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.
Claims 1, 7-10 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D’Ambrosio et al (U.S. Patent Application Publication Number: US 2017/0348470 A1, hereinafter “D’Ambrosio”).
Regarding claim 1, D’Ambrosio teaches a drive device, comprising:
a drive housing (i.e. motor housing, e.g.105 Fig.1, [0044]);
a shaft sleeve assembly (e.g. 103 Fig. 1,5) fixedly connected to the drive housing, wherein the shaft sleeve assembly is provided with a receiving cavity and a detection port communicated with the receiving cavity (e.g. [0052], Figs. 5-7 show a barrier bump 123 that receives a sensor), and the detection port is located on an outer wall of the shaft sleeve assembly (e.g. Figs. 5-7 show a barrier bump 123 that receives a sensor, [0053]);
a rotating shaft (i.e. drive shaft e.g. 104 Figs.1,2,4,5), rotatably passing through the shaft sleeve assembly;
a drive component (i.e. motor e.g. 110 Fig.1), mounted on the drive housing and capable of driving the rotating shaft to rotate; and
a sensor assembly (e.g. 1020 Figs.1,2) comprising a sensor (i.e. optical sensor e.g. [0008], [0053],[0054], the sensor comprising a probe (e.g. Fig.9,[0067]) , wherein the probe is received in the receiving cavity, a position of the probe corresponds to a position of the detection port (e.g. Figs.4-8), and the probe is capable of detecting a fluid pressure (e.g. [0022]) outside the drive device.
Regarding claim 7, D’Ambrosio teaches the sensor assembly (e.g.1100 Fig. 11,1200 Fig. 12) further comprises a soft filler assembly (e.g.1123 Fig 11 and 1223 Fig.12), wherein, the soft filler is provided between the probe and a cavity wall of the receiving cavity; and/or, the soft filler is provided at the detection port, the soft filler seals the detection port (e.g.1123 Fig 11 and 1223 Fig.12), and the soft filler is capable of transmitting the received fluid pressure to the probe (e.g. [0069]).
Regarding claim 8, D’Ambrosio teaches that the sensor (e.g. 1020 Fig1, 4-8, 1900 Fig. 9. Figs 10-12) is an optical fiber pressure sensor (e.g. [0047],[0056],[0067]), the sensor further comprises a transmission fiber (e.g. 1924 Fig.9, 2024Fig. 10, 1124Fig.11, 1224 Fig.12) connected to the probe, and an end of the transmission fiber adjacent to the probe is received in the receiving cavity (e.g. Fig.5).
Regarding claim 9, D’Ambrosio teaches the receiving cavity (e.g. [0053]: recess holds the sensor Figs 4-8 specifically seen in Fig.7) further comprises a communication port, the transmission fiber passes through the communication port, one end of the transmission fiber is received in the receiving cavity and is connected to the probe, the other end of the transmission fiber is extended from the communication port into the drive housing (e.g. Fig.8), a sealing element ( e.g. 2028 Fig.Fig.10-12,[0069]: glue) is provided at the communication port, and the sealing element prevents the receiving cavity from being communicated with the drive housing through the communication port (e.g. Figs. 7,8 and 10-12 show the sensor head which is in the recess of the blood pump in the barrier element and is sealed with glue).
Regarding claim 10, D’Ambrosio teaches the sensor assembly further comprises a packaging tube, a portion of the transmission fiber outside the receiving cavity is packaged in the packaging tube (e.g. 1024 Fig. 4 shows the transmission fiber in a packaging tube outside the receing cavity).
Regarding claim 18, D’Ambrosio teaches a blood pump (e.g. 101 Fig.1) comprising a rotatable impeller (e.g. 113 Fig.6, [0049],[0050]) and the drive device according to claim 1 (as discussed above).
Regarding claim 19, D’Ambrosio teaches the blood pump (e.g. 101 Fig.1) further comprises a cannula assembly (e.g. 102 Fig.1,2) fixedly connected to the drive device (e.g. 110 Fig.1), the cannula assembly (e.g. 102 Fig.1,2) is provided with an outflow port (i.e. outflow cage 400 with outflow port 125 Fig.5 e.g. [0052]) Figs. 4-8), and the impeller (e.g. 113 Figs 5,6 and 8) is capable of rotatably being received in the cannula assembly, and wherein a position of the detection port corresponds to a position of the outflow port, or the position of the detection port is adjacent to the outflow port( e.g. Figs.1,2 4-8 show the sensor assembly 1020 and the detection port comprising the barrier bump, visor notch and sensor visor are located at the outflow cage).
