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 .
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.
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.
Claims 1, 8-12, 14-16, 19-22 and 25-35 are rejected under 35 U.S.C. 103 as being unpatentable over Von Oepen et al. (US 5,916,264) in view of Labrecque et al. (US 2020/0405515).
Regarding claim 1, Von Oepen et al. disclose a stent (10), comprising: a stent body (11/13) having a tubular expanded shape (claim 1; col. 2, lines 16-18); and, a radially expandable (claim 1) structure (12) positioned on an outer surface of the stent body; the radially expandable structure having an expanded diameter larger than the tubular expanded shape of the stent body (evident from Figure 1); wherein the radially expandable structure comprises one or more rings (see rings having zig-zag pattern in Figure 1) at least partially surrounding the stent body.
Von Oepen et al. fail to disclose that the rings comprise loops as claimed.
Labrecque et al. disclose a radially expandable structure (1010; Figures 18A-D) having one or more rings (1014) formed from a plurality of radially expanded wire loops (diamond or double-diamond structure enclosed by one of the dashed boxes below - either loop can be regarded as the claimed loop); each of the one or more rings defining a first plurality of peaks pointing in a proximal direction and a second plurality of peaks pointing in a distal direction (evident from the drawing below and Figures 18C-18D of Labrecque et al.). Labrecque et al. disclose that the loops and peaks help anchor a stent to tissue and/or allow connection to another annular structure such as a fenestration (¶[0160], [0191]; [0230]).
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[AltContent: rect][AltContent: rect][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Peaks)][AltContent: connector][AltContent: connector][AltContent: textbox (Loop)]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the radially expandable structure of Von Oepen et al. with at least one of the above rings (having the loops and peaks) of Labrecque et al. in order to help anchor the stent to tissue and/or allow connection to an anatomical or graft fenestration. With the above modification to Von Oepen et al., each of the first plurality of peaks and each of the second plurality of peaks would define a free end that is not directly attached to the stent body (evident when adding the above ring(s) to member 12 of Von Oepen et al.).
Regarding claim 8, Labrecque et al. disclose that their flared portions (14) can be at each end of a stent (¶[0171]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the above ring at each end of the structure 12 of Von Oepen et al. in order to bettor anchor the stent to tissue or anchor the stent to two fenestrations.
Regarding claim 9, the above rings would at least have portions spaced away from the ends of the stent body as claimed. Alternatively, Von Oepen et al. depict the structure (12) as being shorter than the stent body (Figure 1) but also do not disclose any criticality to the length of the structure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the radially expandable structure equal to or shorter than the stent body in length as an obvious choice from a finite number of identified, predictable solutions (shorter length structure 12, equal length structure, or longer length structure), with a reasonable expectation of success. With member 12 being equal in length, the first ring would spaced away from a distal edge of the stent body and the second ring would be spaced away from a proximal edge of the stent body due to the flared peaks.
Regarding claim 10, Labrecque et al. disclose that the flared peaks can be at any point along the radially expandable structure including at both ends and the middle (¶[0171], [0183]) and further disclose that the flared peaks can point in either a proximal or distal direction (¶[0183]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the above ring of Figures 18A-D at both ends of the radially expandable structure and the middle in order to better anchor the structure.
Regarding claim 11, the one or more rings are positioned circumferentially around the stent body (evident from Figures 18A-D of Labrecque et al.).
Regarding claim 12, the plurality of radially expanded wire loops have a memorized angle within an inclusive range of 5 to 90 degrees towards a middle of the stent and relative to a longitudinal axis of the stent (¶[0172] of Labrecque et al.).
Regarding claim 14, each of the plurality of radially expanded wire loops form a flat plane (at least at the some of the peaks - see left-most peak in above drawing).
Regarding claim 15, each of the plurality of radially expanded wire loops form an arc shape curving radially outwards from the stent body (the top of the left-most peak in above drawing forms an arc shape as claimed).
Regarding claim 16, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the post deployment dilation ability of Labrecque et al. (of over 160% diameter increase) to the stent of Von Oepen et al. in order to allow better sealing of the stent to a deployment site (¶[0223] of Labrecque et al.). With this modification, the rings would have a second dilated diameter that is one of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40% larger than an initial diameter of the stent body.
Regarding claim 19, Von Oepen et al. fail to disclose that the plurality of radially expanded wire loops comprise hydrogel. However, such a material is well-known in the art for constructing stents (for example see ¶[0079] of US 2014/0039537). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a hydrogel to construct the wire loops in order to take advantage of this well-known material for stent construction.
Regarding claim 20, the plurality of radially expanded wire loops each have a first part of the loop angled at a first angle relative to a longitudinal axis of the stent, and a second part of the loop angled at a second angle relative to the longitudinal axis of the stent (the above loops have oppositely oriented triangles forming opposing angles as claimed and evident from Figure 18D of Labrecque et al.; each triangle also forms two angles as claimed and evident from Figure 18D).
Regarding claim 21, the first part of the loop (base of triangle) is wider than the second part of the loop (tip of same triangle or opposite triangle).
Regarding claim 22, the first part of the loop extends and narrows towards a middle of the stent and wherein the second part of the loop extends and narrows away from the middle of the stent (each loop has a tip of a triangle which narrows and extends as claimed).
Regarding claim 25, the first part of the loop radially expands at an angle within an inclusive range of 5 degrees and 90 degrees toward the middle of the stent, and wherein the second part of the loop further radially expands within an inclusive range of 5 degrees and 90 degrees away from the middle of the stent (¶[0172] of Labrecque et al.).
