DETAILED ACTION
Claims 2, 12, and 19 are amended. A complete action on the merits of pending claims 2-21 appears below.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/02/2026 has been entered.
Response to Amendment
Acknowledgment is made to Applicant’s amendments filed on 06/02/2026 which are entered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 2-8, 11-14, 16-18 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Paul Jr. (US 2007/0112374 A1).
Regarding claim 2, Paul Jr. discloses, an embolic protection device (Figures 1-2, medical device (10); Paragraph [0023]) comprising:
a proximal sheath (Figures 1-2, guiding member (16); Paragraph [0023]);
a proximal filter (Figures 1-2, flexible filter portion (12); Paragraph [0023]) having a proximal end (Figure 1, second end of filter portion (12)) coupled to the proximal sheath (Paragraph [0024], discloses, “…the second end is engaged by a lumen formed in the guiding member 16.”) and a distal end (Figures 1-2, first end (13); Paragraph [0024]), the proximal filter having a length extending between the proximal end and the distal end (As clearly seen in Figure 2 and disclosed in Paragraph [0024], filter portion (12) does indeed possess a length the extends between the second end (proximal end) and the first end (13) (distal end)), and wherein the proximal end includes a first width (See annotated Figure 3 below, (First width)) and the distal end includes a second width (See annotated Figure 3 below, (Second width)), wherein when the proximal filter is deployed and entirely outside of the proximal sheath, the second width is larger than the first width (Figures 1, 3, &, 4 along with the disclosure of Paragraph [0024], which states, “The first end 13 extends distally from the guiding member 16 and the second end is engaged by a lumen formed in the guiding member 16. The mesh material includes a plurality of interwoven elements 19. The elements 19 are interwoven such that the diameter of the filter portion 12 can expand or contract while maintaining its generally tubular geometry. To facilitate deployment of the medical device 10, the filter portion 12 may be biased to expand. However, when contracted, the tubular geometry provides a very small profile during insertion of the medical device and facilitates passing the medical device 10 through the stenosis.” Clearly demonstrate the (Second width) is larger than the (First width) when filter portion (12) is deployed and outside the guiding member (16)); and
a tethering member (Figures 1-5, control wires (14)) having a first end affixed to the proximal sheath and a second end affixed to the proximal filter, wherein the tethering member extends proximally along at least a portion of the length of the proximal filter (Figures 1-5; Paragraph [0027]).
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Regarding claim 3, Paul Jr. further discloses, wherein the proximal filter (filter portion (12)) comprises a filter frame element (See annotated Figure 3 above, (Frame element); hoop/rim of filter portion (12) at first end (13) (distal end)) and a filter membrane (Figure 1, interwoven elements (19) creating the mesh material of filter portion (12) which includes openings (18); Paragraphs [0024]-[0025]).
Regarding claim 4, Paul Jr. further discloses, wherein the second end of the tethering member is affixed to the filter frame element (As seen in Figures 1 and 3, the distal/second end of control wire (14) is indeed affixed to the (Frame element); Paragraph [0027], discloses, “The control wires 14 extends proximally from the first end 13 of the filter portion 12 and are received by the guiding member 16 through control wire openings 15.”).
Regarding claim 5, Paul Jr. further discloses, wherein the second end of the tethering member is affixed to the filter membrane (Paragraph [0027] discloses, “To control the filter portion 12, the medical device 10 may include control wires 14 attached to the filter portion 12. The control wires 14 may be attached to the filter portion 12 by any suitable means including sonic bonding, thermal bonding, or adhesive bonding.” The filter portion (12) itself is the mesh material formed of interwoven elements (19) with openings (18) that function as the filter membrane (Paragraphs [0024]-[0025]). Attachment is therefore to the mesh/filter membrane structure. The broad disclosure of attachment to the filter portion (12) satisfies the “affixed to the filter membrane” limitation).
