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 claims filed on April 7th, 2026, have been entered. Claims 2-22 remain pending in the Application. Claim 22 has been added by the Applicant.
Response to Arguments
Applicant's arguments filed April 7th, 2026, have been fully considered but they are not persuasive.
Applicant argues that Harari et al. (Pub. No. 2021/0059695) does not disclose the newly added limitation “the coil is biased in the collapsed configuration to store energy” because the closure wire 36 is a tensioning element that is actuated by pulling from a proximal handle to close the distal opening, and the spiral configuration provides a routing path to accommodate deformation of the braid. Applicant also states that Bowman (Pub. No. 2016/0058459) does not teach this limitation. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Harari et al. was brought in to teach that the coil of Fitzgerald et al. (Pub. No. 2008/0183203) could be made into the shape of a spiral for the purpose of negating any effects of bending the device body resulting from delivery through torturous vessels or changes in length of the device. This modification does not change the underlying functions or qualities of the coil 31 of Fitzgerald et al., which is designed to be compressed from a base form to be in a delivery configuration, and which then pops open to expand when pushed out of the catheter body 22 ([0027]). Since Fitzgerald et al. discloses the new limitation and the modification by Harari et al. does not change the properties of Fitzgerald et al. which disclose the limitation, the limitation does not overcome the prior art rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2-15 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al. (Pub. No. 2008/0183203) in view of Harari et al. (Pub. No. 2021/0059695).
Regarding claim 2, Fitzgerald et al. discloses a clot retrieval device (20; [0026]; FIGs. 4-5) comprising:
a device body (32 and the proximal and distal ends of 26; Annotated FIGs. 4-5 below) comprising a plurality of struts (Annotated FIG. 4: the proximal and distal ends of 26 are made of struts 26) and having a tubular medial section (32; Annotated FIG. 4) and tapered proximal and distal ends (the proximal and distal ends of 26; Annotated FIG. 4); the device body adopting an elongated configuration when in a delivery catheter (Annotated FIG. 5) and a radially expanded configuration when outside of the delivery catheter (Annotated FIG. 4);
a coil (31) positioned within the device body (Annotated FIG. 4: 31 is within 32), wherein the coil is adjustable between a collapsed configuration (Annotated FIG. 5) and an expanded configuration (Annotated FIG. 4), wherein the coil is configured to apply a force against the plurality of struts to prop open the device body ([0027] when 31 is not restrained by 26, 31 expands to its retained state and applies force to 32 to press 32 against the inner walls of the surrounding vessel), wherein the coil is biased in the collapsed configuration to store energy ([0027] when 31 is compressed, 31 stores energy due to 31 being biased to return to the expanded configuration) and is configured to radially expand and linearly compress in the expanded configuration (Annotated FIGs. 4-5: in FIG. 4, 31 are expanded radially outward and are closer together linearly than in FIG. 5) and to radially compress and linearly expand in the collapsed configuration (Annotated FIGs. 4-5: in FIG. 5, 31 are compressed radially inward and are farther apart linearly than in FIG. 4).
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Fitzgerald et al. is silent regarding the plurality of struts are composed of shape memory materials in this first embodiment. However, in a second embodiment disclosed in FIG. 8 and [0033], the cage 45 is formed from a plurality of wire strands 50, where the wire strands may be formed of nitinol, which is a shape memory material, for the purpose of allowing the plurality of struts to self-expand when deployed out of the catheter body 40. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the plurality of struts of the first embodiment to be made out of shape memory material, as taught by the second embodiment, for the purpose of allowing the plurality of struts to self-expand when deployed.
Fitzgerald et al. does not disclose the coil is a spiral.
Harari et al. teaches in the same field of endeavor of occlusion and clot retrieval devices ([0102]), and discloses a clot retrieval device (FIG. 2A) comprising device body (12) and a coil (36), where the coil is a spiral (FIG. 2A) for the purpose of negating any effects of bending the device body resulting from delivery through torturous vessels or changes in length of the device ([0094]).
It would have been obvious to one of ordinary skill in the art to have modified the coil of Fitzgerald et al. to be a spiral, as taught by Harari et al., for the purpose of negating any effects of bending the device body resulting from delivery through torturous vessels or changes in length of the device.
Regarding claim 3, Fitzgerald et al. further discloses the plurality of struts define a plurality of open cells (Annotated FIG. 4: 26 define open struts at the proximal end distal ends).
Regarding claim 4, Fitzgerald et al. further discloses the coil is connected to a distal region of the device body by an elongated end element (Annotated FIG. 4: 26 connect 31 to the distal end of 20).
Regarding claim 5, Fitzgerald et al. further discloses the coil is connected to a proximal region of the device body by an elongated end element (Annotated FIG. 4: 26 connect 31 to the proximal end of 20).
Regarding claim 6, Fitzgerald et al. further discloses the coil is connected to a distal region and a proximal region of the device body by a pair of elongated end elements (Annotated FIG. 4: 26 connect 31 to both the distal and proximal ends of 20).
