DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 1-11 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Mitze et al. (hereinafter ‘Mitze’, U.S. Patent/PGPub No. 2022/0161021).
In regards to claim 1, Mitze discloses an apparatus, comprising a delivery catheter, configured to extend from outside a body of a subject into a left ventricle of the subject (Abstract: "A minimally invasive miniaturized percutaneous mechanical circulatory support system for transcatheter delivery of a pump to the heart that actively unloads the left ventricle by pumping blood from the left ventricle into the ascending aorta and systemic circulation."), an impeller configured for insertion into the left ventricle via the delivery catheter, and configured to rotate within the left ventricle so as to pump blood from the left ventricle into an aorta of the subject, a frame surrounding the impeller ([0007]: "Various aspects and embodiments of mechanical circulatory support systems, devices and methods are described herein. The mechanical circulatory support systems, devices and methods may have one or more of any of the following features: a mechanical circulatory support system comprising a circulatory support catheter, comprising a circulatory support device carried by an elongate flexible catheter shaft, the circulatory support device comprising a tubular housing, a motor, an impeller configured to be rotated by the motor via a shaft..."), a delivery tube distally coupled to the frame and configured to extend from outside the body of the subject into the left ventricle via the delivery catheter ([0007]: "...a method of transcatheter delivery of a pump to the heart, the method comprising advancing the pump through vasculature, wherein the pump is advanced having a guidewire that extends through a first section of a catheter shaft located distal to the pump, through a tubular housing of the pump, external to an impeller and motor of the pump, and back into a second section of the catheter shaft located proximal to the pump..."), a locking unit configured to couple to a proximal end of the delivery catheter, wherein the delivery tube is configured to pass through the locking unit, the locking unit comprising a clip and at least one internal seal configured to surround the delivery tube and to inhibit backflow of blood of the subject, from the delivery catheter, through the locking unit, while the delivery tube passes through the locking unit ([0007]: "...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 catheter shaft; 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 catheter shaft; inward compression of the tabs of the locking mechanism compresses the locking pad against the catheter shaft...the circulatory support device comprises an annular polymeric seal around the shaft; the circulatory support device comprises a seal around the shaft, the seal comprising a distal radial shaft seal having a distal side configured to face distally toward the impeller and a radially inner lip configured to contact the shaft and to extend from the distal side in a proximal direction toward the motor; further comprising a proximal radial shaft seal having a proximal side configured to face proximally toward the motor and a radially inner lip configured to contact the shaft and to extend from the proximal side in a distal direction toward the impeller..."), and a drive cable, which passes through the delivery tube and is configured to rotate the impeller, the clip having only two states, which consist of: a closed state, in which the clip grips the delivery tube so as to inhibit movement of the delivery tube relative to the delivery catheter, and an open state, in which the clip does not grip the delivery tube ([0007]: "...the system may include a motor within the housing and configured to rotate the impeller; the motor may be positioned distal to the third guidewire port...").
In regards to claim 2, Mitze discloses that the clip is an external component of the locking unit ([0007]: "...a method of transcatheter delivery of a pump to the heart, the method comprising advancing the pump through vasculature, wherein the pump is advanced having a guidewire that extends through a first section of a catheter shaft located distal to the pump, through a tubular housing of the pump, external to an impeller and motor of the pump, and back into a second section of the catheter shaft located proximal to the pump...", [0157]: " As further shown in the cross sectional view of FIG. 26B, the insertion tool 2632 may also include a locking mechanism 2641, a locking pad 2642, a hemostatic valve 2649, and/or one or more sealing elements 2643. The locking mechanism 2641 may comprise locking tabs 2646 as further described below.", see Fig. 26E).
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In regards to claim 3, Mitze discloses that the locking unit further comprises a fluid port and is shaped to define a channel in fluid communication with the fluid port and with the delivery catheter ([0007]: "...the guide tube may enter a first guidewire port on a distal end of the housing, exit the housing via a second guidewire port on a side wall of the housing distal to the impeller, reenter the housing via a third guidewire port on a proximal side of the impeller, and extend proximally into the catheter shaft; the system may include at least one inlet port and at least one outlet port on the housing separated by a flexible section of the housing...").
