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 1, 2, 6 and 13 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Lundquist (US 5,322,064).
Regarding claims 1, 2, 6 and 13, the claims describe a meaningful percentage of all ablation catheters with tip electrodes. Lundquist, for example, discloses what can be considered a generic ablation system (fig. 38) with a non-conductive core with a lumen (522, col. 20 lines 29-30), a functional tip coupled to the core (532), where the functional tip is connected to an RF generator by an insulated copper plated stainless steel conductor within the core lumen (541, col. 21 lines 4-5). The language directed to transseptal access is a functional limitation. 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, any ablation catheter with a tip electrode is capable of transseptal access.
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 1-4, 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 above). 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.
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 (18) 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding lead wires being provided with an insulative coating or not, see paragraph [0048] of US 2008/0125705 to Sato. Regarding the general teaching that a guidewire core can be solid or hollow, see paragraph [0058] of US 2008/0077049 to Hirshman. Regarding another relevant guidewire with RF tip electrode, core and coil, see fig. 8 of US 2021/0052860 to Alsheikh and figure 5 of US 9,387323 to Fleischhacker.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794