuitry to deliver spinal cord stimulation to the patient ([0041, 0072, 0209]).
Regarding claim 40, U.S. Patent No. 12,048,848 B2 teaches a computer-readable storage medium comprising instructions that, when executed, cause processing circuitry to ([claim 20]):
receive information indicative of one or more evoked compound action potential (ECAP) signals, the one or more ECAP signals sensed by at least one electrode carried by a medical lead ([claim 20]);
determine at least one characteristic value of the one or more ECAP signals ([claim 20])
receive accelerometer data indicative of patient movement ([claim 20]); and
perform, based on the at least one characteristic value of the one or more ECAP signals and the accelerometer data, an action ([claim 20]).
U.S. Patent No. 12,048,848 B2 does not explicitly teach determine, based on two or more peaks of each ECAP signal of the one or more ECAP signals, the at least one characteristic value of the one or more ECAP signals.
The prior art by Sawchuk is analogous to U.S. Patent No. 12,048,848 B2, as they both teach a medical device that is configured to detect evoked signals ([abstract]).
Sawchuk teaches determining, based on two or more peaks of each ECAP signal of the one or more ECAP signals (the processor 80 of the IMD 16 is configured to monitor a trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0072, 0185-0186]), the at least one characteristic value of the one or more ECAP signals (a characteristic value (e.g., mean peak amplitude) is determined from the trend of ECAP signals (e.g., peak amplitude data over time) [0031, 0185-0186]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify U.S. Patent No. 12,048,848 B2’s processing circuitry to determine the at least one characteristic value of the ECAP signals based on two or more peaks of each ECAP signal, as taught by Sawchuk. The advantage of such modification will allow for determining a “mean peak amplitude” from a trend of ECAP signals (e.g., peak amplitudes) over a period of time (see paragraphs [0031, 0072, 0185-0186] by Sawchuk).
Allowable Subject Matter
11. Claims 22, 25-26, 31, and 33-35 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 and if the double patenting rejections noted above were overcome.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims.
Regarding claim 22, Sawchuk teaches the method of claim 21, further comprising:
determining, by the processing circuitry, the at least one characteristic value of the one or more ECAP signals is below an expected range (the IMD 16 or programmer 24 can determine if the trend of evoked signals deviate more than a threshold amount [0147-0149]).
Sawchuk does not explicitly teach determining, by the processing circuitry and based on the accelerometer data, that a circadian rhythm of a patient is within a normal circadian rhythm range; and
wherein performing the action comprises responsive to determining that the circadian rhythm is within the normal circadian rhythm range and the characteristic value of the one or more ECAP signals is below the expected range, performing the action.
The prior art by Zhang (US 2008/0114219 A1) is analogous to Sawchuk, as they both teach an implantable medical device that provides cardiac stimulation ([0016, 0048])
Zhang teaches determining, by the processing circuitry and based on the accelerometer data, that a circadian rhythm of a patient is within a normal circadian rhythm range (the accelerometer is used to measure the user’s circadian rhythm [0098]. Furthermore, the user’s circadian rhythm is compared to a healthy baseline or threshold [0098]).
However, Sawchuk and Zhang do not explicitly teach wherein performing the action comprises responsive to determining that the circadian rhythm is within the normal circadian rhythm range and the characteristic value of the one or more ECAP signals is below the expected range, performing the action.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 25, Sawchuk teaches the method of claim 24, further comprising:
responsive to a determination that the at least one characteristic value is outside the expected range from the at least one characteristic value of the baseline ECAP signal, performing, as the action, a lead integrity test that comprises measuring an impedance for the at least one electrode carried by the medical lead (as stated previously in claim 24, the characteristic value (e.g., mean peak amplitude) is compared to a baseline ECAP threshold (e.g. absolute upper threshold or absolute lower threshold) to determine if a sensing integrity condition has occurred [0185-0188]. Furthermore, a lead integrity test may be issued when the characteristic value (e.g., mean peak amplitude) deviates from a threshold [0172, 0184-0187]. Specifically, the lead integrity test will indicate if a sensing integrity condition (e.g., negative sensing integrity) has occurred in response to the amplitude data deviating from the threshold [0082, 0172, 0184-0186]. The Examiner respectfully submits that the lead integrity test comprises measuring the impedance of the sensing vectors (e.g., electrodes) that are associated with the leads 18, 20, and 22 [0033, 0157-0158]).
