DETAILED ACTION
This action is in response to applicant's amendments filed 06/10/26.
The examiner acknowledges the amendments to the claims.
Claims 1-5, 7, 9, 11-23, 62-65 are pending in this application.
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 Arguments
Applicant's arguments filed 06/10/26 have been fully considered but they are not persuasive.
Applicant generally argues that Garrison does not disclose “an expander coupled to the open proximal end [of a frame of a cutting device]” as recited in claim 14, since Garrison instead discloses in [0167] that an expander (actuation member) is coupled to a distal end region of a frame of cutting device 300. However, under broadest reasonable interpretation, the open proximal end (defined by the cutting blades 302 of the cutting device 300 in Figure 11; [0114]) is considered to be “coupled to” an expander (“actuation member”; [0167]), since “the cutting portion 300 may be coupled to an actuation member that… causes the capture portion 200 and/or the cutting portion 300 to partially or fully expand” (Id.). Even though Garrison teaches that the expander may be coupled to a “distal end region” of the cutting device, the expander may still be considered as being coupled to the open proximal end via the distal end region. The recited phrase “coupled to” does not require direct contact or connection, and therefore the expander being indirectly connected to the open proximal end reads on the claim limitation. It is noted that Claim 14 does not recite that the expander is “fixed to” or “attached to” the open proximal end, for example. Additionally, Garrison discloses that the expander is operably coupled to the open proximal end, since actuation of the expander causes expansion of the open proximal end, and therefore this operable connection reads on the claim limitation. Therefore, the rejection stands.
Applicant further generally argues that one of ordinary skill in the art would not modify Garrison with Marks, since doing so would render the invention unsatisfactory for its intended purpose of removing and capturing thrombus material. Applicant asserts that the expander taught by Marks would obstruct the open proximal end of Garrison and render the resulting invention inoperable. However, one of ordinary skill in the art would understand that Marks teaches the purpose of collecting thrombus material ([0016]) and when combined with Garrison, the expander structure would still allow thrombus material to pass through an open proximal end and be captured by the collection basket at the distal end, as seen in Figure 19F, [0142] of Marks. Therefore, the combination of Garrison with Marks would not render the invention inoperable for its intended purpose, and the rejection stands.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 14-15 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garrison et al., hereinafter “Garrison” (U.S. Pub. No. 2022/0287817)
Regarding claim 14, Garrison discloses a thrombectomy device (see abstract) comprising
a collection device 200 with a mesh structure (Figure 11, [0115]) having a closed distal end and an open proximal end;
a cutting device 300 comprising a frame (Id.), the frame comprising:
an open distal end coupled to the open proximal end of the collection
device ([0114], the cutting device is open at its distal and proximal ends to allow a thrombus to move from within the cutting device into the collection device 200);
an open proximal end (Id.);
an interior passage spanning between the open proximal end and the open distal end of the frame (Id.); and
one or more cutting blades 302 ([0116]) disposed at the open proximal end; and
an expander (actuation member; [0167]) coupled to the open proximal end (Id.; the actuation member causes the cutting device 300 and its proximal end to expand and collapse), the expander configured to expand and collapse the open proximal end of the cutting device (Id.), wherein the expander is configured to enable a clinician to adjust and maintain a cutting diameter of the one or more cutting blades (via an operator moving or holding a handle of the actuation member at a proximal portion of the device in different expanded positions; Id.).
Regarding claim 15, Garrison discloses the expander is configured to enable the clinician to adjust the diameter of the cutting diameter along a continuum of diameters (Id.; the operator may progressively pull the actuation member resulting in the cutting diameter expanding along a continuum of diameters).
Regarding claim 20-21, Garrison discloses the one or more cutting blades comprises proximally directed cutting points 302 (Figure 11), wherein the one or more-cutting points provide the cutting diameter (Id.).
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.
Claims 1-5, 7, 12, 18-19, 22, and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (U.S. Pub. No. 2022/0287817) in view of Marks et al., hereinafter “Marks” (U.S. Pub. No. 2013/0030460).
Regarding claim 1, Garrison discloses a thrombectomy device configured to remove a thrombus from a vein (see abstract, [0093], [0095])
an inner shaft 102 (Figure 11);
a collection device 200 comprising a basket ([0115]) with a closed distal end coupled to the inner shaft and an open proximal end (Id.);
a cutting device 300 comprising a frame (Id.), the frame comprising:
an open distal end coupled to the open proximal end of the collection
device ([0114], the cutting device is open at its distal and proximal ends to allow a thrombus to move from within the cutting device into the collection device 200;
an open proximal end (Id.);
an interior lumen spanning between the open proximal end and the open
distal end of the frame (Id.); and
one or more cutting blades (cutting blades 302; [0116]) disposed at the open proximal end;
an expansion mechanism (actuation member; [0167]) comprising a distal portion and a proximal portion, and configured to expand the open proximal end of the cutting device (Id.).