Regarding claim 6, Paul Jr. further discloses, wherein the tethering member (control wire (14)) is configured to laterally deflect a portion of the proximal filter (flexible filter portion (12)) when the proximal sheath (guiding member (16)) is retracted proximally (As disclosed in Paragraphs [0027] and [0031]-[0035] with relation to Figures 2-5, after the filter portion (12) is deployed distally from the guiding member (16) (via distal advancement of advancement member (17)), proximal movement of the control wires (14) everts the filter and laterally deflects/tilts the opening (first end (13)) to achieve wall apposition. During retrieval, further proximal pulling on the control wires draws the filter back toward/against the guiding member (16). The guiding member (16) is a retractable tubular sheath/catheter (a tubular catheter/sheath having a lumen (Figures 2-3; Paragraphs [0024] & [0032]). Paragraph [0012] & Abstract state, “The guiding member includes a lumen configured to slidably engage the filter portion.” And Paragraph [0032] states, “The filter portion 12 is contained within the guiding member 16…”. This is the classic structure of a delivery/retrieval catheter or sheath: an outer tubular member (with lumen) that constrains the device during insertion and allows deployment/retrieval by relative movement). One of ordinary skill in the art would understand that relative proximal retraction of the guiding member (16) (while holding the filter or wires) produces the same relative movement that tensions the tethering control wires and causes lateral deflection of the filter portion toward the vessel wall. The structure of Paul Jr. is therefore capable of performing the claimed function. See MPEP 2114 (functional limitations are met if the prior art structure is inherently capable of performing the function) and In re In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997)).
Regarding claim 7, Paul Jr. further discloses, wherein the tethering member (control wire (14)) comprises a flexible material that is a wire (Paragraph [0027] discloses control wire (14) as a “wire”).
Regarding claim 8, Paul Jr. further discloses, wherein the tethering member comprises a rigid or semi-rigid material selected from the group consisting of nitinol, a thermoplastic, and stainless steel (In the embodiment of Figure 6, control wires (42), equivalent to control wires (14) of the Figures 1-5 embodiment are disclosed and in Paragraph [0036] it is stated, “The control wires 42 may be made of a synthetic material, a stainless steel, or a shape memory alloy, such as Nitinol.”).
Regarding claim 11, Paul Jr. further discloses, wherein the tethering member (control wire (14)) comprises a heat-deformable polymer formed into a twisted configuration (Paragraph [0014], discloses, “In addition, the control wires may be comprised of a shape memory material…” Paragraph [0036], discloses, “The control wires 42 (equivalent to control wires (14)) may be made of a synthetic material, a stainless steel, or a shape memory alloy, such as Nitinol.” The limitation, “comprises a heat-deformable polymer formed into a twisted configuration” is a product-by-process limitation. Paul Jr. expressly contemplates polymeric and shape-memory material for the control wires/tethers. When such a heat-deformable polymer tether (Paragraphs [0037]-[0038]) is loaded into the guiding member/sheath in the collapsed state (as required for delivery), it is formed/constrained into a compact twisted configuration by the physical act of loading and packing it into the sheath lumen. The resulting tether structure in the collapsed configuration is the same as that claimed).
Regarding claim 12, Paul Jr. discloses, an embolic protection device (Figures 1-2, medical device (10); Paragraph [0023]) comprising:
a proximal sheath (Figures 1-2, guiding member (16); Paragraph [0023]);
a proximal filter (Figures 1-2, flexible filter portion (12); Paragraph [0023]) having a proximal endpoint (Figure 1, second end of filter portion (12)) coupled to the proximal sheath (Paragraph [0024], discloses, “…the second end is engaged by a lumen formed in the guiding member 16.”), a distal endpoint (Figures 1-2, first end (13); Paragraph [0024]), and a midpoint (See annotated Figure 3 below, (Midpoint)) halfway therebetween separating the proximal filter into a proximal region (See annotated Figure 3 below, (Proximal region)) and a distal region (See annotated Figure 3 below, (Distal region region)), the proximal filter comprising a filter frame element (See annotated Figure 3 above, (Frame element); hoop/rim of filter portion (12) at first end (13) (distal end)) and a filter membrane (Figure 1, interwoven elements (19) creating the mesh material of filter portion (12) which includes openings (18); Paragraphs [0024]-[0025]), and wherein the proximal endpoint includes a first width (See annotated Figure 3 above, (First width)) and the distal endpoint includes a second width (See annotated Figure 3 above, (Second width)) larger than the first width (Figures 1, 3, &, 4 along with the disclosure of Paragraph [0024], which states, “The first end 13 extends distally from the guiding member 16 and the second end is engaged by a lumen formed in the guiding member 16. The mesh material includes a plurality of interwoven elements 19. The elements 19 are interwoven such that the diameter of the filter portion 12 can expand or contract while maintaining its generally tubular geometry. To facilitate deployment of the medical device 10, the filter portion 12 may be biased to expand. However, when contracted, the tubular geometry provides a very small profile during insertion of the medical device and facilitates passing the medical device 10 through the stenosis.” Clearly demonstrate the (Second width) is larger than the (First width) when filter portion (12) is deployed and outside the guiding member (16)); and
