Notice of Pre-AIA or AIA Status
The present reissue application 18/890,385 (“the ‘385 application”) of US Pat. No. 11,446,168 (“the ‘168 patent”), filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which the ‘168 patent is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 7, 9, 14, 18-19, 21, 23-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. No. 6,645,242 to Quinn (“Quinn”).
Regarding claims 1, 7, 9, 14, 19, 21 and 24-28, Quinn discloses a prosthesis (100 and see Figs. 18-22), comprising: a tubular graft main body (200) including a sidewall (see annotated Fig. 18 below) extending between an inflow end (230/240) and an outflow end (240/230), and a main lumen (235) extending between the outflow end and inflow end about a graft longitudinal axis (see annotated Fig. 18 below), the graft main body including an inflow end segment, an outflow end segment, and an intermediate segment interconnecting the inflow end segment and the outflow end segment (see annotated Fig. 18 below) having an opening (250) in the intermediate segment; a trough (within opening 250) comprising a trough boundary (see annotated Fig. 22 below) having a proximal axial side and a distal axial side distal of the proximal axial side and forming an apex (see annotated Fig. 18 below), and a trough wall (280), the trough wall extending radially inwardly and substantially longitudinally from the sidewall at the proximal axial side along the intermediate segment and at least partially within an inner lumen of the tubular graft main body (see Figs. 18-22); and a tubular graft branch (see Figs. 18-22) having a substantially circular proximal opening, a distal opening (see annotated Fig. 18 below), and branch lumen (260) extending therein, the tubular graft branch extending from the distal axial side of the trough wall and within the main lumen (inverted relationship) in a direction away from the inflow end of the graft main body and configured to receive retrograde flow (as described at col. 6, ll. 59-67, “Once deployed, incoming fluid flow. (i.e., arterial or venous blood flow in the typical deployment scenario) may enter either open end 230 or 240 [retrograde configuration] of bifurcated stent graft 100 and pass through main fluid flow channel 235. Upon reaching the inner open end 270 of internal graft channel 260, the incoming fluid flow divides into a portion continuing to flow in the main fluid flow channel 235 and a portion flowing through the branch fluid flow channel within internal graft channel 260 and through side
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opening 250.”, wherein the trough, the branch lumen, and the main lumen are in fluid communication (see Fig. 18), wherein the trough wall has a length extending between an outer surface of the side wall proximal of the tubular graft branch and the tubular graft branch (see annotated Fig. 18), and wherein the proximal opening is disposed immediately adjacent the apex (see annotated Fig. 18), wherein at least a portion of the proximal axial side is unobstructed from stitching and/or trough frames (the two graft sleeves may be joined by fusion bonding, electronic welding, thermal bonding, thermal welding,
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chemical welding, etc., see col. 10, ll. 5-12), thereby providing a continuous unobstructed surface and transition between the trough wall and the sidewall from an outer surface of the side wall to a branch lumen facing surface of the trough wall (continuous unobstructed surface and transition would result from the bonding techniques disclosed at col. 10, ll. 5-12. The tubular graft branch and the trough wall are made from a common graft material. See col. 8, ll. 50-61.
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Regarding claim 2, Quinn discloses the prosthesis of claim 1 and further describes a plurality of stents (210,215,220) coupled along the graft main body, each of the stents including a plurality of interconnected stent members (see Fig. 18), wherein at least a portion of the trough is disposed between a pair of adjacent stent members (between 210 and 220 and also between a plurality of 215, see also Fig. 22) of one of the stents.
Regarding claim 5, Quinn discloses the prosthesis of claim 1 and further describes a proximal stent coupled along the inflow end segment of the graft main body, the proximal stent including a plurality of stent members interconnected at proximal and distal apices, wherein the trough is defined by a trough boundary formed at the sidewall of the graft main body, and a portion of the trough boundary is disposed along a pair of adjacent distal apices of the proximal stent. See annotated Fig. 18.
Regarding claims 18 and 23, Quinn discloses the prosthesis of claims 1 and 14 and further describes a distal end of the graft branch is circumferentially offset from a longitudinal axis of the graft main body. See annotated Fig. 18 below.
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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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-4, 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinn.
Regarding claims 3-4 and 8, Quinn discloses the prosthesis of claims 2 and 7 above and further describes the trough is defined by a trough boundary formed at the sidewall of the graft main body; however, Quinn does not explicitly disclose the trough boundary including both stitchless/frameless portions and stitching along at least one of the pair of adjacent stent members or along a multi-sided opening formed in the sidewall of the graft main body.
However, Quinn does disclose at col. 10, ll. 5-11, “Seams and/or contact points for securing two graft sleeves together and/or securing a sheet of graft sleeve material to a graft sleeve and may be accomplished by any suitable technique (extant or hereafter developed), including but not limited to: sutures, ligatures, clips, other fasteners, fusion bonding, electronic welding, thermal bonding, thermal welding, chemical welding, adhesives, functional equivalents thereof, and/or combinations thereof.” Therefore, at the time of filing it would have been obvious to one skilled in the art to include both stitchless/frameless portions and stitching along at least one of the pair of adjacent stent members or along a multi-sided opening formed in the sidewall of the graft main body since Quinn acknowledges that there are many suitable techniques for securing two graft sleeves together. Furthermore, one skilled in the art would have incorporated both stitchless/frameless portions and stitching in order to accommodate the joining of different materials that would require difference joining materials/techniques. See col. 8, ll. 50-61.
