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 6-13 and 32-35 are pending and examined below
Response to Arguments
The remarks of 02/03/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record doesn't explicitly teach or disclose all of the elements of claim 32, in particular the following claim elements:
“wherein the textile tubular wall having the coating of the elastomeric sealant, 2 at 120 mm Hg pressure or less than 0.16 ml/min/cm2 at 120 mm Hg pressure”
This argument is moot in light of the new 103 rejection below.
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) 32, 6-8, 11-13, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0043428 A1 (Jennings) in view of non-patent literature titled “Coating of Dacron vascular grafts with an ionic polyurethane: a novel sealant with protein binding properties (Phaneuf) in view of US 2003/0149471 (Briana)
Regarding claim 32, Jennings discloses an implantable textile graft (Fig. 1, “vascular stent”, ¶0046) comprising:
a textile tubular wall (Fig. 1 shows a tubular shape, ¶0046 wherein fibers 20,22 correspond to the textile limitation) having a portion disposed between a first open end and an opposed second open end and having an inner surface and an opposed outer surface, the textile tubular wall comprising a textile construction of one or more yarns (Fig. 1, ¶0046, wherein fibers 20,22 correspond to a textile construction of one or more yarns)
wherein the outer surface (Fig. 1, outermost layer 16) comprises a coating (coating 14, Fig.1, ¶0048) of an elastomeric sealant selected from the group consisting of a silicone-containing polymer, a polyurethane-containing polymer, a polycarbonate-containing polymer and combinations thereof, disposed thereon (¶0048, wherein the polyurethane-polyethylene glycol matrix corresponds to a polyurethane containing polymer”);
wherein the textile tubular wall having the coating of the silicone-polyurethane elastomeric sealant is substantially impermeable to water at 120 mm Hg pressure (¶0049, wherein impermeable to all cells corresponds to impermeable to water at 120m HF pressure); and wherein the inner surface is substantially free of the elastomeric sealant (Fig. 1, wherein no sealant is disclosed on the inner surface)
Jennings doesn't explicitly teach or disclose multifilament yarns.
Phaneuf discloses a textile tubular wall comprising a textile construction of one or more multifilament yarns (Page 464, wherein “Dacron” corresponds to one or more multifilament yarns);
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to form the textile tubular wall of Jennings in with one or more multifilament yarns, as taught by Phaneuf, in order to better protect the vascular graft from fraying.
Jennings doesn't explicitly teach or disclose a water permeability of about 0.16ml/min/cm2 at 120 mm HG pressure or less than 0.16 ml/min/cm2 mm HG pressure and wherein the inner surface is substantially free of the elastomeric sealant. Phaneuf doesn't explicitly teach or disclose doesn't explicitly teach or disclose a water permeability of about 0.16ml/min/cm2 at 120 mm Hg pressure or less than 0.16 ml/min/cm2 mm Hg pressure and wherein the inner surface is substantially free of the elastomeric sealant.
Briana discloses wherein the textile tubular wall (¶0009, wherein “vascular prosthesis made of fabric” corresponds to textile tubular wall) having the coating of the elastomeric sealant (¶0009, wherein “Thoralon polymer” corresponds to an elastomeric sealant”, has a water permeability of about 0.16ml/min/cm2 at 120 mm HG pressure or less than 0.16 ml/min/cm2 mm HG pressure (¶0101, wherein 0.24 ml/min/cm2 corresponds to about 0.16ml/min/cm2); and wherein the inner surface is substantially free of the elastomeric sealant (¶0009, wherein “the inner or blood interface surface of the fabric substrates are left uncoated” corresponds to substantially free of the elastomeric sealant)
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 implantable textile graft of Jennings in view Phaneuf with an elastomeric sealant that yields a water permeability of about 0.16ml/min/cm2 and does not coat the inner surface of the graft, as taught by Briana, in order to maintain blood compatibility (¶0009).
Regarding claim 6, Jennings discloses a supporting member (12, Fig. 12) secured to or about the textile tubular wall (18, Fig. 1).
Regarding claims 7, Jennings discloses a tubular textile wall (“vascular stent”, ¶0046, Figure 1) but does not explicitly teach or discloses that the tubular textile wall comprising crimps. Phaneuf does not explicitly teach or discloses that the tubular textile wall is crimped.
Briana discloses a tubular textile wall comprising crimps (Fig. 13, 12, ¶0031, “crimped polyester woven vascular graft”)
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 tubular textile wall of Jennings in view of Phaneuf to comprise crimps, as taught by Briana, in order to avoid undue kinking (¶0003)
Regarding claims 8, Jennings discloses a tubular textile wall (“vascular stent”, ¶0046, Figure 1) but does not explicitly teach or discloses that the tubular textile wall comprises crimps. Phaneuf does not explicitly teach or discloses that the tubular textile wall comprises crimps.
Briana discloses a tubular textile wall comprising crimps (Fig. 13, 12, ¶0031, “crimped polyester woven vascular graft”)
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 tubular textile wall of Jennings in view of Phaneuf to comprise crimps, as taught by Briana, in order to avoid undue kinking (¶0003)
Regarding claim 11, Jennings discloses an elastomeric sealant (“second polymeric layer, ¶0040) which further includes one or more additional components selected from the group consisting of additional elastomeric sealant materials, solvents, a colorant, a therapeutic agent, a dye, and a fluorescent indicator. (“¶0040, wherein polyethylene glycol corresponds to a solvent)
Regarding claim 12, Jennings discloses wherein the additional elastomeric sealant material (¶0040, “second polymeric layer”) is selected from the group consisting of silicones, polyurethanes (¶0040, “polyurethanes”, polycarbonates, thermoplastic elastomers, and combinations thereof.
