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 .
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.
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)(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) 1-5, 8, 10, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson (20150196383).
Regarding claim 1, Johnson discloses an implantable conduit ([0012]; FIG 1A) that is tubular in shape ([0012]) and has an inner lumen ([0012]) and an outer surface ([0012]), the implantable conduit comprising: a plurality of overlap elements (40, 42, 44, 46) including a first overlap element (40) and a second overlap element (42) positioned adjacent the first overlap element (40) to define an adjacent pair of the plurality of overlap elements ([0039]; “partially nested within each other”, ‘A’ in the figure below), the first overlap element (40) overlapping onto the second overlap element (42) to define an overlapping portion ([0057]; “unsupported edge portion 54 of segment 40 is nested within the supported edge portion 56 of segment 42”, ‘B’ in the figure below) between an inward facing surface of the first overlap element and an outward facing surface of the second overlap element ([0057]; “unsupported edge portion 54 of segment 40 is nested within the supported edge portion 56 of segment 42”); and a plurality of attachment features (50) coupling the first overlap element to the second overlap element, the inward facing surface of the first overlap element and the outward facing surface of the second overlap element being separable at the overlapping portion by an external force ([0057]; “when the fluid pressure at the exterior of the stent graft 10 is higher than the fluid pressure within the interior of the stent graft 10… fluid flow can occur in a flow channel between the outer periphery of unsupported edge portion 54 and the inner periphery of supported edge portion 56”) to open an aperture in the overlapping portion between at least two of the plurality of attachment features (50) such that the aperture defines a path (60) between the inner lumen ([0012]) and outer surface ([0012]) of the implantable conduit, the path being sealed absent the external force ([0057]; “when the fluid pressure at the exterior of the stent graft 10 is higher than the fluid pressure within the interior of the stent graft 10”, implies this effect is absent when this pressure is absent).
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Regarding claim 2, Johnson discloses the implantable conduit of claim 1, wherein the plurality of overlap elements (40, 42, 44, 46) are arranged along a length of the implantable conduit (FIG 1A) and the overlapping portion extends in a circumferential direction (FIG 1A).
Regarding claim 3, Johnson discloses the implantable conduit of claim 1, wherein the plurality of overlap elements (40, 42, 44, 46) define a plurality of adjacent pairs of overlap elements (FIG 1A) and a plurality of overlapping portions (FIG 1A), each of the adjacent pairs of overlap elements being separable at a corresponding one of the plurality of overlapping portions to open an aperture that defines a path (60) between the inner lumen ([0012]) and the outer surface ([0012]) of the implantable conduit ([0057]).
Regarding claim 4, Johnson discloses the implantable conduit of claim 1, wherein the plurality of attachment features (50) are elongate strips of material (Fig. 1A) extending in a longitudinal direction along a length of the implantable conduit ([0044]; “ axial reinforcement member 50 defines the overall length of example stent graft device 10,” where axial is equivalent to longitudinal) to couple the first overlap element to the second overlap element ([0044]; “axial reinforcement member 50 links together segments”).
Regarding claim 5, Johnson discloses the implantable conduit of claim 1, wherein the implantable conduit ([0012]; FIG 1A) is configured to close the aperture in the overlapping portion upon removal of the external force ([0057]; “when the fluid pressure at the exterior of the stent graft 10 is higher than the fluid pressure within the interior of the stent graft 10”, implies this effect is absent when this pressure is absent) separating the overlap elements at the overlapping portion to seal the path (60) between the inner lumen ([0012]) and outer surface ([0012]) of the implantable conduit.
Regarding claim 8, Johnson discloses the implantable conduit of claim 1, further comprising a secondary device structure received through the aperture ([0095]; “For example, catheters can be routed through the flow channels”).
Regarding claim 10, Johnson discloses the implantable conduit of claim 1, further comprising a plurality of stent elements (20, 22, 24, 26) coupled to the plurality of overlap elements (stent elements 20, 22, 24, 26 are coupled to tubular membranes 30, 32, 34, 36 of overlap elements 40, 42, 44, 46).
Regarding claim 11, Johnson discloses the implantable conduit of claim 1, wherein the plurality of overlap elements include discrete, adjacent circumferential rings of material (30, 32, 34, 36) that are overlapped in an edgewise manner (Fig. 1A; note that the prior art does not need to disclose the limitation “wherein the plurality of overlap elements are defined by a continuous, helical length of material overlapped edgewise onto itself” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (20150196383).
Regarding claim 6, Johnson discloses the implantable conduit of claim 1, but does not disclose wherein the attachment features (50) include adhesive material. In an alternative embodiment, Johnson teaches attachment features (550) that include adhesive material ([0111], an FEP layer with adhesive properties when exposed to heat). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson’s Fig. 1A attachment features to include adhesive material, as taught by Johnson’s alternate embodiment, in order to allow for secure connection of the attachment features ([0111]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson as applied to claim 1 above, and further in view of Wijay (6340366).
Regarding claim 7, Johnson discloses the implantable conduit of claim 1, but fails to disclose wherein the attachment features (50) are positioned at circumferentially staggered positions from one another about a circumference of the implantable conduit.
Wijay also discloses an implantable conduit (S) and teaches that attachment features (74) are positioned at circumferentially staggered positions from one another about a circumference of the implantable conduit (FIG 10). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson to include attachment features that are positioned at circumferentially staggered positions from one another about a circumference of the implantable, as taught by Wijay, in order to provide an equivalent means for connecting adjacent components as needed ([0037]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (20150196383) as applied to claim 1 above, and further in view of Daugherty (EP3067014B1).
