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
In response to the amendment filed on 01/02/2026, No Claims have been cancelled, and Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, filed 01/02/2026, with respect to the rejection(s) of claim(s) 1, 11, and 17 in view of Saadat and Bonnette 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 Therefore, the rejection has been withdrawn.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 Schucart (US Patent 5,643,228).
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (US PGPub 2022/0409223) in view of Schucart (US Patent 5,643,228).
Regarding Claim 1, Saadat teaches an aspiration catheter, comprising:
a catheter body (103) having a proximal end region, a distal end region (distal most tip) and a lumen extending therein (120; Figures 1A-1B); and
a macerator (129) including a tube having a wall (as seen in Figure 1D) for breaking up clot material (Paragraph 0295)
an impedance sensor (105’ and 105’ in Figure 1B; see also 106 in Figure 1C) disposed along the distal end region of the catheter body (Figures 1A-1D), the impedance sensor configured to sense the impedance difference between blood and thrombus (Paragraph 0288, 0301, and see Paragraph 0307 which discloses the sensors can differentiate between the impedance of blood and clot material).
Saadat fails to disclose that the macerator comprises:
a fluid supply tube including a wall, a longitudinal axis, a proximally projecting jet orifice extending through the wall at an angle relative to the longitudinal axis, and a distally projecting jet orifice extending through the wall at an angle relative to the longitudinal axis.
Schucart teaches a catheter (21; Column 3, Lines 38-45) to perform thrombolysis (abstract; wherein the thrombolysis is breaking up clot material) comprising a fluid supply tube (23; Figure 1-2) including a wall (35; Figure 2; Column 3, Lines 49-50), a longitudinal axis (30; Figure 1), a proximally projecting jet orifice (33) extending through the wall (35) at an angle relative to the longitudinal axis (30; Figures 1 and 3; Column 3, Lines 65-67), and a distally projecting jet orifice (33) extending through the wall (35) at an angle relative to the longitudinal axis (Figures 1-4; Column 3, Lines 65-67 and Column 4, Lines 1-67).
It would have been obvious to one of ordinary skill in the art to modify the macerator taught by Schucart to include proximally projecting and distally projecting jet orifices that extend through the wall at an angle, as taught by Schucart, for the advantage of improving “lysing of a thrombus when the catheter is used to perform thrombolysis. The improvement is believed to arise from eddies in the injected fluid and the adjacent vascular fluid caused by the obliquely angled streams. Some of these eddies are likely to be turbulent. The forces associated with these eddies resemble an agitator-type action and assist in the dispersion of the fluid, as well as improving the ability of the fluid to penetrate the surface 51 of the clot 41.” (Column 4, Lines 34-41; Schucart).
Regarding Claim 2, the combination of references disclosed above teach the aspiration catheter of claim 1, wherein Saadat teaches the impedance sensor includes a first electrode and a second electrode (105 and 105’ Figure 1A).
Regarding Claim 3, the combination of references disclosed above teach the aspiration catheter of claim 2, wherein Saadat teaches the first (105) electrode is radially spaced away from the second electrode (105’) along the catheter body (see Figure 1B).
Regarding Claim 4, the combination of references disclosed above teach 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 (106 Figure 1A but also see 106 in Figure 1C; Paragraph 0032, 0291, and 0293 state that the sensors are flush with the inside wall of the catheter or recessed into the catheter wall).
Regarding Claim 5, the combination of references disclosed above teach 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 (it appears that the electrodes 105 and 105’ are flush with the outer surface of the distal face of the body; furthermore 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 teach the aspiration catheter of claim 1, wherein Schucart 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 (Column 4, Lines 26-35).
Regarding Claim 7, the combination of references disclosed above teaches the aspiration catheter of claim 6, wherein Schucart teaches the distally projecting jet orifice (33; Figures 1-4) expels at least one distally oriented fluid jet from the fluid supply tube within the catheter lumen in a generally distal direction (Column 4, Lines 26-35)
Regarding Claim 8, the combination of references disclosed above teaches the aspiration catheter of claim 7, wherein Schucart teaches the at least one distally projecting jet orifice (33; Figures 1-4) is distal to the at least one proximally projecting jet orifice (as seen in Figures 1-4).