Regarding claim 7, Fitzgerald et al. further discloses the pair of elongated end elements are each comprised of a wire or a tube ([0023] 26 are wires).
Regarding claim 8, Fitzgerald et al. further discloses the coil is radiopaque ([0027] components of 20 are made of radio-opaque materials for visualization, which can include 26).
Regarding claim 9, Fitzgerald et al. further discloses the coil is comprised of a wire ([0023] 31 are made of wires).
Regarding claim 10, Fitzgerald et al. further discloses the medial section of the device body is not tapered (Annotated FIG. 4: the tubular medial section is not tapered).
Regarding claim 11, Fitzgerald et al. further discloses the coil is positioned only within the medial section of the device body and does not extend into the tapered proximal and distal ends of the device body when the device body is in the radially expanded configuration (Annotated FIG. 4: 31 does not extend past 32 when 20 is expanded).
Regarding claim 12, Fitzgerald et al. further discloses the coil has an elongated configuration when the device body is in the collapsed configuration (Annotated FIG. 5: 31 is collapsed while 32 is collapsed).
Regarding claim 13, Fitzgerald et al. further discloses the coil has an expanded configuration when the device body is in the radially expanded configuration (Annotated FIG. 4: 31 is expanded to expand 32).
Regarding claim 14, Fitzgerald et al. further discloses the tapered proximal and distal ends form closed ends (Annotated FIG. 4: the tapered ends are closed at 24 and 34).
Regarding claim 15, Fitzgerald et al. discloses a clot retrieval device (20; [0026]; FIGs. 4-5) comprising:
a device body (32 and the proximal and distal ends of 26; Annotated FIGs. 4-5 below) comprising a plurality of struts (Annotated FIG. 4: the proximal and distal ends of 26 are made of struts 26) and having a medial section (32; Annotated FIG. 4) and tapered proximal and distal ends (the proximal and distal ends of 26; Annotated FIG. 4), the device body adopting an elongated configuration when in a delivery catheter (Annotated FIG. 5) and a radially expanded configuration when outside of the delivery catheter (Annotated FIG. 4); and
a spring (31; it is noted that 31 is a spring because 31 comprises a looped material which can be compressed and then return to a natural state prior to compression when the force applied to 31 is removed) positioned within the device body (Annotated FIG. 4: 31 is within 32); wherein the spring is adjustable between a collapsed configuration (Annotated FIG. 5) and an expanded configuration (Annotated FIG. 4), wherein the spring is configured to apply a force against the plurality of struts to prop open the device body ([0027] when 31 is not restrained by 26, 31 expands to its retained state and applies force to 32 to press 32 against the inner walls of the surrounding vessel) wherein the spring is biased in the collapsed configuration to store energy ([0027] when 31 is compressed, 31 stores energy due to 31 being biased to return to the expanded configuration) and is configured to radially expand and linearly compress in the expanded configuration (Annotated FIGs. 4-5: in FIG. 4, 31 are expanded radially outward and are closer together linearly than in FIG. 5) and to radially compress and linearly expand in the collapsed configuration (Annotated FIGs. 4-5: in FIG. 5, 31 are compressed radially inward and are farther apart linearly than in FIG. 4).
Fitzgerald et al. is silent regarding the plurality of struts are composed of shape memory materials in this first embodiment. However, in a second embodiment disclosed in FIG. 8 and [0033], the cage 45 is formed from a plurality of wire strands 50, where the wire strands may be formed of nitinol, which is a shape memory material, for the purpose of allowing the plurality of struts to self-expand when deployed out of the catheter body 40. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the plurality of struts of the first embodiment to be made out of shape memory material, as taught by the second embodiment, for the purpose of allowing the plurality of struts to self-expand when deployed.
Fitzgerald et al. does not disclose the spring is a spiral.
Harari et al. teaches in the same field of endeavor of occlusion and clot retrieval devices ([0102]), and discloses a clot retrieval device (FIG. 2A) comprising device body (12) and a spring (36), where the spring is a spiral (FIG. 2A) for the purpose of negating any effects of bending the device body resulting from delivery through torturous vessels or changes in length of the device ([0094]).
It would have been obvious to one of ordinary skill in the art to have modified the spring of Fitzgerald et al. to be a spiral, as taught by Harari et al., for the purpose of negating any effects of bending the device body resulting from delivery through torturous vessels or changes in length of the device.
Regarding claim 17, Fitzgerald et al. further discloses the spring is radiopaque ([0027] components of 20 are made of radio-opaque materials for visualization, which can include 26).
Regarding claim 18, Fitzgerald et al. further discloses the spring is comprised of drawn-filled tubing (in the present Spec [0078], a drawn-filled tubing is made of a combination of radiopaque material and nitinol; Fitzgerald et al. [0027] components of 20 are made of radio-opaque materials for visualization, which can include 26, and that the 26 which make up 31 can be nitinol; therefore, 31 is comprised of drawn-filled tubing).
Regarding claim 19, Fitzgerald et al. further discloses the spring is positioned only within the medial section of the device body and does not extend into the tapered proximal and distal ends of the device body when the device body is in the radially expanded configuration (Annotated FIG. 4: 31 does not extend past 32 when 20 is expanded).
Regarding claim 20, Fitzgerald et al. discloses a clot retrieval device (20; [0026]; FIGs. 4-5) comprising:
a device body (32 and the proximal and distal ends of 26; Annotated FIGs. 4-5 below) comprising a plurality of struts (Annotated FIG. 4: the proximal and distal ends of 26 are made of struts 26) and having a tubular medial section (32; Annotated FIG. 4) and tapered proximal and distal ends (the proximal and distal ends of 26; Annotated FIG. 4), the device body adopting an elongated configuration when in a delivery catheter (Annotated FIG. 5) and a radially expanded configuration when outside of the delivery catheter (Annotated FIG. 4); and
an expansion means for propping open the device body (as indicated above, “expansion means” is being interpreted under 112f, and in [0060] of the present Specification, the expansion means are indicated as either a coil or a spring; Fitzgerald et al. 31 satisfies the limitation because, as discussed in the previous rejections of claims 2 and 15, 31 can be a coil or a spring), the expansion means being positioned within the device body (Annotated FIG. 4: 31 is within 32); wherein the expansion means is adjustable between a collapsed configuration (Annotated FIG. 5) and an expanded configuration (Annotated FIG. 4), wherein the expansion means is configured to apply an outward force against the plurality of struts to help prop open the device body to adjust to the radially expanded configuration ([0027] when 31 is not restrained by 26, 31 expands to its retained state and applies force to 32 to press 32 against the inner walls of the surrounding vessel) wherein the expansion means is biased in the collapsed configuration to store energy ([0027] when 31 is compressed, 31 stores energy due to 31 being biased to return to the expanded configuration) and is configured to radially expand and linearly compress in the expanded configuration (Annotated FIGs. 4-5: in FIG. 4, 31 are expanded radially outward and are closer together linearly than in FIG. 5) and to radially compress and linearly expand in the collapsed configuration (Annotated FIGs. 4-5: in FIG. 5, 31 are compressed radially inward and are farther apart linearly than in FIG. 4).
Fitzgerald et al. is silent regarding the plurality of struts are composed of shape memory materials in this first embodiment. However, in a second embodiment disclosed in FIG. 8 and [0033], the cage 45 is formed from a plurality of wire strands 50, where the wire strands may be formed of nitinol, which is a shape memory material, for the purpose of allowing the plurality of struts to self-expand when deployed out of the catheter body 40. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the plurality of struts of the first embodiment to be made out of shape memory material, as taught by the second embodiment, for the purpose of allowing the plurality of struts to self-expand when deployed.
Fitzgerald et al. does not disclose the expansion means is a spiral.
Harari et al. teaches in the same field of endeavor of occlusion and clot retrieval devices ([0102]), and discloses a clot retrieval device (FIG. 2A) comprising device body (12) and an expansion means (36), where the expansion means is a spiral (FIG. 2A) for the purpose of negating any effects of bending the device body resulting from delivery through torturous vessels or changes in length of the device ([0094]).
It would have been obvious to one of ordinary skill in the art to have modified the expansion means of Fitzgerald et al. to be a spiral, as taught by Harari et al., for the purpose of negating any effects of bending the device body resulting from delivery through torturous vessels or changes in length of the device.
Regarding claim 21, Fitzgerald et al. further discloses the expansion means is comprised of a coil or a spring (as discussed in the previous rejections of claims 2 and 15, and shown in Annotated FIGs. 4-5, 31 can be a coil or a spring).
Regarding claim 22, Fitzgerald et al. as modified by Harari et al. further discloses the spiral coil is entirely internal within the device body (Fitzgerald et al. FIG. 2: 31 is entirely within 32, and the modification by Harari et al. only modifies the shape of 31, not the placement within 32).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al. in view of Harari et al., and in further view of Bowman (Pub. No. 2016/0058459).
Regarding claim 16, Fitzgerald et al. as modified by Harai et al. discloses the invention as claimed in claim 15, as discussed above. Fitzgerald et al. does not disclose the clot retrieval device comprises a plurality of connected device bodies.
Bowman teaches in the same field of endeavor of clot retrieval devices (Abstract), and discloses a clot retrieval device (200; FIG. 3) with a plurality of connected device bodies (203) for the purpose of creating space between device bodies to have less material physically contacting the device than a single longer device body, which limits endothelial denudation during clot removal ([0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Fitzgerald et al. to have a plurality of connected device bodies, as taught by Bowman, for the purpose of creating space between device bodies to have less material physically contacting the device than a single longer device body, which limits endothelial denudation during clot removal.
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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