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 § 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 3, 21, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rioux (US 2008/0119846), Shin (US 2019/0059994) and Byrd (US 2019/0307500).
Regarding claims 3, 21, 22 and 24, Rioux discloses an apparatus with a dilator shaft (102, fig. 14), a tip member at the end of the shaft and sized to fit into a human heart which includes an atraumatic distal tip configured to delivery electrical energy (120 and 128) and an exterior dilation surface adjacent to the tip, curving toward the tip, and configured to enlarge an opening made by the tip (129). Rioux further teaches that the dilation surface has a lumen within which the atraumatic distal tip is slidably received (112). The atraumatic distal tip includes an electrode which is part of a guidewire, the electrode configured for transmitting energy to an electrode on the dilator ([0106]). The apparatus of Rioux does not disclose that the tip member includes at least two bipolar tip members adjacent to each other on angular sides of the distal end of the shaft. However, bipolar tip electrodes are common in the art and it is noted that use of the word “dilator” results is a purely functional limitation (i.e. whether the elements are capable of dilation). Shin discloses a shaft with a distal end having at least two bipolar electrodes adjacent to each other across a gap on angular separated sides of a guidewire lumen (fig. 7, see also fig. 15). The electrodes have a “generally” semi-circular cross-sectional shape (at any given point along the longitudinal axis of the electrodes) that together define a “generally” circular cross-sectional shape that “generally” circumferentially surrounds a guidewire lumen (321, fig. 7). Further, the electrodes are located on “generally” cylindrical support body (320, fig. 6). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to provide the conductive tip of Rioux in any commonly known electrode configuration, including two adjacent tip electrodes on a support body such as taught by Shin, that would produce the predictable result of allowing a user to interact with tissue using the various electrodes. The apparatus of Rioux discloses using the atraumatic guidewire electrode to interact with tissue and the apparatus of Shin discloses using first and second electrodes to interact with tissue and on that basis it would be reasonable to include the functionality disclosed by Shin when the electrodes are incorporated into Rioux. However, in the interest of compact prosecution it is also noted that independently controllable electrodes are common in the art and there is no evidence that allowing modes of operation of the various electrodes produces an unexpected result (within the meaning of MPEP 716.02(a)). On the contrary, Applicant has provided limited support for this limitation in the specification. Figure 4B clearly shows bipolar energy passing between the guidewire electrode and a single dilator electrode (as in Rioux) while the discussion of figure 4I notes that dilator electrodes 331a-b can have energy pass between them and omits any discussion of a guidewire electrode (as in Shin). The claims appear to be a concatenation of these two embodiments which does not present any issues under 35 U.S.C. 112(a) because such features are very common in the art. Byrd discloses what can be considered a generic RF treatment device for use in the heart (fig. 1) and teaches that all the electrodes are provided with the ability to be selectively paired ([0038]). Further, it has been held that making an element adjustable is an obvious modification (MPEP 2144.04(V)(D)) where, generally speaking, allowing a user more control over the ablation procedure is beneficial. Therefore, before the application was filed, it would have been obvious to further modify the apparatus of Rioux to include wiring to allow any of the three electrodes to be operated in any combination such as taught by Byrd to produce the predictable result of allowing tissue to be treated according to the knowledge and/or preferences of an operator.
Claim 2 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Rioux, Shin and Byrd, further in view of Cosman (US 7,077,842).
Regarding claim 2, it is not immediately clear that the tip and dilation surface of Rioux define a dome shape. However, dome shapes defined by tips and dilation surfaces are common in the art. Figure 10 of Cosman, for example, shows the tip has a round shape and the dilation surface has a round shape, where the tip is movable relative to the dilation surface. Thus, when the tip is aligned with the dilation surface, together they would define a dome. It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to modify the translatable tip of Rioux to have any commonly known shape, including a round shape such as taught by Cosman, that would produce the predictable result of allowing the tip and dilation surface together to define a dome, thus allowing the device to be used to treat tissue in a desired manner.
Claims 8, 9, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Rioux in view of Gerhart (US 2009/0171187).
Regarding claims 8, 9, 25 and 26, the apparatus of Rioux does not disclose the use of an electromagnetic coil secured to the dilator shaft. However, navigation sensors are common in the art, and in fact Rioux does generally teach the apparatus can be visualized within the body ([0082]). Gerhart discloses an apparatus with a shaft supporting electromagnetic coils for tracking purposes (fig. 4). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Rioux to have electromagnetic tracking coils on the shaft as taught by Gerhart that would produce the predictable result of allowing a user to know where the apparatus is within the body.
Response to Arguments
Applicant's arguments filed 13 November 2025 have been fully considered but, to the extent they are relevant to the amendment claims, they are not persuasive.
First, Applicant has added structural language qualified by the word “generally.” This word results in extremely broad limitations because the only alternative is indefiniteness. For example, either the “generally” rounded prior shapes art are understood to encompass the claimed shapes or what the exact difference is between “generally” and not “generally” is unclear. While it is conceded that Shin discloses a different kind of electrode arrangement than disclosed, it is noted that the conclusions of this and/or the previous Action include references which show electrode/support structures which are closer to the disclosed invention.
Second, Applicant argues that one of ordinary skill in the art would not have combined the teachings of Rioux and Shin. This argument is not unpersuasive because it does not address the rationale presented in the rejection. The fact that the elements are known, the combination is made using processes known in the art, and the result of the modification does exactly what a person of ordinary skill in the art would expect is an argument for, not against, obviousness (MPEP 2141(III)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the general teaching that tip electrodes in medical devices can be placed on support members having an exactly cylindrical shape around a lumen, see figure 3 of US 4,532,924 to Auth.
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.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794