Sawchuk does not explicitly teach determining, by the processing circuitry and based on lead integrity test results, that the measured impedance of the at least one electrode is within one or more thresholds defined by stored instructions; and
outputting, by the processing circuitry based on a successful lead integrity test, a request for a user to adjust a closed-loop stimulation algorithm that controls delivery of electrical stimulation based on the one or more ECAP signals.
The prior art by Krause is analogous to Sawchuk, as they both teach an implantable medical device that is configured to provide cardiac stimulation ([abstract, 0061]).
Krause teaches determining, by the processing circuitry and based on lead integrity test results, that the measured impedance of the at least one electrode is within one or more thresholds defined by stored instructions (the lead integrity test may involve comparing the measured impedance to a threshold [0374-0375]. Specifically, the threshold is defined by instructions of the computer readable medium [0011, 0027, 0374-0375]).
However, Sawchuk and Krause do not explicitly teach outputting, by the processing circuitry based on a successful lead integrity test, a request for a user to adjust a closed-loop stimulation algorithm that controls delivery of electrical stimulation based on the one or more ECAP signals.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 26, Sawchuk teaches the method of claim 24, further comprising:
wherein performing the action comprises responsive to determining that the at least one characteristic value of the one or more ECAP signals is outside the expected range of the at least one characteristic value of the baseline ECAP signal, performing, as the action, a lead integrity test (as stated previously in claim 24, the characteristic value (e.g., mean peak amplitude) is compared to a baseline ECAP threshold (e.g. absolute upper threshold or absolute lower threshold) to determine if a sensing integrity condition has occurred [0185-0188]. Furthermore, a lead integrity test may be issued when the characteristic value (e.g., mean peak amplitude) deviates from a threshold [0172, 0184-0187]. Specifically, the lead integrity test will indicate if a sensing integrity condition (e.g., negative sensing integrity) has occurred in response to the amplitude data deviating from the threshold [0082, 0172, 0184-0186]); and
wherein the lead integrity test comprises measuring an impedance for the at least one electrode carried by the medical lead (the lead integrity test comprises measuring the impedance of the sensing vectors (e.g., electrodes) that are associated with the leads 18, 20, and 22 [0033, 0157-0158]).
Sawchuk does not explicitly teach determining, by the processing circuitry and based on the lead integrity test, that the impedance measured at the at least one electrode of the medical lead is outside one or more thresholds defined by stored instructions; and
responsive to the at least one electrode of the medical lead failing the lead integrity test, requesting, by the processing circuitry, a user to adjust a closed-loop stimulation algorithm that controls delivery of electrical stimulation based on the ECAP signals.
However, Krause teaches determining, by the processing circuitry and based on the lead integrity test, that the impedance measured at the at least one electrode of the medical lead is outside one or more thresholds defined by stored instructions (the lead integrity test may involve comparing the measured impedance to a threshold [0374-0375]. Specifically, the threshold is defined by instructions of the computer readable medium [0011, 0027, 0374-0375]).
Sawchuk and Krause do not explicitly teach responsive to the at least one electrode of the medical lead failing the lead integrity test, requesting, by the processing circuitry, a user to adjust a closed-loop stimulation algorithm that controls delivery of electrical stimulation based on the ECAP signals.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 31, Sawchuk teaches the medical device of claim 30, wherein the processing circuitry is configured to determine the at least one characteristic value of the one or more ECAP signals is below an expected range (the IMD 16 or programmer 24 can determine if the trend of evoked signals deviate more than a threshold amount [0147-0149]).
Sawchuk does not explicitly teach wherein processing circuitry is configured to:
determine, based on the accelerometer data, that a circadian rhythm of a patient is within a normal circadian rhythm range; and
responsive to determining that the circadian rhythm is within the normal circadian rhythm range and the characteristic value of the one or more ECAP signals is below the expected range, performing the action.
The prior art by Zhang is analogous to Sawchuk, as they both teach an implantable medical device that provides cardiac stimulation ([0016, 0048])
Zhang teaches wherein the processing circuitry is configured to:
determine, based on the accelerometer data, that a circadian rhythm of a patient is within a normal circadian rhythm range (the accelerometer is used to measure the user’s circadian rhythm [0098]. Furthermore, the user’s circadian rhythm is compared to a healthy baseline or threshold [0098]).
However, Sawchuk and Zhang do not explicitly teach responsive to determining that the circadian rhythm is within the normal circadian rhythm range and the characteristic value of the one or more ECAP signals is below the expected range, performing the action.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements
Claims 33-35 are considered to contain allowable subject matter, as claims 33-35 depend upon claim 31.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792