DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed on 08/21/2026 have been entered. Claims 1-4 and 6-20 remain pending in the application.
Response to Arguments
Applicants’ arguments, see pages 6-7, filed 08/21/2026, with respect to the rejection(s) of claim(s) 1, 14, and 20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Riel et al. (US 2019/0134668) to teach the winding coil radiopaque marker.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4 and 6-20 are rejected under 35 U.S.C. 103 as being obvious over Brady et al. (US 2016/0113663) in view of Riel et al. (US 2019/0134668).
Regarding claim 1, Brady et al. discloses an obstruction removal system (800, FIG 17a, [0269]), comprising: an elongated member (801); and, an engaging member (combination of sections 802, 804, and 805) comprising a unitary, continuous body (The body is continuous and unitary because each section is formed of a continuation of the same struts/wires of the previous section) including a plurality of struts (0269] discloses “The entire expandable body may be formed from a monolithic structure of struts and connectors”) defining a plurality of open cells (806); the engaging member having a radially compressed configuration (Collapsed delivery configuration, abstract, not shown for device 800 but understood to be the condition when constrained in a microcatheter such as shown in FIGs 2b-2d, [0239]) and a radially expanded configuration (As shown in FIG 17a); wherein the radially expanded configuration forms a longitudinally asymmetric shape having a distal region (805) that has a larger diameter than a middle region and a proximal region (FIG 17a shows the engaging member is asymmetric at least across a vertical axis, and distal region 805 has a larger diameter than middle region 804 and proximal region 802).
Brady further contemplates the use of radiopaque markers ([0231] discloses one or more expandable members may comprise marker bands or radiopaque features such as gold or platinum marker or coils) but is silent regarding wherein at least one of the plurality of struts comprises a radiopaque marker retainer having a middle region, a proximal projection extending outwardly from a proximal end of the middle region, and a distal projection extending outwardly from a distal end of the middle region, and wherein the middle region is narrower than the proximal projection and the distal projection and wherein the radiopaque marker retainer forms an area of increased width relative to proximally and distally adjacent areas of the at least one of the plurality of struts; and a radiopaque material disposed around the radiopaque marker retainer.
However, Riel teaches an exemplary radiopaque marker retainer (206, FIGs 3-5, [0095-0108]) for retaining a radiopaque marker coil (202) and formed along an elongate structure (234, [0095] – equivalent to a strut of the removal system), the radiopaque marker retainer having a middle region (217), a proximal projection (216) extending outwardly from a proximal end of the middle region (FIG 4), and a distal projection (218) extending outwardly from a distal end of the middle region (FIG 4-5), and wherein the middle region is narrower than the proximal projection and the distal projection (As shown in FIGs4-5) and wherein the radiopaque marker retainer forms an area of increased width relative to proximally and distally adjacent areas of the elongate structure (FIG 4 shows that regions 224 and 232 have an increased width relative to 234. [0103] discloses “For example, the diameter of the recessed section 217 could be less than that of the section 234. In another embodiment, the diameter of the recessed section 217 could be greater than that of the section 234 as long as it is less than the maximal diameter of the proximal and distal sections 216 and 218”), and a radiopaque material (202) disposed around the radiopaque marker retainer (Would into a coil as shown in FIG 5, [0095, 0100]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the structure of proximal section 802 of Brady to comprise at least one segment of the struts having a radiopaque marker retainer and radiopaque marker wound around the retainer, as taught by Riel, for the purpose of using a technique commonly known in the art for arranging a radiopaque marker to the struts to therein to achieve the desired imaging functions suggested by Brady.
Regarding claim 2, Brady et al./Riel disclose the invention substantially as claimed, as set forth above for claim 1. Brady further discloses the plurality of open cells have a lower porosity in the distal region than in the middle region ([0269] discloses 805 has a reduced pore size).
Regarding claim 3, Brady et al./ Riel disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses a width of the radiopaque marker retainer is greater than a width of any remaining portion along a length of the at least one of the plurality of struts (Riel [0103] discloses that the diameter at middle region 217 can be greater than the section 234, which is equivalent to the remaining portion of the strut. Proximal and distal projections 216, 218 are also of a greater width than the remainder of the elongate structure).
Regarding claim 4, Brady et al./ Riel disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the radiopaque marker retainer is positioned at an approximate middle portion of the at least one of the plurality of struts (Because the marker/marker retain is positioned along the length of the strut and not at the distal or proximal most end, it is interpreted as being location in a middle ‘region’).
Regarding claims 6, Brady et al./ Riel disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further comprises a radiopaque material disposed around the middle region of the radiopaque marker retainer (In the device as modified by Riel, the coil is wrapped around the middle region of the retainer).
