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 .
Response to Arguments
Applicant’s arguments in combination with amendments, see remarks and claims, filed 08/28/2025, with respect to the rejection(s) of claim(s) under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 5695471 to Wampler. See details below.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5-8, 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over single reference US 2014005467 A1 to Farnan et al. in view of 5695471 to Wampler.
Regarding claim 1. (Original) Farnan discloses a mechanical circulatory support system (figs 1-10), comprising: an elongate flexible catheter shaft (para 0037, cable 164), having a proximal end and a distal end (para 0037, two ends of the cable 164); a circulatory support device carried by the distal end of the shaft (para 0037 “blood pump system 160”), the circulatory support device comprising: a tubular housing (para 0037, 162, 166, 180); a motor (para 0037, “pump motor 176”) having a shaft that is rotationally fixed with respect to a drive magnet array (para 0037 “pump rotor 172 that is magnetically coupled to the rotating output 174 of the pump motor 176”); an impeller (fig. 10, “carrying magnet 172”), rotationally fixed with respect to a driven magnet array(fig. 10, “carrying magnet 172”); and a sealed motor housing coupled with the tubular housing, and encasing the motor and the drive magnet array (para 0037, “pump motor 176 is therefore completely sealed and respective permanent magnets carried on the pump rotor 172 and the rotating output 174 transfer rotation from the output 174 to the rotor 172 which is supported for rotation in the inflow housing 180”). But fails to disclose wherein the driven magnet array and the drive magnet array are configured to rotate about an axis, wherein the driven magnet array and the drive magnet array at least partially axially overlap along the axis, and wherein the driven magnet array is arranged axially staggered along the axis in relation to the drive magnet array.
Wampler, from a similar field of endeavor, teaches having a plurality of magnets on the shaft that are slightly offset axial relation to the second plurality of magnets placed on the impeller to produce a translational loading force, or bias, along the longitudinal axis of the rotor (col 2, lines 10-39, etc., fig. 8). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Farnan with the teachings of Wampler to provide the predictable result of producing a translational loading force, or bias, along the longitudinal axis.
Regarding claim 2. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, wherein the motor is configured to rotate the drive magnet array via the shaft, wherein the rotating drive magnet array magnetically communicates with the driven magnet array through the sealed motor housing to cause the impeller to rotate (fig. 10).
Regarding claim 5. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, wherein the system does not require purging (Farnan does not specify a need for the system to be purged).
Regarding claim 6. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, further comprising a controller that does not include a purging component (it is understood that the system would include a controller; Farnan does not specify a need for the system to be purged).
Regarding claim 7. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 6, wherein the controller does not include a cassette or a port for purging (it is understood that the system would include a controller; Farnan does not specify a need for the system to be purged, a cassette or a port for purging).
Regarding claim 8. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, further comprising at least one blood inlet port and at least one blood outlet port on the tubular housing separated by a flexible section of the tubular housing (fig. 8).
Regarding claim 16. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, wherein the drive magnet array comprises a magnetization being radial or parallel (figs. 9-10).
Regarding claim 17. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, wherein the drive and driven magnet arrays each comprise a same amount of pole pairs (figs. 9-10).
Regarding claim 18. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, further comprising an intermediate space between the sealed motor housing and the driven magnet array configured to guide a flushing blood flow (figs. 9-10 outflow opening).
Regarding claim 19. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 18, wherein the impeller comprises at least one flushing outlet to discharge the flushing blood flow from the intermediate space (figs. 9-10 outflow opening).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan in view of Wampler as applied to claims 1-8, 16-19 above, and further in view of US Pat Pub No. 20110172505 granted to Kim et al. (hereinafter “Kim”).
Regarding claim 8. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose further comprising an ultrasound sensor configured to detect blood volume flow using pulsed Doppler measurements.
Kim, from a similar field of endeavor, teaches that it is known for the blood flow volume measured to be calculated by an ultrasound doppler (para 0247). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan and Wampler with the known teachings of Kim because doing so would provide the predictable result of measuring blood volume flow.
Regarding claim 9. (Original) Farnan as modified by Wampler and Kim renders obvious the mechanical circulatory support system of Claim 8, wherein the system is configured to detect the blood volume flow using an operating parameter of the circulatory support device when a pulse repetition rate of the ultrasound sensor does not exceed twice a maximum Doppler frequency shift of the blood volume flow (Kim, para 0247; it is noted that the system is capable of detecting the blood volume flow at any time including when a pulse repetition rate of the ultrasound sensor does not exceed twice a maximum doppler frequency shift of the blood volume flow. In other words, the claim does not limit to the detection to ‘only’ occur or be based on the pulse repetition rate).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan as modified by Wampler and Kim as applied to claims 8-9 above, and further in view of US Pat Pub No. 20030199727 to Burke et al. (hereinafter “Burke”).
Regarding claim 10. (Original) Farnan as modified by Wampler and Kim renders obvious the mechanical circulatory support system of Claim 9, but fails to explicitly disclose wherein the operating parameter comprises a rotation rate of the drive magnet array or a differential pressure across the circulatory support device.
