DETAILED ACTION
Claims 1, 12, and 20 are amended. A complete action on the merits of pending claims 1-20 appears below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/11/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/11/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 02/11/2026. With regards to the drawing, specification, and claim objections documented in the Final Office Action sent on 09/16/2025, they are all overcome through Applicant’s amendments and are withdrawn.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 should be amended to the following, “The embolic filter assembly of claim 18, wherein a first flexion element of the flexion elements is operably coupled between the proximal apex of a first closed cell of the plurality of closed cells and the distal apex of a second closed cell of the plurality of closed cells.” This will help maintain consistency and avoid ambiguity with regards to the limitation the Applicant is referring to and attempting to claim in claim 19 which depends on claim 12.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 12-20 rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 12 and 20 recite the phrase “closed cells of the plurality of cells” (and the later reference to “adjacent cells of the plurality of cells”) lacks antecedent basis. Each of the claims previously recited only “a plurality of frame elements” and never introduced any “cells” or “plurality of cells.” Further, claims 12 and 20 recite the phrase “each flexion element of the at least one flexion element” also lacks antecedent basis. Each of the claims recites “flexion elements” (plural) but never introduces “at least one flexion element.”
Claims 13-19 are rejected by virtue of their dependency on claim 12.
Claim 18 which depends on claim 12 introduces the limitation “a plurality of closed cells,” which claim 12 failed to provide antecedent basis for. This creates confusion and indefiniteness as to whether Applicant is referring to an entirely new limitation or to whether Applicant is referring to the previously recited limitation in claim 12, raising the question as to why it is being introduced in claim 18, while failing to do introduce and provide antecedent basis for the same limitation in claim 12, that claim 18 depends upon. As such, in view of claim 18, Examiner recommends that claim 12 be amended to, “An embolic filter assembly for deployment in a lumen of a patient, the embolic filter assembly comprising: a frame disposed about a longitudinal axis and operable to expand from a smaller, collapsed configuration to a larger, expanded configuration, the frame including a plurality of frame elements that form a plurality of cells, the plurality of frame elements defining a sealing section and a capture section, the sealing section configured to interface with the lumen of the patient, the capture section including flexion elements positioned between frame elements within the capture section, wherein the capture section and the sealing section are defined by closed cells of the plurality of cells, and the frame being operable to bend away from the longitudinal axis at the flexion elements more than adjacent portions of the frame without flexion elements, and wherein each flexion element of the flexion elements is configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.” (Claim 20 would be amended in a similar fashion; Applicant need not use the same terminology Examiner used, specifically “that form”). Claim 18 should then be amended to the following, “The embolic filter assembly of claim 12, wherein each closed cell including a proximal apex and a distal apex.”
Claim 19 is rejected by virtue of its dependency on claim 18.
Claim Rejections - 35 USC § 103
Claim(s) 1-4, 6-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uchida (JP 2011234769 A (See attached document with translation)), in view of Ferrera (US PGPUB No. 20120022576 A1), and further in view of Joergensen (US PGPUB No. 20040098026 A1).
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Regarding claim 1, Uchida discloses, a foreign matter capturing device, particularly an embolus or clot capture device for use in vascular procedures. Uchida teaches, a medical device (Figure 1, foreign substance capturing device (10); Paragraph [0029]) comprising:
an elongate element (Figure 1, shaft (12); Paragraph [0029]) having a first end (See annotated Figure 1 above, (First end)) and a second end (See annotated Figure 1 above, (Second end)); and
an embolic filter assembly (Figures 1-2, capture body (14); Paragraph [0029]) comprising a frame (Figure 2; Paragraph [0034]) having a capture section (Figure 2, expanding portion (24); Paragraphs [0033]-[0034]) and a sealing section (Figure 2, filter (28); Paragraph [0035]) distal to an attachment section (Figure 2, attachment portion (26); Paragraph [0033]), the capture section (expanding portion (24)) including a plurality of strut elements (See annotated Figure 2 below, (Struts)) arranged to define a plurality of cells (See annotated Figure 2 below, (Cells)) having cell ends (See annotated Figure 2 below, (Cell ends)) and at least one element (See annotated Figure 2 below, (Element)) operably coupled to and between cell ends of two adjacent cells of the plurality of cells (As seen in Figure 2 below, the (Element) is indeed operably coupled to and between (Cell ends) of two adjacent (Cells) of the plurality of (Cells)), wherein the sealing section (filter (28)) is configured to interface with a lumen of a patient (Figure 4; Paragraphs [0048]-[0051] and [0055]).
