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 Amendment filed 10/29/25 has been entered. Claims 1, 8 and 15 are amended. Claims 1- 20 are being addressed by this Action.
Response to Arguments
Applicant’s arguments, see applicant’s Remarks, filed 10/29/25, with respect to the rejection(s) of claim(s) 8- 10 and 15- 17 under 35 U.S.C. 102(a)(1) as being anticipated by Holloway have been fully considered and are persuasive because Holloway does not explicitly disclose the newly added limitations regarding wherein when deployed in free space outside of a vessel the first strut is circumferentially adjacent to and separated from the second strut by a gap having a gap width less than three times a strut width of each of the first strut and the second strut. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Brady et al. (US Pub. No. 2013/0197567 A1) in view of Choe et al. (US Pub. No. 2021/0045761 A1). It is noted that the arguments against Holloway regard the when deployed in free space outside of a vessel feature for which the new reference Brady is relied upon.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady et al. (US Pub. No. 2013/0197567 A1) in view of Choe et al. (US Pub. No. 2021/0045761 A1).
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Regarding claim 1, Brady discloses a mechanical thrombectomy device, comprising:
a support wire (5) (Figs. 1, 4- 6); and
a clot arrestor (2) (Figs. 1- 3, 7, 10- 14) mounted on the support wire (5) (P. [0049] - - The clot engager 2 is connected to a first elongate shaft element which in this case is provided by a support shaft 5 by means of collar 10) and having an open frame cell ring, wherein the open frame cell ring includes a first frame cell having a first strut (S1) (See Annotated Fig. 7) and a second frame cell having a second strut (S2) (See Annotated Fig. 7), wherein the first frame cell and the second frame cell are each circumferentially interconnected to only one adjacent frame cell, and wherein when deployed in free space outside of a vessel (See Fig. 7 - - showing clot engager 2 fully expanded without being restricted by a vessel) the first strut (S1) is circumferentially adjacent to and separated from the second strut (S2) by a gap (48) (Fig. 7) having a gap width (Ps. [0052], [0057] - - clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams; In one case (as shown in FIG. 7) the cells 40 are not fully connected around the device circumference at all points along the length of the device, effectively leaving an open seam 48 extending from the proximal end to distal end. This seam provides a pathway through which an elongate shaft entering the device through the open mouth of section 40 may exit the middle section 43 or distal section 44 of the device, such as shown in FIGS. 1, 2 and 3 … This seam may run axially along the device as shown or may run in a more helical-like pattern around the device, or may be staggered and discontinuous, said seam patterns providing additional engagement features to aid in gripping of the target clot).
Brady further disclosing that elongate shaft 9 passes through gap (48) (P. [0052]), but Brady does not explicitly disclose
(claim 1) a gap width less than three times a strut width of each of the first strut and the second strut as claimed.
However, Choe teaches an apparatus for capturing and retrieving emboli in the same field of invention (Abstract) comprising an elongate shaft (8) (Figs. 2A- 2C, 11A- 11B, 12B, 13B- 14) having an outer diameter that is less than three times a width of a strut (Ps. [0068], [0093] - - Each cell could be made of struts having 0.001-0.010″ width and thickness; the proximal portion (202) of the pusher shaft (8) has a diameter of 0.015 to 0.020″ … the tapered intermediate portion (204) of the pusher shaft (8) has … its largest end matching the diameter of the proximal portion (202) and its smallest distal end matching the diameter of the distal portion (206) of the pusher shaft (8); and the distal portion (206) of the pusher shaft having an outer diameter of 0.005″ to 0.010″).
It is noted that the largest diameter portion of the elongate shaft (8) is 0.020” which is less than three times a strut width.
As the dimensions of a typical clot engaging device is well known in the art of manufacturing a thrombectomy device, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the width of the elongate shaft 9 that passes through the gap (48) associated with Brady such that the width of elongate shaft 9 is less than three times a strut width of each of the first strut and the second strut according to the teachings of Choe, since the modification would have yielded predictable results, namely, providing the dimensions of an elongate shaft capable of supporting a thrombectomy device, which coincidently also provides dimensions for a gap width capable letting an elongate shaft pass therethrough. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 2, Brady in view of Choe discloses the apparatus of claim 1, Brady further disclosing wherein the gap allows the first frame cell to move circumferentially relative to the second frame cell (P. [0057] - - the cells 40 are not fully connected around the device circumference at all points along the length of the device, effectively leaving an open seam 48 extending from the proximal end to distal end; since there is a circumferential open seam 48, the Brady device is capable of moving circumferentially).
Regarding claim 3, Brady in view of Choe discloses the apparatus of claim 1, Brady further disclosing wherein the gap (48) extends radially outward from a cylindrical interior of the clot arrestor between the first strut and the second strut to a surrounding environment (See Fig. 7 - - showing open stream 48 allowing for radially outward extension).
