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 .
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on 12/18/2024, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
Response to Arguments
Applicant's request for reconsideration of the finality of the rejection of the last Office action, at least for claim 25, is persuasive and, therefore, the finality of that action is withdrawn.
See new grounds of rejection below.
Applicant's arguments filed on 03/04/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks against claim 1 and claim 15, such that Ginn is not analogous art as traversed on page 4-5 of Applicant’s Pre-Appeal Brief, Examiner acknowledged, but respectfully disagrees. While Examiner agrees in part that the device of Ginn is heavily discussed for lung assist, it is emphasized that Ginn also discusses that “it is also desirable to use the device of Ginn to assist flow of other fluids through branches of other systems within a patient, e.g., within the cardiovascular system” (Par. 63 of Ginn). Therefore, Ginn is analogous art and his/her device is fully capable of being utilized in branches of the cardiovascular system, such as the claimed artery and vein. Furthermore, in response to applicant's argument that the device of Ginn is “not a vascular shunt between separate and categorically distinct (arterial vs. venous) blood vessels” on page 4 of Applicant’s Pre-Appeal Brief, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the rejection of apparatus claims 1 and 15 are maintained.
See rejection of claims below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 15-20 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ginn US 2003/0024527 A1 (previously cited, hereinafter Ginn), as cited in the IDS.
Regarding claim 15, Ginn discloses a system 110 (Fig. 6A-6C – apparatus 110) for providing fluid flow between fluid vessels of a patient (Par. 62 – “…a vacuum may be created at the opening 136, thereby drawing air from the second branch 96. Because of the vacuum, the valve 150 may open, allowing any air within the diseased region of the lung to be removed via the main passage 96”), the system 110 (Fig. 6A-6C) comprising:
a conduit structure 126 (Fig. 6C – tubular venturi member 126) configured to be implanted within an artery (Par. 55 – member 126 implanted within branch 90; the tubular member 126 is highly capable of being implanted within an artery), the conduit structure 126 (Fig. 6C) comprising a conduit lumen 138 (Fig. 6C – lumen 138) extending between an inlet end segment 130 (Fig. 6C – first end 130) having a first diameter (Fig. 6C – first end 130 has a diameter) and an outlet end segment 132 (Fig. 6C – second end 132), and a narrowed neck segment 134 (Fig. 6C – intermediate region 134) disposed between the inlet end segment 130 (Fig. 6C) and the outlet end segment 132 (Fig. 6C), a second diameter of the narrowed neck segment 134 (Fig. 6C – intermediate region 134 has a diameter) being less than the first diameter (Par. 56 – “a first end 130 and a second end 132 that are substantially larger than an intermediate region 134”); and
a shunt structure 112 (Fig. 6A-6C – support structure 112) comprising an inlet 124 (Fig. 6B – opening 124) and an outlet (Fig. 6C – where opening 136 and support structure 112 meets) attached directly to a Venturi throat 136 (Fig. 6C – opening 136) of the narrowed neck segment 134 (Fig. 6C) of the conduit structure 126 (Fig. 6C) and configured to be at least partly disposed in a vein that is adjacent to the artery (Fig. 6C-6C, and Par. 55 – “The leg 122 may be disposed within a second branch 96…”; the leg 122 of support structure 112 is capable of being implanted within a vein that has lower pressure than the artery);
wherein the conduit structure 126 (Fig. 6C), when implanted in the artery (Fig. 6C, Par. 55 and as established above) with the inlet of the shunt structure implanted in the vein (Par. 55 and as established above), is configured to draw fluid from the vein into the artery through the shunt structure 126 (Fig. 6C, and Par. 62 – “During exhalation, air entering the branch 90 from the first branch 94, i.e., from the healthy region of the lung, passes through the lumen 138 of the venturi member 126 and into the main passage 92. Because of the narrow intermediate region 134, a vacuum may be created at the opening 136, thereby drawing air from the second branch 96. Because of the vacuum, the valve 150 may open, allowing any air within the diseased region of the lung to be removed via the main passage 96”)).
Regarding claim 16, Ginn discloses the invention of claim 15. Ginn further discloses further comprising a delivery catheter (Par. 59 – “catheter”) sized to removably receive the conduit structure 126 (Fig. 6C, and Par. 56 – “The ends 130, 132 of the venturi member 126 may compressible to facilitate insertion, or may be of sufficient size to be inserted”) and the shunt structure 112 (Fig. 6C, and Par. 59 – “the support structure 112 may be constrained to a catheter”), the delivery catheter (Par. 59 – “catheter”) configured to hold at least one of the conduit structure or the shunt structure 112 (Fig. 6C) in a compressed delivery configuration (Par. 59 – “the support structure 112 may be constrained to a catheter”).
Regarding claim 17, Ginn discloses the invention of claim 16. Ginn further discloses wherein the conduit structure 126 (Fig. 6C) is self-expanding (Par. 61 – “The first and second ends 130, 132 may be compressed to facilitate introduction into the branch 90, and may then be released to resiliently expand (or may be otherwise expanded”), and the delivery catheter (Par. 59 – “catheter”) comprises a sheath (Par. 59 – “a catheter or other delivery device, e.g., by an overlying sheath (not shown)…”) configured to slidingly receive the conduit structure 126 (Fig. 6C; the overlying sheath is capable of receiving the conduit structure 126 since the shunt structure 112 is constrained within said sheath).
