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 with respect to the amendments to the claim(s) overcoming the previously presented rejections in the office action dated 5/12/2026 have been fully considered. The amendments distinguish the claimed invention from the embodiment of Center relied upon in the previous action (embodiment shown in figs. 33B, 33C). However, in view of the amendments, the embodiment illustrated in fig. 60 of Center is being relied upon in the below rejections. Briefly, it is noted that the holding portion (mesh cover 1068) can be applied to the inside or outside surface of the frame that forms the retention portion (1064,1064a,1064b). See [0234]. When applied to the outside surface of the retention portion, the retention portion is distal of the end member (portion of holding portion 1068 applied to hub 1062) of the holding portion. Center further teaches that the embodiment shown in fig. 60 may comprise wires attached to a hub ([0233]) and any of the features described with respect to a particular device may also be used with any of the other devices described therein ([0099]), and thus it is understood that the hub may take the form show in figs. 27-29, which includes a plurality of apertures and a plurality of wires passing through the apertures. See the rejections below for a more detailed explanation of how the prior art of Center meets the limitations of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-3, 12-13, and 21 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Center (US 2015/0005810).
Regarding claims 2 and 12, Center discloses an occlusion device (fig. 60) comprising a holding portion (covering component 1068) having a first passage (i.e., the central lumen), the holding portion comprising an interlocked mesh structure (woven Dacron; [0116] and [0234]) having distally extending walls with a first diameter that terminates at an end member (small diameter end of holding member attached to hub 1062) having a second diameter less than the first diameter, and a retention portion (at least portion of expandable frame formed by struts 1064,1064a,1064b) distal to the end member that supports a proximal end of the holding portion (note: Center discloses that holding portion 1068 may cover the ouside surface of the retention portion instead of the inner surface, [0234], and thus struts 1064/1064a/1064b of the retention portion are distal of the end member of the holding portion), and includes a center element (1062 in fig. 60, which may take the form of a hub 1182 with apertures as shown in fig. 28) having a plurality of apertures and a plurality of wires passing through the plurality of apertures distally to form a having a plurality of loops (formed by 1064/1064a,b) that are substantially aligned in a plane perpendicular to a central axis of the retention portion (similar to figs. 55 and 56). In particular, Center discloses that the retention portion (1064/1064a,b) of the embodiment shown in fig. 60 may be made of wires attached to a hub ([0233]) and may have any of the configurations and variations disclosed by Center ([0094]), and thus discloses that the loops may comprise one or more wires that pass through the plurality of apertures within the center element (hub 1182 that receives wire ends; see figs. 27-29; see also [0174] of Center). The center element (1182) is coupled to the end member (noting all portions of the device are considered coupled to each other, either directly or through one or more intermediate portions of the occlusion device), wherein at least one of the holding portion or the center element is configured to detachably connect to at least one of a microcatheter or a pusher. It is noted that the phrase “configured to detachably connect to at least one of a microcatheter or a pusher” is a recitation of intended use, and the microcatheter or pusher are not positively recited in combination with the occlusion device. Since an appropriately sized pusher could be snugly fit either inside of, or around the outside of, the center element of Center, it meets this recitation of intended use.
Regarding claims 3 and 13, it is noted that the at least one of the microcatheter or pusher are not positively recited as part of the occlusion device (see claims 2 and 12: “wherein at least one of the holding portion or the center element is configured to detachably connect to at least one of a microcatheter or a pusher”). Since the prior art of Center discloses a holding portion or center element that is capable of being detached from a microcatheter or pusher in a detached configuration and attached to the microcatheter or pusher in an attached configuration, it meets this limitation.
Regarding claim 21, it is noted that the pusher is not positively recited. Because the holding portion of the prior art of Center is capable of being detachably connected to a pusher (at the proximal end of the occlusion device) having a lumen sized to allow embolic agents to advance through the lumen and the first passage of the holding portion, it meets this recitation of intended use.
Claim Rejections - 35 USC § 103
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.
Claim(s) 4-5, 7-11, 14-15, 17, 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Center in view of Lorenzo (US 2015/0272589).
Regarding claims 4 and 14, Center discloses a catheter (delivery catheter of [0096]) having a second passage (lumen of catheter), wherein each loop of the plurality of loops (formed by 1064,1064a,1064b; fig. 60) is connected near a middle region of the holding portion (e.g., connected at 1062, which is formed at the radial center of the holding portion) and extends radially outward therefrom in a layer distinct from and adjacent to the holding portion (see fig. 60), the plurality of loops being located at a proximal portion of the holding portion (see also [0122]).
The retention portion comprises an aperture (hole through central element). The first passage of the holding portion and the aperture form a continuous passage (noting continuous passage through entire occlusion device), but Center does not expressly disclose that the second passage of the catheter forms a continuous passage with the first passage and aperture.
