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Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/9/26.
Claim Rejections - 35 USC § 102/103
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.
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 of this title, 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, 2, and 4-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schabert (US2017/0049596 - cited in the IDS filed 12/28/23) or, in the alternative as obvious over Schabert in view of Maitland (US2019/0192743).
Regarding claim 1, Schabert discloses an endovascular system, comprising:
an implant (20) configured to be deployed in vessels with diameters ranging from a minimal diameter to a maximal diameter (the implant is intended to be deployed in vessels with various diameters, where the minimum and maximum diameter vessels are is a range selected from the various diameters as listed in [0029]), the implant comprising a distal end (24) and a proximal end (22) and being radially expandable ([0026]); and
a delivery system (12) configured to deliver and deploy the implant to a treatment site in a vessel ([0025]), wherein the delivery system comprises a proximal landing zone indicator (proximalmost marker 50, [0041], where the proximal marker 52 is intended to determine the proximal landing location of the stent, [0033]) comprising a radiopaque marker (the marker 50 is a radiopaque marker, [0041]) having a length from a proximal end to a distal end of the radiopaque marker (the marker has some length as shown in Fig. 4), wherein the proximal end of the radiopaque marker indicates a position of the proximal end of the implant if deployed at a treatment site in a vessel having the minimal diameter, and the distal end of the radiopaque marker indicates a position of the proximal end of the implant if deployed at a treatment site in a vessel having the maximal diameter (the marker 52 has a length as shown in Fig. 4 and indicates a location of the deployed proximal end of the implant, [0041]; where this length is capable of spanning between a minimal and maximal vessel diameter dependent on the minimal and maximal vessel diameters selected, where the a range of vessel diameters is listed in paragraph [0029]).
If Applicant should disagree that Schabert discloses a radiopaque marker having a length from a proximal end to a distal end, Examiner makes an alternative rejection in view of Maitland. Schabert teaches three separate radiopaque markers 50, 51, 52 that are used to determine a projected proximal landing location based on the dimensions of the vessel from a smaller vessel to a larger vessel ([0041]). Maitland teaches a foam implant with a desire of visibility for the entire foam length. The implant has a radiopaque coil that extends through the core and spans the entire device length or a proximal and distal end of the device ([0013]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted a single length of coiled radiopaque marker, as taught by Maitland, for the segmented radiopaque marker of Schabert, since the substitution would have yielded the same predictable result of indicating an end of the implanted device ([0013] of Maitland).
Regarding claim 2, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 1, wherein the delivery system comprises a tubular member (40) and a delivery wire (pusher 30) with the implant being disposed between the tubular member and the delivery wire for delivery (see Fig. 1); yet, does not explicitly disclose wherein the radiopaque marker of the proximal landing zone indicator is provided on the delivery wire. Schabert according to other embodiments teaches the radiopaque marker can be located on the pusher member 30 (guidewire) instead of the catheter 40 ([0046]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the radiopaque marker on the delivery wire for the radiopaque marker on the tubular member (catheter), since the substitution would have yielded the same predictable result of providing a radiopaque marker to indicate the positioning of the implant relative to components for delivery.
Regarding claim 4, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 2, wherein the implant is configured to be deployed in vessels with diameters ranging from the minimal diameter of 5 mm to the maximal diameter of 10 mm ([0029]).
Regarding claim 5, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 2, wherein the implant comprises a braided stent (implant 20 may be a braided stent, [0026]).
Regarding claim 6, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 2, wherein the implant is configured to be deployed in a vessel adjacent to a bifurcation (intended to be placed in a vessel adjacent to a bifurcation, [0025]).
Regarding claim 7, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 1, wherein the delivery system comprises a tubular member (40) and a delivery wire (pusher 30) with the implant being disposed between the tubular member and the delivery wire for delivery (see Fig. 1), and wherein the radiopaque marker is provided on the tubular member ([0041]).
Regarding claim 8, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 7, wherein the implant is configured to be deployed in vessels with diameters ranging from the minimal diameter of 5 mm to the maximal diameter of 10 mm ([0029]).
Regarding claim 9, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 7, wherein the implant comprises a braided stent (implant 20 may be a braided stent, [0026]).
Regarding claim 10, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 7, wherein the implant is configured to be deployed in a vessel adjacent to a bifurcation (intended to be placed in a vessel adjacent to a bifurcation, [0025]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schabert in view of Nygaard (US2021/0085498); or in the alternative Scharbert in view of Maitland, as applied to claim 2, and further in view of Nygaard.
Regarding claim 3, Schabert as modified by Maitland in the alternative discloses the endovascular system of claim 2, wherein the delivery wire comprises a catheter (guidewire is interpreted as a catheter by having a lumen, [0029]). However, Schabert is silent regarding the radiopaque marker is in the form of a coil on the catheter of the delivery wire. Nygaard teaches a delivery system 100 that includes radiopaque materials incorporated into the design of components of the delivery system 100 such as the medical device 130, microcatheter 190, elongate shaft 110, release wires 120, 122 (similar in structure to a guidewire). The radiopaque materials can be radiopaque marker bands and/or coils ([0105]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the radiopaque coil as taught by Nygaard for the radiopaque band of Schabert, since the substitution would have yielded the same predictable result of providing a radiopaque marker on the delivery wire.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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 on (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.
/MIKAIL A MANNAN/Examiner, Art Unit 3774
Prosecution Insights