DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 18, 2026 has been entered.
Currently, claims 1-4, 7-18 and 20 are pending with claims 5, 6 and 19 cancelled, claim 12 withdrawn and claims 1, 2, 13 and 16 amended. Claim 10 stands as objected to as being a dependent claim containing allowable subject matter. The following is a complete response to the May 18, 2026 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 programmed 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 of Townley is functionally programmed so as to deliver energy in a bipolar manner between various ones of the electrode sets; such is in few of the disclosure 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 [0073] discussing the manner in which the energy to each electrode is individually controlled; see also, [0046] providing the generator to include a controller with a memory that is programmed to cause the operation of the system),
wherein, in the first delivery pattern, the energy generator is programmed to:
electrically connect the first electrode and the second electrode of each electrode set to each other (see [0072], the generator of Townley is programmed to electrically connect 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 generator of Townley is programmed to electrically connect 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 generator of Townley is programmed to electrically connect 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 (see [0072], the generator of Townley is programmed so as to not select a third electrode).
Regarding claim 2, Townley provides that the energy generator is further programmed 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 programmed to electrically deliver energy in a bipolar manner between near/proximate electrode sets in a second pattern given, again, the programming of the system per the controller/algorithm/memory as in [0046], [0072] and [0073] discussing the manner in which the generator is programmed to provide each electrode to be 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 generator of Townley is programmed to electrically connect 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 generator of Townley is programmed to electrically connect 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 generator of Townley is programmed to electrically connect 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 (see [0072], the generator of Townley is programmed so as to not select a first electrode).
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 single 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 along a single carrier element” 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 programmed 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 programmed 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 (the generator of Townley is functionally programmed so as to deliver energy in a bipolar manner between various ones of the electrode sets; the generator and the electrodes 1044 are individually connectable to a desired polarity of the generator with the generator functionally programmed so as to couple 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; such is in view of the disclosure 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 [0073] discussing the manner in which the energy to each electrode is individually controlled; see also, [0046] providing the generator to include a controller with a memory that is programmed to cause the operation of the system).
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, 4 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 May 18, 2026 have been fully considered but they are not persuasive.
Applicant argues with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as anticipated by Townley (US Pat. Pub. 2016/0331459) on pages 7-9 of the Remarks. Therein, Applicant contends on page 8, with respect to the disclosure in paragraph [0072], that “the Office has failed to show that this portion of Townley teaches or suggests the specific configuration of connections … recited in independent claim 1”. Applicant further alleges that “the alleged mere capability of the system of Townley is insufficient to anticipate or render obvious the subject matter of claim 1.”
Applicant continues on page 8 in citing to paragraph [0085] of the filed Specification to provide insight that the disclosed generator has been described therein to include various structural features. Applicant then alleges, in citing to various court cases, that the term “configured to” should be interpreted to require that the system set forth in claim 1 is “intentionally designed for the claimed function”, and that “capability” in Townley fails to anticipate this claimed functionality. This is not persuasive.
The Examiner respectfully notes that claim 1 has been amended to remove the specific language of “configured to” therein. As such, while the Examiner recognizes Applicant’s arguments on pages 7-8, the Examiner fails to find such comments as persuasive given that claim 1 has been amended to recite the language of “programmed to” in place of “configured to”.
To this end, Applicant has further argued on pages 8-9 of the Remarks with respect to the updated language in claim 1 of “programmed to”. Applicant alleges, therein, that “the Office has not shown that mere capability alleged by the Office with respect to the system of Townley teaches or suggests a device specifically programmed to perform the functionality recited in independent claim [1] and, in fact, the Office has not shown that Townley makes mentions of defining electrodes into sets of ‘a first electrode, a second electrode, and a third electrode’ or the specific connections and disconnections of electrodes within such sets as recited in claim 1. This is not persuasive.
