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 .
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
Claim Rejections - 35 USC § 103
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 1 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (US 2015/0290372; hereinafter “Muller”) in view of Corbett et al. (US 2018/0055979; hereinafter “Corbett”).
Regarding claim 1, Muller discloses an apparatus, comprising: a left-ventricular assist device comprising: an impeller configured to pump blood from the left ventricle to an aorta of the subject, by rotating (e.g. ¶¶ 106-112, etc.); a frame disposed around the impeller (e.g. ¶¶ 64, 81 – elongate body 96); and a tube configured to traverse an aortic valve of the subject, 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 (e.g. Fig. 19, #508), the distal portion of the tube extending to a distal end of the frame and defining blood-inlet openings that are sized to allow blood to flow from the subject's left ventricle into the tube (e.g. ¶¶ 128).
It is unclear whether Muller discloses the impeller is configured to be placed inside a left ventricle of a subject as claimed. Muller discloses that the impeller target location is across the aortic valve, however, Muller further indicates that “The clinician can adjust the position of the impeller assembly 592 to achieve desirable pressure profiles in the left ventricle 732” (e.g. ¶¶ 153). Muller further indicates that “the clinician can move the impeller assembly 592 relative to the aortic valve 533 until the impeller 508 provides adequate flow rate and reduced ventricular pressure” (e.g. ¶¶ 154). Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to configure the impeller to be placed inside the left ventricle of a subject, distal to the aortic valve, in order to yield the predictable results of providing the required flow rate and ventricular pressure required for the patient’s heart.
Muller discloses the distal portion of the tube defines a plurality of fluid inlets (e.g. ¶¶ 128) but fails to expressly disclose more than 10 blood-inlet openings sized to block structures from the subject's left ventricle from entering into the frame. In the same field of endeavor, Corbett discloses a left ventricular assist device comprising a distal portion defining more than 10 blood-inlet openings that are sized to block structures from the subject's left ventricle from entering into the frame (e.g. Fig. 4, #416; Fig. 3, #316, etc.; ¶¶ 56 – “the struts 317a-c between the plurality of apertures 316 act as a screen to prevent the suctioning of valve leaflets and other tissues to the plurality of apertures”; etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention to apply the known technique of employing more than 10 blood-inlet openings sized to block structures from the subject's left ventricle from entering into the frame, as taught by Corbett, to the known device of Muller to improve the device in the same way yielding the predictable results of preventing the suctioning of valve leaflets and other tissues.
Regarding claim 22, Muller teaches the method, comprising: placing a left-ventricular assist device into a subject such that: an impeller of the left-ventricular assist device is placed inside the heart of a subject (e.g. ¶¶ 106-112, etc.); a frame of the left-ventricular assist device is disposed around the impeller (e.g. ¶¶ 64, 81 – elongate body 96); and a tube of the left-ventricular assist device traverses an aortic valve of the subject, such that a proximal portion of the tube is disposed within an aorta of the subject and a distal portion of the tube is disposed within the subject's left ventricle (e.g. Fig. 19, #508), and driving the impeller to rotate such as to pump blood from the subject's left ventricle to the subject's aorta (e.g. ¶¶ 106-112, etc.), wherein the distal portion of the tube extends to a distal end of the frame and defines openings that are sized such to allow blood to flow from the subject's left ventricle into the tube (e.g. ¶¶ 128).
It is unclear whether Muller discloses the impeller is placed inside a left ventricle of a subject as claimed. Muller discloses that the impeller target location is across the aortic valve, however, Muller further indicates that “The clinician can adjust the position of the impeller assembly 592 to achieve desirable pressure profiles in the left ventricle 732” (e.g. ¶¶ 153). Muller further indicates that “the clinician can move the impeller assembly 592 relative to the aortic valve 533 until the impeller 508 provides adequate flow rate and reduced ventricular pressure” (e.g. ¶¶ 154). Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to configure the impeller to be placed inside the left ventricle of a subject, distal to the aortic valve, in order to yield the predictable results of providing the required flow rate and ventricular pressure required for the patient’s heart.
Muller discloses the distal portion of the tube defines a plurality of fluid inlets (e.g. ¶¶ 128) but fails to expressly disclose more than 10 blood-inlet openings sized to block structures from the subject's left ventricle from entering into the frame. In the same field of endeavor, Corbett discloses a left ventricular assist device comprising a distal portion defining more than 10 blood-inlet openings that are sized to block structures from the subject's left ventricle from entering into the frame (e.g. Fig. 4, #416; Fig. 3, #316, etc.; ¶¶ 56 – “the struts 317a-c between the plurality of apertures 316 act as a screen to prevent the suctioning of valve leaflets and other tissues to the plurality of apertures”; etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention to apply the known technique of employing more than 10 blood-inlet openings sized to block structures from the subject's left ventricle from entering into the frame, as taught by Corbett, to the known device of Muller to improve the device in the same way yielding the predictable results of preventing the suctioning of valve leaflets and other tissues.
