Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
2. Applicant’s response with respect to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 7-8, and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zoll et al. (US Pub.: 2020/0121905 A1).
Regarding claim 1, Zoll teaches A mechanical circulatory support system (e.g. Fig. 1; abstract), comprising:
a circulatory support catheter (e.g. Fig. 1 – elements 107 + 116 + 114 + 111),
comprising a circulatory support device (e.g. Fig. 1 – pump 107)
carried by an elongate flexible catheter shaft (e.g. Fig. 1; paragraph 0012),
the circulatory support device (107) comprising
a tubular housing (e.g. Fig. 1; paragraph 0031),
a motor (e.g. Fig. 1 – motor within motor housing 111; paragraph 0031),
and an impeller configured to be rotated by the motor (e.g. paragraph 0006 – the rotor may include an impeller blade shaped to induce fluid flow when under rotational force);
an insertion tool (e.g. Fig. 1 – sleeve 100) having a tubular body configured to axially movably receive the circulatory support device (107) within an insertion tool lumen of the insertion tool (e.g. paragraphs 0010, 0030);
and an introducer sheath (e.g. Fig. 1 – introducer 118) having a tubular body configured to axially movably receive (e.g. paragraph 0018), within an introducer sheath lumen of the introducer sheath, the insertion tool (100) while the insertion tool has the circulatory support (107) device therein (e.g. Fig. 1; paragraph 0018),
wherein both the insertion tool (100) and introducer sheath (118), while the insertion tool (100) having the circulatory support device (107) therein is within the introducer sheath (118), are configured to extend at least partially distal to an arterial access point (e.g. Fig. 1; paragraphs 0004, 0030).
Regarding claim 2, Zoll discloses the system of claim 1 as discussed above, and Zoll further teaches wherein the impeller is configured to be rotated by the motor via a shaft (e.g. paragraph 0006).
Regarding claim 7, Zoll discloses the system of claim 1 as discussed above, and Zoll further teaches wherein the introducer sheath (118) comprises a hub on a proximal end of the introducer sheath (e.g. Fig. 1; paragraphs 0030, 0033), the hub having a feature for preventing axial and rotational movement of the insertion tool (e.g. paragraphs 0030, 0033).
Regarding claim 8, Zoll discloses the system of claim 7 as discussed above, and Zoll further teaches the hub comprising one or more hemostatic valves (e.g. Fig. 1 – hemostasis valve 120; paragraph 0033).
Regarding claim 19, Zoll discloses the system of claim 1 as discussed above, and Zoll further teaches wherein the tubular housing of the circulatory support device comprises an inlet tube (e.g. Fig. 1 – cannula 106) coupled with a motor housing (e.g. Fig. 1 – motor within motor housing 111), the inlet tube (106) having one or more distal pump inlets (e.g. Fig. 1 – distal openings 112; paragraph 0031) and one or more proximal pump outlets (e.g. Fig. 1 – proximal openings 110), and the impeller adjacent the one or more proximal pump outlets (e.g. Fig. 1; paragraphs 0006, 0031-0032).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Zoll and further in view of Siess et al. (US Patent No. 6,794,789, hereafter referred to as “Siess ‘789” – Previously Cited).
Regarding claim 3, Zoll discloses the system of claim 2 as discussed above. However, Zoll does not explicitly teach wherein the circulatory support device comprises an annular polymeric seal around the shaft.
Siess ‘789, in a same field of endeavor of circulatory/catheter devices, discloses an intravascular blood pump, which is a circulatory support device, with an annular polymeric seal around the shaft (e.g. col. 2 lines 49-52, Fig. 2, sealing bearing 21).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to incorporate an annular polymeric seal around the shaft, as taught and suggested by Siess ‘789, in order to decrease the likelihood of blood leakage through use of an effective seal placement.
Regarding claim 4, Zoll teaches the system of claim 2 as discussed above. However, Zoll does not explicitly teach wherein the circulatory support device comprises a seal around the shaft.
Siess ‘789, in a same field of endeavor of circulatory/catheter devices, discloses an intravascular blood pump, which is a circulatory support device, with a seal around the shaft (e.g. col. 2 lines 49-52, Fig. 2, sealing bearing 21).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to incorporate a seal around the shaft, as taught and suggested by Siess ‘789, in order to decrease the likelihood of blood leakage through use of an effective seal placement.
Regarding claim 6, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach wherein the impeller is configured to be rotated by the motor via a magnetic coupling.
Siess ‘789, in a same field of endeavor of circulatory/catheter devices, discloses an intravascular blood pump wherein the impeller is configured to be rotated by the motor via a magnetic coupling (e.g. abstract, col. 1 lines 19-28, col. 2 lines 43-52, – magnetic coupling 53).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to incorporate a magnetic coupling, as taught and suggested by Siess ‘789, because magnetic couplings are popular in the art of blood pumps in order to reduce friction between moving parts.