a tethering member (Figures 1-5, control wires (14)) having a proximal end coupled to the proximal sheath and a distal end coupled to the distal region of the proximal filter (Figures 1-5; Paragraph [0027]), wherein the tethering member is configured to control deflection and angle of the distal endpoint of the proximal filter relative to the proximal sheath when the proximal sheath is retracted proximally (As disclosed in Paragraphs [0027] and [0031]-[0035] with relation to Figures 2-5, after the filter portion (12) is deployed distally from the guiding member (16) (via distal advancement of advancement member (17)), proximal movement of the control wires (14) everts the filter and laterally deflects/tilts the opening (first end (13)) to achieve wall apposition. During retrieval, further proximal pulling on the control wires draws the filter back toward/against the guiding member (16). The guiding member (16) is a retractable tubular sheath/catheter (a tubular catheter/sheath having a lumen (Figures 2-3; Paragraphs [0024] & [0032]). Paragraph [0012] & Abstract state, “The guiding member includes a lumen configured to slidably engage the filter portion.” And Paragraph [0032] states, “The filter portion 12 is contained within the guiding member 16…”. This is the classic structure of a delivery/retrieval catheter or sheath: an outer tubular member (with lumen) that constrains the device during insertion and allows deployment/retrieval by relative movement). One of ordinary skill in the art would understand that relative proximal retraction of the guiding member (16) (while holding the filter or wires) produces the same relative movement that tensions the tethering control wires and causes lateral deflection (angle of the distal endpoint of filter portion (12)) of the filter portion toward the vessel wall. The structure of Paul Jr. is therefore capable of performing the claimed function. See MPEP 2114 (functional limitations are met if the prior art structure is inherently capable of performing the function) and In re In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997)).
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Regarding claim 13, Paul Jr. further discloses, wherein the tethering member is configured to elastically pull an edge of the filter frame element laterally (The control wires (14) are flexible and resilient (Paragraph [0036], can be Nitinol or synthetic). Proximal pulling everts and laterally deflects the frame/edge at the distal opening toward the vessel wall (Paragraphs [0027] & [0035])).
Regarding claim 14, Paul Jr. further discloses, wherein the distal end of the tethering member is attached to a feature disposed along the filter membrane (The control wires (14) are attached to the filter portion (12), where interwoven elements (19) create the mesh material of filter portion (12). Paragraph [0027], discloses, “The control wires 14 may be attached to the filter portion 12 by any suitable means…”).
Regarding claim 16, Paul Jr. further discloses, wherein the proximal end of the tethering member is attached to an elongate member (Figures 2-3; advancement member (17)) slidably disposed along a length of the proximal sheath (Paragraphs [0027] and [0032]-[0034] along with Figures 2-3, show/describe control wires (14) being received by guiding member (16) through control wire openings (15) and extending along the lumen of guiding member (16), where the lumen of guiding member (16) also contains advancement member (17) that is capable of moving relative to the guiding member (16). As such given that both advancement member (17) and control wires (14) are disposed within the lumen of guiding member (16), there is indeed an interaction between the two components as especially seen in Figure 3, allowing under the broadest reasonable interpretation (BRI) for attachment (interaction) between advancement member (17) and control wires (14)).
Regarding claim 17, Paul Jr. further discloses, wherein the distal end of the tethering member is attached to two or more positions on the proximal filter (Paragraph [0027], “The control wires 14 may be attached to the filter portion 12 by any suitable means…” Further, in the Figure 6 embodiment, control wires (42) (equivalent to control wires (14)) are disclosed in Paragraph [0036] as, “Accordingly, the control wires 42 form a frame structure along the length of the filter portion 12 … The shape memory characteristics of the control wire 42 may be used to support the first end 13 of the filter portion 12 against the inner wall of the vessel 21.” Thus, allowing for attachment of the control wires at two or more positions on the filter portion (12)).
Regarding claim 18, Paul Jr. further discloses, wherein the tethering member is pre-formed into a curved configuration shape (It is disclosed that the control wires (14) may comprise Nitinol or other shape-memory material that can be pre-formed into a curved configuration (Paragraphs [0014], [0024], [0036], and [0038]). The wires create and maintain curvature during deployment to control filter eversion and deflection).
