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 .
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 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) 1-2, 5-6, 10-15, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan (US 11399842 B2).
Regarding claims 1 and 15, Kaplan discloses a left atrial appendage closure (LAAC) device (eg. Abstract, Fig. 2, 4, 14-15) comprising: an expandable frame moveable between a collapsed configuration for delivery and an expanded configuration for deployment (eg. Col. 5, Ln. 10-25, Fig. 8-15, Col. 11, Ln. 57-Col. 12, Ln. 25); one or more space filling elements constrained by the expandable frame (eg. Abstract, Col. 2, Ln. 54-Col. 3. Ln. 19 expandable foam and encapsulated with jackets or skins); and an occlusive element spanning at least part of the expandable frame (eg. Col. 8, Ln. 24-Col. 9, Ln. 14); wherein the one or more space filling elements are adapted to facilitate thrombus formation within the LAAC device (eg. multiple embodiments Col. 2, Ln. 54 – Col. 3, Ln. 20, Col. 9, Ln. 5-39, Col. 12, Ln. 37-64, Col. 17, Ln. 57- Col. 18, Ln. 5).
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 device of Kaplan to have pores and agents to promote thrombus formation for the predictable result of allowing tissue ingrowth into the implant from adjacent non-blood tissue to assist in closure at the ostium (Col. 2, Ln. 54 – Col. 3, Ln. 20, Col. 9, Ln. 5-39, Col. 12, Ln. 37-64, Col. 17, Ln. 57- Col. 18, Ln. 5).
Regarding claims 2 and 17, Kaplan discloses 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. Col. 2, Ln. 40-52, Col. 3, Ln. 20-Col. 4, Ln. 5, Fig. 8-15 and associated paragraphs).
Regarding claim 5, Kaplan discloses the expandable frame further comprises a proximal hub and a distal hub, and 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. Fig. 20, proximal and distal caps).
Regarding claim 6, Kaplan 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. Col. 2, Ln. 40-52, Col. 3, Ln. 20-Col. 4, Ln. 5,, Col. 20, Ln. 65 – Col. 21, Ln. 40, Fig. 8-15 and associated paragraphs).
Regarding claim 10, Kaplan discloses wherein 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. Col. 2, Ln. 54-Col. 3, Ln. 19, Fig. 8-15, Fig. 4, Col. 10, Ln. 45-63 guidewire).
Regarding claims 11 and 18, Kaplan discloses the expandable frame comprises: 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. Fig. 8-15 Col. 5, Ln. 10-25, Fig. 8-15, Col. 11, Ln. 57-Col. 12, Ln. 25).
Regarding claim 12, Kaplan discloses at least some of the one or more space filling elements extend between the first expandable feature and the second expandable feature (Eg. Col. 13, Ln. 37-58 Fig 23 deployable anchors on each side).
Regarding claim 13, Kaplan 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. Col. 13, Ln. 37-58 Fig 23 deployable anchors on each side).
Regarding claim 14, Kaplan discloses a coating disposed over at least a portion of the LAAC device, the coating adapted to encourage thrombus formation (Eg. Col. 14, Ln. 20-39 Col. 17, Ln. 55 – Col. 18, Ln. 5).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan (US 11399842 B2) in view of Lesh (US 6152144).
Regarding claims 3-4, Kaplan discloses the invention of claim 1, but does not disclose at least some of the one or more space filling elements are welded/adhesively secured to the expandable frame.
Lesh teaches a LAAC device that uses an occluding device with a frame structure and a barrier that can be glued or welded together Col. 7, Ln. 30 – Col. 8, Ln. 10, Col. 11, Ln. 39 – Col. 12, Ln. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kaplan to use welding or gluing as taught by Lesh because gluing and welding components of an implant together are well-known in the art.
Claim(s) 7, 9, 16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan (US 11399842 B2) in view of Krivoruchko (US 2020/0367903 A1).
Regarding claims 7 and 16, Kaplan discloses the invention of claim 1, but does not disclose at least some of the one or more space filling elements comprise an embolic coil.
Krivoruchko teaches a LAAC device that uses embolic coils to prevent clots from escaping the LAA (eg. Fig. 24, Para. 77).
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 an embolic coil as taught by Krivoruchko to provide a known alternative expandable structure for preventing the escape of clots from the LAA (eg. Krivoruchko, Para. 77).
Regarding claim 9, the combined invention of Kaplan and Krivoruchko 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. Kaplan Fig. 16, Col. 12, Ln. 39-63, stent and Fig. 28 Col. 19, Ln. 19-37 struts meeting at central point and Krivoruchko, Para. 8-9, 45, Fig. 2, Para. 52, Fig. 5-6, Para. 68, Fig. 13-19).
Regarding claim 19 the combined invention of Kaplan and Krivoruchko discloses Kaplan discloses a left atrial appendage closure (LAAC) device (eg. Kaplan Abstract, Fig. 2, 4, 14-15) comprising: an expandable frame moveable between a collapsed configuration for delivery and an expanded configuration for deployment (eg. Kaplan Col. 5, Ln. 10-25, Fig. 8-15, Col. 11, Ln. 57-Col. 12, Ln. 25); one or more space filling elements constrained by the expandable frame (eg. Kaplan, Abstract, Col. 2, Ln. 54-Col. 3. Ln. 19 expandable foam and encapsulated with jackets or skins); and an occlusive element spanning at least part of the expandable frame (eg. Kaplan Col. 8, Ln. 24-Col. 9, Ln. 14); one or more fibers secured relative to the expandable frame, the one or more fibers adapted to facilitate thrombus formation within the LAAC device (eg. Krivoruchko, eg. Fig. 24, Para. 77, one of ordinary skill would have been able to make the parts integral to each other as an obvious integration/rearrangement of parts to provide more structural support for the parts, See MPEP 2144.04 V-VI)
Regarding claim 20, the combined invention of Kaplan and Krivoruchko discloses a support element extending to a position exterior of the expandable frame, and the one or more fibers are secured to the support element at the position exterior of the expandable frame and extend back into the expandable frame (eg. Col. 2, Ln. 54-Col. 3, Ln. 19, Fig. 8-15, Fig. 4, Col. 10, Ln. 45-63).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan (US 11399842 B2) in view of Dang (US 2021/0401418 A1).
Regarding claim 8, Kaplan 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
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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