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 § 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.
Claims 11-12 & 15 are 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.
Regarding claim 11, the claim recites “irrigation fluid” in line 3 and it is unclear if this is the same irrigation fluid or a different irrigation fluid from that recited in line 2. For examination purposes, these are the same irrigation fluids and the limitation will be interpreted as “the irrigation fluid”.
Claim 12 is also rejected by virtue of its dependency on claim 11.
Regarding claim 15, the claim recites “a plurality of mapping electrodes” in line 2 and it is unclear if these are the same mapping electrodes or are different mapping electrodes from those recited in claim 1, from which claim 15 depends. For examination purposes, these are the same mapping electrodes and the limitation will be interpreted as “a plurality of the mapping electrodes” or similar language to clarify.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 13 & 15 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Buck et al. (U.S. Pub. No. 20250107835, earliest effective filing date), herein referred to as “Buck”
Regarding claim 1, Buck teaches a medical probe (Abstract: A catheter for ablation of tissue through irreversible electroporation is disclosed) comprising:
an inner catheter shaft (central post 258) extending along a longitudinal axis (see Fig. 2A);
an ablation electrode (ablation electrode 262) disposed at a distal end of the inner catheter shaft ([0074]: an ablation electrode 262 disposed on the central post 258), the ablation electrode configured to deliver ablative energy to tissue ([0065]: ablation electrode 260 is configured to receive pulsed electrical signals/waveforms from the electroporation console 130 (FIG. 1), thereby creating pulsed electric fields sufficient for ablating target tissue via irreversible electroporation; [0074]: ablation electrode assembly 260 includes a central post 258 extending from the outer shaft 202 and an ablation electrode 262);
an outer sleeve (outer shaft 202) disposed at least partially around the inner catheter shaft and extending along the longitudinal axis ([0074]: an ablation electrode assembly 260 extending distally from the distal end 209 of the outer shaft 202; see Fig. 2A); and
a plurality of spines (splines 216A-F; see also [0030] & [0039] where the splines are described as comprising a movable spine of the plurality of splines) disposed at a distal end of the outer sleeve ([0067]: each respective spline 216A-216F has a distal end portion 217A-217F, a proximal end portion 218A-218F, and an intermediate portion 219A-219F extending between the distal end portion 217A-217F and the proximal end portion 218A-218F. As shown, each of the proximal end portions 218A-218F is attached to and constrained by the distal end 209 of the outer shaft 202), each spine of the plurality of spines comprising a mapping electrode configured to detect electrophysiological signals ([0071]: the splines 216A-216F include a plurality of spline-disposed mapping electrodes, or sensing electrodes 250), the outer sleeve configured to move axially along the inner catheter shaft to move the plurality of spines axially with respect to the ablation electrode ([0074]: axial length of the ablation electrode assembly 260 can be varied, e.g., such as to extend into the proximal section of the inner space 212 or the distal section of the inner space 212, or variable by a user, such as retractable or extendable to various axial location, for instance, in the inner space 212; wherein this paragraph describes the motion of the ablation electrode relative to the outer shaft, the reciprocal motion of the outer shaft relative to the ablation electrode is possible, depending on which feature is held stationary).
Regarding claim 2, Buck teaches the outer sleeve configured to move the plurality of spines beyond a distal end of the ablation electrode ([0074]: axial length of the ablation electrode assembly 260 can be varied, e.g., such as to extend into the proximal section of the inner space 212 or the distal section of the inner space 212, or variable by a user, such as retractable or extendable to various axial location, for instance, in the inner space 212; wherein this paragraph describes the motion of the ablation electrode relative to the outer shaft, the reciprocal motion of the outer shaft relative to the ablation electrode is possible, depending on which feature is held stationary, see also Fig. 2A where the splines are beyond a distal end of the ablation electrode).
Regarding claim 3, Buck teaches the plurality of spines configured to extend radially outward from the longitudinal axis ([0067]: the mapping electrode assembly 210 is configured to self-expand from a collapsed configuration when constrained within a delivery sheath to the pre-defined expanded configuration defining the inner space 212; see Fig. 2A where the splines extend radially outward from the longitudinal axis).
Regarding claim 4, Buck teaches the plurality of spines configured to be positioned radially around the ablation electrode ([0066]: the ablation electrode assembly is configured to be fully disposed within an undeformed, expanded mapping electrode assembly 210; see Fig. 2A).
