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 .
Information Disclosure Statement
The information disclosure statement filed 9/20/2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Any references that are not in the English language and did not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information have not been considered by the examiner, see attached annotated IDS filed 9/20/2024.
Specification
The abstract of the disclosure is objected to because it contains several instances of the phrase “may be” making it unclear exactly what the claimed invention includes and contains legal phraseology, e.g. “means” (line 7). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). It is further noted that another abstract was filed on 10/8/2024 which is similar to the original abstract filed on 9/20/2024, clarification is required regarding what abstract is the most current version.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Another specification and claim set was also received on 10/8/2024 clarification regarding the specification and claim set filed on 10/8/2024 is also required. It is noted that the amended claim set filed on 9/20/2024 is the claim set that has been used within the office action below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claims 1,4, 14-15 and 19, the phrase "may be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 9 recites the limitation "the learning control" in line 2. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 20, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2-14,16-18 and 20 directly or indirectly depend from claims 1 or 15 and are also rejected to for the reasons stated above regarding claims 1 and 15. For the purposes of examination, as best understood, the phrases “may be” and “in particular” have been interpreted such that the limitations following the phrases are non-limiting.
Claim Rejections - 35 USC § 102
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) 1,3-4, 11-13,15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 6,447,265 to Antaki et al. (Antaki) (cited by applicant).
In reference to at least claim 1
Antaki discloses a control unit (e.g. controller) for a blood pump wherein the blood pump (e.g. rotary pump 10) comprises comprising a rotor (e.g. impeller 14) magnetically supported in a housing (e.g. housing 12) and rotatable about a rotation axis for conveying a fluid (e.g. conveys blood), and a stator (e.g. stator member 18 and motor stator 44), wherein the stator is configured to generate a variable stator magnetic field (e.g. via coils 60) for exerting a bearing force on the rotor which may be varied along a bearing direction of action in accordance with a bearing control signal (e.g. “The coils 60 are controlled to center the impeller 14 between the stationary blades 42. This design is particularly suited for use where fluid flow is required through the four fluid flow regions 58. The levitation means depicts an active radial bearing… Electromagnetic coils 60 wound around the backiron segments 62 direct the magnetic flux from the electromagnetic coils 60 such that the impeller tail 34 is suspended and substantially centered within the downstream passageway 52.”, Col. 7, ll. 41-64); wherein the blood pump is configured to provide a measurement signal (e.g. sensors 65, Fig. 5, Col. 8, ll. 10-16) which is dependent on a bearing position of the rotor along the bearing direction of action (e.g. sensors 65, Fig. 5, Col. 8, ll. 10-16) and which comprises a disturbance component dependent on at least one of a rotation of the rotor about the rotation axis and/or a lateral movement of the rotor perpendicular to the bearing direction of action (e.g. Fig. 5, Col. 8, ll. 10-16); wherein the control unit is configured to detect the measurement signal and determine a disturbance signal dependent on the disturbance component on the basis of the measurement signal detected in a detection interval, to determine, on the basis of the measurement signal and the determined disturbance signal, a specification for the bearing control signal (e.g. “Position errors are measured with 8 position sensors 65 and transformed into the error signals x.sub.i, z.sub.i,x O, z.sub.o and y, while x.sub.i and z.sub.i measurements correspond to the x and z impeller displacement of the impeller measured at the inlet 24 and x.sub.o and z.sub.o are measured at the outlet 26. The error transformation is accomplished with the sensor decoupler 70 shown in FIG. 5 which is simply a matrix multiplication accounting for the position and orientation of the sensors 65. The five principle displacement errors are filtered independently with the five-channel controller 72 which outputs five desired restoring forces to be applied to the impeller 14.”, Col. 8, ll. 16-33) in such a way that the rotor is supported in the housing without contact by means of the bearing force (e.g. “As noted above, the impeller nose 32 and the impeller tail 34 are magnetically suspended and centered within the housing 12 by the magnetic flux created by the electromagnetic coils 60 and directed through the upstream and downstream sets of stationary blades 40 and 42.”, Col. 8, ll. 55-59), wherein a power consumed for exerting the bearing force is reduced compared with a specification for the bearing control signal which may be determined without taking the disturbance signal into account (e.g. “Some examples of control algorithms are proportional-integral-derivative and zero-power control.”, Col. 8, ll. 28-33), and to control the stator according to the bearing control signal in accordance with the determined specification (e.g. Fig. 5, Col. 8, ll. 16-33), wherein the control takes place after the detection interval (e.g. see sequence in Fig. 5).
In reference to at least claim 3
Antaki discloses wherein at least one of the disturbance component and/or the disturbance signal does not depend on the bearing position of the rotor along the bearing direction of action averaged over a period of a rotation of the rotor (e.g. Fig. 5, “In order to magnetically levitate the impeller 14 a feedback controller is used as diagramed in FIG. 5.”, Col. 8, ll. 10-33).
