DETAILED ACTION
1. This office action is in response to the communicated dated 07 October 2025 concerning application number 17/995,840 effectively filed on 07 October 2022.
Notice of Pre-AIA or AIA Status
2. 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.
Information Disclosure Statement
3. The Information Disclosure Statement submitted on 09 October 2025 has been considered by the Examiner.
Status of Claims
4. Claims 1-10 and 12-16 are pending, of which claims 1, 10, 12-13, and 15 have been amended; claim 11 has been cancelled; and claims 1-10 and 12-16 are under consideration for patentability.
Response to Arguments
5. Applicant’s arguments dated 07 October 2025, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
The Examiner has addressed the amended limitations within the updated text below.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 1-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over O’Halloran et al. (WO 2018/185255 A1, with citations to the corresponding US Publication No. 2020/0107836 A1) in view of Li et al. (WO 2021/129455 A1, with citations to the corresponding US Publication No. 2022/0409255 A1).
Regarding claim 1, O’Halloran teaches a device for occlusion of a left atrial appendage of a heart (the device 1 is configured to occlude a body lumen, such as the left atrial appendage (LAA) of the heart 2 [abstract, 0199]), comprising:
an implantable occlusion apparatus (the device 1 comprises an implantable occlusion apparatus 3 [0199]) comprising a radially expansible element (the occlusion apparatus 3 comprises a radially expansible element 5 [0199]) that is adjustable between a contracted orientation suitable for transluminal delivery and a deployed orientation configured to occlude the left atrial appendage ([0199]);
an elongated catheter member (the elongated catheter member 4 [0199]) operably and detachably attached to the implantable occlusion apparatus (the radially expansible element 5 is detachably attached to the elongated catheter member 4 [0199]) and configured for transluminal delivery and deployment of the occlusion apparatus in the left atrial appendage (the elongated catheter member 4 is configured for transluminal delivery and deployment of the occlusion apparatus in the left atrial appendage [0199]); and
an energy delivery module (the energy delivery element 6 [0199]) configured for adjustment from a contracted configuration suitable for transluminal delivery and retraction (“The energy delivery element 6 and the sensor 7 are axially movable independently of the radially expansible element 5 enabling the energy delivery element 6 and the sensor 7 to be transluminally retracted leaving the radially expansible element 5 in-situ occluding the body lumen” [0199]), and a deployed configuration suitable for engagement with adjacent tissue to ablate the tissue (the energy delivery element 6 may be deployed in the form of a radially expansible body 14 having a plurality of V-shaped tissue ablation elements 15 [0201]. Specifically, the plurality of V-shaped tissue ablation elements 15 includes elbows 16 that are configured to contact the tissue [0201, 0206, FIG. 1, FIG. 9B]), wherein the energy delivery module is operably attached to the elongated catheter member proximally of the radially expansible element (figure 9A illustrates the energy delivery module being operably attached to the elongated catheter member 4 proximally of the radially expansible element 5 [0199, 0205-0206, FIG. 9A]) and configured upon deployment to contact and ablate a section of a wall of the left atrium surrounding an ostium of the left atrial appendage (the energy delivery element 6 comprises a plurality of V-shaped tissue ablation elements 15 having elbows 16 that are deployed to contact and ablate the tissue of the wall surrounding the left atrium appendage (LAA) [0178, 0201, 0205-0206, FIG. 1, FIG. 9B]);
wherein the elongated catheter member comprises a first catheter operably and detachably attached to the implantable occlusion apparatus (the radially expansible element 5 is detachably attached to the elongated catheter member 4 [0199]).
However, O’Halloran does not explicitly teach wherein a second catheter operably attached to the energy delivery module, wherein the first catheter and the second catheter are configured for relative axial movement, and wherein the first catheter is disposed inside a lumen of the second catheter.
The prior art by Li is analogous to O’Halloran, as they both teach an implantable device that is configured to occlude the left atrial appendage ([abstract]).
