DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 and 5-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – The claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One - Claim 1 recites a method comprising determining sensor data for one or more sensors of a chromatography device, wherein the sensor data includes profile data representative of pump activity in the chromatography device, and wherein the profile data includes one or more of a flow profile or a pressure profile; determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs; generating, based on the sensor data and the determining a deviation, a component classification for the profile data, wherein the component classification is representative of a component state of the chromatography device; wherein the generating is based on an output of a machine-learning model, and wherein an input to the machine-learning model comprises date representative of the profile data; and generating, based on the component classification, an operational status associated with the chromatography device, wherein the operational status is representative of performance of the chromatography device.
The limitations of “determining sensor data”, “determining, based on the sensor data, a deviation of a pressure from a target value”, “generating, based on the sensor data, a component classification”, and “generating, based on the component classification, an operational status” are processes that, under broadest reasonable interpretation, cover performance of the limitation in the mind. These limitations fall under the abstract idea category of (c) mental processes as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that each of these recitations is directed to a judicial exception. See MPEP § 2106.04(a)(2)(III).
Furthermore, Claim 1 is directed to “wherein the generating is based on an output of a machine-learning model, and wherein an input to the machine-learning model comprises date representative of the profile data”.
This limitation falls under the abstract idea category of (a) mathematical concepts as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that this recitation is directed to a judicial exception. See MPEP § 2106.04(a)(2)(I)(A), directed to mathematical relationships.
A user may “determine sensor data including profile data representative of pump activity” by viewing pressure profile data in graphical form. A user may “determine, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs” by viewing the pressure deviation and cycle time data in tabular or graphical form. The user can then “generate a component classification” by reading a table of classifications vs profile data using a machine learning model as a tool. Finally, a user can “generate an operational status” by reading a table of classifications vs operational status. Claim 2 is directed to further identifying sensor data. Claims 5 and 6 are directed to further identifying the operational status.
Step 2A, Prong Two - These judicial exceptions are not integrated into a practical application. The limitation in Claim 1 of “wherein the operational status is representative of performance of the chromatography device” is recited at a high level and is directed to generally linking the “determining” and “generating” judicial exceptions to a particular technological environment or field of use. See MPEP § 2106.05(h). In addition, Claim 7 recites “performing an action based on the operational status” and includes a list of options. However, as in Claim 1, the options in the list are recited at a high level and are directed to generally linking the “determining” and “generating” judicial exceptions to a particular technological environment or field of use. See MPEP § 2106.05(h).
Step 2B - The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements recited at a high level in Claim 7 of “performing an action based on the operational status” do not result in a particular transformation of the operational status to a different state (i.e., sending a message, outputting an alert, outputting an indication, writing a message to a log file). See MPEP § 2106.05(c). Furthermore, the options of “repeating an injection” and “a self-recovery action” are nothing more than well-understood, routine, and conventional activity. See MPEP § 2106.05(d). Claims 1-2 and 5-7 are not patent eligible.
Claims 8 and 10-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – The claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One - Claim 8 recites a method comprising receiving, based on a user input to a user interface of a chromatography system, data indicative of a procedure for performing a chromatography operation by a chromatography device of the chromatography system; causing, based on the data indicative of the procedure, the chromatography device to perform the chromatography operation; determining, based on sensor data representative of performance of the chromatography device during the chromatography operation, a deviation of a pressure from a target value within a cycle of a pump of the chromatography device, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs; generating, based on the sensor data and the determining a deviation, a classification of the chromatography operation, wherein the classification is representative of one or more of a component state associated with operation of the chromatography device, and wherein the generating is based on an output of a machine-learning model, and wherein an input to the machine-learning model comprises data representative of the profile data; and performing an action based on the classification.
