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 § 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.
Claim(s) 1, 6, 8, 11, 13-18, 25, 27-31, 36-38, 64-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamazaki et al. (US 20030176835) herein after Yamazaki ‘835 in view Yamazaki (US 20040172113), herein after Yamazaki ‘113.
Regarding claim 1, Yamazaki ‘835 discloses a cable 300 arranged to operably connect a blood pump to a controller 200 (Fig. 4-6, section 0114-0123), the cable comprising: a first tubular body 306 (Fig. 6, section 0121) having a distal end (end of 300 positioned in patient body in Fig. 4, section 0114-0115) and a proximal end (end of 300 connect to 200 in fig. 4, section 0114-0115), the first tubular body 306 defining a first lumen therethrough (lumen extending through 306, Fig. 6, section 0121, tube 306 comprise lumen which receives 308), the first tubular body 306 comprises a plurality of layers (Fig. 6 shows and outer layer a cable layer 304 and inner tube layers 302 and inner layer 308), a tubular purge body 302 disposed within the first lumen and extending along at least a portion of a length of the first lumen (top 302, Fig. 6, section 0121-0123, inner tubes 302 taught to circulate fluid between the blood pump100 and external controller 200 and are considered to purge fluid from the blood pump 100), the tubular purge body defining a purge lumen arranged to transfer a fluid therethrough (lumen of top 302, Fig. 6, section 0121-0123); and at least one tubular electrical wire body 304 disposed within the first lumen (Fig. 6 section 0121-0123,), each tubular electrical wire body 304 defining an electrical wire lumen therethrough for receiving one or more electrical wires (Fig. 6, section 0121, cable 304 is taught to include electrical wires connected to the blood pump, wherein the cable is reasonable considered to comprise a lumen to receive the electrical wires).
However, Yamazaki ‘835 does not specfically discloses filler within the first lumen. Yamazaki ‘113 discloses filler within the first lumen (section 0028, 0070, the tube unit of the present invention, it is also preferable for the inner tube to be one of a double-layer tube that has polyvinylidene fluoride on an inside and thermoplastic polyurethane on an outside and a double-layer tube that has polyvinylidene fluoride on an inside and polycarbonate urethane on an outside. Tube unit according to the second embodiment, double-layer tubes that have polyvinylidene fluoride on the inside and thermoplastic polyurethane on the outside). This allows for avoidance of the occurrence of a thrombus or coagulation of blood in the tube unit. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Yamazaki ‘835 by adding filler within the first lumen as taught by Yamazaki ‘113 in order to facilitate avoidance of the occurrence of a thrombus or coagulation of blood in the tube unit.
Regarding claim 6, Yamazaki ‘835 in view of Yamazaki ‘113, specfically Yamazaki ‘113 discloses the filler is disposed around at least a portion of the tubular purge body 302 and the tubular electrical wire body 304 (section 0028, 0070, the tube unit of the present invention, it is also preferable for the inner tube to be one of a double-layer tube that has polyvinylidene fluoride on an inside and thermoplastic polyurethane on an outside and a double-layer tube that has polyvinylidene fluoride on an inside and polycarbonate urethane on an outside. Tube unit according to the second embodiment, double-layer tubes that have polyvinylidene fluoride on the inside and thermoplastic polyurethane on the outside).
Regarding claim 8, Yamazaki ‘835 discloses the tubular purge body 302 comprises a plurality of layers (Fig. 6 section 0121, shows inner tubes 302 with an outer body surrounding an inner lumen that circulates liquid between blood pump and controller).
Regarding claim 11, Yamazaki ‘835 discloses a proximal portion of the tubular purge body 302 (Fig. 4 shows proximal end of tube 300, having inner tubes 302 within, connected to external controller 200) is operably connected to an input connector, the input connector configured to provide a sterile attachment to a fluid source (section 0119, external controller has a system driving section including the circulating liquid pump that supplies the circulating liquid to the periphery of the mechanical seal of the blood pump).
Regarding claim 13, Yamazaki ‘835 discloses the proximal portion of the tubular purge body 302 is connected to a pressure storage set (PSS) assembly comprising the input connector (Fig. 4 shows proximal end of tube 300, having inner tubes 302 within, connected to external controller 200; section 0119, external controller has a system driving section including the circulating liquid pump that supplies the circulating liquid to the periphery of the mechanical seal of the blood pump).
Regarding claim 14, Yamazaki ‘835 discloses the first tubular body 306 comprises an outer surface defining a first opening extending to an inner surface 308 of the first tubular body (Fig. 6 shows and outer layer a cable layer 304 and inner tube layers 302 and inner layer 308), the inner surface defining the first lumen, the tubular purge body 302 configured to enter the first lumen through the first opening (lumen extending through 306, Fig. 6, section 0121, tube 306 comprise lumen which receives 308).
