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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15, 16, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 12,138,151 B2 in view of Ducke (Foreign Patent No. AU2021201336 B1), and Spindler et al. (US PG Pub No. 2021/0154036 A1).
Regarding claim 15 of the present case, Claims 1 and 4 of ‘151 discloses a constraint arrangement for a stent-graft loaded onto a delivery device in combination with a stent-graft (Claim 1, lines 1-2), the stent-graft having: a graft body defining an elongate lumen (Claim 1, lines 2-3); and a positionable region (Claim 1, lines 3-4), a guide wire cannula (Claim 1, line 37), the constraint arrangement comprising: at least one apposition release wire (Claim 1, line 5) releasably securing the graft body with respect to the guide wire cannula along a length of the guide wire cannula (Claim 1, lines 19-24); at least one suture (Claim 1, line 7) sewn circumferentially (Claim 1, line 14, Claim 4, lines 1-4) through and around the graft body (Claim 1, lines 7-8), such that a plurality of external suture portions (Claim 1, lines 7-9) and a plurality of internal suture portions are formed (Claim 1, line 11); a constraint loop formed from a first of the internal suture portions (Claim 1, lines 13-16), the constraint loop passing around the guide wire cannula (Claim 1, lines 17-18), wherein the at least one apposition release wire passes through the constraint loop (Claim 1, lines 19-24).
Claims 1 and 4 of ‘151 fails to disclose the delivery device having a sleeve passing through the elongate lumen, and the sleeve being disposed around a guide wire cannula, the constraint loop constraining the positionable region in close apposition to the sleeve; and a plurality of reducing loops formed from others of the internal suture portions, the plurality of reducing loops extending radially inwards from the graft body, the apposition release wire passed through and each of the plurality of reducing loops, and wherein retraction of the at least one apposition release wire releases the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula.
Ducke also discloses a constraint arrangement (Fig. 7, Paragraph [0053]) for a stent-graft Fig. 7-9B, stent graft 10) loaded onto a delivery device(Paragraph [0053]) in combination with a stent-graft (10), the stent-graft having: a graft body (Fig. 7, graft 20) defining an elongate lumen (Fig. 7, elongate lumen 25); and a positionable region (Fig. 7, positionable region 60), a guide wire cannula (Fig. 7, cannula 80), the constraint arrangement comprising: at least one apposition release wire (Fig. 7, release wire 90) releasably securing (Paragraph [0019]) the graft body (20) with respect to the guide wire cannula (80) along a length of the guide wire cannula (80); at least one suture (Fig. 7, suture 100 and 200) sewn circumferentially through and around the graft body (Paragraph [0053]), such that a plurality of external suture portions (Fig. 7, first fixed end 103, second fixed end 108, third fixed end 203, fourth fixed end 208) and a plurality of internal suture portions (Paragraph [0053], Figs. 8-9B) are formed; a constraint loop (Figs. 8, 9A-9B, loop 120) formed from a first of the internal suture portions (Paragraphs [0053]), the constraint loop (120) passing around the guide wire cannula (Paragraph [0053], 80), wherein the at least one apposition release wire (90) passes through the constraint loop (Paragraph [0055]).
Ducke teaches a plurality of reducing loops (Fig. 7-9B, bights 225, second loop 220) formed from others of the internal suture portions (Figs. 8-9B), the plurality of reducing loops (220 and 225) extending radially inwards (Figs. 9A-9B) from the graft body (20), wherein the at least one apposition release wire (90) passes through the constraint loop (Paragraph [0055]) and each of the plurality of reducing loops (Figs. 9A-9B), and wherein retraction of the at least one apposition release wire releases the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula (Paragraph [0015]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constraint arrangement recited in claims 1 and 4 of ‘151 comprising a plurality of reducing loops formed from others of the internal suture portions, the plurality of reducing loops extending radially inwards from the graft body, the apposition release wire passed through and each of the plurality of reducing loops, and wherein retraction of the at least one apposition release wire releases the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula, as taught by Ducke, in order to releasably secure the stent-graft to the delivery system (Paragraphs [0053-0055]).
Further, Spindler also discloses a delivery device (Fig. 9, delivery assembly 510), an elongate lumen (see Fig. 9, inside graft 530), a guide wire cannula (Fig. 9, cannula 520), a release wire (Paragraph [0060], trigger wires 540a/540b), and a constraint loop and plurality of reducing loops (Paragraph [0060], loops 550). Spindler teaches the delivery device (510) having a sleeve (Fig. 9, sleeve 525) passing through the elongate lumen (see Fig. 9, inside graft 530), and the sleeve (525) being disposed around a guide wire cannula (520), the constraint loop (Ducke 120) is capable of constraining (Ducke Paragraph [0053]) the positionable region (Ducke 60) in close apposition to the guidewire cannula (Ducke 80) thereby in close apposition to a sleeve (525). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constraint arrangement recited in claims 1 and 4 of ‘151 wherein the delivery device having a sleeve passing through the elongate lumen, and the sleeve being disposed around a guide wire cannula, the constraint loop constraining the positionable region in close apposition to the sleeve, as taught by Spindler, in order to cover the guidewire cannula (Paragraph [0060]).
