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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/20/2026 has been entered.
Response to Arguments
Applicant's arguments filed on 07/29/2026 have been fully considered but they are not persuasive. Applicant argues that because Donega considers the EMG to be a contamination in the sensed signal, one of ordinary skill in the art would have consciously avoided modifying the techniques of Dinsmoor with the teachings of Donega to determine one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation-evoked signal. Examiner respectfully disagrees and notes that Donega further teaches that the EMG contamination represents a muscular contraction of the trachea and the larynx [0073] which would be useful in determining if the stimulation is activating an intended target area. One of ordinary skill in the art would appreciate determining a relationship between nerve stimulation and any resulting muscular contraction for this reason. For example, Dinsmoor discloses stimulating the third sacral nerve in order to innervate the bladder wall and urinary sphincter in order to treat urinary incontinence [0070]. Dinsmoor determines if the muscles have been innervated following nerve stimulation by detecting eCMAP biomarkers [0070] which show up in the detected signal following the stimulation pulse and indicate that the stimulation is activating the intended target area [0115].
Donega discloses sensing, following delivery of a stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal ([0073] charts 39 and 41 illustrate the CAP measured in the nerve of different sheep when stimulation was applied to electrode pairs of the second array),
the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve ([0073] the peak appearing at around 10 ms of delay in the nerve recording represents an EMG contamination; Fig. 3b); and
determining one or more aspects of electrical stimulation therapy delivery (muscular innervation) utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal ([0073] EMG contamination from the contraction of the trachea and larynx).
Examiner maintains it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the teachings of Dinsmoor with sensing, following delivery of the stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal, the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve; and determining one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal as taught by Donega. Such a modification would provide the predictable results of determining if the stimulation is activating an intended target area and whether the stimulation is eliciting a slow and/or fast fiber response (Donega, [0074]).
Applicant further argues that Donega does not describe EMG activity as forming a composite stimulation-evoked signal as set forth in claim 1. Examiner respectfully disagrees and maintains that Donega discloses a measured eCAP containing EMG contamination representative of a muscular contraction (Fig. 3b, [0073]) which necessarily forms a composite stimulation-evoked signal.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 11-17, and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of determining one or more aspects of electrical stimulation therapy) without significantly more.
Step 1
The claimed invention in claims 1-9, 11-17, and 19-20 are directed to statutory subject matter as the claims recite methods and a system for determining one or more aspects of electrical stimulation therapy.
Step 2A, Prong One
Regarding claims 1-9, 11-17, and 19-20, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claims 1 and 13-14, the limitations of “determining one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation but for the recitation of generic computer components.
Step 2A, Prong Two
For claims 1-9, 11-17, and 19-20, the judicial exception is not integrated into a practical application. For claims 1 and 13-14, the additional limitation of “processing circuitry” is recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitations of “sensing, following delivery of the stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal with one or more sensing electrodes…” amounts to nothing more than the pre-solution activity of data gathering.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations of “sensing…a composite stimulation-evoked signal…” are directed to the pre-solution activity of mere data gathering which does not amount to an inventive concept. In addition, “one or more stimulation electrodes”, “one or more sensing electrodes”, “a sacral lead including a lead body”, and “a sheath lumen of an introducer sheath” are recited at a high level of generality and considered to be well known, routine, and conventional in the art.
For examples see:
One or more stimulation electrodes
Dinsmoor et al (US 2016/0303376) [0006]
Parker (US 2018/0132760) [0044]
One or more sensing electrodes
Dinsmoor et al (US 2016/0303376) [0006]
Parker (US 2018/0132760) [0044]
A sacral lead including a leady body
Dinsmoor et al (US 2016/0303376) [0060]
Swoyer (US 2003/0045919) [0060]
A sheath lumen of an introducer sheath
Swoyer (US 2003/0045919) [0060] and Figs. 5-8
Hess et al (US 4,800,898) Col. 4, ln 27-29
Dependent claims 2-9, 11-12, 15-17, and 19-20 are further directed to insignificant extra-solution activities (MPEP 2106.05(g)). The above-mentioned claims do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
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) 1-3, 5-9, 11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al (US 2016/0303376) hereinafter Dinsmoor in view of Donega et al (US 2020/0384265) hereinafter Donega.
