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.
Priority
The instant application is a division (DIV) of application number 17/319957, now U.S. Patent No. 12,064,170 with a filing date of 05/13/2021. The instant application was filed 08/09/2024. U.S. Patent No. 12,064,170 was granted 08/20/2024, therefore making the instant application co-pending with U.S. Patent No. 12,064,170. Therefore, the instant application is granted an effective filing date of 05/13/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/09/2024 was filed after the mailing date of the application on 08/09/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, and 14-15 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Just (US Patent No. 9,687,297 B2) herein after “Just”.
Regarding claim 1, Just teaches
“A method for producing a medical device, the method comprising (Abstract, "A method of constructing the family of catheter electrode assemblies is also provided"):”,
“forming a plurality of spines by: for each spine, placing a mandrel alongside a rib” in Figure 3, with the rib being the structural support member 94 found within spline 116 and taught in col. 9, lines 49-50 which states "Each spline may further comprise a structural support member 94", with the lumen 88 being formed by a mandrel (col. 7, lines 34-39 and col. 10, lines 15-25),
“molding a flexible polymer sleeve over the rib and the mandrel” in Figure 2 shows cover 90, which is a polymer (col. 7, lines 64-65) over the rib 94 and lumen 88. Just does describe "molding" the sleeve, but MPEP 2113 I states that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)",
“and after molding the sleeve, removing the mandrel so that the sleeve contains a lumen running parallel to the rib along one side surface of the spine” in Fig. 9 and col. 10, lines 15-25 which describes the use of a mandrel to form the liner tube 88. Figure 3 shows that the 88 does provide a lumen running parallel to the rib along the one side surface of the spine.
“fixing one or more electrodes to the sleeve of each of the spines” Just shows electrodes 62 and 64 on the outside of sleeve/cover 90 in Figure 2 and therefore teaches the limitation as described.
“and connecting respective proximal ends of the spines together to a distal end of an insertion tube which is configured for insertion into a body cavity of a patient.” Just teaches this limitation in Figure 7 with splines 116 connected to the outer tubing 112 and subsequently the catheter for insertion into a body cavity of the patient as shown in Figure 1.
Regarding claim 3, the limitations of claim 1 are taught as described above. Just teaches “wherein ribs are configured to collapse radially inward so that the spines are aligned along an axis of the insertion tube while the device is being inserted into the body cavity” in Fig. 6, which shows a collapsed configuration of the basket catheter where the splines are aligned along an axis of the insertion tube while the device is being inserted into the body cavity and therefore teaches the limitation as described.
Regarding claim 14, Just teaches
“A method for producing a medical device, the method comprising (Abstract, "A method of constructing the family of catheter electrode assemblies is also provided"):”,
placing a mandrel alongside a rib” in Figure 3, with the rib being the structural support member 94 found within spline 116 and taught in col. 9, lines 49-50 which states "Each spline may further comprise a structural support member 94", with the lumen 88 being formed by a mandrel (col. 7, lines 34-39 and col. 10, lines 15-25),
“molding a flexible polymer sleeve over the rib and the mandrel” in Figure 2 shows cover 90, which is a polymer (col. 7, lines 64-65) over the rib 94 and lumen 88. Just does describe "molding" the sleeve, but MPEP 2113 I states that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)",
“and after molding the sleeve, removing the mandrel so that the sleeve contains a lumen running parallel to the rib along one side surface of the spine” in Fig. 9 and col. 10, lines 15-25 which describes the use of a mandrel to form the liner tube 88. Figure 3 shows that the 88 does provide a lumen running parallel to the rib along the one side surface of the spine.
“the spine being configured for attachment to a distal end of an insertion tube such that the lumen aligns with an irrigation manifold of the medical device” in col. 3, lines 38-49 which states "electrode basket catheter can be irrigated in an embodiment such that the catheter 16 may further comprise an inner fluid delivery tubing that may include at least one fluid delivery port (e.g., within and/or at the junction of splines or at the splines themselves of the basket catheter). In the exemplary embodiment wherein the catheter 16 is an irrigated catheter, the catheter 16 can be connected to a fluid source 26 providing a biocompatible fluid such as saline, or a medicament, through a pump 28 (which may comprise, for example, a fixed rate roller pump or variable volume syringe pump with a gravity feed supply from the fluid source 26, as shown) for irrigation." Note that the inner fluid delivery tubing is considered to be the irrigation manifold under broadest reasonable interpretation.
