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.
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.
Claim(s) 1-7, 9-18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Just et al., (US 20130172715; hereinafter Just) in view of Kordis et al., (US 20020198522), VanDusseldorp et al., (US 20030032953; hereinafter VanDusseldorp), and Hall et al., (US 20110213231; hereinafter Hall).
Regarding claim 1, Just (Figures 1-2 and 6-7) discloses an electrophysiology electrode basket catheter (10), comprising: an elongate, deformable shaft (20) defining a longitudinal axis and comprising a proximal end and a distal end ([0036]); a basket electrode assembly (112) coupled to the distal end of the elongate shaft (20), the basket electrode assembly (112) having a proximal portion, a distal portion, and a plurality of support members (124) extending between the distal portion of the basket electrode assembly (112) and extending proximally to a proximal hub (44), ([0044], [0046]); and a plurality of mapping electrodes (54) spaced along plurality of support members (124), ([0052]), wherein the basket electrode assembly (112) transitions between a first (collapsed) configuration and a second (expanded) configuration during operation, wherein the first configuration is different from the second configuration ([0040]), wherein the basket electrode assembly (112) is configured to provide ablation therapy to a target tissue ([0052]).
Just fails to disclose wherein distal portions of the support members are stacked at a distal tip in an axial direction along the longitudinal axis of the elongate shaft. However, Kordis (Figures 22-23) teaches an electrophysiology electrode basket catheter (10) comprising a basket electrode assembly (20), ([0073]-[0074]), with distal portions of the support members (22) stacked at a distal tip (24) in an axial direction along the longitudinal axis of the elongate shaft (40), ([0130]). It would have been obvious to substitute the distal portion configuration of the support members disclosed by Just with a stacked distal portion configuration of the support members, as taught by Kordis, since both distal portion configurations perform the same function of holding the support members together at the distal end of the device to form the shape of the basket electrode assembly, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Just/Kordis fails to teach a central irrigation structure disposed within the basket electrode assembly and extending from the distal end of the elongate catheter shaft comprising a plurality of irrigation ports spaced along the central irrigation structure and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft and through the basket electrode assembly via the plurality of irrigation ports, wherein the central irrigation structure extends along the longitudinal axis. However, VanDusseldorp (Figure 8) teaches a basket catheter comprising a central irrigation structure (14) disposed within a basket assembly (110) and extending from the distal end of an elongate catheter shaft (12) comprising a plurality of irrigation ports (16) spaced along the central irrigation structure (14) and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft (12) and through the basket electrode assembly (110) via the plurality of irrigation ports (16), wherein the central irrigation structure (14) extends along the longitudinal axis ([0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Just/Kordis to include a central irrigation structure disposed within the basket electrode assembly and extending from the distal end of the elongate catheter shaft comprising a plurality of irrigation ports spaced along the central irrigation structure and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft and through the basket electrode assembly via the plurality of irrigation ports, wherein the central irrigation structure extends along the longitudinal axis, as taught by VanDusseldorp, because the modification would provide irrigation ports throughout the length of the central lumen (VanDusseldorp; [0020]) providing an overall distribution of irrigation fluid throughout the basket structure.
Just/Kordis/VanDusseldorp fails to teach wherein each of the plurality of support members comprises a plurality of spine segments separated from each other by an elbow region. However, Hall (Figures 1-3D) teaches an electrophysiology electrode basket catheter (1) comprising a basket electrode assembly (10), wherein each of a plurality of support members (11) of the assembly (10) comprises a plurality of spine segments (straight segments) separated from each other by an elbow region (20), ([0041]-[0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Just/Kordis/VanDusseldorp to include each of the plurality of support members comprising a plurality of spine segments separated from each other by an elbow region, as taught by Hall, because the modification would provide a variance in flexibility along the support members, which can allow the support members to assume a different bent configuration or respond to external factors more positively than possible with support members having a static or near static flexibility or stiffness over the length (Hall; [0009]).
Regarding claim 2, Just (Figures 1-2 and 6-7) further discloses an adjusting member (expander) for transitioning the basket electrode assembly (112) between the first configuration and the second configuration, wherein the first configuration is a collapsed arrangement, and the second configuration is an expanded arrangement, wherein the adjusting member (expander) transitions the basket electrode assembly (112) to a third configuration between the first configuration and the second configuration ([0010], [0040]).