Regarding claim 16 of the present case, Claim 6 of ‘151 aticipates wherein the at least one apposition release wire penetrates the graft body from outside the graft body to inside the graft body and then back from inside the graft body to outside the graft body, but fails to disclose thereby providing a linear attachment zone inside the graft body, and wherein the constraint loop constrains the positionable region of the stent-graft to the sleeve.
Ducke as modified by Spindler teaches thereby providing a linear attachment zone inside the graft body (see annotated Fig. 7 below), and wherein the constraint loop (Figs. 8, 9A-9B, loop 120) constrains (Paragraph [0053]) the positionable region (60) of the stent-graft (Paragraph [0053], the constraint loop 120 holds the positionable region 60 with respect to the cannula 80) to the sleeve (Spindler, 525).
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Claim 22 is anticipated by claims 6 and 7 of ‘151.
Claims 26, 28, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 12,138,151 B2 in view of Ducke (Foreign Patent No. AU2021201336 B1), Spindler et al. (US PG Pub No. 2021/0154036 A1), and King et al. (US PG Pub No. 2022/0087812 A1).
Regarding claim 26 of the present case, Claims 1 and 4 of ‘151 discloses a stent-graft (Col. 7, line 33) and delivery device assembly (Col. 7, line 34) comprising a guide wire cannula (Col. 7, line 37); a stent-graft having: a graft body defining an elongate lumen (Col. 7, lines 34-35); and a positionable region (Col. 7, lines 35-36), at least one suture (Col. 7, line 39) sewn circumferentially (Col. 7, line 46, Col. 8 lines 1-5) through and around the graft body (Col. 7, lines 39-40), such that a plurality of external suture portions (Col. 7, lines 39-41) and a plurality of internal suture portions are formed (Col. 7, line 43); a constraint loop formed from a first of the internal suture portions (Col. 7, lines 45-48), the constraint loop passing around the guide wire cannula (Col. 7, lines 49-50), an apposition release wire (Col. 7, line 37) releasably securing the graft body with respect to the guide wire cannula along a length of the guide wire cannula (Col. 7, lines 52-56); wherein the at least one apposition release wire passes through the constraint loop (Col. 7, lines 52-56).
Claims 1 and 4 of ‘151 fail to disclose a sleeve disposed around the guide wire cannula; a tip at a proximal end of the guide wire cannula; a handle at a distal end of the guide wire cannula, a pusher disposed around the guide wire cannula and extending proximally from the handle; a stent-graft receiving zone located between the tip and the pusher, the stent-graft positioned at the stent-graft receiving zone, the plurality of reducing loops extending radially inwards from the graft body; the apposition release wire passing each of the plurality of reducing loops, and a multi-function wire pull mechanism on the handle, wherein the apposition release wire is operably connected to the multi- function wire pull mechanism such that the multi-function wire pull mechanism is actuatable to release the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula.
Ducke also discloses a stent-graft (Figs. 7-9B, stent-graft 10) and delivery device assembly (Paragraph [0053]), the assembly comprising: a guide wire cannula (Figs. 7-9B, cannula 80), a stent-graft (Fig. 7-9B, stent graft 10) having: a graft body (Fig. 7, graft 20) defining an elongate lumen (Fig. 7, elongate lumen 25); and a positionable region (Fig. 7, positionable region 60), at least one suture (Fig. 7, suture 100 and 200) sewn circumferentially through and around the graft body (Paragraph [0053]), such that a plurality of external suture portions (Fig. 7, first fixed end 103, second fixed end 108, third fixed end 203, fourth fixed end 208) and a plurality of internal suture portions (Paragraph [0053], Figs. 8-9B) are formed; a constraint loop (Figs. 8, 9A-9B, loop 120) formed from a first of the plurality of internal suture portions (Paragraphs [0053]), the constraint loop (120) passing around and constraining (Paragraph [0053]) the guide wire cannula (Paragraph [0053], 80) in close apposition to the positionable region (60); a plurality of reducing loops (Figs. 8-9B, bights 225, second loop 220) formed from others of the plurality of internal suture portions (Figs. 8-9B), an apposition release wire (Fig. 7, release wire 90) releasably securing (Paragraph [0019]) the graft body (20) to the guide wire cannula (Fig. 7, cannula 80) along a length (Fig. 7) of the guide wire cannula (80), the apposition release wire (90) passing through the constraint loop (Paragraph [0055], 120).
Ducke teaches the plurality of reducing loops (220, 225) extending radially inwards (Figs. 9A-9B) from the graft body (20); the apposition release wire (90) passing through each of the plurality of reducing loops (Figs. 9A-9B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constraint arrangement recited in claims 1 and 4 of ‘151 to disclose the plurality of reducing loops extending radially inwards from the graft body; the apposition release wire passing each of the plurality of reducing loops, as taught by Ducke, in order to releasably secure the stent-graft to the delivery system (Paragraphs [0053-0055]).