The limitations of “determining, based on sensor data representative of performance of the chromatography device” and “generating, based on sensor data representative of performance of the chromatography device during the chromatography operation, a classification of the chromatography operation” are processes that, under broadest reasonable interpretation, cover performance of the limitation in the mind. These limitations fall under the abstract idea category of (c) mental processes as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that these recitations are directed to judicial exceptions. See MPEP § 2106.04(a)(2)(III).
Furthermore, Claim 8 is directed to “wherein the generating is based on an output of a machine-learning model, and wherein an input to the machine-learning model comprises date representative of the profile data”.
This limitation falls under the abstract idea category of (a) mathematical concepts as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that this recitation is directed to a judicial exception. See MPEP § 2106.04(a)(2)(I)(A), directed to mathematical relationships.
A user may “determine, based on sensor data representative of performance of the chromatography device during the chromatography operation, a deviation of a pressure from a target value within a cycle of a pump of the chromatography device, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs” by viewing the pressure deviation and cycle time data in tabular or graphical form. A user may “generate a classification of the chromatography operation” by reading a table of classifications vs profile data using a machine learning model as a tool. Claim 10 is directed to further identifying the chromatography operation.
Step 2A, Prong Two - These judicial exceptions are not integrated into a practical application. The limitation in Claim 8 of “performing an action based on the classification” is recited at a high level and is directed to generally linking the “generating” judicial exception to a particular technological environment or field of use. See MPEP § 2106.05(h). In addition, Claims 11 and 12 recite “outputting an advisory message” and Claim 13 recites a list of actions that may be taken. However, as in Claim 1, the outputs and the list are recited at a high level and are directed to generally linking the “determining” and “generating” judicial exceptions to a particular technological environment or field of use. See MPEP § 2106.05(h).
Step 2B - The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements recited at a high level in Claims 11 and 12 of “outputting an advisory message performing an action based on the operational status” do not result in a particular transformation of the operational status to a different state. See MPEP § 2106.05(c). Furthermore, the options in Claim 13 are nothing more than well-understood, routine, and conventional activity. See MPEP § 2106.05(d). Claims 8 and 10-13 are not patent eligible.
Claims 14-16 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – The claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One - Claim 14 recites a method comprising accessing sensor data representative of one or more operations performed by a chromatography device; determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of a pump of the chromatography device, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs; generating, based on the sensor data, an operational status associated with the chromatography device, wherein the operational status is representative of performance of the chromatography device; and causing output, via a user interface and based on the operational status, of a maintenance protocol associated with the chromatography device.
The limitations of “determining, based on the sensor data” and “generating, based on the sensor data, an operational status” are processes that, under broadest reasonable interpretation, cover performance of the limitation in the mind. This limitation falls under the abstract idea category of (c) mental processes as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that each of these recitations is directed to a judicial exception. See MPEP § 2106.04(a)(2)(III).
A user may “determine, based the sensor data, a deviation of a pressure from a target value within a cycle of a pump of the chromatography device, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs” by viewing the pressure deviation and cycle time data in tabular or graphical form. A user can “generate, based on the sensor data, an operational status” by reading a table of operational status vs sensor data. Claims 15 and 16 are directed to identifying operations performed by the chromatography device. Claim 18 is directed to further identifying sensor data. Claims 19 and 20 are directed to further identifying the maintenance protocol.
Step 2A, Prong Two - These judicial exceptions are not integrated into a practical application. The limitation in Claim 14 of “wherein the operational status is representative of performance of the chromatography device” is recited at a high level and is directed to generally linking the “determining” and “generating” judicial exceptions to a particular technological environment or field of use. See MPEP § 2106.05(h). In addition, Claim 14 recites “causing output, via a user interface and based on the operational status, of a maintenance protocol associated with the chromatography device” and includes a list of options. However, Claim 14 does not require the maintenance protocol to be implemented, and the “causing” step is directed to generally linking the “determining” and “generating” judicial exceptions to a particular technological environment or field of use. See MPEP § 2106.05(h).
