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 .
Response to Arguments
Applicant's arguments filed 5/5/2026 have been fully considered but they are not persuasive. The claim amendments fail to distinguish over the previously cited art, as detailed in the rejection below.
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) 1, 2, 4, 6, 8, 17, 21-23, 27, 28, 41, 48, 49 and 69-72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 9,814,466 (Kadam), as evidenced by USPAP 2013/0123830 (Becking)
Kadam discloses an endovascular prosthesis delivery system comprising an elongate delivery device (the catheter 12 and core wire 44 are both elongate), a connection portion (wherein “portion” is given its broadest reasonable interpretation to encompass the area of the assembly wherein the flanges (34) of the delivery device core wire 44 engages with the hub 50 of the implant; Fig. 4; col 6, lines 41-48), an elongate delivery device having a longitudinal axis, the elongate delivery device (core wire 44 and catheter 12 being coupled to an endovascular prosthesis 20 via the connection portion, the connection portion configured detach the prosthesis and delivery device from one another upon application an electric current to the delivery device (see flanges 34 corrode when electric current is applied to the core wire in Fig. 6A, resulting in detachment from the hub 50 of the implant; col 7, line 1-24). Viewing this a different way, the hub (50) of the implant being the “connection portion” detaches from the delivery device (core wire 44) upon application of electric current.
The prosthesis (20) is considered to meet the significantly broad requirement of “elongated” since it has a length along a longitudinal axis (a diameter). The term is not construed to be limited to any particular shape. Further, Kadam discloses that the implant may have an oval or heart-shape (column 5, line 58 to column 6), as disclosed in [0017] and Figure 1A of USPAP 2013/0123830 incorporated by reference at (column 5, line 58 to column 6). Additionally or alternatively, the implant is compressible into a linear shape within a catheter for delivery (column 3, lines 6-12; also see [0019]; [0034]; [0042] of USPAP 2013/0123830).
The language “the endovascular prosthesis (20) in an unsheathed state coupled to the elongate delivery device (44 and 12), such that the prosthesis longitudinal axis is rotatable about the delivery device longitudinal axis” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of being manipulated in this manner. Firstly the implant can have a longitudinal axis parallel/ coincident with the longitudinal axis of the core wire (44) and/or catheter (12). Kadam discloses the flanges (34) are only configured to prevent proximal movement of the core wire (44) relative to the hub (50) of the implant and describes a free range of motion between the hub (50) and the delivery device sleeve (12) (col 6, lines 49-67). The core wire (44) has a cylindrical shape that is capable of freely rotating within the cylindrical hub (50) of the implant (see Fig. 4). Therefore, the delivery device (12 and 44) and implant (20) are considered to be capable of relative rotation in the unsheathed state of the implant in Figure 1.
In regard to claim 2: The language “the endovascular prosthesis is configured to be rotatable with respect to the elongate delivery device at least 180 degrees about a longitudinal axis of the elongate delivery device” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of being manipulated in this manner. Kadam discloses the flanges (34) are only configured to prevent proximal movement of the core wire (44) relative to the hub (50) of the implant and describes a free range of motion between the hub (50) and the delivery device sleeve (12) (col 6, lines 49-67). The core wire (44) has a cylindrical shape that allows 180 degree rotation of the cylindrical hub (50) of the implant relative to the delivery device (44 and/12) (see Fig. 4).
Regarding claim 4: the prosthesis (20) can be described as elongate, wherein its length extends along a prosthesis longitudinal axis from the hub (50) to the distal end (56) (see Fig. 2); the prosthesis longitudinal axis is aligned with the delivery device longitudinal axis (see Fig. 3), such that the prosthesis longitudinal axis is rotatable about delivery device longitudinal axis.
Regarding claim 6, the endovascular prosthesis (20), in an unsheathed state, is coupled to the elongate delivery device (44 and 12) such that the prosthesis longitudinal axis is rotatable at least about 180 degrees about delivery device longitudinal axis. The language “…the prosthesis longitudinal axis is rotatable at least about 180 degrees about delivery device longitudinal axis” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of being manipulated in this manner. As discussed above, the core wire (44) has a cylindrical shape that allows 180 degree rotation of the cylindrical hub (50) of the implant relative to the delivery device (44 and/12) (see Fig. 4), wherein rotation occurs about the longitudinal axis of the prosthesis and/or delivery device (44).
