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.
Claim(s) 1, 3-20 is/are rejected under 35 U.S.C. 102(a) (1) as being anticipated by LaRose (US 20180110908), cited previously.
Regarding claim 1, LaRose discloses a percutaneous circulatory support device 10 (Section 0020, an exemplary inflow cannula constructed in accordance with the principles of the present application and designated generally as “10.”), comprising: a housing 12; an impeller (Fig. 2) disposed within the housing 12 and being rotatable relative to the housing to cause blood to flow through the housing; a cannula 10 coupled to the housing (Figs. 1-2, section 0020, The inflow cannula 10 may be an integral part of an implantable blood pump 12 or may be removably coupled to the blood pump 12. The inflow cannula 10 is configured to be maneuvered through a patient's vascular system, or another portion of a patient's body and is configured to allow for a flow rate through the inflow cannula 10 without collapse); a distal tip portion 24 having a proximal end coupled to a distal end 16 of the cannula 10 opposite the housing 12 and extending distally therefrom (Figs. 1-2 section 0021, 0024, the inflow cannula may include a tube having a distal portion 16 and a proximal portion 18 opposite the distal portion 16. A cannula tip 24 may extend from the inflow portion 16 of the tube 14); a plurality of blood inlet windows 26A-C disposed along the cannula 10 proximal of the distal tip 24 portion (Figs. 1-2, 5-6, section 0021, 0028, The distal portion 16 may also be referred to as the inflow portion. The tip 24 includes three apertures 26a-26c which allow a fluid, such as blood, to flow through the apertures 26 into the tube); and a control wire 34 coupled to the distal tip portion, the control wire being movable to modify at least one of a radius, a stiffness, and a shape of the distal tip portion (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 3, LaRose discloses the control wire is a pull wire (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 4, LaRose disclose the control wire is a first control wire, and further comprising a second control wire being movable to modify a length of the distal tip portion (Section 0031, One or more actuator members 44 and one or more elongated members 46 may be embedded within or on the wall 42. The actuator members 44 may be pull wires, tape, or another structure configured to receive the force of the actuator).
Regarding claim 7, LaRose disclose the control wire 34 extends through the cannula (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 8, LaRose disclose the control wire 34 extends through the housing (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 9, LaRose disclose a housing 10 (Section 0020, an exemplary inflow cannula constructed in accordance with the principles of the present application and designated generally as “10.”); an impeller (Fig. 2) disposed within the housing 10 and being rotatable relative to the housing to cause blood to flow through the housing; a cannula 10 coupled to the housing; a distal tip portion 24 having a proximal end coupled to a distal end 16 of the cannula 10 opposite the housing 12 and extending distally therefrom (Figs. 1-2 section 0021, 0024, the inflow cannula may include a tube having a distal portion 16 and a proximal portion 18 opposite the distal portion 16. A cannula tip 24 may extend from the inflow portion 16 of the tube 14); a plurality of blood inlet windows 26A-C, disposed along the cannula 10 proximal of the distal tip 24 portion (Figs. 1-2, 5-6, section 0021, 0028, The distal portion 16 may also be referred to as the inflow portion. The tip 24 includes three apertures 26a-26c which allow a fluid, such as blood, to flow through the apertures 26 into the tube); a first active control 34 extending distally beyond the plurality of blood inlet windows 26A-C, and coupled to the distal tip portion 24, the first active control being manipulable to modify at least one of a radius, a stiffness, and a shape of the distal tip portion (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip. the pull wire 34 may be pulled in a direction toward the actuator 22 to bend and/or steer the tip 24 when the pull wire 34 is coupled to the tip); and a second active control 44 extending distally beyond the plurality of blood inlet windows 26A-C and coupled to the distal tip portion 24, the second active control being manipulable to modify a length of the distal tip portion (section 0027, 0031, The pull wire 34 may be pulled in a direction toward the actuator 22 to bend and/or steer the tip 24 when the pull wire 34 is coupled to the tip. The pull wire 34 may extend through a driveline 38 from inside the patient's body to outside of the patient's body. The driveline 38 may be coupled to the actuator 22, which may be a lever, a knob, a handle, controller, or the like. One or more actuator members 44 and one or more elongated members 46 may be embedded within or on the wall 42. The actuator members 44 may be pull wires, tape, or another structure configured to receive the force of the actuator).
Regarding claim 11, LaRose disclose the second active control is a pull wire (Section 0031, One or more actuator members 44 and one or more elongated members 46 may be embedded within or on the wall 42. The actuator members 44 may be pull wires, tape, or another structure configured to receive the force of the actuator).
