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 § 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
1. Claims 1, 4-7, 14-17, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0178097 to Tai et al. in view of U.S. Patent Application Publication No. 2012/0059603 to Stering and Millipore Sigma “Vmax® Constant Pressure Test for Sizing Aseptic Filters.”
Tai et al. teaches methods of designing membrane filters that involves applying pressure to a sample that is directed to pass through a filter [0010] and collecting experimental data that is used to design membrane filters on the basis of geometry in relationship to transfilter pressure and total filtration time.
Parameters that Tai et al. takes into consideration include inlet pressure, pressure drop across the membrane, filtration time and temperature. [0009]-[0012], [0043], [0059]-0062],[0070]. These parameters render inherent or otherwise obvious the use of at least pressure and temperature sensors.
While Tai et al. teaches testing membrane filters for purposes of designing filters, Tai et al, does not teach details of the embodiments of the testing set-up or testing system.
Stering teaches a system for testing the integrity of filters and refers to filters used in the pharmaceutical industry. [0036]
Stering teaches that “To carry out the integrity test on the filter device various fluid connections has to be manually connected and disconnected in order to fill, pressurize and drain the filter device,” [0004] indicating that systems to test filters can include various components that can be arranged and connected in various configurations.
Stering teaches that “the test apparatus includes a filter integrity testing device having a pressure sensor and/or a flowmeter. The test apparatus also has an inlet connector and an outlet connector.” [0006].
Stering teaches valves that are controlled by means of the filter integrity testing device. [0006]
Stering further teaches a microprocessor that can receive the measurement data generated by the pressure sensor 17 via a pressure data line 67a as well as the measurement data generated by the flowmeter 63 via a flow data line 67b. The measurement data can be stored to a storage medium and/or transmitted to an external data processing device. [0047].
Stering teaches that the filter material 13 can comprise various shapes, for example flat circular shapes or the shape of a filter candle. [0036].
Tai et al. teaches providing a source of sample fluid for testing and applying pressure to the sample fluid and maintaining a constant pressure drop across the filter [0011]. Tai et al. further teaches maintaining a constant flow rate [0134].
In order to monitor pressure and flow rate for purposes of collecting data and designing filters as taught by Tai et al., it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Tai et al. in view of Stering to include a means to receive and store and calculate data in Tai et al. for automation purposes.
Moreover, it would have been obvious to one of ordinary skill in the art to modify the system of Tai et al. with an inlet and an outlet to the filter holder, a filter to be tested and one or more valves to control fluid flow and a fluid line network in view of Stering and arrange and connect these elements with multiple line sections as necessary, it being noted that the use of a plurality of parts is deemed obvious unless a new and unexpected result is achieved (See MPEP 2144 (VI)(B).
Providing Tai et al. with a data receiving instrument, to receive data from the sensors, which is preassembled on program-related or circuit-related basis concerning the reception of sensor data from the sensors, in view of Stering teaching s microprocessor would have been obvious to one of ordinary skill in the art to receive data from the sensors.
Prior to testing a particular filter, it is necessary that the system of Tai et al. be “preassembled.”
In response to claims 1 and 22 previously being amended to recite that “the control unit is used either to keep the pressure of the test medium at a constant value during the filtration experiment and at least the volume flow of the test medium is measured, or to keep the volume flow of the test medium at a constant value and at least the pressure of the test medium is measured,” Millipore Sigma is being cited and relied upon in combination with Tai et al. and Stering.
Tai et al. in view of Stering do not teach a control unit that is used either to keep the pressure of the test medium at a constant value during the filtration experiment and at least the volume flow of the test medium is measured, or to keep the volume flow of the test medium at a constant value and at least the pressure of the test medium is measured.
Millipore Sigma teaches a filtration testing kit that is used to test filter for purposes of predicting filter area requirements for larger, production scale processes. (page 2).
Millipore Sigma’s filtration testing kit has to be assembled prior to use.