Step 2B - The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements recited at a high level in Claims 14, 19, and 20 of “causing output, via a user interface and based on the operational status, of a maintenance protocol associated with the chromatography device” do not result in a particular transformation of the operational status to a different state. See MPEP § 2106.05(c). Furthermore, the operations in Claims 15 and 16 are nothing more than well-understood, routine, and conventional activity. See MPEP § 2106.05(d). Claims 14-16 and 18-20 are not patent eligible.
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.
Claims 1-2, 5-8, 10-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kaminski et al (US 2021/0063363) in view of Carneiro et al (US 2020/0387790).
With regard to Claim 1, Kaminski et al (Kaminski) discloses a method of monitoring a state of a liquid chromatography (LC) stream of an automated analyzer, including automatically monitoring a system pressure of an injection assembly of the liquid chromatography stream to generate a time series of system pressure, classifying the time series in one of two or more predetermined classes indicating different states of the LC stream and triggering a response based on the classification result (Abstract).
Kaminski discloses a method comprising determining sensor data for one or more sensors of a chromatography device ([0060], system pressure can be monitored by a pressure sensor arranged in the injection assembly or the components attached to the injection assembly). Kaminski discloses wherein the sensor data includes profile data representative of pump activity in the chromatography device, and wherein the profile data includes one or more of a flow profile or a pressure profile ([0059], Figure 3, a system pressure of the injection assembly during the injection process can be monitored to generate a time series).
Kaminski discloses generating, based on the sensor data, a component classification for the profile data, wherein the component classification is representative of a component state of the chromatography device (Abstract, automatically monitoring a system pressure of an injection assembly of the liquid chromatography stream to generate a time series of system pressure, classifying the time series in one of two or more predetermined classes indicating different states of the LC stream).
Kaminski discloses wherein the generating is based on an output of a machine-learning model, and wherein an input to the machine-learning model comprises data representative of the profile data ([0046], in some examples, classifying the time series includes using a classifier trained by a machine learning algorithm; [0072], a time series can be directly used as an input for an artificial neural network or another classifier trained by machine learning).
Kaminski discloses generating, based on the component classification, an operational status associated with the chromatography device, wherein the operational status is representative of performance of the chromatography device ([0074], if an error state occurs as part of an injection process, each of the error states can belong to a different class of states of the LC stream; [0077]-[0082], Kaminski discloses various classes to represent various operational states representative of performance of the chromatography device).
However, Kaminski is silent to determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs; and wherein generating a component classification is based on the determining a deviation.
Carneiro et al (Carneiro) discloses techniques and apparatus for diagnostic processes for analytical instruments (Abstract). Carneiro discloses determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs ([0058], [0060], diagnosis of a “bad check valve” may occur when the check valve ball is not sealing correctly allowing for siphoning of fluid as the pump is performing pump strokes; in exemplary embodiments, diagnosis of a “bad seal” may occur when the pump piston chamber has worn out seals, allowing for siphoning of fluid as the pump is performing pump strokes; [0058]-[0059], pump data may be captured and recorded in a file, suggesting presence of a sensor for determining deviation of a pressure from a target value; [0060], accumulator pressure may have noticeable pressure ripples or higher than normal pressures, suggesting comparison of cyclical pressure data to target value; cyclical pressure data will inherently have a time associated with it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Kaminski to comprise determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs; and wherein generating a component classification is based on the determining a deviation, as taught by Carneiro, in order to determine the presence of noticeable pressure ripples or higher than normal pressures, and for diagnosing pump flow problems.
With regard to Claim 2, Kaminski discloses wherein the chromatography device comprises a high-performance liquid chromatography (HPLC) device ([0005], LC system, of which HPLC is a subset). Kaminski discloses wherein the sensor data includes data representative of one or more of other pump pressure sensor data, compression data, power consumption data, or detector output data ([0061], system pressure can be monitored indirectly by using any sensor capable of monitoring a parameter directly related to the system pressure; [0063], detector data).