Claims 9-12 and 23-27 are rejected under 35 U.S.C 103 as being unpatentable over Zoll and further in view of Schumacher et al. (US Pub.: 2015/0343179 A1, – Previously Cited).
Regarding claim 9, Zoll discloses the system of claim 8 as discussed above, including what appears in Fig. 2 to include an insertion tube 100 with sufficient collapse resistance to maintain patency when passed through the hemostatic valve 120 (because it is depicted as non-collapsed). However, Zoll does not explicitly and expressly teach wherein the tubular body of the insertion tool has sufficient collapse resistance to maintain patency when passed through the one or more hemostatic valves of the introducer sheath.
Schumacher, in a same field of endeavor of catheters, discloses wherein the tubular body of the insertion tool has sufficient collapse resistance to maintain patency when passed through the one or more hemostatic valves of the introducer sheath (e.g. Fig. 15 – the parts can be clamped in place, therefore it has sufficient resistance to maintain patency; paragraph 0132).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to incorporate wherein the tubular body of the insertion tool has sufficient collapse resistance to maintain patency when passed through the one or more hemostatic valves of the introducer sheath, as taught and suggested by Schumacher, in order to ensure that the catheter can be safely used for as long as possible (Schumacher, paragraph 0011).
Regarding claim 10, Zoll discloses the system of claim 7 as discussed above. However, Zoll does not explicitly teach wherein the hub and a relief bend disposed between the hub and the tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool.
Schumacher, in a same field of endeavor of catheters, discloses wherein the hub and a relief bend disposed between the hub and the tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool (e.g. Fig. 17 – relief bend is sloped edge on element 114).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to have the hub and a relief bend disposed between the hub and the tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool, as taught and suggested by Schumacher, in order to allow for more efficient movement of the insertion tool.
Regarding claim 11, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach that the insertion tool comprises a tube with a valve in fluid communication with the insertion tool lumen of the tubular body of the insertion tool configured for flushing with saline.
Schumacher, in a same field of endeavor of catheters, discloses that the insertion tool comprises a tube with a valve in fluid communication with the insertion tool lumen of the tubular body of the insertion tool configured for flushing with saline (e.g. paragraph 0136, – auxiliary sheath 104 has flushing device 109 which is a flushing tube and an opening in the wall of housing 113).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to include wherein the insertion tool comprises a tube with a valve in fluid communication with the insertion tool lumen of the tubular body of the insertion tool configured for flushing with saline, as taught and suggested by Schumacher, for the purpose of maintaining a sterile environment while using the device (Schumacher, paragraph 0136).
Regarding claim 12, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach that the catheter shaft comprises a visual marker spaced proximally from the circulatory support device such that visibility of the visual marker on a proximal side of the introducer sheath indicates the circulatory support device is located within the tubular body of the insertion tool.
Schumacher, in a same field of endeavor of catheters, discloses that the catheter shaft comprises a visual marker spaced proximally from the circulatory support device such that visibility of the visual marker on a proximal side of the introducer sheath indicates the circulatory support device is located within the tubular body of the insertion tool (e.g. paragraph 0114, visible marking 78 on element 76).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to incorporate wherein the catheter shaft comprises a visual marker spaced proximally from the circulatory support device such that visibility of the visual marker on a proximal side of the introducer sheath indicates the circulatory support device is located within the tubular body of the insertion tool, as taught and suggested by Schumacher, in order to make it easier to identify a target position for clamping (Schumacher, paragraph 0114).
Regarding claim 23, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach wherein the insertion tool comprises a hemostatic valve.
Schumacher, in a same field of endeavor of catheters, discloses wherein the insertion tool comprises a hemostatic valve (e.g. paragraph 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to include having the insertion tool comprise a hemostatic valve, as taught and suggested by Schumacher, in order to better control where fluid escapes from the insertion tool (Schumacher, paragraph 0061).
Regarding claim 24, Zoll teaches the system of claim 1 as discussed above. However, Zoll does not explicitly teach that the insertion tool comprises a plug disposed at a proximal end of the insertion tool configured to connect to a sterile shield sleeve.
Schumacher, in a same field of endeavor of catheters, discloses that the insertion tool comprises a plug disposed at a proximal end of the insertion tool configured to connect to a sterile shield sleeve (e.g., paragraphs 0145-0147, – plug disposed at proximal end of insertion tool configured to connect to sterile shield sleeve).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to include that the insertion tool comprises a plug disposed at a proximal end of the insertion tool configured to connect to a sterile shield sleeve, as taught and suggested by Schumacher, for the purpose of maintaining the sterility of the tube in a fluid-tight environment (Schumacher, paragraph 0145).
