DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Claims 4, 8, and 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected expandable electrode shape of helical, curved and basket/balloon, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2026.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5-7, 9-11, 13 and 14 are rejected under 35 U.S.C 102(a)(1) as being anticipated by Koop et al (US20220015826A1) herein referred to as “Koop”
Regarding claim 1, Koop discloses: A system comprising: an elongated tool through which a lumen extends; ([Summary] catheter body extending from a proximal end to a distal end represents the elongated tool. A lumen extends from the proximal end to the distal end) and a stylet including an expandable electrode portion, ([Summary] shaft, equivalent to the stylet, is coupled to the tines which constitute the expandable electrode portion) the expandable electrode portion having a collapsed configuration within the lumen (See FIG 1A below showing the electrodes collapsed inside of the lumen) and having an expanded configuration outside of the lumen, (See FIG 1B below showing the expanded configuration outside of the lumen) a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration, (See FIG 1A which shows a small diameter when the electrodes are collapsed within the lumen and see FIG 1B where the Diameter of the expandable electrodes is larger) wherein in the expanded configuration, the expandable electrode portion is configured to create a plurality of path segments in a target tissue, ([0058] describes the plurality of electrodes penetrating the tissue and carving paths thus creating a plurality of path segments in the target tissue) wherein each path segment in the plurality of path segments is extended in a different direction (See FIG 1B below where each tine is facing in a different direction thus will create path segments in different directions once deployed in the target tissue) and wherein the expandable electrode portion in the expanded configuration is configured to deliver energy to ablate the target tissue ([0058] voltage pulses are applied following deployment of the electrodes and resulting in electroporation of the tissue to be ablated)
Regarding claim 2, Koop discloses: The system of claim 1, wherein the elongated tool and the stylet are flexible ([Abstract] includes a flexible catheter body and a flexible shaft which is equivalent to the stylet).
Regarding claim 5, Koop discloses: The system of claim 1, wherein the expandable electrode portion is expandable to a diameter greater than an outer diameter of the elongated tool when extended distally of the lumen. (FIG 1B below, see the tines (14) extended distally forming a diameter greater than that of the outer diameter of the tool body)
Regarding claim 6, Koop discloses: The system of claim 5, wherein the expandable electrode portion is formed of nitinol. ([0056] the tines which form the expandable electrode are made of Nitinol)
Regarding claim 7, Koop discloses: The system of claim 5, wherein the expandable electrode portion has a straightened configuration in the lumen. (FIG 1A and [0056] can be in a linear configuration when restrained within the lumen)
Regarding claim 9, Koop discloses: The system of claim 1, wherein the stylet includes a cannulated shaft and wherein the expandable electrode portion includes a plurality of electrode tines that extend from the cannulated shaft. ([0017] states that the flexible shaft can be formed of a second wire coil which essentially acts as a sleeve over the first shaft thus forming a cannulated shaft)
Regarding claim 10, Koop discloses: The system of claim 9, wherein the electrode tines are straight and extend outward from the cannulated shaft in a distal direction and the plurality of path segments in the target tissue are generally straight. ([0058] describes the plurality of electrodes penetrating the tissue and carving paths thus creating a plurality of path segments in the target tissue; FIG 1B the electrodes are angled at 90 degrees but straight thus will form straight segments in the target tissue)
Regarding claim 11, Koop discloses: The system of claim 9, wherein the electrode tines extend from a distal end of the cannulated shaft ([Abstract] plurality of tines configured to deploy at the distal end of the catheter body, and FIG 1B below)
Regarding claim 13, Koop discloses: The system of claim 9, wherein the electrode tines are collapsible into the elongated tool by proximal motion of the stylet. ([0036] shaft is moved toward a proximal end of the catheter body to retract the tines into the lumen, this is equivalent to collapsing the tines back into the elongated tool)
Regarding claim 14, Koop discloses: The system of claim 9, wherein the electrode tines are straight and extend outward from the cannulated shaft in a proximal direction and the plurality of path segments in the target tissue are generally straight. (see FIG 1B below)
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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.
Claims 12 and 15 are rejected under 35 U.S.C 103 as being unpatentable over Koop in view of Sundquist et al (US20110106072A1) herein referred to as “Sundquist”
Regarding claim 12, Koop discloses: The system of claim 9, however, Koop does not disclose: wherein the electrode tines extend through openings along the cannulated shaft
Sundquist discloses: wherein the electrode tines extend through openings along the cannulated shaft (Sundquist see annotated FIG 2B below showing electrode tines (18) extending through openings in canulated shaft)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft opening of Koop with the shaft opening of Sundquist. The motivation being, deploying the electrodes at different angles for different lengths allows for treatment of selected areas of tissue (Sundquist [0114]).
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FIG 2B
Regarding claim 15, Koop discloses: The system of claim 9, however, Koop does not explicitly disclose: further comprising an actuator configured to move the electrode tines relative to the cannulated shaft
Sundquist discloses: further comprising an actuator configured to move the electrode tines relative to the cannulated shaft (Sundquist [0141] deployment of the electrodes may be triggered using a push button or sliding mechanism using the catheter handle which is equated to the actuator)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sliding mechanism of Koop to incorporate the actuator of Sundquist. The motivation being the use of an actuator or button allows for the selective deployment of the electrodes within the treatment zone (Sundquist [0141]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794