DETAILED ACTION
Applicant’s amendments and remarks, filed December 18, 2025, are fully acknowledged by the Examiner. Currently, claims 1-4, 7-18 and 20 are pending with claims 5, 6 and 19 cancelled, claims 1-4, 8, 13, 16-18 and 20 amended, and claim 12 withdrawn. Applicant’s amendments and cancellations in the claims have obviated the previously-filed Drawing objections. Similarly, Applicant’s amendments and cancellations in the claims have obviated the previously-filed rejections under 35 U.S.C. 112(b). The following is a complete response to the December 18, 2025 communication.
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 .
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, 13-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley et al. (US Pat. Pub. 2016/0331459 A1).
Regarding claim 1, Townley provides for a system for the delivery of ablation energy, the system comprising:
a medical device (device 202) including a treatment element (212/412) having a plurality of electrodes (see figures 5A-G with the electrodes at 444 and the various ones of 444a…), at least a subset of the plurality of the electrodes being arranged in a plurality of sets of a first electrode, a second electrode, and a third electrode (the various electrodes as noted above can be defined in with a subset of the electrodes forming a plurality of sets that include a first, second and third electrode of each set; the Examiner notes that specific interpretations of respective electrodes defined in each set of the plurality of sets of the subset will be explained in more detail when needed below), and
an energy generator in communication with the treatment element (console 204 including the generator 216, controller 218), the energy generator being configured to transmit ablation energy to the plurality of sets in a first delivery pattern such that adjacent electrode sets deliver bipolar energy therebetween (the generator as defined above is capable of delivering energy in a bipolar manner between near/proximate sets electrode sets given the functionality set forth in at least [0072] providing for “each electrode can be individually activated and the polarity .. of each electrode can be selected by an operator or a control algorithm”; see also [0073] discussing the manner in which the energy to each electrode is individually controlled),
wherein, in the first delivery pattern, the energy generator is configured to:
electrically connect the first electrode and the second electrode of each electrode set to each other (see [0072], the system is capable of electrically connecting a first and second electrode to each other such as, for example, by setting each electrode to the same polarity),
electrically connect the first electrode and the second electrode of every other electrode set to a first polarity of the energy generator (see [0072], the system is capable of electrically connecting a first and second electrode of every other set to the same polarity; “each electrode can be individually activated and the polarity … of each electrode can be selected”).
electrically connect the first electrode and the second electrode of each of a plurality of remaining electrode sets to a second polarity of the energy generator (see [0072], the system is capable of electrically connecting a first and second electrode to each other such as, for example, by setting each electrode to the same polarity with such being either polarity of the generator 216),
electrically disconnect the third electrode of each electrode set from the energy generator (se [0072], the system capable of not selecting a third electrode).
Regarding claim 2, Townley provides that the energy generator is further configured to:
transmit ablation energy to the plurality of sets in a second delivery pattern such that adjacent electrode sets delivery bipolar energy therebetween. The Examiner is of the position the generator as defined in the rejection of claim 1 above is readily functionally capable of delivering energy in a bipolar manner between near/proximate electrode sets in a second pattern given, again, the functional capability of the system set forth in at least [0072] and [0073] discussing the manner in which the energy to each electrode is individually controlled.
