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 Amendment
Applicant’s amendments to the claims, filed 01/07/2026, are accepted and appreciated by the
Examiner.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to claim 1 have been fully considered and are persuasive in light of the amendments. The combination of Ruegenberg (US 20190064125 A1), Witt (US 20190064124 A1), and Fogwill (US 20190113488 A1), does not explicitly teach “using a data processing system to determine a reference derived from the at least one component characteristic for each fluidic component in the first set of fluidic components, the reference defining an expected configuration based on an intended system topology.” Therefore, the 35 U.S.C. 103 rejection of claim 1 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Breimesser (US 20050054111 A1) and Carpency (US 8775138 B2).
Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to claim 13, have been fully considered and are persuasive. The combination of Song (US 20200240960 A1), Witt (US 20190064124 A1), and Fogwill (US 20190113488 A1), does not explicitly teach “a data processing system configured to utilize the at least one component characteristic for each fluidic component in the first set of fluidic components to determine a reference, obtain the output fluidic characteristic, compare the output fluidic characteristic with the reference, and determine a result based on the comparison including detecting a difference between the first configuration and an expected configuration, the difference including a misconfiguration of the fluidic system or the use of a wrong fluidic component.” Therefore, the 35 U.S.C. 103 rejection of claim 13 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Breimesser (US 20050054111 A1) and Carpency (US 8775138 B2).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 4, 5, 9-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With respect to claim 1,
Step 2A Prong One:
The following bold limitations are considered abstract:
“A method of testing a fluidic system, the method comprising; while the fluidic system is in a first configuration, the first fluidic configuration defining a first flow path, the first flow path comprising a first set of fluidic components, wherein each fluidic component comprises at least one respective component characteristic,
applying a fluid with an input fluidic characteristic to the fluidic system and measuring an output fluidic characteristic;
and using a data processing system to determine a reference derived from the at least one component characteristic for each fluidic component in the first set of fluidic components, the reference defining an expected configuration based on an intended system topology;
compare the measured output fluidic characteristic to the reference; and
determine a result based on the comparison, wherein determining a result comprises detecting a difference between the first configuration and an expected configuration, the difference including a misconfiguration of the fluidic system or the use of a fluidic component not intended for the first configuration.”
The above bolded limitations are directed to abstract ideas and would fall within the “Mathematical Concept” and “Mental Process” groupings of abstract ideas. Determining the reference is a mathematical concept as seen in Para(s). [0041 and 0053] of the specification which show that the reference is calculated by summing the back pressures of each component. According to MPEP 2106.04(C) “A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.” Determining a result based on a comparison is a mental process as it can be done in the human mind using observation, judgement, and opinion. A person can look at two data points and compare them to determine if a component is in use that is not expected.
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements –
“while the fluidic system is in a first configuration, the first fluidic configuration defining a first flow path, the first flow path comprising a first set of fluidic components, wherein each fluidic component comprises at least one respective component characteristic,
applying a fluid with an input fluidic characteristic to the fluidic system and measuring an output fluidic characteristic;”
Examiner views these limitations amount to generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
As such Examiner does NOT view that the claims
-Improve the functioning of a computer, or to any other technology or technical field
-Apply the judicial exception with, or by use of, a particular machine - see MPEP
2106.05(b)
-Effect a transformation or reduction of a particular article to a different state or thing -
see MPEP 2106.05(c)
-Apply or use the judicial exception in some other meaningful way beyond generally
linking the use of the judicial exception to a particular technological environment, such that the
claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP
2106.05(e) and Vanda Memo.
Moreover, Examiner views the claims to be merely generally linking the use of the judicial exception to a generic fluidic system. Furthermore, measuring the output fluidic characteristic of and applied fluid is viewed as mere data gathering. Using a data processing system to perform the abstract idea is just using a computer as a tool.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Considering the claim as a whole, one of ordinary skill in the art would not know the practical application of the present invention since the claims do not apply or use the judicial exception in some meaningful way. As currently claimed, Examiner views that the additional elements do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, because the claim fails to recite clearly how the judicial exception is applied in a manner that does not monopolize the exception because the limitations “while the fluidic system is in a first configuration, the first fluidic configuration defining a first flow path, the first flow path comprising a first set of fluidic components, wherein each fluidic component comprises at least one respective component characteristic, applying a fluid with an input fluidic characteristic to the fluidic system and measuring an output fluidic characteristic;” just tie the claim to some fluidic system. Examiner further notes that such additional elements are viewed to be well known routine and conventional as evidenced by Ruegenberg (US 20190064125 A1) and Breimesser (US 20050054111 A1).
