DETAILED ACTION
The following Office Action is in response to the Amendment filed on March 10, 2026. Claims 21-41 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 Arguments
Concerning the “Claim Rejections under 35 U.S.C. §102” and “Claim Rejections 35 U.S.C. §103” sections on pages 12-15 of the Applicant’s Response filed on March 10, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Hartley reference and the combination of the Hartley and King references do not teach the newly added limitation of the second bend being longitudinally positioned between the first bend and the third bend, arguing that the Hartley reference does not disclose the specific positioning of first, second, and third bends relative to a longitudinal axis. However, the examiner asserts that the claims recite “at least one substantially longitudinally extending wire”, wherein the claim does not specify that the first, second, and third bends must be associated with a single wire of the at least one substantially longitudinally extending wire, therein allowing an alternative interpretation of the prior art wherein “the at least one substantially longitudinally extending wire” is two substantially longitudinally extending wires, wherein the first and third bends are associated with a first of the two substantially longitudinally extending wires, while the second bend is associated with a second of the two substantially longitudinally extending wires. This new interpretation is detailed in the rejections below. 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) 21-26, 28, and 30-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartley et al. (US 2013/0158648, hereinafter Hartley).
Concerning claim 21, the Hartley et al. prior art reference teaches a temporary diameter reduction constraint system for a stent graft in combination with a stent graft (Figures 1-6; 10, 16), the stent graft comprising: a proximal end (Figure 1A; 12); a distal end (Figure 1A; 14); an inner lumen between the proximal end and the distal end; a biocompatible graft material tube (Figure 1A; 10); a plurality of longitudinally spaced apart self-expanding stents fastened thereto (Figure 6; 17), including at least an end stent and a plurality of intermediate stents fastened thereto (Figure 6; 17), each intermediate stent being a zig-ag stent (Figure 5A; 70) comprising struts and bends forming peaks and valleys (Figure 5A; 76), the intermediate stents longitudinally spaced apart; a constraint system (Figure 1; 16) comprising: a plurality of loops of threads extending at least partially concentrically about a circumference of the graft material tube and distributed longitudinally along the graft material tube (Figure 1A; 22, 24), each of the plurality of loops of threads comprising a looped end nested between adjacent struts of a stent of the plurality of longitudinally spaced apart self-expanding stents (Figure 5A; 22, 24), wherein the plurality of looped ends of the plurality of loops of threads are both longitudinally and circumferentially offset from each other (Figure 6; 22); and two substantially longitudinally extending wires extending through the plurality of the looped ends (Figure 1A; 18, 20) wherein the two substantially longitudinally extending wires engage a first looped end nested between a first pair of adjacent struts of a first stent (See Annotated Figures 1A-F below; wire 18 of the two wires extends through first looped end between first pair of struts), and a second looped end nested between a second pair of adjacent struts of a second stent (See Annotated Figures 1A-F below; wire 20 of the two wires extends through second looped end between second pair of struts), and a third looped end nested between a third pair of adjacent struts of a third stent (See Annotated Figures 1A-F below; wire 18 of the two wires extends through third looped end between third pair of struts), wherein a first bend is disposed between the first pair of adjacent struts of the first stent, a second bend is disposed between the second pair of adjacent struts of the second stent, and a third bend is disposed between the third pair of adjacent struts of the third stent, wherein the first bend is both longitudinally and circumferentially offset from the second bend, and the second bend is both longitudinally and circumferentially offset from the third bend (Figure 6; the release wires 18 and 20 extends helically along both sides of the longitudinal axis of the stent graft, and are engaged with looped ends of the thread loops 22 in a helical fashion, therein defining bends being both longitudinally and circumferentially offset); wherein the second bend is longitudinally positioned between the first and the third bend (See Annotated Figures 1A-F below), and wherein each of the first bend and the third bend is disposed on a first side of a longitudinal axis extending along the graft material tube from the proximal end to the distal end and the second bend is disposed on a second side of the longitudinal axis (See Annotated Figures 1A-F below).
