DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed 06/24/2026 have been fully considered but they are not persuasive.
In light of the current claim amendments, an updated rejection follows below. While the updated rejection uses the same references, the references are interpreted in a different light in view of the amended claims.
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.
Claims 1, 3-5 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elsbree et al. (hereinafter Elsbree) US 2003/0107588.
Regarding claim 1, Elsbree discloses an apparatus for bioprocess monitoring (mass flow controller or chemical reactor, [0057]) , the apparatus comprising: a controller (PLC 210, [0041]) to monitor a first bioprocess instrument; a data logger to collect data for the first bioprocess instrument, (TrendWorX32 is a powerful collection of real-time trending, historical data logging, reporting and analysis tools, which seamlessly integrates with enterprise-wide information systems. [0068]), a configurator (ToolWorX or TrendWorX32) to configure the first bioprocess instrument [0030, 0064-0065 and 0068] and a user interface (user interface 322, [0050]) to display the data to a user (display terminal 304), the data including real-time bioprocess monitoring data [0064-0065]. See [0039-0087]. Also see whole document.
Elsbree discloses an alert manager, AlarmWorX32, an enterprise wide alarm and events management system. It includes powerful alarm detection, sorting, filtering, viewing, logging, OPC Server, Alarm Tag Browser and much more. The user can define Alarm Schemas, which can include alarm filtering, priorities and alarm notification. This user defined Alarm Schema can be then download to the target Windows CE device, where it can be operated, as discussed below in connection with FIG. 12. A row 1112 can be configured by a user. The smallest pane 1120 is an interactive dialog box that allows a user to configure a single row 1112. The pane 1120 includes a series of tabs 1130 that provide access to the various configuration functions that the user can employ to define an alarm or an event, such as row 1112 [0076-0080]. Therefore, AlarmWorX32 can be programmed to monitor a manually adjustable operation to be performed prior to initiation of a bioprocess associated with the first bioprocess instrument i.e., trigger an alert related to manual operations that are not performed and/or confirmed prior to commencement of an operation.
As to the data including data collected while the first bioprocess instrument is transferred from a first location to a second location; the controller to adjust a setting of the first bioprocess instrument based on the real-time bioprocess monitoring data, the real-time bioprocess monitoring data used to maintain controlled environmental conditions within a vessel of the instrument during ongoing processing when the instrument is in transit from the first location to the second location; and to operate in a first mode at the first location and in a second mode at the second location, the first or second mode determined based on a type of processing at the first or second location, the device disclosed by Elsbree is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Elsbree is capable of providing the operating conditions as listed in the intended use section of the claim in view of [0041-0042, 0050, 0068 and 0076].
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
As interpreted by the examiner, the limitation “an alert manager to monitor a setting of the first bioprocess instrument” has been interpreted as singular. Therefore, the setting required either (1) automatically adjusting operations including at least one of an agitator shaft power or a rate of stirring or (2) manually adjustable operation to be performed prior to initiation of a bioprocess associated with the first bioprocess instrument, but not both.
Regarding claim 3, the rejection of claim 1 above is relied upon. The first bioprocess instrument of Elsbree appears to be stationary. Therefore, Elsbree discloses wherein the data includes data collected while the first bioprocess instrument is stationary.
Regarding claim 4, Elsbree discloses wherein the first bioprocess instrument includes a bioreactor and a pump [0064 and [0066].
Regarding claim 5, Elsbree discloses wherein the real-time bioprocess monitoring data includes a temperature, [0061, 0066 and 0078].
Regarding claim 7, Elsbree discloses a mass flow controller that both measures and controls the flow of a fluid in [0057, 0064 and 0066]. The contents of the mass flow controller depend on the intended use of the apparatus, which in turn does not patentably distinguish it from the prior art. See MPEP § 2114, Therefore, the first bioprocess instrument of Elsbree is capable of transferring intermediate products, buffers, or cell culture media from the first location to the second location.
Regarding claim 8, Elsbree discloses wherein the controller is to generate an alarm notification when the data deviates from a tolerance limit for a nominal value [0042, 0045, 0076 and 0083-0084].
Regarding claim 9, Elsbree discloses wherein the data logger is to receive the data from the first bioprocess instrument using a wireless transmitter-receiver in communication with the first bioprocess instrument [0043, 0062-0063, 0066 and 0083-0084].
Regarding claim 10, the device disclosed by Elsbree is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Elsbree is capable of providing a variety of operating conditions (i.e., the first mode includes a first operating condition and the second mode includes a second operating condition, the first and second operating conditions determined based on a type of bioprocess task to be performed by the first bioprocess instrument, the bioprocess task being a downstream processing task or an upstream processing task.) in view of [0041, 0045 and 0061].