As described on pages 7 and 9 Millipore Sigma teaches a method that involves providing a constant pressure of the test medium during the filtration experiment and determining/measuring the volume flow of the test medium.
It would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering to test filters by providing a constant pressure of the test medium during the filtration experiment and determining/measuring the volume flow of the test medium as taught by Millipore Sigma for purposes of using the testing to determine suitable how to design filters to production scale processes as taught by Millipore Sigma.
With regard to claim 1 being amended to recite a data receiving instrument which is configured to receive and record sensor data from the sensor arrangement, Stering teaches “data lines” [0011] and a microprocessor that receives data from a pressure sensor and a flowmeter, rendering it obvious to receive and record sensor data for any of the parameters taught by Tai et al. in view of Stering and Millipore Sigma.
With regard to claim 1 being amended to recite a data processing device which is configured to select and/or dimension, according to predetermined scaling criteria, an applicable filter of a target system for the respective filter of the filtration experiment system, Stering teaches “the measurement data can be stored to a storage medium and/or transmitted to an external data processing device. [0047] Further as noted above, Millipore Sigma teaches testing filters for purposes of predicting filter area requirements for larger, production scale processes. It would have been obvious to use the data processing device or microprocessor of Stering to select and/or dimension, according to predetermined scaling criteria, an applicable filter of a target system for the respective filter of the filtration experiment system.
With regard to claim 1 being amended to recite a data cable connecting the data receiving instrument with the data processing device, as noted above Stering teaches “data lines” [0011] and a microprocessor that receives data from a pressure sensor and a flowmeter and a data processing device.
With regard to claim 1 being amended to recite automatically detecting a start of the filtration experiment and an end of the filtration experiment, Tai et al. teaches that important design parameters include the filter geometry design, fluid delivery method, transfilter pressure and total filtration time (Abstract), rendering it obvious to time the beginning and end of a filtration test. Automating and detecting the start and end of a filtration test for timing purposes would have been obvious since it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. (MPEP 2144.04(III)).
With regard to claim 1 being amended to recite recording sensor data as experiment data for at least one filter, as noted above Stering teaches receiving and recording sensor data.
With regard to claim 1 being amended to recite selecting or dimensioning, according to the predetermined scaling criteria, an applicable filter of the target system for the respective filter of the filtration experiment section by the data processing device, as noted above, Millipore Sigma teaches testing filters for purposes of predicting filter area requirements for larger, production scale processes. Such production processes would have predetermined parameter requirements that would render obvious selecting or dimensioning, according to the predetermined scaling criteria. Further, Tai et al. teaches designing filtration systems.
I.) Regarding applicant’s claim 1, as noted above, Tai et al. in view of Stering and Millipore Sigma teaches all the elements of claim 1.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious.
II.) Regarding applicant’s claim 4, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the filtration experiment system comprises at least one pump or at least one
pneumatic pressure regulator and wherein at least one data receiving instrument is preassembled on a programming-related and/or circuit-related basis concerning the control of the pump and/or of the pneumatic pressure regulator.
As noted above, Tai et al teaches applying pressure to the sample fluid to be tested and therefore inherently includes a pump.
Alternatively, Stering teaches the use of a pump in filter testing.
It would have been obvious to modify Tai et al. in view of Stering and Millipore Sigma to include a pump to apply pressure to the sample fluid. Further Stering teaches automated control [0002]. It would have similarly been obvious to provide automatic control of the pump in Tai et al. as modified by Stering and Millipore Sigma on a programming-related and/or circuit-related basis.
Preassembly is taught by Millipore Sigma and necessary before use of the system of Tai et al. in view of Stering and Millipore Sigma.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 4 obvious.
IV.) Regarding applicant’s claim 5, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that the at least one data receiving instrument is preassembled on a programming-related or circuit-related basis concerning the control of at least one valve of the valve arrangement for a filter wetting process, for a filter venting process, for a filtration experiment with the test medium or for a draining or flushing process.
Tai et al. teaches monitoring and controlling pressure and flowrate and obtaining measurements of these parameters. As noted above, Stering teaches valves and automatic control.