Regarding claim 4, Brady in view of Choe discloses the apparatus of claim 1, Brady further disclosing wherein the clot arrestor (2) includes a closed frame cell ring (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells).
Regarding claim 5, Brady in view of Choe discloses the apparatus of claim 4, Brady further encompassing or making obvious wherein the open frame cell ring is distal to the closed frame cell ring (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells. In another embodiment the clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams. In one embodiment the shaft 9 is positioned partially within and partially outside of the clot engager 2 in the expanded configuration and fully within the clot engager in the wrapped configuration, passing from within to without via a pathway defined by a seam extending to the distal end of the device; since shaft 9 passes in and out of the closed cells and the open cells, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to position an open frame cell ring distal to at least one closed frame cell ring since there is a limited number possible arrangements of multiple closed and open frame cell rings).
Regarding claim 6, Brady in view of Choe discloses the apparatus of claim 4, Brady further disclosing further comprising a joint (10) (Fig. 1) connecting the clot arrestor (2) to the support wire (5), wherein the clot arrestor (2) has an arrestor mouth (40) (Fig. 7) defined by a plurality of struts curving outward from the joint (10) to a ring connector of the closed frame cell ring (P. [0057] - - This seam provides a pathway through which an elongate shaft entering the device through the open mouth of section 40 may exit the middle section 43 or distal section 44 of the device, such as shown in FIGS. 1, 2 and 3).
Regarding claim 7, Brady in view of Choe discloses the apparatus of claim 4, Brady further encompassing or making obvious wherein the clot arrestor (2) has four or more frame cell rings (See Fig. 7) including the closed frame cell ring and the open frame cell ring, and wherein at least half of the four or more frame cell rings are open frame cell rings (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells. In another embodiment the clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams. In one embodiment the shaft 9 is positioned partially within and partially outside of the clot engager 2 in the expanded configuration and fully within the clot engager in the wrapped configuration, passing from within to without via a pathway defined by a seam extending to the distal end of the device; since shaft 9 passes in and out of the closed cells and the open cells, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to position at least half of the four or more frame cell rings such that the at least half are open frame cell rings since there is a limited number possible arrangements of multiple closed and open frame cell rings).
Regarding claim 8, Brady discloses a mechanical thrombectomy device, comprising:
a support wire (5) (Figs. 1, 4- 6); and
a clot arrestor (2) (Figs. 1- 3, 7, 10- 14) mounted on the support wire (5) (P. [0049] - - The clot engager 2 is connected to a first elongate shaft element which in this case is provided by a support shaft 5 by means of collar 10) and having an open frame cell ring, wherein the open frame cell ring includes a first frame cell having a first strut (S1) (See Annotated Fig. 7) and a second frame cell having a second strut (S2) (See Annotated Fig. 7), wherein the first frame cell and the second frame cell are each circumferentially interconnected to only one adjacent frame cell, wherein when deployed in free space outside of a vessel (See Fig. 7 - - showing clot engager 2 fully expanded without being restricted by a vessel) the first strut (S1) is circumferentially adjacent and parallel to the second strut (S2) in a longitudinal direction on either side of a circumferential gap (48) (Fig. 7) in the open frame cell ring, and wherein the circumferential gap (48) has a gap width (Ps. [0052], [0057] - - clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams; In one case (as shown in FIG. 7) the cells 40 are not fully connected around the device circumference at all points along the length of the device, effectively leaving an open seam 48 extending from the proximal end to distal end. This seam provides a pathway through which an elongate shaft entering the device through the open mouth of section 40 may exit the middle section 43 or distal section 44 of the device, such as shown in FIGS. 1, 2 and 3 … This seam may run axially along the device as shown or may run in a more helical-like pattern around the device, or may be staggered and discontinuous, said seam patterns providing additional engagement features to aid in gripping of the target clot).
Brady further disclosing that elongate shaft 9 passes through gap (48) (P. [0052]), but Brady does not explicitly disclose
(claim 8) wherein the circumferential gap has a gap width less than three times a strut width of each of the first strut and the second strut as claimed.
However, Choe teaches an apparatus for capturing and retrieving emboli in the same field of invention (Abstract) comprising an elongate shaft (8) (Figs. 2A- 2C, 11A- 11B, 12B, 13B- 14) having an outer diameter that is less than three times a width of a strut (Ps. [0068], [0093] - - Each cell could be made of struts having 0.001-0.010″ width and thickness; the proximal portion (202) of the pusher shaft (8) has a diameter of 0.015 to 0.020″ … the tapered intermediate portion (204) of the pusher shaft (8) has … its largest end matching the diameter of the proximal portion (202) and its smallest distal end matching the diameter of the distal portion (206) of the pusher shaft (8); and the distal portion (206) of the pusher shaft having an outer diameter of 0.005″ to 0.010″).
