DETAILED ACTION
Acknowledgement
This final office action is in response to the amendment filed on 10/28/2025.
Status of Claims
Claims 1, 9,11, 13-15, and 17 have been amended.
Claims 1 and 3-17 are now pending.
Response to Arguments
Claim 17 objection is withdrawn in light of amendments.
Applicant's arguments filed on 10/28/2025 regarding the 35 U.S.C. 101 and 103 rejections of claims 1 and 3-17 have been fully considered. The Applicant argues the following.
(1) As per the 101 rejection, the Applicant argues, in summary, that the claims are eligible under 101 because the claims provide a technological improvement similar to Example 46. The claims provide improvements in laboratory processing efficiency such as preventing a complete laboratory system stoppage while providing maintenance, ensuring that the least amount of test sample container carriers expire due to the downtime of laboratory devices, and device retrieval masking avoids having to turn the machines on/off. The claims also provide a system that performs an automated corrective action in response to any disruptions in the system workflow.
The Examiner respectfully disagrees. The Examiner maintains the position that the claims are directed to the abstract grouping of Certain Methods of Organizing Human Activity for the reasons recited in Step 2A(1). The additional elements recited in the claims and listed in Steps 2A(2) and 2B do not integrate the abstract idea into a practical application (i.e. improves technology) or provide an inventive concept (i.e. significantly more). The additional elements are viewed as mere instructions to implement routing workflow instructions and managing resources on a computer and merely indicates a field of use or technological environment in which to apply the abstract idea. The processing efficiency improvement provided via routing and scheduling of the laboratory devices (i.e. abstract idea) is not a technological improvement. Routing and scheduling laboratory equipment to process tests in a specific way during periods of laboratory disruption, at the end of a laboratory shift, and during peak workload periods via retrieval masking techniques (e.g. pausing operation) is a business operations improvement (e.g. scheduling, throughput, etc.) and not an improvement in a specific technology or technological component. There is no direct increase or improvement in the functioning of the laboratory devices themselves. The laboratory devices are receiving instructions from the laboratory middleware to perform normal functions that they are configured to perform (e.g. receive, route, and process test samples). However, in Example 46, the claims reflect an added and improved functionality of the sorting gate and feed dispenser technology with the ability to sort and feed based on animal data and behavior patterns. Example 46 is an example of how the abstract idea (e.g. monitoring and analyzing animal behavior) was integrated with the sorting gate and feed disperser (i.e. additional elements) to improve/add to the sorting gate and feed dispenser’s automated functionality. The Applicant’s claims do not reflect this same type of integration into a practical application. Therefore, the 35 U.S.C. 101 rejection is maintained.
(2) As per the 103 rejections, the Applicant argues, in summary, (i) Furrer does not teach determining if a device is "unavailable", instead Furrer teaches determining if a device is "overloaded" or not. However, such a device would still be "available" for processing test samples and is not "unavailable" as defined in claim 1; (ii) Furrer does not teach rerouting "all" test sample containers to a buffer as claimed; (iii) Furrer does not teach the feature "calculating a new laboratory system workflow for all test sample container carriers rerouted to the buffer during the unavailability...". Applicant claims distinguish between a "buffer" and a "laboratory device" and they are not interchangeable claim elements; (iv) Maetzler utilizes "masking" to refer to powering a device on/off which is a different act than "masking" as used in the present claims. The Applicant submit that Maetzler does not teach "masking" as claimed since the masking, as used in Maetzler, is an entirely different process that that described in the present specification or even the other cited art; and (v) Tran does not use the term "mask" or "retrieval masking" in the specification. Tran appears to teach that a type of "masking" can be applied to biological samples themselves to prevent their retrieval. The "masking" is NOT applied to a device (such as the target laboratory device), but individual samples (e.g., such as test sample container carriers).
The Examiner respectfully disagrees with all arguments. The Examiner submits that based on the context and the broadest reasonable interpretation of amended claim 1, the combination of Furrer, Maetzler, and Fran teach all of the limitations as shown in the updated claim mapping. The Examiner notes that the 103 rejection is based on the concepts and/or the functions recited in the claims being taught by the prior art references and not the exact wording of the claims. The Examiner also notes that the Applicant claims are broad and does not specifically define the terms “unavailable”, “all”, laboratory device, a target laboratory device, which can contextually be different and represent different things.
As per argument (i), Furrer teaches determining if the device is unavailable via determining an overloaded condition via a querying process. Furrer recites an overloaded analytical laboratory is unable to receive additional biological samples in paragraph [0012]. Therefore in this condition, if the laboratory device is unable to receive additional samples, then the samples can’t be processed. However, later on in claim 1, the Examiner stated that Furrer in view of Maetzler teach device unavailability due to a maintenance issue.
As per argument (ii), the term “all” is relative and refers to the test sample container carriers that need to be rerouted. The term “all” does not define a specific amount. Furrer teach dynamically reacting to deviations in dispatch rates by load balancing between laboratory instruments and buffering samples to reduce the load on an overloaded instrument. Therefore, the buffering samples would represent the “all” in this context.
As per argument (iii), Furrer teaches calculating a new system workflow via dynamic load balancing. Load balancing involves changes in workflow of various laboratory instruments. This load balancing involves buffering biological samples to address changes/deviations in workflow. Furrer teaches “buffering may be provided either by laboratory instrument dedicated for temporarily storing biological samples and/or by laboratory instruments 10, which have available temporary storage space for biological sample(s) fulfilling the requirements (temperature, humidity) for sample buffering [0092]”. As shown in Figure 1, the laboratory system include multiple laboratory instruments 10 (e.g. 10AI, 10PRE, and 10 POST) including storage/buffers interconnected by a transportation system 10TRS ([0043] and [0062]-[0065]). Therefore, Furrer teaches separate components of a buffer and a laboratory device. The Applicant’s claims do not define a particular buffer and laboratory device that would be different than Furrer’s laboratory devices that provide the same function.
As per arguments (iv) and (v), the Examiner submits that Furrer, Maetzler, and Tran all teach the concept of device masking. Furrer explicitly teaches “instrument masking” (i.e. device masking) that includes “destination masking” and “input specific masking” (Fig. 4D and [0094]-[0095]). Destination masking refer to the process of preventing one or more of the plurality of laboratory instruments 10 from sending biological sample(s) to the first laboratory instrument 10 (the destination) [0096]. This is that same function taught claim 1. Furrer does not explicitly teach, “unmasking”, however, Maetzler teaches the concept of masking and unmasking [0048]. Maetzler reference was used in the 103 rejection to teach the concept of “unmasking” only. Although Maetzler’s masking unmasking is referenced as a turn off/turn on function, the Applicant’s claim nor specification explicitly recite how the “masking” and “unmasking” is performed to exclude Maetzler’s teaching. Although the Tran reference does not explicitly recite the term “masking”, Tran teaches a function of retrieval masking so that test sample container carriers cannot be retrieved from the target laboratory device. Once again the Examiner emphasizes that the Applicant’s claims nor specification recite how the prevention of retrieval is performed to exclude Tran’s teachings.
Therefore, the 35 U.S.C. 103 rejection is maintained based on the reasons presented.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/12/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1 lines 12-13 limitation of “ wherein an unavailable laboratory device is unavailable to process test sample container carriers due to a maintenance issue;” should read “wherein the unavailable laboratory device is unavailable to process test sample container carriers due to a maintenance issue”.
Claim 1 lines 28, 35, and 38 limitations of “the buffer” should read “the at least one buffer”.
Claim 11 lines 7-8 limitation of “halting loading of test sample container carriers into a laboratory system at an end of a laboratory shift” should read “halting loading of the test sample container carriers into a laboratory system at an end of a laboratory shift”.
Claim 11 lines 9-13 limitations of “device retrieval masking a target laboratory device of the plurality of laboratory devices, by the laboratory middleware, so that test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system and test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system,” should read “device retrieval masking a target laboratory device of the plurality of laboratory devices, by the laboratory middleware, so that test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system”. The bolded limitations should be removed because they are redundant.
Appropriate correction is required.
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 and 3-17 are rejected under 35 U.S.C. 101 because the claimed invention, “Masking of Laboratory Device and Routing of Test Sample Containers in a Laboratory System”, is directed to an abstract idea, specifically Certain Methods of Organizing Human Activity, without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements individually or in combination provide mere instructions to implement the abstract idea on a computer.
Step 1: Claims 1 and 3-17 are directed to a statutory category, namely a process (claims 1, 3-15 and 17) and a system (claim 16).
Step 2A (1): Independent claims 1, 11, 14, and 16 are directed to an abstract idea of Certain Methods of Organizing Human Activity, based on the following underlined claim limitations:
“A method of routing test sample container carriers during periods of laboratory disruption in a laboratory system wherein the laboratory system comprises a plurality of laboratory devices, at least one buffer, a transportation system, and laboratory middleware, the method comprising:
determining a system workflow, by the laboratory middleware, for processing the test sample container carriers;
monitoring the system workflow to determine whether a laboratory device of the plurality of laboratory devices is an unavailable laboratory device after determining the system workflow,
wherein the unavailable laboratory device is a connection point between the transportation system and a target laboratory device; and
wherein an unavailable laboratory device is unavailable to process test sample container carriers due to a maintenance issue
rerouting all test sample container carriers originally routed to the target laboratory device before the unavailability of the unavailable laboratory device to the at least one buffer for a duration of the unavailability of the unavailable laboratory device;
calculating a new system workflow, by the laboratory middleware, for all test sample container carriers rerouted to the buffer during the unavailability of the unavailable laboratory device by the laboratory middleware after the unavailable laboratory device becomes available;
wherein the target laboratory device is included in the calculating of the new systems workflow;
retrieving all the test sample container carriers from the buffer and sending those test sample container carriers to the target laboratory device after the target laboratory device is unmasked; and
automatically processing the retrieved test sample container carriers from the buffer according to the new system workflow (claims 1 and 16)
A method of routing test sample container carriers at an end of a laboratory shift in a laboratory system, wherein the laboratory system comprises a plurality of laboratory devices, at least one buffer, a transportation system, and laboratory middleware, the method comprising:
determining a system workflow by the laboratory middleware, for processing the test sample container carriers;
halting loading of test sample container carriers into a laboratory system at an end of a laboratory shift;
processing all test sample container carriers by laboratory analytic devices of the plurality of laboratory devices in the laboratory system until the test sample container carriers reach the target laboratory device;
calculating a new system workflow by the laboratory middleware at a start of a next laboratory shift for the test sample container carriers that reached the target laboratory device;
retrieving all the test sample container carriers that reached the target laboratory device after the target laboratory device is unmasked, and
automatically processing, according to the new system workflow all test sample container carriers that have open test requests. (claim 11)
“A method of routing test sample container carriers during peak workload periods in a laboratory system, wherein the laboratory system comprises a plurality of laboratory devices, at least one buffer, a transportation system, and laboratory middleware, the method comprising:
determining a system workflow, by the laboratory middleware, for the test sample container carriers;
monitoring the system workflow to determine an incoming increase of test sample container carriers into the laboratory system after determination of the system workflow;
calculating a new system workflow by the laboratory middleware after there is no longer an increase of test sample container carriers; and
retrieving test sample container carriers that have pending open test requests from the target laboratory device that have pending open test requests after the target laboratory device is unmasked; and
automatically processing the retrieved test sample containers according to the new system workflow.” (claim 14)
The underlined claim limitations encompass workflow instructions for routing and managing laboratory test sample and devices to mitigate risks and balance workload. These workflow instructions could be steps performed by a laboratory operator and/or manager, thus managing their personal behavior. These limitations, under the broadest reasonable interpretation, fall within the abstract grouping of “Certain Methods of Organizing Human Activity” which encompasses managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions and fundamental economic principles or practices including mitigating risks. Certain Methods of Organizing Certain Methods of Organizing Human Activity can encompass the activity of a single person (e.g. a person following a set of instructions), activity that involve multiple people (e.g. a commercial interaction), and certain activity between a person and a computer (e.g. a method of anonymous loan shopping).