Regarding claim 13: Jennings discloses wherein the textile construction (Fig. 1, ¶0046, fibers 20 and 22) is selected from the group consisting of a weave of the one or more yarns (¶0050, wherein “woven fabrics” corresponds to a weave of one or more yarns), a knit of the one or more yarns, a braid of the one or more yarns, a web of the one or more yarns, a felt of the one or more yarns, and a mesh of the one or more yarns.
Regarding claim 33, Jennings doesn't explicitly teach or disclose wherein the inner surface is at least 70% free of the elastomeric sealant. Phaneuf doesn't explicitly teach or disclose wherein the inner surface is at least 70% free of the elastomeric sealant.
Briana discloses wherein the inner surface is at least 70% free of the elastomeric sealant (¶0009, wherein “the inner or blood interface surface of the fabric substrates are left uncoated” corresponds to 70% free of the elastomeric sealant)
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 implantable textile graft of Jennings in view of Phaneuf to have an inner surface that is at least 70% free of the elastomeric sealant, as taught by Briana, in order to maintain blood compatibility (¶0009).
Regarding claim 34, Jennings doesn't explicitly teach or disclose wherein the inner surface is at least 90% free of the elastomeric sealant. Phaneuf doesn't explicitly teach or disclose wherein the inner surface is at least 90% free of the elastomeric sealant.
Briana discloses wherein the inner surface is at least 90% free of the elastomeric sealant (¶0009, wherein “the inner or blood interface surface of the fabric substrates are left uncoated” corresponds to 90% free of the elastomeric sealant)
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 implantable textile graft of Jennings in view of Phaneuf to have an inner surface that is at least 90% free of the elastomeric sealant, as taught by Briana, in order to maintain blood compatibility (¶0009).
Regarding claim 35, Jennings doesn't explicitly teach or disclose wherein the inner surface is at least 90% free of the elastomeric sealant. Phaneuf doesn't explicitly teach or disclose wherein the inner surface is at least 95% free of the elastomeric sealant.
Briana discloses wherein the inner surface is at least 95% free of the elastomeric sealant (¶0009, wherein “the inner or blood interface surface of the fabric substrates are left uncoated” corresponds to 95% free of the elastomeric sealant)
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 implantable textile graft of Jennings in view of Phaneuf to have an inner surface that is at least 95% free of the elastomeric sealant, as taught by Briana, in order to maintain blood compatibility (¶0009).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0043428 A1 (Jennings) in view of non-patent literature titled “Coating of Dacron vascular grafts with an ionic polyurethane: a novel sealant with protein binding properties (Phaneuf) in view of US 2003/0149471 (Briana), as applied to claims above, and further in view of US 2016/0302911 (Soletti)
Regarding claim 9, Jennings discloses a textile tubular wall with elastomeric sealant (see rejection of claim 32 above) but doesn’t explicitly teach or disclose portions with a different level of elastomeric sealant. Phaneuf doesn’t explicitly teach or disclose portions with a different level of elastomeric sealant. Briana doesn’t explicitly teach or disclose portions with a different level of elastomeric sealant.
Soletti teaches wherein one portion of the tubular wall (second zone, annotated Fig. 1 below) has a first level of the substantially water- insoluble elastomeric sealant (Figure 1, 110 “fiber matrix”; ¶0009 and ¶0039) to provide a first zone (¶0102, lines 1-9); wherein another portion of the tubular wall has a second level of the substantially water- insoluble elastomeric sealant to provide a second zone having a stiffness greater than the first zone (¶0102, wherein one or more layers of fiber matrix 110 are thicker within end portions 106 and 107); and wherein the second level the substantially water-insoluble elastomeric is greater than the first level of the substantially water-insoluble sealant (¶0102, wherein one or more layers of fiber matrix 110 are thicker within end portions 106 and 107)
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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 tubular wall of Jennings in in view of Phaneuf in view of Briana to have thicker and thinner portions of sealant, as taught by Soletti, to provide properties (e.g. tear resistance and/or resistance to stretching” suitable for supporting anastomosis of ends with suture and/or an anastomotic clip (Soletti, ¶0102)
Regarding claim 10, Jennings discloses a textile tubular wall with elastomeric sealant (see rejection of claim 32 above) but doesn’t explicitly teach or disclose a plurality of portions having different levels of the elastomeric sealant. Phaneuf doesn’t explicitly teach or disclose a plurality of portions having different levels of the elastomeric sealant. Briana doesn’t explicitly teach or disclose a plurality of portions having different levels of the elastomeric sealant
Soletti discloses wherein the textile tubular wall has a plurality of portions (first and second zone, annotated Fig. 1 above) having different levels of the elastomeric sealant to provide a plurality of portions having different levels of stiffnesses (¶0102, wherein “fiber matrix 110 is simply thicker within end portions 106 and 107” is capable of this intended use)
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 tubular wall of Jennings in view of Phaneuf in view of Briana to have a plurality of zones with different levels of sealant, as taught by Soletti, to provide properties (e.g. tear resistance and/or resistance to stretching” suitable for supporting anastomosis of ends with suture and/or an anastomotic clip (Soletti, ¶0102)
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/ Primary Patent Examiner, Art Unit 3774