DETAILED ACTION
Claims 1-22 are pending in this application.
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 Objections
Claim 20 is objected to because of the following informalities: lines 4-5 read “wherein each are each positioned” and should read as --wherein each are positioned--. Appropriate correction is required.
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.
Claims 1-4, 7-8, 10, 12-15, 17-18, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Panetta et al., hereinafter “Panetta” (U.S. Pub. No. 2005/0038468) in view of Ouriel et al., hereinafter “Ouriel” (U.S. Pub. No. 2003/0097114).
Regarding claim 1, Panetta discloses an embolic protection device, comprising:
an elongated catheter body 12 (Figures 2-3);
an embolic balloon 14 ([0052]) located at a distal portion of the elongated catheter body; and,
one or more embolic capture elements (expandable filter 36; [0055]) that are each positioned around the embolic balloon;
wherein the one or more embolic capture elements extend outward from the embolic balloon when the embolic balloon is at an inflated configuration (Figures 2-3; the expandable filter 36 is in contact with and on the outside of the embolic balloon 14, since inflating the embolic balloon may deploy the expandable filter, and the filter extends outward from the balloon at a distal end; [0009]).
However, Panetta does not disclose wherein the one or more embolic capture elements each comprise one or more wires coiled at least once around an outside of the embolic balloon, although teaches the one or more embolic capture elements 26 surrounding an outside of the embolic balloon 14.
In the same field of art, namely embolic protection devices, Ouriel teaches
one or more embolic capture elements (coil members 122, 124; Figures 2-7, [0038]), wherein each comprise one or more wires coiled at least once around an outside of an elongated catheter body 72 (Id.) to form a filter 76 ([0037]-[0038]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the one or more embolic capture elements of Panetta to comprise one or more wires coiled at least once around, as taught by Ouriel, since doing so would be substitution of one known embolic capture element (filter) for another, which would yield predictable results, namely trapping emboli to prevent an embolism. See MPEP 2143. It is noted that when the combination is made, the one or more embolic capture elements will be coiled at least once around an outside of the embolic balloon.
Regarding claim 2, Panetta as modified teaches the one or more embolic capture elements comprise 2 or more embolic capture elements 122, 124 (Ouriel; Figures 2-7, [0038]).
Regarding claim 3, Panetta as modified teaches the one or more embolic capture elements comprise a plurality of embolic capture elements that have a uniform spacing (122, 124 are spaced, or out of phase, with each other; Ouriel, [0038]) or a non-uniform spacing relative to each other.
Regarding claim 4, Panetta as modified teaches the one or more embolic capture elements form a conical shape opening towards a proximal end of the elongated catheter body (36 in Figures 2-3 of Panetta, and 122, 124 in Figure 2, [0043] of Ouriel form a conical shape).
Regarding claim 7, Panetta as modified teaches wherein the one or more wires (122, 124 in Figure 2 of Ouriel) are coiled a plurality of times around the embolic balloon.
Regarding claim 8, Panetta as modified teaches wherein the one or more embolic capture elements comprise a plurality of struts 38 (Figures 2-3, Panetta) connected together to form a web surrounding the embolic balloon 14.
Regarding claim 10, Panetta as modified teaches the claimed invention, as discussed above, except for the one or more embolic capture elements are connected to an outer surface of the embolic balloon via an elastomeric band or ring.
In another embodiment of Panetta shown in Figure 12, [0105]-[0106], one or more embolic capture elements 36 are connected to an outer surface of the embolic balloon 14 via an elastomeric band or ring (42 of expandable filter 36 can include an elastic element that encircles balloon 14) to keep the one or more embolic capture elements from moving longitudinally along the balloon 14 (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Panetta as modified with the one or more embolic capture elements connected to an outer surface of the embolic balloon via an elastomeric band or ring in order to prevent undesirable movement of the one or more embolic capture elements relative to the balloon (Id.).