Regarding claim 15, the limitations of claim 14 are taught as described above. Just shows that the rib is made of a material that can transition between an expanded configuration in Fig. 7 and collapsed configuration in Fig. 6 and therefore teaches the claimed limitation.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Just.
Regarding claim 2, the limitations of claim 1 are taught as described above. Just teaches "conjoining respective distal ends of the spines to form a basket assembly so that that ribs bow radially outward when the device is deployed in the body cavity" in Figure 7. Just does not explicitly teach that the electrodes can contact tissues in the body cavity, however, does teach that the device is not limited to a non-contact catheter (col. 3, lines 53-57) and can be configured for diagnosing and monitoring cardiac tissue (Fig. 1, col. 1, lines 20-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Just to use the electrodes to contact tissue in the body cavity. As shown in Fig. 1 and stated in col. 1, lines 20-55, it is known in the art to use electrophysiological catheters to contact the tissue of a body cavity to treat tissue and produces predictable results of creating lesions to disrupt cardiac activation pathways.
Regarding claim 4, the limitations of claim 1 are taught as described above. Just teaches “wherein the insertion tube comprises a flexible catheter configured for insertion into a chamber of a heart of the patient,” in Figure 1. Just does not explicitly teach that the electrodes can contact myocardial tissue and deliver energy, however, does teach that the device is not limited to a non-contact catheter (col. 3, lines 53-57) and can be configured for ablating cardiac tissue (Fig. 1, col. 1, lines 20-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Just to use the electrodes to contact tissue in the body cavity. As shown in Fig. 1 and stated in col. 1, lines 20-55, it is known in the art to use electrophysiological catheters to contact the tissue of myocardial tissue to deliver electrical energy to myocardial (a type of cardiac tissue) and produces predictable results of creating lesions to disrupt cardiac activation pathways.
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Just in view of West (WO 2004/112629), herein after “West”.
Regarding claim 5, the limitations of claim 1 are taught as described above. Just does not explicitly teach that the rib is a metal slat, but West does in an analogous catheter device. West teaches this limitation in p.[0016], lines 16-26 which states "In one preferred embodiment (see Fig. 3A), each basket arm 20 comprises an extruded body made e.g. from molded plastic (e.g., Peek), stainless steel, or nickel or titanium alloy." When viewed in combination with the system of West, Just could be designed to use a stainless steel extruded body as the rib, which would constitute as a metal slat under broadest reasonable interpretation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a metal slat as the rib, as taught in West, in Just. Using a metal slat as opposed to plastic or another suitable material for use in the human body prevents twisting of the spline/arm and is an obvious substitution known in the art for constructing arms/splines of the basket structure and produces predictable results of desired rigidity within the splines.
Regarding claim 16, the limitations of claim 14 are taught as described above. Just does not explicitly teach that the rib is a metal slat, but West does in an analogous catheter device. West teaches this limitation in p.[0016], lines 16-26 which states "In one preferred embodiment (see Fig. 3A), each basket arm 20 comprises an extruded body made e.g. from molded plastic (e.g., Peek), stainless steel, or nickel or titanium alloy." When viewed in combination with the system of West, Just could be designed to use a stainless steel extruded body as the rib, which would constitute as a metal slat under broadest reasonable interpretation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a metal slat as the rib, as taught in West, in Just. Using a metal slat as opposed to plastic or another suitable material for use in the human body prevents twisting of the spline/arm and is an obvious substitution known in the art for constructing arms/splines of the basket structure and produces predictable results of desired rigidity within the splines.
Claims 6-7 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Just in view of Palmer (US Patent No. 6,575,997 B1), herein after “Palmer”.
