DETAILED ACTION
Claims 1-20 are currently pending and have been examined.
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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-7, 11, & 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US20190344001).
As per claim 1, Salahieh discloses an intravascular blood pump (working portion 265, Fig. 34), comprising: a collapsible blood conduit (expandable member 270, Fig. 34; see also Para. [0191]) having an inner lumen for passing blood therethrough (conduit 268, Fig. 34; see also Paras. [0191] and [0126]), wherein a proximal portion of the blood conduit includes an impeller region configured to accommodate at least a portion of an impeller therein (region in which proximal impeller 266 is disposed, Fig. 34); and a plurality of struts (proximal struts, Para. [0191]) and one or more tension members (helical tension member 269, Fig. 34) extending proximally from the blood conduit and radially inward toward a shaft (Fig. 34), wherein the plurality of struts are proximally coupled to the shaft at a first axial region along the shaft (Para. [0191], as proximal struts are secured to a proximal strut support; see also Fig. 34).
Salahieh fails to explicitly disclose, in the same embodiment, that the one or more tension members is proximally coupled to the shaft at a second axial region along the shaft, wherein the first axial region is at a different axial position along the shaft than the second axial region.
Salahieh teaches in a different embodiment, however, that wiring that follows the periphery of the expandable member in a curvilinear fashion, consistent with helical tension member 269, is proximally coupled to the shaft at a second axial region along the shaft, wherein the first axial region is at a different axial position along the shaft than the second axial region (Fig. 28, as wiring 91 extends into and through the shaft disposed at the proximal end of expandable member 93; see also Para. [0180]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first embodiment of Salahieh to further include that the one or more tension members is proximally coupled to the shaft at a second axial region along the shaft, wherein the first axial region is at a different axial position along the shaft than the second axial region, as taught by the latter embodiment of Salahieh, the motivation being that Salahieh notes such a configuration as an illustration of how such wiring can be incorporated into the expandable member (Figures 28 and 34; see also Paras. [0180] and [0191]).
Regarding Claim 2, Salahieh discloses the intravascular blood pump of claim 1, wherein the plurality of struts and one or more tension members are configured to provide the impeller region resistance to lateral deflection (Para. [0191], as the expandable basked must be stretched to a much greater length, such as approximately double in length, to cause rotation/twisting of the desired segments).
Regarding Claim 3, Salahieh discloses the intravascular blood pump of claim 1, wherein the second axial region extends further proximally along the shaft relative to the first axial region (Figures 28 and 34, as wiring 91 extends into and through the shaft disposed at the proximal end of expandable member 93).
Regarding Claim 5, Salahieh discloses the intravascular blood pump of claim 1, wherein at least a portion of the one or more tension members is radially outside of the plurality of struts (Fig. 34; see also Para. [0191], as helical tension member 269 is disposed along the periphery of the expandable member).
Regarding Claim 6, Salahieh discloses the intravascular blood pump of claim 1, wherein the blood conduit includes an expandable scaffold comprising a pattern of axially and radially extending elements (expandable member 270, Fig. 34; see also Para. [0191]).
Regarding Claim 7, Salahieh discloses the intravascular blood pump of claim 6. scaffold.
Salahieh fails to explicitly disclose, in the same embodiment, that the blood conduit includes a membrane that covers the expandable Salahieh teaches, in a different embodiment, however, a blood conduit that includes a membrane that covers an expandable scaffold (Para. [0096], as conduit 25 is a membrane coupled to an exterior of the expandable member).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first embodiment of Salahieh to further include that the blood conduit includes a membrane that covers the expandable scaffold, as taught by the latter embodiment of Salahieh, the motivation being that such a configuration provides the ability to form a large open surface area that permits sufficient blood inlet flow even if it is pushed against an inner surface of a hollow anatomical structure, while providing a proximal region that opens as an impeller shroud to permit efficient axial pump flow (Para. [0096]).
Regarding Claim 11, Salahieh discloses the intravascular blood pump of claim 1, wherein the one or more tension members includes a plurality of tension members (Para. [0191], as there could alternatively be a helical arrangement of expandable member cells).
Regarding Claim 13, as best understood, Salahieh discloses the intravascular blood pump of claim 11, wherein the plurality of tension members are equally radially distributed around the shaft (Para. [0191], as the expandable member cells are helically arranged).
Regarding Claim 14, Salahieh discloses the intravascular blood pump of claim 1, wherein the plurality of struts are equally radially distributed around a proximal end of the blood conduit (Fig. 34; see also Para. [0191]).
Regarding Claim 15, Salahieh discloses the intravascular blood pump of claim 1, wherein the plurality of struts are equally radially distributed around the shaft (Fig. 34; see also Para. [0191]).
