DETAILED ACTION
Claims 11-19 which were previously withdrawn are canceled. Claims 10 remains withdrawn. Claims 20-21 are newly added claims. Claims 7-9 are amended. A complete action on the merits of pending claims 1-9 and 20-21 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 03/28/2025. Applicant’s amendments to the specification and claims in light of the objections documented in the Non-Final Office Action mailed on 12/31/2024 overcome those abjections and are now withdrawn. However, the claim objection directed to claim 8 and one of the specification objections were not addressed appropriately in Applicant’s response filed on 03/28/2025 (See updated objections below).
Specification
The disclosure is objected to because of the following informalities:
The section, “Field of the Invention” should be placed prior to the “Background” section and after paragraph [0002] on page 1 of the specification. Further, under the section, “Field of the Invention,” the applicant stated, “Not Applicable” which is not accurate/true given that the section should include, “a statement of the field of endeavor to which the invention pertains.”
Appropriate correction is required.
Claim Objections
Claims 8 is objected to because of the following informalities:
Claim 8, should be amended to the following, “The vascular connector of claim 1, wherein the tubular sleeve graft comprises a plurality of side-branches extending therefrom .”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim(s) 1, 3, 4, 7, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holloway (US Patent No. 6752826 B2).
Regarding claim 1, Holloway discloses, a vascular connector (Figures 1-2, stent-graft (10); Col. 3, line 40-42), comprising:
a tubular sleeve graft (Figures 1-2) comprising a first layer (Figure 2, porous outer layer (12); Col. 3, line 40-42 and Col. 3, line 54-Col. 4, line 4) and a second layer (Figure 2, porous lumenal layer (16); Col. 3, line 40-42 and Col. 5, line 49-58); and
a cylindrical connector body (Figure 2, non-porous middle layer (14); Col. 3, line 40-49) positioned within the tubular sleeve graft (Figures 1-2) between the first layer (porous outer layer (12)) and the second layer (porous lumenal layer (16)) (Figure 2; Col. 3, line 42-49 and Col. 5, line 20-21), wherein the cylindrical connector body (non-porous middle layer (14)) is more rigid than the tubular sleeve graft (Col. 5, line 28-39, discloses, “The non-porous middle layer (14) can be made from any suitable non-porous material that can function to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, prevent prolapse of the vessel wall (with some help from the outer and lumenal layers (12) and (16)), and, if desired, block drug delivery from the porous outer layer (12) to the lumen (28) and/or from the porous lumenal layer (16) to the intima. Representative examples of materials for the non-porous middle layer (14) include, but are not limited to, any polymeric material including polyurethanes (e.g. Thoralon®), PTFE, alphitic polyoxaesters, polylactides, and polycaprolactones.” While Col. 3, line 54-Col. 4, line 4 and Col. 5, line 49-58 disclose, porous outer layer (12) and porous lumenal layer (16) of the tubular sleeve graft are made of any suitable porous biocompatible material. Thus, given that non-porous middle layer (14) is non-porous and it functions to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, and prevent prolapse of the vessel wall, it is indeed more rigid than the tubular sleeve graft comprised of the porous outer layer (12) and porous lumenal layer (16)), and
further wherein the cylindrical connector body (non-porous middle layer (14)) is configured to slide longitudinally within the tubular sleeve graft (Figures 1-2) between the first layer (porous outer layer (12)) and the second layer (porous lumenal layer (16)) (Col. 4, line 55-63, discloses, “The porous outer layer (12) also provides the stent-graft (10) with a lubricious surface to significantly decrease adhesion of the material of the porous outer layer (12) to itself while collapsed (e.g. when pinched and folded or radially compressed) and reduce the degree of friction between the stent-graft (10) and a delivery device. The decreased adhesion and reduced friction can be especially beneficial when the non-porous middle layer's material adheres easily to itself or to the inner surface of the delivery device.” Further, Col. 5, line 20-27, discloses, “The non-porous middle layer (14) can be attached to the porous outer layer (12) and the porous lumenal layer (16). FIG. 5 illustrates the non-porous middle layer (14) encapsulating the stent (18) to provide a seamless polymer layer in which the stent (18) is disposed. Accordingly, the non-porous middle layer (14) can be configured to have no gaps or pockets located around the circumferences of the struts (20), between the polymer layer and the surface of the struts (20).” As such, the lubricious surface reduces friction between the porous outer layer (12) and the non-porous middle layer (14), facilitating relative movement. Additionally, the seamless design of the non-porous middle layer allows for smooth interactions between the layers. Together, these features enable the non-porous middle layer (14) to slide longitudinally within the tubular sleeve graft between the porous outer layer (12) and porous lumenal layer (16)).