Further Stering teaches the valve unit can comprise wetting liquid pumping means ([0014]) and a venting port ([0018]) and a data storage medium. [0025]
It would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering and Millipore Sigma to include a circuit-related basis concerning the control of at least one valve for a filter wetting process, for a filter venting process, for a filtration experiment with the test medium or for a draining or flushing process.
The system of Tai et al. in view of Stering and Millipore Sigma would be preassembled before use.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 5 obvious.
VI.) Regarding applicant’s claim 6, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the at least one data receiving instrument comprises a power supply, at least one data interface, a memory for storing raw sensor data and/or processed sensor data, a pneumatic inlet, at least one pneumatic outlet, a pneumatic pressure regulator and/or at least one pneumatic pump.
As noted above, Tai et al. teaches supplying, monitoring and controlling fluid pressure and fluid flowrate and obtaining data to perform calculations on filter parameters for purposes of designing filters. It would have been obvious include a power supply, a data interface, a memory for storing and processing sensor data, pneumatic inlet and outlet, a pressure regulator and a pneumatic pump to more efficiently control the experimental set up of Tai et al. and perform the data calculations that Tai et al. teaches for automation purposes.
Further Stering teaches a storage medium and database in an automated filter testing system that includes data obtaining pressure sensors and a pump.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 6 obvious.
VII.) Regarding applicant’s claim 7, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the filtration experiment system is preassembled on a sensor-related basis concerning a measurement principle, specifications or an installation position of at least one sensor of the sensor arrangement, or wherein the filtration experiment system is preassembled on a fluidics-related basis concerning an operating principle, specifications or an installation position of at least one filter of the filter arrangement, or wherein the filtration experiment system is preassembled on a fluidics-related basis concerning a type of actuation, specifications or an installation position of at least
one valve of a valve arrangement, or wherein the filtration experiment system is preassembled on a fluidics-related basis concerning specifications or an installation position of at least one line section of the fluid line network.
When the system of Tai et al. in view of Stering and Millipore Sigma is used, it would be preassembled before use as noted above on at least a sensor-related basis.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 7 obvious.
VIII.) Regarding applicant’s claim 14, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 14 depends.
Claim 14 recites that the filtration experiment system has a support and wherein only one receptacle is fixable or fixed to the support or only one or more sensors of the sensor arrangement are each fixable or fixed to a common support or only one or more assembly modules are each fixable or fixed to the common support.
It is well known in laboratory testing procedures to use various supports and stands to support items of testing equipment, for example, Millipore Sigma teaches a “lab stand or a retort stand.” (page 5)
Therefore, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Tai et al. in view of Stering and Millipore Sigma to use a support or stand to assembly the elements of the filter testing system together, including supporting a receptacle containing the fluid to be filtered to the support or stand.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 14 obvious.
IX.) Regarding applicant’s claim 15, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 15 depends.
Claim 15 recites that in the mounted state, each pair of sensors fixed to a mounting plate has a filter arranged between them that is itself not fixed to the mounting plate.
Tai et al does teaches monitoring fluid pressure. Stering teaches pressure sensors. As noted above, Millipore Sigma teaches providing a constant pressure.
Mounting plates and mounting stands and supports are well known for use in setting up laboratory testing equipment.
In Tai et al. as modified by Stering and Millipore Sigma, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to use a mounting plate to assembly the elements of the filter testing system. Further, in order to monitor pressure drop across the filter, it would have been obvious to provide and mount press sensors on either of sides of the filter to monitor pressure drop across the filter.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 15 obvious.
X.) Regarding applicant’s claim 16, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 16 depends.
Claim 16 recites that the mounting plate is part of a housing of a data receiving instrument.
As noted above, the use of mounting plates and mounting stands and supports are well known for use in setting up laboratory testing equipment.