Regarding claims 12-13, Panetta as modified teaches further comprising a framework (struts 38; Figures 2-3, Panetta) connected to the one or more embolic capture elements and to the elongated catheter body 12, supporting the one or more embolic capture elements separately of the embolic balloon 14, wherein the framework is connected to the elongated catheter body distally, proximally ([0055]), or both distally and proximally of the embolic balloon.
Regarding claims 14-15, Panetta as modified teaches the claimed invention, as discussed above, except for further comprising a stent that is deployable from the elongated catheter body, and an angioplasty balloon connected on the elongated catheter body.
In another embodiment of Panetta shown in Figs. 9-10, 12, a stent 240 ([0089]) is deployable from the elongated catheter body 12, and an angioplasty balloon 220 is connected on the elongated catheter body (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Panetta as modified with a stent and an angioplasty balloon as claimed, in order to deploy a vascular stent for dilating and supporting a narrowed portion of a blood vessel (Id., Panetta; see abstract).
Regarding claim 17, Panetta discloses an embolic protection device, comprising:
an elongated catheter body 12 (Figures 2-3);
an embolic balloon 14 ([0052]) located at a distal portion of the elongated catheter body; the embolic balloon having an inflated state and a deflated state (Id.); and,
one or more embolic capture elements (expandable filter 36; [0055]) that are each positioned around the embolic balloon;
wherein the one or more embolic capture elements extend radially away from the embolic balloon when the embolic balloon is in the inflated state (Figures 2-3; the expandable filter 36 is in contact with and on the outside of the embolic balloon 14, since inflating the embolic balloon may deploy the expandable filter, and the filter extends outward from the balloon at a distal end; [0009]).
However, Panetta does not disclose wherein the one or more embolic capture elements each comprise one or more wires coiled at least once around an outside of the embolic balloon, although teaches the one or more embolic capture elements 26 surrounding an outside of the embolic balloon 14.
In the same field of art, namely embolic protection devices, Ouriel teaches
one or more embolic capture elements (coil members 122, 124; Figures 2-7, [0038]), wherein each comprise one or more wires coiled at least once around an outside of an elongated catheter body 72 (Id.) to form a filter 76 ([0037]-[0038]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the one or more embolic capture elements of Panetta to comprise one or more wires coiled at least once around, as taught by Ouriel, since doing so would be substitution of one known embolic capture element (filter) for another, which would yield predictable results, namely trapping emboli to prevent an embolism. See MPEP 2143. It is noted that when the combination is made, the one or more embolic capture elements will be coiled at least once around an outside of the embolic balloon.
Regarding claim 18, Panetta as modified teaches the one or more embolic capture elements comprise a plurality of embolic capture elements 122, 124 (Ouriel; Figures 2-7, [0038]).
Regarding claim 20, Panetta discloses an embolic protection device, comprising:
an elongated catheter body 12 (Figures 2-3);
an embolic balloon 14 ([0052]) located at a distal portion of the elongated catheter body; and,
one or more embolic capture means (expandable filter 36; [0055]) for capturing embolic material;
wherein each are positioned around the embolic balloon 14.
However, Panetta does not disclose the one or more embolic capture means
comprise one or more wires coiled at least once around an outside of the embolic balloon.
In the same field of art, namely embolic protection devices, Ouriel teaches
one or more embolic capture elements (coil members 122, 124; Figures 2-7, [0038]), wherein each comprise one or more wires coiled at least once around an outside of an elongated catheter body 72 (Id.) to form a filter 76 ([0037]-[0038]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the one or more embolic capture elements of Panetta to comprise one or more wires coiled at least once around, as taught by Ouriel, since doing so would be substitution of one known embolic capture element (filter) for another, which would yield predictable results, namely trapping emboli to prevent an embolism. See MPEP 2143. It is noted that when the combination is made, the one or more embolic capture elements will be coiled at least once around an outside of the embolic balloon.
