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 .
Response to Arguments
Applicant's arguments filed 11/06/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the prior fail to show certain features of the invention, (i.e. “proximal tunnel graft secured at its proximal end” or a “distal tunnel graft lumen secured at its distal end” the examiner disagrees. Note the examiner references the embodiment shown in figure 1 or 2, further see in [0022] this embodiment is further described in U.S. Pat. No. 6,645,242, the contents of which are incorporated by reference in its entirety. The information incorporated is as much a part of the application as filed as if the text was repeated in the application (See MPEP 2163.07(b)). The embodiment teaches wherein the tunnel grafts can be secured at their outer ends (for example see Quin, figures 4 and 9, or col 5)
In response to applicant's argument that the prior fail to show certain features of the invention, (i.e. “the proximal or distal end of the fenestration orthogonal to the major longitudinal axis” the examiner disagrees. Note “Drawings and pictures can anticipate claims if they clearly show the structure which is claimed“ (See MPEP 2125 (I)). Further see annotated figure below that demonstrates and end of the fenestration orthogonal to a major longitudinal axis.
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In response to applicant's argument that the prior fail to show certain features of the invention, (i.e. “the proximal or distal end of the fenestration having a length greater than at least one of the diameter of the distal end of the proximal tunnel graft and the total diameter of the proximal end of the at least one distal tunnel grafts)” the examiner disagrees. Note “Drawings and pictures can anticipate claims if they clearly show the structure which is claimed“ (See MPEP 2125 (I)). See annotated figure above, the circled end of the fenestration must be wider than the diameter of the tunnel to allow the tubular element 200 to enter the tunnel graft as shown.
In response to applicant's argument that the prior fail to show certain features of the invention, (i.e. the correct direction of branch stent implantation) the examiner disagrees. Note the cites paragraph on page 12 of applicant’s arguments refer to the stent guidewires not the stents. See [0032], [0035], and [0037] states “to the branch vessel to be treated,” “to the remaining branch arteries,” “to treatment sites,” and “deployed to the respective branch vessels” the language indicates that the stents are going to the target area not from the target area.
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 1, 3-9, and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Dake (US 20130211506 A1) in view of Arbefeuille (US 20130184806 A1) and Hartley (US 8394136 B2).
Regarding claim 1, Dake teaches a method for treating vascular disease, (abstract) comprising the steps of a) delivering a stent graft through an aorta ([0023]), the stent graft including: i) a tubular aortic component (element 100, fig 1) defining a lumen (element 110, fig 1) having a proximal end (see annotated fig 1) a distal end (see annotated fig 1), a major longitudinal axis (arrow, fig 1), and defining a fenestration (element 120, fig 1) between the proximal end and the distal end (see orientation in fig 1), wherein the fenestration defines at least one of a fenestration proximal end (right side of element 120, fig 1) and a fenestration distal end (left side of element 120, fig 1) that lies in a plane orthogonal to the major longitudinal axis of the tubular aortic component (see orientation in fig 8, planes are oriented orthogonally); iii) at least one proximal tunnel graft (right element 140, fig 1) having a proximal tunnel graft proximal end and a proximal tunnel graft distal end (right element 140 has two ends, fig 1), and defining at least one proximal tunnel graft lumen (see right element 140 has lumen, fig 1), the proximal tunnel graft being secured at its proximal end to the tubular aortic component (see orientation in annotated fig 1, tunnel graft extends and is secured within proximal end); and iv) at least one distal tunnel graft (left element 140, fig 1) having a distal tunnel graft proximal end and a distal tunnel graft distal end (left element 140 has two ends, fig 1) , and defining at least one distal tunnel graft lumen (see left element 140 has lumen, fig 1), and being secured at its distal end to the tubular aortic component (see orientation in annotated fig 1, tunnel graft extends and is secured within distal end) and wherein at least one of the fenestration proximal end and the fenestration distal end of the fenestration lying in the plane orthogonal to the major longitudinal axis has a length greater than that of at least one of the total diameter of the distal end of the at least one proximal tunnel graft and the total diameter of the proximal end of the at least one distal tunnel graft (view orientation in fig 1 and 8, element 120 ends have a greater length than element 140s diameter) d) delivering at least one branch stent graft through the distal end of the stent graft through the distal tunnel graft lumen to the fenestration, and through the fenestration to a branch of the aorta at the target site, whereby the branch stent graft is radially and releasably constrained by a first branch delivery device ([0032]-[0038]); e) releasing the branch stent graft from the first branch delivery device ([0032]-[0038]); f) retracting the first branch delivery device(inherent, the delivery device does not stay in the body); g) delivering at least one branch stent graft through the proximal end of the stent graft through the proximal tunnel graft lumen to the fenestration, and through the fenestration to a branch of the aorta at the target site, whereby the branch stent graft is radially and releasably constrained by a second branch delivery device ([0032]-[0038]; h) releasing the branch stent graft from the second branch delivery device ([0032]-[0038]; and i) retracting the second branch delivery device (inherent, the delivery device does not stay in the body).
