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 .
Status of Claims
Claims 1-21 are pending in the present application with claims 1 and 12 being independent.
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.
Claim 14 is 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 14 recites the limitation "the external membrane" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 6-12, 14, and 16-21 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Int'l Pub. WO 2020/152611 to Tuval et al. ("Tuval"):
Regarding claim 1, Tuval discloses an apparatus (Figure 1A), comprising:
a left-ventricular assist device (Figure 1C), comprising:
a pump-outlet tube (tube 24) shaped to define one or more blood-outlet openings (openings 109) and configured for insertion, through an aorta (aorta 30) of a subject, into a left ventricle (LV 22) of a heart of the subject such that the pump-outlet tube traverses an aortic valve (AV 26) of the subject with the blood-outlet openings being disposed within the aorta (see far right figure in Figure 1B); and
a blood pump (impeller 50) disposed at least partly within a distal portion (distal portion 102 in Figure 1C) of the pump-outlet tube and configured to pump blood of the subject proximally through the pump-outlet tube (Abstract),
a proximal end of the pump-outlet tube being folded inwardly so as to define one or more surfaces configured to direct the blood through the blood-outlet openings by virtue of being oblique with respect to a longitudinal axis of the pump-outlet tube (Figures 1C and 16B illustrate how proximal portion 42 is folded/bent inwardly defining surfaces configured to direct blood through openings 109 via being oblique/angled relative to longitudinal axis of the tube 24).
Regarding claim 2, Tuval discloses the apparatus according to claim 1, further including wherein the pump-outlet tube comprises a cylindrical portion (Figure 1C illustrates how tube 24 includes a cylindrical portion), and wherein the cylindrical portion of the pump-outlet tube is shaped to define the blood-outlet openings (see how cylindrical portion is shaped to define the openings 109), such that the blood-outlet openings are laterally facing (the openings 109 face sideways/lateral relative to the longitudinal axis of the tube 24).
Regarding claim 7, Tuval discloses the apparatus according to claim 1, further including wherein the pump-outlet tube is configured to curve proximally to the blood pump (Figures 25A-25F).
Regarding claim 8, Tuval discloses the apparatus according to claim 7, further including wherein the pump-outlet tube is configured to curve by virtue of being pre-shaped (91:9-11).
Regarding claim 9, Tuval discloses the apparatus according to claim 7, further including wherein the blood-outlet openings are arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings (92:32-93:1 and 93:8-12).
Regarding claim 10, Tuval discloses the apparatus according to claim 7, further including wherein the pump-outlet tube is further shaped to define one or more blood-inlet openings arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings (92:32-93:8).
Regarding claim 11, Tuval discloses the apparatus according to claim 7, further including wherein the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall (curved element 410 (band) attached/bonded to outer wall of tube 24 in Figure 25F provides tube 24 with a curvature per 93:24-27).
Regarding claim 12, Tuval discloses an apparatus (Figure 1A), comprising:
a left-ventricular assist device (Figures 15C-15E), comprising:
a pump-outlet tube (tube 24) configured for insertion, through an aorta (aorta 30) of a subject, into a left ventricle (LV 22) of a heart of the subject such that the pump-outlet tube traverses an aortic valve (AV 26) of the subject;
an impeller (impeller 50) disposed at least partly within a distal portion of the pump-outlet tube (right portion in Figures 15C-15E) and configured to pump blood of the subject proximally through the pump-outlet tube (Abstract); and
a blood-flow chamber (inside of compartments 267 in Figure 15C, inside of ribbons 264 in Figure 15D, inside of helical tube 268 in Figure 15E) disposed at a proximal end of the pump-outlet tube (left side of the tube 24), the blood-flow chamber defining (a) holes (e.g., see lead lines for 267 in Figure 15C, lead lines for 264 in Figure 15D, and circular openings near lead lines for 268 in Figure 15E), via which blood is pumped into the blood-flow chamber and (b) blood-outlet openings (openings 109), configured to be disposed with within the aorta, via which the blood flows out of the blood-flow chamber and into the aorta (see far right figure in Figure 1B).
Regarding claim 14, Tuval discloses the apparatus according to claim 12, further including wherein the left-ventricular assist device comprises an internal membrane (curved ribbons 262 in Figure 15C) that defines the holes and forms an internal surface of the blood-flow chamber, and wherein the proximal end of the pump-outlet tube is disposed outside the external membrane (far left side of device is the "proximal end" and is disposed outside of outer wall of tube 24 which is the "external membrane) and defines the blood-outlet openings (see openings in far left side of Figure 15C).
Regarding claim 16, Tuval discloses the apparatus according to claim 12, further including wherein the pump-outlet tube comprises a cylindrical portion (Figure 1C illustrates how tube 24 includes a cylindrical portion), and wherein the cylindrical portion of the pump-outlet tube is shaped to define the blood-outlet openings (see how cylindrical portion is shaped to define the openings 109), such that the blood-outlet openings are laterally facing (the openings 109 face sideways/lateral relative to the longitudinal axis of the tube 24).
Regarding claim 17, Tuval discloses the apparatus according to claim 12, further including wherein the pump-outlet tube is configured to curve proximally to the impeller (Figures 25A-25F).
Regarding claim 18, Tuval discloses the apparatus according to claim 17, further including wherein the pump-outlet tube is configured to curve by virtue of being pre-shaped (91:9-11)..
Regarding claim 19, Tuval discloses the apparatus according to claim 17, further including wherein the blood-outlet openings are arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings (92:32-93:1 and 93:8-12).
Regarding claim 20, Tuval discloses the apparatus according to claim 17, further including wherein the pump-outlet tube is further shaped to define one or more blood-inlet openings arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings (92:32-93:8).
Regarding claim 21, Tuval discloses the apparatus according to claim 17, further including wherein the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall (curved element 410 (band) attached/bonded to outer wall of tube 24 in Figure 25F provides tube 24 with a curvature per 93:24-27).
Allowable Subject Matter
Claims 3-6, 13, and 15 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.
Regarding claim 3, the prior art failed to further specifically disclose or suggest the pump-outlet tube to include a narrower section, which comprises the distal portion of the pump-outlet tube; and a wider section, which is proximal to and wider than the narrower section, and which is shaped to define at least a portion of each of the blood-outlet openings such that a normal vector to the portion has a distally-facing component.
Regarding claims 4-6, the prior art failed to further specifically disclose or suggest the surfaces to define a projection having a width that decreases moving distally.
Regarding claim 13, the prior art failed to further specifically disclose or suggest the left-ventricular assist device to include an external membrane that defines the blood-outlet openings and forms an external surface of the blood-flow chamber, and wherein the proximal end of the pump-outlet tube is disposed within the external membrane and defines the holes.
Regarding claim 15, the prior art failed to further specifically disclose or suggest the blood-flow chamber to be configured to inflate such as to center a portion of the left-ventricular assist device within the aorta by virtue of the blood flowing through the blood-flow chamber.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references on the attached PTO-892 disclose various ventricular assistance devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686