First, with respect to the disclosure of Townley and the Examiner’s interpretation in the rejection of claim 1 with respect to the claimed electrode sets, 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 require more than selected groupings of the plurality of electrodes of the claimed medical device. At most, the claimed 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 now-claimed programming of the energy generator and the various connections/disconnections of the respective electrodes of the various sets, the Examiner has updated the rejection of claim 1 to note that the position that the generator of Townley is indeed functionally programmed so as to deliver energy in a bipolar manner between selected electrodes of the electrodes of the electrode sets. Townley, much like the disclosed generator in filed paragraph [0085] highlighted on page 8 of the Remarks, requires its generator (taken as console 204) to include a processor/controller 218 containing programmed instructions therein that results in energy being delivered to the treatment element “in a specific manner”. [0046] highlights that this programmed functionality can be via “an automated control algorithm and/or to receive control instructions from an operator”. Paragraph [0072] provides further insight as to the programmed functionality of Townley’s generator in setting forth 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”. Paragraph [0073] provides further insight to the programmed functionality of the individual energy delivery to electrodes.
Thus, it is for at least the reasoning set forth above highlighting the functional programming of the console of Townley that the Examiner maintains that the Townley reference provides for a proper anticipatory rejection of independent claim 1. The above-discussed programming of the console 208 does indeed provide for each of the various connections/disconnections set forth in claim 1 between the various electrodes of the various sets given that the console 208 of Townley is programmed to individually electrically connect and disconnect the various electrodes of the treatment element in a desired pattern either selected by a user or via a customized control algorithm. In this manner, the Examiner finds that the instant energy generator fails to be structurally and/or functionally defined over console 208 of Townley having its controller/processor and memory with stored instructions given that the console 208 is indeed programmed in a manner to provide the various connections/disconnections set forth in the claimed first delivery pattern.
For the sake of completeness, the Examiner notes that substantially the same rationale as provided above with respect to independent claim 1 is equally applicable to dependent claim 16 and is requirement of the generator to be “programmed”.
Applicant further argues with respect to independent claim 13 on pages 9-10 of the Remarks. Therein, Applicant contends with respect to the amendments set forth in claim 13, that Townley fails to provide for “a plurality of electrodes sequentially positioned along a length of a single carrier element”, and that the Office “has not shown how the separate struts in Townley could be shown to teach or suggest a single carrier element with a plurality of electrode sequentially positioned along the single carrier element’s length.” 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 length of a single carrier element” when taken within the broadest reasonable interpretation of the present claim language. In the instant case, the Examiner has updated the interpretation of the Townley reference so as to rely on element at 412 as the claimed treatment element. This element 412 in Townley readily provides for a single carrier element in the form of the grouping of splines 440 forming the element 412. Accordingly, this single carrier element then includes a plurality of electrodes in the form of the various electrodes at 444a-g that are sequentially positioned along a single carrier element. The sequential positioning is shown in at least figure 5D with the positioning of the electrodes along the splines 440 of the element 412 in a sequence.
While Applicant appears to desire the claim term of “a single carrier element” to be afforded a narrower claim interpretation so as to preclude the interpretation of a plurality of struts of Townley to be applied as a “single carrier element”, the Examiner fails to find that the limitation of “a single carrier element” requires such an interpretation. The Examiner has also failed to find any specific disclosure or special definition in the filed Specification for the term of “single carrier element” that would effectively limit the interpretation to preclude the plurality of struts of being interpreted as “a single carrier element”. The Examiner further notes that while it is well established that the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Accordingly, the Examiner fails to find any requirement by the recitation of the term of “a single carrier element” in claim 13 to require structurally more than for the carrier element to be a single element that contains a plurality of electrodes sequentially disposed thereon. This, again, is met by the grouping of the plurality of splines 440 being considered a single carrier element within the broadest reasonable interpretation of term, and then having the electrodes 444a-g disposed along the splines 440 of the element 412 in a defined sequence so as to fit within the broadest reasonable interpretation of being “sequentially positioned along a single carrier element”.
If a narrower interpretation of the term of “a single carrier element” is desired, Applicant is invited to submit language in the claim to structurally define the single carrier element over the prior art carrier element of Townley.
The Examiner, therefore, is of the position that each of the rejections of independent claims 1 and 13 under 35 U.S.C. 102(a)(1) as being anticipated by Townley et al. (US Pat. Pub. 2016/0331459 A1) remain tenable for at least the reasoning articulated in the rejections and remarks above.
Conclusion
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.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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