Uchida fails to teach, the at least one element as a flexion element such that the frame is operable to bend between the cell ends; wherein the capture section and sealing section are defined by closed cells of the plurality of cells; and wherein each flexion element of the at least one flexion element is configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.
Ferrera discloses, revascularization devices designed for treating vascular blockages. Ferrera teaches, a self-expanding scaffold comprising a plurality of open cells defined by struts and connected by bridges (Figures 8A-9C and 30A-30B; Paragraphs [0021], [0029], & [0035]); the “bridges” (Figure 30B, bridges (3065’)) are the claimed “flexion elements” given that they are the sole structural members “operably coupled to and between cell ends of two adjacent cells.” Ferrera explicitly teaches that the bridges (and struts) are deliberately designed with “varying thickness to impart flexibility to the scaffold” (Paragraph [0274]) and that the overall device is engineered around controlled “cell deformation” (Paragraphs [0026], [0266], & [0274]; Specifically in paragraph [0026], it is stated, “…an expansion diameter of the reperfusion device is configured to provide increased cell deformation of the reperfusion scaffold… In some embodiments, an expansion diameter of the thrombus removal device is configured to provide reduced cell deformation of the removal scaffold…”). Ferrera further explains that this cell deformation is achieved by the geometry and flexibility of the connecting elements (struts and bridges), which allow the scaffold to bend, expand, and be resheathed while the individual cells move relative to one another (Paragraphs [0015], [0025]-[0026], and [0037]-[0043]). When a lattice scaffold such as Ferrera’s bends or radially expands/contracts, the connecting bridges must elongate on the outer radius of the bend (or during expansion) and collapse/compress on the inner radius (or during contraction) in order for adjacent cells to change their relative positions and maintain structural integrity. This’s precisely the claimed functionality: “such that the frame is operable to bend between the cell ends” and each flexion element (bridge) is “configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.”
Joergensen discloses, a resiliently self-expanding foam filter adapted to capture and remove emboli, thrombus, and foreign bodies from a patient's vasculature. Joergensen teaches, a vascular filter (Figures 1A-1C, filter (10); Paragraph [0040]) having a sealing section and capture section defined by a closed-cell foam body (Figures 1A-1C, foam body (12); Paragraph [0040]-[0041]), where porosity and recesses define closed structural cells for sealing and emboli capture (Paragraphs [0041]-[0044] and [0068]-[0069]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s capturing body by first incorporating flexion-type connecting elements between cells as taught by Ferrera, and secondly forming the capture/sealing sections from a closed-cell foam structure as taught by Joergensen, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s capturing body by first incorporating flexion-type connecting elements between cells as taught by Ferrera, and secondly forming the capture/sealing sections from a closed-cell foam structure as taught by Joergensen, as such a modifications would have been predictable, namely, Ferrera expressly teaches that flexion/bridge elements that can elongate, collapse, or deform are beneficial for conforming to vessel walls, controlling size under load, and improving trackability/resheathability (Paragraphs [0015], [0025]-[0026], and [0037]-[0043] of Ferrera); substituting or adding such flexion elements into Uchida’s mesh would predictably improve performance in tortuous anatomy without changing the basic capture function. Furthermore, Joergensen teaches that a closed-cell foam body provides superior wall apposition/sealing and emboli capture while reducing trauma compared to open-strut designs (Paragraphs [0041]-[0044] of Joergensen); substituting Uchida’s open mesh with Joergensen’s closed-cell foam structure would predictably improve sealing and capture reliability. No new or unexpected result is achieved; the combination yields only expected improvements in conformability and capture (MPEP 2143; KSR v. Teleflex, 550 U.S. 398 (2007)).
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Regarding claim 2, Uchida further teaches, wherein the capture section (expanding portion (24)) is radially expandable relative to the attachment section (attachment portion (26)) such that the embolic filter assembly (capture body (14)) is configured to transition from a compressed state toward an expanded state in situ (Figure 2; Paragraphs [0034] and [0036]).