It is noted that the largest diameter portion of the elongate shaft (8) is 0.020” which is less than three times a strut width.
As the dimensions of a typical clot engaging device is well known in the art of manufacturing a thrombectomy device, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the width of the elongate shaft 9 that passes through the circumferential gap (48) associated with Brady such that the width of elongate shaft 9 is less than three times a strut width of each of the first strut and the second strut according to the teachings of Choe, since the modification would have yielded predictable results, namely, providing the dimensions of an elongate shaft capable of supporting a thrombectomy device, which coincidently also provides dimensions for a gap width capable letting an elongate shaft pass therethrough. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 9, Brady in view of Choe discloses the apparatus of claim 8, Brady further disclosing wherein the circumferential gap allows the first frame cell to move circumferentially relative to the second frame cell (P. [0057] - - the cells 40 are not fully connected around the device circumference at all points along the length of the device, effectively leaving an open seam 48 extending from the proximal end to distal end; since there is a circumferential open seam 48, the Brady device is capable of moving circumferentially).
Regarding claim 10, Brady in view of Choe discloses the apparatus of claim 8, Brady further disclosing wherein the circumferential gap (48) extends radially outward from a cylindrical interior of the clot arrestor between the first strut and the second strut to a surrounding environment (See Fig. 7 - - showing open stream 48 allowing for radially outward extension).
Regarding claim 11, Brady in view of Choe discloses the apparatus of claim 8, Brady further disclosing wherein the clot arrestor (2) includes a closed frame cell ring (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells).
Regarding claim 12, Brady in view of Choe discloses the apparatus of claim 11, Brady further encompassing or making obvious wherein the open frame cell ring is distal to the closed frame cell ring (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells. In another embodiment the clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams. In one embodiment the shaft 9 is positioned partially within and partially outside of the clot engager 2 in the expanded configuration and fully within the clot engager in the wrapped configuration, passing from within to without via a pathway defined by a seam extending to the distal end of the device; since shaft 9 passes in and out of the closed cells and the open cells, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to position an open frame cell ring distal to at least one closed frame cell ring since there is a limited number possible arrangements of multiple closed and open frame cell rings).
Regarding claim 13, Brady in view of Choe discloses the apparatus of claim 8, Brady further disclosing further comprising a joint (10) (Fig. 1) connecting the clot arrestor (2) to the support wire (5), wherein the clot arrestor (2) has an arrestor mouth (40) (Fig. 7) defined by a plurality of struts curving outward from the joint (10) to a ring connector of the closed frame cell ring (P. [0057] - - The struts may form at least one closed cell … an elongate shaft entering the device through the open mouth of section 40).
Regarding claim 14, Brady in view of Choe discloses the apparatus of claim 11, Brady further encompassing or making obvious wherein the clot arrestor (2) has four or more frame cell rings (See Fig. 7) including the closed frame cell ring and the open frame cell ring, and wherein at least half of the four or more frame cell rings are open frame cell rings (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells. In another embodiment the clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams. In one embodiment the shaft 9 is positioned partially within and partially outside of the clot engager 2 in the expanded configuration and fully within the clot engager in the wrapped configuration, passing from within to without via a pathway defined by a seam extending to the distal end of the device; since shaft 9 passes in and out of the closed cells and the open cells, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to position at least half of the four or more frame cell rings such that the at least half are open frame cell rings since there is a limited number possible arrangements of multiple closed and open frame cell rings).
Regarding claim 15, Brady discloses a mechanical thrombectomy device, comprising:
a support wire (5) (Figs. 1, 4- 6); and
a clot arrestor (2) (Figs. 1- 3, 7, 10- 14) mounted on the support wire (5) (P. [0049] - - The clot engager 2 is connected to a first elongate shaft element which in this case is provided by a support shaft 5 by means of collar 10) and having an open frame cell ring, wherein the open frame cell ring includes a first frame cell having a first strut (S1) (See Annotated Fig. 7) and a second frame cell having a second strut (S2) (See Annotated Fig. 7), wherein the first frame cell and the second frame cell are each circumferentially interconnected to only one adjacent frame cell, wherein when deployed in free space outside of a vessel (See Fig. 7 - - showing clot engager 2 fully expanded without being restricted by a vessel) a circumferential gap (48) (Fig. 7) separates the first strut (S1) from the second strut (S2) such that the first strut (S1) is circumferentially adjacent to the second strut (S2) and wherein the circumferential gap (48) (Fig. 7) has a gap width (Ps. [0052], [0057] - - clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams; In one case (as shown in FIG. 7) the cells 40 are not fully connected around the device circumference at all points along the length of the device, effectively leaving an open seam 48 extending from the proximal end to distal end. This seam provides a pathway through which an elongate shaft entering the device through the open mouth of section 40 may exit the middle section 43 or distal section 44 of the device, such as shown in FIGS. 1, 2 and 3 … This seam may run axially along the device as shown or may run in a more helical-like pattern around the device, or may be staggered and discontinuous, said seam patterns providing additional engagement features to aid in gripping of the target clot).
