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 1-4, 7, 8, 14, 15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rydell (US 5,047,026) in view of Youssef (US 2008/0208121) and DeMello (US 6,695,836).
Regarding claims 1, 2, 4, 7, 8, 14, 15, 17 and 18, Rydell discloses a system capable of transseptal access comprising a core (20) and a functional tip ablation electrode (24). The system further includes an outer coil around a distal portion of the core proximal to the functional tip (12, col. 2 lines 35-37) and a second electrode (16). The core further includes an outer insulating material (22). Rydell does not disclose the core has a lumen or that the functional tip is electrically connected to an insulated conductor. While it could be argued otherwise since the feature is common in the art, Rydell will also be understood to not have the functional tip “coupled to” the end of the core or the second electrode “coupled to” the coil. Regarding the conductive elements being separate but coupled elements, this is common in the art and there is no evidence that using separate as opposed to integrally formed conductive elements produces an unexpected result (within the meaning of MPEP 716.02(a)). Youssef discloses another ablation system and teaches that an electrode can be integral with a conductor or coupled to the conductor ([0045]), which is understood to be a teaching functional equivalence of those configurations (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Rydell to include any commonly known functional tip/core and coil/second electrode arrangement, including one coupled to the other as taught by Youssef, that would produce the predictable result of functional ablation elements. Regarding the core having a lumen with a conductor connected to the functional tip, this is also an common configuration in the art. DeMello, for example, discloses an ablation system and teaches both that the functional tip can be integrally and electrically connected with a conductive core, or the functional tip can be electrically connected by a separate conductor within a lumen of the core (col. 3 line 58 to col. 4 line 7), which is again understood as a teaching of functional equivalence of those configurations (MPEP 2144.06). Therefore, before the Application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Rydell to include any commonly known electrical connection for the functional tip, including a conductor within a lumen of a core as taught by DeMello, that would produce the predictable result of a usable ablation electrode. Finally, while DeMello does not specifically disclose the conductor is insulated, this is common in the art (if an example is necessary, see Lundquist as cited in the previous Action). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Rydell to insulate the conductor, as is common in the art, to prevent or reduced unwanted electrical interaction between the conductor and other elements. It is noted that Rydell discloses a bipolar arrangement between the electrodes (col. 3 lines 15-30). This arrangement is only possible because the conductive elements that supply electrical energy to each respective electrode other are electrically isolated, otherwise, energy would not pass between the electrodes. Therefore, the conductor must be electrically isolated from the outer coil (which serves as a conductor for the other electrode), one way or another, if the electrodes are to function as described by Rydell (and when modified as discussed above). That is, if the conductors are in electrical contact, the electrodes will not be able to function as bipolar electrodes and so the modifications to Rydell are understood not to deviate from this electrical configuration. In the interest of compact prosecution, see the Conclusion below for a discussion of insulation in bipolar electrosurgical systems.
Regarding claim 3, Rydell discloses as a primary embodiment an electrically insulating coating over the exterior surface of the outer coil (18, fig. 2) and therefore does not recite the claimed inner and outer layers. However, Rydell does teach that other ways of insulating the outer coil are possible, including anodizing the surface of the outer coil (col. 2 lines 59-61). This would result in the outer coil having an inner conductive layer (the un-anodized core) and an outer insulative layer surrounding the inner conductive layer (the anodized exterior surface). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Rydell to include any commonly known type of insulation, including anodizing an external surface of the outer coil, that would produce the predictable result of preventing unwanted electrical interaction between the bipolar conductors. In the interest of compact prosecution, see the Conclusion below for a reference that discloses a polymer insulation for a conductive coil.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rydell, Youssef and DeMello, further in view of Ogata (US 2016/0235463).
Regarding claim 5, Rydell as modified does not disclose the core is a hypotube. However, using hypotubes as a core for an ablation device is common in the art, such as taught by Ogata ([0027]) where it has been held that the simple substitution of one known element for another is an obvious modification (MPEP 2141(III)), where in this case the known elements are a solid core and a hypotube. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any commonly known core construction, including using a hypotube as taught by Ogata, that would produce the predictable result of a functional ablation system.
Claims 6, 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rydell, Youssef and DeMello, further in view of Ciarrocca (US 20020095152).
