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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/25/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1, 7, and 13 is/are amended. Claims 19-21 are canceled. Claims 1-18 are pending examination.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 19-21 is/are withdrawn.
Response to Arguments
Applicant's arguments filed 5/22/2026 with respect to the rejection(s) of claim(s) 1, 7, and 13 under U.S.C. 103 have been fully considered and are persuasive.
Examiner agrees Mellmann fails to explicitly disclose “wherein the first permeable shell and the second permeable shell…are fixedly coupled through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments” for claims 1 and 13 and “wherein the first self-expanding braided mesh and the second self-expanding braided mesh…are fixedly coupled through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments” for claim 7. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lubock in view of Lorenzo and Corcoran.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1, 3, 5, 7, 9, 11, 13 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock et al. (US 20150133989 A1) (noted on IDS) in view of Lorenzo et al. (US 20190223878 A1) (previously of record) and Corcoran et al. (US 20050113861 A1) (noted on IDS).
Regarding claim 1, Lubock discloses a device (1500) for treatment of a patient's cerebral aneurysm, comprising:
a first permeable shell (1516) having a radially constrained elongated delivery configuration in a lumen of a microcatheter (Paragraph 0126) and an expanded, deployed configuration that is longitudinally shorter than the radially constrained expanded, deployed configuration (Figure 15A), the first permeable shell comprising a first plurality of elongate filaments that are woven together to form a first braided mesh (Paragraph 0126; 0163-164), the expanded, deployed configuration having a proximal portion, a distal portion, and an interior cavity, wherein each of the first plurality of elongate filaments has a proximal end (1516a) and a distal end (1516b) (Figure 15A; Paragraph 0165), and
wherein the proximal ends of each of the first plurality of elongate filaments are gathered by a proximal hub (1526) and the distal ends of each of the first plurality of elongate filaments are gathered by a distal hub (1530) (Figure 15A; Paragraph 0165); and
a second permeable shell (1518) having a radially constrained delivery configuration in the lumen of the microcatheter and (Paragraph 0126), an expanded deployed configuration that is longitudinally shorter than the radially constrained elongated delivery configuration of the second permeable shell, the second permeable shell comprising a second plurality of elongate filaments that are woven together to form a second braided mesh (Paragraph 0126; 0163-164), wherein at least a portion of the second permeable shell is in contact with the proximal portion of the first permeable shell (Figure 15A; Paragraph 0167), wherein each of the second plurality of elongate filaments has a proximal end (1518a) and a distal end (1518b) (Figure 15A; Paragraph 0165), wherein the proximal ends of each of the second plurality of elongate filaments of the second permeable shell are gathered in the proximal hub with the proximal ends of each of the first plurality of elongate filaments of the first permeable shell (Figure 15A; Paragraph 0165), and
wherein a length of the expanded, deployed configuration of the second permeable shell is smaller than a length of the expanded, deployed configuration of the first permeable shell (1518 is located entirely inside 1516, thus has a smaller length) (Figure 15A; Paragraph 0165)
wherein the first permeable shell and the second permeable shell are fixedly coupled at the proximal hub (Figure 15A; Paragraph 0164-165).
Lubock discloses the distal end of the second permeable shell not being bound together in a hub (Figure 15A; Paragraph 0165) but fails to explicitly disclose wherein the distal ends of each of the plurality of elongate filaments of the second permeable shell are not bound together and wherein the first permeable shell and the second permeable shell are coupled through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments..