Townley further provides that, in the second delivery pattern, the energy generator is configured to:
electrically connect the second electrode and the third electrode of each electrode set to each other (see [0072], the system is capable of electrically connecting a second and third electrode to each other such as, for example, by setting each electrode to the same polarity),
electrically connect the second electrode and the third electrode of every other electrode set to a first polarity of the energy generator (see [0072], the system is capable of electrically connecting a second and third electrode of every other set to the same polarity; “each electrode can be individually activated and the polarity … of each electrode can be selected”),
electrically connect the second electrode and the third electrode of each of a plurality of remaining electrode sets to a second polarity of the energy generator (see [0072], the system is capable of electrically connecting a second and third electrode to each other such as, for example, by setting each electrode to the same polarity with such being either polarity of the generator 216),
electrically disconnect the first electrode of each electrode set from the energy generator (se [0072], the system capable of not selecting a first electrode), and
Regarding claim 13, Townley provides for a system for the delivery of ablation energy, the system comprising: an energy generator having a first polarity and a second polarity (console 204 including the generator 216, controller 218; see the disclosure throughout that discloses the use of a positive polarity and a negative polarity such as in [0076]) and
a treatment element (element at 412) including a plurality of electrodes (the various electrodes at 444a-g) sequentially positioned along a carrier element (see figure 5D; the Examiner is of the position that the positioning of the electrodes along the splines 440 of the element 412 can be defined in a sequence so as to fit within the broadest reasonable interpretation of being “sequentially positioned” as required by the claim),
wherein in a delivery pattern: at least one active electrode of the plurality of electrodes is in electrical communication with one of the first polarity and the second polarity (see [0072] and [0073] discussing that each electrode 444 of the plurality of electrodes is independently controlled and switchable to a desired polarity; The Examiner is of the position that at least one electrode of the plurality of electrode can be connected to a first polarity in a desired delivery pattern in view of this disclosure), and
a plurality of active electrodes of the plurality of electrodes in electrical communication with another of the first polarity and the second polarity (see [0072] and [0073] discussing that each electrode 444 of the plurality of electrodes is independently controlled and switchable to a desired polarity; The Examiner is of the position that additional active electrodes of the plurality of electrode other than the above noted “at least one active electrode” can be connected to a second polarity different than that of the “at least one active electrode” in a desired delivery pattern in view of this disclosure).
Regarding claim 14, Townley provides that the at least one active electrode includes one active electrode (in view of the rationale set forth in the rejection of claim 13 above, a single one of 444a-g being selected as the “at least one active electrode”).
Regarding claim 15, Townley provides that the plurality of active electrodes includes at least two electrodes ((in view of the rationale set forth in the rejection of claims 13/14 above, at least two others of 444a-g being selected as the “the plurality of active electrodes”).
Regarding claim 16, Townley further provides that the system further comprises,
a first medical device including the treatment element having the plurality of electrodes (medical device formed by the inner device 1012 including the shaft and basket as in figure 10A/B; see also [0102] providing that this inner device can be embodied in the same manner as the device in figure 5D relied upon in the rejection of claim 13 above),
the plurality of electrodes including a first set of electrodes and a second set of electrodes, the first set of electrodes including the at least one active electrode (a first set of at least two electrodes including the active electrode as defined in the rejection above and a second electrode 444) and the second set of electrodes including the plurality of active electrodes (a second of at least three electrodes 444 including those as defined in the rejection of claim 13 above), the first set of electrodes and the second set of electrodes being different (the above interpretation provides that the first and second set of electrodes encompass various ones of 444 that are different from on another), the second set of electrodes including a greater number of electrodes than the first set of electrodes (the interpretation above contemplates that the first set includes two electrodes and the second set includes at least three electrodes), the plurality of electrodes having a first area (each electrode 444 of the plurality of electrodes as defined above would have first area), and
a second medical device including an electrode (shaft 1008 with the electrode 1060 thereon) having a second area that is greater than the first area (as shown in figures 10A and B, the area of electrode 1060 is displayed as larger than that of one of 1044),
wherein the energy generator is in communication with the treatment element, the energy generator being configured to selectively:
deliver bipolar energy through the plurality of electrodes (see [0103] contemplating the bipolar energy delivery), and
deliver unipolar energy through the plurality of electrodes and the ground electrode (via energy delivered via the positive polarity to 1044 and negative polarity to 1060),
the energy generator being further configured to deliver energy having the first polarity through the first set of electrodes and to deliver energy having the second polarity through the second set of electrodes such that a greater amount of energy is delivered through the first set of electrodes than the second set of electrodes (via the generator and the electrodes 1044 being individually connectable to a desired polarity and the generator capable of coupling more electrodes to a first polarity than to a second so as to drive more energy through a first at least one electrode than the second; see [0072] and [0073] disclosing the use of various control algorithms, individual control of the connection of each electrode to the generator, the individual control of polarity, etc.).
Regarding claim 17, Townley provides that the plurality of electrodes includes a third set of electrodes that is electrically disconnected from the energy generator (two additional electrodes 444 form a third set with such being capable of being not connected to the generator).
Regarding claim 18, Townley provides that the plurality of electrodes includes nine electrodes, the first set of electrodes including two electrodes and the second set of electrodes including five electrodes (in view of the interpretation in the rejections of claims 13 and 16 above, the plurality of electrodes includes nine electrodes with figure 5D providing for at least nine electrodes present on the device that can be considered the 9 forming the claimed plurality; this further supports that two of the nine can be considered as the first set and five of the nine can be considered as the second set).