Regarding claim 13, Buck teaches an electromagnetic sensor disposed near the distal end of the inner catheter shaft, the electromagnetic sensor configured to generate a current when subjected to an electromagnetic field ([0065]: the mapping electrode assembly 210 further includes a plurality of mapping and sensing electrodes 250 configured for sensing cardiac electrical signals, localization of the electrode assembly 210 within the patient anatomy (e.g., via the EAM system 70 of FIG. 1), and determining proximity to target tissue within the anatomy; [0058] The EAM system 70 generates a localization field, via the field generator 80, to define a localization volume about the heart 30, and one or more location sensors or sensing elements on the tracked device(s), e.g., the electroporation catheter 100 … the device tracking is accomplished using magnetic tracking techniques, whereby the field generator 80 is a magnetic field generator that generates a magnetic field defining the localization volume, and the location sensors on the tracked devices are magnetic field sensors; [0074]: a magnetic navigation sensor (not shown) may be partially or wholly disposed within the central post 258).
Regarding claim 15, Buck teaches wherein the plurality of spines comprises at least five spines (splines 216A-F; wherein this describes 6 splines), each spine of the at least five spines comprising a plurality of mapping electrodes ([0071]: the splines 216A-216F include a plurality of spline-disposed mapping electrodes, or sensing electrodes 250; see Fig. 2A where each spline 216 has at least one mapping electrode 250).
Claims 16-20 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Werneth et al. (U.S. Pat. No. 10004459), herein referred to as “Werneth”.
Regarding claim 16, Werneth teaches a method (Abstract: The present invention includes systems, devices and methods for treating and/or diagnosing a heart arrhythmia, such as atrial fibrillation) comprising:
inserting a medical probe (catheter 100, 200) into a lumen of a body (Col. 24, lines 30-33: STEP 902, a diagnostic catheter is inserted into a heart chamber, for example the left atrium, the right atrium, the left ventricle, or the right ventricle; lines 39-42: A treatment device such as ablation catheter 200 can also be inserted into a heart chamber, either simultaneously with the diagnostic catheter (e.g. when the ablation catheter shaft resides within a lumen of the diagnostic catheter)), the medical probe comprising:
an inner catheter shaft (ablation catheter 200) extending along a longitudinal axis (see Fig. 1A);
an ablation electrode (ablation element 261) disposed at a distal end of the inner catheter shaft (Col. 18, lines 32-34: ablation element 261 positioned on shaft 220, for example on a distal portion or the distal tip of shaft 220), the ablation electrode configured to deliver ablative energy to tissue (Col. 18, lines 42-45: In the case where ablation element 261 includes one or more electrodes, the electrodes can include electrodes constructed and arranged to deliver radiofrequency (RF) energy);
an outer sleeve (elongate shaft 120) disposed at least partially around the inner catheter shaft and extending along the longitudinal axis (Col. 19, lines 8-12: an elongate shaft 120 which includes lumen 126 exiting its distal end. Ablation catheter 200, which has been removed for clarity, is configured to be slidingly received by lumen 126); and
a plurality of spines (array of splines 130), each spine of the plurality of spines comprising a mapping electrode (electrode 141) configured to detect electrophysiological signals (Col. 17, lines 33-36: Electrodes 141 can be configured to record electric signals such as voltage and/or current signals. System 10 can utilize the recorded signals to produce electrogram information; dipole mapping information);
sliding the outer sleeve along the inner catheter shaft to cause the plurality of spines to extend beyond a distal end of the ablation electrode (Col. 23, lines 54-57: Retraction of diagnostic catheter 100 and/or ablation catheter 200 can be performed by an operator grasping the relevant proximal portion (e.g. a handle) and moving the device proximally relative to sheath 50; Col. 18, lines 65-67 & Col. 19, lines 1-3: Ablation catheter 200 can be steered and advanced by an operator such as a clinician, so as to exit at any opening of the expandable assembly 130, including the space between two splines 131 or through opening 135, such as to be further advanced to contact and ablate cardiac tissue; wherein in the steering of ablation catheter through opening 135 and to between two splines 131, the steering includes sliding the diagnostic catheter along the inner shaft so that the ablation catheter can retract proximally from opening 135); and
receiving one or more electrophysiological signals from at least one mapping electrode disposed on the plurality of spines (Col. 24, lines 61-66: electrical information can also be collected via one or more electrodes positioned on a device, such as electrodes 141 described herein, or one or more electrodes positioned on one or more devices such as devices 100, 200, 500, 600 and/or 700 described herein; see also methods in Figs. 4 & 5).
Regarding claim 17, Werneth teaches generating an electrophysiological map based at least in part on the one or more electrophysiological signals (Col. 25, lines 51-56: STEP 912 where a 3-D map is displayed. The surface data collected from the ultrasound transducers or other transducers can be used to create an anatomical map of the heart chamber, and the surface data collected from the electrodes or other sensors can be used to create an electrical map of the heart chamber).
