DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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.
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 June 2026 has been entered.
Status of Claims
3. Claims 1-10 and 13-16 are pending, of which claims 1-2, 6, 9, 13, and 15 have been amended; claims 11-12 have been cancelled; and claims 1-10 and 12-16 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 12 June 2026, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive.
The Examiner has addressed the amended limitations within the updated text below.
Applicant argues that O’Halloran and Li do not explicitly suggest the amended limitation that recites wherein the energy delivery module is deployable proximally of the implantable occlusion apparatus when the first catheter member is attached to the implantable occlusion apparatus to contact and ablate a section of a wall of a left atrium surrounding an ostium of the left atrial appendage (pages 1-3 of the Arguments). The Examiner respectfully disagrees, as Li teaches the first catheter 21a being detachably attached to the left atrial appendage occluder 10 via the proximal connector 111 ([0057, 0059]). Meanwhile, Li teaches the second catheter 21b being detachably connected to the proximal connector 111 which is further coupled to the sealing portion 11 containing the ablation portion 31 of ablation member 30 ([0035, 0043, 0045, 0059, FIG. 4B]). In this case, Li teaches both of the first catheter 21a and the second catheter 21b being respectively moved or pushed along a longitudinal axis to deploy the left atrial appendage occluder 10 and the ablation portion 31 of the ablation member 30 within the left atrial appendage 101 ([0032, 0034, 0054, 0058-0059, FIG. 1, FIG. 4B]). For example, figure 1 illustrates the fixing portion 12 of the left atrial appendage occluder 10 and the ablation portion 31 of the ablation member 30 being deployed within the left atrial appendage 101 ([0031, 0033-0036, FIG. 1]). Specifically, figure 1 and figure 4B illustrates the ablation portion 31 of the ablation member 30 being deployed proximally of the fixing portion 12 of the left atrial appendage occluder 10 ([FIG. 1, FIG. 4B]). Furthermore, the ablation portion 31 of the ablation member 30 is configured to contact and ablate the left atrium wall surrounding the ostium of the left atrium appendage 101 ([0034-0036]). Therefore, the Examiner respectfully maintains that Li suggests wherein the energy delivery module is deployable proximally of the implantable occlusion apparatus when the first catheter member is attached to the implantable occlusion apparatus to contact and ablate a section of a wall of a left atrium surrounding an ostium of the left atrial appendage.
Claim Objections
5. Claim 1 is objected to because of the following informality.
Claim 1, lines 21-22: The Examiner suggests changing “such that the energy delivery module and implantable occlusion are axially moveable” to “such that the energy delivery module and the implantable occlusion apparatus are axially moveable”.
Appropriate correction is required.
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 13-16 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]);
a first 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 first catheter member proximally of the radially expansible element (figure 9A illustrates the energy delivery module 6 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 such that the energy delivery module and the implantable occlusion apparatus are axially movable relative to each other, wherein the first catheter is disposed inside a lumen of the second catheter, and wherein the energy delivery module is deployable proximally of the implantable occlusion apparatus when the first catheter member is attached to the implantable occlusion apparatus to contact and ablate the section of the wall of the left atrium surrounding the ostium of the left atrial appendage.
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]. Specifically, the left atrial appendage occluder 10 comprises the fixing portion 12 [0031, 0041, 0057]) 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 (e.g., balloon) of the ablation member 30 is arranged on the sealing portion 11 of the proximal connector 111 [0035, 0043, 0045, 0059, FIG. 4B]), wherein the first catheter and the second catheter are configured for relative axial movement such that the energy delivery module and the implantable occlusion apparatus are axially moveable relative to each other (the first catheter 21a and the second catheter 21b are axially movable relative to each other which causes the left atrial appendage occluder 10 to move and the ablation member 30 to move [0032, 0034, 0054, 0058-0059]. In this case, both of the first catheter 21a and the second catheter 21b may be moved or pushed to deliver the left atrial appendage occluder 10 and the ablation member 30 to the left atrial appendage 101 [0032, 0034, 0054, 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]), and wherein the energy delivery module is deployable proximally of the implantable occlusion apparatus when the first catheter member is attached to the implantable occlusion apparatus to contact and ablate the section of a wall of the left atrium surrounding the ostium of the left atrial appendage (as stated previously above, the first catheter 21a is detachably attached to the left atrial appendage occluder 10 via the proximal connector 111 [0057, 0059]. Specifically, the left atrial appendage occluder 10 comprises the fixing portion 12 [0031, 0041, 0057]. In this case, figure 1 and figure 4B illustrates the ablation portion 31 of the ablation member 30 being deployed proximally of the fixing portion 12 of the left atrial appendage occluder 10 [FIG. 4B]. Furthermore, the ablation portion 31 of the ablation member 30 is configured to contact and ablate the left atrium wall surrounding the ostium of the left atrium appendage 101 [0034-0036]).
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). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify O’Halloran’s energy delivery module to be deployable proximally of the implantable occlusion apparatus during the ablation of the left atrium wall surrounding the ostium of the left atrial appendage, as further taught by Li. The advantage of such modification will allow the energy delivery module (e.g., ablation portion) to abut the left atrium wall while the occlusion apparatus (e.g., left atrial appendage occluder) occludes the ostium of the left atrial appendage (see paragraphs [0034-0036] by Li).
Regarding claim 2, O’Halloran teaches in which the first catheter 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 arms 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 energy delivery modules includes a radially deployable member including 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 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]).
Conclusion
8. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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