Burke, from a similar field of endeavor teaches a variable speed blood pump system wherein the speed of the pump is controlled based on a blood pump volume flow sensing system to measure the volumetric flow rate of blood (para 0012). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan as modified by Wampler and Kim with the teachings of Burke because doing so would provide the predictable result of detecting the blood volume flow (i.e., volumetric flow rate of blood through the pump).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan as modified by Wampler and Kim as applied to claims 8-9 above, and further in view of US Pat Pub No. 20180333059 granted to Fernando.
Regarding claim 11. (Original) Farnan as modified by Wampler and Kim renders obvious the mechanical circulatory support system of Claim 9, but fails to disclose wherein the ultrasound sensor comprises an ultrasound transducer proximate a blood inlet port of the housing.
Fernando, from a similar field of endeavor, teaches a blood pump having an inlet element wherein an ultrasound transducer is coupled to the proximal end of the inlet element (para 0040). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan as modified by Wampler and Kim with the teachings of Fernando because doing so would provide the predictable result of placing the ultrasound transducer at a position to measure the volume within a chamber of the heart.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan as modified by Wampler as applied to claims 1-8, 16-19 above, and further in view of US Pat Pub No. 20190344001 granted to Salahieh et al. (hereinafter “Sala”).
Regarding claim 12. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose further comprising: a display device configured to display a state of health of a patient; and a first pressure sensor and a second pressure sensor in communication with the display device to provide information related to a blood pressure difference, a pulse wave velocity of a blood pulse wave, and/or an elasticity of a blood vessel.
Sala, from a similar field of endeavor, teaches that it is known to provide a console with display to provide various information including blood pressure reading (para 0195). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan as modified by Wampler with the teachings of Sala because doing so would provide the predictable result of providing relevant information/feedback to the user.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan in view of Wampler as applied to claims 1-8, 16-19 above, and further in view of US Pat Pub No. 20140030122 to Ozaki et al. (hereinafter “Ozaki”).
Regarding claim 15. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose wherein the driven magnet array comprises a Halbach array.
Ozaki, from a similar field of endeavor, teaches a similar device wherein Halbach magnets are used to reduce a torque ripple of a motor (para 0163). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan in view of Wampler with the teachings of Ozaki because doing so would provide the predictable result of reducing a torque ripple.
Claim(s) 13-14, 20-21, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan in view of Wampler as applied to claims 1-8, 16-19 above, and further in view of US Pat Pub No. 20150290372 A1 granted to Muller et al. (hereinafter “Muller”).
Regarding claim 13. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose further comprising a sensor head device at a distal end of the tubular housing, the sensor head device comprising: a sensor carrying element comprising at least one sensor cavity configured to receive at least one sensor; and at least one signal transmitter cavity configured to receive at least one signal transmitter.
Muller, from a similar field of endeavor, teaches providing a sensor and ultrasound to provide measuring pressure, flow rate, turbulence, viscosity, and/or chemical or biological composition (para 0113). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan as modified by Wampler with the teachings of Muller because doing so would provide the predictable result of measuring pressure, flow rate, turbulence, viscosity, and/or chemical or biological composition.
Regarding claim 14. (Currently Amended) Farnan as modified by Wampler and Muller renders obvious the mechanical circulatory support system of Claim 13, further comprising one or more of the following arranged on an electrically conductive element: a temperature sensor, a pressure sensor, and a signal transmitter comprising an ultrasound element (Muller, para 0113).
Regarding claim 20. (Original), Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose the tubular housing further comprising: an inlet tube; and an electrical conducting element attached to the inlet tube, wherein the electrical conducting element comprises a plurality of layers and a sensor contact region configured to contact at least one sensor.
Muller, from a similar field of endeavor teaches that it is known to provide sensor assembly in or on the cannula wall near the inlet to provide various measurements (para 0011, 0012, 0182-0183). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan as modified by Wampler with the teachings of Muller because doing so would provide the predictable result of providing various measurements.
Regarding claim 21, Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose the tubular housing further comprising: an inlet tube, arranged between a sensor head unit located at a distal end of the tubular housing and an end unit located proximal to the inlet tube; a first connecting element arranged between the inlet tube and the sensor head unit; and a second connecting element arranged between the inlet tube and the end unit.
Muller, from a similar field of endeavor, teaches providing a sensor at the distal end of the catheter assembly (see fig. 18b) having a membrane 526 (inlet tube) positioned between the distal sensor 524C, distal sensor assembly 524 and ultrasound to provide measuring pressure, flow rate, turbulence, viscosity, and/or chemical or biological composition (para 0113). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan as modified by Wampler with the teachings of Muller because doing so would provide the predictable result of measuring pressure, flow rate, turbulence, viscosity, and/or chemical or biological composition.
Regarding claim 30, Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose wherein a distal end of the tubular housing comprises a nose piece having a sensor.
Muller, from a similar field of endeavor, teaches the catheter assembly 500 can include a proximal sensor assembly to provide detecting a suitable fluid property, characteristic, pressure, flow rate (para 0123). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan as modified by Wampler with the teachings of Muller because doing so would provide the predictable result of allowing a detecting a suitable fluid property, characteristic, pressure, flow rate.
Claim(s) 22-25, 27-29 and 35-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan in view of Wampler as applied to claims 1-8, 16-19 above, and further in view of US Pat Pub No. 20120245404 ranted to Smith et al. (hereinafter “Smith”).
Regarding claim 22. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose wherein a distal end or a proximal end of the tubular housing comprises an attachment section configured to attach to an adjacent component of the circulatory support device.
Smith, from a similar field of endeavor, teaches that it is known to provide an attachment section adjacent to the component of the circulatory support device and securing it via mechanical means (para 0079). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan in view of Wampler with the known teachings of Smith because doing so would provide the predictable result of securing various components to the circulatory support device.
Regarding claim 23. (Original) Farnan as modified by Wampler and Smith renders obvious the mechanical circulatory support system of Claim 22, wherein the attachment section is configured to attach to the adjacent component via form-locking or force-locking (Smith, para 0079).
Regarding claim 24. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose further comprising a removable guidewire guide tube.
Smith, from a similar field of endeavor, teaches that it is known to include a guide wire to guide the insertion and placement of the device (para 0074). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan in view of Wampler with the known teachings of Smith because doing so would provide the predictable result of inserting the device through the incision and into the desired location.
Regarding claim 25. (Previously Presented) Farnan as modified by Wampler and Smith renders obvious the mechanical circulatory support system of Claim 24, wherein the guide tube enters a first guidewire port on a distal end of the tubular housing, and exits the tubular housing via a second guidewire port on a side wall of the tubular housing distal to the impeller (fig. 5c, para 0074, “the guide wire 230 extends through a sheath or cover 232 of the power cable 14 of the pump 20, exiting through an opening 234 adjacent or near the location where the cable enters the pump.”).
Regarding claim 27. (Original) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose wherein the tubular housing comprises an inlet tube coupled with an impeller cage.
Smith, from a similar field of endeavor, teaches that it is known to include an inlet cannula adjacent to the component of the circulatory support device and securing it via mechanical means (para 0079-0083). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan in view of Wampler with the known teachings of Smith because doing so would provide the predictable result of securing various components to the circulatory support device.
Regarding claim 28. (Original) Farnan as modified by Wampler and Smith renders obvious the mechanical circulatory support system of Claim 27, wherein the sealed motor housing is coupled with the tubular housing via the impeller cage (Smith, figs 2A, 7).
Regarding claim 29. (Original) Farnan as modified by Wampler and Smith renders obvious the mechanical circulatory support system of Claim 27, wherein the impeller cage at least partially encapsulates the sealed motor housing (Smith, fig. 6, shows the ‘impeller cage’ to at least partially seal the motor housing at 276).
Regarding claim 35. (Previously Presented) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose wherein the tubular housing comprises an inlet tube and a distal tip at a distal end of the inlet tube, and wherein the sealed motor housing is coupled with the tubular housing proximally of the inlet tube.
Smith, from a similar field of endeavor, teaches that it is known to include an inlet cannula adjacent to the component of the circulatory support device and securing it via mechanical means (para 0078-0083). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan in view of Wampler with the known teachings of Smith because doing so would provide the predictable result of securing various components to the circulatory support device.
Regarding claim 36. (Previously Presented) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 1, but fails to disclose wherein the tubular housing comprises a first guidewire port at a distal end thereof and a second guidewire port proximal of the first guidewire port, the first and second guidewire ports configured to receive a guidewire therethrough such that the guidewire is configured to extend: outside the tubular housing distal to the first guidewire port, inside the tubular housing in between the first and second guidewire ports, and outside the tubular housing proximal to the second guidewire port.
Smith, from a similar field of endeavor, teaches that it is known to include a guide wire and various port/openings to guide the insertion and placement of the device (para 0074“guide wire”, “opening”, figs 5A-D). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan in view of Wampler with the known teachings of Smith because doing so would provide the predictable result of inserting the device through the incision and into the desired location.
Regarding claim 38. (Previously Presented) Farnan as modified by Wampler and Smith renders obvious the mechanical circulatory support system of Claim 36, further comprising a guidewire guide tube extending at least between the first guidewire port and the second guidewire port (smith, figs 5A-D, it is understood that the sheath or cover are part of the housing, therefore, the guide wire is understood to extend through the housing).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan as applied to claims 1-8, 16-19 above, and further in view of US Pat Pub No. 20180250456 granted to Nitzan et al. (hereinafter “Nitzan”).
Regarding claim 37. (Currently Amended) Farnan as modified by Wampler renders obvious the mechanical circulatory support system of Claim 36, but fails to disclose wherein the elongate flexible catheter shaft comprises a third guidewire port proximal to the second guidewire port and configured to receive the guidewire therethrough and into the elongate flexible catheter shaft.
Nitzan, from a similar field of endeavor, teaches that it is known to provide a channel extending through the motor having a shaft with a channel extending therethrough to allow a guide wire to be inserted through the shaft (para 0162). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to modify the disclosure of Farnan in view of Wampler with the teachings of Nitzan because doing so would provide the predictable result of allowing the guidewire to be received and pass through the device.
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.
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/SANA SAHAND/Examiner, Art Unit 3796