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 7/6/2026, have overcome:
The objection(s) to claim(s) 14, 18;
The rejection of claim(s) 1-3, 5-6, 8-16, 18-20 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Hall et al. (US 2021/0106444 A1 – as previously cited);
The rejection of claim(s) 1-4, 10-14, 18-20 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Reijnen (US 2023/0045493 A1 - as previously cited);
The aforementioned objections/ rejections have been withdrawn.
Applicant did not provide meaningful arguments concerning the rejection of claim(s) 7, 17 under 35 U.S.C. 103 based on Reijnen (US 2023/0045493 A1 – as previously cited). Instead, Applicant merely refutes the rejection of claim(s) 1, 13, and 18 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Reijnen (US 2023/0045493 A1 - as previously cited). Applicant has not addressed the arguments of why it would be obvious to one having ordinary skill in the art to ends of the lumen beyond the ends of the first and second material structures (as required by amended claim(s) 1, 13, and 18) which mirror previous claim(s) 7 and 17. As such, the aforementioned rejection is modified (due to the claim amendments) and maintained.
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) 1-4, 7, 10-14, 17-20 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Reijnen (US 2023/0045493 A1 – as previously cited).
With respect to claim(s) 1, 7:
Reijnen discloses the invention substantially as claimed. Specifically, Reijnen discloses a fenestrated endovascular prosthesis (medical device 1), as can be seen in figs. 1-3 (paragraph [0025]), comprising:
a body (made up of expandable stents 10, 20 and membranes therefore) comprising a body wall defining a bore (through which expandable member 3 extends) extending a length of the body (made up of expandable stents 10, 20 and membranes therefore), the body wall comprising a first material structure (stent 20 and membrane therefore) and a second material structure (stent 10 and membrane therefore) (paragraphs [0025, 0028, 0038]); and
a lumen (pre-cannulation means 90), wherein:
the lumen (pre-cannulation means 90) extends from an interior of the second material structure (stent 10 and membrane therefore) to an exterior of the first material structure (stent 20 and membrane therefore) (paragraphs [0029, 0033]);
the lumen (pre-cannulation means 90) is disposed between the first material structure (stent 20 and membrane therefore) and the second material structure (stent 10 and membrane therefore);
the lumen (pre-cannulation means 90) comprises a proximal opening (opening closer to transition region 33, in fig. 2) in fluid communication with the bore (through which expandable member 3 extends) and a distal opening (opening further from transition region 33, in fig. 2) in fluid communication with an exterior of the body; and
the lumen (pre-cannulation means 90) is configured to be (is capable of being) selectively transitioned from a sealed configuration (either prior to the entire fenestrated endovascular prosthesis (medical device 1) being expanded when the entire fenestrated endovascular prosthesis (medical device 1) is crimped onto the balloon in the smallest configuration possible OR after the fenestrated endovascular prosthesis (medical device 1) is balloon expanded but prior to the pre-cannulation tube being expanded) to an open configuration (after pre-canulation tube 90 is expanded) (paragraphs [0034, 0046]).
However, Reijnen does not disclose the proximal opening (opening closer to the left side of the page in fig. 1) of the lumen extends from proximal a proximal edge (end of stent 20 closer to the left side of the page in fig. 1) of the first material structure (stent 20 and membrane therefore) nor the distal opening (opening closer to the right side of the page in fig. 1) of the lumen extends distal a distal edge (end of stent 10 closer to the right side of the page in fig. 1) of the second material structure (stent 10 and membrane therefore) (as required by claim(s) 1 and 7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to extend both the proximal and distal openings (opening closer to the left side of the page in fig. 1, opening closer to the right side of the page in fig. 1) of the lumen, as disclosed by Reijnen, proximally and distally (beyond the overlap/ proximal edge (end of stent 10 closer to the right side of the page in fig. 1) of the first material structure (stent 20 and membrane therefore)/ distal edge (end of stent 10 closer to the left side of the page in fig. 1) of the second material structure (stent 10 and the membrane therefore) in order to allow for the easier introduction of the guidewire/ second balloon catheter into the lumen/ fenestration (opening of pre-cannulation means 90) into either end thereof for the delivery of the second stent (paragraph [0046]) and to ensure the guidewire/ second balloon catheter don’t become snagged on either the first material structure (stent 10 and membrane therefore) or the second material structure (stent 20 and membrane therefore) as it exits the lumen/ fenestration (opening of pre-cannulation means 90) (as required by claim(s) 1 and 7).
