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 .
Status of Claims
Claims 1-31 are currently pending and under examination. As per the amendments filed on 04/06/2026, claims 6, 12, 18-19, 25, and 27 are amended.
Response to Arguments
Applicant's arguments, see Remarks page 12 (Objection to the Claims), filed 04/06/2026, with respect to the objections to claims 6, 12, 18, and 25 have been fully considered and are persuasive. Therefore, the objections are withdrawn.
Applicant's arguments, see Remarks page 13 (Claim Rejection Under 35 U.S.C. § 101), filed 04/06/2026, with respect to the rejections of Claims 19 and 27 under 35 USC § 101 been fully considered. Applicant argues:
The Office Action rejected claims 19 and 27 under 35 U.S.C. § 101 based on an assertion that these claims are directed to non-statutory subject matter. Specifically, the Office indicated that the claims are "directed to or encompassing a human organism."1 Applicant respectfully disagrees as the claims are instead directed to a method. Indeed, as discussed in the Interview Summary, the Examiner agreed to withdraw the rejection. (04/06/2026 Remarks, Page 13)
This argument is persuasive. Therefore, the rejections of claims 19 and 27 are withdrawn.
Applicant's arguments, see Remarks page 13 (Claim Rejection Under 35 U.S.C. § 112(b)), filed 04/06/2026, with respect to the rejections of Claims 19 and 27 under 35 USC § 112(b) been fully considered. Applicant argues:
The Office Action rejected claims 19 and 27 under 35 U.S.C. § l 12(b) as allegedly being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Specifically, the Office Action stated that "the brain" lacks antecedent basis. Applicant has amended claims 19 and 27 to correct the antecedent basis issue, and the Examiner agreed to withdraw the rejection. Applicant submits that amended claims 19 and 27 particularly point out and distinctly claim the subject matter which applicant regards as the invention, in accordance with 35 U.S.C. § 112(b). Applicant respectfully requests reconsideration and withdrawal of this rejection. (04/06/2026 Remarks, Page 13)
This argument is persuasive. Therefore, the rejections for claims 19 and 27 are withdrawn.
Applicant's arguments, see Remarks pages 13-17 (Claim Rejections Under 35 U.S.C. § 103), filed 04/06/2026, with respect to the rejections of Claims 1-31 under 35 USC § 103 been fully considered. Regarding independent claims 1, 6, 12, 18, and 25, Applicant argues:
As will be discussed further below, one of ordinary skill in the art would have consciously avoided modifying the device of Li with either Bourn or Kroll to include a "first sensing electrode comprising electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode," as recited by independent claim 1.
In rejecting claim 1, the Office cited Li as disclosing several features, including orientation markers. The Office acknowledged that Li does not disclose other features, such as a "first sensing electrode comprising electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode." However, the Office cited Bourn as disclosing that "electrodes can be used for either sensing or stimulation" and argued that "[i]t would have been obvious to ... incorporate electrodes with can provide either stimulation or sensing functions and can be made of radiopaque materials as seen in Bourn." The Office also cited Kroll as describing a "sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode."
Applicant respectfully disagrees with the rejection. For example, one of ordinary skill in the art would have consciously avoided modifying the imaging marker described by Li to be a sensing electrode because such a modification would have changed the principle of operation of the device of Li. Applicant notes that MPEP § 2143.0l(VI) states that "[i]f a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, there may be no suggestion or motivation to make the proposed modification."
In paragraph [0063], Li explains that "where the imaging marker 200 is made of a conducting material, the imaging marker 200 may be activated by a near-by electrode ... thus resulting in unwanted tissue activation around the imaging marker" and that "[t]he distance D200 between the imaging marker 200 and the electrode region 104 may be selected to be sufficient to avoid activation of the imaging marker 200." Li further explains in paragraph [0063] that "imaging marker 200 may additionally be insulated by providing a layer of electrically nonconducting material (e.g., a polymer) to cover the imaging marker 200."
Based on this description of Li, one of ordinary skill in the art would have consciously avoided modifying imaging marker 200 to operate as an electrode or otherwise avoid activation. Li describes that a conductive imaging marker 200 can even be insulated to prevent this activation. Modifying imaging marker 200 to operate as an electrode would thus render the Li lead unsatisfactory for its intended purpose and would change the principle of operation of the lead. (04/06/2026 Remarks, Page 14-15)
This argument is not persuasive. The [0063] citation in Li was incorporated into the rejection to show that the orientation markers are electrically conductive and can act as an electrode if energized by nearby electrical signals. While Li emphasizes the markers as being used for orientation purposes and avoids electrically activating the markers, the instant application uses a similar placement of the lead elements (as explained in the rejection) while incorporating the uniquely-shaped orientation markers as sensing electrodes. The combination with Bourn demonstrates it is known in the art that orientation markers can serve as sensing or stimulation electrodes. The combination with Kroll demonstrates the electrodes on the extremes of the distal lead have been used to provide a fringe sensing effect to locate electrical signals relative to the fringe electrodes.