Further, Spindler discloses a delivery device (Fig. 9, delivery assembly 510), an elongate lumen (see Fig. 9, inside graft 530), a guide wire cannula (Fig. 9, cannula 520), a release wire (Paragraph [0060], trigger wires 540a/540b), and a constraint loop and plurality of reducing loops (Paragraph [0060], loops 550). Spindler teaches the delivery device (510) having a guide wire cannula (Fig. 9, cannula 520) for sliding over a guide wire; a sleeve (Fig. 9, sleeve 525) disposed around a guide wire cannula (520); a tip (Fig. 9, tip 570) at a proximal end (Fig. 9, proximal end 526) of the guide wire cannula (520); a handle (Fig. 9, handle 590) at a distal end (Fig. 9, distal end 524) of the guide wire cannula (520) the stent-graft (530) positioned at the stent-graft receiving zone (see annotated Fig. 9 below); and a multi-function wire pull mechanism (Paragraph [0060], Fig. 9, thumbwheel 592) on the handle (590), wherein the apposition release wire (Paragraph [0060], trigger wires 540a/540b) is operably connected (Paragraph [0060]) to the multi- function wire pull mechanism (592) such that the multi-function wire pull mechanism (592) is actuatable to release (Paragraph [0060]) the constraint loop (Paragraph [0060], loops 550) and each of the plurality of reducing loops (Paragraph [0060], loops 550) and, thereby allowing the stent-graft to expand and to release from the guide wire cannula (Paragraph [0060]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constraint arrangement recited in claims 1 and 4 of ‘151 to disclose a guide wire for sliding over a guide wire; a sleeve disposed around the guide wire cannula; a tip at a proximal end of the guide wire cannula; a handle at a distal end of the guide wire cannula, the stent-graft positioned at the stent-graft positioned at the stent-graft receiving zone, and a multi-function wire pull mechanism on the handle, wherein the apposition release wire is operably connected to the multi- function wire pull mechanism such that the multi-function wire pull mechanism is actuatable to release the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula, as taught by Spinder, in order to release the stent graft (Paragraph [0060]).
Further, King also discloses a stent graft and delivery device assembly (Figs. 6C and 10, stent graft 10), an elongate lumen (Figs. 6C and 10, inside stent graft 10), a guide wire cannula (Figs. 6C and 10, guide wire cannula 400), a guide wire (Figs. 6C and 10, guide wire cannula 400), and a stent-graft receiving zone (see annotated Fig. 10 below). King teaches a pusher (Figs. 6C and 10, pusher 150) disposed around the guide wire cannula (400) and extending proximally from the handle (Spindler, 590); a stent-graft receiving zone (see annotated Fig. 10 below) located between the tip (Figs. 6C and 10, nose cone capsule 152) and the pusher (150). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constraint arrangement recited in claims 1 and 4 of ‘151 to disclose wherein a pusher disposed around the guide wire cannula and extending proximally from the handle; a stent-graft receiving zone located between the tip and the pusher, as taught by King, in order to deploy the stent-graft (Paragraphs [0079-0080 and 0087-0088]).
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Regarding claim 28 of the present case, Claim 6 of ‘151 anticipates wherein the at least one apposition release wire penetrates the graft body from outside the graft body to inside the graft body and then back from inside the graft body to outside the graft body, but fails to disclose a linear attachment zone inside the graft body, and wherein the constraint loop constrains the positionable region of the stent-graft to the sleeve.
Ducke as modified by Spindler teaches thereby providing a linear attachment zone inside the graft body (see annotated Fig. 7 below), and wherein the constraint loop (Figs. 8, 9A-9B, loop 120) constrains (Paragraph [0053]) the positionable region (60) of the stent-graft (Paragraph [0053], the constraint loop 120 holds the positionable region 60 with respect to the cannula 80) to the sleeve (Spindler, 525).
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Claim 33 is anticipated by claims 6 and 7 of ‘151.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ducke (Foreign Patent No. AU2021201336 B1) and in view of Spindler et al. (US PG Pub No. 2021/0154036 A1).
