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 .
Response to Arguments
The amendments/ arguments, dated 6/11/2026, have overcome:
The objection(s) to claim(s) 1, 4, 18, 20;
The rejection(s) of claim(s) 4, 6-7, 18-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
The aforementioned objections/ rejections have been withdrawn.
Applicant's arguments, with respect to the rejection of claim(s) 1-2, 4-12, 18-20 under 35 U.S.C. 103 based on Hall et al. (US 2016/0250048 A1 – as previously cited) in view of Cully et al. (US 2007/0250153 A1 – as previously cited) (as evidenced by Akhtar et al. (US 2005/0187607 A1 – as previously cited) for claim 12), filed 6/11/2026, have been fully considered but they are not persuasive. Applicant argues: Cully et al. fails to disclose or suggest a multilayers vascular prosthesis including a first PTFE fiber layer, and elastomeric cell-impermeable intermediate layer, and an ePTFE outer layer, as well as failing to disclose or suggest maintaining impermeability to cellular ingrowth when the vascular prosthesis is in the expanded state. Additionally, while Cully et al. does disclose the cover may be non-permeable nothing in Cully et al. describes is the non-permeability of the cover is maintained when the cover is stretched beyond the nominal state. In reading Applicant’s arguments/ remarks it appears Applicant may have misunderstood how Examiner was combining Hall et al. and Cully et al. – specifically, what portion of Cully et al. is being used to modify Hall et al.. It appears Applicant thinks Examiner is replacing the entire graft (layers 110, 140, 150), as disclosed by Hall et al., with the graft layer (cover 62), as taught by Cully et al.. Instead, Examiner is merely replacing the MODE OF ATTACHING the graft (layers 110, 140, 150), as disclosed by Hall et al., with the mode of attaching the graft layer (cover 62), as taught by Cully et al.. In making the aforementioned combination the graft layer (cover 62), as taught by Cully et al., is attached to the scaffolding (stent component 63) while the scaffolding (stent component 63) is in a nominal state/ partially expanded state (at which the cover 62 is applied to the stent component 63) which is smaller (90% is less) than an expanded diameter (fully deployed) resulting in at least two distinct advantages, as taught by Cully et al.. Specifically, (1) it prevents the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al., from having pleats in both the nominal state and the expanded state (thereby eliminating the risk created by pleats of disrupting blood flow and becoming sites for clot deposition) (Cully et al. paragraph [0046]); and (2) it reduces the perforation risks for the graft layer of the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al., during crushing (Cully et al. paragraph [0062]). In the aforementioned method, as taught by Cully et al., to connect the scaffolding (scaffolding structure 130) and the entire graft (layers 110, 140, 150), as disclosed by Hall et al., Examiner is NOT replacing the entire graft (layers 110, 140, 150), as disclosed by Hall et al., with the graft layer (cover 62), as taught by Cully et al.. Instead, the graft (layers 110, 140, 150), as disclosed by Hall et al., is/are attached to the scaffolding (scaffolding structure 130), as disclosed by Hall et al., while the scaffolding (scaffolding structure 130) is in a nominal state (a partially expanded state that is between 50-90% the diameter of the fully expanded diameter) (Cully et al. paragraphs [0057-0058]), as taught by Cully et al.. This combination will result in new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al., having a nominal state with a nominal diameter (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and an expanded state with an expanded diameter (after the vascular prosthesis (medical applicant 100) is fully expanded); wherein the second layer (fourth layer 140), as disclosed by Hall et al., is non-stretched in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) (due to the fact there is no radial stretching as the graft, including the second layer (fourth layer 140), is radially constrained within a constraining tube when the vascular prosthesis (medical applicant 100) is in the nominal state); wherein the expanded diameter (after the vascular prosthesis (medical applicant 100) is fully expanded) is larger than the nominal diameter (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)); wherein the vascular prosthesis (medical applicant 100) is free of pleats (wrinkle free) when the vascular prosthesis (medical applicant 100) is in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and the expanded state (after the vascular prosthesis (medical applicant 100) is fully expanded) (Cully et al. paragraphs [0046, 0062]); wherein the second layer (fourth layer 140), as disclosed by Hall et al., is cell impermeable when the vascular prosthesis (medical applicant 100) is in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and in the expanded state (after the vascular prosthesis (medical applicant 100) is fully expanded) (Hall et al. paragraph [0060]) (the second layer (fourth layer 140) is impermeable in the fully expanded state and inherently would be less permeable/ also be impermeable in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130))/ prior to expansion).
