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) 21-27, 29-34 and 37-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dickinson et al. US 2009/0306755.
Regarding claim 21, Dickinson et al. discloses a device for supplying fluid flow in a human or animal body (paragraph 0013), the device comprising: a first end portion 12 configured to anchor the device in a first vessel (paragraph 0013, end portions for anchoring the device in position); a second end portion 14 configured to anchor the device in a second vessel different than the first vessel (paragraph 0013, end portions for anchoring the device in position, figure 2), wherein the first end portion and the second end portion are diametrically expandable to anchor the device in the first vessel and the second vessel (paragraph 0017, end portions are diametrically expandable to anchor); an intermediate portion 16 between the first end portion and the second end portion and configured to be positioned in a passage 30 between the first vessel and the second vessel (figure 2), wherein the intermediate portion is diametrically expandable to dilate at least the intermediate portion (paragraph 0017); a support structure (paragraph 0004, 0021, 0036, for example, tubular supporting device stent or supporting device mesh); and a polymer tube 18 (paragraph 0035), wherein the first end portion, the second end portion, and the intermediate portion are self- expanding (paragraph 0026, 0059, may be balloon expandable or self-expanding) to an expanded state outside a delivery catheter from a compressed state within the delivery catheter (paragraph 0004, 0059, 0060; held in a collapsed state by a suitably adapted catheter for transport through the artery and which adopt an expanded state when deployed at the site of the blockage, expands when removed from sleeve), and wherein in the expanded state-the first end portion has a first diameter (paragraph 0024, figure 2), the second end portion has a second diameter larger than the first diameter (paragraph 0024, figure 2, passages may have different diameters), and the intermediate portion is configured to be expanded by a balloon (paragraph 0050).
Regarding claim 22, Dickinson et al. discloses wherein the first end portion and the second end portion are configured to be expanded by the balloon or a different balloon after self-expanding (paragraph 0026, end portions may be expanded by a balloon catheter, or alternatively or in addition may be self-expanding).
Regarding claims 23 and 27, Dickinson et al. discloses wherein the support structure comprises a stent (paragraph 0004, supporting device or stent), wherein the stent is configured to self-expand to move the first end portion, the second end portion, and the intermediate portion from the compressed state to the expanded state (self expanded when removed from sleeve, paragraph 0004).
Regarding claim 24, 25 and 26, Dickinson et al. wherein the support structure extends along the first end portion, the intermediate portion, and the second end portion (paragraph 0021), wherein the polymer tube extends along the first end portion, the intermediate portion, and the second end portion (paragraph 0035, device 10 formed of a polymer tube 18 with first region 12, intermediate region 16 and second region 14, figures 1, 3), wherein the support structure and the polymer tube each extend along the first end portion, the intermediate portion, and the second end portion (paragraph 0021, 0035, figures 1, 3).
Regarding claim 29, Dickinson et al. discloses wherein the support structure comprises a mesh (paragraph 0021).
Regarding claim 30, Dickinson et al. discloses wherein the mesh has a first density at the first end portion, and wherein the mesh has a second density at the intermediate portion lower than the first density (paragraph 0021, mesh may have higher density in the end portions than intermediate portion).
Regarding claim 31, Dickinson et al. discloses wherein the intermediate portion is configured to permit movement of the first end portion and the second end portion relative to each another (paragraph 0025, intermediate portion may be flexed to permit insertion of the device in the passages).
Regarding claim 32, Dickinson et al. discloses wherein the polymer tube defines a path for the fluid flow from the first vessel to the second vessel.
Regarding claim 33, Dickinson et al. discloses a device for supplying fluid flow in a human or animal body (paragraph 0013), the device comprising: a first end portion 12 configured to anchor the device in a first vessel (paragraph 0013, end portions for anchoring the device in position); a second end portion 14 configured to anchor the device in a second vessel different than the first vessel (paragraph 0013, end portions for anchoring the device in position, figure 2), wherein the first end portion and the second end portion are diametrically expandable to anchor the device in the first vessel and the second vessel (paragraph 0017, end portions are diametrically expandable to anchor); an intermediate portion 16 between the first end portion and the second end portion and configured to be positioned in a passage 30 between the first vessel and the second vessel (figure 2), wherein the intermediate portion is diametrically expandable to dilate at least the intermediate portion (paragraph 0017); wherein the intermediate portion is self-expanding to an expanded state outside a delivery catheter from a compressed state within the delivery catheter (paragraph 0004, 0026, 0059, 0060; held in a collapsed state by a suitably adapted catheter for transport through the artery and which adopt an expanded state when deployed at the site of the blockage, expands when removed from sleeve), and the intermediate portion is configured to be further expanded by a balloon in the expanded state (paragraph 0027, intermediate portion may be dilated the intermediate portion to dilate the third passage).
Regarding claim 34, Dickinson et al. discloses wherein the support structure extends along the first end portion, the intermediate portion, and the second end portion (paragraph 0021).
Regarding claim 37, Dickinson et al. discloses wherein the support structure comprises a mesh (paragraph 0021).
Regarding claim 38, Dickinson et al. discloses wherein the mesh extends along the first end portion, the intermediate portion, and the second end portion (paragraph 0021, mesh extending in different densities along the end portions and intermediate portion).
Regarding claim 39, Dickinson et al. discloses wherein the mesh has a variable density (paragraph 0021).
Regarding claim 40, Dickinson et al. wherein the first end portion and the second end portion are self-expanding (paragraph 0026, 0059, may be balloon expandable or self-expanding).
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) 28, 35 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al. US 2009/0306755 in view of Heuser et al. US 2012/0239137.
Regarding claims 28, 35 and 36, Dickinson et al. discloses a polymer tube 18 defines a path for the fluid flow from the first vessel to the second vessel (figure 2, paragraph 0009), but fails to explicitly disclose wherein the support structure comprises a stent, and further comprising a graft material coupled to the stent, wherein the graft material defines a path for the fluid flow from the first vessel to the second vessel.
Heuser et al. teaches a support structure or stent suitable for implantation in human blood vessels (paragraph 0007), the stent comprising further comprising a graft material coupled to the stent (paragraph 0007, stents are typically in the form of a stent-graft and an inner scaffold member with a metal structure such as a mesh body with a flexible polymer coating), wherein the graft material defines a path for the fluid flow from the first vessel to the second vessel (paragraph 0003, connecting adjacent blood vessels, e.g. an artery and adjacent vein for creating a pathway).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Dickinson et al. with a device being a stent comprising a graft or graft material, as taught by Heuser et al., as a known in the art to provide a graft material coupled to the stent to define a path and divert fluid flow from the first vessel to the second vessel according to known methods to yield predictable results.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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