Regarding claim 18, Ginn discloses the invention of claim 16. Ginn further discloses wherein the delivery catheter (Par. 59 – “catheter”) comprises a radially expandable balloon (Par. 55 – “may be crimped onto a balloon catheter or other device (not shown) and deformed towards the enlarged condition by expanding an underlying balloon or other expandable element (also not shown)”) configured to deploy the conduit structure 126 (Fig. 6C, and Par. 55; the balloon is capable of deploying the conduit structure since the balloon catheter deploys the shunt structure) within the artery (Par. 55 and as established above).
Regarding claim 19, Ginn discloses the invention of claim 16. Ginn further discloses wherein the delivery catheter (Par. 59 – “catheter”) is configured to deploy the shunt structure 112 (Fig. 6C) between the artery and the vein (Par. 59 – “the support structure 112 may be constrained to a catheter or other delivery device, e.g., by an overlying sheath (not shown), and released within the branch 90, whereupon the support structure 112 may automatically expand to substantially secure itself to tissue surrounding the branch 90”, thus capable of deploying the shunt structure in between the artery and vein).
Regarding claim 20, Ginn discloses the invention of claim 15. Ginn further discloses further comprising a blood vessel anchor 122 (Fig. 6B – leg 122) coupled to the inlet 124 (Fig. 6C) of the shunt structure 112 (Fig. 6C) and configured to secure the shunt structure 112 (Fig. 6C, and Par. 54 – ”The support structure 112 defines a lumen 118 extending between the first and second ends 114, 116, and the leg 122 defines a lateral opening 124 communicating with the lumen 118”) to a wall of the vein (Fig. 6B, Par. 55, and as established above).
Regarding claim 22, Ginn discloses the invention of claim 20. Ginn further discloses wherein the blood vessel shunt anchor 122 (Fig. 6C) has a disk-shaped form (Fig. 6A-6B – leg 122 has a disk shape at opening 124).
Regarding claim 23, Ginn discloses the invention of claim 15. Ginn further discloses wherein the artery is an aorta (Examiner notes that since claim 15 has established in the function language that the conduit structure is configured to be implanted within an artery, thus it could be the aorta) and the vein is an inferior vena cava (Examiner notes that since claim 15 has established in the functional language that the shunt structure is configured to be implanted within a vein, thus it could be the inferior vena cava).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-9, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ginn US 2003/0024527 A1 (previously cited, hereinafter Ginn), as cited in the IDS.
Regarding claim 1, Ginn discloses a device 110 (Fig. 6A-6C – apparatus 110) for drawing flow from a vessel into a vessel of a patient (Par. 62 – “…a vacuum may be created at the opening 136, thereby drawing air from the second branch 96. Because of the vacuum, the valve 150 may open, allowing any air within the diseased region of the lung to be removed via the main passage 96”), comprising:
an hourglass-shaped conduit structure 126 (Fig. 6C – tubular venturi member 126) configured to be implanted within an artery (Par. 55 – member 126 implanted within branch 90; the tubular member 126 is highly capable of being implanted within an artery), the conduit structure 126 (Fig. 6C) comprising first and second end segments 130, 132 (Fig. 6C – first end 130 and second end 132) having an expanded diameter (Par. 56 – “a first end 130 and a second end 132 that are substantially larger…”) dimensioned to anchor against an inner diameter of the artery (Par. 56 – “The ends 130, 132 of the venturi member 126 may compressible to facilitate insertion, or may be of sufficient size to be inserted into a branch 90 while remaining fully expanded”) and a constricted portion 134 (Fig. 6C – intermediate region 134) positioned between the first 130 and second end segments 132 (Fig. 6C, and Par. 56 – “the venturi member 126 may have a cross-section that tapers from the first and second ends 130, 132 inwards towards the intermediate region 134”), the constricted portion 134 (Fig. 6C) having a constricted lumen diameter (Fig. 6C – region 134 has a diameter) that is less than the expanded diameter (Par. 56 – “a first end 130 and a second end 132 that are substantially larger than an intermediate region 134”); and
a shunt structure 112 (Fig. 6A-6C – support structure 112) configured to be at least partially implanted within a vein having lower luminal pressure than the artery (Fig. 6C-6C, and Par. 55 – “The leg 122 may be disposed within a second branch 96…”; the leg 122 of support structure 112 is capable of being implanted within a vein that has lower pressure than the artery), the shunt structure 112 (Fig. 6C) having an outlet (Fig. 6C – where opening 136 and support structure 112 meets) that directly couples to, and provides fluid access to, the constricted portion 134 of the conduit structure 126 (Fig. 6C, and Par. 57 – “allow air flow into the lateral opening 124 (towards the second end 116 of the support structure 112), while limiting flow out of the lateral opening 124”), the shunt structure 112 (Fig. 6C) comprising a shunt lumen (Fig. 6C – leg 122 has a lumen) that is configured to be in fluid communication with a conduit lumen of the conduit structure 126 (Fig. 6C – leg 122 of support structure 112 has a lumen that fluidly communicates with the tubular venturi member 126 via opening 136);
wherein the constricted lumen diameter (Fig. 6C – the diameter of intermediate region 134) of the conduit structure 126 (Fig. 6C) is shaped and dimensioned such that, when the conduit structure 126 (Fig. 6C) is implanted in the artery (Fig. 6C, Par. 55 and as established above) and an inlet 124 (Fig. 6B – opening 124) of the shunt structure 112 (Fig. 6B) is implanted in the vein (Par. 55 and as established above), arterial blood flow through the conduit structure is forced through the constricted portion 134 (Fig. 6C) in a manner as to accelerate blood flow velocity (Claim 21 – “the narrow region causes an increase in velocity…”) and produce a localized low-pressure zone (Par. 62 – “a vacuum may be created…”) in the constricted portion 134 (Fig. 6C) that draws blood from the vein into the artery through the shunt structure 112 (Fig. 6C, and Par. 62 – “During exhalation, air entering the branch 90 from the first branch 94, i.e., from the healthy region of the lung, passes through the lumen 138 of the venturi member 126 and into the main passage 92. Because of the narrow intermediate region 134, a vacuum may be created at the opening 136, thereby drawing air from the second branch 96. Because of the vacuum, the valve 150 may open, allowing any air within the diseased region of the lung to be removed via the main passage 96”).
