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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 2, 4, 5, 8, 10, and 17 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Corbett et al. (WO 2017/210318 – disclosed by Applicant).
In regard to claim 1, Corbett et al. disclose an intracardiac blood pump system comprising:
a blood pump comprising a proximal portion and a distal portion (para 80, figure 3, pump 300 with distal portion 306, and proximal portion 308);
a catheter coupled to the proximal portion of the blood pump (para 70, a catheter is connected to the cannula of a blood pump; para 81, proximal portion 308 connected to catheter 303 at transition portion 309), the catheter having a proximal end and a distal end and an inner lumen extending from the proximal end to the distal end (figure 3 shows the catheter 303 with a proximal portion 311, and is considered to implicitly include a distal portion and lumen);
a rotatable shaft including a proximal end and a distal end, wherein the shaft extends through the inner lumen of the catheter and the distal end of the shaft is coupled to the proximal portion of the blood pump (para 5, 71, cannula of blood pump is rotatable relative to catheter; para 78, the catheter includes a shaft used to position in the cannula of the blood pump in the target location); and
a steering mechanism coupled to a portion of the shaft, wherein the steering mechanism is configured to rotate the shaft to rotate the blood pump (para 21, 30, and 78).
In regard to claim 2, in Corbett et al. the steering mechanism is proximal of the catheter (para 21, 30, and 78).
In regard to claim 4, in Corbett et al., the steering mechanism comprises: a torque input mechanism; and a torque transfer mechanism configured to transfer torque inputted to the torque input mechanism to the shaft to rotate the shaft (para 76, a handle is coupled to the catheter assembly is rotated relative to the catheter assembly or one or more components of the catheter assembly; in this manner the handle applies and transfers a rotational force (i.e., torque) on the catheter).
In regard to claim 5, in Corbett et al. the torque input mechanism comprises a component that is manually rotatable by a user (para 76, the handle is exterior and is considered capable of manually rotated).
In regard to claim 8, in Corbett et al. the shaft comprises a lumen extending from the proximal end to the distal end of the shaft (para 5, 71, cannula of blood pump is rotatable relative to catheter; para 78, the catheter includes a shaft used to position in the cannula of the blood pump in the target location).
In regard to claim 10, in Corbett et al. further comprises a coupling mechanism configured to rotatably couple the proximal portion of the blood pump to the distal end of the catheter (para 70, a catheter and blood pump cannula connected thereto, wherein the state of being coupled implies a coupling mechanism; para 116 may include one or more additional intermediate members being used to attach one another, such additional intermediate member considered to be a coupling mechanism).
In regard to claim 17, Corbett et al. disclose an intracardiac blood pump system comprising:
a blood pump comprising a proximal portion and a distal portion (para 80, figure 3, pump 300 with distal portion 306, and proximal portion 308);
a catheter coupled to the proximal portion of the blood pump (para 70, a catheter is connected to the cannula of a blood pump; para 81, proximal portion 308 connected to catheter 303 at transition portion 309), the catheter having a proximal end and a distal end and an inner lumen extending from the proximal end to the distal end (figure 3 shows the catheter 303 with a proximal portion 311, and is considered to implicitly include a distal portion and lumen); and
a coupling mechanism configured to rotationally couple the proximal portion of the blood pump to the distal end of the catheter (para 70, a catheter and blood pump cannula connected thereto, wherein the state of being coupled implies a coupling mechanism; para 116 may include one or more additional intermediate members being used to attach one another, such additional intermediate member considered to be a coupling mechanism).
Allowable Subject Matter
Claims 26-28 are allowed.
The following is an examiner’s statement of reasons for allowance: the prior art fails to teach the structural features of the steering mechanism.
Claims 3, 6, 7, 9, 11-16, and 18-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art fails to teach or suggest the claimed elements in combination with the elements of the base claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 26 June 2026