In reference to at least claim 4
Antaki discloses wherein the detection interval comprises at least one period of the rotation of the rotor (e.g. Col. 8, ll. 16-33).
In reference to at least claim 11
Antaki discloses the control unit configured to determine the bearing control signal as a corrected bearing control signal, wherein the determined disturbance signal is applied as a compensation signal to an uncorrected bearing control signal determined on the basis of the measurement signal, so that when the stator is controlled in accordance with the corrected bearing control signal, the bearing force exerted on the rotor is influenced less by the disturbance component of the measurement signal than when the stator is controlled in accordance with the uncorrected bearing control signal (e.g. Fig. 5, “The error transformation is accomplished with the sensor decoupler 70 shown in FIG. 5 which is simply a matrix multiplication accounting for the position and orientation of the sensors 65.”, Col. 8, ll. 10-33).
In reference to at least claim 12
Antaki discloses wherein the measurement signal is an uncorrected measurement signal and the control unit is configured to determine a corrected measurement signal by applying the determined disturbance signal as a compensation signal to the measurement signal when determining the bearing control signal, so that a disturbance component of the corrected measurement signal which depends on the rotation of the rotor about the rotation axis or the lateral movement of the rotor perpendicular to the rotation axis is less than the disturbance component of the uncorrected measurement signal (e.g. Fig. 5, “The error transformation is accomplished with the sensor decoupler 70 shown in FIG. 5 which is simply a matrix multiplication accounting for the position and orientation of the sensors 65.”, Col. 8, ll. 10-33).
In reference to at least claim 13
Antaki discloses wherein the control unit is configured to determine the bearing control signal in such a way that the rotor is adjusted into a target bearing position at which external forces acting on the rotor along the bearing direction of action add up to a predetermined force, in particular wherein the predetermined force is a zero force, and/or at which a power applied to generate the variable stator magnetic field is minimal (e.g. “In order to magnetically levitate the impeller 14 a feedback controller is used as diagramed in FIG. 5…..Some examples of control algorithms are proportional-integral-derivative and zero-power control.”, Fig. 5, Col. 8, ll. 10-33).
In reference to at least claim 15
Antaki discloses a pump system comprising a blood pump (e.g. rotary pump 10), wherein the blood pump comprises comprising a rotor (e.g. impeller 14) magnetically supported in a housing (e.g. housing 12) and rotatable about a rotation axis for conveying a fluid (e.g. conveys blood), and a stator (e.g. stator member 18 and motor stator 44), wherein the stator is configured to generate a variable stator magnetic field (e.g. via coils 60) for exerting a bearing force on the rotor which may be varied along a bearing direction of action in accordance with a bearing control signal (e.g. “The coils 60 are controlled to center the impeller 14 between the stationary blades 42. This design is particularly suited for use where fluid flow is required through the four fluid flow regions 58. The levitation means depicts an active radial bearing… Electromagnetic coils 60 wound around the back iron segments 62 direct the magnetic flux from the electromagnetic coils 60 such that the impeller tail 34 is suspended and substantially centered within the downstream passageway 52.”, Col. 7, ll. 41-64); wherein the blood pump is configured to provide a measurement signal (e.g. sensors 65, Fig. 5, Col. 8, ll. 10-16) which is dependent on a bearing position of the rotor along the bearing direction of action (e.g. sensors 65, Fig. 5, Col. 8, ll. 10-16) and which comprises a disturbance component dependent on at least one of a rotation of the rotor about the rotation axis and/or a lateral movement of the rotor perpendicular to the bearing direction of action (e.g. Fig. 5, “Position errors are measured with 8 position sensors 65 and transformed into the error signals x.sub.i, z.sub.i,x O, z.sub.o and y, while x.sub.i and z.sub.i measurements correspond to the x and z impeller displacement of the impeller measured at the inlet 24 and x.sub.o and z.sub.o are measured at the outlet 26.” Col. 8, ll. 10-16); a control unit (e.g. controller) of claim 1 (see claim 1 rejection above) configured to control the blood pump (e.g. Fig. 5, Col. 8, ll. 16-33).
In reference to at least claim 17
Antaki discloses wherein at least one of: the measurement signal corresponds to a back-electromotive force induced due to a rotation of the rotor and the blood pump comprises a sensor a Hall sensor, for providing the measurement signal (e.g. “Any position sensor can be used including a hall-effect, eddy-current or infrared sensors” Col. 7, l. 65-Col. 8, l. 2).
In reference to at least claim 18
Antaki discloses wherein the bearing direction of action is arranged substantially parallel to the rotation axis (e.g. Fig. 5, Col. 8, ll. 10-33).