However, Lorenzo is directed to an occlusion device and teaches a first permeable shell (12) including a radially constrained expanded, deployed configuration configured for delivery within a catheter lumen (Figure 2A; Paragraph 0057; 0060) and a plurality of elongate filaments that are woven together to form a braided mesh (Paragraph 0057), wherein each of the plurality of elongate filaments has a proximal end and a distal end (Figure 2A; Paragraph 0062); a second permeable shell (13) including a radially constrained expanded, deployed configuration configured for delivery within a catheter lumen (Paragraph 0060) and a second plurality of elongate filaments that are woven together to form a braided mesh (Paragraph 0057) wherein each of the second plurality of elongate filaments has a proximal end and a distal end (Figure 2A; Paragraph 0062) wherein the distal ends of each of the second plurality of elongate filaments of the second permeable shell are not bound together (Figure 2A, 8A, 8C; Paragraph 0060; 0062).
Lorenzo teaches it is known in the art for a mesh having a free end to have the distal filaments to be bound together (Figure 8C) or not bound together (Figure 8A), suggesting the configurations are known equivalents. Thus, the rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art, namely resulting in capturing an aneurysm. KSR Int'l Co. v. Teleflex Inc., 550.
Furthermore, Corcoran is directed to an occlusion device and teaches wherein the first permeable shell (44) and the second permeable shell (60) are fixedly coupled together through at least one attachment (62) between a middle section of the first plurality of elongate filaments (each of 44) and a distal section of the second plurality of elongate filaments (fibers creating sheet 60) (Figure 2, 4; Paragraph 0026-27).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lubock as modified by Lorenzo such that the first permeable shell and the second permeable shell are fixedly coupled together through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments., as taught by Corcoran, as the references and the claimed invention are directed to occluders. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock as modified by Lorenzo with the teachings of Corcoran by incorporating wherein the first permeable shell and the second permeable shell are fixedly coupled together through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments in order prevent sliding of the sheet/shell (Corcoran Paragraph 0026).
Regarding claim 3, Lubock further discloses wherein an outer surface of the second permeable shell is in contact with an inner surface of the first permeable shell (Figure 15A; Paragraph 0165).
Regarding claim 5, Corcoran further teaches wherein the at least one attachment comprises mechanical ties (suture/thread) (Figure 2, 4; Paragraph 0026).
Regarding claim 7, Lubock discloses a device (1500) for treatment of a patient's cerebral aneurysm, comprising:
a first self-expanding braided mesh (1516) having a radially constrained delivery configuration in the lumen of the microcatheter and (Paragraph 0126), an expanded, deployed configuration that is longitudinally shorter than the radially constrained expanded, deployed configuration (Figure 15A), and a first plurality of elongate filaments that are woven together to form a the first self-expanding braided mesh (Paragraph 0126; 0163-164), the expanded, deployed configuration having a proximal portion, a distal portion, and an interior cavity, wherein each of the first plurality of elongate filaments has a proximal end (1516a) and a distal end (1516b) (Figure 15A; Paragraph 0165), and
wherein the proximal ends of each of the first plurality of elongate filaments are gathered by a proximal hub (1526) and the distal ends of each of the first plurality of elongate filaments are gathered by a distal hub (1530) (Figure 15A; Paragraph 0165); and
a second self-expanding braided mesh (1518) including a radially constrained delivery configuration in the lumen of the microcatheter and (Paragraph 0126), an expanded, deployed configuration that is longitudinally shorter than the radially constrained expanded, deployed configuration of the second permeable shell, the second self-expanding mesh comprising a second plurality of elongate filaments that are woven together to form the second self-expanding braided mesh (Paragraph 0126; 0163), wherein at least a portion of the second self-expanding mesh is in contact with the proximal portion of the first self-expanding braided mesh (Figure 15A; Paragraph 0167), wherein each of the second plurality of elongate filaments of the second self-expanding braided mesh has a proximal end (1518a) and a distal end (1518b) (Figure 15A; Paragraph 0165), wherein the proximal ends of each of the second plurality of elongate filaments of the second self-expanding braided mesh are gathered in the proximal hub with the proximal ends of each of the first plurality of elongate filaments of the first self-expanding braided mesh (Figure 15A; Paragraph 0165), and
wherein a length of the expanded, deployed configuration of the second self-expanding braided mesh is smaller than a length of the expanded, deployed configuration of the first self-expanding braided mesh (1518 is located entirely inside 1516, thus has a smaller length) (Figure 15A; Paragraph 0165); and
wherein the first self-expanding braided mesh and the second self-expanding braided mesh are fixedly coupled at the proximal hub (Figure 15A; Paragraph 0164-165).
