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 12/02/2025 have been fully considered but they are not persuasive. Regarding arguments pertaining to independent claim 1, it is stated that Shalev does not teach the limitation not presented in Essinger (US Pub No.: 2014/0200649) in view of Gabbay (US Patent No.: 6,264,691), Roeder (US Pub No.: 2014/0277362) (being the limitation stating “wherein the tubular member is configured with an asymmetric shape having a radius of curvature of a first convex portion greater than the radius of curvature of a second convex portion”) and that one of ordinary skill in the art would not incorporate the Shalev reference into the combination involving Essinger. Examiner disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it was stated that it is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate part 16 of Shalev into the tubular portion of Essinger with the geometry of part 16 in figure 4B (of Shalev) for the purpose of providing an arrangement of a tubular member that acts as a fluid flow guide (in [0287]-[0288]) that is expandable (as per [0289]) and can be used to treat an iliac aneurysm in [0041]. A treatment of an iliac aneurysm specifically is not taught within the device of Essinger. From here, with respect to the use of the drawings of Shalev with respect to MPEP chapter 2125, the drawings of Shalev show an asymmetric shape having a radius of curvature of a first convex portion greater than the radius of curvature of a second convex portion. As such, with respect to what Shalev is relied upon to teach, the picture of Shalev will “show all the claimed structural features and how they are put together” as required by the cited MPEP chapter.
Claim Rejections - 35 USC § 103
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.
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) 11, 12, 17, 21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Essinger (US Pub No.: 2014/0200649) in view of Gabbay (US Patent No.: 6,264,691), Roeder (US Pub No.: 2014/0277362) and Shalev (US Pub No.: 2012/0150274).
Regarding claim 11, Essinger (US Pub No.: 2014/0200649) discloses a method for deploying a endovascular graft with an anchoring stent (delivery of a stent graft disclosed in [0174] and an anchoring stent is disclosed in [0123]), the method comprising: inserting an introducer sheath in an artery (as stent delivery is disclosed in the abstract, with a surgery to access an artery in [0077], insertion of the delivery device of the abstract into an artery is disclosed); inserting a first delivery sheath (sheath part 301, called the proximal sheath in [0086] and shown in figure 3) through the introducer sheath (the outer sheath member 302, shown in figure 3 and defined as a sheath in [0086]), the first delivery sheath containing a valve member (a valved member, being the valved-stent is held by a sheath in [0080]. While figure 3 does not define a valve member, it is assumed that the device of figure 3 is delivering a valve as it is defined as being similar to figure 1 in [0086] with an advancement into a ventricle disclosed); wherein the valve member includes: an elongate tubular portion having a proximal end and a distal end defining a length therebetween (as the valve is defined as a valved stent in [0010], an elongate tubular portion with a proximal end and distal end is implied to be present), and a plurality of leaflets (as per the definition of a valve, leaflets are implied to be present in the valved stent of [0010]. Leaflets also disclosed in [0181]), and deploying the valve member out of the first delivery sheath (deployment of a stent valve in [0076]); removing the first delivery sheath (in [0181], as the stent is removed from the delivery sheath, it is assumed that the sheath would be removed from the body).
However, Essinger does not teach that the elongate tubular portion having at least one aperture disposed in a sidewall at a location between the proximal and distal ends,
Instead, Gabbay (US Patent No.: 6,264,691) does teach that the elongate tubular portion having at least one aperture disposed in a sidewall at a location between the proximal and distal ends (shown in figure 1 and defined as parts 22 and 24 in column 3 lines 29-44). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the apertures of Gabbay into the heart valve device of Essinger for the purpose of providing an opening that aligns with the coronary sinus (in column 3 lines 29-44), which are taken as being beneficial as this would allow blood to still flow into the coronary sinus.
Essinger also does not teach an inserting a second delivery sheath through the introducer sheath, the second delivery sheath containing at least one endovascular graft and at least one coronary stent; wherein the at least one endovascular graft includes: a first endovascular graft having a proximal end and a distal end defining a length therebetween and an opening at the proximal and distal ends; deploying the first endovascular graft out of the second delivery sheath; coupling the first endovascular graft coupled to the valve member; deploying the at least one coronary stent out of the second delivery sheath and through the aperture in the valve member.
