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 .
Claims 1-4, 14-17, 34, 36, and 40-45 are currently amended.
Claims 6-9 and 19-33 are canceled.
Claims 46-48 are new.
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) 1-5, 10-18, and 34-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erlick et al. (US Pub No. 2022/0015784 A1) in view of Thress et al. (US Patent No. 12558112).
Regarding claim 1, Erlick in view of Thress discloses a system (Erlick, medical apparatus 10, Fig. 1A) for removing clot material from a blood vessel of patient (Erlick, "… a medical apparatus 10 for treating any form of thrombus …" - Para [0048]), the system comprising:
a delivery catheter (Erlick, sheath 14, Fig. 1A);
an intermediate catheter (Erlick, fourth elongate cannula 36, Fig. 1A) configured to extend through the delivery catheter (Erlick, "… sheath 14 entirely covers the … fourth elongate cannula 36." - Para [0050]);
a balloon (Erlick, inflatable balloon 148, Fig. 1A) coupled to a distal portion of the intermediate catheter (Erlick, "Fourth elongate cannula 36 has … an inflatable balloon 148 connected …" - Para [0074], Fig. 1A), wherein the delivery catheter and intermediate catheter are movable relative to one another (Erlick, "Sheath 14 is movable between an initial extended sheath position 24 … and a retracted sheath position 26 …" - Para [0049], Figs. 1A and 2A-2B) to move the balloon between (a) a first balloon position (Erlick, initial extended sheath position 24, Fig. 2A) in which the balloon is constrained within the delivery catheter (Erlick, "In the initial extended sheath position 24 as depicted in both FIGS. 2A and 2B, sheath 14 entirely covers … fourth elongate cannula 36." - Para [0050]) and (b) a second balloon position (Erlick, retracted sheath position 26, Fig. 1A) in which the balloon is unconstrained by the delivery catheter and configured to expand within the blood vessel (Erlick, "When the sheath 14 is in the retracted position 26, the sheath distal end 18 is entirely proximal to inflatable balloon 148, so that inflatable balloon 148 is entirely exposed and able to be inflated to make contact with venous sidewall 118 of venous lumen 110." - Para [0076]);
a deployment catheter (Erlick, third elongate cannula 34, Fig. 1A) configured to extend through the intermediate catheter (Erlick, "Fourth elongate cannula 36 has a fourth lumen 152 … third elongate cannula 34 is disposed inside fourth lumen 152 …" - Para [0075]);
an elongate shaft (Erlick, second elongate cannula 32, Fig. 1A) configured to extend through the deployment catheter (Erlick, "Third elongate cannula 34 has … a third lumen …", "... second elongate cannula 32 is disposed in third lumen 132." - Para [0071]); and
a clot treatment device (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) coupled to the elongate shaft (Erlick, "Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]), wherein the deployment catheter and the elongate shaft are movable (Erlick, "… the third elongate cannula 34 is configured to be movable …" - Para [0087]) (Erlick, "Second elongate cannula 32 is configured to move …" - Para [0086]) relative to one another to move the clot treatment device (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) between (a) a first clot treatment device position (Erlick, initial third elongate cannula extended position 178, Fig. 10B) in which the clot treatment device is constrained within the deployment catheter (Erlick, "Mechanical thrombectomy whisk 78 is in closed condition 80 …" - Para [0088], Fig. 10B) and (b) a second clot treatment device position (Erlick, third elongate cannula retracted position 180, Fig. 10C) in which the clot treatment device is unconstrained by the deployment catheter (Erlick, "… mechanical thrombectomy whisk 78 must be exposed when sheath 14 is in … the third elongate cannula retracted position 180." - Para [0090]) and configured to expand within the blood vessel (Erlick, "Mechanical thrombectomy whisk 78 is configured to expanded …" - Para [0068]).
Erlick does not expressly disclose a funnel wherein the delivery catheter and intermediate catheter are movable … to move the funnel between a first funnel position in which the funnel is constrained … and a second funnel position in which the funnel is unconstrained, and wherein the funnel has a tapered shape with a distal opening in the second funnel position.
