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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US 2019/0209758; hereinafter “Tuval”) in view of Kanz et al. (US 2021/0170081; hereinafter “Kanz”).
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 (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 examiner considers the axial shaft configuration to include stopper 128 that prevents the axial shaft from undergoing axial motion - the claim language does not require the bearing prevents the axial shaft from undergoing axial motion, just that the distal end of the axial shaft is configured in the claimed manner); and an impeller-stabilizing spring (e.g. Fig. 3, #52) disposed around the axial shaft (e.g. ¶¶ 482 – “the axial shaft, by passing through lumen 62 defined by the impeller, radially stabilizes the impeller”; Figs 3 A-C - the axial shaft passes through the impeller stabilizing spring), the impeller-stabilizing spring being configured to stabilize the impeller (e.g. ¶¶ 475 – “helical elongate elements and the axial support spring, both of which support the film of material.” - spring 54 is configured to support and stabilize the impeller in combination with the elongate elements 67 and film 56, which all work together to provide the stabilizing configuration).
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.
Tuval fails to expressly disclose the impeller-stabilizing spring disposed between a distal end of the impeller and the thrust bearing and the impeller-stabilizing spring is configured to stabilize the distal end of the impeller. In the same field of endeavor, Kanz discloses the common use of tension springs positioned at different points of a blood pump driveline, in order to provide axial compression force between the distal end of an impeller and a bearing, in order to provide compression force on the bearings while also stabilizing the impeller in the opposite direction, on the distal end of the impeller (e.g. ¶¶ 131, 164, 181-185, 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 using springs to provide stabilizing compressive forces along the driveline of blood pumps, as taught by Kanz, to the known device of Tuval, ready for improvement, to yield predictable results of providing a spring providing a compressive force to stabilize both the bearing and impeller during turbulent flow.
Regarding claim 2, 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. ¶¶ 388, 475, etc.).
Regarding claim 3, Tuval discloses the impeller-stabilizing spring is coupled to a distal end of the impeller (e.g. where the impeller stabilizing spring referenced in Tuval is coupled to a distal end of the impeller and in addition the additional spring as offered in the modification in view of Kanz would also be positioned to be coupled to the distal end of the impeller, in the other direction.).
Regarding claim 4, 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. Fig. 3A, #54).
Regarding claim 5, Tuval in view of Kanz obviates the impeller-stabilizing spring coupled to the thrust bearing (i.e. the additional spring as offered in the modification in view of Kanz would also be positioned to be coupled to the thrust bearing, providing compressive force on it, as recited above with respect to claim 1).
Regarding claim 6, Tuval discloses an elastomeric material that is coupled to the impeller-stabilizing spring (e.g. ¶¶ 463, 473, etc. – silicone), 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. the additional spring as offered in the modification in view of Kanz would also be positioned to be coupled to the distal end of the impeller, in the other direction, and covered in the same manner as described in Tuval).
Regarding claim 7, Tuval discloses the impeller-stabilizing spring is coated with the elastomeric material (e.g. ¶¶ 473 – dipped in silicone).
Regarding claim 8, Tuval discloses the impeller-stabilizing spring is embedded within the elastomeric material (e.g. ¶¶ 463 – “the central axial spring support a film 56 of a material”).
Regarding claim 9, Tuval discloses the elastomeric material comprises at least one of silicone and polyurethane (e.g. ¶¶ 463, 473 – “silicone”).
Regarding claim 10, 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 11, 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 – “Typically film 56 of the material (e.g., silicone) changes shape to conform to the shape changes of the helical elongate elements and the axial support spring”).
Regarding claim 12, Tuval discloses the elastomeric material is configured to undergo the changes in shape without the elastomeric material becoming broken or collapsing (e.g. ¶¶ 475 – “without the film becoming broken or collapsing”).
Regarding claim 13, Tuval discloses the elastomeric material is configured not to become creased as a result of the impeller-stabilizing spring being compressed (e.g. ¶¶ 475-477).
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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