CTNF 18/414,815 CTNF 93153 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. Information Disclosure Statement The information disclosure statement (IDS) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections 07-29-01 AIA Claim 17 is objected to because of the following informalities: the claim should be amended to recite “ the first and second electrodes” in line 2 to correct for grammar . 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 (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. 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1-4, 6-8, 14, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roman (US 20100057073) in view of Zhang (US 20140107639) . Regarding claim 1 , Roman discloses a bipolar RF electrode (catheter 100 in fig. 1; paragraph 52 discloses the RF energy can be bipolar), comprising: an electrode shaft (shaft 110 in fig. 1) having a first end portion (end attached to handle 150 in fig. 1) and a second end portion opposite the first end portion (distal portion DP in fig. 1); a first electrode (tip electrode 131 in fig. 3A); a second electrode attached to the second end portion of the electrode shaft (ablation element 121a in fig. 1); a material coupled to, and disposed between, the first electrode and the second electrode (see below, material of the shaft 110 between distalmost electrode 121 and tip electrode 131), the material defining at least one fluid delivery port (see below from fig. 15); and PNG media_image1.png 287 518 media_image1.png Greyscale an electrode hub attached to first end portion of the electrode shaft (handle 150 in fig. 1), wherein the electrode hub or the electrode shaft is configured for attachment of a fluid line (fig. 15 shows the hub 150 attached to tubing 451 and shaft 110 is indirectly attached to tube 405 via plug 404), wherein at least the electrode shaft, the second electrode, and the material form a hollow interior for flow of fluid from the fluid line, when attached, to the at least one fluid delivery port defined by the material and disposed between the first electrode and the second electrode (fig. 15). While it appears necessary that the material between electrodes would be insulative, Roman does not explicitly teach or disclose this limitation. Zhang teaches an ablation catheter comprising a plurality of electrodes (electrodes 62 in fig. 6) with material between electrodes being insulative (paragraph 38 discloses segments 64 being nonconductive). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the material between electrodes to be insulative, as taught by Zhang, in order to conductively isolate the electrodes. Regarding claim 2 , modified Roman teaches all of the claimed limitations set forth in claim 1, as discussed above. However, in this embodiment of Roman, modified Roman does not teach or disclose the at least one fluid delivery port is a plurality of fluid delivery ports disposed around a circumference of the bipolar RF electrode. In a different embodiment (fig. 14), Roman teaches the at least one fluid delivery port is a plurality of fluid delivery ports disposed around a circumference of the bipolar RF electrode (holes 412 in fig. 14 are shown to be diametrically opposed). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the first embodiment of Roman so that saline exits out of the port defined by 405b and another port defined on the opposite side of the electrode, as taught by the second embodiment of Roman, for the purpose of increasing the dispersion area of the saline. Regarding claim 3 , in the modified electrode of Roman, Roman discloses the electrode hub is configured for attachment of the fluid line (fig. 15 shows handle 150 attached to line 451). Regarding claim 4 , in the modified electrode of Roman, Roman discloses the electrode shaft is configured for attachment of the fluid line (fig. 15 shows the shaft 110 indirectly attached to the tube 405a via plug 404). Regarding claim 6 , in the modified electrode of Roman, Roman discloses the first electrode has a closed end (fig. 15). Regarding claim 7 , in the modified electrode of Roman, Zhang discloses the insulative material is part of the electrode shaft (fig. 6). Regarding claim 8 , in the modified electrode of Roman, Roman discloses the second electrode is disposed over a portion of the electrode shaft (fig. 3B shows electrodes 121 over a portion of the shaft 110). Regarding claim 14 , Roman discloses a method for performing RF ablation, the method comprising: positioning the first and second electrodes of the bipolar RF electrode of claim 1 proximate to an ablation target of a patient (fig. 7B; see discussion above); delivering fluid from a fluid source through a fluid line and the bipolar RF electrode coupled to the fluid line and out the at least one fluid delivery port defined by the insulative material of the bipolar RF electrode (paragraph 144 and fig. 15 discloses delivering cooling fluid through port; paragraph 117 and fig. 5 discloses the fluid comes from bag 501); and ablating tissue using the first and second electrodes of the bipolar RF electrode (paragraph 71 discloses delivering energy via the electrodes; paragraph 60 discloses that energy is used to ablate tissues). Regarding claim 18 , in the modified method of Roman, Roman discloses the fluid comprises a conductive liquid to enhance ablation (paragraph 144 discloses saline) . 