With respect to claim 2:
Wherein the lumen (pre-cannulation means 90) comprises a seal region (the sandwiched portion, section between both stents 10, 20, of pre-cannulation means 90) configured to prevent blood flow through the lumen (pre-cannulation means 90) when the lumen (pre-cannulation means 90) is in the sealed configuration (either prior to the entire fenestrated endovascular prosthesis (medical device 1) being expanded when the entire fenestrated endovascular prosthesis (medical device 1) is crimped onto the balloon in the smallest configuration possible OR after the fenestrated endovascular prosthesis (medical device 1) is balloon expanded but prior to the pre-cannulation tube being expanded) (paragraphs [0034, 0046]).
With respect to claim 3:
Wherein the seal region (the sandwiched portion, section between both stents 10, 20, of pre-cannulation means 90) is configured to be selectively un-sealed (expanded) to allow blood flow through the lumen (pre-cannulation means 90) when the lumen (pre-cannulation means 90) is in the open configuration (after pre-canulation tube 90 is expanded) (paragraphs [0034, 0046]).
With respect to claim 4:
Wherein the seal region (the sandwiched portion, section between both stents 10, 20, of pre-cannulation means 90) has a length in a range from 2 mm to 8 mm (overlap zone in which the pre-cannulation means 90 will be positioned is 3-5 mm) (paragraphs [0029, 0052]).
With respect to claim 10:
Wherein the lumen (pre-cannulation means 90) is configured to sealingly receive a secondary endovascular prosthesis (third stent) within the lumen (pre-cannulation means 90) when in the open configuration (after pre-canulation tube 90 is expanded) (paragraph [0034]).
With respect to claim 11:
Further comprising a wire stent (frame structure of either stent 10, 20) coupled to the body (made up of expandable stents 10, 20 and membranes therefore), the wire stent (frame structure of either stent 10, 20) comprising a proximal portion (1/3 subsection of frame structure of either stent 10, 20 closer to the left or right of the page), a distal portion (1/3 subsection of frame structure of either stent 10, 20 closer to the other of the left or right of the page), and a spine (middlemost 1/3 of frame structure of either stent 10, 20) extending between the proximal portion and the distal portion (Please note: for claim 1 and 11 in combination, Examiner is considering the “body” to be made of merely the membranes covering the stents 10, 20; as such, Examiner is considering one of the stents (10, 20) to be the “wire stent” as claimed).
With respect to claim 12:
Wherein the first material structure (stent2 0 and membrane therefore) comprises two material layers (the stent is one layer and the membrane is a second layer) (paragraphs [0038, 0040]), and wherein the second material structure (stent 10 and membrane therefore) comprises two material layers (the stent is one layer and the membrane is a second layer) (paragraphs [0038, 0040]).
With respect to claim(s) 13, 17:
Reijnen discloses the invention substantially as claimed. Specifically, Reijnen discloses a vascular prosthesis system (medical device 1), as can be seen in figs. 1-3 (paragraph [0025]), comprising:
a fenestrated endovascular prosthesis (medical device 1) comprising:
a body (made up of expandable stents 10, 20 and membranes therefore) comprising a body wall defining a bore (through which expandable member 3 extends) extending a length of the body (made up of expandable stents 10, 20 and membranes therefore) (paragraphs [0025, 0028, 0038]); and
a fenestration (pre-cannulation means 90) defining a lumen (passage within pre-cannulation means 90) extending a length of the fenestration (pre-cannulation means 90) (paragraphs [0029, 0033]), wherein:
the fenestration (pre-cannulation means 90) extends between a first material structure (stent 20 and membrane therefore) and a second material structure (stent 10 and membrane therefore) of the body wall (paragraphs [0025, 0028, 0038]);
the lumen (passage within pre-cannulation means 90) comprises a proximal opening (opening of pre-cannulation means 90 closer to the left side of the page in fig. 1) in fluid communication with the bore (through which expandable member 3 extends) and a distal opening (opening of pre-cannulation means 90 closer to the right side of the page in fig. 1) in fluid communication with an exterior of the body (made up of expandable stents 10, 20 and membranes therefore); and
the lumen (passage within pre-cannulation means 90) is selectively transitionable from a sealed configuration (either prior to the entire fenestrated endovascular prosthesis (medical device 1) being expanded when the entire fenestrated endovascular prosthesis (medical device 1) is crimped onto the balloon in the smallest configuration possible OR after the fenestrated endovascular prosthesis (medical device 1) is balloon expanded but prior to the pre-cannulation tube being expanded) to an open configuration (after pre-canulation tube 90 is expanded) (paragraphs [0034, 0046]); and
a branch prosthesis (third stent) configured to be (is capable of being) sealingly disposed in the lumen when the lumen (passage within pre-cannulation means 90) is in the open configuration (after pre-canulation tube 90 is expanded) (paragraph [0034]).
