CTNF 18/892,116 CTNF 96268 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 2 is objected to because of the following informalities: Lines 2-3: “inflatable member disposed” should read –inflatable member is disposed --. Appropriate correction is required. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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 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. 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al., US 20220378498, herein referred to as “Zhang”, in view of Reo et al., US 20230040877, herein referred to as “Reo” . Regarding claim 1, Zhang discloses an electroporation catheter for ablation of cardiac tissue (Figure 1) , the electroporation catheter comprising: an elongated shaft having a distal region (Figure 12: shaft 1202) ; a sensing electrode assembly extending distally from the distal region of the elongated shaft and defining an interior region (Figure 12: distal portion 1206) , the sensing electrode assembly defining a distally located central hub portion (Figure 12) and a plurality of flexible support members each including a distal end portion extending from the central hub portion (Figure 12: splines 1204) , and a proximal end portion attached to and constrained by the shaft (Figure 12 and [0118]) , each of the plurality of flexible support members including a plurality of sensing electrodes (Figure 12: electrodes 1220 and [0120] and [0115]) ; wherein the flexible support members are transitionable between an expanded configuration and a collapsed configuration ([0163]: “splines are expanded and contracted”) , the plurality of flexible support members forming the interior region in the expanded configuration (Figure 12) ; an inflatable member having a proximal portion and a distal portion (Figure 12: balloon 1208) , the inflatable member disposed within the interior region and operably coupled to the distal region ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204. Notably, balloon 1208 functions as an insulator, and generally reduces energy losses relative to catheter assembly 1200, which may result in increased lesion size.”) , the inflatable member transitionable between an inflated configuration and an uninflated configuration ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204.”) ; and an ablation electrode assembly operably coupled to the inflatable member ([0122]: “In addition, in some embodiments, catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1204),”) , the ablation electrode assembly having a distal ablation electrode disposed distal to the inflatable member ([0122]: “In addition, in some embodiments, catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1204),”) , the ablation electrodes configured to generate an electric field to accomplish pulsed field ablation ([0057] and [0006]) . Zhang does not explicitly disclose an electroporation catheter wherein the ablation electrode assembly has a distal ablation electrode disposed distal to the inflatable member and a proximal ablation electrode disposed proximal to the inflatable member. However, Reo teaches an electroporation catheter (Figure 8A) wherein the ablation electrode assembly (Figure 13) has a distal ablation electrode disposed distal to the inflatable member (Figure 8A: selectively deployable electrode 126) and a proximal ablation electrode disposed proximal to the inflatable member (Figure 8A: medial ring electrode 129) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electroporation catheter disclosed by Zhang so that the ablation electrode assembly has a distal ablation electrode disposed distal to the inflatable member and a proximal ablation electrode disposed proximal to the inflatable member as taught by Reo so that the device can be used to ablate nerve tissue (Reo [0105]) . Regarding claim 2, Zhang in view of Reo discloses the electroporation catheter of claim 1, and Zhang further discloses an electroporation catheter wherein the plurality of flexible support members form a basket having the cavity within the basket (Figure 12: splines 1204) , and the inflatable member disposed within the basket (Figure 12 and [0117]: “catheter assembly 1200 includes a balloon 1208 enclosed by splines 1204. ”) . Regarding claim 3, Zhang in view of Reo discloses the electroporation catheter of claim 2, and Zhang further discloses an electroporation catheter wherein the basket includes a distal tip (Figure 12) , and the first ablation electrode is disposed on the distal tip of the basket ([0122]: “catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. ”) . Regarding claim 4, Zhang in view of Reo discloses the electroporation catheter of claim 3, and Zhang further discloses an electroporation catheter wherein the basket is operably coupled to the shaft (Figure 12 and [0121] , and the proximal electrode is coupled to the shaft proximal to the basket ([0122]: “and/or may be used for visualization/mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1202)”) . Reo teaches an electroporation catheter wherein the proximal electrode is an ablation electrode (Figure 8A: medial ring electrode 129) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electroporation catheter disclosed by Zhang so that the proximal electrode is an ablation electrode as taught by Reo so that the device can be used to ablate nerve tissue (Reo [0105]) . Regarding claim 5, Zhang in view