Lubock discloses the distal end of the second self-expanding braided mesh not being bound together in a hub (Figure 15A; Paragraph 0165) but fails to explicitly disclose wherein the distal ends of each of the second plurality of elongate filaments of the second self-expanding braided mesh are not bound together and wherein the first self-expanding braided mesh and the second self-expanding meshes are coupled together through at least one attachment between the first plurality of elongate filaments and the second plurality of elongate filaments.
However, Lorenzo is directed to an occlusion device and teaches a first self-expanding braided mesh (12) including a radially constrained elongated expanded, deployed configuration configured for delivery within a catheter lumen (Figure 2A; Paragraph 0057; 0060) and a plurality of elongate filaments that are woven together to form the first self-expanding braided mesh (Paragraph 0057), wherein each of the first plurality of elongate filaments has a proximal end and a distal end (Figure 2A; Paragraph 0062); a second self-expanding braided mesh (13) comprises a radially constrained elongated expanded, deployed configuration configured for delivery within a catheter lumen (Paragraph 0060) and a second plurality of elongate filaments that are woven together to form the second self-expanding braided mesh (Paragraph 0057) wherein each of the second plurality of elongate filaments has a proximal end and a distal end (Figure 2A; Paragraph 0062) wherein the distal ends of each of the second plurality of elongate filaments of the second self-expanding braided mesh are not bound together (Figure 2A, 8A, 8C; Paragraph 0060; 0062).
Lorenzo teaches it is known in the art for a braided mesh having a free end to have the distal filaments to be bound together (Figure 8C) or not bound together (Figure 8A), suggesting the configurations are known equivalents. Thus, the rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art, namely resulting in capturing an aneurysm. KSR Int'l Co. v. Teleflex Inc., 550.
Furthermore, Corcoran is directed to an occlusion device and teaches wherein the first permeable shell (44) and the second permeable mesh (60) are fixedly coupled together through at least one attachment (62) between a middle section of the first plurality of elongate filaments (each of 44) and a distal section of the second plurality of elongate filaments (fibers creating sheet 60) (Figure 2, 4; Paragraph 0026-27).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lubock as modified by Lorenzo such that the first permeable mesh and the second permeable mesh are fixedly coupled together through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments., as taught by Corcoran, as the references and the claimed invention are directed to occluders. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock as modified by Lorenzo with the teachings of Corcoran by incorporating wherein the first permeable mesh and the second permeable mesh are fixedly coupled together through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments in order prevent sliding of the sheet/shell (Corcoran Paragraph 0026).
Regarding claim 9, Lubock further discloses wherein an outer surface of the second self-expanding braided mesh is in contact with an inner surface of the first self-expanding braided mesh (Figure 15A; Paragraph 0165).
Regarding claim 11, Corcoran further teaches wherein the at least one attachment comprises mechanical ties (suture/thread) (Figure 2, 4; Paragraph 0026).