Please note: Applicant presented no additional arguments/ remarks concerning the rejection of claim(s) 3 under 35 U.S.C. 103 based on Hall et al. (US 2016/0250048 A1 – as previously cited) as modified by Cully et al. (US 2007/0250153 A1 – as previously cited) as applied to claim(s) 1-2, 4, 6-11, 18-20 above, and further in view of Ballard et al. (US 2013/0238086 A1 – as previously cited) (other than those already refuted above). As such, the aforementioned rejection has been maintained.
Claim Objections
Claim(s) 6, 18 is/are objected to because of the following informalities:
Within claim 6, lines 5-6: “wherein the second layer is configured to circumferentially stretch when the vascular prosthesis is expanded.” Is a newly added claim clause (without the proper annotations of such), after a period, that appears to be made in error as it is duplicative of the exact same clause within claim 6, lines 1-3. For the purposes of examination, Examiner is assuming this claim clause was added in error and should just be deleted from the claim.
Within claim 18, line 12: “diameter; and” should be replaced with --diameter;-- (for grammatical purposes).
Within claim 18, line 14: “expanded state” should be replaced with --expanded state; and-- (for grammatical purposes).
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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, 4-12, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US 2016/0250048 A1 – as previously cited) in view of Cully et al. (US 2007/0250153 A1 – as previously cited) (as evidenced by Akhtar et al. (US 2005/0187607 A1 – as previously cited) for claim 12).
With respect to claim 1:
Hall et al. discloses the invention substantially as claimed. Specifically, Hall et al. discloses a multilayered vascular prosthesis (medical applicant 100), as can be seen in figs. 3A-3C, comprising:
a first layer (first layer 110) comprising serially deposited polytetrafluoroethylene (PTFE) fibers (rotational spun PTFE) providing a luminal surface (luminal surface) of a vascular prosthesis (medical applicant 100) (paragraph [0049]);
a second layer (fourth layer 140) comprising an elastomeric material (FEP is considered an elastomeric material as they have “sufficient elasticity” to allow for expansion (Applicant’s specifications [0064])) (paragraphs [0059-0061]);
a third layer (fifth layer 150) comprising expanded polytetrafluoroethylene (ePTFE) (ePTFE) providing an abluminal surface (abluminal surface) of the vascular prosthesis (medical applicant 100) (paragraphs [0059, 0062]), wherein the second layer (fourth layer 140) is disposed between the first layer (first layer 110) and the third layer (fifth layer 150) (paragraph [0059]);
a scaffolding (scaffolding structure 130) disposed between the first layer (first layer 110) and the second layer (fourth layer 140) (paragraph [0059]); and
Wherein the second layer (fourth layer 140) is cell impermeable when the vascular prosthesis (medical applicant 100) is in the expanded state (with an expanded diameter) (paragraph [0061]).
However, Hall et al. is silent regarding: the vascular prosthesis (medical applicant 100) having a nominal state (with a nominal diameter) in addition to an expanded state (with an expanded diameter); wherein the second layer is non-stretched in the nominal state; wherein the expanded diameter is larger than the nominal diameter; wherein the vascular prosthesis (medical applicant 100) is free of pleats when the vascular prosthesis (medical applicant 100) is in the nominal state and the expanded state; wherein the second layer (fourth layer 140) is cell impermeable inn the nominal state (as required by claim 1).