Regarding claim 1, Dinsmoor discloses a method of sensing and stimulation with a sacral lead, the method comprising:
delivering a stimulation signal through one or more stimulation electrodes using one or more electrodes (electrodes 38) when the one or more electrodes are configured to operate as the one or more stimulation electrodes ([0067] deliver, via lead 36 and one or more electrodes 38); and
sensing, following delivery of the stimulation signal, an evoked signal with one or more sensing electrodes using the one or more electrodes (electrodes 38) when the one or more electrodes are configured to operate as the one or more sensing electrodes ([0065] far-field eCMAP signals may be detected by electrodes 38 indicating that muscles in the area near rectum 24 are being activated by applied stimulation),
wherein at least one of the stimulation electrodes or at least one of the sensing electrodes is located within, dorsal, or ventral to a foramen of a sacrum of a patient ([0067] The distal end of lead 36 (containing leads 38) is inserted into sacral foramen 30 of sacrum 28; Figure 2: lead 36, electrodes 38),
wherein a lead body of the sacral lead supports at least some portion of the one or more electrodes (Figure 2: lead 36, electrodes 38),
wherein the lead body is configured to position the at least some portion of the one or more electrodes within or ventral to the foramen (Figure 2 shows the lead 36 being inserted into the posterior opening of the foramen and placing the electrodes ventral to the foramen).
Dinsmoor fails to disclose sensing, following delivery of the stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal, the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve; and
determining one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal.
However, Donega discloses sensing, following delivery of a stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal ([0073] charts 39 and 41 illustrate the CAP measured in the nerve of different sheep when stimulation was applied to electrode pairs of the second array), the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve ([0073] the peak appearing at around 10 ms of delay in the nerve recording represents an EMG contamination; Fig. 3b); and
determining one or more aspects of electrical stimulation therapy delivery (muscular innervation) utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal ([0073] EMG contamination from the contraction of the trachea and larynx).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with sensing, following delivery of the stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal, the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve; and determining one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal as taught by Donega. Such a modification would provide the predictable results of determining if the stimulation is activating an intended target area and whether the stimulation is eliciting a slow and/or fast fiber response (Donega, [0074]).
Regarding claim 2, Dinsmoor discloses wherein the at least one of the stimulation electrodes is located ventral to a posterior opening of the foramen, and wherein the at least one of the sensing electrodes is located ventral to the posterior opening ([0070] lead 36 may directed through sacral foramen 76 in order for stimulator 34 to deliver electrical stimulation to third sacral nerve 78 via one or more electrodes 38 of lead 36).
Regarding claim 3, Dinsmoor discloses wherein the at least one of the stimulation electrodes is located ventral to an anterior opening of the foramen ([0070] lead 36 may directed through sacral foramen 76), and wherein the at least one of the sensing electrodes is located ventral to a posterior opening of the foramen (Examiner notes that directing the lead 36 containing electrodes 38 would place electrodes 38 ventral to both the anterior and posterior openings of the foramen).
Regarding claim 5, Dinsmoor discloses wherein the at least one of the stimulation electrodes is located ventral to a posterior opening of the foramen ([0067] distal end of lead 36 is inserted into sacral foramen), and wherein the at least one of the sensing electrodes is located dorsal to an anterior opening of the foramen (Examiner notes that inserting the distal end of lead 36 into the sacral foramen would place the electrodes dorsal to the anterior opening of the foramen and ventral to the posterior opening of the foramen).
Regarding claim 6, Dinsmoor discloses wherein the at least one of the stimulation electrodes is located dorsal to an anterior opening of the foramen ([0067] distal end of lead 36 is inserted into sacral foramen), and wherein the at least one of the sensing electrodes is located ventral to a posterior opening of the foramen (Examiner notes that inserting the distal end of lead 36 into the sacral foramen would place the electrodes dorsal to the anterior opening of the foramen and ventral to the posterior opening of the foramen).