Regarding claim 13, Lubock discloses a device (1500) for treatment of a patient's cerebral aneurysm, comprising:
a first permeable shell (1516) having a radially constrained delivery configuration in a lumen of a microcatheter (Paragraph 0126), and an expanded , deployed configuration that is longitudinally shorter than the radially constrained elongated delivery configuration, and a first plurality of elongate filaments that are woven together to form a first braided mesh (Paragraph 0126; 0163), the expanded, deployed configuration having a proximal portion, a distal portion, and an interior cavity, wherein each of the first plurality of elongate filaments has a proximal end (1516a) and a distal end (1516b) (Figure 15A; Paragraph 0165), and
wherein the proximal ends of each of the first plurality of elongate filaments are gathered by a proximal hub (1526) and the distal ends of each of the first plurality of elongate filaments are gathered by a distal hub (1530) (Figure 15A; Paragraph 0165); and
a second permeable shell (1518) having a radially constrained delivery configuration in the lumen of the microcatheter and (Paragraph 0126), an expanded, deployed configuration that is longitudinally shorter than the radially constrained expanded, deployed configuration of the second permeable shell, and a second plurality of elongate filaments that are woven together to form a second braided mesh (Paragraph 0126; 0163), wherein at least a portion of the second permeable shell is in contact with the proximal portion of the first permeable shell (Figure 15A; Paragraph 0167), wherein each of the second plurality of elongate filaments of the second permeable shell has a proximal end (1518a) and a distal end (1518b) (Figure 15A; Paragraph 0165), and
wherein the second permeable shell has an open distal end (Figure 15A; Paragraph 0165), and
wherein a length of the expanded, deployed configuration of the second permeable shell is smaller than a length of the expanded, deployed configuration of the first permeable shell (1518 is located entirely inside 1516, thus has a smaller length) (Figure 15A; Paragraph 0165); and
wherein the first permeable shell and the second permeable shell are fixedly coupled at the proximal hub (Figure 15A; Paragraph 0164-165).
Lubock discloses the distal end of the second permeable shell not being bound together in a hub (Figure 15A; Paragraph 0165) but fails to explicitly disclose wherein the distal ends of each of the plurality of elongate filaments of the second permeable shell are not bound together and wherein the first permeable shell and the second permeable shell are fixedly coupled together through at least one attachment between the first plurality of elongate filaments and the second plurality of elongate filaments.
However, Lorenzo is directed to an occlusion device and teaches a first permeable shell (12) including a radially constrained expanded, deployed configuration configured for delivery within a catheter lumen (Figure 2A; Paragraph 0057; 0060) and a plurality of elongate filaments that are woven together to form a first braided mesh (Paragraph 0057), wherein each of the first plurality of elongate filaments has a proximal end and a distal end (Figure 2A; Paragraph 0062); a second permeable shell (13) including a radially constrained expanded, deployed configuration configured for delivery within a catheter lumen (Paragraph 0060) the second permeable shell comprising a second plurality of elongate filaments that are woven together to form a braided mesh (Paragraph 0057) wherein each of the second plurality of elongate filaments has a proximal end and a distal end (Figure 2A; Paragraph 0062) wherein the distal ends of each of the second plurality of elongate filaments of the second permeable shell are not bound together (Figure 2A, 8A, 8C; Paragraph 0060; 0062).
Lorenzo teaches it is known in the art for a mesh having a free end to have the distal filaments to be bound together (Figure 8C) or not bound together (Figure 8A), suggesting the configurations are known equivalents. Thus, the rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art, namely resulting in capturing an aneurysm. KSR Int'l Co. v. Teleflex Inc., 550.
Furthermore, Corcoran is directed to an occlusion device and teaches wherein the first permeable shell (44) and the second permeable shell (60) are fixedly coupled together through at least one attachment (62) between a middle section of the first plurality of elongate filaments (each of 44) and a distal section of the second plurality of elongate filaments (fibers creating sheet 60) (Figure 2, 4; Paragraph 0026-27).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lubock as modified by Lorenzo such that the first permeable shell and the second permeable shell are fixedly coupled together through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments., as taught by Corcoran, as the references and the claimed invention are directed to occluders. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock as modified by Lorenzo with the teachings of Corcoran by incorporating wherein the first permeable shell and the second permeable shell are fixedly coupled together through at least one attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of elongate filaments in order prevent sliding of the sheet/shell (Corcoran Paragraph 0026).
Regarding claim 15, Corcoran further teaches wherein the at least one attachment comprises mechanical ties (suture/thread) (Figure 2, 4; Paragraph 0026).