Regarding claim 19, Paul Jr. discloses, an embolic protection device (Figures 1-2, medical device (10); Paragraph [0023]) comprising:
a proximal sheath (Figures 1-2, guiding member (16); Paragraph [0023]);
a proximal filter (Figures 1-2, flexible filter portion (12); Paragraph [0023]) attached to the proximal sheath (Paragraph [0024], discloses, “…the second end is engaged by a lumen formed in the guiding member 16.”), the filter including a proximal end (Figure 1, second end of filter portion (12)) having a first width (See annotated Figure 3 above, (First width)) and a distal end (Figures 1-2, first end (13); Paragraph [0024]) having a second width (See annotated Figure 3 above, (Second width)) larger than the first width (Figures 1, 3, &, 4 along with the disclosure of Paragraph [0024], which states, “The first end 13 extends distally from the guiding member 16 and the second end is engaged by a lumen formed in the guiding member 16. The mesh material includes a plurality of interwoven elements 19. The elements 19 are interwoven such that the diameter of the filter portion 12 can expand or contract while maintaining its generally tubular geometry. To facilitate deployment of the medical device 10, the filter portion 12 may be biased to expand. However, when contracted, the tubular geometry provides a very small profile during insertion of the medical device and facilitates passing the medical device 10 through the stenosis.” Clearly demonstrate the (Second width) is larger than the (First width) when filter portion (12) is deployed and outside the guiding member (16)), the distal end defining a distally-facing opening (Figures 2-3, opening at first end (13) of filter portion (12)) configured to receive emboli into an interior of the proximal filter (The opening is indeed fully capable of performing the claim function of receiving embolic into an interior of the filter portion (12); Paragraphs [0024] & [0026]); and
a plurality of tethering members (Figures 1-5, control wires (14)), each tethering member of the plurality of tethering members having a first end coupled to the proximal sheath and a second end coupled to the proximal filter (Figures 1-5; Paragraph [0027]), wherein the plurality of tethering members are configured to move portions of the proximal filter towards the proximal sheath when the proximal sheath is retracted proximally relative to the proximal filter (Figures 1 and 5; proximally pulling of the wires (14) or relative retraction of the guiding member (16) (as previously addressed in the earlier claims) draws/collapses the filter back toward/into the sheath/guide member (16); Paragraphs [0027] and [0035]).
Regarding claim 21, Paul Jr. further discloses, wherein the plurality of tethering members (control wires (14)) are configured to control lateral deflection and angle of the proximal filter relative to the proximal sheath in multiple directions when the proximal sheath is retracted proximally (Figures 1 & 4-5; The wires control eversion, lateral deflection, tilting, and angle of the filter opening/first end (13) toward the vessel wall during relative sheath/wire movement (Paragraphs [0027] and [0034]-[0035]). Multiple wires enable multi-directional control).
Claim Rejections - 35 USC § 103
Claims 9-10 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paul Jr., in view of Clubb (US 7,220,271 B2).
Regarding claim 9, Paul Jr. teaches, a proximal sheath (guiding member (16)) and tethering members (control wires (14)) that are constrained within the proximal sheath when the proximal filter (filter portion (12)) is in the collapsed configuration (Figure 2; Paragraphs [0024] and [0032]).
Paul Jr. does not expressly teach, wherein the tethering member is configured to form a coil when the proximal filter is in a collapsed configuration within the proximal sheath.
Clubb discloses in the same field of endeavor, embolic protection filters delivered through catheters or sheaths. Clubb teaches, the use of flexible tethering elements (Figures 2A and 9A-10B, tethers (26a), (94a-c), or (104); Col. 8, line 61-Col. 9, line 30) and braided/wire components connected to filters and sliding elements; the tether-like elements are compressed/packed into a constrained low-profile state inside the delivery catheter/sheath during loading and delivery (Figures 2D-2F; Col. 9, line 44-Col. 10, line 3). Clubb further teaches heat-setting nitinol/braid wire elements into a desired shape, compressing them for delivery, and allowing them to resume the heat-set shape upon release from the sheath (Col. 4, line 46-63).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to configure the tethering control wires of Paul Jr. to form a coil (or compact twisted/packed configuration) when the proximal filter is collapsed inside the proximal sheath, as taught by Clubb, as both references and the claimed invention are directed to embolic protection filters delivered through catheters or sheaths. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the tethering control wires of Paul Jr. to form a coil (or compact twisted/packed configuration) when the proximal filter is collapsed inside the proximal sheath, as taught by Clubb, as such a modification would have been predictable, namely, to achieve a minimal delivery profile, reduce the risk of kinking or tangling inside the sheath, and enable smooth, controlled deployment and retrieval – predictable advantages that are critical for safe navigation in tortuous vasculature (Col. 8, line 23-58 and Col. 13, line 22-65 of Clubb).
