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 .
DETAILED ACTION
Claim Objections
Claims 74, 103 are objected to because of the following informalities: “the agent” should be “the one or more lytic agents”, “one or more lytic agents” (in the last line of claim 74 and in claim 103) should be “the one or more lytic agents”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 74-78, 80-89, 99-100, 102-104, 106-122 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 74, line 9, “the distal end” and “the proximal end” are indefinite because it is unclear if they refer to the ends of the sheath or the catheter body.
In claim 74, line 10, “the catheter” lacks antecedent basis.
In claim 76, “the proximal end” is indefinite because it is unclear if it refers to the end of the sheath or the catheter body.
In claim 118, “a thrombectomy catheter” and “a thrombectomy sheath” are indefinite because it is unclear if they are the same or different from the catheter and sheath of claim 74. Furthermore, “the sheath” is indefinite because it is unclear if it refers to the thrombectomy sheath.
In claim 122, “removal of the captured thrombus or clot from the blood vessel is executed after the infusion of the one or more lytic agents” is indefinite because claim 121 from which it depends requires the opposite order. It is unclear how the operation could be both.
Claim Rejections - 35 USC § 103
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) 74-78, 80-89, 99-100, 103-104, 106-108, 109, 111-112, 114-116 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0250035 (El-Nounou) in view of US 5336178 (Kaplan), US 2021/0100987 (Schultz), and US 2021/0275200 (Green).
Regarding claim 74, El-Nounou teaches a system for treatment of a thrombus or a clot located within a blood vessel of a patient with infusion of one or more lytic agents (Fig 7, para 13-14; “thrombolytic drugs”), comprising: a sheath comprising a body defining a lumen extending from a distal end of the sheath to a proximal end of the sheath (sheath 53 with distal end on right side, proximal end on left side); an elongated catheter body having a proximal end, a distal end, and a length extending from the proximal end and the distal end (body 52 with distal end on right side, proximal end on left side and a length extending therebetween), the elongated catheter body configured to be received within the lumen defined by the body of the sheath (Fig 7, 9), the catheter body defining: one or more first ports in fluid communication with the catheter body at a position along the length that is closer to the distal end than to the proximal end (para 45; agent delivery lumen 63 has a first port at its distal end to deliver the agent into the frame 54), and an interior lumen extending longitudinally through the catheter along at least a portion of the length (interior lumen 63, para 45, Fig 7); wherein the interior lumen comprises: a first lumen in fluid communication with the one or more first ports (first lumen 63), a second lumen extending the length of the catheter body configured to receive a guidewire therethrough (guidewire 57, para 39; “guidewire lumen”), a plurality of tubes each having a sidewall defining a tube lumen in fluid communication with the first lumen at a location that is proximal of the distal end of the catheter body (tubes 54 each with tube lumen receiving the agent), the tube lumen in further fluid communication with the one or more first ports (para 45; agent flows from interior, first lumen 63, through a first port, into tubes 54 to deliver agent), the plurality of tubes comprising a plurality of openings through the sidewall in fluid communication with the tube lumen (openings 61), wherein the plurality of tubes are configured to shift between a collapsed configuration when restrained within the sheath (Fig 7) and an expanded configuration when released from the sheath when the sheath is retracted (Fig 11, para 41), and wherein the plurality of tubes extend along a portion of an outer surface of the catheter body (Fig 7); wherein the plurality of tubes are biased to expand, and when in the expanded configuration, at least part of the plurality of tubes comprise an unconstrained maximum transverse dimension that larger than a corresponding maximum transverse dimension of the catheter body (Fig 11), and wherein in the collapsed configuration, at least part of the plurality of tubes is radially closer to the catheter body than when in the expanded configuration (Fig 7).
El-Nounou teaches an interior lumen but fails to teach the interior lumen being a plurality of interior lumens. However, Kaplan teaches a plurality of interior lumens supplying the one or more first ports and the plurality of tubes (Fig 4A-4E; interior lumens 36 each supplying one of the plurality of expandable tubes 32). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a plurality of interior lumens in order to supply agent to the plurality of tubes, as taught by Kaplan (col 9 l. 53-col 10 l. 17). It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing a plurality of interior lumens yields predictable results (agent delivery).