With regard to Claim 5, Kaminski discloses wherein generating the operational status includes on applying one or more classification rules to the component classification ([0082], classification rules applied to show if the assembly is operating normally or abnormally).
With regard to Claim 6, Kaminski discloses wherein generating the operational status is based on sensor data other than the profile data ([0061], the system pressure can be monitored directly or indirectly using any sensor capable of monitoring a parameter directly related to the system pressure).
With regard to Claim 7, Kaminski discloses performing an action based on the operation status, wherein the action includes sending a message, outputting an alert on a user interface device, requesting a service call, outputting an indication of one or more troubleshooting steps to be performed, repeating an injection, a self-recovery action, or writing a message to a log file ([0084]-[0092], the monitoring technique of the present disclosure can include automatically triggering a response, such as logging the classification result, starting or scheduling an automatic maintenance operation, generating an error message, etc).
With regard to Claim 8, Kaminski et al (Kaminski) discloses a method of monitoring a state of a liquid chromatography (LC) stream of an automated analyzer, including automatically monitoring a system pressure of an injection assembly of the liquid chromatography stream to generate a time series of system pressure, classifying the time series in one of two or more predetermined classes indicating different states of the LC stream and triggering a response based on the classification result (Abstract).
Kaminski discloses a method comprising receiving, based on a user input to a user interface of a chromatography system, data indicative of a procedure for performing a chromatography operation by a chromatography device of the chromatography system ([0041]-[0042], monitoring (i.e., receiving data) takes place during an injection process of a sample; [0025], automated analyzers for conducting predetermined analysis methods; [0088], graphical user interface for an operator; [0107]-[0108], computer program product with program code stored on a machine-readable carrier, in order to perform the method according to one or more embodiments).
Kaminski discloses causing, based on the data indicative of the procedure, the chromatography device to perform the chromatography operation ([0042], injection process can include injecting a sample into an LC column of the LC stream).
Kaminski discloses generating, based on the sensor data, a classification of the chromatography operation (Abstract, automatically monitoring a system pressure of an injection assembly of the liquid chromatography stream to generate a time series of system pressure, classifying the time series in one of two or more predetermined classes indicating different states of the LC stream).
Kaminski discloses wherein the generating is based on an output of a machine-learning model, and wherein an input to the machine-learning model comprises data representative of the profile data ([0046], in some examples, classifying the time series includes using a classifier trained by a machine learning algorithm; [0072], a time series can be directly used as an input for an artificial neural network or another classifier trained by machine learning).
Kaminski discloses wherein the classification is representative of one or more of a components state associated with operation of the chromatography device ([0074], if an error state occurs as part of an injection process, each of the error states can belong to a different class of states of the LC stream; [0077]-[0082], Kaminski discloses various classes to represent various operational states representative of performance of the chromatography device).
Kaminski discloses performing an action based on the classification ([0084]-[0092], the monitoring technique of the present disclosure can include automatically triggering a response, such as logging the classification result, starting or scheduling an automatic maintenance operation, generating an error message, etc).
If Kaminski is silent to receiving, based on a user input to a user interface of a chromatography system, data indicative of a procedure for performing a chromatography operation by a chromatography device of the chromatography system, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that a user or operator could select a predetermined analysis method based on the automated analyzers of [0025] from a graphical user interface ([0088]) and have the system run the method according to the computer program product with program code stored on a machine-readable carrier ([0107]-[0108]), in order to fully automate the chromatography operation, which are widespread in today’s laboratory and hospital environments (Kaminski, [0003]).
However, Kaminski is silent to determining, based on sensor data representative of performance of the chromatography device during the chromatography operation, a deviation of a pressure from a target value within a cycle of a pump of the chromatography device, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs; and wherein the generating is based on the determining a deviation.