Regarding claim 21, Panetta discloses a method of using an embolic protection device ([0109]-[0112)), comprising:
advancing a distal portion of an elongated catheter body 12 (Figure 12) near a treatment location ([0109]);
inflating an embolic balloon 14 ([0098], [0110]) located at a distal portion of the elongated catheter body such that one or more embolic capture elements (expandable filter 36; [0099]) extend radially from the embolic balloon ([0105]; the filter extends outward from the balloon at a distal end); and
performing a treatment at the treatment location such that embolic material is captured by the one or more embolic capture elements ([0110]).
However, Panetta does not disclose the one or more embolic capture elements each comprise one or more wires coiled at least once around an outside of the embolic balloon.
In the same field of art, namely embolic protection devices, Ouriel teaches
one or more embolic capture elements (coil members 122, 124; Figures 2-7, [0038]), wherein each comprise one or more wires coiled at least once around an outside of an elongated catheter body 72 (Id.) to form a filter 76 ([0037]-[0038]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the one or more embolic capture elements of Panetta to comprise one or more wires coiled at least once around, as taught by Ouriel, since doing so would be substitution of one known embolic capture element (filter) for another, which would yield predictable results, namely trapping emboli to prevent an embolism. See MPEP 2143. It is noted that when the combination is made, the one or more embolic capture elements will be coiled at least once around an outside of the embolic balloon
Regarding claim 22, Panetta as modified teaches wherein performing the treatment further comprises inflating an angioplasty balloon 220 and/or delivering a stent 240 (Figure 12, [0098], [0112]; Panetta)
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Panetta (U.S. Pub. No. 2005/0038468) in view of Daniel et al., hereinafter “Daniel” (U.S. Patent No. 5,814,064).
Regarding claims 1 and 5, Panetta discloses an embolic protection device, comprising:
an elongated catheter body 12 (Figures 2-3);
an embolic balloon 14 ([0052]) located at a distal portion of the elongated catheter body; and,
one or more embolic capture elements (expandable filter 36; [0055]) that are each positioned around the embolic balloon;
wherein the one or more embolic capture elements extend outward from the embolic balloon when the embolic balloon is at an inflated configuration (Figure 2; the expandable filter 36 is in contact with and on the outside of the embolic balloon 14, since inflating the embolic balloon may deploy the expandable filter; [0009]).
However, Panetta does not disclose wherein the one or more embolic capture elements each comprise one or more wires coiled at least once around an outside of the embolic balloon, although teaches the one or more embolic capture elements 26 surrounding an outside of the embolic balloon 14, and wherein the one or more embolic capture elements form a flat disc shape around the embolic balloon.
In the same field of art, namely embolic protection devices, in Figures 11A-11B Daniel teaches one or more embolic capture elements, wherein each comprise one or more wires 94/108 coiled at least once around an outside of an elongated catheter body 92/106 (Id.) to form a filter 90/104. In Figure 11A, the one or more embolic capture elements 94 form a flat disc shape around the elongated catheter (col. 6, lines 37-44).
It would have been obvious to one of ordinary skill before the effective filing date to modify the one or more embolic capture elements of Panetta to comprise one or more wires coiled at least once around, wherein the one or more embolic capture elements form a flat disc shape, as taught by Daniel, since doing so would be substitution of one known embolic capture element (filter) for another, which would yield predictable results, namely trapping emboli to prevent an embolism. See MPEP 2143. It is noted that when the combination is made, the one or more embolic capture elements will be coiled at least once around an outside of the embolic balloon to form the flat disc shape.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Panetta (U.S. Pub. No. 2005/0038468) in view of Wensel et al., hereinafter “Wensel” (U.S. Pub. No. 2001/0031980).
Regarding claims 1 and 6, Panetta discloses an embolic protection device, comprising:
an elongated catheter body 12 (Figures 2-3);
an embolic balloon 14 ([0052]) located at a distal portion of the elongated catheter body; and,
one or more embolic capture elements (expandable filter 36; [0055]) that are each positioned around the embolic balloon;
wherein the one or more embolic capture elements extend outward from the embolic balloon when the embolic balloon is at an inflated configuration (Figure 2; the expandable filter 36 is in contact with and on the outside of the embolic balloon 14, since inflating the embolic balloon may deploy the expandable filter; [0009]).