Regarding claim 8, as best shown in Fig. 4, a distal portion of the connection portion (flanges 34) extends along the delivery device longitudinal axis (axis of core wire 44) distally with respect to a connection point (location of hub 50 of implant) between the endovascular prosthesis (20) and the elongate delivery device (44).
Regarding claim 17, Kadam discloses another embodiment of a connection portion in Figures 11A-C that comprises a first retention element (50), a second retention element (ball 96) and a spacer element (end cap 82) to maintain the first retention element and the second retention element in a spaced relationship (col 8, lines 31-44).
Regarding claim 21, the connection portion (flanges 34 of the core wire 44) is detachable from the endovascular prosthesis (20/50) upon application an electric current to the delivery device (see Fig. 6A-D; col 7, lines 1-24).
Regarding claim 22, wherein the connection portion (for the purposes of this claim, the connection portion is the hub 50 of the implant) is configured to be detachable from the elongate delivery device (44) upon application an electric current to the elongate delivery device (see Fig. 6A-D; col 7, lines 1-24).
In regard to claim 23, the connection portion (for the purposes of this claim, the connection portion is the hub 50 of the implant) remains coupled to the endovascular prosthesis (20) after detachment of the connection portion from the elongate delivery device.
Regarding claim 27, an intermediate portion of the elongate delivery device proximal of the connection portion (flanges 34 and hub 50) comprises a core wire element (44) coupled to the connection portion (34)of the elongate delivery device.
In regard to claim 28, the core wire element (44) is non-annular/ solid (as indicated by solid shading in cross-sections of Figs. 7B, 8B, 9B and 10B).
Regarding claim 41 at least a distal portion of the intermediate portion (core wire 44) is curved with respect to a longitudinal axis of the elongate delivery device in a resting state of the elongate delivery device. Figures 7B, 8B, 9B and 10B illustrate the cross-section of the intermediate portion -core wire 44 – that has a circular cross-section that meets the broad requirement of “curved with respect to a longitudinal axis.”
Regarding claim 48, the endovascular prosthesis (20) can be described as having an anchor portion (portion within an aneurysm) and a blood occlusion portion (portion about hub 50 that blocks the opening of the aneurysm; Fig. 3).
Regarding claim 49, Kadam incorporates USPAP 2013/0123830 at column 6, line 9-10. This reference teaches the outside diameter of the delivery system is less than about 0.034 inches (see catheter size 0.021” and 0.027” diameter disclosed in [0016]).
Regarding claim 69: Kadam discloses an endovascular prosthesis delivery system comprising an elongate delivery device (the catheter 12 and core wire 44 are both elongate) having a longitudinal axis, the delivery device coupled to an endovascular prosthesis (20) by a connection portion (wherein “portion” is given its broadest reasonable interpretation to encompass the area of the assembly wherein the flanges (34) of the delivery device core wire 44 engages with the hub 50 of the implant; Fig. 4; col 6, lines 41-48), the connection portion comprising a wire element (core wire 44), the wire element (44) configured to be detachable from the prosthesis (20) upon application of an electric current to the delivery device (flanges 34 corrode when electric current is applied to the core wire in Fig. 6A, resulting in detachment from the hub 50 of the implant; col 7, line 1-24).
The language “the endovascular prosthesis (20) in an unsheathed state coupled to the elongate delivery device (44 and 12), such that the prosthesis longitudinal axis is rotatable about the delivery device longitudinal axis” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of being manipulated in this manner. Firstly the implant can have a longitudinal axis parallel/ coincident with the longitudinal axis of the core wire (44) and/or catheter (12). Kadam discloses the flanges (34) are only configured to prevent proximal movement of the core wire (44) relative to the hub (50) of the implant and describes a free range of motion between the hub (50) and the delivery device sleeve (12) (col 6, lines 49-67). The core wire (44) has a cylindrical shape that is capable of freely rotating within the cylindrical hub (50) of the implant (see Fig. 4). Therefore, the delivery device (12 and 44) and implant (20) are considered to be capable of relative rotation in the unsheathed state of the implant in Figure 1.
Regarding claim 70: the wire element (44) configured to be detachable from the prosthesis (20) upon application of an electric current to the delivery device (flanges 34 corrode when electric current is applied to the core wire in Fig. 6A, resulting in detachment from the hub 50 of the implant; col 7, line 1-24).
Regarding claims 71 and 72: in another embodiment of Figures 11A-C, a wire element (94) of the connection portion detaches from the elongate delivery device (sleeve 92) upon application of electric current while remaining connected to the implant (98 is part of implant 20) see column 8, lines 4 – 45).
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