Regarding claim 6, the limitations of claim 1 are taught as described above. Just does not teach the limitation "wherein the flexible polymer sleeve comprises a thermoplastic elastomer", however, Palmer does. Palmer teaches this limitation in Col. 14, lines 4-9 "Alternate or additional materials for the basket portion of the device may include a shape memory polymer thermoset, elastomer, thermoplastic constituents such as nylon, or other metal either pure or alloyed, as well as composite materials such as a combination of glass, aramid, or carbon in a binding matrix. A secondary mesh of the same or dissimilar material may be added to the basket." Note that secondary mesh is similar to a sleeve and further that Palmer anticipates the use of a thermoplastic elastomer in the construction of the basket or spline structure. Thus, it is considered to be known in the art to use thermoplastic elastomers, either in addition to (in the form a sleeve, mesh, layer, coating, or otherwise) splines or as the structure of the splines entirely. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a thermoplastic elastomer sleeve, as taught in Palmer, in Just to
arrive at the claimed invention. Using a thermoplastic elastomer sleeve electrically isolates the remainder of the spline except the exposed electrodes and produces predictable results of encapsulation of the spline.
Regarding claim 7, the limitations of claim 6 are taught as described above. Neither Palmer nor Just explicitly teaches the step "molding the flexible polymer sleeve comprises heating the thermoplastic elastomer tube to a temperature sufficient to cause the thermoplastic elastomer tube to shrink to the shape of the rib and the mandrel", however, MPEP 2113 I state that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" Because Palmer teaches that the flexible polymer comprises a thermoplastic elastomer (which the Examiner notes would inherently be applied through the use of heating the thermoplastic elastomer to cause it to shrink), Palmer teaches the claimed invention
Regarding claim 17, the limitations of claim 14 are taught as described above. Just does not teach the limitation "wherein the flexible polymer sleeve comprises a thermoplastic elastomer", however, Palmer does. Palmer teaches this limitation in Col. 14, lines 4-9 "Alternate or additional materials for the basket portion of the device may include a shape memory polymer thermoset, elastomer, thermoplastic constituents such as nylon, or other metal either pure or alloyed, as well as composite materials such as a combination of glass, aramid, or carbon in a binding matrix. A secondary mesh of the same or dissimilar material may be added to the basket." Note that secondary mesh is similar to a sleeve and further that Palmer anticipates the use of a thermoplastic elastomer in the construction of the basket or spline structure. Thus, it is considered to be known in the art to use thermoplastic elastomers, either in addition to (in the form a sleeve, mesh, layer, coating, or otherwise) splines or as the structure of the splines entirely. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a thermoplastic elastomer sleeve, as taught in Palmer, in Just to arrive at the claimed invention. Using a thermoplastic elastomer sleeve electrically isolates the remainder of the spline except the exposed electrodes and produces predictable results of encapsulation of the spline.
Regarding claim 18, the limitations of claim 17 are taught as described above. Neither Palmer nor Just explicitly teaches the step "molding the flexible polymer sleeve comprises heating the thermoplastic elastomer tube to a temperature sufficient to cause the thermoplastic elastomer tube to shrink to the shape of the rib and the mandrel", however, MPEP 2113 I state that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" Because Palmer teaches that the flexible polymer comprises a thermoplastic elastomer (which the Examiner notes would inherently be applied through the use of heating the thermoplastic elastomer to cause it to shrink), Palmer teaches the claimed invention.
Claims 8-9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Just in view Wu (US 2016/0374582), herein after “Wu”.