Thress teaches a funnel (funnel 120, Fig. 2B) wherein the delivery catheter and intermediate catheter are movable … to move the funnel (funnel 120, Fig. 2B) between a first funnel (funnel 120, Fig. 2B) position in which the funnel (funnel 120, Fig. 2B) is constrained … … and a second funnel (funnel 120, Fig. 2B) position in which the funnel (funnel 120, Fig. 2B) is unconstrained, and wherein the funnel has a tapered shape (as shown in Fig. 2) with a distal opening in the second funnel position (Fig. 2B depicts the second funnel position).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Erlick to include a funnel wherein the delivery catheter and intermediate catheter are movable … to move the funnel between a first funnel position in which the funnel is constrained … and a second funnel position in which the funnel is unconstrained, and wherein the funnel has a tapered shape with a distal opening in the second funnel position as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 2, Erlick in view of Thress discloses the system (Erlick, medical apparatus 10, Fig. 1A) as recited above, wherein
in the second balloon position (Erlick, retracted sheath position 26, Fig. 1A), the balloon (Erlick, inflatable balloon 148, Fig. 1A) is configured to expand to a diameter of the blood vessel (Erlick, "When the sheath 14 is in the retracted position 26, the sheath distal end 18 is entirely proximal to inflatable balloon 148, so that inflatable balloon 148 is entirely exposed and able to be inflated to make contact with venous sidewall 118 of venous lumen 110." - Para [0076]).
Erlick does not expressly disclose the second funnel position, and that the funnel is configured to expand.
Thress teaches the second funnel (funnel 120, Fig. 2B) position (as shown in Fig. 2B), and that the funnel (funnel 120, Fig. 2B)is configured to expand.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Erlick to include the second funnel position, and that the funnel is configured to expand as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 3, Erlick in view of Thress discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
the balloon (Erlick, inflatable balloon 148, Fig. 1A) is impermeable to blood (Erlick, "Inflatable balloon 148 may be constructed from a thermoplastic elastomer, such as PEBAX®." - Para [0075]).
Erlick does not expressly disclose the funnel.
Thress teaches the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Erlick to include the funnel as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 4, Erlick in view of Thress discloses the system (Erlick, medical apparatus 10, Fig. 1A) as recited above, wherein
in the second balloon position (Erlick, retracted sheath position 26, Fig. 1A), the balloon (Erlick, inflatable balloon 148, Fig. 1A) is configured to substantially prevent blood flow through the blood vessel (when inflatable balloon 148 is inflated to have an expanded balloon diameter that makes contact with venous sidewall 118, inflatable balloon 148 blocks or prevents blood flow. " - Para [0077]).
Erlick does not expressly disclose the second funnel position and that the funnel is configured to substantially prevent blood flow.
Thress teaches the second funnel (funnel 120, Fig. 2B) position (as shown in Fig. 2B) and that the funnel (funnel 120, Fig. 2B) is configured to substantially prevent blood flow.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Erlick to include the second funnel position and that the funnel is configured to substantially prevent blood flow as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 5, Erlick in view of Thress discloses the system (Erlick, Erlick, medical apparatus 10, Fig. 1A) as recited above, wherein
Erlick does not expressly disclose that the blood vessel is a periphery artery.
Thress teaches that the blood vessel is a periphery artery ("… the present technology can be used to extract any formation of material in a vessel (e.g., a venous or arterial vessel) …" - Para [12]). .
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Erlick to include that the blood vessel is a periphery artery as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 10, Erlick in view of Thress discloses the system (Erlick, medical apparatus 10, Fig. 1A) as recited above, further comprising
Erlick does not expressly disclose a valve assembly fixedly coupled to a proximal portion of the deployment catheter; and a hub fixedly coupled to a proximal portion of the elongate shaft, wherein the valve assembly is movable relative to the hub to retract the deployment catheter relative to the elongate shaft to move the clot treatment device between the first clot treatment position and the second clot treatment position.
Thress teaches a valve assembly (control assembly 130, Fig. 1A) fixedly coupled to a proximal portion of the deployment catheter (outer shaft 102, Fig. 1A) ("… the outer shaft 102 is operably coupled to a control assembly 130." - Para [19]); and a hub (sealable hub 110, Fig. 1A) fixedly coupled to a proximal portion of the elongate shaft ("… the sealable hub 110 can be rotatable coupled to the inner shaft 104 …" - Para [16]), wherein the valve assembly is movable relative to the hub to retract the deployment catheter relative to the elongate shaft to move the clot treatment device ("The control assembly 130 is operable to move the outer shaft 102 distally and proximally relative to the inner shaft 104 to constrain the release the funnel 120." - Para [19]) between the first clot treatment position (first position, Figs. 1 and 2A) and the second clot treatment position (second position, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Erlick to include a valve assembly fixedly coupled to a proximal portion of the deployment catheter; and a hub fixedly coupled to a proximal portion of the elongate shaft, wherein the valve assembly is movable relative to the hub to retract the deployment catheter relative to the elongate shaft to move the clot treatment device between the first clot treatment position and the second clot treatment position as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 13, Erlick in view of Thress discloses the system (Erlick, medical apparatus 10, Fig. 1A) as recited above, further comprising
an aspiration source fluidly coupled to the delivery catheter (Erlick, fourth elongate cannula 36, Fig. 1A) (Erlick, " Aspiration passageway 158 is configured to capture debris 112." - Para [0079]) (Erlick, "Fourth elongate cannula 36 also includes … an aspiration passageway 158 …" - Para [0078]).
Examiner interprets the aspiration passageway to be connected to an aspiration source.
Regarding claim 14, Erlick in view of Thress discloses a method (Erlick, method, Figs. 11A-11B) of removing clot material from a blood vessel of a patient, the method comprising:
advancing a delivery catheter (Erlick, sheath 14, medical apparatus 10, Fig. 1A) through the blood vessel such that a distal portion of the delivery catheter is proximate to the clot material (Erlick, Insert guidewire into venous lumen having a thrombus treatment site, S100, Introduce a medical apparatus over the guidewire, S102, Fig. 11A);
positioning a balloon through the delivery catheter (Erlick, “…sheath 14 entirely covers … fourth elongate cannula 36.” – Para [0050], Fig. 2B), wherein the balloon is coupled to a distal portion of an intermediate catheter (Erlick, "Fourth elongate cannula 36 has … an inflatable balloon 148 connected …" - Para [0074], Fig. 1A);
retracting the delivery catheter to allow the embolic filter to expand within the blood vessel at least partially proximal to the clot material (Erlick, Retract the sheath to the retracted sheath position to expose the thrombectomy device, the expandable embolic filter automatically opens as the sheath retracts, S108, Fig. 11A);
advancing a clot treatment assembly (Erlick, mechanical thrombectomy whisk 78, medical apparatus 10, Fig. 1A) through the intermediate catheter (Erlick, third elongate catheter 34, Fig. 1A) (Erlick, "Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]) (Erlick, "Third elongate cannula 34 has … a third lumen …", "... second elongate cannula 32 is disposed in third lumen 132." - Para [0071]) and at least partially through the clot material (Erlick, Advance the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen, S106, Fig. 11A);
retracting a deployment catheter of the clot treatment assembly relative to a clot treatment device of the clot treatment assembly (Erlick, Retract the sheath to the retracted sheath position to expose the thrombectomy device, S108, Fig. 11A) to allow the clot treatment device to expand within the blood vessel at least partially distal to the clot material (Erlick, Expand mechanical thrombectomy whisk to the venous lumen diameter, S116, Fig. 11B); and
withdrawing the clot treatment device proximally though the clot material and into the balloon (retract the medical apparatus from the venous lumen, S126, Fig. 11B).
Examiner interprets that if the medical apparatus has to pass through the thrombus when it is initially being advanced, it must also pass through the thrombus as it is being retracted.
Erlick does not expressly disclose positioning a funnel through the delivery catheter, wherein the funnel is coupled to a distal portion of the intermediate catheters, retracting the delivery catheter to allow the funnel to expand, and withdrawing the clot treatment device … into the funnel.
Thress teaches positioning a funnel (funnel 120, Fig. 2B) through the delivery catheter, wherein the funnel (funnel 120, Fig. 2B) is coupled to a distal portion of the intermediate catheters, retracting the delivery catheter to allow the funnel (funnel 120, Fig. 2B) to expand, and withdrawing the clot treatment device … into the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include positioning a funnel through the delivery catheter, wherein the funnel is coupled to a distal portion of the intermediate catheters, retracting the delivery catheter to allow the funnel to expand, and withdrawing the clot treatment device … into the funnel as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 15, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
the method further comprises substantially inhibiting blood flow through the blood vessel with the balloon after expanding the balloon (Erlick, "When inflatable balloon 148 is inflated to have an expanded balloon diameter that makes contact with venous sidewall 118, inflatable balloon 148 blocks or prevents blood flow. " - Para [0077]).
Erlick does not expressly disclose inhibiting blood flow through the blood vessel with the funnel after expanding the funnel.
Thress teaches inhibiting blood flow through the blood vessel with the funnel (funnel 120, Fig. 2B) after expanding the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include inhibiting blood flow through the blood vessel with the funnel after expanding the funnel as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 16, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
allowing the balloon (Erlick, inflatable balloon 148, Fig. 1A) to expand includes allowing the balloon to expand to a diameter of the blood vessel (Erlick, "... inflatable balloon 148 is entirely exposed and able to be inflated to make contact with venous sidewall 118 of venous lumen 110." - Para [0076]).
Erlick does not expressly disclose that allowing the funnel to expand includes allowing the funnel to expand to a diameter of the blood vessel.
Thress teaches that allowing the funnel to expand includes allowing the funnel to expand to a diameter of the blood vessel.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include allowing the funnel to expand includes allowing the funnel to expand to a diameter of the blood vessel as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 17, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
the balloon (Erlick, inflatable balloon 148, Fig. 1A) is impermeable to blood (Erlick, "Inflatable balloon 148 may be constructed from a thermoplastic elastomer, such as PEBAX®." - Para [0075]).
Erlick does not expressly disclose that the funnel is impermeable to blood.
Thress teaches that the funnel is impermeable to blood.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include that the funnel is impermeable to blood as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21])
Regarding claim 18, Erlick in view of Thress discloses the method (method, Figs. 11A-11B) as recited above, wherein
Erlick does not expressly disclose that the blood vessel is a periphery artery.
Thress teaches that the blood vessel is a periphery artery ("… the present technology can be used to extract any formation of material in a vessel (e.g., a venous or arterial vessel) …" - Para [12]). .
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include that the blood vessel is a periphery artery as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 34, Erlick in view of Thress discloses a method (Erlick, method, Figs. 11A-11B) of removing clot material from a blood vessel of a patient using a clot treatment system, the method comprising:
inserting a catheter to proximate the clot material within the blood vessel (Erlick, Insert guidewire into venous lumen having a thrombus treatment site, S100, Fig. 11A)( Erlick, Introduce a medical apparatus over the guidewire, S102, Fig. 11A) while radially constraining a clot treatment device (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) and a balloon (Erlick, inflatable balloon 148, Fig. 1A) within the catheter (Erlick, initial extended sheath position 24, Fig. 2A);
moving an intermediate deployment shaft (Erlick, third elongate cannula 34, Fig. 1A) of the clot treatment system (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) proximally to deploy the clot treatment device at least partially distal to the clot material within the blood vessel (Erlick, Advance the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen, S106, Fig. 11A) (Erlick, Retract the sheath to the retracted sheath position to expose the thrombectomy device, S108, Fig. 11A), wherein the clot treatment device is carried by a first shaft of the clot treatment system (Erlick, "Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]), and wherein the intermediate deployment shaft is positioned radially outward of the first shaft (Erlick, "Third elongate cannula 34 has … a third lumen …", "... second elongate cannula 32 is disposed in third lumen 132." - Para [0071]); and
moving the catheter proximally to deploy the embolic filter at least partially proximal to the clot material (Erlick, Retract the sheath to the retracted sheath position to expose the thrombectomy device, the expandable embolic filter automatically opens as the sheath retracts, S108, Fig. 11A), wherein the balloon is carried by a second shaft of the clot treatment system (Erlick, "Fourth elongate cannula 36 has … an inflatable balloon 148 connected …" - Para [0074]), and wherein the second shaft is configured to receive the intermediate deployment shaft (Erlick, "Fourth elongate cannula 36 has a fourth lumen 152 … third elongate cannula 34 is disposed inside fourth lumen 152 …" - Para [0075]).
Erlick does not expressly disclose constraining a clot treatment device and a funnel, moving the catheter proximally to deploy the funnel, wherein the funnel is carried by a second shaft.
Thress teaches constraining a clot treatment device and a funnel (funnel 120, Fig. 2B), moving the catheter proximally to deploy the funnel (funnel 120, Fig. 2B), wherein the funnel (funnel 120, Fig. 2B) is carried by a second shaft.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include constraining a clot treatment device and a funnel, moving the catheter proximally to deploy the funnel, wherein the funnel is carried by a second shaft as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 35, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, further comprising
mechanically disrupting at least part of the clot material by retracting the clot treatment device through the clot material toward the catheter (Erlick, Advance the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen, S106, Fig. 11A) (Erlick, "As sheath 14 covers thrombectomy device 20, mechanical thrombectomy whisk 78 and expandable embolic filter 134 automatically collapse, trapping any debris 112 collected … " - Para [0104]).
Examiner interprets that if the medical apparatus has to pass through the thrombus when it is initially being advanced, it must also pass through the thrombus as it is being retracted.
Regarding claim 36, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, further comprising
retracting the clot treatment device through the clot material and at least partially into the embolic filter (Erlick, "As sheath 14 covers thrombectomy device 20, mechanical thrombectomy whisk 78 and expandable embolic filter 134 automatically collapse, trapping any debris 112 collected … " - Para [0104])( Erlick, "… expandable embolic filter 134 is aligned with and overlaps over mechanical thrombectomy whisk 78." - Para [0088]).
Erlick does not expressly disclose retracting the clot treatment device … into the funnel.
Thress teaches retracting the clot treatment device … into the funnel.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include retracting the clot treatment device … into the funnel as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 37, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, further comprising
aspirating at least part of the clot material via a lumen defined at least partially by the clot treatment system (Erlick, " Aspiration passageway 158 is configured to capture debris 112." - Para [0079]) ("Fourth elongate cannula 36 also includes … an aspiration passageway 158 …" - Para [0078]).
Regarding claim 38, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
lumen is a catheter lumen defined by the catheter (Erlick, "Fourth elongate cannula 36 also includes … an aspiration passageway 158 …" - Para [0078]).
Regarding claim 39, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
the lumen (Erlick, aspiration passageway 158, Fig. 6B) is deployment lumen defined by the intermediate deployment shaft (Erlick, fourth elongate cannula 36, Fig. 1A) (Erlick, "Fourth elongate cannula 36 also includes … an aspiration passageway 158 …" - Para [0078]).
Regarding claim 40, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
inserting the clot treatment system includes directly contacting the embolic filter with an inner surface of the catheter (Erlick, "The third elongate cannula has … an expandable embolic filter." - Para [0013])( Erlick, "Fourth elongate cannula 36 has a fourth lumen 152 … third elongate cannula 34 is disposed inside fourth lumen 152 …" - Para [0075]) to radially-constrain the embolic filter (Erlick, Fig. 2B) while advancing the catheter and the embolic filter together (Erlick, "… advancing the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen; retracting the sheath to the retracted sheath position to expose the thrombectomy device, whereby the expandable embolic filter automatically expands as the sheath retracts ..." - Para [0017]).
Erlick does not expressly disclose directly contacting the funnel with an inner surface of the catheter to radially-constrain the funnel while advancing the catheter and the funnel.
Thress teaches contacting the funnel (funnel 120, Fig. 2B) with an inner surface of the catheter to radially-constrain the funnel (funnel 120, Fig. 2B) while advancing the catheter and the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include contacting the funnel with an inner surface of the catheter to radially-constrain the funnel while advancing the catheter and the funnel as taught by Thress as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 41, Erlick in view of Thress discloses the method (method, Figs. 11A-11B) as recited above, wherein
inserting the clot treatment system includes advancing the catheter (Erlick, "advancing the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen; retracting the sheath to the retracted sheath position to expose the thrombectomy device, whereby the expandable embolic filter automatically expands as the sheath retracts ..." - Para [0017]) with (a) the embolic filter (Erlick, expandable embolic filter 134, Fig. 1A) and the clot treatment device (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) positioned therein (Erlick, Fig. 2B) and (b) the clot treatment device positioned distal to the embolic protection device (Erlick, "… expandable embolic filter 134 is proximal to mechanical thrombectomy whisk 78 …" - Fig. 1A).
Erlick does not expressly disclose the funnel.
Thress teaches the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include the funnel as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 42, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, further comprising
positioning the embolic filter within the catheter prior to deploying the embolic filter (Erlick, "advancing the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen; retracting the sheath to the retracted sheath position to expose the thrombectomy device, whereby the expandable embolic filter automatically expands as the sheath retracts ..." - Para [0017], Fig. 2B).
Erlick does not expressly disclose positioning the funnel within the catheter prior to deploying the funnel.
Thress teaches positioning the funnel (funnel 120, Fig. 2B)within the catheter prior to deploying the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include positioning the funnel within the catheter prior to deploying the funnel as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 43, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, further comprising
positioning the clot treatment device within the second shaft (Erlick, "Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]) prior to deploying the embolic filter (Erlick, "advancing the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen; retracting the sheath to the retracted sheath position to expose the thrombectomy device …" - Para [0017], Fig. 2B).
Erlick does not expressly disclose deploying the funnel.
Thress teaches deploying the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include deploying the funnel as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 44, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
positioning the embolic filter is within the catheter (Erlick, Fig. 2B) and deploying the embolic filter from the catheter (Erlick, "At step S108, sheath 14 is retracted to retracted sheath position 26 to expose thrombectomy device 20, and expandable embolic filter 134 automatically opens as sheath 14 retracts proximally past expandable embolic filter 134." - Para [0096]) occur prior to positioning the clot treatment device within the second shaft (Erlick, "At step S124, sheath 14 is extended to initial extended sheath position 24, which is over thrombectomy device 20. As sheath 14 covers thrombectomy device 20, mechanical thrombectomy whisk 78 and expandable embolic filter 134 automatically collapse…" - Para [0104]).
Erlick does not expressly disclose positioning the funnel … and deploying the funnel.
Thress teaches positioning the funnel (funnel 120, Fig. 2B) … and deploying the funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include positioning the funnel … and deploying the funnel as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Examiner interprets the collapsed whisk to be back within second shaft, as it is before deployment.
Regarding claim 45, Erlick in view of Thress discloses the method (Erlick, method, Figs. 11A-11B) as recited above, wherein
deploying the clot treatment device includes deploying the clot treatment device distally of the deployed embolic filter (Erlick, "… expandable embolic filter 134 is proximal to mechanical thrombectomy whisk 78 …" - Fig. 1A).
Erlick does not expressly disclose the deployed funnel.
Thress teaches the deployed funnel (funnel 120, Fig. 2B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Erlick to include the deployed funnel as taught by Thress for treating vascular thrombi (Thress, Para [11]).
Regarding claim 46, Erlick in view of Thress discloses a system (Erlick, medical apparatus 10, Fig. 1A) for removing clot material from a blood vessel of patient (Erlick, "… a medical apparatus 10 for treating any form of thrombus …" - Para [0048]), the system comprising:
a delivery catheter (Erlick, sheath 14, Fig. 1A);
an intermediate catheter (Erlick, fourth elongate cannula 36, Fig. 1A) configured to extend through the delivery catheter (Erlick, "… sheath 14 entirely covers the … fourth elongate cannula 36." - Para [0050]);
a balloon (Erlick, inflatable balloon 148, Fig. 1A) having a proximal portion fixedly coupled to a distal portion of the intermediate catheter (Erlick, "Fourth elongate cannula 36 has … an inflatable balloon 148 connected …" - Para [0074], Fig. 1A), wherein the delivery catheter and intermediate catheter are movable relative to one another (Erlick, "Sheath 14 is movable between an initial extended sheath position 24 … and a retracted sheath position 26 …" - Para [0049], Figs. 1A and 2A-2B) to move the balloon between (a) a first balloon position (Erlick, initial extended sheath position 24, Fig. 2A) in which the balloon is constrained within the delivery catheter (Erlick, "In the initial extended sheath position 24 as depicted in both FIGS. 2A and 2B, sheath 14 entirely covers … fourth elongate cannula 36." - Para [0050]) and (b) a second balloon position (Erlick, retracted sheath position 26, Fig. 1A) in which the balloon is unconstrained by the delivery catheter and configured to expand within the blood vessel (Erlick, "When the sheath 14 is in the retracted position 26, the sheath distal end 18 is entirely proximal to inflatable balloon 148, so that inflatable balloon 148 is entirely exposed and able to be inflated to make contact with venous sidewall 118 of venous lumen 110." - Para [0076]);
a deployment catheter (Erlick, third elongate cannula 34, Fig. 1A) configured to extend through the intermediate catheter (Erlick, "Fourth elongate cannula 36 has a fourth lumen 152 … third elongate cannula 34 is disposed inside fourth lumen 152 …" - Para [0075]);
an elongate shaft (Erlick, second elongate cannula 32, Fig. 1A) configured to extend through the deployment catheter (Erlick, "Third elongate cannula 34 has … a third lumen …", "... second elongate cannula 32 is disposed in third lumen 132." - Para [0071]); and
a clot treatment device (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) coupled to the elongate shaft (Erlick, "Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]), wherein the deployment catheter and the elongate shaft are movable (Erlick, "… the third elongate cannula 34 is configured to be movable …" - Para [0087]) (Erlick, "Second elongate cannula 32 is configured to move …" - Para [0086]) relative to one another to move the clot treatment device (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) between (a) a first clot treatment device position (Erlick, initial third elongate cannula extended position 178, Fig. 10B) in which the clot treatment device is constrained within the deployment catheter (Erlick, "Mechanical thrombectomy whisk 78 is in closed condition 80 …" - Para [0088], Fig. 10B) and (b) a second clot treatment device position (Erlick, third elongate cannula retracted position 180, Fig. 10C) in which the clot treatment device is unconstrained by the deployment catheter (Erlick, "… mechanical thrombectomy whisk 78 must be exposed when sheath 14 is in … the third elongate cannula retracted position 180." - Para [0090]) and configured to expand within the blood vessel (Erlick, "Mechanical thrombectomy whisk 78 is configured to expanded …" - Para [0068]).
Erlick does not expressly disclose a funnel including a braid of filaments having … a distal portion defining a distal opening wherein the delivery catheter and intermediate catheter are movable … to move the funnel between a first funnel position in which the funnel is constrained … and a second funnel position in which the funnel is unconstrained, wherein the funnel includes a coating over at least a portion of the filaments that is impermeable to blood, and wherein the funnel has a tapered shape with a distal opening in the second funnel position.
Thress teaches a funnel (funnel 120, Fig. 2B) including a braid of filaments (“… the funnel 120 can be formed from at least one of a castellated nitinol braid …” – Col. 5 Line 12) having … a distal portion defining a distal opening (as shown in Fig. 2B) wherein the delivery catheter and intermediate catheter are movable … to move the funnel (funnel 120, Fig. 2B) between a first funnel (funnel 120, Fig. 2B) position in which the funnel (funnel 120, Fig. 2B) is constrained … and a second funnel (funnel 120, Fig. 2B) position in which the funnel (funnel 120, Fig. 2B) is unconstrained, wherein the funnel includes a coating over at least a portion of the filaments that is impermeable to blood ("… the funnel 120 can include a covering over at least a portion thereof that is … non-permeable to blood." - Col. 5 Line 20), and wherein the funnel has a tapered shape (as shown in Fig. 2) with a distal opening in the second funnel position (Fig. 2B depicts the second funnel position).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Erlick to include a funnel including a braid of filaments having … a distal portion defining a distal opening wherein the delivery catheter and intermediate catheter are movable … to move the funnel between a first funnel position in which the funnel is constrained … and a second funnel position in which the funnel is unconstrained, wherein the funnel includes a coating over at least a portion of the filaments that is impermeable to blood, and wherein the funnel has a tapered shape with a distal opening in the second funnel position as taught by Thress so an operator can distally advance and proximally retract the outer shaft relative to the inner shaft (Thress, Para [21]).
Regarding claim 47, Erlick in view of Thress discloses the system (Erlick, medical apparatus 10, Fig. 1A) as recited above, wherein
the clot treatment device (Erlick, mechanical thrombectomy whisk 78, Fig. 1A) has a proximal portion fixedly coupled to the elongate shaft (Erlick, second elongate cannula 32, Fig. 1A) (Erlick, "Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]) and a distal portion slidable over the elongate shaft (Erlick, support 97, Figs. 4C and 4E) (Erlick, as shown in Fig. 4C and 4E, the whisk slides over the support 97 portion of the elongate shaft 32 as it expands and contracts).
Regarding claim 48, Erlick in view of Thress discloses the system (Erlick, medical apparatus 10, Fig. 1A) as recited above, wherein
the elongate shaft is configured to receive a guidewire therethrough (Erlick, Insert guidewire into venous lumen having a thrombus treatment site, S100, Fig. 11A)( Erlick, Introduce a medical apparatus over the guidewire, S102, Fig. 11A).
Examiner interprets the elongate shaft to be a part of the medical apparatus.
Response to Arguments
Applicant’s arguments, see pages 11-12, filed 8/05/2026, with respect to the rejection(s) of claim(s) 1, 14, and 34 under 35 USC 102 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 Erlick in view of Thress.
Applicant argues that The Office Action relies on the inflatable balloon 148 of Erlick for allegedly disclosing the "embolic protection device" previously recited in independent claim 1. (Office Action, pg. 3.) But the inflatable balloon 148 is not a "funnel" having a "tapered shape with a distal opening" as recited in amended claim 1. In the rejection of previously-pending dependent claim 6, contradicting the rejection of independent claim 1, the Office Action asserts that "the embolic protection device (expandable embolic filter 134, Fig. 1A) is a funnel." (Id. at pg. 6.)
However, if the embolic filter 134 of Erlick could somehow be construed as the claimed "funnel" (which the Applicant does not concede), this reference still fails to disclose or suggest the "deployment catheter," "elongate shaft," and "clot treatment device" recited in independent claim 1. Namely, the mechanical thrombectomy whisk 78 (i.e., the alleged "clot treatment device") is attached to the second elongate cannula 32 (i.e., the alleged "elongate shaft") which extends through the third elongate cannula 34 (i.e., the alleged "deployment catheter"). (Office Action, pg. 4; Erlick, 1 [0057].) But in that interpretation, the third elongate cannula 34 cannot be the claimed "deployment catheter" because it is attached to the embolic filter 134. (Erlick,1 [0071].)
Examiner interprets that Erlick in view of Thress disclose the claimed “funnel” as recited in the rejection above.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the deployment catheter cannot be attached to the funnel or embolic protection device) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the applicant’s argument the rejection above teaches the claimed limitations. The rejection above is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
