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 .
Claim Rejections - 35 USC § 112
Claim 20 is 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.
Claim 20 recites the limitation “while the hemostasis valve is in the first position, aspirating the catheter lumen such that the at least portion of the clot material is aspirated into the catheter lumen” in lines 5-6. Claim 17 already recites “wherein a valve lumen of the hemostasis valve is constricted in the first position to inhibit fluid flow from a catheter lumen of the catheter through the valve lumen” in lines 5-7. Therefore, it is unclear how the catheter lumen can be aspirated in the first position if the first position of the hemostasis valve inhibits fluid flow from a catheter lumen of the catheter through the valve lumen. Claim 20 is unable to be examined because it is unclear how to interpret the limitation.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 17-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US 20150173782 A1), hereinafter referred to as “Garrison” and Cradio et al. US (20090024072 A1), hereinafter referred to as “Cradio”.
Regarding Claim 1, Garrison teaches a method of treating clot material in a vasculature of a patient (methods to treat acute ischemic stroke by removing occlusions, see Paragraph [0007]; Figure 1 and 34), the method comprising:
advancing a catheter (2030) at least partially through the vasculature of the patient such that a distal end portion of the catheter is positioned proximate to the clot material (distal end of catheter 2030 positioned at the clot 10, see Figure 2);
actuating a hemostasis valve (the hemostasis valve 226, see Figure 6 and 34) from a first position to a second position (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; the first position being an closed), wherein a valve lumen of the hemostasis valve is constricted in the first position to inhibit fluid flow from a catheter lumen of the catheter through the valve lumen (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; the first position being an closed), and wherein the valve lumen is at least partially open in the second position to permit fluid flow from the catheter lumen through the valve lumen (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; the second position being an open); controlling blood flow via the flow controller while the hemostasis valve is in the second position (flow controller 3400 providing aspiration while hemostasis valve is open , see Paragraph [0049] and [0133])
However, Garrison does not explicitly disclose detecting blood flow through the valve lumen while the hemostasis valve is in the second position; determining that the distal end portion of the catheter is positioned proximal to the clot material based on the detected blood flow; and after determining that the distal end portion of the catheter is positioned proximal to the clot material, aspirating the catheter lumen such that at least a portion of the clot material is aspirated into the catheter lumen.
Cradio teaches a flow control assembly 1165 adapted to regulate and/or monitor the retrograde flow from the common carotid artery to the internal jugular vein (see Paragraph [0117]; Figure 11),
detecting blood flow through the valve lumen while the hemostasis valve is in the second position (the flow control actuator 1165 can be located near the hemostasis valve where any interventional tools are introduced into the patient in order to facilitate access to the flow control actuator 1165 during introduction of the tools, see PAragraph [0117]);
determining that the distal end portion of the catheter is positioned proximal to the clot material based on the detected blood flow (the flow control assembly can include or interact with one or more sensors, which communicate with the system 100 and/or communicate with the patient's anatomy and adapted to respond to a physical stimulus, i.e. flow of blood being reduced next to clot material, see Paragraph [0120]-[0123]); and
after determining that the distal end portion of the catheter is positioned proximal to the clot material (as described above), aspirating the catheter lumen such that at least a portion of the clot material is aspirated into the catheter lumen (the system 100 comprises a closed-loop control system the controller 1130 and may include software that causes the controller 1130 to signal the components of the flow control assembly 125 to adjust the flow rate, see Paragraph [0124]; i.e. increasing aspiration within the system).
Garrison and Cradio are analogous art because both teach a method of treating clot material in a vasculature of a patient.
Cradio teaches it is beneficial to detect the blood flow so the sensor feed relevant data to the controller, which continuously adjusts an aspect of the system as necessary to maintain a desired retrograde flow rate (see Paragraph [0124]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the hemostasis valve of Garrison and further including a flow controller configured to detect blood flow through the valve lumen while the hemostasis valve is in the second position; determining that the distal end portion of the catheter is positioned proximal to the clot material based on the detected blood flow; and after determining that the distal end portion of the catheter is positioned proximal to the clot material, aspirating the catheter lumen such that at least a portion of the clot material is aspirated into the catheter lumen, as taught by Cradio.
