DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the amendment filed 7/2/2024. Claims 1-12 are currently pending.
Claim Rejections - 35 USC § 101
3. 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.
3.1. Claims 1-12 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regard to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1 and 11, and their respective dependent claims are directed, in part, to a method and system for operating a laboratory system.
In regard to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. Here, the claims are merely automating (“applying a computer”) to a manual process that is performed by humans. For example, independent claims 1 and 11, as a whole, are directed to a method and system for operating a laboratory system by managing sample processing and more specifically, by providing and processing samples and sample containers, assigning containers to target devices, determining target device workload states, assigning sample containers to target devices according to target device workload states, and providing sample containers to target devices for handling according to the assignments, etc. which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations. In addition, dependent claim 4 recites and is directed to an equation for determining the target device workload state of the target device and thus, recites and is directed to an abstract idea under the grouping of a mathematical concept.
Furthermore, assuming arguendo, the claims are not directed to certain methods of organizing human activities, the claims, nevertheless, are directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper.
CLAIM 1:
A method for operating a laboratory system, comprising
providing a laboratory system having:
a plurality of sample containers configured to contain a sample to be processed for at least one of pre-analysis and analysis in the laboratory system;
a plurality of laboratory devices providing for a plurality of target devices each configured to handle one or more sample containers from the plurality of sample containers, the one or more sample containers being assigned for handling to the target device in operation of the laboratory system; and
a control device configured to at least control assignment of the plurality of sample containers to the plurality of target devices; and
assigning the plurality of sample containers to the plurality of target devices in operation of the laboratory system, comprising:
determining a target device workload state for each of the plurality of target devices, the target device workload state being
in a range between a first range limit indicative of a first capacity for handling sample containers and a second range limit indicative of a second capacity for handling sample containers, the second capacity being a higher capacity than the first capacity for handling sample containers, and
determined according to a metric being proportional to
a resource target device state indicative of a present number of sample containers assigned to the target device, and
a power of an output flow of the target device, the output flow being indicative of output of sample containers per time by the target device;
assigning the plurality of sample containers to the plurality of target devices according to the target device workload states; and
providing the plurality of sample containers to the plurality of target devices for handling according to the assignment.
CLAIM 2:
The method of claim 1, wherein the metric is proportional to the output flow of the target device raised to the power of a weighting factor, the weighting factor weighting the output flow of the target device for determining the target device workload state.
CLAIM 3:
The method of claim 1 or 2, wherein the metric is inversely proportional to an initial resource target device state indicative of a starting number of sample containers assigned to the target device.
CLAIM 4:
The method of the claim 1, wherein the target device workload state of the target device i (WLSTDi) is determined as follows:
WLStd i = Ri/Rinit ·
k
s
c
ⅈ
w
· 100
wherein Rᵢ is the resource target device state of the target device, Rᵢₙᵢₜ is the initial resource target device state of the target device, and
k
s
c
ⅈ
w
is the output flow of the target device provided with the weighting factor w.
CLAIM 5:
The method of claim 1, further comprising determining an updated target device workload state for the target device in response to at least one of the following: updating the resource target device state of the target device, and recalculating output flow of the target device.
CLAIM 6:
The method of claim 1, further comprising
providing a plurality of sub-ranges for a first range of the target device workload state for a first target device, wherein an overlapping range is provided for adjacent sub-ranges from the plurality of sub-ranges in which the adjacent sub-ranges are overlapping;
determining a first target device workload state for the first target device, the first target device workload state being in a non-overlapping range of a first sub-range in which the first subrange is not overlapping with a second sub-range adjacent to the first sub-range;
assigning the plurality of sample containers to the first target device according to the first target device workload state;
determining a second target device workload state for the first target device, the second target device workload state being different from the first target device workload state and being in the overlapping range in which the first sub-range and the second sub-range are overlapping;
continuing with assigning the plurality of sample containers to the first target device according to the first target device workload state;
determining a third target device workload state for the first target device, the third target device workload state being different from both the first and the second target device workload states and being in a non-overlapping range of the second sub-range in which the first subrange and the second sub-range are not overlapping; and
assigning the plurality of sample containers (1) to the first target device according to the second target device workload state.
CLAIM 7:
The method of claim 1, further comprising
providing first priority data indicative of a first priority for handling a first sample container from the plurality of sample containers;
providing second priority data indicative of a second priority for handling the first sample container, the second priority being indicative of lower urgency for handling the first sample container in operation than the first priority;
determining a first priority target device workload state for the first sample container according to the first priority;
determining a second priority target device workload state for the first sample container according to the second priority;
selecting one of the first priority target device workload state and the second priority target device workload state; and
assigning the target device workload state selected to the first sample container.
CLAIM 8:
The method of claim 1, wherein
the assigning of the plurality of sample containers to the plurality of target devices further comprises providing target device queue status data by processing the target device workload state for at least some target devices from the plurality of target devices, the target device queue status data providing an indirect performance indicator for the target device and being indicative of at least a device identification of the target device and the target device workload state; and
the providing of the plurality of sample containers to the plurality of target devices further comprises controlling a work flow for the at least some target devices in the laboratory system in dependence on the target device queue status data.
