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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 6-11, 14, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 9833161 B2) in view of Moak (US 20200008883 A1) and Rodriguez (US 20230181087 A1).
Regarding claim 1, Govari teaches a system for improving far-field noise cancellation from electrophysiological (EP) signals, the system comprising: a catheter, comprising one or more catheter electrodes (Fig 2; catheter 37, electrodes 49); which is: (a) coupled to the distal end of the sheath (Fig 2), and (b) configured to acquire a reference signal indicative of a far-field signal generated by the organ (Fig 3; [23] In expanded form of the electrode assembly 43 at least a portion of the spline electrodes 49 of the splines 45 contact endocardial surface 53 of the heart 12 and acquire signals corresponding to electropotentials generated at their points of contact with the surface. However, since the spline electrodes 49 are in a conductive medium (the blood), in addition to the electropotentials from the points of contact the acquired signals also include far-field components from other regions of the heart 12) ([24] To counteract the interference, embodiments of the present invention position the far-field electrode 51 on the contraction wire 47. In the expanded configuration of the electrode assembly 43, the far-field electrode 51 is located on the contraction wire 47 so as to be approximately equidistant from all corresponding spline electrodes 49, i.e., spline electrodes 49 that are equidistant from a fixed reference point on the long axis of the catheter, such as reference point 55 at the proximal end of the electrode assembly 43, and is prevented from contacting the surface of the heart by the splines); and a processor ([9] processor 22) configured to: use the reference signal for cancellation of the far-field noise in the EP signals acquired by at least one of the one or more catheter electrodes ([24] The far-field components constitute an interfering signal on the endocardial surface electropotentials…However the signals acquired by the spline electrodes 49 have both a far-field and a surface (near-field) component. The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49 so as to counteract the interference suffered by these electrodes, i.e., by subtraction of the signals: e(t)-x(t)); one or more of the catheter electrodes (Fig 2; spline electrodes 49).
Govari fails to teach a sheath configured to (i) allow passage of the catheter having the one or more catheter electrodes for collecting EP signals in an organ of a patient, the catheter passing through a distal end of the sheath, (ii) be navigated in the organ to a blood pool and avoid contact with tissue of the organ, the sheath comprises at least a sheath electrode, which is: (a) coupled to the distal end of the sheath; calculate one or more distances; between (i) the sheath electrode; respectively and normalize the EP signals based on the one or more calculated distances.
However, Moak teaches a sheath (Fig 1; sheath 110) configured to (i) allow passage of the catheter having the one or more catheter electrodes for collecting EP signals in an organ of a patient (Fig 1; [0024] The distal end of the sheath 110 can be constructed to create a smooth transition from the sheath 110 to the dilator 120) ([0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120), the catheter passing through a distal end of the sheath ([0026] A retractable transseptal needle 130 can be placed through the lumen of the dilator 120), (ii) be navigated in the organ to a blood pool and avoid contact with tissue of the organ ([0023] The dilator 120 also facilitates the transition of the sheath through a small hole, such as the one made in the interatrial septum for accessing the left atrium), the sheath comprises at least a sheath electrode (Fig 1; [0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120), which is: (a) coupled to the distal end of the sheath (Fig 2), between (i) the sheath electrode ([0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include a sheath configured to (i) allow passage of the catheter having the one or more catheter electrodes for collecting EP signals in an organ of a patient, the catheter passing through a distal end of the sheath, (ii) be navigated in the organ to a blood pool and avoid contact with tissue of the organ, the sheath comprises at least a sheath electrode, which is: (a) coupled to the distal end of the sheath. Doing so allows for the far field reference to be acquired from an electrode that stays off the tissue while the catheter electrodes contact the wall.
