DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/08/2025 has been entered.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 11/26/2025. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant's arguments, see page 6, alleging that the prior art of record fails to disclose or teach that the proximal eyelet is positioned rearward of the peripheral edge between the peripheral edge and the distal eyelet have been fully considered but they are not persuasive. The Examiner respectfully disagrees. It is the Examiner’s position that Bridgeman expressly discloses the proximal eyelet (35) is positioned rearward of the peripheral edge (37) between the peripheral edge (37) and the distal eyelet (50) (as shown in Fig. 3b and annotated Fig. 1a below).
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Applicant's arguments, see page 6, alleging that the prior art of record fails to disclose or teach the plurality of struts defining a plurality of petals at the occlusive face have been fully considered but they are not persuasive. The Examiner respectfully disagrees. It is the Examiner’s position that Bridgeman expressly discloses the plurality of struts defining a plurality of petals at the occlusive face (37) (as shown in annotated Fig. 3b below, greyed area depicts struts forming traditionally shaped flower petals at the peripheral edge).
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Claim Rejections - 35 USC § 103
Claim 1-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bridgeman et al. (US 2011/0054515) in view of Quinn et al. (US 2007/0162048).
Bridgeman discloses (see Figs. 1a-16) an occlusive device and system comprising the following claim limitations:
(claims 1 and 11) An occlusive device (1, Fig. 1c) comprising a proximal eyelet (35, Fig. 3b); a distal eyelet (i.e. central eyelet aperture 50 of cap portion 15, as shown in Figs. 1a-1b); a frame element (10, Fig. 1a) having a longitudinal axis (i.e. dotted line longitudinal axis shown in Fig. 1a) defined by a plurality of struts (as shown in Figs. 1a-1c; see Abstract; struts/legs of frame 10 expressly depicted) extending between the proximal eyelet (35) and the distal eyelet (50) (as expressly shown in Figs. 1a-1c); a membrane (19, Figs. 1a-1c) attached to at least a portion of the frame element (10) (as shown in Figs. 1a-1c); an occlusive face (5, Figs. 1a-1c) defining a peripheral edge (37, Fig. 1a) and having a substantially concave orientation formed by the membrane (19) and portions of the plurality of struts (i.e. frame 10) (as shown in Figs. 1a-1c; proximally facing concavity disposed about proximal eyelet 35 expressly depicted), the plurality of struts (10) including curved portions (30, Fig. 3b) extending away from the occlusive face (5) toward the distal end (6, Fig. 1a) (as shown in Figs. 1a-1c and 3b; curved portion 30 expressly depicted curving and extending away from the proximal occlusive face 5) (regarding claim 1) such that the proximal eyelet (35) is positioned rearward of the peripheral edge (37) between the peripheral edge (37) and the distal eyelet (50) (as shown in annotated Fig. 1a above in the Response to Arguments section) and/or (regarding claim 11) the plurality of struts defining a plurality of petals at the occlusive face (37) (as shown in annotated Fig. 3b above in the Response to Arguments section, greyed area depicts struts forming traditionally shaped flower petals at the peripheral edge); a tapered region (i.e. tapered region expressly shown along the body of device 1 at the indicator line for reference numeral “10” in Fig. 1a) that extends between the distal end and the proximal end formed by other portions of the plurality of struts (10) (as expressly shown in Fig. 1a); and a plurality of anchors (47, Figs. 1a-1c) arranged on the tapered region (as shown in Figs. 1a-1c) and configured to anchor at an ostium ([0003]-[0005]; [0031]; [0032]; [0038]; [0042]-[0044]; [0046]; [0064]); and a delivery catheter (400, Figs. 9-13) configured to (i.e. capable of) interface with at least one of the proximal eyelet (35) and the distal eyelet and deploy the occlusive device (1) (as shown in Figs. 9-16; [0061]-[0063]; delivery catheter 400 expressly interfaces with the proximal eyelet 35 via its deployment wire);
(claims 2 and 13) wherein the occlusive face (5) is configured to (i.e. capable of) span a shape of an ostium in a deployed configuration (as shown in Fig. 16; [0005]; [0043]);
(claims 3 and 14) wherein at least one of the proximal eyelet (35) and the distal eyelet (50) are configured to (i.e. capable of) attach to a delivery system ([0061]; proximal eyelet 35 expressly configured to be releasably connected to a deployment wire via connection 300; and the distal eyelet 50 is fully capable of being attached with a hook, graspers or any other desired delivery system members);