Carneiro et al (Carneiro) discloses techniques and apparatus for diagnostic processes for analytical instruments (Abstract). Carneiro discloses determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs ([0058], [0060], diagnosis of a “bad check valve” may occur when the check valve ball is not sealing correctly allowing for siphoning of fluid as the pump is performing pump strokes; in exemplary embodiments, diagnosis of a “bad seal” may occur when the pump piston chamber has worn out seals, allowing for siphoning of fluid as the pump is performing pump strokes; [0058]-[0059], pump data may be captured and recorded in a file, suggesting presence of a sensor for determining deviation of a pressure from a target value; [0060], accumulator pressure may have noticeable pressure ripples or higher than normal pressures, suggesting comparison of cyclical pressure data to target value; cyclical pressure data will inherently have a time associated with it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Kaminski to comprise determining, based on the sensor data representative of performance of the chromatography device during the chromatography operation, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs; and wherein generating a component classification is based on the determining a deviation, as taught by Carneiro, in order to determine the presence of noticeable pressure ripples or higher than normal pressures, and for diagnosing pump flow problems.
With regard to Claim 10, Kaminski discloses wherein the chromatography operation comprises one or more of a chromatography injection operation or analysis of a material ([0042], injection operation).
With regard to Claim 11, Kaminski discloses wherein the action includes outputting an advisory message via the user interface, and wherein the advisory message includes an indication that the chromatography operation is invalid, a warning regarding accuracy of the chromatography operation, or a recommendation to repeat the chromatography operation ([0084]-[0092], the response can include generating an error message including outputting a message on an interface (e.g., a graphical user interface) for the operator).
With regard to Claim 12, Kaminski discloses wherein the action includes outputting an advisory message via the user interface, and wherein the advisory message includes a recommendation to schedule maintenance, an indication of a faulty component of the chromatography device, or a recommendation to change an operational parameter related to the chromatography operation ([0084]-[0092], the response can include asking an operator to perform a predetermined check or maintenance operation including outputting a message on an interface (e.g., a graphical user interface) for the operator).
With regard to Claim 13, Kaminski discloses wherein the action includes causing a part to be ordered, changing a parameter of the chromatography device, scheduling a maintenance operation, causing the chromatography device to perform a recovery action, or causing the chromatography device to perform a diagnostic test ([0084]-[0092], the response can be to schedule an automatic maintenance operation).
With regard to Claim 14, Kaminski et al (Kaminski) discloses a method of monitoring a state of a liquid chromatography (LC) stream of an automated analyzer, including automatically monitoring a system pressure of an injection assembly of the liquid chromatography stream to generate a time series of system pressure, classifying the time series in one of two or more predetermined classes indicating different states of the LC stream and triggering a response based on the classification result (Abstract).
Kaminski discloses a method comprising accessing sensor data representative of one or more operations performed by a chromatography device ([0060], system pressure can be monitored by a pressure sensor arranged in the injection assembly or the components attached to the injection assembly; [0059], Figure 3, a system pressure of the injection assembly during the injection process can be monitored to generate a time series).
Kaminski discloses generating, based on the sensor data, an operational status associated with the chromatography device, wherein the operational status is representative of performance of the chromatography device ([0074], if an error state occurs as part of an injection process, each of the error states can belong to a different class of states of the LC stream; [0077]-[0082], Kaminski discloses various classes to represent various operational states representative of performance of the chromatography device).
Kaminski discloses causing output, via a user interface and based on the operation status, of a maintenance protocol associated with the chromatography device ([0084]-[0092], the response can include asking an operator to perform a predetermined check or maintenance operation including outputting a message on an interface (e.g., a graphical user interface) for the operator).
However, Kaminski is silent to determining, based on sensor data, a deviation of a pressure from a target value within a cycle of a pump of the chromatography device, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs.
