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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/17/2026 has been entered.
Response to Amendment
In response to the amendment filed on 06/17/2026, Claims 7-9 have been cancelled, and Claims 1-6 and 10-20 are pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11, and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-6 and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US PGPub 2019/0209745) in view of Saadat (US PGPub 2022/0409223).
Regarding Claim 1, Hanson teaches an aspiration catheter (abstract), comprising:
a catheter body (12; Figure 1) having a proximal end region (14; Figure 1; Paragraph 0044), a distal end region (16; Figure 1; Paragraph 0044), a wall (as seen in Figure 2), and a lumen (29; Figure 2; Paragraph 0046) extending therein, the wall including an opening (24) in communication with the lumen (29; Figure 1-2; Paragraph 0045-0046);
a fluid supply tube (30) including a wall (Figure 2; Paragraph 0046), a longitudinal axis (along element 30), a proximally projecting jet orifice (34/36) extending through the wall at an angle relative to the longitudinal axis (Paragraph 0046 states “In some instances, the fluid jet 34 may be oriented at an angle relative to the inner tube 30; alternatively see Figures 3-4 and paragraph 0053 which states “the jet orifices 138 may be oriented at an angle relative to the longitudinal axis of the shaft 130”
wherein the opening (24; Figure 2) in the wall of the catheter body is positioned proximal to the proximally projecting jet orifice (34/36; see Figure 2; but see also Figure 4 which show a distal most proximally directed get orifice and Paragraph 0054 which states some of the entrapped thrombogenic material may exit the catheter shaft 112 through a second orifice (not shown) positioned proximally of the inflow orifice 122, recirculate to the inflow orifice 122 (e.g., one or more times), and then move through the lumen 129.);
Hanson fails to disclose an impedance sensor disposed along the distal end region of the catheter body proximal to the opening in the wall of the catheter body, the impedance sensor configured to sense the impedance difference between blood and thrombus.
Saadat teaches an aspiration catheter (Figure 85; Paragraph 0487-0488), comprising:
a catheter body (8513; Figure 85; Paragraph 0487) a distal end region comprising an aspiration opening (8521) in the wall of the catheter body (Paragraph 0487 also contemplates multiple side openings which are not visible in Figure 85)
an impedance sensor (8507 and 8507’) disposed along the distal end region of the catheter body (Figure 85; Paragraph 0488) proximal to the opening (8521) in the wall of the catheter body (8513) (Paragraph 0488 states “impedance sensing electrodes 8507, 8507′ are positioned just proximal to the aspiration opening”, the impedance sensor (8507 and 8507’) configured to sense the impedance difference between blood and thrombus (Paragraph 0488, 0288, 0301, and see Paragraph 0307 which discloses the sensors can differentiate between the impedance of blood and clot material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the aspiration catheter of Hanson, to include the impedance sensor teachings, of Saadat, for the advantage “to detect material (e.g., clot material) within the suction lumen and may be used in conjunction (or coordinated) with the aspiration opening sensor electrodes to confirm that the aspiration opening is in contact with clot material, or to distinguish from vessel wall when force (e.g., suction) is applied to drive the distal end region, including the aspiration opening, into a material” (Paragraph 0488; Saadat).
Regarding Claim 2, the combination of references disclosed above teaches the aspiration catheter of claim 1, wherein Saadat teaches the impedance sensor includes a first electrode and a second electrode (8507 and 8507’; Figure 85; Paragraph 0488).
Regarding Claim 3, the combination of references disclosed above teaches the aspiration catheter of claim 2, wherein Saadat, in a separate embodiment, teaches the first electrode is radially spaced away from the second electrode along the catheter body (Figures 7-13; Paragraph 0298).
It would have been obvious to one of ordinary skill in the art to substitute the sensor of Figure 85 with the radially spaced sensors, as taught in Paragraph 0298, since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
Regarding Claim 4, the combination of references disclosed above teaches the aspiration catheter of claim 2, wherein Saadat teaches the first electrode, the second electrode or both the first electrode and the second electrode are positioned substantially flush with an inner surface of the catheter body (Paragraph 0293).
Regarding Claim 5, the combination of references disclosed above teaches the aspiration catheter of claim 2, wherein Saadat teaches the first electrode, the second electrode or both the first electrode and the second electrode are positioned substantially flush with an outer surface of the catheter body (Paragraph 0468 states that the sensing electrodes can be flush with the wall of the catheter. Paragraph 0458 states the electrodes can be flush with the tip. Figures 20-21 show he sensors on the outside surface of the catheter body).