Regarding claim 9, Johnson discloses the implantable conduit of claim 1, but fails to disclose wherein the implantable conduit defines a varying diameter. Daugherty also discloses an implantable conduit (700) and teaches the implantable conduit defines a varying diameter (FIG 7). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson’s implantable conduit to define a varying diameter, as taught by Daugherty, in order to control the mechanical properties of the stent ([0047]).
Claim(s) 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (20150196383) in view of Greenberg (20130172984).
Regarding claim 12, Johnson discloses the implantable conduit of claim 1, but fails to disclose that the plurality of overlap elements (40, 42, 44, 46) are defined by a tubular body having a pleated configuration to define a plurality of pleats, the plurality of attachment features coupling the overlap elements in the pleated configuration.
Greenberg also discloses an implantable conduit (114) with overlap elements (138, 140) and teaches that the plurality of overlap elements (138, 140) are defined by a tubular body having a pleated configuration to define a pleat (144, 146, 148) and a plurality of attachment features (sutures 162) coupling the overlap elements in the pleated configuration (Fig. 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson to include that the plurality of overlap elements are defined by a tubular body having a pleated configuration to define a plurality of pleats, the plurality of attachment features coupling the overlap elements in the pleated configuration, as taught by Greenberg, in order to prevent leaks between the overlap elements ([0007]).
Regarding claim 13, Johnson as modified by Greenberg discloses the implantable conduit of claim 12, and further wherein the pleats are circumferentially oriented (see Greenberg’s FIG 5), and optionally, wherein the aperture is formed in one of the pleats (see Greenberg’s FIG 6).
Regarding claim 14, Johnson discloses an implantable conduit (FIG 2A or FIG 5) comprising: a tube of flexible material having a length, a first end, and a second end (FIG 2A or FIG 5), the tube formed with multiple overlap elements (252, 254 of 230 or 540, 542, 544, 546) along its length, a stiffening element (stent 220 or tape 550) reinforcing the overlap elements so as to resist the overlap elements from unfolding upon application of tension along the length of the tube (see FIG 2A or FIG 5), wherein the tube is configured to be fenestrated within a pleat to provide a side portal along the length of the tube to allow for the introduction of a side branch tube (430) through the portal (FIG 4, [0095]). Johnson fails to disclose that the overlap elements form multiple pleats along the length of the tube, wherein the fenestrated pleat is configured to overlap and resist leakage around the side branch tube.
Greenberg also discloses an implantable conduit comprising a tube of flexible material ([0035]) having a length, a first end, and a second end (FIG 5), and teaches the tube formed with overlapping sections (138, 140), wherein the overlapping sections form a pleat (144, 146, 148) configured to be fenestrated (see Fig. 6), wherein the fenestrated pleat is configured to overlap and resist leakage around the side branch tube ([0007]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson’s multiple overlap elements to be formed as overlapping sections forming pleats, wherein the fenestrated pleat is configured to overlap and resist leakage around the side branch tube, as taught by Greenberg, in order to prevent leaks between the overlap elements ([0007]).
Regarding claim 15, Johnson as modified by Greenberg discloses the implantable conduit of claim 14, but fails to disclose wherein the tube includes a radiopaque marker to indicate a point of fenestration. Greenberg further teaches wherein the tube includes a radiopaque marker to indicate a point of fenestration ([0038]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson to include a radiopaque marker to indicate a point of fenestration, as taught by Greenberg, in order to provide a visual marker for the operator ([0037]).
Regarding claim 16, Johnson as modified by Greenberg discloses the implantable conduit of claim 14, and further discloses wherein the stiffening element comprises a stent element (stent 220).
Regarding claim 17, Johnson as modified by Greenberg discloses the implantable conduit of claim 14, wherein the stiffening element (550) comprises a tape (see [0110]).
Regarding claim 18, Johnson discloses an implantable conduit (FIG 5) comprising: a tube of flexible material having a length, a first end, and a second end (FIG 5), the tube formed with overlap elements (540, 542, 544, 546) along its length, a longitudinal element (550) attached along the length to resist the overlap elements from unfolding upon application of tension along the length of the tube ([see Fig. 5 and [0110]), wherein the tube is configured to be fenestrated within a pleat to provide a side portal along the length of the tube to allow for the introduction of a side branch tube (430) through the portal (FIG 4, [0095]). Johnson fails to disclose that the overlap elements form multiple pleats, wherein the fenestrated pleat is configured to overlap and resist leakage around the side branch tube.
Greenberg also discloses an implantable conduit comprising a tube of flexible material ([0035]) having a length, a first end, and a second end (FIG 5), and teaches the tube formed with overlapping sections (138, 140), wherein the overlapping sections form a pleat (144, 146, 148) configured to be fenestrated (see FIG 6), and wherein the fenestrated pleat is configured to overlap and resist leakage around the side branch tube ([0007]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson’s multiple overlap elements to be formed as overlapping sections forming pleats, wherein the fenestrated pleat is configured to overlap and resist leakage around the side branch tube, as taught by Greenberg, in order to prevent leaks between the overlap elements ([0007]).
Regarding claim 19, Johnson as modified by Greenberg discloses the implantable conduit of claim 18, wherein the longitudinal element (550) comprises at least one spine (see FIG 5).
Regarding claim 20, Johnson as modified by Greenberg discloses the implantable conduit of claim 14, wherein the longitudinal element (550) comprises a tape (see [0110]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774