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
In view of the amendments, the 112(b) Rejection is withdrawn.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the previous combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In view of the amendments, an updated search was conducted resulting in the modified 103 Rejection set forth below.
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) 1-4, 6-12, 17, 19-22, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwahashi (2023/0088350) in view of Miller et al. (6542846).
With respect to claims 1, 17, and 19-21, Iwahashi teaches of a malfunction inspection method for an ultrasound imaging system [0006]. Iwahashi teaches of one or more medical imaging devices each having a processor, memory, and sensor or malfunctioning element detection unit 134 and malfunction state determination unit 135 [0056]. Iwahashi teaches of a controller device with stored program with instructions for receiving a selection of one more imaging procedures or imaging modes [0053, 0056], determining an operating parameter of each of the devices based on the selection of the medical procedure where the operating parameter comprises determining signal to noise ratio [0059, 0096, 0097], receiving operational data from the sensor or malfunction detecting unit of the one or more medical devices [0093-0095, 0108], and receiving operation data from the detection unit of each of the devices or detecting when the probe or transducer is misaligned [0093, 0095]. Iwahashi teaches of receiving selected series of medical procedures such as harmonic imaging, Doppler blood flow imaging, elastography to allow measurement of blood flow or elasticity [0107] and therefore coordinating a treatment protocol for a single patient in which the mentioned one or more medical procedures is performed using a plurality of medical devices. Iwahashi therefore teaches of receiving data from the detecting unit on the one or more medical devices to indicate normal functioning or where emission is performed unexpectedly, or other malfunctions [0112, 0116].
With respect to claims 1, 17, and 19-21, Iwahashi does not explicitly teach of the calculating a estimation representing the runtime period or rest state period of the ultrasound imaging device or how long the ultrasound imaging device can be used to perform the selected medical procedure before reaching a maximum/shut-off temperature. In a similar field of endeavor Miller et al. teach of a thermal management system for a portable ultrasound imaging device that includes a thermal management controller 32 to control system temperature, modifying system parameters to change an operating mode of the ultrasound system, controlling timing of the system, controlling display or whether the system is in an overheated state and allowing the operator to take action to reduce temperature and automatically powering off the device if the temperature level reaches a high level (col. 5 lines 30-42). Miller et al. teach of the ultrasound system using modifiable processing algorithms to perform different imaging applications, scanning formats, operating modes and aperture modes (col. 8 lines 66-col. 9 line 2). Miller et al. teach of controlling the ultrasound system temperature based on sensed temperature relative to different temperature levels and if the highest sensed temperature value is greater than temperature level D, the thermal management controller automatically shuts off the ultrasound system (col. 10 lines 5-30). Miller et al. teach of comparing the average or weighted average of the detected temperatures to the critical temperature levels A-D to decide what action to take to determine how long the ultrasound system can run before being automatically shut down (col. 9 lines 65-col. 10 line 1). Under broadest reasonable interpretation, Miller et al. therefore teach of calculating a capability estimation that represents how long the ultrasound imaging device can be used to perform the medical procedure before reaching the maximum/shut-off temperature or the highest sensed temperature being greater than the temperature level D. With respect to claim 20, the combination of the Iwahashi and Miller references therefore teaches of the ultrasound imaging system comprising plurality of operating modes (as set forth by Iwahashi) and calculating the capability estimation based on the operation mode of the devices with respect to the temperature monitoring to prevent overheating (as set forth by Miller). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Miller et al. to modify Iwahashi to more effectively control the operation of the ultrasound imaging system without overheating (Miller, col. 10 lines 35-39).
With respect to claim 2, Iwahashi in view of Miller et al. teach of receiving a mode input based on the operating mode of the imaging device or where the malfunction detection results determines the mode input for operating the device or the [Iwahashi, 0077].
With respect to claims 3 and 10, Iwahashi in view of Miller et al. teach of outputting the capability estimation by displaying on a display 140 where the determination result output unit outputs the results by the malfunction unit and displays the results [Iwahashi, 0098].
With respect to claim 4, 6, 18, and 22, Iwahashi does not explicitly teach of receiving a temperature reading of the ultrasound imaging device as the operational parameter. Miller et al. teach of controlling the display to display an icon informing the operator of the system temperature or whether the system is in an overheated state and thereby allowing the operator to take action to reduce the temperature and automatically powering off the device if the temperature level reaches an acceptable high level (col. 5 lines 36-42, col. 6 lines 57-60). Miller et al. teach of determining the operating parameter by determining historical recorded temperatures sensed by the sensors or according to software polling routine stored in the thermal management controller. Since the Miller reference teaches of providing a display indicating the temperature monitoring and if the temperature level is at an unacceptable level and shutting off if this level is reached, then under broadest reasonable interpretation, the reference teaches of providing an indication of whether the imaging device can complete the medical procedure based on the temperature level/reading of the ultrasound device. Iwahashi also teaches of providing an indication of whether the imaging device can complete the procedure or whether to continue to stop in a case where imaging is difficult [0118]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Miller et al. to modify Iwahashi to more effectively control the operation of the ultrasound imaging system without overheating (Miller, col. 10 lines 35-39).
