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 .
Status of Claims
Claims 1-3 are currently pending. Claims 1-2 are currently amended. No new subject matter is added.
Response to Arguments
Applicant’s arguments, see pg. 1, filed 01/23/2026, with respect to claim objection have been fully considered and are persuasive. The claim objection of claim 1 has been withdrawn.
Applicant’s arguments, see pg. 1, filed 01/23/2026, with respect to the rejection(s) of claims 1 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Butters et al. (US 6019788 A).
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. In regards of the term “a reinforcement structure” its interpretation is dependent on Merriam Websters definition of reinforcement “something that strengthens or something designed to provide additional strength”.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden et al. (WO 2009011918 A1), hereinafter referred to as “Boyden” in view of Butters et al. (US 6019788 A), hereinafter referred to as “Butters”.
Regarding Claim 1, Boyden teaches a graft device (system 100, see Figures 1 and 3A-C), wherein the graft comprises: a porous tubular conduit (blood vessel 300, see Paragraph [0074]; it is commonly known that blood vessels are porous), and a 3D covering (a custom-fitted blood vessel sleeve 112/306) surrounding the porous tubular conduit (see Figure 3C) wherein at least one physical property of the 3D covering is defined by thickness data of the porous conduit (the at least one device 102, three-dimensional modeling unit 104, and/or sleeve-fitting unit 106 may be used to perform various data querying, recall, and/or manipulation techniques with respect to the anatomical blood vessel data 120, in order to, for example, construct a model of a portion of a blood vessel or determine specifications of a blood vessel sleeve for use in treating a portion of a blood vessel, see Paragraph [0068]; anatomical blood vessel data can thickness data of a blood vessel).
Boyden teaches all of the limitations as discussed above. However, Boyden does not explicitly disclose an engineered porous tubular conduit.
Butters teaches a graft device (device 10) wherein the graft comprises: an engineered porous tubular conduit (blood conduit 16 that has a first end 18 attached to the artery 12 and a second end 20 attached to the vein 14 to create a arterio-venous (AV) access fistulas, see Figure 1).
Boyden and Butters are analogous art because both teach a graft device used for a blood vessel.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tubular conduit of Boyden and further include wherein the tubular conduit is an engineered porous tubular conduit, such as a arterio-venous (AV) access fistula, as taught by Butters. Butters teaches it is beneficial to implant a vascular graft between an artery and vein to create a shunt for dialysis access. Typically, these grafts comprise a biocompatible conduit, either autologous (vein or artery) or synthetic, which can withstand repeated cannulation during the course of prolonged therapy (see Col. 1 lines 18-23)
Regarding Claim 2, Boyden and Butters teaches all of the limitations as discussed above in claim 1 and Boyden further teaches wherein the 3D covering (custom-fitted blood vessel sleeve 700, see Figure 7A) comprises a reinforcement structure (having a middle layer 704 may comprise a material that is a shape-forming material to provide a desired degree of structural stiffness, see Paragraph [00110], the exemplary embodiments may be executed in a number of other environments and contexts, and/or in modified versions of FIGS. 1 -9, see Paragraph [0073]) in between the engineered tubular conduit and the 3D cover for kink resistance (middle layer 704 is in between the blood vessel in the lumen 708 and external layer 702 of the 3D cover, see Figure 7A).
Regarding Claim 3, Boyden and Butters teaches all of the limitations as discussed above in claim 1 and Boyden further teaches wherein the 3D covering is porous (custom- fitted blood vessel sleeve 709 may be structured to expand or collapse via pleats, a folding mesh structure, see Paragraph [00352]); the exemplary embodiments may be executed in a number of other environments and contexts, and/or in modified versions of FIGS. 1 -9, see Paragraph [0073]).
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 ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC RASSAVONG/ (6/11/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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