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 .
Status of the Claims
Claims 1-21 are currently pending.
Information Disclosure Statement
The information disclosure statement submitted on April 3, 2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by Examiner.
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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-21 are within the four statutory categories. Claims 1-18 are drawn to a method for tracking samples for diagnostic testing, which is within the four statutory categories (i.e. process). Claims 19-21 are drawn to a system for tracking samples for diagnostic testing, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 19, which is representative of the inventive concept, recites: A diagnostic laboratory system, comprising:
a plurality of analyzers in the diagnostic laboratory system;
a process manager server in communication with the plurality of analyzers, the process manager server including data input and a display screen configured and operable, through executable instructions executable on a processor, to:
generate and display on the display screen, a visual image of the diagnostic laboratory system including visual images of at least the plurality of analyzers;
receive and store status updates in a database from two or more of the plurality of analyzers for each sample that has been scheduled for testing at the two or more of the plurality of analyzers;
receive a status request for a particular selected sample, the particular selected sample scheduled for testing at the two or more of the analyzers;
retrieve from the database a respective status update for the particular selected sample from each analyzer at which the particular selected sample has been scheduled for testing, the status update including whether the particular selected sample has been tested, is being tested, or is scheduled to be tested; and
display on the visual image, for the particular selected sample scheduled for testing, a respective status indicator located proximate to each of the visual images of the analyzers on which tests have been scheduled, each respective status indicator being dynamically updated in response to analyzer generated status changes and being spatially associated with a corresponding analyzer image, wherein each of the respective status indicators denotes:
a) the testing is completed on that analyzer (processed),
b) the testing is currently being conducted by that analyzer (current), or
c) the testing is pending at that analyzer (to do).
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, the steps of receiving status updates, status requests, retrieving the status update for the sample, and displaying the status indicator recites collecting information, analyzing the information, and displaying certain results of the collection and analysis) or using a pen and paper, but for the recitation of generic computer components (i.e. the process server), and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of generating a display of a laboratory and displaying the various statuses for the samples at various analyzers recite steps for organizing/managing and displaying data for activities (i.e. testing/tasks) to be undertaken for the samples), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claim 1 is identical as the abstract idea for Claim 19, because the only difference between Claims 1 and 19 is that Claim 1 recites a method, whereas Claim 19 recites a system.
Dependent Claims 2-18 and 20-21 include other limitations, for example Claims 2-3, 11-16, 18, and 20 recite types of status indicator data to be displayed, Claim 4 recites a source of the status data, Claims 5 and 21 recite further including ancillary equipment in the visual display, Claim 6 recites displaying the visual image on a display screen, Claims 7-8 recite enabling a search for a particular sample and displaying certain sample data, Claims 9-10 recite displaying a name of an analyzer and a name of a test being performed on the sample, and Claim 17 recites receiving a user selection prompting the status data to be identified, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2-18 and 20-21 are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 19.
Prong 2 of Step 2A
Claims 1 and 19 are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the actual analyzers themselves, the process manager server, the database, and the display screen) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of analyzers, a process manager server, the database, and a display screen, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see [0028]-[0029] and [0050]-[0052] of the present Specification, see MPEP 2106.05(f);
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language of the analyzers in a diagnostic laboratory system, which amounts to limiting the abstract idea to the field of diagnostic testing, see MPEP 2106.05(h); and/or
add insignificant extra-solution activity to the abstract idea – for example, the recitation of displaying the visual image on the display screen, which amounts to an insignificant application, see MPEP 2106.05(g).
Additionally, dependent Claims 2-18 and 20-21 include other limitations, but these limitations also amount to no more than mere instructions to apply an exception (e.g. the display screen recited in dependent Claim 6), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data recited in dependent Claims 2-3, 11-16, and 20), and/or do not include any additional elements beyond those already recited in independent Claims 1 and 19, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-21 do not include additional elements that integrate the judicial exception into a practical application.
Step 2B
Claims 1 and 19 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the actual analyzers themselves, the process manager server, and the display screen), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
[0028]-[0029] and [0050]-[0052] of the Specification disclose that the additional elements (i.e. the actual analyzers themselves, the process manager server, and the display screen) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. generating a display) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. diagnostic testing);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives sample and analyzer data from the analyzers, and transmits the data to the process manager server to enable the display of the visual image, e.g. see [0023] of the present Specification;
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the additional elements merely recite the creating and maintaining of status update data in the database; and/or
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the additional elements recite storing status update data in a database and/or electronic memory, and retrieving the status update data from storage in order to display the status for the samples.
