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 .
Response and Amendment Filed
Applicant’s response and amendment, filed February 20, 2026, has been entered and made of record. Claims 19 and 20 are newly added.
Previously Set Forth Rejections
The status of the rejections set forth in the previous Office action (mailed November 24, 2026) is as follows:
The 35 USC 112(b) rejection of claims 1-19 has been overcome by amendments to independent claims 1, 7 and 11 and to claim 13.
The 35 USC 102(a)(1) rejection of claims 1-3 and 5-17 as being anticipated by Govari (EP 3785656) is hereby withdrawn.
The 35 USC 103 rejection of claim 4 as being unpatentable over Govari (EP 3785656) (hereinafter Govari ‘656) in view of Govari (EP 3053517) (hereinafter Govari ‘517) is hereby withdrawn.
The provisional non-statutory double patenting rejection of claims 1, 3, 5, 7, 8, 11, 12, 16 and 17 as being unpatentable over claims 1, 2, 5, 6, 8, 10, 14, 15 and 17 of copending application no. 18/536,392 is hereby withdrawn.
The following new grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
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.
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.
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.
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.
Claims 1-3, 5, 7-17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being obvious over Govari (EP 3785656 -- hereinafter Govari ‘656) in view of Govari et al. (CN 115363746 – hereinafter Govari ‘746).
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 1, 5, 7, 8-14, 17, 19 and 20, Govari ‘656 teaches a system 20 comprised of a shaft 22 and a balloon catheter 40 where the balloon catheter 40 is coupled to the distal end of the shaft 22 at a proximal base section (see Figs. 1 and 2 and para. 0025). Figure 2 shows that when expanded, the balloon catheter 40 defines an inner volume. Balloon catheter 40 includes a plurality of ablation electrodes 50 that are at least partially external to the inner volume of the balloon catheter 40 and are configured to be placed in contact with wall tissue (see Fig. 2 and para. 0027). A stem (ring) electrode 51 is located on the proximal base section externally to the inner volume of the balloon catheter 40 (see Fig. 2 and para. 0027). Govari ‘656 also teaches a console 24 with a processor 41 that has interface circuits 44 for transmitting and receiving signals and controls a relay 60 that forms a connection 64 between the ablation electrodes 50 and the stem electrode 51 for measuring impedances between the ablation electrodes 50 and the stem electrode 51 to verify that full physical contact with the tissue has been achieved (see Figs. 1 and 4 and paras. 0031, 0041-0044). Table I depicts threshold impedance measurements that are used to determine if tissue contact is sufficient (see para. 0040). Govari ‘656 is silent as to an insulating coating on the inner side of the electrodes. However, Govari ‘746 teaches a similar basket-shaped catheter 40 with a shaft 22 and a plurality of electrodes 48 where the electrodes 48 are coated on their inner portions with a layer of electrical insulator 55 on the part facing the blood so that the insulator 55 reduces a portion of the electrical signal that is applied and/or collected via blood (see Fig 2 and page 4 of the attached translation). Govari ‘746 thus demonstrates that an insulating coating on the inner surface of an electrode facing the blood 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 electrodes 50 of Govari ‘656 with the electrical insulator 55 of Govari ‘746 in order to reduce a portion of the electrical signal that is applied and/or collected via blood. In regard to claims 2 and 15, Figure 2 of Govari shows that the stem electrode 51 is fitted on the external perimeter of the proximal base section. Furthermore, electrical insulation of the stem electrode 51 is implicit to perform impedance measurements as disclosed by Govari. In regard to claims 3 and 16, Govari teaches the use of an expandable frame which inherently includes the use of splines (see para. 0013). As such, the ablation electrodes 50 on the balloon catheter 40 would be coupled to the splines.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari (EP 3785656 -- hereinafter Govari ‘656) in view of Govari et al. (CN 115363746 – hereinafter Govari ‘746) and further in view of Govari (EP 3053517 -- hereinafter Govari ‘517).
In regard to claim 4, Govari ‘656 is silent as to a far-field electrode located within the inner volume of the balloon catheter 40. However, Govari ‘517 teaches a similar basket electrode assembly 43 where a far-field electrode 51 is positioned within the inner volume of the basket electrode assembly (see Fig. 3 and para. 0038). Govari ‘517 thus demonstrates that it is well known in the art to utilize a far-field electrode within the inner volume of an expandable catheter. 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 balloon catheter 40 of Govari ‘656 with the far-field electrode 51 disclosed by Govari ’517.
Double Patenting
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.
Claims 1, 3-8, 11, 12 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 6, 8, 10, 11, 14, 15, 17 and 19 of copending Application No. 18/536,392 in view of Govari et al. (CN 115363746 – hereinafter Govari ‘746). Claims 1, 2, 5, 6, 8, 10, 11, 14, 15, 17 and 19 of copending application 18/536,392 recite all of the features of claims 1, 3-8, 11, 12 and 16-20 of the instant invention except for the recitation of an insulating coating on the inner side of the electrodes. However, as noted above, Govari ‘746 teaches a similar basket-shaped catheter 40 with a shaft 22 and a plurality of electrodes 48 where the electrodes 48 are coated on their inner portions with a layer of electrical insulator 55 on the part facing the blood so that the insulator 55 reduces a portion of the electrical signal that is applied and/or collected via blood (see Fig 2 and page 4 of the attached translation). Govari ‘746 thus demonstrates that an insulating coating on the inner surface of an electrode facing the blood 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 electrodes of copending application no. 18/536,392 with the electrical insulator 55 of Govari ‘746 in order to reduce a portion of the electrical signal that is applied and/or collected via blood.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794