Regarding claim 3, Holloway further discloses, wherein the tubular sleeve graft comprises polyethylene terephthalate (Col. 3, line 54-Col. 4, line 4 and Col. 5, line 49-58 disclose the porous outer layer (12) and porous lumenal layer (16) of the tubular sleeve graft as being made from any suitable porous biocompatible material including polyethylene terephthalate (PET)).
Regarding claim 4, Holloway further discloses, wherein the tubular sleeve graft comprises polytetrafluoroethylene (Col. 3, line 54-Col. 4, line 4 and Col. 5, line 49-58 disclose the porous outer layer (12) and porous lumenal layer (16) of the tubular sleeve graft as being made from any suitable porous biocompatible material including expanded polytetrafluoroethylene (ePTFE), ePTFE is a well-known variant of PTFE that retains the fundamental properties of polytetrafluoroethylene, including its biocompatibility, chemical resistance, and low friction characteristics. The term "polytetrafluoroethylene" encompasses both standard PTFE and its expanded form, as ePTFE is derived from PTFE through a specific manufacturing process that enhances its properties for medical applications).
Regarding claim 7, Holloway further discloses, further comprising an additional cylindrical connector body (Figures 1-2, stent (18); Col. 3, line 42-44 and Col. 6, line 16-20) positioned within the tubular sleeve graft (As shown in Figure 2 and disclosed in Col. 6, line 16-Col. 7, line 26, the stent (18) is indeed positioned within the outer and lumenal layers (12 and 16) of the tubular sleeve graft).
Regarding claim 20, Holloway discloses, a vascular connector (Figures 1-2, stent-graft (10); Col. 3, line 40-42), comprising:
a tubular sleeve graft (Figures 1-2) comprising a first layer (Figure 2, porous outer layer (12); Col. 3, line 40-42 and Col. 3, line 54-Col. 4, line 4) and a second layer (Figure 2, porous lumenal layer (16); Col. 3, line 40-42 and Col. 5, line 49-58); and
a rigid cylindrical connector body (Figure 2, non-porous middle layer (14); Col. 3, line 40-49) positioned within the tubular sleeve graft (Figures 1-2) between the first layer (porous outer layer (12)) and the second layer (porous lumenal layer (16)) (Figure 2; Col. 3, line 42-49 and Col. 5, line 20-21), wherein the rigid cylindrical connector body (non-porous middle layer (14)) is more rigid than the tubular sleeve graft (Col. 5, line 28-39, discloses, “The non-porous middle layer (14) can be made from any suitable non-porous material that can function to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, prevent prolapse of the vessel wall (with some help from the outer and lumenal layers (12) and (16)), and, if desired, block drug delivery from the porous outer layer (12) to the lumen (28) and/or from the porous lumenal layer (16) to the intima. Representative examples of materials for the non-porous middle layer (14) include, but are not limited to, any polymeric material including polyurethanes (e.g. Thoralon®), PTFE, alphitic polyoxaesters, polylactides, and polycaprolactones.” While Col. 3, line 54-Col. 4, line 4 and Col. 5, line 49-58 disclose, porous outer layer (12) and porous lumenal layer (16) of the tubular sleeve graft are made of any suitable porous biocompatible material. Thus, given that non-porous middle layer (14) is non-porous and it functions to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, and prevent prolapse of the vessel wall, it is indeed more rigid than the tubular sleeve graft comprised of the porous outer layer (12) and porous lumenal layer (16)), and further wherein the cylindrical connector body (non-porous middle layer (14)) is configured to slide longitudinally within the tubular sleeve graft (Figures 1-2) between the first layer (porous outer layer (12)) and the second layer (porous lumenal layer (16)) (Col. 4, line 55-63, discloses, “The porous outer layer (12) also provides the stent-graft (10) with a lubricious surface to significantly decrease adhesion of the material of the porous outer layer (12) to itself while collapsed (e.g. when pinched and folded or radially compressed) and reduce the degree of friction between the stent-graft (10) and a delivery device. The decreased adhesion and reduced friction can be especially beneficial when the non-porous middle layer's material adheres easily to itself or to the inner surface of the delivery device.” Further, Col. 5, line 20-27, discloses, “The non-porous middle layer (14) can be attached to the porous outer layer (12) and the porous lumenal layer (16). FIG. 5 illustrates the non-porous middle layer (14) encapsulating the stent (18) to provide a seamless polymer layer in which the stent (18) is disposed. Accordingly, the non-porous middle layer (14) can be configured to have no gaps or pockets located around the circumferences of the struts (20), between the polymer layer and the surface of the struts (20).” As such, the lubricious surface reduces friction between the porous outer layer (12) and the non-porous middle layer (14), facilitating relative movement. Additionally, the seamless design of the non-porous middle layer allows for smooth interactions between the layers. Together, these features enable the non-porous middle layer (14) to slide longitudinally within the tubular sleeve graft between the porous outer layer (12) and porous lumenal layer (16)).