Regarding claim 26, the second part of the loop has a triangular shape (the first and second parts are triangles or portions of the same triangle as explained above in regard to claim 20).
Regarding claim 27, Von Oepen et al. disclose a stent (10; Figure 1), comprising; a stent body (11/13) having a tubular expanded shape; and, one or more rings (see zig-zag rings of member 12 in Figure 1) located on an outer surface of the stent body.
Von Oepen et al. fail to disclose that the rings comprise loops as claimed.
Labrecque et al. disclose a stent (1010; Figures 18A-D) having one or more rings (1014) formed from a plurality of radially expanded wire loops (diamond or double-diamond structure enclosed by one of the dashed boxes above - either loop can be regarded as the claimed loop); each of the one or more rings defining a first plurality of peaks pointing in a proximal direction and a second plurality of peaks pointing in a distal direction (evident from the drawing above and Figures 18C-18D of Labrecque et al.). Labrecque et al. disclose that the loops and peaks help anchor a stent to tissue and/or allow connection to another annular structure such as a fenestration (¶[0160], [0191]; [0230]). Labrecque et al. further disclose that the flared loops can be provided at both ends of a stent and/or the middle (¶[0171], [0183]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided member 12 of Von Oepen et al. with one of the above rings (having the loops and peaks) of Labrecque et al. at each end of member 12 in order to help anchor the stent to tissue and/or allow connection to an anatomical or graft fenestration. With the above modification to Von Oepen et al., each of the first plurality of peaks and each of the second plurality of peaks would define a free end that is not directly attached to the stent body (evident when adding the above ring(s) to member 12 of Von Oepen et al.). Furthermore, with the above modification, at least one of the rings would be offset or spaced from one of the ends of the stent by at least 5% of a length of the stent.
Regarding claim 28, each of the plurality of wire loops have a first part of the loop angled at a first angle relative to a longitudinal axis of the stent, and a second part of the loop angled at a second angle relative to the longitudinal axis of the stent (the above loops have oppositely oriented triangles forming opposing angles as claimed and evident from Figure 18D of Labrecque et al.; each triangle also forms two angles as claimed and evident from Figure 18D).
Regarding claim 29, the first part of each of the plurality of wire loops extends towards a middle of the stent and wherein the second part of each of the plurality of wire loops extends away from the middle of the stent (the loops would have a triangle or part angled towards the middle of the stent and another triangle or second part angled away from the middle of the stent).
Regarding claim 30, the first part of each of the plurality of wire loops radially expands at an angle within an inclusive range of 5 degrees and 90 degrees toward the middle of the stent, and wherein the second part of each of the plurality of wire loops further radially expands within an inclusive range of 5 degrees and 90 degrees away from the middle of the stent (¶[0172] of Labrecque et al.).
Regarding claim 31, Von Oepen et al. disclose a stent, comprising; a stent body (11/13) having a tubular expanded shape and a plurality of rings (zig-zag structures of 12) on an outer surface of the stent body having an expanded diameter larger than the tubular expanded shape of the stent body.
Von Oepen et al. fail to disclose that the rings have wire loop means as claimed.
Labrecque et al. disclose a stent (1010; Figures 18A-D) having a plurality of wire loop means (see loops in above drawing) for anchoring the stent (¶[0160], [0191]; [0230]) and forming rings (1014) where the loop means folds backward upon itself two or more times to define two or more free peaks (evident from above drawing - the triangles formed by the folding). Labrecque et al. disclose that the loops and peaks help anchor a stent to tissue and/or allow connection to another annular structure such as a fenestration (¶[0160], [0191]; [0230]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided member 12 of Von Oepen et al. with one of the above rings (having the loops and peaks) of Labrecque et al. in order to help anchor the stent to tissue and/or allow connection to an anatomical or graft fenestration. With the above modification, the above peaks would not be directly connected to the stent body when in the flared configuration.
Regarding claim 32, an inflection point (1040 of Labrecque et al.) between the first part of the loop and the second part of the loop is at about 50% of a length of each of the plurality of radially expanded wire loops.
Regarding claim 33, all of the plurality of radially expanded wire loops comprise a same size of the first part of the loop and the second part of the loop (two out of the 4 triangles in the above loop have the same size).
Regarding claim 34, the plurality of radially expanded wire loops alternate between loops having different sizes of the first part of the loop and the second part of the loop (the above loop having only 2 triangles would form a plurality of loops as claimed).
Regarding claim 35, Von Oepen et al. disclose a stent (10), comprising; a stent body (11/13) having a tubular expanded shape; and, a radially expandable structure (12) positioned on an outer surface of the stent body; the radially expandable structure having an expanded diameter larger than the tubular expanded shape of the stent body (Figure 1); wherein the radially expandable structure comprises one or more rings (forming zig-zag ring structure) circumferentially surrounding the stent body.
Von Oepen et al. fail to disclose that the rings are formed from loops as claimed.
However, Labrecque et al. disclose the above rings having loops with peaks as claimed (see drawing above having opposing peaks) in order to help anchor a stent to tissue and/or allow connection to another annular structure such as a fenestration (¶[0160], [0191]; [0230]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided member 12 of Von Oepen et al. with one of the above rings (having the loops and peaks) of Labrecque et al. in order to help anchor the stent to tissue and/or allow connection to an anatomical or graft fenestration. With the above modification, the above peaks would each be spaced radially apart from and free of the stent body such that the first peak and each of the plurality of second peaks are not directly attached to the stent body.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771