Instead, Roeder (US Pub No.: 2014/0277362) does teach an inserting a second delivery sheath through the introducer sheath (advancement of a prosthesis from a peel-away sheath into a delivery sheath in the abstract, it is argued that the device of Roeder can be advanced into the delivery sheath of Essinger), the second delivery sheath containing at least one endovascular graft and at least one coronary stent (stent part 36 and graft part 30 in [0032], stent graft in [0002]. In certain embodiments, the graft will be part 30 in figure 14); wherein the at least one endovascular graft includes: a first endovascular graft having a proximal end and a distal end defining a length therebetween and an opening at the proximal and distal ends (shown in figure 1, with the graft being part 30); deploying the first endovascular graft out of the second delivery sheath; coupling the first endovascular graft coupled to the valve member (graft placement in a sheath in [0041] for delivery, where graft part 60 is taken to be equivalent to graft part 30 as per [0040]); deploying the at least one coronary stent out of the second delivery sheath (in [0040]) and through the aperture in the valve member. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the graft and stent combination of Roeder into Essinger for the purpose of providing a graft and stent in the aorta (in [0003] and [0036]) that would allow for an aneurysm treatment in [0002].
From here, Essinger in view of Gabbay and Roeder does not teach wherein the tubular member is configured with an asymmetric shape having a radius of curvature of a first convex portion greater than the radius of curvature of a second convex portion
Instead, Shalev (US Pub No.: 2012/0150274) teaches wherein the tubular member is configured with an asymmetric shape having a radius of curvature of a first convex portion greater than the radius of curvature of a second convex portion (tubular portion part 16 with an asymmetric shape shown in figure 4B. the radius of curvature of the leftmost and rightmost end of part 16 is depicted as being different such that the leftmost part of part 16 has a larger radius of curvature than the rightmost convex portion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate part 16 of Shalev into the tubular portion of Essinger with the geometry of part 16 in figure 4B (of Shalev) for the purpose of providing an arrangement of a tubular member that acts as a fluid flow guide (in [0287]-[0288]) that is expandable (as per [0289]) and can be used to treat an iliac aneurysm in [0041].
Regarding claim 12, Essinger in view of Gabbay, Roeder and Shalev teach the method of claim 11. However, Essinger does not teach an instance, further comprising /deploying a second endovascular graft out of the second delivery sheath, wherein: the second endovascular graft includes a proximal end and a distal end defining a length therebetween and an opening at the proximal and distal ends, the second endovascular graft having a bifurcated lumen including a main lumen extending the length of the graft and a branched lumen longitudinally offset to a side of the main lumen; and coupling the second endovascular graft to the first endovascular graft.
Instead, Roeder does teach an instance further comprising deploying a second endovascular graft out of the second delivery sheath (insertion of a second prosthesis 25 in [0040], and a second graft 60 in [0037], shown in figure 14), wherein: the second endovascular graft includes a proximal end and a distal end defining a length therebetween and an opening at the proximal and distal ends (part 60 is shown in figure 14), the second endovascular graft having a bifurcated lumen (in [0059], bifurcation shown at part 68 and 70 in figure 14, parts 68 and 70 extending from part 25) including a main lumen extending the length of the graft (being the lumen at part 25 within device 60) and a branched lumen longitudinally offset to a side of the main lumen (parts 68 and 70 extend across the horizontal length of part 25 and are offset of part 25 in figure 14); and coupling the second endovascular graft to the first endovascular graft (part 25 is coupled to part 30 in figure 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the graft and stent combination of Roeder into Essinger for the purpose of providing a graft and stent in the aorta (in [0003] and [0036]) that would allow for an aneurysm treatment in [0002].
Regarding claim 21, Essinger in view of Gabbay, Roeder and Shalev teach the method of claim 11, wherein Essinger discloses that the artery is the femoral, iliac, axillary, carotid, or brachiocephalic artery (the valve is placed through the femoral artery in [0002].
Regarding claim 24, Essinger in view of Gabbay, Roeder and Shalev teach the method of claim 11, wherein the tubular portion includes a concave portion disposed proximal to the first convex portion (tubular portion part 16 with an asymmetric shape shown in figure 4B. The portion that curves inward in part 16 is concave, which is proximal to the portion of part 16 that curves outward). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate part 16 of Shalev into the tubular portion of Essinger with the geometry of part 16 in figure 4B (of Shalev) for the purpose of providing an arrangement of a tubular member that acts as a fluid flow guide (in [0287]-[0288]) that is expandable (as per [0289]) and can be used to treat an iliac aneurysm in [0041].
Claim(s) 13-15, 18-19, and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Essinger (US Pub No.: 2014/0200649) in view of Gabbay (US Patent No.: 6,264,691), Roeder (US Pub No.: 2014/0277362) and Shalev (US Pub No.: 2012/0150274) in further view of Pearson (US Pub No.: 2013/0289713).
