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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims use the term “pump head” there is no mention of it in the detailed description that accurately describes this feature. There is mention of a pump portion 27, a ventricular assist device, or a pump/impeller 50, but it isn’t clear if pump head refers to which one of these elements.
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.
Claim(s) 15-17 is/are 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 15-17 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 this is a new catheter, the “delivery catheter” mentioned in claim 3, or the “left-ventricular assist device” mentioned in 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 purging fluid (section 0153, saline), the apparatus comprising:
a left-ventricular assist device 600 comprising a pump head 625 that comprises: an axial shaft 630;
a radially-expandable impeller 605 coupled to the axial shaft 630 and configured to be deployed within a left ventricle of a subject (Fig. 15A, 26, section 0136); and
a proximal radial bearing 672 disposed around the axial shaft 630 proximally to the impeller 605 (Fig. 23A-B), and a distal radial bearing 672 disposed around the axial shaft 630 distally to the impeller 605 (Figs. 23A-B), the left-ventricular assist device defining a purging-fluid lumen 670 configured to direct the purging fluid to an interface between the axial shaft 630 and the distal radial bearing 672, thereby purging the interface 675 between the axial shaft 630 and the distal radial bearing 672 (Section 0153).
Regarding claim 2, McBride discloses the apparatus according to claim 1, wherein
the purging-fluid lumen 670 is further configured to direct the purging fluid (saline) to an interface between the axial shaft and the proximal radial bearing 672, thereby purging the interface 675 between the axial shaft and the proximal radial bearing (Section 0153).
Regarding claim 3, McBride discloses the apparatus according to claim 1, wherein:
the apparatus is configured for use with a guidewire 680 and a delivery catheter 625 (section 0168);
the impeller 605 is configured to be advanced to the subject’s left ventricle 900 over the guidewire 680 by advancing the left-ventricular assist device over the guidewire with the guidewire disposed in the purging-fluid lumen 670 and while the pump head is maintained in a radially-constrained configuration within the delivery catheter (section 0165, 0172); and
the impeller 605 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 (section 0169-0170, 0172-0173).
Regarding claim 4, McBride discloses The apparatus according to claim 3, wherein,
subsequent to the impeller having been advanced to the subject’s left ventricle and the guidewire having been retracted, the purging-fluid lumen is configured to direct the purging fluid to the interface between the axial shaft and the distal radial bearing (section 0165, 0172).
Regarding claim 5, McBride discloses The apparatus according to claim 3, wherein
the impeller 605 is configured to assume its non-radially-constrained configuration by axially contracting (section 0149).
Regarding claim 6, McBride discloses The apparatus according to claim 3, wherein
the pump head further comprises a frame 626 disposed around the impeller 605, wherein the frame 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 (section 0149).
Regarding claim 7, McBride discloses The apparatus according to claim 1, wherein
the left-ventricular assist device further comprises: a tube configured to traverse an aortic valve of a subject (section 0131), such that a proximal portion of the tube is disposed within the subject’s aorta 905 and a distal portion of the tube is disposed within the subject’s left ventricle 900 (section 0168), the tube 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 (Fig. 3, 10, section 0120, 0131).
Regarding claim 8, McBride discloses The apparatus according to claim 7, wherein
the impeller 605 is configured such that, when the impeller and the tube 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 9, McBride discloses The apparatus according to claim 7, wherein
the impeller 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 10, McBride discloses The apparatus according to claim 1, wherein
the axial shaft 630 defines a portion of the purging-fluid lumen 670 (section 0136).
Regarding claim 11, McBride discloses The apparatus according to claim 10, 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 second portion of the purging-fluid lumen 670 (Section 0131, 0151).
Regarding claim 12, McBride discloses The apparatus according to claim 11, wherein
the portions of the purging-fluid lumen 670 defined by the drive cable and the axial shaft 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 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 purging-fluid lumen 670 (Fig. 17).
Regarding claim 14, McBride discloses The apparatus according to claim 13, wherein
the portions of the purging-fluid lumen 670 defined by the drive cable, the axial shaft, and the distal tip portion have the same diameter as each other (Fig. 23A-B).
Regarding claim 15, McBride discloses The apparatus according to claim 13, wherein
the left-ventricular assist device catheter comprises a hemostasis 689 valve disposed at a distal end of the distal tip portion 646 (Fig. 22, section 0155).
Regarding claim 16, McBride discloses The apparatus according to claim 15, wherein:
the apparatus is configured for use with a guidewire 680 and a delivery catheter (Fig. 21A);
the impeller 605 is configured to be advanced to the subject’s left ventricle 900 over the guidewire 680 by advancing the left-ventricular assist device over the guidewire with the guidewire disposed in the purging-fluid lumen and while the pump head is maintained in a radially-constrained configuration within the delivery catheter (section 0165, 0172); and
the hemostasis valve 689 is configured to seal the distal end 646 of the distal tip portion subsequent to the guidewire being retracted from the purging fluid lumen (Fig. 22, section 0155).
Regarding claim 17, McBride discloses The apparatus according to claim 15, wherein
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 18, 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 purging-fluid lumen (section 0151).
Regarding claim 19, McBride discloses The apparatus according to claim 18, wherein:
the left-ventricular assist device comprises one or more outer tubes disposed around the drive cable (Fig. 26);
the drive cable comprises coiled wires (section 0152); 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 purging-fluid lumen defined by the drive cable by passing through the coiled wires (Section 0155).
Regarding claim 20, McBride discloses A method comprising:
deploying a pump head of a left-ventricular assist device 600 in a left ventricle 900 of a subject, the pump head including: an axial shaft 630 (Fig. 26);
a radially-expandable impeller 605 coupled to the axial shaft 630; and
a proximal radial bearing 672 disposed around the axial shaft proximally to the impeller 605, and a distal radial bearing 672 disposed around the axial shaft distally to the impeller 605 (Figs. 23A-B, section 0153-0154); and
purging an interface between the axial shaft and the distal radial bearing, by pumping purging fluid into a purging-fluid lumen defined by the left-ventricular assist device (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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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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