With respect to claim 13,
Step 2A Prong One:
The following bold limitations are considered abstract:
“A testing system configured for testing a fluidic system, the testing system comprising:
at least one sensor device configured to facilitate measuring an output fluidic characteristic of the fluidic system in a first configuration, the first configuration defining a first flow path comprising a first set of fluidic components wherein each fluidic component comprises at least one component characteristic, respectively;
a data processing system configured to utilize the at least one component characteristic for each fluidic component in the first set of fluidic components to determine a reference, obtain the output fluidic characteristic, compare the output fluidic characteristic with the reference, and determine a result based on the comparison including detecting a difference between the first configuration and an expected configuration, the difference including a misconfiguration of the fluidic system or the use of a wrong fluidic component.”
The above bolded limitations are directed to abstract ideas and would fall within the “Mathematical Concept” and “Mental Process” groupings of abstract ideas. Determining the reference is a mathematical concept as seen in Para(s). [0041 and 0053] of the specification which show that the reference is calculated by summing the back pressures of each component. According to MPEP 2106.04(C) “A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.” Determining a result based on a comparison is a mental process as it can be done in the human mind using observation, judgement, and opinion. A person can look at two data points and compare them to determine if a component is in use that is not expected.
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements –
“A testing system configured for testing a fluidic system, the testing system comprising:
at least one sensor device configured to facilitate measuring an output fluidic characteristic of the fluidic system in a first configuration, the first configuration defining a first flow path comprising a first set of fluidic components wherein each fluidic component comprises at least one component characteristic, respectively;”
Examiner views these limitations amount to generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
As such Examiner does NOT view that the claims
-Improve the functioning of a computer, or to any other technology or technical field
-Apply the judicial exception with, or by use of, a particular machine - see MPEP
2106.05(b)
-Effect a transformation or reduction of a particular article to a different state or thing -
see MPEP 2106.05(c)
-Apply or use the judicial exception in some other meaningful way beyond generally
linking the use of the judicial exception to a particular technological environment, such that the
claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP
2106.05(e) and Vanda Memo.
Moreover, Examiner views the claims to be merely generally linking the use of the judicial exception to a generic fluidic system. Furthermore, measuring the output fluidic characteristic of and applied fluid using a generic sensor is viewed as mere data gathering. Using a data processing system to perform the abstract idea is just using a computer as a tool.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Considering the claim as a whole, one of ordinary skill in the art would not know the practical application of the present invention since the claims do not apply or use the judicial exception in some meaningful way. As currently claimed, Examiner views that the additional elements do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, because the claim fails to recite clearly how the judicial exception is applied in a manner that does not monopolize the exception because the limitations “while the fluidic system is in a first configuration, the first fluidic configuration defining a first flow path, the first flow path comprising a first set of fluidic components, wherein each fluidic component comprises at least one respective component characteristic, applying a fluid with an input fluidic characteristic to the fluidic system and measuring an output fluidic characteristic;” just tie the claim to some fluidic system. Examiner further notes that such additional elements are viewed to be well known routine and conventional as evidenced by Ruegenberg (US 20190064125 A1) and Breimesser (US 20050054111 A1).
Dependent claims 2, 4, 5, 9-12, 14, and 15 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claims are not directed to an abstract idea, as detailed below:
The dependent claims are directed to a further analysis of the sensor data using mathematical concepts and abstract ideas. The claims are also directed to defining what the measured characteristics are such as pressure, flow rate, fluidic resistance, and back pressure. However, these definitions just loosely link the claim to known concepts. Furthermore, claims 14 and 15 include a memory device which is a well-known computer component and is also viewed as using a computer as a tool.
Therefore, dependent claims 2, 4, 5, 9-12, 14, and 15 further limit the abstract idea with an abstract idea and thus the claims are still directed to an abstract idea without significantly more.
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.
Claims 1, 4, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Breimesser (US 20050054111 A1) in view of Carpency (US 8775138 B2).
