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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 8th, 2026, has been entered.
Response to Amendment
The claims filed on May 27th, 2026, have been entered. Claims 1-7, 10-19, 22-30, and 35-37 remain pending in the Application. The claim amendments overcome the previous 112(a) rejections.
Response to Arguments
Applicant's arguments filed May 27th, 2026, have been fully considered but they are not persuasive.
Applicant argues that the newly added claim limitations “a first hub component is positioned on a first side of the occlusion frame” and “a second hub component positioned on a second side of the occlusion frame” in independent claim 1 (with similar limitations added to independent claims 13, 25, 26, and 29) are not disclosed by Erzberger et al. (Pub. No. 2013/0218192). Examiner respectfully disagrees. The occlusion frame was defined in the Final Rejection dated April 16th, 2026, for Erzberger et al. as being the cap framework 12 (FIG. 1; [0014]) comprising a plurality of elongate frame members 22 ([0015]), while the first hub component was defined as proximal post 16 and the second hub component was defined as intermediate post 18. As shown in the Annotated FIG. 1 below, the proximal post 16 is positioned on the proximal side of the cap framework 12 while the intermediate post is positioned on the distal side of cap framework 12 (both the disc and the elongate frame members 22).
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Claim Rejections - 35 USC § 102
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) 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erzberger et al. (Pub. No. 2013/0218192).
Regarding claim 25, Erzberger et al. discloses an occlusive device ([0014] LAA device 10; FIG. 1), comprising:
a covering component ([0019] single sail 66) configured to modulate passage of blood or thrombus through the covering component ([0019] 66 is used to occlude the LAA, with a cut 64 preventing complete occlusion);
an occlusion frame ([0014] cap framework 12; FIG. 1) comprising a plurality of elongate frame members ([0015] wire loop 22; FIG. 1) arranged to form a generally disc-shaped member (FIG. 1: 12 has a generally disc-shape) and each of the elongate frame members originating at a different circumferential position about a hub (FIG. 1: 22 have different circumferential positions about 16) when the occlusion frame assumes an expanded configuration (FIG. 1: 12 is in the expanded configuration), each of the elongate frame members forming a generally disc-shaped member ([0019] 70 and 72, which is the equivalent of 22, form a general disc-shape; FIG. 3), wherein adjacent petals of the generally disc-shaped member at least partially overlap one another ([0019] the petals of 70 and 72 partially overlap adjacent petals; FIG. 3), and wherein the occlusion frame is at least partially covered by the covering component ([0019] 66 partially covers 12);
an anchor frame ([0014] bulb framework 14; FIG. 1) comprising first and second anchor arms ([0016] wire loops 24; FIG. 1), wherein the first and second anchor arms are configured to anchor the occlusive device at an implant location ([0017] 14 is used to anchor the device in the implant location, such as using barbs 52; FIG. 2), the first anchor arm being oriented opposite the second anchor arm (FIG. 2: some 24 are on the opposite side of other 24);
a first hub component ([0015] proximal post 16; FIG. 1) positioned on a first side of the occlusion frame (FIG. 1: 16 is on the proximal side of 12) and from which the plurality of elongate frame members extend (FIG. 1: 22 extend distally from 16), the first hub component disposed between the occlusion frame and the anchor frame (FIG. 1: a portion of 16 is between at least a portion of 12 and 14);
a second hub component ([0015] intermediate post 18; FIG. 1) positioned on a second side of the occlusion frame (FIG. 1: 18 is on the distal side of 12) and from which the plurality of elongate frame members extend (FIG. 1: 22 extend from 18), the second hub component disposed between the occlusion frame and the anchor frame (FIG. 1: a portion of 18 is between 12 and 14); and
a flexible connecting member ([0023] a single flexible wire 22 connects 16 and 18; FIG. 1) comprising first and second end portions, wherein the first end portion is attached to the first hub component (FIG. 1: 22 has a first end connected to 16), and the second end portion is attached to the second hub component (FIG. 1: 22 has a second end connected to 18),
wherein the plurality of elongate frame members terminate at the first and second hub components (FIG. 1: 22 has a first end terminating at 16, and a second end terminating at 18).
Claim Rejections - 35 USC § 103
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) 1-5, 10-17, 22-24, 26-27, 29, and 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erzberger et al. in view of Kornblau et al. (Pub. No. 2014/0371786).
