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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-11 and 13-15 is/are pending. Claim(s) 14 is/are withdrawn. Claim(s) 12 is/are canceled.
Allowable Subject Matter
Claim(s) 1-11 are allowable.
Response to Arguments
Applicant’s arguments, filed 7/22/2026, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 1 and 5-6 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 7/22/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-12 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments with respect to claim(s) 1-11 and 13-15 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.
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.
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.
Claims 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully, et al (Cully) (US 2005/0131515 A1) in view of Pavcnik, et al (Pavcnik) (US 7,686,842 B2).
Regarding Claim 13, Cully teaches a graft device (e.g. Figures 1, 4B), comprising:
(a) an inner tubular mesh layer (e.g. [0018], both surfaces are covered; [0033] the permeable embodiment is a mesh) of electro-spinnable fibers (e.g. [0050], the ePTFE is made of fibers that could have been electro-spun to create the cover);
(b) an outer tubular mesh layer (e.g. [0018], both surfaces are covered; [0033] the permeable embodiment is a mesh) of electro-spinnable fibers (e.g. [0050], the ePTFE is made of fibers that could have been electro-spun to create the cover); and
(c) a graft support device (e.g. Figures 1, 4B, #14) defined as a patterned helix (e.g. [0050]) having an inner tubular surface and an outer tubular surface (e.g. Figures 1, 4B),
wherein the inner tubular mesh layer matches the inner tubular surface (e.g. [0018]),
wherein the outer tubular mesh layer matches the outer tubular surface (e.g. [0018]),
wherein together the inner tubular mesh layer and the outer tubular mesh layer sandwich the patterned helix (e.g. Figures 1, 4B; [0018]; [0042]),
Cully discloses the invention substantially as claimed but fails to teach the sandwiched layers distinguishing laminated areas and non-laminated areas
wherein the laminated areas and the non-laminated areas are both in between the inner and the outer tubular mesh layer[s], and
wherein the non-laminated areas enable bending of the patterned helix, while preventing kinking of the graft support device.
Cully teaches attaching the graft material via sutures (e.g. [0042]), but does not specify the location of the sutures.
Pavcnik teaches a stent frame surrounded on its radially inner and outer sides by graft coverings (e.g. column 1, line 64 – column 2, line 11) where the sandwiched layers distinguish laminated areas and non-laminated areas (e.g. column 1, line 64 – column 2, line 11; the sutures are only at the stent frame; therefore, the laminated areas are immediately adjacent and at the suture locations and the non-laminated areas are the remaining portions of the graft material).
Cully and Pavcnik are concerned with the same field of endeavor as the claimed invention, namely stent frames that are sandwiched between inner and outer graft layers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cully such that the mechanical attachment is as taught by Pavcnik as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of graft material attached to a stent frame.
The combination of Cully and Pavcnik teaches the non-laminated areas enable bending of the patterned helix (the corners allow for compression and expansion of the stent by allowing the struts to be compressed closer to one another and when the compression is released the corners are able to open up upon expansion), while preventing kinking of the graft support device (as the stent is trapped between and attached to the covering layers, it is unable to bend back on itself to form kinks).
Regarding Claim 15, the graft device at one end or at both ends have a circular ring connected to the craft device (here a terminal end ring is considered the circular ring, while the remainder of the stent is the patterned helix; e.g. Cully, Figure 1, the terminal end rings form the tubular body and thus are circular in cross-section).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 9/18/2026
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