In reference to at least claim 19
Antaki discloses a method for controlling a blood pump wherein the blood pump (e.g. rotary pump 10) comprising a rotor (e.g. impeller 14) magnetically supported in a housing (e.g. housing 12) and rotatable about a rotation axis for conveying a fluid (e.g. conveys blood), and a stator (e.g. stator member 18 and motor stator 44), wherein the stator is configured to generate a variable stator magnetic field (e.g. via coils 60) for exerting a bearing force on the rotor which may be varied along a bearing direction of action in accordance with a bearing control signal (e.g. “The coils 60 are controlled to center the impeller 14 between the stationary blades 42. This design is particularly suited for use where fluid flow is required through the four fluid flow regions 58. The levitation means depicts an active radial bearing… Electromagnetic coils 60 wound around the backiron segments 62 direct the magnetic flux from the electromagnetic coils 60 such that the impeller tail 34 is suspended and substantially centered within the downstream passageway 52.”, Col. 7, ll. 41-64); wherein the blood pump is configured to provide a measurement signal (e.g. sensors 65, Fig. 5, Col. 8, ll. 10-16) which is dependent on a bearing position of the rotor along the bearing direction of action (e.g. sensors 65, Fig. 5, Col. 8, ll. 10-16) and which comprises a disturbance component dependent on at least one of a rotation of the rotor about the rotation axis and/or a lateral movement of the rotor perpendicular to the bearing direction of action (e.g. Fig. 5, “Position errors are measured with 8 position sensors 65 and transformed into the error signals x.sub.i, z.sub.i,x O, z.sub.o and y, while x.sub.i and z.sub.i measurements correspond to the x and z impeller displacement of the impeller measured at the inlet 24 and x.sub.o and z.sub.o are measured at the outlet 26.”, Col. 8, ll. 10-16); wherein the method comprises: detecting the measurement signal and determining a disturbance signal dependent on the disturbance component on the basis of the measurement signal detected in a detection interval, to determining, on the basis of the measurement signal and the determined disturbance signal, a specification for the bearing control signal (e.g. Col. 8, ll. 16-33) in such a way that the rotor is supported in the housing without contact by means of the bearing force (e.g. “As noted above, the impeller nose 32 and the impeller tail 34 are magnetically suspended and centered within the housing 12 by the magnetic flux created by the electromagnetic coils 60 and directed through the upstream and downstream sets of stationary blades 40 and 42.” Col. 8, ll. 55-59), wherein a power consumed for exerting the bearing force is reduced compared with a specification for the bearing control signal which may be determined without taking the disturbance signal into account (e.g. “Some examples of control algorithms are proportional-integral-derivative and zero-power control.”, Col. 8, ll. 28-33), and after the detection interval (e.g. see sequence in Fig. 5) controlling the stator according to the bearing control signal in accordance with the determined specification (e.g. Fig. 5, Col. 8, ll. 16-33).
In reference to at least claim 20
Antaki discloses wherein at least one of: the measurement signal corresponds to a back-electromotive force induced due to a rotation of the rotor and the blood pump comprises a sensor a Hall sensor, for providing the measurement signal (e.g. “Any position sensor can be used including a hall-effect, eddy-current or infrared sensors” Col. 7, l. 65-Col. 8, l. 2).
Claim Rejections - 35 USC § 103
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) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 6,447,265 to Antaki et al. (Antaki) in view of US 2012/0095280 to Timms (Timms) (cited by applicant).
In reference to at least claim 7
Antaki discloses a control unit according to claim 1 but does not explicitly teach the control unit being configured to determine the disturbance signal by means of a learning control where the learning control is at least one of an iteratively learning control, a repetitive control, and a run-to-run control.
Timms, in the same field of endeavor of heart pump controllers, discloses a controller for a magnetic bearing system that utilizes control algorithms (e.g. “control algorithms”, para. [0017]) including a control algorithm that uses feedback parameters to stabilize and maintain impeller levitation (e.g. “ These displacement measurements are feedback parameters used by a control algorithm to stabilize the system. Control gains are output to a power amplifier, which generates the required current in the corresponding coil to alter the flux density in the magnetic gap and thus attractive force to maintain impeller levitation”, para. [0224]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit of Antaki to include utilizing a learning control including a repetitive control or run-to-run control, as taught by Timms, in order to stabilize the system and maintain impeller levitation (‘280, para. [0224]).
In reference to at least claim 10
Antaki discloses a control unit according to claim 1 but does not explicitly teach the control unit being configured to store a course of the disturbance signal as a function of a rotation angle of the rotor about the rotation axis. It was well-known in the art to utilize a storage and/or memory within a control device to store certain predetermined or determined values as evidence by Timms (e.g. “typically stored in the memory”, para. [0202], “typically previously determined and stored in the memory 301”, para. [0206], [0208]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit of Antaki to include storage or memory for storing a course of the disturbance signal as a function of a rotation angle of the rotor about the rotation axis as such technique was known and would have yielded the predictable result of allowing storage of determined values for aid in operation of the heart pump.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2025/0205475 to Peters et al. which teaches a control unit for a blood pump, pump system and method. US Patent No. 6,368,075 to Fremerey which discloses a pump with a magnetically supported rotor.
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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