Regarding claim 1, Erzberger et al. discloses an occlusive device ([0014] LAA device 10; FIG. 1), comprising:
a covering component ([0019] single sail 66) configured to modulate passage of blood or thrombus through the covering component ([0019] 66 is used to occlude the LAA, with a cut 64 preventing complete occlusion);
an occlusion frame ([0014] cap framework 12; FIG. 1) comprising a plurality of elongate frame members ([0015] wire loop 22; FIG. 1) having shape memory properties ([0015] 22 are made of nitinol), each of which comprise a portion of a tube (FIG. 1: 22 form a portion of the tubular 10), the plurality of elongate frame members arranged to form a generally disc-shaped member when the occlusion frame assumes an expanded configuration (FIG. 1: 12 has a generally disc-shape), each of the elongate frame members forming a petal of the generally disc-shaped member ([0019] 70 and 72, which is the equivalent of 22, form petals; FIG. 3), wherein adjacent petals of the generally disc-shaped member at least partially overlap one another ([0019] the petals of 70 and 72 partially overlap adjacent petals; FIG. 3), and wherein the occlusion frame is at least partially covered by the covering component ([0019] 66 partially covers 12);
an anchor frame ([0014] bulb framework 14; FIG. 1) comprising a plurality of anchor members ([0016] wire loop 24; FIG. 1) configured to anchor the occlusive device at an implant location ([0017] 14 is used to anchor the device in the implant location, such as using barbs 52; FIG. 2);
a first hub component ([0015] proximal post 16; FIG. 1) positioned on a first side of the occlusion frame (FIG. 1: 16 is on the proximal side of 12) and from which the plurality of elongate frame members extend (FIG. 1: 22 extend distally from 16), the first hub component disposed between the occlusion frame and the anchor frame (FIG. 1: part of 16 is between 12 and 14);
a second hub component ([0015] intermediate post 18; FIG. 1) positioned on a second side of the occlusion frame (FIG. 1: 18 is on the distal side of 12) and from which the plurality of elongate frame members extend (FIG. 1: 22 extend from 18), the second hub component disposed between the occlusion frame and the anchor frame (FIG. 1: a portion of 18 is between 12 and 14); and
a connecting member that connects the first hub component to the second hub component (as discussed above, this limitation is being examined under 112(f), and will be satisfied with any nitinol wire which connecting the hub components; [0023] a single nitinol wire 22 connects 16 and 18; FIG. 1).
Erzberger et al. does not disclose the first hub component and the plurality of elongate frame members are of one material and seamless, and the second hub component and the plurality of elongate frame members are of one material and seamless.
Kornblau et al. teaches in the same field of endeavor of occlusive anchor devices ([0008]), and discloses an anchor device (1; [0029]; FIGs. 1A-1B) comprising a first hub component (Annotated FIG. 1B below), a second hub component (Annotated FIG. 1B), and a plurality of elongate frame members (Annotated FIG. 1B), where the first hub component, the second hub component, and the plurality of elongate frame members are all made of a single cut tube ([0027]), for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs ([0006]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first hub component, the second hub component, and the plurality of elongate frame members of Erzberger et al. to be made of a single cut tube instead of wire loops (Erzberger et al. [0015]), as taught by Kornblau et al., for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs.
Regarding claim 2, Erzberger et al. further discloses each anchor member of the plurality of anchor members comprises a wire ([0015] 24 are wires).
Regarding claim 3, Erzberger et al. further discloses each anchor member of the plurality of anchor members comprises a portion of the tube (FIG. 1: 24 also help form the overall tubular structure of 10).
Regarding claim 4, Erzberger et al. further discloses each anchor member of the plurality of anchor members comprises a portion of a second tube (FIG. 1: 24 also help form the overall tubular structure of 10, as a second distal tube).
Regarding claim 5, Erzberger et al. further discloses the connecting member comprises one or more nitinol wires ([0015] 22 are nitinol wires).
Regarding claim 10, Erzberger et al. further discloses each of the anchor members includes a first portion that extends generally radially from the second hub component (FIG. 1: 24 extends radially outward from 18), and a second portion that extends from the first portion in a generally proximal direction (FIG. 2: 52 extends from 24 and in a generally proximal direction).
Regarding claim 11, Erzberger et al. further discloses the connecting member is flexible ([0023] 22 is made of a flexible wire) and includes a first end portion that is attached to the first hub component (FIG. 1: 22 has a first end connected to 16) and a second end portion that is attached to the second hub component (FIG. 1: 22 has a second end connected to 18).
Regarding claim 12, Erzberger et al. further discloses the tube comprises nitinol ([0014] both frameworks are made of nitinol, so the tube is made of nitinol).
Regarding claim 13, Erzberger et al. discloses an occlusive device ([0014] LAA device 10; FIG. 1), comprising:
a covering component ([0019] single sail 66) configured to modulate passage of blood or thrombus through the covering component ([0019] 66 is used to occlude the LAA, with a cut 64 preventing complete occlusion);
an occlusion frame ([0014] cap framework 12; FIG. 1) comprising a plurality of elongate frame members ([0015] wire loop 22; FIG. 1) having shape memory properties ([0015] 22 is made of nitinol), the plurality of elongate frame members arranged to form a generally disc-shaped member when the occlusion frame assumes an expanded configuration (FIG. 1: 12 has a generally disc-shape), each of the elongate frame members forming a petal of the generally disc-shaped member ([0019] 70 and 72, which is the equivalent of 22, form petals; FIG. 3), wherein adjacent petals of the generally disc-shaped member at least partially overlap one another ([0019] the petals of 70 and 72 partially overlap adjacent petals; FIG. 3), and wherein the occlusion frame is at least partially covered by the covering component ([0019] 66 partially covers 12);
an anchor frame ([0014] bulb framework 14; FIG. 1) comprising a plurality of anchor members ([0016] wire loop 24; FIG. 1), each of which comprise a portion of a tube (FIG. 1: 24 help form the overall tubular structure of 10), wherein the plurality of anchor members are configured to anchor the occlusive device at an implant location ([0017] 14 is used to anchor the device in the implant location, such as using barbs 52; FIG. 2);
a first hub component ([0015] proximal post 16; FIG. 1) positioned on a first side of the occlusion frame (FIG. 1: 16 is on the proximal side of 12) and from which the plurality of elongate frame members extend (FIG. 1: 22 extend distally from 16), the first hub component disposed between the occlusion frame and the anchor frame (FIG. 1: part of 16 is between 12 and 14);
a second hub component ([0015] intermediate post 18; FIG. 1) positioned on a second side of the occlusion frame (FIG. 1: 18 is on the distal side of 12) and from which the plurality of elongate frame members extend (FIG. 1: 22 extend from 18); and
a connecting member that connects the first hub component to the second hub component (as discussed above, this limitation is being examined under 112(f), and will be satisfied with any nitinol wire which helps connect the hub components; [0023] a single wire 22 connects 16 and 18; FIG. 1).
Erzberger et al. does not disclose the first hub component and the second hub component are parts of a single cylindrical tube prior to cutting to define the plurality of elongate frame members.
Kornblau et al. teaches in the same field of endeavor of occlusive anchor devices ([0008]), and discloses an anchor device (1; [0029]; FIGs. 1A-1B) comprising a first hub component (Annotated FIG. 1B below) and a second hub component (Annotated FIG. 1B), where the first hub component and the second hub component are made of a single cut tube prior to cutting to define the plurality of elongate frame members ([0027] 1 is a cut metal tube, where cuts made in an expandable metal tube create the plurality of elongate frame members), for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs ([0006]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first hub component and the second hub component of Erzberger et al. to be made of a single cut tube instead of separate components connected by wire loops (Erzberger et al. [0015]), as taught by Kornblau et al., for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs.
Regarding claim 14, Erzberger et al. further discloses each elongate frame member of the plurality of elongate frame members comprises a wire ([0015] 22 are wires).
Regarding claim 15, Erzberger et al. further discloses each anchor member of the plurality of anchor members comprises a portion of the tube (FIG. 1: 22 form a portion of the tubular 10).
Regarding claim 16, Erzberger et al. further discloses each anchor member of the plurality of anchor members comprises a portion of a second tube (FIG. 1: 22 also help form the overall tubular structure of 10, as a second proximal tube).
Regarding claim 17, Erzberger et al. further discloses the connecting member comprises one or more nitinol wires ([0015] 22 are nitinol wires).