However, Reijnen does not disclose the proximal opening (opening of pre-cannulation means 90 closer to the left side of the page in fig. 1) of the lumen is disposed proximal a proximal edge (end of stent 20 closer to the left side of the page in fig. 1) of the first material structure (stent 20 and membrane therefore) nor the distal opening (opening of pre-cannulation means 90 closer to the right side of the page in fig. 1) of the lumen is disposed distal a distal edge (end of stent 10 closer to the right side of the page in fig. 1) of the second material structure (stent 10 and membrane therefore) (as required by claim(s) 13 and 17).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to extend both the proximal and distal openings (opening of pre-cannulation means 90 closer to the left side of the page in fig. 1, opening of pre-cannulation means 90 closer to the right side of the page in fig. 1) of the lumen, as disclosed by Reijnen, proximally and distally (beyond the overlap/ proximal edge (end of stent 20 closer to the right side of the page in fig. 1) of the first material structure (stent 20 and membrane therefore)/ distal edge (end of stent 10 closer to the left side of the page in fig. 1) of the second material structure (stent 10 and the membrane therefore) in order to allow for the easier introduction of the guidewire/ second balloon catheter into the lumen/ fenestration (opening of pre-cannulation means 90) into either end thereof for the delivery of the second stent (paragraph [0046]) and to ensure the guidewire/ second balloon catheter don’t become snagged on either the first material structure (stent 10 and membrane therefore) or the second material structure (stent 20 and membrane therefore) as it exits the lumen/ fenestration (opening of pre-cannulation means 90) (as required by claim(s) 13 and 17).
With respect to claim 14:
Wherein:
a proximal end of the branch prosthesis (third stent) is configured to be (is capable of being) disposed in the bore (through which expandable member 3 extends) of the body (made up of expandable stents 10, 20 and membranes therefore) when the branch prosthesis (third stent) is sealingly disposed in the lumen (passage within pre-cannulation means 90) of the fenestration (pre-cannulation means 90) (due to the length of third stent, as can be seen in fig. 3, it is capable of being positioned such that a proximal end thereof is in the bore (through which expandable member 3 extends) of the body (made up of expandable stents 10, 20 and membranes therefore); and
the branch prosthesis (third stent) comprises a branch lumen (passage within third stent) configured to be in fluid communication with the bore (through which expandable member 3 extends) when the branch prosthesis (third stent) is sealingly disposed in the lumen (passage within pre-cannulation means 90) of the fenestration (pre-cannulation means 90) (paragraphs [0034, 0041]).
With respect to claim 18:
Reijnen discloses the invention substantially as claimed. Specifically, Reijnen discloses an endovascular prosthesis system comprising:
a fenestrated endovascular prosthesis (medical device 1), as can be seen in figs. 1-3 (paragraph [0025]), comprising:
a tubular body (made up of expandable stents 10, 20 and membranes therefore), the tubular body (made up of expandable stents 10, 20 and membranes therefore) comprising:
a bore (through which expandable member 3 extends) defined by a wall;
a proximal portion (stent 10 and membrane therefore) (paragraphs [0025, 0028, 0038]); and
a distal portion (stent 20 and membrane therefore) (paragraphs [0025, 0028, 0038]);
a first material structure (stent 20 and membrane therefore) defining the wall in the distal portion (stent 20 and membrane therefore); and
a second material structure (stent 10 and membrane therefore) defining the wall in the proximal portion (stent 10 and membrane therefore);
a fenestration opening (pre-cannulation means 90) extending from the bore (through which expandable member 3 extends) to an exterior of the tubular body (made up of expandable stents 10, 20 and membranes therefore), as can be seen in fig. 1 (paragraphs [0029, 0033]),
wherein:
the fenestration opening (pre-cannulation means 90) is disposed between the first material structure (stent 10 and membrane therefore) and the second material structure (stent 20 and membrane therefore);
the fenestration opening (pre-cannulation means 90) is in fluid communication with the bore (through which expandable member 3 extends) in the proximal portion (stent 10 and membrane therefore) (paragraph [0029]); and
the fenestration opening (pre-cannulation means 90) is in fluid communication with the exterior of the tubular body (made up of expandable stents 10, 20 and membranes therefore) in the distal portion (stent 20 and membrane therefore) (paragraph [0029]); and
a guidewire (preloaded second guidewire) extending through the fenestration opening (opening of pre-cannulation means 90) from the bore (through which expandable member 3 extends) to the exterior of the tubular body (made up of expandable stents 10, 20 and membranes therefore) (paragraph [0034]), wherein:
the fenestration opening (opening of pre-cannulation means 90) is configured to be (is capable of being) sealed around the guidewire (preloaded second guidewire) in a sealed configuration (prior to the entire fenestrated endovascular prosthesis (medical device 1) being expanded when the entire fenestrated endovascular prosthesis (medical device 1) is crimped onto the balloon in the smallest configuration possible the fenestration opening (opening of pre-cannulation means 90) is capable of being crimped down to “seal” around the guidewire (preloaded second guidewire)) (paragraphs [0034, 0046]).