Concerning claim 22, the Hartley reference teaches the constraint system of claim 21, wherein a plurality of loops of threads circumferentially overlap a plurality of struts of a stent of the plurality of intermediate stents (Figure 5A; 76).
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Annotated Figures 1A-F
Concerning claim 23, the Hartley reference teaches the constraint system of claim 21, wherein a plurality of loops of threads circumferentially overlap a plurality of struts of a terminal end stent of the plurality of intermediate stents (Figure 6; plurality of loops 22, 24 engage the stent struts in the same manner along the length of the stent-graft including at the end stent).
Concerning claim 24, the Hartley reference teaches the constraint system of claim 21, wherein the at least one substantially longitudinally extending wire is configured to be withdrawn in a distal direction to release engagement of the at least one substantially longitudinally extending wire with the looped ends and expand the stent graft ([¶ 0009]).
Concerning claim 25, the Hartley reference teaches the constraint system of claim 21, wherein the stent graft comprises at least one fenestration (Figure 1; 13).
Concerning claim 26, the Hartley reference teaches the constraint system of claim 25, wherein the at least one substantially extending wire is disposed circumferentially away from the at least one fenestration (Figure 1A; 13, 18).
Concerning claim 28, the Hartley reference teaches the constraint system of claim 23, wherein the terminal end stent does not extend beyond the proximal end of the stent (Figure 6; proximal most stent does not extend past proximal end 12).
Concerning claim 30, the Hartley reference teaches the constraint system of claim 21, wherein the at least one substantially longitudinally extending wire is capable of being tensioned to at least partially reduce the diameter of the stent graft depending on how and in what direction a user tensions the extending wire.
Concerning claim 31, the Hartley reference teaches the constraint system of claim 21, wherein each loop of the plurality of loop threads has an end attached to the stent graft ([¶ 0052]).
Concerning claim 32, the Hartley reference teaches the constraint system of claim 32, wherein each loop of the plurality of loop threads has an end knotted to the stent graft (Figure 5B; 78).
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) 27, 29, and 33-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley et al. (US 2013/0158648, hereinafter Hartley) in view of King (US 2014/0148895).
Concerning claim 27, the Hartley reference teaches the constraint system of claim 26, but does not specifically teach the stent graft comprising two fenestrations.
However, the King reference teaches a temporary diameter reduction constraint system for a stent graft in combination with a stent graft similar to that of the Hartley reference, wherein the King reference teaches that the stent graft may comprise two fenestrations (Figure 4; 25).
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 stent graft of the Hartley reference include two fenestrations as in the King reference to allow for access of any branch arteries (King; [¶ 0064]).
Concerning claim 29, the Hartley reference teaches the constraint system of claim 28, but does not specifically teach a proximally extending uncovered stent.
However, the King reference teaches a temporary diameter reduction constraint system for a stent graft in combination with a stent graft similar to that of the Hartley reference, wherein the King reference teaches the stent graft including a proximally extending uncovered stent (Figure 2b; 14).
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 stent graft of the Hartley reference include a proximally extending uncovered stent as in the King reference given the King reference teaches that such a stent is known to be incorporated into a stent graft to provide an additional barbed stent for fixing the stent graft into a vessel ([¶ 0079]).