Dependent claims 3-6, 10, 12-13, and 15 further reiterate the same abstract idea as above with limitations of: “alerting a laboratory operator that the laboratory device is unavailable (claim 3), wherein the alerting is a visual indicator (claim 4), wherein the alerting is a…notification (claim 5), the method further comprising, manually accessing test sample container carriers by a laboratory operator… (claim 6), further comprising, rerouting test sample container carriers from the masked target device to other laboratory devices …(claim 10), the method further comprising, shortening buffer duration time… to retrieve and route test sample container carriers…faster (claim 12), …routing test sample container carriers… after the test samples in the test sample container carriers have been processed (claim 13),… retrieving the test sample container carriers for the test samples in the test sample container carriers that have pending open test requests from the at least one buffer and sending those test sample container carriers to laboratory analytic devices in the laboratory system from the at least one buffer after the at least one buffer is unmasked (claim 15). Therefore, claims 1 and 3-17 are directed to an abstract idea and are not patent eligible.
Step 2A (2): This judicial exception is not integrated into a practical application. In particular, claims 1 and 3-17 recite additional elements of “test sample container carriers; a laboratory system wherein the laboratory system comprises a plurality of laboratory devices, at least one buffer, a transportation system, and laboratory middleware; a laboratory device of the plurality of laboratory devices;…wherein the unavailable laboratory device is a connection point between the transportation system and a target laboratory device; device retrieval masking a target laboratory device of the plurality of laboratory devices connected to the unavailable laboratory device, by the laboratory middleware, so that test sample container carriers are not sent to the target laboratory device by any component of the laboratory system and test sample container carriers cannot be retrieved from the target laboratory device, by any component of the laboratory system; wherein the device retrieval masking prevents retrieval of test sample container carriers from the target laboratory device by any component of the laboratory system while the target laboratory device is device retrieval masked; a buffer located in the laboratory system; unmasking the target laboratory device (claims 1, 11, 14, and 16); wherein the retrieval masking maintains the target laboratory device in an active state during the retrieval masking (claims 11, 14, and 17); laboratory device (claim 3), visual indicator on the unavailable laboratory device (claim 4); software (claim 5); target laboratory device (claim 6); the target laboratory device is an archival device (claim 7); wherein the archival device is a refrigerator (claim 8); wherein the masking and unmasking of the target laboratory device is automatically triggered by laboratory middleware of the laboratory system (claim 9); test sample container carriers from the masked target device, other laboratory devices in the plurality of laboratory devices in the laboratory system (claim 10); laboratory analytic devices of the plurality of laboratory devices in the laboratory system (claim 11); at least one buffer in the laboratory system and test sample container carriers, archival devices (claims 12-13); device retrieval masking the at least one buffer so that test sample container carriers cannot be retrieved from the at least one buffer…; unmasking the at least one buffer, laboratory analytic devices in the laboratory system (claim 15)”. These additional elements do not integrate the abstract idea into a practical application because the claims do not recite (a) an improvement to another technology or technical field and (b) an improvement to the functioning of the computer itself and (c) implementing the abstract idea with or by use of a particular machine, (d) effecting a particular transformation or reduction of an article, or (e) applying the judicial exception in some other meaningful way beyond generally linking the use of an abstract idea to a particular technological environment. These additional elements evaluated individually and in combination are viewed as computing devices and components that are used to perform the abstract idea and objects being managed by the abstract process. Limitations that recite mere instructions to implement an abstract idea on a computer or merely uses a computer as a tool to perform an abstract idea are not indicative of integration into a practical application (see MPEP 2106.05(f)). Also limitations that amount to merely indicating a field of use or technological environment (e.g. laboratory system) in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application (see MPEP 2106.05(h)). Therefore, claims 1 and 3-17 do not include individual or a combination of additional elements that integrate the judicial exception into a practical application and thus are not patent eligible.
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1 and 3-17 recite additional elements as stated above. As per the Applicant’s PGPub US 2023/0058833 A1, test sample container may be selected from the group comprising of: a vessel; a vial; a syringe; a cartridge; an ampoule; or a container [0022]; test sample container carriers may be single holders and sample racks [0023]; The term 'laboratory instrument' or "laboratory device" as used herein can encompass any apparatus or apparatus component operable to execute and/or cause the execution of one or more processing steps/workflow steps on one or more biological samples and/or one or more reagents [0026]; the temporary buffer 170 can serve as place to house the test sample container carriers 160 in order to prevent logjams and bottleneck traffic flow issues on the transportation system 110 [0068]; the term 'laboratory middleware' as used in the present description can refer to any physical or virtual processing device configurable to control a laboratory instrument/device or system comprising one or more laboratory instruments/devices in a way that workflow(s) and workflow step(s) can be conducted by the laboratory instrument/system [0027]; and an analytical laboratory device 140 can be designed, for example, to use a test sample or part of the test sample and a test reagent in order to produce a measurable signal, based on which it is possible to determine whether an analyte is present, and if desired in what concentration [0066]. These additional elements are viewed as mere instructions to implement an abstract idea on a computer and merely indicates a field of use or technological environment in which to apply a judicial exception. Applying an abstract idea on a computer does not integrate a judicial exception into a practical application or provide an inventive concept (see MPEP 2106.05(f)). Therefore, claims 1 and 3-17 do not include individual or a combination of additional elements that are sufficient to amount to significantly more than the judicial exception and thus 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.
Claims 1, 6-10, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Furrer et al. (US 2021/0132093 A1) in view of Maetzler (US 2021/0190802 A1) and in further view of Tran et al. (US 2021/0356481 A1).
As per claim 1 (Currently Amended), Furrer teaches a method of routing test sample container carriers during periods of laboratory disruption in a laboratory system wherein the laboratory system comprises a plurality of laboratory devices, at least one buffer, a transportation system, and laboratory middleware, the method comprising (Furrer e.g. Fig. 1, A computer-implemented method of operating an analytical laboratory [0002]. An analytical system and method of operating an analytical laboratory comprising a laboratory middleware communicatively connected to a plurality of laboratory instruments configured to process biological samples is presented. The method can comprise steps of…dispatching biological samples by the laboratory middleware to laboratory instrument(s) at a dispatch rate not greater than the instrument load limit [0014]. As shown on FIG. 1, the analytical laboratory 1 can further comprise a sample transportation system 10TRS interconnecting the plurality of laboratory instruments 10AI, 10PRE, 10POST. The sample transportation system 10TRS can be a one-dimensional conveyor-belt based system [0067]. The pre-analytical instruments 10PRE comprised by the analytical laboratory 1 may be one or more from the list comprising: an instrument for centrifugation of samples, a capping-, decapping- or recapping instrument, aliquoter, a buffer to temporarily store biological samples or aliquots thereof [0063]. FIG. 6 shows a pre-analytical laboratory instrument 10 PRE comprising a sample container sorting unit 14 configured to sort sample containers 30 holding biological samples into sample racks 40, each sample rack 40 being identified by a rack identifier of a rack tag 42 attached to the sample rack 40 [0105]. The terms 'sample container', 'sample holder' and 'sample tube' can refer to any individual container for storing, transporting, and/or processing a sample [0035].):
Furrer teaches determining a system workflow, by the laboratory middleware, for processing the test sample container carriers; (Furrer e.g. After the biological sample has been received and identified by a pre-analytical laboratory instrument, a laboratory middleware retrieves the corresponding test orders and determines which instruments are required to process the biological sample according to the test order(s) [0004]. Having identified the required instrument(s), the laboratory middleware determines a sample workflow for each sample according to the test order(s). The sample workflow comprises a sequence and/or timing of carrying out the one or more test orders by the one or more analytical instruments [0004].)
Furrer teaches monitoring the system workflow to determine whether a laboratory device of the plurality of laboratory devices is an unavailable laboratory device after determining the system workflow, (Furrer e.g. It has been observed that the performance of laboratory instruments sometimes deviates (significantly) from the maximum instrument capacity. Such deviations have various causes, such as (un) availability of instrument consumables, degradation/wear of certain components of the instrument; unfavorable environmental conditions; necessity of more frequent calibration/quality control procedures and/or overloading of the laboratory instruments with biological samples at rates higher than their current capacity [0007]. At a certain point, an overloaded analytical laboratory is unable to receive additional biological samples [0012]. The laboratory middleware 20 can check whether respective laboratory instrument 10 has all resources (such as consumables, reagents, quality control) available and ready to process the biological sample according to the corresponding test order (i.e. availability) [0070]. The laboratory middleware can monitor a query rate of the plurality of laboratory instruments in order to determine an effective flow rate corresponding to each laboratory instrument [0053]. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. The laboratory middleware 20 can check whether respective laboratory instrument 10 has all resources (such as consumables, reagents, quality control) available and ready to process the biological sample according to the corresponding test order [0070]. The laboratory middleware 20 can then compare the effective flow rate of each laboratory instrument 10 with the dispatch rate of biological samples to that laboratory instrument 10 (referred to hereafter as first laboratory instrument 10). If the effective flow rate of a first laboratory instrument 10 is lower than the dispatch rate to the first laboratory instrument 10, the laboratory middleware 20, in a step 109, can decrease its load limit (of the first laboratory instrument 10). In other words, if the laboratory middleware 20 determines that the first laboratory instrument 10 is not able to process its workload (dispatched samples), it can reduce its load limit to avoid overloading the instrument [0075]. Overall, in optimizing the processing of biological sample(s), the laboratory middleware 20 can monitor and control the load of the sample transportation system 10TRS similarly to other laboratory instruments 10, namely monitoring its effective flow rate and adjusting its load limit (in this case transportation capacity) to avoid overloading and/or underutilization of the sample transportation system 10TRS [0091]. The Examiner submits that an overloaded laboratory instrument is unable to perform the test dispatched to it (i.e. original workflow), then the laboratory instrument is considered unavailable at that moment in time.)
