DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed on 03/23/2026 have been entered. Claims 1-22 remain pending in the application.
Response to Arguments
Applicant’s arguments, see page 7-8, filed 03/23/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bonnette et al. (US 2014/0303658) in view of Osborne et al. (US 2018/0103974).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bonnette et al. (US 2014/0303658) in view of Osborne et al. (US 2018/0103974).
Regarding claim 1, Bonnette et al. discloses a method for removing a thrombus from a blood vessel of a patient (FIGs 17-18D, [0111-0131]), the method comprising: introducing an elongate catheter (1600, [0111]) having a funnel (See funnel at 1616, FIG 17) to a thrombus location (1800) in a blood vessel (FIG 18A, [0126]) at least partially occluding the blood vessel (The widened diameter at 1616 at least partially occludes the blood vessel); drawing at least a section of the thrombus into the funnel portion (Thrombus material 1800 being drawn into the funnel in FIG 18A, [0126] “thrombus plug 1800 has been freed from the vessel wall and is lodged across or at least partially across the aspiration orifice 1616”); after drawing at least the section of the thrombus into the funnel, directing fluid toward the thrombus from at least two different points ([0116] discloses one or more infusion orifices 1700, which create the jets 1702. Although only one is shown in FIGs 17-18B, one or more jets is contemplated) within the expandable funnel to break up the thrombus within the funnel ([0129] “infusion jet 1702 is generated internally within the catheter body 1602. The hydrodynamic engagement of the infusion jet 1702 with the thrombus plug 1800 macerates the thrombus plug into particulate 1808 within the catheter body 1602”); aspirating at least a portion of the thrombus into the elongate catheter ([0129] “The particulate is held within the catheter body 1602 and is accordingly not free to move outside of the catheter body 1602 and into the general vasculature of the patient. Instead, the infusion flow from the infusion orifice 1700 cooperates with the aspiration source, for instance an aspiration pump, coupled with the thrombectomy catheter 1600 to draw the particulate 1808 of the thrombus plug 1800 proximally through the aspiration lumen 1614 to an effluent bag coupled with a thrombectomy catheter system”); removing the elongate catheter from the blood vessel ([0130] “ After completion of the thrombectomy procedure the expanded member 1704 as well as the infusion orifice 1700 are withdrawn into the catheter body 1602 again through the guide function provided by the guide member 1706 to facilitate the withdrawal of the thrombectomy catheter 1600 from the vasculature”).
Bonnette is silent regarding the funnel being expandable and therefore does not disclose expanding the expandable funnel from the closed configuration to an open configuration and collapsing the funnel into the closed configuration.
However, Osborne et al. teaches in the same field of endeavor a method for removing a thrombus from a blood vessel (V) of a patient ([0062-0063], FIG 11-12, wherein the steps of FIG 14 are understood to also show deployment and use of a funnel shaped embodiment such as that of FIG 11/12, [0067-0072]), the method comprising: introducing an elongate catheter (624) having an expandable funnel (652) to a thrombus location (674) in a blood vessel ("V") in a closed configuration (FIG 2 and 14 show the closed delivery configurations. [0067]); expanding the funnel from the closed configuration to an open configuration to at least partially occlude the blood vessel (FIG 12 and 14 wherein the edge of the funnel expands to the wall of the blood vessel thereby at least partially occluding it, [0068]); and collapsing the funnel into the closed configuration (Step 705, FIG 14, [0071]) for removal form the vasculature.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the funnel of Bonnette to be expandable and for the method to comprise a step of expanding the funnel from a closed configuration to an open configuration and collapsing the funnel into the closed configuration, as taught by Osborne, for the purpose of reducing the overall delivery profile of the catheter by forming the funnel such that it can expand and collapse, therefore increasing the navigability of the device through the vasculature.
Regarding claim 2, Bonnette/Osborne et al. disclose the invention substantially as claimed, as set forth above for claim 1. Bonnette further discloses the drawing is by suction applied via an aspiration lumen of the elongate catheter (aspiration lumen 1614, [0112, 0115-0116]).
Regarding claim 3, Bonnette/Osborne et al. discloses the invention substantially as claimed, as set forth above for claim 1. Bonnette further discloses the fluid has an average velocity of at least 5 meters/second (m/s) ([0116] discloses velocities of around 1 to 300 meters per second)
Regarding claim 4, Bonnette/Osborne et al. disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the funnel is sealed in the closed configuration to prevent ingress of blood or tissue in the closed configuration (FIG 14 step 701 shows the folded, collapsed configuration of the funnel, which at least partially prevents ingress of blood or tissue relative to the expanded funnel configuration).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bonnette et al. (US 2014/0303658) in view of Osborne et al. (US 2018/0103974), further in view of Casey et al. (US 2021/0153884).