Dependent Claims 2-18 and 20-21 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the display screen recited in dependent Claim 6), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data recited in dependent Claims 2-3, 11-16, and 20), and/or the limitations recited by the dependent claims do not recite any additional elements not already recited in independent Claims 1 and 19, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-21 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-21 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-6, 9-13, 16, and 18-21 rejected under 35 U.S.C. 103 as being unpatentable over Chirica (US 2009/0222746) in view of Knafel (US 2019/0120866), further in view of Murata (US 2011/0259129).
Regarding Claim 1, Chirica teaches the following: A method of identifying status of samples of a diagnostic laboratory system, comprising:
displaying a visual image of the diagnostic laboratory system including analyzers (The system includes a workflow server, e.g. see Chirica [0051], wherein the workflow server includes interface modules that construct an interface (i.e. a visual image) displaying the virtual laboratory including virtual representations of the various stations, e.g. see Chirica [0116]-[0117].);
receiving a status request for a particular selected sample (The system receives a data request that indicates a desire to determine a current status associated with a specimen (i.e. a selected sample), e.g. see Chirica [0120].), the particular selected sample scheduled for testing at the two or more of the analyzers (The system includes a workflow indicator that displays the stations the specimen is to visit, wherein the workflow indicator may display that the specimen is to visit a plurality (i.e. two or more) of stations, e.g. see Chirica [0127] and [0138], Fig. 9A.); and
displaying on the visual image proximate each analyzer at which testing has been scheduled, for the particular selected sample, a respective status indicator that denotes a status of the testing at each analyzer at which testing has been scheduled for the particular selected sample (The displayed virtual laboratory includes a specimen indicator and a workflow indicator (i.e. the combination of the specimen and workflow indicators is interpreted as “a respective status indicator”), wherein the specimen indicator indicates a specimen location, a specimen station, a specimen flow, and a specimen state/status, e.g. see Chirica [0116]-[0117], [0120]-[0121]. Additionally, the specimen indicator is displayed at a location proximate to the station (i.e. analyzer) the specimen is located at, e.g. see Chirica [0120]-[0121], Figs. 8, 9A-10A, and is updated and moves as the specimen moves between stations to show the progression of the sample through the various stations, e.g. see Chirica [0120]-[0121], [0127], and [0138], Figs. 8, 9A-10A – that is, the specimen indicator and the workflow indicator show the status of testing at each station because when the specimen indicator is located at for example the “grossing” station, it is currently located at that station, where the workflow indicator shows that it was previously at the “receiving and accessioning” station, and is scheduled next to move to the “tissue processing and embedding station,” e.g. see Chirica Fig. 10A.), each respective status indicator being dynamically updated in response to analyzer generated status changes and being spatially associated with a corresponding visual representation of the analyzer (The specimen indicator changes (i.e. is updated) as the specimen moves from station to station through the virtual laboratory (i.e. the status indicator is spatially associated with a visual representation of the analyzer), in accordance with the workflow indicator, e.g. see Chirica [0120], [0131], [0133], and [0138].).
But Chirica does not teach and Knafel teaches the following:
receiving and storing status updates in a database from each of one or more of the analyzers for each sample that has been scheduled for testing at the two or more of the analyzers (The system includes a Sample Workflow Manager (SWM) comprising a database, e.g. see Knafel [0160], wherein the SWM receives and stores a process status from analysis system components, wherein the process status of the analysis system components is used for planning or controlling the workflow of a biological sample as it is being analyzed by the analysis system, e.g. see Knafel [0122] and [0125], and wherein the process status of the analysis system components is descriptive of the current process status of the analysis system components and changes (i.e. updates) as the biological sample is being analyzed, e.g. see Knafel [0134], Fig. 2. Furthermore, the process statuses correspond to a processing route that is a sequence of two or more analysis system components to which the sample is transported to (i.e. a schedule for the sample), e.g. see Knafel [0121], [0125], and [0134], wherein the analysis system components may be analyzers for characterizing a property of a biological sample, e.g. see Knafel [0116]. Alternatively, the system includes receiving sample tracking messages that encompass data which is descriptive of the physical location and/or the processing status of the sample, and wherein the system is able to update or change commands for processing the sample based on its status, e.g. see Knafel [0138].);
retrieving from the database a respective status update for the particular selected sample from each analyzer at which the particular selected sample has been scheduled for testing (The SWM receives and stores updated instrument status information from two or more analyzers, wherein the system includes a preconfigured processing route dictating the sequence of analysis for the samples and analyzers (i.e. a schedule for testing), and wherein the updated instrument status information includes the current process status of the analyzers as a biological sample is being analyzed, e.g. see Knafel [0122], [0125], and [0134], Fig. 2. Alternatively, the system includes receiving sample tracking messages that encompass data which is descriptive of the physical location and/or the processing status of the sample, and wherein the system is able to update or change commands for processing the sample based on its status, e.g. see Knafel [0138].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Chirica to incorporate retrieving the status updates from a plurality of analyzers on the processing route for the sample as taught by Knafel in order to ensure the efficient operation and management of calibration and quality control of an analyzer, e.g. see Knafel [0001].