Regarding claim 18, Werneth teaches actuating a pull wire to cause the inner catheter shaft, ablation electrode, outer sleeve, and the plurality of spines to deflect radially outward away from the longitudinal axis (Col. 24, lines 11-25: pull wires and anchors for sheath 50, diagnostic catheter 100 and ablation catheter 200, each set configured to steer their respective device. Sheath 50 includes pull wire 52 and anchor 53 which can be connected to a lever, a cam, or other wire control mechanism which is operably connected to a knob or slide positioned on a handle, all not shown but located at a proximal end of sheath 50. Similarly, diagnostic catheter 100 includes pull wire 122 and anchor 123, and ablation catheter 200 includes pull wire 222 and anchor 223, each pull wire 122 and 222 typically controlled as described above by a control on a handle. Each device can be independently controlled via its respective steering pull wire and anchor, however if desired two or more devices can be controlled in concert, such as via a single control).
Regarding claim 19, Werneth teaches retracting the outer sleeve along the inner catheter shaft to cause the ablation electrode to extend beyond a distal end of the plurality of spines (Col. 32, lines 52-54: Once advanced distal to opening 135, ablation element 261 can positioned to contact and/or deliver energy to tissue such as heart wall tissue; wherein the motion of the ablation catheter extending beyond opening 135 includes the motion of the diagnostic catheter moving proximally/retracting relative to the ablation catheter).
Regarding claim 20, Werneth teaches delivering ablative energy to tissue via the ablation electrode (Col. 26, line 49: STEP 930, the target tissue is ablated).
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.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Buck as applied to claim 1 above, and further in view of Solis et al. (U.S. Pub. No. 20170071494, cited in IDS), herein referred to as “Solis”.
Regarding claim 5, Buck describes that the axial length of the ablation electrode assembly may be varied in [0074] but fails to explicitly disclose a first handle disposed at a proximal end of the inner catheter shaft and a second handle disposed at a proximal end of the outer sleeve.
However, Solis discloses a first handle (control handle 12) disposed at a proximal end of the inner catheter shaft (inner tubular member 26; [0028]: Control handle 12 may be secured to inner tubular member 26) and a second handle (actuator 28) disposed at a proximal end of the outer sleeve (outer tubular member 24; [0028]: an actuator 28 may be secured to the proximal end of outer tubular member 24). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical probe of Buck to include first and second handles, as taught by Solis, so that by manipulating control handle and actuator to slide longitudinally relative to each other, an electrophysiologist may control the distance between proximal multiray array and distal multiray array at the distal end of catheter (Solis: [0028]).
Regarding claim 6, Buck in view of Solis discloses wherein the second handle configured to be moved axially along the longitudinal axis with respect to the first handle, thereby causing the outer sleeve to move axially along the inner catheter shaft (Solis: [0028]: by manipulating control handle 12 and actuator 28 to slide longitudinally relative to each other, an electrophysiologist may control the distance between proximal multiray array 20 and distal multiray array 22 at the distal end of catheter 10; [0037]: outer tubular member 24 may be withdrawn proximally, such as by manipulation of actuator 28).
Regarding claim 7, Buck fails to disclose a pull wire configured to cause the inner catheter shaft to deflect radially outward from the longitudinal axis.
However, Solis discloses a pull wire (puller wire 34) configured to cause the inner catheter shaft to deflect radially outward from the longitudinal axis ([0039]: Rotating deflection arm 36 places puller wire 34 under tension, producing a deflection of inner tubular member 26). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical probe of Buck to include a pull wire, as taught by Solis, for the purpose of deflecting the distal end to impart further control over which areas of tissue are contacted (Solis: [0039]).
Regarding claim 8, Buck in view of Solis discloses the first handle (Solis: control handle 12) comprising an actuator (rotating deflection arm 36) configured to pull the pull wire to cause the inner catheter shaft to deflect radially outward from the longitudinal axis ([0039]: Rotating deflection arm 36 places puller wire 34 under tension, producing a deflection of inner tubular member 26).
Regarding claim 9, Buck in view of Solis discloses the outer sleeve configured to deflect radially outward when the inner catheter shaft is caused to deflect radially outward from the longitudinal axis (Solis: [0039]: Rotating deflection arm 36 places puller wire 34 under tension, producing a deflection of inner tubular member 26 … Alternatively or in addition, outer tubular member 24 may also be deflectable as desired using similar techniques).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Buck in view of Solis as applied to claim 5 above, and further in view of Harlev et al. (U.S. Pub. No. 20230172661), herein referred to as “Harlev”.