With respect to claim 1,
Breimesser teaches,
A method of testing a fluidic system, the method comprising; while the fluidic system is in a first configuration, the first fluidic configuration defining a first flow path, the first flow path comprising a first set of fluidic components, wherein each fluidic component comprises at least one respective component characteristic, (Para. [0011] teaches “This means that the monitored fluid paths are the fluid-conducting structures in the individual parallel-connected micro-fluidic components.” Para. [0020] teaches “In these micro-channels 5, the two combined fluids are mixed in successive mixing stages 6 and may react in the process.” Para. [0021] teaches “Each of the micro-channels 5 has, for example, a pressure sensor 7, which is disposed, in this embodiment, midway in the center.” (i.e. each microchannel has mixing stages and microchannels each with a component characteristic as they change the flow rate and the pressure of the system)
applying a fluid with an input fluidic characteristic to the fluidic system and measuring an output
fluidic characteristic; (Para. [0021] teaches “Each of the micro-channels 5 has, for example, a pressure sensor 7, which is disposed, in this embodiment, midway in the center. The pressure sensors 7 and two additional pressure sensors 8 and 9 for measuring the input and output pressures of the micro-fluidic component 1 are connected to an evaluation unit 10”)
and using a data processing system to determine a reference the reference defining an expected configuration based on an intended system topology; (Para. [0006] teaches “evaluation unit, which diagnoses a change in the operating state of the micro-fluidic system based on deviations in the parameters measured by the sensors.” Para. [0012] teaches “The reference pressure can be the input pressure or output pressure of the fluid at the input or output of the parallel connection, such that, in the event of an obstruction of the fluid path, it can be determined whether the obstruction is located between the input and the site of the pressure measurement or between the site of the pressure measurement and the output.” (i.e. the reference is a path without an obstruction but with the same components. Therefore, it is based on an intended system topology.)
compare the measured output fluidic characteristic to the reference; and determine a result based on the comparison, wherein determining a result comprises detecting a difference between the first configuration and an expected configuration, the difference including a misconfiguration of the fluidic system or the use of a fluidic component not intended for the first configuration. (Para. [0021] teaches “If one of the micro-channels 5 is completely obstructed, e.g., at the location identified by 29, then the associated pressure sensor 7 measures the same pressure as the pressure sensor 8, such that the pressure difference between the associated sensor 7 and the sensor 8 is zero and between the sensor 7 and the sensor 9 equals the total pressure drop across the micro-channels 5. Thus, the evaluation unit 10 can diagnose changes in the operating state of the micro-fluidic component 1 and localize faults in the individual micro-channels 5 based on pressure differences measured by the sensors 7.” (i.e. the microchannel is not intended to be obstructed. Therefore, it is comparing the system without an obstruction or expected configuration with the first configuration with the obstruction. The fluidic component with the obstruction is not intended.)
Breimesser does not explicitly teach,
and using a data processing system to determine a reference derived from the at least one component characteristic for each fluidic component in the first set of fluidic components.
Carpency teaches,
and using a data processing system to determine a reference derived from the at least one component characteristic for each fluidic component in the first set of fluidic components. (Claim 1 teaches “the reference model includes at least one simulated intermediate fluid stream, one of the intermediate streams being a designated intermediate stream, (A) the designated intermediate stream having a total mass flow rate {F} within the reference model, (B) the designated intermediate stream including a third vector of rank j of molecular components {C}, j .gtoreq.1, and (C) each of the j molecular components of the designated intermediate stream having a corresponding mass flow rate {CF.sub.j} within the reference model, the sum of each of the component mass flow rates {CF.sub.j} being substantially equal to the total mass flow rate {F}; and (iv) at least one of the outputs simulates an output fluid from the reference model.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Breimesser with using a data processing system to determine a reference derived from the at least one component characteristic for each fluidic component in the first set of fluidic components such as that of Carpency.
One of ordinary skill would have been motivated to modify Breimesser, because each element would impact the flow of the fluid. Any reference would need to account for all of the components in order to reflect the actual system in an accurate way. Therefore, one would be motivated to combine the references for a more accurate comparison.
