DETAILED ACTION
This action is in response to amendments received on 7/7/2026. Claims 1-20 were previously pending with claims 3-5, 7 and 13-20 withdrawn from consideration. Claims 1, 8 and 9 have been amended and claim 2 canceled. A complete action on the merits of claims 1, 6 and 8-12 follows below.
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 .
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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Visram (US Pub. No. 2005/0159738) in view of Jain (US Pub. No. 2003/0045871).
Regarding Claim 1, Visram teaches a system for tissue puncture (abstract), comprising:
a radiofrequency (RF) generator 128 comprising an RF output port and a ground return port ([0039] and [0055]); an RF puncture device (622 and tip electrode 612 together as seen in Fig. 6) comprising an elongate member 622 having a shaft and a tip (Fig. 6), wherein the tip comprises an intracorporeal RF puncture electrode 612 that is positionable adjacent a target site within a patient's body (Figs. 8-9B and electrode 612 is similar to electrode 112 discussed in [0048]), and the shaft comprises a first electrical conductor 618 that is electrically connected to the intracorporeal RF puncture electrode 612 and is electrically connectable to the RF output port for delivering RF energy from the RF generator to the intracorporeal RF puncture electrode 612 ([0055]); and
at least a first intracorporeal grounding electrode 614 that is positionable within the patient's body proximate the target site (Fig. 6), wherein the first intracorporeal grounding electrode 614 is electrically connectable to the ground return port for returning current to the RF generator ([0055]);
wherein the first intracorporeal grounding electrode 614 [and the second intracorporeal grounding electrode are] is disposed on the RF puncture device (Fig. 6 and [0051]), on an intracorporeal accessory through which the RF puncture device is advanceable, or on a diagnostic catheter used concurrently with the RF puncture device, and wherein the first intracorporeal grounding electrode 614 [and the second intracorporeal grounding electrode are] is spaced from both the intracorporeal RF puncture electrode and the target site (Fig. 6). Please note that the underlined section above are directed to non-elect embodiments withdrawn from consideration.
However, Visram only teaches the use of one grounding electrode 614 in Fig. 6 and not two.
In the same field of invention Jain teaches the use of more than one grounding electrodes such as 106 in Figs. 6-8 (please note that Figs. 4-5 show the different non-elect embodiment of “on a diagnostic catheter used concurrently with the RF puncture device”). Jain specifically teaches that “If more than one secondary electrode 106 is used, each secondary electrode is connected to the switching device 84 (FIG. 3) to selectively couple one of the secondary electrodes to the electrical device 85” in [0045]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add more than one ground electrode to the embodiment of Fig. 6 of Visram, connecting the ground electrodes to a similar switching device disclosed by Jain in order to selectively activate and deactivate each ground electrode in order to allow a user to create a desire lesion while selectively coupling the system to the ground electrode most optimal for use.
Regarding Claim 6, Visram teaches wherein the RF puncture device comprises the first intracorporeal grounding electrode 614 (Fig. 6, please note that claim 1 already claims this limitation along with two other options which are directed to non-elect embodiments).
Regarding Claim 8, Visram teaches wherein the system further comprises a dilator 602 through which the RF puncture device 622 is advanceable to position the intracorporeal RF puncture electrode 612 at the target site ([0052]-[0054] and Fig. 6), wherein the dilator comprises dilator distal portion that tapers in diameter towards a dilator distal end (Fig. 6), a dilator proximal portion that is opposite the dilator distal portion and that defines a dilator proximal end (the proximal end 606 in Fig. 6), a dilator sidewall extending between the dilator distal end and the dilator proximal end, and a dilator lumen defined by the dilator sidewall and extending between the dilator distal end and the dilator proximal end (Fig. 6); in the dilator distal portion, the dilator sidewall comprises a first window extending radially therethrough from an outer surface of the dilator to the dilator lumen (given the broadest reasonable interpretation the opening in the side wall that allows ground electrode 614 to be exposed is considered a window); and when the intracorporeal RF puncture device 622 is advanced through the dilator 602 to position the RF puncture electrode 612 at the target site, the first intracorporeal grounding electrode 614 is aligned with the first window (Fig. 6).