Furrer teaches wherein the unavailable laboratory device is a connection point between the transportation system and a target laboratory device, and (Furrer e.g. As shown on FIG. 1, the analytical laboratory 1 can further comprise a sample transportation system 10TRS interconnecting the plurality of laboratory instruments 10AI, 10PRE, 10POST. The sample transportation system 10TRS can be a one-dimensional conveyor-belt based system [0067]. The laboratory middleware 20 can check whether respective laboratory instrument 10 has all resources (such as consumables, reagents, quality control) available and ready to process the biological sample according to the corresponding test order [0070]. The Examiner submits that any of the plurality of laboratory instruments 10AI, 10PRE, 10POST could be the unavailable laboratory device.)
Furrer teaches device…masking a target laboratory device of the plurality of laboratory devices connected to the unavailable laboratory device, by the laboratory middleware, so that test sample container carriers are not sent to the target laboratory device by any component of the laboratory system and… (Furrer e.g. The method of operating an analytical laboratory wherein an overloading of the entire analytical laboratory can be prevented…can further comprise the step of masking one or more of the plurality of laboratory instruments, wherein masking can comprise preventing one or more of the plurality of laboratory instruments from receiving biological sample(s), in particular biological sample(s) having at least one associated test order which the first laboratory instrument is configured to carry out. Preventing one or more of the plurality of laboratory instruments from receiving biological sample(s) can comprise preventing (physically) even the loading of the respective biological sample(s) (i.e. receiving) and/or automatically unloading the biological sample(s), e.g., into an error output ([0060] and [0098]). Masking of laboratory instruments can be performed with respect to all laboratory instruments, other than one or more laboratory instruments reserved for receiving biological samples of high priority [0061]. FIG. 4D illustrates various methods of a process called instrument masking. Instrument masking, in general, can refer to the process of hiding a particular laboratory instruments 10 from other instruments, as if it would not be available; would be offline; and/or would not exist [0094]. According to embodiments disclosed herein, instrument masking can be ordered into two main categories: destination masking and input specific masking [0095]. Destination masking can refer to the process of preventing one or more of the plurality of laboratory instruments 10 from sending biological sample(s) to the first laboratory instrument 10 (the destination) [0096]. According to a first embodiment of destination masking (step 114a), referred to as overall destination specific masking, masking can comprise preventing one or more of the plurality of laboratory instruments 10 from sending any biological sample(s) to the first laboratory instrument 10 [0096].)
Furrer teaches rerouting all test sample container carriers originally routed to the target laboratory device before the unavailability of the unavailable laboratory device to the at least one buffer for a duration of the unavailability of the unavailable laboratory device; (Furrer e.g. The present disclosure addresses the need for an analytical laboratory and method of operating an analytical laboratory which prevents overloading/underutilization of laboratory instruments by determining an effective flow rate of the laboratory instruments and dynamically reacting to the deviations of the effective flow rate by controlling the load limit of each instrument ([0015] and [0051]). The laboratory middleware 20 can be configured to control the analytical laboratory 1 to carry out the steps of one or more of the methods herein disclosed and can be communicatively connected to the data storage unit 22 [0066]. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument (i.e. unavailable instrument) [0059]. Buffering may be provided either by laboratory instrument dedicated for temporarily storing biological samples and/or by laboratory instruments 10, which have available temporary storage space for biological sample(s) fulfilling the requirements (temperature, humidity) for sample buffering [0092]. In order to (re) distribute the workload between laboratory instruments 10 (load balancing-step 110), the laboratory middleware 20 can determine a second laboratory instrument 10 of the plurality of laboratory instruments 10 ( other than the first laboratory instrument 10) configured to carry out the same test order corresponding to the respective biological sample as the first laboratory instrument 10 (Fig. 4B and [0090]). Having determined an alternative instrument to process the biological sample(s), in a step 110a, the laboratory middleware 20 can increase the load limit of the second laboratory instrument 10 by the difference between the effective flow rate and the dispatch rate of the first laboratory instrument 10. Thereafter, in a step 110c, the laboratory middleware 20 can redirect samples from the first laboratory instrument 10 to the second laboratory instrument 10 at a rate equal to the difference between the effective flow rate and the dispatch rate of the first laboratory instrument 10 (Fig. 4B and [0090]). After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample(s) can be kept in a buffer only as long as needed [0092].)
Furrer teaches calculating a new system workflow, by the laboratory middleware, for all test sample container carriers rerouted to the buffer during the unavailability of the unavailable laboratory device by the laboratory middleware after the unavailable laboratory device becomes available, wherein the target laboratory device is included in the calculating of the new system workflow; (Furrer e.g. After the biological sample has been received and identified by a pre-analytical laboratory instrument, a laboratory middleware retrieves the corresponding test orders and determines which instruments are required to process the biological sample according to the test order(s) [0004]. Having identified the required instrument(s), the laboratory middleware determines a sample workflow for each sample according to the test order(s). The sample workflow comprises a sequence and/or timing of carrying out the one or more test orders by the one or more analytical instruments [0004]. The laboratory middleware determines the sample workflow based on a load limit for each laboratory instrument based on a maximum instrument capacity [0005]. In addition, the laboratory middleware may be operable to evaluate and/or process gathered analysis data, to control the loading, storing and/or unloading of samples to and/or from any one of the analyzers [0048]. The laboratory middleware can monitor a query rate of the plurality of laboratory instruments in order to determine an effective flow rate corresponding to each laboratory instrument [0053]. Since the laboratory instruments send the test queries at a time when they are ready to process the biological sample(s), the query rate can be a good indication of the effective processing capacity of the respective laboratory instrument at that time [0054]. Adjusting the load limit of laboratory instruments as a reaction to their effective flow rate can avoid overloading, or underutilization ([0057] and [0077]). Figs. 3A-C show how the middleware 20 can determine the amount the load limit can be increased/decreased [0078]. Overall, in optimizing the processing of biological sample(s), the laboratory middleware 20 can monitor and control the load of the sample transportation system 10TRS similarly to other laboratory instruments 10, namely monitoring its effective flow rate and adjusting its load limit (in this case transportation capacity) to avoid overloading and/or underutilization of the sample transportation system 10TRS [0091]. After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample(s) can be kept in a buffer only as long as needed [0092].)
Furrer teaches retrieving all the test sample container carriers from the buffer and sending those test sample container carriers to the target laboratory device after the target laboratory device is available; and (Furrer e.g. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. Alternatively, or additionally, to load balancing (step 110), if the effective flow rate of the first laboratory instrument 10 is lower than the corresponding dispatch rate, the laboratory middleware 20 can buffer biological samples to temporarily reduce the workload of the laboratory instruments 10 (Fig. 4C and [0092]). In a first step, the laboratory middleware 20 can determine whether any laboratory instrument 10 (referred hereafter as third laboratory instrument) has available buffer capacity. Buffering may be provided either by laboratory instrument dedicated for temporarily storing biological samples and/or by laboratory instruments 10, which have available temporary storage space for biological sample(s) fulfilling the requirements (temperature, humidity) for sample buffering [0092]. If there is available buffer capacity, in a step 112a, the laboratory middleware 20 can dispatch biological samples to the third laboratory instrument 10 having available buffer capacity [0092]. After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample( s) can be kept in a buffer only as long as needed [0092].)
Furrer teaches automatically processing the retrieved test sample container carriers from the buffer according to the new workflow. (Furrer e.g. After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample(s) can be kept in a buffer only as long as needed [0092]. The biological samples can be dispatched to laboratory instrument(s) configured to carry out at least one test order corresponding to the biological sample [0014]. Thereafter, the laboratory instruments 10 can receive and identify the biological sample(s) dispatched thereto. Upon identifying the biological samples, each laboratory instrument 10 can send test order queries to the laboratory middleware 20, the test order query comprising data identifying the biological sample. A test order can comprise data indicative of one or more processing steps to be carried out on the biological sample [0071]. The laboratory instruments 10 can then process the biological sample(s) according to the test orders sent to them by the laboratory middleware 20 [0072].)
Furrer does not explicitly teach the following: (1) wherein an unavailable laboratory device is unavailable to process test sample container carriers due to a maintenance issue, (2) device retrieval masking so that test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system, wherein the device retrieval masking prevents retrieval of test sample container carriers from the target laboratory device by any component of the laboratory system while the target laboratory device is device retrieval masked; and (3) unmasking the target laboratory device;.
However, Maetzler teaches wherein an unavailable laboratory device is unavailable to process test sample container carriers due to a maintenance issue; (Maetzler e.g. Maetzler teaches a method to optimize analyzer use in a laboratory having a plurality of analyzers based on laboratory workload [0014]. One of the analyzers in the plurality of analyzers can be masked if it is determined that the next estimated maintenance event at that particular analyzer falls within a certain time period [0030]. For example, if that certain time period is determined to occur during the processing of the current laboratory workload, that particular analyzer can be masked until the maintenance is performed on the analyzer. Once the maintenance has been completed, that analyzer can be unmasked [0050].)
Maetzler also teaches unmasking the target laboratory device; (Maetzler e.g. Maetzler teaches a method to optimize analyzer use in a laboratory having a plurality of analyzers based on laboratory workload [0014]. The method comprises the steps of determining current laboratory workload, calculating workload capability of the plurality of analyzers minus one analyzer if the current laboratory workload is below a threshold criteria and if there are two or more analyzers in the plurality of analyzers, masking one of the plurality of analyzers if the current workload is met by the plurality of analyzers minus one analyzer, proceeding with current workload, and repeating the above steps until the current laboratory workload has been completed [0014]. The method can further comprise unmasking any available masked analyzers if the current workload is not met by the capability of the plurality of analyzers minus one analyzer [0018]. In other embodiment, the control device 20 can take into consideration the throughput capability of the analyzer when deciding whether to mask or unmask a certain analyzer in the laboratory 10 [0048]. For example, if that certain time period is determined to occur during the processing of the current laboratory workload, that particular analyzer can be masked until the maintenance is performed on the analyzer. Once the maintenance has been completed, that analyzer can be unmasked [0050]. If the laboratory workload grows, the control device 20 has the ability to unmask analyzers in order for the unmasked analyzers to help with the laboratory workload [0053].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify Furrer’s analytical laboratory monitoring operation to include identifying the laboratory device is unavailable due to a maintenance issue and unmasking the target laboratory device after the new laboratory workflow is calculated as taught by Maetzler in order to in order to adjust the number of analyzers needed to complete the laboratory workload in the most efficient manner and optimize analyzer (i.e. laboratory equipment) workload for a laboratory (Maetzler e.g. [0002] and [0058]).
