DETAILED ACTION
Applicant's amendments and remarks, filed 11/7/25, are fully acknowledged by the Examiner. Currently, claims 1, 12, 14, and 15 are pending with claims 2-11, 13, and 16-25 canceled, and claims 1, 12, 14, and 15 amended. The following is a complete response to the 11/7/25 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 12, and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. it is at least unclear to examiner what level of rigidity is required to be substantially rigid, especially given the inflating and deflating balloon structure associated with the elongate ablation elements.
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 elongate 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 elongate ablation elements are substantially rigid.However, Kunis teaches ablation elements made of metal (par. [0133] and electrodes 172 as in Fig. 10 on balloons).
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. 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 elongate ablation elements are arranged to resiliently project radially from a 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, see the remarks, filed 11/7/25, with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kunis as a secondary reference.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794