But the combination of Chirica and Knafel does not teach and Murata teaches the following:
the status update including whether the particular selected sample has been tested, is being tested, or is scheduled to be tested (The system tracks samples for testing, wherein each sample includes a status, e.g. see Murata [0011], wherein the sample status include “analysis successfully completed” and “analysis in progress” (i.e. the sample has been tested and/or is being tested), e.g. see Murata [0012], [0038], and [0051], Figs. 2 and 4. Additionally, the system display changes the status display following a change in measurement status (i.e. a status update) for each sample, e.g. see Murata [0011].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Chirica and Knafel to incorporate the sample status as taught by Murata in order to inform a user of the status of a sample to enable a sample required for reanalysis to be prepared in advance, e.g. see Murata [0009].
Regarding Claim 2, Chirica discloses the limitations of Claim 1, but does not teach and Murata teaches the following: The method of claim 1, wherein the status indicators comprise at least one of:
a) the testing is completed on one or more of the analyzers (processed) (The sample statuses include a status of “analysis successfully completed,” e.g. see Murata [0038] and [0051], Figs. 2 and 4.),
b) the testing is currently being conducted on one or more analyzers (current) (The sample statuses include a status of “analysis in progress,” e.g. see Murata [0038] and [0051], Figs. 2 and 4.), or
c) the testing is pending on one or more analyzers (to do).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Chirica to incorporate the sample status as taught by Murata in order to inform a user of the status of a sample to enable a sample required for reanalysis to be prepared in advance, e.g. see Murata [0009].
Regarding Claim 3, the combination of Chirica and Murata teaches the limitations of Claim 2, and Murata further teaches the following:
The method of claim 2, further comprising any combination of a) through c) (The system processes a plurality of samples, wherein each of the samples may include a status, wherein the statuses include “analysis successfully completed,” and/or “analysis in progress,” e.g. see Murata [0038] and [0051], Figs. 2 and 4.).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Chirica to incorporate the sample statuses as taught by Murata in order to inform a user of the status of a sample to enable a sample required for reanalysis to be prepared in advance, e.g. see Murata [0009].
Regarding Claim 4, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, wherein the retrieving comprises receiving data regarding the status of the particular selected sample from a middleware database (The workflow server includes modules (i.e. middleware) that obtain the specimen status, e.g. see Chirica [0065] and [0120]-[0121], Fig. 2.).
Regarding Claim 5, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, wherein the visual image of the diagnostic laboratory system further comprises a layout of one or more ancillary test processing apparatus that are ancillary to the analyzers (Given the broadest reasonable interpretation in view of the present Specification, an “ancillary test processing apparatus” may be interpreted as any type of equipment that processes the sample prior to the sample being sent to an analyzer, e.g. see [0026] of the present Specification. The virtual laboratory comprises a plurality of stations, any of which may be interpreted as an “analyzer” or an “ancillary test processing apparatus,” e.g. see Chirica [0116]-[0117] and [0120]-[0121], Figs. 8, 9A, 10A – for example, a sample may initially be sent to a “receiving and accessioning” station prior to a “grossing” station, wherein the receiving and accessioning station may be considered “ancillary” to the grossing station.).
Regarding Claim 6, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, wherein the visual image of the diagnostic laboratory system is displayed on a display screen (The virtual laboratory is displayed on a display of a workstation or other suitable device, e.g. see Chirica [0114].).