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 11, the rejection of claim 1 above is relied upon. The first bioprocess instrument of Elsbree is capable of being used for a first batch process, the first and second locations corresponding to locations serving the first batch process.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Elsbree US 2003/0107588 as applied to claims 1, 3-5 and 7-11 above.
Regarding claim 21, the rejection of claim 1 above is relied upon. Elsbree does not expressly disclose wherein the manually adjustable operation includes a bag change in a mixer. However, Elsbree discloses that AlarmWorX32 can be configured by a user. The user can define Alarm Schemas, which can include alarm filtering, priorities and alarm notification. The smallest pane 1120 is an interactive dialog box that allows a user to configure a single row 1112. The pane 1120 includes a series of tabs 1130 that provide access to the various configuration functions that the user can employ to define an alarm or an event, such as row 1112 [0076-0080].
Therefore, absent unexpected results, it would have been prima facie obvious to program AlarmWorX32 to define an alarm or an event to signal a bag change in a mixer so that action can be taken in a timely manner to ensure effective process control.
Claims 2 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Elsbree US 2003/0107588 as applied to claims 1, 3-5, 7-11 and 21 above, and further in view of Cannon et al. (hereinafter Cannon) US 2020/0172852.
Regarding claim 2, Elsbree discloses a settings modifier (computer 10) to modify a setting of the instrument based on the first mode or the second mode; and an operating condition identifier (sensors) to determine an operating condition of the instrument, the operating condition based on the first mode or the second mode [0041].
As to a locator to determine a location of the instrument, Elsbree discloses that sensors are attached to the device. However, Elsbree does not explicitly disclose that the sensor is a proximity/location sensor.
Cannon discloses the use of proximity sensors, and RFID devices to provide location information [0009, 0042, 0158 and 0160].
It would have been obvious to one of ordinary skill to modify Elsbree with the proximity sensors and RFID devices as taught by Cannon in order to keep track of large laboratory equipment such as instruments, refrigerators, liquid nitrogen tanks, etc., so that if one of these is removed or replaced by another piece of equipment, that change will be recorded.
Regarding claim 12, Elsbree discloses wherein the controller is to monitor the first bioprocess instrument and a second bioprocess instrument, the first bioprocess instrument used for a first batch process and the second bioprocess instrument used for a second batch process[0041, 0064 and 0068]. Elsbree also discloses sensors attached to the devices however, Elsbree does not explicitly disclose that the sensor is a proximity/location sensor.
Elsbree also does not disclose that the controller is used to determine a change in location of the first or second bioprocess instrument.
Cannon discloses the use of proximity sensors, and RFID devices to provide location information [0009, 0042, 0158 and 0160].
It would have been obvious to one of ordinary skill to modify Elsbree with the proximity sensors and RFID devices as taught by Cannon in order to keep track of large laboratory equipment such as instruments, refrigerators, liquid nitrogen tanks, etc., so that if one of these is removed or replaced by another piece of equipment, that change will be recorded. Thereby, providing a means for the controller to determine a change in location of the first or second bioprocess instrument.
Regarding claim 13, Elsbree discloses wherein the controller is to monitor the first bioprocess instrument and a second bioprocess instrument, the first instrument used for a first batch process and the second bioprocess instrument used for a second batch process[0041, 0064 and 0068]. Elsbree also discloses sensors attached to the devices however, Elsbree does not explicitly disclose that the sensor is a proximity/location sensor. Elsbree also does not disclose that the controller determines the change in location of the first or second bioprocess instrument based on a type of batch process, a number of bioprocess instruments available, or a location of collection points for the first batch process or the second batch process.
Cannon discloses the use of proximity sensors, and RFID devices to provide location information [0009, 0042, 0158 and 0160].
It would have been obvious to one of ordinary skill to modify Elsbree with the proximity sensors and RFID devices as taught by Cannon in order to keep track of large laboratory equipment such as instruments, refrigerators, liquid nitrogen tanks, etc., so that if one of these is removed or replaced by another piece of equipment, that change will be recorded. Thereby, providing a means for the controller to determine the change in location of the first or second bioprocess instrument based on a type of batch process, a number of bioprocess instruments available, or a location of collection points for the first batch process or the second batch process.
Claims 1, 3-5, 7-11 and 21 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Elsbree US 2003/0107588 in view of Mao et al. (hereinafter Mao) CN 105543085 cited in the IDS filed 04/03/2023.