However, Ginn does not disclose a device for drawing blood flow from a relatively low-pressure blood vessel into a relatively high-pressure blood vessel of a patient; the constricted portion having a constricted lumen diameter that is less than 80% of the expanded diameter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made Ginn’s diameter of the constricted lumen to be less than 80% of the expanded diameter, in order to fit the particular procedure being done since this claimed dimension of the constricted lumen diameter does not change the constricted lumen ability to form a Venturi effect within the device, to provide, and to direct a fluid flow path. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 40 of Applicant’s PG-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Furthermore, while Ginn is silent to a relatively low-pressure blood vessel versus a relative high-pressure blood vessel and drawing blood from the former into the latter, the tubular Venturi member 126 of Ginn describes in Par. 62 demonstrates that the flow can be sucked into the intermediate region/constricted portion 134 of tubular Venturi member 126 due to the Venturi effect. Therefore, one of ordinary skill in the art would have been motivated to use the apparatus in other branched system of a patient, in order to provide isolated assistance in evacuating and isolating for a diseased region (Par. 62 of Ginn).
Regarding claim 2, Ginn discloses the invention of claim 1. Gin further discloses wherein the shunt lumen (Fig. 6C – the lumen of leg 122 of support structure 112) has a shunt lumen diameter (Fig. 6C – lumen of leg 122 has a diameter).
However, Ginn does not disclose that a shunt lumen diameter is no greater than the constricted lumen diameter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the shunt lumen diameter not greater than the constricted lumen diameter of device of Ginn, in order to fit the particular procedure being done since these claimed diameters do not change the lumen ability to provide and direct a fluid flow path. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 86 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 3, Ginn discloses the invention of claim 2. However, Ginn does not disclose wherein the shunt lumen diameter is less than 80% of the constricted lumen diameter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the shunt lumen diameter less than 80% of constricted lumen diameter of device of Ginn, in order to fit the particular procedure being done since these claimed diameters do not change the lumen ability to provide and direct a fluid flow path. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 86 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 4, Ginn discloses the invention of claim 1. Ginn further discloses wherein the shunt structure 112 (Fig. 6B) comprises an anchor flange 150 (Fig. 6B – valve 150) that projects from an inlet end 124 (Fig. 6B) of the shunt structure 112 (Fig. 6B – valve 150 is disposed from the opening 124) and is configured to be secured to, and seal, an opening in at least a portion of the vein (Fig. 6B shows that valve 150 circumferentially seals the diameter of branch 96, and Par. 60 – “The valve 150 may be expanded… within the second branch 96 or may be secured to the leg 122 of the support structure 112”).
Regarding claim 5, Ginn discloses the invention of claim 1. Ginn further discloses wherein the shunt structure 112 (Fig. 6B) comprises a shunt anchor 122 (Fig. 6B – leg 122) associated with an inflow end 124 (Fig. 6B) of the shunt structure 112 (Fig. 6B, and Par. 54) that is comprises a stent (Par. 6 – “the support structure may include a tubular mesh, possibly including engagement elements, such as barbs, for engaging tissue surrounding the branch”, Par. 25 – “mesh structures, similar to those used for stents”, and Par. 55 – “The support structure 112 may be formed from an elastic, superelastic, and/or shape memory material, e.g., Nitinol, such that the support structure 112 may be compressed to a contracted condition (not shown) for facilitating delivery”) adapted to be radially deployed within the vein (Fig. 5B and established above) and anchored circumferentially against an inner diameter of placed into contact with a wall of the vein (Par. 58 – “The leg 122 may be disposed within a second branch 96”, and Fig. 6B shows that leg 122 is circumferentially deployed against the diameter of branch 96).