Regarding claim 21, Holloway discloses, a vascular connector (Figures 1-2, stent-graft (10); Col. 3, line 40-42), comprising:
a tubular sleeve graft (Figures 1-2) comprising a first layer (Figure 2, porous outer layer (12); Col. 3, line 40-42 and Col. 3, line 54-Col. 4, line 4) and a second layer (Figure 2, porous lumenal layer (16); Col. 3, line 40-42 and Col. 5, line 49-58); and
a rigid cylinder (Figure 2, non-porous middle layer (14); Col. 3, line 40-49) positioned within the tubular sleeve graft (Figures 1-2) between the first layer (porous outer layer (12)) and the second layer (porous lumenal layer (16)) (Figure 2; Col. 3, line 42-49 and Col. 5, line 20-21), wherein the rigid cylinder (non-porous middle layer (14)) is more rigid than the tubular sleeve graft (Col. 5, line 28-39, discloses, “The non-porous middle layer (14) can be made from any suitable non-porous material that can function to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, prevent prolapse of the vessel wall (with some help from the outer and lumenal layers (12) and (16)), and, if desired, block drug delivery from the porous outer layer (12) to the lumen (28) and/or from the porous lumenal layer (16) to the intima. Representative examples of materials for the non-porous middle layer (14) include, but are not limited to, any polymeric material including polyurethanes (e.g. Thoralon®), PTFE, alphitic polyoxaesters, polylactides, and polycaprolactones.” While Col. 3, line 54-Col. 4, line 4 and Col. 5, line 49-58 disclose, porous outer layer (12) and porous lumenal layer (16) of the tubular sleeve graft are made of any suitable porous biocompatible material. Thus, given that non-porous middle layer (14) is non-porous and it functions to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, and prevent prolapse of the vessel wall, it is indeed more rigid than the tubular sleeve graft comprised of the porous outer layer (12) and porous lumenal layer (16)), and further wherein the rigid cylinder (non-porous middle layer (14)) is configured to slide longitudinally within the tubular sleeve graft (Figures 1-2) between the first layer (porous outer layer (12)) and the second layer (porous lumenal layer (16)) (Col. 4, line 55-63, discloses, “The porous outer layer (12) also provides the stent-graft (10) with a lubricious surface to significantly decrease adhesion of the material of the porous outer layer (12) to itself while collapsed (e.g. when pinched and folded or radially compressed) and reduce the degree of friction between the stent-graft (10) and a delivery device. The decreased adhesion and reduced friction can be especially beneficial when the non-porous middle layer's material adheres easily to itself or to the inner surface of the delivery device.” Further, Col. 5, line 20-27, discloses, “The non-porous middle layer (14) can be attached to the porous outer layer (12) and the porous lumenal layer (16). FIG. 5 illustrates the non-porous middle layer (14) encapsulating the stent (18) to provide a seamless polymer layer in which the stent (18) is disposed. Accordingly, the non-porous middle layer (14) can be configured to have no gaps or pockets located around the circumferences of the struts (20), between the polymer layer and the surface of the struts (20).” As such, the lubricious surface reduces friction between the porous outer layer (12) and the non-porous middle layer (14), facilitating relative movement. Additionally, the seamless design of the non-porous middle layer allows for smooth interactions between the layers. Together, these features enable the non-porous middle layer (14) to slide longitudinally within the tubular sleeve graft between the porous outer layer (12) and porous lumenal layer (16)).