Regarding claim 1, Elsbree discloses an apparatus for bioprocess monitoring (mass flow controller or chemical reactor, [0057]) , the apparatus comprising: a controller (PLC 210, [0041]) to monitor a first bioprocess instrument; a data logger to collect data for the first bioprocess instrument, (TrendWorX32 is a powerful collection of real-time trending, historical data logging, reporting and analysis tools, which seamlessly integrates with enterprise-wide information systems. [0068]) and a user interface (user interface 322, [0050]) to display the data to a user (display terminal 304), the data including real-time bioprocess monitoring data [0064-0065]. See [0039-0087]. Also see whole document.
Assuming arguendo that one of ordinary skill would not consider ToolWorX or TrendWorX32 of Elsbree to be a configurator to configure the first bioprocess instrument.
Mao disclose the use of a LabVIEW computer. See whole document. LabVIEW is well known in the art to function a configurator. Therefore, absent unexpected results, it would have been obvious to one of ordinary skill in to make a simple substitution of one known element for another (i.e., modifying Elsbree with LabVIEW computer as taught by Mao) motivated by an expectation of success.
Elsbree discloses an alert manager, AlarmWorX32, an enterprise wide alarm and events management system. It includes powerful alarm detection, sorting, filtering, viewing, logging, OPC Server, Alarm Tag Browser and much more. The user can define Alarm Schemas, which can include alarm filtering, priorities and alarm notification. This user defined Alarm Schema can be then download to the target Windows CE device, where it can be operated, as discussed below in connection with FIG. 12. A row 1112 can be configured by a user. The smallest pane 1120 is an interactive dialog box that allows a user to configure a single row 1112. The pane 1120 includes a series of tabs 1130 that provide access to the various configuration functions that the user can employ to define an alarm or an event, such as row 1112 [0076-0080]. Therefore, AlarmWorX32 can be programmed to monitor a manually adjustable operation to be performed prior to initiation of a bioprocess associated with the first bioprocess instrument i.e., trigger an alert related to manual operations that are not performed and/or confirmed prior to commencement of an operation.
As to the data including data collected while the first bioprocess instrument is transferred from a first location to a second location; the controller to adjust a setting of the first bioprocess instrument based on the real-time bioprocess monitoring data, the real-time bioprocess monitoring data used to maintain controlled environmental conditions within a vessel of the instrument during ongoing processing when the instrument is in transit from the first location to the second location; and to operate in a first mode at the first location and in a second mode at the second location, the first or second mode determined based on a type of processing at the first or second location, the device disclosed by Elsbree is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Elsbree is capable of providing the operating conditions as listed in the intended use section of the claim in view of [0041-0042, 0050, 0068 and 0076].
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
As interpreted by the examiner, the limitation “an alert manager to monitor a setting of the first bioprocess instrument” has been interpreted as singular. Therefore, the setting required either (1) automatically adjusting operations including at least one of an agitator shaft power or a rate of stirring or (2) manually adjustable operation to be performed prior to initiation of a bioprocess associated with the first bioprocess instrument, but not both.
Regarding claim 3, the rejection of claim 1 above is relied upon. The first bioprocess instrument of Elsbree appears to be stationary. Therefore, Elsbree discloses wherein the data includes data collected while the first bioprocess instrument is stationary.
Regarding claim 4, Elsbree discloses wherein the first bioprocess instrument includes a bioreactor and a pump [0064 and [0066].
Regarding claim 5, Elsbree discloses wherein the real-time bioprocess monitoring data includes a temperature, [0061, 0066 and 0078].
Regarding claim 7, Elsbree discloses a mass flow controller that both measures and controls the flow of a fluid in [0057, 0064 and 0066]. The contents of the mass flow controller depend on the intended use of the apparatus, which in turn does not patentably distinguish it from the prior art. See MPEP § 2114, Therefore, the first bioprocess instrument of Elsbree is capable of transferring intermediate products, buffers, or cell culture media from the first location to the second location.
Regarding claim 8, Elsbree discloses wherein the controller is to generate an alarm notification when the data deviates from a tolerance limit for a nominal value [0042, 0045, 0076 and 0083-0084].
Regarding claim 9, Elsbree discloses wherein the data logger is to receive the data from the first bioprocess instrument using a wireless transmitter-receiver in communication with the first bioprocess instrument [0043, 0062-0063, 0066 and 0083-0084].