Regarding claim 13, LaRose disclose the first active control 34 extends through the cannula (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 14, LaRose disclose the first active control 34 extends through the housing (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 15, LaRose disclose the second active control extends through the cannula (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 16, LaRose disclose the second active control extends through the housing (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 17, LaRose disclose a method for positioning a percutaneous circulatory support device 10 within a patient (Section 0020, an exemplary inflow cannula constructed in accordance with the principles of the present application and designated generally as “10.”), comprising: inserting the percutaneous circulatory support device into the vasculature of the patient (section 0020, The inflow cannula 10 is configured to be maneuvered through a patient's vascular system, or another portion of a patient's body and is configured to allow for a flow rate through the inflow cannula 10 without collapse), the percutaneous circulatory support device comprising a housing 12, an impeller (fig. 2) disposed within the housing and being rotatable relative to the housing to cause blood to flow through the housing, a cannula coupled to the housing, a distal tip portion 24 having a proximal end coupled to a distal end 16 of the cannula 10 opposite the housing 12 and extending distally therefrom (Figs. 1-2 section 0021, 0024, the inflow cannula may include a tube having a distal portion 16 and a proximal portion 18 opposite the distal portion 16. A cannula tip 24 may extend from the inflow portion 16 of the tube 14), a plurality blood inlet windows 26A-C (Figs. 5-6) disposed along the cannula 10 proximal of the distal tip 24 portion (Figs. 1-2, 5-6, section 0021, 0028, The distal portion 16 may also be referred to as the inflow portion. The tip 24 includes three apertures 26a-26c which allow a fluid, such as blood, to flow through the apertures 26 into the tube); and a control wire 34 coupled to the distal tip 24 portion, the control wire extending distally beyond the plurality of blood inlet windows (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip. the pull wire 34 may be pulled in a direction toward the actuator 22 to bend and/or steer the tip 24 when the pull wire 34 is coupled to the); thereafter moving the control wire to modify at least one of a radius, a stiffness, and a shape of the distal tip portion; and thereafter advancing the percutaneous circulatory support device in the vasculature of the patient (Fig. 4, section 0026-0027, One or more actuator members, such as a pull wire 34, may be disposed within the inflow cannula 10 and coupled to the tube. a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip).
Regarding claim 18, LaRose disclose advancing the percutaneous circulatory support device in the vasculature of the patient comprises crossing a heart valve with the distal tip portion (Section 0020, The inflow cannula 10 may be an integral part of an implantable blood pump 12 or may be removably coupled to the blood pump 12. The inflow cannula 10 is configured to be maneuvered through a patient's vascular system, or another portion of a patient's body and is configured to allow for a flow rate through the inflow cannula 10 without collapse. In one configuration, the blood pump 12 may be positioned within an aorta and may extend from a left ventricle through an aortic valve into the aorta).
Regarding claim 19, LaRose disclose wherein the heart valve is an aortic valve (section 0020, The inflow cannula 10 may be an integral part of an implantable blood pump 12 or may be removably coupled to the blood pump 12. The inflow cannula 10 is configured to be maneuvered through a patient's vascular system, or another portion of a patient's body and is configured to allow for a flow rate through the inflow cannula 10 without collapse. In one configuration, the blood pump 12 may be positioned within an aorta and may extend from a left ventricle through an aortic valve into the aorta).
Regarding claim 20, LaRose disclose moving the control wire to modify at least one of the radius, the stiffness, and the shape of the distal tip portion comprises positioning the distal tip portion in a prolapsed configuration, and wherein crossing the heart valve with the distal tip portion comprises crossing the heart valve in the prolapsed configuration (Section 0027, a force may be applied to the pull wire 34 through the actuator 22, causing at least a portion of the tube 14 to bend or deflect to achieve a deflected configuration. The portion of the tube 14 configured to bend or deflect may vary depending upon the location of the pull wire 34 with respect to the elongated members 28 and/or the tip 24. In other words, the portion of the inflow cannula 10 configured to bend or deflect may vary depending upon the structure and material of the tube 14 and the steering assembly 20. The deflection section 27 may take a pre-determined shape that is defined by the physical construction of the individually ribs 36. In one configuration, the pull wire 34 may be pulled in a direction toward the actuator 22 to bend and/or steer the tip 24 when the pull wire 34 is coupled to the tip 24. As such, the tip 24 may be movable with respect to the tube 14. When the tube 14 and/or the tip 24 are in the bent or deflected state, the tube 14 is configured to be steerable through the vasculature or another portion of the patient's body).
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 2 is rejected under 35 U.S.C. 103(a) as being unpatentable over LaRose (US 20180110908), cited previously, as applied to claim 1 above, and further in view of Saadat et al. (US 20080058591).
LaRose discloses the invention substantially as claimed however does not show the control wire is a push wire. Saadat discloses the control wire is a push wire (section 0011, the distal end of the deployment catheter or separate manipulatable catheters may be articulated through various controlling mechanisms such as push-pull wires manually). This allows for more control and steerability to manipulate the device when implanting. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of LaRose by adding the control wire is a push wire as taught by Saadat in order to facilitate more control and steerability to manipulate the device when implanting.
Claim(s) 5-6, 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over in LaRose (US 20180110908) in view of Aboul-Hosn et al. (US 10279095), both cited previously.
Regarding claim 5 and 10, LaRose discloses the invention substantially as claimed however does not show the distal tip portion comprises a spiral shape. Aboul-Hosn discloses the distal tip portion 1174 comprises a spiral shape (Fig. 30, column 26 lines 45-48). This allows for proper crossing and implanting into the target site. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of LaRose by adding the distal tip portion comprises a spiral shape as taught by Aboul-Hosn in order to facilitate for proper crossing and implanting into the target site.
Regarding claims 6 and 12, LaRose discloses the invention substantially as claimed however does not show the control wire comprises a radiopaque material. Aboul-Hosn discloses the control wire comprises a radiopaque material (Column 33 lines 45-47). This allows for wire visible to x-ray radiation for visualizing the cannula during its use. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of LaRose by adding the control wire comprises a radiopaque material as taught by Aboul-Hosn in order to facilitate makes portion of the cannula and wire visible to x-ray radiation for visualizing the cannula during its use.
Response to Arguments
Applicant's arguments filed 2/18/2026 have been fully considered but they are not persuasive. Examiner finds that LaRose discloses a plurality of blood inlet windows 26A-C disposed along the cannula 10 proximal of the distal tip 24 portion (Figs. 1-2, 5-6, section 0021, 0028, The distal portion 16 may also be referred to as the inflow portion. The tip 24 includes three apertures 26a-26c which allow a fluid, such as blood, to flow through the apertures 26 into the tube).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796