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 § 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 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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schumacher et al. (US 2015/0343179; hereinafter “Schumacher”).
Regarding claim 1, Schumacher discloses an apparatus for use with a percutaneous ventricular assist device that comprises a self-expandable pump head and that is configured to be delivered to a subject's left ventricle using a delivery catheter, while the pump head is disposed in a radially-constrained configuration within the delivery catheter (e.g. ¶¶ 65), the apparatus comprising: packaging for the ventricular assist device, the packaging being shaped to define a pump-head chamber in which the pump head is packaged in a non-radially constrained configuration (e.g. Fig. 6, #30 - where the packaging is shaped to define a pump head chamber in which the pump head is packaged in a non-radially constrained configuration when not retracted in); and a catheter-securement piece, the catheter-securement piece being shaped to define a hole and being configured to secure a distal end of the delivery catheter to the packaging by securing the delivery catheter within the hole, the packaging being configured such that the pump head is configured to be radially constrained by being retracted into the distal end of the delivery catheter, while the delivery catheter is secured within the hole (e.g. ¶¶ 72-77).
Regarding claim 2, Schumacher discloses the catheter-securement piece is reversibly coupled to the packaging and is configured to secure the delivery catheter within the hole by being coupled to the packaging with the delivery catheter disposed within the hole (e.g. ¶¶ 76).
Regarding claim 3, Schumacher discloses the pump-head chamber is configured to be filled with a solution prior to the pump head being retracted into the distal end of the delivery catheter (e.g. ¶¶ 85 – “the pump is first filled with sterile physiological saline solution and is thereby completely vented of air”).
Regarding claim 4, Schumacher discloses the packaging defines a surface that is slanted downward, and wherein the catheter-securement piece is configured to secure the delivery catheter to the surface that is slanted downwards, such that the distal end of the delivery catheter is oriented in a downward slant (e.g. ¶¶ 101 – “second clamping ring 56 extends in the form of a cone at its distal end… second stop 57 is designed accordingly in an opposing conical shape”).
Regarding claim 6, Schumacher discloses an apparatus for use with a percutaneous ventricular assist device that comprises a self-expandable pump head and that is configured to be delivered to a subject's left ventricle using a delivery catheter, while the pump head is disposed in a radially-constrained configuration within the delivery catheter (e.g. ¶¶ 65), the apparatus comprising: packaging for the ventricular assist device, the packaging comprising a surface that is slanted downwards (e.g. ¶¶ 101 – “second clamping ring 56 extends in the form of a cone at its distal end… second stop 57 is designed accordingly in an opposing conical shape”), the packaging being shaped to define a pump-head chamber in which the pump head is packaged in a non-radially constrained configuration (e.g. Fig. 6, #30 - where the packaging is shaped to define a pump head chamber in which the pump head is packaged in a non-radially constrained configuration when not retracted in), the pump-head chamber being configured to be filled with a solution prior to the pump head being retracted into a distal end of the delivery catheter (e.g. ¶¶ 85 – “the pump is first filled with sterile physiological saline solution and is thereby completely vented of air”), and the packaging being configured to secure a distal end of the delivery catheter to the surface that is slanted downwards, such that the distal end of the delivery catheter is oriented in a downward slant (e.g. ¶¶ 72-77).
Regarding claim 7, Schumacher discloses the surface that is slanted downwards is configured to reduce a likelihood of air bubbles entering the distal end of the delivery catheter as the pump head is retracted into the distal end of delivery catheter, relative to if the distal end of the delivery catheter were to be secured to a horizontal surface (e.g. ¶¶ 5 – “flush the element to be inserted and/or the sheath intake prior to insertion or during insertion in order to prevent bacteria and/or air”; ¶¶ 23 – “at least one opening in the outer surface of the housing of the auxiliary sheath can be provided, which can serve either for discharging the flushing fluid or for venting”)
Regarding claim 8, Schumacher discloses a catheter-securement piece, the catheter-securement piece being shaped to define a hole and being configured to secure the distal end of the delivery catheter to the surface that is slanted downwards by securing the delivery catheter within the hole, the packaging being configured such that the pump head is configured to be radially constrained by being retracted into the distal end of the delivery catheter, while the delivery catheter is secured within the hole (e.g. ¶¶ 72-77).
Regarding claim 9, Schumacher discloses the catheter-securement piece is reversibly coupled to the packaging and is configured to secure the delivery catheter within the hole by being coupled to the packaging with the delivery catheter disposed within the hole (e.g. ¶¶ 76).
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