Regarding Claim 9, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, further comprising displaying a name of an analyzer proximate to an analyzer currently conducting one or more tests on the particular selected sample (The system displays a name for a particular laboratory device proximate to the device, e.g. see Chirica [0144], Fig. 14B.),
Regarding Claim 10, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 9, and Chirica further teaches the following:
The method of claim 9, further comprising displaying a name of a test being conducted on the particular selected sample at a location proximate to the name of the analyzer (The system displays a text component proximate to a laboratory device, wherein the text component may describe the tasks carried out, e.g. see Chirica [0127], Figs. 9A-9B and 14B.),
Regarding Claim 11, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, wherein the status indicators include consecutive numbers illustrating a sequence of the testing scheduled for the particular selected sample (The system displays a sample image as well as consecutive numbers indicative of a step by step of the workflow (i.e. a sequence of testing) for the sample, e.g. see Chirica [0134], Fig. 9B.).
Regarding Claim 12, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, wherein the status indicators comprise numbered circles (The system displays a sample image as well as consecutive numbered circles indicative of a step by step of the workflow (i.e. a sequence of testing) for the sample, e.g. see Chirica [0134], Fig. 9B.).
Regarding Claim 13, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, wherein the status indicators comprise consecutive numbers denoting an order of the testing (The system displays a sample image as well as consecutive numbers indicative of a step by step of the workflow (i.e. an order of the testing) for the sample, e.g. see Chirica [0134], Fig. 9B.).
Regarding Claim 16, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, wherein the status indicators are accompanied on the visual image with an image of a process path of the particular selected sample (The system displays a sample image in the virtual laboratory (i.e. the visual image), and further displays a workflow indicator (i.e. the process path), e.g. see Chirica [0117], [0126], and [0138], Fig. 8.).
Regarding Claim 18, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, and Chirica further teaches the following:
The method of claim 1, further comprising displaying on the visual image proximate one or more ancillary test processing apparatus a respective status indicator that denotes a status of the processing of the particular selected sample scheduled to be processed at the one or more ancillary test processing apparatus (Given the broadest reasonable interpretation in light of [002] of the as-filed Specification, an “ancillary test processing apparatus” may include various types of test processing equipment such as sample container input/output loaders, quality check modules and the like that pre-process samples before they arrive at an analyzer for actual testing of the sample. The displayed virtual laboratory includes a plurality of stations (i.e. given the broadest reasonable interpretation, any of the stations other than the “staining” station and the “imaging” station (i.e. testing stations) may be interpreted as “ancillary test processing apparatuses”), a specimen indicator, and a workflow indicator (i.e. the combination of the specimen and workflow indicators is interpreted as “a respective status indicator”), wherein the specimen indicator indicates a specimen location, a specimen station, a specimen flow, and a specimen state/status, e.g. see Chirica [0116]-[0117], [0120]-[0121]. Additionally, the specimen indicator is displayed at a location proximate to the station (i.e. ancillary test processing apparatus) that the specimen is located at, e.g. see Chirica [0120]-[0121], Figs. 8, 9A-10A, and is updated and moves as the specimen moves between stations to show the progression of the sample through the various stations, e.g. see Chirica [0120]-[0121], [0127], and [0138], Figs. 8, 9A-10A – that is, the specimen indicator and the workflow indicator show the status of testing at each station because when the specimen indicator is located at for example the “grossing” station, it is currently located at that station, where the workflow indicator shows that it was previously at the “receiving and accessioning” station, and is scheduled next to move to the “tissue processing and embedding station,” e.g. see Chirica Fig. 10A.).
Regarding Claim 19, Chirica teaches the following: A diagnostic laboratory system, comprising:
a plurality of analyzers in the diagnostic laboratory system (The system generates a virtual laboratory that represents a physical laboratory, wherein the physical and virtual laboratories includes various stations (i.e. analyzers), e.g. see Chirica [0051] and [0116]-[0117].);
a process manager server in communication with the plurality of analyzers, the process manager server including data input and a display screen (The system includes a workflow server that is in communications with the various stations, e.g. see Chirica [0051], wherein the workflow server includes a central processing unit and a display, e.g. see Chirica [0055].) configured and operable, through executable instructions executable on a processor, to:
generate and display on the display screen, a visual image of the diagnostic laboratory system including visual images of at least the plurality of analyzers (The workflow server includes interface modules that construct an interface (i.e. a visual image) displaying the virtual laboratory including virtual representations of the various stations, e.g. see Chirica [0116]-[0117].);
receive a status request for a particular selected sample (The system receives a data request that indicates a desire to determine a current status associated with a specimen (i.e. a selected sample), e.g. see Chirica [0120].);
display on the visual image, for the particular selected sample scheduled for testing, a respective status indicator located proximate to each of the visual images of the analyzers on which tests have been scheduled (The displayed virtual laboratory includes a specimen indicator and a workflow indicator (i.e. the combination of the specimen and workflow indicators is interpreted as “a respective status indicator”), wherein the specimen indicator indicates a specimen location, a specimen station, a specimen flow, and a specimen state/status, e.g. see Chirica [0116]-[0117], [0120]-[0121]. Additionally, the specimen indicator is displayed at a location proximate to the station (i.e. analyzer) the specimen is located at, e.g. see Chirica [0120]-[0121], Figs. 8, 9A-10A, and is updated and moves as the specimen moves between stations to show the progression of the sample through the various stations, e.g. see Chirica [0120]-[0121], [0127], and [0138], Figs. 8, 9A-10A – that is, the specimen indicator and the workflow indicator show the status of testing at each station because when the specimen indicator is located at for example the “grossing” station, it is currently located at that station, where the workflow indicator shows that it was previously at the “receiving and accessioning” station, and is scheduled next to move to the “tissue processing and embedding station,” e.g. see Chirica Fig. 10A.).
