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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim(s) 1-20 recites the limitation "pump head" in the claims. There is insufficient antecedent basis for this limitation in the claim. The specification states a “blood pump potion 27”, “device 20”, “distal tip potion 120” but no explicit terminology for “pump head”.
Claim 13 recites the limitation "the left-ventricular assist device catheter" in the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the language of claim 13 for a “the left-ventricular assist device catheter” refers to “delivery catheter” of claim 1, a newly introduced different catheter, or “the left-ventricular assist device” of claim 1.
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McBride et al. (US 20080114339).
Regarding claim 1, McBride discloses an apparatus for use with a guidewire 680 and a delivery catheter (Section 0168), the apparatus comprising:
a left-ventricular assist device 600 that defines a guidewire lumen 670 and that comprises a pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136), the pump head being configured to be advanced to a subject’s left ventricle over the guidewire 680 (section 0155), while the pump head 646 is maintained in a radially-constrained configuration within the delivery catheter 660 (Fig. 23B, Section 0137, 0149);
the pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136) comprising an impeller 605 that is configured to automatically assume a non-radially-constrained configuration upon being released from the delivery catheter within the subject’s left ventricle, by the impeller self-expanding (Fig. 23A, Sections 0149, 0154).
Regarding claim 2, McBride discloses the apparatus according to claim 1, wherein
the apparatus is for use with a purging fluid (saline solution) and wherein, subsequent to the pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136) having been advanced to the subject’s left ventricle and the guidewire 680 having been retracted, the guidewire lumen 670 is configured to provide a channel through which the purging fluid flows (section 0132).
Regarding claim 3, McBride discloses the apparatus according to claim 1, wherein
the impeller 605 is configured to assume its non-radially-constrained configuration by axially contracting (section 0137).
Regarding claim 4, McBride discloses The apparatus according to claim 1, wherein
the pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136) further comprises a frame 626 disposed around the impeller 605, wherein the frame 626 is configured to automatically assume a non-radially-constrained configuration upon being released from the delivery catheter within the subject’s left ventricle, by the frame self-expanding (Fig. 22A-B, section 0147, 0155).
Regarding claim 5, McBride discloses the apparatus according to claim 1, wherein
the left-ventricular assist device further comprises: a tube 626 configured to traverse an aortic valve 905 of a subject (Fig. 26), such that a proximal portion of the tube is disposed within the subject’s aorta and a distal portion of the tube is disposed within the subject’s left ventricle (section 0171), the tube 626 comprising a blood-impermeable material (Section 0139);
wherein the impeller 605 is disposed inside the distal portion of the tube and is configured to rotate such as to pump blood from the left ventricle to the aorta (section 0171).
Regarding claim 6, McBride discloses The apparatus according to claim 5, wherein
the impeller 605 is configured such that, when the impeller 605 and the tube 626 are deployed within the subject’s body, a gap between an outer edge of the impeller and an inner surface of the tube is less than 1 mm (section 0096 impeller are 6mm in diameter, section 0150, the expanded state, portion 626 had a nominal inner diameter of 6.6 mm in the expanded section; The gap between is the impeller and an inner surface would be less than 1mm based on the disclosed diameters in McBride).
Regarding claim 7, McBride discloses The apparatus according to claim 5, wherein the
impeller 605 is configured to be stabilized with respect to the tube, such that, during rotation of the impeller, a gap between the outer edge of the impeller and the inner surface of the tube is maintained (Fig. 3, section 0072, 0076).
Regarding claim 8, McBride discloses The apparatus according to claim 1, wherein
the impeller defines an impeller lumen therethrough, and the left-ventricular assist device further comprises an axial shaft 630 that passes through the impeller lumen 670, the axial shaft defining a portion of the guidewire lumen 670 (section 0152-0153).
Regarding claim 9, McBride discloses The apparatus according to claim 8, wherein
the left-ventricular assist device 600 further comprises: a motor configured to be disposed outside a body of a subject, and configured to drive the impeller to pump blood within the subject's body, by rotating the impeller (section 0131, 0151); and
a drive cable configured to extend from outside the subject's body to the axial shaft, the drive cable being configured to impart rotational motion from the motor to the impeller by rotating, wherein the drive cable defines at least a second portion of the guidewire lumen 670 ().
