DETAILED ACTION
Claims 1, 12, and 18-20 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.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 06/11/2026. With regards to the claim objection documented in the Non-Final Office Action sent on 04/29/2026, it is overcome through Applicant’s amendment to claim 19 and is withdrawn. With regards to the 35 USC 112(b) rejections documented in the Non-Final Office Action sent on 04/29/2026, Applicant’s amendments to claims 12 and 18 overcome the respective 112(b) rejections of each of those claims and are withdrawn, however, the 112(b) rejection of claim 20 is maintained as it was not addressed in Applicant’s response/amendments filed on 06/11/2026, even though Applicant’s remarks mentioned that it was amended to address the 112(b) rejection of claim 20.
Claim Rejections - 35 USC § 112
Claim 20 is 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.
Claim 20 recites the phrase “closed cells of the plurality of cells” (and the later reference to “adjacent cells of the plurality of cells”) which lacks antecedent basis. The claim previously recited only “a plurality of frame elements” and never introduced any “cells” or “plurality of cells.” Further, claim 20 recites the phrase “each flexion element of the at least one flexion element” which also lacks antecedent basis. The claim only recites “flexion elements” (plural) and never introduces “at least one flexion element.” For purposes of examination, Examiner will interpret claim 20 as follows (Similar to how Applicant amended claim 12 to address the same 112(b) rejection documented in the Non-Final Office Action sent on 04/29/2026): “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 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, and wherein the capture section and sealing section are defined by a plurality of cells including closed cells, and the frame being operable to be partially deployed such that the sealing section is operable to expand to an expanded diameter while at least a portion of the capture section is maintained at a collapsed diameter, and wherein each flexion element of the s is configured to longitudinally elongate and collapse to effectuate relative movement between adjacent cells of the plurality of cells.”
Appropriate correction is required.
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 longitudinally elongate and 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 longitudinally 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 longitudinally elongate and 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 longitudinally 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 a plurality of cells including closed cells; and wherein each flexion element of the flexion elements is configured to longitudinally elongate and 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 longitudinally 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 longitudinally elongate and 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 longitudinally 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 each closed cell (Cells) includes a proximal apex (First apex) and a distal apex (Second apex).
Regarding claim 19, modified Uchida teaches, wherein a first flexion element (Element) of the flexion elements (The “flexion” aspect as stated previously, is provided/taught by the bridges (3065’) of Ferrera) 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 a plurality of cells including closed cells; and wherein each flexion element of the flexion elements is configured to longitudinally elongate and 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 longitudinally 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 longitudinally elongate and 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 longitudinally 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 06/11/2026 have been fully considered but they are not persuasive.
Applicant asserts that the amended limitation requiring each flexion element to be “configured to longitudinally elongate and collapse to effectuate relative movement between adjacent cells of the plurality of cells” is not shown in Uchida or Ferrera, contending that those references “at most teach a lateral deflection” and do not teach both longitudinal elongation and collapse. Applicant further asserts that claims 12 and 20 are allowable for the same reason.
The Examiner respectfully disagrees. While Uchida does not teach the flexion elements, Ferrera expressly teaches connecting bridges between adjacent cells of a self-expanding scaffold (see, e.g., Figures 8A-9C & 30A-30B; Paragraphs [0021], [0029], [0035], & [0274]). Those bridges are deliberately configured with varying thickness and geometry “to impart flexibility to the scaffold” and to enable controlled “cell deformation” (Paragraphs [0026], [0037], [0266], & [0274]). Ferrera further teaches that the geometry and flexibility of the bridges allow the scaffold to bend, expand, contract, and be resheathed while the individual cells move relative to one another (Paragraphs [0015], [0025]-[0026], & [0037]-[0043]).
When a lattice scaffold of the type disclosed by Ferrera bends away from its longitudinal axis or radially expands/contracts, the connecting bridges necessarily lengthen (elongate) along the local cell-to-cell axis on the outer or expanding side and shorten (collapse) on the inner or contracting side. That relative length change is longitudinal with respect to the axis between adjacent cells and produces precisely the claimed relative movement between those cells. Applicant’s characterization of Ferrera as teaching only “lateral deflection” is therefore incomplete; the disclosed deformation includes both the longitudinal elongation and the collapse required by the amended claims.
Because Ferrera teaches the amended limitation, the combination of Uchida in view of Ferrera and Joergensen continues to render claims 1, 12, 20, and their dependents obvious under 35 U.S.C. 103. The amendments do not patentably distinguish the claims from the prior-art combination, and the rejections are maintained.
See updated rejections above.
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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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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