Regarding claim 7, Ginn discloses the invention of claim 1. Ginn further discloses wherein:
in an expanded configuration (Fig. 6B-6C show an expanded configuration), the first and second end segments 130, 132 (Fig. 6C) of the conduit structure 126 (Fig. 6C) define a cylinder boundary (see annotated Fig. 6C below); and
the outlet of the shunt structure 112 (Fig. 6C – the left side of leg 122) connects to the constricted portion 134 (Fig. 6C) of the conduit structure 126 (Fig. 6C) at a juncture 136 (Fig. 6C – opening 136) that is positioned radially inside of the cylinder boundary (see annotated Fig. 6C below – opening 136, which is the fluidic communicating interface between leg 122 and intermediate region 134, is within the annotated cylinder boundary).
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Annotated Fig. 6C of Ginn
Regarding claim 8, Ginn discloses the invention of claim 1. Ginn further discloses wherein the conduit structure 126 (Fig. 6C) comprises a frame that has a delivery configuration (Par. 56 – “The ends 130, 132 of the venturi member 126 may compressible to facilitate insertion”) and an expanded configuration (Fig. 6C shows an expanded configuration).
However, Ginn does not disclose a self-expanding stent frame, the self-expanding stent frame being biased toward the expanded configuration.
Ginn, in another embodiment, teaches a self-expanding stent frame (Par. 28 – “the housing 12 is formed from a superelastic and/or shape memory material, such as Nitinol, …”), the self-expanding stent frame being biased toward the expanded configuration (Par. 28 – “the housing 12 is formed from a superelastic and/or shape memory material, such as Nitinol, such that the housing 12 is resiliently compressible to the contracted condition, yet is biased to expand towards the enlarged condition”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit structure of Ginn to be a self-expanding stent frame, since it has been held to be 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. In re Leshin, 125 USPQ 416. Furthermore, Ginn also discusses that shape memory material, such as Nitinol can facilitate insertion for implantation (Par. 28 of Ginn).
Regarding claim 9, Ginn discloses the invention of claim 1. Ginn further discloses wherein the shunt structure 112 (Fig. 6C) each comprise a self-expanding wireframe structure (Par. 6 – “the support structure may include a tubular mesh, possibly including engagement elements, such as barbs, for engaging tissue surrounding the branch”, Par. 25 – “mesh structures, similar to those used for stents”, and Par. 55 – “The support structure 112 may be formed from an elastic, superelastic, and/or shape memory material, e.g., Nitinol,…”).
However, Ginn does not disclose wherein the conduit structure comprise a self-expanding wireframe structure.
Ginn, in another embodiment, teaches wherein the structure comprise a self-expanding wireframe structure (Par. 28 – “the housing 12 is formed from a superelastic and/or shape memory material, such as Nitinol, …”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit structure of Ginn to be a self-expanding stent frame, since it has been held to be 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. In re Leshin, 125 USPQ 416. Furthermore, Ginn also discusses that shape memory material, such as Nitinol can facilitate insertion for implantation (Par. 28 of Ginn).
Regarding claim 11, Ginn discloses the invention of claim 1. Ginn further discloses wherein the first end segment 130 (Fig. 6C) of the conduit structure 126 (Fig. 6C) is positioned upstream of the constricted portion 134 (Fig. 6C) and the second end segment 132 (Fig. 6C) is positioned downstream of the constricted portion 134 (Fig. 6C).
Regarding claim 14, Ginn discloses the invention of claim 1. Ginn further discloses wherein the constricted lumen diameter (Fig. 6C – region 134 has a diameter) is less than 50% of the expanded diameter (Par. 56 – “a first end 130 and a second end 132 that are substantially larger than an intermediate region 134”).
However, Ginn does not disclose wherein the constricted lumen diameter is less than 50% of the expanded diameter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made Ginn’s diameter of the constricted lumen to be less than 50% of the expanded diameter, in order to fit the particular procedure being done since this claimed dimension of the constricted lumen diameter does not change the constricted lumen ability to form a Venturi effect within the device, to provide, and to direct a fluid flow path. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 40 of Applicant’s PG-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn as applied to claim 1 above, and further in view of Lederman et al. US 2016/0151056 A1 (previously cited, hereinafter Lederman).
Regarding claim 6, Ginn discloses the invention of claim 1. Ginn further discloses wherein the conduit structure 126 (Fig. 6A-6C) comprises a stent frame (Par. 6 – “the support structure may include a tubular mesh, possibly including engagement elements, such as barbs, for engaging tissue surrounding the branch”, Par. 25 – “mesh structures, similar to those used for stents”).
However, Ginn does not disclose wherein the conduit structure comprises a lining.
Lederman, in the same field of endeavor of access tract between a vein and an adjacent artery (Par. 2), teaches disclose wherein the conduit structure 160 (Fig. 2 – device 160) comprises a lining (Par. 74 – “some of the walls of the occlusion device can also comprise a graft material or polymeric material lining the surface of the mesh”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit structure of Gin to further include a lining as taught by Lederman, in order to promote immediate sealing and healing and promote tissue ingrowth to secure the device over time (Par. 75 of Lederman).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn.
Regarding claim 21, Ginn discloses the invention of claim 20. Ginn further discloses wherein the blood vessel anchor 122 (Fig. 6C) comprises a stent (Par. 6 – “the support structure may include a tubular mesh, possibly including engagement elements, such as barbs, for engaging tissue surrounding the branch”, Par. 25 – “mesh structures, similar to those used for stents”; since leg 122 is a part of shunt structure 112, the anchor/leg 122 is also a stent) configured to be radially deployed (Fig. 6C) within the vein (Par. 55 and as established above).
