DETAILED ACTION
The following Office Action is in response to the Amendment filed on August 13, 2026. Claims 1-15 are currently pending.
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 Amendment
Concerning the “Claim Objections” section on page 4 of the Applicant’s Response filed on August 13, 2026, the amendments to claims 2, 10, and 12 to address the informalities have obviated the necessity of the objections to the claims. Therefore, the objections are withdrawn.
Concerning the “Rejections Under 35 U.S.C. §112” section on page 5 of the Applicant’s Response filed on August 13, 2026, the amendments to claims 5, 10, and 14 to address the issues of indefiniteness have obviated the necessity of the rejections to the claims under 35 U.S.C. §112(b). Therefore, the rejections are withdrawn.
Response to Arguments
Concerning the “Rejections Under 35 U.S.C. § 102 & § 103” section on pages 5-6 of the Applicant’s Response filed on August 13, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Baylis reference fails to teach the newly added limitation of the actuation line including a bifurcation defining a first branch and a second branch, arguing that the Office Action calls one end of the line in Baylis the first branch and the other end the second branch, wherein the line in Baylis is a single stranded line. However, the examiner asserts that the Y-piece (Figure 1; 20 | Page 6 Lines 22-27) has been interpreted as the actuation line given the broad nature of the term “actuation line”. The Y-piece includes a bifurcation that defines first and second branches (Figure 1; 30 | Page 6 Lines 22-27). Therefore, the rejections of the claims under 35 U.S.C. §102 and 35 U.S.C. §103 stand.
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) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baylis (WO 2012/136984).
Concerning claim 1, the Baylis prior art reference teaches a delivery system (Figure 5) comprising: a catheter having a leading end and a trailing end (Figure 2; 10); an expandable device arranged near the leading end of the catheter (Figure 5; 200), and including a proximal end (Figure 5; proximal end may be interpreted as the end towards the nose cone 100), a distal end, and a flow lumen extending therebetween, an actuation line including a bifurcation (Figure 1; 20 | Page 6 Lines 22-27, y-piece = actuation line defining bifurcation) defining a first branch and a second branch (Figure 1; 30 | Page 6 Lines 22-27) coupled to the expandable device at different locations (Figure 5; 31) configured to facilitate maintaining at least a portion of the expandable device substantially perpendicular to a target area (Figure 5; arms 30 hold open proximal end of expandable device to keep it perpendicular to the longitudinal axis of a vessel).
Concerning claim 2, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to maintain the portion of the expandable device substantially perpendicular to the target area during and after deployment (the arms will hold the proximal end of expandable device in a perpendicular orientation when the expandable device is in both a collapsed and expanded configuration).
Concerning claim 3, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to mitigate against non-perpendicular, angled, or flat deployment, given the abutment of the arms pushing open the proximal end of the expandable member (Figure 5).
Concerning claim 4, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to maintain the proximal end of the expandable device approximately perpendicular to an inflection point in a curvature of a tortious vessel during delivery of the expandable device.
Concerning claim 5, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is coupled to the expandable device adjacent the proximal end via at least one tether (Figure 5; 50) arranged through the actuation wire and a portion of the expandable device (Page 7, Lines 28-33).
Concerning claim 6, the Baylis reference teaches the delivery system of claim 1, wherein the first branch and the second branch are coupled to the expandable device near the proximal end thereof (Figure 5; 30).
Concerning claim 7, the Baylis reference teaches the delivery system of claim 1, wherein the first branch and second branch are configured to steer the expandable device by distributing forces that result from a user manipulating or applying force to the actuation line to steer the expandable device (expandable device is steered via catheter 10 which in turn transmits a pushing force to the first and second branch of actuation line 20 which in turn transmits a force to a proximal end of the expandable device).
Concerning claim 8, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to remain in tension through a length thereof when force is applied to the actuation line by the user (thread 60 may be pulled to keep the actuation line in a collapsed configuration, which may be interpreted as the actuation line being in tension while the actuation line is being pushed | Page 7, Lines 14-20).
Concerning claim 9, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line includes a stiffness such that the actuation line does not become relaxed or slacked in response to the user applying force to steer the expandable device proximally or distally (Page 6, Lines 22-27, actuation line is formed of nitinol, which is a stiff material that does not become relaxed or slack).
Concerning claim 10, the Baylis reference teaches the delivery system of claim 1, further comprising two tethers configured to couple the actuation wire to two locations on the expandable device (Figure 3; 50).
Concerning claim 11, the Baylis reference teaches the delivery system of claim 1, further comprising a sleeve attached to an exterior portion of the expandable device through which the actuation wire is arranged (Figure 5; flexible sheet material forming graft of 200 defines a sleeve).
Concerning claim 12, the Baylis reference teaches the delivery system of claim 11, wherein the sleeve comprises a layer of graft material that forms a lumen between the sleeve and the expandable device (Figure 5; 200 flexible sheet defines graft to form lumen).
Concerning claim 13, the Baylis reference teaches the delivery system of claim 1, wherein the sleeve includes a shorter length than the expandable device (Figure 5; sleeve may be interpreted as only being the proximal portion of stent graft material, and not including the legs).
Concerning claim 14, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line includes a bifurcation including the first branch and the second branch (Figure 1; 30).
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baylis (WO 2012/136984) in view of Trout, III et al. (US 2003/0195607, hereinafter Trout).
Concerning claim 15, the Baylis reference teaches the delivery system of claim 1, but does not specifically teach the first branch and the second branch being coupled to the expandable device by an adhesive.
However, the Trout reference includes an expandable graft including attachment wires, therein being in the same field of endeavor as the Baylis reference, wherein the Trout reference teaches that adhesives may be an alternative for attaching and releasing attachment wires to a graft, which is an obvious alternative to other suitable release mechanisms ([¶ 0077]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the first branch and the second branch of the Baylis reference be coupled to the expandable device by an adhesive as in the Trout reference as an obvious alternative for attaching and releasing the first and second branch to the expandable device (Trout; [¶ 0077]).
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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 10/13/2026