Regarding claim 22, Erzberger et al. further discloses each of the anchor members includes a first portion that extends generally radially from the second hub component (FIG. 1: 24 extends radially outward from 18), and a second portion that extends from the first portion in a generally proximal direction (FIG. 2: 52 extends from 24 and in a generally proximal direction).
Regarding claim 23, Erzberger et al. further discloses the connecting member is flexible ([0023] 22 is made of a flexible wire) and includes a first end portion that is attached to the first hub component (FIG. 1: 22 has a first end connected to 16) and a second end portion that is attached to the second hub component (FIG. 1: 22 has a second end connected to 18).
Regarding claim 24, Erzberger et al. further discloses the tube comprises nitinol ([0014] both frameworks are made of nitinol, so the tube is made of nitinol).
Regarding claim 26, Erzberger et al. discloses an occlusive device ([0014] LAA device 10; FIG. 1) comprising:
a first portion ([0014] cap framework 12; FIG. 1) comprising one or more first portion elongate members ([0015] wire loop 22; FIG. 1) that are configured to form a first shape (FIG. 1: 12 forms a disc-shape),
a first central hub ([0015] proximal post 16; FIG. 1) positioned on a first side of the occlusion frame (FIG. 1: 16 is on the proximal side of 12) and from which at least some of the plurality of elongate frame members extend (FIG. 1: 22 extend distally from 16), wherein the one or more first portion elongate frame members originate at a different circumferential position about the first central hub relative to each other (FIG. 1: 22 have different circumferential positions about 16);
a second portion ([0014] bulb framework 14; FIG. 1) comprising one or more second portion elongate members ([0016] wire loop 24; FIG. 1) that are configured to form a second shape (FIG. 1: 14 forms a puck-shape);
a second central hub ([0015] intermediate post 18; FIG. 1) positioned on a second side of the occlusion device (FIG. 1: 18 is on the distal side of 12) and from which at least some of the plurality of elongate frame members extend (FIG. 1: 22 extend from 18), wherein the second central hub is configured to be interlocked with the first central hub ([0023] a single wire 22 connects 16 and 18; FIG. 1); and
a covering component ([0019] single sail 66) on the first portion (FIG. 3: 66 is on 12), wherein the covering component is configured to modulate passage of body materials through the covering component ([0019] 66 is used to occlude the LAA, with a cut 64 preventing complete occlusion).
Erzberger et al. does not disclose the one or more first portion elongate members, the first central hub, the second portion, and the second central hub are unitary and are defined from a cut tube.
Kornblau et al. teaches in the same field of endeavor of occlusive anchor devices ([0008]), and discloses an anchor device (1; [0029]; FIGs. 1A-1B) comprising a first central hub (Annotated FIG. 1B below), a second central hub (Annotated FIG. 1B), a first portion (Annotated FIG. 1B), and one or more first portion elongate members (Annotated FIG. 1B), where the first central hub, the second central hub, the first portion, and the one or more elongate members are all made of a single cut tube ([0027] 1 is an expandable metal tube that has been cut to create the elongate members between multiple hubs) for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs ([0006]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first central hub, the second central hub, the first portion, and the one or more elongate members of Erzberger et al. to be made of a single cut tube instead of wire loops (Erzberger et al. [0015]), as taught by Kornblau et al., for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs. While this modification does not explicitly disclose the second portion is also made of a single cut tube, one or ordinary skill in the art would find making the cut tube with three hubs (adding an intermediate hub between the first central hub and the second central hub) obvious since [0041] of Kornblau et al. discloses having an intermediate section. Adding the intermediate hub would therefore create a second portion which is also unitary with the first central hub, the second central hub, and the one or more elongate members.
Regarding claim 27, Erzberger et al. further discloses the first shape is a disc shape (FIG. 1: 12 forms a disc-shape).
