The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Application
This communication is a Final Office Action in response to the Amendment to the Claims and Remarks filed on 11/19/2025. Claims 22, 24-30, and 32-34 are currently pending in this case and have been examined and addressed below.
Claims 22 and 28 are currently amended.
Claims 1-21, 23, and 31 remain cancelled and not considered at this time.
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 22, 24-30, and 32-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 22 and 24-27 fall within the statutory category of a process. Claims 28-30 and 32-34 fall within the statutory category of an apparatus or system.
Step 2A, Prong One
As per Claims 22 and 28, the limitation of analyzing a plurality of specimens, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. Performing an analysis reasonably can be characterized as an evaluation that can be performed in the human mind. The limitation of detecting a large out-of-control condition which renders at least a portion of specimens evaluation to be unreliable is a mental process. Determining the existence of a condition reasonably can be characterized as an evaluation that can be performed in the human mind using observation, evaluation and judgment. The limitation of automatically generating a notification to the user can also be characterized as a mental process because it involves formulating an opinion in the human mind which falls into the category of mental process. The limitation analyzing specimen test data to determine a scope of potential error caused by the out-of-control condition which are functions which can be performed in the human mind using evaluation, observation, judgement and opinion and also fall into the mental process grouping of abstract ideas, similar to the limitation discussed above regarding analyzing a plurality of specimens. The limitation of designing a CUSUM rule based on the predicted error characteristics by determining an average relative error, computing a reference factor from that average relative error, determining an expected number of evaluations to false rejection, and selecting a decision interval from a stored table indexed by those parameters and initializing one-sided upper and lower CUSUM accumulators is a mental process because a person can design a CUSUM rule based on using evaluation, judgement or opinion that can be performed in the human mind to design the rule. The limitation of re-evaluating at least a portion of previously tested specimens in reverse order of testing based on the predicted number of incorrect results to generate new test data recites a step of making an evaluation which falls into the grouping of a mental process including making an evaluation with the human mind. The limitation of applying the designed CUSUM rule to the new test data by calculating, for each specimen, a composite test value based on bias-adjusted differences and imprecision functions, updating the upper and lower CUSUM accumulators, and rejecting the new test data when either accumulator exceeds the decision interval or when a predetermined number of evaluations has been reached falls into the grouping of mental processes because applying design rules to make improved predictions can be characterized as an evaluation that can be performed in the human mind. The limitation of updating previously tested specimen data by replacing unpublished results with re-evaluated results and, for published results, generating a correction list for specimens whose re-evaluated results cross a medical-decision limit or differ from the reported results by more than an allowable total error recites a step in which a human mind can make a replacement of information using evaluation, observation, judgement or opinion. The generation of a correction list based on the published results also can be performed using human mental evaluation, observation, judgement or opinion. Therefore, the limitation falls into the grouping of a mental process. The limitation of generating for a user a report identifying the re-evaluated specimen data, similar to the above discussion of generating a notification, amounts to a mental process. A person can generate a report in the human mind using evaluation, judgement, opinion and observation because it involves formulating an opinion in the human mind which falls into the category of mental process. If a claim limitation, under its broadest reasonable interpretation, covers the performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. The claims also recite statistical operations comprising: estimating a magnitude of the out-of-control condition from quality-control specimens using bias and historic impression functions, calculating a probability of each specimen result being incorrect using a normal cumulative-distribution model, and computing a predicted number of incorrect results as a total of the individual probabilities to determine the scope of potential error. These statistical operations including estimating a magnitude using bias and historic impression functions, calculating a probability using normal cumulative-distribution model, and computing a predicted number of incorrect results are mathematical functions or algorithms and therefore fall into the abstract grouping of mathematical concepts. Additionally, the limitations of determining an average relative error, computing a reference factor from that average relative error, determining an expected number of evaluations to false rejection are mathematical equations or functions and therefore can also fall into the abstract grouping of mental processes. As per the October 2019 Update on Subject Matter Eligibility, a claim can recite more than one judicial exception and claims which recite a series of steps that recite mental steps which are also mathematical calculations are identified as both. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional element – clinical diagnostic analyzer. The clinical diagnostic analyzer in these steps is recited as comprising a processor, a user interface device and a display. These computer components are recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component. The claims recite performing the abstract idea including re-evaluating tested specimens automatically without human intervention. As per The October 2019 Update, a claim that requires a computer may still recite a mental process. A concept that is performed on a generic computer, in a computer environment, or is merely using a computer as a tool to perform the concept recites a mental process. As per MPEP 2106.05(f)(2), the use of a computer to perform the abstract idea amounts to mere instructions to apply the exception. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims also recite an electronic database associated with the clinical diagnostic analyzer as the setting for updating previously tested specimen data, which does nothing more than generally link a judicial exception to a particular technological environment. The electronic database is the setting for the abstract concept of updating previously tested specimen data. As per MPEP 2106.05(h), a claim directed to a judicial exception cannot be made eligible by simply having the applicant acquiesce to limiting the reach of the patient to a particular technical use. The claims also recite the additional elements of accepting input from a user, presenting information to a user, receiving user input from the user interface device, and retrieving electronic test result data from one or more clinical diagnostic analyzers which amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of accepting input, presenting information, receiving input, and retrieving data are mere data collecting and displaying in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). The claims also recite the additional elements of the updated data being stored in an electronic database associated with the clinical diagnostic analyzer and the report electronically recorded in association with test session data. These elements are merely storing data which results from the abstract idea and are thus insignificant extra-solution activity similar to MPEP 2106.05(g) which describes that adding a final step of storing data to a process does not add meaningful limitations to the abstract idea and is therefore insignificant extra-solution activity. Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of a clinical diagnostic analyzer to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The system including the "processor”, “user interface device” and “display” are recited at a high level of generality and are recited as generic computer components by reciting a system with elements that are well-known, existing elements implemented in accordance with the present invention. The system includes any of the well-known components including a desktop personal computer, workstation, laptop computer, etc. (Specification, [0022]), which do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims also recite an electronic database associated with the clinical diagnostic analyzer as the setting for updating previously tested specimen data, which does nothing more than generally link a judicial exception to a particular technological environment. As per MPEP 2106.05(h), a claim directed to a judicial exception cannot be made eligible by simply having the applicant acquiesce to limiting the reach of the patient to a particular technical use. The claims also include the additional elements of accepting input from a user, presenting information to a user, receiving user input from the user interface device, and retrieving electronic test result data from one or more clinical diagnostic analyzers which are elements that are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data as well as presenting data, which have been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added) and (iv) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93). The claims also include the updated data being stored in an electronic database associated with the clinical diagnostic analyzer and the report electronically recorded in association with test session data which are elements that are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include storing and retrieving data in memory, which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(iv) Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). 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 the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims 23-27 and 29-34 add further limitations which are also directed to an abstract idea. For example, Claim 25 includes calculating an expected number of evaluations to false rejection and determining a decision interval which also recite an evaluation in the human mind. Claim 34 includes updating a portion of the specimen test data with re-evaluated specimen data which also recites a mental process including evaluation in the human mind using evaluation, observation, judgment, and opinion. The claim also includes that the data is updated to the electronic database associated with the clinical diagnostic analyzer which is insignificant extra-solution activity because it is a final step of storing data that is well-understood, routine, and conventional for the same reasons as the elements of the independent claims. Claims 24, 26-27, 29-30, 32-33 include limitations which further specify or limit the elements of the independent claims, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 22 and 28. Because the additional elements do not impose meaningful limitations on the judicial exception, the claims are directed to an abstract idea and are not patent eligible.
Response to Arguments
Applicant’s arguments, see Pages 10-14, “Rejections Under 35 U.S.C. §101”, filed 11/19/2025 with respect to claims 22 and 28 have been fully considered but they are not persuasive.
Applicant argues that the present claims do not recite a mental process because the analyzing steps are not expressed as generic mental processes for instead require the performance of particular statistical algorithms. Examiner respectfully disagrees that the claims are not directed to an abstract idea. The amended steps of the performance of statistical operations are directed to mathematical concepts. The statistical analysis steps recite using bias and historic imprecision functions to estimate a magnitude of the out-of-control condition, using a normal cumulative-distribution model to calculate a probability, and computing a predicted number of incorrect results as a total of the individual probabilities. These are all mathematical formulas/equations or calculations which fall into the abstract grouping of mathematical concepts. Additionally, Applicant argues that the step of designing a CUSUM rule cannot be performed using mental processes because the steps of determining an average relative error, deriving a reference factor from that value, determining an expected number of evaluations to false rejection, selecting a decision interval from a stored table, and initializing one-sided upper and lower CUSUM accumulators are not mental processes. Examiner respectfully disagrees. The steps of determining an average relative error, deriving a reference factor, and determining an expected number of evaluations to false rejection can be performed using human mental processing. They also describe mathematical equations/algorithms or calculations and therefore can also fall into the abstract grouping of mathematical concepts. The steps of selecting a decision interval from a stored table and initializing one-sided upper and lower CUSUM accumulator can be performed using human mental processing, as making a selection from a table and initializing the upper and lower parameter values (as described in specification [0087]), can be performed using mental human analysis or with the aid of pen and paper. The use of electronic devices to perform the steps of the abstract idea amounts to mere instructions to apply the exception.
Applicant argues that the present claims integrate the abstract idea into a practical application because the invention improves the operation of a clinical diagnostic analyzer by determining which previously tested specimens are unreliable following a large out-of-control event, re-evaluating only those specimens, and autonomously updating the analyzer’s data records to reflect corrected values. Examiner respectfully disagrees. These steps are directed to the abstract idea itself and thus cannot integrate the abstract idea into a practical application. Applicant further argues that the current invention provides an improvement to the technical problem of requiring testing of all specimens when a major control failure occurred which provides a specific improvement to analyzer functionality by reducing unnecessary retests, minimizing downtime, and improving overall data integrity. Examiner respectfully disagrees that a technical improvement to a technical problem is provided in the claims. The present invention is directed to analyzing specimen data to detect and correct large out-of-control conditions, which is performed through the steps of a mental process and mathematical concepts. There is no improvement recited to the analyzer functionality itself. The claims do not show any improvement to the processor or system performance. Any reduction in processing is a result of the abstract idea itself based on the analysis which is conducted and not to actual performance of the system. With regard to reducing unnecessary retests, minimizing downtime, and improving data integrity, these improvement are based on the steps of the analysis itself and this is an improvement to the abstract idea itself and not a technical improvement to a technical problem.
Applicant argues that the present claims provide significantly more than the abstract idea because the ordered combination of statistical computations and autonomous control steps provide a technological improvement to the field of laboratory quality control. Examiner respectfully disagrees. The statistical computations which are involved in the steps of the claims are directed to mathematical concepts and therefore are not additional elements to be considered as providing significantly more than the abstract idea. Therefore, this does not provide significantly more than the abstract idea. The result of the claim limitations is to control a self-correcting laboratory process, but this is carried out as a result of the abstract idea itself. Therefore, any improvement is an improvement to the abstract idea itself and does not provide significantly more than the abstract idea. The data analysis steps of the claims are directed to the abstract idea itself and therefore are not additional elements which are analyzed for consideration in determining if the claim provides significantly more than the abstract idea. Therefore, Examiner is not persuaded that the claims provide an additional element which provides significantly more. The rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682