Regarding claim 13, Essinger in view of Gabbay, Roeder and Shalev teach the method of claim 12. However, said prior art does not teach an instance further comprising deploying at least one anchoring stent from the second endovascular graft, wherein the at least one anchoring stent having a proximal end and a distal end defining a length therebetween and an opening at the proximal and distal ends; and coupling the at least one anchoring stent to the second endovascular graft with the proximal end of the at least one anchoring stent disposed within the main lumen and between the proximal and distal ends of the second endovascular graft, and the distal end of the at least one anchoring stent extending outward from the second endovascular graft at a location between the proximal and distal ends of the second endovascular graft.
Instead, Pearson (US Pub No.: 2013/0289713) does teach an instance further comprising deploying at least one anchoring stent (disclosed in [0022]) from the second endovascular graft (as the anchor stent of Pearson is disclosed to attach to a graft 102 in [0022], wherein the at least one anchoring stent having a proximal end and a distal end defining a length therebetween and an opening at the proximal and distal ends (shown in figure 1); and coupling the at least one anchoring stent to the second endovascular graft with the proximal end of the at least one anchoring stent disposed within the main lumen and between the proximal and distal ends of the second endovascular graft (it is argued that the anchoring stent can be coupled to the second endovascular graft brought in from Roeder about the main lumen 25 of Roeder), and the distal end of the at least one anchoring stent extending outward from the second endovascular graft at a location between the proximal and distal ends of the second endovascular graft (it is argued that the part of the anchoring stent would extend outward to attach to the interior wall of a body vessel, as per [0022], wherein said part that attaches to the body vessel can be defined as the distal end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
Regarding claim 14, Essinger in view of Gabbay, Roeder, Shalev, and Pearson teach the method of claim 13. However, Essinger does not teach an instance wherein the at least one anchoring stent is deployed from within a central lumen of the second endovascular graft.
Instead, Pearson does teach an instance wherein the at least one anchoring stent is deployed from within a central lumen of the second endovascular graft (the anchor stent part 112 is disclosed as extending outside or beyond the first edge part 106 of the graft 102 in [0022], implying that the anchor stent 112 is within the graft and extends outward with respect to the edge 106 of the graft. From here, it is argued that a deployment from within the central lumen of the second endovascular graft of Roeder would be provided for with the anchor stent of Pearson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
Regarding claim 15, Essinger in view of Gabbay, Roeder, Shalev and Pearson teach the method of claim 13. However, Essinger does not teach an instance wherein the at least one anchoring stent is deployed in a distal-proximal fashion.
Instead, Pearson does teach an instance wherein the at least one anchoring stent is deployed in a distal-proximal fashion (in figures 8-9, as per [0037]-[0038], the distal end of part 112 is deployed first).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
Regarding claim 18, Essinger in view of Gabbay, Roeder, Shalev and Pearson teach the method of claim 13. However, Essinger does not teach an instance wherein the at least one anchoring stent is a self- expanding anchoring stent.
Instead, Pearson does teach an instance wherein the at least one anchoring stent is a self- expanding anchoring stent (self-expanding in [0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
Regarding claim 19, Essinger in view of Gabbay, Roeder, Shalev, and Pearson teach the method of claim 13. However, Essinger does not teach an instance wherein the at least one anchoring stent is coupled to the second endovascular graft at an opening disposed on the second endovascular graft.
Instead, Pearson does teach an instance wherein the at least one anchoring stent is coupled to the second endovascular graft at an opening disposed on the second endovascular graft (part 112 is coupled to the edge part 106 of the stent in figure 1, wherein part 106 is at an opening. It is also argued that Pearson can be incorporated about the bottommost opening(s) of Pearson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
Regarding claim 22, Essinger in view of Gabbay, Roeder, Shalev and Pearson teach the method of claim 13. However, Essinger does not teach an instance wherein the second endovascular graft and the at least one anchoring stent are crimped within the delivery sheath.
Here, Roeder does teach that the second endovascular graft is crimped within the delivery sheath (in [0041], the second endovascular graft 60 with prosthesis part 25 are compressed into a sheath, the sheath being part 90 shown in figured 13 and 14. Said compression of part 60 is considered to be a crimped configuration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
From here, Pearson does teach the least one anchoring stent are crimped within the delivery sheath (anchor stent in a “reduced diameter configuration” within a sheath during delivery in [0029]. As the anchoring stent is in a reduced diameter configuration during delivery, a crimped state is present for the anchoring stent. From here, the reduced diameter configuration of the anchoring stent would be implemented onto the second endovascular graft part 60 of Roeder, so both part 60 of Roeder and the anchor stent 112 of Pearson in [0029] would be in a reduced configuration such that a sheath, like part 90 of figures 13 and 14 of Roeder, will be able to contain part 60 and the anchor stent of Pearson, where part 60 expands in figure 14 and [0041] while the anchor 112 also expands in [0022] of Pearson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
Regarding claim 23, Essinger in view of Gabbay, Roeder, Shalev and Pearson teaches the method of claim 13. However, Essinger does not teach an instance wherein the at least one anchoring stent comprises a cross-section, the cross-section including a first diameter greater than a second diameter of the artery in which the anchoring stent is disposed.
