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 § 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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US 2019/0209758; hereinafter “Tuval”).
Regarding claim 1, Tuval discloses an apparatus, comprising: a ventricular assist device (e.g. ¶¶ 448) comprising: an axial shaft (e.g. Fig. 4, #92); an impeller disposed on the axial shaft (e.g. Fig. 4, #50), the impeller being configured to pump blood (e.g. ¶¶ 460); a frame disposed around the impeller (e.g. Fig. 4, #34); a distal bearing disposed within the frame (e.g. ¶¶ 482 – element 118), the distal end of the axial shaft being configured to engage with the distal bearing such as to prevent the axial shaft from undergoing axial motion in response to variations in the pressure gradient against which the impeller pumps blood (e.g. ¶¶ 489 – where the configuration includes stopper 128 that prevents the axial shaft from undergoing axial motion; where the examiner highlights the claim language does not require the thrust bearing preventing the axial shaft from undergoing axial motion, just that the distal end of the axial shaft is configured in that manner); and a plurality of connecting struts extending radially inwardly from the frame to the distal bearing and coupling the bearing to the frame (e.g. Fig. 4 - struts 40 extend radially inward and couple to bearing 118) the frame and the connecting struts being formed as a single integral body (e.g. Fig. 4 – where it is clear elements #34 and #40 form a single integral body).
Tuval fails to expressly disclose that the bearing element 118 is a distal thrust bearing as claimed; however, Tuval does indicate that in some scenarios, a thrust bearing is disposed distally to the impeller and in contact with the subject's blood, such that the thrust bearing is cooled by the subject's blood, in order to maintain the axial position of the impeller. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the disclosed thrust bearing in place of the stopper 128, in order to yield the predictable results of maintaining the axial positioning of the impeller, while allowing effective rotation.
Regarding claim 2, Tuval discloses the frame, the connecting struts, and the thrust bearing are all formed as a single integral body (e.g. Figs 6A-C – where it shows that element 34 extends into a component of the thrust bearing which joints the rest of the frame as an integral structure).
Regarding claim 3, Tuval discloses the ventricular assist device further comprises an impeller-stabilizing spring disposed around the axial shaft between a distal end of the impeller and the thrust bearing, the impeller-stabilizing spring being configured to stabilize the distal end of the impeller (e.g. ¶¶ 463-465).
Regarding claim 4, Tuval discloses the impeller is configured to be radially constrained by becoming axially elongated and wherein the impeller-stabilizing spring is configured to become compressed such as to accommodate the axial elongation of the impeller (e.g. ¶¶ 471 – “the spring is inserted into the cut and shape-set tube while the spring is in an axially compressed state, and the spring is configured to be held in position with respect to the tube, by exerting a radial force upon the proximal and distal bushings”).
Regarding claim 5, Tuval discloses the impeller-stabilizing spring is coupled to a distal end of the impeller (e.g. ¶¶ 465 – “distal ends of spring 54 and helical elongate elements 52 extend from a distal bushing 58 of the impeller”).
Regarding claim 6, Tuval discloses the ventricular assist device further comprises a proximal bearing and a proximal impeller-stabilizing spring disposed around the axial shaft between a proximal end of the impeller and the proximal bearing (e.g. ¶¶ 465 – “proximal ends of spring 54 and helical elongate elements 52 extend from a proximal bushing (i.e., sleeve bearing) 64 of the impeller”).
Regarding claim 7, Tuval discloses the impeller-stabilizing spring is coupled to the thrust bearing (e.g. ¶¶ 465 – where the examiner considers the spring coupled to the thrust bearing through the distal impeller bushing and axial shaft 92).
Regarding claim 8, Tuval discloses an elastomeric material that is coupled to the impeller-stabilizing spring, such that at least a portion of the axial shaft between a distal end of the impeller and the thrust bearing is covered by a combination of the impeller-stabilizing spring and the elastomeric material (e.g. ¶¶ 559 – “the distal tip portion may include a spring 249 and/or an elastomeric material that is configured to retract the distal end of the distal tip portion”).
Regarding claim 9, Tuval discloses the impeller-stabilizing spring is coated with the elastomeric material (e.g. ¶¶ 475 – “silicone”).
Regarding claims 10-11, Tuval discloses the impeller-stabilizing spring is embedded within the elastomeric material comprising at least one of silicone and polyurethane (e.g. ¶¶ 475 – “silicone”).
Regarding claim 12, Tuval discloses the ventricular assist device comprises a purging system that is configured to pump a purging fluid through a lumen defined by the axial shaft, such that at least a portion of the purging fluid flows proximally through an interface between the axial shaft and the combination of the impeller-stabilizing spring and the elastomeric material (e.g. ¶¶ 452, 499, etc.).
Regarding claim 13, Tuval discloses the elastomeric material is coupled to the impeller-stabilizing spring in such a manner that the elastomeric material changes shape to conform to shape changes that the impeller-stabilizing spring undergoes (e.g. ¶¶ 475 – “the material (e.g., silicone) changes shape to conform to the shape changes of the helical elongate elements and the axial support spring, both of which support the film of material”).
Regarding claim 14, Tuval discloses the elastomeric material is configured to undergo the changes in shape without the elastomeric material becoming broken or collapsing (e.g. ¶¶ 475 – “using a spring to support the inner edge of the film allows the film to change shape without the film becoming broken or collapsing”).
Regarding claim 15, Tuval discloses the elastomeric material is configured not to become creased as a result of the impeller-stabilizing spring being compressed (e.g. ¶¶ 477).
Regarding claim 16, Tuval discloses the ventricular assist device further comprises a pump-outlet tube configured to traverse an aortic valve of the subject, such that a proximal portion of the pump-outlet tube is disposed within an aorta of the subject and a distal portion of the pump-outlet tube is disposed within the subject's left ventricle, the distal portion of the pump-outlet tube extending to the distal end of the frame and defining one or more lateral blood inlet openings that are configured to allow blood to flow from the subject's left ventricle into the pump-outlet tube (e.g. ¶¶ 455).
Regarding claim 17, Tuval discloses a porosity of the distal portion of the pump-outlet tube, which defines the blood-inlet openings, is lower within a proximal region of the distal portion of the pump-outlet tube than within a distal region of the distal portion of the pump-outlet tube that is distal to the proximal region (e.g. ¶¶ 18).
Regarding claim 18, Tuval discloses the distal portion of the pump-outlet tube has a porosity of more than 40 percent (e.g. ¶¶ 455 – between 2-8 openings).
Regarding claims 19-20, Tuval discloses that the openings are sized (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. ¶¶ 455 – “preventing retrograde blood flow into the left ventricle from the aorta”) but fails to expressly disclose the distal portion of the pump-outlet tube defines more than 50 blood-inlet openings. With regard to additional openings, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In addition, with more openings, a size change would be expected; however, a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to modify the number and size of inlet openings to more than 10 or more than 50, as the modification of these components are recognized as within the level of ordinary skill in the art.
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
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