El-Nounou fails to teach one or more pressure sensors coupled to and/or integrated with the body of the sheath and/or coupled to and/or integrated with the catheter body, and configured to measure pressure; and a controller in operative communication with the one or more pressure sensors, the controller comprising a processor configured to execute programmed instructions, and a memory in operative communication with the processor, the processor configured to monitor the measured pressure, wherein when the plurality of tubes are in an expanded configuration, the one or more pressure sensors are located proximal to the tubes; a user-interface display in operative connection with the controller, wherein the controller is configured to generate control signals to perform one or more operations including monitoring the measured pressures during an infusion of the one or more lytic agents through the plurality of openings in the one or more tubes, displaying the monitored pressure, and/or transmitting alerts based on a change of the monitored pressure such that, based on the displayed monitored pressure and/or the change in the monitored pressure, a flow rate of the agent maybe altered, wherein, the change in the monitored pressure is configured to monitor progress of the treatment and/or determine when the treatment thrombus or a clot located within a blood vessel with one or more lytic agents is sufficiently completed. However, Schultz teaches one or more pressure sensors coupled to and/or integrated with the body of the sheath and/or coupled to and/or integrated with the catheter body, and configured to measure pressure (para 132; catheter body comprising a lumen for pressure measurement; para 138, 151-152; pressure sensing ports); and a controller in operative communication with the one or more pressure sensors, the controller comprising a processor configured to execute programmed instructions, and a memory in operative communication with the processor, the processor configured to monitor the measured pressure (para 225-229; controller 910, control circuitry 911, memory 914, processing circuitry 912 communicating with pressure sensor 926), wherein when the plurality of tubes are in an expanded configuration, the one or more pressure sensors are located proximal to the tubes (para 151, 152); a user-interface display in operative connection with the controller, wherein the controller is configured to generate control signals to perform one or more operations including monitoring the measured pressures during an infusion of the one or more lytic agents through the plurality of openings in the one or more tubes, displaying the monitored pressure, and/or transmitting alerts based on a change of the monitored pressure (para 201, 210, 225-230; console/display/screen displays and monitors measurements and allows user control). Green teaches monitoring pressure within the blood vessel (e.g. a pressure sensor) such that, based on the displayed monitored pressure and/or the change in the monitored pressure, a flow rate of the agent maybe altered, wherein, the change in the monitored pressure is configured to monitor progress of the treatment and/or determine when the treatment thrombus or a clot located within a blood vessel with one or more lytic agents is sufficiently completed (para 61; “pressure transducer system” allows “for immediate indication of successful elimination of an occlusion”; “by monitoring the blood pressure during deployment and use of an catheter of the present disclosure, a successful operation may be indicated by an immediate drop in blood pressure as blood flow is restored”). Kaplan teaches that once treatment is completed, “drug delivery may be terminated” (col 17 ll. 3-5). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide one or more pressure sensors coupled to and/or integrated with the body of the sheath and/or coupled to and/or integrated with the catheter body, and configured to measure pressure; and a controller in operative communication with the one or more pressure sensors, the controller comprising a processor configured to execute programmed instructions, and a memory in operative communication with the processor, the processor configured to monitor the measured pressure, wherein when the plurality of tubes are in an expanded configuration, the one or more pressure sensors are located proximal to the tubes; a user-interface display in operative connection with the controller, wherein the controller is configured to generate control signals to perform one or more operations including monitoring the measured pressures during an infusion of the one or more lytic agents through the plurality of openings in the one or more tubes, displaying the monitored pressure, and/or transmitting alerts based on a change of the monitored pressure such that, based on the displayed monitored pressure and/or the change in the monitored pressure, a flow rate of the agent maybe altered, wherein, the change in the monitored pressure is configured to monitor progress of the treatment and/or determine when the treatment thrombus or a clot located within a blood vessel with one or more lytic agents is sufficiently completed in order to monitor pressure within the blood vessel, notify and display the information to the user, determine when the thrombus or clot has been eliminated (e.g. the treatment is completed), and reduce the delivery of the agent, as taught by Schultz, Green, and Kaplan. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing one or more pressure sensors coupled to and/or integrated with the body of the sheath and/or coupled to and/or integrated with the catheter body, and configured to measure pressure; and a controller in operative communication with the one or more pressure sensors, the controller comprising a processor configured to execute programmed instructions, and a memory in operative communication with the processor, the processor configured to monitor the measured pressure, wherein when the plurality of tubes are in an expanded configuration, the one or more pressure sensors are located proximal to the tubes; a user-interface display in operative connection with the controller, wherein the controller is configured to generate control signals to perform one or more operations including monitoring the measured pressures during an infusion of the one or more lytic agents through the plurality of openings in the one or more tubes, displaying the monitored pressure, and/or transmitting alerts based on a change of the monitored pressure such that, based on the displayed monitored pressure and/or the change in the monitored pressure, a flow rate of the agent maybe altered, wherein, the change in the monitored pressure is configured to monitor progress of the treatment and/or determine when the treatment thrombus or a clot located within a blood vessel with one or more lytic agents is sufficiently completed yields predictable results (monitoring and displaying information, determining treatment status, controlling agent delivery).