Regarding claim 7, Brady et al./ Riel disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the radiopaque marker retainer comprises a dog bone shape (the narrowed middle portion and widen distal and proximal portions is interpreted as forming a dog bone shape, FIG 4 of Riel).
Regarding claims 8-9, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 1.
Brady is silent regarding the engaging member comprises a radiopaque distal tip and wherein the radiopaque distal tip is comprised of a wire disposed around a distal end of the engaging member.
However, Brady teaches in an alternative embodiment (FIGs 1a and 1f) a device wherein the engaging member (10) comprises a radiopaque distal tip (8, [0237]) and wherein the radiopaque distal tip is comprised of a wire (The coil is formed by a wrapped wire of platinum or gold) disposed around a distal end of the engaging member ([0237] discless the coil is wrapped around the distal arm 32 of the engaging member).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal end of the engaging member to comprise a radiopaque coil disposed thereon, as taught by the alternative embodiment, for the purpose of having the ability to visualize a distal end of the engaging member to ensure proper placement.
Regarding claim 10, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 1. Brady further discloses a mesh structure connected to the engaging member ([0269] distal section 805 can include additional fibres or wires or a membrane to form a net, which is interpreted as a mesh structure).
Regarding claim 11, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 10. Brady further discloses the mesh structure is positioned within the engaging member (The mesh fibers being incorporated into the struts of 805 is interpreted as being positioned within the engaging member).
Regarding claim 12, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 10. Brady further discloses the mesh structure is positioned outside of and adjacent to the engaging member (The mesh fibers being incorporated into the struts of 805 is interpreted as being positioned adjacent to engaging member).
Regarding claim 13, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 1.
Brady is silent regarding a support wire disposed within the engaging member.
However, Brady teaches in an alternative embodiment of FIG 3a-4b, a device wherein a support wire (86, [0240]) is disposed within the engaging member (82) in order to facilitate expanding and movement of one second of the expandable member relative to another ([0240]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the engaging member to comprise a support wire therein, as taught by the alternative embodiment, for the purpose of aiding in the deployment and expansion/contraction of the distal region of the expandable member relative to the middle region or between the middle region and the proximal region.
Regarding claim 14, Brady et al. discloses an obstruction removal system (800, FIG 17a, [0269]), comprising: an elongated member (801); and a plurality of engaging members (802, 804, and 805), wherein at least one of the plurality of engaging members is comprised of a plurality of struts (([0269], “the entire expandable body may be formed from a monolithic structure of struts and connectors”) having a plurality of open cells (806); the plurality of engaging members having a radially compressed configuration (Collapsed delivery configuration, abstract, not shown for device 800 but understood to be the condition when constrained in a microcatheter such as shown in FIGs 2b-2d, [0239]) and a radially expanded configuration (As shown in FIG 17a); wherein the radially expanded configuration forms a longitudinally asymmetric shape having a distal region (805) that has a larger diameter than a middle region and a proximal region (FIG 17a shows the engaging member is asymmetric at least across a vertical axis, and distal region 805 has a larger diameter than middle region 804 and proximal region 802).
Brady further contemplates the use of radiopaque markers ([0231] discloses one or more expandable members may comprise marker bands or radiopaque features such as gold or platinum marker or coils) but is silent regarding a plurality of radiopaque marker retainers, each of the plurality being positioned centrally along a length of a strut of the plurality of struts, each comprising a middle region, a proximal projection extending outwardly from a proximal end of the middle region, and a distal projection extending outwardly from a distal end of the middle region, and wherein the middle region is narrower than the proximal projection and the distal projection; a radiopaque marker wound around one or more of the plurality of radiopaque marker retainers; and wherein the middle region of each of the radiopaque marker retainers is greater than a width of each of the plurality of struts.
However, Riel teaches an exemplary radiopaque marker retainer (206, FIGs 3-5, [0095-0108]) for retaining a radiopaque marker coil (202) and formed centrally along an elongate structure (234, [0095] – equivalent to a strut of the removal system), the radiopaque marker retainer having a middle region (217), a proximal projection (216) extending outwardly from a proximal end of the middle region (FIG 4), and a distal projection (218) extending outwardly from a distal end of the middle region (FIG 4-5), and wherein the middle region is narrower than the proximal projection and the distal projection (As shown in FIGs4-5) and wherein the middle region of radiopaque marker retainer is greater than a width of the elongate structure ([0103] discloses “the diameter of the recessed section 217 could be greater than that of the section 234 as long as it is less than the maximal diameter of the proximal and distal sections 216 and 218”), and a radiopaque material marker (202) wound around the radiopaque marker retainer (Would into a coil as shown in FIG 5, [0095, 0100]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the structure of proximal section 802 of Brady to comprise a plurality of radiopaque marker retainers and a radiopaque marker wound around the retainers, as taught by Riel, for the purpose of using a technique commonly known in the art for arranging a radiopaque marker to the struts to therein to achieve the desired imaging functions suggested by Brady.