However, Ginn does not disclose the stent being oriented at a perpendicular orientation relative to an axis of the shunt structure.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the stent to so it was perpendicular to the shunt structure since this claimed position of the stent does not change the system ability to regulate flow through the conduit structure and shunt structure. Since applicant has not given any criticality to why the position of the stent disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn in view of Bellomo et al. US 2018/0085128 A1 (previously cited, hereinafter Bellomo).
Regarding claim 24, Ginn discloses the invention of claim 15. However, Ginn does not disclose wherein the diameter of the narrowed portion of the conduit structure is adjustable.
Bellomo, in the same field of endeavor of medical apparatus for deployment within an anatomical blood vessel (Abstract), teaches wherein the diameter of the narrowed portion 120 (Fig. 6A – inner tubular wall 120) of the conduit structure 110 (Fig. 6A – outer tubular wall 110) is adjustable (Par. 73 and Par. 86 – “constricting member 130 can cause a gradual reduction of the effective diameter…” and “the circumference of the loop section 131 can be adjusted”) via a lasso suture 131+132 (Fig. 6C – loop section 131 and tail section 132).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified narrowed portion of Ginn such that it is adjustable via lasso suture as taught by Bellomo, so that the Venturi effect can be adjusted as desired. As discussed in claim 15, then narrower the diameter, the lower the pressure formed and the higher the velocity at the constricted portion, causing adjacent flow to entrain the flow at the constricted portion. Having the ability to adjust the diameter of the conduit structure can result in different Venturi effect and allow the operators to select an appropriate dimension for the patient receiving treatment.
Claims 25-34 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. WO 0197878 A1 (newly cited, hereinafter Levin) in view of Brenneman et al. US 2019/0143011 A1 (previously cited, hereinafter Brenneman) in view of Duncan et al. US 2021/0290357 A1 (previously cited, hereinafter Duncan).
Regarding claim 25, Levin discloses a method of providing a fluid connection 94 (Fig. 7 – end to end anastomosis 94) between fluid vessels 4, 6 (Fig. 7 – artery 4 and vein 6; Page 1, line 5-7 – “method for controllably perfusing venous blood into the arterial side of the lower circulatory system”, and Page 27, line 20-28 – “…anastomosis (26) formation... a T-graft end to end anastomosis (94)”), comprising:
a relatively high-pressure artery 4 (Fig. 7 – artery 4), an hourglass-shaped conduit structure 46 (Fig. 7 – Venturi implantable flow diversion device 46 with venturi throat 95) and a shunt structure 37 (Fig. 7 – T-graft 37) attached thereon (Fig. 7);
deploying the hourglass-shaped conduit structure 46 (Fig. 7) within the artery 4 (Fig. 7), the conduit structure 46 (Fig. 7) including first and second end segments (see annotated Fig. 7 below) having a first diameter (see annotated Fig. 7 below – the annotated segments inherently have a first diameter) dimensioned to anchor against an inner diameter of the artery 4 (see annotated Fig. 7 below – the annotated segments anchor against and within the diameter of the artery 4), and a narrow neck segment 95 (Fig. 7 – venturi throat 95) disposed axially between the first and second end segments (see annotated Fig. 7 below) and having a second diameter (see annotated Fig. 7 below – the Venturi throat 95 inherently has a diameter,) that is smaller than the first diameter of the first and second segments (see annotated Fig. 7 below – the diameter of the Venturi throat 95 is depicted to be smaller than that of the annotated segments);
deploying the shunt structure 37 (Fig. 7) in anatomy between the artery 4 (Fig. 7) and an adjacent relatively low-pressure vein 6 (Fig. 7), with an inlet 26 (Fig. 7 – lumen anastomosis 26) of the shunt structure 37 (Fig. 7) fluidly open in the vein 6 (Fig. 7) and directly coupled to the narrow neck segment 95 (Fig. 7) of the conduit structure 46 (Fig. 7); and
directing artery blood flow through the conduit structure 46 (Fig. 7) and through the narrow neck segment 95 (Fig. 7), thereby accelerating blood flow velocity through the narrow neck segment 95 (Fig. 7) to create a local low-pressure region 48 (Fig. 7 – low relative pressure location 48) in the narrow neck segment 95 (Fig. 7, Page 27, line 28-30 – “…a low relative pressure location (48), the low relative pressure being induced by high relative velocity of fluid flowing within the venturi throat (95)”) that draws venous blood flow from the relatively low-pressure vein 6 (Fig. 7, and Page 27, line 23 – “an implantable flow diversion device (34) at the venous export location (72)…”, thus indicating that venous blood is exported from vein 6) through the shunt structure 37 (Fig. 7) into the narrow neck segment 95 (Fig. 7) of the conduit structure 46 (Fig. 7, Page 27, last pagraph and Page 28, first pargraph – blood flows towards the Venturi structure 95).
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Annotated Fig. 7 of Levin
However, Levin does not explicitly disclose advancing a delivery catheter to a target location within a relatively high-pressure aorta, an adjacent relatively low-pressure inferior vena cava (IVC), the delivery catheter transporting an hourglass-shaped conduit structure and a shunt structure attached thereon; to increase renal artery pressure and reduce renal vein pressure.