Regarding claim 20, Townley provides that the treatment element includes a carrier element having an at least substantially circular shape (the treatment element has a substantially circular cross-section shape with respect to the embodiment in figure 5D), the plurality of electrodes being radially distributed on the carrier element (see for example, the electrodes 444 being radially distributed about the splines of the element of figure 5D), the first set of electrodes being at a first position on the carrier element and the second set of electrodes being at a second location on the carrier element that is approximately 1800 from the first position (via respective first and second electrodes being opposed 180 degrees from one another; see figure 5D).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al. (US Pat. Pub. 2016/0331459 A1) as applied to claim 1 above, and further in view of He (US Pat. Pub. 2003/0028185 A1).
Regarding claim 3, Townley provides for an elongate body having a distal portion and a proximal portion (204/408 having a proximal and a distal portion), and wherein the treatment element is positioned at the distal portion of the elongate body (as in the figures). While Townley provides for the treatment element to be generally cylindrical in shape, Townley fails to provides the plurality of electrodes of the treatment element include at least one concave electrode, the at least one concave electrode having at least one of a concave cylindrical configuration and a hemispherical configuration. He discloses a similar device as that of Townley having a plurality of electrode along a device. He specifically provides for the use of electrode that include a concave portion (see figures 7A/B with the plurality of concave portions at 76a on each of the individual electrode 76; see also fig. 9 providing for a first concave portion on a first side of the electrode 36 and a second concave portion at a second side of the electrode 36). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized concave portions as taught by He on each of the electrodes of Townley to provide for a combined electrode arrangement that increases the convective cooling of the electrode thereby allowing for the creation of a larger lesion by the device during treatment (see at least [0001] of He).
Regarding claim 4, in view of the combination of He above, the at least one concave electrode includes a plurality of concave electrodes, each of the plurality of concave electrodes having a concave cylindrical configuration.
Regarding claim 7, in view of the combination with He above, the combined device provides that the at least one concave electrode includes a plurality of concave electrodes each having a concave cylindrical configuration (via the combination with He above being applied to the plurality of electrodes), the treatment element including a flexible carrier element bearing the plurality of concave electrodes (the treatment element 442 of Townley is flexible).
Claim 8, 9 and 11are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al. (US Pat. Pub. 2016/0331459 A1) as applied to claim 1 above, and further in view of Littman et al. (WO 94/16619).
Regarding claims 8, 9 and 11, while Townley provides for the treatment element including the plurality of electrodes, Townley fails to specifically provides for at least one insulated protuberant segment, the at least one protuberant segment being immediately adjacent to the at least one electrode of the plurality of electrodes, the at least one insulated protuberant segment having at least one protrusion with a diameter that is greater than a greatest diameter of the at least one electrode.
Littmann discloses an exemplary manner of placing a plurality of electrodes on a flexible device for placement within the body. Littmann specifically provides for a plurality of electrodes (electrodes 46) on a carrier structure (shaft of device 22) wherein the arrangement includes at least one insulated protuberant segment (see figure 2 with the larger section of the distal portion of the shaft 42 in between each electrodes 46), the at least one protuberant segment being immediately adjacent to the at least one electrode of the plurality of electrodes (figure 2 displays the enlarged portions adjacent each 46), the at least one insulated protuberant segment having at least one protrusion with a diameter that is greater than a greatest diameter of the at least one electrode (figure 2 displays that the insulated portion has a larger diameter than each 46). Littmann further provides that the treatment element further includes a carrier element (shaft of 42 is a carrier element), each of the at least one electrode and the at least one insulated protuberant segment being on the carrier element (as in figure 2), the greatest diameter of the at least one electrode being greater than a diameter of the carrier element (again as shown in figure 2). Littman also provides that the treatment element includes an insulated carrier element (shaft of 42), the insulated carrier element defining the at least one insulated protuberant segment (via the extended segments defined above being a portion of the shaft 42).
Allowable Subject Matter
Claim 10 is 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.
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
Applicant argues with respect to independent claim 1 on pages 10-11 of the Remarks with respect to the prior rejection under 35 U.S.C 102(a)(1) as anticipated by Townley. Applicant specifically contends with respect to the disclosure of Townley that “Townley fails to teach or suggest that specific configuration of connections (both between electrodes as well as to different polarities of the energy generator) recited in independent claim 1”. Applicant further alleges that “the specific connections and controls described in FIGS. 5A-5G of Townley similarly fails to teach or suggest the subject matter of claim 1 as none of these embodiments disclose defining a plurality of sets of electrodes, wherein each set includes ‘a first electrode, a second electrode, and a third electrode’ or the specific connections and disconnections of electrodes within such set as recited in claim 1.”
