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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 June 2026 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.
Claims 52-56, 60, 61, 63, 64 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Deem (US 2015/0238242) in view of DeSimone (US 2018/0296264).
Regarding claims 52-56, 60, 61, 63, 64 and 67, Deem discloses an apparatus with an elongate body (262, fig. 10), two expandable members including electrodes (electrodes 264a/b on struts 266) separated by an occluder/balloon/third expandable member (268) supplied with a filling material (whatever fluid is used to inflate the balloon) by an outlet (whatever outlet allows fluid to inflate the balloon). The apparatus further includes a controller for controlling delivery of electric fields applied by a pulse generator (100, fig. 4, [0084], which can be a nanosecond pulsed field generator [0034]). While the claims do not require this specifically, in the interest of compact prosecution, Deem does not disclose a reservoir with a specific material (such as saline) is used to fill the third expandable member, presumably because a person of ordinary skill in the art would know how to fill a balloon, and thus does not disclose the material forms an electrically conductive region. However, using a conductive material is common in the art for inflating balloons. DeSimone, for example, discloses a similar device (fig. 10) and teaches that the balloon can be inflating using saline, water, carbon dioxide, air, or other commonly known material ([0039]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to inflate the third expandable member of Deem using any commonly known fluid from a reservoir, including a conductive fluid like saline such as taught by DeSimone (which would by definition “control conductivity” between the electrodes at least relative to a different fluid), that would produce the predictable result of allowing the balloon to be positioned and sized in a desired manner. The conductive fluid within the expandable member forms an electrically conductive region. It is noted that claims 52 and 63 recite some functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, the expandable member will prevent or disrupt arcing relative to some hypothetical scenario (depending also on the parameters of a hypothetical electrical signal) once inflated by the conductive region fluid.
Claims 57-59 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Deem and DeSimone, further in view of Burnett (US 2012/0136343).
Regarding claims 57-59 and 62, Deem does not disclose that the controller further confirms that the filling material has filled the space between the electrodes (i.e. the third expandable member) by using pressure to reach a sealing state between the third expandable member and tissue, after which pulsed energy is applied. However, confirming a medical device is in a desired state using sensed information prior to ablation is very common in the art. Burnett, for example, discloses an apparatus with a controller that confirms balloons are inflated to a desired pressure to seal against tissue prior to treating tissue ([0006]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the device of Deem to modify the controller to allow ensuring the third expandable member is inflated to a sealing state with tissue using pressure, prior to treating tissue, such as taught by Burnett, to produce the predictable result of allowing a user to treat tissue in a safe and effective manner. It is noted that a sealing pressure is understood to be one of the pressure values that would allow the third expandable member to perform the centering function disclosed by Deem ([0092]).
Response to Arguments
Applicant's arguments filed 27 February 2026 regarding the rejections in view of Deem have been fully considered but they are not persuasive. Applicant is reading limitations into the claims that the claim language does not require. The claims recite the purely functional limitation that the fluid employed “prevents or disrupts arcing” without reciting any of the electrical parameters applied to the electrode or the other circumstances that would influence that behavior including the type of tissue into which the apparatus is inserted, the size/shape/number of the electrodes/expandable members, the spacing between the electrodes or expandable members, etc. Regarding the independent claims, Applicant has not recited what specific material is employed at all. Further, the fact that Applicant appears to be arguing that a prior art device with not only the exactly claimed structure, but even the exactly claimed filling material, does not perform the claimed functions, suggests that there are significant issues under 32 U.S.C. 112(b) (because it is not clear what structure can be used to “prevent or disrupt arcing” if not the structure recited by the claim) and 35 U.S.C. 112(a) (because Applicant has in fact explicitly disclosed that saline can prevent or disrupt arcing, e.g. [0047] of the submitted specification). It is noted the rejections are generous with the claim limitations directed to the filling material. The independent claims do not positively recite the material (“configured to”) such that the rejections could easily have been Deem anticipating the claims on the grounds that Deem would be capable of being used with any fluid including one of the fluids claimed (where all fluids originate from “a reservoir”). But in the interest of compact prosecution, a specific reference is used that teaches saline can be used to inflate expandable members. It is further noted that it is well-established that the motivation for a combination of features other than that employed by Applicant is permissible (MPEP 2144(IV)). Therefore, the prior art need not express any particular concern for “preventing or disrupting arcing” as long as the structure disclosed renders the claimed structure, including structure capable of performing the claimed functions, an obvious modification. It is also noted that if Applicant has any question about how an amendment will be received relative to the rejections that exist, an interview can be conducted prior to submitting those amendments.
Allowable Subject Matter
Claims 43-51 are allowed.
Claim 66 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. See previous Action for reasons for indicating allowable subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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