In regards to claim 4, Mitze discloses that the clip is configured to remain in the open state, following a placement of the clip in the open state, unless the clip is returned to the closed state ([0168]: "FIG. 26E shows an exploded view of the insertion tool 2632 according to FIGS. 26A-D and to some embodiments. As shown, the tube 2644 that may be fluidly connected to the longitudinal lumen of the insertion tool 2632 and may have a valve 2645, such as a stopcock, at its opposite end. The valve 2645 may be adjusted to prevent or allow fluid flow through the valve 2645.").
In regards to claim 5, Mitze discloses that the clip is configured to return to the closed state, following a placement of the clip in the open state, unless the clip is held in the open state ([0168]: "FIG. 26E shows an exploded view of the insertion tool 2632 according to FIGS. 26A-D and to some embodiments. As shown, the tube 2644 that may be fluidly connected to the longitudinal lumen of the insertion tool 2632 and may have a valve 2645, such as a stopcock, at its opposite end. The valve 2645 may be adjusted to prevent or allow fluid flow through the valve 2645.").
In regards to claim 6, Mitze discloses that the locking unit is a first locking unit, the clip is a first clip, the closed state is a first closed state, and the open state is a first open state, and wherein the apparatus further comprises: an introducer sheath, configured to extend from outside the body of the subject into the body of the subject; and a second locking unit, configured to couple to a proximal end of the introducer sheath and comprising a second clip, wherein the delivery catheter is configured to pass through the second locking unit and introducer sheath, and wherein the second clip has only two states, which consist of: a second closed state, in which the second clip grips the delivery catheter so as to inhibit movement of the delivery catheter relative to the introducer sheath, and a second open state, in which the second clip does not grip the delivery catheter ([0061]: "Proximal hub 122 may have a lock for preventing axial movement of the insertion tool 32 and/or the dilator 114.").
In regards to claim 7, Mitze discloses that the second locking unit further comprises at least one internal seal configured to surround the delivery catheter and to inhibit backflow of blood of the subject, from the introducer sheath, through the second locking unit, while the delivery catheter passes through the second locking unit ([0061]: "Proximal hub 122 may additionally be provided with a side port 126, at least one and optionally two or more attachment features such as an eye 128 to facilitate suturing to the patient, and at least one and optionally a plurality of hemostasis valves for providing a seal around a variety of introduced components such as a standard 0.035″ guidewire, a 5 Fr or 6 Fr diagnostic catheter, an 0.018″ placement guidewire 100, the shaft 16, and the insertion tool 32.").
In regards to claim 8, Mitze discloses that the second clip is an external component of the second locking unit ([0061]: "The introducer kit 110 may comprise the introducer sheath 112 and/or the dilator 114. The introducer sheath 112 may comprise an elongate tubular body 116, extending between a proximal end 118 and a distal end 120. The tubular body 116 terminates proximally in a proximal hub 122.").
In regards to claim 9, Mitze discloses that the second locking unit further comprises a fluid port and is shaped to define a channel in fluid communication with the fluid port and with the introducer sheath ([0061]: "Proximal hub 122 may additionally be provided with a side port 126, at least one and optionally two or more attachment features such as an eye 128 to facilitate suturing to the patient, and at least one and optionally a plurality of hemostasis valves for providing a seal around a variety of introduced components such as a standard 0.035″ guidewire, a 5 Fr or 6 Fr diagnostic catheter, an 0.018″ placement guidewire 100, the shaft 16, and the insertion tool 32.").
In regards to claim 10, Mitze discloses that the second clip is configured to remain in the second open state, following a placement of the second clip in the open state, unless the second clip is returned to the second closed state ([0007]: "...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 catheter shaft…").
In regards to claim 11, Mitze discloses that the second clip is configured to return to the second closed state, following a placement of the second clip in the second open state, unless the second clip is held in the second open state ([0007]: "...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 catheter shaft…").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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