Claim Rejections - 35 USC § 103
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holloway.
Regarding claim 2, Holloway discloses the claimed invention except for, “wherein the cylindrical connector body comprises polyoxymethylene.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the cylindrical connector body comprise polyoxymethylene, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Col. 5, line 28-39, discloses, “The non-porous middle layer (14) can be made from any suitable non-porous material that can function to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, prevent prolapse of the vessel wall (with some help from the outer and lumenal layers (12) and (16)), and, if desired, block drug delivery from the porous outer layer (12) to the lumen (28) and/or from the porous lumenal layer (16) to the intima. Representative examples of materials for the non-porous middle layer (14) include, but are not limited to, any polymeric material including polyurethanes (e.g. Thoralon®), PTFE, alphitic polyoxaesters, polylactides, and polycaprolactones.” As such, the disclosure stating that the non-porous middle layer can be made from "any suitable non-porous material," Polyoxymethylene, being a type of polymer known for its non-porous characteristics and suitability in medical applications, is considered a suitable candidate for the non-porous middle layer (14) to be comprised of. In re Leshin.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holloway, in view of Kaster (US Patent No. 4366819).
Regarding claim 5, Holloway teaches, the cylindrical connector body of the vascular connector of claim 1 (See above rejection of claim 1).
Holloway fails to teach, further comprising a band configured to compress vascular tissue between the cylindrical connector body and the band.
Kaster discloses an anastomotic fitting for connecting a vascular graft to the wall of the ascending aorta. Kaster teaches, a band (Figure 1, fixation ring (16); Col. 7, line 4-10) configured to compress vascular tissue between the cylindrical connector body (Figure 1, tube (12); Col. 7, line 4-10) and the band (Col. 12, line 39-43).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holloway such that it further comprises a band configured to compress vascular tissue as taught by Kaster between the cylindrical connector body taught by Holloway which in Col. 5, line 28-32, discloses, “The non-porous middle layer (14) can be made from any suitable non-porous material that can function to prevent protrusion of the stent (18) from the stent-graft (10), block intimal growth, prevent prolapse of the vessel wall (with some help from the outer and lumenal layers (12) and (16))…” which indicates that the non-porous middle layer is designed to maintain the position of the stent-graft and support the surrounding vascular tissue, which is an indication that it exerts pressure on the tissue to fulfill its function and the band taught by Kaster, as both references and the claimed invention are directed to surgical prosthesis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holloway such that it further comprises a band configured to compress vascular tissue as taught by Kaster between the cylindrical connector body taught by Holloway and the band taught by Kaster, as such a modification would have been predictable, namely, to gain the advantage of an anastomotic fitting that securely engages with the outside aortic wall.
Regarding claim 6, Holloway teaches, the cylindrical connector body of the vascular connector of claim 1 (See above rejection of claim 1).
Holloway fails to teach, wherein the cylindrical connector body comprises grooves along an external surface thereof configured to enable secure placement of the band.
Kaster teaches, the cylindrical connector body (tube (12)) comprises grooves (Figure 1, locking ring grooves (12e)) along an external surface (Figure 1) thereof configured to enable secure placement of the band (fixation ring (16)) (Figure 1; Col. 7, line 22-26).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holloway such that the cylindrical connector body comprises grooves along an external surface thereof configured to enable secure placement of the band as taught by Kaster, as both references and the claimed invention are directed to surgical prosthesis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holloway such that the cylindrical connector body comprises grooves along an external surface thereof configured to enable secure placement of the band as taught by Kaster, as such a modification would have been predictable, namely, to gain the advantage of an anastomotic fitting that securely engages with the outside aortic wall.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holloway, in view of McDonald (US PGPUB No. 20190223996 A1).
Regarding claim 8, Holloway teaches, the tubular sleeve graft of the vascular connector of claim 1 (See above rejection of claim 1).
Holloway fails to teach, wherein the tubular sleeve graft comprises a plurality of side-branches extending therefrom.