Regarding claim 15, Yamazaki ‘835 discloses the tubular purge body 302 is configured to extend through the first lumen from the distal end of the first tubular body to the proximal end of the first tubular body (Fig. 4, shows and outer layer of tube 300 with inner tube layers 302 that connects from distal end, in the patient body, to proximal end that connects to the external controller 200).
Regarding claim 16, Yamazaki ‘835 discloses the at least one tubular electrical wire 304 body is configured to receive at least one electrical wire in electrical communication with a motor (Section 0119, a pump control unit that electrically controls the driving of the blood pump 100 via a cable 304 that is enclosed in the tube).
Regarding claim 17, Yamazaki ‘835 discloses the at least one tubular electrical wire body 304 comprises a plurality of tubular electrical wire bodies, including a first tubular electrical wire body and a second tubular electrical wire body (Fig. 6, section 0121, cable 304 is taught to include electrical wires connected to the blood pump, wherein the cable is reasonable considered to comprise a lumen to receive the electrical wires).
Regarding claim 18, Yamazaki ‘835 discloses at least one electrical wire extending through the second tubular electrical wire body is in electrical communication with a sensor (section 0119, a pump control unit that electrically controls the driving of the blood pump 100 via a cable 304 that is enclosed in the tube 300, a display unit that displays data and the operating states of the various components, a communication unit that exchanges information with external devices, a power supplying unit that supplies these components with electrical power, and a control unit for controlling these components. This system driving section is enclosed in a compact case).
Regarding claim 27, Yamazaki ‘835 discloses the cable extends 300 from a handle 400 for controlling the blood pump 200 (Fig. 4, section 0125, the protector 400 according to the third embodiment protects the tube entry part where the tube 300 passes through the skin of a living body from infection, and includes a sticking part 420 that is stuck onto the skin of the living body in a periphery of the tube entry part and a covering 460 that covers the tube entry part, forms an internal space that surrounds the tube entry part, and has a passage 462 through which the tube 300 passes).
Regarding claim 29, Yamazaki ‘835 discloses a first overmold, the first overmold 400 440 connected to a portion of the first tubular body 306 at a location distal to a defined opening extending from an outer surface of first tubular body 306 to an inner surface of the first tubular body 308, and connected to a portion of both the tubular purge body 302 and the first tubular body at a location proximal to the defined opening (fig. 4,7, section 0124, the protector 400 according to the third embodiment of the present invention. FIG. 8 is a drawing showing the components that compose the protector 400 according to the third embodiment of the present invention. FIG. 9 is a three-view drawing of a sticking part 420 that forms part of the protector 400 according to the third embodiment of the present invention. FIG. 10 is a three-view drawing of a tube fixing part 440 that forms part of the protector) .
Regarding claim 30, Yamazaki ‘835 discloses a second overmold, the second overmold 400, 460 connected to a portion of the first tubular body 306 at a location proximal from the first overmold (fig. 4,7, section 0134, the protector 400 according to the third embodiment of the present invention. FIG. 8 is a drawing showing the components that compose the protector 400 according to the third embodiment of the present invention. FIG. 9 is a three-view drawing of a sticking part 420 that forms part of the protector 400 according to the third embodiment of the present invention. FIG. 10 is a three-view drawing of a tube fixing part 440 that forms part of the protector. A covering that forms part of the protector according to the third embodiment of the present invention).
Regarding claim 31, Yamazaki ‘835 discloses a case 480 configured to surround at least a portion of the first tubular body proximal to the first overmold 400, 440, the case configured to connect to the first overmold such that any component surrounded by the case cannot be twisted, pulled apart, or pushed apart (Fig. 7, section 0124-0125, a cap that forms part of the protector 400 according to the third embodiment of the present invention).
Regarding claim 36, Yamazaki ‘835 discloses a controller 200; a pump 100; and a cable 300 according to claim 1, the cable operably connecting the pump 100 to the controller 200 (Fig. 4 shows proximal end of tube 300, having inner tubes 302 within, connected to external controller 200).
Regarding claim 37, Yamazaki ‘835 discloses the cable extends 300 from a handle 400 to a controller 200 (Fig. 4, section 0125, the protector 400 according to the third embodiment protects the tube entry part where the tube 300 passes through the skin of a living body from infection, and includes a sticking part 420 that is stuck onto the skin of the living body in a periphery of the tube entry part and a covering 460 that covers the tube entry part, forms an internal space that surrounds the tube entry part, and has a passage 462 through which the tube 300 passes).