Carneiro et al (Carneiro) discloses techniques and apparatus for diagnostic processes for analytical instruments (Abstract). Carneiro discloses determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs ([0058], [0060], diagnosis of a “bad check valve” may occur when the check valve ball is not sealing correctly allowing for siphoning of fluid as the pump is performing pump strokes; in exemplary embodiments, diagnosis of a “bad seal” may occur when the pump piston chamber has worn out seals, allowing for siphoning of fluid as the pump is performing pump strokes; [0058]-[0059], pump data may be captured and recorded in a file, suggesting presence of a sensor for determining deviation of a pressure from a target value; [0060], accumulator pressure may have noticeable pressure ripples or higher than normal pressures, suggesting comparison of cyclical pressure data to target value; cyclical pressure data will inherently have a time associated with it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Kaminski to comprise determining, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs, as taught by Carneiro, in order to determine the presence of noticeable pressure ripples or higher than normal pressures, and for diagnosing pump flow problems.
With regard to Claim 15, Kaminski discloses wherein the one or more operations performed by the chromatography device comprise one or more of a chromatography injection operation or analysis of material ([0042], injection operation).
With regard to Claim 16, modified Kaminski is silent to wherein the one or more operations comprise a diagnostic operation or an operation while in standby mode.
Carneiro et al (Carneiro) discloses techniques and apparatus for diagnostic processes for analytical instruments (Abstract). Carneiro discloses diagnostic services processes may operate to perform testing processes, for instance, detecting and/or diagnosing instrument issues(s) (for instance, non-standard operation conditions) for an analytical instrument and/or components thereof ([0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the one or more operations of modified Kaminski comprise a diagnostic operation or an operation while in standby mode, as taught by Carneiro, in order to detect or diagnose instrument issues such as non-standard operation conditions.
With regard to Claim 18, modified Kaminski is silent to identifying, in the data representative of a pump pressure of the chromatography device; and generating the operational status is based on the data representative of the pump pressure.
Carneiro et al (Carneiro) discloses techniques and apparatus for diagnostic processes for analytical instruments (Abstract). Carneiro discloses identifying an individual portion of the profile data as corresponding to an individual stroke of a pump of the chromatography device; wherein the data representative of the profile data includes data representative of the identified individual portion of the profile data ([0058], [0060], diagnosis of a “bad check valve” may occur when the check valve ball is not sealing correctly allowing for siphoning of fluid as the pump is performing pump strokes; in exemplary embodiments, diagnosis of a “bad seal” may occur when the pump piston chamber has worn out seals, allowing for siphoning of fluid as the pump is performing pump strokes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of modified Kaminski to further comprise identifying, in the data representative of a pump pressure of the chromatography device; and generating the operational status is based on the data representative of the pump pressure, as taught by Carneiro, in order to identify when a bad check valve or bad seal is occurring.
With regard to Claims 19 and 20, Kaminski discloses that the pressure sensor can be provided to detect failures of the pump or for monitoring pressurization operations performed by the pump ([0060]). Kaminski discloses that the response can include starting or scheduling an automatic maintenance operation if the classification of the pressure time series yields an abnormal sample composition ([0086]). However, modified Kaminski is silent to wherein the maintenance protocol comprises an indication of one or more components of the chromatography device to replace (Claim 19), wherein the maintenance protocol further includes timing information for replacing the one or more components (Claim 20).
If the pump pressure data is showing pump failure, it would be obvious to one of ordinary skill in the art to replace the pump or components of the pump such as seals or check valves.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the maintenance protocol of modified Kaminski comprises an indication of one or more components of the chromatography device to replace (Claim 19), wherein the maintenance protocol further includes timing information for replacing the one or more components (Claim 20), if the pressure time series and classification shows that the pump or components of the pump has failed.
Response to Arguments
Applicant's arguments filed 3 November 2025 have been fully considered but they are not persuasive.
Applicant argues on Pages 6 and 7 of the filing that the newly amended features are incapable of being performed by a human mind. Applicant argues “wherein the generating is based on an output of a machine-learning model, and wherein an input to the machine-learning model comprises data representative of the profile data cannot be practically performed in the human mind, as the human mind is not equipped to function as a machine learning model.
