DETAILED ACTION
Claims 1-20 are pending. Claims 1, 8, 9, 13-16, and 20 are amended.
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 of this title, 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-7, 9-12, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dietz et al. [US 2020/0041589 A1; hereinafter “Dietz”] in view of Maji et al. [US 2024/0277309 A1; hereinafter “Maji”].
Regarding claim 1, Dietz teaches a system for mechanical failure prediction, comprising: a non-transitory memory device for storing computer-readable program code; and a processor in communication with the non-transitory memory device, the processor being operative with the computer-readable program code to perform operations (a computer program is also conceivable, which performs the steps of a method according to the disclosure when it is executed on a control device – 0068) including
acquiring vibration data (sensor data acquired from the at least one vibration sensor – 0075) (vibration sensors oriented to measure - 0079) from multiple vibration sensors embedded in a medical device (embedded in the coil body, which plate comprises threaded holes for mounting vibration sensors - 0081), the multiple vibration sensors are located on different areas of the component of the medical device (figure 3, multiple vibration sensors 8 located on the coil body – 0078),
pre-processing the vibration data to generate pre-processed data (analyze sensor data acquired from the at least one vibration sensor … determine characteristics of at least one measured oscillation, which may include one or more of a frequency, a frequency spectrum, harmonic information, a phase angle between two oscillation components, a time constant, and/or a spatial relationship value, etc. - 0075), and
predicting an imminent onset of failure of the medical device based on the pre- processed data (said operating-life prediction algorithm can be used to predict operating lives for gradient coil assemblies 7 currently in use, so that when the operating-life end lies a predetermined time interval ahead, notification of preventive maintenance can be output and the gradient coil assembly 7 can be replaced ideally without prolonged downtimes - 0085).
Dietz further teaches acquiring vibration data from multiple vibration sensors embedded in a medical device and the multiple vibration sensors are located on different areas of the component of the medical device (figure 3, multiple vibration sensors 8 located on the coil body – 0078).
Dietz does not specifically disclose the multiple vibration sensors are located on different components of the medical device.
However, Maji teaches multiple smart sensors are located on different components of a medical device (In certain embodiments, multiple components 54 of the medical imaging system 50 may have integrated one or more smart sensors 52 (of a same type and/or different types). Examples of components 54 of the medical imaging system 50 that may have one or more smart sensors 52 integrated include a gantry, a gantry housing, an X-ray source (e.g., X-ray tube), a power distribution unit, a table, or any other component 54. The component 54 may be part of a sub-system of the medical imaging system 50 – 0029) (the smart sensors 52 still further include vibration sensors 94. In certain embodiments, the vibration sensors 94 include accelerometers. One or more vibration sensors 94 may be coupled to one or more components of medical imaging system (e.g., gantry, gantry housing, or a part within the gantry or gantry housing) - 0044);
initiating different types of mechanical stimuli of a medical device (A range of motion before or during an acquisition, or between different image acquisitions – Maji – 0070, 0071; Prior to acquiring an image of the subject 1010 or a portion of the subject 1010, the imaging detectors 1002, gantry 1004, and/or patient table 1020 may be adjusted - 0075) and predicting different types of failures in response to the different types of mechanical stimuli (monitoring a plurality of medical imaging systems … one or more smart sensors are integrated within one or more components of each medical imaging system of the plurality of medical imaging systems. The one or more smart sensors are configured to monitor for one or more conditions or parameters (e.g., dust accumulation, smoke, fire, oil leaks, vibration, gantry-table leveling, animal presence, etc.) for or related to a respective medical imaging system… - Maji – 0050, feedback is an alarm - 0051) (generate an alarm based on a comparison of a received measured parameter or condition to a corresponding threshold where the threshold is exceeded. In certain embodiments, a shutdown signal may be sent to turn off the imaging system (e.g., in response to smoke or fire). In certain embodiments, a notification may be provided to indicate a condition (e.g., animal detected, oil leak, vibration, incorrectly leveled gantry-table, etc.) – Maji - 0053).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the teachings of Dietz to further include coupling the vibration sensors to the one or more components of the medical imaging system as taught by Maji for the benefits of identifying and ensuring proper operations of the medical imaging system, e.g. predictive maintenance, fault diagnosis, component level root cause identification, excessive vibration detection (Maji – 0044).