However, Garrison does not disclose a plurality of shafts including an inner expander shaft and an outer expander shaft, and the expansion mechanism comprising a plurality of members spanning between the proximal portion and the distal portion, the distal portion coupled to the inner expander shaft, the proximal portion coupled to the outer expander shaft, and the plurality of members coupled to the one or more cutting blades; wherein the expansion mechanism is configured to expand the open proximal end of the cutting device with the proximal portion and distal portion moved toward each other such that the plurality of members move radially outward with the one or more cutting blades; and wherein the expansion mechanism is configured to collapse the open proximal end of the cutting device with the proximal portion and the distal portion moved away from each other such that the plurality of members move radially inward with the one or more cutting blades.
In Figures 7A-7D, Marks teaches a thrombectomy device (see abstract) including a plurality of shafts including an inner expander shaft 10 and an outer expander shaft 20/461/462, and an expansion mechanism (supportive element 420) comprising a distal portion, a proximal portion, and a plurality of members (wires; [0008]-[0009]) spanning between the proximal portion and the distal portion, the distal portion coupled to the inner expander shaft ([0113]), the proximal portion coupled to the outer expander shaft (Id.; Figure 7B), and the plurality of members coupled to one or more cutting blades of a cutting device 410 (the wires of supportive element 420 are coupled to cutting blades [wires] of reconfigurable element 410 via connectors 430 at plateau points 480, wherein during expansion the radial force applied by the expansion mechanism to the cutting device is selectively enhanced to cut through or break a thrombus more easily; [0113], [0114], [0122]);
wherein the expansion mechanism 420 is configured to expand the open proximal end of the cutting device 410 with the proximal portion and distal portion moved toward each other such that the plurality of members move radially outward with the one or more cutting blades (as in Figure 7D, [0137]); and
wherein the expansion mechanism 420 is configured to collapse the open proximal end of the cutting device 410 with the proximal portion and the distal portion moved away from each other such that the plurality of members move radially inward with the one or more cutting blades (as in Figure 7A, [0137]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Garrison with an inner expander shaft and an outer expander shaft and an expansion mechanism, as taught by Marks, since doing so would be substitution of one known expansion mechanism for another, which would yield predictable results, namely expanding the cutting device to engage and cut into a thrombus of a vein. See MPEP 2143.
Regarding claims 2-3, Garrison as modified teaches wherein the inner expander shaft (control element 10 in Marks; Figures 7A-7D) is configured to be distally advanced relative to the outer expander shaft 20/461/462 to collapse the expansion mechanism (supportive element 420), wherein the inner expander shaft is configured to be proximally retracted relative to the outer expander shaft to expand the expansion mechanism (Marks, [0106]).
Regarding claim 4, Garrison as modified teaches the one or more cutting blades comprise proximally-pointed cutting points (302; Figure 11 of Garrison).
Regarding claim 5, Garrison as modified teaches the frame of the cutting device 300 (Figure 11; Garrison) comprises a plurality of struts coupled together to form diamond-shaped cells (Id.).
Regarding claim 7, Garrison as modified teaches the one or more cutting blades comprises four cutting blades (302; Figure 11 of Garrison).
Regarding claim 12, Garrison as modified teaches the inner expander shaft 10 includes a handle 490 ([0130]; Marks). Although Marks does not expressly teach that the outer expander shaft also includes a handle, one of ordinary skill in the art would have found it obvious to add a handle to the proximal end of the outer expander shaft so that the operator can easily hold and stabilize the proximal end of the device (Id.).
Regarding claims 18-19, Garrison discloses the claimed invention, as discussed above, except for an inner expander shaft and an outer expander shaft, wherein the expander is coupled to the inner expander shaft and the outer expander shaft such that relative axial movement between the inner expander shaft and the outer expander shaft expand or collapse the expander, wherein the expander comprises members configured to move radially outward with distal ends of the inner expander shaft and the outer expander shaft moved closer together.