Dake fails to teach wherein the disease is occurring at an aneurysm site, and wherein the device has pockets and flared openings. Arbefeuille teaches a method of using a graft system (abstract) wherein the target site may include treating a suprarenal or thoracoabdominal aortic aneurysm ([0011]) and the following steps of 1) delivering the graft to an aneurysm site of a patient, the stent graft being radially and releasably constrained by a delivery device ([0007]), wherein the stent graft includes a pocket (element 84, fig 2a) at the fenestration (element 20, fig 1A), the pocket defining a pocket proximal opening and a pocket distal opening opposite the pocket proximal opening within the lumen (the element 84 had a proximal and distal opening [0060], fig 2a); the tunnel graft (element 28, fig 2a) extending within the lumen from the opening of the pocket (see orientation in fig 2a), and being secured at its end to the tubular aortic component (see dotted circle defining end in fig 2a), and 2) aligning the fenestration at the aneurysm site of the patient with at least one branch of the aorta at the aneurysm site ([0007]); c) releasing the stent graft from the delivery device ([0007]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the current tunnel orientation of the stent device taught by Dake by including the tunnel pockets, as taught by Arbefeuille, in order to guide the members received by the tunnels to stay positioned.
Dake in view of Arbefeuille fails to teach wherein the device has flared openings. Hartley teaches a graft system with internal lumens (abstract) wherein an end of a tunnel graft defines a flared opening (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the current tunnel orientation of the stent device taught by Dake by including the flared opening, as taught by Hartley, in order to guide and facilitate access to the tunnel.
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Annotated fig 1
Regarding claim 3, Dake further teaches wherein the fenestration (element 120, fig 1) defines a fenestration proximal end (right side of element 120, fig 1) that lies in a plane orthogonal to the major longitudinal axis of the tubular aortic component (see orientation in fig 8, planes are oriented orthogonally).
Regarding claim 4, Dake further teaches wherein the fenestration (element 120, fig 1) defines a fenestration distal end (left side of element 120, fig 1) that lies in a plane orthogonal to the major longitudinal axis of the tubular aortic component (see orientation in fig 8, planes are oriented orthogonally).
Regarding claim 5, Dake in view of Arbefeuille fails to teach a flared opening support stent. Hartley teaches a stent system with an internal lumen (abstract) further including at least one stent supporting the flared opening of at least one tunnel graft ends (col 2 lines 16-22, internal tube supporting flare).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the current tunnel orientation of the stent device taught by Dake by including the flared opening, as taught by Hartley, in order to in order to guide and facilitate access to the tunnel.
Regarding claim 6, Dake in view of Arbefeuille fails to teach wherein the device has flared openings. Hartley teaches a graft system with internal lumens (abstract) wherein tunnel graft end (end of element 15, fig 1) defines a flared opening (element 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the current tunnel orientation of the stent device taught by Dake by including the flared opening, as taught by Hartley, in order to guide and facilitate access to the tunnel.
Regarding claim 7, Dake in view of Arbefeuille fails to teach wherein the device has flared openings. Hartley teaches a graft system with internal lumens (abstract) wherein the tunnel graft end (end of element 15, fig 1) defines a flared opening (element 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the current tunnel orientation of the stent device taught by Dake by including the flared opening, as taught by Hartley, in order to guide and facilitate access to the tunnel.
Regarding claim 8, Dake further teaches including at least one stent supporting the distal tunnel graft and the proximal tunnel graft (elements 140 have support stent, fig 1).