Lorenzo discloses an occlusion device comprising a catheter (e.g., 14) having a second passage (e.g., 15) at a distal end, the passage forming a continuous passage with an aperture formed in a center element (control ring 22) formed at the end of the occlusion device, the continuous passage sized to allow embolic agents to advance through the continuous passage (fig. 4-6). The embolic agents advantageously substantially fill the aneurysm sac and anchor the holding portion of the occlusion device against the interior wall of the aneurysm to block the neck of the aneurysm ([0038] of Lorenzo).
It would have been obvious to one of ordinary skill in the art to have modified the prior art device of Center, which can be used for the occlusion of aneurysms ([0098] of Center), to construct the catheter such that the lumen of the catheter (claimed “second passage”) forms a continuous passage with the aperture of the center element and the first passage of the holding portion in view of Lorenzo in order to allow the delivery of embolic coils into an aneurysm that has been sealed by the occlusion device as taught by Lorenzo. One skilled in the art would have understood that such a modification leads to the predictable result of enhancing occlusion of the aneurysm by allowing filling of the aneurysm with embolic agent after it has been sealed by the occlusion device, and to advantageously ensure that the occlusive device maintains a desired position at the neck of the aneurysm as disclosed by Lorenzo.
Regarding claims 5 and 15, the plurality of loops (fig. 60) is clover shaped since the loops form petal shapes arranged around a central axis, thus resembling a clover, noting clovers may have any number of petals.
Regarding claim 7, noting that the holding portion includes mesh 1068, Center discloses that mesh holding portions may affixed to the frame on which they are disposed by banding that may comprise suture materials, wherein the suture material banding may be considered a tie (par. [0111]: covering component, i.e., mesh holding portion, can be attached to elongate members or hubs using banding; suture material banding may be considered a tie). Center is silent on the number of ties. However, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Center to affix the mesh 1068 of the holding portion to the retention portion with a plurality of ties since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art (St. Regis Paper Co. v. Bemis Co. 193 USPQ 8) and such a modification merely leads to the predictable result of providing multiple attachment points (versus one attachment point) between the holding portion and the retention portion.
Regarding claim 8, the plurality of loops surrounds the aperture of the retention portion (see fig. 60 of Center) in the same manner as the loops of the instant application.
Regarding claim 9, the expanded shape of the holding portion 1068 is positioned across the expanded shape of the retention portion (loops formed by 1064,1064a,1064b) and forms walls extending distally beyond the retention portion 1064,1064a,1064b (fig. 60 of Center).
Regarding claim 10, Center does not expressly disclose that the mesh structure comprises a plurality of braided wires as claimed. Lorenzo discloses that the mesh structure forming the holding portion of an occlusion device may comprise a plurality of braided wires include radiopaque wires, which may be platinum ([0042]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Center to construct the mesh as a plurality of braided wires, wherein the plurality includes platinum wires in view of Lorenzo’s teaching that such a material is suitable for the construction of a mesh holding portion of an occlusive device and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Regarding claims 11 and 17, the holding portion can be positioned above or underneath the retention portion (depending on orientation in which device is held).
Regarding claim 24, the plurality of loops supports a proximal end of the holding portion (at end member of holding portion since they are connected).
Regarding claim 26, the interlocked mesh structure forms a largest opening at its distal end (larger end) (see fig. 60 of Center).
Regarding claim 25, it is noted that the holding portion of Center may be considered the portion of covering component (1068, which is mesh) that covers the retention portion (struts 1064,1064a,1064b; fig. 60) such that the plurality of loops are configured to prevent embolic agents from moving proximally from an interior of the interlocked mesh structure of the holding portion since they support the proximal surface of the holding portion and block portions of the mesh, noting the loops are inside the mesh covering frame 1068. This is consistent with the instant application, wherein the retention portion forming loops that rest against an inner or outer proximal surface of the mesh holding portion are considered “configured to prevent embolic agents from moving proximally from an interior of the interlocked mesh structure of the holding portion”.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Center in view of Wilson et al. (US 2005/0043755). Center discloses the invention substantially as stated above including that the occlusion device may be detachably connected to a catheter but is silent on the exact structure of the detachable connection.