Regarding claim 3, Just (Figures 1-2 and 6-7) further discloses in the expanded arrangement, the plurality of electrodes (54) form a radial array of electrodes (54) in a plane perpendicular to the longitudinal axis ([0040], [0052]).
Regarding claim 4, Just (Figures 1-2 and 6-7) further discloses wherein each of the plurality of support members (124) includes a distal portion, a proximal portion, and an intermediate portion disposed between the distal portion and the proximal portion, wherein the plurality of electrodes (54) are disposed along the distal portion of each of the plurality of support members (124), ([0046], [0052]).
Regarding claim 5, Just (Figures 1-2 and 6-7) further discloses wherein the intermediate portion of each of the plurality of support members (124) twists radially rotationally about the longitudinal axis during operation ([0046]).
Regarding claim 6, Just (Figures 1-2 and 6-7) further discloses wherein the adjusting member (expander) is selectively and slidably moveable along the longitudinal axis ([0010], [0040]).
Regarding claim 7, Just (Figures 1-2 and 6-7) further discloses wherein the adjusting member (expander) extends into and is slidably received within the elongate shaft (20), ([0010], [0040]).
Regarding claim 9, Just (Figures 1-2 and 6-7) further discloses wherein the plurality of support members (124) are symmetric about the longitudinal axis in the first configuration and in the second configuration ([0040], [0046]).
Regarding claim 10, Just (Figures 1-2 and 6-7) further discloses wherein the basket catheter (10) is an ablation catheter ([0052]).
Regarding claim 11, Just (Figures 1-2 and 6-7) discloses a method for ablating target tissue within a heart of a patient to treat atrial fibrillation ([0004]), the method, comprising: advancing a sheath (delivery sheath) into cardiac vasculature of a body of a patient; advancing an electrophysiology electrode basket catheter (10) through the sheath (delivery sheath) and into the cardiac vasculature proximal to a target tissue ([0006], [0054]), the electrophysiology basket catheter (10) comprising: an elongate, deformable shaft (20) defining a longitudinal axis and comprising a proximal end and a distal end ([0036]); and a basket electrode assembly (112) coupled to the distal end of the elongate shaft (20) and having a proximal portion, a distal portion, and a plurality of support members (124) extending between the distal portion of the basket electrode assembly (112) and extending proximally to a proximal hub (44), ([0044], [0046]); and a plurality of mapping electrodes (54) spaced along the plurality of support members (124), ([0052]); transitioning the basket electrode assembly (112) from a first configuration to a second configuration during operation, wherein the first configuration is different from the second configuration ([0040]); and ablating the target tissue via the basket electrode assembly (112), ([0052]).
Just fails to disclose wherein distal portions of the support members are stacked at a distal tip in an axial direction along the longitudinal axis of the elongate shaft. However, Kordis (Figures 22-23) teaches an electrophysiology electrode basket catheter (10) comprising a basket electrode assembly (20), ([0073]-[0074]), with distal portions of the support members (22) stacked at a distal tip (24) in an axial direction along the longitudinal axis of the elongate shaft (40), ([0130]). It would have been obvious to substitute the distal portion configuration of the support members disclosed by Just with a stacked distal portion configuration of the support members, as taught by Kordis, since both distal portion configurations perform the same function of holding the support members together at the distal end of the device to form the shape of the basket electrode assembly, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Just/Kordis fails to teach a central irrigation structure disposed within the basket electrode assembly and extending from the distal end of the elongate catheter shaft comprising a plurality of irrigation ports spaced along the central irrigation structure and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft and through the basket electrode assembly via the plurality of irrigation ports, wherein the central irrigation structure extends along the longitudinal axis. However, VanDusseldorp (Figure 8) teaches a basket catheter comprising a central irrigation structure (14) disposed within a basket assembly (110) and extending from the distal end of an elongate catheter shaft (12) comprising a plurality of irrigation ports (16) spaced along the central irrigation structure (14) and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft (12) and through the basket electrode assembly (110) via the plurality of irrigation ports (16), wherein the central irrigation structure (14) extends along the longitudinal axis ([0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Just/Kordis to include a central irrigation structure disposed within the basket electrode assembly and extending from the distal end of the elongate catheter shaft comprising a plurality of irrigation ports spaced along the central irrigation structure and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft and through the basket electrode assembly via the plurality of irrigation ports, wherein the central irrigation structure extends along the longitudinal axis, as taught by VanDusseldorp, because the modification would provide irrigation ports throughout the length of the central lumen (VanDusseldorp; [0020]) providing an overall distribution of irrigation fluid throughout the basket structure.