With respect to claim 7-9 and 27, Iwahashi teaches of determining an operating parameter of each of the devices based on the selection of the medical procedure where the operating parameter comprises determining signal to noise ratio [0059, 0096, 0097], receiving operational data from the sensor or malfunction detecting unit of the one or more medical devices [0093-0095, 0108], and receiving operation data from the detection unit of each of the devices or detecting when the probe or transducer is misaligned [0093, 0095]. Iwahashi therefore teaches of receiving data from the detecting unit on the one or more medical devices to indicate normal functioning or where emission is performed unexpectedly, or other malfunctions [0112, 0116]. With respect to claims 8 and 9, Iwahashi teaches of receiving selected series of medical procedures such as harmonic imaging, Doppler blood flow imaging, elastography to allow measurement of blood flow or elasticity [0107] and therefore coordinating a treatment protocol for a single patient in which the mentioned one or more medical procedures is performed using a plurality of medical devices. Iwahashi therefore teaches of receiving data from the detecting unit on the one or more medical devices to indicate normal functioning or where emission is performed unexpectedly, or other malfunctions [0112, 0116]. Iwahashi also teaches of calculating three types of indicators that indicate the malfunctioning state [0077], number of malfunctioning continuous elements [0079] and ration of malfunctioning local elements [0082].
Iwahashi does not explicitly teach of the calculating a estimation representing the runtime period or rest state period of the ultrasound imaging device or how long the ultrasound imaging device can be used to perform the selected medical procedure before reaching a maximum/shut-off temperature. In a similar field of endeavor Miller et al. teach of a thermal management system for a portable ultrasound imaging device that includes a thermal management controller 32 to control system temperature, modifying system parameters to change an operating mode of the ultrasound system, controlling timing of the system, controlling display or whether the system is in an overheated state and allowing the operator to take action to reduce temperature and automatically powering off the device if the temperature level reaches a high level (col. 5 lines 30-42). Miller et al. teach of the ultrasound system using modifiable processing algorithms to perform different imaging applications, scanning formats, operating modes and aperture modes (col. 8 lines 66-col. 9 line 2). Miller et al. teach of controlling the ultrasound system temperature based on sensed temperature relative to different temperature levels and if the highest sensed temperature value is greater than temperature level D, the thermal management controller automatically shuts off the ultrasound system (col. 10 lines 5-30). Miller et al. teach of comparing the average or weighted average of the detected temperatures to the critical temperature levels A-D to decide what action to take to determine how long the ultrasound system can run before being automatically shut down (col. 9 lines 65-col. 10 line 1). Under broadest reasonable interpretation, Miller et al. therefore teach of calculating a capability estimation that represents how long the ultrasound imaging device can be used to perform the medical procedure before reaching the maximum/shut-off temperature or the highest sensed temperature being greater than the temperature level D. Miller et al. also teach of providing an estimate of how long the imaging device needs to charge to be fully charged power or the charging profile of the battery (col. 5 lines 35-36). The combination of the Iwahashi and Miller references therefore teaches of the ultrasound imaging system comprising plurality of operating modes (as set forth by Iwahashi) and calculating the capability estimation based on the operation mode of the devices with respect to the temperature monitoring to prevent overheating (as set forth by Miller) with respect to each imaging procedure. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Miller et al. to modify Iwahashi to more effectively control the operation of the ultrasound imaging system without overheating (Miller, col. 10 lines 35-39).
With respect to claims 11 and 12 Iwahashi in view of Miller et al. teach of receiving selected series of medical procedures and includes a consideration of each medical procedure in the series such as harmonic imaging, Doppler blood flow imaging, elastography to allow measurement of blood flow or elasticity [Iwahashi, 0107, 0108] and the calculation of capability estimation factors in the medical procedure in the series such as external factors tied to each occasion of imaging [0118]. Miller et al. additionally teach of the calculation of the capability estimation with respect to the monitoring of the temperature levels and automatically shutting of the system based on this level. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Miller et al. to modify Iwahashi to more effectively control the operation of the ultrasound imaging system without overheating (Miller, col. 10 lines 35-39).
With respect to claim 19, Iwahashi in view of Miller et al. teach of the controller being configured to coordinate a treatment protocol for a signal patient where the one or more medical procedures is performed using a plurality of medical devices or various imaging and tracking systems that are adapted to utilize data from and generate an image for display which provides any suitable information to a clinician that is performing a medical procedure [Iwahashi, 0081].
Claim(s) 18, 23, 24-26, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwahashi in view of Miller et al. and further in view of Haider et al. (8764662). The previous references do not explicitly teach of the algorithm calculating a temperature curve using real-time and historical, recorded temperatures. In a related field of endeavor Haider et al. teach of the ultrasound imaging system and method for temperature management that includes temperature sensing devices to determine the actual temperature of the heat producing regions of the probe where the signal processing system analyzes the signals received from the temperature sensing device to generate a report on temperatures observed on the heat producing regions of the probe and generating a graph displaying amplitudes of electric signals outputted by the sensing devices (col. 5 lines 58-65). Haider et al. teach of the operator observing the graph on display and raise an alert of the probe when the temperature exceeds a threshold (col. 5 lines 65-col. 6 line 14). Haider et al. also teach of the controller configured to activate a cooling system to actively cool the probe (col. 6 lines 22-25, col. 7 lines 33-39) and therefore the temperature sensing provides estimate of how long before the imaging device will cool to a target or predefined temperature (col. 7 lines 61-col. 8 line 3). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Haider et al. to modify the previous teachings to provide effective temperature control of the probe and obtain high quality ultrasound images (Haider, col. 1 line 65-col. 2 line 2).
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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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797