Regarding claim 2, Dietz teaches the medical device comprises a radiological medical scanner (a magnetic resonance data acquisition scanner or simply as a scanner - 0069).
Regarding claim 3, Dietz in combination with Maji further teaches the medical device comprises a Computed Tomographic (CT) or a Position Emission Tomographic (PET) scanner and at least one of the multiple vibration sensors is located in a detector or an X-ray source of the medical device (CT imaging systems, positron emission tomography (PET) imaging system – Maji, 0026) (One or more vibration sensors 94 may be coupled to one or more components of medical imaging system (e.g., gantry, gantry housing, or a part within the gantry or gantry housing – Maji, 0044).
Regarding claim 4, Dietz in combination with Maji further teaches at least one of the multiple vibration sensors is located on a printed circuit board inside (integrated vibration sensors fully in … encapsulated therein – Dietz, 0081) (MEMS accelerometer – Dietz, 0077) a combined Position Emission Tomographic (PET)-magnetic resonance imaging (MRI) gantry of the medical device (Maji – 0026, 0029, 0075).
Regarding claim 5, Dietz teaches at least one of the multiple vibration sensor is removably attached to at least one component of the medical device (may be replaceably (e.g., removably) mounted on the surface of the coil body - 0081).
Regarding claim 6, Dietz teaches at least of the multiple vibration sensors comprises a piezo-based sensor, a capacitive sensor, a strain gauge type sensor, or a combination thereof is embedded in at least one component of the medical device (strain gages and/or microphones can also be implemented as at least one of the at least one vibration sensors - 0024) ( Piezoelectric sensors and/or acceleration sensors, in this example accelerometers in the form of MEMS, may be implemented as the vibration sensors 8 - 0077).
Regarding claim 7, Dietz teaches at least one of the multiple vibration sensor comprises a microelectromechanical-based accelerometer ( Piezoelectric sensors and/or acceleration sensors, in this example accelerometers in the form of MEMS, may be implemented as the vibration sensors 8 - 0077).
Regarding claim 9, Dietz teaches a method of predicting mechanical failure, comprising:
acquiring vibration data (sensor data acquired from the at least one vibration sensor – 0075) (vibration sensors oriented to measure - 0079) from multiple vibration sensors embedded in a medical device (embedded in the coil body, which plate comprises threaded holes for mounting vibration sensors - 0081), the multiple vibration sensors are located on different areas of the component of the medical device (figure 3, multiple vibration sensors 8 located on the coil body – 0078);
pre-processing the vibration data to generate pre-processed data (analyze sensor data acquired from the at least one vibration sensor … determine characteristics of at least one measured oscillation, which may include one or more of a frequency, a frequency spectrum, harmonic information, a phase angle between two oscillation components, a time constant, and/or a spatial relationship value, etc. - 0075); and
predicting an imminent onset of failure of the medical device based on the pre-processed data (Said operating-life prediction algorithm can be used to predict operating lives for gradient coil assemblies 7 currently in use, so that when the operating-life end lies a predetermined time interval ahead, notification of preventive maintenance can be output and the gradient coil assembly 7 can be replaced ideally without prolonged downtimes - 0085).
Dietz further teaches acquiring vibration data from multiple vibration sensors embedded in a medical device and the multiple vibration sensors are located on different areas of the component of the medical device (figure 3, multiple vibration sensors 8 located on the coil body – 0078).
Dietz does not specifically disclose the multiple vibration sensors are located on different components of the medical device.