CLAIM 9:
The method of claim 8, wherein the controlling of the work flow is further comprising at least one of
disabling a target device from the plurality of target devices, thereby, preventing assignment of a sample container to the disabled target device in a first work flow status of the laboratory system; and
enabling a target device from the plurality of target devices, thereby, allowing assignment of a sample container to the enabled target device in a second work flow status of the laboratory system.
CLAIM 10:
The method of claim 9, wherein the controlling of the work flow is further comprising
providing a target device workload state value indicative of the target device workload state;
providing a workload state threshold value; and
at least one of the following:
disabling the target device if the target device workload state value is above the workload state threshold value; and
enabling the target device if the target device workload state value is equal to or below the workload state threshold value.
CLAIM 11:
A laboratory system, comprising
a plurality of sample containers configured to contain a sample;
a plurality of laboratory devices providing for a plurality of target devices each configured to handle one or more sample containers from the plurality of sample containers, the one or more sample containers being assigned for handling to the target device in operation of the laboratory system; and
a control device configured to at least control assignment of the plurality of sample containers to the plurality of target devices;
wherein the laboratory system is configured to process the plurality of sample containers for at least one of pre-analysis and analysis of the sample and further to
assign the plurality of sample containers to the plurality of target devices in operation, comprising:
determining a target device workload state for each of the plurality of target devices, the target device workload state being
in a range between a first range limit indicative of a first capacity for handling sample containers and a second range limit indicative a second capacity for handling sample containers, the second capacity being a higher capacity than the first capacity for handling sample containers, and
determined according to a metric being proportional to
a resource target device state indicative of a present number of sample containers assigned to the target device, and
a power of an output flow of the target device, the output flow being indicative of output of sample containers per time by the target device;
assign the plurality of sample containers to the plurality of target devices according to the target device workload states; and
provide the plurality of sample containers to the plurality of target devices for handling according to the assignment.
CLAIM 12:
The system of claim 11, wherein the plurality of laboratory devices providing for the plurality of target devices comprise one or more laboratory devices from the following group of laboratory devices:
a pre-analysis laboratory device configured to perform a pre-analytical task;
an analysis laboratory device configured to perform an analytical task for the sample;
a post-analysis laboratory device configured to perform post-analytical task;
a sample transport device configured for sample container transport;
a sorter device configured for sample container sorting; and
a storage device configured to store one or more sample containers.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., laboratory system, control device, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “control device configured to”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0047]-[0051] of applicant's specification (US 2021/0304857) recites that the system/method is implemented using a control device with software applications running on one or more processors connectable with a data storage device which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Allowable Subject Matter
4. Claims 1-12 appear to recite subject matter that is novel over the prior art.
4.1. The following is an examiner’s statement of reasons for allowance:
The first exemplary prior art Varlet et al. (WO 2020/106696) teaches a method may be provided for determining an optimal scheduling for an analyzer in a laboratory environment. This may comprise determining a load of each diagnostic analyzer amongst a plurality of diagnostic analyzers, wherein each diagnostic analyzer amongst the plurality of diagnostic analyzers may be configured to perform tasks that comprise performing a test corresponding to a discipline. Such methods may further comprise, for each of a plurality of tubes comprising a patient sample, classifying that tube into a discipline based on a requested test for that tube, which disciplines may be different for each of the tubes. Such methods may further comprise, based on a total number of requested tests and a number of tubes available to perform the requested tests and the load of each of the diagnostic analyzers, assigning each tube to a specific analyzer or a sequence of analyzers for performing the requested tests (See, for example, Varlet: abstract; ¶¶ [0003]; FIGS. 1-10).
The next exemplary prior art Tarnawski et al. (U.S. Pat. Pub. No. 2023/0324423) teaches methods of controlling diagnostic laboratory systems include providing one or more modules, each of the one or more modules configured to process a specimen container and/or analyze a specimen; providing middleware configured to communicate with the one or more modules, wherein the middleware is configured to generate instructions to change an operational state of at least one of the one or more modules to enabled or disabled; generating, by the middleware, one or more instructions to change the operational state of at least one of the one or more modules; and changing the operational state of at least one of the one or more modules in response to one or more instructions generated by the middleware. Systems including a middleware server configured to carry out the methods are provided as are other aspects (See, for example, Tarnawski: abstract; ¶¶ [0004]-[0006]; FIGS. 1-8).
The cited prior art, however, does not disclose, teach and/or suggest the combination of features as presented in the claims including, inter alia, “the target device workload state being in a range between a first range limit indicative of a first capacity for handling sample containers and a second range limit indicative of a second capacity for handling sample containers, the second capacity being a higher capacity than the first capacity for handling sample containers, and determined according to a metric being proportional to a resource target device state indicative of a present number of sample containers assigned to the target device, and a power of an output flow of the target device, the output flow being indicative of output of sample containers per time by the target device; assigning the plurality of sample containers to the plurality of target devices according to the target device workload states,” as recited in independent claim 1 and similarly in independent claim 11.
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681