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
This action is in response to the preliminary amendment filed on 3/10/2025. In the amendment, claims 1-76 have been canceled and claims 77-96 have been added.
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 77, 83, 84, & 92-96 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonnette et al. (US Pub. No. 2009/0171267 A1).
Regarding claim 77, Bonnette et al. disclose a thrombus removal device, comprising: an elongate shaft 14 (Fig. 2) comprising a working end (distal end of 14); at least one fluid lumen 50 (Fig. 2; paragraph [0056] - ‘tube 50…can be utilized for the delivery of high pressure ablation liquids’) in the elongate shaft 14; and two or more apertures disposed at or near the working end, the two or more apertures 112a-112n, 44a-44n, 126a-126n (Figs. 5, 11, & 13) in fluid communication with the at least one fluid lumen 50 and configured to generate two or more fluid streams (high velocity jet streams 114 - Fig. 5) that interact within or near the working end at an interaction region (‘high velocity fluid jet streams 114 pass outwardly through outflow orifices 44a-44n creating cross stream jets 120’ - paragraph [0068] ; Fig. 7), the two or more fluid streams (multiple streams 120 shown in Fig. 7; also more streams shown in Fig. 13) having a flow rate and proximity sufficient to induce cavitation at the interaction region that is configured to mechanically morcellate a target thrombus (paragraph [0068] - ‘high velocity fluid jet streams 114 drive deeply into thrombetic deposits or lesions 118 and gradually soften and then break apart the thrombetic deposits or lesions 118. Once broken, the entrained thrombus is macerated into microscopic particles and re-entrained into inflow gap 40 at a high rate’).
Regarding claim 83, Bonnette et al. further disclose wherein the interaction region comprises a focal point of the two or more fluid streams (cross streams 120 meet at focal point 122 as seen in Fig. 13).
Regarding claim 84, Bonnette et al. further disclose wherein the two or more fluid streams are generally orthogonal to a longitudinal axis of the elongate shaft (as seen in Fig. 11, fluid streams 124a-n exit the apertures 126 perpendicular to the longitudinal axis, and apertures 44a-44n have a flow axis that extends perpendicular to the longitudinal axis -Fig. 9).
Regarding claim 92, Bonnette et al. disclose a method for removing a thrombus from a blood vessel of a patient (Figs. 7 & 13 show thrombectomy - discussed throughout as the use for the device), the method comprising: introducing a distal portion of an elongate catheter 14 (Figs. 7 & 13) to a thrombus location in a blood vessel; drawing at least a section of the thrombus into the distal portion (thrombus movement shown to be drawn into inflow port 122 in Fig. 13, thrombus also shown localized at the distal portion of the catheter in Fig. 7); and generating two or more fluid streams 120 that interact within or near the distal portion at an interaction region (‘high velocity fluid jet streams 114 pass outwardly through outflow orifices 44a-44n creating cross stream jets 120’ - paragraph [0068]; more fluid jet streams 114 are delivered through apertures 112a-112n shown in Figs. 11 & 13; Fig. 7 & 13; all cross stream jets 120 focalize at the inflow port 122), wherein the two or more fluid streams are configured to apply at least four distinct breaking forces to the thrombus (the following force discussion is not considered to be a ‘step’ of the method, the step is ‘generating two or more fluid streams that interact within or near the distal portion at an interaction region’, which is met by Bonnette et al.’s device/method, thus, the streams are considered to be capable of meeting these breaking forces since no further direction is indicated in the method as to what creates such forces besides the generating step) including : 1) a slicing force as the two or more fluid streams initially cut through the thrombus prior to meeting at the interaction region (paragraph [0068] - ‘high velocity fluid jet streams 114 drive deeply into thrombetic deposits or lesions 118 and gradually soften and then break apart the thrombetic deposits or lesions 118. Once broken, the entrained thrombus is macerated into microscopic particles and re-entrained into inflow gap 40 at a high rate’); 2) a cavitation force at the interaction region when the two or more fluid streams interact to generate cavitation (paragraph [0068] - ‘high velocity fluid jet streams 114 drive deeply into thrombetic deposits or lesions 118 and gradually soften and then break apart the thrombetic deposits or lesions 118. Once broken, the entrained thrombus is macerated into microscopic particles and re-entrained into inflow gap 40 at a high rate’); 3) a shearing force caused by the two or more fluid streams moving against each other to generate shearing cavitation (paragraph [0068] - ‘high velocity fluid jet streams 114 drive deeply into thrombetic deposits or lesions 118 and gradually soften and then break apart the thrombetic deposits or lesions 118. Once broken, the entrained thrombus is macerated into microscopic particles and re-entrained into inflow gap 40 at a high rate’); and 4) a rotational fluid motion force caused by the shearing force and the cavitation force (paragraph [0068] - ‘high velocity fluid jet streams 114 drive deeply into thrombetic deposits or lesions 118 and gradually soften and then break apart the thrombetic deposits or lesions 118. Once broken, the entrained thrombus is macerated into microscopic particles and re-entrained into inflow gap 40 at a high rate’).
Regarding claim 93, Bonnette et al. further disclose wherein the drawing is by suction applied via an aspiration lumen of the elongate catheter (‘exhaust branch 18’ - exhaust regulator 106 and collection chamber 108 are connected to the exhaust branch 18 - the roller pump or suitable device is considered to create suction in order to collect the macerated thrombus particles; paragraph [0066]; Fig. 6).