Further, Rodriguez teaches calculate one or more distances ([0083] As a distance from the reference electrode for a particular electrode increases, a weight decreases (e.g., the farther away, a smaller a weighting)) ([0093] For example, an electrode 560 is designated as the reference electrode q. Further, as the distance from the electrode 560 increases, a weight decreases…Note that distance between each of the electrodes 534 can be measured with respect to a three dimensional space (i.e., using x, y, z, coordinates). In turn, the electrodes 564 and 566 may or may not have the same weight); respectively and normalize the EP signals based on the one or more calculated distances ([0018] the mapping engine weights electrodes in opposite proportion to distances to identify a common signal component across the electrodes. This common signal component is used by the mapping engine to precisely reduce or cancel far field interference) ([0082] According to one or more embodiments of spatial electrode signal analysis, the electrodes surrounding the specific electrode are weighted in opposite proportion to a distance from that specific electrode…The mapping engine 101 analyzes a first electrode and can assign a weight function thereto. An example weight function includes 1-0.25*D, where D is the distance of another electrode from the first electrode. In turn, the mapping engine 101 generates a weighting vector of [w11,w21,w31]=[1, 0.5, 0] and analyzes the first electrode based on multiplying the first electrode by w11=1, a second electrode by w21=0.5, and a third electrode by w31=0). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include calculating one or more distances and normalizing the EP signals based on the one or more calculated distances. Doing so allows for the far field cancellation to account for the references not all being the same distance from the reference.
Regarding claim 4, Govari teaches the system according to claim 1, the catheter electrodes (spline electrodes 49), utilizing intensity decay rates of signal propagation in the blood pool ([7] conductive medium (the blood)).
Govari fails to teach wherein the processor is configured to normalize the EP signals by considering the calculated distance between the sheath electrode and a reference electrode; utilizing intensity decay rates of signal propagation modeled as inversely proportional to the calculated distance.
However, Moak teaches the sheath electrode ([0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include the sheath electrode. Doing so allows for the far field cancellation to account for the sheath electrode and the reference electrode not recognizing the same far field signals.
Further, Rodriguez teaches wherein the processor is configured to normalize the EP signals by considering the calculated distance ([0018] the mapping engine weights electrodes in opposite proportion to distances to identify a common signal component across the electrodes. This common signal component is used by the mapping engine to precisely reduce or cancel far field interference) ([0083] As a distance from the reference electrode for a particular electrode increases, a weight decreases (e.g., the farther away, a smaller a weighting)) ([0093] For example, an electrode 560 is designated as the reference electrode q. Further, as the distance from the electrode 560 increases, a weight decreases…Note that distance between each of the electrodes 534 can be measured with respect to a three dimensional space (i.e., using x, y, z, coordinates). In turn, the electrodes 564 and 566 may or may not have the same weight), modeled as inversely proportional to the calculated distance ([0082] According to one or more embodiments of spatial electrode signal analysis, the electrodes surrounding the specific electrode are weighted in opposite proportion to a distance from that specific electrode) [0083] As a distance from the reference electrode for a particular electrode increases, a weight decreases (e.g., the farther away, a smaller a weighting). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the processor is configured to normalize the EP signals by considering the calculated distance, modeled as inversely proportional to the calculated distance. Doing so allows for the far field cancellation to account for the reference and the catheter electrodes not seeing the same far field signals.
Regarding claim 6, Govari teaches the system according to claim 1, wherein the processor is configured to extract electrocardiogram (ECG) data from the reference signal ([15] Typically, the system 10 includes other elements, which are not shown in the figures for the sake of simplicity. For example, the system 10 may include an electrocardiogram (ECG) monitor, coupled to receive signals from one or more body surface electrodes, in order to provide an ECG synchronization signal to the console 24) ([24] The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49), and to improve accuracy of the EP signals based on the ECG data ([24] The far-field components constitute an interfering signal on the endocardial surface electropotentials…However the signals acquired by the spline electrodes 49 have both a far-field and a surface (near-field) component. The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49 so as to counteract the interference suffered by these electrodes, i.e., by subtraction of the signals: e(t)-x(t)).
Regarding claim 7, Govari teaches the system according to claim 1, catheter electrodes (ring spline electrode 49), but fails to teach the sheath electrode. However, Moak teaches the sheath electrode (Fig 2; electrode 140c).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to size Moak’s sheath electrode 140c so that is at least half the size of Govari’s ring spline electrode 49. Electrode 140c is substituted for Govari’s cylindrical far-field electrode 51.