Regarding Claim 16, Salahieh discloses the intravascular blood pump of claim 1, wherein the plurality of struts are coupled to a hub of the shaft (Fig. 34; see also Para. [0191], as the proximal struts are secured to a proximal strut support).
Regarding Claim 17, Salahieh discloses the intravascular blood pump of claim 1, wherein the one or more tension members is coupled to a hub of the shaft (Fig. 28, as wiring 91 extends into and through the shaft disposed at the proximal end of expandable member 93; see also Para. [0180]).
Regarding Claim 18, Salahieh discloses the intravascular blood pump of claim 1, wherein the plurality of struts are coupled at the same axial position along the shaft (Fig. 34; see also Para. [0191], as the proximal struts are secured to a proximal strut support).
Regarding Claim 19, Salahieh discloses the intravascular blood pump of claim 1.
Salahieh fails to explicitly disclose, in the same embodiment, that the plurality of struts are coupled along at different axial positions along the shaft. Salahieh teaches, in a different embodiment, however, a plurality of struts that are coupled along at different axial positions along a shaft (struts 29 near proximal region 23, Fig. 2A).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first embodiment of Salahieh to further include that the plurality of struts are coupled along at different axial positions along the shaft, as taught by the latter embodiment of Salahieh, the motivation being that such a configuration functions to center and stabilize the shaft and the impeller to prevent the impeller blades from engaging the expandable member when they are rotating (Para. [0095]).
Regarding Claim 20, Salahieh discloses the intravascular blood pump of claim 1, wherein the one or more tension members includes a plurality of tension members, wherein the plurality of tension members are coupled at the same axial position along the shaft (Para. [0191], together). as the helical tension member can alternatively be a helical arrangement of expandable member cells, which would therefore be coupled.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US20190344001) in view of to Campbell (US20120172655).
Regarding Claim 4, Salahieh discloses the intravascular blood pump of claim 1. Salahieh fails to explicitly disclose wherein the first axial region extends further proximally along the shaft relative to the second axial region.
Campbell, however, teaches to a catheter assembly where struts are attached to different regions along a shaft (Fig. 24; para. 156).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the intravascular blood pump of Salahieh to further include that the catheter assembly where struts are attached to different regions along a shaft, as taught by Campbell, the motivation for enhancing stiffness (Campbell, Para. [0156]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US20190344001) in view of to Hildebrand et al (hereinafter, "Hildebrand")(US20200246527).
Regarding Claim 8, Salahieh discloses the intravascular blood pump of claim 1. Salahieh fails to explicitly disclose that the one or more tension members is fixedly coupled to the shaft at the second axial region. Hildebrand is in the field of intravascular blood pumps (Abstract), and teaches one or more tension members that is fixedly coupled to a shaft at a second axial region (Para. [0321], as the tensioning member may extend proximally and extend from a handle that includes an actuator that actuates the tensioning member).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the intravascular blood pump of Salahieh to further include that the one or more tension members is fixedly coupled to the shaft at the second axial region, as taught by Hildebrand, the motivation being that such a configuration provides a means of actuating and controlling the tensioning members, and therefore deflection in the desired region (Hildebrand, Para. [0321]).
Regarding Claim 9, Salahieh discloses the intravascular blood pump of claim 1. Salahieh fails to explicitly disclose that the one or more tension members is coupled to the shaft by a tension control element that is configured to move axially relative to the shaft, wherein axial movement of the tension control element adjusts an amount of tension placed on the one or more tension members and an amount of lateral stiffness imparted to the impeller region of the blood conduit.
Hildebrand is in the field of intravascular blood pumps (Abstract), and teaches that one or more tension members (at least one tensioning member 143, Fig. 27; see also Para. [0321]) is coupled to a shaft by a tension control element that is configured to move axially relative to the shaft (Para. [0321]), wherein axial movement of the tension control element adjusts an amount of tension placed on the one or more tension members and an amount of lateral stiffness imparted to the impeller region of the blood conduit (Para. [0321]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the intravascular blood pump of Salahieh to further include that the one or more tension members is coupled to the shaft by a tension control element that is configured to move axially relative to the shaft, wherein axial movement of the tension control element adjusts an amount of tension placed on the one or more tension members and an amount of lateral stiffness imparted to the impeller region of the blood conduit, as taught by Hildebrand, the motivation being that such a configuration provides a means of actuating and controlling the tensioning members, and therefore deflection in the desired region (Hildebrand, Para. [0321]; see also Salahieh, Para. [0191]).
Allowable Subject Matter
Claims 10 & 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tuval (US 20200237981 A1) teaches to an apparatus and methods are described including a left-ventricular assist device that includes a tube configured to traverse a subject's aortic valve, with a distal portion of the tube disposed within the subject's left ventricle. A frame is disposed within the distal portion of the tube. A pump disposed within the frame pumps blood through the tube
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/Jonathan Ng/ Primary Examiner, Art Unit 3619