Regarding claim 3, Uchida teaches, wherein the capture section (expanding portion (24)) includes a seal establishment zone operable to establish a seal with tissue of a patient (Paragraph [0051], discloses, “Therefore, even when the deployment unit 24 is deployed without a gap against the wall surface of the blood vessel (38)…” Thus, expanding portion (24) includes some region that is construed as a “seal establishment zone,” given that the expanding portion confirming against the vessel wall to trap emboli).
Uchida fails to teach, a flexion zone operable to flex to conform to tortious anatomy of a patient.
Ferrera teaches, a flexion zone (Figure 30B, the zone where bridges (3065’) are located) operable to flex to conform to tortious anatomy of a patient (Paragraph [0274]).
Joergensen further supports the sealing functionality by disclosing closed-cell structures adapted to press against the lumen wall to block embolic bypass (Paragraph [0041], [0043], and [0068]-[0069]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements such that there is a flexion zone operable to flex to conform to tortious anatomy of a patient, and use closed-cell sealing bodies to enhance sealing against the lumen wall as taught by Joergensen, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sealing and flexion teachings of Ferrera and Joergensen into Uchida’s filter assembly, as such modifications would have been predictable, namely, enhance sealing reliability and flexibility (predictable modifications for devices of this type).
Regarding claim 4, Uchida teaches, the frame (Figure 2) of the embolic filter assembly (capture body (14)).
Uchida fails to teach, wherein the flexion element defines the flexion zone in which the frame has greater flexibility than in adjacent portions of the frame.
Ferrera teaches, the flexion element (bridges (3065’)) defines the flexion zone (the zone where bridges (3065’) are located represents the flexion zone, which indeed indicates bridges (3065’) do define the flexion zone) in which the frame has greater flexibility than in adjacent portions of the frame (Paragraph [0274]).
Joergensen teaches aspects of the medical device according to claim 1 (See above rejection of claim 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements such that the flexion element defines the flexion zone in which the frame has greater flexibility than in adjacent portions of the frame, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements such that the flexion element defines the flexion zone in which the frame has greater flexibility than in adjacent portions of the frame, as such a modification would have been predictable, namely, enhances compliance and flexibility, allowing the device to be more effective in tortuous anatomy.
Regarding claim 6, Uchida further teaches, wherein the plurality of cells (Cells) are closed cells (As seen in Figure 2, the (Cells) are indeed closed cells).
Regarding claim 7, Uchida further teaches, wherein each of the plurality of closed cells (Cells) includes a first apex (See annotated Figure 2 below, (First apex)) and a second apex (See annotated Figure 2 below, (Second apex)) opposite the first apex (As clearly seen in Figure 2, the (Second apex) is indeed opposite the (First apex)).
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Regarding claim 8, Uchida teaches, wherein the at least one element (Element) is operably coupled between the first apex (First apex) of a first closed cell of the plurality of closed cells (Cells) and the second apex (Second apex) of a second closed cell of the plurality of closed cells (Cells) (As clearly seen in Figure 2, the (Element) is indeed operably coupled between the (First apex) of a first cell of the (Cells) and the (Second apex) of second closed cell of the (Cells)).
Uchida fails to teach, the at least one flexion element (bridges (3065’)).
Ferrera teaches, the at least one flexion element (bridges (3065’)).
Joergensen teaches aspects of the medical device according to claim 1 (See above rejection of claim 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements, as such a modification would have been predictable, namely, enhances compliance and flexibility, allowing the device to be more effective in tortuous anatomy.
Regarding claim 9, Uchida teaches, wherein the plurality of closed cells (Cells) form a first cell row (See annotated Figure 2 above, (First row)) and a second cell row (See annotated Figure 2 above, (Second row)) along a longitudinal length of the frame (Figure 2), wherein each second apex (Second apex) of the plurality of closed cells (Cells) of the first cell row (First row) is operably coupled to each first apex (First apex) of the plurality of closed cells (Cells) of the second cell row (Second row) via the element (Element).
Uchida fails to teach, the flexion element (bridges (3065’)).
Ferrera teaches, the flexion element (bridges (3065’)).
Joergensen teaches aspects of the medical device according to claim 1 (See above rejection of claim 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements, as such a modification would have been predictable, namely, enhances compliance and flexibility, allowing the device to be more effective in tortuous anatomy.