Further, it would have been an obvious matter of design choice wherein the sheath electrode has a first size that matches at least half of a second size of at least one of the catheter electrodes, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 8, Govari teaches the system according to claim 1, be positioned within the blood pool ([7] conductive medium (the blood)), configured to produce the reference signal ([24] The far-field components constitute an interfering signal on the endocardial surface electropotentials…The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49 so as to counteract the interference suffered by these electrodes, i.e., by subtraction of the signals: e(t)-x(t)).
Govari fails to teach wherein the sheath is configured to: (i) pass through a septum of the organ, and wherein the sheath electrode, which is not affected by a movement of the catheter in the organ.
However, Moak teaches wherein the sheath (Fig 2; sheath 110) is configured to: (i) pass through a septum of the organ ([0027] Furthermore, a magnetic-field sensor can be included at distal end 135 of the transseptal needle that enables electromagnetic positioning and monitoring of sheath location within a cardiac chamber), and wherein the sheath electrode (Electrode 140c), which is not affected by a movement of the catheter in the organ ([0033] the transseptal needle 130 is extended out the distal end of dilator 120) ([0023] The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in FIG. 1) (sheath remains the access into the left atrium; electrode 140c remains on sheath while the catheter advances). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the sheath is configured to: (i) pass through a septum of the organ, and wherein the sheath electrode, which is not affected by a movement of the catheter in the organ. Doing so allows for the far field reference to be acquired from an electrode that has crossed the septum and stays in the chamber while the catheter moves.
Regarding claim 9, Govari teaches the system according to claim 1, within the blood pool of the organ ([7] conductive medium (the blood)), and wherein the electrode is configured to acquire the reference signal that is less susceptible to motion artifacts compared to EP signals collected by the catheter electrodes ([24] the far-field electrode 51 is located on the contraction wire 47 so as to be approximately equidistant from all corresponding spline electrodes 49, i.e., spline electrodes 49 that are equidistant from a fixed reference point on the long axis of the catheter, such as reference point 55 at the proximal end of the electrode assembly 43, and is prevented from contacting the surface of the heart by the splines. When the far-field electrode 51 is at least 0.5 cm removed from the spline electrodes 49 in the expanded configuration of the electrode assembly 43 it acquires a far-field signal, but not a near-field signal from the endocardial surface 53).
Govari fails to teach wherein the sheath is configured to (i) maintain a position of the sheath electrode; and (ii) allow movement of the catheter, and wherein the sheath electrode.
However, Moak teaches wherein the sheath (Fig 2; sheath 110) is configured to (i) maintain a position of the sheath electrode (Fig 2; sheath 110 remains the access into the left atrium; electrode 140c remains on sheath while the catheter advances) ([0027] Furthermore, a magnetic-field sensor can be included at distal end 135 of the transseptal needle that enables electromagnetic positioning and monitoring of sheath location within a cardiac chamber), and (ii) allow movement of the catheter ([0023] The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in FIG. 1), and wherein the sheath electrode (Electrode 140c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the sheath is configured to (i) maintain a position of the sheath electrode; and (ii) allow movement of the catheter, and wherein the sheath electrode. Doing so allows for the far-field reference to remain in the blood pool while the catheter electrodes move and contact tissue.
Regarding claim 10, Govari teaches the system according to claim 1, wherein the organ comprises a heart ([7] In the expanded form of a basket catheter, the electrodes of the spline contact the surface of the heart and acquire signals corresponding to electropotentials generated at their points of contact with the surface).