Regarding Claim 9, Visram teaches wherein the system further comprises a sheath (guide sheath 700 in Fig. 7A) having a sheath distal portion that is positionable proximate the target site and that defines a sheath distal end (Fig. 7), a sheath proximal portion that is opposite the sheath distal portion and that defines a sheath proximal end, a sheath sidewall extending between the sheath distal end and the sheath proximal end, and a sheath lumen defined by the sheath sidewall and extending between the sheath distal end and the sheath proximal end (Fig. 7); the RF puncture device 622 and the dilator 602 are advanceable through the sheath lumen to position the dilator distal portion proud of the sheath distal end and to position the RF puncture electrode 612 proud of the dilator distal end and the sheath distal end and at the target site ([0036], [0051] and [0055]); in the sheath distal portion, the sheath sidewall comprises a second window extending radially therethrough from an outer surface of the sheath to the sheath lumen (in view of Jain adding multiple ground electrodes to the outer sheath as shown in Fig. 8 of Jain, each ground electrode would be configured to be coupled to a conductor internal to the sheath of RF puncture device 622 of Visram, thereby the opening allowing the second ground electrode to be exposed on the outer surface is here interpreted to be a second window); and when the dilator is advanced through the sheath and the RF puncture device is advanced through the dilator to position the intracorporeal RF puncture electrode 612 at the target site (Fig. 6), the second intracorporeal grounding electrode is aligned with the second window (in view of the teachings of Jain, providing at least two grounding electrodes on the outer surface of the sheath would require two openings, here interpreted to be windows allowing the grounding electrodes to be exposed as well as coupling to the internal conductors).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Visram in view of Jain as applied above in view of Eyster (US Pub. No. 2021/0393327).
Regarding Claim 10, Visram teaches further comprising an ECG monitoring system in combination with the RF generator coupled to the same set of electrodes (Fig. 1), but does not teach an electroanatomical mapping (EAM) system to which the first intracorporeal grounding electrode is electrically connectable for use of the first intracorporeal grounding electrode as an EAM electrode.
In the same field of invention, Eyster teaches an electroanatomic mapping system electrically couplable to the treatment catheter and a switching system that toggles the energy transmission between the first path and the second path for ablation and mapping ([0175]-[0177] and Figs. 27-28). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add n electroanatomic mapping system electrically coupled to the electrodes of Visram along with a switching system in order to allow switching between mapping and ablation by the same electrodes positioned within the body in order to eliminate further devices to be advanced to the target area.
Regarding Claim 11, Visram in view of Eyster teaches further comprising a switching device (13 in Figs. 27-28 of Eyster), wherein the RF puncture electrode is electrically connectable to the RF output port via the switching device (though path 32 in Figs. 27-28 of Eyster); the first intracorporeal grounding electrode is electrically connectable to the EAM system via the switching device (Figs. 27-28 of Eyster); and the first intracorporeal grounding electrode is electrically connectable to the ground return port via the switching device (Figs. 27-28 of Eyster).
Regarding Claim 12, Visram in view of Eyster teaches wherein the switching device is configured to allow the first intracorporeal grounding electrode to be electrically connected to only one of the ground return port and the EAM system at a given time (Figs. 27-28 of Eyster).
Response to Arguments
Applicant’s arguments see page 2, filed 7/7/2026 on the grounds that Visram only teaches a single return/reference electrode have been fully considered and are persuasive; however, this limitation is newly added that was not previously presented. Upon further consideration, a new ground(s) of rejection is made in view of Jain as seen above.
Conclusion
THIS ACTION IS MADE FINAL. 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 KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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