Regarding claim 16, Lubock further discloses wherein the distal ends of each of the plurality of elongate filaments of the second permeable shell are not attached to the first permeable shell (Figure 15A; Paragraph 0165).
Regarding claim 17, Lubock further discloses wherein the proximal ends of each of the plurality of elongate filaments of the second permeable shell are gathered in the proximal hub with the proximal ends of each of the plurality of elongate filaments of the first permeable shell (Figure 15A; Paragraph 0165).
Claim(s) 2, 6, 8, 12, 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock in view of Lorenzo and Corcoran and further in view of an alternative embodiment of Lorenzo.
Regarding claim 2, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 1, but fails to explicitly teach wherein the second permeable shell is stiffer than the first permeable shell.
However, an alternative embodiment of Lubock discloses wherein the second permeable shell (18) is stiffer than the first permeable shell (16) (Paragraph 0128).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lubock (disclosed in Figure 15A) as modified by Lorenzo and Corcoran with the teachings of Lubock by incorporating wherein the second permeable shell is stiffer than the first permeable shell in order to provide enough radial force to inhibit movement, dislodgement and potential embolization of the occlusion device (Lorenzo Paragraph 0128) while simultaneously allowing for the occlusion device to have sufficient radial stiffness for stability, limited pore size for rapid promotion of hemostasis leading to occlusion, and a collapsed profile which is small enough to allow insertion through an inner lumen of a vascular catheter (Lorenzo Paragraph 0130). Further, Lorenzo suggests incorporating braid filaments of varying diameters may be combined in the same layer of the lattice or portions of the lattice to impart different characteristics including, e.g., stiffness, elasticity, structure, radial force, pore size, embolic filtering ability, and/or other features (Lorenzo Paragraph 0127).
Regarding claim 6, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 1, but fails to explicitly disclose wherein a diameter of each of the second plurality of elongate filaments of the second permeable shell is larger than a diameter of each of the plurality of first elongate filaments of the first permeable shell.
However, an alternative embodiment of Lubock teaches a diameter of each of the second plurality of elongate filaments of the second permeable shell (18) is larger than a diameter of each of the first plurality of elongate filaments of the first permeable shell (16) (Paragraph 0127).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lubock (disclosed in Figure 15A) as modified by Lorenzo and Corcoran with the teachings of Lubock by incorporating wherein a diameter of each of the plurality of elongate filaments of the second permeable shell is larger than a diameter of each of the first plurality of elongate filaments of the first permeable shell in order to provide increased radial stiffness in the second shell to provide enough radial force to inhibit movement, dislodgement and potential embolization of the occlusion device (Lorenzo Paragraph 0128) while simultaneously allowing for the occlusion device to have sufficient radial stiffness for stability, limited pore size for rapid promotion of hemostasis leading to occlusion, and a collapsed profile which is small enough to allow insertion through an inner lumen of a vascular catheter (Lorenzo Paragraph 0130). Further, Lorenzo suggests incorporating braid filaments of varying diameters may be combined in the same layer of the lattice or portions of the lattice to impart different characteristics including, e.g., stiffness, elasticity, structure, radial force, pore size, embolic filtering ability, and/or other features (Lorenzo Paragraph 0127).
Regarding claim 8, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 7, but fails to explicitly disclose wherein the second self-expanding braided mesh is stiffer than the first self-expanding braided mesh.
