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 .
Terminal Disclaimer
The terminal disclaimer filed on 12/16/2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11317921 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1, 6-10, 12-13 and 16-17 is/are amended. Applicant stated in the arguments that claims 19-21 were canceled, however, they appear with the heading “previously presented” in the claim set. Thus, claims 1-21 are pending examination.
The objections to the claims are withdrawn.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 4 and 10 is/are withdrawn.
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered but they are not persuasive.
Regarding the limitation in claims 1, 7, and 13 of “wherein the first permeable shell and the second permeable shell are fixedly coupled together at the proximal hub”, Applicant argues Lubock fails to disclose the limitation. Examiner respectfully disagrees. Paragraph 0164 mentions “outer occlusive braid 1516 with a proximal end 1516a fixed to the proximal hub 1526”, thus the first permeable shell is fixedly coupled to the proximal shell 1526 and Paragraph 0165 mentions “an inner structural braid 1518 with a proximal end 1518a fixed to the proximal hub 1526”, thus the second permeable shell is fixedly coupled at the proximal hub 1526. Thus, Lubock does teach “wherein the first permeable shell and the second permeable shell are fixedly coupled together at the proximal hub”. Further, Applicant argues Mellmann does not teach fixed attachment between the elongate members and the jacket and attaches them in a way that they can still move relative to the longitudinal axis. Firstly, the claims do not require a fixed attachment between a middle section of the first plurality of elongate filaments and a distal section of the second plurality of filaments. Rather, the fixed coupling is required between the first permeable shell and second permeable shell at the proximal hub, which is taught by Lubock. Nonetheless, Mellmann also states “In other embodiments they are fixedly locked to each other and no relative movement is possible any more” (Paragraph 0015). Further, Mellmann states “the occluding membrane is fixed to the first jacket and the second jacket is fixed to the occluding membrane” (Paragraph 0028). Therefore, Mellman teaches a fixed coupling.
Additionally, regarding claim 1, Applicant argues that Mellman cannot be used as a teaching reference since Mellmann is not directed to a braided mesh. However, Lubock discloses “the first permeable shell comprising a first plurality of elongate filaments that are woven together to form a first braided mesh” and “the second permeable shell comprising a second plurality of elongate filaments that are woven together to form a second braided mesh”, as Lubock states throughout the disclosure that “The lattice structure of the occlusion device can have one or more braided or mesh layers” (Paragraph 0163) and refers to the cited first and second permeable braided meshes 1516 and 1518, respectively as occlusive and structural braids 1516 and 1518, thus Mellmann is not relied upon for teaching a braided mesh. Mellman is still directed to a similar device, i.e., an occlusive shell, and teaches wherein the first permeable shell (1), comprising elongate members creating a shell pattern similar to that of Lubock, and the second permeable shell (6), a jacket shaped to cover the elongate members 1, are coupled together through at least one attachment (8), as the components are sewn together, between a middle section of the first plurality of elongate filaments (elongate members 1) and a distal section of the second plurality of elongate filaments (fibers creating jacket 6) (Figure 10B; Paragraph 0096). Thus, the combination with Lubock would result in the claimed limitations as Lubock teaches a first and second braided mesh and Mellmann teaches wherein the first permeable shell and the second permeable shell are coupled together at the proximal hub and 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 response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Similar claim limitations are found in claims 7 and 13 thus are rejected for the same reasons.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 19-21 claim “the at least one attachment couples a distal portion of the second permeable shell/mesh to the first permeable shell/mesh”, however, the corresponding independent claims were amended to include the limitation “wherein the first permeable shell/mesh and the second permeable shell/mesh are 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”. The amended independents recite a narrower scope than claims 19-21, claims 19-21 fail to further limit the independent claims from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For examination purposes, the limitation will be seen as being rejected by the corresponding independent claims.
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 and 19-21 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 Mellmann et al. (US 20170258475 A1) (previously of record).
Regarding claim 1 and 19, 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, Mellmann is directed to an occlusion device and teaches wherein the first permeable shell (1) and the second permeable shell (6) are coupled together through at least one attachment (8) between a middle section of the first plurality of elongate filaments (each of elongate members 1) and a distal section of the second plurality of elongate filaments (fibers creating jacket 6) (Figure 10B; Paragraph 0096-97).
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 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 Mellmann, 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 Mellmann by incorporating wherein the first permeable shell and the second permeable shell are 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 to affix the shells together while still allowing relative movement (Mellmann Paragraph 0096).
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, Mellmann further teaches wherein the at least one attachment comprises mechanical ties (suture/thread) (Figure 10; Paragraph 0096).
Regarding claim 7 and 20, 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, Mellmann is directed to an occlusion device and teaches wherein the first permeable shell (1) and the second permeable shell (6) are coupled together through at least one attachment (8) between a middle section of the first plurality of elongate filaments (each of elongate members 1) and a distal section of the second plurality of elongate filaments (fibers creating jacket 6) (Figure 10B; Paragraph 0096-97).
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 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 Mellmann, 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 Mellmann by incorporating wherein the first permeable mesh and the second permeable mesh are 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 to affix the shells together while still allowing relative movement (Mellmann Paragraph 0096).
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, Mellmann further teaches wherein the at least one attachment comprises mechanical ties (suture/thread) (Figure 10; Paragraph 0096).
Regarding claim 13 and 21, 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, Mellmann is directed to an occlusion device and teaches wherein the first permeable shell (1) and the second permeable shell (6) are coupled together through at least one attachment (8) between a middle section of the first plurality of elongate filaments (each of elongate members 1) and a distal section of the second plurality of elongate filaments (fibers creating jacket 6) (Figure 10B; Paragraph 0096-97).
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 Mellmann, 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 Mellmann by incorporating wherein the first permeable shell and the second permeable shell are 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 to affix the shells together while still allowing relative movement (Mellmann Paragraph 0096).
Regarding claim 15, Mellmann further teaches wherein the at least one attachment comprises mechanical ties (suture/thread) (Figure 10; Paragraph 0096).
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 Mellmann and further in view of an alternative embodiment of Lorenzo.
Regarding claim 2, Lubock as modified by Lorenzo and Mellmann 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 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann and further in view of Connor (US 20180140305 A1) (previously of record).
Regarding claim 4, Lubock as modified by Lorenzo and Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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 Mellmann 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Z.J./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771