DETAILED ACTION
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.
Claim(s) 1-3, and 6-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brandt et al (US20210023285A1); hereinafter Brandt in view of Hoffman et al (US20140276051A1); hereinafter Hoffman .
Regarding claims 1 and 15, Brandt teaches an apparatus, comprising:
a blood pump ([0011] catheter blood pump), comprising:
an axial shaft ([0065] elongate shaft 1610) configured for insertion into, and rotation within, a body of a subject ([0091] The proximal struts in proximal expandable scaffold 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 entire device is inserted into the body);
an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject ([0011] The pump portion also includes one or more expandable impellers); and
a frame surrounding the impeller ([0071] one or more collapsible impellers can comprise a super elastic wire frame).
Brandt fails to teach steering wires.
Hoffman teaches one or more steering wires coupled to the frame and configured to extend from the frame, to outside the body of the subject, while the frame is within the body (fig. 6a-6d part 606d, 608d,610d,604d, [0114] the steering wires may be manipulated by the operator - if they are manipulated by the operator then they extend to the outside of the body of the subject).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Brandt with Hoffman because there is some teaching, suggestion, or motivation to do so. Hoffman teaches that the motivation to include steering wires is that the purpose is “to permit selective articulation and bending of the distal end of the second lumen 1104” ([0127]).
Regarding claim 2, the combination of Brandt and Hoffman teaches the apparatus according to claim 1. Brandt further teaches the axial shaft is coupled to the drive cable such that the axial shaft rotates with the drive cable ([0065] impellers are in operable communication with a drive cable 1612 - the shaft is a part of the impeller so if the impeller rotates then the drive cable should as well, [0082] the two impellers even though they are distinct and separate impellers, are in operable communication with a common drive mechanism (e.g., drive cable 1117), such that when the drive mechanism is activated the two impellers rotate together).
Regarding claim 3, the combination of Brandt and Hoffman teaches the apparatus according to claim 1. Brandt teaches a drive cable, wherein the axial shaft is a distal portion of the drive cable (fig. 7 - part 1117 drive cable feeds into part 1119 shaft).
Regarding claims 6 and 16, the combination of Brandt and Hoffman teaches the apparatus according to claim 1. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Brandt and Hoffman so that the steering wires comprise optical fibers because it constitutes simple substitution of one known element for another to obtain predictable results. The steering wires of claim 1 are generic and optical fibers are commonly used in biomedical applications, therefore substituting the generic wires of claim 1 with specifically optical fibers would have been obvious.
Regarding claim 7, the combination of Brandt and Hoffman teaches the apparatus of claim 1. Hoffman further teaches a handle comprising a steering control, wherein the steering wires are coupled to the steering control so as to be controllable via the steering control (fig. 17 - handle 1701).
Regarding claim 8, the combination of Brandt and Hoffman teaches the apparatus of claim 1. Brandt further teaches the blood pump further comprises:
a radial bearing, configured to radially stabilize the axial shaft while the axial shaft rotates ([0091] bearing 361); and
a bearing housing that houses the radial bearing and is coupled to the frame,
wherein one of the steering wires is coupled to the frame by virtue of being coupled to the bearing housing ([0091] bearing 349, bearing 350).
Regarding claim 9, the combination of Brandt and Hoffman teaches the apparatus according to claim 1. Hoffman further teaches the steering wires are configured for orienting the frame (fig. 6a-6d part 606d, 608d,610d,604d, [0114] the steering wires may be manipulated by the operator, to guide a flexible transbronchial needle to a site of interest).
Regarding claims 10, 17, and 18, the combination of Brandt and Hoffman teaches the apparatus of claim 9. Brandt further teaches the steering wires are configured to extend from the frame while the frame is within a left ventricle of a heart of the subject, and wherein the steering wires are configured for orienting the frame within the left ventricle ([0095] The sheath or shaft can be moved proximally (towards the ascending aorta “AA” and away from left ventricle “LV”) to allow for deployment and expansion of working portion 1104.).
