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 .
Election/Restrictions
Claims 4, 5, 7, 10, 24, 25 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Applicant’s original election of the embodiment of Figure 2, made in the response of March 20, 2026, did not traverse the election of species by virtue of making no arguments for traversal.
The response of July 30, 2026, filed in response to the Notice of Non-Compliance of April 30, 2026, indicates that the examiner has exceeded the scope of restriction practice as applicant may not claim the hybrid embodiment disclosed in paragraphs {0010] and [0022]. The examiner disagrees. The examiner maintains that a statement that two embodiments may be combined does not necessarily afford applicant the right to claim such a hybrid embodiment, particularly where the specification fails to adequately describe the suggested combination. Figure 1 shows a system including a single catheter that employs a number of patch electrodes to serve as return electrodes, a combination typically known in monopolar systems. Figure 2 shows an embodiment having two separate catheters, one of the catheters having one or more active electrodes and the second catheter having one or more return electrodes thereby forming a typical bipolar arrangement of electrodes. There is no discussion in the specification as to how the bipolar, two catheter system could effectively be incorporated into a monopolar system having patch electrodes, or the operation of such a hybrid system. There is no disclosure of a switching mechanism to allow the switching between a monopolar and a bipolar mode of operation. Moreover, there is no discussion of what purpose the patch electrodes would serve in a system where bipolar electrodes are provided in the body since the purpose of the second catheter (i.e. having the return electrodes) is to function as the return path and there would be no reason to have the patch electrodes. Applicant has offered no discussion as to whether or not there would (or could) be stray currents that could be returned to the patch electrodes when the device is operated in the bipolar mode. And again, there is no discussion of a switching mechanism that would allow the system to switch between a monopolar operation and a bipolar operation. As such, the examiner maintains that the generalized statement in the specification that the embodiment of Figure 2 may be used in the system of Figure 1 lacks sufficient description to support the statement. Further, the examiner maintains that there is a written description concern, particularly since applicant has failed to adequately describe the “hybrid” embodiment beyond making a generalized statement that the two embodiments could be combined.
Regarding claims 24, 25 and 29, the examiner could find no mention of the claimed “spacer” in the context of Figure 2. In fact, the examiner could find no use of the term “spacer” anywhere in the specification. As such, these limitations are deemed to not be drawn to the embodiment of Figure 2.
Currently, claims 1-15 and 21-29 are pending, with claims 4, 5, 7, 10, 24, 25 and 29 being withdrawn from consideration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 8, 9, 11-14, 21-23 and 26-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stewart et al (2019/0223948).
Regarding claim 1, Stewart et al disclose a catheter assembly comprising a catheter (28) comprising at least one lesion generating electrode (12) configured to be positioned within a patient (para. [0080], for example). There is at least one return array (Figure 3) configured to be positioned within the patient, the return array comprising at least one return electrode (14). Energy is provided between the lesion generating electrode (12) and the return electrode (14) to generate lesions in tissue. See, for example, paragraphs [0085] and [0091].
Regarding claim 2, the return electrode has a larger surface area than the lesion generating electrode (para. [0085] and [0091]). Regarding claim 3, the return electrode is provided on an additional (i.e. second) catheter (56) as shown in Figure 3. Regarding claim 6, the return electrode is a catheter and is configured to be positioned in a blood stream of a patient (para. [0091], “within a cardiac vein, within a cardiac artery”). Regarding claim 8, the return electrode may comprise a plurality of ring electrodes (14) as shown in Figures 1 and 46. Note, the description of the Figure 3 embodiment (para. [0091]) expressly discloses the use of one or more electrodes on the second catheter (e.g. “the energy return electrode(s)”) Regarding claim 9, the return electrode may be a single elongated structure (as shown by electrode 14 in Figure 3). Regarding claim 21, Stewart et al disclose the use of multiple return electrodes, and Figure 46 shows such return electrodes that may comprise a first array at a distal end of the catheter (i.e. the distal-most three electrodes) and a second return array (i.e. the proximally located three electrodes) proximal of the first array. Regarding claim 22, each of the arrays addressed with respect to claim 21 include a plurality of return electrodes. Regarding claim 23, Stewart disclose numerous times that the return electrodes have a larger surface area then the lesion generating electrode.
Regarding claim 11, Stewart et al provide an ablation system comprising a generator (22) and a catheter assembly coupled to the generator including a catheter (28) comprising at least one lesion generating electrode (12) configured to be positioned within a patient (para. [0080], for example). There is at least one return array (Figure 3) configured to be positioned within the patient, the return array comprising at least one return electrode (14). Energy is provided between the lesion generating electrode (12) and the return electrode (14) to generate lesions in tissue. See, for example, paragraphs [0085] and [0091].
Regarding claims 12 and 13, see discussion of claims 2 and 3 above. Regarding claim 14, see discussion of claim 6 above. Regarding claims 26-28, see discussion of claims 21-23 above.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al (‘948) in view of the teaching of Pope et al (2009/0171341).
Stewart et al fail to disclose a resistive component associated with the multiple return electrodes to facilitate evenly distributing current over the array.
Pope et al teach that it is known to provide a resistive component to a return electrode array in order to more uniformly distribute current across the array to avoid burning of tissue. See, for example, paragraph [0042].
To have provided the Stewart et al device with a resistive component connected across the return electrode array to facilitate even distribution across the electrode array to avoid burning of tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Pope et al fairly teach it is known to provide such a resistive component across electrodes of a return electrode array for that purpose.
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, 6, 8, 9, 11-15 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 8, 9, 11-15, 25 and 27 of copending Application No. 19/472,634 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘634 application claims were substantially identical to the originally filed application claims of the instant application, and only differ by the minor amendments made to independent claims 1 and 11 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stewart et al (2019/0254735) discloses a substantially analogous catheter system to the Stewart et al (‘948) reference used in the above rejections. Nguyen et al (11,612,430), Shuros et al (2022/0022953) and Danitz et al (11,571,569) disclose other catheter systems that employ a first catheter for delivering energy to tissue and a second catheter having multiple electrodes serving as the return electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/October 9, 2026