However, Chirica does not teach and Knafel teaches the following:
receive and store status updates in a database from one or more of the plurality of analyzers for each sample that has been scheduled for testing at the one or more of the plurality of analyzers (The system includes a Sample Workflow Manager (SWM) comprising a database, e.g. see Knafel [0160], wherein the SWM receives and stores a process status from analysis system components, wherein the process status of the analysis system components is used for planning or controlling the workflow of a biological sample as it is being analyzed by the analysis system, e.g. see Knafel [0122] and [0125], and wherein the process status of the analysis system components is descriptive of the current process status of the analysis system components and changes (i.e. updates) as the biological sample is being analyzed, e.g. see Knafel [0134], Fig. 2. Furthermore, the process statuses correspond to a processing route that is a sequence of analysis system components to which the sample is transported to (i.e. a schedule for the sample), e.g. see Knafel [0125] and [0134]. Alternatively, the system includes receiving sample tracking messages that encompass data which is descriptive of the physical location and/or the processing status of the sample, and wherein the system is able to update or change commands for processing the sample based on its status, e.g. see Knafel [0138].);
retrieve from a database a respective status update for the particular selected sample from each analyzer at which the particular selected sample has been scheduled for testing (The SWM receives and stores updated instrument status information from two or more analyzers, wherein the system includes a preconfigured processing route dictating the sequence of analysis for the samples and analyzers (i.e. a schedule for testing), and wherein the updated instrument status information includes the current process status of the analyzers as a biological sample is being analyzed, e.g. see Knafel [0122], [0125], and [0134], Fig. 2. Alternatively, the system includes receiving sample tracking messages that encompass data which is descriptive of the physical location and/or the processing status of the sample, and wherein the system is able to update or change commands for processing the sample based on its status, e.g. see Knafel [0138].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Chirica to incorporate retrieving the status updates from a plurality of analyzers on the processing route for the sample as taught by Knafel in order to ensure the efficient operation and management of calibration and quality control of an analyzer, e.g. see Knafel [0001].
However, the combination of Chirica and Knafel does not teach and Murata teaches the following:
the status update including whether the particular selected sample has been tested, is being tested, or is scheduled to be tested (The system tracks samples for testing, wherein each sample includes a status, e.g. see Murata [0011], wherein the sample status include “analysis successfully completed” and “analysis in progress” (i.e. the sample has been tested and/or is being tested), e.g. see Murata [0012], [0038], and [0051], Figs. 2 and 4. Additionally, the system display changes the status display following a change in measurement status (i.e. a status update) for each sample, e.g. see Murata [0011].).
wherein each of the respective status indicators (The system tracks samples for testing, wherein each sample includes a status, e.g. see Murata [0011].) denotes:
a) the testing is completed on one or more analyzers (processed) (The sample statuses include a status of “analysis successfully completed,” e.g. see Murata [0012], [0038], and [0051], Figs. 2 and 4.),
b) the testing is currently being conducted on one or more analyzers (current) (The sample statuses include a status of “analysis in progress,” e.g. see Murata [0012], [0038], and [0051], Figs. 2 and 4.), or
c) the testing is pending on one or more analyzers (to do).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Chirica and Knafel to incorporate the sample status as taught by Murata in order to inform a user of the status of a sample to enable a sample required for reanalysis to be prepared in advance, e.g. see Murata [0009].