Regarding claim 10, modified Paul Jr. teaches, wherein the coil is configured to untwist and straighten as the proximal filter is deployed from the proximal sheath (In Clubb, heat-set braided/wire/tether elements that are compressed inside the delivery catheter/sheath recover and resume their heat-set (expanded or functional) shape upon deployment when the catheter is withdrawn or the support member is advanced relative to the sheath (Figures 2D-2F; Col. 4, line 46-63 and Col. 9, line 44-Col. 10, line 3). Paul Jr’s tethering wires are already manipulated (pulled proximally) during deployment and retrieval to evert and collapse the filter. Substituting or modifying Paul Jr’s wires with Clubb’s heat-set, shape-recovering tether configuration would predictably cause the tether to untwist/straighten as the filter exits the sheath and is tensioned into position. One of ordinary skill would be motivated to do so for the same reasons stated above: improved low-profile delivery and reliable deployment/wall apposition with minimal procedural risk).
Regarding claim 20, Paul Jr. teaches, a proximal sheath (guiding member (16)) and tethering members (control wires (14)) that are constrained within the proximal sheath when the proximal filter (filter portion (12)) is in the collapsed configuration (Figure 2; Paragraphs [0024] and [0032]).
Paul Jr. does not expressly teach, wherein at least one of the plurality of tethering members is configured to form a coil when the proximal filter is in a collapsed configuration within the proximal sheath.
Clubb teaches, the use of flexible tethering elements (Figures 2A and 9A-10B, tethers (26a), (94a-c), or (104); Col. 8, line 61-Col. 9, line 30) and braided/wire components connected to filters and sliding elements; the tether-like elements are compressed/packed into a constrained low-profile state inside the delivery catheter/sheath during loading and delivery (Figures 2D-2F; Col. 9, line 44-Col. 10, line 3). Clubb further teaches heat-setting nitinol/braid wire elements into a desired shape, compressing them for delivery, and allowing them to resume the heat-set shape upon release from the sheath (Col. 4, line 46-63).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to configure the tethering control wires of Paul Jr. to form a coil (or compact twisted/packed configuration) when the proximal filter is collapsed inside the proximal sheath, as taught by Clubb, as both references and the claimed invention are directed to embolic protection filters delivered through catheters or sheaths. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the tethering control wires of Paul Jr. to form a coil (or compact twisted/packed configuration) when the proximal filter is collapsed inside the proximal sheath, as taught by Clubb, as such a modification would have been predictable, namely, to achieve a minimal delivery profile, reduce the risk of kinking or tangling inside the sheath, and enable smooth, controlled deployment and retrieval – predictable advantages that are critical for safe navigation in tortuous vasculature (Col. 8, line 23-58 and Col. 13, line 22-65 of Clubb).
Claim 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paul Jr., in view of Osborne (US 2004/0117004 A1).
Regarding claim 15, Paul Jr. teaches, the filter membrane (interwoven elements (19) creating the mesh material of filter portion (12) which includes openings (18)).
Paul Jr. does not expressly teach, wherein the feature comprises a rib formed on the filter membrane.
Osborne discloses, a method of forming a mesh/braid for introduction within human or animal bodies for the repair of damaged vessels such as blood vessels. Osborne teaches, reinforcing ribs or struts formed as curved wire-like members extending from the mesh/filter surface (Figures 9-11; Paragraph [0131], discloses, “The embodiment of FIG. 9 may be more appropriate, however, if the frame is formed from nitinol (NiTi) or other superelastic alloys, as forming certain type of bends, such as coil (14), may actually decrease fatigue life of a device of superelastic materials. Therefore, the bend (12) should be of a structure that minimizes bending fatigue.” These ribs provide attachment points for tethers or other securing members).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to configure the filter membrane of Paul Jr. to comprise a rib (protruding looped strut), as taught by Osborne, to enable attachment of the tethering member to the filter membrane/proximal filter, as both references and the claimed invention are directed to intravascular devices delivered through catheters or sheaths. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the filter membrane of Paul Jr. to comprise a rib (protruding looped strut), as taught by Osborne, to enable attachment of the tethering member to the filter membrane/proximal filter, as such a modification would have been predictable, namely, improved attachment/anchoring (predictable results).
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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