Regarding claim 10, the device disclosed by combination of Elsbree and Mao is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of combination of Elsbree and Mao is capable of providing a variety of operating conditions (i.e., the first mode includes a first operating condition and the second mode includes a second operating condition, the first and second operating conditions determined based on a type of bioprocess task to be performed by the first bioprocess instrument, the bioprocess task being a downstream processing task or an upstream processing task.) in view of [0041, 0045 and 0061 of Elsbree].
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 11, the rejection of claim 1 above is relied upon. The first bioprocess instrument of combination of Elsbree and Mao is capable of being used for a first batch process, the first and second locations corresponding to locations serving the first batch process.
Regarding claim 21, the rejection of claim 1 above is relied upon. Elsbree does not expressly disclose wherein the manually adjustable operation includes a bag change in a mixer. However, Elsbree discloses that AlarmWorX32 can be configured by a user. The user can define Alarm Schemas, which can include alarm filtering, priorities and alarm notification. The smallest pane 1120 is an interactive dialog box that allows a user to configure a single row 1112. The pane 1120 includes a series of tabs 1130 that provide access to the various configuration functions that the user can employ to define an alarm or an event, such as row 1112 [0076-0080].
Therefore, absent unexpected results, it would have been prima facie obvious to program AlarmWorX32 to define an alarm or an event to signal a bag change in a mixer so that action can be taken in a timely manner to ensure effective process control.
Claims 2 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Elsbree US 2003/0107588 in view of Mao CN 105543085 as applied to claims 1, 3-5, 7-11 and 21 above, and further in view of Cannon et al. (hereinafter Cannon) US 2020/0172852.
Regarding claim 2, Elsbree as modified discloses a settings modifier (computer 10) to modify a setting of the instrument based on the first mode or the second mode; and an operating condition identifier (sensors) to determine an operating condition of the instrument, the operating condition based on the first mode or the second mode [0041].
As to a locator to determine a location of the instrument, Elsbree as modified discloses that sensors are attached to the device. However, Elsbree as modified does not explicitly disclose that the sensor is a proximity/location sensor.
Cannon discloses the use of proximity sensors, and RFID devices to provide location information [0009, 0042, 0158 and 0160].
It would have been obvious to one of ordinary skill to modify Elsbree and Mao the proximity sensors and RFID devices as taught by Cannon in order to keep track of large laboratory equipment such as instruments, refrigerators, liquid nitrogen tanks, etc., so that if one of these is removed or replaced by another piece of equipment, that change will be recorded.
Regarding claim 12, Elsbree as modified discloses wherein the controller is to monitor the first bioprocess instrument and a second bioprocess instrument, the first bioprocess instrument used for a first batch process and the second bioprocess instrument used for a second batch process[0041, 0064 and 0068]. Elsbree as modified also discloses sensors attached to the devices. However, Elsbree as modified does not explicitly disclose that the sensor is a proximity/location sensor.
Elsbree as modified also does not disclose that the controller is used to determine a change in location of the first or second bioprocess instrument.
Cannon discloses the use of proximity sensors, and RFID devices to provide location information [0009, 0042, 0158 and 0160].
It would have been obvious to one of ordinary skill to modify Elsbree and Mao with the proximity sensors and RFID devices as taught by Cannon in order to keep track of large laboratory equipment such as instruments, refrigerators, liquid nitrogen tanks, etc., so that if one of these is removed or replaced by another piece of equipment, that change will be recorded. Thereby, providing a means for the controller to determine a change in location of the first or second bioprocess instrument.
Regarding claim 13, Elsbree as modified discloses wherein the controller is to monitor the first bioprocess instrument and a second bioprocess instrument, the first instrument used for a first batch process and the second bioprocess instrument used for a second batch process[0041, 0064 and 0068]. Elsbree as modified also discloses sensors attached to the devices however, Elsbree as modified does not explicitly disclose that the sensor is a proximity/location sensor. Elsbree as modified also does not disclose that the controller determines the change in location of the first or second bioprocess instrument based on a type of batch process, a number of bioprocess instruments available, or a location of collection points for the first batch process or the second batch process.
Cannon discloses the use of proximity sensors, and RFID devices to provide location information [0009, 0042, 0158 and 0160].
It would have been obvious to one of ordinary skill to modify Elsbree and Mao with the proximity sensors and RFID devices as taught by Cannon in order to keep track of large laboratory equipment such as instruments, refrigerators, liquid nitrogen tanks, etc., so that if one of these is removed or replaced by another piece of equipment, that change will be recorded. Thereby, providing a means for the controller to determine the change in location of the first or second bioprocess instrument based on a type of batch process, a number of bioprocess instruments available, or a location of collection points for the first batch process or the second batch process.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
