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 1-13 are pending and examined below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13 – the claim recites “wherein the plurality of comprises at least two layers, preferably at least three layers”. This renders this claim indefinite because it is unclear how many layers are required. Appropriate correction is required. For examination purposes – the claim will be interpreted to require at least three layers.
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) 1, 2, 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt)
Regarding claim 1, Greenhalgh discloses a vascular access prosthesis for hemodialysis (Fig. 1, 10), comprising:
at least one support or flexible stent (Fig. 1, first stent member 26), and
at least one liner (Fig. 1, graft 12) made of patterned woven material (Col. 5, Line 66, “plain-woven”) fixed to said at least one support or stent (Col. 5, Line 51, “combined stent/graft structure”) and comprising:
a plurality of concentric weave layers (Fig. 4C, wherein 40 and 42 corresponds to a plurality of layers) with respect to a longitudinal geometric axis (Fig. 1, wherein woven graft 12 is concentric to axis 16)
wherein each of the layers has an open weave weft (see Fig. 4a, which corresponds to an open weave weft); and
the layers are superimposed together (see Fig. 4a) in order to define a wall of the prosthesis that presents labyrinthine interstices (see Fig. 4a, wherien the spaces between the weave corresponds to labyrinth interstices) capable of being crossed by a sharp element without breaking, tearing or cutting (see Fig. 4a, wherein the layers of the liner are configured for this intended use due to the weave configuration and the use up high denier yarns described in Col. 8, Lines 1-15), and
wherein, these layers of weave together form a fixation matrix for the fibrin of the blood which seals these labyrinthine interstices (Fig. 4C, see also Col. 7. Lines wherein “sealing ability” corresponds to forming a fixation matrix for the fibrin of the blood which seal these labyrinthine interstices)
Greenhalgh doesn't explicitly teach or disclose wherein at least one of the layers of weave is an elastic layer that includes at least one elastomeric thread.
Schmitt discloses wherein at least one of the layers of weave is an elastic layer that includes at least one elastomeric thread (Fig. 1, 19, see also Col 6, Lines 28-29, wherein the elastomeric thread 19 is 140 denier Lycra polyurethane)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify one of the layers of Greenhalgh with an elastomeric thread, as taught by Schmitt, in order to provide a graft has increased strength and elasticity within the layers.
Regarding claim 2, Greenhalgh further discloses wherien the stent is a self-expanding nitinol stent (See Col. 6, Lines 38-46, wherein the stent can be self-expanding and formed of nitinol).
Regarding claim 6, Greenhalgh discloses wherein all the layers (Fig. 4cC, 40 and 42 are of the same type of weave (see Fig. 4C wherien both layers are formed as a plain weave)
Regarding claim 9, Greenhalgh further discloses wherein said weave is a weft and warp weave (Fig. 4a, wherein the weave shown has vertical warps and horizontal wefts)
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt), as applied to claims above, and further in view of US 2011/0118821 (Brocker)
Regarding claim 3, Greenhalgh discloses a stent that extends along the entire at least one liner (See Fig. 9) but doesn't explicitly teach or disclose wherein said stent protrudes beyond the ends of the at least one liner forming anchoring sections against the wall of a vessel. Schmitt doesn't explicitly teach or disclose wherein said stent protrudes beyond the ends of the at least one liner forming anchoring sections against the wall of a vessel.
Brocker discloses wherein said stent protrudes beyond the ends of the at least one liner (see Fig. 19, wherein stent protrudes past graft 704 at both ends) forming anchoring sections against the wall of a vessel (¶0003, wherein “engage with a health portion of a vessel wall” corresponds to forming anchoring sections against the wall of a vessel)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the stent of Greenhalgh in view of Schmitt to protrude beyond the ends of at least oner liner, as taught by Brocker, in order to provide endovascular graft fixation (¶0003).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt), as applied to claims above, and further in view of US 2006/0257447 (Hinds)
Regarding claim 4, Greenhalgh discloses a plurality of layers (see rejection of claim 1) but doesn't explicitly teach or disclose wherein each layer has the same porosity. Schmitt doesn't explicitly teach or disclose wherein each layer has the same porosity.
Hinds discloses wherein each layer has the same porosity (¶0084, “the porosity of each layer may be the same or different”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the layers of Greenhalgh in view of Schmitt to be the same porosity, as taught by Hinds, in order to improve implantation in the body.
Regarding claim 5, Greenhalgh discloses a plurality of layers (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the layers have different porosities. Schmitt doesn't explicitly teach or disclose wherein the layers have different porosities.