Regarding claim 29, Erzberger et al. discloses an occlusive device ([0014] LAA device 10; FIG. 1), comprising:
a covering component ([0019] single sail 66) configured to modulate passage of blood or thrombus through the covering component ([0019] 66 is used to occlude the LAA, with a cut 64 preventing complete occlusion);
an occlusion frame ([0014] cap framework 12; FIG. 1) comprising a plurality of elongate occlusion frame members ([0015] wire loop 22; FIG. 1) and having shape memory properties ([0015] 22 are made of nitinol), each of which comprise a portion of a tube (FIG. 1: 22 form a portion of the tubular 10), the plurality of elongate frame members arranged to form an interconnected occlusion structure ([0014-15] 22 form the interconnected structure 12), the interconnected occlusion structure comprising a generally disc-shaped member when the occlusion frame assumes an expanded configuration (FIG. 1: 12 has a generally disc-shape), and wherein the occlusion frame is at least partially covered by the covering component ([0019] 66 partially covers 12);
an anchor frame ([0014] bulb framework 14; FIG. 1) comprising a plurality of anchor members ([0016] wire loop 24; FIG. 1), each of which comprise a portion of the tube (FIG. 1: 24 help to form the general tube shape of 10), the anchor frame configured to anchor the occlusive device at an implant location ([0017] 14 is used to anchor the device in the implant location, such as using barbs 52; FIG. 2), the elongate anchor frame members arranged to form an interconnected anchor structure (FIG. 1: 24 come together to form 14), the interconnected anchor structure comprising a generally cylindrical member when the anchor frame assumes an expanded configuration (FIG. 2: 14 is a generally cylindrical member in the expanded deployment configuration);
a first hub component ([0015] proximal post 16; FIG. 1) positioned on a first side of the occlusion frame (FIG. 1: 16 is on the proximal side of 12) and from which at least some of the plurality of elongate frame members extend (FIG. 1: 22 extend distally from 16),
a second hub component ([0015] intermediate post 18; FIG. 1) positioned on a second side of the occlusion frame (FIG. 1: 18 is on the distal side of 12) and from which at least some of the plurality of elongate frame members extend (FIG. 1: 22 extend from 18), and from which at least some of the elongate anchor frame members extend (FIG. 1: 24 extend from 18), the second hub component disposed between the occlusion frame and the anchor frame (FIG. 1: a portion of 18 is between 12 and 14).
Erzberger et al. does not disclose the occlusion frame, the anchor frame, the first hub component, and the second hub component are unitary and of one-piece.
Kornblau et al. teaches in the same field of endeavor of occlusive anchor devices ([0008]), and discloses an anchor device (1; [0029]; FIGs. 1A-1B) comprising a first hub component (Annotated FIG. 1B below), a second hub component (Annotated FIG. 1B), and an occlusion frame (Annotated FIG. 1B), where the first hub component, the second hub component, and the occlusion frame are all made of a single cut tube ([0027]) for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs ([0006]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first hub component, the second hub component, and the occlusion frame of Erzberger et al. to be made of a single cut tube instead of wire loops (Erzberger et al. [0015]), as taught by Kornblau et al., for the purpose of achieving the benefits of wire-based anchors while reducing manufacturing costs. While this modification does not explicitly disclose the anchor frame is also made of a single cut tube, one or ordinary skill in the art would find making the cut tube with three hubs (adding an intermediate hub between the first central hub and the second central hub) obvious since [0041] of Kornblau et al. discloses having an intermediate section. Adding the intermediate hub would therefore create the anchor frame, which is unitary and of one-piece with the first hub component, the second hub component, and the occlusion frame.
Regarding claim 35, Erzberger et al. further discloses the first and second hub components are cylindrical tubes (FIG. 1: 16 and 18 are cylindrical tubes).
Regarding claim 36, Erzberger et al. further discloses the plurality of elongate frame members terminate at the first and second hub components (FIG. 1: 22 has a first end terminating at 16, and a second end terminating at 18).
Regarding claim 37, Erzberger et al. further discloses the anchor members include portions directed in a proximal direction toward the generally disc-shaped member (FIG. 1: the anchor members 24 extend proximally towards 12 from the distal post 20 to the intermediate post 18).
Claim(s) 6-7, 18-19, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erzberger et al. in view of Kornblau et al., and in further view of Heipl et al. (Pub. No. 2014/0296909).
Regarding claim 6, Erzberger et al. as modified by Kornblau et al. discloses the invention as claimed in claim 1, as discussed above. Erzberger et al. is silent regarding the first hub component, the second hub component, and the connecting member being covered by the covering component.