Levin, in another embodiment, teaches advancing a delivery catheter 86 (Fig. 14A – delivery catheter 86) to a target location within a relatively high-pressure artery 4 (Fig. 14A, and Page 33, line 1-5 – “a delivery catheter (86) is shown with a push-wire (88) pushing an instrumented implantable flow diversion device (47) into the lumen of an artery (4) at a desired arterial export location (74)”)¸ the delivery catheter transporting including an instrumented implantable flow diversion device 46 (Fig. 14A, and Page 33, line 1-5).
Brenneman, in the same field of endeavor of device and method for establishing an arterio-venous fistula (Title), teaches advancing a delivery catheter 23 (Fig. 6-10 – delivery catheter 23) to a target location 31/32 within a relatively high-pressure aorta 31 (Fig. 6 – aorta 31), an adjacent relatively low-pressure inferior vena cava (IVC) 32 (Fig. 6 – vena cava 32).
Duncan, in the same field of endeavor of apparatus and system for altering blood flow in a vessel of a patient (Abstract), teaches directing aortic blood flow through the structure (Par. 15 – “altering blood flow in a vessel of a patient includes a stent element”), draws venous blood flow from the relatively low-pressure IVC to increase renal artery pressure and reduce renal vein pressure (Par. 24 – “the vessel is an aorta, and the stent element is configured to increase flow into renal arteries of the patient to improve kidney perfusion” and Par. 57 – “by dropping pressure in the renal veins may increase kidney perfusion hemodynamically”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Levin to further include a delivery catheter that contains the implant device and advance towards the target implant location, also as taught by Levin, in order to deliver the implant device into the lumen of an artery at a desired location (Page 33, line 3-4 of Levin). While the embodiment of Fig. 7 of Levin does not explicitly disclose a delivery catheter for the device with a Venturi throat and its shunt, one of ordinary skill in the art would have had the technological capability to reasonably deduce that the established modification by Levin’s embodiment of Fig. 14A results in a delivery catheter that include said device 46 and its shunt structure 37 so that deployment can take place at the target location.
Since the method of Levin discusses forming anastomosis between artery and vein as a treatment for cardiopulmonary systems (Page 5, last paragraph of Levin), for example, many discussions within the disclosure of Levin impart or suggest an inclination of device implantation at an aorta (Page 5, last paragraph of Levin), and even inferior vena cava (Page 6, first paragraph of Levin), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Levin to advance the delivery catheter towards the aorta and inferior vena cava for deployment of the implant as taught by Brenneman, in order to permitting and maintain flow from one blood vessel to the other, also for treatment of cardiopulmonary systems (Par. 3 and Par. 6 of Brenneman). The hour-glass device 46 of Levin will still maintain in the artery, particularly the aorta after modification by Brenneman; the shunt structure 37 of Levin will still maintain in the vein, particularly the IVC after modification by Brenneman.
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of the combination to further apply the Venturi flow principle of Duncan, in order to drop pressure in the renal veins and increase kidney function (Par. 24 and Par. 57 of Duncan).
Regarding claim 26, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses wherein the advancing the delivery catheter 86 (Fig. 14A of Levin) to the target location 31/32 (Fig. 6 of Brenneman) comprises advancing the delivery catheter 23 within the IVC 32 (Par. 75 of Brenneman – “the distal tip of the delivery catheter is pushed through a small aperture in the walls of… vena cava”).
Examiner notes that once the modification is made as discussed in claim 25, the delivery catheter 86 of Levin will advance towards the IVC 32 as taught by Brenneman.
Regarding claim 27, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses further comprising:
creating a passage 26+94 (Fig. 7 of Levin – anastomoses 26 and 91) within the anatomy (Fig. 7 of Levin);
wherein the advancing the delivery catheter 23 (Fig. 6-7 of Brenneman) into the anatomy comprises advancing the delivery catheter 23 into the passage (Fig. 7 of Brenneman – the delivery catheter 23 entering the aperture created on the walls of vein 32 and artery 31).
Examiner notes that once the modification is made as discussed in claim 25, advancement of the delivery catheter of Brenneman is incorporated into the method of Levin, thus including advancement into the passage.
Regarding claim 28, Levin in view of Brenneman in view of Duncan discloses the invention of claim 27. The combination further discloses wherein the deploying (Fig. 7 of Levin) the shunt structure 37 (Fig. 7 of Levin) in the anatomy between the aorta 31 and the IVC 32 (Fig. 7 of Brenneman) comprises sealing the passage 26+94 (Fig. 7 of Levin) such that fluid flow through the passage 26+94 (Fig. 7 of Levin) is prevented except for fluid flow 16 (Fig. 7 of Levin) through the shunt structure 37 (Fig. 7 of Levin).
Regarding claim 29, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. However, the combination does not currently disclose wherein the deploying the shunt structure in the anatomy is performed after the deploying the conduit structure within the aorta.
Examiner notes that according to Fig. 1, Figs. 6-10 of Brenneman, and Par. 68 of Brenneman, the deployment of the modified shunt is approached from the left femoral artery 9L (see annotated Fig. 1 and 6 of Brenneman below, and Par. 68 of Brenneman) to ultimately reach the inferior vena cava 6 (which is a vein and is depicted as IVC 32 in Fig. 6). Furthermore, according to the modification as discussed above in claim 25, the conduit structure 46 of Levin is deployed in the aorta 31 of Brenneman and the shunt structure 37 of Levin in the aperture between the vein and artery of Brenneman, thus making the deployment of shunt structure 37 before the deployment of the conduit structure 9¸ which is a reversed order of the claimed invention.