However, Reijnen does not disclose the proximal opening (opening closer to the left side of the page in fig. 2) of the fenestration opening (pre-cannulation means 90) is disposed proximal a proximal edge (end of stent 20 closer to the left side of the page in fig. 2) of the first material structure (stent 20 and membrane therefore) nor the distal opening (opening closer to the right side in fig. 2) of the fenestration opening (pre-cannulation means 90) is disposed distal a distal edge (end of stent 100 closer to the right side of the page in fig. 2) of the second material structure (stent 10 and membrane therefore) (as required by claim 17).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to extend both the proximal and distal openings (opening closer to transition region 33, in fig. 2, opening further from transition region 33, in fig. 2) of the lumen, as disclosed by Reijnen, proximally and distally (beyond the overlap/ proximal edge (end of stent 10 closer to the right side of the page in fig. 1) of the first material structure (stent 10 and membrane therefore)/ distal edge (end of stent 20 closer to the left side of the page in fig. 1) of the second material structure (stent 20 and the membrane therefore) in order to allow for the easier introduction of the guidewire/ second balloon catheter into the lumen/ fenestration (opening of pre-cannulation means 90) into either end thereof for the delivery of the second stent (paragraph [0046]) and to ensure the guidewire/ second balloon catheter don’t become snagged on either the first material structure (stent 10 and membrane therefore) or the second material structure (stent 20 and membrane therefore) as it exits the lumen/ fenestration (opening of pre-cannulation means 90) (as required by claim 17).
With respect to claim 19:
Further comprising a secondary endovascular prosthesis (third stent) configured to be advanced along the guidewire (preloaded second guidewire) (paragraph [0034]), wherein the secondary endovascular prosthesis (third stent) is configured to be sealingly disposed in a lumen (passage of pre-cannulation means 90) of the fenestration opening (opening of pre-cannulation means 90) when the fenestration opening (opening of pre-cannulation means 90) is in an open configuration (after both third stent and pre-cannulation means 90 are expanded) (paragraph [0034]).
With respect to claim 20:
wherein:
the fenestration opening (pre-cannulation means 90) extends from inside the second material structure (structure of stent 10 and membrane therefore) to outside the first material structure (structure of stent 20 and membrane therefore), as can be seen in fig. 2 (paragraph [0029]).
Claim(s) 5-6, 8-9, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reijnen (US 2023/0045493 A1 – as previously cited) as applied to claim(s) 1-4, 7, 10-14, 17-20 above, and further in view of Hall et al. (US 2021/0106444 A1 – as previously cited).
With respect to claim(s) 5-6:
Reijnen (as modified above) discloses the invention substantially as claimed. However, Reijnen (as modified above) does not disclose the seal region (the sandwiched portion, section between both stents 10, 20, of pre-cannulation means 90) to comprise an adhesive, specifically FEP.