(claims 4 and 15) wherein the frame (10) further includes a generally cylindrical region extending from the occlusive face (5) in a distal direction, wherein the tapered region extends from the cylindrical region toward the distal end (as expressly shown in annotated Fig. 1a below);
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(claims 5 and 16) wherein the plurality of anchors (47) disposed near a junction of the cylindrical region and the tapered region (anchors 47 shown near the junction of the cylindrical and tapered regions in annotated Fig. 1a above);
(claim 6) wherein each of the plurality of anchors (47) includes a tissue engagement member (i.e. free end of barb 47) that protrudes outwardly relative to the frame element (as shown in Fig. 1a; tip of barb 47 protrudes outwardly by a penetration depth 49);
(claim 7) wherein the membrane (19) covers at least a majority of the frame element (10) (as expressly shown in at least Fig. 2);
(claim 8) wherein the plurality of elongate members converge at the distal eyelet (as expressly shown in Fig. 1b, converging struts/legs form the distal eyelet aperture disposed opposite the membrane 19);
(claim 9) wherein the frame element (10) comprises nitinol ([0044]); and
(claim 12) wherein the diameter of the occlusive face (5) can be (i.e. is capable of) altered or adjusted during deployment of the occlusive device (1) (as shown in Fig. 16; [0033]; [0042]; [0044]; [0064]; implant device is expressly composed of flexible and deformable nitinol and is fully capable of conforming to the individual structure of the LAA and it effectively follow the LAA shape).
Bridgeman, as applied above, discloses an occlusive device and system comprising all the limitations of the claim except for the plurality of anchors being staggered relative to the longitudinal axis of the frame element in a manner such that a first longitudinal position of a first anchor is different/staggered from a second longitudinal position of a second anchor, wherein at least a portion of at least one of the plurality of anchors protrudes through the membrane in a delivery configuration, wherein the first longitudinal position of the first anchor is aligned with/positioned at a peripheral edge of the occlusive face, and wherein the second longitudinal position is distal to the peripheral edge of the occlusive face.
However, Quinn teaches (as shown in Fig. 4) a similar occlusive device (26) and system comprising a plurality of anchors configured to anchor at an ostium (as shown in Fig. 2; [0005]; [0047]-[0048]; [0053]; [0059]-[0060]; [0062]; [0065]) and positioned on the peripheral edge of the occlusive face (see annotated Fig. 4 below; anchors 64 expressly depicted at peripheral edge of the proximal end face 52) and on the tapered region (see Fig. 4; anchors 64 expressly depicted at the tapering region of the distal end face 56), wherein the plurality of anchors (64) are staggered relative to the longitudinal axis of the frame element (46) in a manner such that a first longitudinal position of a first anchor different/staggered from a second longitudinal position of a second anchor (as expressly shown in annotated Fig. 4 below; anchors 64 are shown disposed at three different longitudinally staggered positions along the frame 46 with first anchors 64 at periphery of the proximal end face 52, second anchors at periphery of the distal end face 56, and third anchors at the mid-section of the device (similar to anchors 47 in Bridgeman)), wherein at least a portion of at least one of the plurality of anchors (64) protrudes through the membrane (48) in a delivery configuration (as expressly shown in Fig. 4; see claim 6; [0049]; [0055]; [0064]; one or more membrane layers expressly overlay the struts 62 of the frame 46 with anchors 64 expressly shown protruding therefrom) in order to beneficially provide anchors at each of three respective implant regions to inhibit proximal migration of the implant out of the intended target location, such as the left atrial appendage or other body cavities or lumens ([0052]; [0064]-[0065]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/system of Bridgeman to have a plurality of anchors configured to anchor at an ostium and positioned on the peripheral edge of the occlusive face and on the tapered region, wherein the plurality of anchors are staggered relative to the longitudinal axis of the frame element in a manner such that a first longitudinal position of a first anchor different/staggered from a second longitudinal position of a second anchor, wherein at least a portion of at least one of the plurality of anchors protrudes through the membrane in a delivery configuration in order to beneficially provide anchors at each of three respective implant regions to inhibit proximal migration of the implant out of the intended target location, such as the left atrial appendage or other body cavities or lumens, as taught by Quinn.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771