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Annotated Fig. 1 and Fig. 6 of Brenneman
Brenneman, in another embodiment, teaches that the right femoral vein 9R also provides a straight pathway to the same site on the vena cava side, and may be also be used as an access pathway (Par. 68). This means that deployment of the implant can also be achieved by approaching the fistula 7 (Fig. 1 of Brenneman) from the right femoral vein 9R, reaching the aorta 31 first.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to approach the fistula from the right femoral vein, as Brenneman teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.). Upon this modification, as established above, one of ordinary skill in the art would have recognized that the conduit structure 46 of Levin has to be deployed first in the aorta 31 because the delivery catheter 23 approaches the aorta 31 firstly. Therefore, it also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have reversed the orientation of the implant within the delivery catheter in the fight femoral vein pathway, by placing the conduit structure nearest to the distal tip of the delivery catheter in order to deploy the conduit structure first into the artery, followed by the deployment of shunt structure/neck, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167. In the instant case, the reversal of the implant within the delivery catheter will still yield the same outcome of having the conduit structure 46 of Levin deployed in the aorta 31 of Brenneman without new and unexpected result. Thus, the limitation of “wherein the deploying the shunt structure in the anatomy is performed after the deploying the conduit structure within the aorta” is met.
Regarding claim 30, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses wherein the shunt structure 37 (Fig. 7 of Levin) comprises an anchor 34 (Fig. 7 of Levin – flow diversion device 34) associated with an inlet 26 (Fig. 7 of Levin) to the shunt structure 37 (Fig. 7 of Levin), and the method further comprises deploying the anchor 34 (Fig. 7 of Levin) within the vein IVC (Fig. 6 of Brenneman).
Examiner notes that once the modification is made as discussed in claim 25, the vein 6 where device 34 of Levin is deployed will particularly be within the IVC as modified by Brenneman.
Regarding claim 31, Levin in view of Brenneman in view of Duncan discloses the invention of claim 30. However, the combination does not currently disclose wherein the deploying the anchor within the IVC is performed after the deploying the shunt structure in the anatomy.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have identified a finite number of predictable procedural order to deploy the device of the combination, i.e. to deploy the anchor before or after the shunt structure, with the anticipated success of implantation of the combined device within the blood vessels. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have tried and pursue the known options within his or her technical grasp, as it is likely the product not of innovation but of ordinary skill and common sense. MPEP 2143.
Regarding claim 32, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses wherein a space is formed around the narrow neck segment 95 (Fig. 7 of Levin – there is a space around the Venturi throat 95) within the aorta 31 (Fig. 6 of Brenneman).
Regarding claim 33, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses wherein the advancing the delivery catheter 23 (Fig. 6 of Brenneman) to the target location 31/32 (Fig. 6 of Brenneman).
However, the combination does not currently disclose comprises advancing the delivery catheter through a femoral vein and through the inferior vena cava.
Examiner notes that the current pathway of the combination is from the femoral artery and through the abdominal aorta (Par. 68 of Brenneman).
Brenneman, in another embodiment, teaches advancing the delivery catheter 2 (Fig. 1 – delivery catheter 2) through a femoral vein 9R (Fig. 1 – right femoral vein 9R) and through the inferior vena cava 6 (Fig. 1 – inferior vena cava 6, and Par. 68 – “the right femoral vein 9R also provides a straight pathway to the same site on the vena cava side, and may be also be used as an access pathway”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to approach the fistula from the right femoral vein and through the inferior vena cava, as Brenneman teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.)
Regarding claim 34, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses further comprising securing the shunt structure 37 (Fig. 7 of Levin) to the delivery catheter 86 (Fig. 14A of Levin) prior to advancing the delivery catheter 86 (Fig. 14A of Levin) to the target location 31/32 (Fig. 6 of Brenneman).
Examine notes that once the modification is made as discussed in claim 25, the delivery catheter 86 transporting the device 46 of Levin will have to contain the implant device first before advancing the delivery catheter 86 into the cavity.
Regarding claim 37, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses wherein the deploying the conduit structure 46 (Fig. 7 of Levin) within the aorta 31 (Fig. 6 of Brenneman; see modification discussed in claim 25) comprises radially expanding the conduit structure 46 (Fig. 7 of Levin shows the deployed/expanded state, which is a radial expansion), and the deploying the shunt structure 37 (Fig. 7 of Levin) in the anatomy (Fig. 7 of Levin, Fig. 6 of Brenneman; see modification discussed in claim 25) comprises radially expanding the shunt structure 37 (Fig. 7 of Levin shows the deployed/expanded state, which is a radial expansion).
Regarding claim 38, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. However, the combination does not currently disclose wherein the conduit structure and the shunt structure are each self-expanding.
