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)(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 1-5, 12, and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhirong et al (WO2023134693A1, hereinafter “Zhirong”; English translation and original reference attached to this action, citations below correspond to the page numbers provided in upper-right hand corner of document).
Regarding claim 1, Zhirong discloses an interventional blood pump, comprising a pump body and a driving unit, the pump body comprising a blood inlet and a blood outlet (figures 1 and 2, see pages 5 and 34 of translated document), wherein the pump body comprises: a rotatable rigid impeller configured to increase power for the flow of blood and accommodated in a rigid impeller outer cylinder (page 5, “casing 100 is a rigid tube structure”), a proximal end of the impeller being connected to a distal end of the driving unit through a flexible shaft (figure 3; page 11, “the pump casing 100 is provided with a bearing seat 140, a rotating shaft 150 and a transmission shaft 160, the rotating shaft 150 is arranged in the bearing seat 140 through a bearing 170, and the impeller 200 is suspended on the rotating shaft 150. The distal end of the transmission shaft 160 is coaxially connected to the proximal end of the rotating shaft 150, and the proximal end of the transmission shaft 160 is connected to a rotating drive member. The rotating drive member can be a power component such as a motor or a motor, and its specific structure is not limited. Apparently, the rotating drive member drives the transmission shaft 160 and the rotating shaft 150 to rotate, and then drives the impeller 200 to rotate, so as to output the blood pumping driving force for the whole blood pumping device”), wherein a distal end of the impeller outer cylinder communicates with the blood inlet (figures 11-12; pages 10-11, inlet 110), and a proximal end of the impeller outer cylinder comprises an impeller outlet (figures 11-12; page 10, outlets 120); and a radially expandable catheter arranged outside the flexible shaft and extending in at least one part of a length of the flexible shaft (figures 1-2; page 5, flexible tube 300, “When the whole blood pumping device is running, the flexible tube of the blood pumping device 300 expands and compresses synchronously when the heart valve opens and closes. After the blood continuously enters the outflow channel 310, the volume of the flexible tube 300 continues to expand and increase. When the volume of the flexible tube 300 expands to the maximum state, the flexible tube 300 is in a filling state, and the caliber of the outflow window 320 set on the flexible tube 300 expands to the maximum simultaneously.”), a distal end of the radially expandable catheter being hermetically connected to the impeller outer cylinder and covering the impeller outlet, and a proximal end of the radially expandable catheter being provided with the blood outlet (page 5, flexible tube 300); when the radially expandable catheter is in a radial expansion state, a gap between the radially expandable catheter and the flexible shaft forms a blood flow channel communicating with the blood inlet and the blood outlet (page 5); wherein when the pump body is at an operating position in the heart, the blood inlet is located in the left ventricle or right ventricle, the blood outlet is located in the aorta or pulmonary artery, and the radially expandable catheter spans a corresponding artery flap (figures 5-6; pages 5-6).
Regarding claim 2, Zhirong discloses a length of the flexible shaft is set, so that when the pump body is at the operating position in the heart, the driving unit is located in the aorta or pulmonary artery (figures 5-6; pages 5-6).
Regarding claim 3, Zhirong discloses the driving unit is arranged outside the blood outlet and adjacent to the blood outlet (figures 11-12; page 10, outlets 120 and rotating drive member and shafts 150/160).
Regarding claim 4, Zhirong discloses the proximal end of the radially expandable catheter is hermetically connected to a housing of the driving unit (figures 1-2; page 5, flexible tube 300 coupled to the drive member).
Regarding claim 5, Zhirong discloses the pump body further comprises a plurality of rigid outlet brackets connected to the proximal end of the impeller outer cylinder, wherein the outlet brackets define the impeller outlet, and when the impeller rotates, the blood entering from the blood inlet flows through a gap between the impeller and the impeller outer cylinder, flows into the blood flow channel through the impeller outlet, and flows out from the blood outlet (figures 11-12; pages 5-6 and 10, outlets 120).
Regarding claim 12, Zhirong discloses a length of the flexible shaft is 50 mm to 80 mm (figures 3, 5-6; page 11 which show the flexible shaft which has a length where at least a portion is 50-80 mm).
Regarding claim 17, Zhirong discloses an interventional catheter that is hollow, wherein a distal end of the interventional catheter is connected to a proximal end of the driving unit, and the interventional catheter contains at least a cable for supplying power to the driving unit (page 11).
Regarding claim 18, Zhirong discloses the driving unit is arranged outside the blood outlet and adjacent to the blood outlet (figures 11-12; page 10, outlets 120 and rotating drive member and shafts 150/160).
Regarding claim 19, Zhirong discloses the proximal end of the radially expandable catheter is hermetically connected to a housing of the driving unit (figures 1-2; page 5, flexible tube 300 coupled to the drive member).
Allowable Subject Matter
Claims 6-11, 13-16, and 20 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.
Conclusion
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799
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