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 1-5, 14, 15, 17 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Nae et al. (US 2019/0110911).
Regarding claim 1, Nae et al. disclose a stent (Figure 16A; Abstract; see drawing below), comprising: an elongate body comprising a structure set in an expanded configuration (Abstract), wherein, when in the expanded configuration, the elongate body comprises (see drawing below) a first flange (grey area, with or without the internal stent frame), a second flange (analogous area to grey area in white, with or without the internal stent frame), and a central portion (black area) therebetween formed from the elongate body in an expanded configuration, wherein ends of the elongate body are doubled back into the respective first and second flanges having a double walled structure protruding radially outward from the central portion (a triple walled structure encompasses a double walled structure), and wherein the first and second flanges extend to form saddle interaction regions that overlap (where ends 214 and 215 overlap), at least partially, with each other in a lateral direction in the central portion.
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[AltContent: textbox (First Flange (grey))][AltContent: textbox (Central Portion (black))][AltContent: arrow][AltContent: arrow]
Nae et al. fail to disclose that the structure is formed from braided wire. However Nae et al. disclose that the graft tube (216) partially forming the stent can be a mesh structure (¶[0055]). It is notoriously well-known in the art to form a mesh structure for a stent from braided filaments or wires (e.g. see ¶[0048] of US 2014/0228935).
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 mesh of Nae et al. from braided wires or filaments in order to take advantage of this well-known means used to form a mesh.
Regarding claim 2, the elongate body is formed across an inner opening of the first and second flanges (evident from Figure 16A inasmuch as this limitation is met by Applicant’s Figure 4D).
Regarding claim 3, the stent comprises an unexpanded configuration when constrained by a delivery device prior to being deployed (¶[0085]).
Regarding claim 4, a diameter of the first flange, the second flange, or both is larger than a diameter of the elongate body (at the central portion) in the expanded configuration (evident from Figure 16A).
Regarding claim 5, at least one other one of the first or second flanges is doubled back entirely into the respective first or second flange such that the respective end of the stent comprise an aflush end face that is flush with the respective end of the stent (e.g. see flush terminal ends of the stent in Figure 20B).
Regarding claim 14, Nae et al. disclose a stent (Figure 16A; Abstract), comprising: a stent body having a constrained configuration and an expanded configuration (Abstract), the stent body comprising (see drawing above) a tubular structure including a first portion (grey area), a second portion (analogous area to grey area in white), and a central portion (black area) extending therebetween in the expanded configuration, wherein the stent body is set in the expanded configuration (Abstract), wherein one or both of the first portion and the second portion are doubled back toward the opposing portion to form, respectively, a first flange and second flange (the first and second portions are flanges), and wherein the first and second flanges extend to form saddle interaction regions that overlap, at least partially, with each other in a lateral direction (evident from drawing above and Figure 16A).
Nae et al. fail to disclose that the structure is formed from braided wire. However Nae et al. disclose that the graft tube (216) partially forming the stent can be a mesh structure (¶[0055]). It is notoriously well-known in the art to form a mesh structure for a stent from braided filaments or wires (e.g. see ¶[0048] of US 2014/0228935).
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 mesh of Nae et al. from braided wires or filaments in order to take advantage of this well-known means used to form a mesh.
Regarding claim 15, the stent body is formed across an inner opening of the first and second flanges ((evident from Figure 16A inasmuch as this limitation is met by Applicant’s Figure 4D).
Regarding claim 17, at least one other one of the first or second flanges is doubled back entirely into the respective first or second flange such that the respective end of the stent comprise a flush end face that is flush with the respective end of the stent (e.g. see flush terminal ends of the stent in Figure 20B).
Regarding claim 19, the stent further comprises a coating (231 or adhesive ¶[0070]).
Regarding claim 20, the coating constrains at least one doubled back end of the tubular structure along a radially outward surface of the tubular structure (evident from Figure 22B).
Regarding claim 21, at least one of the first and second flanges comprises a protruding lip at a distal end (see lips formed by undulating end in Figure 23A).
Regarding claim 22, at least one of the first and second flanges comprises a protruding lip at a distal end of the double walled structure (see lips formed by undulating end in Figure 23A).
Response to Arguments
Applicant's arguments filed July 8th 2026 have been fully considered but they are not persuasive.
Applicant has argued that argued that the graft (216) of Nae et al. is not part of the stent. Applicants claims appear to be directed towards the embodiment of Figure 4E where the entire device (400E) is referred to as a stent even though it has a covering (220). In view of this disclosure, it would be reasonable to consider the entire device in Figure 16A of Nae et al. as a stent. Applicant has argued that the stent frame has been used to identify the flanges and central portion while the graft has been used to identify the doubled back limitation and this would be an improper hindsight-driven reconstruction of the claims. It is not understood how this interpretation of Nae et al. would be improper. However, it is noted that the portions of the stent frame within the flanges can also be considered as part of the flanges and portions of the graft have been used to identify the flanges as well as the central portion above.
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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