Cully et al. teaches a vascular prosthesis (implantable device 60), as can be seen in figs. 1a-2c, comprising: a graft layer (cover 62) and a self-expanding scaffolding (stent component 63) (paragraph [0046]). The vascular prosthesis (implantable device 60) is manufactured by attaching the graft layer (cover 62) to the self-expanding scaffolding (stent component 63) while the self-expanding scaffolding (stent component 63) is in a nominal diameter (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) which is smaller (90% is less) than an expanded diameter (fully deployed, as can be seen in fig. 2c) (paragraphs [abstract, 0049, 0055-0059, 0062]). This method of attaching/ manufacturing the vascular prosthesis (implantable device 60) both prevents the vascular prosthesis (implantable device 60) from having pleats in both the nominal state (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) and the expanded state (fully deployed, as can be seen in fig. 2c) (pleats can disrupt blood flow and become sites for clot deposition) (paragraphs [0046]) and reduces the perforation risks for the graft layer (cover 62) during crushing (paragraph [0062]). When the vascular prosthesis (implantable device 60) in in the in the nominal state (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) the graft layer (cover 62) will be non-stretched (as there is no radial stretching as the graft is radially constrained within a constraining tube) (paragraph [0058]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to attach the first layer (first layer 110), second layer (fourth layer 140), and third layer (fifth layer 150) to the scaffolding (scaffolding structure 130), as disclosed by Hall et al., using the method with the attachment/ connection therebetween in a nominal diameter (i.e. while the scaffolding (scaffolding structure 130) is in a nominal state (partially expanded/ diameter smaller (90% or less) than the fully expanded state)), as taught by Cully et al., thereby preventing the newly formed vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al., from having pleats in both the nominal state (partially expanded/ diameter smaller than the fully expanded state) and the fully expanded state and requiring less crushing (and thereby reducing the risks of perforations) during the collapse of the vascular prosthesis (medical applicant 100) for delivery, as taught by Cully et al.. This combination will result in new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al., having a nominal state with a nominal diameter (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and an expanded state with an expanded diameter (after the vascular prosthesis (medical applicant 100) is fully expanded); wherein the second layer (fourth layer 140), as disclosed by Hall et al., is non-stretched in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) (due to the fact there is no radial stretching as the graft, including the second layer (fourth layer 140), is radially constrained within a constraining tube when the vascular prosthesis (medical applicant 100) is in the nominal state); wherein the expanded diameter (after the vascular prosthesis (medical applicant 100) is fully expanded) is larger than the nominal diameter (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)); wherein the vascular prosthesis (medical applicant 100) is free of pleats (wrinkle free) when the vascular prosthesis (medical applicant 100) is in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and the expanded state (after the vascular prosthesis (medical applicant 100) is fully expanded) (Cully et al. paragraphs [0046, 0062]); wherein the second layer (fourth layer 140), as disclosed by Hall et al., is cell impermeable when the vascular prosthesis (medical applicant 100) is in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and in the expanded state (after the vascular prosthesis (medical applicant 100) is fully expanded) (Hall et al. paragraph [0060]) (the second layer (fourth layer 140) is impermeable in the fully expanded state and inherently would be less permeable/ also be impermeable in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130))/ prior to expansion).
With respect to claim 2:
Wherein the second layer (fourth layer 140) is cell impermeable (impermeable regardless of state) (Hall et al. paragraph [0060]) when the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is stretched up to 100% of the nominal state (partially expanded/ diameter smaller than the fully expanded state) (as the fourth layers 140 is disclosed to be impermeable which would be regardless of state) (Hall et al. paragraphs [0060-0061]).
With respect to claim 4:
Wherein the axis of expansion (axis of expansion) of one or more sublayers (any single layer) of the third layer (fifth layer 150) of ePTFE (ePTFE), as disclosed by Hall et al., is disposed at an angle of between 0° and 25° to a longitudinal axis (aligned with a central axis of the prosthesis) of the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above) (Hall et al. paragraph [0073]).