Regarding claim 75-78, 80-89, El-Nounou in view of Schultz, Green, and Kaplan further teaches the change in the monitored pressure comprises a decrease in pressure (as discussed above, Green teaches: “an immediate drop in blood pressure as blood flow is restored”), wherein the pressure sensor is located closer to the distal end of the sheath than to the proximal end (as discussed above, the pressure sensor detects pressure in the blood vessel, closer to the distal end of the sheath and the plurality of openings), wherein the controller is further configured to monitor the measured pressure for a decrease in magnitude below a predetermined threshold (in Green, “indication of successful elimination of an occlusion” implicitly comprises a threshold for pressure that would provide the indication – e.g. a sufficient “drop in blood pressure”), a decreasing monitored pressure magnitude is correspondent with a progression of the treatment of the thrombus or clot comprising infusion of the at least one lytic agent (Green para 45; the lytic agent is infused in order to eliminate the thrombus or clot; therefore, the decreasing pressure – e.g. elimination of the occlusion - is correspondent to the infusion of the lytic agent), the progression of the treatment of the thrombus or clot is correspondent with the displayed monitored pressure (as discussed above, the display/console/screen may display information about sensor readings – e.g. monitored pressure; treatment of the thrombus/clot is indicated by the pressure – e.g. correspondent with the pressure), wherein the controller is configured to generate an alert when the measured pressure's magnitude is below the predetermined threshold (Schultz para 210, 216; display/console may alert users to modulate characteristics of the system), wherein the controller is configured to display the generated alert on the user-interface display (Schultz para 210, 216; display/console may alert users to modulate characteristics of the system), wherein the infusion of the at least one lytic agent is terminated by an operator when the monitored pressure drops below the predetermined threshold (Schultz para 176, 210; a user/operator may change setting manually), wherein the controller is configured to terminate the infusion of the at least one lytic agent when the monitored pressure drops below the predetermined threshold (Green para 61; a drop in pressure below a predetermined threshold indicates the occlusion being eliminated; Kaplan col 17 ll. 3-5; delivery of the agent is terminated when treatment is completed), wherein the controller is configured to modify a rate of infusion of the at least one lytic agent as the monitored pressure decreases (Green para 61; a drop in pressure below a predetermined threshold indicates the occlusion being eliminated; Kaplan col 17 ll. 3-5; delivery of the agent is terminated when treatement is completed; the termination is construed as modified), wherein the controller is configured to slow the rate of infusion of the at least one lytic agent as the monitored pressure decreases (Green para 61; a drop in pressure below a predetermined threshold indicates the occlusion being eliminated; Kaplan col 17 ll. 3-5; delivery of the agent is terminated when treatment is completed; the termination is construed as slowing), wherein the rate of infusion of the at least one lytic agent is slowed or terminated based on the decrease in pressure (Green para 61; a drop in pressure below a predetermined threshold indicates the occlusion being eliminated; Kaplan col 17 ll. 3-5; delivery of the agent is terminated when treatement is completed), one or more sensors selected from the group consisting of: a flow sensor, a blood oxygenation sensor, a pHsensor, a hemoglobin sensor, an optical sensor, and a strain gauge, wherein the one or more sensors are coupled to and/or integrated with the elongated catheter body and/or the sheath (Schultz para 152, 206, 365; flow rate sensor, strain gauge integrated into the catheter body).