Regarding Claim 20, the combination of Chirica and Murata teaches the limitations of Claim 19, and Murata further teaches the following:
The diagnostic laboratory system of claim 19, wherein the status indicators located proximate to the visual images of the analyzers on which the tests are scheduled denote any combination of a) through c) (The system processes a plurality of samples, wherein each of the samples may include a status, wherein the statuses include “analysis successfully completed,” and/or “analysis in progress,” e.g. see Murata [0038] and [0051], Figs. 2 and 4.).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Chirica to incorporate the sample statuses as taught by Murata in order to inform a user of the status of a sample to enable a sample required for reanalysis to be prepared in advance, e.g. see Murata [0009].
Regarding Claim 21, the combination of Chirica and Murata teaches the limitations of Claim 19, and Chirica further teaches the following:
The diagnostic laboratory system of claim 19, wherein the visual image of the diagnostic laboratory system further comprises images of one or more ancillary test processing apparatus that are ancillary to the plurality of analyzers (Given the broadest reasonable interpretation in view of the present Specification, an “ancillary test processing apparatus” may be interpreted as any type of equipment that processes the sample prior to the sample being sent to an analyzer, e.g. see [0026] of the present Specification. The virtual laboratory comprises a plurality of stations, any of which may be interpreted as an “analyzer” or an “ancillary test processing apparatus,” e.g. see Chirica [0116]-[0117] and [0120]-[0121], Figs. 8, 9A, 10A – for example, a sample may initially be sent to a “receiving and accessioning” station prior to a “grossing” station, wherein the receiving and accessioning station may be considered “ancillary” to the grossing station.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chirica, Knafel, and Murata in view of Ariyoshi (US 2011/0035237).
Regarding Claim 7, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, but does not teach and Ariyoshi teaches the following:
The method of claim 1, further comprising receiving in a search field on a display screen a sample number for the particular selected sample (The system displays a search screen for test results that enables a user to input a specimen ID (i.e. a sample number), e.g. see Ariyoshi [0106].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Chirica, Knafel, and Murata to incorporate the input of the specimen ID as taught by Ariyoshi in order to enable the viewing of the specimen data without viewing the personal information of the subject, e.g. see Ariyoshi [0005].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chirica, Knafel, Murata, and Ariyoshi in view of Taylor (US 2006/0200391).
Regarding Claim 8, the combination of Chirica, Knafel, Murata, and Ariyoshi teaches the limitations of Claim 7, but does not teach and Taylor teaches the following: The method of claim 7, further comprising displaying for the particular selected sample, one or more of:
a collection date and time (The system stores and displays specimen information, wherein the specimen information includes the date the specimen was received, e.g. see Taylor [0032].),
an order received date and time, and
a sample loaded date and time (The system stores and displays specimen information, wherein the specimen information includes the date the specimen was tested, e.g. see Taylor [0032].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Chirica, Knafel, Murata, and Ariyoshi to incorporate displaying the specimen information as taught by Taylor in order to ensure that the specimen data is properly tracked, e.g. see Taylor [0006].
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chirica, Knafel, and Murata in view of Leber (US 2016/0026959).
Regarding Claim 14, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, but does not teach and Leber teaches the following:
The method of claim 1, wherein the status indicators comprise coloring that denotes status (The system tracks batches of samples for clinical testing, e.g. see Leber [0002], wherein the batch statuses are displayed, and wherein the statuses may be denoted by various colors, e.g. see Leber [0037] and [0045], Figs. 1A-1B, 3.).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1 to incorporate the colors indicative of the sample status as taught by Leber in order to enable a user to easily identify workflow data and issues such as bottlenecks, e.g. see Leber [0016].
Regarding Claim 15, the combination of Chirica, Knafel, Murata, and Leber teaches the limitations of Claim 14, and Leber further teaches the following:
The method of claim 14, wherein status corresponding to the coloring is identified in a status legend block (The system displays a color legend identifying the meanings of the colors for the batches, e.g. see Leber [0045], Fig. 3.),
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Chirica, Knafel, and Murata to incorporate the color legend indicative of the sample status as taught by Leber in order to enable a user to easily identify workflow data and issues such as bottlenecks, e.g. see Leber [0016].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Chirica, Knafel, and Murata in view of Minato (US 2012/0010899).
Regarding Claim 17, the combination of Chirica, Knafel, and Murata teaches the limitations of Claim 1, but does not teach and Minato teaches the following:
The method of claim 1, wherein the method of identifying status of samples in a diagnostic laboratory system is selectable by a user by selecting a tracking tab (The system stores and displays testing item information, wherein the testing information is displayed in response to the user selecting a testing department (i.e. a tracking) tab, e.g. see Minato [0061]-[0065], Figs. 4 and 5.),
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Chirica, Knafel, and Murata to incorporate the testing department tab as taught by Minato in order enable a user to smoothly perform testing operations, e.g. see Minato [0010].