Claims 1, 2, and 4-22 are rejected under 35 U.S.C. 103 as being unpatentable over Corbett in view of Muller.
Regarding claim 1, Corbett discloses an apparatus, comprising: a left-ventricular assist device (e.g. Fig. 25; ¶¶ 9) comprising: an impeller configured to pump blood from the left ventricle to an aorta of the subject, by rotating (e.g. ¶¶ 17); a frame disposed around the impeller (e.g. Fig. 2A-C, #34); and a tube configured to traverse an aortic valve of the subject, 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 (e.g. Fig. 25; ¶¶ 51 – “plurality of apertures 116 may be positioned past the aortic valve in the left ventricle, in order to pull blood from the left ventricle and expel the blood into the aorta”), the distal portion of the tube extending to a distal end of the frame and defining more than 10 blood-inlet openings that are sized such as (a) to allow blood to flow from the subject's left ventricle into the tube and (b) to block structures from the subject's left ventricle from entering into the frame (e.g. Fig. 4, #416; Fig. 3, #316, Fig .25, #2516, etc.; ¶¶ 56 – “the struts 317a-c between the plurality of apertures 316 act as a screen to prevent the suctioning of valve leaflets and other tissues to the plurality of apertures”; etc.).
Corbett fails to expressly disclose an impeller configured to be placed inside a left ventricle of a subject as claimed. In the same field of endeavor, Muller discloses a left ventricular assist device with an impeller capable of being positioned both proximal and distal to the aortic valve – specifically where “The clinician can adjust the position of the impeller assembly 592 to achieve desirable pressure profiles in the left ventricle 732” (e.g. ¶¶ 153). Muller further indicates that “the clinician can move the impeller assembly 592 relative to the aortic valve 533 until the impeller 508 provides adequate flow rate and reduced ventricular pressure” (e.g. ¶¶ 154). Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to modify the device of Corbett with a more centrally positioned impeller as taught by Muller, where the impeller is configured be placed inside the left ventricle of a subject, distal to the aortic valve, in order to yield the predictable results of providing the required flow rate and ventricular pressure required for the patient’s heart.
Regarding claim 22, Corbett teaches the method, comprising: placing a left-ventricular assist device into a subject such that: an impeller of the left-ventricular assist device is placed inside the heart of a subject (e.g. Fig. 25; ¶¶ 9); a frame of the left-ventricular assist device is disposed around the impeller (e.g. Fig. 3, #302); and a tube of the left-ventricular assist device traverses an aortic valve of the subject, such that a proximal portion of the tube is disposed within an aorta of the subject and a distal portion of the tube is disposed within the subject's left ventricle (e.g. Fig. 25; ¶¶ 51 – “plurality of apertures 116 may be positioned past the aortic valve in the left ventricle, in order to pull blood from the left ventricle and expel the blood into the aorta”), and driving the impeller to rotate such as to pump blood from the subject's left ventricle to the subject's aorta (e.g. ¶¶ 56), wherein the distal portion of the tube extends to a distal end of the frame and defines more than 10 blood-inlet openings that are sized such as (a) to allow blood to flow from the subject's left ventricle into the tube and (b) to block structures from the subject's left ventricle from entering into the frame (e.g. Fig. 4, #416; Fig. 3, #316, Fig .25, #2516, etc.; ¶¶ 56 – “the struts 317a-c between the plurality of apertures 316 act as a screen to prevent the suctioning of valve leaflets and other tissues to the plurality of apertures”; etc.).
Corbett fails to expressly disclose an impeller configured to be placed inside a left ventricle of a subject as claimed. In the same field of endeavor, Muller discloses a left ventricular assist device with an impeller capable of being positioned both proximal and distal to the aortic valve – specifically where “The clinician can adjust the position of the impeller assembly 592 to achieve desirable pressure profiles in the left ventricle 732” (e.g. ¶¶ 153). Muller further indicates that “the clinician can move the impeller assembly 592 relative to the aortic valve 533 until the impeller 508 provides adequate flow rate and reduced ventricular pressure” (e.g. ¶¶ 154). Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to modify the device of Corbett with a more centrally positioned impeller as taught by Muller, where the impeller is configured be placed inside the left ventricle of a subject, distal to the aortic valve, in order to yield the predictable results of providing the required flow rate and ventricular pressure required for the patient’s heart.
Regarding claim 2, Corbett discloses the frame is shaped such that, in a non-radially constrained configuration of the frame, the frame defines a proximal conical portion, a central cylindrical portion, and a distal conical portion, wherein the distal portion of the tube extends distally over the distal conical portion of the frame (e.g. Fig. 4 – where the examiner notes the generic embodiment shows proximal and distal conical portions and a central cylindrical portion), and wherein at least some of the blood-inlet openings are at least partially disposed over the distal conical portion of the frame (e.g. Fig. 12, #1242 – where the examiner considers the distal conical portion to extend into the most distal apertures as the recited portions above do not specify a distal and proximal boundary).
Regarding claim 4, Corbett discloses each of the blood-inlet openings defines an area of less than 1 square mm (e.g. ¶¶ 61).