Regarding claim 10, Uchida teaches, aspects of the medical device according to claim 1 (See above rejection of claim 1).
Uchida fails to teach, wherein the at least one flexion element is adapted to bend at a plurality of flex points between first and second ends of the flexion element.
Ferrera teaches, the at least one flexion element (bridges (3065’)) is adapted to bend at a plurality of flex points between first and second ends of the flexion element (Figure 30B; Paragraph [0274], discloses in part, “The bridges (3065′) connecting the struts (3060′) can form X-shaped connections of varying thickness (as shown). The varying thickness of the struts (3060′) and/or the bridges (3060′) advantageously can impart flexibility, kinkability, or bendability, which improves wall apposition on curves and bends, and can improve thrombus engagement. For example, the struts (3060′) can flex at two or more points (e.g., two, three, four) rather than one.”).
Joergensen teaches aspects of the medical device according to claim 1 (See above rejection of claim 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements that results in an element adapted to bend at a plurality of flex points between first and second ends of the flexion element, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements that results in an element adapted to bend at a plurality of flex points between first and second ends of the flexion element, as such a modification would have been predictable, namely, to enable multi-point bending and achieve better adaptability.
Regarding claim 11, Uchida teaches, aspects of the medical device according to claim 1 (See above rejection of claim 1).
Uchida fails to teach, wherein the at least one flexion element is adapted to extend in length.
Ferrera teaches, the at least one flexion element (bridges (3065’)) is adapted to extend in length (Paragraph [0274], discloses in part, “With reference to FIG. 30B, the expandable scaffolds can comprise cells having struts and/or bridges that vary in thickness. FIG. 30B illustrates a representative cell (3050′) of an expandable scaffold having struts (3060′) and bridges (3065′) of varying thickness (e.g., dual thickness, step-wise thickness changes or gradually varying thickness). The struts (3060′) vary in thickness along their length, with an increased thickness at a central portion (3070) of the struts (3060′). The bridges (3065′) connecting the struts (3060′) can form X-shaped connections of varying thickness (as shown). The varying thickness of the struts (3060′) and/or the bridges (3060′) advantageously can impart flexibility, kinkability, or bendability, which improves wall apposition on curves and bends, and can improve thrombus engagement. For example, the struts (3060′) can flex at two or more points (e.g., two, three, four) rather than one. In some embodiments, each cell (3050′) of the expandable scaffold flexes independently of each other.” Where the varying thickness and the ability to flex at multiple points and deform under force, imparting length variability to the structure).
Joergensen teaches aspects of the medical device according to claim 1 (See above rejection of claim 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements that results in an element capable of extending in length under physiological forces, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements that results in an element capable of extending in length under physiological forces, as such a modification would have been predictable, namely, enhances compliance and flexibility, allowing the device to be more effective in tortuous anatomy.
Regarding claim 12, Uchida teaches, an embolic filter assembly (capture body (14)) for deployment in a lumen of a patient (Figure 4; Paragraphs [0048] and [0050]-[0051]), the embolic filter assembly (capture body (14)) comprising:
a frame (Figure 2) disposed about a longitudinal axis (Figure 2) and operable to expand from a smaller, collapsed configuration to a larger, expanded configuration (Paragraphs [0033]-[0034]), the frame including a plurality of frame elements (Struts) defining a sealing section (filter (28); Paragraph [0055]) and a capture section (expanding portion (24)), the sealing section (filter (28)) configured to interface with the lumen of the patient (Paragraphs [0035] and [0051]), the capture section (expanding portion (24)) including elements (Element) positioned between frame elements (Struts) within the capture section (expanding portion (24)).
Uchida fails to teach, the elements as flexion elements and the frame being operable to bend away from the longitudinal axis at the flexion elements more than adjacent portions of the frame without flexion elements; wherein the capture section and sealing section are defined by closed cells of the plurality of cells; and wherein each flexion element of the flexion elements is configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.