Maetzler does not explicitly teach, however, Tran teaches the following:
Tran teaches a type of device retrieval masking so that test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system, wherein the device retrieval masking prevents retrieval of test sample container carriers from the target laboratory device by any component of the laboratory system while the target laboratory device is device retrieval masked; (Tran e.g. Systems and methods for guiding the management of blood/plasma screening laboratory workflow are disclosed (Abstract). The processor can be configured to determine presence of a first external control preventing a release of a biological component to a biological sample analyzing device, and in response to the determination that the first external control is present, prevent release of biological components run after the first external control to the biological sample analyzing device to perform analysis of the biological components until the first external control is released [0006]. FIG. 1 illustrates a workflow 100 for biological sample screening, such as blood and/or plasma screening, according to some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap/sort stage 106, a pooler stage 108, an analyzer stage 110, a review stage 112, and a storage stage 114 [0032]. Analyzer systems can measure different chemicals and other characteristics in a plurality of biological samples [0045]. The transporting between stations (e.g. analyzer systems, pooler systems, etc.) can occur automatically, semi automatically, manually, and/or a combination thereof. For example, the sample tubes can be transported from the sorter system to the pooler system manually by a technician, and from the pooler system to the analyzer system automatically (e.g. by use of robotics to move the sample tubes) [0046]. FIG. 6 illustrates an embodiment of a process 600 for managing the release of test results according to some embodiments. The process 600 can be implemented by a screening workflow system, such as the system 200 [0081]. A configuration of external controls may prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, the external controls can be loaded into an analyzer [0081].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Maetzler’s analytical laboratory masking operation with Tran’s system for analyzing biological samples step of preventing release/retrieval of test samples from laboratory device by other laboratory devices in order to adjust and/or optimize workflows periodically and/or in response to an activity, such as the completion or delay of a test (Tran e.g. [0038]).
Furrer, Maetzler, and Tran’s inventions are directed towards laboratory system operations. Furthermore, all of the claimed elements were known in the prior arts of Furrer, Maetzler, and Tran and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
As per claim 6 (Original), Furrer in view of Maetzler and Tran teach the method according to claim 1, Furrer teaches further comprising, manually accessing test sample container carriers by a laboratory operator in the masked target laboratory device while the target laboratory device is masked. (Furrer e.g. The method of operating an analytical laboratory… can further comprise the step of masking one or more of the plurality of laboratory instruments, wherein masking can comprise preventing one or more of the plurality of laboratory instruments from receiving biological sample(s), in particular biological sample(s) having at least one associated test order which the first laboratory instrument is configured to carry out [0060]. Preventing one or more of the plurality of laboratory instruments from receiving biological sample(s) can comprise preventing (physically) even the loading of the respective biological sample(s) and/or automatically unloading the biological sample(s), e.g., into an error output [0060]. The Examiner submits that the sample can be manually accessed from the error output.)
As per claim 7 (Original), Furrer in view of Maetzler and Tran teach the method according to claim 1, Furrer teaches wherein the target laboratory device is an archival device. (Furrer e.g. As shown on FIG. 1, the analytical laboratory 1 can further comprise a sample transportation system 10TRS interconnecting the plurality of laboratory instruments 10AI, 10PRE, 10POST [0067]. FIG. 9 illustrates a highly schematic block diagram of a post-analytical laboratory instrument of the disclosed laboratory system [0028]. The term 'post-analytical instrument' as used herein can encompass any apparatus or apparatus component that can be configured to perform one or more post-analytical processing steps/workflow steps comprising-but not limited to-sample unloading, transport, recapping, decapping, temporary storage/buffering, archiving (refrigerated or not), retrieval and or disposal [0043].)
As per claim 8 (Original), Furrer in view of Maetzler and Tran teach the method according to claim 7, Furrer teaches wherein the archival device is a refrigerator. (Furrer e.g. The term 'post-analytical instrument' as used herein can encompass any apparatus or apparatus component that can be configured to perform one or more post-analytical processing steps/workflow steps comprising-but not limited to-sample unloading, transport, recapping, decapping, temporary storage/buffering, archiving (refrigerated or not), retrieval and or disposal [0043].)
As per claim 9 (Currently Amended), Furrer in view of Maetzler and Tran teach the method according to claim 1, wherein the device retrieval masking and unmasking of the target laboratory device is automatically triggered by laboratory middleware of the laboratory system.
Furrer teach device masking of the target laboratory device is automatically triggered by laboratory middleware of the laboratory system (Furrer e.g. The laboratory middleware 20 can be configured to control the analytical laboratory 1 to carry out the steps of one or more of the methods herein disclosed and can be communicatively connected to the data storage unit 22 [0066]. The term 'laboratory middleware' as used herein can encompass any physical or virtual processing device configurable to control a laboratory instrument/or system comprising one or more laboratory instruments in a way that workflow(s) and workflow step(s) can be conducted by the laboratory instrument/system [0045]. The laboratory middleware can increase or decrease the load limit of the first laboratory instrument using continuously modulated control such as, for example, a proportional-integral-derivative PID, a proportional-integral PI, a proportional-derivative PD, a proportional or an integral control algorithm [0058]. The method of operating an analytical laboratory… can further comprise the step of masking one or more of the plurality of laboratory instruments, wherein masking can comprise preventing one or more of the plurality of laboratory instruments from receiving biological sample(s), in particular biological sample(s) having at least one associated test order which the first laboratory instrument is configured to carry out [0060].)
Furrer does not explicitly teach, however, Maetzler teaches unmasking of the target laboratory device is automatically triggered by laboratory middleware of the laboratory system (Maetzler e.g. The method can further comprise unmasking any available masked analyzers if the current workload is not met by the capability of the plurality of analyzers minus one analyzer [0018]. This method is repeated throughout the processing of the laboratory workflow. If, however, there comes a time that is determined in step 220 that the single analyzer can no longer meet the demand of the current laboratory workload, the other analyzer can be unmask, i.e., turn on, and return to service to meet the demand of the current laboratory workload [0042]. The control device 20 can take into consideration the throughput capability of the analyzer when deciding whether to mask or unmask a certain analyzer in the laboratory 10 [0048]. If the laboratory workload grows, the control device 20 has the ability to unmask analyzers in order for the unmasked analyzers to help with the laboratory workload [0053].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer’s analytical laboratory automatic masking operation with Maetzler's laboratory system process of automatically unmasking the target laboratory device in order to optimize analyzer (i.e. laboratory equipment) workload for a laboratory (Maetzler e.g. [0002]).
Furrer nor Maetzler explicitly teach device retrieval masking/unmasking, however, Tran teaches a type of device retrieval masking/unmasking (Tran e.g. Systems and methods for guiding the management of blood/plasma screening laboratory workflow are disclosed (Abstract). The processor can be configured to determine presence of a first external control preventing a release of a biological component to a biological sample analyzing device, and in response to the determination that the first external control is present, prevent release of biological components run after the first external control to the biological sample analyzing device to perform analysis of the biological components until the first external control is released [0006]. FIG. 1 illustrates a workflow 100 for biological sample screening, such as blood and/or plasma screening, according to some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap/sort stage 106, a pooler stage 108, an analyzer stage 110, a review stage 112, and a storage stage 114 [0032]. Analyzer systems can measure different chemicals and other characteristics in a plurality of biological samples [0045]. The transporting between stations (e.g. analyzer systems, pooler systems, etc.) can occur automatically, semi automatically, manually, and/or a combination thereof. For example, the sample tubes can be transported from the sorter system to the pooler system manually by a technician, and from the pooler system to the analyzer system automatically (e.g. by use of robotics to move the sample tubes) [0046]. FIG. 6 illustrates an embodiment of a process 600 for managing the release of test results according to some embodiments. The process 600 can be implemented by a screening workflow system, such as the system 200 [0081]. A configuration of external controls may prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, the external controls can be loaded into an analyzer [0081].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Maetzler’s analytical laboratory masking operation with Tran’s system for analyzing biological samples step of preventing release/retrieval of test samples from laboratory device by other laboratory devices in order to adjust and/or optimize workflows periodically and/or in response to an activity, such as the completion or delay of a test (Tran e.g. [0038]).
As per claim 10 (Original), Furrer in view of Maetzler and Tran teach the method according to claim 1, Furrer teaches further comprising, rerouting test sample container carriers from the masked target device to other laboratory devices in the plurality of laboratory devices in the laboratory system while the target laboratory device is masked. (Furrer e.g. The present disclosure addresses the need for an analytical laboratory and method of operating an analytical laboratory which prevents overloading/underutilization of laboratory instruments by determining an effective flow rate of the laboratory instruments and dynamically reacting to the deviations of the effective flow rate by controlling the load limit of each instrument ([0015] and [0051]). The laboratory middleware 20 can be configured to control the analytical laboratory 1 to carry out the steps of one or more of the methods herein disclosed and can be communicatively connected to the data storage unit 22 [0066]. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. In order to (re) distribute the workload between laboratory instruments 10 (load balancing-step 110), the laboratory middleware 20 can determine a second laboratory instrument 10 of the plurality of laboratory instruments 10 ( other than the first laboratory instrument 10) configured to carry out the same test order corresponding to the respective biological sample as the first laboratory instrument 10 (Fig. 4B and [0090]). Having determined an alternative instrument to process the biological sample(s), in a step 110a, the laboratory middleware 20 can increase the load limit of the second laboratory instrument 10 by the difference between the effective flow rate and the dispatch rate of the first laboratory instrument 10. Thereafter, in a step 110c, the laboratory middleware 20 can redirect samples from the first laboratory instrument 10 to the second laboratory instrument 10 at a rate equal to the difference between the effective flow rate and the dispatch rate of the first laboratory instrument 10 (Fig. 4B and [0090]).)
As per claim 16 (Original), Furrer in view of Maetzler and Tran teach a laboratory system, the laboratory system comprising: a plurality of laboratory devices, wherein the plurality of laboratory devices comprises input devices, archival target devices, laboratory analytic devices, and buffer targets; a transportation system connected to the plurality of laboratory devices and configured to transport test sample container carriers between the plurality of laboratory devices; and a laboratory middleware configured to mask and unmask the plurality of laboratory devices for retrieval and/or distribution of the test sample container carriers according to the method of claim 1. (See claim 1 response.)
As per claim 17 (Currently Amended), Furrer in view of Maetzler and Tran teach the method according to claim 1, Furrer in view of Maetzler do not explicitly teach, however, Tran teaches wherein the device retrieval masking maintains the target laboratory device in an active state during the retrieval masking (Tran e.g. Systems and methods for guiding the management of blood/plasma screening laboratory workflow are disclosed (Abstract). The processor can be configured to determine presence of a first external control preventing a release of a biological component to a biological sample analyzing device, and in response to the determination that the first external control is present, prevent release of biological components run after the first external control to the biological sample analyzing device to perform analysis of the biological components until the first external control is released [0006]. FIG. 1 illustrates a workflow 100 for biological sample screening, such as blood and/or plasma screening, according to some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap/sort stage 106, a pooler stage 108, an analyzer stage 110, a review stage 112, and a storage stage 114 [0032]. Analyzer systems can measure different chemicals and other characteristics in a plurality of biological samples [0045]. The transporting between stations (e.g. analyzer systems, pooler systems, etc.) can occur automatically, semi automatically, manually, and/or a combination thereof. For example, the sample tubes can be transported from the sorter system to the pooler system manually by a technician, and from the pooler system to the analyzer system automatically (e.g. by use of robotics to move the sample tubes) [0046]. FIG. 6 illustrates an embodiment of a process 600 for managing the release of test results according to some embodiments. The process 600 can be implemented by a screening workflow system, such as the system 200 [0081]. A configuration of external controls may prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, the external controls can be loaded into an analyzer [0081].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Maetzler’s analytical laboratory masking operation with Tran’s system for analyzing biological samples step of preventing release/retrieval of test samples from laboratory device by other laboratory devices and keeping the device in an active state in order to adjust and/or optimize workflows periodically and/or in response to an activity, such as the completion or delay of a test (Tran e.g. [0038]).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Furrer et al. (US 2021/0132093 A1) in view of Maetzler (US 2021/0190802 A1), in further view of Tran et al. (US 2021/0356481 A1), and in further view of Torres et al. (US 2020/0049725 A1).