Li teaches the first catheter operably and detachably attached to the implantable occlusion apparatus (the first catheter 21a is detachably attached to the left atrial appendage occluder 10 via the proximal connector 111 [0057, 0059]) and a second catheter operably attached to the energy delivery module (the second catheter 21b is detachably connected to the proximal connector 111 [0059, FIG. 4B]. Meanwhile, the ablation portion 31 of the ablation member 30 is arranged on the sealing portion 11 of the proximal connector 111 [0043, 0045, 0059, FIG. 4B]), wherein the first catheter and the second catheter are configured for relative axial movement (the first catheter 21a and the second catheter 21b are axially movable relative to each other [0058-0059]), and wherein the first catheter is disposed inside a lumen of the second catheter (the first catheter 21a is disposed inside the lumen of the second catheter 21b [0058-0059, FIG. 4B]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify O’Halloran’s first catheter be disposed inside the lumen of a second catheter which is attached to energy delivery module, as taught by Li. This modification is beneficial, as one of the catheters may be used to push the implantable occlusion apparatus (e.g., the LAA occluder 10) and the other catheter may provide a cryogenic fluid to achieve cryoablation (see paragraphs [0043, 0045, 0057, 0059] by Li).
Regarding claim 2, O’Halloran teaches in which the elongated catheter member and implantable occlusion apparatus when attached provide a through lumen configured to allow advancement of a sensor (the catheter member 4 comprises a delivery sheath 25 that allows the advancement and retraction of the sensor 7 [0205-0207]) through the through lumen into the left atrial appendage when the implantable occlusion apparatus is deployed in the left atrial appendage (the sensor is advanced through the delivery sheath 25 into the distal wall of the left atrial appendage [0206]. Meanwhile, the energy delivery element 6 is deployed in the form of a radially expansible body 14 having a plurality of V-shaped tissue ablation elements 15 contacting the wall of the left atrial appendage [0201, 0206]).
Regarding claim 3, O’Halloran teaches in which the energy delivery module comprises an array of radially deployable arms (the energy delivery element 6 may be deployed in the form of a radially expansible body 14 having a plurality of V-shaped tissue ablation elements 15 [0201]), each arm comprising an electrode configured to ablate tissue (the radially expansible body 14 includes a plurality of V-shaped tissue ablation elements or electrodes 15 [0201, 0206]).
Regarding claim 4, O’Halloran teaches in which the energy delivery module comprises an array of radially deployable arms (the energy delivery element 6 may be deployed in the form of a radially expansible body 14 having a plurality of V-shaped tissue ablation elements 15 [0201]. Alternatively, the energy delivery element 6 may be deployed in the form of a radially expansible body 21 having a plurality of outwardly curved elements 23 [0203]), each arm comprising an electrode configured to ablate tissue, and in which the electrodes are disposed at or adjacent a tip of the radially deployable arms (the energy delivery element 6 may be deployed in the form of a radially expansible body 14 having a plurality of V-shaped tissue ablation elements or electrodes 15 contacting the wall of the left atrial appendage [0201, 0206, FIG. 1]. Alternatively, the energy delivery element 6 may be deployed in the form of a radially expansible body 21 having a plurality of outwardly curved elements 23 [0203, FIGS. 5-6, FIG. 8]. Specifically, the ablation electrodes 23A are disposed on the tip of the curved elements 23 [0203, FIGS. 5-6, FIG. 8]).
Regarding claim 5, O’Halloran in view of Li suggests a device according to claim 1. O’Halloran teaches the energy delivery module comprising an array of radially deployable arms (the energy delivery element 6 may be deployed in the form of a radially expansible body 21 having a plurality of outwardly curved elements 23 [0203]), each arm comprising an electrode configured to ablate tissue, and in which the electrodes are disposed at or adjacent a tip of the radially deployable arms, and including an outer electrode disposed at or adjacent to the tip of the radially deployable arm (the ablation electrodes 23A are disposed on the tip of the outwardly curved elements 23 [0203, FIGS. 5-6, FIG. 8]).
O’Halloran and Li do not explicitly teach an inner electrode disposed radially inwardly of the outer electrode.
