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 .
Claim Rejections - 35 USC § 102
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) 21, 26-28, 30-32, 36, 38 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dickinson et al. US 2009/0306755.
Regarding claim 21, 32, 38 and 40, Dickinson et al. discloses a device for rerouting blood flow, the device comprising: a support structure 22 comprising: a first end portion configured to coaxially appose sidewalls of a first vessel (figure 1, support structure 22, paragraph 0036, end 12 shown coaxially apposing sidewalls of a first vessel 26, support structure along the entire device, paragraph 0019), the first end portion configured to anchor in a first passage (paragraph 0013, 0017, end portions anchor the device in position), wherein the first end portion comprises a first diameter (diameter of portion 12); a second end portion configured to coaxially appose sidewalls of a second vessel (figure 1, support structure 22, paragraph 0036, end 14 shown coaxially apposing sidewalls of a second vessel 28), the second end portion configured to anchor in a second passage different than the first passage (paragraph 0013, 0017, end portions anchor the device in position), wherein the second end portion comprises a second diameter greater than the first diameter (paragraph 0024, two end portions may have different diameters); and an intermediate portion 16 longitudinally between the first end portion and the second end portion and configured to be positioned in a passage between the first vessel and the second vessel (figure 2; in a passage 30 between vessels 26 and 28), wherein the intermediate portion is frustoconical or tapered from the first diameter to the second diameter along an entire length of the intermediate portion (figure 2, intermediate portion 16 between ends 12 and 14 having a different diameter would result in a frustoconical configuration or tapered configuration as they are tapered between the smaller and larger end portion diameters); and a tube 18 coupled to the support structure (paragraph 0018, 0020; tube coupled with the supporting structure embedded within or on the outside of the tube), wherein the tube comprises a polymer (paragraph 0018), and wherein the tube at least partially forms a lumen configured to divert blood flow from the first vessel, through the passage, and into the second vessel (paragraph 0013, 0015, figure 2, fluid flow through the first vessel through the passage to the second vessel through the device).
Regarding claim 26, Dickinson et al. discloses wherein the support structure is self-expanding (paragraph 0022, 0026).
Regarding claim 27, Dickinson et al. discloses wherein the support structure is balloon expandable (paragraph 0004, 0026)
Regarding claim 28, Dickinson et al. discloses wherein the support structure comprises a wire (paragraph 0022, 0036, mesh 22 of metal wire).
Regarding claim 30, Dickinson et al. discloses wherein the intermediate portion is frustoconical along an entire length of the intermediate portion between the first end portion and the second end portion (figure 2, paragraph 0024, end portions 12 and 14 may be different diameters, creating a frustoconical shape 16 tapering between the two diameters of the first and second end portions).
Regarding claim 31, Dickinson et al. discloses wherein the first end portion 12, the second end portion 14, and the intermediate portion 16 are self-expanding to an expanded state outside a delivery catheter from a compressed state within the delivery catheter (paragraph 0026, self-expanding when removed from the retaining sleeve or catheter), and wherein the first end portion has the first diameter and the second end portion has the second diameter in the expanded state (figure 2, once expanded within target vessel).
Regarding claim 36, Dickinson et al. discloses wherein the support structure is self-expanding (paragraph 0022, 0026).
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.
Claim(s) 22-25, 29, 33-35, 37 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al. US 2009/0306755 in view of White et al. US 5782904.
Regarding claims 22-25, 29, 33-35, 37 and 39, Dickinson et al. discloses wherein the first and second end portions are varying diameters (paragraph 0024, figure 2, creating at least an intermediate portion being tapered or frustoconical) the end portions being cylindrical (for example, shown in figures 1, 3; first and second ends 12 and 14 are cylindrical), wherein the first vessel is an artery (figure 2, artery 26), wherein the second vessel is a vein (figure 2, vein 28) wherein the support structure comprises a laser-perforated shape memory or nitinol tube, and wherein the tube comprises a polymer or PTFE (paragraphs 0018, 0061, 0062, 0063; tube may be a biocompatible polymer such as PTFE, support structure or mesh may be made from any suitable material such as nitinol, or wire mesh may be another structure which supports such as a laser-perforated tube) but fails to explicitly disclose wherein the second end portion is frustoconical, and the first end portion is frustoconical.
White et al. discloses a device for rerouting blood flow comprising a first end, second end and intermediate portion, the device may comprising a generally cylindrical or a frusto-conical in shape with a diameter that increases or decreases along the entire length of the device (column 3, lines 34-41).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dickinson et al. with wherein the second end portion may be cylindrical or frustoconical, and the first end portion may be cylindrical or frustoconical, as taught by White et al. as necessary for a particular procedure as known in the art to yield predictable results for placing a device within variously sized vessels.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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