Heipl et al. teaches in the same field of endeavor of LAA occluders ([0002]), and discloses a device ( [0105]) with an outer membrane ([0105] the implant can be covered with a PTFE non-fibrous film membrane) which covers the entire outside of the device ([0105] the membrane can cover the entire expanded diameter of the implant) for the purpose of improving occlusion and rapid endothelialization through greater overall coverage ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering component of Erzberger et al. to cover the entire device, including the hub components and connecting member, as taught by Heipl et al., for the purpose of improving occlusion and rapid endothelialization through greater overall coverage.
Regarding claim 7, Erzberger et al. as modified by Kornblau et al. discloses the invention as claimed in claim 1, as discussed above. Erzberger et al. is silent regarding the anchor frame is at least partially covered by the covering component.
Heipl et al. teaches in the same field of endeavor of LAA occluders ([0002]), and discloses a device ([0105]) with an outer membrane ([0105] the implant can be covered with a PTFE non-fibrous film membrane) which covers the entire outside of the device ([0105] the membrane can cover the entire expanded diameter of the implant) for the purpose of improving occlusion and rapid endothelialization through greater overall coverage ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering component of Erzberger et al. to cover the entire device, including the anchor frame, as taught by Heipl et al., for the purpose of improving occlusion and rapid endothelialization through greater overall coverage.
Regarding claim 18, Erzberger et al. as modified by Kornblau et al. discloses the invention as claimed in claim 13, as discussed above. Erzberger et al. is silent regarding the first hub component, the second hub component, and the connecting member being covered by the covering component.
Heipl et al. teaches in the same field of endeavor of LAA occluders ([0002]), and discloses a device ([0105]) with an outer membrane ([0105] the implant can be covered with a PTFE non-fibrous film membrane) which covers the entire outside of the device ([0105] the membrane can cover the entire expanded diameter of the implant) for the purpose of improving occlusion and rapid endothelialization through greater overall coverage ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering component of Erzberger et al. to cover the entire device, including the hub components and connecting member, as taught by Heipl et al., for the purpose of improving occlusion and rapid endothelialization through greater overall coverage.
Regarding claim 19, Erzberger et al. as modified by Kornblau et al. discloses the invention as claimed in claim 13, as discussed above. Erzberger et al. is silent regarding the anchor frame is at least partially covered by the covering component.
Heipl et al. teaches in the same field of endeavor of LAA occluders ([0002]), and discloses a device ([0105]) with an outer membrane ([0105] the implant can be covered with a PTFE non-fibrous film membrane) which covers the entire outside of the device ([0105] the membrane can cover the entire expanded diameter of the implant) for the purpose of improving occlusion and rapid endothelialization through greater overall coverage ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering component of Erzberger et al. to cover the entire device, including the anchor frame, as taught by Heipl et al., for the purpose of improving occlusion and rapid endothelialization through greater overall coverage.
Regarding claim 28, Erzberger et al. as modified by Kornblau et al. discloses the invention as claimed in claim 26, as discussed above. Erzberger et al. is silent regarding the covering component comprises ePTFE or PTFE, though Erzberger et al. discloses the covering component can be any polymer fabric of the type known and used in implantable medical devices ([0019]).
Heipl et al. teaches in the same field of endeavor of LAA occluders ([0002]), and discloses a device ([0105]) with an outer membrane ([0105] the implant can be covered with a PTFE non-fibrous film membrane) which covers the entire outside of the device ([0105] the membrane can cover the entire expanded diameter of the implant) for the purpose of improving occlusion and rapid endothelialization through greater overall coverage ([0105]).It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering component of Erzberger et al. to be made of PTFE, as taught by Heipl et al., for the purpose of being a polymer fabric well-known in the art to be used in implantable medical devices.
Regarding claim 30, Erzberger et al. as modified by Kornblau et al. discloses the invention as claimed in claim 29, as discussed above. Erzberger et al. is silent regarding the anchor frame is at least partially covered by the covering component.
Heipl et al. teaches in the same field of endeavor of LAA occluders ([0002]), and discloses a device ( [0105]) with an outer membrane ([0105] the implant can be covered with a PTFE non-fibrous film membrane) which covers the entire outside of the device ([0105] the membrane can cover the entire expanded diameter of the implant) for the purpose of improving occlusion and rapid endothelialization through greater overall coverage ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering component of Erzberger et al. to cover the entire device, including the anchor frame, as taught by Heipl et al., for the purpose of improving occlusion and rapid endothelialization through greater overall coverage.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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