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
Applicants’ arguments regarding the IDS, claim objections, and 112b rejections of record has been considered, objections/rejections of record have been withdrawn.
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1 regarding the amended suture ring have been fully considered and are persuasive. However, a new ground(s) of rejection is made in view of Douthitt, see below rejection wherein a “ring of sutures” is taught by figure 3 and paragraph [0057].
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “selectively form different fenestrations according to the requirements….) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the prior art does not teach the amended feature of “a section that can be removed by at least one of fracturing and cutting through…” a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The structure is not distinguished, see rejection below.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “how to move the aperture, etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 112
Claims 1-9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a section that can be removed” and then recites that the section includes a station, a ring structure, a stent frame structure, and graft material. This makes it seem as if the station, the ring structure, the stent frame, and the graft are all removed but the specification in paragraph [0037] appears to describe just a secondary ring structure that is removed, therefore the language is unclear and does not clearly define the metes and bounds of the claimed invention.
Additionally, the language “can be” is indefinite, as it appears to be an optional requirement. It is unclear whether removal of the section is required.
Further, it is unclear whether the “section that can be removed” is the same structure as the “selectively open aperture” or whether these are two different elements.
Claim 9 recites “and another physical characteristic.” The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Dependent claims are likewise rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Douthitt (US 20170027683 A1) and Roselli (US 20160067067 A1).
Regarding claim 1, Douthitt teaches a stent graft comprising [0005]: an elongated body (element 260, fig 3) having proximal (element 261, fig 3) and distal end portions (element 262, fig 3) longitudinally separated by an intermediate portion (stent body in between ends, fig 3), a lumen extending at least partially through the intermediate portion (element 263, fig 3), and a frame structure having inner and outer surfaces (element 264, fig 3), at least one of the inner and outer surfaces being at least partially covered by a graft material (element 266, fig 3), wherein at least one of the proximal and distal end portions includes an aperture in fluid communication with the lumen (stent has apertures at both ends, also additional apertures [0047]) and defined by a portion of the frame structure (see fig 3) and at least one station (see annotated fig 3) positioned on the graft material of the elongated body (see fig 3), the station having a perimeter defined by a ring structure connected to the graft material covering the frame structure (see annotated fig 3), wherein the ring structure comprises a ring of sutures (fig 3, [0057]) and a section that can be removed (prior art does not need to disclose this “can be” removed feature as it appears to be optional) by at least one of fracturing and cutting through a part of the ring structure for forming a fenestration in the stent graft (intended use, the structure is capable of having a section removed, the structure is capable of being cut or fractured by at least some existing surgical cutting tool and/or removed before implantation with a cutting tool), the section including the at least one station, the ring structure, a portion of the frame structure of the elongated body, and the graft material at least partially covering the elongated body, the section extending into the aperture at the proximal or distal end portion of the elongated body (there is a section of the stent that includes these things, see fig 3, the term section is significantly broad enough to encompass any arbitrarily designated portion that comprises these features ).
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Annotated figure 3
Douthitt does not explicitly teach the details of the graft material as a selective covering. Roselli teaches a stent graft (abstract) that is defined by a portion of the frame structure (fig 3a) and a selectively open aperture bounded by the perimeter (fig 3a), wherein the aperture of the at least one station is selectively covered by the graft material ([0061], graft strip cover can be peeled away to selectively open aperture).
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 Douthitt by including the selective opening of the aperture, as taught by Roselli, in order to selectively open and close the aperture via the graft material and assist in delivery ([0066-0067]).
Regarding claim 2, Douthitt teaches wherein the at least one station is positioned proximate the proximal end portion of the elongated body (see station around 265B in the proximal portion 261 in fig 3) to substantially align with at least one branch vessel of an aorta when the stent graft is located therein ([0047]).
Regarding claim 3, Douthitt teaches wherein the at least one branch vessel is one of a brachiocephalic artery, a left common carotid artery, and a left subclavian artery (intended use, the structure is capable of being used in this way).
Regarding claim 4, Douthitt does not exactly teaches the selective opening. Roselli teaches a stent graft (abstract) wherein a fenestration in the stent graft is created by at least one of: opening at least a section of the graft material selectively covering the aperture of the at least one station ([0061], graft strip cover can be peeled away to selectively open aperture).
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 Douthitt by including the selective opening of the aperture, as taught by Roselli, in order to selectively open and close the aperture and assist in delivery ([0066-0067]).
Regarding claim 7, Douthitt teaches wherein the perimeter is at least one of a rectilinear shape, a curvilinear shape, a circle, an oval, a rectangle, and a polygon (see fig 3).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douthitt (US 20170027683 A1) and Roselli (US 20160067067 A1) and in further view of Sun (US 20090030502 A1).
Regarding claim 5, Douthitt in view of Roselli doesn’t exactly teach secondary stents details. Sun teaches an aortic stent ([0006]) wherein the fenestration of the at least one station (element 25, fig 2) provides a site in the stent graft at which a secondary stent can be introduced to at least one branch vessel (see stent structure attached to element 25 in fig 2 or element 88 in fig 10).
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 Douthitt in view of Roselli by including the secondary stent, as taught by Sun, in order to maintain patency in the body ([0003]).
Regarding claim 6, Douthitt in view of Roselli doesn’t exactly teach secondary stents details. Sun teaches an aortic stent ([0006]) wherein a secondary stent at least partially passing through the fenestration of the at least one station (see fig 10, stent is at least partially though fenestration to avoid leakage), a secondary stent having a distal end positioned at least partially in the at least one branch vessel (top part of element 88 in branch vessel, fig 10) and a proximal end positioned at least partially in the stent graft (bottom part of element 88 in stent graft, stent is at least partially though fenestration to avoid leakage, fig 10), wherein the secondary stent is configured to allow fluid communication between the at least one branch vessel and the lumen of the elongated body (see fig 10).
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 Douthitt in view of Roselli by including the secondary stent, as taught by Sun, in order in order to maintain patency in the body ([0003]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douthitt (US 20170027683 A1) and Roselli (US 20160067067 A1) and in further view of Huser (US 10188503 B2).
Regarding claim 8, Douthitt fails to teach a secondary ring within the station. Huser teaches a graft prosthesis (abstract) wherein the at least one station (element 30, fig 1) further includes at least one secondary ring structure located within the perimeter defined by the ring structure (element 26, figure 1), wherein the at least one secondary ring structure is located within the ring structure and defines a smaller area than the area of the station, for creating a fenestration in the station (see figure 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 device taught by Douthitt in view of Roselli by including the secondary ring, as taught by Huser, in order to create a pivotable fenestration that accommodates patient anatomy (col 2, lines 5-14).
Regarding claim 9, Douthitt fails to teach a secondary ring within the station. Huser teaches a graft prosthesis (abstract) wherein the at least one station (element 30 and internal elements) further includes at least a first station (element 30 perimeter, fig 1) and a second station (element 26 perimeter, fig 1), wherein the second station has a perimeter that is different in at least one of shape, size, location on the graft, perimeter footprint, cross-sectional area, and another physical characteristic, than a perimeter of the first station (see figure 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 device taught by Douthitt in view of Roselli by including the secondary ring, as taught by Huser, in order to create a pivotable fenestration that accommodates patient anatomy (col 2, lines 5-14).
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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/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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