The Examiner fails to find these arguments as persuasive.
Claim 1, as presently amended, requires:
“a treatment element having a plurality of electrodes, at least a subset of the plurality of the electrodes being arranged in a plurality of sets of a first electrode, a second electrode, and a third electrode”
The Examiner fails to find the requirement in claim 1 of at least two sets (as encompassed by “a plurality of sets”) with each set of the at least two sets including a first electrode, a second electrode and a third electrode to be more than an arbitrary grouping of the electrodes of the claimed medical device. At most, the medical device structurally requires six electrodes in total across the plurality of sets. This interpretation assumes that no electrodes are common between any of the claimed plurality of sets. Accordingly, the Examiner maintains the position set forth in the rejection of claim 1 above that, for example, figure 5D of Townley with the electrodes at 444a-g provide for a plurality of electrodes that can be defined as a plurality of sets of a first electrode, a second electrode, and a third electrode. The Examiner reiterates that the various electrodes as noted above can be defined in with a subset of the electrodes forming a first set including a first, second and third electrode and a second set that includes a separate first, second and third electrode. For the sake of argument, a first set can include electrodes 444a-c and a second set can include electrodes 444d-f.
Turning to the functional limitations prescribed to the claimed the claimed energy generator, the Examiner notes that the specific combinations and patterns of energy transmission set forth therein are all contained within functional limitations regarding the intended use of the claimed energy generator. It is well established that a functional 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.
In the instant case, the console 204 of Townley that includes the generator 216 and the controller 218 is readily capable of providing for the first delivery pattern as claimed. To reiterate, paragraph [0072] of Townley provides that “each electrode 444 can be operated independently of the other electrodes 444” such that “each electrode can be individually activated and the polarity and amplitude of each electrode can be selected by an operator or a control algorithm”. Accordingly, the Examiner has failed to find that the claimed first delivery pattern presently set forth in claim 1 functions to structurally distinguish the claimed energy generator from the prior art generator of Townley when the generator of Townley is readily structurally capable of providing for each of the connections for each of the first/second/third electrode of each of the first and the second set.
Applicant further argues with respect to independent claim 13 on pages 11-13 of the Remarks. Therein, Applicant contends that Townley displays in figures 5A-G for “a plurality of struts with electrodes disposed on one or more struts and none of these configurations teach or suggest ‘a plurality of electrodes sequentially positioned along a carrier element”. This is not persuasive.
The Examiner is of the position that Townley readily provides for “a treatment element including a plurality of electrodes sequentially positioned along a carrier element” when taken within the broadest reasonable interpretation of the claim language. In particular, the Examiner has take the treatment element to be the element at 412 in Townley and the carrier element to be the splines 440 of the element 412. Accordingly, the carrier element and the treatment element then include a plurality of electrodes in the form of the various electrodes at 444a-g. The Examiner maintains the position, as proffered in the rejection of claim 13 above, that the positioning of the electrodes along the splines 440 of the element 412 can be defined in a sequence so as to fit within the broadest reasonable interpretation of being “sequentially positioned” as required by the claim. There is nothing in the claim that requires any of the treatment element or the carrier element to be a single flexible structure akin to Applicant’s displayed 32/36 in the figures.
Applicant further argues with respect to claim 13 that Townley fails to provide for the specific configuration of connections set forth in the claim. Much like the remarks set forth with respect to claim 1 above, the Examiner is of the position that the delivery pattern requirement in claim 13 is a functional recitation of the intended use of the system set forth therein and that there is nothing in the functional requirement ath would result in a structural difference between the claimed invention and the disclosed system in Townley so as to patentably distinguish the claimed invention from that of Townley.
For the sake of completeness, the Examiner notes that Applicant’s amendments to claim 8 to overcome the prior issues under 35 U.S.C. 112(b) have necessitated the new grounds of rejection for claims 8, 9 and 11 under 35 U.S.C. 103 above. To this end, dependent claim 10 has been objected for depending on a rejected claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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, Joseph Stoklosa can be reached at (571) 272-1213. 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.
/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794