Regarding Claim 2, Garrison and Cradio teach all of the limitations as discussed above in claim 1 and Cradio further teaches after determining that the distal end portion of the catheter is positioned proximal of the clot material based on the detected blood flow (as described in claim 1), moving the hemostasis valve to the first position (the controller 1130 may include software that causes the controller 1130 to signal the components of the flow control assembly 125 to adjust the flow rate such that the flow rate is maintained at a constant state despite differing blood pressures from the patient, see Paragraph [0124]); and
while the hemostasis valve is in the first position, aspirating the catheter lumen such that the at least portion of the clot material is aspirated into the catheter lumen (the system 100 comprises a closed-loop control system the controller 1130 and may include software that causes the controller 1130 to signal the components of the flow control assembly 125 to adjust the flow rate, see Paragraph [0124]; i.e. putting the hemostasis valve in the first position and providing aspiration).
Regarding Claim 3, Garrison and Cradio teach all of the limitations as discussed above in claim 1 and Cradio further teaches wherein detecting blood flow through the valve lumen comprises detecting a first level of blood flow (an aspiration state, see Claim 2), and wherein the method further comprises: before detecting the first level of blood flow through the valve lumen, detecting a second level of blood flow through the valve lumen while the hemostasis valve is in the second position (an off state, see Claim 2);
determining that the distal end portion of the catheter is positioned within the clot material based on the detected second level of blood flow (one or more sensors, which communicate with the system 100 and/or communicate with the patient's anatomy can be signals of embolic particles, see Paragraph [0123] it is understood lower blood flow rate would be present when the catheter is near clot material); and Garrison further teaches retracting the catheter proximally through the vasculature (the thrombus, once captured into the catheter, may be sucked all the way into the aspiration device, or alternately will be lodged in the lumen of the catheter where the catheter is no longer expanded, and at that point can be removed by retraction of the entire catheter, see Paragraph [0120]).
Garrison further teaches retracting the catheter proximally through the vasculature (the thrombus, once captured into the catheter, may be sucked all the way into the aspiration device, or alternately will be lodged in the lumen of the catheter where the catheter is no longer expanded, and at that point can be removed by retraction of the entire catheter, see Paragraph [0120]).
Regarding Claim 4, Garrison and Cradio teach all of the limitations as discussed above in claim 3 and Cradio further teaches wherein the second level of blood flow is less than the first level of blood flow (the first and second blood flow state are selected from the group comprising a passive flow state, an active flow state, an aspiration state, and an off state, see Claim 2; second level of blood flow can be an off state and first level of blood flow can be a aspiration state).
Regarding Claim 5, Garrison and Cradio teach all of the limitations as discussed above in claim 3 and Cradio further teaches wherein the second level of blood flow comprises no blood flow (second blood flow state can be an off state, see Claim 2).
Regarding Claim 6, Garrison and Cradio teach all of the limitations as discussed above in claim 1 and Garrison further teaches wherein the catheter lumen (lumen of catheter 2030) is fluidly coupled along a fluid path to an aspiration container (fluidly coupled to receptacle 3100, see Figure 33 and 34; the receptacle and source of aspiration may be combined into a single device such as a syringe, see Paragraph [0131]), and wherein aspirating the catheter lumen comprises:
generating vacuum pressure in the aspiration container (active source of aspiration may be a locking syringe, see Paragraph [0134]) while an aspiration valve (3325) positioned along the fluid path between the catheter and the aspiration container is in a first position that inhibits fluid flow along the fluid path from the catheter lumen to the aspiration container (the valve 3325 may enable one device, the other device, both devices, or neither device to be connected to the aspiration source at any given time, see Paragraph [0132]); and
moving the aspiration valve from the first position with the vacuum pressure generated in the aspiration container to a second position (during the procedure when the tip of the aspiration device (either the arterial access device or the catheter) is near or at the face of the occlusion, the user may open the connection to the aspiration syringe, see Paragraph [0134]), thereby applying the vacuum pressure to the catheter lumen such that the at least portion of the clot material is aspirated into the catheter lumen (enable the maximum level of aspiration in a rapid fashion at the clot material, see Paragraph [0134]), wherein in the second position the valve permits fluid flow along the fluid path from the catheter lumen to the aspiration container (user may open the connection to the aspiration syringe which would be opening valve 3325, see Paragraph [0132]).