It would have been obvious to one of ordinary skill in the art at the time of the invention to make the progression of the treatment of the thrombus or clot is correspondent with the displayed monitored pressure, wherein the controller is configured to generate an alert when the measured pressure's magnitude is below the predetermined threshold, wherein the controller is configured to display the generated alert on the user-interface display, wherein the infusion of the at least one lytic agent is terminated by an operator when the monitored pressure drops below the predetermined threshold, wherein the controller is configured to terminate the infusion of the at least one lytic agent when the monitored pressure drops below the predetermined threshold, wherein the controller is configured to modify a rate of infusion of the at least one lytic agent as the monitored pressure decreases, wherein the controller is configured to slow the rate of infusion of the at least one lytic agent as the monitored pressure decreases, wherein the rate of infusion of the at least one lytic agent is slowed or terminated based on the decrease in pressure, one or more sensors selected from the group consisting of: a flow sensor, a blood oxygenation sensor, a pHsensor, a hemoglobin sensor, an optical sensor, and a strain gauge, wherein the one or more sensors are coupled to and/or integrated with the elongated catheter body and/or the sheath in order to display information to the user, alert the user to a completion of the treatment, allow the user to adjust flow of the agent, reduce or terminate delivery of the agent upon the completion, and measure pressure and flow rate, as taught by Schultz, Green, and Kaplan. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the progression of the treatment of the thrombus or clot correspondent with the displayed monitored pressure, wherein the controller is configured to generate an alert when the measured pressure's magnitude is below the predetermined threshold, wherein the controller is configured to display the generated alert on the user-interface display, wherein the infusion of the at least one lytic agent is terminated by an operator when the monitored pressure drops below the predetermined threshold, wherein the controller is configured to terminate the infusion of the at least one lytic agent when the monitored pressure drops below the predetermined threshold, wherein the controller is configured to modify a rate of infusion of the at least one lytic agent as the monitored pressure decreases, wherein the controller is configured to slow the rate of infusion of the at least one lytic agent as the monitored pressure decreases, wherein the rate of infusion of the at least one lytic agent is slowed or terminated based on the decrease in pressure, one or more sensors selected from the group consisting of: a flow sensor, a blood oxygenation sensor, a pHsensor, a hemoglobin sensor, an optical sensor, and a strain gauge, wherein the one or more sensors are coupled to and/or integrated with the elongated catheter body and/or the sheath yields predictable results (monitoring and displaying information, determining treatment status, controlling agent delivery).
Regarding claim 99-100, El-Nounou in view of Schultz, Green, and Kaplan further teaches the one or more tubes comprise a shape memory material, wherein the shape memory material comprises nitinol (Green para 8, 44, 57). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the one or more tubes comprise a shape memory material, wherein the shape memory material comprises nitinol in order to expand and contract the tubes, as taught by Green. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the one or more tubes comprise a shape memory material, wherein the shape memory material comprises nitinol yields predictable results (deformation of the tubes).
Regarding claim 103, El-Nounou in view of Schultz, Green, and Kaplan further teaches a method to treat a thrombus or a clot within a blood vessel, comprising: providing the system comprising the elongated catheter and the sheath of claim 74 (as discussed above); ensuring that the plurality of tubes achieves an expanded position relative to the elongated catheter such that the expanded position results in the one or more tubes moving through a portion of the thrombus or clot in at least a radial or lateral direction (El-Nounou Fig 11); monitoring pressure within the blood vessel at a location that is proximal to the thrombus or clot (as discussed above; Green teaches: pressure is monitored within the vessel to determine the thrombus or clot is eliminated, therefore “an immediate drop in blood pressure as blood flow is restored”); initiating thrombolysis with infusion of one or more lytic agents through the one or more tubes and into the thrombus or clot while continuing to monitor the pressure within the blood vessel at a location that is proximal to the thrombus or clot (as discussed above, thrombolytic agent is infused for the purpose of eliminating the thrombus or clot; pressure is monitored to determine when the thrombus or clot is eliminated); monitoring, by the monitored pressure, the progress of the thrombolysis (Green: pressure is monitored to determine when the thrombus or clot is eliminated); and determining the thrombolysis is sufficient; and terminating the thrombolysis (as discussed above, Green para 61; a drop in pressure below a predetermined threshold indicates the occlusion being eliminated; Kaplan col 17 ll. 3-5; delivery of the agent is terminated when treatment is completed).
