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 § 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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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, 18, and 19, the claims recite “testing the sensor probe for performance characteristics” (claim 1); “a testing station coupled to the control computer and configured to test one or more sensor probes in response to the determination of static performance characteristics” (claim 18); and to “test the sensor probe for static performance characteristics after use in the biomanufacturing system” (claim 19) without defining the test or which function or status of the sensor is being tested. For instance, the claims do not appear to explicitly define whether the test is to determine that the sensor is broken, unstable, out-of-power, or malfunctioning, etc. Further, the phrases “static performance characteristics” (claims 18 and 19) and “performance characteristics” (claim 1) do not appear to define the function or status of the sensor is being tested. For examination purposes, the phrases “testing” (claim 1), “to test” (claim 18), and to “test” (claim 19) will be interpreted as any tests or determination that can detect when the sensor status becomes unstable, unusable, or broken, etc. Further clarification is respectfully requested.
Regarding claim 13, the claim recites “dynamic performance characteristics” and “static performance characteristics” without explaining how these performance characteristics are distinct from one another. For examination purposes, “dynamic performance characteristics” will be understood as sensor’s measurement data, and “static performance characteristics” will be understood as sensor’s status data. Further clarification is respectfully requested.
Regarding claim 19, the claim recites “a computer-executable method for tracking performance characteristics of equipment embodied in a computer-readable medium” without defining whether “a computer-readable medium” refers to transitory signals (1) or non-transitory (2) form of signal (see MPEP 2106.03). Further clarification is respectfully requested.
Claims 2-12, 14-17, 20 are rejected as being dependent on the rejected base claims.
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.
Claims 1-5, 7-11, 13-15, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (WO 2020/167676) (hereafter Patrick) in view of Hartmann et al. (Pat. No. US 12,055,417) (hereafter Hartmann).
Regarding claim 1, Patrick teaches a method for tracking performance characteristics of equipment, comprising:
affixing a trackable identification (i.e., a detection feature to automatically identify an identity of the one or more sensor (e.g., Serial Number, sensor ID)) (see paragraph section [0040]) to a sensor probe (i.e., sensor 109) (see Fig. 1) configured to be used in a biomanufacturing system (i.e., bioreactor 100) (see Fig. 1), the trackable identification associated with a data set stored in a data store (i.e., a database 510. may be accessible to the device and may provide a library storing model copies, history design models, history performance, printing parameters, fermentation experiment results and the like) (see paragraph section [0077]);
assigning initial meta data to the respective data set about the associated sensor probe in the data store that is associated with the trackable identification (i.e., an identity of the sensor (e.g., Serial Number) may be identified automatically by a sensor (e.g., RFID transmitter) located at the head-plate) (see paragraph section [004331]);
using the sensor probe in an experiment in the biomanufacturing system (i.e., The head-plate 101 may provide coupling means to couple the various components such as sensors/probes, gas inputs, feed inputs may be removably assembled to the bioreactor via any suitable mechanical coupling means) (see paragraph section [0042]); after using the sensor probe, removing the sensor probe from the experiment (i.e., by the removal of the head-plate) (see Fig. 4); but does not explicitly teach testing the sensor probe for performance characteristics; and changing the meta data in the data store in response to the testing.