With respect to claim 4,
Breimesser further teaches,
the method of claim 1, wherein each of the at least one component characteristic respectively comprises a component fluidic resistance, at least one feature indicative for the component fluidic resistance or any combination thereof. (Para. [0004] teaches “micro-fluidic systems are subject to operational changes in the effective flow resistance due to both local fluctuations in the viscosity of the fluid and obstructions in the fluid paths, which can further change the operating conditions and cause progressive obstruction, resulting eventually in complete failure of the system.” (i.e. feature indicative of component fluidic resistance)
With respect to claim 10,
Breimesser further teaches,
the method of claim 1, wherein measuring an output fluidic characteristic comprises measuring the output fluidic characteristic with at least one sensor device configured to measure the output fluidic characteristic, a feature indicative of the output fluidic characteristic or any combination thereof. (Para. [0021] teaches “The pressure sensors 7 and two additional pressure sensors 8 and 9 for measuring the input and output pressures of the micro-fluidic component 1 are connected to an evaluation unit 10.”)
With respect to claim 13,
Breimesser teaches,
A testing system configured for testing a fluidic system, the testing system comprising; at least one sensor device configured to facilitate measuring an output fluidic characteristic of the fluidic system in a first configuration, the first configuration defining a first flow path comprising a first set of fluidic components wherein each fluidic component comprises at least one component characteristic, respectively; (Para. [0011] teaches “This means that the monitored fluid paths are the fluid-conducting structures in the individual parallel-connected micro-fluidic components.” Para. [0020] teaches “In these micro-channels 5, the two combined fluids are mixed in successive mixing stages 6 and may react in the process.” Para. [0021] teaches “Each of the micro-channels 5 has, for example, a pressure sensor 7, which is disposed, in this embodiment, midway in the center. The pressure sensors 7 and two additional pressure sensors 8 and 9 for measuring the input and output pressures of the micro-fluidic component 1 are connected to an evaluation unit 10”” (i.e. each microchannel has mixing stages and microchannels each with a component characteristic as they change the flow rate and the pressure of the system)
a data processing system configured to obtain the output fluidic characteristic, compare the output fluidic characteristic with the reference, and determine a result based on the comparison including detecting a difference between the first configuration and an expected configuration, the difference including a misconfiguration of the fluidic system or the use of a wrong fluidic component. (Para. [0006] teaches “evaluation unit, which diagnoses a change in the operating state of the micro-fluidic system based on deviations in the parameters measured by the sensors.” Para. [0012] teaches “The reference pressure can be the input pressure or output pressure of the fluid at the input or output of the parallel connection, such that, in the event of an obstruction of the fluid path, it can be determined whether the obstruction is located between the input and the site of the pressure measurement or between the site of the pressure measurement and the output.” (i.e. the reference is a path without an obstruction but with the same components. Therefore, it is based on an intended system topology. Para. [0021] teaches “If one of the micro-channels 5 is completely obstructed, e.g., at the location identified by 29, then the associated pressure sensor 7 measures the same pressure as the pressure sensor 8, such that the pressure difference between the associated sensor 7 and the sensor 8 is zero and between the sensor 7 and the sensor 9 equals the total pressure drop across the micro-channels 5. Thus, the evaluation unit 10 can diagnose changes in the operating state of the micro-fluidic component 1 and localize faults in the individual micro-channels 5 based on pressure differences measured by the sensors 7.” (i.e. the microchannel is not intended to be obstructed. Therefore, it is comparing the system without an obstruction or expected configuration with the first configuration with the obstruction. The fluidic component with the obstruction is considered wrong.)
Breimesser does not explicitly teach,
a data processing system configured to utilize the at least one component characteristic for each fluidic component in the first set of fluidic components to determine a reference,
Carpency teaches,
a data processing system configured to utilize the at least one component characteristic for each fluidic component in the first set of fluidic components to determine a reference, (Claim 1 teaches “the reference model includes at least one simulated intermediate fluid stream, one of the intermediate streams being a designated intermediate stream, (A) the designated intermediate stream having a total mass flow rate {F} within the reference model, (B) the designated intermediate stream including a third vector of rank j of molecular components {C}, j .gtoreq.1, and (C) each of the j molecular components of the designated intermediate stream having a corresponding mass flow rate {CF.sub.j} within the reference model, the sum of each of the component mass flow rates {CF.sub.j} being substantially equal to the total mass flow rate {F}; and (iv) at least one of the outputs simulates an output fluid from the reference model.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Breimesser with a data processing system configured to utilize the at least one component characteristic for each fluidic component in the first set of fluidic components to determine a reference such as that of Carpency.