Regarding claim 104, El-Nounou in view of Schultz, Green, and Kaplan further teaches a method to treat a thrombus or a clot within a blood vessel, comprising: providing the system comprising the elongated catheter and the sheath of claim 74 (as discussed above); inserting the elongated catheter into the lumen of the sheath such that the plurality of tubes are restrained in a collapsed configuration within the lumen of the sheath and the distal end of the catheter body is within the lumen of the sheath (El-Nounou Fig 7); translating the sheath with the elongated catheter through the thrombus or clot such that the distal end of the sheath is distal to the thrombus or clot (Fig 7 or 11; the thrombus or clot is on the interior of the vessel wall 17); monitoring pressure within the sheath lumen (as discussed in the combination above, the pressure sensors are in the catheter body proximal to the plurality of openings, and are therefore inside the sheath lumen in the position of Fig 7); retracting the sheath to a point that is proximal of the thrombus or clot to release the one or more tubes to an expanded configuration (Fig 11), wherein the expanded configuration comprises the one or more tubes traversing through a portion of the thrombus or clot in at least a radial or lateral direction (Fig 11-12; tubes 54 extend through/into the clot in the radial direction); continuing to monitor the pressure proximal of the thrombus or clot (as discussed above, taught by Green and Schultz); infusing the one or more lytic agents into the first lumen such that the one or more lytic agents flow through the one or more tubes and expelled through the plurality of openings and into the thrombus or clot (El-Nounou Fig 11, para 43-45); monitoring the pressure proximal of the thrombus or clot during the infusing (Schultz para 151, 152 and Green para 61; pressure monitored proximal the tubes, and therefore proximal the thrombus or clot to determine when the thrombus or clot is eliminated); comparing the monitored pressure proximal of the thrombus or clot with a predetermined magnitude or threshold during the infusing (Green; pressure is monitored to determine when the thrombus or clot is eliminated; comparison of monitored pressure to a predetermined threshold is implicit in order to make the indication that the clot/thrombus is eliminated); determining the monitored pressure is below the predetermined magnitude or threshold (Green; indication that the thrombus/clot is eliminated is made when the monitored pressure is below the threshold); and altering a flow rate of the one or more lytic agents and/or terminating the infusing (Kaplan as discussed above; delivery of lytic agent is terminated).
Regarding claim 106-108, El-Nounou in view of Schultz, Green, and Kaplan further teaches the plurality of tubes is configured to expand and engage a portion of the thrombus or clot when the plurality of tubes is in an expanded configuration and further configured to retract into the sheath lumen with the engaged portion of the thrombus or clot for removal from the blood vessel (El-Nounou Fig 11-13; para 39-41; tubes expand to engage the clot and retract into the sheath; furthermore, “configured to expand” and “configured to retract … with the engaged portion …” are statements of intended use; it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" see MPEP 2114 [R-1]; in this case, El-Nounou teaches all the structural limitations – tubes that expand and retract; how they are intended to be employed does not differentiate the claimed apparatus), the removal of the thrombus or clot from the blood vessel is executed before the infusion of the one or more lytic agents (“the removal … is executed before the infusion” is a statement of intended use; it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" see MPEP 2114 [R-1]; in this case, El-Nounou teaches all the structural limitations – tubes that expand and retract; how they are intended to be employed does not differentiate the claimed apparatus), the removal of the thrombus or clot from the blood vessel is executed after the infusion of the one or more lytic agents (as discussed above, the thrombolytic agent dissolves the thrombus/clot; therefore the removal occurs after infusion; further, “the removal … is executed after the infusion” is a statement of intended use; it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" see MPEP 2114 [R-1]; in this case, El-Nounou teaches all the structural limitations – tubes that expand and retract; how they are intended to be employed does not differentiate the claimed apparatus).