Regarding changing the meta data, teaches a trackable identification (i.e., the sensor unit comprises one or more unique identity of the sensor unit visible for human interaction, e.g. by radio frequency ID (RFID), such as a readable name, label, bar code, and/or GS1 datamatrix, such as a GS1 GRAI code) (see Column 9, lines 4-22) associated with a data set stored in a data store (i.e., The sensor units are placed on a rack 7, which is electrically connected to an external source, e.g. by a multiplexer, such that the electronic information associated with the calibration, such as the calibration values and the validation, are stored on each of the sensor units) (see Column 12, line 62, to Column 13, line 3); after using the sensor probe (i.e., after a predetermined time of operation, the calibration of the sensor unit will no longer be validated) (see Column 14, lines 22-27), removing the sensor probe from the experiment (i.e., the gateway may have the sensor unit replaced with another validated and traceable calibrated sensor unit any number of times) (see Column 14, lines 55-61), and testing the sensor probe for performance characteristics (i.e., to improve the reliability of the sensor measurements, it may be advantageous to repeat the calibration after a certain or predetermined period of using the sensor unit. A second indicator unit configured to be activated when the measured parameters deviate from a predetermined threshold value. Thus, when the calibration is no longer validated, or the sensor unit becomes broken or unstable, the sensor unit must be recalibrated or replaced) (see Column 13, line 17, to Column 14, line 61); and changing the meta data in the data store (i.e., the sensor unit may be configured for traceably storing the entire calibration history, i.e., traceable information related to all calibrations carried out over the lifespan of the sensor unit) (see Column 8, lines 34-61) in response to the testing (i.e., the inoperable sensor unit may be recalibrated) (see Column 14, lines 44-54). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 2, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the changing the meta data further comprises incrementing a counter for total number of uses of the associated sensor probe. However, Hartman teaches that the changing the meta data further comprises incrementing a counter for total number of uses of the associated sensor probe (i.e., the sensor unit may be configured for traceably storing the entire calibration history, i.e., traceable information related to all calibrations carried out over the lifespan of the sensor unit) (see Column 8, lines 34-61). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 3, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the changing the meta data further comprises incrementing a counter for specific number and type of experiments. However, Hartmann teaches that the changing the meta data further comprises incrementing a counter for specific number and type of experiments (i.e., the sensor unit may be configured for traceably storing the entire calibration history, i.e., traceable information related to all calibrations carried out over the lifespan of the sensor unit) (see Column 8, lines 34-61). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 4, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the changing the meta data further comprises adding calibration data after calibration testing. However, Hartmann teaches that the changing the meta data further comprises adding calibration data after calibration testing (i.e., the sensor unit may be configured for traceably storing the entire calibration history, i.e., traceable information related to all calibrations carried out over the lifespan of the sensor unit) (see Column 8, lines 34-61). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 5, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach calibrating the associated sensor probe in response to the testing. However, Hartman teaches calibrating the associated sensor probe in response to the testing (i.e., the inoperable sensor unit may be recalibrated. A second indicator unit configured to be activated when the measured parameters deviate from a predetermined threshold value. Thus, when the calibration is no longer validated, or the sensor unit becomes broken or unstable, the sensor unit must be recalibrated or replaced) (see Column 14, lines 4-54). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 7, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the changing the meta data further comprises adding an indication to the meta data to retire the sensor probe from use in response to the testing. However, Hartmann teaches that the changing the meta data further comprises adding an indication to the meta data to retire the sensor probe from use in response to the testing (i.e., when the calibration is no longer validated, or the sensor unit becomes broken or unstable, the sensor unit must be replaced. A second indicator unit configured to be activated when the measured parameters deviate from a predetermined threshold value) (see Column 14, lines 4-27). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 8, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the changing the meta data further comprises adding an indication to the meta data to recalibrate the sensor probe in response to the testing. However, Hartmann teaches that the changing the meta data further comprises adding an indication to the meta data to recalibrate the sensor probe in response to the testing (i.e., when the calibration is no longer validated, or the sensor unit becomes broken or unstable, the sensor unit must be recalibrated. A second indicator unit configured to be activated when the measured parameters deviate from a predetermined threshold value) (see Column 14, lines 4-27). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 9, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the testing further comprises testing responsiveness to pH detection. However, Hartmann teaches that the testing further comprises testing responsiveness (i.e., to improve the reliability of the sensor measurements, it may be advantageous to repeat the calibration after a certain or predetermined period of using the sensor unit. This way, the reliability of the sensor measurements carried out are retrospectively verified) (see Column 10, line 38, to Column 14, line 27) to pH detection (i.e., the environmental parameter is selected from the group of: temperature, pressure, pH, humidity, CO2, O2, acceleration, sound, light, GPS, particulate matter, and combinations thereof) (see Column 10, lines 38-49). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 10, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the testing further comprises testing responsiveness to dissolved oxygen detection. However, Hartmann teaches that the testing further comprises testing responsiveness (i.e., to improve the reliability of the sensor measurements, it may be advantageous to repeat the calibration after a certain or predetermined period of using the sensor unit. This way, the reliability of the sensor measurements carried out are retrospectively verified) (see Column 10, line 38, to Column 14, line 27) to dissolved oxygen detection (i.e., the environmental parameter is selected from the group of: temperature, pressure, pH, humidity, CO2, O2, acceleration, sound, light, GPS, particulate matter, and combinations thereof) (see Column 10, lines 38-49). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 11, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the testing further comprises testing responsiveness to temperature detection. However, Hartmann teaches that the testing further comprises testing responsiveness (i.e., to improve the reliability of the sensor measurements, it may be advantageous to repeat the calibration after a certain or predetermined period of using the sensor unit. This way, the reliability of the sensor measurements carried out are retrospectively verified) (see Column 10, line 38, to Column 14, line 27) to temperature detection (i.e., the environmental parameter is selected from the group of: temperature, pressure, pH, humidity, CO2, O2, acceleration, sound, light, GPS, particulate matter, and combinations thereof) (see Column 10, lines 38-49). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 13, Patrick teaches a system for tracking performance characteristics of probes used in biomanufacturing procedures, the system comprising:
a bioreactor array that includes a plurality of vessels (i.e., a bioreactor array may comprise one or more bioreactors) (see paragraph section [0083]), each vessel having one or more sensor probes configured to be removably attached to a respective vessel (i.e., one or more sensors can be coupled to the bioreactor via the head-plate 101) (see paragraph section [0038]);
a control computer communicatively coupled to each vessel in the bioreactor array (i.e., a data communication may occur between a bioreactor and one or more external devices, such as one or more local controllers that may provide instructions that may affect operation of the bioreactor) (see paragraph sections [0100]-[0102]), the control computer having a processor configured to execute instructions to control experiments in each vessel and to receive sensor data from each sensor probe (i.e., the bioreactor may comprise one or more local controllers that may provide instructions that may affect operation of the bioreactor) (see paragraph sections [0100]-[0102]); and
a data store communicatively coupled to the control computer and configured to store meta data about each sensor probe (i.e., the head-plate may comprise a detection feature to automatically identify an identity of the one or more sensor (e.g., Serial Number, sensor ID) and track the port the sensor is attached to. The detection feature can be implemented using any suitable electronics such as sensors. Suitable sensors such as Dallas chip, EEPROM, RFID, barcode and the like may be utilized to track the sensor probe identity, location and/or usage of the sensor probes. In an example, a barcode or RFID (e.g., Serial Number) configured to be read by a reader may be located on the sensor probe and can be read by a reader located on the head- plate) (see paragraph section [0040]); but does not explicitly teach that the control computer is further configured to: determine dynamic performance characteristics during an experiment such that meta data in the data store is altered in response to the receiving the queried performance characteristics; and determine static performance characteristics during an experiment such that meta data in the data store is altered in response to the receiving the queried performance characteristics.
Regarding the performance characteristics, Hartmann teaches that the control computer is further configured to:
determine dynamic performance characteristics during an experiment such that meta data in the data store is altered in response to the receiving the queried performance characteristics (i.e., the memory unit is dimensioned for storing the measured parameters) (see Column 5, lines 1-20; and Column 7, lines 50-59); and
determine static performance characteristics during an experiment such that meta data in the data store is altered in response to the receiving the queried performance characteristics (i.e., the memory unit is dimensioned for storing the validated calibration status, including the user retrievable calibration certificate in compliance to ISO17025 or NIST version of same, the correction values, and information related to the encryption or hash secured, or HASH'ed data) (see Column 5, lines 21-67; and Column 7, lines 50-59). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have stored the performance characteristics on the sensor unit storage device in order to further improve the reliability and to simplify the system.