However, Maji teaches multiple smart sensors are located on different components of a medical device (In certain embodiments, multiple components 54 of the medical imaging system 50 may have integrated one or more smart sensors 52 (of a same type and/or different types). Examples of components 54 of the medical imaging system 50 that may have one or more smart sensors 52 integrated include a gantry, a gantry housing, an X-ray source (e.g., X-ray tube), a power distribution unit, a table, or any other component 54. The component 54 may be part of a sub-system of the medical imaging system 50 – 0029) (the smart sensors 52 still further include vibration sensors 94. In certain embodiments, the vibration sensors 94 include accelerometers. One or more vibration sensors 94 may be coupled to one or more components of medical imaging system (e.g., gantry, gantry housing, or a part within the gantry or gantry housing) - 0044).
However, Maji teaches multiple smart sensors are located on different components of a medical device (In certain embodiments, multiple components 54 of the medical imaging system 50 may have integrated one or more smart sensors 52 (of a same type and/or different types). Examples of components 54 of the medical imaging system 50 that may have one or more smart sensors 52 integrated include a gantry, a gantry housing, an X-ray source (e.g., X-ray tube), a power distribution unit, a table, or any other component 54. The component 54 may be part of a sub-system of the medical imaging system 50 – 0029) (the smart sensors 52 still further include vibration sensors 94. In certain embodiments, the vibration sensors 94 include accelerometers. One or more vibration sensors 94 may be coupled to one or more components of medical imaging system (e.g., gantry, gantry housing, or a part within the gantry or gantry housing) - 0044);
initiating different types of mechanical stimuli of a medical device (A range of motion before or during an acquisition, or between different image acquisitions – Maji – 0070, 0071; Prior to acquiring an image of the subject 1010 or a portion of the subject 1010, the imaging detectors 1002, gantry 1004, and/or patient table 1020 may be adjusted - 0075) and predicting different types of failures in response to the different types of mechanical stimuli (monitoring a plurality of medical imaging systems … one or more smart sensors are integrated within one or more components of each medical imaging system of the plurality of medical imaging systems. The one or more smart sensors are configured to monitor for one or more conditions or parameters (e.g., dust accumulation, smoke, fire, oil leaks, vibration, gantry-table leveling, animal presence, etc.) for or related to a respective medical imaging system… - Maji – 0050, feedback is an alarm - 0051) (generate an alarm based on a comparison of a received measured parameter or condition to a corresponding threshold where the threshold is exceeded. In certain embodiments, a shutdown signal may be sent to turn off the imaging system (e.g., in response to smoke or fire). In certain embodiments, a notification may be provided to indicate a condition (e.g., animal detected, oil leak, vibration, incorrectly leveled gantry-table, etc.) – Maji - 0053).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the teachings of Dietz to further include coupling the vibration sensors to the one or more components of the medical imaging system as taught by Maji for the benefits of identifying and ensuring proper operations of the medical imaging system, e.g. predictive maintenance, fault diagnosis, component level root cause identification, excessive vibration detection (Maji – 0044).
Regarding claim 10, Dietz teaches predicting the imminent onset of failure comprises detecting a static change in the pre-processed data (detecting spikes – 0059, 0060, 0089).
Regarding claim 11, Dietz teaches detecting the static change in the vibration data comprises detecting a change in orientation (oriented and measure in Z-direction, X-direction, Y-direction 0078-0081).
Regarding claim 12, Dietz teaches predicting the imminent onset of failure comprises detecting a dynamic change in the pre-processed data in response to a mechanical stimulation of the medical device (oscillation behavior – 0040, 0053, 0086) (detecting spikes – 0059, 0089).
Regarding claim 14, Dietz teaches initiating the different types of mechanical stimuli of the medical device comprises operating a medical scanner component (The main magnet may be referred to as a magnetic resonance data acquisition scanner or simply as a scanner – 0069).