Regarding claim 25, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach that the insertion tool comprises a locking mechanism, the locking mechanism comprising a recess configured to accept a locking pad configured to releasably lock with the circulatory support catheter.
Schumacher, in a same field of endeavor of catheters, discloses that the insertion tool comprises a locking mechanism, the locking mechanism comprising a recess configured to accept a locking pad configured to releasably lock with the circulatory support catheter (e.g. paragraph 0127, Fig. 14, clamping device can be clamped so that smaller diameter catheter is clamped in receiving space, which is the recess, using radial compression of clamping ring 56’).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to include that the insertion tool comprises a locking mechanism, the locking mechanism comprising a recess configured to accept a locking pad configured to releasably lock with the circulatory support catheter, as taught and suggested by Schumacher, for the purpose of allowing the smaller diameter catheter to be clamped in the receiving space using radial compression (Schumacher, paragraph 0127).
Regarding claim 26, Zoll in view of Schumacher teaches the system of claim 25 as discussed above, and Schumacher further teaches that the insertion tool comprises a housing surrounding at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls spaced farther than opposing second inner surface walls, wherein the at least a portion of the locking mechanism comprises radially outwardly extending tabs, and wherein the housing is configured to rotate to inwardly compress the tabs to prevent axial movement of the circulatory support catheter (e.g. paragraph 0123, clamping device has flexible clamping ring 56’, which is conical and forced against mechanical stop 57’; axial pressure is exerted on clamping ring by pressure screws, and by screwing in the device; the screw threads are radially outwardly extending tabs; Fig. 13c, paragraph 0114 depicts beads which are radially outwardly extending tabs, for clamping, but they can also be screwed, that is rotated, to inwardly compress the tabs to prevent axial movement.).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Zoll and Schumacher to include that the insertion tool comprises a housing surrounding at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls spaced farther than opposing second inner surface walls, wherein the at least a portion of the locking mechanism comprises radially outwardly extending tabs, and wherein the housing is configured to rotate to inwardly compress the tabs to prevent axial movement of the circulatory support catheter, as taught and suggested by Schumacher, for the purpose of making the insertion tool more secure while it is in use (Schumacher, paragraphs 0114, 0123)
Regarding claim 27, Zoll in view of Schumacher teaches the system of claim 26 as discussed above, and Schumacher further teaches wherein inward compression of the tabs of the locking mechanism compresses the locking pad against the circulatory support catheter (e.g. paragraphs 0114, 0123).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Zoll and Schumacher to include wherein inward compression of the tabs of the locking mechanism compresses the locking pad against the circulatory support catheter, as taught and suggested by Schumacher, in order to further improve the security of the insertion device while it is in use.
Claims 13-16 are rejected under 35 U.S.C 103 as being unpatentable over Zoll and further in view of Muller et al. (US Patent No.: 10,449,279 B2) (hereinafter “Muller ‘279”).
Regarding claim 13, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach a first guidewire port on a distal end of the tubular housing of the circulatory support device, and a second guidewire port on a sidewall of the tubular housing of the circulatory support device and distal to the impeller.
Muller ‘279, in a same field of endeavor of catheter devices, discloses a first guidewire port on a distal end of the tubular housing of the circulatory support device, a second guidewire port on a sidewall of the tubular housing of the circulatory support device and distal to the impeller (e.g. Fig. 16, see annotated figure below; column 23, lines 16-30).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll to incorporate a first guidewire port on a distal end of the tubular housing of the circulatory support device and to place the second guidewire port on a sidewall of the tubular housing of the circulatory support device and distal to the impeller, in order to better guide the device and to bypass the pump with the guidewire, and not have the guidewire passing through the impeller. The reason is to reduce the profile of the device by eliminating the need for a guidewire channel through the middle of the device (Muller ‘279, column 23, lines 16-35).
Regarding claim 14, Zoll in view of Muller ‘279 teaches the system of claim
13 as discussed above, and Muller ‘279 further teaches wherein a distal end of the tubular body of the insertion tool detachably connects to a guidewire aid configured to facilitate entry of a guidewire through the first guidewire port (e.g. column 22, lines 44-67 and column 23, lines 1-15).
Regarding claim 15, Zoll in view of Muller ‘279 teaches the system of claim
13 as discussed above, and Muller ‘279 further teaches wherein a removable guidewire guide tube enters the first guidewire port on the distal end of the tubular housing, and exits the tubular housing via the second guidewire port on the sidewall of the tubular housing distal to the impeller (e.g. Fig. 16; column 22, lines 45-54; column 23, lines 16-35).