Regarding Claim 9, the combination of references disclosed above teaches the aspiration catheter of claim 8, wherein Schucart teaches the at least one distally projecting jet orifice (33) extends through a sidewall (35) of the fluid supply tube (see Figures 2-3).
Regarding Claim 10, the combination of references disclosed above teaches the aspiration catheter of claim 7, wherein Saadat teaches the catheter body (103) further includes an entrainment inflow orifice (distal opening of catheter 103) positioned along the distal end region of the catheter body (as seen in Figure 1C).
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Saadat (US PGPub 2022/0409223) in view of Bonnette (US PGPub 2014/0155830) and Schucart (US Patent 5,643,228)
Regarding Claim 11, Saadat teaches a thrombectomy system, comprising:
a processor (104; Figure 1A) coupled to a pump (109; Figure 1A) and a thrombectomy catheter (103; Figure 1A), wherein the thrombectomy catheter includes:
a catheter body (103) having a proximal end region, a distal end region (distal most tip) and a lumen extending therein (120; Figures 1A-1B); and
an impedance sensor (105’ and 105’ in Figure 1B; see also 106 in Figure 1C) disposed along the distal end region of the catheter body (Figures 1A-1D),
wherein the impedance sensor configured to sense the impedance of a first bodily substance adjacent to the impedance sensor (Paragraph 0288, 0301, and see Paragraph 0307 which discloses the sensors can differentiate between the impedance of blood and clot material).
Saadat fails to disclose:
a fluid supply tube extending within the lumen of the catheter body and coupled to the pump.
Bonnette teaches thrombectomy aspiration catheter (Figures 17-18 and Figures 25-26; Paragraph 0104-0105, 0115, and 0117-0120) comprising a fluid supply tube (52C; Figure 17) including at least one proximally projecting jet orifice (106a-106n) for expelling at least one proximally oriented fluid jet from the fluid supply tube within the catheter lumen (12) in a generally proximal direction (see Figures 17-18; Paragraph 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Saadat such that in includes a fluid supply tube as taught by Bonnette, for the advantage of providing multiple jet streams (proximally radially and distally) to break off and direct thrombus back towards the proximal end of the catheter for removal from the body (see paragraph 0109 and Figure 22).
The combination of references fails to disclose that the fluid supply tube comprises:
a fluid supply tube including a wall, a longitudinal axis, a proximally projecting jet orifice extending through the wall at an angle relative to the longitudinal axis, and a distally projecting jet orifice extending through the wall at an angle relative to the longitudinal axis.
Schucart teaches a catheter (21; Column 3, Lines 38-45) to perform thrombolysis (abstract; wherein the thrombolysis is breaking up clot material) comprising a fluid supply tube (23; Figure 1-2) including a wall (35; Figure 2; Column 3, Lines 49-50), a longitudinal axis (30; Figure 1), a proximally projecting jet orifice (33) extending through the wall (35) at an angle relative to the longitudinal axis (30; Figures 1 and 3; Column 3, Lines 65-67), and a distally projecting jet orifice (33) extending through the wall (35) at an angle relative to the longitudinal axis (Figures 1-4; Column 3, Lines 65-67 and Column 4, Lines 1-67).
It would have been obvious to one of ordinary skill in the art to modify the fluid supply tube taught by Bonnette to include proximally projecting and distally projecting jet orifices that extend through the wall at an angle, as taught by Schucart, for the advantage of improving “lysing of a thrombus when the catheter is used to perform thrombolysis. The improvement is believed to arise from eddies in the injected fluid and the adjacent vascular fluid caused by the obliquely angled streams. Some of these eddies are likely to be turbulent. The forces associated with these eddies resemble an agitator-type action and assist in the dispersion of the fluid, as well as improving the ability of the fluid to penetrate the surface 51 of the clot 41.” (Column 4, Lines 34-41; Schucart).
Furthermore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute fluid supply tube taught by Bonnette with the fluid supply tube as taught by Schucart 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; the fluid supply tube of Schucart would be sufficient to provide thrombolytic action to the user.
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 (105 and 105’ Figure 1A).
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 Bonnette teaches the pump (115) is configured to inject fluid through the fluid supply tube based on the signal received from the processor (Paragraph 0115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Saadat such that the pump was capable of expelling fluid, rather than just suction, for the advantage of using the jet streams to help break up thrombus).
