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.
Claim(s) 1-3, 5-6, 9-11, 13-14, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster, JR. et al., (US 6292695; hereinafter Webster) in view of Edwards et al., (US 20150045789; hereinafter Edwards).
Regarding claim 1, Webster (Figures 1 and 2B) discloses a method for controlling the size of an electrode (14) of a catheter (10), the method comprising: inserting, into an organ of a patient, a catheter (10) having an expandable distal-end assembly (12), which is coupled to a shaft (32) and comprises multiple splines, wherein at least a given spline among the multiple splines comprises an electrode (basket 12 uninsulated along the entire length as shown in Figure 2B) configured to be placed in contact with tissue of the organ (Col. 6, lines 50-60; Col, 9, lines 25-40).
Webster fails to disclose controlling at least a size of a section of the electrode that is exposed to the tissue by moving an outer tube over at least a portion of the expandable distal-end assembly, the outer tube having an upper edge contacting outer regions of the multiple splines to thereby control a degree of expansion of the expandable distal-end assembly as the outer tube moves over the at least a portion of the expandable distal end assembly, and maintaining a physical separation between the multiple splines while the tube is over the at least a portion of the expandable distal-end assembly based on sliding the multiple splines through multiple channels formed in the outer tube, the multiple channels being enclosed within the outer tube, the multiple channels moving with the outer tube as the outer tube moves over the at least a portion of the expandable distal end assembly. However, Edwards (Figure 2b) teaches a method for controlling the size of an end effector (20) of a catheter (10), comprising controlling at least a size of a section of the end effector (20) that is exposed to the tissue by moving an outer tube (18) over at least a portion of the expandable distal-end assembly (20), the outer tube (20) having an upper (outer) edge contacting outer regions of the multiple splines (21) to thereby control a degree of expansion of the expandable distal-end assembly (21) as the outer tube (18) moves over the at least a portion of the expandable distal end assembly (20), and maintaining a physical separation between multiples splines (21) while the tube (18) is over at least the at least a portion of the expandable distal-end assembly (20) based on sliding the multiples splines (21) through multiple channels (19) formed in the tube (18), the multiple channels (19) being enclosed within the outer tube (18), the multiple channels (19) moving with the outer tube (18) as the outer tube (18) moves over the at least a portion of the expandable distal end assembly (20), ([0048]-[0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster to include the steps of controlling at least a size of a section of the electrode that is exposed to the tissue by moving an outer tube over at least a portion of the expandable distal-end assembly, the outer tube having an upper edge contacting outer regions of the multiple splines to thereby control a degree of expansion of the expandable distal-end assembly as the outer tube moves over the at least a portion of the expandable distal end assembly, and maintaining a physical separation between the multiple splines while the tube is over the at least a portion of the expandable distal-end assembly based on sliding the multiple splines through multiple channels formed in the outer tube, the multiple channels being enclosed within the outer tube, the multiple channels moving with the outer tube as the outer tube moves over the at least a portion of the expandable distal end assembly, as taught by Edwards, because the modification would ensure each spline is separated during deployment (Edwards; [0048]-[0049]) to prevent any tangled/stuck wires and ensuring a uniform movement of the splines to form the basket structure as required. Furthermore, in the modified device, the end effector would be the electrode of the primary reference (basket 12 uninsulated along the entire length as shown in Figure 2B of Webster).
Regarding claim 2, Webster (Figures 1 and 2B) further discloses wherein controlling at least the size comprises, controlling a position of at least the given spline (14) along a perimeter of the tube (40), (Col. 6, lines 50-60; Col, 9, lines 25-40).
Regarding claim 3, Webster (Figures 1 and 2B) further discloses wherein the splines are coupled between a distal apex and a proximal apex of the distal-end assembly (12), and wherein controlling at least the size comprises: (i) moving the tube (40) toward the proximal apex for increasing the size of the section, and (ii) moving the tube (40) toward the distal apex for reducing the size of the section (Col. 6, lines 50-60; Col, 9, lines 25-40).
Regarding claim 5, Webster (Figures 1 and 2B) further discloses wherein at least the given spline is electrically conductive and the electrode (14) is used for one or both of: (i) applying an ablation signal to the tissue, and (ii) sensing an electro-anatomic (EA) signal in the tissue (Col. 11, lines 1-25; Col, 12, lines 12-35).
Regarding claim 6, Webster (Figures 1 and 2B) further discloses (i) applying the ablation signal when the size of the section is increased, and (ii) sensing the EA signal when the size of the section is reduced (Col. 6, lines 50-60; Col, 9, lines 25-40; Col. 11, lines 1-25; Col, 12, lines 12-35).