Regarding Claim 17, Garrison teaches a method of treating clot material in a vasculature of a patient (methods to treat acute ischemic stroke by removing occlusions, see Paragraph [0007]; Figure 1 and 34), the method comprising:
advancing a catheter (2030) at least partially through the vasculature of the patient such that a distal end portion of the catheter is positioned proximate to the clot material (distal end of catheter 2030 positioned at the clot 10, see Figure 2);
actuating a hemostasis valve (the hemostasis valve 226, see Figure 6; see below) from a first position to a second position (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; the first position being closed), wherein a valve lumen of the hemostasis valve is constricted in the first position to inhibit fluid flow from a catheter lumen of the catheter through the valve lumen (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; the first position being closed), and wherein the valve lumen is at least partially open in the second position to permit fluid flow from the catheter lumen through the valve lumen (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; the second position being an open); controlling blood flow via the flow controller while the hemostasis valve is in the second position (flow controller 3400 providing aspiration while hemostasis valve is open , see Paragraph [0049] and [0133]); and
retracting the catheter proximally through the vasculature (the thrombus, once captured into the catheter, may be sucked all the way into the aspiration device, or alternately will be lodged in the lumen of the catheter where the catheter is no longer expanded, and at that point can be removed by retraction of the entire catheter, see Paragraph [0120]).
However Garrison does not explicitly disclose detecting a first level of blood flow through the valve lumen while the hemostasis valve is in the second position; determining that the distal end portion of the catheter is positioned within the clot material based on the detected first level of blood flow; detecting a second level of blood flow through the valve lumen while the hemostasis valve is in the second position, wherein the second level of blood flow is greater than the first level of blood flow; determining that the distal end portion of the catheter is positioned proximal to the clot material based on the detected second level of blood flow; and after determining that the distal end portion of the catheter is positioned proximal to the clot material, aspirating the catheter lumen such that at least a portion of the clot material is aspirated into the catheter lumen.
Cradio teaches a flow control assembly 1165 adapted to regulate and/or monitor the retrograde flow from the common carotid artery to the internal jugular vein (see Paragraph [0117]; Figure 11),
detecting a first level of blood flow through the valve lumen while the hemostasis valve is in the second position (flow control actuator 1165 can be located near the hemostasis valve where any interventional tools are introduced into the patient in order to facilitate access to the flow control actuator 1165 during introduction of the tools, see Paragraph [0117]; a flow sensor 1135 can detect flow when hemostasis valve is open, see Paragraph [0123]);
determining that the distal end portion of the catheter is positioned within the clot material based on the detected first level of blood flow (the flow control assembly can include or interact with one or more sensors, which communicate with the system 100 and/or communicate with the patient's anatomy and adapted to respond to a physical stimulus, i.e. flow of blood being reduced next to clot material, see Paragraph [0120]-[0123]);
detecting a second level of blood flow through the valve lumen while the hemostasis valve is in the second position (the flow control assembly can include or interact with one or more sensors, which communicate with the system 100 and/or communicate with the patient's anatomy and adapted to respond to a physical stimulus, i.e. flow of blood away from clot material, see Paragraph [0120]-[0123]), wherein the second level of blood flow is greater than the first level of blood flow (wherein the first and second blood flow state are selected from the group comprising a passive flow state, an active flow state, an aspiration state, and an off state, see claim 2);
determining that the distal end portion of the catheter is positioned proximal to the clot material based on the detected second level of blood flow (the flow control assembly can include or interact with one or more sensors, which communicate with the system 100 and/or communicate with the patient's anatomy and adapted to respond to a physical stimulus, i.e. flow of blood being reduced next to clot material, see Paragraph [0120]-[0123]); and
after determining that the distal end portion of the catheter is positioned proximal to the clot material (as described above), aspirating the catheter lumen such that at least a portion of the clot material is aspirated into the catheter lumen (the system 100 comprises a closed-loop control system the controller 1130 and may include software that causes the controller 1130 to signal the components of the flow control assembly 125 to adjust the flow rate, see Paragraph [0124]; i.e. increasing aspiration within the system).