Ferrera teaches, a self-expanding scaffold comprising a plurality of open cells defined by struts and connected by bridges (Figures 8A-9C and 30A-30B; Paragraphs [0021], [0029], & [0035]); the “bridges” (Figure 30B, bridges (3065’)) are the claimed “flexion elements” given that they are the sole structural members “operably coupled to and between cell ends of two adjacent cells.” Ferrera explicitly teaches that the bridges (and struts) are deliberately designed with “varying thickness to impart flexibility to the scaffold” (Paragraph [0274]) and that the overall device is engineered around controlled “cell deformation” (Paragraphs [0026], [0266], & [0274]; Specifically in paragraph [0026], it is stated, “…an expansion diameter of the reperfusion device is configured to provide increased cell deformation of the reperfusion scaffold… In some embodiments, an expansion diameter of the thrombus removal device is configured to provide reduced cell deformation of the removal scaffold…”). Ferrera further explains that this cell deformation is achieved by the geometry and flexibility of the connecting elements (struts and bridges), which allow the scaffold to bend, expand, and be resheathed while the individual cells move relative to one another (Paragraphs [0015], [0025]-[0026], and [0037]-[0043]). When a lattice scaffold such as Ferrera’s bends or radially expands/contracts, the connecting bridges must elongate on the outer radius of the bend (or during expansion) and collapse/compress on the inner radius (or during contraction) in order for adjacent cells to change their relative positions and maintain structural integrity. This’s precisely the claimed functionality: “the frame being operable to bend away from the longitudinal axis at the flexion elements more than adjacent portions of the frame without flexion elements” and each flexion element (bridge) is “configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.”
Joergensen teaches, a vascular filter (Figures 1A-1C, filter (10); Paragraph [0040]) having a sealing section and capture section defined by a closed-cell foam body (Figures 1A-1C, foam body (12); Paragraph [0040]-[0041]), where porosity and recesses define closed structural cells for sealing and emboli capture (Paragraphs [0041]-[0044] and [0068]-[0069]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s capturing body by first incorporating flexion-type connecting elements between cells as taught by Ferrera, and secondly forming the capture/sealing sections from a closed-cell foam structure as taught by Joergensen, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s capturing body by first incorporating flexion-type connecting elements between cells as taught by Ferrera, and secondly forming the capture/sealing sections from a closed-cell foam structure as taught by Joergensen, as such a modifications would have been predictable, namely, Ferrera expressly teaches that flexion/bridge elements that can elongate, collapse, or deform are beneficial for conforming to vessel walls, controlling size under load, and improving trackability/resheathability (Paragraphs [0015], [0025]-[0026], and [0037]-[0043] of Ferrera); substituting or adding such flexion elements into Uchida’s mesh would predictably improve performance in tortuous anatomy without changing the basic capture function. Furthermore, Joergensen teaches that a closed-cell foam body provides superior wall apposition/sealing and emboli capture while reducing trauma compared to open-strut designs (Paragraphs [0041]-[0044] of Joergensen); substituting Uchida’s open mesh with Joergensen’s closed-cell foam structure would predictably improve sealing and capture reliability. No new or unexpected result is achieved; the combination yields only expected improvements in conformability and capture (MPEP 2143; KSR v. Teleflex, 550 U.S. 398 (2007)).
Regarding claim 13, Uchida teaches, wherein the elements (Element) are aligned around a circumference of the frame at a common, longitudinal position along a length of the frame (As seen in Figure 2, the (Element) which there is a plurality of is indeed aligned around a circumference of the frame at a common, longitudinal position along a length of the frame).
Uchida fails to teach, the elements as flexion elements.
Ferrera teaches, flexion elements (bridges (3065’)).
Joergensen teaches, aspects of the embolic filter assembly according to claim 12 (See above rejection of claim 12).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements, as such a modification would have been predictable, namely, enhances compliance and flexibility, allowing the device to be more effective in tortuous anatomy.
Regarding claim 14, Uchida further teaches, wherein the frame (Figure 2) is operable to be partially deployed such that the sealing section (filter (28)) is operable to expand to an expanded diameter (Figure 2) while at least a portion of the capture section (expanding portion (24)) is maintained at a collapsed diameter (Paragraph [0048], discloses, that when capture body (14) (which includes filter (28) and expanding portion (24) of the frame seen in Figure 2) is accommodated in the sheath (40) shown in Figure 4, it is restrained in a folded state by the sheath (40) until it is deployed in the blood vessel to capture foreign matter as disclosed in paragraph [0050] and shown in Figure 4. Further, paragraph [0051], discloses the welded connection between shaft (12) and capture body (14). Thus, upon deployment, different portions of capture body (14) will expand sequentially, with filter (28) expanding first, while at least part of the expanding portion (24) remains constrained before fully deploying).