Regarding claim 15, Ducke discloses a constraint arrangement (Fig. 7, Paragraph [0053]) for a stent-graft (Fig. 7-9B, stent graft 10) loaded onto a delivery device (Paragraph [0053]) in combination with a stent-graft (Fig. 7-9B, stent graft 10), the stent-graft having: a graft body (Fig. 7, graft 20) defining an elongate lumen (Fig. 7, elongate lumen 25); and a positionable region (Fig. 7, positionable region 60), a guide wire cannula (Fig. 7, cannula 80),
the constraint arrangement comprising:
at least one apposition release wire (Fig. 7, release wire 90) releasably securing (Paragraph [0019]) the graft body (20) with respect to the guide wire cannula (80) along a length of the guide wire cannula (80);
at least one suture (Fig. 7, suture 100 and 200) sewn circumferentially through and around the graft body (Paragraph [0053]), such that a plurality of external suture portions (Fig. 7, first fixed end 103, second fixed end 108, third fixed end 203, fourth fixed end 208) and a plurality of internal suture portions (Paragraph [0053], Figs. 8-9B) are formed;
a constraint loop (Figs. 8, 9A-9B, loop 120) formed from a first of the internal suture portions (Paragraphs [0053]), the constraint loop (120) passing around the guide wire cannula (Paragraph [0053], 80) and constraining (Paragraph [0053]) the positionable region (60) in close apposition to the sleeve;
and a plurality of reducing loops (Fig. 7-9B, bights 225, second loop 220) formed from others of the internal suture portions (Figs. 8-9B), the plurality of reducing loops (220 and 225) extending radially inwards (Figs. 9A-9B) from the graft body (20), wherein the at least one apposition release wire (90) passes through the constraint loop (Paragraph [0055]) and each of the plurality of reducing loops (Figs. 9A-9B), and wherein retraction of the at least one apposition release wire releases the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula (Paragraph [0015]).
Ducke fails to disclose the delivery device having a sleeve passing through the elongate lumen (25), and the sleeve being disposed around a guide wire cannula (Fig. 7, cannula 80), the constraint loop (120) constraining (Paragraph [0053]) the positionable region (60) in close apposition to the sleeve.
Spindler also discloses a delivery device (Fig. 9, delivery assembly 510), an elongate lumen (see Fig. 9, inside graft 530) and a guide wire cannula (Fig. 9, cannula 520). Spindler teaches the delivery device (510) having a sleeve (Fig. 9, sleeve 525) passing through the elongate lumen (see Fig. 9, inside graft 530), and the sleeve (525) being disposed around a guide wire cannula (520), the constraint loop (Ducke 120) is capable of constraining (Ducke Paragraph [0053]) the positionable region (Ducke 60) in close apposition to the guidewire cannula (Ducke 80) thereby in close apposition to a sleeve (525). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke’s constraint arrangement wherein the delivery device having a sleeve passing through the elongate lumen, and the sleeve being disposed around a guide wire cannula, the constraint loop constraining the positionable region in close apposition to the sleeve, as taught by Spindler, as the modification merely involves a combination of known catheters that obtains a predictable result of covering a guidewire cannula ([0060]).
Regarding claim 16, Ducke as modified by Spindler discloses wherein the at least one apposition release wire (Fig. 7, release wire 90) penetrates (Paragraph [0013]) the graft body (Fig. 7, graft 20) from outside the graft body to inside the graft body and then back from inside the graft body to outside the graft body (see annotated Fig. 7 below), thereby providing a linear attachment zone inside the graft body (see annotated Fig. 7 below), and wherein the constraint loop (Figs. 8, 9A-9B, loop 120) constrains (Paragraph [0053]) the positionable region (60) of the stent-graft (Paragraph [0053], the constraint loop 120 holds the positionable region 60 with respect to the cannula 80) to the sleeve (Spindler, 525).
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Regarding claim 17, Ducke as modified by Spindler discloses wherein the at least one apposition release wire (Fig. 7, release wire 90) includes an apposition release wire proximal end (see annotated Fig. 7 above), the apposition release wire proximal end (see annotated Fig. 7 above) within the sleeve (Spindler, 525) in a loaded position (Figs. 6A and 9A) and outside the sleeve (Spindler, 525) in a deployed position (Figs. 6B and 9B).
Regarding claim 18, Ducke as modified by Spindler fails to disclose wherein the constraint loop engages the at least one apposition release wire at a location proximal to a location where the plurality of reducing loops engages the apposition release wire. Instead Ducke discloses wherein the constraint loop (Figs. 8, 9A-9B, loop 120) engages (Paragraph [0055]) the at least one apposition release wire (Fig. 7, release wire 90) and the plurality of reducing loops (Figs. 9A-9B, bights 225, second loop 220) engages (Paragraph [0055]) the apposition release wire (Fig. 7, release wire 90). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange wherein the constraint loop engages the at least one apposition release wire to a location proximal to a location where the plurality of reducing loops engages the apposition release wire, as doing so would have yielded predictable results, namely constraining the positionable region.
Regarding claim 19, Ducke as modified by Spindler fails to disclose wherein the constraint loop engages the at least one apposition release wire at a location distal to a location where the plurality of reducing loops engages the apposition release wire. Instead Ducke discloses wherein the constraint loop (Figs. 8, 9A-9B, loop 120) engages (Paragraph [0055]) the at least one apposition release wire (Fig. 7, release wire 90) and the plurality of reducing loops (Figs. 9A-9B, bights 225, second loop 220) engages (Paragraph [0055]) the apposition release wire (Fig. 7, release wire 90). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange wherein the constraint loop engages the at least one apposition release wire to a location distal to a location where the plurality of reducing loops engages the apposition release wire, as doing so would have yielded predictable results, namely constraining the positionable region.