The Examiner respectfully submits, as O’Halloran teaches the use of electrodes (the outwardly curved elements 23 include the ablation electrodes 23A [0203, FIGS. 5-6, FIG. 8]), configuring the plurality of electrodes to include an inner electrode that is disposed radially inwardly of the outer electrode would be a matter of duplicating and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 6, O’Halloran teaches in which at least one of the radially deployable arm has a loop configuration comprising two loop elements (the energy delivery element 6 may be deployed in the form of a radially expansible body 14 having a plurality of elbows 16 [0201, 0206, FIG. 1]. Specifically, figure 1 illustrates each of the elbows 16 forming a respective loop [0201, 0206, FIG. 1]), configured to radially contact the wall of the left atrium around the ostium of the left atrial appendage when deployed (the elbows 16 are configured to radially contact the wall of left atrial appendage (LAA) when deployed [0201, 0206, FIG. 1, FIG. 9B]).
Regarding claim 7, O’Halloran in view of Li suggests a device according to claim 6. O’Halloran teaches a distal tip of the loop comprises an outer electrode (the energy delivery element 6 comprises a plurality of V-shaped tissue ablation elements or electrodes 15 having elbows 16 that are deployed to contact and ablate the tissue of the wall surrounding the left atrium appendage (LAA) [0178, 0201, 0205-0206, FIG. 1, FIG. 9B]. The Examiner respectfully submits that the elbows 16 of V-shaped tissue ablation elements 15 have an outer electrode surface which contacts and ablates the tissue [0201, 0205-0206, FIG. 1, FIG. 9B]. As stated previously in claim 6, figure 1 illustrates each of the elbows 16 forming a respective loop [0201, 0206, FIG. 1, FIG. 9B]).
However, O’Halloran and Li do not explicitly teach one or both of the loop elements include an inner electrode proximal of the tip of the loop.
The Examiner respectfully submits, as O’Halloran teaches the use of electrodes (the plurality of V-shaped tissue ablation elements or electrodes 15 [0201, 0205-0206, FIG. 1, FIG. 9B]) and loop elements (each of the V-shaped tissue ablation elements 15 comprises elbows 16 that forms a respective loop [0201, 206, FIG. 1, FIG. 9B]), configuring the plurality of electrodes to include an inner electrode that is disposed proximally of the tip of the loop would be a matter of duplicating and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 8, O’Halloran teaches in which the radially deployable arms are resiliently deformable to allow at least part of the radially deployable arm to conform to the wall of the left atrium surrounding the ostium of the left atrial appendage (the energy delivery element 6 may be deployed in the form of a radially expansible body 21 having a plurality of outwardly curved elements 23 [0024, 0203]. Specifically, the curved elements 23 have tissue ablation electrodes 23A that are configured to contact the wall of the left atrial appendage (LAA) [0199, 0201, 0203-0204, FIG. 5, FIG. 10A]. Furthermore, the curved elements 23 are composed of a shape-memory material to conform to the wall of the left atrial appendage [0024, 0199, 0203-0204, FIG. 5, FIG. 10A]).
Regarding claim 9, O’Halloran teaches in which the radially deployable member comprises an inflatable balloon ([0036, 0077, 0114, 0209]), in which the inflatable balloon is configured to receive cryogenic liquid ([0036, 0077, 0114, 0209]).
Regarding claim 10, O’Halloran teaches in which the energy delivery module is configured for rotational movement relative to the first catheter (the energy delivery element 6 is configured for rotational movement relative to the elongated catheter member 4 [0195, 0205]).
Regarding claim 12, O’Halloran teaches an outer deployment catheter that is axially adjustable relative to the elongated catheter member (the delivery sheath 25 is axially adjustable relative to the elongated catheter member 4 [0205-0206]), in which the device is configured for adjustment between:
a first delivery configuration in which the implantable occlusion apparatus and energy delivery module are disposed within a distal end of the elongated deployment catheter (the delivery sheath 25 is provided in a first position where it covers the radially expansible element 5 of the occlusion apparatus 3 and the energy delivery element 6 [0199, 0205-0206]);
a second partially deployed configuration in which the implantable occlusion apparatus is exposed distally of a distal end of the elongated deployment catheter and deployed (figure 9A illustrates the expansible element of the occlusion apparatus 3 being exposed from a distal end of the delivery sheath 25 [0205-0206, FIG. 9A]) and the energy delivery module is disposed within the distal end of the elongated deployment catheter (the energy delivery element 6 is disposed within the distal end of the delivery sheath 25 [FIG. 9A, 0205-0206]);
a third fully deployed configuration in which the energy delivery module is exposed distally of a distal end of the elongated deployment catheter and deployed (the energy delivery element 6 is deployed in the form of a radially expansible body 14 having a plurality of V-shaped tissue ablation elements 15 [0201]. Specifically, the radially expansible body 14 is exposed from the delivery sheath 25 [FIG. 9A, FIG. 9D, 0205-0207]); and
a fourth configuration in which the first catheter is detached from the implantable occlusion apparatus (figures 9E-9F illustrates the catheter member 4 being detached from the radially expansible element 5 of the occlusion apparatus 3 [0199, 0205-0207, FIGS. 9E-9F]), the energy delivery module and the first catheter are retracted into the elongated deployment catheter (the energy delivery element 6 comprises V-shaped tissue ablation elements 15 that may be retracted into the delivery sheath 25 and catheter member 3 [0201, 0205-0207, FIGS. 9D-9F]), and the elongated deployment catheter and energy delivery module are retracted (the delivery sheath 25 and the V-shaped tissue ablation elements 15 of the energy delivery element 6 are retracted [0205-0207, FIGS. 9D-9F]); and
Li teaches wherein the second catheter is retracted into the elongated deployment catheter (the first catheter 21a and the second catheter 21b are withdrawn into the delivery sheath 22 [0059-0060]).
Regarding claim 13, O’Halloran teaches an electrical controller operably connected to processor ([0208]) in which the energy delivery module comprises an array of radially deployable arms (the energy delivery element 6 may be deployed in the form of a radially expansible body 21 having a plurality of outwardly curved elements 23 [0203]), each arm comprising an electrode configured to ablate tissue (the curved elements 23 comprises a plurality of ablation electrodes 23A [0203, FIGS. 5-6, FIG. 8]), and in which the electrical controller is operably connected to the electrode ([0203, 0208]) and actuatable to energize the electrode and/or receive electrical signals from the electrode and/or send electrical signals to the electrode ([0208]).
Regarding claim 14, O’Halloran teaches in which the processor is configured to detect an electrical parameter of a signal between the electrode of the energy delivery module and a sensing electrode disposed in the left atrial appendage in contact with the wall of the left atrial appendage ([0193, 0199, 0208]).
Regarding claim 15, O’Halloran teaches in which the processor is configured to detect an electrical parameter of a signal between the electrode of the energy delivery module and a sensing electrode disposed in the left atrial appendage in contact with the wall of the left atrial appendage ([0193, 0199, 0208]), the system including a sensor comprising an electrode (sensor 7 [0193, 0199, 0206]) configured for delivery through the through lumen into the left atrial appendage (the sensor 7 is configured to detect a parameter from the wall of the left atrial appendage [0193, 0199, 0206]), wherein the processor is configured to detect an electrical parameter of the signal between the electrode of the radially deployable member and the electrode of the sensor disposed in the left atrial appendage to determine electrical isolation of the left atrial appendage ([0016, 0193, 0199, 0208]).
Regarding claim 16, O’Halloran teaches in which the electrical controller and processor are configured to pass an electrical signal between two electrodes (the energy controller and the processor are configured to provide an electrical signal between the ablation electrodes [0208]) and detect an electrical parameter of a signal between the two electrodes (the processor may be coupled to coupled to a sensor to detect an electrical parameter between the ablation electrodes [0193, 0208]).
Statement on Communication via Internet
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Conclusion
9. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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/J.B.S./Examiner, Art Unit 3792
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796