Regarding claim 9, Webster (Figures 1 and 2B) discloses a catheter (10) with an adjustable size electrode (14), the catheter (10) comprising: a shaft (32) for insertion into an organ of a patient; an expandable distal-end assembly (12), which is coupled to the shaft (32) and comprises multiple splines, wherein at least a given spline among the multiple splines comprises an electrode (14) that is configured to be placed in contact with tissue of the organ (Col. 6, lines 50-60; Col, 9, lines 25-40).
Webster fails to disclose an outer tube, which is configured to be threaded over at least a portion of the expandable distal-end assembly, and is movable along the distal-end assembly for controlling at least a size of a section of the electrode in contact with the tissue, such that the outer tube is configured to encompass an exterior region of the expandable distal-end assembly, wherein the tube is formed with multiple channels configured to physically separate the multiple splines while the tube is over the encompassed exterior region of the distal-end assembly, the multiple channels being enclosed within the outer tube. However, Edwards (Figure 2b) teaches a method for controlling the size of an end effector (20) of a catheter (10), comprising controlling at least a size of a section of the end effector (20) that is exposed to the tissue by moving an outer tube (18) over at least a portion of the expandable distal-end assembly (20), the outer tube (20) having an upper (outer) edge contacting outer regions of the multiple splines (21) to thereby control a degree of expansion of the expandable distal-end assembly (21) as the outer tube (18) moves over the at least a portion of the expandable distal end assembly (20), and maintaining a physical separation between multiples splines (21) while the tube (18) is over at least the at least a portion of the expandable distal-end assembly (20) based on sliding the multiples splines (21) through multiple channels (19) formed in the tube (18), the multiple channels (19) being enclosed within the outer tube (18), the multiple channels (19) moving with the outer tube (18) as the outer tube (18) moves over the at least a portion of the expandable distal end assembly (20), ([0048]-[0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster to include the steps of controlling at least a size of a section of the electrode that is exposed to the tissue by moving an outer tube over at least a portion of the expandable distal-end assembly, the outer tube having an upper edge contacting outer regions of the multiple splines to thereby control a degree of expansion of the expandable distal-end assembly as the outer tube moves over the at least a portion of the expandable distal end assembly, and maintaining a physical separation between the multiple splines while the tube is over the at least a portion of the expandable distal-end assembly based on sliding the multiple splines through multiple channels formed in the outer tube, the multiple channels being enclosed within the outer tube, the multiple channels moving with the outer tube as the outer tube moves over the at least a portion of the expandable distal end assembly, as taught by Edwards, because the modification would ensure each spline is separated during deployment (Edwards; [0048]-[0049]) to prevent any tangled/stuck wires and ensuring a uniform movement of the splines to form the basket structure as required. Furthermore, in the modified device, the end effector would be the electrode of the primary reference (basket 12 uninsulated along the entire length as shown in Figure 2B of Webster).
Regarding claim 10, Webster (Figures 1 and 2B) further discloses wherein the tube (40) has at least a channel for controlling a position of at least the given spline along a perimeter of the tube (40), (Col. 6, lines 50-60; Col, 9, lines 25-40).
Regarding claim 11, Webster (Figures 1 and 2B) further discloses wherein the splines are coupled between a distal apex and a proximal apex of the distal-end assembly (12), and wherein the tube (40) is configured to be moved: (i) toward the proximal apex for increasing the size of the section, and (ii) toward the distal apex for reducing the size of the section (Col. 6, lines 50-60; Col, 9, lines 25-40).
Regarding claim 13, Webster (Figures 1 and 2B) further discloses wherein at least the given spline is electrically conductive and the electrode (14) is configured to perform one or both of: (i) applying an ablation signal to the tissue, and (ii) sensing an electro-anatomic (EA) signal in the tissue (Col. 11, lines 1-25; Col, 12, lines 12-35).
Regarding claim 14, Webster (Figures 1 and 2B) further discloses wherein at least the electrode (14) is configured to: (i) apply the ablation signal when the size of the section is increased, and (ii) sense the EA signal when the size of the section is reduced (Col. 6, lines 50-60; Col, 9, lines 25-40; Col. 11, lines 1-25; Col, 12, lines 12-35).