Regarding Claim 6, the combination of references disclosed above teaches the aspiration catheter of claim 1, wherein Hanson teaches the proximally projecting jet orifice expels at least one proximally oriented fluid jet from the fluid supply tube within the catheter lumen in a generally proximal direction (Figures 2-3; Hanson).
Regarding Claim 10, the combination of references disclosed above teaches the aspiration catheter of Claim 1, wherein Hanson teaches the catheter body includes an entrainment inflow orifice (22) positioned along the distal end region (16) of the catheter body (12; Figure 1; Paragraph 0045)
Regarding Claim 11, Hanson teaches a thrombectomy system, comprising:
a thrombectomy catheter, wherein the thrombectomy catheter includes:
a catheter body (12; Figure 1) having a proximal end region (14; Figure 1; Paragraph 0044), a distal end region (16; Figure 1; Paragraph 0044), a wall (as seen in Figure 2), and a lumen (29; Figure 2; Paragraph 0046) extending therein, the wall including an opening (24) in communication with the lumen (29; Figure 1-2; Paragraph 0045-0046);
a fluid supply tube (30) including a wall (Figure 2; Paragraph 0046), a longitudinal axis (along element 30), a proximally projecting jet orifice (34/36) extending through the wall at an angle relative to the longitudinal axis (Paragraph 0046 states “In some instances, the fluid jet 34 may be oriented at an angle relative to the inner tube 30; alternatively see Figures 3-4 and paragraph 0053 which states “the jet orifices 138 may be oriented at an angle relative to the longitudinal axis of the shaft 130”
wherein the opening (24; Figure 2) in the wall of the catheter body is positioned proximal to the proximally projecting jet orifice (34/36; see Figure 2; but see also Figure 4 which show a distal most proximally directed get orifice and Paragraph 0054 which states some of the entrapped thrombogenic material may exit the catheter shaft 112 through a second orifice (not shown) positioned proximally of the inflow orifice 122, recirculate to the inflow orifice 122 (e.g., one or more times), and then move through the lumen 129.)
Hanson fails to teach a system comprising:
a processor coupled to the pump (the Examiner notes that a pump is inherent to Hanson even though Hanson is silent on the pump)
an impedance sensor disposed along the distal end region of the catheter body proximal to the opening in the wall of the catheter body;
wherein the processor is configured to sense a change in impedance of a first bodily substance adjacent to the impedance sensor.
Saadat teaches an aspiration catheter (Figure 85; Paragraph 0487-0488), comprising:
a processor (104; Figure 1A) coupled to a pump (109; Figure 1A) and a thrombectomy catheter (103; Figure 1A), the thrombectomy catheter comprising:
a catheter body (8513; Figure 85; Paragraph 0487) a distal end region comprising an aspiration opening (8521) in the wall of the catheter body (Paragraph 0487 also contemplates multiple side openings which are not visible in Figure 85)
an impedance sensor (8507 and 8507’) disposed along the distal end region of the catheter body (Figure 85; Paragraph 0488) proximal to the opening (8521) in the wall of the catheter body (8513) (Paragraph 0488 states “impedance sensing electrodes 8507, 8507′ are positioned just proximal to the aspiration opening”, the impedance sensor (8507 and 8507’) configured to sense the impedance of a first bodily substance adjacent to the impedance sensor (Paragraph 0488, 0288, 0301, and see Paragraph 0307 which discloses the sensors can differentiate between the impedance of blood and clot material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the aspiration catheter of Hanson, to include the impedance sensor and processor teachings, of Saadat, for the advantage “to detect material (e.g., clot material) within the suction lumen and may be used in conjunction (or coordinated) with the aspiration opening sensor electrodes to confirm that the aspiration opening is in contact with clot material, or to distinguish from vessel wall when force (e.g., suction) is applied to drive the distal end region, including the aspiration opening, into a material” (Paragraph 0488; Saadat).
Regarding Claim 12, the combination of references disclosed above teaches the aspiration catheter of claim 11, wherein Saadat teaches the impedance sensor includes a first electrode and a second electrode (8507 and 8507’; Figure 85; Paragraph 0488).
Regarding Claim 13, the combination of references disclosed above teaches the thrombectomy system of claim 11, wherein Saadat teaches the processor is configured to sense and compare the impedance of the first bodily substance with a second bodily substance (Paragraph 0307-0308).
Regarding Claim 14, the combination of references disclosed above teaches the thrombectomy system of claim 13, wherein Saadat teaches the first bodily substance is blood (Paragraph 0307-0308).
Regarding Claim 15, the combination of references disclosed above teaches the thrombectomy system of claim 14, wherein Saadat teaches the second bodily substance is thrombus (Paragraph 0307-0308).