Hinds discloses wherein the layers have different porosities (¶0084, “the porosity of each layer may be the same or different”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the layers of Greenhalgh in view of Schmitt to be different porosities, as taught by Hinds, in order to make the device easier to manufacture.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt), as applied to claims above and further in view of US 2012/0165918 (Du)
Regarding claim 7, Greenhalgh discloses a plurality of layers (See rejection of claim 1) but doesn't explicitly teach or disclose wherein all the layers are of different types of weaves. Schmitt doesn't explicitly teach or disclose wherein all the layers are of different types of weaves.
Du discloses wherien all the layers are of different types of weaves (Fig. 4A, wherien base layer 60 has a different weave than velour layer 62)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the layers of Greenhalgh in view of Schmitt to have different types of weaves, as taught by Du, in order to vary the mechanical properties of the prosthesis.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt), as applied to claims above and further in view of WO 2017/186706 (Barone)
Regarding claim 8, Greenhalgh disclose a weave (see rejection of claim 1) but doesn't explicitly teach or disclose a knitted weave. Schmitt disclose a weave (see rejection of claim 1) but doesn't explicitly teach or disclose a knitted weave.
Barone discloses wherien said weave is a knitted weave (Page 11, Line 13, “knitted weave”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the weave of Greenhalgh in view of Schmitt with a knitted weave, as taught by Barone, in order to increase the elasticity of the graft.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt), as applied to claims above and further in view of EP 0113196 (Temple)
Regarding claim 10, Greenhalgh discloses a weave (see rejection of claim 1) but doesn't explicitly teach or disclose a weave consisting of several layers of weave formed from a single tubular weave invaginated in a zigzag fashion. Schmitt doesn't explicitly teach or disclose a weave consisting of several layers of weave formed from a single tubular weave invaginated in a zigzag fashion
Temple discloses a weave consisting of several layers of weave formed from a single tubular weave invaginated in a zigzag fashion (see Fig. 4, wherein the pattern shown corresponds to several layers of weave formed from a single tubular weave invagination in a zigzag fashion.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the weave of Greenhalgh in view of Schmitt to consist of several layers of weave formed from a single tubular weave invaginated in a zigzag fashion, as taught by Temple, in order to improve the mechanical strength of the overall structure.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt), as applied to claims above and further in view of US 6,440,166 (Kolluri)
Regarding claim 11, Greenhalgh discloses a plurality of layers (see rejection of claim 1) but doesn't explicitly teach or disclose that it consists of several layers of weave independent of each other. Schmitt doesn't explicitly teach or disclose a weave consisting of several layers of weave independent of each other.
Kolluri discloses a prosthesis (Fig. 1) consisting of several layers of weave independent of each other (Col. 4, Lines 31-34, wherein “two or more zones with different and substantially independent chemical and biological characteristics” corresponds to several layers of weave independent of each other)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthesis of Greenhalgh in view of Schmitt with several layers of weave independent of each other, as taught by Kolluri, in order to create a prosthesis with a balance of strength and elasticity not found in a homogenous weave.
Regarding claim 12, Greenhalgh discloses a plurality of layers (see rejection of claim1) but doesn't explicitly teach or disclose wherein the plurality of layers comprises at least three layers. Schmitt doesn't explicitly teach or disclose at least three layers.
Kolluri discloses a multilayer graft (Fig. 1) wherien said plurality said plurality of layers comprises at least three layers (Fig. 1, wherien graft 10 comprises three layers: 12, 11, and 14)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the vascular access prosthesis of Greenhalgh in view of Schmitt with at least three layers, as taught by Kolluri, in order to provide a non-thrombogenic inner surface while still maintaining the necessary mechanical properties.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,159,239 (Greenhalgh) in view of US 5,496,364 (Schmitt), as applied to claims above, and further in view of US 2005/0038503 (‘503)
Regarding claim 13, Greenhalgh discloses a vascular prosthesis (see rejection of claim 1) but doesn't explicitly teach or disclose an elastomeric thread. Schmitt discloses an elastomeric thread but doesn't explicitly teach or disclose wherein the elastomeric thread is at least one elastic composite thread.
‘503 discloses a prosthesis device (Fig. 1) wherein the elastomeric thread is at least one elastic composite thread (¶0032, wherein “filaments may be composed of an elastic metal, polymer, or composite of both” corresponds to at least one elastic composite thread”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the elastomeric thread of Greenhalgh in view of Schmitt with at least one elastic composite thread, as taught by Greenhalgh, in order to produce a weave that is both biostable and mechanically sound for implantation in the body (¶0032).
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
US 2010/0324667 – discloses a composite vascular graft
US 9,295,542 – discloses an ePTFE access graft
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774