One of ordinary skill would have been motivated to modify Breimesser, because each element would impact the flow of the fluid. Any reference would need to account for all of the components in order to reflect the actual system in an accurate way. Therefore, one would be motivated to combine the references for a more accurate comparison.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Breimesser (US 20050054111 A1) in view of Carpency (US 8775138 B2) as applied to claim 1 above, and further in view of Ruegenberg (US 20190064125 A1).
With respect to claim 2,
Breimesser does not explicitly teach,
the method of claim 1, wherein the input fluidic characteristic is a flow rate and the output fluidic characteristic is a pressure or wherein the input fluidic characteristic is a pressure and the output fluidic characteristic is a flow rate.
Ruegenberg teaches,
the method of claim 1, wherein the input fluidic characteristic is a flow rate and the output fluidic characteristic is a pressure or wherein the input fluidic characteristic is a pressure and the output fluidic characteristic is a flow rate. (Para. [0502] “Via the intake pipes 300a and 300b, two pump blocks 302a and 302b aspirate the solvent from solvent containers 301a and 301b. Pressure sensors 303a and 302b detect the pressures at the outlets of the pump blocks 302a, 302b.” Para. [0503] teaches “The temperature-controlled flow sensors 200a and 200b according to embodiments of the invention constantly measure the two partial flows and forward the measurement values to a control unit 320.”. As seen in Fig. 17 these flow rate sensors are placed on the outputs of respective flow paths. So, the input fluidic characteristic is pressure and the output characteristic is flow rate.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breimesser and Carpency wherein the input fluidic characteristic is a flow rate and the output fluidic characteristic is a pressure or wherein the input fluidic characteristic is a pressure and the output fluidic characteristic is a flow rate such as that of Ruegenberg.
One of ordinary skill would have been motivated to modify the combination of Breimesser and Carpency, because Breimesser teaches measuring flow rate as seen in Para. [0008]. Since there is only one input sensor and one output sensor in the system of Breimesser it would be obvious to try one of them being a flow rate sensor and the other being a pressure sensor. Furthermore, the sensor configuration in Ruegenberg allows for high precision as seen in Para. [0032].
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Breimesser (US 20050054111 A1) in view of Carpency (US 8775138 B2) as applied to claim 1 above, and further in view of Schlake (US 20180345175 A1).
With respect to claim 5,
The combination of Breimesser and Carpency teaches the method of claim 1.
Breimesser further teaches,
wherein measuring an output fluidic characteristic comprises measuring an output fluidic characteristic corresponding to the first flow path, (Para. [0021] teaches “The pressure sensors 7 and two additional pressure sensors 8 and 9 for measuring the input and output pressures of the micro-fluidic component 1 are connected to an evaluation unit 10.”)
Breimesser does not explicitly teach,
and wherein measuring an output fluidic characteristic corresponding to the first flow path comprises determining a backpressure of the first flow path.
Schlake teaches,
and wherein measuring an output fluidic characteristic corresponding to the first flow path comprises determining a backpressure of the first flow path. (Para. [0017] teaches “The controller is configured and operable to: receive the real-time flowrate and real-time back pressure from the flow controller and back pressure regulator, respectively; compare the real-time flowrate against a preselected setpoint flowrate operating preprogrammed into the controller; automatically adjust the flow controller to maintain the setpoint flowrate; compare the real-time back pressure against a preselected setpoint minimum back pressure preprogrammed into the controller; and automatically adjust the back pressure regulator to maintain the minimum back pressure on the chromatography vessel. The controller simultaneously controls the flow control metering valve and back pressure regulator in tandem to maintain the liquid mobile phase composed of a liquified gas and miscible organic solvent as a single-phase liquid.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breimesser and Carpency wherein measuring an output fluidic characteristic corresponding to the first flow path comprises determining a backpressure of the first flow path such as that of Schlake.
One of ordinary skill would have been motivated to modify the combination of Breimesser and Carpency, because a large increase or decrease in backpressure could indicate a blockage or a leak. Therefore, monitoring backpressure would allow the method to tell if there is something wrong with the system thus preventing catastrophic error.