With respect to claim 5:
Hall et al. discloses the invention substantially as claimed, as discussed above. However, Hall et al. is silent with respect to the dimensions of the vascular prosthesis (medical applicant 100) (specifically, the nominal diameter ranging from 2-55 mm and the expanded diameter ranging from 4-55 mm (as required by claim 5)).
Cully et al. additionally teaches the vascular prosthesis (implantable device 60) to have an expanded diameter (fully deployed, as can be seen in fig. 2c) of 8 mm (paragraph [0089]) and a nominal diameter (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) of 4 mm (paragraphs [0081, 0084]).
It would further have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), to have the same/ similar dimensions (both during the manufacturing and for the final product), as taught by Cully et al., as both structures are used for the same/ similar purposes (as grafts within a patients vascular) (thus resulting in the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), having a nominal diameter (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) of 4 mm and an expanded diameter (fully deployed, as can be seen in fig. 2c) of 8 mm).
With respect to claim 6:
Wherein the second layer (fourth layer 140) is configured to circumferentially stretch when new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is expanded from the nominal state (partially expanded/ diameter smaller than (90% or less) the fully expanded state) to the expanded state (fully expanded state), and wherein the circumferential stretch ranges from 0% to 200%, as taught by Cully et al. (Cully et al. paragraph [0049] – the nominal state (partially expanded/ diameter smaller than the fully expanded state) is 90% or less the size of the expanded state (fully expanded state); as such, when new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), as a whole expands from the nominal state (partially expanded/ diameter smaller than the fully expanded state) to the expanded state (fully expanded state) circumferential stretch will be at least 100% but less than 200% (for cases when the nominal state (partially expanded/ diameter smaller than the fully expanded state) is 50% the expanded state (fully expanded state)).
With respect to claim 7:
Wherein each of the first layer (first layer 110) and the third layer (fifth layer 150) circumferentially stretch when new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is expanded from the nominal state (partially expanded/ diameter smaller than (90% or less) the fully expanded state) to the expanded state (fully expanded state), and wherein the circumferential stretch ranges from 0% to 200%, as taught by Cully et al. (Cully et al. paragraph [0049] – the nominal state (partially expanded/ diameter smaller than the fully expanded state) is 90% or less the size of the expanded state (fully expanded state); as such, when new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), as a whole expands from the nominal state (partially expanded/ diameter smaller than the fully expanded state) to the expanded state (fully expanded state) circumferential stretch will be at least 100% but less than 200% (for cases when the nominal state (partially expanded/ diameter smaller than the fully expanded state) is 50% the expanded state (fully expanded state)).
With respect to claim 8:
Wherein the scaffolding (scaffolding structure 130) of the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is configured to resist a radially inward oriented force applied by the second layer (fourth layer 140) to prevent the vascular prosthesis (medical applicant 100) from contracting from the expanded state (fully expanded state) to the nominal state (partially expanded/ diameter smaller than the fully expanded state) (Cully et al. paragraph [0062] – the stent component stretched the graft component, as such the stent must resist the radial inward force of the graft component due to the graft component stretching).
With respect to claim 9:
Wherein the scaffolding (scaffolding structure 130) of the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is configured to apply a radially outward oriented force (stretching) to circumferentially stretch the second layer (fourth layer 140) 100% (to the fully expanded state which is considered 100%) (Cully et al. paragraph [0062] – the stent component stretched the graft component, as such the stent must resist the radial inward force of the graft component due to the graft component stretching).
With respect to claim 10:
Wherein the serially deposited PTFE fibers (PTFE fibers of the first layer 110), as disclosed by Hall et al., are rotational spun (rotationally spun) (Hall et al. paragraph [0049]).
With respect to claim 11:
Wherein the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is a self-expanding stent graft (the scaffold structure 130 which is responsible for the expansion of the vascular prosthesis (medical applicant 100) is made from nitinol, a self-expanding material) (Hall et al. paragraph [0059]).