However, an alternative embodiment of Lubock discloses wherein the second self-expanding braided mesh (18) is stiffer than the first self-expanding braided mesh (16) (Paragraph 0128).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lubock (disclosed in Figure 15A) as modified by Lorenzo and Corcoran with the teachings of Lubock by incorporating wherein the second self-expanding braided mesh is stiffer than the first self-expanding braided mesh in order to provide enough radial force to inhibit movement, dislodgement and potential embolization of the occlusion device (Lorenzo Paragraph 0128) while simultaneously allowing for the occlusion device to have sufficient radial stiffness for stability, limited pore size for rapid promotion of hemostasis leading to occlusion, and a collapsed profile which is small enough to allow insertion through an inner lumen of a vascular catheter (Lorenzo Paragraph 0130). Further, Lorenzo suggests incorporating braid filaments of varying diameters may be combined in the same layer of the lattice or portions of the lattice to impart different characteristics including, e.g., stiffness, elasticity, structure, radial force, pore size, embolic filtering ability, and/or other features (Lorenzo Paragraph 0127).
Regarding claim 12, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 7, but fails to explicitly teach wherein a diameter of each of the second plurality of elongate filaments of the second self-expanding braided mesh is larger than a diameter of each of the first plurality of elongate filaments of the first self-expanding braided mesh.
However, an alternative embodiment of Lubock teaches a diameter of each of the second plurality of elongate filaments of the second self-expanding braided mesh (18) is larger than a diameter of each of the first plurality of elongate filaments of the first self-expanding braided mesh (16) (Paragraph 0127).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lubock (disclosed in Figure 15A) as modified by Lorenzo and Corcoran with the teachings of Lubock by incorporating wherein a diameter of each of the plurality of elongate filaments of the second self-expanding braided mesh is larger than a diameter of each of the plurality of elongate filaments of the first self-expanding braided mesh in order to provide increased radial stiffness in the second shell to provide enough radial force to inhibit movement, dislodgement and potential embolization of the occlusion device (Lorenzo Paragraph 0128) while simultaneously allowing for the occlusion device to have sufficient radial stiffness for stability, limited pore size for rapid promotion of hemostasis leading to occlusion, and a collapsed profile which is small enough to allow insertion through an inner lumen of a vascular catheter (Lorenzo Paragraph 0130). Further, Lorenzo suggests incorporating braid filaments of varying diameters may be combined in the same layer of the lattice or portions of the lattice to impart different characteristics including, e.g., stiffness, elasticity, structure, radial force, pore size, embolic filtering ability, and/or other features (Lorenzo Paragraph 0127).
Regarding claim 14, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 13, but fails to explicitly disclose wherein the second permeable shell is stiffer than the first permeable shell.
However, an alternative embodiment of Lubock discloses wherein the second permeable shell (18) is stiffer than the first permeable shell (16) (Paragraph 0128).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lubock (disclosed in Figure 15A) as modified by Lorenzo and Corcoran with the teachings of Lubock by incorporating wherein the second permeable shell is stiffer than the first permeable shell in order to provide enough radial force to inhibit movement, dislodgement and potential embolization of the occlusion device (Lorenzo Paragraph 0128) while simultaneously allowing for the occlusion device to have sufficient radial stiffness for stability, limited pore size for rapid promotion of hemostasis leading to occlusion, and a collapsed profile which is small enough to allow insertion through an inner lumen of a vascular catheter (Lorenzo Paragraph 0130). Further, Lorenzo suggests incorporating braid filaments of varying diameters may be combined in the same layer of the lattice or portions of the lattice to impart different characteristics including, e.g., stiffness, elasticity, structure, radial force, pore size, embolic filtering ability, and/or other features (Lorenzo Paragraph 0127).
Regarding claim 18, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 13, but fails to explicitly teach wherein a diameter of each of the second plurality of elongate filaments of the second permeable shell is larger than a diameter of each of the first plurality of elongate filaments of the first permeable shell.