Regarding claim 9, Dake in view of Arbefeuille fails to teach flared openings. Hartley teaches a stent graft with an internal tube (abstract) wherein tunnel graft distal end defines a flared opening (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the current tunnel orientation of the stent device taught by Dake by including flared openings, as taught by Hartley, in order to in order to in order to guide and facilitate access to the tunnel.
Regarding claim 11, Dake further teaches including at least two branch stent grafts (elements 200, fig 4), each branch stent graft extending through the fenestration and within at least one of the proximal tunnel graft lumen and the distal tunnel graft lumen (see orientation in fig 4).
Regarding claim 12, Dake further teaches including at least two branch stent grafts (elements 200, fig 4), wherein the at least two branch stent grafts each extend through the fenestration, and wherein at least one of the branch stent grafts extends through one of the proximal tunnel graft lumen and the distal tunnel graft lumen (see orientation in fig 4).
Regarding claim 13, Dake further teaches wherein at least one of the proximal tunnel graft and the distal tunnel graft includes a septum that partitions at least one of the proximal tunnel graft lumen and the distal tunnel graft lumen into two sublumens (see septum splitting element 140’ in half in fig 3), each sublumen having a proximal end and a distal end (the sublumens in fig 3 has a proximal and distal end).
Regarding claim 14, Dake further teaches including a plurality of septums (see multiple septum splitting elements 140’ in fig 10), wherein one septum partitions the proximal tunnel graft lumen into two lumens and one septum partitions the distal tunnel graft lumen into two sublumens (see multiple septum splitting elements 140’ in fig 10 on opposite sides).
Regarding claim 15, Dake further teaches including at least two branch stent grafts (elements 200, fig 10), each branch stent graft extending through the fenestration and within one of the two sublumens of the proximal tunnel graft (see orientation of elements 200 in fig 10).
Regarding claim 16, Dake further teaches including at least two branch stent grafts (elements 200, fig 10), each extending through the fenestration and each, independently, extending within one of the sublumens of the distal tunnel graft (see orientation of elements 200 in fig 10).
Regarding claim 17, Dake further teaches wherein both of the proximal tunnel graft and the distal tunnel graft is supported by a stent graft (elements 140 have support stent, fig 1).
Regarding claim 18, Dake teaches wherein each septum partitions the proximal and distal tunnel graft lumens into two sublumens (fig 10). Dake in view of Arbefeuille fails to teach the flared openings. Hartley teaches a stent system with an internal tube (abstract) with a flared distal opening that is not split by a septum (fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the current tunnel orientation of the stent device taught by Dake by including flared openings, as taught by Hartley, in order to in order to in order to guide and facilitate access to the tunnel.
Regarding claim 19, Dake further teaches including four branch stent grafts (elements 200, fig 10), all of which extend through the fenestration, and each of which extends independently within one of the sublumens (see orientation of elements 200 in fig 10).
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dake (US 20130211506 A1) in view of Arbefeuille (US 20130184806 A1) and Hartley (US 8394136 B2) in further view of Allen (US 20030199967 A1).
Regarding claim 2, Dake in view of Arbefeuille and Hartley fails to teach branched ends. Allen teaches a stent graft (abstract) wherein the distal end (bottom of fig 12) of the tubular aortic component (fig 12) is bifurcated (see orientation in fig 12), thereby defining two legs of the stent graft (see orientation in fig 12, two legs at bottom of stent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Dake by including the bifurcation, as taught by Allen, in order to improve sealing of the implant in a branched site.
Regarding claim 10, Dake in view of Arbefeuille and Hartley fails to teach the specific features of the bare stent. Allen teaches a stent graft (abstract) wherein the system further including a bare stent (element 26, fig 3) having proximal apices (overhanging peaks at element 24, fig 3) and distal apices (valleys at bottom of element 24 in fig 3), the bare stent affixed to the proximal end of the tubular aortic component at the distal apices (the distal apices are secured to the proximal end of the tubular part of fig 3) and wherein the proximal apices extend proximally beyond the proximal end of the tubular aortic component (overhanging peaks at element 24, fig 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Dake by including the bare stent features, as taught by Allen, in order to further engage with surrounding tissue.
Conclusion
THIS ACTION IS MADE FINAL. 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 HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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