DETAILED ACTION
This action is in response to applicant’s election of group one in the response to a restriction requirement received on 3/19/2026. Claims 1-20 were previously pending. Claims 13-20 have been withdrawn from consideration. A complete action on the merits of claims 1-12 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.
Election/Restrictions
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group of invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/19/2026.
Furthermore, per a phone interview applicant elected Species V; thereby, claims 3-5 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of invention, there being no allowable generic or linking claim. Election was made without traverse in the phone interview on 3/30/2026.
Claim Objections
Claims 1 and 8-9 are objected to because of the following informalities:
“the intracorporeal RF electrode” in claim 1 should be amended to recite --the intracorporeal RF puncture electrode-- to be consistent.
“the RF puncture electrode” in various places in claims 8 and 9 should be amended to recite --the intracorporeal RF puncture electrode-- to be consistent.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 9 recites the limitation “the second intracorporeal grounding electrode is aligned with the second window”. There is insufficient antecedent basis for this limitation in the claim. Since no second intracorporeal grounding electrode has been introduced prior to this recitation, it is at most unclear what second intracorporeal grounding electrode is being referred to. Clarification and appropriate correction is required.
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 1-2, 6 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Visram (US Pub. No. 2005/0159738).
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 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]).
Regarding Claim 2, Visram teaches further comprising an intracorporeal accessory (conducting wire 624) comprising the first intracorporeal grounding electrode 614 (Fig. 6).
Regarding Claim 6, Visram teaches wherein the RF puncture device comprises the first intracorporeal grounding electrode 614 (Fig. 6).
Regarding Claim 8, Visram teaches wherein the system further comprises a dilator 602 though which the RF puncture device 622 is advanceable to position the 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 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; and when the dilator is advanced through the sheath and the RF puncture device is advanced through the dilator to position the RF puncture electrode at the target site, the second intracorporeal grounding electrode is aligned with the second window (in view of the 112 rejection above, it is unclear what second intracorporeal grounding electrode is being referred to since only one grounding electrode has been introduced, therefore, given the broadest reasonable interpretation the second grounding electrode is interpreted to be the first grounding electrode and thus the distal end opening of the guiding sheath 700 is interpreted to be a second window which when the dilator 602 is advanced through the sheath 700 and the RF puncture device 622 is advanced through the dilator 602 to position the RF puncture electrode 612 at the target site, the second intracorporeal grounding electrode 614 is aligned with the second window as it exits the second window).
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 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Visram 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).
Conclusion
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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