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, Saadat teaches a thrombectomy system, comprising:
a processor (104; Figure 1A) coupled to a fluid pump (109; Figure 1A) and a thrombectomy catheter (103; Figure 1A), wherein the thrombectomy catheter includes:
a catheter body (103) having a proximal end region, a distal end region (distal most tip) and a lumen extending therein (120; Figures 1A-1B); and
an impedance sensor (105’ and 105’ in Figure 1B; see also 106 in Figure 1C) disposed along the distal end region of the catheter body (Figures 1A-1D),
wherein the impedance sensor configured to sense the impedance of a bodily substance adjacent to the impedance sensor (Paragraph 0288, 0301, and see Paragraph 0307 which discloses the sensors can differentiate between the impedance of blood and clot material).
Saadat fails to disclose:
a fluid supply tube extending within the lumen of the catheter body and coupled to the pump, wherein the fluid supply tube includes at least one proximally projecting jet orifice for expelling at least one proximally oriented fluid jet from the fluid supply tube within the catheter lumen in a generally proximal direction, and wherein the fluid supply tube includes at least one distally projecting jet orifice for expelling at least one distally oriented fluid jet from the fluid supply tube within the catheter lumen in a generally distal direction;
Bonnette teaches thrombectomy aspiration catheter (Figures 17-18 and Figures 25-26; Paragraph 0104-0105, 0115, and 0117-0120) comprising a fluid supply tube (52C; Figure 17) including at least one proximally projecting jet orifice (106a-106n) for expelling at least one proximally oriented fluid jet from the fluid supply tube within the catheter lumen (12) in a generally proximal direction (see Figures 17-18; Paragraph 0104) and wherein the fluid supply tube (52C; Figure 17) includes at least one distally projecting jet orifice (122a-122n; Figure 17) for expelling at least one distally oriented fluid jet from the fluid supply tube within the catheter lumen in a generally distal direction (see Figure 22 and see Figure 26 of Bonnette)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Saadat such that in includes a fluid supply tube as taught by Bonnette, for the advantage of providing multiple jet streams (proximally radially and distally) to break off and direct thrombus back towards the proximal end of the catheter for removal from the body (see paragraph 0109 and Figure 22).
The combination of references fails to disclose that the fluid supply tube comprises:
a fluid supply tube including a wall, a longitudinal axis, a proximally projecting jet orifice extending through the wall at an angle relative to the longitudinal axis, and a distally projecting jet orifice extending through the wall at an angle relative to the longitudinal axis.
Schucart teaches a catheter (21; Column 3, Lines 38-45) to perform thrombolysis (abstract; wherein the thrombolysis is breaking up clot material) comprising a fluid supply tube (23; Figure 1-2) including a wall (35; Figure 2; Column 3, Lines 49-50), a longitudinal axis (30; Figure 1), a proximally projecting jet orifice (33) extending through the wall (35) at an angle relative to the longitudinal axis (30; Figures 1 and 3; Column 3, Lines 65-67), and a distally projecting jet orifice (33) extending through the wall (35) at an angle relative to the longitudinal axis (Figures 1-4; Column 3, Lines 65-67 and Column 4, Lines 1-67).
It would have been obvious to one of ordinary skill in the art to modify the fluid supply tube taught by Bonnette to include proximally projecting and distally projecting jet orifices that extend through the wall at an angle, as taught by Schucart, for the advantage of improving “lysing of a thrombus when the catheter is used to perform thrombolysis. The improvement is believed to arise from eddies in the injected fluid and the adjacent vascular fluid caused by the obliquely angled streams. Some of these eddies are likely to be turbulent. The forces associated with these eddies resemble an agitator-type action and assist in the dispersion of the fluid, as well as improving the ability of the fluid to penetrate the surface 51 of the clot 41.” (Column 4, Lines 34-41; Schucart).
Furthermore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute fluid supply tube taught by Bonnette with the fluid supply tube as taught by Schucart 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; the fluid supply tube of Schucart would be sufficient to provide thrombolytic action to the user.
Regarding Claim 20, the combination of references disclosed above teaches the thrombectomy system of claim 19, wherein Saadat teaches the processor (104) is configured to sense the impedance difference between blood and thrombus (Paragraph 0288, 0301, and see Paragraph 0307 which discloses the sensors can differentiate between the impedance of blood and clot material).
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 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 G GABR/Primary Examiner, Art Unit 3771
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