As per claim 3 (Original), Furrer in view of Maetzler and Tran teach the method according to claims 1, Furrer in view of Maetzler and Tran do not explicitly teach, however, Torres teaches further comprising, alerting a laboratory operator that the laboratory device is unavailable. (Torres e.g. A dashboard interface may be displayed on a lab instrument to provide aggregate status information from a plurality of other interfaces organized into a single interface (Abstract). The lab instrument 100 may also comprise a communication device 114 and a status indicator 116. The status indicator 116 may be a light indicator, speaker, or other device operable to notify a user of an error, alert, status change, or other occurrence associated with the lab instrument 100 (Fig. 3 and [0032]). FIG. 3 shows the status indicator 116 as a light indicator that may be lit at varying levels of brightness, colors, and sequences to provide visual information to nearby users. For example, if the lab instrument 100 is currently inoperable due to insufficient levels of the testing materials 106, the status indicator 116 may intermittently flash a red light indicating its inoperability [0032].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify Furrer in view of Maetzler and Tran’s analytical laboratory system to include alerting a laboratory operator that the laboratory device is unavailable as taught by Torres in order to allow a user to efficiently determine the status of the lab instrument and resolve issues related to the lab instrument (Torres e.g. [0034]).
Furrer, Maetzler, Tran, and Torres’s inventions are directed towards laboratory system operations. Furthermore, all of the claimed elements were known in the prior arts of Furrer, Maetzler, Tran, and Torres and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
As per claim 4 (Original), Furrer in view of Maetzler, Tran, and Torres teach the method according to claim 3, Furrer in view of Maetzler, Tran, and Torres teach wherein the alerting is a visual indicator on the unavailable laboratory device. (Torres e.g. A dashboard interface may be displayed on a lab instrument to provide aggregate status information from a plurality of other interfaces organized into a single interface (Abstract). The lab instrument 100 may also comprise a communication device 114 and a status indicator 116. The status indicator 116 may be a light indicator, speaker, or other device operable to notify a user of an error, alert, status change, or other occurrence associated with the lab instrument 100 (Fig. 3 and [0032]). FIG. 3 shows the status indicator 116 as a light indicator that may be lit at varying levels of brightness, colors, and sequences to provide visual information to nearby users. For example, if the lab instrument 100 is currently inoperable due to insufficient levels of the testing materials 106, the status indicator 116 may intermittently flash a red light indicating its inoperability [0032].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify Furrer in view of Maetzler and Tran’s analytical laboratory system to include alerting a laboratory operator that the laboratory device is unavailable as taught by Torres in order to allow a user to efficiently determine the status of the lab instrument and resolve issues related to the lab instrument (Torres e.g. [0034]).
As per claim 5 (Original), Furrer in view of Maetzler, Tran, and Torres teach the method according to claim 3, Furrer in view of Maetzler, Tran, and Torres teach wherein the alerting is a software notification. (Torres e.g. The lab instrument 100 also comprises a processor 118 coupled with a memory 120, that may be configured to store various instructions and configurations that are executable by the processor 118 to...control the various devices and features of the lab instrument (e.g., receiving data from the testing equipment 108 indicating an error, causing the status indicator 116 to flash red, providing a description via the display 102 and the communication device 114 of the error) [0033].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify Furrer in view of Maetzler and Tran’s analytical laboratory system to include alerting a laboratory operator that the laboratory device is unavailable as taught by Torres in order to allow a user to efficiently determine the status of the lab instrument and resolve issues related to the lab instrument (Torres e.g. [0034]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Furrer et al. (US 2021/0132093 A1) in view of Silbert (WO-2021216932-A1), in further view of Tran et al. (US 2021/0356481 A1), and in further view of Maetzler (US 2021/0190802 A1).
As per claim 11 (Currently Amended), Furrer teaches a method of routing test sample container carriers at an end of a laboratory shift in a laboratory system, wherein the laboratory system comprises a plurality of laboratory devices, at least one buffer, a transportation system, and laboratory middleware, the method comprising (Furrer e.g. A computer-implemented method of operating an analytical laboratory [0002]. The method can comprise steps of… dispatching biological samples by the laboratory middleware to laboratory instrument(s) at a dispatch rate not greater than the instrument load limit [0014]. Fig. 1, An analytical system and method of operating an analytical laboratory comprising a laboratory middleware communicatively connected to a plurality of laboratory instruments configured to process biological samples is presented [0014]. As shown on FIG. 1, the analytical laboratory 1 can further comprise a sample transportation system 10TRS interconnecting the plurality of laboratory instruments 10AI, 10PRE, 10POST. The sample transportation system 10TRS can be a one-dimensional conveyor-belt based system [0067]. The pre-analytical instruments 10PRE comprised by the analytical laboratory 1 may be one or more from the list comprising: an instrument for centrifugation of samples, a capping-, decapping- or recapping instrument, aliquoter, a buffer to temporarily store biological samples or aliquots thereof [0063]. FIG. 6 shows a pre-analytical laboratory instrument 10 PRE comprising a sample container sorting unit 14 configured to sort sample containers 30 holding biological samples into sample racks 40, each sample rack 40 being identified by a rack identifier of a rack tag 42 attached to the sample rack 40 [0105]. The terms 'sample container', 'sample holder' and 'sample tube' can refer to any individual container for storing, transporting, and/or processing a sample [0035].):
Furrer teaches determining a system workflow, by the laboratory middleware, for processing the test sample container carriers; (Furrer e.g. After the biological sample has been received and identified by a pre-analytical laboratory instrument, a laboratory middleware retrieves the corresponding test orders and determines which instruments are required to process the biological sample according to the test order(s) [0004]. Having identified the required instrument(s), the laboratory middleware determines a sample workflow for each sample according to the test order(s). The sample workflow comprises a sequence and/or timing of carrying out the one or more test orders by the one or more analytical instruments [0004].)
Furrer teaches halting loading of test sample container carriers into a laboratory system… (Furrer e.g. The method of operating an analytical laboratory…can further comprise the step of masking one or more of the plurality of laboratory instruments, wherein masking can comprise preventing one or more of the plurality of laboratory instruments from receiving biological sample(s), in particular biological sample(s) having at least one associated test order which the first laboratory instrument is configured to carry out [0060]. Preventing one or more of the plurality of laboratory instruments from receiving biological sample(s) can comprise preventing (physically) even the loading of the respective biological sample(s) and/or automatically unloading the biological sample(s), e.g., into an error output [0060].)
Furrer teaches device…masking a target laboratory device of the plurality of laboratory devices, by the laboratory middleware,… (Furrer e.g. FIG. 4D illustrates various methods of a process called instrument masking. Instrument masking, in general, can refer to the process of hiding a particular laboratory instruments 10 from other instruments, as if it would not be available; would be offline; and/or would not exist [0094]. According to embodiments disclosed herein, instrument masking can be ordered into two main categories: destination masking and input specific masking [0095]. Destination masking can refer to the process of preventing one or more of the plurality of laboratory instruments 10 from sending biological sample(s) to the first laboratory instrument 10 (the destination) [0096]. Preventing one or more of the plurality of laboratory instruments 10 from receiving biological sample(s) can comprise preventing (physically) even the loading of the respective biological sample(s) and/or automatically unloading the biological sample(s), e.g., into an error output [0098].)
Furrer teaches processing all test sample container carriers by laboratory analytic devices of the plurality of laboratory devices in the laboratory system until the test sample container carriers reach the target laboratory device; (Furrer e.g. After the biological sample has been received and identified by a pre-analytical laboratory instrument, a laboratory middleware retrieves the corresponding test orders and determines which instruments are required to process the biological sample according to the test order(s). Having identified the required instrument(s), the laboratory middleware determines a sample workflow for each sample according to the test order(s). The sample workflow comprises a sequence and/or timing of carrying out the one or more test orders by the one or more analytical instruments [0004]. The method can comprise steps of...dispatching biological samples by the laboratory middleware to laboratory instrument( s) at a dispatch rate not greater than the instrument load limit [0014]. In addition, the laboratory middleware may be operable to evaluate and/or process gathered analysis data, to control the loading, storing and/or unloading of samples to and/or from any one of the analyzers [0048]. As shown on the block diagram of FIG. 1, embodiments of the disclosed analytical laboratory 1 for processing biological sample(s) can comprise a plurality of laboratory instruments 10AI, 10PRE, 10POST and a laboratory middleware 20 communicatively connected by a communication network. The plurality of laboratory instruments 10AI, 10PRE, 10 POST can be configured to execute processing steps on the biological samples according to instructions from the laboratory middleware 20 [0062]. As shown on FIG. 1, the analytical laboratory 1 can further comprise a sample transportation system 10TRS interconnecting the plurality of laboratory instruments 10AI, 10PRE, 10POST [0067]. The laboratory middleware 20 can check whether respective laboratory instrument 10 has all resources (such as consumables, reagents, quality control) available and ready to process the biological sample according to the corresponding test order [0070]. Thereafter, the laboratory instruments 10 can receive and identify the biological sample(s) dispatched thereto [0071]. The laboratory instruments 10 can then process the biological sample(s) according to the test orders sent to them by the laboratory middleware 20 [0072].)
Furrer teaches calculating a new system workflow by the laboratory middleware at a start of a next laboratory shift for the test sample container carriers that reached the target laboratory device; (Furrer e.g. In addition, the laboratory middleware may be operable to evaluate and/or process gathered analysis data, to control the loading, storing and/or unloading of samples to and/or from any one of the analyzers [0048]. The laboratory middleware can monitor a query rate of the plurality of laboratory instruments in order to determine an effective flow rate corresponding to each laboratory instrument [0053]. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. The laboratory middleware 20 can check whether respective laboratory instrument 10 has all resources (such as consumables, reagents, quality control) available and ready to process the biological sample according to the corresponding test order [0070]. Adjusting the load limit of laboratory instruments as a reaction to their effective flow rate can avoid overloading, or underutilization ([0057] and [0077]). Figs. 3A-C show how the middleware 20 can determine the amount the load limit can be increased/decreased [0078]. In order to (re) distribute the workload between laboratory instruments 10 (load balancing-step 110), the laboratory middleware 20 can determine a second laboratory instrument 10 of the plurality of laboratory instruments 10 ( other than the first laboratory instrument 10) configured to carry out the same test order corresponding to the respective biological sample as the first laboratory instrument 10 [0090]. The Examiner submits that the process of calculating workflows (e.g. load balancing, buffering, or rerouting/redistribute) occurs at any time of day during normal operations.)