Regarding claim 7, Dinsmoor discloses wherein the at least one of the stimulation electrodes is located dorsal to an anterior opening of the foramen ([0067] distal end of lead 36 is inserted into sacral foramen), and wherein the at least one of the sensing electrodes is located dorsal to the anterior opening of the foramen (Examiner notes that inserting lead 36 into the foramen would cause electrodes 38 to be dorsal to the anterior opening of the foramen).
Regarding claim 8, Dinsmoor discloses wherein the at least one of the stimulation electrodes includes a first electrode, and wherein the at least one of the sensing electrodes includes the first electrode ([0006] the same electrode, or electrodes, may be configured to deliver stimulation signals and detect the eCMAP; [0062] deliver, via lead 36 and one or more electrodes 38, electrical stimulation; [0065] eCMAP signals may be detected by electrodes 38).
Regarding claim 9, Dinsmoor discloses wherein the one or more electrodes includes a plurality of electrodes ([0060] electrodes 38), and wherein sensing the composite stimulation-evoked signal with one or more sensing electrodes comprises sensing the composite stimulation-evoked signal with the plurality of electrodes ([0065] eCMAP signals may be detected by electrodes 38).
Regarding claim 11, Dinsmoor discloses wherein the one or more electrodes includes a first electrode ([0060] electrodes 38), and further comprising:
switching, using processing circuitry ([0062] therapy delivery module), the configuration of the first electrode at least from a first configuration to a second configuration as the lead body remains substantially stationary relative to the sacrum of the patient ([0070] system 22 may be configured to control delivery of electrical stimulation and sense eCMAP biomarkers),
wherein the first electrode is configured to operate as one of the stimulation electrodes in the first configuration ([0062] deliver, via lead 36 and one or more electrodes 38, electrical stimulation), and
wherein the first electrode is configured to operate as one of the sensing electrodes in the second configuration ([0065] eCMAP signals may be detected by electrodes 38).
Regarding claim 14, Dinsmoor discloses a sacral lead system (Fig. 2), comprising:
one or more electrodes ([0060] electrodes 38),
wherein the one or more electrodes are configured to operate as one or more stimulation electrodes and one or more sensing electrodes ([0062] deliver, via lead 36 and one or more electrodes 38; [0065] eCMAP signals may be detected by electrodes 38);
a sacral lead including a lead body ([0060] lead 36),
wherein the lead body supports at least some portion of the one or more electrodes ([0060] lead 36 carrying electrodes 38), and
wherein the lead body is configured to position at least some portion of the one or more electrodes within, dorsal to, or ventral to a foramen of a sacrum of a patient ([0067] distal end of lead 36 is inserted into sacral foramen 30 of sacrum 28); and
processing circuitry ([0067] therapy delivery module) configured to:
deliver, using the one or more electrodes configured to operate as the one or more stimulation electrodes, a stimulation signal ([0062] deliver, via lead 36 and one or more electrodes 38, electrical stimulation); and
sense, following delivery of the stimulation signal, and using the one or more electrodes configured to operate as the one or more sensing electrodes, a stimulation-evoked signal (eCMAP signal) evoked in response to the stimulation signal ([0065] eCMAP signals may be detected by electrodes 38 indicating that muscles in the area near rectum 24 are being activated by applied stimulation).
Dinsmoor fails to disclose processing circuitry configured to: sense, following delivery of the stimulation signal, and using the one or more electrodes configured to operate as the one or more sensing electrodes, a composite stimulation-evoked signal evoked in response to the stimulation signal,
the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve; and
determine one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation-evoked signal.
However, Donega discloses processing circuitry ([0140] physiological data processing 115) configured to: sense, following delivery of a stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal ([0073] charts 39 and 41 illustrate the CAP measured in the nerve of different sheep when stimulation was applied to electrode pairs of the second array),
the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve ([0073] the peak appearing at around 10 ms of delay in the nerve recording represents an EMG contamination; Fig. 3b); and
determine one or more aspects of electrical stimulation therapy delivery (muscular innervation) utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation-evoked signal ([0073] EMG contamination from the contraction of the trachea and larynx).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with processing circuitry configured to: sense, following delivery of the stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal, the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve; and determine one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation-evoked signal as taught by Donega. Such a modification would provide the predictable results of determining if the stimulation is activating an intended target area and whether the stimulation is eliciting a slow and/or fast fiber response (Donega, [0074]).