Regarding claims 109, 111-112, 114, El-Nounou in view of Kaplan, Schultz, and Green further teaches capturing and removing a portion of the thrombus or clot with the plurality of tubes by expanding the plurality of tubes into the thrombus or clot, capturing the portion of the thrombus or clot within the plurality of tubes, retracting the plurality of tubes into the sheath with the captured portion, and removing the captured thrombus or clot from the blood vessel (Green, para 35; thrombolysis may include both mechanical and pharmaceutical means; para 53; “basket” 130 including the plurality of tubes mechanically captures portions of the thrombus/clot and removes it from the vessel; El-Nounou; removal would include retracting the tubes into the sheath as shown in Fig 7), executing the removing of the thrombus or clot from the blood vessel is executed after the infusion of the one or more lytic agents (Green para 64; “infuse therapeutic medication to the site, then returned to a closed first position for removal”). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide steps of capturing and removing a portion of the thrombus or clot with the plurality of tubes by expanding the plurality of tubes into the thrombus or clot, capturing the portion of the thrombus or clot within the plurality of tubes, retracting the plurality of tubes into the sheath with the captured portion, and removing the captured thrombus or clot from the blood vessel; and executing the removing of the thrombus or clot from the blood vessel is executed after the infusion of the one or more lytic agents in order to examine the thrombus or clot, as taught by Green. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing steps of capturing and removing a portion of the thrombus or clot with the plurality of tubes by expanding the plurality of tubes into the thrombus or clot, capturing the portion of the thrombus or clot within the plurality of tubes, retracting the plurality of tubes into the sheath with the captured portion, and removing the captured thrombus or clot from the blood vessel; and executing the removing of the thrombus or clot from the blood vessel is executed after the infusion of the one or more lytic agents yields predictable results (removing the thrombus or clot).
Regarding claims 115-116, El-Nounou in view of Kaplan, Schultz, and Green further teaches an annular gap between the sheath and the elongated body (El-Nounou, Fig 7, 9; annular gap between 52, 53), the annular gap configured to inject a contrast solution into the blood vessel (“configured to inject a contrast solution” is a statement of intended use; it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" see MPEP 2114 [R-1]; in this case, El-Nounou teaches all the structural limitations – the annular gap; how it is intended to be employed does not differentiate the claimed apparatus), wherein the elongated catheter body comprises a maximum transverse diameter that is less than or equal to 10 French (El-Nounou para 53 or Green para 63). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the elongated catheter body comprises a maximum transverse diameter that is less than or equal to 10 French in order to fit in a desired vessel, as taught by El-Nounou and Green. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, the elongated catheter body comprises a maximum transverse diameter that is less than or equal to 10 French yields predictable results (fitting a desired vessel).
Claim(s) 117 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0250035 (El-Nounou) in view of US 5336178 (Kaplan), US 2021/0100987 (Schultz), and US 2021/0275200 (Green), and further in view of US 2011/0137245 (Schaeffer).
Regarding claim 117, El-Nounou in view of Kaplan, Schultz, and Green fails to teach wherein the elongated catheter body comprises a maximum transverse diameter that is greater than 10 French. However, Schaeffer teaches that a catheter body outer diameter may be greater than 10 French (para 68; 3.5 mm or up to 12 French). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the elongated catheter body comprise a maximum transverse diameter that is greater than 10 French in order to fit a desired application, as taught by Schaeffer. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, the elongated catheter body comprises a maximum transverse diameter that is greater than 10 French yields predictable results (fitting a desired vessel).
Claim(s) 118-122 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0250035 (El-Nounou) in view of US 5336178 (Kaplan), US 2021/0100987 (Schultz), and US 2021/0275200 (Green), US 2011/0137245 (Schaeffer) and further in view of WO 2018/080590 (Marchand).