Just/Kordis/VanDusseldorp fails to teach wherein each of the plurality of support members comprises a plurality of spine segments separated from each other by an elbow region. However, Hall (Figures 1-3D) teaches an electrophysiology electrode basket catheter (1) comprising a basket electrode assembly (10), wherein each of a plurality of support members (11) of the assembly (10) comprises a plurality of spine segments (straight segments) separated from each other by an elbow region (20), ([0041]-[0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Just/Kordis/VanDusseldorp to include each of the plurality of support members comprising a plurality of spine segments separated from each other by an elbow region, as taught by Hall, because the modification would provide a variance in flexibility along the support members, which can allow the support members to assume a different bent configuration or respond to external factors more positively than possible with support members having a static or near static flexibility or stiffness over the length (Hall; [0009]).
Regarding claim 12, Just (Figures 1-2 and 6-7) further discloses actuating an adjusting member (expander) to transition the basket electrode assembly (10) to a third configuration between the first configuration and the second configuration ([0010], [0040]).
Regarding claim 13, Just (Figures 1-2 and 6-7) further discloses in the second configuration, the plurality of electrodes (54) form a radial array of electrodes (54) distributed over a flat surface ([0040], [0052]).
Regarding claim 14, Just (Figures 1-2 and 6-7) further discloses wherein the plurality of electrodes (54) are disposed along a distal portion of each of the plurality of support members (124), ([0046], [0052]).
Regarding claim 15, Just (Figures 1-2 and 6-7) further discloses wherein the adjusting member (expander) extends into and is slidably received within the elongate shaft (20), ([0010], [0040]).
Regarding claim 16, Just (Figures 1-2 and 6-7) further discloses wherein transitioning the basket electrode assembly (10) from the first configuration to the second configuration includes moving intermediate portions of the plurality of support members (124) in an axial direction ([0040], [0046]).
Regarding claim 17, Just (Figures 1-2 and 6-7) further discloses wherein transitioning the basket electrode assembly (112) from the first configuration to the second configuration includes radially rotationally twisting the plurality of support members (214) about the longitudinal axis during operation ([0046]).
Regarding claim 18, Just (Figures 1-2 and 6-7) further discloses wherein the adjusting member (expander) is selectively and slidably moveable along the longitudinal axis ([0010], [0040]).
Regarding claim 21, Just (Figures 1-2 and 6-7) discloses an electrophysiology electrode basket catheter (10), comprising: an elongate, deformable shaft (20) defining a longitudinal axis and comprising a proximal end and a distal end ([0036]); a basket electrode assembly (112) coupled to the distal end of the elongate shaft (20), the basket electrode assembly (112) having a proximal portion, a distal portion, and a plurality of support members (124) extending between the distal portion of the basket electrode assembly (112) and extending proximally to a proximal hub (44), ([0044], [0046]); and a plurality of mapping electrodes (54) spaced along the plurality of support members (124), ([0052]), wherein the basket electrode assembly (112) is configured to provide ablation therapy to a target tissue ([0052]).