Regarding claim 11, Govari teaches a method for improving far-field noise cancellation from electrophysiological (EP) signals, the method comprising: inserting into an organ of a patient ([21] There is further provided according to embodiments of the invention a method, which is carried out by inserting a catheter into a heart of a subject), a catheter comprising one or more catheter electrodes (Fig 2; catheter 37, electrodes 49), navigating the sheath in the organ to a blood pool ([23] since the spline electrodes are in a conductive medium (the blood)), acquiring a reference signal indicative of a far-field signal generated by the organ (Fig 3; [23] In expanded form of the electrode assembly 43 at least a portion of the spline electrodes 49 of the splines 45 contact endocardial surface 53 of the heart 12 and acquire signals corresponding to electropotentials generated at their points of contact with the surface. However, since the spline electrodes 49 are in a conductive medium (the blood), in addition to the electropotentials from the points of contact the acquired signals also include far-field components from other regions of the heart 12) ([24] To counteract the interference, embodiments of the present invention position the far-field electrode 51 on the contraction wire 47. In the expanded configuration of the electrode assembly 43, the far-field electrode 51 is located on the contraction wire 47 so as to be approximately equidistant from all corresponding spline electrodes 49, i.e., spline electrodes 49 that are equidistant from a fixed reference point on the long axis of the catheter, such as reference point 55 at the proximal end of the electrode assembly 43, and is prevented from contacting the surface of the heart by the splines), and using the reference signal for cancellation of the far-field noise in the EP signals acquired by at least one of the one or more catheter electrodes ([24] The far-field components constitute an interfering signal on the endocardial surface electropotentials…However the signals acquired by the spline electrodes 49 have both a far-field and a surface (near-field) component. The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49 so as to counteract the interference suffered by these electrodes, i.e., by subtraction of the signals: e(t)-x(t)); one or more of the catheter electrodes (Fig 2; spline electrodes 49).
Govari fails to teach through a sheath, wherein the sheath comprises at least a sheath electrode coupled to a distal end of the sheath, while avoiding contact with tissue of the organ, collecting EP signals using the one or more catheter electrodes, using the sheath electrode, calculating one or more distances between (i) the sheath electrode, and normalizing the EP signals based on the one or more calculated distances.
However, Moak teaches through a sheath (Fig 1; sheath 110), wherein the sheath comprises at least a sheath electrode coupled to a distal end of the sheath (Fig 1; [0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120); while avoiding contact with tissue of the organ ([0023] The dilator 120 also facilitates the transition of the sheath through a small hole, such as the one made in the interatrial septum for accessing the left atrium); collecting EP signals using the one or more catheter electrodes (Fig 1; [0024] The distal end of the sheath 110 can be constructed to create a smooth transition from the sheath 110 to the dilator 120) ([0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120), using the sheath electrode (Fig 1; [0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120) (Fig 1; Electrode 140c), between (i) the sheath electrode ([0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include through a sheath, wherein the sheath comprises at least a sheath electrode coupled to a distal end of the sheath, while avoiding contact with tissue of the organ, collecting EP signals using the one or more catheter electrodes, using the sheath electrode. Doing so allows for the far field reference to be acquired from an electrode that stays off the tissue while the catheter electrodes contact the wall.
Further Rodriguez teaches calculating one or more distances ([0083] As a distance from the reference electrode for a particular electrode increases, a weight decreases (e.g., the farther away, a smaller a weighting)) ([0093] For example, an electrode 560 is designated as the reference electrode q. Further, as the distance from the electrode 560 increases, a weight decreases…Note that distance between each of the electrodes 534 can be measured with respect to a three dimensional space (i.e., using x, y, z, coordinates). In turn, the electrodes 564 and 566 may or may not have the same weight), and normalizing the EP signals based on the one or more calculated distances ([0018] the mapping engine weights electrodes in opposite proportion to distances to identify a common signal component across the electrodes. This common signal component is used by the mapping engine to precisely reduce or cancel far field interference) ([0082] According to one or more embodiments of spatial electrode signal analysis, the electrodes surrounding the specific electrode are weighted in opposite proportion to a distance from that specific electrode…The mapping engine 101 analyzes a first electrode and can assign a weight function thereto. An example weight function includes 1-0.25*D, where D is the distance of another electrode from the first electrode. In turn, the mapping engine 101 generates a weighting vector of [w11,w21,w31]=[1, 0.5, 0] and analyzes the first electrode based on multiplying the first electrode by w11=1, a second electrode by w21=0.5, and a third electrode by w31=0). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include calculating one or more distances and normalizing the EP signals based on the one or more calculated distances. Doing so allows for the far field cancellation to account for the references not all being the same distance from the reference.
Regarding claim 14, Govari teaches the method according to claim 11, the one or more catheter electrodes (spline electrodes 49), utilizing intensity decay rates of signal propagation in the blood pool ([7] conductive medium (the blood)).
Govari fails to teach wherein the processor is configured to normalize the EP signals by considering the calculated distance between the sheath electrode and a reference electrode; utilizing intensity decay rates of signal propagation modeled as inversely proportional to the calculated distance.
However, Moak teaches the sheath electrode ([0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include the sheath electrode. Doing so allows for the far field cancellation to account for the sheath electrode and the reference electrode not recognizing the same far field signals.
Further, Rodriguez teaches wherein the processor is configured to normalize the EP signals by considering the calculated distance ([0018] the mapping engine weights electrodes in opposite proportion to distances to identify a common signal component across the electrodes. This common signal component is used by the mapping engine to precisely reduce or cancel far field interference) ([0083] As a distance from the reference electrode for a particular electrode increases, a weight decreases (e.g., the farther away, a smaller a weighting)) ([0093] For example, an electrode 560 is designated as the reference electrode q. Further, as the distance from the electrode 560 increases, a weight decreases…Note that distance between each of the electrodes 534 can be measured with respect to a three dimensional space (i.e., using x, y, z, coordinates). In turn, the electrodes 564 and 566 may or may not have the same weight), modeled as inversely proportional to the calculated distance ([0082] According to one or more embodiments of spatial electrode signal analysis, the electrodes surrounding the specific electrode are weighted in opposite proportion to a distance from that specific electrode) [0083] As a distance from the reference electrode for a particular electrode increases, a weight decreases (e.g., the farther away, a smaller a weighting). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the processor is configured to normalize the EP signals by considering the calculated distance, modeled as inversely proportional to the calculated distance. Doing so allows for the far field cancellation to account for the reference and the catheter electrodes not seeing the same far field signals.
Regarding claim 16, Govari teaches the method according to claim 11, further comprising extracting electrocardiogram (ECG) data from the reference signal ([15] Typically, the system 10 includes other elements, which are not shown in the figures for the sake of simplicity. For example, the system 10 may include an electrocardiogram (ECG) monitor, coupled to receive signals from one or more body surface electrodes, in order to provide an ECG synchronization signal to the console 24) ([24] The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49) and improving accuracy of the EP signals based on the ECG data ([24] The far-field components constitute an interfering signal on the endocardial surface electropotentials…However the signals acquired by the spline electrodes 49 have both a far-field and a surface (near-field) component. The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49 so as to counteract the interference suffered by these electrodes, i.e., by subtraction of the signals: e(t)-x(t)).
Regarding claim 17, Govari teaches the method according to claim 11, catheter electrodes (ring spline electrode 49), but fails to teach the sheath electrode. However, Moak teaches the sheath electrode (Fig 2; electrode 140c).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to size Moak’s sheath electrode 140c so that is at least half the size of Govari’s ring spline electrode 49. Electrode 140c is substituted for Govari’s cylindrical far-field electrode 51.
Further, it would have been an obvious matter of design choice wherein the sheath electrode has a first size that matches at least half of a second size of at least one of the catheter electrodes, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 18, Govari teaches the method according to claim 11, positioning the sheath within the blood pool ([7] conductive medium (the blood)), and (c) producing the reference signal ([24] The far-field components constitute an interfering signal on the endocardial surface electropotentials…The far-field component signal x(t) acquired by the far-field electrode 51 is removed from signals e(t) acquired by the spline electrodes 49 so as to counteract the interference suffered by these electrodes, i.e., by subtraction of the signals: e(t)-x(t)).
Govari fails to teach further comprising (a) passing the sheath through a septum of the organ, which is not affected by a movement of the catheter in the organ, using the sheath electrode.
However, Moak teaches further comprising (a) passing the sheath (Fig 2; sheath 110) through a septum of the organ ([0027] Furthermore, a magnetic-field sensor can be included at distal end 135 of the transseptal needle that enables electromagnetic positioning and monitoring of sheath location within a cardiac chamber), which is not affected by a movement of the catheter in the organ ([0033] the transseptal needle 130 is extended out the distal end of dilator 120) ([0023] The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in FIG. 1) (sheath remains the access into the left atrium; electrode 140c remains on sheath while the catheter advances), using the sheath electrode (Fig 2; Electrode 140c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include further comprising (a) passing the sheath through a septum of the organ, which is not affected by a movement of the catheter in the organ, using the sheath electrode. Doing so allows for the far field reference to be acquired from an electrode that has crossed the septum and stays in the chamber while the catheter moves.
Regarding claim 19, Govari teaches the method according to claim 11, within the blood pool of the organ ([7] conductive medium (the blood)), wherein the reference signal is less susceptible to motion artifacts compared to EP signals collected by the catheter electrodes ([24] the far-field electrode 51 is located on the contraction wire 47 so as to be approximately equidistant from all corresponding spline electrodes 49, i.e., spline electrodes 49 that are equidistant from a fixed reference point on the long axis of the catheter, such as reference point 55 at the proximal end of the electrode assembly 43, and is prevented from contacting the surface of the heart by the splines. When the far-field electrode 51 is at least 0.5 cm removed from the spline electrodes 49 in the expanded configuration of the electrode assembly 43 it acquires a far-field signal, but not a near-field signal from the endocardial surface 53).
Govari fails to teach further comprising (a) maintaining a position of the sheath electrode; (b) allowing movement of the catheter, and (c) acquiring the reference signal using the sheath electrode.
However, Moak teaches further comprising (a) maintaining a position of the sheath electrode (Fig 2; sheath 110 remains the access into the left atrium; electrode 140c remains on sheath while the catheter advances) ([0027] Furthermore, a magnetic-field sensor can be included at distal end 135 of the transseptal needle that enables electromagnetic positioning and monitoring of sheath location within a cardiac chamber), (b) allowing movement of the catheter ([0023] The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in FIG. 1), and (c) acquiring the reference signal using the sheath electrode (Fig 2; Electrode 140c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include further comprising (a) maintaining a position of the sheath electrode; (b) allowing movement of the catheter, and (c) acquiring the reference signal using the sheath electrode. Doing so allows for the far-field reference to remain in the blood pool while the catheter electrodes move and contact tissue.
Regarding claim 20, Govari teaches the method according to claim 11, wherein the organ comprises a heart of the patient ([7] In the expanded form of a basket catheter, the electrodes of the spline contact the surface of the heart and acquire signals corresponding to electropotentials generated at their points of contact with the surface).
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 9833161 B2) in view of Moak (US 20200008883 A1) and Rodriguez (US 20230181087 A1), further in view of Govari (2) (US 20230112251 A1).
Regarding claim 2, Govari teaches the system according to claim 1, but fails to teach wherein, based the reference signal, the processor is configured to improve accuracy of an estimation of a Tissue Proximity Index (TPI), indicative of whether a given electrode among the one or more catheter electrodes is placed in contact with the tissue.
However, Govari (2) teaches wherein, based the reference signal, the processor is configured to improve accuracy of an estimation of a Tissue Proximity Index (TPI) ([0053] At a physical contact determination step 86, based on the measured impedances, processor 41 determines, for each functional electrode 50, whether the electrode is in contact with tissue, as defined above, or at least in sufficient proximity), indicative of whether a given electrode among the one or more catheter electrodes is placed in contact with the tissue ([0053]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein, based the reference signal, the processor is configured to improve accuracy of an estimation of a Tissue Proximity Index (TPI), indicative of whether a given electrode among the one or more catheter electrodes is placed in contact with the tissue. Doing so allows for the processor to determine tissue contact from the same blood-pool reference used for the far-field signal.
Regarding claim 12, Govari teaches the method according to claim 11, but fails to teach wherein, based the reference signal, the processor is configured to improve accuracy of an estimation of a Tissue Proximity Index (TPI), indicative of whether a given electrode among the one or more catheter electrodes is placed in contact with the tissue.
However, Govari (2) teaches wherein, based the reference signal, the processor is configured to improve accuracy of an estimation of a Tissue Proximity Index (TPI) ([0053] At a physical contact determination step 86, based on the measured impedances, processor 41 determines, for each functional electrode 50, whether the electrode is in contact with tissue, as defined above, or at least in sufficient proximity), indicative of whether a given electrode among the one or more catheter electrodes is placed in contact with the tissue ([0053]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein, based the reference signal, the processor is configured to improve accuracy of an estimation of a Tissue Proximity Index (TPI), indicative of whether a given electrode among the one or more catheter electrodes is placed in contact with the tissue. Doing so allows for the processor to determine tissue contact from the same blood-pool reference used for the far-field signal.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 9833161 B2) in view of Moak (US 20200008883 A1) and Rodriguez (US 20230181087 A1), further in view of Govari (2) (US 20230112251 A1) and Govari (3) (US 20210059743 A1).
Regarding claim 3, Govari teaches the method according to claim 2, but fails to teach wherein the processor is configured to improve the accuracy of the TPI based on a first position of the sheath electrode relative to one or more second positions of the one or more catheter electrodes.
However, Govari (3) teaches wherein the processor is configured to improve the accuracy of the TPI based on a first position of the sheath electrode (stem electrode) relative to one or more second positions of the one or more catheter electrodes (ablation electrode on balloon) ([0018] at least one ablation electrode, (ii) an electrode disposed on the distal end of the shaft just proximally to the balloon (named hereinafter “stem electrode”), and (iii) an electrode disposed on the distal end of the shaft just distally to the balloon (named hereinafter “edge electrode”). Using impedance measurements between each ablation electrode and the stem and edge electrodes, a processor of the ablation system determines, for each ablation electrode, if the ablation electrode is in full contact with tissue) ([0019] In some embodiments, the processor of the system compares measured in-situ impedances between an ablation electrode intended to have contact with tissue, and the stem and edge electrodes when the ablation electrode is at least partially exposed to blood, to the same measured impedances). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the processor is configured to improve the accuracy of the TPI based on a first position of the sheath electrode relative to one or more second positions of the one or more catheter electrodes. Doing so allows for the processor to distinguish full tissue contact from partial blood exposure.
Regarding claim 13, Govari teaches the method according to claim 12, but fails to teach wherein improving the accuracy of the TPI is based on a first position of the sheath electrode relative to one or more second positions of the one or more catheter electrodes.
However, Govari (3) teaches wherein improving the accuracy of the TPI is based on a first position of the sheath electrode (stem electrode) relative to one or more second positions of the one or more catheter electrodes (ablation electrode on balloon) ([0018] at least one ablation electrode, (ii) an electrode disposed on the distal end of the shaft just proximally to the balloon (named hereinafter “stem electrode”), and (iii) an electrode disposed on the distal end of the shaft just distally to the balloon (named hereinafter “edge electrode”). Using impedance measurements between each ablation electrode and the stem and edge electrodes, a processor of the ablation system determines, for each ablation electrode, if the ablation electrode is in full contact with tissue) ([0019] In some embodiments, the processor of the system compares measured in-situ impedances between an ablation electrode intended to have contact with tissue, and the stem and edge electrodes when the ablation electrode is at least partially exposed to blood, to the same measured impedances). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein improving the accuracy of the TPI is based on a first position of the sheath electrode relative to one or more second positions of the one or more catheter electrodes. Doing so allows for the processor to distinguish full tissue contact from partial blood exposure.
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 9833161 B2) in view of Moak (US 20200008883 A1) and Rodriguez (US 20230181087 A1), further in view of Shuros (US 20190150842 A1).
Regarding claim 5, Govari teaches the system according to claim 1, but fails to teach wherein the sheath comprises first and second sheath electrodes, positioned at first and second distances from the tissue, respectively, the first and second sheath electrodes being configured to produce first and second reference signals, respectively, wherein the second distance is larger than the first distance, and wherein, based on the first and second distances, the processor is configured to select the second reference signal for cancellation of the far-field noise in the EP signals.
However, Moak teaches wherein the sheath comprises first and second sheath electrodes, positioned at first and second distances from the tissue (Fig 2; [0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120) ([0006] the second electrode can be spaced from the first electrode by a distance of from 1 to 5 millimeters). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the sheath comprises first and second sheath electrodes, positioned at first and second distances from the tissue. Doing so allows for the electrodes to be at different distances to produce varying signals for the need for cancelling noise.
Further, Shuros teaches the first and second sheath electrodes being configured to produce first and second reference signals, respectively, wherein the second distance is larger than the first distance ([abstract] The processing device is configured to: receive the sensed unipolar electrical signals, determine an electrode having a high level of contact with the tissue, and determine an electrode having a lower level of contact with the tissue than the electrode having the high level of contact with the tissue), and wherein, based on the first and second distances, the processor is configured to select the second reference signal for cancellation of the far-field noise in the EP signals ([0006] determine an electrode of the plurality of electrodes having a high level of contact with the tissue; determine an electrode of the plurality of electrodes having a lower level of contact with the tissue than the electrode having the high level of contact with the tissue; determine a sensed near-field electrical signal based on the unipolar electrical signal received from the electrode having the high level of contact and the unipolar electrical signal received from the electrode having the lower level of contact; and output the determined near-field electrical signal to a display device) ([0007] wherein the electrode of the plurality of electrodes having a lower level of contact comprises more than one electrode of the plurality of electrodes and wherein the processing device is further configured to average the unipolar electrical signals received from the more than one electrode having the lower level of contact). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include the first and second sheath electrodes being configured to produce first and second reference signals, respectively, wherein the second distance is larger than the first distance, and wherein, based on the first and second distances, the processor is configured to select the second reference signal for cancellation of the far-field noise in the EP signals. Doing so allows for the second electrode to be further from the blood and therefore improves the cancellation of far-field noise.
Regarding claim 15, Govari teaches the system according to claim 11, but fails to teach wherein the sheath comprises first and second sheath electrodes, positioned at first and second distances from the tissue, respectively, the first and second sheath electrodes and being configured to produce first and second reference signals, respectively, wherein the second distance is larger than the first distance, and wherein the method further comprises selecting, based on the first and second distances, the second reference signal for cancellation of the far-field noise in the EP signals.
However, Moak teaches wherein the sheath comprises first and second sheath electrodes, positioned at first and second distances from the tissue (Fig 2; [0025] One or more electrodes 140 can be positioned axially at or near the distal end of the dilator 120) ([0006] the second electrode can be spaced from the first electrode by a distance of from 1 to 5 millimeters), respectively, the first and second sheath electrodes and being configured to produce first and second reference signals ([0032] two adjacent electrodes could be spaced by anywhere from 1 to 5 millimeters and still participate in bipolar recordings of electrophysiological signals). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the sheath comprises first and second sheath electrodes, positioned at first and second distances from the tissue, respectively, the first and second sheath electrodes and being configured to produce first and second reference signals. Doing so allows for reference signals at different distances for an improved noise cancellation depending on the signal.
Further, Shuros teaches wherein the second distance is larger than the first distance ([abstract] The processing device is configured to: receive the sensed unipolar electrical signals, determine an electrode having a high level of contact with the tissue, and determine an electrode having a lower level of contact with the tissue than the electrode having the high level of contact with the tissue), and wherein the method further comprises selecting, based on the first and second distances, the second reference signal for cancellation of the far-field noise in the EP signals ([0006] determine an electrode of the plurality of electrodes having a high level of contact with the tissue; determine an electrode of the plurality of electrodes having a lower level of contact with the tissue than the electrode having the high level of contact with the tissue; determine a sensed near-field electrical signal based on the unipolar electrical signal received from the electrode having the high level of contact and the unipolar electrical signal received from the electrode having the lower level of contact; and output the determined near-field electrical signal to a display device) ([0007] wherein the electrode of the plurality of electrodes having a lower level of contact comprises more than one electrode of the plurality of electrodes and wherein the processing device is further configured to average the unipolar electrical signals received from the more than one electrode having the lower level of contact). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Govari to include wherein the second distance is larger than the first distance, and wherein the method further comprises selecting, based on the first and second distances, the second reference signal for cancellation of the far-field noise in the EP signals. Doing so allows for the second distance to be further from the blood and serves as a reference signal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