Regarding claim 10, McBride discloses The apparatus according to claim 9, wherein
the portions of the guidewire lumen 670 defined by the drive cable and the axial shaft have the same diameter as each other (Figs. 23A-B).
Regarding claim 11, McBride discloses The apparatus according to claim 9, wherein
the left-ventricular assist device further comprises a distal tip portion 646 disposed distally of the impeller 605 (Fig. 17, section 0147), wherein the drive cable, the axial shaft and the distal tip portion define respective portions of the guidewire lumen 670 (Fig. 17).
Regarding claim 12, McBride discloses the apparatus according to claim 11, wherein
the portions of the guidewire lumen 670 defined by the drive cable, the axial shaft, and the distal tip portion have the same diameter as each other (Figs. 23A-B).
Regarding claim 13, McBride discloses The apparatus according to claim 11, wherein
the left-ventricular assist device catheter comprises a hemostasis valve 689 disposed at a distal end of the distal tip portion 646 (Fig. 22, section 0155).
Regarding claim 14, McBride discloses The apparatus according to claim 13, wherein
the hemostasis valve 689 is configured to seal the distal end of the distal tip portion subsequent to the guidewire being retracted from the guidewire lumen (Fig. 22, section 0155).
Regarding claim 15, McBride discloses The apparatus according to claim 13, wherein:
the apparatus is for use with a purging fluid (saline, sections 0153, 0156, 0165);
subsequent to the pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136) having been advanced to a subject’s left ventricle and the guidewire having been retracted, the guidewire lumen is configured to provide a channel through which the purging fluid flows (section 0132, 0155); and
the hemostasis valve 689 is configured to cause the purging fluid to flow proximally through the distal tip portion toward a distal end of the axial shaft, by preventing the purging fluid from flowing out of a distal end of the distal tip portion (section 0155).
Regarding claim 16, McBride discloses The apparatus according to claim 1, wherein
the left-ventricular assist device further comprises: a motor configured to be disposed outside a body of a subject, and configured to drive the impeller to pump blood within the subject's body, by rotating the impeller (section 0131, 0151); and
a drive cable configured to extend from outside the subject's body to the axial shaft, the drive cable being configured to impart rotational motion from the motor to the impeller by rotating, wherein the drive cable defines at least a portion of the guidewire lumen (Section 0151).
Regarding claim 17, McBride discloses The apparatus according to claim 16, wherein:
the apparatus is for use with a purging fluid (saline, sections 0153, 0156, 0165);
subsequent to the pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136) having been advanced to a subject’s left ventricle and the guidewire having been retracted, the guidewire lumen is configured to provide a channel through which the purging fluid flows (section 0132, 0155);
the left-ventricular assist device comprises one or more outer tubes 626 disposed around the drive cable (Fig. 22A, Section 0151);
the drive cable comprises coiled wires (Section 0151); and
the apparatus further comprises a purging system configured to pump the purging fluid into at least one of the one or more outer tubes, such that the purging fluid passes into the portion of the lumen defined by the drive cable by passing through the coiled wires (sections 0153, 0156, 0165).
Regarding claim 18, McBride discloses A method comprising:
advancing a guide wire 680 into a left ventricle 900 of a subject (section 0155);
guiding a pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136) of a left-ventricular assist device to the subject’s left ventricle over the guidewire 680, the pump head (Fig. 17 device from distal end 646 to proximal end 648, section 0136) being disposed in a radially-constrained configuration within a delivery catheter during the guiding (Fig. 21A); and
when the pump head is disposed within the subject’s left ventricle 900, releasing the pump-head from within the delivery catheter, thereby causing an impeller 605 of the pump head to automatically assume a non-radially-constrained configuration by the impeller self-expanding (Fig. 22A-B, section 0147, 0155).
Regarding claim 19, McBride discloses The method according to claim 18, further comprising,
subsequent to guiding the pump head to the subject’s left ventricle, retracting the guidewire and flowing purging fluid through the guidewire lumen (section 0132, 0155).
Regarding claim 20, McBride discloses The method according to claim 19, wherein
the impeller 605 is coupled to an axial shaft which is stabilized by a proximal radial bearing disposed proximally with respect to the impeller and a distal radial bearing disposed distally with respect to the impeller (Fig. 3, section 0072, 0076), and wherein flowing purging fluid via the guidewire lumen comprises purging interfaces of the axial shaft with each of the proximal and the distal radial bearings 672 (Section 0153).
Conclusion
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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