Regarding claim 5, Bonnette/Osborne discloses the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding expanding the funnel further comprises expanding distal struts of the funnel with one or more pull wires.
However, Casey et al. teaches in the same field of endeavor of clot retrieval catheters (Abstract) a catheter (100) having an elongate catheter shaft (220, [0054]) and an expandable funnel (110) wherein expanding the funnel further comprises expanding distal struts (112, 113, [0055]) of the funnel with one or more pull wires (120, [0060, 0062-0066]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the funnel to comprise struts which are expandable by a plurality of pull wires, as taught by Casey, for the purpose of using a commonly known mechanism for achieving the predictable result of expanding the funnel to a deployed shape with the reliable and repeatable use of pull wires, which can be actuated by the user.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bonnette et al. (US 2014/0303658) in view of Osborne et al. (US 2018/0103974), further in view of Turjman et al. (US 2017/0215890).
Regarding claim 6, Bonnette/Osborne discloses the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding expanding the funnel further comprises dilating the blood vessel.
However, Turjman et al. teaches in the same field of endeavor of clot retrieval catheters (Abstract) an elongate catheter (100) having an expandable tip (140) wherein the catheter is placed in the vessel proximal to a thrombus (150) and expanding the tip comprises dilating the blood vessel ([0086] discloses balloon 140 is inflated into contact against the vessel interior wall, the balloon 140 may be overinflated by introducing additional fluid into the balloon interior such that the diameter of the vessel is increased by, e.g., 4% to 50% compared to its normal diameter during diastole, and that the balloon 140 may be overinflated and left in its expanded configuration during clot suctioning to facilitate dislodgement of the clot).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method such that expanding the funnel further comprises dilating the blood vessel, as taught by Turjman, for the purpose of facilitating dislodging of the thrombus before applying aspiration (Turjman [0086]) while still maintaining the seal with the vessel wall (Turjman [0087]).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bonnette et al. (US 2014/0303658) in view of Osborne et al. (US 2018/0103974), further in view of Kelly et al. (US 2020/0281611).
Regarding claim 7, Bonnette/Osborne discloses the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding expanding the funnel further comprises allowing shape memory distal struts of the funnel to automatically expand.
However, Kelly et al. teaches in the same field of endeavor of clot retrieval catheters (Abstract) a catheter (100) having an elongate catheter shaft (102) and an expandable funnel (110, FIG 1A, [0056-0059]) wherein expanding the funnel further comprises allowing shape memory distal struts of the funnel to automatically expand ([0058-0059], the funnel shape expands to a predetermined shape as a result of the shape memory material used to form the struts).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the funnel to comprise shape memory distal struts which automatically expand, as taught by Kelly, for the purpose of using a commonly known mechanism for achieving the predictable result of expanding the funnel to a deployed shape at a predictable time which can be altered based on the transition properties of the materials (Kelly [0058-0059]).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bonnette et al. (US 2014/0303658) in view of Osborne et al. (US 2018/0103974), further in view of Bonnette et al. (US 6,875,193).
Regarding claim 22, Bonnette/Osborne discloses the invention substantially as claimed, as set forth above for claim 1. Bonnette ‘658 further discloses the directing fluid step further comprises directing fluid toward the thrombus from at least two different points within the expandable funnel ([0116] discloses one or more infusion orifices 1700, which create the jets 1702. Although only one is shown in FIGs 17-18B, one or more jets is contemplated. [0129] “infusion jet 1702 is generated internally within the catheter body 1602. The hydrodynamic engagement of the infusion jet 1702 with the thrombus plug 1800 macerates the thrombus plug into particulate 1808 within the catheter body 1602”).
Bonnette is silent regarding directing fluid towards an intersection point within the expandable funnel to break up the thrombus within the expandable funnel.
However, Bonnette ‘193 teaches a distal plug (56, FIG 3 and 9-12) comparable to 1622 of the device of Bonnette ‘658, having a plurality of jet orifices (88a-n) which direct fluid towards an intersection point (FIG 10 shows the flow directions 100 which extend radially inward and therefor cross at an intersection point) to break up a thrombus (col 11 line 54-col 12 line 23 and col 14 line 22-col 15 line 10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bonnette ‘658 to further comprise jets which are directed radially inward towards an intersection point, as taught by Bonnette ‘193, for the purpose of providing an additional direction of fluid flow to further macerate the thrombus material within the funnel.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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