Concerning claims 33, 34, 36, 37, and 39, the Hartley et al. prior art reference teaches a temporary diameter reduction constraint system for a stent graft comprising: a stent graft comprising a proximal end (Figure 1A; 12); a distal end (Figure 1A; 14); an inner lumen between the proximal end and the distal end, a biocompatible graft material tube (Figure 1A; 10), a graft material sidewall, at least one fenestration within the graft sidewall (Figure 1A; 13), and a plurality of longitudinally spaced apart self-expanding stents (Figure 6; 17), including at least an end stent and a plurality of intermediate stents fastened thereto (Figure 6; 17), each intermediate stent being a zig-ag stent (Figure 5A; 70) comprising struts and bends forming peaks and valleys (Figure 5A; 76); a guidewire catheter extending longitudinally through the lumen of the stent graft (Figure 3; 42); a plurality of loops of threads extending at least partially concentrically about a circumference of the graft material tube and distributed longitudinally along the graft material tube (Figure 1A; 22, 24), each of the plurality of loops of threads comprising a looped end nested between adjacent struts of a stent of the plurality of longitudinally spaced apart self-expanding stents (Figure 5A; 22, 24), wherein a plurality of the looped ends of the plurality of loops of threads are both longitudinally and circumferentially offset from each other (Figure 6; 22); and two substantially longitudinally extending wires extending through the plurality of the looped ends (Figure 1A; 18, 20) wherein the two substantially longitudinally extending wires engage a first looped end nested between a first pair of adjacent struts of a first stent (See Annotated Figures 1A-F above; wire 18 of the two wires extends through first looped end between first pair of struts), and a second looped end nested between a second pair of adjacent struts of a second stent (See Annotated Figures 1A-F above; wire 20 of the two wires extends through second looped end between second pair of struts), and a third looped end nested between a third pair of adjacent struts of a third stent (See Annotated Figures 1A-F above; wire 18 of the two wires extends through third looped end between third pair of struts), wherein a first bend is disposed between the first pair of adjacent struts of the first stent, a second bend is disposed between the second pair of adjacent struts of the second stent, and a third bend is disposed between the third pair of adjacent struts of the third stent, wherein the first bend is both longitudinally and circumferentially offset from the second bend, and the second bend is both longitudinally and circumferentially offset from the third bend (Figure 6; the release wires 18 and 20 extends helically along both sides of the longitudinal axis of the stent graft, and are engaged with looped ends of the thread loops 22 in a helical fashion, therein defining bends being both longitudinally and circumferentially offset); wherein the second bend is longitudinally positioned between the first and the third bend (See Annotated Figures 1A-F above), and wherein each of the first bend and the third bend is disposed on a first side of a longitudinal axis extending along the graft material tube from the proximal end to the distal end and the second bend is disposed on a second side of the longitudinal axis (See Annotated Figures 1A-F above); wherein each loop of the plurality of loops of threads has an end attached to the stent graft ([¶ 0052]); wherein each loop of the plurality of loops of threads has an end knotted to the stent graft (Figure 5B; 78); wherein a plurality of loops of threads circumferentially overlap a plurality of struts of a stent of the plurality of intermediate stents (Figure 5A; 76); wherein a plurality of loops of threads circumferentially overlap a plurality of struts of a terminal end stent of the plurality of intermediate stents (Figure 6; plurality of loops 22, 24 engage the stent struts in the same manner along the length of the stent-graft including at the end of the stent), and wherein the two substantially longitudinally extending wires are disposed circumferentially away from the at least one fenestration (Figure 1A; 13, 18), but it does not specifically teach a proximally extending bare stent.
However, the King reference teaches a temporary diameter reduction constraint system for a stent graft in combination with a stent graft similar to that of the Hartley reference, wherein the King reference teaches the stent graft including a proximally extending bare stent (Figure 2b; 14).
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 stent graft of the Hartley reference include a proximally extending bare stent as in the King reference given the King reference teaches that such a stent is known to be incorporated into a stent graft to provide an additional barbed stent for fixing the stent graft into a vessel ([¶ 0079]).
Concerning claims 35 and 40, the combination of the Hartley and King references as discussed above teaches the constraint system of claim 33 and 39, wherein the King reference further teaches that the stent graft may comprise two fenestrations (Figure 4; 25).
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 stent graft of the Hartley reference include two fenestrations as in the King reference to allow for access of any branch arteries (King; [¶ 0064]).
Concerning claims 38 and 41, the combination of the Hartley and King references as discussed above teaches the constraint system of claims 33 and 39, wherein the Hartley reference further teaches the at least one substantially longitudinally extending wire being configured to be withdrawn in a distal direction to release engagement of the at least one substantially longitudinally extending wire with the looped ends and expand the stent graft ([¶ 0009]).
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.
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/MARTIN T TON/Examiner, Art Unit 3771 3/27/2026