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 1-5, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Basu (US 2021/0077183) in view of Weber (US 2015/0366608).
Regarding claims 1, 2, 5 and 21, Basu discloses an end effector (fig. 2B) comprising a flexible circuit with a plurality of electrodes (232) disposed on an insulative material (252, fig. 5, see also [0055] regarding the electrode traces also being disposed on the insulative material). Any part of the electrode exposed to the ambient environment, that is, not covered by insulation, constitutes a “contact surface” by definition. Basu explicitly shows the insulative material is contiguous with the contact surfaces (fig. 5), although if the electrodes are disposed on the insulative material and have exposed surfaces, it is unclear in what scenario the exposed surfaces would not be contiguous with the insulative material. Basu further discloses a framework (250, fig. 5) contagious to the insulative material and is formed around at least a portion of one of the flex circuits and/or the framework, such as, for example, when viewed from the angle shown in figure 2B. Basu clearly does not show the electrodes are disposed in the material such that the contact surface of the electrode is coplanar with the outer surface of the insulative material. However, the prior art is very familiar with electrode construction and teaches that electrodes in and on flexible substrates are both useful for the same purpose. Weber, for example, discloses electrodes (152, fig. 4) on a flexible substrate (130) and teaches that the electrode can be on the outer surface (as in Basu), or in the outer surface ([0087]). If the electrode is in the outer surface, it can further extend slightly above the surface, be flush/coplanar with the outer surface or be slightly recessed below the surface ([0087]). It is of note that Weber further teaches that another electrode (154) can have the same configuration as the first electrode ([0088]), thus teaching that the electrodes can have a different configuration from each other. Note the substrate must be insulative if the electrodes are to have different polarities ([0087]-[0088]) This is understood to be a teaching both that the level of ordinary skill in the art includes the knowledge of positioning electrodes relative to a surface and also of the functional equivalence of these configurations (MPEP 2144.06). It has been held that both the combination of known elements according to known methods to yield predictable results and the simple substitution of one known element for another are obvious modifications (MPEP 2141) where in this case the known element is the relationship of an electrode positioned on a flexible substrate. Therefore, before the application was filed, it would have been obvious to modify the electrodes of Basu to have any commonly known relationship to the flexible, insulative in and slightly above the substrate, in and slightly below the substrate, or in and flush with the substrate, all of which are taught by Weber, that would produce the predictable result of allowing a user to treat tissue using the electrodes and the substrate.
Regarding claims 3 and 4, each column (in the proximal-to-distal direction) of electrodes shown by Basu can be considered a flex circuit within the breath of the claim language (232, fig. 2B), resulting in four flex circuits, each having the characteristics described with respect to claims 1 and 2. The framework (250), spanning the array, also exists between the flex circuits.
Regarding claim 22, as discussed above with respect to claim 1 (the only claim from which 22 depends), Basu as modified discloses an insulative material (252, fig. 5) having coplanar electrodes (240, 232 and/or 234 in fig. 5, when modified as taught by Weber). This insulative material is a single insulative mass comprising polymer ([0055]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Basu and Weber, further in view of Voth (US 2021/0153932).
Regarding claim 6, the end effector of Basu does not disclose that a second flex circuit is disposed opposite the first flex circuit across the framework. However, placing electrodes as part of flex circuits on opposite sides of a framework is known in the art and there is no evidence that this configuration produces an unexpected result (within the meaning of MPEP 716.02(a)). Voth, for example, discloses a planar array of flex circuits with electrodes (274, fig. 7A) on opposite sides of a framework (276). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the at to modify the end effector of Basu to have any commonly known electrode configuration, including flex circuits with electrodes on opposite sides of the framework as taught by Voth, that would produce the predictable result of allowing a user to interact with tissue on either side of the end effector.
Regarding claims 7 and 8, Basu further discloses the contact surfaces are parallel to the outer surface of the insulative material which forms a contiguous, generally planar surface, such that the electrodes extend vertically and outwardly therefrom (232, fig. 5). Basu also teaches that the framework can be strips ([0054]) but does not specifically show that embodiment so that it is not clear what the relationship is between the insulative material and the strips (i.e. whether the strips are within a single mass of insulation). However, Basu does disclose sheets of insulation that extend between the various flex circuits (252/214 and 254-216, figs. 2B and 5), and it has been held that making elements integral is an obvious modification (MPEP 2144.04(V)(B)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the end effector of Basu to use any commonly known framework, including strips as taught by Basu, and to provide the sheets of insulation between the framework and the electrodes as integral elements (thus forming a single mass), that would produce the predictable result of a end effector that has desired mechanical and/or electrical properties useful for treating tissue according to the preferences of an operator. The claim language of “fused” is a product-by-process limitation as discussed above.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding other teachings of electrodes embedded/flush/coplanar with substrates, see also fig. 4 of US 2014/0276712 to Mallin. Regarding the general teaching that an electrode can be above, below or coplanar with a surface, see figs 11-13 of US 5,515,848 to Corbett. Regarding the general teaching that electrodes flush with the substrate can reduce the risk of damage to tissue as the device is navigated through the body, see paragraph [0024] of US 2006/0167448 to Kozel.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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