Stering teaches an apparatus housing. [0051]
It would have been obvious to house the data receiving and processing means of Tai et al. in view of Stering and Millipore Sigma and incorporate the housing together with a mounting plate to set up the test system to protect any electronic components (data receiving instrument) from fluid contamination.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 16 obvious.
XI.) Regarding applicant’s claim 17, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 17 depends.
Claim 17 recites that the respective support and/or the respective stand is mechanically connected to the housing of the balance of the weighing arrangement.
As noted above, it would have been obvious to modify Tai et al. in view of Stering and Millipore Sigma to include a support or stand.
Tai et al. in view of Stering does not teach a weighing arrangement.
Millipore Sigma teaches a balance for weighing filtrate. (pages 5 and 7)
Tai et al. does teach monitoring liquid flowrate.
It is well known to determine flowrate by dividing the amount of fluid - volume or weight - over a time interval.
It would have been obvious to one of ordinary skill in the art to include a include a weighing arrangement in Tai et al. in view of Stering and Millipore Sigma, supported by a support or stand to weigh the amount of test liquid over time to determine the flowrate and any weight loss that might be associated with liquid retained in the test system, including the filter.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 17 obvious.
XII.) Regarding applicant’s claim 21, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 21 depends.
Claim 21 recites the preassembly of the filtration experiment system includes the provision of the software or electrical circuit for a certain filtration experiment in a manner specific to said experiment to the at least one data receiving instrument.
As noted above, Stering teaches automated control [0002] which renders obvious control of the system of Tai et al. as modified by Stering on a programming-related and/or circuit-related basis based on data received from the sensors.
In Tai et al. in view of Stering and Millipore Sigma, the system would necessarily be preassembled before use.
Therefore, Tai et al. in view of Stering and Millipore Sigma render claim 21 obvious.
XIII.) Regarding applicant’s claim 22, claim 22 recites a bioprocessing filtration experiment system for filtering a liquid test medium on small scale as part of a filtration experiment in a filtration experiment section of the filtration experiment system, which filtration experiment section runs from a receptacle for holding the test medium to be filtered to a fluid outlet for the filtered test medium, wherein the filtration experiment system is designed to ascertain, as part of the filtration experiment, sensor data as experiment data for at least one filter, said experiment data being able to be taken as a basis for selecting and/or dimensioning the filter of a target system on large scale according to predetermined scaling criteria; the filtration experiment system comprises:
(i) a filter arrangement containing one or more liquid filters,
(ii) a fluid line network containing multiple line sections via which the test medium reaches the respective filter, and
(ii) a Sensor arrangement containing one or more volume flow sensors or a weighing arrangement containing a balance;
wherein the filtration experiment system is preassembled on an at least partially fluidics-related and/or at least partially sensor-related basis concerning
a) the measurement principle, the specifications and/or the installation position of at least one sensor of the sensor arrangement, and/or
b) the operating principle, the specifications and/or the installation position of at least one filter of the filter arrangement, and/or
c) the type of actuation, the specifications and/or the installation position of at least one valve of the valve arrangement, and/or
d) the specifications and/or the installation position of at least one line section of the fluid line network.
As noted above, Tai et al. teaches methods of designing membrane filters that involves applying pressure to a sample that is directed to pass through a filter [0010] and collecting experimental data that is used to design membrane filters on the basis of geometry in relationship to transfilter pressure and total filtration time.
Parameters that Tai et al. takes into consideration include inlet pressure, pressure drop across the membrane, filtration time and temperature. [0009]-[0012], [0043], [0059]-0062],[0070]. These parameters render inherent or otherwise obvious the use of at least pressure and temperature sensors.
While Tai et al. teaches testing membrane filters for purposes of designing filters, Tai et al, does not teach details of the embodiments of the testing set-up or testing system.
Stering teaches a system for testing the integrity of filters and refers to filters used in the pharmaceutical industry. [0036]
Stering teaches that “To carry out the integrity test on the filter device various fluid connections has to be manually connected and disconnected in order to fill, pressurize and drain the filter device,” [0004] indicating that systems to test filters can include various components that can be arranged and connected in various configurations. As noted above, Stering teaches valves, a fluid line network and a receptacle 27.