Regarding claim 14, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach that the meta data for each sensor probe includes one or more of the group that comprises number of uses, duration of use, number of powerups, number of calibrations, number of autoclaves, slope of calibration, type of experiment, responsiveness to pH detection, responsiveness to DO detection, and responsiveness to temperature detection. However, Hartmann teaches that the meta data for each sensor probe includes number of calibrations (i.e., the sensor unit may be configured for traceably storing the entire calibration history, i.e., traceable information related to all calibrations carried out over the lifespan of the sensor unit) (see Column 8, lines 34-61). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 15, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach a calibration station coupled to the control computer and configured to calibrate one or more sensor probes in response to the determination of static performance characteristics. However, Hartmann teaches a calibration station coupled to the control computer and configured to calibrate one or more sensor probes (i.e., a calibration process for a multiple of sensor units, where (A) the multiple sensor units 1 are placed on a rack 7, and (B) subsequently immersed in a calibration liquid 8. The sensor units are placed on a rack 7, which is electrically connected to an external source, e.g. by a multiplexer, such that the electronic information associated with the calibration, such as the calibration values and the validation, are stored on each of the sensor units) (see Column 12, line 50, to Column 13, line 24) in response to the determination of static performance characteristics (i.e., a second indicator unit configured to be activated when the measured parameters deviate from a predetermined threshold value and when the calibration is no longer validated, or the sensor unit becomes broken or unstable, the sensor unit must be recalibrated or replaced) (see Column 14, lines 4-67)
Regarding claim 17, Patrick teaches a user interface computer coupled to the control computer through a computer network and configured to provide an interface for a remote user to interact with the control computer (i.e., external devices 531-1, 531-2, 531-3 are a computing device configured to perform design analysis, fermentation experiment analysis, fermentation test result analysis, simulations via CFD or optimizations) (see paragraph section [0078]).
Regarding claim 18, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach a testing station coupled to the control computer and configured to test one or more sensor probes in response to the determination of static performance characteristics. However, Hartmann teaches that a testing station coupled to the control computer and configured to test one or more sensor probes in response to the determination of static performance characteristics (i.e., an alert or warning is activated if the sensor unit and/or gateway detects a deviation in the measured parameter from a predetermined threshold value) (see Colum 14, lines 4-62). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have performed routine tests or surveillance in order to detect any sensor instability or malfunction.
Regarding claim 19, Patrick teaches a computer-executable method for tracking performance characteristics of equipment embodied in a computer-readable medium, that when executed by a computer processor (i.e., A bioreactor may comprise one or more memory storage units. The one or more memory storage units may comprise non-transitory computer readable media that may comprise code, logic, or instructions for executing one or more steps) (see paragraph section [0091]) cause the computer system to:
assign a trackable identification (i.e., a detection feature to automatically identify an identity of the one or more sensor (e.g., Serial Number, sensor ID)) (see paragraph section [0040]) to a sensor probe (i.e., sensor 109) (see Fig. 1) configured to be used in a biomanufacturing system (i.e., bioreactor 100) (see Fig. 1), the trackable identification associated with a data set stored in a data store (i.e., a database 510. may be accessible to the device and may provide a library storing model copies, history design models, history performance, printing parameters, fermentation experiment results and the like) (see paragraph section [0077]);
assign initial meta data the respective data set about the associated sensor probe in the data store that is associated with the trackable identification (i.e., an identity of the sensor (e.g., Serial Number) may be identified automatically by a sensor (e.g., RFID transmitter) located at the head-plate) (see paragraph section [004331]);
determine dynamic performance characteristics of the sensor probe during use in the biomanufacturing system (i.e., The head-plate 101 may provide coupling means to couple the various components such as sensors/probes, gas inputs, feed inputs may be removably assembled to the bioreactor via any suitable mechanical coupling means) (see paragraph section [0042]); but does not explicitly teach change the meta data in the data store in response to the determined dynamic performance characteristics; test the sensor probe for static performance characteristics after use in the biomanufacturing system; and change the meta data in the data store in response to the determined static performance characteristics.