Brady further disclosing that elongate shaft 9 passes through gap (48) (P. [0052]), but Brady does not explicitly disclose
(claim 15) a gap width less than three times a strut width of each of the first strut and the second strut as claimed.
However, Choe teaches an apparatus for capturing and retrieving emboli in the same field of invention (Abstract) comprising an elongate shaft (8) (Figs. 2A- 2C, 11A- 11B, 12B, 13B- 14) having an outer diameter that is less than three times a width of a strut (Ps. [0068], [0093] - - Each cell could be made of struts having 0.001-0.010″ width and thickness; the proximal portion (202) of the pusher shaft (8) has a diameter of 0.015 to 0.020″ … the tapered intermediate portion (204) of the pusher shaft (8) has … its largest end matching the diameter of the proximal portion (202) and its smallest distal end matching the diameter of the distal portion (206) of the pusher shaft (8); and the distal portion (206) of the pusher shaft having an outer diameter of 0.005″ to 0.010″).
It is noted that the largest diameter portion of the elongate shaft (8) is 0.020” which is less than three times a strut width.
As the dimensions of a typical clot engaging device is well known in the art of manufacturing a thrombectomy device, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the width of the elongate shaft 9 that passes through the gap (48) associated with Brady such that the width of elongate shaft 9 is less than three times a strut width of each of the first strut and the second strut according to the teachings of Choe, since the modification would have yielded predictable results, namely, providing the dimensions of an elongate shaft capable of supporting a thrombectomy device, which coincidently also provides dimensions for a gap width capable letting an elongate shaft pass therethrough. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 16, Brady in view of Choe discloses the apparatus of claim 15, Brady further disclosing wherein the gap allows the first frame cell to move circumferentially relative to the second frame cell (P. [0057] - - the cells 40 are not fully connected around the device circumference at all points along the length of the device, effectively leaving an open seam 48 extending from the proximal end to distal end; since there is a circumferential open seam 48, the Brady device is capable of moving circumferentially).
Regarding claim 17, Brady in view of Choe discloses the apparatus of claim 15, Brady further disclosing wherein the gap (48) extends radially outward from a cylindrical interior of the clot arrestor between the first strut and the second strut to a surrounding environment (See Fig. 7 - - showing open stream 48 allowing for radially outward extension).
Regarding claim 18, Brady in view of Choe discloses the apparatus of claim 15, Brady further disclosing wherein the clot arrestor (2) includes a closed frame cell ring (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells).
Regarding claim 19, Brady in view of Choe discloses the apparatus of claim 18, Brady further encompassing or making obvious wherein the open frame cell ring is distal to the closed frame cell ring (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells. In another embodiment the clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams. In one embodiment the shaft 9 is positioned partially within and partially outside of the clot engager 2 in the expanded configuration and fully within the clot engager in the wrapped configuration, passing from within to without via a pathway defined by a seam extending to the distal end of the device; since shaft 9 passes in and out of the closed cells and the open cells, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to position an open frame cell ring distal to at least one closed frame cell ring since there is a limited number possible arrangements of multiple closed and open frame cell rings).
Regarding claim 20, Brady in view of Choe discloses the apparatus of claim 18, Brady further encompassing or making obvious wherein the clot arrestor (2) has four or more frame cell rings (See Fig. 7) including the closed frame cell ring and the open frame cell ring, and wherein at least half of the four or more frame cell rings are open frame cell rings (P. [0052] - - The struts may form at least one closed cell. The shaft 9 may pass through at least one of the closed cells. In another embodiment the clot engager 2 comprises multiple struts, forming multiple cells and forming a generally tubular shape, with at least one open seam along the length of the engager 2, and with the shaft 9 passing through one of said seams. In one embodiment the shaft 9 is positioned partially within and partially outside of the clot engager 2 in the expanded configuration and fully within the clot engager in the wrapped configuration, passing from within to without via a pathway defined by a seam extending to the distal end of the device; since shaft 9 passes in and out of the closed cells and the open cells, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to position at least half of the four or more frame cell rings such that the at least half are open frame cell rings since there is a limited number possible arrangements of multiple closed and open frame cell rings).
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.
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 KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771