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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 29, 2026 has been entered.
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.
Claim(s) 1, 2, 5, 8, 19-21, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Basu, U.S. 2021/0077183 (hereinafter Basu) in view of Prutchi, U.S. 6,152,882 (hereinafter Prutchi).
Regarding claims 1, 8, and 26, Basu discloses (note figs. 2-9; paragraph 136) a device comprising: a shaft (130) having a proximal end and a distal end; and a conformable electrode assembly (210/410) located at the distal end of the shaft, the electrode assembly having a first side (see fig. 3) and a second side (see fig. 4) opposite the first side, wherein the first side includes a first non-conductive portion (surface ‘214’ and corresponding surface in fig. 9), a first electrode (center-most ‘432’ in fig. 9) centrally located on the first side, and a first plurality of peripheral electrodes (230/430) located on a periphery of the first side, and the second side includes a second electrode (any one of the medially-disposed 234’s seen in fig. 4), wherein the first electrode is configured to deliver electroporation therapy to tissue located adjacent to the first side of the electrode assembly (note paragraph 49), 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. 9), wherein the second side includes a second non-conductive portion (surface ‘216’ and corresponding surface in fig. 9), wherein the second electrode is affixed to the second non-conductive portion (see fig. 5) and is necessarily ‘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, and wherein the third surface area is greater than the fourth surface area (see fig. 4). While Basu discloses a first electrode on the first side of the assembly for delivering electroporation therapy, as well as different electrodes (‘230’ and second electrode ‘234’) on opposing sides of the assembly for mapping/sensing tissue (note paragraph 51), Basu fails to explicitly disclose that the first electrode and the second electrode are configured to deliver electroporation therapy to tissue located adjacent to the first side of the electrode assembly. Prutchi teaches a similar device (note figs. 7 and 8B) comprising a first (82/102A) and second (84/104) electrode on opposing sides of a conformable assembly (70/100), wherein the electrodes are configured to map/sense tissue (note abstract; col. 21, line 8) and deliver electroporation therapy (note col. 8, line 48; col. 21, line 26) to tissue located adjacent to the first side of the assembly. It is well known in the art that this electrode configuration, which utilizes multi-purpose electrodes (e.g., electrodes that electroporate and map/sense tissue), would result in increased efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the apparatus of Basu (in view of Prutchi) to comprise electrodes on opposing sides of the assembly, wherein the electrodes are configured to map/sense tissue and deliver electroporation therapy to tissue located adjacent to the first side of the assembly in order to increase efficiency. It should be noted that this modification would have merely comprised a simple substitution with a known electrode configuration in order to produce a predictable result.
Regarding claim 2, Basu discloses (see above) a device wherein the first electrode and the first non-conductive portion form a ‘relatively planar’ surface for contacting tissue (note paragraph 40).
Regarding claim 5, Basu discloses (see above) a device wherein the first non-conductive portion is flexible (see fig. 2A).
Regarding claims 19 and 20, Basu discloses (note figs. 1-9) a system comprising: a catheter comprising: a handle (110); a conformable electrode assembly (210/410) having a first side (see fig. 3) and a second side (see fig. 4) opposite the first side, wherein the first side includes a first non-conductive portion (surface ‘214’ and corresponding surface in fig. 9), a first electrode (center-most ‘432’ in fig. 9) affixed to the first non-conductive portion, and the second side includes a second electrode (any one of the medially-disposed 234’s seen in fig. 4), and a first plurality of peripheral electrodes (230/430) located on a periphery of the first side of the conformable electrode assembly, wherein the first electrode is centrally located and wherein the first non-conductive portion surrounds the first electrode in a plane defined by the first side (note paragraph 40), 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 (note paragraphs 34 and 49) coupled to the catheter to deliver electroporation pulses to the first electrode (note paragraph 49) to cause electroporation therapy to be delivered to tissue located adjacent to the first side of the electrode. While Basu discloses a first electrode on the first side of the assembly for delivering electroporation therapy, as well as different electrodes (‘230’ and second electrode ‘234’) on opposing sides of the assembly for mapping/sensing tissue (note paragraph 51), Basu fails to explicitly disclose that the first electrode and the second electrode are configured to deliver electroporation pulses therebetween to cause electroporation therapy to be delivered to tissue located adjacent to the first side of the electrode assembly. Prutchi teaches a similar device (note figs. 7 and 8B) comprising a first (82/102A) and second (84/104) electrode on opposing sides of a conformable assembly (70/100), wherein the electrodes are configured to map/sense tissue (note abstract; col. 21, line 8) and deliver electroporation energy therebetween (note col. 8, line 48; col. 21, line 26) to cause electroporation therapy to be delivered to tissue located adjacent to the first side of the assembly. It is well known in the art that this electrode configuration, which utilizes multi-purpose electrodes (e.g., electrodes that electroporate and map/sense tissue), would result in increased efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the apparatus of Basu (in view of Prutchi) to comprise electrodes on opposing sides of the assembly, wherein the electrodes are configured to map/sense tissue and deliver electroporation pulses therebetween to cause electroporation therapy to be delivered to tissue located adjacent to the first side of the assembly, in order to increase efficiency. It should be noted that this modification would have merely comprised a simple substitution with a known electrode configuration in order to produce a predictable result.
