DETAILED ACTION
This action is in response to applicant’s response to the restriction requirement received on 4/3/2026. Claims 9 and 15 have been withdrawn from consideration. A complete action on the merits of claims 1-8 and 10-14 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Claims 9 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/3/2026.
Claim Objections
Claims 1-8 and 10-12 objected to because of the following informalities:
“the ablation electrodes” in claim 1 should be amended to recite --the plurality of ablation electrodes-- to be consistent.
“The medical device …” in the preamble of the dependent claims 2-8 and 10-12 should be amended to recite --The radiofrequency medical device …-- to be consistent with claim 1. 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 1-8 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Werneth (US Pub. No. 2022/0183752).
Regarding Claim 1, Werneth teaches a radiofrequency medical device (catheter 1), comprising:
an elongate body 13/20 having a proximal portion, a distal portion (in one embodiment distal end 17 is interpreted to be the distal end, in a second interpretation distal end 21 is interpreted to be the distal portion), and an outer diameter (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67);
a tip electrode 128/116/105/23 located on the distal portion, wherein the tip electrode includes an outer surface having a diameter larger than the outer diameter of the distal portion (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67);
a plurality of ablation electrodes 114/127/132/22 disposed along the distal portion 17/21 (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67), the ablation electrodes configured to delivery ablation energy ([0017], [0021]-[0025] and [0232]);
a handle 103 coupled to the proximal portion of the elongate body (Figs. 1, 3, 16-17, 46, 52, 62a-62c); and a steering mechanism (steering device 144) operably associated with the handle ([0162]), the steering mechanism being configured to deflect the distal portion of the elongate body ([0022], [0161]-[0166] and [0371] and Figs. 14-16 and 46).
Regarding Claim 2, Werneth teaches wherein the elongate body includes a lumen 118 extending from the proximal portion to the distal portion ([0110], [0114]-[0115], [0121], [0371] and Figs. 24, 28, 52-53, 67).
Regarding Claim 3, Werneth teaches wherein the plurality of ablation electrodes 114/127 are configured to delivery bipolar RF energy ([0035], [0091], [0189], [0219] and Fig. 55).
Regarding Claim 4, Werneth teaches wherein the plurality of ablation electrodes 114/127/132/22 are positioned proximal of the tip electrode 128/116/105/23 (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67).
Regarding Claim 5, Werneth teaches wherein the plurality of ablation electrodes are individually actuatable to change the size of a tumor ablation boundary (“In one aspect, if two electrodes are used, it is contemplated that the distal electrode would be one and each of the body electrodes would be selected based on the length requirements of the ablation” [0378] and “In one aspect, this array could be a plurality or series of monopolar and/or bipolar probes arranged in various shapes, configurations, or combinations in order to allow for the ablation of multiple shapes and sizes of target regions of tissue. Various array patterns can reduce the need to reposition the electrode array during treatment by allowing multiple selectively activatable electrode patterns 112” [0379]).
Regarding Claim 6, Werneth teaches wherein the steering mechanism 144 includes a rotatable knob (“said steering device 144 is drivable in rotation with respect to said handle 103 so that a rotation of said steering device 144 with respect to said handle causes a rotation of said elongate shaft 13” [0163] and Fig. 52 shows a rotation knob on the handle).
Regarding Claim 7, Werneth teaches wherein the steering mechanism 144 includes a pull wire 25 or a push rod 26 ([0022], [0114]-[0115], [0121], [0150]-[0158], [0164], [0252], [0371] and Figs. 24, 28, 52-53, 67).
Regarding Claim 8, Werneth teaches wherein the pull wire 25 or push rod 26 is attached to the elongate body offset from a longitudinal axis of the elongate body (mandrel 26 in Fig. 53 or at least one of the steering wires 25 in Figs. 24 and 67).
Regarding Claim 10, Werneth teaches wherein the handle 103 is removably attached to the elongate body (since the handle is a separate element and thus can be taken apart, given the broadest reasonable interpretation, it is interpreted to be removably attached to the catheter).
Regarding Claim 11, Werneth teaches further comprising: a connector (8 or 9 or 10) configured to removably engage an RF generator ([0038]-[0039], [0376], [0381]-[0382] and Figs. 62a-62c).
Regarding Claim 12, Werneth teaches wherein the elongate body 13 has a variable stiffness between the proximal portion and the distal portion (“elongate shaft 13 may include difference is the stiffness of the shaft along its length” [0022], also see [0083] and [0143]).
Regarding Claim 13, Werneth teaches a system for performing a medical procedure, comprising: an elongate body 13/20 having a proximal portion, a distal portion 17/21, and an outer diameter (Figs. 25-27, 41 and 44); a tip electrode 128/116/105/23 located on the distal portion, wherein the tip electrode includes an outer surface having a diameter larger than the outer diameter of the distal portion (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67); a handle 103 (Figs. 1, 3, 16-17, 41, 46, 52, 62a-62c); a steering mechanism associated with the handle (steering device 144), the steering mechanism being configured to deflect the distal portion of the elongate body ([0022], [0161]-[0166] and [0371] and Figs. 14-16 and 46); and a connector (8 or 9 or 10) configured for electrically connecting with a radiofrequency generator ([0038]-[0039], [0376], [0381]-[0382] and Figs. 62a-62c).
Regarding Claim 14, Werneth teaches further comprising: a radiofrequency generator ([0003], [0198], [0372]-[0373] and [0387]-[0390]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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