Garrison and Cradio are analogous art because both teach a method of treating clot material in a vasculature of a patient.
Cradio teaches it is beneficial to detect the blood flow so the sensor feed relevant data to the controller, which continuously adjusts an aspect of the system as necessary to maintain a desired retrograde flow rate (see Paragraph [0124]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the hemostasis valve of Garrison and further including a flow controller configured to detecting a first level of blood flow through the valve lumen while the hemostasis valve is in the second position; determining that the distal end portion of the catheter is positioned within the clot material based on the detected first level of blood flow; detecting a second level of blood flow through the valve lumen while the hemostasis valve is in the second position, wherein the second level of blood flow is greater than the first level of blood flow; determining that the distal end portion of the catheter is positioned proximal to the clot material based on the detected second level of blood flow; and after determining that the distal end portion of the catheter is positioned proximal to the clot material, aspirating the catheter lumen such that at least a portion of the clot material is aspirated into the catheter lumen, as taught by Cradio.
Regarding Claim 18, Garrison and Cradio teach all of the limitations as discussed above in claim 17 and Garrison further teaches wherein retracting the catheter proximally through the vasculature until detecting the second level of blood flow through the valve lumen (as described in claim 17) comprises: retracting the catheter proximally (the thrombus, once captured into the catheter, may be sucked all the way into the aspiration device, or alternately will be lodged in the lumen of the catheter where the catheter is no longer expanded, and at that point can be removed by retraction of the entire catheter, see Paragraph [0120]) while the hemostasis valve is in the second position (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; the second position being open to allow for introduction and removal of catheters).
Regarding Claim 19, Garrison and Cradio teach all of the limitations as discussed above in claim 17 and Garrison further teaches wherein retracting the catheter proximally through the vasculature until detecting the second level of blood flow through the valve lumen (as described above) comprises: retracting the catheter proximally through the vasculature to a fixed position while the hemostasis valve is in the first position (the thrombus, once captured into the catheter, may be sucked all the way into the aspiration device, or alternately will be lodged in the lumen of the catheter where the catheter is no longer expanded, and at that point can be removed by retraction of the entire catheter, see Paragraph [0120]); actuating the hemostasis valve from the first position to the second position while the catheter is at the fixed position (hemostasis valve 226 can be an adjustable-opening valve, see Paragraph [0063]; therefore opening the valve).
Cradio further teaches detecting the second level of blood flow through the valve lumen while the hemostasis valve is in the second position and while the catheter is at the fixed position (the flow control assembly can include or interact with one or more sensors, which communicate with the system 100 and/or communicate with the patient's anatomy and adapted to respond to a physical stimulus, i.e. flow of blood away from clot material, see Paragraph [0120]-[0123]).
Regarding Claim 21, Garrison and Cradio teach all of the limitations as discussed above in claim 17 and Cradio further teaches wherein the first level of blood flow comprises no blood flow (wherein the first and second blood flow state are selected from the group comprising a passive flow state, an active flow state, an aspiration state, and an off state, see claim 2; first level of blood flow can be an off state).