Regarding claim 15, Dietz teaches initiating the different types of mechanical stimuli comprises pulse excitation and vibration excitation (the oscillation behavior of the gradient coil assembly can be recorded together with the parameters describing the image acquisition process, for instance including the position of the patient couch, the patient weight, the patient height, the body/mass index of the patient, the position of the patient and/or the acquisition region (for instance abdomen, head, pelvis, legs, etc.) - 0053).
Regarding claim 16, Dietz teaches initiating the different types of mechanical stimuli comprises starting rotation of a computed tomographic (CT) scanner gantry (via image acquisition process – 0051) (patient to be scanned and/or the acquisition region of the patient and/or attributes of the patient can also be included - 0053).
Regarding claim 17, Dietz teaches acquiring the vibration data from the multiple vibration sensors comprises acquiring orientation data, acceleration data, velocity data, position data or a combination thereof (oriented and measure in Z-direction, X-direction, Y-direction 0078-0081).
Regarding claim 18, Dietz teaches predicting the imminent onset of failure of the medical device based on the pre-processed data comprises monitoring changes in orientation, amplitude or frequency indicated by the pre-processed data (Stop frequencies or frequency stopbands, which are meant to be taken into account by operating parameters of the magnetic resonance device - 0087) (oriented and measure in Z-direction, X-direction, Y-direction 0078-0081).
Regarding claim 19, Dietz teaches predicting the imminent onset of failure of the medical device based on the pre-processed data comprises monitoring a time waveform or frequency spectrum of the pre-processed data (determining at least one characteristic of at least one measured oscillation, such as determining, for example, one or more of a frequency, a frequency spectrum, harmonic information, amplitude information, a phase angle between two oscillation components, a time constant, and/or a spatial relationship value – 0040, determine characteristics of at least one measured oscillation, which may include one or more of a frequency, a frequency spectrum - 0075).
Regarding claim 20, Dietz teaches one or more non-transitory computer readable media embodying a program of instructions executable by machine to perform (The computer program can be stored on an electronically readable data storage medium (e.g., a non-transitory computer readable medium) which therefore comprises electronically readable control information stored thereon that comprises at least one said computer program and is designed such that it performs a method - 0068) operations for predicting mechanical failure, the operations comprising:
acquiring vibration data (sensor data acquired from the at least one vibration sensor – 0075) (vibration sensors oriented to measure - 0079) from multiple vibration sensors embedded in a medical device (embedded in the coil body, which plate comprises threaded holes for mounting vibration sensors - 0081), the multiple vibration sensors are located on different areas of the component of the medical device (figure 3, multiple vibration sensors 8 located on the coil body – 0078);
pre-processing the vibration data to generate pre-processed data (analyze sensor data acquired from the at least one vibration sensor … determine characteristics of at least one measured oscillation, which may include one or more of a frequency, a frequency spectrum, harmonic information, a phase angle between two oscillation components, a time constant, and/or a spatial relationship value, etc. - 0075); and
predicting an imminent onset of failure of the medical device based on the pre-processed data (Said operating-life prediction algorithm can be used to predict operating lives for gradient coil assemblies 7 currently in use, so that when the operating-life end lies a predetermined time interval ahead, notification of preventive maintenance can be output and the gradient coil assembly 7 can be replaced ideally without prolonged downtimes - 0085).
Dietz further teaches acquiring vibration data from multiple vibration sensors embedded in a medical device and the multiple vibration sensors are located on different areas of the component of the medical device (figure 3, multiple vibration sensors 8 located on the coil body – 0078).
Dietz does not specifically disclose the multiple vibration sensors are located on different components of the medical device.