Regarding claim 20, Ducke fails to disclose further comprising at least one proximal release wire, the at least one proximal release wire releasably securing a portion of the positionable region to the guide wire cannula. Spindler also discloses a delivery device (Fig. 2, delivery assembly 210), an apposition release wire (Fig. 2, trigger wire 240b), an elongate lumen (see Fig. 2, inside cannula 220), a stent (Fig. 2, top stent 232), a positionable region (Fig. 2, attachment of loops 250 to apices 234) and a guide wire cannula (Fig. 2, cannula 220). Spindler teaches further comprising at least one proximal release wire (Fig. 2, trigger wire 240a), the at least one proximal release wire (240a) releasably (Paragraph [0049], “stent released by trigger wires”) securing a portion of the positionable region (Fig. 2, attachment of loops 250 to apices 234) to the guide wire cannula (see Fig. 2, 220). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke’s constraint arrangement further comprising at least one proximal release wire, the at least one proximal release wire releasably securing a portion of the positionable region to the guide wire cannula, as taught by Spindler, in order to attach the stent graft to the delivery assembly (Paragraph [0049]).
Regarding claim 21, Ducke as modified by Spindler further disclose a proximal stent (Fig. 2, top stent 232) attached to the graft body (Fig. 2, stent graft 230), wherein the at least one proximal release wire (Fig. 2, trigger wire 240a) passes through a proximal end (Fig. 2, apices 234) of the proximal stent (232).
Regarding claim 22, Ducke as modified by Spindler discloses wherein the at least one apposition release wire (Fig. 7, release wire 90) repeatedly penetrates (Paragraph [0013]) the graft body (Fig. 7, graft 20) from inside graft body to outside the graft body (see annotated Fig. 7 above) around the guide wire cannula (Fig. 7, cannula 80) and then back from outside the graft body to inside the graft body so as to repeatedly loop over the guide wire cannula along a longitudinal length of the stent-graft (Fig. 7-9B, stent graft 10) (see annotated Fig. 7 above), thereby securing (Paragraph [0053]) the stent-graft (10) with respect to the guide wire cannula (Fig. 7, cannula 80).
Regarding claim 24, Ducke as modified by Spindler discloses wherein the at least one suture (Fig. 7, suture 100 and 200) includes a first suture (200) and a second suture (100), wherein the constraint loop (Figs. 8, 9A-9B, loop 120) is formed from an internal suture portion (Paragraph [0053], Figs. 8-9B) of the second suture, and wherein the plurality of reducing loops (Figs. 9A-9B, bights 225, second loop 220) is formed from internal suture portions (Paragraphs [0053-0055]) of the first suture (200).
Claim 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ducke (Foreign Patent No. AU2021201336 B1) and Spindler et al. (US PG Pub No. 2021/0154036 A1), as applied to claim 15 above, and further in view of Arbefeuille et al. (US PG Pub No. 2022/0160529 A1).
Regarding claims 23 and 25, Ducke as modified by Spindler discloses wherein the at least one apposition release wire (Fig. 7, release wire 90) passes through (Paragraph [0055]) the constraint loop (Figs. 8, 9A-9B, loop 120) and wherein retraction of the at least one apposition release wire releases the constraint loop (Paragraph [0055], “releasably secures”) thereby allowing the stent-graft to expand and to release from the guide wire cannula (Paragraph [0057]).
Ducke as modified by Spindler fails to disclose further comprising a reducing loop release wire wherein the reducing loop release wire passes through each of the plurality of reducing loops () and wherein retraction of the reducing loop release wire releases each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula.. Arbefeuille also discloses a delivery device (Fig. 37), an elongate lumen (Fig. 37, lumen 725), an apposition release wire (Fig. 37, wire 801), a plurality of reducing loops (Fig. 37, loop 826), a stent graft (Fig. 37, stent graft 738), a constraint arrangement (Fig. 37, radial constraint 820), and a guide wire cannula (Fig. 37, guidewire catheter 724). Arbefeuille teaches further comprising a reducing loop release wire (Fig. 37, wire 800) wherein the reducing loop release wire (800) passes through each of the plurality of reducing loops (826) and wherein retraction (Paragraph [0230]) of the reducing loop release wire (800) releases (Paragraph [0230]) each of the plurality of reducing loops (826) and, thereby allowing the stent-graft (738) to expand and to release (Paragraph [0230]) from the guide wire cannula (724). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke as modified by Spindler further comprising a reducing loop release wire wherein the reducing loop release wire passes through each of the plurality of reducing loops and wherein retraction of the reducing loop release wire releases each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula, as taught by Arbefeuille, in order to release the stent from the constraint arrangement (Paragraph [0230]).
Claims 26-31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Ducke (Foreign Patent No. AU2021201336 B1) and in view of Spindler et al. (US PG Pub No. 2021/0154036) and King et al. (US PG Pub No. 2022/0087812).