Regarding claim 15, Dinsmoor discloses wherein the sacral lead system is configured to perform at least one of:
position at least one electrode configured to operate as the one or more stimulation electrodes ventral to a posterior opening of the foramen ([0070] lead 36 may directed through sacral foramen 76 in order for stimulator 34 to deliver electrical stimulation to third sacral nerve 78 via one or more electrodes 38 of lead 36) when at least one electrode configured to operate as the one or more sensing electrodes is positioned ventral to the posterior opening (Examiner notes directing lead 36 through the foramen would place electrodes 38 ventral to the posterior opening);
position the at least one electrode configured to operate as the one or more stimulation electrodes ventral to an anterior opening of the foramen ([0070] lead 36 may directed through sacral foramen 76 ) when the at least one electrode configured to operate as the one or more sensing electrodes is positioned ventral to the posterior opening (Examiner notes directing lead 36 through the foramen would place electrodes 38 ventral to the posterior and anterior openings)
position the at least one electrode configured to operate as the one or more stimulation electrodes within the foramen when the at least one electrode configured to operate as the one or more sensing electrodes is positioned ventral to the anterior opening;
position the at least one electrode configured to operate as the one or more stimulation electrodes ventral to the posterior opening when the at least one electrode configured to operate as the one or more sensing electrodes is positioned dorsal to the anterior opening ([0067] distal end of lead 36 is inserted into sacral foramen; Examiner notes this would place electrodes 38 dorsal to the anterior opening and ventral to the posterior opening);
position the at least one electrode configured to operate as the one or more stimulation electrodes dorsal to the anterior opening when the at least one electrode configured to operate as the one or more sensing electrodes is positioned ventral to the posterior opening ([0067] distal end of lead 36 is inserted into sacral foramen; Examiner notes this would place electrodes 38 dorsal to the anterior opening and ventral to the posterior opening); or
position the at least one electrode configured to operate as the one or more stimulation electrodes dorsal to the anterior opening when the at least one electrode configured to operate as the one or more sensing electrodes is located dorsal to the anterior opening ([0067] distal end of lead 36 is inserted into sacral foramen; Examiner notes this would place electrodes 38 dorsal to the anterior opening).
Regarding claim 16, Dinsmoor discloses wherein the lead body supports each of the one or more electrodes ([0060] lead 36 carrying electrodes 38 near a distal end of lead 36).
Regarding claim 17, Dinsmoor discloses wherein the one or more electrodes includes a first electrode ([0060] electrodes 38),
wherein the first electrode is configured to operate as one of the one or more stimulation electrodes in a first configuration ([0062] deliver, via lead 36 and one or more electrodes 38, electrical stimulation) and one of the one or more sensing electrodes in a second configuration ([0065] eCMAP signals may be detected by electrodes 38), and
wherein the processing circuitry ([0062] therapy delivery module) is configured to switch the first electrode at least from the first configuration to the second configuration as the lead body remains substantially stationary relative to the sacrum of the patient ([0070] system 22 may be configured to control delivery of electrical stimulation and sense eCMAP biomarkers).
Claim(s) 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 2016/0303376) in view of Donega (US 2020/0384265) and further in view of Swoyer et al (US 2003/0045919) hereinafter Swoyer.
Regarding claim 4, Dinsmoor discloses wherein the at least one of the stimulation electrodes is located within the foramen ([0067] distal end of lead 36 is inserted into sacral foramen), and wherein the at least one of the sensing electrodes is located ventral to an anterior opening of the foramen ([0070] lead 36 may directed through sacral foramen 76; Fig 2), but fails to explicitly disclose wherein the at least one of the stimulation electrodes is located within the foramen and wherein the at least one of the sensing electrodes is located ventral to an anterior opening of the foramen at the same time.
However, Swoyer discloses wherein the at least one of the stimulation electrodes is located within the foramen and wherein the at least one of the sensing electrodes is located ventral to an anterior opening of the foramen (Fig. 6 shows electrodes being located within the foramen and ventral to an anterior opening of the foramen). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with wherein the at least one of the stimulation electrodes is located within the foramen and wherein the at least one of the sensing electrodes is located ventral to an anterior opening of the foramen as taught by Swoyer. Such a modification would provide the predictable results of selectively stimulating the S3 sacral nerve (Swoyer, [0008]).
Regarding claim 19, the modified Dinsmoor discloses the system of claim 14 as discussed above, but fails to disclose wherein the lead body includes one or more markers configured to be imaged by an imaging modality when the imaging modality images one or more anatomical features of the patient and at least one of the one or more markers. However, Swoyer discloses wherein the lead body includes one or more markers configured to be imaged by an imaging modality when the imaging modality images one or more anatomical features of the patient and at least one of the one or more markers ([0058] Visual and radiographic imaging bands 90 and 95 are formed around the lead body 15 distal to and proximal to, respectively, the tine element array 120 to be employed in determining the location of the tine element array 120 within the introducer lumen and as the introducer is withdrawn to expose the tine element array 120; Figure 2: imaging bands 90 and 95).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with wherein the lead body includes one or more markers configured to be imaged by an imaging modality when the imaging modality images one or more anatomical features of the patient and at least one of the one or more markers as taught by Swoyer. Such a modification would provide the predictable results of using the imaging bands as markers to check if the lead was correctly placed.
Claim(s) 12-13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 2016/0303376) in view of Donega (US 2020/0384265) and Swoyer (US 2003/0045919) and further in view of Hess et al (US 4, 800, 898) hereinafter Hess.
Regarding claim 12, the modified Dinsmoor discloses the method of claim 1 as discussed above, but fails to disclose extending the sacral lead, using the lead body, through a sheath lumen of an introducer sheath configured to extend within or ventral to the foramen, wherein the introducer sheath defines one or more windows defining one or more openings in a sheath wall of the introducer sheath, translating, using the lead body, the sacral lead within the sheath lumen to cause at least one window of the introducer sheath to align with at least one of the one or more stimulation electrodes or at least one of the one or more sensing electrodes.
Swoyer discloses extending the sacral lead, using the lead body, through a sheath lumen (lead body lumen) of an introducer sheath (introducer 200) configured to extend within or ventral to the foramen ([0060] assembly is advanced percutaneously at a selected angle until the introducer distal end is disposed at the selected foramen as shown in FIG. 5). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with extending the sacral lead, using the lead body, through a sheath lumen of an introducer sheath configured to extend within or ventral to the foramen as taught by Swoyer since such a modification would provide the predictable results of effectively placing the electrodes at a selected nerve or muscle.
Hess discloses wherein the introducer sheath defines one or more windows defining one or more openings (Fig. 3: elongate slots 38) in a sheath wall (Col. 2: ln 61: exterior wall) of the introducer sheath, and
translating, using the lead body, the sacral lead within the sheath lumen (Claim 1: assembly can be slidably mounted over the end of the neural stimulator lead) to cause at least one window of the introducer sheath to align with at least one of the one or more stimulation electrodes or at least one of the one or more sensing electrodes (Col. 2, ln 59-63 in the aforementioned electrode elements at least one opening extends through the exterior wall of the sheath at the electrode for communicating the electrode with the exterior wall).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with wherein the introducer sheath defines one or more windows defining one or more openings in a sheath wall of the introducer sheath, and translating, using the lead body, the sacral lead within the sheath lumen to cause at least one window of the introducer sheath to align with at least one of the one or more stimulation electrodes or at least one of the one or more sensing electrodes as taught by Hess. Such a modification would provide the predictable results of allowing the electrical current from the electrode to be conducted from the tip in a specific direction rather than omnidirectionally from the tip (Col. 4, ln 32-37).