However, Panetta does not disclose wherein the one or more embolic capture elements each comprise one or more wires coiled at least once around an outside of the embolic balloon, although teaches the one or more embolic capture elements 26 surrounding an outside of the embolic balloon 14, and wherein the one or more embolic capture elements form a wave-like shape that progressively increases and decreases in radius along a longitudinal length of the embolic balloon.
In the same field of art, namely embolic protection devices, in Figures 7 and 12 Wensel teaches one or more embolic capture elements (coil can be used as a filter; [0069]), wherein each comprise one or more wires 40 coiled at least once around to form a filter and wherein the one or more embolic capture elements form a wave-like shape (barrel shape in Figure 7; [0055]) that progressively increases and decreases in radius along a longitudinal length of the device.
It would have been obvious to one of ordinary skill before the effective filing date to modify the one or more embolic capture elements of Panetta to comprise one or more wires coiled at least once around, wherein the one or more embolic capture elements form a wave-like shape that progressively increases and decreases in radius, as taught by Wensel, since doing so would be substitution of one known embolic capture element (filter) for another, which would yield predictable results, namely trapping emboli to prevent an embolism. See MPEP 2143. It is noted that when the combination is made, the one or more embolic capture elements will be coiled at least once around an outside of the embolic balloon and will form a wave-like shape that progressively increases and decreases in radius along a longitudinal length of the embolic balloon.
Claims 9, 16, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Panetta (U.S. Pub. No. 2005/0038468) in view of Ouriel (U.S. Pub. No. 2003/0097114), as applied to claims 1 and 17 above, and further in view of Hunt (U.S. Pub. No. 2011/00987388).
Regarding claims 9, 16, 19, Panetta as modified teaches the claimed invention, as discussed above, except for wherein the one or more embolic capture elements comprise a plurality of braided wires that form a mesh surrounding the embolic balloon,, or further comprising a filter material having a plurality of pores allowing blood to pass therethrough, or wherein the coil further comprises a blood permeable membrane connected to a proximal side or a distal side of the coil.
In the same field of art, namely embolic protection devices, in Figures 1-2 Hunt teaches one or more embolic capture elements each comprising one or more wires 22 coiled at least once around, and wherein the one or more embolic capture elements further comprise a plurality of braided wires 30 ([0031]) that form a mesh, and further comprising a filter material 30 having a plurality of pores allowing blood to pass therethrough (Id.), and wherein the coil 22 further comprises a blood permeable membrane 30 connected to a proximal side or a distal side of the coil.
It would have been obvious to one of ordinary skill before the effective filing date to modify Panneta such that the one or more embolic capture elements comprising one or more coiled wires also include a mesh, filter material, or blood permeable membrane as claimed, as taught by Hunt, in order to enhance the trapping capability of the embolic protection device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Panetta (U.S. Pub. No. 2005/0038468) in view of Ouriel (U.S. Pub. No. 2003/0097114), as applied to claim 1 above, and further in view of Uflacker et al., hereinafter “Uflacker” (U.S. Pub. No. 2006/0173487).
Regarding claim 11, Panetta as modified teaches the claimed invention, as discussed above, except for the one or more embolic capture elements are embedded within a wall of the embolic balloon.
Uflacker teaches a device pertinent to the particular problem of engaging an element with a balloon, in Figures 6b-6d Uflacker teaches elements 30 being embedded within a wall of balloon 16.
It would have been obvious to one of ordinary skill before the effective filing date to modify Panetta as modified such that the one or more embolic capture elements are embedded within a wall of the embolic balloon, as taught by Uflacker, in order to facilitate securement of the position of the elements relative to the balloon.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