Regarding claim 26, Ducke discloses a stent-graft (Figs. 6-9B, stent-graft 10) and delivery device assembly (Paragraph [0053]), the assembly comprising: a guide wire cannula (Figs. 6-9B, cannula 80), a stent-graft (Fig. 6-9B, stent graft 10) having: a graft body (Fig. 7, graft 20) defining an elongate lumen (Fig. 7, elongate lumen 25); and a positionable region (Fig. 7, positionable region 60), at least one suture (Fig. 7, suture 100 and 200) sewn circumferentially through and around the graft body (Paragraph [0053]), such that a plurality of external suture portions (Fig. 7, first fixed end 103, second fixed end 108, third fixed end 203, fourth fixed end 208) and a plurality of internal suture portions (Paragraph [0053], Figs. 8-9B) are formed; a constraint loop (Figs. 8, 9A-9B, loop 120) formed from a first of the plurality of internal suture portions (Paragraphs [0053]), the constraint loop (120) passing around and constraining (Paragraph [0053]) the guide wire cannula (Paragraph [0053], 80) in close apposition to the positionable region (60); a plurality of reducing loops (Figs. 8-9B, bights 225, second loop 220) formed from others of the plurality of internal suture portions (Figs. 8-9B), the plurality of reducing loops (220, 225) extending radially inwards (Figs. 9A-9B) from the graft body (20); an apposition release wire (Fig. 7, release wire 90) releasably securing (Paragraph [0019]) the graft body (20) to the guide wire cannula (Fig. 7, cannula 80) along a length (Fig. 7) of the guide wire cannula (80), the apposition release wire (90) passing through the constraint loop (Paragraph [0055], 120) and each of the plurality of reducing loops (Figs. 9A-9B).
Ducke fails to disclose a guide wire for sliding over a guide wire; a sleeve disposed around the guide wire cannula; a tip at a proximal end of the guide wire cannula; a handle at a distal end of the guide wire cannula, the stent-graft positioned at the stent-graft positioned at the stent-graft receiving zone, and a multi-function wire pull mechanism on the handle, wherein the apposition release wire is operably connected to the multi-function wire pull mechanism such that the multi-function wire pull mechanism is actuatable to release the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula.
Spindler also discloses a delivery device (Fig. 9, delivery assembly 510), an elongate lumen (see Fig. 9, inside graft 530), a guide wire cannula (Fig. 9, cannula 520), a release wire (Paragraph [0060], trigger wires 540a/540b), and a constraint loop and plurality of reducing loops (Paragraph [0060], loops 550). Spindler teaches the delivery device (510) having a guide wire cannula (Fig. 9, cannula 520) for sliding over a guide wire; a sleeve (Fig. 9, sleeve 525) disposed around a guide wire cannula (520); a tip (Fig. 9, tip 570) at a proximal end (Fig. 9, proximal end 526) of the guide wire cannula (520); a handle (Fig. 9, handle 590) at a distal end (Fig. 9, distal end 524) of the guide wire cannula (520) the stent-graft (530) positioned at the stent-graft receiving zone (see annotated Fig. 9 below); and a multi-function wire pull mechanism (Paragraph [0060], Fig. 9, thumbwheel 592) on the handle (590), wherein the apposition release wire (Paragraph [0060], trigger wires 540a/540b) is operably connected (Paragraph [0060]) to the multi-function wire pull mechanism (592) such that the multi-function wire pull mechanism (592) is actuatable to release (Paragraph [0060]) the constraint loop (Paragraph [0060], loops 550) and each of the plurality of reducing loops (Paragraph [0060], loops 550) and, thereby allowing the stent-graft to expand and to release from the guide wire cannula (Paragraph [0060]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Ducke’s stent-graft and delivery device assembly comprising a guide wire for sliding over a guide wire; a sleeve disposed around the guide wire cannula; a tip at a proximal end of the guide wire cannula; a handle at a distal end of the guide wire cannula, the stent-graft positioned at the stent-graft positioned at the stent-graft receiving zone, and a multi-function wire pull mechanism on the handle, wherein the apposition release wire is operably connected to the multi-function wire pull mechanism such that the multi-function wire pull mechanism is actuatable to release the constraint loop and each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula, as taught by Spinder, in order to release the stent graft (Paragraph [0060]).
Ducke as modified by Spindler fails to disclose a pusher disposed around the guide wire cannula and extending proximally from the handle; a stent-graft receiving zone located between the tip and the pusher.
King also discloses a stent graft and delivery device assembly (Figs. 6C and 10, stent graft 10), an elongate lumen (Figs. 6C and 10, inside stent graft 10), a guide wire cannula (Figs. 6C and 10, guide wire cannula 400), a guide wire (Figs. 6C and 10, guide wire cannula 400), and a stent-graft receiving zone (see annotated Fig. 10 below). King teaches a pusher (Figs. 6C and 10, pusher 150) disposed around the guide wire cannula (400) and extending proximally from the handle (Spindler, 590); a stent-graft receiving zone (see annotated Fig. 10 below) located between the tip (Figs. 6C and 10, nose cone capsule 152) and the pusher (150). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke as modified by Spindler wherein a pusher disposed around the guide wire cannula and extending proximally from the handle; a stent-graft receiving zone located between the tip and the pusher, as taught by King, in order to deploy the stent-graft (Paragraphs [0079-0080 and 0087-0088]).