Regarding claim 15, Uchida further teaches, wherein the capture section (expanding portion (24)) is operable to filter fluid flowing through the capture section (expanding portion (24)) when the capture section (expanding portion (24)) is partially deployed (Paragraph [0035]).
Regarding claim 16, Uchida teaches, the frame (Figure 2) deployed within the lumen (Figure 4).
Uchida fails to teach, wherein the frame is operable to angulate at the flexion elements to maintain the frame in an orthogonal orientation within the lumen when deployed.
Ferrera teaches, the frame (Figure 30B) is operable to angulate at the flexion elements (bridges (3065’)) to maintain the frame in an orthogonal orientation within the lumen when deployed (Paragraph [0274], discloses, bridges (3065’) that allow a scaffold to bend and conform to vessel anatomy. Further, the varying thickness imparts flexibility, allowing portions of the frame to bend while maintaining proper orientation).
Joergensen teaches, aspects of the embolic filter assembly according to claim 12 (See above rejection of claim 12).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements such that the frame is operable to angulate at the flexion elements to maintain the frame in an orthogonal orientation within the lumen when deployed, as both references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s disclosure of flexion elements such that the frame is operable to angulate at the flexion elements to maintain the frame in an orthogonal orientation within the lumen when deployed, as such a modification would have been predictable, namely, to ensure proper orientation within the vessel, particularly in tortuous anatomy.
Regarding claim 18, Uchida further teaches, wherein the frame elements (Struts) form a plurality of closed cells (Cells), each closed cell including a proximal apex (First apex) and a distal apex (Second apex).
Regarding claim 19, Uchida teaches, wherein a first element (Element) is operably coupled between the proximal apex (First apex) of a first closed cell of the plurality of closed cells (Cells) and the distal apex (Second apex) of a second closed cell of the plurality of closed cells (Cells) (Figure 2 clearly shows an (Element) which there is a plurality of is operably coupled between the (First apex) of a first cell of the (Cells) and the (Second apex) of a second cell of the (Cells)).
Regarding claim 20, Uchida teaches, an embolic filter assembly (capture body (14)) for deployment in a lumen of a patient (Figure 4; Paragraphs [0048] and [0050]-[0051]), the embolic filter assembly (capture body (14)) comprising:
a frame (Figure 2) disposed about a longitudinal axis (Figure 2) and operable to expand from a smaller, collapsed configuration to a larger, expanded configuration (Paragraphs [0033]-[0034]), the frame including a plurality of frame elements (Struts) defining a sealing section (filter (28); Paragraph [0055]) and a capture section (expanding portion (24)), the sealing section (filter (28)) configured to interface with the lumen of the patient (Paragraphs [0035] and [0051]), the capture section (expanding portion (24)) including elements (Element) positioned between frame elements (Struts) within a capture section (expanding portion (24)), the frame (Figure 2) being operable to be partially deployed such that the sealing section (filter (28)) is operable to expand to an expanded diameter (Figure 2) while at least a portion of the capture section (expanding portion (24)) is maintained at a collapsed diameter (Paragraph [0048], discloses, that when capture body (14) (which includes filter (28) and expanding portion (24) of the frame seen in Figure 2) is accommodated in the sheath (40) shown in Figure 4, it is restrained in a folded state by the sheath (40) until it is deployed in the blood vessel to capture foreign matter as disclosed in paragraph [0050] and shown in Figure 4. Further, paragraph [0051], discloses the welded connection between shaft (12) and capture body (14). Thus, upon deployment, different portions of capture body (14) will expand sequentially, with filter (28) expanding first, while at least part of the expanding portion (24) remains constrained before fully deploying).
Uchida fails to teach, the elements as flexion elements; wherein the capture section and sealing section are defined by closed cells of the plurality of cells; and wherein each flexion element of the flexion elements is configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.
