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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/27/2026 has been entered.
Response to Amendment
The Amendments filed April 27, 2026 have been entered. Currently, claims 1, 15, 17-18 have been amended, and claims 1-20 are pending in the application.
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, 7-13, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Basu (E.P. Application No. 3153124 B1), in view of Stewart (U.S. Application No. 20130030425 A1).
Regarding independent claim 1, Basu discloses an ablation catheter (10) (pa. 0019 & Figs. 1-2A) connected to a radio frequency (RF) energy source (pa. 0053), wherein the ablation catheter comprises:
a shaft (12) having a longitudinal axis (19) (pa. 0019), a proximal end and a distal end (i.e., deflection section 114 extending from the shaft, pa. 0021); and
an ablation assembly (15) located at the distal end of the shaft (pa. 0021), the ablation assembly having:
at least a first electrode (combination of surface electrodes 30 and ring electrodes 20) (pa. 0024) and
a non-conductive portion (18) (pa. 0021-0022) having:
a first end (22) that encircles the longitudinal axis of the shaft and is connected to the shaft (pa. 0021 & Figs. 1-2A); and
a second end (24) positioned radially outward from the first end (pa. 0021),
wherein the non-conductive portion forms a wall of non-conductive material that spans between the first end and the second end (pa. 0021-22);
wherein the first electrode is located adjacent to the first end of the non-conductive portion and radially inward of the second end of the non-conductive portion (pa. 0024).
However, Basu does not disclose the catheter providing electroporation therapy.
Stewart, in the same field of endeavor, teaches a catheter with electrodes (37) capable of providing radiofrequency ablation or electroporation therapy (pa. 0006) via an energy source (58) configured and programmed to deliver pulsed, high voltage density, pulsed energy (pa. 0044-0046).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the energy source of Stewart to be electrically connectable to the electrodes of Basu for the purpose of providing dual ablation or electroporation therapy to the targeted tissue.
Regarding claim 2, Basu/Stewart combination discloses wherein the non-conductive portion is cone- shaped having an apex at the first end connected to the shaft (Basu, pa. 0021, 0023).
Regarding claim 3, Basu/Stewart combination discloses wherein the non-conductive portion extends away from the shaft in a distal direction from the first end to the second end (Basu, pa. 0021, 0023).
Regarding claim 4, Basu discloses wherein the ablation assembly further includes a second electrode (ring electrode 23), wherein the second electrode is proximally located along the shaft (specifically in a connector tubing 146 which extends between a distal end of the deflection section 114 and a proximal end of the distal assembly 15, pa. 0037) relative to the first electrode and wherein the first end of the non-conductive portion is connected to the shaft between the first electrode and the second electrode (pa. 0072 & Fig. 8).
However, Basu does not disclose the catheter providing electroporation therapy.
Stewart, in the same field of endeavor, teaches a catheter with electrodes (37) capable of providing radiofrequency ablation or electroporation therapy (pa. 0006) via an energy source (58) configured and programmed to deliver pulsed, high voltage density, pulsed energy (pa. 0044-0046).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the energy source of Stewart to be electrically connectable to the electrodes of Basu for the purpose of providing dual ablation or electroporation therapy to the targeted tissue.
Regarding claim 7, Basu/Stewart combination discloses wherein the non-conductive portion is a sleeve (Basu, pa. 0021-0023).
Regarding claim 8, Basu/Stewart combination discloses wherein the non-conductive portion is movable between an undeployed state and a deployed state, wherein a radius of the non-conductive portion is greater in the deployed state (Basu, pa. 0069).
Regarding claims 9 and 16, Basu/Stewart combination discloses wherein the non-conductive portion is passively deployed via removal of a sheath (150) located on an outer periphery of the non-conductive portion (Basu, pa. 0069).
Regarding claim 10, Basu/Stewart combination discloses wherein the non-conductive portion is passively deployed between an undeployed state and a deployed state (Basu pa. 0069).
However, this embodiment of Basu does not disclose the non-conductive portion being actively deployed via a mechanism having a first end coupled to the electroporation assembly and a second end connected to a handle located on the proximal end of the shaft.
An alternative embodiment of Basu describes the non-conductive portion being an inflatable member (18’), wherein expansion is accomplished when the operator/user dispenses cryogenic fluid from a cryogenic source to an interior cavity (44) via fluid tubings (48), wherein the fluid tubings exit the catheter shaft (12) via apertures (50) formed in the shaft (pa. 0030, 0071 & Fig. 5A). In this embodiment, the non-conductive portion is actively deployed via a fluid mechanism having a first end (distal portion of the fluid tubings inside the cavity) coupled to the electroporation assembly and a second end (proximal portion of the fluid tubings) connected to a handle located on the proximal end of the shaft.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the non-conductive portion of the first embodiment of Basu with the inflatable non-conductive portion described in the second embodiment for the purpose of allowing the user to have more control over the pressure/contact applied to the targeted tissue by the distal assembly.
Regarding claim 11, Basu/Stewart combination discloses wherein the non-conductive portion comprises a compliant non-conductive material (Basu, pa. 0022).
Regarding claim 12, Basu/Stewart combination discloses wherein the non-conductive portion comprises a memory shape material (Basu, pa. 0022).
Regarding claim 13, Basu/Stewart combination discloses wherein the compliant, non-conductive portion comprises one or more silicone, polyurethane, rubber, and/or a non-conductive polymer (Basu, pa. 0022).
