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Claims 11-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/15/26.
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.
Claims 1, 3-6, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohlenschlaeger (US2005/0107862).
Regarding claim 1, Ohlenschlaeger discloses a retention system comprising:
a stent-graft (48) including:
a proximal body (proximal portion of exposed stent 50) having a proximal-most stent ring (proximal most ring of exposed stent 50, see Fig. 7);
a graft material (graft material of stent graft 48); and
a loop (58) attached to a proximal end of the stent-graft, wherein the stent-graft has a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment ([0048], where the stent graft 48 of the embodiment of Fig. 7 would have a compressed and an expanded configuration in the same manner as described in paragraph [0048]), and
a delivery catheter (40) including:
an inner shaft (guide wire catheter 42) having a shaft lumen (lumen 15) extending from a distal end to a proximal end of the inner shaft, wherein the stent-graft is disposed over a distal portion of the inner shaft in the radially compressed configuration (see Fig. 7);
a distal tip (capsule 46) coupled to the distal end of the inner shaft, the distal tip including a tip lumen (lumen of capsule 46, see Fig. 7) and a slot (54) extending through a sidewall of the distal tip (see Fig. 7), wherein the tip lumen is fluidly connected to the shaft lumen to form a trigger wire lumen of the delivery catheter (lumen defined by space between the guide wire catheter 42 and capsule 46, see Fig. 7); and
a trigger wire (52) extending through the trigger wire lumen of the delivery catheter (see Fig. 7), wherein the slot of the distal tip exposes a portion of the trigger wire within the tip lumen (see Fig. 7), wherein the trigger wire extends through the loop of the stent-graft at the slot of the distal tip of the delivery catheter ([0052], see Fig. 7) and is configured to retain the proximal end of the stent-graft in the radially expanded configuration via the loop to prevent distal migration and compression of the stent-graft ([0052], and wherein proximal retraction of the trigger wire releases the loop of the stent-graft such that the stent-graft is no longer coupled to the delivery catheter ([0047]).
Regarding claim 3, Ohlenschlaeger discloses the retention system of claim 1, wherein the loop is attached to the proximal- most stent ring at the proximal end of the stent-graft (the loop 58 is indirectly attached to the proximal-most stent ring at the proximal end of the stent graft by being engaged with the material of the stent graft 48, [0052], see Fig. 7).
Regarding claim 4, Ohlenschlaeger discloses the retention system of claim 1, wherein the loop is attached to the graft material at the proximal end of the stent-graft (the loop 58 is at least indirectly attached to the graft material by being engaged with the material of the stent graft 48, [0052], see Fig. 7).
Regarding claim 5, Ohlenschlaeger discloses the retention system of claim 1, wherein the trigger wire is a guidewire for the delivery catheter (trigger wire is capable of acting as a guidewire by extending to through the catheter).
Regarding claim 6, Ohlenschlaeger discloses the retention system of claim 1, wherein the loop is a single loop (see Fig. 7) such that the proximal end of the stent-graft includes exactly one loop ([0019]).
Regarding claim 9, Ohlenschlaeger discloses the retention system of claim 1, wherein the proximal-most stent ring of the stent-graft includes a plurality of proximal-most crowns (crowns are interpreted as the peaks of the stent frame 50 as shown in Fig. 7).
Regarding claim 10, Ohlenschlaeger discloses the retention system of claim 9, wherein the loop is coupled to a single proximal-most crown of the proximal-most stent ring (the loop 58 coupled to a single proximal-most crown by being engaged with the material of the stent graft 48, [0052], see Fig. 7).
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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ohlenschlaeger
Regarding claim 7, Ohlenschlaeger discloses the retention system of claim 1; yet, does not explicitly disclose wherein the loop has a length of about 3-20 mm. Ohlenschlaeger teaches the length of suture having some length and is knotted, therefore the length of the loop can be adjusted ([0046]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length to the loop to be about 3-20 mm, since the length of the loop is a result effective variable that can be changed dependent on the size of the stent-graft to be implanted. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Modifying the length of the loop to be about 3-20 mm would allow for the suture to be engaged by the trigger wire at tautness that would allow for a stent graft of a certain size to be engaged. In re Aller, 105 USPQ 233.
Regarding claim 8, Ohlenschlaeger discloses the retention system of claim 1; yet, does not explicitly disclose wherein the loop is configured to constrain less than 20% of a perimeter of the stent-graft when the stent-graft is in the radially expanded configuration. Ohlenschlaeger teaches some portion of the stent graft is constrained by the engagement of the loop and the suture as shown in Fig. 1. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of the perimeter of the stent graft that is constrained by the loop to be less than 20%, since the amount of stent-graft constrained by the loop is a result effective variable that can be changed dependent on where the loop is positioned on the stent-graft and how large the loop is. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Modifying the loop to constrain less than 20% of a perimeter of the stent would allow for a predetermined portion of the stent graft to be engaged by the loop. In re Aller, 105 USPQ 233.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ohlenschlaeger (US2005/0107862) in view of Spindler (US2018/0214259).
Regarding claim 2, Ohlenschlaeger discloses the retention system of claim 1; however, is silent regarding wherein the stent-graft is a bifurcated stent- graft, the bifurcated stent-graft having an internal branch and an external branch that extend distally from the proximal body. Spindler teaches a bifurcated stent-graft that includes a stent body that has an first leg 39 (external branch) and an second leg 40 (internal branch). The stent graft having an opening 12 with a stent portion having a proximal most stent ring 15 (see Fig. 1). 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 bifurcated stent-graft of Spindler for the stent-graft of Ohlenschlaeger, since the substitution would have yielded the same predictable result of providing a stent-graft for treatment of a vascular defect, while also providing the added benefit of dividing the flow path for repair of a specific vascular defect.
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.
/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights