DETAILED ACTION
The following Office Action is in response to the Amendment filed on April 15, 2026. Claims 1-7, 9, 11-16, and 18-20 are currently pending.
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
Concerning the “Claim Rejections – 35 U.S.C. § 112” section on page 8 of the Applicant’s Response filed on April 15, 2026, the amendments to claims 6 and 13 have obviated the necessity of the rejections of the claims under 35 U.S.C. §112(b). Therefore, the rejections are withdrawn.
Response to Arguments
Concerning the “Claim Rejections - 35 U.S.C. § 103” section on pages 8-12 of the Applicant’s Response filed on April 15, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Claim Objections
Claims 1, 9, and 16 are objected to because of the following informalities: Lines 12-13 of claims 1, 9, and 16, each recite the phrase “each the plurality of arched wires”, wherein the word “of” appears to be mistakenly omitted between “each” and “the plurality”. Appropriate correction is required.
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) 1-6, 9, 11-13, 15-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2021/0068854, hereinafter Wallace) in view of Vale et al. (US 2021/0393277, hereinafter Vale).
Concerning claim 1, the Wallace et al. prior art reference teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1-18; 100), the thrombectomy apparatus comprising: a catheter (Figure 3A; 307) having a distal region including a distal end, the catheter defining a lumen extending proximally from the distal end, the catheter having an outer surface; a funnel secured to the distal end and extending distally therefrom (Figure 3B; 308), the funnel including: a braided inner layer (Figure 11A; 1118, inside layer), a braided outer layer (Figure 11A; 1118, outside layer), and a reinforcing structure disposed between the braided inner layer and the braided outer layer (Figure 11A; 1111); a tractor (Figure 2A; 305) adapted to extend over the outer surface of the catheter and the funnel in an uninverted configuration (Figure 3B; portion of 305 outside of catheter and funnel) and to extend in an inverted configuration through the funnel and into the lumen (Figure 3B; portion of 305 extending into tunnel and lumen), the tractor adapted to invert by rolling over the distal end of the funnel when the tractor moves proximally within the lumen ([¶ 0113]); and an elongate member extending through the lumen and secured to an end of the tractor disposed within the lumen (Figure 3A; 303), but it does not specifically teach the reinforcing structure comprising a tubular base member, a plurality of fingers extending distally from the tubular base member, and a plurality of arched wires, each of the plurality of arched wires having a first end secured to a distal end of the first finger of the plurality of fingers and a second end secured to a distal end of a second finger of the plurality of fingers.
However, the Vale reference also teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1) comprising a catheter (Figure 2; 35) having a distal region including a distal end and a funnel secured to the distal end and extending distally therefrom (Figure 2; 100), the funnel including a membrane (Figure 21A; 50) which may define inner and outer layers surrounding ([¶ 0102]) a reinforcing structure (Figure 21A; 110), wherein the reference teaches a number of reinforcing structures, one of which may be interpreted as comprising a tubular base member (Figure 3A; 35), a plurality of fingers extending distally from the tubular base (Figure 3A; 116), and a plurality of arched wires (Figure 3A; 118), each of the plurality of arched wires having a first end secured to a distal end of a first finger of the plurality of fingers and a second end secured to a distal end of a second finger of the plurality of fingers (Figure 3A; 121), wherein the plurality of arched wires are adapted to engage the membrane when the funnel is subjected to axial compression ([¶ 0103]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the reinforcing structure of the Wallace reference with the reinforcing structure of the Vale reference having a tubular base member, a plurality of fingers extending distally from the tubular base member, and a plurality of arched wires, each of the plurality of arched wires having a first end secured to a distal end of the first finger of the plurality of fingers and a second end secured to a distal end of a second finger of the plurality of fingers, to provide a reinforcing structure that has a large, expandable mouth for improved efficiency while balancing flexibility for delivery with adequate radial force and atraumatic deployment (Vale; [¶ 0005]), wherein such a reinforcing structure would engage the braided inner layer and/or the braided outer layer when the funnel is subjected to axial compression as the tractor is pulled proximally over the funnel by nature of the positioning of the reinforcing structure within the layers of the braided inner and braided outer layer.
Concerning claim 2, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claim 1, wherein the Wallace reference further teaches the tractor being adapted to engage the clot and pull the clot into the funnel as the tractor inverts over the distal end of the funnel (Figure 1C; 109 | [¶ 113]).
Concerning claim 3, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claim 2, wherein the Wallace reference further teaches the tractor comprising a flexible tube comprising a plurality of loops that lie flat before teaching the distal end of the catheter and after passing the distal end of the catheter, but temporarily extend radially outwardly as the tractor inverts over the distal end of the catheter, the plurality of loop temporarily extending radially outward as the tractor inverts over the distal end of the catheter engage the clot and pull the clot proximally (Figure 5A; [¶ 0134]).
Concerning claim 4, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claim 1, wherein the Vale reference further teaches that the plurality of arched wires may form a closed loop funnel braid (Figure 3A; 110).
Concerning claim 5, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claim 4, wherein the limitation of the first end and the second end of the plurality of arched wires each being welded to the first finger of the plurality of fingers and the second plurality of fingers is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. Thus, even though the Wallace and Vale combination may not specifically teach the first end and the second end of the plurality of arched wires being welded to the first finger of the plurality of fingers and the second plurality of fingers, the reinforcing structure of the Wallace and Vale combination still reads on the claimed reinforcing structure because the structure is the same despite a difference in the method by which said structure is achieved. Furthermore, it is noted by the examiner that the Vale reference does teach that sections of the reinforcing structure may be welded to one another (Vale; [¶ 0066]).
Concerning claim 6, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claim 4, wherein the Wallace reference teaches the thickness of the reinforcing structure being greater than a diameter of a filament diameter for one or more filaments forming the braided inner layer and/or braided outer layer, wherein it would further be obvious to have the diameter of the plurality of wires forming the closed loop funnel braid of the combination have a wire diameter greater than the filament diameter of the one or more filaments forming the braided inner layer and/or braided outer layer to provide proper reinforcement to the funnel.
Concerning claims 9, 15, 16, and 20, the Wallace et al. prior art reference teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1-18; 100), the thrombectomy apparatus comprising: a catheter (Figure 3A; 307) having a distal region including a distal end, the catheter defining a lumen extending proximally from the distal end, the catheter having an outer surface; a funnel secured to the distal end and extending distally therefrom (Figure 3B; 308), the funnel including: a braided member (Figure 11A; 1118) including a braided inner layer (Figure 11A; 1118, inside layer), a braided outer layer (Figure 11A; 1118, outside layer), and a reinforcing structure disposed between the braided inner layer and the braided outer layer (Figure 11A; 1111); a tractor (Figure 2A; 305) adapted to extend over the outer surface of the catheter and the funnel in an uninverted configuration (Figure 3B; portion of 305 outside of catheter and funnel) and to extend in an inverted configuration through the funnel and into the lumen (Figure 3B; portion of 305 extending into tunnel and lumen), the tractor adapted to invert by rolling over the distal end of the funnel when the tractor moves proximally within the lumen ([¶ 0113]); wherein the reinforcing structure is adapted to engage the braided member when the braided member is subject to axial compression as a result of the tractor being pulled proximally over a distal end of the funnel (the reinforcing structure is always engaged with the braided member given it is encapsulated inside it, including when the braided member is subject to axial compression), but it does not specifically teach the reinforcing structure comprising a tubular base member, a plurality of fingers extending distally from the tubular base member, and a plurality of arched wires, each of the plurality of arched wires having a first end secured to a distal end of the first finger of the plurality of fingers and a second end secured to a distal end of a second finger of the plurality of fingers.
However, the Vale reference also teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1) comprising a catheter (Figure 2; 35) having a distal region including a distal end and a funnel secured to the distal end and extending distally therefrom (Figure 2; 100), the funnel including a membrane (Figure 21A; 50) which may define inner and outer layers surrounding ([¶ 0102]) a reinforcing structure (Figure 21A; 110), wherein the reference teaches a number of reinforcing structures, one of which may be interpreted as comprising a tubular base member (Figure 3A; 35), a plurality of fingers extending distally from the tubular base (Figure 3A; 116), and a plurality of arched wires (Figure 3A; 118), each of the plurality of arched wires having a first end secured to a distal end of a first finger of the plurality of fingers and a second end secured to a distal end of a second finger of the plurality of fingers (Figure 3A; 121)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the reinforcing structure of the Wallace reference with the reinforcing structure of the Vale reference having a tubular base member, a plurality of fingers extending distally from the tubular base member, and a plurality of arched wires, each of the plurality of arched wires having a first end secured to a distal end of the first finger of the plurality of fingers and a second end secured to a distal end of a second finger of the plurality of fingers, to provide a reinforcing structure that has a large, expandable mouth for improved efficiency while balancing flexibility for delivery with adequate radial force and atraumatic deployment (Vale; [¶ 0005]).
Concerning claims 11 and 18, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claims 9 and 16, wherein the Vale reference further teaches that the plurality wires may form a closed loop funnel braid (Figure 3A; 110).
Concerning claims 12 and 19, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claims 11 and 18, wherein the limitation of the first end and the second end of the plurality of arched wires each being welded to the first finger of the plurality of fingers and the second plurality of fingers is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. Thus, even though the Wallace and Vale combination may not specifically teach the first end and the second end of the plurality of arched wires being welded to the first finger of the plurality of fingers and the second plurality of fingers, the reinforcing structure of the Wallace and Vale combination still reads on the claimed reinforcing structure because the structure is the same despite a difference in the method by which said structure is achieved. Furthermore, it is noted by the examiner that the Vale reference does teach that sections of the reinforcing structure may be welded to one another (Vale; [¶ 0066]).
Concerning claim 13, the combination of the Wallace and Vale references as discussed above teaches the apparatus of claim 11, wherein the Wallace reference teaches the thickness of the reinforcing structure being greater than a diameter of a filament diameter for one or more filaments forming the braided member, wherein it would further be obvious to have the diameter of the plurality of wires forming the closed loop funnel braid of the combination have a wire diameter greater than the filament diameter of the one or more filaments forming the braided inner layer and/or braided outer layer to provide proper reinforcement to the funnel.
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2021/0068854, hereinafter Wallace) in view of Vale et al. (US 2021/0393277, hereinafter Vale) as applied to claims 1-6, 9, 11-13, 15-16, and 18-20 above, and further in view of Martin (US 2014/0005712).
Concerning claims 7 and 14, the combination of the Wallace and Vale references as discussed above teaches the thrombectomy apparatus of claims 4 and 13, but does not a specifically teach the wire diameter of the plurality of wires forming the closed loop funnel braid.
However, the Martin reference teaches a thrombectomy device including a braided structure formed form a plurality of wires to form a closed loop funnel braid (Figure 5E; 260), wherein the reference teaches that the wires may include a diameter of 0.003 inches or may include a larger diameter to increase the overall strength of the device ([¶ 0110]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the diameter of the plurality of wires forming the closed loop funnel braid of the Wallace and Vale combination have a wire diameter in the range of 0.007 inches to 0.0011 inches to provide the proper strength for the closed loop funnel braid structure (Martin; [¶ 0110]).
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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 6/16/2026
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