Regarding the performance characteristics, teaches determine dynamic performance characteristics of the sensor probe during use in the biomanufacturing system (i.e., the environmental parameter is selected from the group of: temperature, pressure, pH, humidity, CO2, O2, acceleration, sound, light, GPS, particulate matter, and combinations thereof) (see Column 10, lines 38-49); change the meta data in the data store in response to the determined dynamic performance characteristics (i.e., the memory unit is dimensioned for storing the measured parameters) (see Column 5, lines 1-20; and Column 7, lines 50-59); test the sensor probe for static performance characteristics after use in the biomanufacturing system (i.e., to improve the reliability of the sensor measurements, it may be advantageous to repeat the calibration after a certain or predetermined period of using the sensor unit. A second indicator unit configured to be activated when the measured parameters deviate from a predetermined threshold value) (see Column 13, line 17, to Column 14, line 61); and change the meta data in the data store in response to the determined static performance characteristics (i.e., the sensor unit may be configured for traceably storing the entire calibration history, i.e., traceable information related to all calibrations carried out over the lifespan of the sensor unit) (see Column 8, lines 34-61). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Regarding claim 20, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach determining that the sensor probe is unfit for further use in response to determining the dynamic performance characteristics or the static performance characteristics. However, Hartmann teaches determining that the sensor probe is unfit for further use in response to determining the dynamic performance characteristics or the static performance characteristics (i.e., when the calibration is no longer validated, or the sensor unit becomes broken or unstable, the sensor unit must be replaced or recalibrated. A second indicator unit configured to be activated when the measured parameters deviate from a predetermined threshold value) (see Column 14, lines 4-62). In view of the teaching of Hartmann, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have recalibrated the sensor probe when sensor becomes unstable over time, in order to improve the reliability of the sensor measurements.
Claims 6, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (WO 2020/167676) (hereafter Patrick) in view of Hartmann et al. (Pat. No. US 12,055,417) (hereafter Hartmann) and in further view of Grimm et al. (Pat. No. US 11,542,464) (hereafter Grimm)
Regarding claim 6, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach autoclaving the associated sensor probe in response to the testing. However, Grimm teaches autoclaving the associated sensor probe in response to the testing (i.e., in a first part of the integrity check the previously defined measurement-principle-specific quality parameters of the single use probe are determined by a commonly used quality control method before the radiation sterilization. In a second part of the integrity check the same quality parameters are determined again after the radiation sterilization, preferably again in a contactless way, so that the single use component need not be unpacked) (see Column 6, line 7, to Column 8, line 67). In view of the teaching of Grimm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have performed autoclaving in order to further prevent contamination.
Regarding claim 12, Patrick as modified by Hartmann as disclosed above does not directly or implicitly teach autoclaving the associated sensor probe in response to the testing. However, Grimm teaches autoclaving the associated sensor probe in response to the testing (i.e., in a first part of the integrity check the previously defined measurement-principle-specific quality parameters of the single use probe are determined by a commonly used quality control method before the radiation sterilization. In a second part of the integrity check the same quality parameters are determined again after the radiation sterilization, preferably again in a contactless way, so that the single use component need not be unpacked) (see Column 6, line 7, to Column 8, line 67). In view of the teaching of Grimm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have performed autoclaving in order to further prevent contamination.
Regarding claim 16, Patrick and Hartmann as disclosed above does not directly or implicitly teach an autoclave station coupled to the control computer and configured to calibrate one or more sensor probes in response to the determination of static performance characteristics. However, Grimm teaches an autoclave station coupled to the control computer and configured to calibrate one or more sensor probes in response to the determination of static performance characteristics (i.e., in a first part of the integrity check the previously defined measurement-principle-specific quality parameters of the single use probe are determined by a commonly used quality control method before the radiation sterilization. In a second part of the integrity check the same quality parameters are determined again after the radiation sterilization, preferably again in a contactless way, so that the single use component need not be unpacked) (see Column 6, line 7, to Column 8, line 67). In view of the teaching of Grimm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have performed autoclaving in order to further prevent contamination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see PTO-892
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/Tran M. Tran/Examiner, Art Unit 2855