Furrer teaches retrieving all the test sample container carriers that reached the target laboratory device…; and (Furrer e.g. The term 'post-analytical instrument' as used herein can encompass any apparatus or apparatus component that can be configured to perform one or more post-analytical processing steps/workflow steps comprising-but not limited to-sample unloading, transport, recapping, decapping, temporary storage/buffering, archiving (refrigerated or not), retrieval and or disposal [0043]. Buffering may be provided either by laboratory instrument dedicated for temporarily storing biological samples and/or by laboratory instruments 10, which have available temporary storage space for biological sample(s) fulfilling the requirements (temperature, humidity) for sample buffering [0092]. FIG. 9 shows an embodiment of a post-analytical laboratory instrument 10POST comprising a sample storage unit 19. The post-analytical laboratory instrument 10AI can be configured to store respectively retrieve sample containers 30 into respectively from the sample storage unit 19. Correspondingly, when queried by a post-analytical laboratory instrument 10POST, the laboratory middleware can transmit data indicative of a sample container 30 to be retrieved from the sample storage unit 19. In response to the data indicative of a sample container 30 to be stored respectively retrieved, the post-analytical laboratory instrument 10POST can store respectively retrieves the sample container 30 from the sample storage unit 19 [0108].)
Furrer teaches automatically processing, according to the new system workflow all test sample container carriers that have open test requests. (Furrer e.g. After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample( s) can be kept in a buffer only as long as needed [0092]. The biological samples can be dispatched to laboratory instrument(s) configured to carry out at least one test order corresponding to the biological sample [0014]. A test order can comprise data indicative of one or more processing steps to be carried out on the biological sample [0071].)
Furrer does not explicitly teach (1) halting loading of test sample containers into a laboratory system “at the end of a laboratory shift” (2) device retrieval masking so that the test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system and test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system; wherein the device retrieval masking maintains the target laboratory device in an active state during the device retrieval masking, and wherein the device retrieval masking prevents retrieval of test sample containers from the target laboratory device by other laboratory devices of the plurality of laboratory devices; and (3) unmasking the target laboratory device;
Furrer teaches halting the loading of carriers during destination masking (Furrer e.g. Destination masking can refer to the process of preventing one or more of the plurality of laboratory instruments 10 from sending biological sample(s) to the first laboratory instrument 10 (the destination) [0096]. Preventing one or more of the plurality of laboratory instruments 10 from receiving biological sample(s) can comprise preventing (physically) even the loading of the respective biological sample(s) and/or automatically unloading the biological sample(s ), e.g., into an error output [0098].)
Furrer does not explicitly teach, halting the loading of carrier at the end of a shift.
However, Silbert teaches halting the loading of test sample container carriers into a laboratory system at the end of a laboratory shift (Silbert e.g. Silbert teaches automated systems and methods for processing samples contained in discrete sample containers and grouping sample containers according to the assay to be performed on the sample contained therein so that multiple samples can be processed by analyzers simultaneously [0002]. The system may include two or more analyzers, and each analyzer may be configured to perform one or more functional assays on sample extracted from a sample container [0007]. Patient samples may be loaded into an analyzer (manually or via an automated system), which can then perform one or more reactions or processes, such as, immunoassays, chemistry' tests, or other observable tests on each sample [00304]. The functional assays of the analyzer stations of the system may vary with time, depending on the changing availability of one or more analyzers or changes in status of one or more analyzers. For example, as described in more detail below, analyzer stations may be taken off line, so that the functional assay(s) of the off line analyzer are no longer available to the system [00341]. The user can request - e.g., at the end of the day or the end of a shift - that all sample containers having remaining open assays (or possible remaining open assays) be moved from the container storage module 214 to the output module 216. This will leave only fully completed sample containers in the container storage module 214, which can be removed en masse by removing the rack(s) holding such sample containers [00402]. Output module 216 is configured to receive sample containers from the track 202 and to hold sample containers 120, e.g., on one or more sample container racks 124, after all processing of the sample container is complete, e.g., no remaining open assays, and then the sample container can be removed from the output module 216 and thus from the system 100 [00335]. The Examiner submits that at the end of a shift sample containers are removed from the system (i.e. not loaded).)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer’s analytical laboratory operation with Silbert’s end of shift/day laboratory procedure in order to improve throughput and efficiency while reducing consumable usage (Silbert e.g. [00451]).
Silbert does not explicitly teach, however, Tran teaches a type of device retrieval masking so that the test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system and test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system; wherein the device retrieval masking maintains the target laboratory device in an active state during the device retrieval masking, and wherein the device retrieval masking prevents retrieval of test sample containers from the target laboratory device by other laboratory devices of the plurality of laboratory devices (Tran e.g. Systems and methods for guiding the management of blood/plasma screening laboratory workflow are disclosed (Abstract). The processor can be configured to determine presence of a first external control preventing a release of a biological component to a biological sample analyzing device, and in response to the determination that the first external control is present, prevent release of biological components run after the first external control to the biological sample analyzing device to perform analysis of the biological components until the first external control is released [0006]. FIG. 1 illustrates a workflow 100 for biological sample screening, such as blood and/or plasma screening, according to some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap/sort stage 106, a pooler stage 108, an analyzer stage 110, a review stage 112, and a storage stage 114 [0032]. Analyzer systems can measure different chemicals and other characteristics in a plurality of biological samples [0045]. The transporting between stations (e.g. analyzer systems, pooler systems, etc.) can occur automatically, semi automatically, manually, and/or a combination thereof. For example, the sample tubes can be transported from the sorter system to the pooler system manually by a technician, and from the pooler system to the analyzer system automatically (e.g. by use of robotics to move the sample tubes) [0046]. FIG. 6 illustrates an embodiment of a process 600 for managing the release of test results according to some embodiments. The process 600 can be implemented by a screening workflow system, such as the system 200 [0081]. A configuration of external controls may prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, the external controls can be loaded into an analyzer [0081].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Silbert’s analytical laboratory masking operation with Tran’s system for analyzing biological samples step of preventing release/retrieval of test samples from laboratory device by other laboratory devices and keeping the device in an active state in order to adjust and/or optimize workflows periodically and/or in response to an activity, such as the completion or delay of a test (Tran e.g. [0038]).
Silbert nor Tran explicitly teach, however, Maetzler teaches unmasking the target laboratory device; (Maetzler e.g. Maetzler teaches a method to optimize analyzer use in a laboratory having a plurality of analyzers based on laboratory workload [0014]. The method comprises the steps of determining current laboratory workload, calculating workload capability of the plurality of analyzers minus one analyzer if the current laboratory workload is below a threshold criteria and if there are two or more analyzers in the plurality of analyzers, masking one of the plurality of analyzers if the current workload is met by the plurality of analyzers minus one analyzer, proceeding with current workload, and repeating the above steps until the current laboratory workload has been completed [0014]. The method can further comprise unmasking any available masked analyzers if the current workload is not met by the capability of the plurality of analyzers minus one analyzer [0018]. In other embodiment, the control device 20 can take into consideration the throughput capability of the analyzer when deciding whether to mask or unmask a certain analyzer in the laboratory 10 [0048]. For example, if that certain time period is determined to occur during the processing of the current laboratory workload, that particular analyzer can be masked until the maintenance is performed on the analyzer. Once the maintenance has been completed, that analyzer can be unmasked [0050]. If the laboratory workload grows, the control device 20 has the ability to unmask analyzers in order for the unmasked analyzers to help with the laboratory workload [0053].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Silbert and Tran’s analytical laboratory masking operation with Maetzler's laboratory system process of unmasking the target laboratory device after the new laboratory workflow is calculated in order to optimize analyzer (i.e. laboratory equipment) workload for a laboratory (Maetzler e.g. [0002]).
As per claim 12 (Original), Furrer in view of Silbert, Tran, and Maetzler teach the method according to claim 11, Furrer teaches further comprising, shortening buffer duration time of the at least one buffer in the laboratory system to retrieve and route test sample container carriers to archival devices faster. (Furrer e.g. After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample( s) can be kept in a buffer only as long as needed [0092].)
As per claim 13 (Currently Amended), Furrer in view of Silbert, Tran, and Maetzler teach the method according to claim 11, further comprising, device retrieval masking the at least one buffer from use; and routing test sample container carriers directly to archival devices of the plurality of laboratory devices after the test samples in the test sample container carriers have been processed.
Furrer teaches device masking the at least one buffer from use; and routing test sample container carriers directly to archival devices of the plurality of laboratory devices after the test samples in the test sample container carriers have been processed (Furrer e.g. The method of operating an analytical laboratory…can further comprise the step of masking one or more of the plurality of laboratory instruments, wherein masking can comprise preventing one or more of the plurality of laboratory instruments from receiving biological sample(s), in particular biological sample(s) having at least one associated test order which the first laboratory instrument is configured to carry out [0060]. The term 'laboratory instrument' as used herein can encompass any apparatus or apparatus component operable to execute one or more processing steps/workflow steps on one or more biological samples and/or one or more reagents. The term 'instrument' can cover pre-analytical instruments, post-analytical instruments as well as analytical instruments [0040]. The term 'post-analytical instrument' as used herein can encompass any apparatus or apparatus component that can be configured to perform one or more post-analytical processing steps/workflow steps comprising-but not limited to-sample unloading, transport, recapping, decapping, temporary storage/buffering, archiving (refrigerated or not), retrieval and or disposal [0043]. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. Alternatively, or additionally, to load balancing (step 110), if the effective flow rate of the first laboratory instrument 10 is lower than the corresponding dispatch rate, the laboratory middleware 20 can buffer biological samples to temporarily reduce the workload of the laboratory instruments 10 (Fig. 4C and [0092]). Similarly to load balancing, the laboratory middleware 20 can also take into consideration a transportation time of the biological sample(s) to the third laboratory instrument 10 for buffering. In this way, it can be avoided that biological sample(s) are dispatched for buffering (temporary storage) for periods of time potentially shorter than the time it can take the sample transportation system 10TRS to transport the samples for buffering. Such embodiments can be advantageous since waste of both buffering and transportation capacity can be prevented [0093]. Overall, in optimizing the processing of biological sample(s), the laboratory middleware 20 can monitor and control the load of the sample transportation system 10TRS similarly to other laboratory instruments 10, namely monitoring its effective flow rate and adjusting its load limit (in this case transportation capacity) to avoid overloading and/or underutilization of the sample transportation system 10TRS [0091]. In such a way, the overall turn-around-time TAT of the respective biological sample(s) can be significantly improved by ensuring the biological sample(s) are transported to the laboratory instruments 10 as efficiently as possible [0091].)