07-22-aia AIA Claim (s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roman in view of Zhang , as applied to claim 1 above, and further in view of Cosman (US 20170050041) Regarding claim 5 , in the modified electrode of Roman, Roman discloses a plurality of conductors extending along the electrode shaft (paragraph 72 discloses “signal wires” traveling within shaft 110), wherein at least one conductor is electrically coupled to the first electrode (paragraph 73) and at least one other conductor is electrically coupled to the second electrode (paragraph 74). While it appears that Roman discloses a cable extending from the electrode hub (fig. 1A shows a line extending from hub 150 to ECG interface 191), modified Roman does not explicitly teach or disclose a cable extending from the electrode hub and the plurality of conductors extending along the cable. Cosman teaches a catheter (fig. 5B) which comprises a cable (cable branch 533 in fig. 5A) extending from an electrode hub (hub 520 in fig. 5A) and a plurality of conductors extending along the cable and the catheter shaft (wires 536 and 537 in fig. 5B). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the electrode of modified Roman to include the cable of Cosman extending from the electrode hub and so that the plurality of conductors extend along the cable for the purpose of better protecting the conductors . 07-22-aia AIA Claim (s) 9-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roman in view of Zhang , as applied to claim s 1 and 14 above, and further in view of Rittman (US 20080200972) . Regarding claim 9 , modified Roman teaches the bipolar RF electrode of claim 1 (see discussion above) and further discloses a cannula (paragraph 170). However, modified Roman does not teach or disclose the cannula configured for insertion of the electrode shaft through the cannula. Rittman teaches a cannula (needle 32 in fig. 1) and an electrode shaft (stimulation device 12 in fig. 1) which is inserted through the cannula (fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the kit of modified Roman to include the cannula of Rittman for the purpose of enabling introduction of the shaft into the patient (paragraph 80). Regarding claim 10 , in the modified kit of Roman, Roman discloses the fluid line (tubing 451 and tube 405a in fig. 15 form the “fluid line”). Regarding claim 11 , modified Roman teaches a RF ablation system (system 10 in fig. 1A of Roman), comprising: the bipolar RF electrode of claim 1 (see discussion above); a RF generator configured for electrically coupling to the bipolar RF electrode and energizing at least one of the first electrode or the second electrode (RF generator 190 in fig. 1A). Roman further discloses a cannula (paragraph 170). However, modified Roman does not teach or disclose the cannula configured for insertion of the electrode shaft through the cannula. Rittman teaches a cannula (needle 32 in fig. 1) and an electrode shaft (stimulation device 12 in fig. 1) which is inserted through the cannula (fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of modified Roman to include the cannula of Rittman for the purpose of enabling introduction of the shaft into the patient (paragraph 80). Regarding claim 12 , in the modified system of Roman, Roman discloses the fluid line (tubing 451 and tube 405a in fig. 15 form the “fluid line”). Regarding claim 13 , in the modified system of Roman, Roman discloses a fluid source coupleable to the fluid line for providing fluid to the fluid line for delivery through the bipolar RF electrode and out the at least one fluid delivery port (bag 501 in fig. 5). Regarding claim 15 , modified Roman teaches all of the claimed limitations set forth in claim 14, as discussed above, but does not teach or disclose the fluid comprises a numbing agent. Rittman is directed towards a similar method comprising an electrode device (stimulation device 12 in fig. 1) having a plurality of fluid delivery ports (infusion ports 30 in fig. 3). Rittman further teaches that the fluid delivered through the fluid delivery ports is a numbing agent (paragraph 109 discloses delivering a local anesthetic). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of modified Roman so that the fluid comprises a numbing agent, as taught by Rittman to improve patient comfort . 