Regarding independent claim 15, Basu discloses a method of delivering ablation therapy to a patient (pa. 0019-0020 & Figs. 1-3C), the method comprising:
introducing a catheter (10) into the patient (pa. 0023) the catheter including a shaft (12) having a proximal end attached to a handle (16) (pa. 0019) and a distal end (i.e., deflection section 114 extending from the shaft, pa. 0021) that includes an ablation assembly (15);
navigating the ablation assembly in an undeployed state to a desired tissue site (pa. 0069), wherein the electroporation assembly includes at least a first electrode (combination of surface electrodes 30 and ring electrodes 20) (pa. 0024) and a cone-shaped non-conductive portion (18) (pa. 0021-0022) attached on a first end (22) to the shaft, wherein the cone shaped non-conductive portion terminates in a free distal edge (24) (pa. 0021, 0023), and wherein the first electrode is located adjacent to the first end of the non-conductive portion and radially inward of the free distal edge of the non-conductive portion (pa. 0024).
deploying the ablation assembly, wherein deployment of the ablation assembly includes allowing the free distal edge of the non-conductive portion to extend radially outward so that at least the free distal edge is brought into contact with the desired tissue site (pa. 0069-0070); and
delivering ablation energy to the first electrode (pa. 0020, 0053).
However, Basu does not disclose the catheter providing electroporation therapy.
Stewart, in the same field of endeavor, teaches a catheter with electrodes (37) capable of providing radiofrequency ablation or electroporation therapy (pa. 0006) via an energy source (58) configured and programmed to deliver pulsed, high voltage density, pulsed energy (pa. 0044-0046).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the energy source of Stewart to be electrically connectable to the electrodes of Basu for the purpose of providing dual ablation or electroporation therapy to the targeted tissue.
Regarding claim 17, Basu/Stewart combination discloses wherein the non-conductive portion is passively deployed between an undeployed state and a deployed state (Basu pa. 0069).
However, this embodiment of Basu does not disclose the non-conductive portion being actively deployed by activating a mechanism in the handle to cause the free distal edge of the non-conductive portion to expand radially outward.
An alternative embodiment of Basu describes the non-conductive portion being an inflatable member (18’), wherein expansion is accomplished when the operator/user dispenses cryogenic fluid from a cryogenic source to an interior cavity (44) via fluid tubings (48), wherein the fluid tubings exit the catheter shaft (12) via apertures (50) formed in the shaft (pa. 0030, 0071 & Fig. 5A). In this embodiment, the non-conductive portion is actively deployed by activating a fluid mechanism in the handle to cause the free distal edge of the non-conductive portion to expand radially outward.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the non-conductive portion of the first embodiment of Basu with the inflatable non-conductive portion described in the second embodiment for the purpose of allowing the user to have more control over the pressure/contact applied to the targeted tissue by the distal assembly.
Regarding claim 18, Basu/Stewart combination discloses wherein the free distal edge of the non-conductive portion is brought into contact with the tissue to be treated, wherein the tissue to be treated is approximately planar (Basu, pa. 0023 & Figs. 3A-3B).
Regarding claim 19, Basu/Stewart combination discloses wherein an outer surface of the non-conductive portion is brought into contact with the tissue to be treated, wherein the tissue to be treated is tubular (pa. 0023 & Figs. 3A-3C).
Examiner notes that the claim language is broad and does not require that the outer surface of the non-conducting portion be brought into direct contact with the tissue to be treated. As such, the embodiments illustrated in Figs. 3A-3C of Basu describe how when the ablation assembly is inverted or turned inside-out with an inner surface (25) now facing outwardly, for diagnostic mapping purposes, the inner surface of the non-conducting portion is then pressed into circumferential contact with the ostium. Hence, providing for at least, indirect contact between the outer surface of the non-conductive portion and the tissue treated.
Regarding claim 20, Basu discloses the catheter providing ablation therapy (pa. 0053).
However, Basu does not disclose the catheter providing irreversible electroporation therapy.
Stewart, in the same field of endeavor, teaches a catheter with electrodes (37) capable of providing radiofrequency ablation or irreversible electroporation therapy (pa. 0006) via an energy source (58) configured and programmed to deliver pulsed, high voltage density, pulsed energy (pa. 0044-0046).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the energy source of Stewart to be electrically connectable to the electrodes of Basu for the purpose of providing dual ablation or electroporation therapy to the targeted tissue.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Basu and Stewart as applied to claim 1 above, and further in view of Jackson (W.O. Application No. 2007044244 A2).
Regarding claim 14, Basu/Stewart combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose the non-conductive portion comprises a non-compliant material.
Jackson, in the same field of endeavor, teaches an expandable, non-compliant insulative member (28) with a plurality of electrodes (32) suitable to contact the tissue to apply ablation treatment (pa. 0080-0082).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the compliant non-conductive material of the non-conductive portion of Basu with a non-compliant material as taught by Jackson in order to allow for precise control and consistent force application.
Response to Arguments
Applicant' s arguments, see pages 6-10 of the Remarks filed 04/27/2026, with respect to the rejection of claim 15 under 35 U.S.C. 102 as unpatentable over Deem have been fully considered and are persuasive. Specifically, Applicant’s amendments to the claim to further require wherein the cone shaped non-conductive portion terminates in a free distal edge is defined over Deem given that it does not contemplate this claimed structure. Therefore, the prior rejections based on the first embodiment of Deem has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-4, 7-13, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Basu (E.P. Application No. 3153124 B1), in view of by Stewart (U.S. Application No. 20130030425 A1).
It is the Examiner’s position that the newly filed rejections based on the combination is tenable for at least the reasoning set forth in the action above.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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