Regarding claim 22, Webster (Figures 1 and 2B) discloses a catheter (10) with an adjustable size electrode (14), the catheter (10) comprising: a shaft (32) for insertion into an organ of a patient; an expandable distal-end assembly (12), which is coupled to the shaft (32) and comprises multiple splines, wherein at least a given spline among the multiple splines comprises an electrode (14) that is configured to be placed in contact with tissue of the organ (Col. 6, lines 50-60; Col, 9, lines 25-40).
Webster fails to disclose an outer tube, the outer tube being movable along an exterior region of the expandable distal-end assembly to thereby control a degree of expansion of the expandable distal-end assembly, the outer tube defining a plurality of channels, each channel of the plurality of channels slidably receiving a respective spline of the multiple splines, the multiple splines being configured to slide within the plurality of channels of the outer tube as theouter tube is moved along the exterior region of the expandable distal-end assembly, such that the multiple splines cooperate with the plurality of channels of the outer tube to maintain physical separation of the multiple splines as the outer tube is moved along the exterior region of the expandable distal-end assembly, the plurality of channels being enclosed within the outer tube. However, Edwards (Figure 2b) teaches a method for controlling the size of an end effector (20) of a catheter (10), comprising controlling at least a size of a section of the end effector (20) that is exposed to the tissue by moving an outer tube (18) over at least a portion of the expandable distal-end assembly (20), the outer tube (20) having an upper (outer) edge contacting outer regions of the multiple splines (21) to thereby control a degree of expansion of the expandable distal-end assembly (21) as the outer tube (18) moves over the at least a portion of the expandable distal end assembly (20), and maintaining a physical separation between multiples splines (21) while the tube (18) is over at least the at least a portion of the expandable distal-end assembly (20) based on sliding the multiples splines (21) through multiple channels (19) formed in the tube (18), the multiple channels (19) being enclosed within the outer tube (18), the multiple channels (19) moving with the outer tube (18) as the outer tube (18) moves over the at least a portion of the expandable distal end assembly (20), ([0048]-[0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster to include the steps of controlling at least a size of a section of the electrode that is exposed to the tissue by moving an outer tube over at least a portion of the expandable distal-end assembly, the outer tube having an upper edge contacting outer regions of the multiple splines to thereby control a degree of expansion of the expandable distal-end assembly as the outer tube moves over the at least a portion of the expandable distal end assembly, and maintaining a physical separation between the multiple splines while the tube is over the at least a portion of the expandable distal-end assembly based on sliding the multiple splines through multiple channels formed in the outer tube, the multiple channels being enclosed within the outer tube, the multiple channels moving with the outer tube as the outer tube moves over the at least a portion of the expandable distal end assembly, as taught by Edwards, because the modification would ensure each spline is separated during deployment (Edwards; [0048]-[0049]) to prevent any tangled/stuck wires and ensuring a uniform movement of the splines to form the basket structure as required. Furthermore, in the modified device, the end effector would be the electrode of the primary reference (basket 12 uninsulated along the entire length as shown in Figure 2B of Webster).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster/Just, as applied to claim 3 above, and further in view of Marecki et al., (US 20150342491; hereinafter Marecki).
Regarding claim 4, Webster/Just teaches the method according to claim 3, but fails to teach that moving the tube comprises using a stopper of the tube for limiting the movement of the tube between the proximal apex and the distal apex of the distal-end assembly. However, Marecki (Figures 1-3B) teaches a method for controlling a catheter, wherein moving a tube (retractable sheath) comprises using a stopper (48) of the tube (retractable sheath) for limiting the movement of the tube (retractable sheath) between the proximal apex and the distal apex of a distal-end assembly (30), ([0061]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster/Just to include that moving the tube comprises using a stopper of the tube for limiting the movement of the tube between the proximal apex and the distal apex of the distal-end assembly, as taught by Marecki, because the modification would facilitate manipulation of the tube in relation to the distal-end assembly through a simple actuator (Marecki; [0061]), making the device easy to use.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster/Just, as applied to claim 5 above, and further in view of Xu et al., (US 20190298443; hereinafter Xu).
Regarding claim 7, Webster (Figures 1 and 2B) further discloses wherein applying the ablation signal comprises applying a unipolar ablation signal between the electrode (14) and an additional electrode (20), (Col. 6, lines 50-60; Col. 11, lines 1-25; Col, 12, lines 12-35), but Webster/Just fails to teach that the additional electrode is coupled to an inner surface of the tube or embedded within a wall of the tube. However, Xu (Figure 4) teaches a treatment method using a catheter, wherein an additional indifferent electrode (440) is embedded within a wall of an outer tube (450), ([0035], [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster/Just to include the additional electrode coupled to an inner surface of the tube or embedded within a wall of the tube, as taught by Xu, because the modification would position the additional electrode separately at a location that may be advantageous for the desired procedure, e.g., at a location that will minimize the side effects of therapy delivery on the patient (as evidenced by US 20130338467 to Grasse et al., hereinafter Grasse; [0074]).