Regarding claim 20, D’Ambrosio teaches that the blood pump further comprises a catheter assembly (i.e. catheter shaft e.g. 106 Fig.1,2) fixedly connected to the drive housing, the catheter assembly is capable of passing perfusate ([0050]: purge fluid passed through a lumen) into the drive housing, a gap for the perfusate to pass through is provided between the rotating shaft and the shaft sleeve assembly, and the probe is sealed in the receiving cavity (e.g. [0050]: plurality of lumens, transmission fiber of the probe is in a separate lumen and the sensor head 721 Fig.5 of the sensor probe 1020 lies in the barrier bump. The sensor assembly details as shown in Figs 9-12 show that the sensor is sealed e.g. Figs 9-12, [0069).
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 (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 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, 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 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over D’Ambrosio et al (U.S. Patent Application Publication Number: US 2017/0348470 A1, hereinafter “D’Ambrosio”) in view of Siess et al (U.S. Patent Number: US 5964694, hereinafter “Siess”).
Regarding claims 11 and 12, D’Ambrosio teaches the claimed invention as discussed above and teaches magnetic drive components transfer torque from the blood pump motor to the impeller 113 ( e.g. [0049]) but does not specifically teach that the drive component (i.e. motor) comprises a drive stator and a magnetic assembly, wherein the drive stator comprises a plurality of first magnetic cores and a plurality of first coils respectively wound around the plurality of first magnetic cores, and the plurality of first magnetic cores are arranged at intervals around the axis of the rotating shaft for one circle, the drive stator is fixedly connected to the drive housing, the drive stator and the rotating shaft are spaced along an axis of the rotating shaft, the magnetic assembly comprises a first magnet, the first magnet is fixedly connected to the rotating shaft, wherein the drive stator is capable of generating a rotating magnetic field which drives the first magnet to rotate to drive the rotating shaft to rotate.
In a similar field of endeavor, Seiss teaches a blood pump comprising a drive unit (e.g. 11 Fig. 4) that comprises a drive stator (e.g. 24 Fig 4) and a magnetic assembly that comprises a plurality of first magnetic cores and a plurality of first coils respectively wound around the plurality of first magnetic cores, and the plurality of first magnetic cores are arranged at intervals around the axis of the rotating shaft for one circle (i.e. small ferritic ring-shaped layers and of interior windings), the drive stator is fixedly connected to the drive housing (e.g. col. 6 lines 26-47: stator 24 is solidly attached to the interior of motor housing 20), the drive stator and the rotating shaft ( e.g. 25 Fig.4) are spaced along an axis of the rotating shaft, the magnetic assembly comprises a first magnet (e.g. col. 6 lines 26-47), the first magnet is fixedly connected to the rotating shaft, wherein the drive stator is capable of generating a rotating magnetic field which drives the first magnet to rotate to drive the rotating shaft to rotate. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the drive component in the teachings of D’Ambrosio with the teachings of Seiss in order to provide the predictable results of providing a reliable, safe and efficient pumping mechanism with optimum performance.
Allowable Subject Matter
Claims 2-6 and 13-17 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 following is a statement of reasons for the indication of allowable subject matter:
While the prior art generally teaches the claimed subject matter of a pump and a drive device comprising a detection port with an optical sensor assembly located adjacent to an outflow portion of the blood pump cannula, the prior art does not disclose or fairly render unpatentable the combination of elements including the configuration of claim 2 that includes an adapter sleeve that is fixedly connected to the drive housing, the first shaft sleeve is fixedly connected to the adapter sleeve, and the rotating shaft is capable of rotatably passing through the first shaft sleeve and the adapter sleeve, and wherein, the receiving cavity is at least partially located on the first shaft sleeve, and the detection port is at least partially located on the first shaft sleeve; or, both the receiving cavity and the detection port are located on the adapter sleeve.
Additionally, the prior art fails to disclose or fairly render unpatentable the limitations of claim 13 drawn to a power stator fixedly connected to the drive housing, the power stator and the drive stator are arranged along the axis of the rotating shaft, the rotating shaft is capable of rotatably passing through the power stator, the magnetic assembly further comprises a second magnet, the second magnet is fixedly connected to the rotating shaft, the power stator is capable of generating a rotating magnetic field which drives the second magnet to rotate as required by the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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