07-22-aia AIA Claim (s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roman in view of Zhang in view of Rittman , as applied to claim s 14 and 15 above, and further in view of Kaufmann (US 20210093869) . Regarding claim 16 , modified Roman teaches all of the claimed limitations set forth in claims 14 and 15, as discussed above, but does not teach or disclose confirming the positioning of the first and second electrodes by numbing of the patient by the numbing agent. Kaufmann is directed towards a method comprising the step of confirming electrode placement by numbing of the patient (paragraph 5 discloses a patient verbally confirming the numbing to indicate that electrodes are properly placed). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of modified Roman to have the step of confirming the positioning of the first and second electrodes by numbing of the patient by the numbing agent, as taught by Kaufmann to ensure the patient feels no/minimal pain . 07-22-aia AIA Claim (s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roman in view of Zhang , as applied to claim 14 above, and further in view of Gelfand (US 20140243809) . Regarding claim 17 , modified Roman teaches all of the claimed limitations set forth in claim 14, as discussed above, but does not teach or disclose a contrast agent, the method further comprising imaging the ablation target and first and second electrodes after delivery of the contrast agent. Gelfand teaches a catheter which is configured to deliver a contrast agent (paragraph 129 discloses delivering a contrast medium via the central lumen 55 of the catheter 49) and the step of imaging the ablation target and first and second electrodes after delivery of the contrast agent (paragraph 129 discloses delivering contrast and imaging the placement of the electrodes to confirm proper placement). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the fluid of modified Roman to include contrast agent and to include the method of imaging the ablation target and first and second electrodes after delivery of the contrast agent, as taught by Gelfand, to ensure proper placement of the electrodes (paragraph 129) . 07-22-aia AIA Claim (s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roman in view of Zhang , as applied to claim 14 above, and further in view of Edwards (US 20020183735) . Regarding claim 19 , modified Roman teaches all of the claimed limitations set forth in claim 14, as discussed above, but does not teach or disclose the fluid comprises a healing medication, wherein the delivering occurs after the ablating. Edwards is directed towards a catheter configured to deliver a fluid (fig. 1) which comprises a healing medication (paragraph 11 discloses the catheter delivers antibiotics), wherein delivering the healing medication occurs after the ablating (paragraph 11 discloses “after ablation”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the fluid of modified Roman to include a healing medication and to deliver the healing medication after ablating, as taught by Edwards, since Edwards teaches that this step can aid in repair of tissue (paragraph 11) . 07-22-aia AIA Claim (s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roman in view of Zhang , as applied to claim 14 above, and further in view of Long (US 20110160514) . Regarding claim 20 , modified Roman teaches all of the claimed limitations set forth in claim 14, as discussed above, but does not teach or disclose the fluid comprises embolic beads configured to starve tissue of blood flow. Long is directed towards a similar method involving fluid comprising embolic beads configured to starve tissue of blood flow (paragraph 115). Since Roman discloses that the method is used for tumor ablation (paragraph 67), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the fluid of modified Roman to comprise embolic beads configured to starve tissue of blood flow, as taught by Long, since Long teaches that this agent is useful in treating tumors by causing necrosis (paragraph 115). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM 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, BHISMA MEHTA can be reached at 571-272-3383. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783 Application/Control Number: 18/414,815 Page 2 Art Unit: 3783 Application/Control Number: 18/414,815 Page 3 Art Unit: 3783 Application/Control Number: 18/414,815 Page 4 Art Unit: 3783 Application/Control Number: 18/414,815 Page 5 Art Unit: 3783 Application/Control Number: 18/414,815 Page 6 Art Unit: 3783 Application/Control Number: 18/414,815 Page 7 Art Unit: 3783 Application/Control Number: 18/414,815 Page 8 Art Unit: 3783 Application/Control Number: 18/414,815 Page 9 Art Unit: 3783 Application/Control Number: 18/414,815 Page 10 Art Unit: 3783 Application/Control Number: 18/414,815 Page 11 Art Unit: 3783 Application/Control Number: 18/414,815 Page 12 Art Unit: 3783
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