Regarding claims 6, 12 and 16, the system of Rydell does not disclose that the hollow core is made from a non-conductive material. However, creating hollow cores (i.e. tubes) out of coated metals or polymers such as polyimide is very common in the art and the fact that Applicant has claimed mutually exclusive constructions for the hollow core suggests that neither produces an unexpected result. Ciarrocca discloses an ablation system and teaches that a hollow core can be made out of insulated metal or out of an insulating material such as polyimide ([0230]), a teaching that these tube structures are functionally equivalent (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Rydell to include any commonly known hollow core construction, including by using polyimide as taught by Ciarrocca, that would produce the predictable result of a functional medical system. Any sufficiently small hollow core, such as in Rydell as modified, can be considered a “hypotube” (where it is noted Applicant’s specification is silent about a non-conductive hypotube, in fact specifically noting the hypotube is conductive, [0063]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rydell, Youssef and DeMello, further in view of Lupton (US 2015/0032027).
Regarding claims 9 and 19, the system of Rydell does not disclose that the core includes a helical groove along an outer surface for holding the conductor. However, this is a common arrangement for holding conductors and the fact that Applicant has disclosed several mutually exclusive species of conductor/core arrangements suggests that none of them produce an unexpected result. Lupton discloses a core with a helical groove for holding a conductor (fig. 1). It has been held that the simple substation of one known element for another is an obvious modification (MPEP 2141(III)), where in this case the known elements are a wire within a hollow core or a wire along an external, helical groove in a core. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Rydell to include any commonly known structure for routing a lead along a hollow core, including external, helical grooves in the core such as taught by Lupton, that would produce the predictable result of allowing a user to use the system to interact with tissue in a desired manner.
Claims 10, 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rydell, Youssef and DeMello, further in view of Reynolds (US 2004/0064069).
Regarding claims 10, 11 and 20, Rydell discloses the coil is covered by an insulating layer but does not disclose the use of radiopaque material or a polymer doped with radiopaque materials. However, providing ablation systems with radiopaque coils made in various ways is common in the art and there is no evidence either of the claimed ways produces an unexpected result. Reynolds, for example, discloses a coil for a guidewire and teaches that the coil can be made of any number of materials including polymers and radiopaque material, and doped with radiopaque material ([0026]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Rydell to include coils that are radiopaque either by using a radiopaque material and/or by doping any material including polymers with radiopaque material, both taught by Reynolds, that would produce the predictable result of allowing the system to be tracked by an imaging system. It is noted that Applicant’s specification is silent about radiopacity being provided by radiopaque material and radiopaque doping, but since this seems possible and essentially irrelevant to the inventive concept a similarly broad rejection is provided with the understanding that a person of ordinary skill in the art would be able to create this configuration if desired based on the ubiquity of both (see also MPEP 2144.06(I)).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rydell, Youssef and DeMello, further in view of McCaffrey (US 2020/0129196).
Regarding claim 13, Rydell does not disclose the conductor is made from the claimed materials. However, the claimed materially are commonly used for conductive elements in electrosurgical systems, such as taught by McCaffrey ([0115]) and there is no evidence that their use here produces an unexpected result. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Rydell to include any material commonly known for use as a conductor, including platinum-iridium alloys, copper or copper-tungsten alloys as taught by McCaffery that would produce the predictable result of a system that has desired mechanical and/or electrical properties.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but, to the degree they are relevant to the amended claims, are unpersuasive. The remarks engage in a degree of piecemeal analysis of the references which is typically not a persuasive line of argument. For example, the remarks note that neither DeMello nor Youssef disclose a particular relationship between a conductor, the core lumen and the outer coil. But this does not take into account the teachings of Rydell which clearly includes the conductor for one electrode being electrically isolated from the conductor of the other electrode such that the electrodes can function to generate a spark between them. Obviousness rejections are not only based on the explicit teachings of the cited references but also on the level of ordinary skill in the art. Such a person would recognize the conductors must be electrically isolated if the electrodes are to be operated in the bipolar manner described by Rydell. Stated differently, there is no reason why a person of ordinary skill in the art would be motivated to change the electrical configuration disclosed by Rydell even as other modifications are made. Those modifications include the use of distinct electrodes replacing exposed distal ends of leads such that the leads are not exposed to create electrodes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the conductors in bipolar systems being electrically insulated from each other along a length so as to prevent unwanted electrical interaction between conductors, see for example the abstract of US 4,905,691 to Rydell, paragraph [0056] of US 2007/0265617 to Falkenstein and paragraph [0038] of US 2009/0036899 to Carlton. Regarding another guidewire with a tip electrode, a coil and an insulated lead, see the discussion associated with figure 2 of US 4,984,581 to Stice. Regarding a teaching that a conductive wire coil can be provided with a polymer coating over an external surface rather than an anodized layer, see paragraph [0088] of US 2004/0049231 to Hafer.
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
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