DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/30/2026 has been entered.
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) 1-8 and 22-23 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), Lau et al., (US 8565851; hereinafter Lau), and Francis et al., (US 20160073913; hereinafter Francis).
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 outer 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 outer 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 outer 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 outer 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).
Webster/Edwards fails to teach sensing an electro-anatomic (EA) signal in the tissue via an electrode of at least one spline of the multiple splines and an additional electrode. However, Lau (Figure 13) teaches a method for using a catheter (36) comprising sensing an EA signal in the tissue via an electrode (60) of at least one spline (44) of the multiple splines (44) and an additional electrode (54), (Col. 4, line 42 – Col. 5, line 28: the electrodes of the splines may be configured as combination recording+ablation electrodes 60, wherein they are configured to sense an EA signal in combination with reference electrode 54). 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/Edwards to include sensing an EA signal in the tissue via an electrode of at least one spline of the multiple splines, wherein the electrode of each spline is configured as a combination recording+ablation electrode, and an additional electrode, as taught by Lau, because the modification would provide recording and ablating functionality within one device (Lau; Col. 4, line 42 – Col. 5, line 28).
Webster/Edwards/Lau fails to teach the additional electrode being positioned within the outer tube such that the additional electrode is prevented from contacting tissue. However, Francis (Figure 7b) teaches a method for using a catheter, wherein an additional reference electrode (316) is positioned within an outer tube (312) such that the additional reference electrode (316) is prevented from contacting tissue ([0097]). 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/Edwards/Lau to include the additional electrode being positioned within the outer tube such that the additional electrode is prevented from contacting tissue, as taught by Francis, because the modification would enable unipolar treatment with all the electrodes of the spines without the need for an external electrode (Francis; [0097]).
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 4, Webster/Edwards/Lau/Francis further teaches wherein moving the outer tube (Edwards; 18) comprises using a stopper (Edwards; 18”) of the outer tube (Edwards; 18) for limiting the movement of the outer tube (Edwards; 18) between the proximal apex and the distal apex of the distal-end assembly (Webster; 12).
Regarding claim 5, Webster (Figures 1 and 2B) further discloses applying an ablation signal to the tissue via an electrode (14) of at least one spline of the multiple splines (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 7, Webster/Edwards/Lau/Francis further teaches wherein applying the ablation signal comprises applying a unipolar ablation signal between the electrode (Webster; 14) of at least one spline of the multiple splines and the additional electrode (taught by Lau/Francis).
Regarding claim 8, Webster/Edwards/Lau/Francis further teaches wherein sensing the EA signal comprises sensing a unipolar EA signal between the electrode (Webster; 14) and the additional electrode (taught by Lau/Francis), which is coupled to an inner surface of the tube or embedded within a wall of the tube (as explained in the rejection of claim 1 above).
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 the outer 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).
Webster/Edwards fails to teach an additional electrode being configured to provide one or both of: cooperation with an electrode of at least one spline of the multiple splines to ablate tissue, or cooperation with an electrode of at least one spline of the multiple splines to sense an EA signal. However, Lau (Figure 13) teaches a catheter (36) comprising an additional reference electrode (54) being configured to provide one or both of: cooperation with an electrode (60) of at least one spline (44) of the multiple splines (44) to ablate tissue, or cooperation with an electrode (60) of at least one spline of the multiple splines to sense an EA signal (Col. 4, line 42 – Col. 5, line 28: the electrodes of the splines may be configured as combination recording+ablation electrodes 60, wherein they are configured to ablate tissue or sense an EA signal in combination with reference electrode 54). 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/Edwards to include an additional electrode being configured to provide one or both of: cooperation with an electrode of at least one spline of the multiple splines to ablate tissue, or cooperation with an electrode of at least one spline of the multiple splines to sense an EA signal, as taught by Lau, because the modification would provide recording and ablating functionality within one device (Lau; Col. 4, line 42 – Col. 5, line 28).
Webster/Edwards/Lau fails to teach the additional electrode being positioned within the outer tube such that the additional electrode is prevented from contacting tissue. However, Francis (Figure 7b) teaches a method for using a catheter, wherein an additional reference electrode (316) is positioned within an outer tube (312) such that the additional reference electrode (316) is prevented from contacting tissue ([0097]). 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/Edwards/Lau to include the additional electrode being positioned within the outer tube such that the additional electrode is prevented from contacting tissue, as taught by Francis, because the modification would enable unipolar treatment with all the electrodes of the spines without the need for an external electrode (Francis; [0097]).
Regarding claim 23, Webster/Edwards/Lau/Francis further teaches the outer tube (Edwards; 18) having a distal edge (shown in Figure 2b of Edwards), the stopper (18”) being positioned at the distal edge of the outer tube (Edwards; 18).
Claim(s) 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster in view of Edwards.
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, and a stopper positioned inside the outer tube, the stopper being positioned between a proximal apex of the expandable distal-end assembly and a distal apex of the expandable distal-end assembly, the stopper being configured to limit movement of the outer tube relative to the distal end assembly. However, Edwards (Figure 2b) teaches a method for controlling the size of an end effector of a catheter (10), comprising controlling at least a size of a section of the end effector 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 (18) 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 (20) 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]), and a stopper (18”) positioned inside the outer tube (18), the stopper (18”) being positioned between a proximal apex of the expandable distal-end assembly (20) and a distal apex of the expandable distal-end assembly (20), the stopper (18”) being configured to limit movement of the outer tube (18) relative to the distal end assembly (20), ([0047]: stopper 18” limits the outer tube from moving distally past the distal end of the distal-end assembly 20). 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, and a stopper positioned inside the outer tube, the stopper being positioned between a proximal apex of the expandable distal-end assembly and a distal apex of the expandable distal-end assembly, the stopper being configured to limit movement of the outer tube relative to the 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 12, Webster/Edwards/Lau/Francis further teaches wherein the stopper (Edwards; 18”) is configured to limit the movement of the outer tube (Edwards; 18) between the proximal apex and the distal apex of the distal-end assembly (Webster; 12).
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).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster/Edwards, as applied to claim 13 above, and further in view of Xu et al., (US 20190298443; hereinafter 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/Edwards 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/Edwards 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/Edwards 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/Edwards 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]).
Response to Arguments
Applicant’s arguments, filed 07/30/2026, 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 references Lau and Francis, as well as a new interpretation of the Edwards reference. Lau teaches a catheter/method, wherein a combination ablation+recording electrode of at least one spline of multiple splines is configured to either apply an ablation signal or sense an EA signal in cooperation with an additional indifferent electrode and Francis teaches that the additional indifferent electrode may be positioned within the outer tube. Therefore, the modified Webster/Edwards/Lau/Francis device/method teaches the invention as recited in at least in amended independent claims 1 and 22. Furthermore, under the new interpretation of the Edwards reference, a stopper (18”) is positioned inside the outer tube (18) at the distal edge of the outer tube (18), the stopper (18”) being positioned between a proximal apex of the expandable distal-end assembly (20) and a distal apex of the expandable distal-end assembly (20), the stopper (18”) being configured to limit movement of the outer tube (18) relative to the distal end assembly (20). Therefore, the modified Webster/Edwards device/method, under the new interpretation, teaches the invention as recited in at least in amended independent claim 9.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