Regarding claim 21, Basu discloses (see above) a system wherein the first electrode and the first plurality of peripheral electrodes are located on a shape memory flexible substrate (250) that has a preset geometry, wherein the conformable electrode assembly is configured to fit within a lumen of the shaft (see fig. 2).
Claim(s) 3 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Prutchi as applied to claims 1, 2, 5, 8, 19-21, and 26 above, and further in view of Eggers, U.S. 7,217,268 (hereinafter Eggers).
Regarding claims 3 and 22-25, Basu discloses (see above) an electroporation system/device having a first electrode, a first plurality of peripheral electrodes (230/430) located on a periphery of the first side of the conformable electrode assembly, and a first non-conductive portion, wherein the first plurality of peripheral electrodes and the non-conductive portion necessarily form a ‘relatively planar’ surface (note paragraph 40), and wherein the first plurality of peripheral electrodes include a surface that extends beyond a surface of the non-conductive portion (note fig. 5; paragraph 55). However, Basu fails to explicitly disclose that the first electrode is recessed within the first non-conductive portion. Eggers teaches (note figs. 2A-B) a similar system/device comprising electrodes (58) and a non-conductive surface (distal surface of ‘48’), wherein the electrodes may be “flush with or recessed from or extending from” the non-conductive surface (note col. 5, line 37). It should be noted that Applicant has failed to provide this specific configuration with any evidence of criticality or unexpected results. Furthermore, it is well known in the art that these different electrode configurations are widely considered to be interchangeable (as can be seen in Eggers). Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the system/device of Basu to comprise any of a variety of different electrode configurations (including the claimed recessed electrode). This is because this modification would have merely comprised a simple substitution of interchangeable electrode configurations in order to produce a predictable result (see MPEP 2143).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Prutchi as applied to claims 1, 2, 5, 8, 19-21, and 26 above, and further in view of Bencini, U.S. 2016/0302858 (hereinafter Bencini).
Regarding claim 4, Basu discloses (see above) an electroporation device having a first electrode and a first non-conductive portion, wherein a surface of the first electrode extends beyond a surface of the first non-conductive portion (note fig. 5). However, Basu fails to explicitly disclose that the first electrode is affixed within a recess in the first non-conductive portion. Bencini teaches a similar device comprising electrodes positioned on a non-conductive spline (i.e., surface – note paragraph 74), wherein the electrodes may be ‘embedded within the spline or bonded to an outer surface thereof’ (note paragraph 77). It should be noted that Applicant has failed to provide this specific configuration with any evidence of criticality or unexpected results. Furthermore, it is well known in the art that these different electrode configurations are widely considered to be interchangeable (as can be seen in Bencini). Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Basu to comprise any of a variety of different electrode configurations (including the claimed embedded electrode). This is because this modification would have merely comprised a simple substitution of interchangeable electrode configurations in order to produce a predictable result (see MPEP 2143).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Prutchi as applied to claims 1, 2, 5, 8, 19-21, and 26 above, and further in view of Bakczewitz, U.S. 2014/0142570 (hereinafter Bakczewitz).
Regarding claims 10-12, Basu discloses (see above) a device wherein the first electrode is affixed to the first side, and wherein the assembly is flexible and includes an underlying shape memory layer (250) having a preset geometry, said preset geometry being one of convex, concave, and planar (note paragraph 40). However, Basu fails to explicitly disclose that the non-conductive portion includes an aperture aligned with the first electrode, wherein the first electrode is recessed relative to the non-conductive portion. Eggers teaches (note figs. 2A-B) a similar device comprising a non-conductive portion (distal surface of ‘48’) that includes apertures aligned with (i.e., surrounding) the electrodes (58), wherein the electrodes may be “flush with or recessed from or extending from” the non-conductive surface (note col. 5, line 37). It should be noted that Applicant has failed to provide this specific configuration with any evidence of criticality or unexpected results. Furthermore, it is well known in the art that these different electrode configurations are widely considered to be interchangeable (as can be seen in Eggers). Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Basu to comprise any of a variety of different electrode configurations (including the claimed ‘electrode recessed within an aperture’). This is because this modification would have merely comprised a simple substitution of interchangeable electrode configurations in order to produce a predictable result (see MPEP 2143).
It should be noted that Basu does not give much detail concerning the electrode leads/wires, and Basu further fails to explicitly disclose a device having an electrode affixed to an underlying flexible circuit board. Bakczewitz teaches (see fig. 9) a relevant device having several different embodiments for connecting an electrode to a power source, including the use of traditional leads (note fig. 8) and an underlying flexible circuit board (note fig. 9; paragraph 49). It is well known in the art that these different ‘electrode coupling’ configurations are widely considered to be interchangeable (as can be seen in the different embodiments of Bakczewitz). Once again, Applicant has failed to provide this specific configuration with any evidence of criticality or unexpected results. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the apparatus of Basu to comprise an electrode affixed to an underlying flexible circuit board (as opposed to the current leads/wires). This is because this modification would have merely comprised a simple substitution of interchangeable ‘electrode coupling’ configurations in order to produce a similar result (see MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because they do not apply to the current rejections.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794