Regarding claim 13, Dinsmoor discloses a method of sensing and stimulation with a sacral lead, the method comprising:
a lead body supporting one or more electrodes ([0060] a medical lead 36 carrying electrodes 38 near a distal end of lead 36), and
wherein the lead body is configured to position at least some portion of the one or more electrodes dorsal to, within or ventral to the foramen ([0067] distal end of lead 36 is inserted into sacral foramen 30);
delivering a stimulation signal through one or more stimulation electrodes using the one or more electrodes when the one or more electrodes are configured to operate as the one or more stimulation electrodes ([0067] deliver, via lead 36 and one or more electrodes 38, electrical stimulation); and
sensing, following delivery of the stimulation signal, an evoked signal with one or more sensing electrodes using the one or more electrodes (electrodes 38) when the one or more electrodes are configured to operate as the one or more sensing electrodes ([0065] far-field eCMAP signals may be detected by electrodes 38 indicating that muscles in the area near rectum 24 are being activated by applied stimulation),
wherein at least one of the stimulation electrodes or at least one of the sensing electrodes is located within, dorsal, or ventral to a foramen of a sacrum of a patient ([0067] The distal end of lead 36 (containing leads 38) is inserted into sacral foramen 30 of sacrum 28; Figure 2: lead 36, electrodes 38).
Dinsmoor fails to disclose extending, using a lead body of the sacral lead, the sacral lead through a sheath lumen of an introducer sheath configured to extend dorsal to or within the foramen,
wherein the introducer sheath defines one or more windows defining one or more openings in a sheath wall of the introducer sheath;
aligning, using the lead body, at least one window of the introducer sheath with at least one of the one or more electrodes; and
sensing, following delivery of the stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal, the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve; and
determining one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal.
Swoyer discloses extending, using the lead body of the sacral lead, the sacral lead through a sheath lumen (lead body lumen) of an introducer sheath (introducer 200) configured to extend dorsal to or within the foramen ([0060] assembly is advanced percutaneously at a selected angle until the introducer distal end is disposed at the selected foramen as shown in FIG. 5). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with extending, using a lead body of the sacral lead, the sacral lead through a sheath lumen of an introducer sheath configured to extend dorsal to or within the foramen as taught by Swoyer. Such a modification would provide the predictable results of effectively placing the electrodes at a selected nerve or muscle.
Hess discloses wherein the introducer sheath defines one or more windows defining one or more openings (Fig. 38 elongate slots 38) in a sheath wall of the introducer sheath (Col. 2, ln 59-63 in the aforementioned electrode elements at least one opening extends through the exterior wall of the sheath at the electrode for communicating the electrode with the exterior wall); and
aligning, using the lead body, at least one window of the introducer sheath with at least one of the one or more electrodes (Claim 1: hereby said tip assembly can be slidably mounted over the end of the neural stimulator lead; Col. 4, ln 27-29, The electrode 30 communicates through the sheath 18 to the exterior thereof by way of one or more openings which pass through the sheath to the conductor).
It would have been obvious before the effective filing date of the claimed inventio to one having ordinary skill in the art to modify the method as taught by Dinsmoor with the introducer sheath defines one or more windows defining one or more openings in a sheath wall of the introducer sheath; and aligning, using the lead body, at least one window of the introducer sheath with at least one of the one or more electrodes as taught by Hess. Such a modification would provide the predictable results of allowing the electrical current from the electrode to be conducted from the tip in a specific direction rather than omnidirectionally from the tip (Hess, Col. 4, ln 32-37).