With respect to claim 9,
The combination of Breimesser and Carpency teaches the method of claim 1.
Breimesser does not explicitly teach,
wherein determining the reference comprises calculating a nominal backpressure of the first flow path.
Schlake teaches,
wherein determining the reference comprises calculating a nominal backpressure of the first flow path. (Para. [0017] teaches “compare the real-time back pressure against a preselected setpoint minimum back pressure preprogrammed into the controller; and automatically adjust the back pressure regulator to maintain the minimum back pressure on the chromatography vessel.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breimesser and Carpency wherein determining the reference comprises calculating a nominal backpressure of the first flow path such as that of Schlake.
One of ordinary skill would have been motivated to modify the combination of Breimesser and Carpency, because if there is a significant increase or decrease in the back pressure, this may indicate a leak or a blockage in the system. The reference should be determined by back pressure because it is a critical measurement for the health of the system.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Breimesser (US 20050054111 A1) in view of Carpency (US 8775138 B2) as applied to claim 1 above, and further in view of Bozic (US 20170167476 A1).
With respect to claim 11,
The combination of Breimesser and Carpency does not explicitly teach,
the method of claim 1, wherein comparing the measured output fluidic characteristic to a reference comprises calculating a distance metric between the measured output fluidic characteristic and the reference, defining a lower threshold margin and/or an upper threshold margin, and comparing the distance metric to the lower threshold margin and/or to the upper threshold margin.
Bozic teaches,
wherein comparing the measured output fluidic characteristic to a reference comprises calculating a distance metric between the measured output fluidic characteristic and the reference, defining a lower threshold margin and/or an upper threshold margin, and comparing the distance metric to the lower threshold margin and/or to the upper threshold margin. (Para. [0064] teaches “In the event that the pressure difference p1-p2 between first output pressure p1 and second output pressure p2 is above a given upper threshold x1 in a next step 206 the second pump 30 will be activated. As a consequence, the second output pressure p2 rises which will be measured in step 202. If the pressure difference p1-p2 is still too large the loop of steps 202, 204, 206 continues until it is determined in step 204 that the pressure difference between first and second output pressures p1, p2 is smaller than x1 but larger than x2 defining a lower threshold of the difference between p1 and p2.” Where p2 would be the reference.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breimesser and Carpency wherein comparing the measured output fluidic characteristic to a reference comprises calculating a distance metric between the measured output fluidic characteristic and the reference, defining a lower threshold margin and/or an upper threshold margin, and comparing the distance metric to the lower threshold margin and/or to the upper threshold margin such as that of Bozic.
One of ordinary skill would have been motivated to modify the combination of Breimesser and Carpency, because comparing data to two different defined thresholds could indicate different concerns regarding the system as seen in Bozic.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Breimesser (US 20050054111 A1) in view of Carpency (US 8775138 B2) as applied to claim 1 above, and further in view of Choikhet (US 9417219 B2).
With respect to claim 12,
The combination of Breimesser and Carpency does not explicitly teach,
the method of claim 1, wherein the method further comprises determining a result based on the comparison and wherein determining a result comprises at least one of detecting and locating a difference between the first configuration and an expected configuration wherein locating the difference comprises identifying which fluidic component's stored component characteristic is inconsistent with the measured output fluidic characteristic.
Choikhet teaches,
wherein the method further comprises determining a result based on the comparison and wherein determining a result comprises at least one of detecting and locating a difference between the first configuration and an expected configuration wherein locating the difference comprises identifying which fluidic component's stored component characteristic is inconsistent with the measured output fluidic characteristic. (Col. 8 Ln. [19 -25] teach “For example, the action may comprise operating a pump delivering a respective fluid to a respective fluid supply path having a detected and located leak with an increased flow rate as compared to a leak-free operation in accordance with a leak rate in the respective fluid supply path.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breimesser and Carpency wherein the method further comprises determining a result based on the comparison and wherein determining a result comprises at least one of detecting and locating a difference between the first configuration and an expected configuration wherein locating the difference comprises identifying which fluidic component's stored component characteristic is inconsistent with the measured output fluidic characteristic such as that of Choikhet.
