DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of the amendments, the previous objections have been overcome.
In light of the amendments, the previous 112(b) rejections have been overcome.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 08/14/2025, the following has occurred: claims 1-3, 5-12, 14-18, and 20 have been amended and no new claims have been added.
Claims 1-3, 5-12, 14-18, and 20 are pending.
Effective Filing Date: 02/07/2022
Response to Arguments
Foreign Priority:
Examiner thanks Applicant for correcting Examiner’s claim of incorrect foreign priority. No claim for foreign priority was made.
Claim Objections:
Applicant amended the claims to overcome the previous claim objections. Examiner withdraws these previous objections.
35 U.S.C. 112(b) Rejections:
Applicant amended the claims to overcome the previous 112(b) claim rejections. Examiner withdraws these previous rejections.
35 U.S.C. 101 Rejections:
Step 2A, Prong One:
Applicant states that the claims are not similar to the examples provided for the abstract groupings that are recited in the MPEP. The claims are not limited to the examples in the MPEP however. The claims do indeed recite both mathematical concepts and certain methods of organizing human activity as shown in the updated 35 U.S.C. 101 rejection section.
Step 2A, Prong Two:
Applicant states that the claims are integrated into a practical application, and states that presently a workflow does not distinguish between patients in a manner where patients are being correctly prioritized. The claims however discuss load management in a manner which recites an abstract idea which applies generic computing technology to it. The improvement to a binary designation by instead factoring in other information in the claims is an improvement to the abstract idea involving managing assignments of instrument to patient samples. The encoding is being viewed as part of the abstract idea in the updated 101 rejection section as humans can encode in the manner as claimed.
Step 2B:
Applicant argues with respect to the encoding limitation. That limitation is now viewed as part of the abstract idea and does not amount to significantly more as it is not an additional element.
35 U.S.C. 103 Rejections:
Applicant argues with respect to the newly amended claim language. These arguments are deemed moot in view of the updated 103 art rejection section which now relies on the Barrett et al. reference.
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 1-3, 5-12, 14-18, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-3 and 5-9 are drawn to a method, claims 10-12 and 14-15 are drawn to a system, and claims 16-18 and 20 are drawn to a medium, each of which is within the four statutory categories. Claims 1-3, 5-12, 14-18, and 20 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a method of patient-centric load planning for a diagnostic laboratory including a plurality of instruments, comprising:
1) receiving, at a) a computer server, b) computer readable data comprising:
a list of patient samples provided by one or more patients;
a list of requested tests to be performed for each of the patient samples; and
patient-centric information for the one or more patients, and
2) determining a load plan for the plurality of instruments from the b) computer readable data via a1) a load planning module executing on the computer server, the load plan comprising computer executable instructions configured to:
2a) assign a menu of selected tests to each of the plurality of instruments;
2b) order each respective patient sample by:
2b1) encoding at least a portion of c) an electronic health record (EHR) of the patient providing the respective patient sample into a vector-based fingerprint representing the patient's health using an encoder network,
2b2) generating a priority score for the respective patient sample based on the vector-based fingerprint, and
2b3) ordering the respective patient sample based on the priority scores; and
2c) process the patient samples using instruments of the plurality of instruments that are assigned to perform the requested tests.
Claim 1 recites, in part, performing the steps of 1) receiving data comprising: a list of patient samples provided by one or more patients, a list of requested tests to be performed for each of the patient samples, and patient-centric information for the one or more patients, and 2) determining a load plan for the plurality of instruments from the data, 2a) assign a menu of selected tests to each of the plurality of instruments, 2b) order each respective patient sample by: 2b2) generating a priority score for the respective patient sample, and 2b3) ordering the respective patient sample based on the priority scores, and 2c) process the patient samples using instruments of the plurality of instruments that are assigned to perform the requested tests. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes how one could assign instruments to patient samples.
Claim 1 also recites, in part, performing the steps of 2b) order each respective patient sample by: 2b1) encoding at least a portion of a health record (HR) of the patient providing the respective patient sample into a vector-based fingerprint representing the patient's health using an encoder network, and 2b2) generating a priority score for the respective patient sample based on the vector-based fingerprint. These steps correspond to Mathematical Concepts.
Going forward the abstract concepts above will be considered a singular abstract idea for further analysis. Independent claims 10 and 16 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-3, 5-9, 11-12, 14-15, 17-18, and 20 include all of the limitations of claims 1, 10, and 16, and therefore likewise incorporate the above described abstract idea. Depending claims 5 and 14 add the additional step of “processing the vector-based fingerprint using a multi-layer perceptron (MLP) to output the priority score”; claims 6, 15, and 20 add the additional steps of “accessing a database using the vector-based fingerprint for a particular patient to determine a predicted set of tests for the particular patient”, “providing results of the requested tests and the predicted set of tests to a medical professional”, and “predicting a future test demand for the diagnostic laboratory using the predicted set of tests”; and claim 7 adds the additional step of “optimizing for at least one of reduced turn-around-time (TAT), load balancing, efficient reagent usage, lower quality assurance costs, and improved system robustness”. Additionally, the limitations of depending claims 2-3, 8-9, 11-12, and 17-18 further specify elements from the claims from which they depend on without adding any additional steps. Furthermore, the limitations of claims 2-3, 5, 8-9, 11-12, 14, and 17-18 only further serve to limit the abstract idea. Thus, depending claims 2-3, 5-9, 11-12, 14-15, 17-18, and 20 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 10, and 16 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a computer server/a computer server coupled to the system controller (from claim 10), b) computer readable data, a1) a load planning module executing on the computer server, the load planning module comprising computer executable instruction, c) the electronic health record (EHR), and d) a system controller (from claim 10) to perform the claimed steps.