Regarding claim 8, Webster (Figures 1 and 2B) further discloses wherein sensing the EA signal comprises sensing a unipolar EA signal between the electrode (14) and an additional electrode (20), (Col. 6, lines 50-60; Col. 11, lines 1-25; Col, 12, lines 12-35), but Webster/Just fails to teach that the additional electrode is coupled to an inner surface of the tube or embedded within a wall of the tube. However, Xu (Figure 4) teaches a treatment method using a catheter, wherein an additional indifferent electrode (440) is embedded within a wall of an outer tube (450), ([0035], [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster/Just to include the additional electrode coupled to an inner surface of the tube or embedded within a wall of the tube, as taught by Xu, because the modification would position the additional electrode separately at a location that may be advantageous for the desired procedure, e.g., at a location that will minimize the side effects of therapy delivery on the patient (as evidenced by Grasse; [0074]).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster/Just, as applied to claim 13 above, and further in view of Xu.
Regarding claim 15, Webster (Figures 1 and 2B) further discloses an additional electrode (20), wherein the distal-end assembly (12) is configured to apply a unipolar ablation signal between the electrode (14) and the additional electrode (20), (Col. 6, lines 50-60; Col. 11, lines 1-25; Col, 12, lines 12-35), but Webster/Just fails to teach that the additional electrode is coupled to an inner surface of the tube or embedded within a wall of the tube. However, Xu (Figure 4) teaches a treatment method using a catheter, wherein an additional indifferent electrode (440) is embedded within a wall of an outer tube (450), ([0035], [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster/Just to include the additional electrode coupled to an inner surface of the tube or embedded within a wall of the tube, as taught by Xu, because the modification would position the additional electrode separately at a location that may be advantageous for the desired procedure, e.g., at a location that will minimize the side effects of therapy delivery on the patient (as evidenced by Grasse; [0074]).
Regarding claim 16, Webster (Figures 1 and 2B) further discloses an additional electrode (20), wherein the distal-end assembly (12) is configured to sense a unipolar EA signal between the electrode (14) and the additional electrode (20), (Col. 6, lines 50-60; Col. 11, lines 1-25; Col, 12, lines 12-35), but Webster/Just fails to teach that the additional electrode is coupled to an inner surface of the tube or embedded within a wall of the tube. However, Xu (Figure 4) teaches a treatment method using a catheter, wherein an additional indifferent electrode (440) is embedded within a wall of an outer tube (450), ([0035], [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster/Just to include the additional electrode coupled to an inner surface of the tube or embedded within a wall of the tube, as taught by Xu, because the modification would position the additional electrode separately at a location that may be advantageous for the desired procedure, e.g., at a location that will minimize the side effects of therapy delivery on the patient (as evidenced by Grasse; [0074]).
Claim(s) 21 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster/Just, as applied to claim 9 above, and further in view of Marecki.
Regarding claims 21 and 12, Webster/Just teaches the catheter of claim 9, fails to teach wherein the tube has a stopper for limiting a movement of the tube between the proximal apex and the distal apex of the distal-end assembly. However, Marecki (Figures 1-3B) teaches a method for controlling a catheter, wherein moving a tube (retractable sheath) comprises using a stopper (48) of the tube (retractable sheath) for limiting the movement of the tube (retractable sheath) between the proximal apex and the distal apex of a distal-end assembly (30), ([0061]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Webster/Just to include the tube having a stopper for limiting a movement of the tube between the proximal apex and the distal apex of the distal-end assembly, as taught by Marecki, because the modification would facilitate manipulation of the tube in relation to the distal-end assembly through a simple actuator (Marecki; [0061]), making the device easy to use.
Response to Arguments
Applicant’s arguments, filed 01/14/2026, with regard to the newly amended claim limitations, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference Edwards, which teaches a catheter and method in which an outer tube of a basket catheter comprises channels carrying splines of the basket in order to control the size of the splines of the basket. In combination with Webster, the modified device/method teaches the invention as presently claimed in the amended claims 1, 9, and 22.
Conclusion
THIS ACTION IS MADE FINAL. 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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