McDonald discloses a prosthetic device for use as a hybrid endograft in a patient requiring surgery, particularly an intervention to treat a vascular pathology. McDonald teaches, the tubular sleeve graft (Figure 1, tubular main body (3)) comprises a plurality of side-branches (Figure 1, docking branch (5), access branch (7), and main body access branches (9)) extending therefrom (Paragraph [0083]-[0090]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holloway such that the tubular sleeve graft comprises a plurality of side-branches extending therefrom as taught by McDonald, as both references and the claimed invention are directed to surgical prosthesis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holloway such that the tubular sleeve graft comprises a plurality of side-branches extending therefrom as taught by McDonald, as such a modification would have been predictable, namely, to gain the advantage of connecting with the aortic arch branch vessels using the branches of the device.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holloway, in view of Banas (US Patent No. 6004348).
Regarding claim 9, Holloway teaches, the cylindrical connector body of the vascular connector of claim 1 (See above rejection of claim 1).
Holloway fails to teach, wherein the cylindrical connector body includes a plurality of holes extending circumferentially therearound.
Banas discloses, an endoluminal graft. Banas teaches, the cylindrical connector body (Figure 2, tubular support member (22); Col. 12, line 30-34) includes a plurality of holes (Figure 2, openings (30)) extending circumferentially therearound (Col. 14, line 37-Col. 15, line 4).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holloway such that the cylindrical connector body includes a plurality of holes extending circumferentially therearound as taught by Banas, as both references and the claimed invention are directed to surgical prosthesis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holloway such that the cylindrical connector body includes a plurality of holes extending circumferentially therearound as taught by Banas, as such a modification would have been predictable, namely, to gain the advantage of increased strength and durability of the vascular connector.
Response to Arguments
Applicant's arguments filed on 03/28/2025 have been fully considered but they are not persuasive.
The applicant argues that Holloway fails to disclose a “cylindrical connector body that is more rigid than a tubular sleeve graft,” asserting that Holloway merely describes that the non-porous middle material can be non-porous and can encompass a stent, and that all layers “can also be flexible enough to easily fold with the stent,” allegedly introducing uncertainty about relative rigidity. However, these arguments are unpersuasive for the following reasons:
Explicit Material Properties Support Relative Rigidity:
Holloway explicitly describes the non-porous middle layer (14) as made from materials such as polyurethanes (e.g., Thoralon®), PTFE, polylactides, and polycaprolactones (Col. 5, lines 35–39), all of which are widely recognized in the art as more rigid and less porous than the porous biocompatible materials (e.g., hydrogels, ePTFE) used for the outer (12) and lumenal (16) layers (Col. 3, lines 56–Col.4, line 4 and Col. 5, line 49-58).
Accordingly, the relative rigidity between these layers is inherently disclosed, as the middle layer's function demands structural integrity to prevent stent protrusion and vessel prolapse.
Functional Description Implies Increased Rigidity:
Holloway discloses that the middle layer (14) “functions to prevent protrusion of the stent (18), block intimal growth, and prevent prolapse of the vessel wall” (Col. 5, lines 28–35), functions that inherently require greater structural rigidity than the porous outer and lumenal layers, which serve purposes like drug delivery and biocompatibility. The reliance on the middle layer to bear mechanical loads further confirms its relatively rigid nature.
“Flexible Enough to Fold” Does Not Preclude Relative Rigidity:
The cited language at Col. 7, lines 5–7 states that the layers can be flexible enough to fold with the stent. This does not imply that all three layers are equally flexible or possess the same rigidity. Rather, it indicates that the overall assembly can conform during delivery. Even a rigid component can possess some flexibility or be thin enough to permit folding without undermining its relatively more rigid nature compared to softer, porous layers.
Sliding Configuration is Implicit in Holloway:
Holloway discloses that the porous outer layer (12) provides a lubricious surface to reduce adhesion and friction between the layers and with the delivery system (Col. 4, lines 55–63). This lubricity, coupled with the middle layer being disposed between the outer and lumenal layers, supports the interpretation that the non-porous middle layer (14) is configured to slide longitudinally within the tubular sleeve graft, as recited in the claim.
Applicant’s Intended Use Limitation is Not Limiting:
The applicant’s reference to use “as an anastomotic device” is not recited in claim 1 and therefore cannot serve to distinguish the claimed structure from Holloway. A device’s intended purpose does not impose structural limitations absent such language in the claim.
In summary, Holloway expressly or inherently discloses all limitations of claim 1 and in newly added claims 20-21, including the claimed configuration and relative material rigidity. The applicant’s arguments fail to overcome the anticipation rejection under 35 U.S.C. § 102(a)(1).
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.
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/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771