DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first
inventor to file provisions of the AIA .
Status of Claims
Claims 1 and 15 are amended.
Claim 20 is added as a new claim.
Response to Arguments
Applicant’s arguments, see pages 5-9, filed 1/6/2026, with respect to the rejection(s) of claim(s) 1-7 and 9-20 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Salahieh.
35 U.S.C. 102 and 103:
Regarding independent claims 1 and 15, applicant argues Syed, alone or in combination with the prior, does not teach “the distal assembly comprising electrodes and shape memory material configured to assume a predetermined deployed state in a concave profile for conforming to a convex curvature of the epicardial tissue.” After further search and consideration, the examiner will now rely on Salahieh to teach this limitation (fig. 17A-D; paragraph 121). It is disclosed in the applicant’s specification (page 8-9, lines 28-31 and 1-7)) that the memory material may be nitinol. Salahieh discloses that “the expandable structure 93 can be a shape memory material such as Nitinol.” Furthermore, figure 17C specifically shows a concave profile for the distal assembly to conform to a convex curvature of the epicardial tissue.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal assembly of Syed with the memory material and shape from Salahieh for the benefit of providing firmer electrode contact to the epicardial tissue and to provide optimal stimulation treatment.
Regarding claims dependent claims 5 and 7, the applicant argues that Asirvatham, alone or in combination with the prior art does not teach “wherein the plurality of electrodes are staggered with respect to each other so that in the collapsed state of the distal assembly the electrodes alternately fit adjacent one another; and wherein each of the frame elements defines a closed contour with the distal end of the shaft.” After further search and consideration, the examiner respectfully disagrees and argues that (fig. 3 and 9-10; paragraph 52, 55, and 96). The expandable member may be made of nitinol, which is also disclosed to be an acceptable memory material in the applicant’s specification. Figure 9 shows a staggered assembly of the electrodes and figure 10 shows a closed contour state of the assembly. Furthermore, the examiner has shown that Salahieh teaches the limitations as disclosed above.
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 1-4, 6, 8-20 are rejected under 35 U.S.C. 103 as being unpatentable by Syed et al.
US Pub.: US 20190224477 A1, hereinafter Syed in view of Salahieh et al. US Pub.: US 20100204560 A1, hereinafter Salahieh.
Regarding claim 1, Syed teaches a catheter for mapping and ablation of epicardial tissue, comprising (fig. 2a-b; paragraph 30-32 and 40):
a shaft configured for insertion into a body of a subject (fig. 2a-b; paragraph 33-34); Steerable sheath 120.
a distal assembly configured at a distal end of the shaft, the distal assembly being expandable from a collapsed state to a deployed state (fig. 2b; paragraph 68); Distal shaft pacing leads 210a-b and spacing member 220. These distal members are expandable and may be collapsed.
the distal assembly comprising at least two frame elements (fig. 2b; paragraph 68); Distal shaft pacing leads 210a-b
each frame element comprising an arched distal portion on which a plurality of electrodes for delivery of ablation energy are disposed (fig. 3a-4; paragraph 45 and 50); It is disclosed “first pacing lead 210a and second pacing lead 210b are inherently curved to a convexity similar to the contours of the epicardial surface.”
wherein in the deployed state, the distal assembly assumes a concave profile for conforming to a curvature of the epicardium (fig. 3a-4; paragraph 45 and 50); It is disclosed “first pacing lead 210a and second pacing lead 210b are inherently curved to a convexity similar to the contours of the epicardial surface.”
and a plurality of position sensors disposed on one or both of the shaft and the frame elements for tracking a position and an orientation of at least a portion of the distal assembly or the shaft (fig. 2a-b; paragraph 36, 43, 49, 68, 72). The electrodes 214ba-db indicates the orientation of the distal end assemble equates to the plurality of position sensors.
However, Syed does not teach the distal assembly comprising at least two frame elements comprising shape memory material configured to assume a predetermined deployed state; wherein in the deployed state, the at least two frame elements cause the distal assembly to assume a concave profile for conforming to a convex curvature of the epicardial tissue;
Salahieh, in the same field of endeavor, teaches the distal assembly comprising at least two frame elements comprising shape memory material configured to assume a predetermined deployed state; wherein in the deployed state, the at least two frame elements cause the distal assembly to assume a concave profile for conforming to a convex curvature of the epicardial tissue (fig. 17A-D; paragraph 121). It is disclosed in the applicant’s specification (page 8-9, lines 28-31 and 1-7)) that the memory material may be nitinol. Salahieh discloses that “the expandable structure 93 can be a shape memory material such as Nitinol.” Furthermore, figure 17C specifically shows a concave profile for the distal assembly to conform to a convex curvature of the epicardial tissue.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal assembly of Syed with the memory material and shape from Salahieh for the benefit of providing firmer electrode contact to the epicardial tissue and to provide optimal stimulation treatment.