Wilson discloses another occlusion device, the device including a device coupling ring (34) and a tether (40; figs. 4,5) detachably connected to the device coupling ring and a distal end of the pusher (24) held within a catheter. Wilson further teaches a heater coil (44), wherein the heater coil is positioned such that, when in a heated configuration, the heater coil melts at least a portion of the tether in order to detach the tether from the coupling ring (34) associated with the implantable portion of the occlusion device, and where, in an unheated configuration, the heater coil does not melt the portion of the tether ([0030]; figs. 4, 5). The portion that is melted is also considered detached from the pusher. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Center to include the coupling ring, pusher, a tether and heater coil configuration as taught by Wilson, wherein the heater coil melts a portion of the tether to disconnect the tether from the coupling ring, since Center is silent on the exact configuration of the detachable connection between the delivery catheter and the occlusion device, and Wilson discloses that such an arrangement is known in the art as satisfactory for detachably connecting an occlusion device to a delivery catheter.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Center in view of Amplatz (US 2015/0272589) and Lorenzo. Center discloses an occlusion device comprising a catheter having a first passage, a holding portion (1068; fig. 60) having a second passage (i.e., the central lumen), the holding portion comprising a mesh structure (cover may be woven dacron), the mesh structure having a first diameter that terminates at an end member (portion attached to hub 1062) having a second diameter less than the first diameter, and a retention portion (portion of frame formed by 1064,1064a,1064b) distal to the end member that supports a proximal end of the holding portion (note: Center discloses that the mesh 1068 may line the outer surface of the frame and thus the retention portion is distal of the end member of the holding portion) and includes a center element (1182; fig. 28) having a plurality of apertures and a plurality of wires passing through the plurality of apertures distally to form a plurality of loops distal to the center element that are substantially aligned in a plane perpendicular to a central axis of the retention portion (as understood in view of fig 56 and its corresponding side view fig. 55). In particular, Center discloses that the retention portion (1064/1064a,b) of the embodiment shown in fig. 60 may be made of wires attached to a hub ([0233]) and may have any of the configurations and variations disclosed by Center ([0094]), and thus discloses that the loops may comprise one or more wires that pass through the plurality of apertures within the center element (hub 1182 that receives wire ends; see figs. 27-29; see also [0174] of Center) distally to form the loops distal to the center element. The center element (1182) is coupled to the end member (noting all portions of the device shown in fig. 60 are considered coupled to each other, either directly or through one or more intermediate portions of the occlusion device), wherein at least one of the holding portion or the center element is configured to detachably connect to at least one of a microcatheter or a pusher. It is noted that the phrase “configured to detachably connect to at least one of a microcatheter or a pusher” is a recitation of intended use, and the microcatheter or pusher are not positively recited in combination with the occlusion device. Since an appropriately sized pusher could be snugly fit either inside of, or around the outside of, the center element of Center, it meets this recitation of intended use.
Center fails to expressly disclose that the mesh structure connects to the first passage of the catheter via the second passage of the holding portion, the first and second passage forming a continuous passage sized to allow embolic agents to advance through the continuous passage.
Lorenzo discloses an occlusion device comprising a catheter (e.g., 14) having a second passage (e.g., 15) at a distal end, the passage forming a continuous passage with an aperture formed in a center element (control ring 22) formed at the end of the occlusion device, the continuous passage sized to allow embolic agents to advance through the continuous passage (fig. 4-6). The embolic agents advantageously substantially fill the aneurysm sac and anchor the holding portion of the occlusion device against the interior wall of the aneurysm to block the neck of the aneurysm ([0038] of Lorenzo).
It would have been obvious to one of ordinary skill in the art to have modified the prior art device of Center, which can be used for the occlusion of aneurysms ([0098] of Center), to construct the catheter such that the lumen of the catheter (claimed “first passage”) forms a continuous passage with the aperture of the center element and the second passage of the holding portion in view of Lorenzo in order to allow the delivery of embolic coils into an aneurysm that has been sealed by the occlusion device as taught by Lorenzo. One skilled in the art would have understood that such a modification leads to the predictable result of enhancing occlusion of the aneurysm by allowing filling of the aneurysm with embolic agent after it has been sealed by the occlusion device, and to advantageously ensure that the occlusive device maintains a desired position at the neck of the aneurysm as disclosed by Lorenzo.
Center also fails to disclose a first and second marker band as claimed. Amplatz discloses another occlusion device comprising a mesh structure (fabric made of braided or interwoven strands as per [0033]; figs. 2-3c). Amplatz teaches that the fibers of the mesh structure are held together at their proximal ends by a first radiopaque marker band (21; fig. 2) placed around the mesh structure and a second radiopaque marker band (23) placed inside the mesh structure (see par. [0057], wherein inner and outer clamp members may be radiopaque) and aligned concentrically with the first radiopaque marker band (21). The ends (24) of the wires forming the mesh structure are crimped between the inner and outer radiopaque marker bands ([0057]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Center with first and second concentric radiopaque marker bands between which the ends of the filaments forming the mesh structure (738) are crimped as taught by Amplatz in order to prevent the ends of the filaments forming the mesh from separating and to enhance visualization of the device within the body.
Regarding claim 19, in a detached configuration, the holding portion is detached from the at least one microcatheter or pusher, and in an attached configuration, the holding portion is attached to the at least one microcatheter or pusher, noting that the at least one microcatheter or pusher are not positively recited.
Regarding claim 20, each loop of the plurality of loops (formed by 1064,1064a,1064b; fig. 60) is connected near a middle region of the holding portion (e.g., middle region formed at the radial center of the holding portion) and extends radially outward therefrom in a layer distinct from and adjacent to the holding portion (see fig. 60), the plurality of loops being substantially aligned in a single plane and located at a proximal portion of the holding portion (as understood in view of figs. 55, 56). The retention portion comprises a central aperture (central aperture in 1182) at the center element, wherein the first passage, the second passage, and the central aperture form the continuous passage in view of Lorenzo as discussed above.
Allowable Subject Matter
Claim 23 is allowed.
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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 10/13/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
