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 .
Response to Arguments
Applicant’s arguments and amendments, see pages 6-9, filed 4/29/2026, with respect to the rejection(s) of claim(s) 1-20 under USC 103 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 Therefore, the rejection has been withdrawn.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 Krivoruchko (US 2020/0367903 A1) in view of Lesh (US 6152144).
Claim Rejections - 35 USC § 103
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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-7, and 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (US 2020/0367903 A1) in view of Lesh (US 6152144).
Regarding claims 1 15, and 19, Krivoruchko discloses a left atrial appendage closure (LAAC) device (eg. Fig. 2, occlusion device 100, Para. 44-49), comprising: an expandable frame moveable between a collapsed configuration for delivery and an expanded configuration for deployment (eg. Para. 67-75, Fig. 13-19), the expandable frame including:a distal hub (eg. collar 306); a proximal hub (eg. collar 304); and a plurality of struts extending between the distal hub and the proximal hub and connected at either end to the distal hub and to the proximal hub (eg. struts 302); but does not explicitly disclose one or more space filling elements constrained by the expandable frame; and an occlusive element spanning at least part of the expandable frame; wherein the one or more space filling elements are adapted to facilitate thrombus formation within the LAAC device.
Lesh teaches an occlusive body configured to at least partially fill the volume of the left atrial appendage (eg. Col. 4, Ln. 4 – Col. 5, Ln. 10, Col. 10, Ln. 52 – Col. 11, Ln. 11) and a barrier/mesh material in an outwardly expanded state of substantially occupy at least a portion of the cross section of a cavity (eg. Col. 2, Ln. 21-56, Col. 5, Ln. 1-10, Col. 7, Ln. 30 – Col. 8, Ln. 10, Col. 9, Ln. 1- 42, Col. 10, Ln. 47-61) and may be augmented by thrombogenesis caused by the occlusive member (eg. Col 4, Ln. 32-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Krivoruchko with the thrombogenic space filling occlusive body and spanning barrier as taught by Lesh because they are both directed to percutaneous LAA occlusion using an expandable frame that carries occlusive space filling material across the appendage and the use of a known thrombogenic occlusive material within a known expandable occlude frame would obtain the predictable result of sealing the ostium and filling the appendage volume to promote thrombus organization and prevent embolization.
Regarding claim 2, the combined invention of Krivoruchko and Lesh discloses wherein at least some of the one or more space filling elements are constrained by being secured to the expandable frame prior to implantation of the LAAC device (eg. Lesh, Col. 4, Ln. 32 – Col. 5, Ln. 10).
Regarding claims 3-4, the combined invention of Krivoruchko and Lesh discloses wherein at least some of the one or more space filling elements are welded to the expandable frame (Col. 7, Ln. 30 – Col. 8, Ln. 10, Col. 11, Ln. 39 – Col. 12, Ln. 10).
Regarding claim 5, the combined invention of Krivoruchko and Lesh discloses at least some of the one or more space filling elements are secured to at least one of the proximal hub and the distal hub (eg. Krivoruchko, Para. 69-73).
Regarding claim 6, the combined invention of Krivoruchko and Lesh discloses at least some of the one or more space filling elements are constrained by being trapped within the expandable frame prior to implantation (eg. Krivoruchko, Para. 69-73 struts 302 defines an interior volume combined with the occlusive space filling body of Lesh as disclosed above).
Regarding claims 7 and 16, the combined invention of Krivoruchko and Lesh discloses at least some of the one or more space filling elements comprise an embolic coil secured at one end to the proximal hub and at a second end to the distal hub (Eg. Krivoruchko, Para. 77, Lesh, Col. 4, Ln. 32-55, the collars 304 and 306 are established fixation points at each ends of the cage, securing the coil between them provides the predictable result of retention of that appendage filling volume).
Regarding claim 9, the combined invention of Krivoruchko and Lesh discloses the expandable frame comprises a plurality of struts forming a plurality of strut intersections, and at least some of the one or more space filling elements comprise fibers each extending between two or more of the plurality of struts and/or two or more of the plurality of strut intersections (eg. Krivoruchko, Para. 68).
Regarding claim 10, the combined invention of Krivoruchko and Lesh discloses at least one of the one or more space filling elements comprise: an expandable element that is adapted to be secured to the expandable frame; and one or more fibers extending from the expandable element (eg. Lesh, Col. 9 ,Ln. 15-60 member 65 with linked elements 66).
Regarding claim 11, the combined invention of Krivoruchko and Lesh discloses a first expandable feature that is moveable between a collapsed configuration for delivery and an expanded configuration for deployment; and a second expandable feature that is secured relative to the first expandable feature and that is moveable between a collapsed configuration for delivery and an expanded configuration for deployment (eg. Krivoruchko, Para. 68-74).
Regarding claim 12, the combined invention of Krivoruchko and Lesh discloses at least some of the one or more space filling elements extend between the first expandable feature and the second expandable feature (eg. Krivoruchko, Para. 68-74).
Regarding claim 13, the combined invention of Krivoruchko and Lesh discloses at least some of the one or more space filling elements are disposed within at least one of the first expandable feature and the second expandable feature (eg. Krivoruchko, Para. 68-74 and Lesh, Col. 12, Ln. 24-50, polymer mass inside the expandable regions of the device to provide the predictable result of achieving occlusion).
Regarding claim 14, the combined invention of Krivoruchko and Lesh discloses a coating disposed over at least a portion of the LAAC device, the coating adapted to encourage thrombus formation (eg. Lesh, Col. 9, Ln. 43-60).
Regarding claim 17, the combined invention of Krivoruchko and Lesh discloses the embolic coil is secured to the expandable frame prior to implantation (eg. Krivoruchko, Para. 77, Lesh, Col. 4, Ln. 32-55, coil already part of the structure before delivery).
Regarding claim 18, the combined invention of Krivoruchko and Lesh discloses the embolic coil is adapted to move between a collapsed configuration for delivery and an expanded configuration for deployment (eg. Krivoruchko, Para. 77 Lesh, Col. 4, Ln. 32-55, coiled mass transitions from collapsed delivery state to an expanded deployed state).
Regarding claim 19, the combined invention of Krivoruchko and Lesh discloses an expandable frame moveable between a collapsed configuration for delivery and an expanded configuration for deployment; one or more polymeric fibers secured relative to the expandable frame, the one or more polymeric fibers adapted to facilitate thrombus formation within the LAAC device; and an occlusive element spanning at least part of the expandable frame (eg. Krivoruchko, Para. 48, 60, 6, 69, 78, part of occlusion device body).
Regarding claim 20, the combined invention of Krivoruchko and Lesh discloses a support element extending to a position exterior of the expandable frame, and the one or more polymeric fibers are secured to the support element at the position exterior of the expandable frame and extend back into the expandable frame (eg. Krivoruchko, Para. 48, 60, 6, 69, 78, polymers part of the occlusion device body).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (US 2020/0367903 A1) in view of Lesh (US 6152144), further in view of Dang (US 2021/0401418 A1).
Regarding claim 8, the combined invention of Krivoruchko and Lesh discloses the invention of claim 1, but does not disclose at least some of the one or more space filling elements comprises fibrous material.
Dang teaches an expandable LAAC device that uses a membrane made of polyester fibers (Eg. Para. 61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Kaplan to include material made from polyester fibers as taught by Dang to facilitate tissue growth in and around the occlude (Eg. Dang, Para. 61).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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