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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/26 has been entered.
Response to Arguments
Applicant's arguments filed 05/26/26 have been fully considered but they are not persuasive.
On pages 7-10 Applicant argues amendments overcome the rejection of record. Applicant argues in the instant application, only the liner 40 contacts the graft 12 in the space defined by fenestration 24, and the ring 36 does not contact the graft at the sidewall thickness of the fenestration. Applicant argues that Chafke’s invention on the other hand has a ring 70 whose edges contact the thickness of the graft 22 at the fenestration 26. Applicant concludes Chafke does not meet the amended claim language since the spring sits between the fenestration 26 and ring 20, so the ring 70 occupies the space adjacent the fenestration perimeter and the liner 72 does not sit flush with the fenestration.
The Examiner respectfully disagrees, pointing out that while Chafke teaches their ring lying within the fenestration, the rejection of record, as amended in view of Arbefeuille, adjusts the ring location slightly so it sides on the outside of the graft as opposed to in the thickness of the ring. It appears Applicant’s arguments fail to take into account the modification made in view of Arbefeuille. Further, the argument is unclear since the Examiner does not understand how Applicant believes the presence of the ring (no matter its location) would affect whether or not the liner 72 forms a seal with the fenestration perimeter. The seal would still be formed whether or not the ring 70 is inside (although the proposed modification does move the ring so it is on the outside of the graft as opposed to within the perimeter), which makes this argument unclear.
On pages 9-10 Applicant argues that if Chafke is amended to move the ring to the outside of the graft as is suggested by the Examiner, the spring could not perform its intended function since it would not be able to grasp the implant within the fenestration.
The Examiner respectfully disagrees, noting there does not appear to be any reason why the movement of the ring would affect its function at all. It would still be able to properly grip, as is intended.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 15, 20, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chafke et al. (US 20150216686 A1) hereinafter known as Chafke in view of Arbefeuille (US 20190247178 A1).
Regarding claim 1 Chakfe discloses a stent-graft comprising:
a tubular graft component (22) defining an inside surface (Figure 3 luminal surface), outside surface (Figure 3 abluminal surface), an open proximal end (33a), an open distal end (33b), and at least one fenestration (60);
a proximal stent located on the graft component proximal to the fenestration (Figure 3 item 30; [0091] framework);
a ring extending along the graft and around the fenestration (Figures 1-6 item 70);
and a liner (72) extending between the inside and outside surfaces (Figures 3-6),
wherein the ring extends along the graft at a perimeter that defines the fenestration (Figures 3-7), such that the diameter of the fenestration is smaller than that of the internal diameter of the ring (Figures 3-6 show how the inner diameter of the ring is slightly larger than the diameter of the fenestration which fits inside),
wherein the liner extends through the fenestration (Figures 3-6 item 20; [0133])
but is silent with regards to the ring 70 extending along the graft outside the perimeter that defines the fenestration so it is sealed from exposure at the radially outer side of the ring by the liner and the graft, with a portion of the graft extending from the ring to the perimeter of the fenestration, so the liner conforms to the perimeter of the fenestration to form a seal therewith.
However, regarding claim 1 Arbefeuille teaches that a stent-graft ([0025]) fenestration (Figure 5 item 24) can include a liner (Figure 5 items 42/52 together) which seals a ring (Figures 5-7 item 50; [0035]), so the ring 50 extends along the graft outside the perimeter that defines the fenestration 24 so it is sealed from exposure at the radially outer side of the ring by the liner 42/52 and graft 12, with a portion of the graft 12 extending from the ring 50 to the perimeter of the fenestration 24 (Figure 4). Chakfe and Arbefeuille are involved in the same field of endeavor, namely stent-grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent-graft of Chakfe by having the ring 70 of Chafke sealed against exposure from a surface of a liner by both the liner and the graft as is taught by Arbefeuille since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. The Examiner notes that the difference between the ring 70 of Chafke being sealed from exposure on one side with the liner 72 alone, versus the liner 72 (with layers 80/82) and graft 22 depends entirely on the extent of the graft inward towards the fenestration 60, and how far the graft 22 extends inward between the surfaces 80/82 of the liner to meet the ring 70 directly at its perimeter, or whether it extends slightly above or below the ring into the space where ring 70 is set between the liner surfaces 80/82. In another way of looking at things, the ring 70 of Chafke may be positioned not directly on the inner perimeter of the fenestration 60, but rather slightly set back from the innermost fenestration (as can be seen in Arbefeuille Figures 6a-7). This slight change can be understood as a very slight dimension change in the graft or a very slight location change of the ring. Both are considered obvious to a person of ordinary skill as slight shape changes which does not affect the function of the combination.
The Examiner notes further that within this Combination, the end result is that the liner 72 will extend through the fenestration (Figures 3-6 item 20; [0133]), conforming to the perimeter of the fenestration to form a seal with the perimeter of the fenestration (see for example Figure 20, which shows the liner 72 having the same shape/outline of the fenestration perimeter 26, particularly when the ring 70 is moved to sit on the outside surface of the graft as is taught by the modification made above in view of Arbefeuille).
Regarding claim 2 the Chakfe Arbefeuille Combination teaches the stent-graft of claim 1 substantially as is claimed,
wherein Chakfe further discloses the liner includes a first layer (Figure 6 item 80) defining a first opening (defined at the edge 86 where the first layer transitions into the second layer), and a second layer (Figure 6 item 82) defining a second opening (defined at the edge 86 where the second layer transitions into the first layer),
wherein the two openings are aligned (Figure 4-6) and the two layers are secured to each other at the openings (integrally secured),
and wherein the first/second layer each define a perimeter at which they are secured to the inside or outside surface (Figure 4 item 88; [0128]).