Regarding claim 8, the limitations of claim 1 are taught as described above. Just teaches "coupling the lumen of each of the spines to an irrigation manifold running through the insertion tube" in col. 3, lines 38-49 which states "electrode basket catheter can be irrigated in an embodiment such that the catheter 16 may further comprise an inner fluid delivery tubing that may include at least one fluid delivery port (e.g., within and/or at the junction of splines or at the splines themselves of the basket catheter). In the exemplary embodiment wherein the catheter 16 is an irrigated catheter, the catheter 16 can be connected to a fluid source 26 providing a biocompatible fluid such as saline, or a medicament, through a pump 28 (which may comprise, for example, a fixed rate roller pump or variable volume syringe pump with a gravity feed supply from the fluid source 26, as shown) for irrigation." Note that the inner fluid delivery tubing is considered to be the irrigation manifold under broadest reasonable interpretation. However, Just does not teach the remaining limitations "and forming irrigation outlets through the flexible polymer sleeve to the lumen in a vicinity of the electrodes" and "whereby an irrigation fluid passing through the irrigation manifold exits the lumen through the irrigation outlets". Wu does teach these limitations in an analogous basket catheter device in p.[0048] which states "In other embodiments, irrigated ring electrodes 371 are carried on the spines 25, as shown in FIGS. 7A, 7B and 7C. Each spine 25 is covered by a respective multi-lumened tubing 80 having, for example, a first lumen 81 through which the spine extends, a second lumen 82 for lead wires 40S, and a third lumen 83 for passing irrigation fluid via a passage 88 formed in the sidewall of the tubing 80 to annular space gap G between outer wall of the tubing 80 and side wall of the ring electrode 371 which are formed with fluid ports 85" As shown in Figure 7A, the irrigation outlets pass through the multi-lumened tubing to the vicinity of the electrodes, which allows for fluid to pass through the irrigation lumen and exit through the irrigation outlets. Note that Just already anticipates the use of a flexible polymer sleeve and irrigation fluid structure, however, does not specifically teach irrigation outlets that pass through the sleeve to provide an exit for the irrigation fluid. Further note that while Wu describes ring electrodes instead of planar or flat electrodes, ring electrodes and planar electrodes are obvious variants of one another and produce predictable results. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Just in view of Wu to teach the limitations as described above. Placing the irrigation ports/outlets within the sleeve and adjacent to the electrodes allows for the irrigation fluid to be applied directly to the electrodes, which provides passive cooling, and also applies the irrigation fluid directly to the tissue being treated by the electrodes and provides predictable results of irrigating the electrodes.
Regarding claim 9, the limitations of claim 8 are taught as described above. Just does not teach the limitation "wherein the irrigation outlets include at least two irrigation outlets disposed around each electrode", however, Wu does. Wu teaches this limitation in Figure 7A. Figure 7A shows a plurality of irrigation outlets 85 surrounding electrode 371 and thus under broadest reasonable interpretation teaches this limitation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use at least two irrigation outlets disposed around the electrode, as taught in Wu, in Just. Providing additional irrigation outlets allows for more rapid cooling of the
electrode and treated tissue and produce predictable results of more rapidly cooled tissue.
Regarding claim 19, the limitation of claim 14 are taught as described above. Just does not teach the limitations "forming irrigation outlets through the flexible polymer sleeve to the lumen in a vicinity of the electrodes" and "whereby an irrigation fluid passing through the irrigation manifold exits the lumen through the irrigation outlets", but Wu does teach these limitations in an analogous basket catheter device in p.[0048] which states "In other embodiments, irrigated ring electrodes 371 are carried on the spines 25, as shown in FIGS. 7A, 7B and 7C. Each spine 25 is covered by a respective multi-lumened tubing 80 having, for example, a first lumen 81 through which the spine extends, a second lumen 82 for lead wires 40S, and a third lumen 83 for passing irrigation fluid via a passage 88 formed in the sidewall of the tubing 80 to annular space gap G between outer wall of the tubing 80 and side wall of the ring electrode 371 which are formed with fluid ports 85" As shown in Figure 7A, the irrigation outlets pass through the multi-lumened tubing to the vicinity of the electrodes, which allows for fluid to pass through the irrigation lumen and exit through the irrigation outlets. Note that Just already anticipates the use of a flexible polymer sleeve and irrigation fluid structure, however, does not specifically teach irrigation outlets that pass through the sleeve to provide an exit for the irrigation fluid. Further note that while Wu describes ring electrodes instead of planar or flat electrodes, ring electrodes and planar electrodes are obvious variants of one another and produce predictable results. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Just in view of Wu to teach the limitations as described above. Placing the irrigation ports/outlets within the sleeve and adjacent to the electrodes allows for the irrigation fluid to be applied directly to the electrodes, which provides passive cooling, and also applies the irrigation fluid directly to the tissue being treated by the electrodes and provides predictable results of irrigating the electrodes.
Claims 10-12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Just in view Wu, further in view of Wang (US 2009/0143779).