Stering teaches that “the test apparatus includes a filter integrity testing device having a pressure sensor and/or a flowmeter. The test apparatus also has an inlet connector, an outlet connector,” [0006].
Stering teaches valves that are controlled by means of the filter integrity testing device. [0006]
Stering further teaches a microprocessor that can receive the measurement data generated by the pressure sensor 17 via a pressure data line 67a as well as the measurement data generated by the flowmeter 63 via a flow data line 67b. The measurement data can be stored to a storage medium and/or transmitted to an external data processing device. [0047].
Stering teaches that the filter material 13 can comprise various shapes, for example flat circular shapes or the shape of a filter candle. [0036].
Tai et al. teaches providing a source of sample fluid for testing and applying pressure to the sample fluid and maintaining a constant pressure drop across the filter [0011]. Tai et al. further teaches maintaining a constant flow rate [0134].
In order to monitor pressure and flowrate for purposes of collecting data and designing filters as taught by Tai et al., it would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering to include a means to receive, store and calculate date in Tai et al. for automation purposes.
Moreover, it would have been obvious to modify the system of Tai et al. with an inlet and an outlet to the filter holder, a filter to be tested and one or more valves to control fluid flow and a fluid line network in view of Stering and arrange and connect these elements with multiple line sections as necessary, it being noted that the use of a plurality of parts is deemed obvious unless a new and unexpected result is achieved (See MPEP 2144 (VI)(B).
Providing Tai et al. with a date receiving instrument, to receive data from the sensors, which is preassembled on program-related or circuit-related basis concerning the reception of sensor data from the sensors, in view of Stering teaching s microprocessor would have been obvious to one of ordinary skill in the art to receive data from the sensors.
Prior to testing a particular filter, it is necessary that the system of Tai et al. be “preassembled.”
In response to claims 1 and 22 being previously amended to recite that “the control unit is used either to keep the pressure of the test medium at a constant value during the filtration experiment and at least the volume flow of the test medium is measured, or to keep the volume flow of the test medium at a constant value and at least the pressure of the test medium is measured,” Millipore Sigma is being cited and relied upon in combination with Tai et al. and Stering.
Tai et al. in view if Stering do not teach a control unit that is used either to keep the pressure of the test medium at a constant value during the filtration experiment and at least the volume flow of the test medium is measured, or to keep the volume flow of the test medium at a constant value and at least the pressure of the test medium is measured.
Millipore Sigma teaches a filtration testing kit that is used to test filter for purposes of predicting filter area requirements for larger, production scale processes. (page 2).
Millipore Sigma’s filtration testing kit has to be assembled prior to use.
As described on pages 7 and 9 Millipore Sigma teaches a method that involves providing a constant pressure of the test medium during the filtration experiment and determining/measuring the volume flow of the test medium.
It would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering to test filters by providing a constant pressure of the test medium during the filtration experiment and determining/measuring the volume flow of the test medium as taught by Millipore Sigma for purposes of using the testing to determine suitable how to design filters to production scale processes as taught by Millipore Sigma.
== With regard to claim 22 being amended to recite a data receiving instrument which is configured to receive and record sensor data from the sensor arrangement, Stering teaches “data lines” [0011] and a microprocessor that receives data from a pressure sensor and a flowmeter, rendering it obvious to receive and record sensor data for any of the parameters taught by Tai et al. in view of Stering and Millipore Sigma.
With regard to claim 22 being amended to recite a data processing device which is configured to select and/or dimension, according to predetermined scaling criteria, an applicable filter of a target system for the respective filter of the filtration experiment system, Stering teaches “the measurement data can be stored to a storage medium and/or transmitted to an external data processing device. [0047] Further as noted above, Millipore Sigma teaches testing filters for purposes of predicting filter area requirements for larger, production scale processes. It would have been obvious to use the data processing device or microprocessor of Stering to select and/or dimension, according to predetermined scaling criteria, an applicable filter of a target system for the respective filter of the filtration experiment system.