However, an alternative embodiment of Lubock teaches a diameter of each of the second plurality of elongate filaments of the second permeable shell (18) is larger than a diameter of each of the first plurality of elongate filaments of the first permeable shell (16) (Paragraph 0127).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lubock (disclosed in Figure 15A) as modified by Lorenzo and Corcoran with the teachings of Lubock by incorporating wherein a diameter of each of the second plurality of elongate filaments of the second permeable shell is larger than a diameter of each of the first plurality of elongate filaments of the first permeable shell in order to provide increased radial stiffness in the second shell to provide enough radial force to inhibit movement, dislodgement and potential embolization of the occlusion device (Lorenzo Paragraph 0128) while simultaneously allowing for the occlusion device to have sufficient radial stiffness for stability, limited pore size for rapid promotion of hemostasis leading to occlusion, and a collapsed profile which is small enough to allow insertion through an inner lumen of a vascular catheter (Lorenzo Paragraph 0130). Further, Lorenzo suggests incorporating braid filaments of varying diameters may be combined in the same layer of the lattice or portions of the lattice to impart different characteristics including, e.g., stiffness, elasticity, structure, radial force, pore size, embolic filtering ability, and/or other features (Lorenzo Paragraph 0127).
Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock in view of Lorenzo and Corcoran and further in view of Connor (US 20180140305 A1) (previously of record).
Regarding claim 4, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 1, but fails to explicitly disclose wherein the length of the expanded, deployed configuration of the second permeable shell is between about 10% to about 40% of the length of the expanded, deployed configuration of the first permeable shell.
However, Connor is directed to an occlusive device and teaches wherein the length of the expanded, deployed configuration of the second permeable shell (201) is between about 10% to about 40% of the length of the expanded, deployed configuration of the first permeable shell (202) (As shown in Figure 5-6, 201 comprises between 10-40% of 202) (Figure 5-6; Paragraph 0074).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lubock as modified by Lorenzo and Corcoran such that wherein the length of the expanded, deployed configuration of the second permeable shell is between about 10% to about 40% of the length of the expanded, deployed configuration of the first permeable shell, as taught by Connor, as both references and the claimed invention are directed to occlusive devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock as modified by Lorenzo and Corcoran with the teachings of Connor by incorporating wherein the length of the expanded, deployed configuration of the second permeable shell is between about 10% to about 40% of the length of the expanded, deployed configuration of the first permeable shell in order to allow the first shell to occlude the aneurysm and the second shell to support the device in the opening of the aneurysm (Paragraph 0074). Further, Lubock suggests 1516 and 1518 can have different lengths without causing one of the braids to bunch upon collapse for delivery because the braids can move relative to each other to accommodate compression into a contracted state (Paragraph 0164).
Regarding claim 10, Lubock as modified by Lorenzo and Corcoran teaches the device of claim 7, but fails to specifically disclose wherein the length of the expanded, deployed configuration of the second self- expanding braided mesh is between about 10% to about 40% of the length of the expanded, deployed configuration of the first self-expanding braided mesh.
However, Connor is directed to an occlusive device and teaches wherein the length of the expanded, deployed configuration of the second self- expanding mesh (201) is between about 10% to about 40% of the length of the expanded, deployed configuration of the first self- expanding mesh (202) (As shown in Figure 5-6, 201 comprises between 10-40% of 202) (Figure 5-6; Paragraph 0074).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lubock as modified by Lorenzo and Corcoran such that wherein the length of the expanded, deployed configuration of the second self- expanding braided mesh is between about 10% to about 40% of the length of the expanded, deployed configuration of the first self- expanding braided mesh, as taught by Connor, as both references and the claimed invention are directed to occlusive devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock as modified by Lorenzo and Corcoran with the teachings of Connor by incorporating wherein the length of the expanded, deployed configuration of the second self- expanding braided mesh is between about 10% to about 40% of the length of the expanded, deployed configuration of the first self- expanding braided mesh in order to allow the first shell to occlude the aneurysm and the second shell to support the device in the opening of the aneurysm (Paragraph 0074). Further, Lubock suggests 1516 and 1518 can have different lengths without causing one of the braids to bunch upon collapse for delivery because the braids can move relative to each other to accommodate compression into a contracted state (Paragraph 0164).
Conclusion
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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