Instead, Pearson does teach an instance wherein the at least one anchoring stent comprises a cross-section (part 112 would have a cross section in figure 1), the cross-section including a first diameter greater than a second diameter of the artery in which the anchoring stent is disposed (as part 112 would embed into and anchor into the vascular tissue of the body vessel in [0022], it is argued that the first diameter of the cross section of the anchoring stent would be larger than the diameter of the artery itself if the anchoring stent would embed itself into the walls of the vessel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the anchor stent of Pearson into the combination Essinger, Gabbay and the second endovascular graft of Roeder for the purpose of providing an anchoring into a vascular tissue (in [0022]) which will hold the prosthesis of Roeder in place when the graft is deployed like the graft of Pearson is deployed in [0022].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Essinger (US Pub No.: 2014/0200649) in view of Gabbay (US Patent No.: 6,264,691), Roeder (US Pub No.: 2014/0277362), Shalev (US Pub No.: 2012/0150274) and Pearson (US Pub No.: 2013/0289713), in further view of Cragg (US Patent No.: 8,858,613).
Regarding claim 16, Essinger, Gabbay, Roeder, Shalev and Pearson teach the method of claim 13. However, said combination of art does not teach an instance wherein the at least one anchoring stent is deployed in a proximal-distal fashion.
Instead, Cragg (US Patent No.: 8,858,613) teaches an instance wherein the at least one anchoring stent is deployed in a proximal-distal fashion (in figures 4-6, the stent graft (stent graft disclosed in the abstract) is deployed from the distal sheath 248 including the anchoring portion 222 that is on frame portion 104. As the anchor is extending from the distal sheath 328, a proximal to distal deployment of part 104 with anchor 222 is present) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the means of deployment of Cragg into Essinger, Gabbay, Roeder, and Pearson for the purpose of providing a system involving a proximal and distal catheter that allows for a low stent deployment force that enables a greater degree of control and precision during deployment, as per column 2 lines 60-67 into column 3 lines 1-5.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Essinger (US Pub No.: 2014/0200649) in view of Gabbay (US Patent No.: 6,264,691), Roeder (US Pub No.: 2014/0277362) and Shalev (US Pub No.: 2012/0150274), in further view of Paine (US Pub No.: 2005/0222674).
Regarding claim 17, Essinger in view of Gabbay, Roeder and Shalev teach the method of claim 11. However, Essinger does not teach an instance wherein at least one of the first delivery sheath or the second delivery sheath is inserted through the introducer sheath in a retrograde fashion.
Instead, Paine (US Pub No.: 2005/0222674) teaches an instance wherein at least one of the first delivery sheath or the second delivery sheath is inserted through the introducer sheath (being the thick walled tube 241 that is inserted within part 230 in [0067], shown in figures 8-9) in a retrograde fashion (in [0079], the sheath is withdrawn to just proximal of the distal attachment 240, to which part 24o includes part 231 in figure 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the arrangement of the sheaths as presented in Paine into the combination involving Essinger for the purpose of providing a delivery device with a sheath that provides a hemostatic seal as per [0073], that is taken as being beneficial as it would provide a sealing to the device that is being inserted into the body (said device being a valve in the abstract)
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Essinger (US Pub No.: 2014/0200649) in view of Gabbay (US Patent No.: 6,264,691), Roeder (US Pub No.: 2014/0277362), Shalev (US Pub No.: 2012/0150274) and Pearson (US Pub No.: 2013/0289713), in further view of Shank (US Pub No.: 2012/0179086).
Regarding claim 20, Essinger, Gabbay, Roeder, Shalev and Pearson teach the method of claim 13. However, said combination of art does not teach an instance wherein the at least one anchoring stent is formed with a bend of up to 90 degrees.
Instead, Shank (US Pub No.: 2012/0179086) teaches an instance wherein the at least one anchoring stent is formed with a bend of up to 90 degrees (the anchor of Shank comprises a protrusion in [0006], where the protrusion extends between 45 degrees to 135 degrees in claim 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the protrusion that is part of the anchor of Shank into the device in order to provide an additional means to secure the anchor member to a wall of a lumen (in [0006] and claim 26)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rothstein (US Pub No.: 2015/0119974) disclosed for a modular prosthesis with an anchor stent in the abstract). Roeder (US Pub No.: 2014/0257474) disclosed for a prosthetic valve with apertures 48a and 48b in figures 1 and 5.
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774