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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-20, in the reply filed on 7 October 2025 is acknowledged. Claims 21-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/group, there being no allowable generic or linking claim.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 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonnette et al. (US 2006/0229645; hereinafter “Bonnette”).
Regarding claim 1, Bonnette discloses a system for inserting a collapsible blood pump into a patient, the system comprising: an introducer (e.g. Fig. 8, #16a), the introducer comprising an introducer hub (e.g. Fig. 8, #152 and proximal) and an introducer sheath extending distally from the introducer hub (e.g. Fig. 8, #54), the introducer sheath comprising an introducer sheath lumen (e.g. ¶¶ 48-52; Fig. 5b – where there is clearly a passage or central lumen for 14 to pass through), the introducer hub comprising a hub connector and a distal hub lumen surrounding a proximal end of the introducer shaft (e.g. Fig. 8, elements proximal to and including 152); and a transfer tool (e.g. Fig. 89, #12) comprising a transfer sheath, the transfer sheath comprising a transfer sheath lumen having a diameter substantially equal to a diameter of the introducer sheath lumen (e.g. Fig. 8, catheter tube 14 having substantially equal to the introducer sheath lumen) and a transfer tool connector adapted to connect to the hub connector, a distal portion of the transfer sheath extending into the hub when the transfer tool connector is connected to the hub connector (e.g. ¶¶ 61-66; Fig. 8, #160/162 connect to 166).
Regarding claim 2, Bonnette discloses the distal portion of the transfer sheath extends into the distal hub lumen when the transfer tool connector is connected to the hub connector (e.g. ¶¶ 61-66).
Regarding claim 3, Bonnette discloses the distal end of the transfer sheath abuts a proximal end of the introducer sheath when the transfer tool connector is connected to the hub connector (e.g. as shown in Fig.7).
Regarding claim 4, Bonnette discloses the introducer hub further comprises a tapered surface extending proximally and radially outwardly from the distal hub lumen (e.g. Fig. 8, wher e the threaded portion is tapered to a smaller diameter than element 152).
Regarding claim 5, Bonnette discloses the introducer further comprises a one-way valve disposed in the introducer hub proximal to the introducer sheath lumen and configured to seal against vascular pressure (e.g. ¶¶ 66).
Regarding claim 6, Bonnette discloses the introducer further comprises a seal disposed in the introducer hub proximal to the introducer sheath and configured to seal against vascular pressure around a range of diameters of devices inserted through the seal (e.g. ¶¶ 47).
Regarding claim 7, Bonnette discloses the introducer further comprising a disc valve disposed in the introducer hub proximal to the introducer sheath and configured to seal against vascular pressure around a range of diameters of devices inserted through the valve (e.g. ¶¶ 47 – “catheter tube 14 extends through and seals against the interior of a strain relief 32 and through the connector 30 to communicate with the manifold 12”).
Regarding claim 8, Bonnette discloses the introducer hub further comprises a purge fluid port in fluid communication with the distal hub lumen (e.g. ¶¶ X).
Regarding claim 9, Bonnette discloses the hub connector comprises threads disposed on the introducer hub (e.g. Fig. 8, #166).
Regarding claim 10, Bonnette discloses the hub connector and transfer tool connector are configured to provide an axial force to move the transfer sheath and introducer sheath toward each other (e.g. ¶¶ 52, 54 – exhaust branch 22).
Regarding claim 11, Bonnette discloses the transfer tool further comprises a proximal hub surrounding a proximal portion of the transfer sheath (e.g. Fig. 8, #20).
Regarding claim 12, Bonnette discloses the transfer tool proximal hub comprises a central lumen, the proximal portion of the transfer sheath being disposed in the central lumen, the central lumen having a reduced diameter portion proximal to a proximal end of the transfer sheath (e.g. Fig. 8 – ¶¶ 60-66 – where the lumen sizing is reduced in diameter to fit within the introducer lumen).
Regarding claim 13, Bonnette discloses the transfer tool proximal hub further comprises a purge fluid port communicating with the central lumen (e.g. ¶¶ 52, 54 – exhaust branch 22).
Regarding claim 14, Bonnette discloses the transfer tool proximal hub further comprises a seal adapted to seal around a catheter portion of a blood pump (e.g. ¶¶ 51).
Regarding claim 15, Bonnette discloses the transfer tool further comprises a handle surrounding the transfer sheath (e.g. ¶¶ 48-52).
Regarding claim 16, Bonnette discloses the handle extends proximally from the transfer tool connector (e.g. ¶¶ Fig. 8, #64/66).
Regarding claim 17, Bonnette discloses the transfer tool further comprises a proximal hub, the handle extending from the transfer tool connector to the proximal hub (e.g. ¶¶ 51).
Regarding claim 18, Bonnette discloses the transfer tool connector comprises threads disposed at a distal end of the handle, the distal portion of the transfer sheath extending distally beyond the transfer tool connector (e.g. ¶¶ 60-66).
Regarding claim 19, Bonnette discloses the transfer tool connector comprises a rotatable ring with internal threads (e.g. ¶¶ 60-66).
Regarding claim 20, Bonnette discloses the distal portion of the transfer sheath is radially expandable (e.g. ¶¶ 54-55).
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