Regarding claim 6, Quinn discloses the prosthesis of claim 5 but fails to explicitly teach wherein a length of the stent members defining the pair of adjacent distal apices is shorter than a length of remaining stent members of the proximal stent. However, modifying the proximal stent to have pair of adjacent distal apices shorter than the length of the remain proximal stent members would have been obvious in light of Quinn alone. Quinn discloses at col. 5, ll. 28-32 that “Each stent segment and the corresponding open end may preferably be adapted for engaging an endoluminal surface of a main vessel and forming a substantially fluid-tight seal therewith.” Therefore, at the time of filing, it would have been obvious to one of skill in the art to make the pair of adjacent distal apices shorter than the length of the remain proximal stent members of Quinn in order to provide a stent structure configured for the individual needs of a patient and thereby improve the outcome of the graft placement within the patient.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinn in view of US Pat. No. 8,021,412 to Hartley et al (“Hartley”).
Regarding claims 10-11, Quinn teaches the prosthesis of claim 1 but fails to explicitly disclose wherein a scalloped fenestration is formed along the inflow end (claim 10) and wherein the scalloped fenestration is sized to extend beyond the trough in both circumferential directions (claim 11).
However, Hartley teaches scalloped fenestrations along the inflow end which are sized to extend beyond the trough in both circumferential directions. See Fig. 5A. Hartley discloses that this provides the stent with “a petal effect,” e.g. attachment points to the native vessel.
At the time of filing, one skilled in the art would have found it obvious to incorporate the scalloped fenestrations of Hartley into the invention of Quinn. Both references are analogous in the art of endoluminal stent/grafts; therefore, a combination is proper. Additionally, one skilled in the art would have made the incorporation in order to provide a stent attachment structure configured for the individual needs of a patient and thereby improve the outcome of the graft placement within the patient
Claim(s) 12-13, 15-17 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinn in view of US Pub. No. 2006/0247761 to Greenberg et al. (“Greenberg”).
Regarding claims 12-13, Quinn meets the claim limitations as describe above for independent claim 1 but fails to teach that the graft branch axis is skewed relative to the graft longitudinal axis (claim 12); and that the graft branch axis extends obliquely relative to a radial axis that is orthogonal from the graft longitudinal axis (claim 13).
Regarding claims 17 and 22, Quinn meets the claim limitations as describe above for independent claims 1 and 14 but fails to teach that the tubular graft branch extends within the main lumen in a helical pattern.
Regarding independent claims 15-16, Quinn meets the same claim limitations detailed above for independent claims 1 and 14 but fails to disclose that the tubular graft branch extends from the distal axial side of the trough wall and within the main lumen in a helical pattern (claims 15 and 16).
However, Greenberg discloses a endoluminal device with an internal branch graft that extends in a helical pattern which makes the branch graft axis i) skewed relative to the graft longitudinal axis and ii) extending obliquely relative to a radial axis that is orthogonal from the graft longitudinal axis. See Figs. 28b-31. Additionally, Greenberg discloses at para. [0094] that “The helical turn in the prosthetic branch may reduce the forces on the branch extension by shifting the hemodynamic forces from the prosthetic branch and the interconnection between the branch extension to the prosthetic trunk. This may help prevent the branch extension from pulling out under those forces. The helical turn may also allow a wider variation in the radial orientation ("angle of access") of the prosthetic trunk and may prevent kinking of the prosthetic branch or branch extension. This design may also improve the hemodynamics by, for example, promoting laminar flow.”
Therefore, at the time of filing, one skilled in the art would have found it obvious to incorporate the helical pattern of the branch graft into the branch graft of Quinn. Both references are analogous in the art of endolumenal grafts; therefore, a combination is proper. Additionally, Greenberg itself provides the motivation which would have been to provide the device of Quinn with a configuration that, among other reasons, “may also improve the hemodynamics by, for example, promoting laminar flow” which would thereby improve the performance of the graft once implanted in the patient.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinn in view of US Pat. No. 8,945,203 to Shalev et al. (“Shalev”).
Regarding claim 20, Quinn meets the claim limitations as described above for claim 1 but fails to teach that the first proximal segment includes barbs disposed through the graft main body.
However, Shalev teaches barbs and discloses, “For some applications, one or more of stent-grafts 20, 22, 24, and/or 26 comprise one or more anchoring elements, such as barbs, that extend radially outwardly when the stent-grafts assume their radially-expanded states. The anchoring elements anchor the prosthesis to a vascular wall, helping prevent dislodgement.”
At the time of filing, it would have been obvious to one skilled in the art to incorporate barbs as taught by Shalev into the first proximal segment graft main body of Quinn. Both reference are analogous in the endoluminal graft art; therefore, a combination is proper. Additionally, the motivation to make the incorporation is provided by Shalev itself in providing that the barbs help prevent dislodgement which would thereby enhance the outcome of the graft after implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
Conferees:
/WILLIAM V GILBERT/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
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