Regarding claim 10, the limitations of claim 9 are taught as described above. Neither Just nor Wu teach that the irrigation outlet is configured to direct irrigation fluid toward a respective electrode of the electrodes, but Wang does in an analogous irrigated catheter. Wang teaches in p.[0017] that "The at least one passageway is configured to direct a fluid flow through the outlet in a distal direction at a taper angle with respect to a longitudinal axis of the irrigated ablation electrode assembly. The external surface adjacent and distal to the outlet is tapered to expand outwardly in the distal direction at an angle substantially equal to the taper angle to allow the at least one passageway to produce an external flow that is generally parallel to the tapered external surface adjacent and distal to the outlet", where Figures 3 and 4A show that the fluid outlet is configured to direct irrigation fluid towards the electrode. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Wang in Just/Wu in order to arrive at the claimed invention. As stated in Wang p.[0035], angling the irrigation outlet "further assists in the delivery of the fluid to the targeted tissue areas, further decreases the risk of coagulation of the bodily fluids during ablation procedures, and allows for improved measurement and control of the ablation assembly 11 during operation. More specifically, the passageways 24 are oriented to direct irrigation fluid flow at the target area adjacent, preferably immediately adjacent, the intersection between the proximal member 20 and the distal member 18. Blood coagulation is more likely to occur in the target area due to a sharp rise in RF intensity."
Regarding claim 11, the limitations of claim 10 are taught as described above. Neither Just nor Wu nor Wang explicitly teaches “wherein a second irrigation outlet of the at least two irrigation outlets in the vicinity of each of the electrodes is configured to direct irrigation fluid away from the respective electrode of the electrodes” however it is the Examiner’s position that, pending a statement of criticality, changing the orientation of the irrigation outlets so the irrigation fluid is away from the electrode would have been one of a finite number of identified, predictable solutions, with a reasonable expectation of success. It is known in the art that irrigation is used to cool the catheter during use for improved temperature control while minimizing coagulation and unwanted tissue damage (as stated in p.[0008], p.[0018] of Wang) and produces predictable results of minimizing coagulation and tissue damage.
Regarding claim 12, the limitations of claim 9 are taught as described above. Neither Just nor Wu teaches the claimed limitation that " wherein the at least two irrigation outlets are formed to produce a desired irrigation flow pattern around each of the electrodes" but Wang does in an analogous irrigated catheter. Wang teaches in p.[0035] that the irrigation outlets can be "angled in a second dimension" to provide fluid to the external portion of the assembly in a swirling, or helical fashion (considered to be a desired irrigation flow pattern) around the electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Wang in Just/Wu. As stated in Wang, the use of this angled feature and swirling/helical irrigation pattern "keeps the fluid in closer proximity to the electrode assembly, thereby further preventing against coagulation during operation" and produces predictable results of limited coagulation of blood during operation.
Regarding claim 20, the limitations of claim 19 are taught as described. Neither Just nor Wu nor Wang explicitly teaches “wherein a second irrigation outlet of the at least two irrigation outlets in the vicinity of each of the electrodes is configured to direct irrigation fluid away from the respective electrode of the electrodes” however it is the Examiner’s position that, pending a statement of criticality, changing the orientation of the irrigation outlets so the irrigation fluid is away from the electrode would have been one of a finite number of identified, predictable solutions, with a reasonable expectation of success. It is known in the art that irrigation is used to cool the catheter during use for improved temperature control while minimizing coagulation and unwanted tissue damage (as stated in p.[0008], p.[0018] of Wang) and produces predictable results of minimizing coagulation and tissue damage.
Claim 13 rejected under 35 U.S.C. 103 as being unpatentable over Just in view Lim (US 2017/0202619), herein after “Lim”.
Regarding claim 13, the limitations of claim 1 are taught as described above. Just does not teach the limitation of "further comprising a wire through the lumen and connecting the wire electrically to at least one of the electrodes", however Lim does. Lim teaches this limitation in p.[0125] which states "A copper wire 1051 (50 to 100 micrometers in diameter) runs on the inside wall of the spline to connect to the electrode. (FIG. 6, FIG. 9). Each of the electrodes is attached via connecting wires and one or more connectors such as a conduit to an energy delivery apparatus, preferably an RF energy delivery unit, which is also attached to a patch electrode but preferably a conductive pad attached to the back of the patient." It would have been obvious to one of ordinary skill in the art to include a wire running through the lumen of the spline to attach and provide energy for the electrode, as taught in Lim, in Just. In order for the electrode to produce energy and treat the tissue as desired, energy must travel from an energy source through the wire to the electrode and produces predictable results of powering the electrode.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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