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 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 43, 45-48 and 51-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pikus (US 2012/0065554).
Regarding claims 43, 45-48 and 51-56, Pikus discloses an apparatus (fig. 8) including an elongate body (104, see fig. 5), two laterally offset expandable members/occluders/balloons (112a/b) each with an electrode (113a/b) and outlets for delivering saline from a reservoir (i.e. wherever the saline is delivered from) into the space between the expandable members/occluders/balloons ([0070]). Saline, being conductive, results in an electrically conductive region. The apparatus further includes a pulse generator (since “pulse” is undefined and can mean application of energy over a time duration) and controller for controlling the delivery of electric fields (fig. 9). It is noted that the claim language of the occluders being located “on” the expandable member is being interpreted as extremely broad rather than indefinite (note paragraph [00077] of the submitted specification which states that the expandable members are the occluders, see also [00091]). The rest of the language in the claim is functional. 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, electrodes can be used to apply any signals to tissue and the saline will at least “disrupt” arcing between the electrodes.
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 44 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Pikus in view of Stewart (US 2019/0254735).
Regarding claims 44 and 60, Pikus does not disclose the use of a pulsed electric field generator. However, it is well established that various energy modalities can be used for the destruction of tissue including radiofrequency and electroporation, including by using nanosecond pulsed electric fields, such as taught by Stewart ([0054], see also [0051]) which is understood to be a teaching of functional equivalence (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to provide the apparatus of Pikus with a generator capable of outputting any energy known to be useful for ablation, including nanosecond pulsed electric fields such as taught by Stewart, that would produce the predictable result of allowing a user to ablate tissue in a desired manner.
Claims 57-59 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Deem 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]).
Claims 43, 49, 50, 52, 56, 61, 63 and 64 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 43, 49, 50, 52, 56, 61, 63 and 64, Deem discloses an apparatus with an elongate body (262, fig. 10), two expandable electrodes (264a/b) 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]). Deem does not disclose what material 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, including a conductive fluid such as taught by DeSimone, 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 claim 43 recites 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 at least reduce arcing relative to some hypothetical scenario (depending also on the parameters of a hypothetical electrical signal) once inflated by the conductive region fluid.
Response to Arguments
Applicant's arguments filed 27 February 2026 regarding the rejection of claim 1 in view of Pikus have been fully considered but they are not persuasive. First, Applicant reads limitations into the claim that are not there. The independent claims do not recite that the outlet is between the balloons. Instead, the claims recite that the outlet is intended to deliver a hypothetical material between the balloons. Pikey clearly discloses fluid delivery between the balloons both as noted in the rejection and in Applicant’s remarks. Further, even though the plain reading of the claims makes it clear that the outlet itself is not necessary between the balloons, dependent claims such as claim 51 clearly state that the outlet is not necessarily between the balloons. Thus, Applicant argues the rejection is improper on the grounds that the rejection accounts for some dependent claims. Second, Applicant asserts that the openings which allow fluid to leave the balloons are not outlets. This is not persuasive, not least because it is unclear how Applicant can read Pikus, note that fluid passes from inside the balloon to the space between the balloons, and decide that there is no way for fluid to pass through the balloon. Any structure that “lets” a fluid “out” can reasonably be considered an “outlet.” The claims require nothing more. Finally, it is noted that Applicant’s assertion that it would not be obvious to put a fluid inlet port on the shaft of Pikus because there is a teaching of using a vacuum to pull tissue in is unpersuasive. Pikus already has fluid delivery to the same space to which vacuum is applied and there is no evidence it makes any difference where the inlet/outlets are. Further, it is common in the art to provide fluid to a suction space by using spaced apart inlets/outlets (e.g. [0094] of US 2008/0114354 to Whayne).
Allowable Subject Matter
Claims 65 and 66 are 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.
The following is a statement of reasons for the indication of allowable subject matter: While using an outlet on a shaft between two balloons is fairly common in the art, there appears to be no teaching or suggestion to provide an extra sleeve outside the shaft and between the electrodes which supports the outlet in the context of the other limitations recited. The prior art seems content to put the outlet on the shaft itself without a superfluous “sleeve” (see e.g. 814 in fig. 10 of US 2018/0296264 to DeSimone, 46 in fig. 2 of US 2019/0117242 to Lawinger, 28 in fig. 7 of US 2003/0088246 to Swartz, 170 in fig. 7 of US 2015/0282858 to Baust, 88 in fig. 8 of US 5,464,437 to Reid, etc.). Ignoring the expandable members and electrodes, there are many references that use fluid outlets on sleeves (e.g. outlet 120 in sleeve 110 around shaft 116 in fig. 1 of US 2019/0380761 to Catanzaro and outlet 26 in sleeve 12 around shaft 52 in fig. 3 of US 4,869,246 to Adair) but there is no reason to combine those elements with prior art that does have the expandable members with electrodes.
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 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