With respect to claim 12:
Wherein the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is a balloon expandable stent graft (the scaffold structure 130 which is responsible for the expansion of the vascular prosthesis (medical applicant 100) is made from stainless steel, a balloon material) (Hall et al. paragraph [0059]) (stainless steel is a balloon expandable material as evidenced by Akhtar et al. paragraph [0025]).
With respect to claim 18:
Hall et al. discloses the invention substantially as claimed. Specifically, Hall et al. discloses a multilayered vascular prosthesis (medical applicant 100), as can be seen in figs. 3A-3C, comprising:
a first layer (first layer 110) comprising polytetrafluoroethylene (PTFE) providing a luminal surface (luminal surface) of a vascular prosthesis (medical applicant 100) (paragraph [0049]);
a second layer (fourth layer 140) comprising an elastomeric material (FEP is considered an elastomeric material as they have “sufficient elasticity” to allow for expansion (Applicant’s specifications [0064])) (paragraphs [0059-0061]);
a third layer (fifth layer 150) comprising expanded polytetrafluoroethylene (ePTFE) (ePTFE) providing an abluminal surface (abluminal surface) of the vascular prosthesis (medical applicant 100) (paragraphs [0059, 0062]), wherein the second layer (fourth layer 140) is disposed between the first layer (first layer 110) and the third layer (fifth layer 150) (paragraph [0059]);
a scaffolding (scaffolding structure 130) disposed between the first layer (first layer 110) and the second layer (fourth layer 140) (paragraph [0059]); and
Wherein the second layer (fourth layer 140) is cell impermeable when the vascular prosthesis (medical applicant 100) is in the expanded state (with an expanded diameter) (paragraph [0061]).
However, Hall et al. is silent regarding: the vascular prosthesis (medical applicant 100) having a nominal state (with a nominal diameter) and an expanded state (with an expanded diameter); wherein the second layer is non-stretched in the nominal state; wherein the expanded diameter is larger than the nominal diameter; wherein the vascular prosthesis (medical applicant 100) is free of pleats when the vascular prosthesis (medical applicant 100) is in the nominal state and the expanded state; and wherein the second layer (fourth layer 140) is cell impermeable inn the nominal state (as required by claim 18).
Cully et al. teaches a vascular prosthesis (implantable device 60), as can be seen in figs. 1a-2c, comprising: a graft layer (cover 62) and a self-expanding scaffolding (stent component 63) (paragraph [0046]). The vascular prosthesis (implantable device 60) is manufactured by attaching the graft layer (cover 62) to the self-expanding scaffolding (stent component 63) while the self-expanding scaffolding (stent component 63) is in a nominal diameter (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) which is smaller than an expanded diameter (fully deployed, as can be seen in fig. 2c) (paragraphs [abstract, 0055-0059, 0062]). This method of attaching/ manufacturing the vascular prosthesis (implantable device 60) both prevents the vascular prosthesis (implantable device 60) from having pleats in both the nominal state (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) and the expanded state (fully deployed, as can be seen in fig. 2c) (pleats can disrupt blood flow and become sites for clot deposition) (paragraphs [0046]) and reduces the perforation risks for the graft layer (cover 62) during crushing (paragraph [0062]). When the vascular prosthesis (implantable device 60) in in the in the nominal state (at which the cover 62 is applied to the stent component 63, as can be seen in fig. 2b) the graft layer (cover 62) will be non-stretched (as there is no radial stretching as the graft is radially constrained within a constraining tube) (paragraph [0058]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to attach the first layer (first layer 110), second layer (fourth layer 140), and third layer (fifth layer 150) to the scaffolding (scaffolding structure 130), as disclosed by Hall et al., using the method with the attachment/ connection therebetween in a nominal diameter (i.e. while the scaffolding (scaffolding structure 130) is in a nominal state (partially expanded/ diameter smaller (90% or less) than the fully expanded state)), as taught by Cully et al., thereby preventing the newly formed vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al., from having pleats in both the nominal state (partially expanded/ diameter smaller than the