Regarding claim 5, Corbett discloses the blood-inlet openings are shaped such as to block chordae tendineae, trabeculae carneae, and papillary muscles of the subject from entering into the frame and to thereby prevent the chordae tendineae, trabeculae carneae, and papillary muscles from being damaged by the impeller during rotation of the impeller (e.g. ¶¶ 56 – “the struts 317a-c between the plurality of apertures 316 act as a screen to prevent the suctioning of valve leaflets and other tissues to the plurality of apertures”).
Regarding claim 6, Corbett discloses the left-ventricular assist device further comprises an axial shaft, the impeller being disposed on the axial shaft (e.g. ¶¶ 88 – “The impeller blade may have any suitable number of blades and may be rotated by a drive shaft connected to a motor.”), and wherein the blood-inlet openings are shaped such as to block chordae tendineae, trabeculae carneae, and papillary muscles of the subject from entering into the frame and to thereby prevent the chordae tendineae, trabeculae carneae, and papillary muscles from being damaged by the axial shaft during rotation of the impeller (e.g. ¶¶ 56 – “the struts 317a-c between the plurality of apertures 316 act as a screen to prevent the suctioning of valve leaflets and other tissues to the plurality of apertures”).
Regarding claim 7, Corbett discloses the ventricular assist device further comprises a structure configured to separate the blood-inlet openings from the internal structures of the ventricle, the structure being selected from the group consisting of: a braid and a mesh (e.g. ¶¶ 88 – “the cannula may be comprised of a mesh, such as a nitinol mesh, covered by an elastic covering”).
Regarding claims 8-9, Corbett fails to expressly disclose the tube defines more than 50 blood-inlet openings or more than 100 blood-inlet openings (e.g. ¶¶ 47 – “it will be understood that the heart pump assembly may be configured to have any suitable number of apertures arranged in any number of rings, not limited to the arrangements described here”).
Regarding claim 10, Corbett discloses the blood-inlet openings are shaped such that a ratio of lengths to widths of each of the blood-inlet openings is between 1.1:1 and 4:1 (e.g. Fig. 4, 19, etc. ¶¶ 57).
Regarding claim 11, Corbett discloses the lateral blood inlet openings are shaped such that a ratio of lengths to widths of each of the blood-inlet openings is between 3:2 and 5:2 (e.g. Fig. 4, 5, 9, etc. ¶¶ 57).
Regarding claim 12, Corbett discloses the proximal portion of the tube defines one or more blood-outlet openings that are configured to allow blood to flow from the tube into the subject's aorta (e.g. ¶¶ 60 - #424).
Regarding claim 13, Corbett discloses the tube defines a generally- cylindrical central portion, and a proximal conical portion that narrows from a proximal end of the central portion to a proximal end of the tube (e.g. Fig. 4 – where the examiner notes the generic embodiment shows proximal and distal conical portions and a central cylindrical portion), and wherein the one or more blood-outlet openings extend at least partially into the proximal conical portion of the tube (e.g. Fig. 4, #424 – where the examiner considers the distal conical portion to extend into the most distal apertures as the recited portions above do not specify a distal and proximal boundary).
Regarding claim 14, Corbett discloses the blood-outlet openings are teardrop shaped (e.g. ¶¶ 57 – “the plurality of apertures 116 can be oblong, oval, square, tear-shaped…”).
Regarding claim 15, Corbett discloses the tube defines between two and eight blood-outlet openings (e.g. Fig. 4, #424).
Regarding claim 16, Corbett discloses the tube defines between two and four blood-outlet openings (e.g. ¶¶ 57, 47 – “it will be understood that the heart pump assembly may be configured to have any suitable number of apertures arranged in any number of rings, not limited to the arrangements described here”).
Regarding claims 17-18, Corbett discloses a region of the tube that defines the blood-inlet openings has a porosity of more than 50 percent (e.g. ¶¶ 61; Fig. 5/6, #518a/b where the porosity of this region is clearly more than 50%).
Regarding claims 19-21, Corbett discloses each of the blood-inlet openings defines a span of less than 0.8 mm in at least one direction (e.g. ¶¶ 61).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett in view of Muller, further in view of Shifflette (US 2009/0062597). Corbett fails to expressly disclose at least a portion of the tube is collapsible, such that: in response to pressure outside of the portion of the tube exceeding pressure inside the collapsible portion of the tube, the collapsible portion of the tube collapses inwardly, and during operation of the impeller, pressure of the blood flow through the tube maintains the collapsible portion of the tube in an open state. In the same field of endeavor, Shifflette discloses at least a portion of the tube is collapsible, such that: in response to pressure outside of the portion of the tube exceeding pressure inside the collapsible portion of the tube, the collapsible portion of the tube collapses inwardly, and during operation of the impeller, pressure of the blood flow through the tube maintains the collapsible portion of the tube in an open state (e.g. ¶¶ 123). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention to apply the known technique of pressure collapsible impeller components as taught by Shiflette to the device of Corbett in order to yield the same results of providing an easily advanceable pump unit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
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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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796