Furrer nor Silbert explicitly teach device retrieval masking, however, Tran teaches a type of device retrieval masking (Tran e.g. Systems and methods for guiding the management of blood/plasma screening laboratory workflow are disclosed (Abstract). The processor can be configured to determine presence of a first external control preventing a release of a biological component to a biological sample analyzing device, and in response to the determination that the first external control is present, prevent release of biological components run after the first external control to the biological sample analyzing device to perform analysis of the biological components until the first external control is released [0006]. FIG. 1 illustrates a workflow 100 for biological sample screening, such as blood and/or plasma screening, according to some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap/sort stage 106, a pooler stage 108, an analyzer stage 110, a review stage 112, and a storage stage 114 [0032]. Analyzer systems can measure different chemicals and other characteristics in a plurality of biological samples [0045]. The transporting between stations (e.g. analyzer systems, pooler systems, etc.) can occur automatically, semi automatically, manually, and/or a combination thereof. For example, the sample tubes can be transported from the sorter system to the pooler system manually by a technician, and from the pooler system to the analyzer system automatically (e.g. by use of robotics to move the sample tubes) [0046]. FIG. 6 illustrates an embodiment of a process 600 for managing the release of test results according to some embodiments. The process 600 can be implemented by a screening workflow system, such as the system 200 [0081]. A configuration of external controls may prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, the external controls can be loaded into an analyzer [0081].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Silbert’s analytical laboratory masking operation with Tran’s system for analyzing biological samples step of preventing release/retrieval of test samples from laboratory device by other laboratory devices in order to adjust and/or optimize workflows periodically and/or in response to an activity, such as the completion or delay of a test (Tran e.g. [0038]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Furrer et al. (US 2021/0132093 A1) in view of Tran et al. (US 2021/0356481 A1) and in further view of Maetzler (US 2021/0190802 A1).
As per claim 14 (Currently Amended), Furrer teaches a method of routing test sample container carriers during peak workload periods in a laboratory system, wherein the laboratory system comprises a plurality of laboratory devices, at least one buffer, a transportation system, and laboratory middleware, the method comprising (Furrer e.g. A computer-implemented method of operating an analytical laboratory [0002]. The method can comprise steps of… dispatching biological samples by the laboratory middleware to laboratory instrument(s) at a dispatch rate not greater than the instrument load limit [0014]. Fig. 1, An analytical system and method of operating an analytical laboratory comprising a laboratory middleware communicatively connected to a plurality of laboratory instruments configured to process biological samples is presented [0014]. As shown on FIG. 1, the analytical laboratory 1 can further comprise a sample transportation system 10TRS interconnecting the plurality of laboratory instruments 10AI, 10PRE, 10POST. The sample transportation system 10TRS can be a one-dimensional conveyor-belt based system [0067]. The pre-analytical instruments 10PRE comprised by the analytical laboratory 1 may be one or more from the list comprising: an instrument for centrifugation of samples, a capping-, decapping- or recapping instrument, aliquoter, a buffer to temporarily store biological samples or aliquots thereof [0063]. FIG. 6 shows a pre-analytical laboratory instrument 10 PRE comprising a sample container sorting unit 14 configured to sort sample containers 30 holding biological samples into sample racks 40, each sample rack 40 being identified by a rack identifier of a rack tag 42 attached to the sample rack 40 [0105]. The terms 'sample container', 'sample holder' and 'sample tube' can refer to any individual container for storing, transporting, and/or processing a sample [0035].):
Furrer teaches determining a system workflow, by the laboratory middleware, for processing the test sample container carriers; (Furrer e.g. After the biological sample has been received and identified by a pre-analytical laboratory instrument, a laboratory middleware retrieves the corresponding test orders and determines which instruments are required to process the biological sample according to the test order(s) [0004]. Having identified the required instrument(s), the laboratory middleware determines a sample workflow for each sample according to the test order(s). The sample workflow comprises a sequence and/or timing of carrying out the one or more test orders by the one or more analytical instruments [0004].)
Furrer teaches monitoring the system workflow to determine an incoming increase of test sample container carriers into the laboratory system after determination of the system workflow; (Furrer e.g. The laboratory middleware can monitor a query rate of the plurality of laboratory instruments in order to determine an effective flow rate corresponding to each laboratory instrument [0053]. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. The laboratory middleware 20 can then compare the effective flow rate of each laboratory instrument 10 with the dispatch rate of biological samples to that laboratory instrument 10 (referred to hereafter as first laboratory instrument 10). If the effective flow rate of a first laboratory instrument 10 is lower than the dispatch rate to the first laboratory instrument 10, the laboratory middleware 20, in a step 109, can decrease its load limit (of the first laboratory instrument 10). In other words, if the laboratory middleware 20 determines that the first laboratory instrument 10 is not able to process its workload (dispatched samples), it can reduce its load limit to avoid overloading the instrument [0075]. Overall, in optimizing the processing of biological sample(s), the laboratory middleware 20 can monitor and control the load of the sample transportation system 10TRS similarly to other laboratory instruments 10, namely monitoring its effective flow rate and adjusting its load limit (in this case transportation capacity) to avoid overloading and/or underutilization of the sample transportation system 10TRS [0091].)
Furrer teaches device…masking a target laboratory device of the plurality of laboratory devices, by the laboratory middleware, so that test sample container carriers are not sent to the target laboratory device by any component of the laboratory system… (Furrer e.g. The method of operating an analytical laboratory…can further comprise the step of masking one or more of the plurality of laboratory instruments, wherein masking can comprise preventing one or more of the plurality of laboratory instruments from receiving biological sample(s), in particular biological sample(s) having at least one associated test order which the first laboratory instrument is configured to carry out [0060]. Destination masking can refer to the process of preventing one or more of the plurality of laboratory instruments 10 from sending biological sample(s) to the first laboratory instrument 10 (the destination) [0096]. Alternatively, or additionally, to load balancing (step 110), if the effective flow rate of the first laboratory instrument 10 is lower than the corresponding dispatch rate, the laboratory middleware 20 can buffer biological samples to temporarily reduce the workload of the laboratory instruments 10 (Fig. 4C and [0092]).)
Furrer teaches wherein the device…masking maintains the target laboratory device in an active state during the device…masking for a duration of the increase of test sample container carriers; (Furrer e.g. Masking of laboratory instruments can be performed with respect to all laboratory instruments, other than one or more laboratory instruments reserved for receiving biological samples of high priority [0061]. FIG. 4D illustrates various methods of a process called instrument masking. Instrument masking, in general, can refer to the process of hiding a particular laboratory instruments 10 from other instruments, as if it would not be available; would be offline; and/or would not exist [0094]. According to embodiments disclosed herein, instrument masking can be ordered into two main categories: destination masking and input specific masking [0095]. The second category of instrument masking, input specific masking, can relate to ensuring that the analytical laboratory 1 can still receive and process urgent biological samples (i.e. active state) while still controlling the overall load of the analytical laboratory 1 [0099]. Within input specific masking, two embodiments can be distinguished: 1) Overall input specific masking 114c, wherein one or more of the plurality of laboratory instruments 10 other than the first laboratory instrument 10 and other than one or more laboratory instruments 10 reserved for receiving biological samples of high priority are prevented from receiving any biological sample(s). 2) Test and input specific masking 114d, wherein one or more of the plurality of laboratory instruments 10 other than the first laboratory instrument 10 and other than one or more laboratory instruments 10 reserved for receiving biological samples of high priority are prevented from receiving biological sample(s) having at least one associated test order which the first laboratory instrument 10 is configured to carry out (Fig. 4D and [0100]-[0102]).)
Furrer teaches calculating a new system workflow, by the laboratory middleware, after there is no longer an increase of test sample container carriers; (Furrer e.g. After the biological sample has been received and identified by a pre-analytical laboratory instrument, a laboratory middleware retrieves the corresponding test orders and determines which instruments are required to process the biological sample according to the test order(s) [0004]. Having identified the required instrument(s), the laboratory middleware determines a sample workflow for each sample according to the test order(s). The sample workflow comprises a sequence and/or timing of carrying out the one or more test orders by the one or more analytical instruments [0004]. The laboratory middleware determines the sample workflow based on a load limit for each laboratory instrument based on a maximum instrument capacity [0005]. In addition, the laboratory middleware may be operable to evaluate and/or process gathered analysis data, to control the loading, storing and/or unloading of samples to and/or from any one of the analyzers [0048]. The laboratory middleware can monitor a query rate of the plurality of laboratory instruments in order to determine an effective flow rate corresponding to each laboratory instrument [0053]. Since the laboratory instruments send the test queries at a time when they are ready to process the biological sample(s), the query rate can be a good indication of the effective processing capacity of the respective laboratory instrument at that time [0054]. Adjusting the load limit of laboratory instruments as a reaction to their effective flow rate can avoid overloading, or underutilization ([0057] and [0077]). Figs. 3A-C show how the middleware 20 can determine the amount the load limit can be increased/decreased [0078].)
Furrer teaches retrieving test sample container carriers from the target laboratory device that have pending open test requests after the target laboratory device is available; and (Furrer e.g. The term 'post-analytical instrument' as used herein can encompass any apparatus or apparatus component that can be configured to perform one or more post-analytical processing steps/workflow steps comprising-but not limited to-sample unloading, transport, recapping, decapping, temporary storage/buffering, archiving (refrigerated or not), retrieval and or disposal [0043]. FIG. 9 shows an embodiment of a post-analytical laboratory instrument 10POST comprising a sample storage unit 19. The post-analytical laboratory instrument 10AI can be configured to store respectively retrieve sample containers 30 into respectively from the sample storage unit 19 [0108]. Overall, in optimizing the processing of biological sample(s), the laboratory middleware 20 can monitor and control the load of the sample transportation system 10TRS similarly to other laboratory instruments 10, namely monitoring its effective flow rate and adjusting its load limit (in this case transportation capacity) to avoid overloading and/or underutilization of the sample transportation system 10TRS [0091]. After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample( s) can be kept in a buffer only as long as needed [0092].)
Furrer teaches automatically processing the retrieved test sample containers according to the new system workflow. (Furrer e.g. The biological samples can be dispatched to laboratory instrument(s) configured to carry out at least one test order corresponding to the biological sample [0014]. A test order can comprise data indicative of one or more processing steps to be carried out on the biological sample [0071]. The laboratory middleware 20 can check whether respective laboratory instrument 10 has all resources (such as consumables, reagents, quality control) available and ready to process the biological sample according to the corresponding test order [0070]. Thereafter, the laboratory instruments 10 can receive and identify the biological sample(s) dispatched thereto. Upon identifying the biological samples, each laboratory instrument 10 can send test order queries to the laboratory middleware 20, the test order query comprising data identifying the biological sample. A test order can comprise data indicative of one or more processing steps to be carried out on the biological sample [0071]. The laboratory instruments 10 can then process the biological sample(s) according to the test orders sent to them by the laboratory middleware 20 [0072].)