Regarding Claim 16, the combination of references disclosed above teaches the thrombectomy system of claim 13, wherein Saadat teaches the processor is configured to send a signal to the pump based on the comparison of the impedance of the first bodily substance with the impedance of the second bodily substance (Paragraph 0308-0309).
Regarding Claim 17, the combination of references disclosed above teaches the thrombectomy system of claim 16, wherein Saadat teaches the pump is configured to inject fluid through the fluid supply tube based on the signal received from the processor (Paragraph 0027 and 0294).
Regarding Claim 18, the combination of references disclosed above teaches the thrombectomy system of claim 17, wherein Saadat the processor/controller (104; Figure 1A) is wireless and thus can and is configured to wirelessly couple to the pump (Paragraph 0026, 0294, 0360, 0460).
Regarding Claim 19, Hanson teaches a thrombectomy system, comprising:
a thrombectomy catheter, wherein the thrombectomy catheter includes:
a catheter body (12; Figure 1) having a proximal end region (14; Figure 1; Paragraph 0044), a distal end region (16; Figure 1; Paragraph 0044), a wall (as seen in Figure 2), and a lumen (29; Figure 2; Paragraph 0046) extending therein, the wall including an opening (24) in communication with the lumen (29; Figure 1-2; Paragraph 0045-0046);
a fluid supply tube (30) extending within the lumen of the catheter body (Figure 2 and Figure 4) and coupled to the pump (inherent but not described in spec), wherein the fluid supply tube (30) including a wall (Figure 2; Paragraph 0046), a longitudinal axis (along element 30), a proximally projecting jet orifice (34/36) extending through the wall at an angle relative to the longitudinal axis (Paragraph 0046 states “In some instances, the fluid jet 34 may be oriented at an angle relative to the inner tube 30; alternatively see Figures 3-4 and paragraph 0053 which states “the jet orifices 138 may be oriented at an angle relative to the longitudinal axis of the shaft 130”
wherein the opening (24; Figure 2) in the wall of the catheter body is positioned proximal to the proximally projecting jet orifice (34/36; see Figure 2; but see also Figure 4 which show a distal most proximally directed get orifice and Paragraph 0054 which states some of the entrapped thrombogenic material may exit the catheter shaft 112 through a second orifice (not shown) positioned proximally of the inflow orifice 122, recirculate to the inflow orifice 122 (e.g., one or more times), and then move through the lumen 129.),
and wherein the at least one proximally projecting jet orifice (34/36; Figure 1) (138; Figure 4) expels at least one proximally oriented fluid jet from the fluid supply tube within the catheter lumen (129) in a generally proximal direction (as seen in Figure 1 and Figure 4).
Hanson fails to teach a system comprising:
a processor coupled to the pump (the Examiner notes that a pump is inherent to Hanson even though Hanson is silent on the pump)
an impedance sensor in communication with the processor, the impedance sensor disposed along the distal end region of the catheter body proximal to the opening in the wall of the catheter body;
wherein the processor is configured to sense a change in impedance of a first bodily substance adjacent to the impedance sensor.
Saadat teaches an aspiration catheter (Figure 85; Paragraph 0487-0488), comprising:
a processor (104; Figure 1A) coupled to a pump (109; Figure 1A) and a thrombectomy catheter (103; Figure 1A), the thrombectomy catheter comprising:
a catheter body (8513; Figure 85; Paragraph 0487) a distal end region comprising an aspiration opening (8521) in the wall of the catheter body (Paragraph 0487 also contemplates multiple side openings which are not visible in Figure 85)
an impedance sensor (8507 and 8507’) disposed along the distal end region of the catheter body (Figure 85; Paragraph 0488) proximal to the opening (8521) in the wall of the catheter body (8513) (Paragraph 0488 states “impedance sensing electrodes 8507, 8507′ are positioned just proximal to the aspiration opening”, the impedance sensor (8507 and 8507’) configured to sense the impedance of a first bodily substance adjacent to the impedance sensor (Paragraph 0488, 0288, 0301, and see Paragraph 0307 which discloses the sensors can differentiate between the impedance of blood and clot material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the aspiration catheter of Hanson, to include the impedance sensor and processor teachings, of Saadat, for the advantage “to detect material (e.g., clot material) within the suction lumen and may be used in conjunction (or coordinated) with the aspiration opening sensor electrodes to confirm that the aspiration opening is in contact with clot material, or to distinguish from vessel wall when force (e.g., suction) is applied to drive the distal end region, including the aspiration opening, into a material” (Paragraph 0488; Saadat).
Regarding Claim 20, the combination of references disclosed above teaches the thrombectomy system of claim 19, wherein Saadat teaches the processor is configured to sense the impedance difference between blood and thrombus (Paragraph 0307-0308).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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