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.
Claim Objections
Claims 10 and 14 are objected to because of the following informalities: In claim 10, lines 3 and 5, both occurrences of “can be connected” should be replaced with -capable of being connected-; In claim 14, lines 2 and 4, both occurrences of “the electrode” should be replaced with -the at least one electrode-. Appropriate correction is required.
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.
Claim(s) 1-7 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melsky, U.S. 2022/0323143 (hereinafter Melsky).
Regarding claim 1, Melsky discloses (note figs. 1-3) an ablation catheter arrangement comprising: at least one inner catheter module having a first shaft (2) and a first flexible outer structure (8) fastened to the first shaft, said first flexible outer structure being configured to assume a collapsed state (note fig. 2) and an expanded state (note fig. 1/3); and an outer catheter module having a second shaft (1) and a second flexible outer structure (composed of 4’s) fastened to the second shaft, said second flexible outer structure being configured to assume an initial state (note fig. 2) and an end state (note fig. 1/3), wherein the second shaft is configured to receive an inner catheter module of the at least one inner catheter module in the second shaft in such a manner that the second flexible outer structure assumes the initial state when the first flexible outer structure is in the collapsed state, and the second flexible outer structure assumes the end state when the first flexible outer structure is in the expanded state (note paragraph 60).
Regarding claim 2, Melsky discloses (see above) an ablation catheter arrangement wherein the at least one inner catheter module is configured as a balloon catheter module or includes a balloon catheter module, and the first flexible outer structure is configured as a flexible membrane or includes a flexible membrane.
Regarding claim 3, Melsky discloses (see above) an ablation catheter arrangement wherein a plurality of electrodes (5) are arranged on an outer side of the second flexible outer structure.
Regarding claim 4, Melsky discloses (see above) an ablation catheter arrangement wherein the second flexible outer structure includes a plurality of ‘ribs’ (4) or is formed by a plurality of ‘ribs’ (4).
Regarding claim 5, Melsky discloses (see above) an ablation catheter arrangement wherein at least one electrode (5) is arranged or formed on each of the plurality of ribs (note figs. 1-3).
Regarding claim 6, Melsky discloses (see above) an ablation catheter arrangement wherein the second flexible outer structure is necessarily ‘basket-shaped’ (note fig. 1).
Regarding claim 7, Melsky discloses (see above) an ablation catheter arrangement wherein an inner shaft is arranged and configured in the second shaft in such a manner as to receive an inner catheter module of the at least one inner catheter module (note fig. 6; paragraph 100).
Regarding claim 10, Melsky discloses (see above) a device for the ablation of a tissue of a patient, comprising: an ablation catheter arrangement (see above); a ‘signal generator’ arrangement connected to or can be connected to the ablation catheter arrangement (note fig. 14); and a ‘control and evaluation unit’ (note fig. 14) connected to or can be connected to the ablation catheter arrangement and/or the signal generator arrangement.
Regarding claim 11, Melsky discloses (see above) a device wherein the signal generator arrangement includes a first signal generator (18) for generating a radio frequency (RF) signal and a second signal generator (29) for generating a signal for a pulsed field ablation (note paragraph 61).
Regarding claim 12, Melsky discloses (see above) a device wherein the control and evaluation unit is configured to actuate the first signal generator and/or the second signal generator to deliver a signal (note paragraph 70).
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) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melsky in view of Townley, U.S. 2016/0331459 (hereinafter Townley).
Regarding claims 8-9, Melsky discloses (see above) an ablation catheter arrangement wherein a plurality of electrodes are arranged on an outer side of the second flexible outer structure of the outer catheter module. However, Melsky fails to explicitly disclose an ablation catheter arrangement having an annular electrode attached to second shaft. Townley teaches a similar device comprising embodiments having an expandable distal assembly with electrodes thereon (note figs. 5D and 8-9), and comprising a different embodiment further including an annular electrode attached to an outer shaft (note fig. 10A). It is well known in the art that these different electrode configurations are widely considered to be interchangeable, as can be seen by the different embodiments depicted in Townley. 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 Melsky to comprise any of a number of different electrode configurations (including comprising an annular electrode attached to the second shaft). 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) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melsky in view of Edwards, U.S. 2008/0167649 (hereinafter Edwards).
Regarding claims 13-14, Melsky discloses (see above) a device comprising: an ablation catheter arrangement, a ‘signal generator’ arrangement, and a ‘control and evaluation unit’, wherein the signal generator arrangement includes multiple signal generators, and wherein the control and evaluation unit is configured to actuate the signal generators. However, Melsky fails to explicitly disclose that the control and evaluation unit is configured to actuate signal generators to deliver their signals in dependence on at least one electrode temperature, wherein the first signal generator delivers the signal if the electrode temperature falls below a temperature limit value and the second signal generator delivers the signal if the electrode temperature assumes or exceeds the temperature limit value. Edwards teaches a similar system comprising a controller (48) and multiple energy sources (note paragraphs 90 and 127), wherein the controller is configured to actuate the different energy sources (i.e., switch between said sources) based on sensed electrode temperature (note paragraphs 91 and 93). It is well known in the art that the use of feedback-based control results in increased safety and 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 system of Melsky to comprise a control and evaluation unit that is configured to actuate the different signal generators (i.e., switch between said generators) based on sensed electrode temperature, in order to utilize feedback-based control to increase safety and efficiency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2019/0231421 (Viswanathan).
U.S. 2003/0023287 (Edwards).
U.S. 2022/0378498 (Zhang).
U.S. 2022/0110675 (Govari).
U.S. 6,036,689 (Tu).
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