Regarding claim 118, El-Nounou in view of Kaplan, Schultz, Green, and Schaeffer teaches a thrombectomy catheter configured to translate within a thrombectomy sheath (El-Nounou; catheter 52 inside sheath 53) and comprising an expandable cage configured to achieve a collapsed configuration when restrained within the sheath and an expanded configuration when released from the sheath (El-Nounou; collapsed within the sheath Fig 7; expanded when released Fig 11) but fails to teach an interwoven cage. Marchand teaches an expandable interwoven cage configured to achieve a collapsed configuration when restrained within the sheath and an expanded configuration when released from the sheath (Fig 8-9; interwoven cage 704 is collapsed inside a sheath and expanded when released). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an expandable interwoven cage configured to achieve a collapsed configuration when restrained within the sheath and an expanded configuration when released from the sheath in order to capture thrombus, as taught by Marchand (para 121-123). It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing an expandable interwoven cage configured to achieve a collapsed configuration when restrained within the sheath and an expanded configuration when released from the sheath yields predictable results (fitting a desired vessel).
Regarding claim 119-120, El-Nounou in view of Kaplan, Schultz, Green, Schaeffer, and Marchand further teaches a maximum transverse diameter of the thrombectomy sheath is greater than the maximum transverse diameter of the elongated catheter body (Fig 8 of Marchand, Fig 11 of El-Nounou), wherein the expandable interwoven cage is released from the sheath to an expandable portion configured to capture a portion of the thrombus or clot and further configured to collapse when retracted back into the sheath to a collapsed configuration for removal of the captured thrombus or clot from the blood vessel (para 121-127 of Marchand).
Regarding claim 121-122, El-Nounou in view of Kaplan, Schultz, Green, Schaeffer, and Marchand further teaches the removal of the captured thrombus or clot is executed before the infusion of the one or more lytic agents and the removal of the captured thrombus or clot is executed after the infusion of the one or more lytic agents. Marchand teaches that removing the thrombus or clot may occur before, during, or after infusion of the lytic agent (para 160). It would have been obvious to one of ordinary skill in the art at the time of the invention to execute the removing of the thrombus or clot from the blood vessel before or after the infusion of the one or more lytic agents, as taught by Marchand. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, executing the removing of the thrombus or clot from the blood vessel before or after the infusion of the one or more lytic agents yields predictable results (thrombolysis).
Claim(s) 102 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0250035 (El-Nounou) in view of US 5336178 (Kaplan), US 2021/0100987 (Schultz), and US 2021/0275200 (Green), and further in view of US 2019/0160266 (Ngo-Chu).
Regarding claim 102, El-Nounou in view of Kaplan, Schultz, and Green fails to teach a steering wire that extends within the catheter body from a proximal handle to a distal tip of the catheter body, the steering wire configured to manipulate the orientation of the distal tip of the catheter body. However, Ngo-Chu teaches a steering wire that extends within the catheter body from a proximal handle to a distal tip of the catheter body, the steering wire configured to manipulate the orientation of the distal tip of the catheter body (para 92-95, Fig 18A-18B; steering wire 412 extends from handle 424 to distal tip of the catheter). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a steering wire that extends within the catheter body from a proximal handle to a distal tip of the catheter body, the steering wire configured to manipulate the orientation of the distal tip of the catheter body in order to control the orientation/direction of the catheter tip, as taught by Ngo-Chu. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing a steering wire that extends within the catheter body from a proximal handle to a distal tip of the catheter body, the steering wire configured to manipulate the orientation of the distal tip of the catheter body yields predictable results (steering of the distal tip).
Claim(s) 110, 113 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0250035 (El-Nounou) in view of US 5336178 (Kaplan), US 2021/0100987 (Schultz), and US 2021/0275200 (Green), and further in view of WO 2018/080590 (Marchand).
Regarding claim 110, 113, El-Nounou in view of Kaplan, Schultz, and Green fails to teach executing the removing of the thrombus or clot from the blood vessel before the infusion of the one or more lytic agents. However, Marchand teaches that removing the thrombus or clot may occur before, during, or after infusion of the lytic agent (para 160). It would have been obvious to one of ordinary skill in the art at the time of the invention to execute the removing of the thrombus or clot from the blood vessel before the infusion of the one or more lytic agents, as taught by Marchand. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, executing the removing of the thrombus or clot from the blood vessel before the infusion of the one or more lytic agents yields predictable results (thrombolysis).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0049761 teaches a catheter with expandable tubes delivering a therapeutic fluid.
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741
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