Ferrera discloses, revascularization devices designed for treating vascular blockages. Ferrera teaches, a self-expanding scaffold comprising a plurality of open cells defined by struts and connected by bridges (Figures 8A-9C and 30A-30B; Paragraphs [0021], [0029], & [0035]); the “bridges” (Figure 30B, bridges (3065’)) are the claimed “flexion elements” given that they are the sole structural members “operably coupled to and between cell ends of two adjacent cells.” Ferrera explicitly teaches that the bridges (and struts) are deliberately designed with “varying thickness to impart flexibility to the scaffold” (Paragraph [0274]) and that the overall device is engineered around controlled “cell deformation” (Paragraphs [0026], [0266], & [0274]; Specifically in paragraph [0026], it is stated, “…an expansion diameter of the reperfusion device is configured to provide increased cell deformation of the reperfusion scaffold… In some embodiments, an expansion diameter of the thrombus removal device is configured to provide reduced cell deformation of the removal scaffold…”). Ferrera further explains that this cell deformation is achieved by the geometry and flexibility of the connecting elements (struts and bridges), which allow the scaffold to bend, expand, and be resheathed while the individual cells move relative to one another (Paragraphs [0015], [0025]-[0026], and [0037]-[0043]). When a lattice scaffold such as Ferrera’s bends or radially expands/contracts, the connecting bridges must elongate on the outer radius of the bend (or during expansion) and collapse/compress on the inner radius (or during contraction) in order for adjacent cells to change their relative positions and maintain structural integrity. This’s precisely the claimed functionality: each flexion element (bridge) is “configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.”
Joergensen teaches, a vascular filter (Figures 1A-1C, filter (10); Paragraph [0040]) having a sealing section and capture section defined by a closed-cell foam body (Figures 1A-1C, foam body (12); Paragraph [0040]-[0041]), where porosity and recesses define closed structural cells for sealing and emboli capture (Paragraphs [0041]-[0044] and [0068]-[0069]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s capturing body by first incorporating flexion-type connecting elements between cells as taught by Ferrera, and secondly forming the capture/sealing sections from a closed-cell foam structure as taught by Joergensen, as all the references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s capturing body by first incorporating flexion-type connecting elements between cells as taught by Ferrera, and secondly forming the capture/sealing sections from a closed-cell foam structure as taught by Joergensen, as such a modifications would have been predictable, namely, Ferrera expressly teaches that flexion/bridge elements that can elongate, collapse, or deform are beneficial for conforming to vessel walls, controlling size under load, and improving trackability/resheathability (Paragraphs [0015], [0025]-[0026], and [0037]-[0043] of Ferrera); substituting or adding such flexion elements into Uchida’s mesh would predictably improve performance in tortuous anatomy without changing the basic capture function. Furthermore, Joergensen teaches that a closed-cell foam body provides superior wall apposition/sealing and emboli capture while reducing trauma compared to open-strut designs (Paragraphs [0041]-[0044] of Joergensen); substituting Uchida’s open mesh with Joergensen’s closed-cell foam structure would predictably improve sealing and capture reliability. No new or unexpected result is achieved; the combination yields only expected improvements in conformability and capture (MPEP 2143; KSR v. Teleflex, 550 U.S. 398 (2007)).
Claim(s) 5 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uchida, in view of the embodiment of Figure 30B of Ferrera, further in view of Joergensen, and even further in view of the embodiment of Figure 38 of Ferrera.
Regarding claim 5, Uchida teaches, aspects of the medical device according to claim 1 (See above rejection of claim 1).
Uchida fails to teach, wherein the flexion element is serpentine shaped having at least one curve in a first direction and at least one curve in a second, opposite direction from the first direction.
The embodiment of Figure 30B of Ferrera teaches, the flexion element (bridges (3065’)).
Joergensen teaches other aspects of the medical device according to claim 1 (See above rejection of claim 1).
The embodiment of Figure 38 of Ferrera teaches, a bridging element is serpentine shaped having at least one curve in a first direction and at least one curve in a second, opposite direction from the first direction (Figure 38; Paragraph [0317]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s embodiment of Figure 30B disclosure of flexion elements and Ferrera’s embodiment of Figure 38 disclosure of serpentine shaped having at least one curve in a first direction and at least one curve in a second, opposite direction from the first direction, as both references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s embodiment of Figure 30B disclosure of flexion elements and Ferrera’s embodiment of Figure 38 disclosure of serpentine shaped having at least one curve in a first direction and at least one curve in a second, opposite direction from the first direction, as such a modification would have been predictable, namely, enhances compliance and flexibility, allowing the device to be more effective in tortuous anatomy.