Just fails to disclose wherein distal portions of the support members are stacked at a distal tip in an axial direction along the longitudinal axis of the elongate shaft. However, Kordis (Figures 22-23) teaches an electrophysiology electrode basket catheter (10) comprising a basket electrode assembly (20), ([0073]-[0074]), with distal portions of the support members (22) stacked at a distal tip (24) in an axial direction along the longitudinal axis of the elongate shaft (40), ([0130]). It would have been obvious to substitute the distal portion configuration of the support members disclosed by Just with a stacked distal portion configuration of the support members, as taught by Kordis, since both distal portion configurations perform the same function of holding the support members together at the distal end of the device to form the shape of the basket electrode assembly, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Just/Kordis fails to teach a central irrigation structure disposed within the basket electrode assembly and extending from the distal end of the elongate catheter shaft comprising a plurality of irrigation ports spaced along the central irrigation structure and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft and through the basket electrode assembly via the plurality of irrigation ports, wherein the central irrigation structure extends along the longitudinal axis. However, VanDusseldorp (Figure 8) teaches a basket catheter comprising a central irrigation structure (14) disposed within a basket assembly (110) and extending from the distal end of an elongate catheter shaft (12) comprising a plurality of irrigation ports (16) spaced along the central irrigation structure (14) and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft (12) and through the basket electrode assembly (110) via the plurality of irrigation ports (16), wherein the central irrigation structure (14) extends along the longitudinal axis ([0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Just/Kordis to include a central irrigation structure disposed within the basket electrode assembly and extending from the distal end of the elongate catheter shaft comprising a plurality of irrigation ports spaced along the central irrigation structure and along the longitudinal axis, wherein irrigation fluid is directed from the distal end of the elongate shaft and through the basket electrode assembly via the plurality of irrigation ports, wherein the central irrigation structure extends along the longitudinal axis, as taught by VanDusseldorp, because the modification would provide irrigation ports throughout the length of the central lumen (VanDusseldorp; [0020]) providing an overall distribution of irrigation fluid throughout the basket structure.
Just/Kordis/VanDusseldorp fails to teach wherein each of the plurality of support members comprises a plurality of spine segments separated from each other by an elbow region. However, Hall (Figures 1-3D) teaches an electrophysiology electrode basket catheter (1) comprising a basket electrode assembly (10), wherein each of a plurality of support members (11) of the assembly (10) comprises a plurality of spine segments (straight segments) separated from each other by an elbow region (20), ([0041]-[0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Just/Kordis/VanDusseldorp to include each of the plurality of support members comprising a plurality of spine segments separated from each other by an elbow region, as taught by Hall, because the modification would provide a variance in flexibility along the support members, which can allow the support members to assume a different bent configuration or respond to external factors more positively than possible with support members having a static or near static flexibility or stiffness over the length (Hall; [0009]).
Regarding claim 22, Just/Kordis/VanDusseldorp/Hall teaches the catheter of claim 1, and Just (Figures 32A-32C) further discloses a ring (176) having a plurality of indicator slots (180) coupled to the proximal end of the elongate shaft (20), wherein a proximal portion of each of the plurality of support members (60) is spaced along and coupled to an outer circumference of the ring (176) relative to the plurality of indicator slots (180) through a respective notch (174), wherein the proximal portions of each of the plurality of support members (60) are parallel to each other and the longitudinal axis of the elongate shaft (20), ([0149]).
Just/Kordis/VanDusseldorp fails to teach at least two shaft electrodes disposed at the distal end of the elongate shaft and spaced apart for visualization and mapping. However, Hall (Figure 2A) teaches at least two shaft electrodes (19) disposed at the distal end of an elongate shaft (16) and spaced apart for visualization and mapping ([0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Just/Kordis/VanDusseldorp to include at least two shaft electrodes disposed at the distal end of the elongate shaft and spaced apart for visualization and mapping, as taught by Hall, because the modification would provide visualization and mapping functionality (Hall; [0047]) to properly guide the catheter during treatment.
Regarding claim 23, Just/Kordis/VanDusseldorp/Hall further teaches wherein the plurality of mapping electrodes spaced along the plurality of support members between the elbows. Specifically, the modified catheter taught by Just/Kordis/VanDusseldorp/Hall would include the plurality of mapping electrodes spread along the plurality of support members as disclosed by Just, wherein the elbows taught by Hall are included in the plurality of support members. Therefore, the plurality of mapping electrodes would be spaced along the plurality of support members between the elbows in the modified catheter.
Response to Arguments
Applicant’s arguments filed 06/17/2026, with regard to the newly filed amendments of independent claims 1, 11, and 21 have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection is/are made in view of newly found prior art reference Hall, which teaches a basket catheter, wherein each of the plurality of support members comprises a plurality of spine segments separated from each other by an elbow region. In combination with Just/Kordis/VanDusseldorp, the modified device teaches the invention as recited at least in amended claims 1, 11, and 21.
Conclusion
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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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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