DETAILED ACTION
Applicant's amendments and remarks, filed 7/17/26, are fully acknowledged by the Examiner. Currently, claims 1, 12, 14, and 15 are pending with claims 1, 12, 14, and 15 amended. Applicant's amendment to claim 1 has overcome the previously filed 35 USC 112(b) rejection. The following is a complete response to the 7/17/26 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/17/26 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, 12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sara (US 2017/0135740) in view of Kunis (US 2007/0083194).
Regarding claim 1, Sara teaches a cardiac ablation system for treating cardiac tissue comprising a catheter (catheter 12) and a head, the head being an ablation end of the cardiac ablation system for cardiac tissue (head 18), and the catheter being a flexible tubular connector used by the cardiac ablation system to couple to the head (28 to connect to 18 as in par. [0026]), wherein:
the head comprises a plurality of elongate ablation elements (18 as multiple lobes 20); each ablation element is provided with a contact surface for contacting cardiac tissue and a flexible support body for supporting the contact surface (54), wherein an energy acting part is arranged on the contact surface (54 as the energy acting part);
at least some of the ablation elements are arranged for resilient engagement with the tissue (54 of lobes 20 to contact tissue as in par. [0029]);
the ablation elements are individually movable (20 inflates and deflates), the resilient engagement comprising resilient displacement (20 inflates and deflates to place the lobe accordingly and par. [0040]), the ablation element has two operating states of contraction and extension at the head position of the cardiac ablation system (lobes may be inflated and deflated); in the contraction state, a plurality of individual ablation elements aggregate with each other and present a minimum volume (lobes deflated as in Fig. 8); in the extension state, one or more mutually individual ablation elements open and adapt to various shape changes at the point where the cardiac tissue is contacted through the contact surfaces on each ablation element (Fig. 7, lobes inflated to contact cardiac wall as in par. [0037]), the head includes at least one inflatable balloon (18), the balloon coupled to the head and the ablation elements are arranged around a peripheral edge of the balloon (20 around 18), wherein on inflation, the balloon is arranged to bias the elongate ablation elements to be displaced so as to project radially outwards from a center of the head (as in at least Figs. 4-5).
Sara is not explicit regarding the balloon being a separate element from the ablation elements and being central to the ablation elements relative to a center of the head, the balloon individually movable relative to the ablation elements.
However, Kunis teaches ablation elements made of metal as a separate element from a balloon, the balloon being centered relative to the ablation elements and moving relative to the ablation elements. (par. [0133] and electrodes 172 as in Fig. 10 on a central balloon).
It would have been obvious to one of ordinary skill in the art to modify Sara with the electrodes as the ablation element as in Kunis, such that the device does RF . Sara suggests other energy modalities may be used such as RF energy, using electrodes (par. [0034]). Using the electrodes of Kunis as the energy modality would allow for such electrosurgical treatment of tissue on a balloon interface that can be adjusted.
Regarding claim 12, Sara teaches wherein the head includes a selectively movable housing, the housing arranged to selectively move the ablation elements from a distal or proximal position to a position opposite the distal or proximal position, such that the ablation elements are arranged to resiliently project radially from the center of the head (lobes 20 project from the head as in at least Fig. 5).
Regarding claim 14, Sara teaches wherein there are a plurality of balloons coupled to the head, the balloons selectively inflatable, the balloons arranged to be of a different inflation, the elements arranged to be displaced differently (Fig. 8).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sara in view of Kunis, in further view of Tilson (US 2015/0141917).
Regarding claim 15, Sara is silent wherein the balloons are annular.
However, Tilson teaches balloons for a similar ablation use as annular (par. [0214]).
It would have been obvious to one of ordinary skill in the art to modify Sara with the annular balloons of Tilson, allowing for blood flow through the balloons.
Response to Arguments
Applicant's arguments filed 7/17/26 have been fully considered but they are not persuasive. Kunis teaches ablation elements separate from the balloon for a different treatment modality, as desired by Sara.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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