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 § 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) 1-10, 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 20190143018), cited previously in view of Brandt (US 20210023285, effective filing date on 7/22/2019).
The applied reference has a common Assignee/Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Salahieh discloses intravascular catheter blood pump, comprising: a collapsible blood conduit 356 (section 0043) and one or more impellers 341, 342 at least partially disposed therein (Fig. 3A, section 0064) ;
the first and second blood conduit support struts of each set having distal ends that join together via a circumferential connector 346 that circumferentially spaces the distal ends of the first and second blood conduit support struts of each set from each other (Section 0056, 0064, The distal struts of proximal expandable member 343 extend to and are secured to a proximal region (to a proximal end in this case) of central tubular member 346, which is disposed axially in between the expandable members, Distal struts of distal expandable member extend to and are secured to shaft section),
However, Salahieh does not specfically disclose a plurality of sets of first and second blood conduit support struts coupled to the blood conduit and extending proximally from the blood conduit at an outflow of a pump portion of the blood pump, and the first and second support struts of each set having proximal ends axially and circumferentially spaced from one another.
Brandt discloses a plurality of sets of first and second blood conduit support struts 622 coupled to the blood conduit and extending proximally from the blood conduit at an outflow of a pump portion of the blood pump (Fig. 14A, section 0167, 0172, exemplary strut assemblies that includes a plurality of struts that are configured to be non-unitary with an end region of an expandable blood conduit. The exemplary strut assemblies shown in FIGS. 14A, 14B and 15B may be disposed at a pump outflow, and they may be proximal struts at a proximal end of the pump portion) and the first and second support struts of each set having proximal ends axially and circumferentially spaced from one another (Fig. 14A, 15, shows plurality of neighboring struts 602, 622 are arranged around the circumference of the blood conduit, the struts are axially elongated which give it both axial and circumferential spacing between individual neighboring struts). These struts allow for secure and greater stiffness for the scaffold at the outflow region of the blood pump. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Salahieh by adding a plurality of sets of first and second blood conduit support struts coupled to the blood conduit and extending proximally from the blood conduit at an outflow of a pump portion of the blood pump, and the first and second support struts of each set having proximal ends axially and circumferentially spaced from one another as taught by Brandt in order to facilitate secure and greater stiffness for the scaffold at the outflow region of the blood pump.
Regarding claim 2, Salahieh discloses at least one of the first and second support struts is positioned and configured to facilitate collapse of the blood conduit in response to a sheathing force applied from a sheathing member moving in a distal direction (section 0043).
Regarding claim 3, Salahieh discloses the first support strut has a surface positioned proximally relative to the second strut such that the surface is positioned to contact the sheathing member moving in the distal direction (section 0061).
Regarding claim 4, Salahieh discloses the first and second struts are disposed and arranged relative to one another such that radially inward collapsing movement of the first strut in response to contact from a distally moving sheathing member causes radially inward collapsing movement of the second strut (section 0061).
Regarding claim 5, Salahieh discloses the second strut has a second strut region with a greater slope than a central region of the first strut (Fig. 3c-d), wherein the central region is better adapted to facilitate collapse from contact from a sheathing member than the second strut region (section 0043), and wherein the second strut region is better adapted to provide radial support to the fluid conduit than the central region (section 0081).
Regarding claim 6, Salahieh discloses the first and second struts are arranged relative to each other such that initiation of radial collapse of the first strut causes a distal end region of the second strut to radially collapse (section 0043).
Regarding claim 7, Salahieh discloses the first and second struts are unitarily formed from the same starting material (Fig. 1, 0039).
Regarding claim 8, Salahieh discloses the first strut has a proximal end formed from the starting material and deformed radially outward from the starting material, and wherein a proximal end of the second strut is not deformed radially outward from the starting material (Section 0077).
Regarding claim 9, Salahieh discloses proximal ends of each of the first and second struts extend from a common surface (Fig. 1-2).
Regarding claim 10, Salahieh discloses none of the first strut is circumferentially overlapping with the second strut (section 0056).
Regarding claim 13, Salahieh discloses first and second struts are unitarily formed with at least a proximal scaffold region 345, 361 of the blood conduit (Fig. 3C).
Regarding claim 14, Salahieh discloses the first and second struts have linear configurations in an end view of the device (section 0043).
Regarding claim 15, Salahieh discloses the first and second support struts are disposed in the inflow (Fig. 3D, section 0064 , The proximal struts of distal expandable member 344 extend to and secured to a distal region (to a distal end in this case) of central tubular member 346. Bearing 350 is also coupled to the distal region of central tubular member 346, as is shown in FIG. 3D. The drive cable extends through and rotates relative to bearing 350. Distal struts of distal expandable member extend to and are secured to shaft section 347).
Regarding claim 16, Salahieh discloses the first and second support struts are disposed in the outflow (Fig. 3C, Section 0064, The proximal struts in proximal expandable member 343 extend to and are secured to shaft section 345, which is coupled to bearing 361, through which the drive cable extends and is configured and sized to rotate. The distal struts of proximal expandable member 343 extend to and are secured to a proximal region (to a proximal end in this case) of central tubular member 346, which is disposed axially in between the expandable members).
Regarding claim 17, Salahieh discloses widths of the first and second struts are different (Section 0064).
Regarding claim 18, Salahieh discloses the first strut is distal to the second strut, and the first strut has a width that is less than a width of the second strut (Section 0064).
Regarding claim 19, Salahieh discloses the width of the first strut causes less flow effects than if the first strut had the same width as the second strut (Section 0040).
Regarding claim 20, Salahieh discloses the second strut supports at least one other structural member 1612 , such as a sensor wire (section 0042, drive cable).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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