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 .
Election/Restrictions
Claims 57-59 and 62-64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/07/2026.
Claim Rejections - 35 USC § 112
Claims 17, 23 and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 17 and 23: the limitation “the connection portion of the elongate delivery device” lacks proper antecedent basis. Claim 1 states “the elongate delivery device being coupled to an endovascular prosthesis via a connection portion.” Claim 1 does not state the connection portion is part of the elongate delivery device.
Claim 28: The term “i.e., solid” renders the claim indefinite, as the meets and bounds of the claim are unclear.
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 and 49 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) in regards to claim 49.
Kadam discloses an endovascular prosthesis delivery system comprising an elongate delivery device comprising a delivery device longitudinal axis, the elongate delivery device being coupled to an endovascular prosthesis (20) via a connection portion (flanges 34 of delivery device core wire 44 or the hub 50 of the implant; Fig. 4; col 6, lines 41-48), the flanges (34) of the connection portion detach from the endovascular prosthesis (20) 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 (44) upon application of electric current.
The language “the endovascular prosthesis (20) in an unsheathed state and the elongate delivery device (12) being rotatable with respect to one another 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. 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 regards 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 regards 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 regards 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]).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774