Regarding claim 2, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches further comprising an inflatable element extendable from the distal end of the shaft and positioned, when inflated, to back the distal assembly and apply pressure onto the distal assembly from a side opposite a tissue contacting side of the distal assembly, so as to push the plurality of electrodes of the distal assembly against the tissue (fig. 3a-4; paragraph 45 and 50); It is disclosed “first pacing lead 210a and second pacing lead 210b are inherently curved to a convexity similar to the contours of the epicardial surface.”
Regarding claim 3, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein each of the plurality of electrodes comprises an energy emitting surface configured to contact the tissue, and wherein the plurality of electrodes are disposed on the frame elements such that their energy emitting surfaces are on a tissue contacting side of the distal assembly (fig. 2e-f; paragraph 58). A shaft 212d has about an 135° exposed (non-insulated) electrode surface.
Regarding claim 4, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the energy emitting surfaces of the plurality of electrodes face a center of the concavity defined by the distal assembly (fig. 2e-f; paragraph 58). A shaft 212d has about an 135° exposed (non-insulated) electrode surface. Various amounts of exposed electrode surface is disclosed.
Regarding claim 6, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein in the deployed state of the distal assembly the at least two frame elements at least partially overlap (fig. 3a-4; paragraph 45 and 50). They overlap in at least one plane.
Regarding claim 8, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein each of the frame elements is comprised of shape memory material (fig. 2a-f; paragraph 50-51). The frame elements are disclosed to be malleable. Therefore, any desired shape may be formed.
Regarding claim 9, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the plurality of electrodes are configured to deliver radiofrequency (RF) ablation energy or pulsed-field ablation (PFA) energy (paragraph 32). A plurality of modalities are disclosed. This includes therapy that involves radiofrequency (RF) ablation energy and pulsed-field ablation (PFA) energy, such as targeted interrogation and ablation of the autonomic ganglia and cardiac nerves as modulators of arrhythmia, cardiac contractility modulation.
Regarding claim 10, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the plurality of electrodes are configured for sensing cardiac electrical activity (paragraph 32). A plurality of modalities are disclosed. This includes therapy that involves cardiac mapping and contractility modulation.
Regarding claim 11, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches further comprising an external sheath in which the shaft and the distal assembly, when in the collapsed state, are contained; and wherein the distal assembly is configured to expand from the collapsed state to the deployed state upon protruding from a distal end of the sheath (fig. 2a-b; paragraph 41). First pacing lead 210a and second pacing lead 210b are separate shafts that are individually slidably disposed within one or more lumens of sheath 120 and are configured to be partially extendable beyond the distal end of sheath 120.
Regarding claim 12, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the plurality of position sensors include one or more of: a single axis position sensor, a dual axis position sensor, and a triple axis position sensor, the position sensors being operable with a magnetic pad of a position sensing system (fig. 2b; paragraph 68); Distal shaft pacing leads 210a-b has a plurality of dual axis position sensors 214.
Regarding claim 13, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the inflatable element comprises a plurality of apertures through which fluid is allowed to flow (fig. 2a-b and 3f; paragraph 43 and 66). First shaft 212a and/or second shaft 212b can include one or more apertures. Cooling manifold 326 is a tubular channel through which a cooling fluid (liquid or gas) can flow to cool pacing lead 322.
Regarding claim 14, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the inflatable element comprises a single inflatable cell, or multiple inflatable cells (fig. 3a-4; paragraph 45 and 50); It is disclosed “first pacing lead 210a and second pacing lead 210b are inherently curved to a convexity similar to the contours of the epicardial surface in an inflated state.”
Regarding claim 15, Syed teaches a method of ablating epicardial tissue, comprising:
introducing a catheter comprising, at a distal tip thereof, a distal assembly configured to assume a concave profile for conforming to a curvature of the epicardial tissue (fig. 2b; paragraph 68); Distal shaft pacing leads 210a-b and spacing member 220. These distal members are expandable and may be collapsed.
inflating an inflatable element on a back side of the distal assembly (fig. 3a-4; paragraph 45 and 50); It is disclosed “first pacing lead 210a and second pacing lead 210b are inherently curved to a convexity similar to the contours of the epicardial surface.”
and delivering ablation energy via the electrodes to the epicardial tissue (paragraph 32). A plurality of modalities are disclosed. This includes therapy that involves radiofrequency (RF) ablation energy and pulsed-field ablation (PFA) energy, such as targeted interrogation and ablation of the autonomic ganglia and cardiac nerves as modulators of arrhythmia, cardiac contractility modulation.
