CTNF 18/810,160 CTNF 71152 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 filed January 2, 2025 has been entered and the references cited therein have been considered by the examiner. Drawings 06-22 AIA The drawings are objected to because in Figure 3A, the insulator should be numbered 330, not 380 and in Figure 3B, the insulator should be numbered 380, not 330. This is to align with the description at para. 0081 . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 06-22-01 The drawings are objected to under 37 CFR 1.83(a) because they fail to show the insulator 480 in Figure 4B as described in the specification at para. 0085. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 07-29 AIA The disclosure is objected to because of the following informalities: At para. 0070, 224 is used to describe both the “central portion” and the “medial portion”; At para. 0071, 210 is used to describe both the “electrode assembly” and the “ablation electrode”; At para. 0076, line 7, “fulling” should be “fully”; At para. 0077, line 1, the “hull” should be numbered 212; At para. 0085, 410 and 460 are used for both the “electrode assembly” and the “conductive basket”; and At para. 0088, line 6, the “equator” should be numbered 482, not 484 . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. Claim 19 recites the limitation "the ablation electrode" in line 1. There is insufficient antecedent basis for this limitation in the claim or in independent claim 18, from which claim 19 depends. 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gandionco et al. (PCT Publication No. 2022/192522) in view of Webster, Jr. (U.S. Patent No. 5,782,239) . In regard to claims 1, 8, 12, 16 and 18 , Gandionco et al. teach a tissue modification system 100 for treating conditions of the heart using irreversible electroporation (see paras. 0005 and 00119) comprised of a treatment catheter 1502 having a shaft 1504 with a proximal end and a distal end 1506 and a basket-type energy delivery body 1522 extending from the distal end 1506 of the shaft 1504 (see Fig. 34 and para. 00221). The energy delivery body 1522 comprises a plurality of longitudinally-extending conductive splines 1524 that each have a proximal portion secured to the distal end 1506 of the shaft 1504 where the body 1522 is transitionable between a collapsed configuration and an expanded configuration (see Fig. 34 and para. 00224). Figure 34 shows that the splines 1524 define a spherical shape in the expanded state and have a central portion with a maximum radial dimension and a distal portion opposite the shaft 1504. Each of the splines 1524 are operable as a first ablation electrode configured to generate an electric field when a pulsed waveform is delivered to each spline 1524 as each of the splines 1524 are connected to a conductive wire that extends through the shaft 1504 for connection with the energy generator (see para. 00226). Gandionco et al. also teach that the splines 1524 are partially covered by insulative material 1528 located on the proximal side of the energy delivery body 1522 so that energy is directed through the uninsulated portions of the splines 1524 (see para. 00222 and Figs. 34-35). Gandionco et al. do not specifically state that the insulative material 1528 extends from the proximal ends of the splines 1524 to the central portion. However, Webster, Jr. teaches a similar electrode assembly with arms 102 where each the entire proximal half 111 of each arm is coated with a polyurethane coating 114 (see Fig. 18a and col. 12, lines 35-39) for the purpose of localizing the application of RF energy to the area needed (see col. 12, lines 52-57). Webster, Jr. thus demonstrates that coating the entire proximal half of a spline (from the proximal portion to the central portion) in an electrode assembly is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the splines 1524 of Gandionco et al. with the insulative material 1528 on the entire proximal half of the splines 1524 (from the proximal portion to the central portion) in order to localizing the application of RF energy to the area needed. With further respect to claim 16 , Gandionco et al. teach a waveform generator 108 that is electrically connected to the catheter 102 and creates high frequency short duration energy that is delivered to the catheter 102 (see Fig. 1 and para. 00121). With further respect to claim 18 and in regard to claims 9-11, 13 and 17 , Gandionco et al. teach shaft electrodes 1542, 1544 and the delivery of energy and both monopolar and bipolar modes (see Fig. 34 and para. 00222). In regard to claims 2-4 and 19 , Figure 35 of Gandionco et al. shows that in the expanded state, the maximum radial dimension defines an equator of the body 1522 where the maximum radial dimension is greater than a maximum radial dimension of the distal region of the shaft 1504. With further respect to claim 4 , as broadly as claimed and in light of the combination of Gandionco et al. and Webster, Jr. (see above), the insulative material 1528 (as applied over the entire proximal region of the splines 1524) would extend from the proximal end to the equator. In regard to claims 5 and 19 , Webster, Jr. teaches that any part of the electrodes can be coated depending upon the requirements of specific ablation applications (see col. 12, lines 49-52). Accordingly, in light of the combination of Gandionco et al. and Webster, Jr. (see above), the insulative material 1528 would extend from the proximal end to a chord distal to the equator. In regard to claims 6, 7 and 20 , see Figures 33A and 33B of Gandionco et al. In regard to claims 14 and 15 , Webster, Jr. teaches both that the coating 114 can be applied on the distal portion of the electrodes and that any part of the electrodes can be coated depending upon the requirements of specific ablation applications (see col. 12, lines 39-52). Thus, in light of the combination of Gandionco et al. and Webster, Jr. (see above), a second insulator distal to the proximal insulation portion can be disposed on the splines 1524. Webster, Jr. also teach that the coating 118 can be disposed on the inner side 120 of the electrode assembly (see col. 12, lines 39-49) . Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-37 AIA Claim s 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of copending Application No. 18/810,110 in view of Gandionco et al. (PCT Publication No. 2022/192522) and Webster, Jr. (U.S. Patent No. 5,782,239). Claims 1-20 of copending Application No. 18/810,110 teach all of the limitations of claims 1-20 of the instant application with the exception of the particulars of the insulation portion (i.e., how it extends from the proximal end to the central portion, etc.) and monopolar/bipolar operation. However, as noted above, these features are taught by Gandionco et al. and Webster, Jr. (U.S. Patent No. 5,782,239). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device taught in claims 1-20 of copending Application No. 18/810,110 with the insulation portion and monopolar/bipolar opertation taught by Gandionco et al. and Webster, Jr . This is a provisional nonstatutory double patenting rejection. Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dale et al., PCT Publication No. WO 2020/227086; Fischbach et al., U.S. Patent Application Publication No. 2023/0329769; Zhang et al., U.S. Patent Application Publication No. 2022/0378498; and Willard et al., U.S. Patent Application Publication No. 2014/0025069 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM. 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, Linda Dvorak can be reached at 571-272-4764. 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. 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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. /BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794 Application/Control Number: 18/810,160 Page 2 Art Unit: 3794 Application/Control Number: 18/810,160 Page 3 Art Unit: 3794 Application/Control Number: 18/810,160 Page 4 Art Unit: 3794 Application/Control Number: 18/810,160 Page 5 Art Unit: 3794 Application/Control Number: 18/810,160 Page 6 Art Unit: 3794 Application/Control Number: 18/810,160 Page 7 Art Unit: 3794 Application/Control Number: 18/810,160 Page 8 Art Unit: 3794 Application/Control Number: 18/810,160 Page 9 Art Unit: 3794 Application/Control Number: 18/810,160 Page 10 Art Unit: 3794 Application/Control Number: 18/810,160 Page 11 Art Unit: 3794 Application/Control Number: 18/810,160 Page 12 Art Unit: 3794
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