Furrer does not explicitly teach (1) device retrieval masking so that test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system; wherein the device retrieval masking maintains the target laboratory device in an active state during the device retrieval masking…wherein the retrieval masking prevents retrieval of test sample containers from the target laboratory device by any component of the laboratory system while the target device is device retrieval masked; (2) unmasking the target laboratory device;
However, Tran teaches a type of device retrieval masking so that test sample container carriers cannot be retrieved from the target laboratory device by any component of the laboratory system; wherein the device retrieval masking maintains the target laboratory device in an active state during the device retrieval masking…wherein the device retrieval masking prevents retrieval of test sample containers from the target laboratory device by any component of the laboratory system while the target device is device retrieval masked (Tran e.g. Systems and methods for guiding the management of blood/plasma screening laboratory workflow are disclosed (Abstract). The processor can be configured to determine presence of a first external control preventing a release of a biological component to a biological sample analyzing device, and in response to the determination that the first external control is present, prevent release of biological components run after the first external control to the biological sample analyzing device to perform analysis of the biological components until the first external control is released [0006]. FIG. 1 illustrates a workflow 100 for biological sample screening, such as blood and/or plasma screening, according to some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap/sort stage 106, a pooler stage 108, an analyzer stage 110, a review stage 112, and a storage stage 114 [0032]. Analyzer systems can measure different chemicals and other characteristics in a plurality of biological samples [0045]. The transporting between stations (e.g. analyzer systems, pooler systems, etc.) can occur automatically, semi automatically, manually, and/or a combination thereof. For example, the sample tubes can be transported from the sorter system to the pooler system manually by a technician, and from the pooler system to the analyzer system automatically (e.g. by use of robotics to move the sample tubes) [0046]. FIG. 6 illustrates an embodiment of a process 600 for managing the release of test results according to some embodiments. The process 600 can be implemented by a screening workflow system, such as the system 200 [0081]. A configuration of external controls may prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, the external controls can be loaded into an analyzer [0081].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer’s analytical laboratory masking operation with Tran’s system for analyzing biological samples step of preventing release/retrieval of test samples from laboratory device by other laboratory devices in order to adjust and/or optimize workflows periodically and/or in response to an activity, such as the completion or delay of a test (Tran e.g. [0038]).
Tran does not explicitly teach, however, Maetzler teaches unmasking the target laboratory device; (Maetzler e.g. The control device 20 can take into consideration a total workload estimation, i.e., future predicted workload changes, of the laboratory 10 when deciding which analyzers in the plurality of analyzers 15 in the laboratory 10 to mask or unmask [0051]. For example, if it is known that first thing in the morning, i.e., the start of the typical work day, the laboratory workload is quite high, the control device 20 may unmask all the analyzers in the plurality of analyzers 10. In contrast, if it is known that the laboratory workload tends to taper off in the late evening hours, the control device 20 may plan to mask some of the analyzers in the plurality of analyzers 15 during this time period [0051].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Tran’s analytical laboratory masking operation with Maetzler's laboratory system process of unmasking the target laboratory device after the new laboratory workflow is calculated in order to optimize analyzer (i.e. laboratory equipment) workload for a laboratory (Maetzler e.g. [0002]).
As per claim 15 (Currently Amended), Furrer in view of Tran and Maetzler teach the method according to claim 14, further comprising,
Furrer teaches device…masking the at least one buffer…during peak workload periods; (Furrer e.g. The method of operating an analytical laboratory…can further comprise the step of masking one or more of the plurality of laboratory instruments, wherein masking can comprise preventing one or more of the plurality of laboratory instruments from receiving biological sample(s), in particular biological sample(s) having at least one associated test order which the first laboratory instrument is configured to carry out [0060]. The term 'laboratory instrument' as used herein can encompass any apparatus or apparatus component operable to execute one or more processing steps/workflow steps on one or more biological samples and/or one or more reagents. The term 'instrument' can cover pre-analytical instruments, post-analytical instruments as well as analytical instruments [0040]. The term 'post-analytical instrument' as used herein can encompass any apparatus or apparatus component that can be configured to perform one or more post-analytical processing steps/workflow steps comprising-but not limited to-sample unloading, transport, recapping, decapping, temporary storage/buffering, archiving (refrigerated or not), retrieval and or disposal [0043]. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. Alternatively, or additionally, to load balancing (step 110), if the effective flow rate of the first laboratory instrument 10 is lower than the corresponding dispatch rate, the laboratory middleware 20 can buffer biological samples to temporarily reduce the workload of the laboratory instruments 10 (Fig. 4C and [0092]). Similarly to load balancing, the laboratory middleware 20 can also take into consideration a transportation time of the biological sample(s) to the third laboratory instrument 10 for buffering. In this way, it can be avoided that biological sample(s) are dispatched for buffering (temporary storage) for periods of time potentially shorter than the time it can take the sample transportation system 10TRS to transport the samples for buffering. Such embodiments can be advantageous since waste of both buffering and transportation capacity can be prevented [0093]. Overall, in optimizing the processing of biological sample(s), the laboratory middleware 20 can monitor and control the load of the sample transportation system 10TRS similarly to other laboratory instruments 10, namely monitoring its effective flow rate and adjusting its load limit (in this case transportation capacity) to avoid overloading and/or underutilization of the sample transportation system 10TRS [0091]. In such a way, the overall turn-around-time TAT of the respective biological sample(s) can be significantly improved by ensuring the biological sample(s) are transported to the laboratory instruments 10 as efficiently as possible [0091].)
Furrer teaches retrieving the test sample container carriers for the test samples in the test sample container carriers that have pending open test requests from the at least one buffer and sending those test sample container carriers to laboratory analytic devices in the laboratory system from the at least one buffer…(Furrer e.g. In addition to controlling (i.e. increasing or decreasing) the load limit, further embodiments disclosed herein can react to deviations of the effective flow rate from the dispatch rate by performing load balancing between laboratory instruments and/or buffering biological sample(s) to temporarily reduce the load on an otherwise overloaded instrument [0059]. Alternatively, or additionally, to load balancing (step 110), if the effective flow rate of the first laboratory instrument 10 is lower than the corresponding dispatch rate, the laboratory middleware 20 can buffer biological samples to temporarily reduce the workload of the laboratory instruments 10 (Fig. 4C and [0092]). After dispatching biological sample(s) for buffering, the laboratory middleware 20 can keep monitoring the effective flow rate of the first laboratory instrument 10 and-in a step 112b----can dispatch biological samples from the third laboratory instrument 10 to the first laboratory instrument 10 as soon as the effective flow rate of the first laboratory instrument 10 is equal to or greater than the corresponding dispatch rate. This way, biological sample( s) can be kept in a buffer only as long as needed [0092].)
Furrer does not explicitly teach (1) retrieval masking the at least one buffer so that test sample container carriers cannot be retrieved from the at least one buffer; (2) unmasking the at least one buffer after there is no longer an increase of test sample container carriers into the laboratory system; (3) and retrieving…and sending test sample container carriers…after the at least one buffer is unmasked.
However, Tran teaches a type of device retrieval masking so that test sample container carriers cannot be retrieved from a laboratory device (Tran e.g. Systems and methods for guiding the management of blood/plasma screening laboratory workflow are disclosed (Abstract). The processor can be configured to determine presence of a first external control preventing a release of a biological component to a biological sample analyzing device, and in response to the determination that the first external control is present, prevent release of biological components run after the first external control to the biological sample analyzing device to perform analysis of the biological components until the first external control is released [0006]. FIG. 1 illustrates a workflow 100 for biological sample screening, such as blood and/or plasma screening, according to some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap/sort stage 106, a pooler stage 108, an analyzer stage 110, a review stage 112, and a storage stage 114 [0032]. Analyzer systems can measure different chemicals and other characteristics in a plurality of biological samples [0045]. The transporting between stations (e.g. analyzer systems, pooler systems, etc.) can occur automatically, semi automatically, manually, and/or a combination thereof. For example, the sample tubes can be transported from the sorter system to the pooler system manually by a technician, and from the pooler system to the analyzer system automatically (e.g. by use of robotics to move the sample tubes) [0046]. FIG. 6 illustrates an embodiment of a process 600 for managing the release of test results according to some embodiments. The process 600 can be implemented by a screening workflow system, such as the system 200 [0081]. A configuration of external controls may prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, the external controls can be loaded into an analyzer [0081].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer’s analytical laboratory masking operation with Tran’s system for analyzing biological samples step of preventing release/retrieval of test samples from laboratory device by other laboratory devices in order to adjust and/or optimize workflows periodically and/or in response to an activity, such as the completion or delay of a test (Tran e.g. [0038]).
Tran does not explicitly teach, however, Maetzler teaches unmasking a laboratory device after there is no longer an increase of test sample container carriers into the laboratory system (i.e. a workflow change); (Maetzler e.g. The control device 20 can take into consideration the throughput capability of the analyzer when deciding whether to mask or unmask a certain analyzer in the laboratory 10 [0048]. The control device 20 can take into consideration a total workload estimation, i.e., future predicted workload changes, of the laboratory 10 when deciding which analyzers in the plurality of analyzers 15 in the laboratory 10 to mask or unmask [0051]. If the laboratory workload grows, the control device 20 has the ability to unmask analyzers in order for the unmasked analyzers to help with the laboratory workload [0053]. For example, if it is known that first thing in the morning, i.e., the start of the typical work day, the laboratory workload is quite high, the control device 20 may unmask all the analyzers in the plurality of analyzers 10. In contrast, if it is known that the laboratory workload tends to taper off in the late evening hours, the control device 20 may plan to mask some of the analyzers in the plurality of analyzers 15 during this time period [0051].) and retrieving …and sending test sample container carriers… after the laboratory device is unmasked. (Maetzler e.g. Maetzler teaches a method to optimize analyzer use in a laboratory having a plurality of analyzers based on laboratory workload [0014]. The method comprises the steps of determining current laboratory workload, calculating workload capability of the plurality of analyzers minus one analyzer if the current laboratory workload is below a threshold criteria and if there are two or more analyzers in the plurality of analyzers, masking one of the plurality of analyzers if the current workload is met by the plurality of analyzers minus one analyzer, proceeding with current workload, and repeating the above steps until the current laboratory workload has been completed [0014]. In other embodiment, the control device 20 can take into consideration the throughput capability of the analyzer when deciding whether to mask or unmask a certain analyzer in the laboratory 10 [0048]. For example, if that certain time period is determined to occur during the processing of the current laboratory workload, that particular analyzer can be masked until the maintenance is performed on the analyzer. Once the maintenance has been completed, that analyzer can be unmasked [0050]. If the laboratory workload grows, the control device 20 has the ability to unmask analyzers in order for the unmasked analyzers to help with the laboratory workload [0053]. For example, at point B in Fig. 4, the second analyzer is unmasked, i.e., the second analyzer begins to accept samples to analyze again or, in other words, is turned on [0057].)
The Examiner submits that before the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Furrer in view of Tran’s analytical laboratory masking operation with Maetzler's laboratory system process of unmasking the target laboratory device after there is no longer an increase of test sample container carriers into the laboratory system and retrieving and sending test sample container carriers…after the laboratory device is unmasked…in order to optimize analyzer (i.e. laboratory equipment) workload for a laboratory (Maetzler e.g. [0002]).
Conclusion
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.
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/A.M./Examiner, Art Unit 3624
/Jerry O'Connor/Supervisory Patent Examiner,Group Art Unit 3624