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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/24/2026 has been entered.
Response to Arguments
Applicant’s arguments, see page 6-8, filed 08/24/2026, 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 Therefore, the rejection has been withdrawn.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 Berrada et al. (US 2023/0346416).
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Berrada et al. (US 2023/0346416); having the effective filing date of PCT/US2021/020915.
Regarding claim 1, Berrada et al. discloses a method for removing a thrombus from a blood vessel of a patient ( [0053-0070]), the method comprising: introducing an elongate catheter (102, FIG 1G) having an expandable funnel (104a, 109, [0027]] describing the chamber as expandable) to a thrombus location in a blood vessel ([0054]) in a closed configuration ([0057]); expanding the expandable funnel from the closed configuration to an open configuration ([0057]) to at least partially occlude the blood vessel ([0030]); drawing at least a section of the thrombus into the funnel portion ([0045, 0055]); after drawing at least the section of the thrombus into the funnel, directing at least two fluid streams (136a, 136b, FIG 1G, [0045]) towards an intersection point (137) within the thrombus ([0045]) and the funnel (FIG 1G) from at least two different fluid ports (139a, 139b) within the expandable funnel (FIG 1G, [0045]) to break up the thrombus within the funnel ([0045]); aspirating (via aspiration mechanism 140, [0040-0041]) at least a portion of the thrombus into the elongate catheter ([0069]); removing the elongate catheter from the blood vessel ([0027] “when the thrombectomy procedure is completed, the expandable chamber 109 can be transformed back into the low-profile configuration and withdrawn into the delivery sheath for removal from the patient’s body”).
Regarding claim 2, Berrada et al. discloses the drawing is by suction applied via an aspiration lumen of the elongate catheter (aspiration lumen 106, [0027, 0040]).
Regarding claim 4, Berrada et al. discloses the funnel is sealed in the closed configuration to prevent ingress of blood or tissue in the closed configuration ([0027] discloses the low profile delivery configuration can comprise a flattened configuration of the funnel 109, which at least partially prevents ingress of blood or tissue relative to the expanded funnel configuration).
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) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Berrada et al. (US 2023/0346416) in view of Bonnette et al. (US 2014/0303658).
Regarding claim 3, Berrada et al. discloses the invention substantially as claimed, as set forth above for claim 1.
Berrada is silent regarding a stream of the at least two fluid streams has an average velocity of at least 5 meters/second (m/s).
However, Bonnette discloses the use of a fluid stream (1702) to macerate a thrombus ([0116]) wherein the velocity of the fluid stream is at least 5 m/s ([0116] discloses velocities of around 1 to 300 meters per second).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify an average velocity of the fluid streams to be at least 5 m/s, as taught by Bonnette, for the purpose of selecting a velocity known in the art for being sufficient to macerate a thrombus for aspiration.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Berrada et al. (US 2023/0346416) in view of Casey et al. (US 2021/0153884).
Regarding claim 5, Berrada discloses the invention substantially as claimed, as set forth above for claim 1.
Berrada 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 Berrada et al. (US 2023/0346416) in view of Turjman et al. (US 2017/0215890).
Regarding claim 6, Berrada discloses the invention substantially as claimed, as set forth above for claim 1.
Berrada et al. discloses expanding the funnel to substantially the same cross sectional dimension as the blood vessel ([0030]) but is silent regarding 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 Berrada et al. (US 2023/0346416) in view of Kelly et al. (US 2020/0281611).
Regarding claim 7, Berrada discloses the invention substantially as claimed, as set forth above for claim 1.
Berrada further discloses the funnel being self expanding ([0027]) but 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]).
Conclusion
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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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