Levin, in another embodiment, teaches that the implantable flow diversion device is made of nitinol (Page 27, 8-10 – “An implantable flow diversion device (34) provides vacuum support and facilitates a robust anastomosis structure, as in above-described variations . A braided vacuum support structure made of nickel titanium alloy or nitinol…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to be of a self-expanding material such as Nitinol as taught by Levin, in order to ensure patency of the tubular structure (Page 27, line 10-11 of Levin), and it has been held to be 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. In re Leshin, 125 USPQ 416.
Regarding claim 39, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses wherein:
the deploying the conduit structure 46 (Fig. 7 of Levin) within the aorta 31 (Fig. 6 of Brenneman; see modification of claim 25 above);
the deploying the shunt structure 37 (Fig. 7 of Levin) in the anatomy (Fig. 6 of Brenneman; see modification of claim 25 above).
However, the combination does not disclose wherein the delivery catheter comprises a sheath; the deploying the conduit structure within the aorta comprises slidingly retracting the sheath with respect to the conduit structure; and the deploying the shunt structure in the anatomy comprises slidingly retracting the sheath with respect to the shunt structure.
Brenneman, in the same field of endeavor of device and method for establishing an arterio-venous fistula (Title), teaches wherein the delivery catheter 23 (Fig. 6) comprises a sheath 24 (Fig. 6 – outer sheath 24); the deploying the structure within the aorta comprises slidingly retracting the sheath with respect to the structure (Fig. 9 of Brenneman, and Par. 76 of Brenneman – Then the outer sheath is pulled further proximally to release the proximal petaloids, as shown in FIG. 9”); and the deploying the shunt structure in the anatomy comprises slidingly retracting the sheath with respect to the shunt structure (Fig. 7 of Brenneman, and Par. 75 of Brenneman – “After the distal tip has entered the vena cava, the outer sheath is pulled proximally to release the distal petaloids, as shown in FIG. 8”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further include a sheath for the delivery catheter for the deployment as taught by Brenneman, in order to allow locational adjustment by pulling the implant back into the sheath prior to complete release (Par. 75 of Brenneman).
Claims 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Brenneman in view of Duncan as applied to claim 25 above, and further in view of Bellomo.
Regarding claim 35, Levin in view of Brenneman in view of Duncan discloses the invention of claim 25. The combination further discloses deploying the conduit structure 46 (Fig. 7 of Levin) within the aorta 31 (Fig. 6 of Brenneman; Examiner notes that upon the modification as discussed in claim 25, the conduit structure 46 of Levin will be deployed in the aorta 31 of Brenneman).
However, the combination does not disclose the method further comprising adjusting the second diameter of the narrow neck segment of the conduit structure after deploying the conduit structure within the artery.
Bellomo, in the same field of endeavor of medical apparatus for deployment within an anatomical blood vessel (Abstract), teaches the method further comprising adjusting the diameter (Par. 73 and Par. 86 – “constricting member 130 can cause a gradual reduction of the effective diameter…” and “the circumference of the loop section 131 can be adjusted”) of the narrow neck segment 120 (Fig. 6A – inner tubular wall 120) of the conduit structure 110 (Fig. 6A – outer tubular wall 110) after deploying the conduit structure 110 (Fig. 6A) within the fluid vessel (Par. 86 – “the circumference adjustment can be conducted while the medical apparatus is within the blood vessel (150), e.g. during the implantation procedure and/or any time after implantation”).
Since page 28, first paragraph of Levin affirms that “The venturi throat (95) geometry must be fine-tuned for proper operation. In other words, the length and diameter of the throat must be customized for the viscosity of the individual's blood and pressures and flows available to operate the venturi desirably”, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further include a diameter adjustment step of the conduit structure as taught by Bellomo, so that the Venturi effect can be adjusted as desired.
Regarding claim 36, Levin in view of Brenneman in view of Duncan in view of Bellomo discloses the invention of claim 35. The combination further discloses wherein the adjusting the diameter (Par. 73 of Bellomo and Par. 86 of Bellomo – “constricting member 130 can cause a gradual reduction of the effective diameter…” and “the circumference of the loop section 131 can be adjusted”) of the narrow neck segment 120 (Fig. 6A of Bellomo) of the conduit structure 46 (Fig. 7 of Levin) comprises using a tensioning line 132 (Fig. 6C of Bellomo – tail section 132) that extends through the conduit structure 110 (Fig. 6A of Bellomo and Fig. 6C of Bellomo – tail section 132 extends through the lumen of outer tubular wall 110 to reach the inner tubular wall 120) to reduce the second diameter of the narrow neck segment 120 (Fig. 6A of Bellomo, 6C of Bellomo, and Par. 90 of Bellomo – “tail section configured to be pulled or pushed by a mechanism in the delivery system and thereby adjust the circumference… of the inner tubular wall”; Par. 91 of Bellomo – “pulling the wire’s tail section 132… thereby its circumference is reduced”) of the conduit structure 110 (Fig. 6A of Bellomo and 6C of Bellomo).
Examiner notes that once the modification is made as discussed in claim 35, the method of adjusting the diameter of the second section of Bellomo is incorporated into the second section of the combination, including the tensioning line of Bellomo. Thus, the limitation is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hettel et al. US 2022/0249757 A1 teaches a Venturi tubular structure for diverting blood flow.
Goldberg US 2025/0161656 A1 teaches a device deployed across the aorta and IVC.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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