Regarding claim 38, Yamazaki discloses an overmold 400 for a first tubular body 306 defining a first lumen therethrough (Fig. 6), the first tubular body having a second tubular body 302, 304 within the first lumen, the second tubular body defining a second lumen therethrough (Fig. 6), the second tubular body 302, 304 configured to enter the first lumen through an opening defined by an outer surface of the first tubular body, the opening extending to the first lumen (lumen extending through 306, Fig. 6, section 0121, tube 306 comprise lumen which receives 308), the overmold comprising: a distal portion connected to a portion of the first tubular body at a location distal to the defined opening; and a proximal portion connected to a portion of both the first tubular body and the second tubular body at a location proximal to the defined opening, the proximal portion configured to connect to a case such that the case cannot twist, push, or pull apart from the overmold (fig. 4,7, section 0124, the protector 400 according to the third embodiment of the present invention. FIG. 8 is a drawing showing the components that compose the protector 400 according to the third embodiment of the present invention. FIG. 9 is a three-view drawing of a sticking part 420 that forms part of the protector 400 according to the third embodiment of the present invention. FIG. 10 is a three-view drawing of a tube fixing part 440 that forms part of the protector).
Regarding claim 64, Yamazaki ‘835 discloses a two-part case configured to contain a PSS assembly and clamp 440 around an overmold 400, the overmold 400 surrounding a portion of a first tubular body 306 and a second tubular body 302, 304, the second tubular body being connected to the PSS assembly 100 (Fig, 4, tube 300 connected to controller 200), the two-part case comprising: a first part comprising either a pin 480, a boss, or a combination thereof, and a plurality of depressed portions 464 on an exterior surface of the first part (Fig. 13, section 0138-0139); and a second part comprising a pin, a boss, or a combination thereof 440, and at least one raised portion 422 on an interior surface of the second part; wherein each pin or boss 480, 440 is configured to align with a boss or pin, respectively, on an opposite part , and wherein the at least one raised portion is configured to interact with each depressed portion such that the first part and the second part cannot be pulled apart (Fig. 13, section 0138-0139).
Regarding claim 65, Yamazaki ‘835 discloses tubular purge body 302 consists of a single tubular purge body within the first lumen (Fig. 6 section 0121, shows inner tubes 302 with an outer body surrounding an inner lumen that circulates liquid between blood pump and controller).
Claim(s) 25 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamazaki et al. (US 20030176835) herein after Yamazaki ‘835 in view Yamazaki (US 20040172113), herein after Yamazaki ‘113 and further in view of Calomeni et al. (US 20210008261).
Regarding claim 25, Yamazaki ‘835 in view of Yamazaki ‘113 discloses the invention substantially as claimed however does not show a tubular optical fiber body within the first lumen, the tubular optical fiber body defining an optical fiber lumen therethrough.
Calomeni discloses a tubular optical fiber body within the first lumen, the tubular optical fiber body defining an optical fiber lumen therethrough (section 0164-0165). This allows for proper sensing of blood pressure may be included on an intravascular blood pump for a variety of purposes, such as, for example without limitation, estimating flow or detecting the position of the blood pump. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Yamazaki ‘835 in view of Yamazaki ‘113 by adding a tubular optical fiber body within the first lumen as taught by Calomeni in order to facilitate sensing of blood pressure may be included on an intravascular blood pump for a variety of purposes, such as, for example without limitation, estimating flow or detecting the position of the blood pump.
Regarding claim 28, Yamazaki ‘835 in view of Yamazaki ‘113 discloses the controller is configured to control a fluid flowing through the purge lumen (section 0119, external controller has a system driving section including the circulating liquid pump that supplies the circulating liquid to the periphery of the mechanical seal of the blood pump).However, Yamazaki ‘835 does not disclose receive optical data through an optical fiber slidably positioned within the optical fiber lumen, and control a motor through at least one electrical wire.
Calomeni discloses receiving optical data through an optical fiber slidably positioned within the optical fiber lumen, and control a motor through at least one electrical wire (section 0164-0165). This allows for proper sensing of blood pressure may be included on an intravascular blood pump for a variety of purposes, such as, for example without limitation, estimating flow or detecting the position of the blood pump. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Yamazaki ‘835 in view of Yamazaki ‘113 by adding a tubular optical fiber body within the first lumen as taught by Calomeni in order to facilitate sensing of blood pressure may be included on an intravascular blood pump for a variety of purposes, such as, for example without limitation, estimating flow or detecting the position of the blood pump.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 6, 8, 11, 13-18, 25, 27-31, 36-38, 64 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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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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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796