fully expanded state) and the fully expanded state and requiring less crushing (and thereby reducing the risks of perforations) during the collapse of the vascular prosthesis (medical applicant 100) for delivery, as taught by Cully et al.. This combination will result in new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al., having a nominal state with a nominal diameter (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and an expanded state with an expanded diameter (after the vascular prosthesis (medical applicant 100) is fully expanded); wherein the second layer (fourth layer 140), as disclosed by Hall et al., is non-stretched in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) (due to the fact there is no radial stretching as the graft, including the second layer (fourth layer 140), is radially constrained within a constraining tube when the vascular prosthesis (medical applicant 100) is in the nominal state); wherein the expanded diameter (after the vascular prosthesis (medical applicant 100) is fully expanded) is larger than the nominal diameter (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)); wherein the vascular prosthesis (medical applicant 100) is free of pleats (wrinkle free) when the vascular prosthesis (medical applicant 100) is in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and the expanded state (after the vascular prosthesis (medical applicant 100) is fully expanded) (Cully et al. paragraphs [0046, 0062]); wherein the second layer (fourth layer 140), as disclosed by Hall et al., is cell impermeable when the vascular prosthesis (medical applicant 100) is in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130)) and in the expanded state (after the vascular prosthesis (medical applicant 100) is fully expanded) (Hall et al. paragraph [0060]) (the second layer (fourth layer 140) is impermeable in the fully expanded state and inherently would be less permeable/ also be impermeable in the nominal state (the diameter smaller that the fully expanded diameter where the graft (layers 110, 140, 150), as disclosed by Hall et al., are attached to the scaffolding (scaffolding structure 130))/ prior to expansion).
With respect to claim 19:
Wherein the second layer (fourth layer 140) is cell impermeable (impermeable regardless of state) (Hall et al. paragraph [0060]) when the new vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), is stretched up to 100% of the nominal state (partially expanded/ diameter smaller than the fully expanded state) (as the fourth layers 140 is disclosed to be impermeable which would be regardless of state) (Hall et al. paragraphs [0060-0061]).
With respect to claim 20:
Wherein an axis of expansion (axis of expansion) of one or more sublayers (any single layer) of the third layer (fifth layer 150) of ePTFE (ePTFE), as disclosed by Hall et al., is disposed at an angle of between 0° and 25° to a longitudinal axis (aligned with a central axis of the prosthesis) of the vascular prosthesis (medical applicant 100) (Hall et al. paragraph [0073]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US 2016/0250048 A1 – as previously cited) as modified by Cully et al. (US 2007/0250153 A1 – as previously cited) as applied to claim(s) 1-2, 4, 6-11, 18-20 above, and further in view of Ballard et al. (US 2013/0238086 A1 – as previously cited).
With respect to claim 3:
Hall et al. as modified by Cully et al. discloses the invention substantially as claimed, as discussed above. However, Hall et al. as modified by Cully et al. does not disclose the elastomeric material (FEP) of the second layer (fourth layer 140) to comprise silicone or polyurethane.
Ballard et al. teaches a multilayered vascular prosthesis, as can be seen in figs. 2A-2B, comprising:
a luminal first layer (inner layer 220) (paragraph [0045]);
an impermeable second layer (tie layer) (paragraph [0046]);
an abluminal third layer (outer layer 210) (paragraph [045]); and
a scaffolding (wire 110). The impermeable second layer (tie layer) maybe made from FEP, silicone, polyurethane (paragraphs [0047]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the FEP of the second layer (fourth layer 140) of the vascular prosthesis, as disclosed by Hall et al. as modified by Cully et al. (as discussed above), with either silicone or polyurethane, as taught by Ballard et al., as Ballard et al. teaches the materials to be interchangeable in creating an impermeable bonding layer between two other graft layers.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
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