Regarding claim 16, Zoll in view of Muller ‘279 teaches the system of claim
15 as discussed above, and Muller ‘279 further teaches wherein the tubular body of the insertion tool is configured to receive the circulatory support device with the removable guidewire guide tube (e.g. column 22, lines 45-54; column 23, lines 16-38).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zoll and further in view of Muller ‘279 and further in view of Yokota et al. (US Patent No.: 11,291,800 B2, – Previously Cited).
Regarding claim 17, Zoll in view of Muller ‘279 teaches the system of claim 16 as discussed above. However, Zoll in view of Muller ‘279 does not explicitly teach wherein the tubular body of the insertion tool and the guidewire guide tube are transparent.
Yokota, in a same field of endeavor of catheters, discloses wherein the tubular body of the insertion tool and the guidewire guide tube are transparent (e.g. column 6, lines 6-15).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Zoll and Muller ‘279 to incorporate the modifications of making the tubular body of the insertion tool and the guidewire guide tube transparent, as taught and suggested by Yokota, in order to make it easier for the user to visually confirm blood (e.g. flashback) as well as to be able to use optical imaging modalities to see the placement of the guidewire in the tube.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Zoll and further in view of Muller ‘279 and further in view of Scheckel et al. (US Pub.: 2020/0139028 A1, – Previously Cited).
Regarding claim 18, Zoll discloses the system of claim 1 as discussed above.
However, Zoll does not explicitly teach wherein the tubular body of the insertion tool has a length within a range of from about 85 mm to about 160 mm and an inside diameter within a range of from about 4.5 mm to about 6.5 mm. Muller ‘279, in a same field of endeavor of catheter devices, teaches a percutaneous catheter pump with guide features (Muller ‘279, abstract) that has a catheter size of about 12.5 Fr (Muller ‘279, col. 7, lines 18-21). Based on this teaching, it would have been obvious to one having ordinary skill in the art to modify the system of Zoll to include an inside diameter of the insertion tool within a range of about 4.5 mm to about 6.5 mm in order to be on around the same scale as the catheter taught by Muller ‘279, an effective diameter for passing through bodily lumina. Scheckel, in a same field of endeavor of catheter devices, teaches that for a flexible catheter for putting a blood pump into the heart (Scheckel, abstract), wherein the distal end, which corresponds to the tubular body of the insertion tool, has a length within a range of about 85 mm to about 160 mm (Scheckel, paragraph 0072, distal end about 13.5 cm long). It would have been obvious to one having ordinary skill in the art to modify the combination of Zoll and Muller ‘279 with a teaching of the tubular body of the insertion tool having a length within a range of about 85 mm to about 160 mm in order to use a short catheter that may easily navigate through bodily lumina of people of all sizes, without being too bulky.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zoll and further in view of Siess et al. (US Pub.: 2017/0043074 A1, hereafter referred to as “Siess ‘074”, – Previously Cited).
Regarding claim 20, Zoll teaches the system of claim 1 as discussed above. However, Zoll does not explicitly teach wherein the system does not require purging.
Siess ‘074, in a same field of endeavor of catheters, teaches that a miniature blood pump may be designed not to require purging (e.g. paragraph 0006).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Zoll with Siess ‘074’s teachings to incorporate design elements such that the system does not require purging, in order to make the design smaller by eliminating the need to use a purge fluid.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zoll and further in view of Rau et al. (US Patent No.: 6,176,848, – Previously Cited).
Regarding claim 21, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach the exact dimensions of the introducer sheath.
Rau, in a same field of endeavor of catheters, teaches a minimally invasive blood pump with an introducer sheath size of 16 French (Fr) sheath (e.g. col. 1 lines 59-63, pump diameter restricted to 5-7 mm, which incorporates an outer diameter of 16 French, which is 5.33 mm).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Rau’s teaching into the system of Zoll in order to ensure that the device passes easily through the user’s blood vessels.
Regarding claim 22, Zoll discloses the system of claim 1 as discussed above. However, Zoll does not explicitly teach a flow rate of a circulatory support device to be used with the system.
Rau, in a same field of endeavor of catheters, teaches a minimally invasive circulatory support device with a flow rate of about 4.0 liters per minute (e.g. col. 1 lines 63-65). Rau does not specify a time limitation on the pump. It would have been obvious to one having ordinary skill in the art to apply Rau’s teaching of flow rate to the system of Zoll in order to successfully treat cardiac problems. Since Rau does not teach a time limitation on the operation of the pump, it would further have been obvious to one having ordinary skill in the art to use Rau’s pump to provide this flow rate for about 6 hours as it is notorious in the art to provide the patient treatment for a clinically significant period of time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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