Donega discloses sensing, following delivery of a stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal ([0073] charts 39 and 41 illustrate the CAP measured in the nerve of different sheep when stimulation was applied to electrode pairs of the second array),
the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve ([0073] the peak appearing at around 10 ms of delay in the nerve recording represents an EMG contamination; Fig. 3b); and
determining one or more aspects of electrical stimulation therapy delivery (muscular innervation) utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal ([0073] EMG contamination from the contraction of the trachea and larynx).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Dinsmoor with sensing, following delivery of the stimulation signal, a composite stimulation-evoked signal evoked in response to the stimulation signal, the composite stimulation-evoked signal comprising a combination of an electromyogram (EMG) signal evoked from stimulating a muscle and an evoked compound action potential (eCAP) signal evoked from stimulating a nerve; and determining one or more aspects of electrical stimulation therapy delivery utilizing both the EMG signal and the eCAP signal that, in the combination, form the composite stimulation- evoked signal as taught by Donega. Such a modification would provide the predictable results of determining if the stimulation is activating an intended target area and whether the stimulation is eliciting a slow and/or fast fiber response (Donega, [0074]).
Regarding claim 20, the modified Dinsmoor discloses the system of claim 14 as discussed above, but fails to disclose an introducer sheath defining a sheath lumen, wherein:
the introducer sheath is configured to extend through the foramen;
the lead body and the one or more electrodes are slidably translatable within the lumen;
the introducer sheath includes one or more windows configured to allow at least one stimulation electrode to emit the stimulation signal through the one or more windows when the lead body and the at least one stimulation electrode are positioned within the lumen and the at least one stimulation electrode is aligned with at least one of the one or more windows; or
allow at least one sensing electrode to sense the composite stimulation-evoked signal through the one or more windows when the lead body and the at least one sensing electrode are positioned within the lumen and the at least one sensing electrode is aligned with at least one of the one or more windows,
wherein the introducer sheath is configured to align the at least one window and at least one of the at least one stimulation electrode or the at least one sensing electrode when the lead body slidably translates within the lumen.
Swoyer discloses an introducer sheath ([0060] introducer 200) defining a sheath lumen (Figures 5-8), wherein:
the introducer sheath is configured to extend through the foramen ([0060] assembly is advanced percutaneously at a selected angle until the introducer distal end is disposed at the selected foramen as shown in FIG. 5); and
the lead body and the one or more electrodes are slidably translatable within the lumen (Figure 7 shows the lead body 10 being slidably translatable within the lumen).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with an introducer sheath defining a sheath lumen, wherein: the introducer sheath is configured to extend through the foramen; the lead body and the one or more electrodes are slidably translatable within the lumen as taught by Swoyer. Such a modification would provide the predictable results of effectively placing the electrodes at a selected nerve or muscle.
Hess discloses an introducer sheath includes one or more windows (Fig. 3: elongate slots 38) configured to allow at least one stimulation electrode to emit the stimulation signal through the one or more windows when the lead body and the at least one stimulation electrode are positioned within the lumen and the at least one stimulation electrode is aligned with at least one of the one or more windows (Col. 4, ln 27-29, The electrode 30 communicates through the sheath 18 to the exterior thereof by way of one or more openings which pass through the sheath to the conductor); or
allow at least one sensing electrode to sense the composite stimulation-evoked signal through the one or more windows when the lead body and the at least one sensing electrode are positioned within the lumen and the at least one sensing electrode is aligned with at least one of the one or more windows,
wherein the introducer sheath is configured to align the at least one window and at least one of the at least one stimulation electrode or the at least one sensing electrode when the lead body slidably translates within the lumen (Claim 1: hereby said tip assembly can be slidably mounted over the end of the neural stimulator lead; Col. 2, ln 59-63 in the aforementioned electrode elements at least one opening extends through the exterior wall of the sheath at the electrode for communicating the electrode with the exterior wall).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Dinsmoor with an introducer sheath includes one or more windows configured to allow at least one stimulation electrode to emit the stimulation signal through the one or more windows when the lead body and the at least one stimulation electrode are positioned within the lumen and the at least one stimulation electrode is aligned with at least one of the one or more windows; wherein the introducer sheath is configured to align the at least one window and at least one of the at least one stimulation electrode or the at least one sensing electrode when the lead body slidably translates within the lumen as taught by Hess since such a modification would provide the predictable results of allowing the electrical current from the electrode to be conducted from the tip in a specific direction rather than omnidirectionally from the tip (Hess, Col. 4, ln 32-37).
Conclusion
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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