One of ordinary skill would have been motivated to modify the combination of Breimesser and Carpency because finding a leak in the system as done in Choikhet would prevent further malfunctioning of the system.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Breimesser (US 20050054111 A1) in view of Carpency (US 8775138 B2) as applied to claim 13 above, and further in view of Song (US 20200240960 A1).
With respect to claim 14,
Breimesser further teaches,
wherein the fluidic system comprises a plurality of fluidic components, each comprising a respective volume that can be occupied by a fluid flowing in the fluidic system, wherein each fluidic component comprises at least one component characteristic, respectively, (Para. [0020] teaches “Fig. 1 shows that the microchannels 5 and the mixing stages 6 contain a volume of fluid. These micro-channels 5 are arranged between two inputs 2 and 3 for two fluids to be mixed and an output 4 for the product being produced by mixing. In these micro-channels 5, the two combined fluids are mixed in successive mixing stages 6 and may react in the process.”)
Breimesser does not explicitly teach,
wherein the testing system further comprises a memory device and wherein the memory device is configured to store a data system, and wherein the data system is configured to store the at least one component characteristic of each fluidic component.
Song further teaches,
wherein the testing system further comprises a memory device and wherein the memory device is configured to store a data system, and wherein the data system is configured to store the at least one component characteristic of each fluidic component. (Para. [0069] “on-board computer readable memory, such as flash memory or any other form of electronic memory device, as well as an on-board electronic processor.” Fig. 2 shows a plurality of fluidic components. Para. [0069] teaches “The on-board memory, if present, may be used to store data relating to the use of the columns of the cartridge, such as supported chromatographic methods or column usage history.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breimesser and Carpency wherein the testing system further comprises a memory device and wherein the memory device is configured to store a data system, and wherein the data system is configured to store the at least one component characteristic of each fluidic component such as that of Song.
One of ordinary skill would have been motivated to modify the combination of Breimesser and Carpency because, using memory would allow the system to access those values at later time.
With respect to claim 15,
Breimesser further teaches,
the testing system of claim 14, utilizing those to calculate the reference and obtain the output fluidic characteristic by obtaining sensor data outputted by the at least one sensor device after performing measurement and based thereon determining the output fluidic characteristic and generate a result based on the comparison. (Para. [0021] teaches “If one of the micro-channels 5 is completely obstructed, e.g., at the location identified by 29, then the associated pressure sensor 7 measures the same pressure as the pressure sensor 8, such that the pressure difference between the associated sensor 7 and the sensor 8 is zero and between the sensor 7 and the sensor 9 equals the total pressure drop across the micro-channels 5. Thus, the evaluation unit 10 can diagnose changes in the operating state of the micro-fluidic component 1 and localize faults in the individual micro-channels 5 based on pressure differences measured by the sensors 7.” (i.e. the microchannel is not intended to be obstructed. Therefore, it is comparing the system without an obstruction or expected configuration with the first configuration with the obstruction. The fluidic component with the obstruction is not intended.)
Breimesser does not explicitly teach,
wherein the data processing system is configured to obtain the reference by obtaining component characteristics and/or fluid characteristics from the memory device.
Song teaches,
wherein the data processing system is configured to obtain the reference by obtaining component characteristics and/or fluid characteristics from the memory device. (Para. [0008] teaches “Nonetheless, by comparing the properties of a solvent—such as viscosity and compressibility—with the expected values which can be obtained through user input or by means of a sensor mechanism, such as bar code, the solvent identity can be validated.” Para. [0110] teaches “In the decision step 708 of the method 700, if the pressure increase meets the expected pressure increase profile—that is, if the pressure increase is not less than that expected from a pre-determined profile, within a tolerance—then pumping continues at Step 714. Otherwise (if the pressure increase is less than that expected), then one or more air or gas bubbles or pockets are interpreted to be present in the fluid pathway and a warning or notification of this condition is provided at Step 710.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breimesser and Carpency wherein the testing system further comprises a memory device and wherein the memory device is configured to store a data system, and wherein the data system is configured to store the at least one component characteristic of each fluidic component such as that of Song.
One of ordinary skill would have been motivated to modify the combination of Breimesser and Carpency because, the evaluation unit of Breimesser would need to recall values from memory in order to perform the calculations.
Conclusion
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/JOSHUA L FORRISTALL/Examiner, Art Unit 2857
/LINA CORDERO/Primary Examiner, Art Unit 2857
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