Regarding claim 15 the Chakfe Arbefeuille Combination teaches the stent-graft of claim 1 substantially as is claimed,
wherein Chakfe further discloses the ring is a support ring (the ring 70 is understood to be a “support” ring as it supports the fenestration 60).
Regarding claim 20 the Chakfe Arbefeuille Combination teaches the stent-graft of claim 1 substantially as is claimed,
wherein Chafke further teaches the ring 70 is radiopaque ([0156]), and the Combination teaches (please see the modification of the ring location made in the rejection to claim 1 above) that that ring is positioned between the graft (22) and liner (72). Further, Arbefeuille teaches that a radiopaque marker (Figures 1-3, 7 item 49) can be a distinct element from the ring. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Chakfe Arbefeuille Combination so that the marker is a discrete element from the ring 70, since a ring made of radiopaque material and a ring with a radiopaque marker located thereon, are considered obvious alternative to the person of ordinary skill.
Regarding claim 26 the Chakfe Arbefeuille Combination teaches the stent-graft of claim 1 substantially as is claimed,
wherein Arbefeuille teaches both a proximal stent proximal to the fenestration, and a distal stent distal to the fenestration (Figures 1-2 items 26).
Claims 3-8, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakfe in view of Arbefeuille as is applied above, further in view of Roeder et al. (EP 2749250 A1) hereinafter known as Roeder.
Regarding claim 3 the Chakfe Arbefeuille Combination teaches the stent-graft of claim 2 substantially as is claimed,
wherein Chakfe further discloses the ring is radiopaque ([0156]),
but is silent with regards to the ring including a plurality of elongate marker bands.
However, regarding claim 3 Roeder teaches that stent-graft rings can include a plurality of markers (Figure 11 item 35; [0044] the inner perimeter 26 includes a reinforcement frame 44b; markers 35 are placed around the inner perimeter 26), and also teaches that markers can take the shape of a plurality of elongate marker bands (Figure 11; Figure 6 item 35). Chakfe Roeder are involved in the same field of endeavor, namely stent-grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent-graft of the Chakfe Arbefeuille Combination to have the ring include the elongate marker bands as is taught by Roeder since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the radiopaque ring of the Combination would perform equally well shaped as disclosed by Chakfe.
Regarding claim 4 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 3 substantially as is claimed,
wherein Roeder further teaches a portion of the markers are encapsulated by fabric independent of the liner ([0037] markers which are sewn into the graft material are understood to have a portion which is encapsulated within the graft fabric).
Regarding claim 5 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 4 substantially as is claimed,
wherein Roeder further teaches the fabric is fixed to the graft ([0037] the fabric is integral therewith).
Regarding claim 6 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 3 substantially as is claimed,
wherein Roeder further teaches the markers are sewn to the graft ([0037] the markers can be sewn or sutured to the graft).
Regarding claim 7 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 3 substantially as is claimed,
wherein Roeder further teaches a portion of the markers are elongate cylinders or tubes (Figure 6 item 35; see also [0037] the markers can comprise
tubes).
Regarding claim 8 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 3 substantially as is claimed,
wherein Roeder further teaches a support ring extending around the fenestration (Figures 1-11 item 30; [0038] reinforcement frames can be secured to the outer perimeter 30).
Regarding claim 8 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 3 substantially as is claimed,
wherein Roeder further teaches a support ring extending around the fenestration (Figures 1-11 item 30; [0038] reinforcement frames can be secured to the outer perimeter 30).
Regarding claim 12 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 8 substantially as is claimed,
wherein the Combination further teaches the support ring is sealed by the liner (Figures 1-11 item 30; [0038] reinforcement frames can be secured to the outer perimeter 30; the liner (Chafke item 72) is understood to extend to the outer perimeter of Chafke 88 (corresponding to Roeder 30)).
Regarding claim 13 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 8 substantially as is claimed,
wherein the Combination further teaches the support ring extends around the perimeter of the first or second layer (Chafke, figures 1-6 shows how the liner 72 with two layers 80/82 creates a distinct inner (86) and outer (88) perimeter around a fenestration 60, with the ring 70 lying at/near the inner perimeter 86; Roeder Figures 1-11 shows how the stent-graft’s distinct inner (26) and outer (30) perimeters include support rings ([0038]), resulting in the Combination having the outer support ring 44 extending around the outer perimeter (88 or Chafke, 30 of Roeder) of both layers 80/82).
Regarding claim 14 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 8 substantially as is claimed,
wherein Roeder further teaches the support ring is sewn to the graft ([0038]).
Claim 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakfe, Arbefeuille, and Roeder as is applied above, further in view of Chuter et al. (US 20100312326 A1) hereinafter known as Chuter.
Regarding claim 27 the Chakfe Arbefeuille Roeder Combination teaches the stent-graft of claim 1 substantially as is claimed,
but is silent with regards to the graft being bifurcated.
However, regarding claim 27 Chuter teaches stent-grafts can be bifurcated (Figure 16 item ) distal to a fenestration (Figure 18 item 611). Chakfe and Chuter are involved in the same field of endeavor, namely stent-grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent-graft of the Chakfe Arbefeuille Roeder Combination by having the prosthesis be bifurcated as is taught by Chuter in order to allow the invention to be used in a specific location that would help treat an aneurysm near a bifurcation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/04/26
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