Regarding claim 17, Uchida teaches, aspects of the medical device according to claim 12 (See above rejection of claim 12).
Uchida fails to teach, wherein the flexion elements include a serpentine shape.
The embodiment of Figure 30B of Ferrera teaches, the flexion element (bridges (3065’)).
Joergensen teaches other aspects of the medical device according to claim 12 (See above rejection of claim 1).
The embodiment of Figure 38 of Ferrera teaches, a bridging element is serpentine shaped.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s embodiment of Figure 30B disclosure of flexion elements and Ferrera’s embodiment of Figure 38 disclosure of serpentine shaped, as both references and the claimed invention are directed to intravascular devices that involve deployable filter assemblies used to capture emboli within blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ushida’s bridging elements (which interconnect struts) in view of Ferrera’s embodiment of Figure 30B disclosure of flexion elements and Ferrera’s embodiment of Figure 38 disclosure of serpentine shaped, as such a modification would have been predictable, namely, enhances compliance and flexibility, allowing the device to be more effective in tortuous anatomy.
Response to Arguments
Applicant's arguments filed on 02/11/2026 have been fully considered but they are not persuasive.
Applicant argues that the amended/newly incorporated limitation, “wherein each flexion element of the at least one flexion element is configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells,” is not taught by Ferrera’s flexion elements (bridges (3065’)). Applicant specifically argues, Ferrera’s bridges are “straight struts extending between cells” and are “incapable of elongating” to produce relative cell movement.
The Examiner respectfully disagrees. Ferrera expressly discloses the claimed flexion elements and their configuration to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells. Ferrera teaches, a self-expanding scaffold comprising a plurality of open cells defined by struts and connected by bridges (Figures 8A-9C and 30A-30B; Paragraphs [0021], [0029], & [0035]); the “bridges” (Figure 30B, bridges (3065’)) are the claimed “flexion element” given that they are the sole structural members “operably coupled to and between cell ends of two adjacent cells.” The bridges are not disclosed as being limited to purely straight, rigid members incapable of length change. Instead, Ferrera repeatedly teaches that the bridges (and the struts) are deliberately designed with “varying thickness to impart flexibility to the scaffold” (Paragraph [0274]) and that the overall device is engineered around controlled “cell deformation” (Paragraphs [0026], [0266], & [0274]; Specifically in paragraph [0026], it is stated, “…an expansion diameter of the reperfusion device is configured to provide increased cell deformation of the reperfusion scaffold… In some embodiments, an expansion diameter of the thrombus removal device is configured to provide reduced cell deformation of the removal scaffold…” and in paragraph [0039] states, “…the struts and the bridges have varying thickness to impart flexibility to the scaffold. For example, a central portion of each strut can have a greater thickness than adjacent portions of the strut.”).
Further, Ferrera emphasizes that the scaffold must be capable of repeated resheathing and unsheathing while deployed in tortuous vasculature (Paragraphs [0015], [0025]-[0026], and [0037]-[0043]). In any flexible lattice scaffold of this type, when the structure bends, expands radially, or is resheathed, adjacent cells must move relative to one another. The only physical mechanism by which this relative movement occurs is through the connecting bridges (flexion elements) elongating on the outer side of a bend (or during expansion) and collapsing/compressing on the inner side (or during contraction). Ferrera’s explicit design goals of tunable “cell deformation” via flexible, variable-thickness bridges therefore directly teaches the claimed limitation: each flexion element (bridge) is “configured to elongate or collapse to effectuate relative movement between adjacent cells of the plurality of cells.”
Applicant’s characterization of Ferrera’s bridge elements as rigid “straight struts” is not supported by the disclosure. Ferrera’s bridges are not limited to straight geometry, the figures and specification of Ferrera show/describe curved, S-shaped, C-shaped, or otherwise deformable connections with their operation being described with terms such as “flexibility” and “cell deformation”. The claimed functionality is therefore taught by Ferrea and the 35 USC 103 rejection is maintained.
See updated rejections above.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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