Regarding claim 94, Bonnette et al. further disclose wherein generating the two or more fluid streams 114 further comprises directing the two or more fluid streams proximally relative to fluid stream apertures of the elongate catheter (the fluid streams 114 produced by apertures 112a-112n flow proximally - demonstrated in Fig. 11 and seen in Fig. 13 as the element 52a is located distally of the flow path).
Regarding claim 95, Bonnette et al. further disclose wherein generating the two or more fluid streams further comprises directing the two or more fluid streams 114, 120 distally relative to fluid stream apertures 44a-44n of the elongate catheter (shown in Figs. 7 & 13).
Regarding claim 96, Bonnette et al. further disclose wherein generating the two or more fluid streams further comprises directing the two or more fluid streams generally orthogonal to a longitudinal axis of the elongate catheter (further apertures 126a-126n of element 52a as shown in Fig. 11 show the fluid flow path 124a-124n of these apertures to be perpendicular to the longitudinal axis).
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 78-82 & 91 are rejected under 35 U.S.C. 103 as being unpatentable over Bonnette et al. (US Pub. No. 2009/0171267 A1) in view of Bonnette et al. (US Pub. No. 2017/0172603 A1).
Regarding claims 78-82, Bonnette et al. fail to explicitly disclose any flow rate for the fluid streams, and in particular the claimed flow rates of between 50m/s and 90m/s [claim 78], at least 50m/s [claim 79], a lumen flow rate of 3m/s results in fluid stream flow rate of at least 50m/s [claim 80]; a lumen flow rate of 4m/s results in fluid stream flow rate of at least 70m/s [claim 81]; and a lumen flow rate of 5m/s results in fluid stream flow rate of at least 90m/s [claim 82].
However, Bonnette et al. (US Pub. No. 2017/0172603 A1) teach thrombectomy devices to include operation with flow rates of at least 50m/s, 70m/s, and 90m/s (paragraph [0081] - flow rate range of 1 to 250m/s). It is considered that such a range of flow rate is well known in the art and choosing a flow rate in said range suggested and taught by Bonnette et al. would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Furthermore, designing a device to produce such a flow rate would inherently involve designing the proper lumen and aperture dimensions to produce such a flow rate, which would have been an obvious design modification to a device to achieve said flow rates desired for a proper and successful thrombectomy procedure. Since Bonnette et al. is silent to a specific flow rate of the fluid streams produced, it is considered that designing the dimensions of the lumens and apertures to achieve the art known thrombectomy flow rates would have been obvious at the time the invention was filed.
Regarding claim 91, Bonnette et al. disclose a method for removing a thrombus from a blood vessel of a patient, the method comprising: introducing a distal portion of an elongate catheter to a thrombus location in a blood vessel; drawing at least a section of the thrombus into the distal portion; and generating two or more fluid streams that interact at an interaction region to create cavitation within the thrombus. Bonnette et al. fail to explicitly disclose any flow rate for the fluid streams, and in particular the claimed flow rate of at least 50 m/s.
However, Bonnette et al. (US Pub. No. 2017/0172603 A1) teach thrombectomy devices to include operation with flow rates of at least 50m/s (paragraph [0081] - flow rate range of 1 to 250m/s). It is considered that such a range of flow rate is well known in the art and choosing a flow rate in said range would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as suggested and taught by Bonnette et al.
Claims 85-87 & 90 are rejected under 35 U.S.C. 103 as being unpatentable over Bonnette et al. (US Pub. No. 2009/0171267 A1) in view of Walzman (US Pub. No. 2021/0236257 A1).
Regarding claims 85-87 & 90, Bonnette et al. fail to further disclose, teach, or suggest a cavitation detection sensor disposed on or within the thrombus removal device [claim 85]; wherein the cavitation detection sensor is disposed on or within a funnel at the working end of the thrombus removal device [claim 86]; wherein the cavitation detection sensor is disposed on or within an aspiration lumen at the working end of the thrombus removal device [claim 87]; and a real-time imaging device configured to image the cavitation in real-time [claim 90].
However, Walzman teaches a thrombectomy device/system (paragraph [0305]) and further teaches/suggests that a built in camera can be provided in any of the catheters disclosed therein for visualization during insertion and during the procedure to visualize directly intravascularly (paragraph [0567]). It is considered that a camera reads upon a ‘cavitation detection sensor’ since cavitation can be detected visually, which is what the camera would sense (visual of the procedure). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it beneficial through the teachings/suggestions of Walzman to include a built in camera in Bonnette et al.’s thrombectomy device to monitor the placement and progress of the procedure to ensure a successful thrombectomy. Furthermore, the built in camera could be provided in any part of the catheter deemed suitable for the construction of such an element, to include within Bonnette et al.’s funnel 96 (seen in Figs. 9 & 12) or on or within an aspiration lumen at the working end of the device (at ‘122’ of Bonnette et al.’s device).
Allowable Subject Matter
Claims 88 & 89 are 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: the prior art utilized in the above rejections and the prior art cited by applicant fail to disclose, teach, or suggest the thombus removal device of claims 77 and intervening claim 85 to further include: wherein the cavitation detection sensor comprises an ultrasound transducer element [claim 88]; or wherein the cavitation detection sensor comprises a laser [claim 89].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 February 6, 2026