With regard to claim 22 being amended to recite a data cable connecting the data receiving instrument with the data processing device, as noted above Stering teaches “data lines” [0011] and a microprocessor that receives data from a pressure sensor and a flowmeter and a data processing device.
With regard to claim 22 being amended to recite automatically detecting a start of the filtration experiment and an end of the filtration experiment, Tai et al. teaches that important design parameters include the filter geometry design, fluid delivery method, transfilter pressure and total filtration time (Abstract), rendering it obvious to time the beginning and end of a filtration test. Automating and detecting the start and end of a filtration test for timing purposes would have been obvious since it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. (MPEP 2144.04(III)).
With regard to claim 22 being amended to recite selecting or dimensioning, according to the predetermined scaling criteria, an applicable filter of the target system for the respective filter of the filtration experiment section by the data processing device, as noted above, Millipore Sigma teaches testing filters for purposes of predicting filter area requirements for larger, production scale processes. Such production processes would have predetermined parameter requirements that would render obvious selecting or dimensioning, according to the predetermined scaling criteria. Further, Tai et al. teaches designing filtration systems.
Therefore, Tai et al. in view of Stering and Millipore Sigma renders claim 22 obvious.
2. Claims 8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tai et al. in view of Stering and Millipore Sigma as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2017/0252703 to Adhikari et al.
I.) Regarding applicant’s claim 8, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 8 depends.
Claim 8 recites at least one sensor of the sensor arrangement, at least one filter of the filter arrangement, at least one valve of a valve arrangement or at least one receptacle together with at least one line section of the fluid line network form an assembly module preassembled on a fluidics-related and/or sensor-related basis, an assembly module or multiple such assembly modules.
Tai et al. teaches a source of test fluid that can be pressurized (inherently in a receptacle) and delivering the fluid to a filter (inherently through a line section).
Stering teaches valves, a fluid line network and a receptacle 27. Millipore Sigma also teaches valves.
Tai in view of Stering and Millipore Sigma does not teach modular configurations.
Adhikari et al. teaches interface modules for filter integrity testing which modules include filters, valves, and fluid networks (See Fig. 2; [0050]) preassembled on a fluids-related basis.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Tai et al. in view of Stering and Millipore Sigma and provide components of the filter testing system in modular form as taught by Adhikari et al. for purposes of convenience of setting up the system and being able to test different filters easily.
Therefore, Tai et al. in view of Stering, Millipore Sigma, and Adhikari et al. renders claim 8 obvious.
II.) Regarding applicant’s claim 11, as noted above Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. renders claim 8 obvious from which claim 11 depends.
Claim 11 recites wherein every assembly module on which a filter is arrangeable or arranged has precisely one associated filter.
As noted above, It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Tai et al. in view of Stering and Millipore Sigma and provide components of the filter testing system in modular form as taught by Adhikari et al. for purposes of convenience of setting up the system and being able to test different filters easily.
Providing one filter in each interchangeable module would have been obvious for purposes of testing only one filter at a time.
Therefore, Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. renders claim 11 obvious.
III.) Regarding applicant’s claim 12, as noted above Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. renders claim 8 obvious from which claim 12 depends.
Claim 12 recites the respective assembly module comprises at least one pneumatic interface, at least one hydraulic interface and/or at least one electrical interface.
Adhikari et al. teaches pneumatically connecting modules to the house. [0022].
It would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. to include a pneumatic interface to connect the modules to source of fluids used during testing procedures.
Therefore. Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. renders claim 12 obvious.
IV.) Regarding applicant’s claim 13, as noted above Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. renders claim 8 obvious from which claim 13 depends.
Claim 13 recites a mechanical connection of two assembly modules to one another forms at least one pneumatic connection, at least one hydraulic connection or at least one electrical connection between the assembly modules by way of each pair of mutually corresponding interfaces.
As noted above, Adhikari et al. teaches pneumatically connecting modules to the house. [0022].