Regarding claim 15, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 14. Brady further discloses the plurality of engaging members includes a distal engaging member (805) and a proximal engaging member (802), and wherein a width of the distal engaging member is less than a width of the proximal engaging member (a width can be taken at the point shown in annotated FIG 17a below wherein the width of 805 is the shortest).
Regarding claim 16, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 15. Brady further discloses the plurality of engaging members includes a medial engaging member (One of petals 803 is interpreted as a medial engaging member) between the distal engaging member and the proximal engaging member (FIG 17a), wherein a width of the medial engaging member is greater than the width of the distal engaging member (See FIG 17a below), and wherein the width of the medial engaging member is less than the width of the proximal engaging member (See FIG 17a below).
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Regarding claim 17, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 14. Brady further discloses the plurality of open cells have a lower porosity in the distal region than in the middle region ([0269] discloses 805 has a reduced pore size).
Regarding claim 18, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 14. Brady further discloses a mesh structure connected to at least one of the engaging members ([0269] distal section 805 can include additional fibres or wires or a membrane to form a net, which is interpreted as a mesh structure).
Regarding claim 19, Brady et al./ Riel discloses the invention substantially as claimed, as set forth above for claim 14. The device as modified further discloses each of the plurality of radiopaque marker retainers are radially offset from each other (Due to the configuration of the struts of the engaging members, the marker retainers are radially offset from one another in a circumferential direction of the cylindrical shaped device).
Regarding claim 20, Brady et al. discloses an obstruction removal system (800, FIG 17a, [0269]), comprising: an elongated member (801); an engagement means for capturing a thrombus (combination of sections 802, 804, and 805) including a plurality of open cells (806); the engagement means has a radially compressed configuration (Collapsed delivery configuration, abstract, not shown for device 800 but understood to be the condition when constrained in a microcatheter such as shown in FIGs 2b-2d, [0239]) and a radially expanded configuration (As shown in FIG 17a), and wherein the engagement means comprises a plurality of struts (0269] discloses “The entire expandable body may be formed from a monolithic structure of struts and connectors”); wherein the radially expanded configuration forms a unitary, continuous body (The body is continuous and unitary because each section is formed of a continuation of the same struts/wires of the previous section) longitudinally asymmetric shape having a distal region (805) that has a larger diameter than a middle region and a proximal region (FIG 17a shows the engaging member is asymmetric at least across a vertical axis, and distal region 805 has a larger diameter than middle region 804 and proximal region 802).
Brady further contemplates the use of radiopaque markers ([0231] discloses one or more expandable members may comprise marker bands or radiopaque features such as gold or platinum marker or coils) but is silent regarding wherein at least one of the plurality of struts comprises a retainer means for retaining a radiopaque marker, wherein the retaining means comprises a middle region, a proximal projection extending outwardly from a proximal end of the middle region, and a distal projection extending outwardly from a distal end of the middle region, and wherein the middle region is narrower than the proximal projection and the distal projection; wherein the radiopaque marker is wound around the middle region of the retainer means; and wherein the middle region of the retainer means has a greater width than any width along a remaining length of the at least one of the plurality of struts.
However, Riel teaches an exemplary retainer means (206, FIGs 3-5, [0095-0108]) for retaining a radiopaque marker coil (202) and formed centrally along an elongate structure (234, [0095] – equivalent to a strut of the removal system), the retainer means having a middle region (217), a proximal projection (216) extending outwardly from a proximal end of the middle region (FIG 4), and a distal projection (218) extending outwardly from a distal end of the middle region (FIG 4-5), and wherein the middle region is narrower than the proximal projection and the distal projection (As shown in FIGs4-5) and wherein the middle region of the retainer means is greater than a width of the elongate structure ([0103] discloses “the diameter of the recessed section 217 could be greater than that of the section 234 as long as it is less than the maximal diameter of the proximal and distal sections 216 and 218”), and a radiopaque marker (202) wound around the middle region of the retainer means (Would into a coil as shown in FIG 5, [0095, 0100]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the structure of proximal section 802 of Brady such that the struts comprise at least one retainer means and a radiopaque marker wound around the middle region of the retainers, as taught by Riel, for the purpose of using a technique commonly known in the art for arranging a radiopaque marker to the struts to therein to achieve the desired imaging functions suggested by Brady.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