In response, this limitation falls under the abstract idea category of (a) mathematical concepts as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that this recitation is directed to a judicial exception. See MPEP § 2106.04(a)(2)(I)(A), directed to mathematical relationships.
A user can “generate a component classification” by reading a table of classifications vs profile data using a machine learning model as a tool. Applicant’s arguments are respectfully not persuasive.
Applicant argues that likewise, a human mind is not equipped to determine, based on sensor data representative of performance of the chromatography device during the chromatography operation, a deviation of a pressure from a target value within a cycle of a pump of the chromatography device, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs. Applicant argues that this new feature fails to recite any abstract idea.
In response, the limitation of “determining, based on the sensor data, a deviation of a pressure from a target value” is a process that, under broadest reasonable interpretation, covers performance of the limitation in the mind. These limitations fall under the abstract idea category of (c) mental processes as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that each of these recitations is directed to a judicial exception. See MPEP § 2106.04(a)(2)(III).
A user may “determine, based on the sensor data, a deviation of a pressure from a target value within a cycle of the pump, and a time within the cycle of the pump at which a maximum deviation of the pressure from the target value occurs” by viewing the pressure deviation and cycle time data in tabular or graphical form.
Applicant argues that these newly added features integrate any allegedly recited abstract ideas into a practical application. Applicants cites [0025] and [0061]-[0068] as showing benefits which are realized by Claim 1 as currently amended.
In response, the Examiner respectfully disagrees that “generating, based on the component classification, an operational status associated with the chromatography device, wherein the operational status is representative of performance of the chromatography device” results in the method of Claim 1 being integrated into a practical application.
The limitation in Claim 1 of “wherein the operational status is representative of performance of the chromatography device” is recited at a high level and is directed to generally linking the “determining” and “generating” judicial exceptions to a particular technological environment or field of use. See MPEP § 2106.05(h). In addition, Claim 7 recites “performing an action based on the operational status” and includes a list of options. However, as in Claim 1, the options in the list are recited at a high level and are directed to generally linking the “determining” and “generating” judicial exceptions to a particular technological environment or field of use. See MPEP § 2106.05(h). Applicant’s arguments are not persuasive.
Applicant argues on Page 7 of the filing that Claim 1 also recites a particular machine as further evidence of an integration of a practical application of any allegedly recited judicial exception. Applicant argues that “chromatography device” is an example of a particular machine, as a chromatography device cannot simply be a general purpose computer. Applicant argues that the benefits resulting from the features of Claim 1 relate to the operation of the chromatography device.
In response, the Examiner respectfully disagrees. A chromatography device as claimed is a general machine. See examples discussed in MPEP § 2106.05(b)(I). For example, the claim from Mackay Radio & Tel. Co. vs Radio Corp. of America, 306 U.S. 86, 40 USPQ 199 (1939) recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly length and angle at which they were arranged. MPEP § 2106.05(b)(I) also cites Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 1923), in which gravity was applied by a Fourdrinier machine arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web. The Examiner notes that such particular machine as claimed integrates the judicial exception into a practical application.
Applicant’s arguments with respect to Claims 1, 8, and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The 35 USC 102 and/or 102/103 rejections of Claims 1, 8, and 14 over Kaminski are withdrawn, but Claims 1, 8, and 14 are rejected under 35 USC 103 over Kaminski in view of Carneiro.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dolan, J., “Troubleshooting basics, Part II: Pressure problems” discusses ways to estimate what normal system pressure should be and some likely causes of various pressure abnormalities (Page 1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN LEBRON whose telephone number is (571)272-0475. The examiner can normally be reached 9 AM - 5:30 PM.
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Benjamin Lebron
Primary Examiner
Art Unit 1777
/BENJAMIN L LEBRON/Primary Examiner, Art Unit 1777