Applicant additionally argues:
The reference of Bourn does not overcome the above description by Li. In paragraph [0090], Bourn describes that "electrodes 44 or a separate marker loaded in or formed on lead body 42, may include a radio-opaque material that is detectable by imaging techniques, such as fluoroscopic imaging or x-ray imaging." Although Bourn explains that electrodes or a separate marker may be formed using radio-opaque material, Bourn does not describe or suggest that the separate marker could be configured to be used as an electrode. Instead, Bourn explicitly describes the marker as separate. One of ordinary skill in the art would understand that orientation markers, even if constructed from materials similar to an electrode, may be constructed using different thicknesses, shapes, or positions that would be undesirable for an electrode. Indeed, as discussed above, Li explicitly states that the imaging marker 200 should not be activated and can be insulated. Kroll also does not provide any contrary description. Therefore, one of ordinary skill in the art would have consciously avoided modifying imaging marker 200 of Li to arrive at a "first sensing electrode comprising electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode," as recited by independent claim 1.
For at least these reasons, none of Li, Bourn, Kroll, or any proper combination thereof, describes or suggests the subject matter of independent claim 1. Independent claims 6 and 18 are patentable over Li, Bourn, Kroll, or any proper combination thereof, for at least the same reasons discussed above with respect to claim 1. (04/06/2026 Remarks, Page 15-16)
This argument is not persuasive. The citation [0090] in Bourn is interpreted as stating that an electrode can be made of a radiopaque material to serve as its own marker or a separate radiopaque marker can be used to locate the electrode (which is described in Li). Li teaches placement of conductive orientation markers to prevent contamination by nearby electrodes, which would be a pertinent teaching for spacing to prevent contamination if the radiopaque markers also function as electrodes with a fringe sensing wiring as taught by the combination with Bourn and Kroll. Therefore, the rejections of claims 1, 6, and 18 are maintained.
Specially regarding independent claims 12 and 25, Applicant argues:
In rejecting independent claim 12, the Office argued that Li discloses several features but acknowledged that Li does not describe proximal contact directly coupled to a sensing module.7 However, the Office cited paragraph [0039] of Ronen as disclosing "not using a switch module where conductors are directly coupled to the relevant modules" and argued that "[i]t would have been obvious to ... have modified Li's implantable medical device ... without a switch module [as] in Ronen."8 The Office also cited Bourn and Kroll has disclosing other features not described by Li.
Applicant respectfully disagrees with the rejection. The Office has not shown that Ronen describe generally "not using a switch module where conductors are directly coupled to the relevant modules." The actual paragraph [0039] of Ronen explains that "[i]n other examples, however, stimulation generator 21 does not include a switch module. In these examples, stimulation generator 21 comprises a plurality of pairs of voltage sources, current sources, voltage sinks, or current sinks connected to each of electrodes such that each pair of electrodes has a unique signal generator." This passage describes not using a switch module for connecting stimulation electrodes to the stimulation generator. This passage does not describe contacts directly coupled to a sensing module. Without any disclosure describing that contacts are directly coupled to a sensing module, one of ordinary skill in the art would have had no rational reason to modify the switch module of Li to arrive at "a second plurality of proximal connectors on the proximal end of the lead body, each proximal connector of the second plurality of proximal connectors being coupled to a corresponding proximal contact that is directly coupled to the sensing module,"9 as recited by independent claim 12.
For at least these reasons, none of Li, Bourn, Kroll, Ronen, or any proper combination thereof, describes or suggests the subject matter of independent claim 12. Independent claims 25 is patentable over Li, Bourn, Kroll, Ronen, or any proper combination thereof, for at least the same reasons discussed above with respect to claim 12. (04/06/2026 Remarks, Page 16)
This argument is not persuasive. Li discloses a switch module which switches between a stimulation generator and switch module ([0050-0051]). Claims 12 and 25 require “a second plurality of proximal connectors on the proximal end of the lead body, each proximal connector of the second plurality of proximal connectors being coupled to a corresponding proximal contact that is directly coupled to the sensing module,” where the sensing module has connections both to the switching module and proximal lead (see instant Fig. 1). Ronen describes “a switch module may be a switch array, switch matrix, multiplexer, or any other type of switching module configured to selectively couple stimulation energy to selected electrodes and to selectively sense bioelectrical neural signals of the spine with selected electrodes” ([0038]). Ronen further alternatively describes how the modules can be directly connected to particular electrode combinations via the proximal lead without the need for electrode switching ([0039]). The implementation of independent electrode control for at least some electrodes was interpreted as obvious to try via the rationale presented in the rejection. Therefore, the rejections of claims 12 and 25 are maintained.
Regarding dependent claims, Applicant argues:
For at least the reasons discussed above, independent claims 1, 6, 12, 18, and 25 are patentable over cited references. The dependent claims, i.e., claims 2-5, 7-11, 13-17, 19-24, and 26-31, incorporate the requirements of the respective independent claims. 10 Accordingly, the dependent claims are likewise patentable.
For at least these reasons, the Office has failed to establish a prima facie case for nonpatentability of Applicant's claims 1-31 under 35 U.S.C. § 103. Applicant therefore respectfully requests reconsideration and withdrawal of this rejection. (04/06/2026 Remarks, Page 17)
This argument is not persuasive. The rejections of independent claims 1, 6, 12, 18, and 25 are maintained. In the absence of any additional arguments, the rejections of the dependent claims are similarly maintained.
Summary: The 35 U.S.C. § 103 rejections for claims 1-31 are maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-11 and 18-24 are rejected under U.S.C 103 as being unpatentable over Li (US 2020/0230397 A1) in view of Bourn (US 2009/0054947 A1), and Kroll (US 7587239 B1).
Regarding Claim 1, Li discloses an implantable medical lead configured for implantation within a patient ([0001]), comprising:
a lead body ([0055] – main body 100 with proximal end 101 and distal end 102);
a first plurality of proximal contacts on a proximal end of the lead body ([0057] – stimulation contacts within the IMD);
a second plurality of proximal contacts on the proximal end of the lead body ([0051] – sensing contacts within the IMD);
at least one distal electrode on a distal end of the lead body ([0058] – any number of electrode configurations of distal electrodes is allowed), the at least one distal electrode comprising a segmented electrode having segments separated circumferentially about the lead body with each of the segments having at least one edge at circumferential positions about the lead body (Figures 11C-11D display segmented electrodes as part of electrodes 140 on the distal end of the lead; [0059] – segmented electrodes arranged around the circumference). Segmented electrodes with a stimulation signal are used to direct stimulation more exactly to specific body targets ([0004]);
a first sensing electrode on the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a second sensing electrode located at a second longitudinal position of the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a first plurality of conductors surrounded by the lead body and extending longitudinally (Figs. 11A–11B; [0090] – the electrical connections with an electrode positioned within the lead body) each conductor of the first plurality of conductors interconnecting one of the proximal contacts of the first plurality of proximal contacts to one of the segments of the segmented electrode on the distal end of the lead body ([0057] – the electrical connections attach the electrodes and stimulation contacts within the IMD); and
a second plurality of conductors surrounded by the lead body and extending longitudinally ([0051] – a sensing function is carried out by distal electrodes, [0090] – the electrical connections with an electrode positioned within the lead body), a first conductor of the second plurality of conductors interconnecting one of the proximal connectors of the second plurality of proximal connectors to the first sensing electrode and a second conductor of the second plurality of conductors interconnecting another one of the proximal connectors of the second plurality of proximal connectors to the second sensing electrode ([0051] – connections between sensing electrodes and sensing module facilitated by electrical connections through the lead body).
Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose:
a first sensing electrode on the distal end of the lead body the sensing electrode being radiopaque and being located at a first longitudinal position of the distal end of the lead body relative to the at least one distal electrode, the first sensing electrode comprising electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode;
a second sensing electrode located at a second longitudinal position of the distal end of the lead body so that the at least one distal electrode is longitudinally between the first sensing electrode and the second sensing electrode.
Bourn, in the same field of endeavor of an electrical stimulator with a sensing function ([0040]), teaches electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn. This would have been obvious because both Li and Bourn teach stimulation leads with radio-opaque markers and Bourn provides a solution/improvement for directly locating electrodes (electrodes as the markers) in addition to orientation of the lead as a whole for directional sensing or stimulation and having directional markers having a stimulatory or sensing function. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Li by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn.
Kroll, in the same field of endeavor of a stimulator with a sensing function (Col 1, Lines 12-15), teaches a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location from which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19), where these extreme locations are comparable to a fringe location. The distal and proximal reference electrodes are electrically coupled to a first terminal contact (Col 3, Lines 29-32).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll. This would have been obvious because both Li and Kroll teach stimulation leads with stimulation and sensing functions and Kroll provides a solution/improvement for determining the origin location of the sensed signal with reference electrodes at the extreme locations on the lead to filter out extraneous far-field signals which may negatively impact stimulation control. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Li by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll.
Regarding Claim 6, Li discloses an implantable medical system configured to provide stimulation and sensing within a patient ([0001]), comprising:
an implantable medical device comprising a stimulation module ([0048]), a sensing module ([0048]), a first plurality of contacts coupled to the stimulation module ([0057]), and a second plurality of contacts coupled to the sensing module ([0051]); and
an implantable medical lead ([0001]) comprising:
a lead body ([0055] – main body 100 with proximal end 101 and distal end 102);
a first plurality of proximal connectors on a proximal end of the lead body, each proximal connector of the first plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the stimulation module ([0057] – stimulation contacts within the IMD);
a second plurality of proximal connectors on the proximal end of the lead body, each proximal connector of the second plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the sensing module ([0051] – sensing contacts within the IMD);
at least one distal electrode on a distal end of the lead body ([0058] – any number of electrode configurations of distal electrodes is allowed), the at least one distal electrode comprising a segmented electrode having segments separated circumferentially about the lead body with each of the segments having at least one edge at circumferential positions about the lead body (Figures 11C-11D display segmented electrodes as part of electrodes 140 on the distal end of the lead; [0059] – segmented electrodes arranged around the circumference). Segmented electrodes with a stimulation signal are used to direct stimulation more exactly to specific body targets ([0004]);
a first sensing electrode on the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a second sensing electrode located at a second longitudinal position of the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a first plurality of conductors surrounded by the lead body and extending longitudinally ([0090] – the electrical connections with an electrode positioned within the lead body), each conductor of the first plurality of conductors interconnecting one of the proximal contacts of the first plurality of proximal contacts to one of the segments of the segmented electrode on the distal end of the lead body ([0057] – the electrical connections attach the electrodes and stimulation contacts within the IMD); and
a second plurality of conductors surrounded by the lead body and extending longitudinally ([0051] – a sensing function is carried out by distal electrodes, [0090] – the electrical connections with an electrode positioned within the lead body), a first conductor of the second plurality of conductors interconnecting one of the proximal connectors of the second plurality of proximal connectors to the first sensing electrode and a second conductor of the second plurality of conductors interconnecting another one of the proximal connectors of the second plurality of proximal connectors to the second sensing electrode ([0051] – connections between sensing electrodes and sensing module facilitated by electrical connections through the lead body).
Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose:
a first sensing electrode on the distal end of the lead body the sensing electrode being radiopaque and being located at a first longitudinal position of the distal end of the lead body relative to the at least one distal electrode, the first sensing electrode comprising electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode;
a second sensing electrode located at a second longitudinal position of the distal end of the lead body so that the at least one distal electrode is longitudinally between the first sensing electrode and the second sensing electrode.
Bourn, in the same field of endeavor of an electrical stimulator with a sensing function ([0040]), teaches electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn. This would have been obvious because both Li and Bourn teach stimulation leads with radio-opaque markers and Bourn provides a solution/improvement for directly locating electrodes (electrodes as the markers) in addition to orientation of the lead as a whole for directional sensing or stimulation and having directional markers having a stimulatory or sensing function. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Li by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn.
Kroll, in the same field of endeavor of a stimulator with a sensing function (Col 1, Lines 12-15), teaches a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location from which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19), where these extreme locations are comparable to a fringe location. The distal and proximal reference electrodes are electrically coupled to a first terminal contact (Col 3, Lines 29-32).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll. This would have been obvious because both Li and Kroll teach stimulation leads with stimulation and sensing functions and Kroll provides a solution/improvement for determining the origin location of the sensed signal with reference electrodes at the extreme locations on the lead to filter out extraneous far-field signals which may negatively impact stimulation control. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Li by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll.
Regarding Claim 18, Li discloses a method of providing stimulation and sensing within a patient ([0001]), comprising:
providing an implantable medical device comprising a stimulation module ([0048]), a sensing module ([0048]), a plurality of contacts coupled to the stimulation module ([0057]), and a plurality of contacts coupled to the sensing module ([0051]);
providing an implantable medical lead ([0001]) comprising:
a lead body ([0055] – main body 100 with proximal end 101 and distal end 102);
a first plurality of proximal connectors on a proximal end of the lead body, each proximal connector of the first plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the stimulation module ([0057] – stimulation contacts within the IMD);
a second plurality of proximal connectors on the proximal end of the lead body, each proximal connector of the second plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the sensing module ([0051] – sensing contacts within the IMD);
at least one distal electrode on a distal end of the lead body ([0058] – any number of electrode configurations of distal electrodes is allowed), the at least one distal electrode comprising a segmented electrode having segments separated circumferentially about the lead body with each of the segments having at least one edge at circumferential positions about the lead body (Figures 11C-11D display segmented electrodes as part of electrodes 140 on the distal end of the lead; [0059] – segmented electrodes arranged around the circumference). Segmented electrodes with a stimulation signal are used to direct stimulation more exactly to specific body targets ([0004]);
a first sensing electrode on the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a second sensing electrode located at a second longitudinal position of the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a first plurality of conductors surrounded by the lead body and extending longitudinally ([0090] – the electrical connections with an electrode positioned within the lead body), each conductor of the first plurality of conductors interconnecting one of the proximal contacts of the first plurality of proximal contacts to one of the segments of the segmented electrode on the distal end of the lead body ([0057] – the electrical connections attach the electrodes and stimulation contacts within the IMD); and
a second plurality of conductors surrounded by the lead body and extending longitudinally ([0051] – a sensing function is carried out by distal electrodes, [0090] – the electrical connections with an electrode positioned within the lead body), a first conductor of the second plurality of conductors interconnecting one of the proximal connectors of the second plurality of proximal connectors to the first sensing electrode and a second conductor of the second plurality of conductors interconnecting another one of the proximal connectors of the second plurality of proximal connectors to the second sensing electrode ([0051] – connection between sensing electrodes and sensing module facilitated by electrical connections through the lead body);
determining which segment of the segmented electrode to provide a stimulation signal based on the location of the orientation feature of each of the imaging markers ([0062] – the markers are positioned and configured to be able to identify the angular orientation of the lead, [0054] – the angular position of the lead is used to position stimulation electrodes);
providing the stimulation signal from the stimulation module to the determined segment of the segmented electrode ([0049] – specific electrode combinations and stimulation waveforms controlled using the hardware described in [0048]).
Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose:
a first sensing electrode on the distal end of the lead body, the first sensing electrode being radiopaque and being located at a first longitudinal position of the distal end of the lead body relative to the at least one distal electrode, the first sensing electrode comprising electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode;
a second sensing electrode located at a second longitudinal position of the distal end of the lead body so that the at least one distal electrode is longitudinally between the first sensing electrode and the second sensing electrode; and
sensing at the sensing module for a biomarker signal occurring between the first sensing electrode and the second sensing electrode.
Bourn, in the same field of endeavor of an electrical stimulator with a sensing function ([0040]), teaches electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead method by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn. This would have been obvious because both Li and Bourn teach stimulation leads with radio-opaque markers and Bourn provides a solution/improvement for directly locating electrodes (electrodes as the markers) in addition to orientation of the lead as a whole for directional sensing or stimulation and having directional markers having a stimulatory or sensing function. Therefore, a person of ordinary skill in the art would be motivated to improve the method in Li by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn.
Kroll, in the same field of endeavor of a stimulator with a sensing function (Col 1, Lines 12-15), teaches a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location from which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19), where these extreme locations are comparable to a fringe location. The distal and proximal reference electrodes are electrically coupled to a first terminal contact (Col 3, Lines 29-32).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead method by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll. This would have been obvious because both Li and Kroll teach stimulation leads with stimulation and sensing functions and Kroll provides a solution/improvement for determining the origin location of the sensed signal with reference electrodes at the extreme locations on the lead to filter out extraneous far-field signals which may negatively impact stimulation control. Therefore, a person of ordinary skill in the art would be motivated to improve the method in Li by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll.
Regarding Claims 2, 8, and 21, the implantable medical lead, system, and method according to Claims 1, 6, and 18 is obvious over Li in view of Bourn (where it was established electrodes can be radiopaque and serve as orientation markers) and Kroll, as indicated hereinabove. Li discloses a first sensing electrode on the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes) and a second sensing electrode located at a second longitudinal position of the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes). However, Li does not disclose wherein the first sensing electrode is proximal of the second sensing electrode.
As respectively established in claims 1, 6, and 18, the proposed combination with Kroll further yields a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location form which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19).
Regarding Claims 3, 9, and 22, the implantable medical lead, system, and method according to Claims 1, 6, and 18 is obvious over Li in view of Bourn and Kroll, as indicated hereinabove. Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose wherein the second sensing electrode has a shape that has an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode.
As respectively established in claims 1, 6, and 18, the proposed combination with Bourn further yields electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
Regarding Claims 4, 10, and 23, the implantable medical lead, system, and method according to Claims 1, 6, and 18 is obvious over Li in view of Bourn (where it was established electrodes can be radiopaque and serve as orientation markers) and Kroll, as indicated hereinabove. Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose wherein the electrode fragments of the first sensing electrode are electrically connected together.
As respectively established in claims 1, 6, and 18, the proposed combination with Kroll further yields a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location from which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19). The distal and proximal reference electrodes are electrically coupled together to a first terminal contact (Col 3, Lines 29-32).
Regarding Claims 5, 11, and 24, the implantable medical lead, system, and method according to Claims 1, 6, and 18 is obvious over Li in view of Bourn and Kroll, as indicated hereinabove. Li discloses an imaging marker made of a platinum and iridium mixture ([0060]). However, Li does not disclose wherein the first and second sensing electrodes comprise platinum-iridium.
As respectively established in claims 1, 6, and 18, the proposed combination with Bourn further yields electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials (such as platinum-iridium) can be used to determine placement of the lead or electrodes ([0090]).
Regarding Claim 7, the implantable medical system according to Claim 6 is obvious over Li in view of Bourn and Kroll, as indicated hereinabove. Li further discloses a switching module coupled to the stimulation module and electrically coupled to the first plurality of contacts, and wherein the switching module provides the electrical coupling of the first plurality of contacts to the stimulation module (Figure 13, [0050] – the switch controls which signals are passed to the electrodes through the contacts; [0057] – stimulation contacts within the IMD).
Regarding Claim 19, the method of providing stimulation and sensing within a patient according to Claim 18 is obvious over Li in view of Bourn and Kroll, as indicated hereinabove. Li further discloses determining, based on a position of the orientation feature indicated by radiological imaging data ([0062] – the markers are positioned and configured to be able to identify the angular orientation of the lead under radiological imaging), an orientation of the segmented electrode within a brain ([0043] – achieving the correct position for stimulation in the brain under radiological imaging).
Regarding Claim 20, the method of providing stimulation and sensing within a patient according to Claim 18 is obvious over Li in view of Bourn and Kroll, as indicated hereinabove. Li further discloses wherein providing the implantable medical device further comprises providing a switching module coupled to the stimulation module and electrically coupled to the first plurality of contacts ([0050] – switch module 48 delivers the signal from signal generator 44 to combinations of electrodes), and wherein the switching module provides the electrical coupling of the first plurality of contacts to the stimulation module ([0057] – stimulation contacts within the IMD, Figure 13 – the conduction pathway passes through the switch module 48).
Claims 12-17 and 25-31 are rejected under U.S.C 103 as being unpatentable over Li (US 2020/0230397 A1) in view of Bourn (US 2009/0054947 A1), Kroll (US 7587239 B1), and Ronen (US 2020/0337637 A1).
Regarding Claim 12, Li discloses an implantable medical system configured to provide stimulation and sensing within a patient ([0001]), comprising:
an implantable medical device comprising a stimulation module ([0048]), a sensing module ([0048]), a switching module coupled to the stimulation module ([0050]), and the sensing module, a plurality of contacts coupled to the switching module ([0051]), and a plurality of contacts coupled to the sensing module ([0051]); and
an implantable medical lead comprising:
a lead body ([0055] – main body 100 with proximal end 101 and distal end 102);
a first plurality of proximal connectors on a proximal end of the lead body, each proximal connector of the first plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the switching module (Figure 13, [0050] – the switch controls which signals are passed to the electrodes through the contacts; [0057] – stimulation contacts within the IMD);
a second plurality of proximal connectors on the proximal end of the lead body, each proximal connector of the second plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the switch module ([0050]);
at least one distal electrode on a distal end of the lead body ([0058] – any number of electrode configurations of distal electrodes is allowed), the at least one distal electrode comprising a segmented electrode having segments separated circumferentially about the lead body with each of the segments having at least one edge at circumferential positions about the lead body (Figures 11C-11D display segmented electrodes as part of electrodes 140 on the distal end of the lead; [0059] – segmented electrodes arranged around the circumference). Segmented electrodes with stimulation signals are used to direct stimulation more exactly to specific body targets ([0004]);
a first sensing electrode on the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a second sensing electrode located at a second longitudinal position of the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a first plurality of conductors surrounded by the lead body and extending longitudinally ([0090] – the electrical connections with an electrode positioned within the lead body), each conductor of the first plurality of conductors interconnecting one of the proximal contacts of the first plurality of proximal contacts to one of the segments of the segmented electrode on the distal end of the lead body ([0057] – the electrical connections attach the electrodes and stimulation contacts within the IMD); and
a second plurality of conductors surrounded by the lead body and extending longitudinally ([0051] – a sensing function is carried out by distal electrodes, [0090] – the electrical connections with the electrode a positioned within the lead body), a first conductor of the second plurality of conductors interconnecting one of the proximal connectors of the second plurality of proximal connectors to the first sensing electrode and a second conductor of the second plurality of conductors interconnecting another one of the proximal connectors of the second plurality of proximal connectors to the second sensing electrode ([0051] – connection between sensing electrodes and sensing module facilitated by electrical connections through the lead body).
Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose:
• a first sensing electrode on the distal end of the lead body, the sensing electrode being located at a first longitudinal position of the distal end of the lead body relative to the at least one distal electrode;
• a second sensing electrode located at a second longitudinal position of the distal end of the lead body so that the at least one distal electrode is longitudinally between the first sensing electrode and the second sensing electrode;
• corresponding proximal contact that directly coupled to the sensing module.
Bourn, in the same field of endeavor of an electrical stimulator with a sensing function ([0040]), teaches electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn. This would have been obvious because both Li and Bourn teach stimulation leads with radio-opaque markers and Bourn provides a solution/improvement for directly locating electrodes (electrodes as the markers) in addition to orientation of the lead as a whole for directional sensing or stimulation and having directional markers having a stimulatory or sensing function. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Li by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn.
Kroll, in the same field of endeavor of a stimulator with a sensing function (Col 1, Lines 12-15), teaches a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location from which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19), where these extreme locations are comparable to a fringe location. The distal and proximal reference electrodes are electrically coupled to a first terminal contact (Col 3, Lines 29-32).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll. This would have been obvious because both Li and Kroll teach stimulation leads with stimulation and sensing functions and Kroll provides a solution/improvement for determining the origin location of the sensed signal with reference electrodes at the extreme locations on the lead to filter out extraneous far-field signals which may negatively impact stimulation control. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Li by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll.
Ronen, in the same field of endeavor of an electrical stimulator with a sensing function ([0032]), teaches electrodes can be used for either sensing or stimulation ([0036]) and the system can assess electrode combinations which provide optimal sensing capabilities ([0023]). Ronen teaches either separate orientation markers can be used to determine placement of the lead or electrodes ([0058-0060]). Ronen also teaches configurations using a switch module to control stimulation or sensing ([0038]) and not using a switch module where conductors are directly coupled to the relevant modules ([0039]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Li’s implantable medical device 20 which contains a switch module by using an implantable medical device without a switch module in Ronen. Given different variants of system both using and not using a switch module are taught in Ronen, it would have been obvious to try an implantable medical device without a switching module in Li. A person of ordinary skill in the art would have a reasonable expectation of successfully using the implantable medical device in Li without a switching module.
Regarding Claim 25, Li discloses a method of providing stimulation and sensing within a patient ([0001]), comprising:
providing an implantable medical device comprising a stimulation module ([0048]), a sensing module ([0048]), a switching module (48) coupled to the stimulation module ([0050]) and the sensing module ([0051]), a plurality of contacts coupled to the switching module ([0051]), and a plurality of contacts coupled to the sensing module ([0051]);
providing an implantable medical lead ([0001]) comprising:
a lead body ([0055] – main body 100 with proximal end 101 and distal end 102);
a first plurality of proximal connectors on a proximal end of the lead body, each proximal connector of the first plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the switching module ([0057] – stimulation contacts within the IMD, Figure 13 – the conduction pathway passes through the switch module 48);
a second plurality of proximal connectors on the proximal end of the lead body, each proximal connector of the second plurality of proximal connectors being coupled to a corresponding proximal contact that is coupled to the switch module ([0050]);
at least one distal electrode on a distal end of the lead body ([0058] – any number of electrode configurations of distal electrodes are allowed), the at least one distal electrode comprising a segmented electrode having segments separated circumferentially about the lead body with each of the segments having at least one edge at circumferential positions about the lead body (Figures 11C-11D display segmented electrodes as part of electrodes 140 on the distal end of the lead; [0059] – segmented electrodes arranged around the circumference). Segmented electrodes with stimulation signals are used to direct stimulation more exactly to specific body targets ([0004]);
a first sensing electrode on the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a second sensing electrode located at a second longitudinal position of the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes);
a first plurality of conductors surrounded by the lead body and extending longitudinally ([0090] – the electrical connections with an electrode positioned within the lead body), each conductor of the first plurality of conductors interconnecting one of the proximal contacts of the first plurality of proximal contacts to one of the segments of the segmented electrode on the distal end of the lead body ([0057] – the electrical connections attach the electrodes and stimulation contacts within the IMD); and
a second plurality of conductors surrounded by the lead body and extending longitudinally ([0051] – a sensing function is carried out by distal electrodes, [0090] – the electrical connections with an electrode positioned within the lead body), a first conductor of the second plurality of conductors interconnecting one of the proximal connectors of the second plurality of proximal connectors to the first sensing electrode and a second conductor of the second plurality of conductors interconnecting another one of the proximal connectors of the second plurality of proximal connectors to the second sensing electrode ([0051] – connection between sensing electrodes and sensing module facilitated by electrical connections through the lead body);
configuring the switching module to signal connect a contact of the implantable medical device that corresponds to a desired segment of the segmented electrode to the stimulation module ([0050] – switch connects the stimulation generator with multiple electrodes, [0057] – stimulation from multiple electrodes);
providing a stimulation signal from the stimulation module to the desired segment of the segmented electrode ([0049] – specific electrode combinations and stimulation waveforms controlled using the hardware described in [0048]); and
Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose:
a first sensing electrode on the distal end of the lead body, the first sensing electrode being located at a first longitudinal position of the distal end of the lead body relative to the at least one distal electrode;
a second sensing electrode located at a second longitudinal position of the distal end of the lead body so that the at least one distal electrode is longitudinally between the first sensing electrode and the second sensing electrode;
sensing at the sensing module for a biomarker signal occurring between the first sensing electrode and the second sensing electrode; and
corresponding proximal contact that directly coupled to the sensing module.
Bourn, in the same field of endeavor of an electrical stimulator with a sensing function ([0040]), teaches electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead method by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn. This would have been obvious because both Li and Bourn teach stimulation leads with radio-opaque markers and Bourn provides a solution/improvement for directly locating electrodes (electrodes as the markers) in addition to orientation of the lead as a whole for directional sensing or stimulation and having directional markers having a stimulatory or sensing function. Therefore, a person of ordinary skill in the art would be motivated to improve the method in Li by incorporating electrodes which can provide either stimulation or sensing functions and can be made of radio-opaque materials as seen in Bourn.
Kroll, in the same field of endeavor of a stimulator with a sensing function (Col 1, Lines 12-15), teaches a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location from which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19), where these extreme locations are comparable to a fringe location. The distal and proximal reference electrodes are electrically coupled to a first terminal contact (Col 3, Lines 29-32).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Li’s stimulator lead method by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll. This would have been obvious because both Li and Kroll teach stimulation leads with stimulation and sensing functions and Kroll provides a solution/improvement for determining the origin location of the sensed signal with reference electrodes at the extreme locations on the lead to filter out extraneous far-field signals which may negatively impact stimulation control. Therefore, a person of ordinary skill in the art would be motivated to improve the method in Li by incorporating a sensing arrangement with reference electrodes placed proximal and distal to an intermediate sensing electrode in Kroll.
Ronen, in the same field of endeavor of an electrical stimulator with a sensing function ([0032]), teaches electrodes can be used for either sensing or stimulation ([0036]) and the system can assess electrode combinations which provide optimal sensing capabilities ([0023]). Ronen teaches either separate orientation markers can be used to determine placement of the lead or electrodes ([0058-0060]). Ronen also teaches configurations using a switch module to control stimulation or sensing ([0038]) and not using a switch module where conductors are directly coupled to the relevant modules ([0039]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Li’s implantable medical device method which contains a switch module by using an implantable medical device without a switch module in Ronen. Given different variants of system both using and not using a switch module are taught in Ronen, it would have been obvious to try an implantable medical device without a switching module in Li. A person of ordinary skill in the art would have a reasonable expectation of successfully using the implantable medical device method in Li without a switching module.
Regarding Claim 13, the implantable medical system according to Claim 12 is obvious over Li in view of Bourn, Kroll, and Ronen, as indicated hereinabove. Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers ([0065]) and electrodes ([0059]) are arranged around the circumference of the lead. Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose wherein the first sensing electrode comprises electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode.
As established in claim 12, the proposed combination with Bourn further yields electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
Regarding Claims 14 and 28, the implantable medical system and method according to Claims 13 and 25 is obvious over Li in view of Bourn, Kroll, and Ronen, as indicated hereinabove. Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose wherein the second sensing electrode has a shape that has an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode.
As respectively established in claims 12 and 25, the proposed combination with Bourn further yields electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
Regarding Claims 15 and 29, the implantable medical system and method according to Claims 12 and 25, is obvious over Li in view of Bourn (where it was established electrodes can be radiopaque and serve as orientation markers), Kroll, and Ronen as indicated hereinabove. Li discloses a first sensing electrode on the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes) and a second sensing electrode located at a second longitudinal position of the distal end of the lead body ([0051] – a sensing function is carried out by distal electrodes). However, Li does not disclose wherein the first sensing electrode is proximal of the second sensing electrode.
As respectively established in claims 12 and 25, the proposed combination with Kroll further yields a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location from which the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19).
Regarding Claims 16 and 30, the implantable medical system and method according to Claims 12 and 28 is obvious over Li in view of Bourn (where it was established electrodes can be radiopaque and serve as orientation markers), Kroll and Ronen, as indicated hereinabove. Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose wherein the electrode fragments of the first sensing electrode are electrically connected together.
As respectively established in claims 12 and 25, the proposed combination with Kroll further yields a sensing electrode arrangement with an intermediate electrode placed between a distal and proximal electrode (Col 3, Lines 5-17). The distal/intermediate electrode difference and proximal/intermediate electrode difference are compared in order to determine the location the sensing signal originated (Col 4, Lines 1-8) in order to eliminate far-field signals representing tissue signals outside the area of interest (Col 4, Lines 9-24). The distal electrode is referred to as being placed on or near the lead’s tip (Col 6, Lines 9-19). The distal and proximal reference electrodes are electrically coupled together to a first terminal contact (Col 3, Lines 29-32).
Regarding Claims 17 and 31, the implantable medical system and method according to Claims 12 and 25 is obvious over Li in view of Bourn and Kroll, as indicated hereinabove. Li discloses an imaging marker made of a platinum and iridium mixture ([0060]). However, Li does not disclose wherein the first and second sensing electrodes comprise platinum-iridium.
As respectively established in claims 12 and 25, the proposed combination with Bourn further yields electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials (such as platinum-iridium) can be used to determine placement of the lead or electrodes ([0090]).
Regarding Claim 26, the method of providing stimulation and sensing within a patient according to Claim 25 is obvious over Li in view of Bourn, Kroll, and Ronen, as indicated hereinabove. Li discloses orientation markers placed on the lead proximal to the distal electrodes ([0060]). The orientation markers can be made of a conductive material which can conduct nearby electrical signals ([0063]). The orientation markers can have different shapes, sizes, or orientations in order to differentiate the locations under an imaging modality ([0074]). Markers are depicted in Figures 6E-6F as being roughly aligned with the sets of segmented electrodes. However, Li does not disclose the use of marker electrodes in wherein the first sensing electrode comprises electrode fragments having characteristics that are visually distinguishable from each other and where the characteristics have an orientation feature that aligns circumferentially with an aspect of a corresponding one of the segments of the segmented electrode.
As established in claim 25, the proposed combination with Bourn further yields electrodes can be used for either sensing or stimulation and the system can assess electrode combinations which provide optimal sensing capabilities ([0040]). Bourn teaches either separate markers or electrodes made of radio-opaque materials can be used to determine placement of the lead or electrodes ([0090]).
Regarding Claim 27, the method of providing stimulation and sensing within a patient according to Claim 26 is obvious over Li in view of Bourn, Kroll, and Ronen, as indicated hereinabove. Li further discloses determining, based on a position of the orientation feature indicated by radiological imaging data ([0062] – the markers are positioned and configured to be able to identify the angular orientation of the lead under radiological imaging), an orientation of the segmented electrode within a brain ([0043] – achieving the correct position for stimulation in the brain under radiological imaging); and determining a desired segment of the segmented electrode based on the determined orientation ([0062] – the markers are positioned and configured to be able to identify the angular orientation of the lead, [0054] – the angular position of the lead is used to position stimulation electrodes).
Conclusions
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights