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 1-10, 13-20, and 34-45 are examined in this office action.
Claim 1 is currently amended.
Claims 11, 12, and 21-33 are withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “136” has been used to designate both the embolic protection device and the actuation component. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election without traverse of Species II (Fig. 1B) in the reply filed on March 20, 2026 is acknowledged.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-9, 13-17, 19-20, and 34 - 45 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Erlick et al. (US Pub No. 2022/0015784 A1).
Regarding claim 1, Erlick discloses a system (medical apparatus 10, Fig. 1A) for removing clot material from a blood vessel of patient ("… a medical apparatus 10 for treating any form of thrombus …" - Para [0048]), the system comprising:
a delivery catheter (sheath 14, Fig. 1A);
an intermediate catheter (fourth elongate cannula 36, Fig. 1A) configured to extend through the delivery catheter ("… sheath 14 entirely covers the … fourth elongate cannula 36." - Para [0050]);
an embolic protection device (inflatable balloon 148, Fig. 1A) coupled to a distal portion of the intermediate catheter ("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 ("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 embolic protection device between (a) a first embolic protection device position (initial extended sheath position 24, Fig. 2A) in which the embolic protection device is constrained within the delivery catheter ("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 embolic protection device position (retracted sheath position 26, Fig. 1A) in which the embolic protection device is unconstrained by the delivery catheter and configured to expand within the blood vessel ("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 (third elongate cannula 34, Fig. 1A) configured to extend through the intermediate catheter ("Fourth elongate cannula 36 has a fourth lumen 152 … third elongate cannula 34 is disposed inside fourth lumen 152 …" - Para [0075]);
an elongate shaft (second elongate cannula 32, Fig. 1A) configured to extend through the deployment catheter ("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 (mechanical thrombectomy whisk 78, Fig. 1A) coupled to the elongate shaft ("Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]), wherein the deployment catheter and the elongate shaft are movable ("… the third elongate cannula 34 is configured to be movable …" - Para [0087]) ("Second elongate cannula 32 is configured to move …" - Para [0086]) relative to one another to move the embolic protection device between (a) a first clot treatment device position (initial third elongate cannula extended position 178, Fig. 10B) in which the clot treatment device is constrained within the deployment catheter ("Mechanical thrombectomy whisk 78 is in closed condition 80 …" - Para [0088], Fig. 10B) and (b) a second clot treatment device position (third elongate cannula retracted position 180, Fig. 10C) in which the clot treatment device is unconstrained by the deployment catheter ("… 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 ("Mechanical thrombectomy whisk 78 is configured to expanded …" - Para [0068]).
Regarding claim 2, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
in the second embolic protection device position (retracted sheath position 26, Fig. 1A), the embolic protection device (inflatable balloon 148, Fig. 1A) is configured to expand to a diameter of the blood vessel ("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]).
Regarding claim 3, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
the embolic protection device (inflatable balloon 148, Fig. 1A) is impermeable to blood ("Inflatable balloon 148 may be constructed from a thermoplastic elastomer, such as PEBAX®." - Para [0075]).
Regarding claim 4, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
in the second embolic protection device position (retracted sheath position 26, Fig. 1A), the embolic protection device (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]).
Regarding claim 6, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
the embolic protection device (expandable embolic filter 134, Fig. 1A) is a funnel having a tapered shape (Fig. 1A).
Regarding claim 7, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
the embolic protection device (inflatable balloon 148, Fig. 1A) is impermeable to blood ("Inflatable balloon 148 may be constructed from a thermoplastic elastomer, such as PEBAX®." - Para [0075]).
Regarding claim 8, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
the embolic protection device is a balloon (inflatable balloon 148, Fig. 1A).
Regarding claim 9, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, wherein
in the second embolic protection device position (retracted sheath position 26, Fig. 1A), the balloon (inflatable balloon 148, Fig. 1A) is configured to expand to a diameter of the blood vessel 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]).
Regarding claim 13, Erlick discloses the system (medical apparatus 10, Fig. 1A) as recited above, further comprising
an aspiration source fluidly coupled to the delivery catheter (fourth elongate cannula 36, Fig. 1A) (" Aspiration passageway 158 is configured to capture debris 112." - Para [0079]) ("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 discloses a method (method, Figs. 11A-11B) of removing clot material from a blood vessel of a patient, the method comprising:
advancing a delivery catheter (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 (Insert guidewire into venous lumen having a thrombus treatment site, S100, Introduce a medical apparatus over the guidewire, S102, Fig. 11A);
advancing an embolic protection device through the delivery catheter (“…sheath 14 entirely covers … fourth elongate cannula 36.” – Para [0050], Fig. 2B), wherein the embolic protection device is coupled to a distal portion of an intermediate catheter ("Fourth elongate cannula 36 has … an inflatable balloon 148 connected …" - Para [0074], Fig. 1A);
retracting the delivery catheter to allow the embolic protection device to expand within the blood vessel at least partially proximal to the clot material (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 (mechanical thrombectomy whisk 78, medical apparatus 10, Fig. 1A) through the intermediate catheter (third elongate catheter 34, Fig. 1A) ("Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]) ("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 (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 (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 (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 embolic protection device (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.
Regarding claim 15, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
the method further comprises substantially inhibiting blood flow through the blood vessel after expanding the embolic protection device ("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]).
Regarding claim 16, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
allowing the embolic protection device (inflatable balloon 148, Fig. 1A) to expand includes allowing the embolic protection device to expand to a diameter of the blood vessel ("... inflatable balloon 148 is entirely exposed and able to be inflated to make contact with venous sidewall 118 of venous lumen 110." - Para [0076]).
Regarding claim 17, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
the embolic protection device (inflatable balloon 148, Fig. 1A) is impermeable to blood ("Inflatable balloon 148 may be constructed from a thermoplastic elastomer, such as PEBAX®." - Para [0075]).
Regarding claim 19, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
the embolic protection device (expandable embolic filter 134, Fig. 1A) is a funnel having a tapered shape (Fig. 1A).
Regarding claim 20, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
the embolic protection device is a balloon (inflatable balloon 148, Fig. 1A), and wherein allowing the embolic protection device to expand includes inflating the balloon ("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]).
Regarding claim 34, Erlick discloses a method (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 (Insert guidewire into venous lumen having a thrombus treatment site, S100, Fig. 11A)(Introduce a medical apparatus over the guidewire, S102, Fig. 11A) while radially constraining a clot treatment device (mechanical thrombectomy whisk 78, Fig. 1A) and an embolic protection device (inflatable balloon 148, Fig. 1A) within the catheter (initial extended sheath position 24, Fig. 2A);
moving an intermediate deployment shaft (third elongate cannula 34, Fig. 1A) of the clot treatment system (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 (Advance the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen, S106, Fig. 11A) (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 ("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 ("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 protection device at least partially proximal to the clot material (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 embolic protection device is carried by a second shaft of the clot treatment system ("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 ("Fourth elongate cannula 36 has a fourth lumen 152 … third elongate cannula 34 is disposed inside fourth lumen 152 …" - Para [0075]).
Regarding claim 35, Erlick discloses the method (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 (Advance the medical apparatus over the guidewire until the first marker has passed the thrombus in the venous lumen, S106, Fig. 11A) ("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 discloses the method (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 protection device ("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])("… expandable embolic filter 134 is aligned with and overlaps over mechanical thrombectomy whisk 78." - Para [0088]).
Regarding claim 37, Erlick discloses the method (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 (" 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 discloses the method (method, Figs. 11A-11B) as recited above, wherein
lumen is a catheter lumen defined by the catheter ("Fourth elongate cannula 36 also includes … an aspiration passageway 158 …" - Para [0078]).
Regarding claim 39, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
the lumen (aspiration passageway 158, Fig. 6B) is deployment lumen defined by the intermediate deployment shaft (fourth elongate cannula 36, Fig. 1A) ("Fourth elongate cannula 36 also includes … an aspiration passageway 158 …" - Para [0078]).
Regarding claim 40, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
inserting the clot treatment system includes directly contacting the embolic protection device with an inner surface of the catheter ("The third elongate cannula has … an expandable embolic filter." - Para [0013])("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 protection device (Fig. 2B) while advancing the catheter and the embolic protection device together ("… 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]).
Regarding claim 41, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
inserting the clot treatment system includes advancing the catheter ("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 protection device (expandable embolic filter 134, Fig. 1A) and the clot treatment device (mechanical thrombectomy whisk 78, Fig. 1A) positioned therein (Fig. 2B) and (b) the clot treatment device positioned distal to the embolic protection device ("… expandable embolic filter 134 is proximal to mechanical thrombectomy whisk 78 …" - Fig. 1A).
Regarding claim 42, Erlick discloses the method (method, Figs. 11A-11B) as recited above, further comprising
positioning the embolic protection device within the catheter prior to deploying the embolic protection device ("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).
Regarding claim 43, Erlick discloses the method (method, Figs. 11A-11B) as recited above, further comprising
positioning the clot treatment device within the second shaft ("Mechanical thrombectomy whisk 78 may be … affixed to second elongate cannula 32." - Para [0061]) prior to deploying the embolic protection device ("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).
Regarding claim 44, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
positioning the embolic protection device is within the catheter (Fig. 2B) and deploying the embolic protection device from the catheter ("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 ("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]).
Examiner interprets the collapsed whisk to be back within second shaft, as it is before deployment.
Regarding claim 45, Erlick discloses the method (method, Figs. 11A-11B) as recited above, wherein
deploying the clot treatment device includes deploying the clot treatment device distally of the deployed embolic protection device ("… expandable embolic filter 134 is proximal to mechanical thrombectomy whisk 78 …" - Fig. 1A).
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) 5, 10, and 18 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 5, Erlick discloses the system (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 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 18, , Erlick 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]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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