Response to Arguments
Applicant’s arguments, see Remarks, filed April 3, 2026, with respect to the rejections of Claims 1-21 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicants first allege that the claimed invention is patent eligible because the newly amended claim limitations demonstrate that the claimed invention is not directed towards an abstract idea but is instead directed to “a specific improvement in visualization and human-machine interaction for complex diagnostic laboratory systems,” and because the claimed invention is not properly interpreted as following rules or instructions, e.g. see pgs. 8-9 of Remarks – Examiner disagrees
Initially, Examiner notes that Applicants provide no disclosure as to what the alleged improvements to visualization and human-machine interactions actually are. [003] of the as-filed Specification discloses that “the operations of such large-scale diagnostic laboratories undergo continuous monitoring, evaluation, and intervention/manipulation by human operators,” and [0020] of the as-filed Specification discloses that the claimed limitations “provide improved visualization of any sample’s status within the diagnostic laboratory system,” and “the ability to rapidly visualize sample status can lead to improved system flexibility.” That is, the as-filed Specification discloses that the alleged improved visualization of the sample status leads to improved system flexibility with regards to human operators. Hence, the claimed invention recites, at most, an improvement to the abstract idea of a mental process and/or a certain method of organizing human activities, and an improvement in the abstract idea itself is not an improvement in technology, e.g. see MPEP 2106.05(a)(II).
Hence, the claimed invention is properly interpreted as reciting a mental process and/or a certain method of human activities.
For the aforementioned reasons, Claims 1-21 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed April 3, 2026, with respect to the rejections of Claims 1-21 under 35 U.S.C. 103 have been fully considered but are not persuasive.
Applicants allege that Chirica is deficient because it teaches a selection of a virtual laboratory station rather than a selection of a particular sample, because the current state of the sample of Chirica differs from the claimed testing status indicators, because Chirica does not teach displaying status indicators for two or more stations simultaneously for a single sample, and because Chirica does not teach distinguishing between analyzers at which the sample is scheduled to be tested versus analyzers at which the sample is not scheduled to be tested, e.g. see pgs. 11-12 of Remarks – Examiner disagrees.
Regarding the claimed selected sample limitation, [0120] of Chirica discloses that “a data request indicates a desire to determine a current status associated with a specimen, request processing module 204 may utilize specimen tracking module 210 to obtain data about a requested specimen.” That is, Chirica teaches receiving a data request, and in response to the data request retrieving data for a specimen corresponding to the request, and hence Chirica teaches a selected sample.
Regarding the claimed status indicator limitation, Claims 1 and 19 recite that a “status indicator” “denotes a status of the testing at each analyzer at which testing has been scheduled for the particular selected sample.” Hence, given the broadest reasonable interpretation, the language of Claims 1 and 19 requires that the status indicator denote some status of testing of the sample at each analyzer. Chirica teaches a specimen indicator and a workflow indicator which are collectively interpreted as a “status indicator,” wherein the workflow indicator displays a path the specimen is scheduled to take among a plurality of stations, and wherein the specimen indicator displays a location of the specimen as well as where the specimen has been and where it is going, e.g. see Chirica [0116]-[0117], and [0120]-[0121], Fig. 9A. For example, the specimen indicator may depict a jar and request form when it has not yet entered the grossing station, and upon entering the grossing station the specimen indicator may depict a barcoded cassette, e.g. see Chirica [0120]. That is, the workflow indicator and the specimen indicator taught by Chirica “denotes a status of the testing at each analyzer” in that the icon shows where the specimen has been, where the specimen is currently, and where the specimen is to go in the future. Examiner notes that this also teaches displaying a status for each of the stations for the single sample because it shows that a station has already processed the specimen, is currently processing the specimen, or is to eventually process the specimen.
Regarding distinguishing between analyzers at which the sample is scheduled to be tested versus analyzers at which the sample is not scheduled to be tested, this feature is not recited by the Claims. For example, the Claims do not recite displaying a different indication or icon for analyzers the specimen is not scheduled to be tested at. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For the aforementioned reasons, Chirica is not deficient to teach the features it is cited for.
Applicants further allege that Knafel is deficient because it does not teach retrieving a status update for the selected sample from the database, e.g. see pgs. 11-12 of Remarks – Examiner disagrees.