In Figures 7A-7D, Marks teaches a thrombectomy device (see abstract) including an inner expander shaft 10 and an outer expander shaft 20/461/462, and an expander (supportive element 420) coupled to the inner expander shaft and the outer expander shaft such that relative axial movement between the inner expander shaft and the outer expander shaft expand (Figure 7D) or collapse the expander (Figure 7A), wherein the expander comprises members (wires; [0008]-[0009]) configured to move radially outward with distal ends of the inner expander shaft and the outer expander shaft moved closer together (Figure 7D).
It would have been obvious to one of ordinary skill before the effective filing date to modify Garrison with an inner expander shaft and an outer expander shaft and expander as claimed, as taught by Marks, since doing so would be substitution of one known expansion mechanism for another, which would yield predictable results, namely expanding the cutting device to engage and cut into a thrombus of a vein. See MPEP 2143.
Regarding claim 22, Garrison discloses a method of removing a thrombus ([0004], [0163]), the method comprising:
unsheathing a thrombectomy device distal of the thrombus ([0105]; initially the device is positioned distal to the obstructive material, and then a sheath is retracted from the device);
expanding an expansion device (actuation member) to expand radially outward to expand a cutting diameter of a frame of a cutting device 300 ([0105], [0167]);
proximally retracting the thrombectomy device to bring the cutting diameter of
the frame in contact with the thrombus to cut the thrombus ([105]; 300 is pulled proximally to cut through the obstructive material);
receiving the cut thrombus through an interior lumen of the frame and into a
collection basket 200 (Id.).
Garrison discloses that the cutting device can be collapsed, as it may be repeatedly expanded and collapsed to engage and cut thrombus ([0137]).
However, Garrison does not disclose proximally retracting an inner expander shaft relative to an outer expander shaft such that members of the expansion device coupled to the inner expander shaft and the outer expander shaft expand radially outward to expand a cutting diameter of a frame of a cutting device; and distally advancing the inner expander shaft relative to the outer expander shaft such that the members of the expansion device coupled to the inner expander shaft and the outer expander shaft collapse radially inward to collapse the cutting diameter of the
frame.
In Figures 7A-7D, Marks teaches a thrombectomy device (see abstract) including an inner expander shaft 10 and an outer expander shaft 20/461/462, and an expansion device (supportive element 420) coupled to the inner expander shaft and the outer expander shaft, wherein proximally retracting the inner expander shaft relative to the outer expander shaft causes members (wires; [0008]-[0009]) of the expansion device to expand radially outward to expand a cutting diameter of a frame of a cutting device 410 ([0113], [0114], [0122]); and distally advancing the inner expander shaft relative to the outer expander shaft such that the members of the expansion device coupled to the inner expander shaft and the outer expander shaft collapse radially inward to collapse the cutting diameter of the frame ([0106]-[0107]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Garrison with an inner expander shaft and an outer expander shaft and expander as claimed, as taught by Marks, since doing so would be substitution of one known expansion mechanism for another, which would yield predictable results, namely expanding the cutting device to engage and cut into a thrombus of a vein. See MPEP 2143.
Regarding claim 62, Garrison as modified teaches the one or more cutting blades 302 define the open proximal end of the cutting device (Garrison; Figure 11).
Claims 9, 11, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (U.S. Pub. No. 2022/0287817) in view of Marks (U.S. Pub. No. 2013/0030460), as applied to claims 1 and 22 above, and further in view of Shiber (U.S. Patent No. 5,041,082).
Regarding claims 9, 11, 23, Garrison as modified teaches the claimed invention, as discussed above, except for a conductor configured to be heated, the conductor disposed proximate the one or more cutting blades and the cutting diameter to ease cutting the thrombus, wherein the conductor is heated with electrical energy.
In Figure 9 and col. 5, lines 25-42, Shiber teaches a thrombectomy device (see abstract) including a conductor 50 configured to be heated, the conductor disposed proximate a cutting diameter of one or more cutting blades 42 to ease cutting a thrombus, wherein the conductor is heated with electrical energy (via electrical current).
It would have been obvious to one of ordinary skill before the effective filing date to modify Garrison as modified with a conductor as claimed, as taught by Shiber, in order to assist the cutting blades in penetrating a thrombus (Id.).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison (U.S. Pub. No. 2022/0287817) in view of Marks (U.S. Pub. No. 2013/0030460), as applied to claim 12 above, and further in view of Roorda et al., hereinafter “Roorda” (U.S. Pub. No. 2013/0060269).
Regarding claim 13, Garrison as modified teaches the claimed invention, as discussed above, except for a threaded connection between the handle of the inner expander shaft and the handle of the outer expander shaft, wherein rotation of the handle of the inner expander shaft is configured to distally advance or proximally retract the inner expander shaft relative to the outer expander shaft.