Regarding Claim 22, Garrison and Cradio teach all of the limitations as discussed above in claim 17 and Garrison further teaches wherein the catheter lumen (lumen of cathteter 2030) is fluidly coupled along a fluid path to an aspiration container (fluidly coupled to receptacle 3100, see Figure 33 and 34; the receptacle and source of aspiration may be combined into a single device such as a syringe, see Paragraph [0131]), and wherein aspirating the catheter lumen comprises:
generating vacuum pressure in the aspiration container (active source of aspiration may be a locking syringe, see Paragraph [0134]) while an aspiration valve (3325) positioned along the fluid path between the catheter and the aspiration container is in a first position that inhibits fluid flow along the fluid path from the catheter lumen to the aspiration container (the valve 3325 may enable one device, the other device, both devices, or neither device to be connected to the aspiration source at any given time, see Paragraph [0132]); and
moving the aspiration valve from the first position with the vacuum pressure generated in the aspiration container to a second position (during the procedure when the tip of the aspiration device (either the arterial access device or the catheter) is near or at the face of the occlusion, the user may open the connection to the aspiration syringe, see Paragraph [0134]), thereby applying the vacuum pressure to the catheter lumen such that the at least portion of the clot material is aspirated into the catheter lumen (enable the maximum level of aspiration in a rapid fashion at the clot material, see Paragraph [0134]), wherein in the second position the valve permits fluid flow along the fluid path from the catheter lumen to the aspiration container (user may open the connection to the aspiration syringe which would be opening valve 3325, see Paragraph [0132]).
Claims 7-12 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison and Cradio, as applied to claims 1 and 22 above, and further in view of Laub (US 20170043066 A1).
Regarding Claim 7, Garrison and Cradio teach all of the limitations as discussed above in claim 6. However, Garrison and Cradio do not explicitly disclose wherein the clot material comprises a pulmonary embolism.
Laub teaches a system for treating clot material in the vasculature of a patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), the system comprising: a catheter (200) having a distal end portion (210) configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the catheter is positioned proximate to the clot material (aspiration catheter 200 configured to be inserted into the patient's body, e.g. into a vein or artery, and aspirate blood and other material, e.g. thrombi, see Paragraph [0024]) and wherein the clot material comprises a pulmonary embolism (to remove clots from patients suffering from or at risk of pulmonary embolisms, see Paragraph [0005]).
Garrison, Cradio, and Laub are all analogous art because all teach a method of treating clot material in a vasculature of a patient.
Laub teaches it is beneficial to remove material from the body of a patient, for example, unwanted material such as emboli, thrombi, tumors, or debris (see Paragraph [0002]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter system of Modified Garrison and further include wherein the catheter is configured to treat a pulmonary embolism, as taught by Laub.
Regarding Claim 8, Modified Garrison teaches all of the limitations as discussed above in claim 7 and Laub further teaches wherein advancing the catheter comprises advancing the catheter such that the distal end portion of the catheter is positioned proximate to the pulmonary embolism within a pulmonary artery of the vasculature of the patient (maneuvering catheter 200 through a patient's pulmonary artery, see Paragraph [0053]).
Regarding Claim 9, Modified Garrison teaches all of the limitations as discussed above in claim 8 and Laub further teaches wherein the catheter has a size of 16 French or greater (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]).
Regarding Claim 10, Garrison and Cradio teach all of the limitations as discussed above in claim 6. However, Garrison and Cradio do not explicitly disclose wherein the clot material comprises a deep vein thrombosis.
Laub teaches a system for treating clot material in the vasculature of a patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), the system comprising: a catheter (200) having a distal end portion (210) configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the catheter is positioned proximate to the clot material (aspiration catheter 200 configured to be inserted into the patient's body, e.g. into a vein or artery, and aspirate blood and other material, e.g. thrombi, see Paragraph [0024]) and wherein the clot material comprises a deep vein thrombosis (clot material may be thrombi including deep vein thrombosis, see Paragraph [0003]).
Garrison, Cradio, and Laub are all analogous art because all teach a method of treating clot material in a vasculature of a patient.
Laub teaches it is beneficial to remove material from the body of a patient, for example, unwanted material such as emboli, thrombi, tumors, or debris (see Paragraph [0002]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter system of Modified Garrison and further include wherein the catheter is configured to treat a deep vein thrombosis, as taught by Laub.
Regarding Claim 11, Modified Garrison teaches all of the limitations as discussed above in claim 10 and Laub further teaches wherein advancing the catheter comprises advancing the catheter such that the distal end portion of the catheter is positioned proximate to the deep vein thrombosis (aspiration catheter 200 configured to be inserted into the patient's body, e.g. into a vein or artery, and aspirate blood and other material, e.g. thrombi, see Paragraph [0024]; thrombi including DVT) within a peripheral portion of the vasculature of the patient (aspiration catheter 200 inserted into vein 1000, see Paragraph [0046]).
Regarding Claim 12, Modified Garrison teaches all of the limitations as discussed above in claim 11 and Laub further teaches wherein the catheter has a size of 16 French or greater (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]).
Regarding Claim 23, Garrison and Cradio teach all of the limitations as discussed above in claim 22. However, Garrison and Cradio do not explicitly disclose wherein the clot material comprises a pulmonary embolism, wherein the catheter has a size of 16 French or greater, and wherein advancing the catheter comprises advancing the catheter such that the distal end portion of the catheter is positioned proximate to the pulmonary embolism within a pulmonary artery of the vasculature of the patient.
Laub teaches a system for treating clot material in the vasculature of a patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), the system comprising: a catheter (200) having a distal end portion (210) configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the catheter is positioned proximate to the clot material (aspiration catheter 200 configured to be inserted into the patient's body, e.g. into a vein or artery, and aspirate blood and other material, e.g. thrombi, see Paragraph [0024]) and wherein the clot material comprises a pulmonary embolism (to remove clots from patients suffering from or at risk of pulmonary embolisms, see Paragraph [0005]), wherein the catheter has a size of 16 French or greater (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]), and wherein advancing the catheter comprises advancing the catheter such that the distal end portion of the catheter is positioned proximate to the pulmonary embolism (see Paragraph [0024]) within a pulmonary artery of the vasculature of the patient (maneuvering catheter 200 through a patient's pulmonary artery, see Paragraph [0053]).
Garrison, Cradio, and Laub are all analogous art because all teach a method of treating clot material in a vasculature of a patient.
Laub teaches it is beneficial to remove material from the body of a patient, for example, unwanted material such as emboli, thrombi, tumors, or debris (see Paragraph [0002]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter system of Modified Garrison and further include wherein the catheter is configured to treat a pulmonary embolism, as taught by Laub.
Regarding Claim 24, Garrison and Cradio teach all of the limitations as discussed above in claim 22. However, Garrison and Cradio do not explicitly disclose wherein the clot material comprises a deep vein thrombosis, wherein the catheter has a size of 16 French or greater, and wherein advancing the catheter comprises advancing the catheter such that the distal end portion of the catheter is positioned proximate to the deep vein thrombosis within a peripheral portion of the vasculature of the patient.
Laub teaches a system for treating clot material in the vasculature of a patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), the system comprising: a catheter (200) having a distal end portion (210) configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the catheter is positioned proximate to the clot material (aspiration catheter 200 configured to be inserted into the patient's body, e.g. into a vein or artery, and aspirate blood and other material, e.g. thrombi, see Paragraph [0024]) and wherein the clot material comprises a deep vein thrombosis (clot material may be thrombi including deep vein thrombosis, see Paragraph [0003]), wherein the catheter has a size of 16 French or greater (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]), and wherein advancing the catheter comprises advancing the catheter such that the distal end portion of the catheter is positioned proximate to the deep vein thrombosis (see Paragraph [0024]) within a peripheral portion of the vasculature of the patient (aspiration catheter 200 inserted into vein 1000, see Paragraph [0046]).
Garrison, Cradio, and Laub are all analogous art because all teach a method of treating clot material in a vasculature of a patient.
Laub teaches it is beneficial to remove material from the body of a patient, for example, unwanted material such as emboli, thrombi, tumors, or debris (see Paragraph [0002]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter system of Modified Garrison and further include wherein the catheter is configured to treat a deep vein thrombosis, as taught by Laub.
Claims 13-16 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison and Cradio, as applied to claims 1 and 22 above, and further in view of Schaffer et al. (US 20030225379 A1), hereinafter referred to as “Schaffer”.