Knafel teaches a Sample Worflow Manager (SWM) comprising a database, e.g. see Knafel [0060], wherein the database receives and stores a current process status of various analysis system components, e.g. see Knafel [0122] and [0125]. Furthermore, Knafel teaches that the process status includes the current process status of the analyzers as a biological sample is being analyzed, e.g. see Knafel [0122], [0125], and [0134], Fig. 2. Additionally, the system includes receiving sample tracking messages that encompass data which is descriptive of the physical location and/or the processing status of the sample, and wherein the system is able to update or change commands for processing the sample based on its status, e.g. see Knafel [0138].
Moreover, Examiner notes that Claims 1 and 19 define “a respective status update for the particular selected sample” as “including whether the particular selected sample has been tested, is being tested, or is scheduled to be tested.” Hence, Claims 1 and 19 require a status update for the sample, wherein the status update indicates the processing status of the sample at an analyzer, and Knafel teaches at least tracking a process status of a sample at various analysis system components, e.g. see Knafel [0122], [0125], and [0134], and/or the processing status of the sample itself, e.g. see Knafel [0138].
For the aforementioned reasons, Knafel is not deficient to teach the features it is cited for.
Applicant also alleges that Murata is deficient because it does not teach displaying a spatial layout of analyzers in a diagnostic laboratory system and/or displaying multiple sample status indicators proximate each corresponding analyzer on an image of the laboratory layout, e.g. see pgs. 13-14 of Remarks – Examiner disagrees.
As an initial matter, Examiner agrees that Murata does not teach the particular layout/orientation of the system as a whole. However, Murata is not cited to teach these features. As shown above, Murata is only cited to teach the specific descriptive data/labels of the status indicators. Namely, Murata teaches that sample labels may include at least “analysis in progress,” “failed analysis,” and “analysis successfully completed,” e.g. see Murata [0038], Fig. 2.
Regarding the “optional” language previously stated in the Final Rejection mailed on December 4, 2025, Examiner did not intend to, and does not, contend that the step/function of displaying the status update was in itself an optional step. Examiner intended to state that the status update “optionally” could be any one of “has been tested,” “is being tested,” or “is scheduled to be tested.” That is, Claims 1 and 19 claim that the status update can be any one of “the particular selected sample has been tested,” “is being tested,” or “is scheduled to be tested.” Hence, Claims 1 and 19 do not require that the status update be “is scheduled to be tested,” because Claims 1 and 19 recite that the status update includes “the particular selected sample has been tested,” “is being tested,” or “is scheduled to be tested.” Hence, although Murata does not specifically teach a status of, for example, “analysis scheduled but not completed,” this particular limitation is not required by the present claim language of Claims 1 and 19, as long as one of “has been tested” or “is being tested” is taught.
Applicants further allege that the combination of Chirica, Knafel, and Murata is deficient because it would have not been obvious to combine the references, e.g. see pgs. 14-16 of Remarks – Examiner disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as shown above, Knafel teaches that incorporating the cited functions would ensure the efficient operation and management of calibration and quality control of an analyzer, e.g. see Knafel [0001], and Murata teaches that incorporating the cited functions would inform a user of the status of a sample to enable a sample required for reanalysis to be prepared in advance, e.g. see Murata [0009], and hence the citations of Knafel and Murata include a teaching, suggestion, or motivation to incorporate them with the citations of Chirica.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Hence, the combination of Chirica, Knafel, and Murata is not improper.
Additionally, regarding the newly amended limitations reciting that the sample is scheduled for testing at two or more of the analyzers, and the status indicator being dynamically updated in response to analyzer status changes and being spatially associated with a visual representation of the analyzer, as shown above, Chirica teaches that the generated display may indicate that a specimen is to visit two or more stations, e.g. see Chirica [00127] and [0138], Fig. 9A, and further teaches that the specimen indicator changes (i.e. is updated) as the specimen moves from station to station through the virtual laboratory (i.e. the status indicator is spatially associated with a visual representation of the analyzer), in accordance with the workflow indicator, e.g. see Chirica [0120], [0131], [0133], and [0138].
Hence, Claims 1-21 are nonetheless rejected under 35 U.S.C. 103 for the reasons disclosed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Gelbman (US 2014/0370608) – teaches a system for displaying statuses for various sample carriers, including completion statuses.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm Pacific.
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/JOHN P GO/Primary Examiner, Art Unit 3681
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