In Figures 5-6D, Roorda teaches a thrombectomy device (see abstract) including an inner expander shaft 506 having a handle 512, and an outer expander shaft 504 having a handle 510, and a threaded connection 506D/504E ([0066]) between the handle of the inner expander shaft and the handle of the outer expander shaft, wherein rotation of the handle of the inner expander shaft is configured to distally advance or proximally retract the inner expander shaft relative to the outer expander shaft (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the handles of Garrison as modified with a threaded connection as claimed, as taught by Roorda, to facilitate selective actuation by a user and precise adjustment of the inner expander shaft relative to the outer expander shaft.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison (U.S. Pub. No. 2022/0287817).
Regarding claim 16, Garrison discloses the claimed invention, as discussed above, except for the expander comprises a balloon that is configured to be inflated to expand the open proximal end of the cutting device 300 and to be deflated to collapse the open proximal end of the cutting device.
However, in [0152] Garrison teaches in another embodiment of the cutting device an expander such as a balloon may be disposed radially inwardly of the cutting device to expand and add radial force to the cutting device.
It would have been obvious to one of ordinary skill before the effective filing date to modify Garrison (Figure 11) to have a balloon expander for the cutting device, since doing so would be substitution of one known expansion mechanism for another, which would yield predictable results, namely expanding the cutting device to engage and cut into a thrombus of a vein. See MPEP 2143.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison (U.S. Pub. No. 2022/0287817) in view of Shiber (U.S. Patent No. 5,041,082).
Regarding claim 17, Garrison discloses the claimed invention, as discussed above, except for a conductor configured to be disposed proximate the one or more cutting blades, the conductor configured to be heated to facilitate cutting a thrombus.
In Figure 9 and col. 5, lines 25-42, Shiber teaches a thrombectomy device (see abstract) including a conductor 50 configured disposed proximate one or more cutting blades 42, the conductor configured to be heated to facilitate cutting a thrombus.
It would have been obvious to one of ordinary skill before the effective filing date to modify Garrison as modified with a conductor as claimed, as taught by Shiber, in order to assist the cutting blades in penetrating a thrombus (Id.).
Claim 64-65 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (U.S. Pub. No. 2022/0287817) in view of Marks (U.S. Pub. No. 2013/0030460), as applied to claim 1 above, and further in view of Avneri et al., hereinafter “Avneri” (U.S. Pub. No. 2014/0296889).
Regarding claims 64-65, Garrison as modified teaches the claimed invention, as discussed above, except for each of the one or more cutting blades comprises a curved portion, the curved portion curving radially inward relative to the frame, wherein each of the one or more cutting blades further comprises an offset cutting portion, the offset cutting portion extending from the curved portion, the offset cutting portion offset radially inward relative to the frame.
In the same field of art, namely a thrombectomy device, in Figures 7A-8 Avneri teaches a cutting device comprising a frame (including guard 62 and blade 61), the frame comprising one or more cutting blades 61 or more cutting blades comprising a curved portion (arch; [0108]), the curved portion curving radially inward relative to the frame (Figure 8), wherein each of the one or more cutting blades further comprises an offset cutting portion (distal tip of 61), the offset cutting portion extending from the curved portion, the offset cutting portion offset radially inward relative to the frame (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the one or more cutting blades of Garrison as modified with a curved portion and offset cutting portion, as taught by Avneri, in order to facilitate penetrating through a thrombus within a blood vessel wall (Avneri; [0108]).
Allowable Subject Matter
Claim 63 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious a thrombectomy device including, inter alia, a collection device comprising a basket with a closed distal end, a cutting device comprising a frame comprising an open distal end coupled to an open proximal end of the collection device, the frame including one or more cutting blades disposed at the open proximal end, an expansion including a plurality of members coupled to the one or more cutting blades, wherein the expansion mechanism is configured to expand the open proximal end of the cutting device such that the plurality of members move radially outward with the one or more cutting blades and is configured to collapse the open proximal end of the cutting device such that the plurality of members move radially inward with the one or more cutting blades, and wherein each of the plurality of members are fixed to respective ones of the one or more cutting blades.
Marks, as discussed above, is silent with respect to a plurality of members (wires of 420; Figures 7A-7D, [0113], [0114], [0122]) being fixed to respective ones of the one or more cutting blades (wires of 410), and merely teaches the plurality of members engaging the cutting blades.
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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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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