of Reo discloses the electroporation catheter of claim 1, and Reo further discloses an electroporation catheter wherein the distal ablation electrode is configured as one of a cathode and an anode and wherein the proximal ablation electrode is configured as the other of the cathode and the anode (Figure 13: selectively deployable electrode 126 is connected to the positive terminal of first amplifier 1312a, while medial ring electrode 129 is connected to the negative terminal) , and wherein the electroporation catheter is operable in a bipolar mode (Table 1 and Figure 13) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electroporation catheter disclosed by Zhang so that the distal ablation electrode is configured as one of a cathode and an anode and wherein the proximal ablation electrode is configured as the other of the cathode and the anode as taught by Reo so that the device can be used to ablate nerve tissue (Reo [0105]) . Regarding claim 6, Zhang in view of Reo discloses the electroporation catheter of claim 1, and Zhang further discloses an electroporation catheter wherein the plurality of ablation electrodes includes one distal ablation electrode disposed distal to the inflatable member ([0122]: “In addition, in some embodiments, catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1204),”) . Reo discloses an electroporation catheter wherein the plurality of ablation electrodes includes one distal ablation electrode disposed distal to the inflatable member (Figure 8A: selectively deployable electrode 126) and one proximal ablation electrode disposed proximal to the inflatable member (Figure 8A: medial ring electrode 129) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electroporation catheter disclosed by Zhang so that the plurality of ablation electrodes includes one proximal ablation electrode disposed proximal to the inflatable member as taught by Reo so that the device can be used to ablate nerve tissue (Reo [0105]) . Regarding claim 7, Zhang in view of Reo discloses the electroporation catheter of claim 1, and Zhang further discloses an electroporation catheter wherein the inflatable member is formed of an insulating material ([0117]: “balloon 1208 functions as an insulator”) . Regarding claim 8, Zhang in view of Reo discloses the electroporation catheter of claim 7, and Zhang further discloses an electroporation catheter wherein the inflatable member in the inflated configuration includes a non-conductive fluid ([0092]) . Regarding claim 9, Zhang in view of Reo discloses the electroporation catheter of claim 1, and Zhang further discloses an electroporation catheter wherein the plurality of flexible support members includes a plurality of splines (Figure 12: splines 1204) . Regarding claim 10, Zhang in view of Reo discloses the electroporation catheter of claim 9, and Zhang further discloses an electroporation catheter wherein each spline includes a set of the plurality of sensing electrodes longitudinally spaced along the spline ([0119]-[0120]) . Regarding claim 11, Zhang discloses an electrophysiology system (Figure 1) , comprising: an electroporation console configured to generate pulsed electrical signals for electroporation ablation (Figure 1: electroporation generator 26 and [0057]) ; an electroanatomical mapping system configured to receive cardiac signals (Figure 1: computer system 32 and [0115]) ; and an electroporation catheter operably coupled to the electroporation console and the electroanatomical mapping system (Figure 1: catheter 14 and Figure 12) , the electroporation catheter comprising: an elongated shaft having a distal region (Figure 12: shaft 1202) ; a sensing electrode assembly extending distally from the distal region of the elongated shaft and defining an interior region (Figure 12: distal portion 1206) , the sensing electrode assembly defining a distally located central hub portion (Figure 12) and a plurality of flexible support members each including a distal end portion extending from the central hub portion (Figure 12: splines 1204) , and a proximal end portion attached to and constrained by the shaft (Figure 12 and [0118]) , each of the plurality of flexible support members including a plurality of sensing electrodes (Figure 12: electrodes 1220 and [0120] and [0115]) ; wherein the flexible support members are transitionable between an expanded configuration and a collapsed configuration ([0121]: “During delivery, splines 1204 may be collapsed in towards shaft 1202. Subsequently, to perform ablation, splines 1204 are deployed to extend radially outward.”) , the plurality of flexible support members forming the interior region in the expanded configuration (Figure 12) ; an inflatable member having a proximal portion and a distal portion (Figure 12: balloon 1208) , the inflatable member disposed within the interior region and operably coupled to the distal region ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204. Notably, balloon 1208 functions as an insulator, and generally reduces energy losses relative to catheter assembly 1200, which may result in increased lesion size.”) , the inflatable member transitionable between an inflated configuration and an uninflated configuration ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204.”) ; and an ablation electrode assembly operably coupled to the inflatable member ([0122]: “In addition, in some