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Regarding claim 27, Ducke in view of Spindler and as modified by King fails to disclose further comprising at least one proximal release wire, the at least one proximal release wire releasably securing a portion of the positionable region to the guide wire cannula, wherein the multi-function wire pull mechanism is actuatable to release the at least one proximal release wire.
Spindler also discloses a delivery device (Fig. 9, delivery assembly 510), an apposition release wire (Paragraph [0060], Fig. 9, trigger wire 540b), an elongate lumen (see Fig. 9, inside graft 530), a stent (Paragraph [0060], Fig. 9, top stent 532), a positionable region (Paragraph [0060], Fig. 9, attachment of loops 550 to top stent 532) and a guide wire cannula (Fig. 9, cannula 520). Spindler teaches further comprising at least one proximal release wire (Paragraph [0060], Fig. 9, trigger wire 540a), the at least one proximal release wire (540a) releasably (Paragraph [0060], “releasing the stent graft”) securing a portion of the positionable region (Paragraph [0060], Fig. 9, attachment of loops 550 to top stent 532) to the guide wire cannula (see Fig. 9, 520),
wherein the multi-function wire pull mechanism (Paragraph [0060], Fig. 9, thumbwheel 592) is actuatable to release the at least one proximal release wire (Paragraph [0060], trigger wires 540a/540b). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke as modified by King, wherein the multi-function wire pull mechanism is actuatable to release the at least one proximal release wire, as taught by Spindler, in order to release the stent-graft (Paragraph [0060]).
Regarding claim 28, Ducke as modified by Spindler and King discloses wherein the apposition release wire (Fig. 7, release wire 90) penetrates (Paragraph [0013]) the graft body (Fig. 7, graft 20) from outside the graft body to inside the graft body and then back from inside the graft body to outside the graft body (see annotated Fig. 7 below), thereby providing a linear attachment zone inside the graft body (see annotated Fig. 7 below), and wherein the constraint loop (Figs. 8, 9A-9B, loop 120) is capable of constraining (Ducke Paragraph [0053]) the positionable region (Ducke 60) in close apposition to the guidewire cannula (Ducke 80) thereby in close apposition to a sleeve (Spindler, 525). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke’s constraint arrangement wherein the delivery device having a sleeve passing through the elongate lumen, and the sleeve being disposed around a guide wire cannula, the constraint loop constraining the positionable region in close apposition to the sleeve, as taught by Spindler, in order to cover the guidewire cannula (Paragraph [0060]).
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Regarding claim 29, Ducke as modified by Spindler and King discloses wherein the apposition release wire (Fig. 7, release wire 90) includes an apposition release wire proximal end (see annotated Fig. 7 above), the apposition release wire proximal end (see annotated Fig. 7 above) within the guide wire cannula (Figs. 6-9, cannula 80) in a loaded position (Figs. 6A and 9A) and outside the guide wire cannula (80) in a deployed position (Figs. 6B and 9B).
Regarding claim 30, Ducke as modified by Spindler and King fails to disclose wherein the constraint loop engages the apposition release wire at a location proximal to a location where the plurality of reducing loops engages the apposition release wire.
Instead Ducke discloses wherein the constraint loop (Figs. 8, 9A-9B, loop 120) engages (Paragraph [0055]) the at least one apposition release wire (Fig. 7, release wire 90) and the plurality of reducing loops (Figs. 9A-9B, bights 225, second loop 220) engages (Paragraph [0055]) the apposition release wire (Fig. 7, release wire 90). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange wherein the constraint loop engages the at least one apposition release wire to a location proximal to a location where the plurality of reducing loops engages the apposition release wire, as doing so would have yielded predictable results, namely constraining the positionable region.
Regarding claim 31, Ducke as modified by Spindler and King fails to disclose wherein the constraint loop engages the apposition release wire at a location distal to a location where the plurality of reducing loops engages the apposition release wire. Instead Ducke discloses wherein the constraint loop (Figs. 8, 9A-9B, loop 120) engages (Paragraph [0055]) the at least one apposition release wire (Fig. 7, release wire 90) and the plurality of reducing loops (Figs. 9A-9B, bights 225, second loop 220) engages (Paragraph [0055]) the apposition release wire (Fig. 7, release wire 90). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange wherein the constraint loop engages the at least one apposition release wire to a location distal to a location where the plurality of reducing loops engages the apposition release wire, as doing so would have yielded predictable results, namely constraining the positionable region.
Regarding claim 33, Ducke as modified by Spindler and King discloses wherein the at least one suture (Fig. 7, suture 100 and 200) includes a first suture (200) and a second suture (100), wherein the constraint loop (Figs. 8, 9A-9B, loop 120) is formed from an internal suture portion (Paragraph [0053], Figs. 8-9B) of the second suture, and wherein the plurality of reducing loops (Figs. 9A-9B, bights 225, second loop 220) is formed from internal suture portions (Paragraphs [0053-0055]) of the first suture (200).