Regarding claims 11 and 19, the combination of Brandt and Hoffman teaches the apparatus of claim 1. Hoffman further teaches one of the steering wires is coupled to a proximal end of the frame (fig. 11c).
Regarding claim 12, the combination of Brandt and Hoffman teaches the apparatus according to claim 11. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Brandt and Hoffman and couple the steering wire to the distal end of the frame because it constitutes an obvious design choice. The steering wires must be connected to at least one end of the frame in order for the user to be able to manipulate it to achieve the purpose of the invention. Therefore, the steering wires must be coupled to either the proximal or distal end of the frame and choosing one is a simple matter of design choice.
Regarding claim 13, the combination of Brandt and Hoffman teaches the apparatus according to claim 1. Brandt further teaches a delivery tube coupled to the frame and configured to extend from the frame, to outside the body of the subject, while the frame is within the body, wherein the steering wires pass through the delivery tube ([0163] delivery sheath).
Regarding claim 14, the combination of Brandt and Hoffman teaches the apparatus according to claim 13. Brandt further teaches a drive-cable-bearing tube coupled to the frame and configured to extend from the frame, to outside the body of the subject, within the delivery tube,
wherein the steering wires are disposed between the drive-cable-bearing tube and the delivery tube ([0070] outer shaft).
Regarding claim 20, the combination of Brandt and Hoffman teaches the method of claim 19. Hoffman further teaches a delivery tube is coupled to the frame and extends to the frame from outside the body of the subject, and wherein orienting the frame comprises orienting the frame by applying a force to the steering wire coupled to the proximal end of the frame while applying a counterforce to the delivery tube ([0112] Such assemblies may be manipulated by an operator to steer the needle to a site identified to be of interest).
Regarding claim 21, the combination of Brandt and Hoffman teaches the method of claim 19. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Brandt and Hoffman and couple the steering wire to the distal end of the frame because it constitutes an obvious design choice. The steering wires must be connected to at least one end of the frame in order for the user to be able to manipulate it to achieve the purpose of the invention. Therefore, the steering wires must be coupled to either the proximal or distal end of the frame and choosing one is a simple matter of design choice. Hoffman further teaches orienting the frame comprises orienting the frame by applying a force to the steering wire coupled to the proximal end of the frame while applying a counterforce to the steering wire coupled to the distal end of the frame ((fig. 6a-6d part 606d, 608d,610d,604d, [0114]) the steering wires may be manipulated by the operator).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brandt and Hoffman further in view MacDonald et al (US 20100152523 A1); hereinafter MacDonald.
Regarding claim 4, the combination of Brandt and Hoffman teaches the apparatus according to claim 1. The combination fails to teach elongation resistant fibers. MacDonald teaches the steering wires comprise respective elongation-resistant fibers ([0019] Still other suitable materials for the formation of the struts include carbon fiber composites and/or other composites, such as aramid fiber (e.g., KEVLAR.RTM. brand fibers commercially available from DuPont; and TWARON.RTM. brand fibers from Teijin Co.), and glass fiber). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Brandt and Hoffman with MacDonald because there is some teaching, suggestion, or motivation to do so. MacDonald teaches that “ultimately, one of skill in the art will appreciate that suitable materials include those that are spring-like (stiff and flexible), having a high modulus of elasticity (stiffness) and a suitable yield point (degree of stretch or bending at failure)” ([0019]).
Regarding claim 5, the combination of Brandt and Hoffman teaches the apparatus according to claim 1. The combination of Brandt and Hoffman fails to teach the steering wires comprise aramid fibers. MacDonald teaches the steering wires comprise respective aramid fibers ([0019] Still other suitable materials for the formation of the struts include carbon fiber composites and/or other composites, such as aramid fiber (e.g., KEVLAR.RTM. brand fibers commercially available from DuPont; and TWARON.RTM. brand fibers from Teijin Co.), and glass fiber).
Conclusion
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/D.S.D./ Examiner, Art Unit 3796
/CARL H LAYNO/ Supervisory Patent Examiner, Art Unit 3796