Regarding Claim 13, Garrison and Cradio teach all of the limitations as discussed above in claim 1. However, Garrison and Cradio do not explicitly disclose wherein moving the hemostasis valve from the first position to the second position comprises depressing at least one button of the hemostasis valve, and wherein the hemostasis valve comprises a biasing member configured to bias the hemostasis valve to the first position.
Schaffer teaches a hemostasis valve (10) wherein moving the hemostasis valve from the first position to the second position (an open position and closed position, see Paragraph [0050]) comprises depressing at least one button of the hemostasis valve (actuator button 261 is depressed, each actuator 50 slides along the cylindrical interior wall 11 of the housing 20. The proximal end 273 of each actuator button 261 compresses the distal end 271 of each resilient member 267 which in turn, the proximal end 269 of each resilient member 267 compresses against the inner flange wall 265 of the housing 20. Such movement allows each engaged actuating member 55 to forcibly disengage opposing outer walls 27 of the seal module 100 allowing the portion 108 of the containment structure 160 to retract to an uncollapsed configuration where gases and fluids can pass therethrough, see Paragraph [0077]), and wherein the hemostasis valve comprises a biasing member configured to bias the hemostasis valve to the first position (the first position the actuator 50 is, in one option, disposed and held against a portion of the seal module 100 which depresses and at least partially collapses, for example, the central portion 110 of the containment structure 160 by a compressive force 67 from a resilient member (e.g., by a spring 210), see Paragraph [0050]).
Garrison, Cradio, and Schaffer are all analogous art because all teach a hemostasis valve.
Schaffer teaches the design of hemostasis valve is beneficial for a durable stasis valve that blocks the flow of gas or fluid completely and immediately with or without an instrument in place within the gas/fluid path (see Paragraph [0008]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the hemostasis valve of Modified Garrison and replace it with the hemostasis valve wherein moving the hemostasis valve from the first position to the second position comprises depressing at least one button of the hemostasis valve, and wherein the hemostasis valve comprises a biasing member configured to bias the hemostasis valve to the first position, as taught by Schaffer.
Regarding Claim 14, Garrison and Cradio teach all of the limitations as discussed above in claim 1. However, Garrison and Cradio do not explicitly disclose wherein the hemostasis valve comprises a tubular member at least partially defining the valve lumen and a pair of filaments extending at least partially around the tubular member, wherein in the first position the filaments circumferentially constrict the tubular member such that the valve lumen is constricted, and wherein in the second position the filaments are moved such that the valve lumen is at least partially open.
Schaffer teaches a hemostsis valve (10) wherein moving the hemostasis valve from the first position to the second position (an open position and closed position, see Paragraph [0050]) wherein the hemostasis valve comprises a tubular member at least partially defining the valve lumen (open lumen of seal module 100, see Figure 34) and a pair of filaments extending at least partially around the tubular member (actuating members 55 which is U shaped, see Figures 33-34; Paragrap [0076]), wherein in the first position the filaments circumferentially constrict the tubular member such that the valve lumen is constricted (see Figure 33), and wherein in the second position the filaments are moved such that the valve lumen is at least partially open (see Figure 34).
Garrison, Cradio, and Schaffer are all analogous art because all teach a hemostasis valve.
Schaffer teaches the design of hemostasis valve is beneficial for a durable stasis valve that blocks the flow of gas or fluid completely and immediately with or without an instrument in place within the gas/fluid path (see Paragraph [0008]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the hemostasis valve of Modified Garrison and replace it with the hemostasis valve wherein the hemostasis valve comprises a tubular member at least partially defining the valve lumen and a pair of filaments extending at least partially around the tubular member, wherein in the first position the filaments circumferentially constrict the tubular member such that the valve lumen is constricted, and wherein in the second position the filaments are moved such that the valve lumen is at least partially open, as taught by Schaffer.
Regarding Claim 15, Modified Garrison teaches all of the limitations as discussed above in claim 14 and Schaffer further teaches wherein moving the hemostasis valve from the first position to the second position comprises depressing at least one button of the hemostasis valve to reduce a tension in the filaments (actuator button 261 is depressed, each actuator 50 slides along the cylindrical interior wall 11 of the housing 20. The proximal end 273 of each actuator button 261 compresses the distal end 271 of each resilient member 267 which in turn, the proximal end 269 of each resilient member 267 compresses against the inner flange wall 265 of the housing 20. Such movement allows each engaged actuating member 55 to forcibly disengage opposing outer walls 27 of the seal module 100 allowing the portion 108 of the containment structure 160 to retract to an uncollapsed configuration where gases and fluids can pass therethrough, see Paragraph [0077]).
Regarding Claim 16, Modified Garrison teaches all of the limitations as discussed above in claim 14 and Schaffer further teaches wherein the hemostasis valve further comprises a biasing member configured to bias the hemostasis valve to the first position (the first position the actuator 50 is, in one option, disposed and held against a portion of the seal module 100 which depresses and at least partially collapses, for example, the central portion 110 of the containment structure 160 by a compressive force 67 from a resilient member (e.g., by a spring 210), see Paragraph [0050]).
Regarding Claim 25, Garrison and Cradio teach all of the limitations as discussed above in claim 1. However, Garrison and Cradio do not explicitly disclose wherein the hemostasis valve comprises a tubular member at least partially defining the valve lumen and a pair of filaments extending at least partially around the tubular member, wherein in the first position the filaments circumferentially constrict the tubular member such that the valve lumen is constricted, wherein in the second position the filaments are moved such that the valve lumen is at least partially open, and wherein moving the hemostasis valve from the first position to the second position comprises depressing at least one button of the hemostasis valve to reduce a tension in the filaments.
Schaffer teaches a hemostasis valve (10) wherein the hemostasis valve comprises a tubular member at least partially defining the valve lumen (open lumen of seal module 100, see Figure 34) and a pair of filaments extending at least partially around the tubular member (actuating members 55 which is U shaped, see Figures 33-34; Paragraph [0076]), wherein in the first position the filaments circumferentially constrict the tubular member such that the valve lumen is constricted (see Figure 33), wherein in the second position the filaments are moved such that the valve lumen is at least partially open (see Figure 34), and wherein moving the hemostasis valve from the first position to the second position comprises depressing at least one button of the hemostasis valve to reduce a tension in the filaments (actuator button 261 is depressed, each actuator 50 slides along the cylindrical interior wall 11 of the housing 20. The proximal end 273 of each actuator button 261 compresses the distal end 271 of each resilient member 267 which in turn, the proximal end 269 of each resilient member 267 compresses against the inner flange wall 265 of the housing 20. Such movement allows each engaged actuating member 55 to forcibly disengage opposing outer walls 27 of the seal module 100 allowing the portion 108 of the containment structure 160 to retract to an uncollapsed configuration where gases and fluids can pass therethrough, see Paragraph [0077]).
Garrison, Cradio, and Schaffer are all analogous art because all teach a hemostasis valve.
Schaffer teaches the design of hemostasis valve is beneficial for a durable stasis valve that blocks the flow of gas or fluid completely and immediately with or without an instrument in place within the gas/fluid path (see Paragraph [0008]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the hemostasis valve of Modified Garrison and replace it with the hemostasis valve wherein the hemostasis valve comprises a tubular member at least partially defining the valve lumen and a pair of filaments extending at least partially around the tubular member, wherein in the first position the filaments circumferentially constrict the tubular member such that the valve lumen is constricted, wherein in the second position the filaments are moved such that the valve lumen is at least partially open, and wherein moving the hemostasis valve from the first position to the second position comprises depressing at least one button of the hemostasis valve to reduce a tension in the filaments, as taught by Schaffer.
Regarding Claim 26, Modified Garrison teaches all of the limitations as discussed above in claim 25 and Schaffer further teaches wherein the hemostasis valve further comprises a biasing member configured to bias the hemostasis valve to the first position (the first position the actuator 50 is, in one option, disposed and held against a portion of the seal module 100 which depresses and at least partially collapses, for example, the central portion 110 of the containment structure 160 by a compressive force 67 from a resilient member (e.g., by a spring 210), see Paragraph [0050]).
Conclusion
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/ERIC RASSAVONG/ (5/12/2026)Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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