The a) a computer server/a computer server coupled to the system controller, b) computer readable data, a1) a load planning module executing on the computer server, the load planning module comprising computer executable instruction, c) the electronic health record (EHR), and d) a system controller in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification where these components are described in a generic manner, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. 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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these 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. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a computer server/a computer server coupled to the system controller, b) computer readable data, a1) a load planning module executing on the computer server, the load planning module comprising computer executable instruction, c) the electronic health record (EHR), and d) a system controller amounts to no more than mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity and certain mathematical concepts. Specifically, MPEP 2106.05(f) recites that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention processes patient samples utilizing a) a computer server/a computer server coupled to the system controller (from claim 10), b) computer readable data, a1) a load planning module executing on the computer server, the load planning module comprising computer executable instruction, c) the electronic health record (EHR), and d) a system controller, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-3, 5-12, 14-18, and 20 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 1-3, 7-12, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2020/0303066 to Bowers et al. in view of U.S. 2022/0254499 to Barrett et al.
As per claim 1, Bowers et al. teaches a method of patient-centric load planning for a diagnostic laboratory including a plurality of instruments, (see: FIG. 10 and paragraph [0102] where there is such planning) comprising:
--receiving, at a computer server, computer readable data (paragraph [0160] where there is worklist of samples being received) comprising:
--a list of patient samples provided by one or more patients; (see: FIGS. 2A and 2B and paragraph [0160] where there is worklist of samples being received for patients)
--a list of requested tests to be performed for each of the patient samples; (see: FIG. 10 and paragraph [0102] where there is reception of an order of performance of assays, thus there is a list of requested tests) and
--patient-centric information for the one or more patients, (see: paragraph [0163] where there is reception of patient information (patient-centric information)) and
--determining a load plan for the plurality of instruments from the computer readable data via a load planning module executing on the computer server, (see: FIG. 11 and paragraph [0112] where there is schematic illustration of a non-limiting example of determining an order of performance of the assay steps for samples to maximize performance) the load plan comprising computer executable instructions configured to:
--assign a menu of selected tests to each of the plurality of instruments; (see: FIG. 11 and paragraph [0112] where there is an analysis system and it may include three resources A, B, and C. the three resources may be a vortexer, a pipette, and a heat plate. Assays 1, 2, and 3 require the use of the three resources in the order of A, B, and C, A, C, and B, and B, A, and C. To maximize performance, assay steps for different assays that require the same resources may be batched together. There is an assigning of a menu of selected tests here in the form of steps using the instruments)
--order each respective patient sample (see: FIG. 10 and paragraph [0110] where the method 1000 proceeds to a decision block 1040 to determine whether the assay instructions include and special instructions. For example, a special instruction may state that the assay instructions for a particular patient is a rush instruction and has the highest priority. Also see: FIG. 3A and paragraph [0061] where there is a device connected to a network receiving patient records. There is an ordering of patient samples here based on a priority score of the patient’s record) by:
--ordering the respective patient sample based on the priority scores; (see: FIG. 10 and paragraph [0110] where the method 1000 proceeds to a decision block 1040 to determine whether the assay instructions include and special instructions. For example, a special instruction may state that the assay instructions for a particular patient is a rush instruction and has the highest priority. Also see: FIG. 3A and paragraph [0061] where there is a device connected to a network receiving patient records. There is an ordering of patient samples here based on a priority score of the patient’s record) and
--process the patient samples using instruments of the plurality of instruments that are assigned to perform the requested tests (see: FIG. 11 and paragraph [0112] where the samples are being processed using the instruments A, B, and C).
Bowers et al. may not further, specifically teach:
1) --encoding at least a portion of an electronic health record (EHR) of the patient providing the respective patient sample into a vector-based fingerprint representing the patient's health using an encoder network; and
2) --generating a priority score for the respective patient sample based on the vector-based fingerprint.
Barrett et al. teaches:
1) --encoding at least a portion of an electronic health record (EHR) of the patient providing the respective patient sample into a vector-based fingerprint representing the patient's health using an encoder network; (see: paragraph [0134] where there is such an encoding process which generates a vector fingerprint) and
2) --generating a priority score for the respective patient sample based on the vector-based fingerprint (see: paragraph [0134] where there is generation of a priority score based on the vector).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to 1) encode at least a portion of an electronic health record (EHR) of the patient providing the respective patient sample into a vector-based fingerprint representing the patient's health using an encoder network and 2) generate a priority score for the respective patient sample based on the vector-based fingerprint as taught by Barrett et al. in the method as taught by Bowers et al. with the motivation(s) of improving the prediction accuracy (see: paragraph [0055] of Barrett et al.).
As per claim 2, Bowers et al. and Barrett et al. in combination teaches the method of claim 1, see discussion of claim 1. Bowers et al. further teaches wherein determining a load plan comprises minimizing the number of the plurality of instruments that are needed to perform the requested tests for a patient sample (see: FIG. 11 and paragraph [0112] where there are different run times for order of performances. A performance metric may be maximized is a rush instruction includes assay 1. The steps of the assays require resource B may be batched to minimize the total running time while performing the rush instruction first).
As per claim 3, Bowers et al. and Barrett et al. in combination teaches the method of claim 2, see discussion of claim 2. Bowers et al. further teaches wherein minimizing the number of the plurality of instruments is performed for all patient samples in the list of patient samples according to the priority score for each patient sample (see: FIGS. 10-11 and paragraph [0112] where assays 1, 2, and 3 require the use of the three resources in the order A, B, and C, A, C, and B, and B, A, and C. To maximize performance, assay steps for different assays require the same resources may be batched together).
As per claim 7, Bowers et al. and Barrett et al. in combination teaches the method of claim 1, see discussion of claim 1. