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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/06/2023 is being considered by the examiner.
Status of Claims
Claims 1-31 are currently pending and are under examination.
Priority
The instant application (filed on 06/08/2023) is a non-provisional application filed under 35 USC 111(a). Acknowledgment is made of applicant's claim for domestic priority based on provisional application 63/353,023 filed on 06/16/2022. Instant claims 1-31 are sufficiently described in the provisional application to receive an effective filing date of 06/16/2022. Therefore, all prior art will be evaluated with respect to this date.
Claim Objections
The following claims are objected to because of the following informalities:
• Claims 6, 12, 18, and 25: The limitation “a plurality of contacts signal coupled to the … module, and a plurality of contacts coupled to the sensing module” appears to lack consistency by having “signal” placed between “contacts” and “coupled.”
Appropriate correction is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 19 and 27 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 19 and 27 contain limitations which claim the device and a body region. In order to provide a distinction between the device and the human organism (body region), the claim could incorporate language equivalent to “configured to” with respect to the device.
Claim 19 recites “determining an orientation of the segmented electrode within the brain based on position of the orientation feature as revealed by radiological imaging,” which requires a user’s body region (brain), and therefore encompasses a human organism. The rejection may be overcome by amending the claim so that the segmented electrode is configured to be placed within the brain.
Claim 27 recites “determining an orientation of the segmented electrode within the brain based on position of the orientation feature as revealed by radiological imaging,” which requires a user’s body region (brain), and therefore encompasses a human organism. The rejection may be overcome by amending the claim so that the segmented electrode is configured to be placed within the brain.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 and 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 and 27: The use of “the brain” lacks an antecedent basis, thus rendering claims 19 and 27 indefinite. The term “a brain” would correct the lack of antecedence.
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 PG Pub 2020/0230397 A1, see “Notice of References Cited”) in view of Bourn (US PG Pub 2009/0054947 A1, see “Notice of References Cited”), and Kroll (US 7587239 B1, see “Notice of References Cited”).
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.
Therefore, Claim 1 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 2, the implantable medical lead according to Claim 1 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.
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 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).
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.
Therefore, Claim 2 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 3, the implantable medical lead according to Claim 1 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.
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.
Therefore, Claim 3 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 4, the implantable medical lead according to Claim 1 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.
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 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).
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.
Therefore, Claim 4 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 5, the implantable medical lead according to Claim 1 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] – “the imaging marker 200 may be constructed of or include materials that are radio opaque. Examples of suitable materials include metals, such as platinum, iridium, tantalum, and the like, and mixtures thereof”). However, Li does not disclose wherein the first and second sensing electrodes comprise platinum-iridium.
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 (such as platinum-iridium) 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.
Therefore, Claim 5 is obvious over Li in view of Bourn and 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 signal 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.
Therefore, Claim 6 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 7, the implantable medical system according to Claim 6 is obvious over Li in view of Bourn and Kroll, as indicated hereinabove. 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).
Therefore, Claim 7 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 8, the implantable medical system according to Claim 6 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.
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 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).
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.
Therefore, Claim 8 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 9, the implantable medical system according to Claim 6 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 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.
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.
Therefore, Claim 9 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 10, the implantable medical system according to Claim 6 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.
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 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).
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..
Therefore, Claim 10 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 11, the implantable medical system according to Claim 6 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] – “the imaging marker 200 may be constructed of or include materials that are radio opaque. Examples of suitable materials include metals, such as platinum, iridium, tantalum, and the like, and mixtures thereof”). However, Li does not disclose wherein the first and second sensing electrodes comprise platinum-iridium.
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 (such as platinum-iridium) 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.
Therefore, Claim 11 is obvious over Li in view of Bourn and 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 signal 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.
Therefore, Claim 18 is obvious over Li in view of Bourn and Kroll.
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 further comprising determining an orientation of the segmented electrode within the brain ([0043] – achieving the correct position for stimulation in the brain under radiological imaging) based on position of the orientation feature as revealed by radiological imaging ([0062] – the markers are positioned and configured to be able to identify the angular orientation of the lead under radiological imaging).
Therefore, Claim 19 is obvious over Li in view of Bourn and Kroll.
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).
Therefore, Claim 20 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 21, the method of providing stimulation and sensing within a patient according to Claim 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.
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 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).
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.
Therefore, Claim 21 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 22, 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 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.
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.
Therefore, Claim 22 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 23, the method of providing stimulation and sensing within a patient according to Claim 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.
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 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).
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.
Therefore, Claim 23 is obvious over Li in view of Bourn and Kroll.
Regarding Claim 24, 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 discloses an imaging marker made of a platinum and iridium mixture ([0060] – “the imaging marker 200 may be constructed of or include materials that are radio opaque. Examples of suitable materials include metals, such as platinum, iridium, tantalum, and the like, and mixtures thereof”). However, Li does not disclose wherein the first and second sensing electrodes comprise platinum-iridium.
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 (such as platinum-iridium) 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.
Therefore, Claim 24 is obvious over Li in view of Bourn and Kroll.
Claims 12-17 and 25-31 are rejected under U.S.C 103 as being unpatentable over Li (US PG Pub 2020/0230397 A1, see “Notice of References Cited”) in view of Bourn (US PG Pub 2009/0054947 A1, see “Notice of References Cited”), Kroll (US 7587239 B1, see “Notice of References Cited”), and Ronen (US PG Pub 2020/0337637 A1, see “Notice of References Cited”).
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 signal 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.
Therefore, Claim 12 is obvious over Li in view of Bourn, Kroll, and Ronen.
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.
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 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 as seen in Bourn.
Therefore, Claim 13 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 14, the implantable medical system according to Claim 13 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. Li additionally discloses a sensing function is carried out by distal electrodes ([0051]). 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.
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.
Therefore, Claim 14 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 15, the implantable medical system according to Claim 12 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.
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 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).
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.
Therefore, Claim 15 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 16, the implantable medical system according to Claim 12 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.
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 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).
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.
Therefore, Claim 16 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 17, the implantable medical system according to Claim 12 is obvious over Li in view of Bourn, Kroll, and Ronen, as indicated hereinabove. Li discloses an imaging marker made of a platinum and iridium mixture ([0060] – “the imaging marker 200 may be constructed of or include materials that are radio opaque. Examples of suitable materials include metals, such as platinum, iridium, tantalum, and the like, and mixtures thereof”). However, Li does not disclose wherein the first and second sensing electrodes comprise platinum-iridium.
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 (such as platinum-iridium) 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.
Therefore, Claim 17 is obvious over Li in view of Bourn, Kroll, and Ronen.
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 signal 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.
Therefore, Claim 25 is obvious over Li in view of Bourn, Kroll, and Ronen.
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 Li further discloses 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.
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 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 as seen in Bourn.
Therefore, Claim 26 is obvious over Li in view of Bourn, Kroll, and Ronen.
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 an orientation of the segmented electrode within the brain ([0043] – achieving the correct position for stimulation in the brain under radiological imaging) based on position of the orientation feature as revealed by radiological imaging ([0062] – the markers are positioned and configured to be able to identify the angular orientation of the lead under radiological imaging); and determining which segment of the segmented electrode is desired 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).
Therefore, Claim 27 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 28, 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 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.
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.
Therefore, Claim 28 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 29, the method of providing stimulation and sensing within a patient according to Claim 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.
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 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).
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.
Therefore, Claim 29 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 30, the method of providing stimulation and sensing within a patient according to Claim 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 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.
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 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).
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.
Therefore, Claim 30 is obvious over Li in view of Bourn, Kroll, and Ronen.
Regarding Claim 31, 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 an imaging markers made of a platinum and iridium mixture ([0060] – “the imaging marker 200 may be constructed of or include materials that are radio opaque. Examples of suitable materials include metals, such as platinum, iridium, tantalum, and the like, and mixtures thereof”). However, Li does not disclose wherein the first and second sensing electrodes comprise platinum-iridium.
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 (such as platinum-iridium) 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 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 as seen in Bourn.
Therefore, Claim 31 is obvious over Li in view of Bourn, Kroll, and Ronen.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796