Regarding claim 10, Buck discloses irrigation port 161 but Buck in view of Solis the first handle comprising an irrigation coupler configured to receive irrigation fluid from an irrigation supply and the ablation electrode comprising a plurality of apertures each configured to permit the irrigation fluid to pass therethrough.
However, Harlev discloses the first handle (handle 120) comprising an irrigation coupler (fluid line connector 148) configured to receive irrigation fluid from an irrigation supply ([0178]: The fluid line 115 can be connectable to the fluid line connector 148 and, in use, irrigation fluid (e.g., saline) can be delivered from the irrigation pump 114 to the catheter 104) and the ablation electrode comprising a plurality of apertures each configured to permit the irrigation fluid to pass therethrough ([0338]: an irrigation element (such as the irrigation element 228 in FIG. 21) itself can be used as a center electrode; [0316]: The irrigation element 228 can include a nozzle portion 229 disposed along an end of a substantially cylindrical body 230. The plurality of irrigation holes 234 can be defined along one or both of the nozzle portion 229 and the substantially cylindrical body 230). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical probe of Buck in view of Solis to comprise an irrigation coupler and for the ablation electrode to comprise a plurality of apertures, as taught by Harlev, for the purpose of directing irrigation fluid toward the deformable portion of the ablation electrode/distal assembly and entraining blood and increasing the volume velocity of fluid over the ablation electrode and tissue (Harlev: [0316]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Buck in view of Solis as applied to claim 5 above, and further in view of Olson (U.S. Pub. No. 20210244360, cited in IDS), herein referred to as “Olson”.
Regarding claim 11, Buck in view of Solis fails to disclose the second handle comprising an irrigation coupler configured to receive irrigation fluid from an irrigation supply, the outer sleeve configured to deliver irrigation fluid to the plurality of spines.
However, Olson discloses the second handle (handle 24) comprising an irrigation coupler (cable connector or interface 26) configured to receive irrigation fluid from an irrigation supply ([0024]: The connector 26 provides mechanical, fluid, and electrical connections for conduits or cables extending from the pump 20), the outer sleeve configured to deliver irrigation fluid to the plurality of spines ([0039]: Some or all of the catheterlets 66 can include an irrigation port (not shown) at various locations such as at the electrode, proximate the electrode, through the electrode, and/or proximate the point of furcation of each of the plurality of catheterlets 66. A fluid can be circulated through an irrigant lumen and out through the irrigation ports; see Figs. 2A-3B where the sheath 62 delivers irrigation fluid via catheterlets 66A). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical probe of Buck in view of Solis to comprise an irrigation coupler and fluid delivery to the plurality of spines, as taught by Olson, for the purpose of enabling a fluid to be circulated and out of through the irrigation ports (Olson: [0039]).
Regarding claim 12, Buck in view of Solis and Olson disclose each spine of the plurality of spines comprising an aperture configured to permit the irrigation fluid to pass therethrough (Olson: [0039]: Some or all of the catheterlets 66 can include an irrigation port (not shown) at various locations such as at the electrode, proximate the electrode, through the electrode, and/or proximate the point of furcation of each of the plurality of catheterlets 66. A fluid can be circulated through an irrigant lumen and out through the irrigation ports).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Buck as applied to claim 1 above, and further in view of Govari et al. (U.S. Pat. No. 8357152, cited in IDS), herein referred to as “Govari”.
Regarding claim 14, Buck fails to disclose a force sensor disposed proximal to the ablation electrode, the force sensor configured to detect a force applied to the ablation electrode.
However, Govari discloses a force sensor (resilient member 58 & sensor 62) disposed proximal to the ablation electrode (electrode 50), the force sensor configured to detect a force applied to the ablation electrode (Col. 6, lines 61-67 & Col. 7, lines 1-4: The relative movement of the distal tip relative to the distal end of the insertion tube gives a measure of the deformation of resilient member 58. Generally speaking, this deformation is proportional to the force that is exerted on the resilient member, which is roughly equal to the force that is exerted on the distal tip by the heart tissue with which the distal tip is in contact. Thus, the combination of field generator 64 with sensor 62 serves as a pressure sensing system, for determining the approximate pressure exerted by the endocardial tissue on the distal tip of the catheter (or equivalently, the pressure exerted by electrode 50 against the endocardial tissue)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical probe of Buck to include a force sensor, as taught by Govari, for the purpose of determining the approximate pressure exerted by the endocardial tissue on the distal tip of the catheter (or equivalently, the pressure exerted by electrode against the endocardial tissue) (Govari: Col. 7, lines 1-4).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794