However Syed does not teach the distal assembly comprising electrodes and shape memory material configured to assume a predetermined deployed state in a concave profile for conforming to a convex curvature of the epicardial tissue.
Salahieh, in the same field of endeavor, teaches the distal assembly comprising electrodes and shape memory material configured to assume a predetermined deployed state in a concave profile for conforming to a convex curvature of the epicardial tissue (fig. 17A-D; paragraph 121). It is disclosed in the applicant’s specification (page 8-9, lines 28-31 and 1-7)) that the memory material may be nitinol. Salahieh discloses that “the expandable structure 93 can be a shape memory material such as Nitinol.” Furthermore, figure 17C specifically shows a concave profile for the distal assembly to conform to a convex curvature of the epicardial tissue.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal assembly of Syed with the memory material and shape from Salahieh for the benefit of providing firmer electrode contact to the epicardial tissue and to provide optimal stimulation treatment.
Regarding claim 16, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the inflatable element is inflated between the epicardium and the parietal layer of the pericardium (fig. 3a-4; paragraph 45 and 50); It is disclosed “first pacing lead 210a and second pacing lead 210b are inherently curved to a convexity similar to the contours of the epicardial surface.”
Regarding claim 17, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches wherein the catheter further comprises a plurality of position sensors and wherein said method comprises tracking a position and an orientation of at least a portion of the catheter using the position sensors (fig. 2a-b; paragraph 36, 43, 49, 68, 72). The electrodes 214ba-db indicates the orientation of the distal end assemble equates to the plurality of position sensors.
Regarding claim 18, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches further comprising sensing cardiac electrical activity via electrodes of the distal assembly (paragraph 32). A plurality of modalities are disclosed. This includes therapy that involves electrical activity such as cardiac mapping and contractility modulation.
Regarding claim 19, Syed in view of Salahieh teaches the claimed invention and Syed further
teaches comprising identifying, based on the sensed cardiac electrical activity, arrhythmic patterns associated with an epicardial source (paragraph 32). A plurality of modalities are disclosed. This includes therapy that involves electrical activity such as contractility modulation with cardiac nerves as modulators of arrhythmia.
Regarding claim 20, Syed in view of Salahieh teaches the claimed invention and Salahieh further
teaches the shape memory material configured to assume a predetermined deployed state of the at least two frame elements in a spoon shaped curvature to conform to a convex epicardium surface (fig. 17A-D; paragraph 121). It is disclosed in the applicant’s specification (page 8-9, lines 28-31 and 1-7)) that the memory material may be nitinol. Salahieh discloses that “the expandable structure 93 can be a shape memory material such as Nitinol.” Furthermore, figure 17A-C specifically shows a plurality of profiles to conform to a convex curvature of the epicardial tissue. Specifically, 17B may conform into the shape of a spoon if pressure is applied to appropriate areas.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Syed in view of
Salahieh in view of Asirvatham et al. US Pub.: US 20160051322 A1, hereinafter Asirvatham.
Regarding claim 5, Syed does not teach wherein the plurality of electrodes
are staggered with respect to each other so that in the collapsed state of the distal assembly the electrodes alternately fit adjacent one another.
Asirvatham, in the same field of endeavor, teaches wherein the plurality of electrodes are staggered with respect to each other so that in the collapsed state of the distal assembly the electrodes alternately fit adjacent one another (fig. 9-10). It is shown in figures 9 and 10 that the electrodes are staggered.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the distal assembly of Syed in view of Salahieh with the staggering of electrodes from Asirvatham for the benefit of alternately fitting the electrodes adjacent to one another in a collapsed state.
Regarding claim 7, Syed does not teach wherein each of the frame elements defines a closed contour with the distal end of the shaft.
Asirvatham, in the same field of endeavor, teaches wherein each of the frame elements defines a closed contour with the distal end of the shaft (fig. 10). The electrode assembly is shown in a closed contour state.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the distal assembly of Syed with the closed contour shape from Asirvatham for the benefit of improving energy efficiency, biocompatibility, and signal quality.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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