embodiments, catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1204),”) , the ablation electrode assembly having a distal ablation electrode disposed distal to the inflatable member ([0122]: “In addition, in some embodiments, catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1204),”) , the ablation electrodes configured to generate an electric field to accomplish pulsed field ablation ([0057] and [0006]) . Zhang does not explicitly disclose an electrophysiological system wherein the ablation electrode assembly has a distal ablation electrode disposed distal to the inflatable member and a proximal ablation electrode disposed proximal to the inflatable member. However, Reo teaches an electrophysiological system (Figure 8A) wherein the ablation electrode assembly (Figure 13) has a distal ablation electrode disposed distal to the inflatable member (Figure 8A: selectively deployable electrode 126) and a proximal ablation electrode disposed proximal to the inflatable member (Figure 8A: medial ring electrode 129) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrophysiological system disclosed by Zhang so that the ablation electrode assembly has a distal ablation electrode disposed distal to the inflatable member and a proximal ablation electrode disposed proximal to the inflatable member as taught by Reo so that the device can be used to ablate nerve tissue (Reo [0105]) . Regarding claim 12, Zhang in view of Reo discloses the electrophysiological system of claim 11, and Zhang further discloses an electrophysiological system further comprising an infusion device, wherein the inflatable member is fluidically coupled to the infusion device to transition between the inflated configuration and the uninflated configuration in response to an infusion of fluid from the infusion device ([0092] and [0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204.”) . Regarding claim 13, Zhang in view of Reo discloses the electrophysiological system of claim 11, and Reo further discloses an electrophysiological system wherein an ablation electrode in the plurality of ablation electrodes is configured as one of a cathode and an anode and another ablation electrode in the plurality of ablation electrodes is configured as the other of the cathode and the anode (Figure 13: selectively deployable electrode 126 is connected to the positive terminal of first amplifier 1312a, while medial ring electrode 129 is connected to the negative terminal) , and the electroporation catheter is operable in a bipolar mode (Table 1 and Figure 13) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrophysiological system disclosed by Zhang so that an ablation electrode in the plurality of ablation electrodes is configured as a cathode and another ablation electrode in the plurality of ablation electrodes is configured as an anode as taught by Reo so that the device can be used to ablate nerve tissue (Reo [0105]) . Regarding claim 14, Zhang teaches a method for an electrophysiological procedure (Figure 1) , the method comprising: providing an electroporation catheter (Figure 1: catheter 14 and Figure 12) comprising: an elongated shaft having a distal region (Figure 12: shaft 1202) ; a sensing electrode assembly extending distally from the distal region of the elongated shaft and defining an interior region (Figure 12: distal portion 1206) , the sensing electrode assembly defining a distally located central hub portion (Figure 12) and a plurality of flexible support members each including a distal end portion extending from the central hub portion (Figure 12: splines 1204) , and a proximal end portion attached to and constrained by the shaft (Figure 12 and [0118]) , each of the plurality of flexible support members including a plurality of sensing electrodes (Figure 12: electrodes 1220 and [0120] and [0115]) ; wherein the flexible support members are transitionable between an expanded configuration and a collapsed configuration ([0121]: “During delivery, splines 1204 may be collapsed in towards shaft 1202. Subsequently, to perform ablation, splines 1204 are deployed to extend radially outward.”) , the plurality of flexible support members forming the interior region in the expanded configuration (Figure 12) ; an inflatable member having a proximal portion and a distal portion (Figure 12: balloon 1208) , the inflatable member disposed within the interior region and operably coupled to the distal region ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204. Notably, balloon 1208 functions as an insulator, and generally reduces energy losses relative to catheter assembly 1200, which may result in increased lesion size.”) , the inflatable member transitionable between an inflated configuration and an uninflated configuration ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204.”) ; and an ablation electrode assembly operably coupled to the inflatable member ([0122]: “In addition, in some embodiments, catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1204),”) , the ablation electrode assembly having a distal ablation electrode disposed distal to the inflatable member ([0122]: “In addition, in some embodiments, catheter assembly 1200 includes a distal electrode (not shown) positioned distal of splines 1204. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1204),”) , the ablation electrodes configured to generate an electric field to accomplish pulsed field ablation ([0057] and [0006]) ; deploying the electroporation catheter in the expanded configuration and the inflatable member in the inflated configuration into a pulmonary vein ostium ([0057]: “Pulsed field ablation (PFA) has been shown to be an effective form of ablation for treatment of cardiac arrhythmias, particularly for instantaneous pulmonary vein isolation (PVI).” And [0119]: “Further, as shown in FIG. 12, electrodes 1220 are generally positioned closer to distal end 1212 than proximal end 1210 to correspond to portions of spline 1204 that will contact pulmonary vein 320.”) ; delivering electroporation ablation energy to the ablation electrodes to ablate a wall of the pulmonary vein ostium with the deployed electroporation catheter in the expanded configuration and the inflatable member in the inflated configuration ([0119]: “Further, as shown in FIG. 12, electrodes 1220 are generally positioned closer to distal end 1212 than proximal end 1210 to correspond to portions of spline 1204 that will contact pulmonary vein 320.” And [0122]: “The distal electrode may be used to perform point ablation”) ; and obtaining cardiac signals with the sensing electrodes with the deployed electroporation catheter in the expanded configuration ([0115]) . Zhang does not explicitly disclose a method wherein the ablation electrode assembly has a distal ablation electrode disposed distal to the inflatable member and a proximal ablation electrode disposed proximal to the inflatable member. However, Reo teaches a method (Figure 8A) wherein the ablation electrode assembly (Figure 13) has a distal ablation electrode disposed distal to the inflatable member (Figure 8A: selectively deployable electrode 126) and a proximal ablation electrode disposed proximal to the inflatable member (Figure 8A: medial ring electrode 129) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Zhang so that the ablation electrode assembly has a distal ablation electrode disposed distal to the inflatable member and a proximal ablation electrode disposed proximal to the inflatable member as taught by Reo so that the device can be used to ablate nerve tissue (Reo [0105]) . Regarding claim 15, Zhang in view of Reo discloses the method of claim 14, and Zhang further discloses a method wherein deploying the electroporation catheter includes inflating the inflatable member into the cavity after expanding the flexible support members to form the cavity ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204.”) . Regarding claim 16, Zhang in view of Reo discloses the method of claim 14, and Zhang further discloses a method wherein deploying the electroporation catheter includes infusing the inflatable member with a fluid ([0117]: “Balloon 1208 may be selectively inflated to fill the space between splines 1204.” And [0092]) . Regarding claim 17, Zhang in view of Reo discloses the method of claim 14, and Zhang further discloses a method wherein the flexible support members include splines (Figure 12: splines 1204) and deploying the electroporation catheter includes forming the basket in the expanded state ([0121]: “Subsequently, to perform ablation, splines 1204 are deployed to extend radially outward.”) . Regarding claim 18, Zhang in view of Reo discloses the method of claim 14, and Zhang further discloses a method wherein delivering electroporation ablation energy to the ablation electrodes to ablate a wall of the pulmonary vein ostium with the deployed electroporation catheter in the expanded configuration and the inflatable member in the inflated configuration includes occluding the pulmonary vein ostium ([0094]) . Regarding claim 19, Zhang in view of Reo discloses the method of claim 14, and Zhang further discloses a method wherein the inflatable member is formed of an insulating material ([0117]: “balloon 1208 functions as an insulator”) , and wherein delivering electroporation ablation energy to the ablation electrodes to ablate a wall of the pulmonary vein ostium includes directing the electric field toward the wall of the pulmonary vein ostium with the inflatable member ([0117] and [0119] and [0121]) . Regarding claim 20, Zhang in view of Reo discloses the method of claim 14, and Zhang further discloses a method wherein the obtaining cardiac signals with the sensing electrodes includes occluding the pulmonary vein ostium ([0094] and [0115]) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST. 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, Joanne Rodden can be reached on 3032974276. 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. /N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794 Application/Control Number: 18/892,116 Page 2 Art Unit: 3794 Application/Control Number: 18/892,116 Page 3 Art Unit: 3794 Application/Control Number: 18/892,116 Page 4 Art Unit: 3794 Application/Control Number: 18/892,116 Page 5 Art Unit: 3794 Application/Control Number: 18/892,116 Page 6 Art Unit: 3794 Application/Control Number: 18/892,116 Page 7 Art Unit: 3794 Application/Control Number: 18/892,116 Page 8 Art Unit: 3794 Application/Control Number: 18/892,116 Page 9 Art Unit: 3794 Application/Control Number: 18/892,116 Page 10 Art Unit: 3794 Application/Control Number: 18/892,116 Page 11 Art Unit: 3794 Application/Control Number: 18/892,116 Page 12 Art Unit: 3794 Application/Control Number: 18/892,116 Page 13 Art Unit: 3794
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