DETAILED ACTION
Currently, claims 1-5, 8, 10-12, and 19-26 are being examined, while the remaining claims have either been cancelled or are withdrawn.
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 (i.e., changing from AIA to pre-AIA ) 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 § 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.
Claim(s) 1, 5, 8, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Viswanathan, U.S. 10,130,423 (hereinafter Viswanathan).
Regarding claim 1, Viswanathan discloses (note figs. 6 and 33A) an electroporation device comprising: a shaft (610/3310) having a proximal end and a distal end; and a conformable electrode assembly (i.e., basket) located at the distal end of the shaft, the electrode assembly having a first side and a second side opposite the first side (e.g., see splines on opposite sides of the basket), wherein the first side includes a first non-conductive portion (spline ‘614/3330’), a first electrode (proximal ‘616’; distal ‘3334’) centrally located on the first side and the second side includes a second electrode (corresponding electrode on the opposing spline), wherein the first electrode and the second electrode are configured to deliver irreversible electroporation therapy to tissue located adjacent to the first side of the electrode assembly (note col. 38, line 39; col. 40, line 21), wherein the first non-conductive portion is defined by a first surface area and the first electrode is defined by a second surface area, wherein the first surface area is greater than the second surface area (see figs. 6 and 33A). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 5, Viswanathan discloses (see above) a device wherein the first non-conductive portion is flexible (the collapsable splines are necessarily flexible).
Regarding claim 8, Viswanathan discloses (see above) an electroporation device wherein the second side includes a second non-conductive portion (opposing spline), wherein the second electrode is affixed to the second non-conductive portion and is centrally located on the second side, wherein the second non- conductive portion is defined by a third surface area and the second electrode is defined by a fourth surface area, wherein the third surface area is greater than the fourth surface area (see figs. 6 and 33A).
Regarding claim 26, Viswanathan discloses (see above) an electroporation device further including a first plurality of ‘peripheral electrodes’ (see remainder of electrodes on corresponding spline) located on a ‘periphery’ of the first side of the conformable electrode assembly.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vakharia, U.S. 2009/0062792 (hereinafter Vakharia).
Regarding claim 19, Vakharia discloses (note figs. 12-18) an electroporation therapy system comprising: a catheter comprising: a handle (170); a ‘conformable electrode assembly’ (124) having a first side (126a) and a second side (126b) ‘opposite’ the first side, wherein the first side includes a first non-conductive portion (136a), a first electrode (134a) affixed to the first non-conductive portion, and the second side includes a second electrode (134b), wherein the first electrode is centrally located (see fig. 13) and wherein the first non-conductive portion surrounds the first electrode in a plane defined by the first side (i.e., by the jaw surface – see fig. 13); and a shaft (122) coupled to the handle at a proximal end and to the electrode assembly at a distal end; and an electroporation generator (14) coupled to the catheter to deliver electroporation pulses between the first electrode and the second electrode to cause irreversible electroporation therapy to be delivered to tissue located adjacent to the first side of the electrode assembly (note paragraph 80).
Claim(s) 1, 5, 8, and 26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Olson, U.S. 2022/0304745 (hereinafter Olson).
The applied reference has a common Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Olson discloses (note figs. 1 and 3) an electroporation device comprising: a shaft (122) having a proximal end and a distal end; and a conformable electrode assembly (i.e., basket) located at the distal end of the shaft, the electrode assembly having a first side and a second side opposite the first side (e.g., see splines on opposite sides of the basket), wherein the first side includes a first non-conductive portion (spline ‘202’), a first electrode (central ‘226’) centrally located on the first side and the second side includes a second electrode (corresponding electrode on the opposing spline), wherein the first electrode and the second electrode are configured to deliver irreversible electroporation therapy to tissue located adjacent to the first side of the electrode assembly (note paragraphs 26 and 50), wherein the first non-conductive portion is defined by a first surface area and the first electrode is defined by a second surface area, wherein the first surface area is greater than the second surface area (see fig. 3). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 5, Olson discloses (see above) a device wherein the first non-conductive portion is flexible (the collapsable splines are necessarily flexible).
Regarding claim 8, Olson discloses (see above) an electroporation device wherein the second side includes a second non-conductive portion (opposing spline), wherein the second electrode is affixed to the second non-conductive portion and is centrally located on the second side, wherein the second non- conductive portion is defined by a third surface area and the second electrode is defined by a fourth surface area, wherein the third surface area is greater than the fourth surface area (see fig. 3).
Regarding claim 26, Olson discloses (see above) an electroporation device further including a first plurality of ‘peripheral electrodes’ (see remainder of electrodes on corresponding spline) located on a ‘periphery’ of the first side of the conformable electrode assembly.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because they do not apply to the current rejections.
Allowable Subject Matter
Claims 2-4, 10-12, and 20-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