Hall et al. teaches a fenestrated endovascular prosthesis (vascular prosthesis 100) (paragraph [0042]), as can be seen in figs. 1A-2B, comprising:
a body (tubular body 110 not including ducts 130) comprising a body wall defining a bore (bore 113) extending a length of the body (tubular body 110 not including ducts 130) (paragraphs [0044]), the body wall comprising a first material structure (in combination distal portion 112 and tapered portion 114) and a second material structure (proximal portion 111) (paragraph [0042]); and
a plurality of lumens (all of the passages defined by all of the ducts 130) (paragraph [0044]), wherein:
each lumen (passage defined by one of ducts 130) extends from an interior of the second material structure (proximal portion 111) to an exterior of the first material structure (distal portion 112 and tapered portion 114), as can be seen in fig. 1B. The plurality of lumens (ducts 130) are adhered to an inner wall of the second material structure (proximal portion 111) with a layer of FEP adhesive (paragraph [0049]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the FEP adhesive layer, as taught by Hall et al., to the outer surface of the seal region (the sandwiched portion, section between both stents 10, 20, of pre-cannulation means 90), as disclosed by Reijnen (as modified above), in order to further anchor the lumen (passage defined by one of ducts 130) to the first and second material structures (stents 10, 20 and membranes therefore) preventing dislodgement therefrom during delivery or deployment of the branch prosthesis (third stent). (Please note: In making the aforementioned combination, Examiner is considering the FEP coating, as taught by Hall et al., on the seal region (the sandwiched portion, section between both stents 10, 20, of pre-cannulation means 90), as disclosed by Reijnen (as modified above), to be part of the seal region (the sandwiched portion, section between both stents 10, 20, of pre-cannulation means 90), as disclosed by Reijnen (as modified above).)
With respect to claim(s) 8, 15-16:
Reijnen (as modified above) discloses the invention substantially as claimed. However, Reijnen (as modified above) does not disclose the lumen (pre-cannulation means 90)/ branch prosthesis (third stent) to be one of a plurality of lumens (pre-cannulation means 90)/ branch prostheses (third stent).
Hall et al. teaches a fenestrated endovascular prosthesis (vascular prosthesis 100) (paragraph [0042]), as can be seen in figs. 1A-2B, comprising:
a body (tubular body 110 not including ducts 130) comprising a body wall defining a bore (bore 113) extending a length of the body (tubular body 110 not including ducts 130) (paragraphs [0044]), the body wall comprising a first material structure (in combination distal portion 112 and tapered portion 114) and a second material structure (proximal portion 111) (paragraph [0042]); and
a plurality of lumens (all of the passages defined by all of the ducts 130) (paragraph [0044]), wherein:
each lumen (passage defined by one of ducts 130) extends from an interior of the second material structure (proximal portion 111) to an exterior of the first material structure (distal portion 112 and tapered portion 114), as can be seen in fig. 1B. The plurality of lumens (ducts 130) allow the prosthesis (vascular prosthesis 100) to be positioned within vessels where there are one or multiple bifurcations.
A plurality of branch prostheses (expandable tubular prosthesis 171a) configured to be scalingly disposed in the lumens (ducts 130) when the lumens (ducts 130) is/are in the open configuration (open configuration) (paragraphs [0061-0063]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the singular lumen (pre-cannulation means 90)/ branch prosthesis (third stent), as disclosed by Reijnen (as modified above), a plurality thereof, as taught by Hall et al., in order to allow the use thereof in a greater number of locations in the body (in places where there are more than one bifurcation) such as with the thoracic aorta.
With respect to claim 9:
Reijnen (as modified above) discloses the invention substantially as claimed. However, Reijnen (as modified above) does not disclose the material making up the lumen (pre-cannulation means 90).
Hall et al. teaches a fenestrated endovascular prosthesis (vascular prosthesis 100) (paragraph [0042]), as can be seen in figs. 1A-2B, comprising:
a body (tubular body 110 not including ducts 130) comprising a body wall defining a bore (bore 113) extending a length of the body (tubular body 110 not including ducts 130) (paragraphs [0044]), the body wall comprising a first material structure (in combination distal portion 112 and tapered portion 114) and a second material structure (proximal portion 111) (paragraph [0042]); and
a plurality of lumens (all of the passages defined by all of the ducts 130) (paragraph [0044]), wherein:
each lumen (passage defined by one of ducts 130) extends from an interior of the second material structure (proximal portion 111) to an exterior of the first material structure (distal portion 112 and tapered portion 114), as can be seen in fig. 1B. The lumen (passage defined by one of ducts 130) maybe made from PTFE or silicone (paragraphs [0042, 0044]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the lumen (pre-cannulation means 90), as disclosed by Reijnen (as modified above), from the same materials (including PTFE or silicone), as taught be Hall et al., as the two structures are functional equivalents for each other (both are graft tubes used to create grafts which bridge between a main vessel and a branch extending therefrom) and therefore can be made from the same materials.
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 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.
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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