However, Maji teaches multiple smart sensors are located on different components of a medical device (In certain embodiments, multiple components 54 of the medical imaging system 50 may have integrated one or more smart sensors 52 (of a same type and/or different types). Examples of components 54 of the medical imaging system 50 that may have one or more smart sensors 52 integrated include a gantry, a gantry housing, an X-ray source (e.g., X-ray tube), a power distribution unit, a table, or any other component 54. The component 54 may be part of a sub-system of the medical imaging system 50 – 0029) (the smart sensors 52 still further include vibration sensors 94. In certain embodiments, the vibration sensors 94 include accelerometers. One or more vibration sensors 94 may be coupled to one or more components of medical imaging system (e.g., gantry, gantry housing, or a part within the gantry or gantry housing) - 0044);
However, Maji teaches multiple smart sensors are located on different components of a medical device (In certain embodiments, multiple components 54 of the medical imaging system 50 may have integrated one or more smart sensors 52 (of a same type and/or different types). Examples of components 54 of the medical imaging system 50 that may have one or more smart sensors 52 integrated include a gantry, a gantry housing, an X-ray source (e.g., X-ray tube), a power distribution unit, a table, or any other component 54. The component 54 may be part of a sub-system of the medical imaging system 50 – 0029) (the smart sensors 52 still further include vibration sensors 94. In certain embodiments, the vibration sensors 94 include accelerometers. One or more vibration sensors 94 may be coupled to one or more components of medical imaging system (e.g., gantry, gantry housing, or a part within the gantry or gantry housing) - 0044);
initiating different types of mechanical stimuli of a medical device (A range of motion before or during an acquisition, or between different image acquisitions – Maji – 0070, 0071; Prior to acquiring an image of the subject 1010 or a portion of the subject 1010, the imaging detectors 1002, gantry 1004, and/or patient table 1020 may be adjusted - 0075) and predicting different types of failures in response to the different types of mechanical stimuli (monitoring a plurality of medical imaging systems … one or more smart sensors are integrated within one or more components of each medical imaging system of the plurality of medical imaging systems. The one or more smart sensors are configured to monitor for one or more conditions or parameters (e.g., dust accumulation, smoke, fire, oil leaks, vibration, gantry-table leveling, animal presence, etc.) for or related to a respective medical imaging system… - Maji – 0050, feedback is an alarm - 0051) (generate an alarm based on a comparison of a received measured parameter or condition to a corresponding threshold where the threshold is exceeded. In certain embodiments, a shutdown signal may be sent to turn off the imaging system (e.g., in response to smoke or fire). In certain embodiments, a notification may be provided to indicate a condition (e.g., animal detected, oil leak, vibration, incorrectly leveled gantry-table, etc.) – Maji - 0053).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the teachings of Dietz to further include coupling the vibration sensors to the one or more components of the medical imaging system as taught by Maji for the benefits of identifying and ensuring proper operations of the medical imaging system, e.g. predictive maintenance, fault diagnosis, component level root cause identification, excessive vibration detection (Maji – 0044).
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dietz et al. [US 2020/0041589 A1; hereinafter “Dietz”] and Maji et al. [US 2024/0277309 A1; hereinafter “Maji”] and further in view of MILLER et al. [US 2025/0090112 A1; hereinafter “MILLER”].
Regarding claims 8 and 13, while Dietz and Maji teach the above limitations, neither disclose different types of failures including loosening of at least one fastening point and breakage of at least one component.
However, MILLER discloses a method and apparatus for monitoring the operational safety of an imaging system (Abstract) and discusses different types of failures of components such as the tendency for components to loosen, welds softening, components crack, break, etc. (0003).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the teachings of Dietz in combination with Maji to further include monitoring the different types of failures at discussed by MILLER to provide timely warning of safety issues thereby preventing system malfunctions and minimizing risks of injury and damage (MILLER - 0003-0007).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 regarding the rejection under 35 USC 103(a) have been considered but are moot because the new ground of rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 RICKY GO whose telephone number is (571)270-3340. The examiner can normally be reached on Monday through Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arleen M. Vazquez can be reached on (571) 272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICKY GO/Primary Examiner, Art Unit 2857
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