Claims 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Ducke (Foreign Patent No. AU2021201336 B1) and in view of Spindler et al. (US PG Pub No. 2021/0154036 A1) and King et al. (US PG Pub No. 2022/0087812 A1) as applied to claims 26 and 33 above, and further in view of Arbefeuille et al. (US PG Pub No. 2022/0160529 A1).
Regarding claim 32, Ducke as modified by Spindler and King discloses wherein the apposition release wire (Fig. 7, release wire 90) passes through (Paragraph [0055]) the constraint loop (Figs. 8, 9A-9B, loop 120) and wherein retraction of the apposition release wire releases the constraint loop (Paragraph [0055], “releasably secures”) thereby allowing the stent-graft to expand and to release from the guide wire cannula (Paragraph [0057]).
Ducke as modified by Spindler and King fails to disclose further comprising a reducing loop release wire wherein the reducing loop release wire passes through each of the plurality of reducing loops and wherein retraction of the reducing loop release wire releases each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula. Arbefeuille also discloses a delivery device (Fig. 37), an elongate lumen (Fig. 37, lumen 725), an apposition release wire (Fig. 37, wire 801), a plurality of reducing loops (Fig. 37, loop 826), a stent graft (Fig. 37, stent graft 738), a constraint arrangement (Fig. 37, radial constraint 820), and a guide wire cannula (Fig. 37, guidewire catheter 724). Arbefeuille teaches further comprising a reducing loop release wire (Fig. 37, wire 800) wherein the reducing loop release wire (800) passes through each of the plurality of reducing loops (826) and wherein retraction (Paragraph [0230]) of the reducing loop release wire (800) releases (Paragraph [0230]) each of the plurality of reducing loops (826) and, thereby allowing the stent-graft (738) to expand and to release (Paragraph [0230]) from the guide wire cannula (724). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke as modified by Spindler and King further comprising a reducing loop release wire wherein the reducing loop release wire passes through each of the plurality of reducing loops () and wherein retraction of the reducing loop release wire releases each of the plurality of reducing loops and, thereby allowing the stent-graft to expand and to release from the guide wire cannula, as taught by Arbefeuille, in order to release the stent from the constraint arrangement (Paragraph [0230]).
Regarding claim 34, Ducke as modified by Spindler and King discloses further comprising a reducing loop release wire, wherein the apposition release wire (Fig. 7, release wire 90) passes through (Paragraph [0055]) the constraint loop (Figs. 8, 9A-9B, loop 120) formed from the internal suture portion (Paragraph [0053], Figs. 8-9B) of the second suture (100), and the reducing loop release wire passes through each of the plurality of reducing loops formed from the internal suture portions (Paragraph [0053], Figs. 8-9B) of the first suture (200), and wherein retraction of the apposition release wire (90) releases the constraint loop (Paragraph [0055], “releasably secures”) thereby allowing the stent-graft to expand and to release from the guide wire cannula (Paragraph [0057]).
Ducke fails to disclose a reducing loop wire passed through each of the plurality of reducing loops formed from the internal suture portions (Paragraph [0053], Figs. 8-9B) of the first suture (200) and retraction of the reducing loop release wire releases each of the plurality of reducing loops.
Arbefeuille also discloses a delivery device (Fig. 37), an elongate lumen (Fig. 37, lumen 725), an apposition release wire (Fig. 37, wire 801), a plurality of reducing loops (Fig. 37, loop 826), a first suture (Fig. 37, ligatures 822), a stent graft (Fig. 37, stent graft 738), a constraint arrangement (Fig. 37, radial constraint 820), and a guide wire cannula (Fig. 37, guidewire catheter 724). Arbefeuille teaches a reducing loop wire (Fig. 37, wire 800) passed through each of the plurality of reducing loops (826) formed from the internal suture portions of the first suture (822) and retraction (Paragraph [0230]) of the reducing loop release wire (800) releases (Paragraph [0230])each of the plurality of reducing loops (826). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ducke as modified by Spindler and King wherein a reducing loop wire passed through each of the plurality of reducing loops formed from the internal suture portions (Ducke Paragraph [0053], Figs. 8-9B) of the first suture (Ducke 200) and retraction of the reducing loop release wire releases each of the plurality of reducing loops, as taught by Arbefeuille, in order to release the stent from the constraint arrangement (Paragraph [0230]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith et al. (US PG Pub No. 2022/0211482 A1) also discloses a stent-graft (Figs. 1-5, stent-graft) delivery system (Paragraph [0066]), an elongate lumen (Figs. 1-5, inside cannula 46), a guide wire cannula (Figs. 1-5, cannula 46), a release wire (Figs. 1-5, release wire 44), and a constraint loop and plurality of reducing loops (Figs. 1-5, reducing loops 32 and 34).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./ Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774
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