It would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. to include a pneumatic interfaces on multiple modules that allow multiple modules to connect together so that multiple filters could be tested either parallelly or serially.
Therefore, Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. render claim 13 obvious.
3. Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tai et al. in view of Stering and Millipore Sigma as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2017/0252703 to Adhikari et al. and U.S. Application Publication No. 2017/0189858 to Armgart et al.
I.) Regarding applicant’s claim 9, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 9 depends.
Claim 9 recites that the respective assembly module comprises a housing for holding at least one sensor of the sensor arrangement, at least one filter of the filter arrangement, at least one valve of a valve arrangement or at least one line section of the fluid line network.
Tai et al. in view of Stering and Millipore Sigma does not teach modules.
Adhikari et al. teaches an interface module for filter integrity testing which module refers to a separable unit that can be attached to and detached from a filter testing device. The unit is replaceable or exchangeable with other units identically or similarly constructed [0014].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Tai et al. in view of Stering and Millipore Sigma and provide components of the filter testing system in modular form as taught by Adhikari et al. for purposes of convenience of setting up the system and being able to test different filters easily.
Tai et al., Stering and Millipore Sigma teach monitoring pressures.
Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. does not teach a modular housing for holding at least one sensor.
Armgart et al. teaches a method and device for testing the integrity of filters. Armgart et al. teaches that supply modules and control modules can be included [0075].
It would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. to include a sensor in a module in for control purposes in view of Armgart et al. teaching that modules used in filter integrity testing can include control features.
Therefor claim 9 is obvious over Tai et al. in view of Stering, Millipore Sigma, Adhikari et al. and Armgart et al.
II.) Regarding applicant’s claim 10, as noted above Tai et al. in view of Stering and Millipore Sigma renders claim 1 obvious from which claim 10 depends.
Claim 10 recites that an assembly module is free of filters or comprises a pump [[and/]]or comprises electronics having at least one electrical circuit board for receiving sensor data, and/or for controlling at least one valve or for controlling a pump.
As noted above, Tai et al. in view of Stering and Millipore Sigma does not teach modules.
Adhikari et al. teaches an interface module for filter integrity testing which module refers to a separable unit that can be attached to and detached from a filter testing device. The unit is replaceable or exchangeable with other units identically or similarly constructed [0014].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Tai et al. in view of Stering and Millipore Sigma and provide components of the filter testing system in modular form as taught by Adhikari et al. for purposes of convenience of setting up the system and being able to test different filters easily.
Tai et al., Stering and Millipore Sigma teach monitoring pressures.
Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. does not teach a modular housing for holding at least one sensor.
Armgart et al. teaches a method and device for testing the integrity of filters. Armgart et al. teaches that supply modules and control modules can be included [0075].
It would have been obvious to one of ordinary skill in the art to modify Tai et al. in view of Stering, Millipore Sigma and Adhikari et al. to include a module that contains electronics in view of Armgart et al. teaching that control modules can be used in filter integrity testing.
Therefor claim 10 is obvious over Tai et al. in view of Stering, Millipore Sigma, Adhikari et al. and Armgart et al.
Response to Arguments
Applicant's arguments filed 11/03/2025 have been fully considered but they are not persuasive.
With regard to applicant’s arguing that the prior art of record does not teach the newly added claim limitations, each of the newly added claim limitations is specifically addressed above in a manner which renders the limitations obvious.
Applicant argues that Millipore Sigma does not teach a date receiving instrument which is configured to receive and record sensor data from the sensor arrangement and that the system of Millipore Sigma does not include the data processing device which actually selects and/or dimensions an applicable filter of a target system for the respective filters.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. (MPEP 2144.04 (III))
As noted above, Stering teaches a date receiving instrument which is configured to receive and record sensor data from a sensor arrangement, and the combination of Tai et al. Stering and Millipore Sigma renders obvious a data processing device which selects and/or dimensions an applicable filter of a target system for the respective filters.
Conclusion
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/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798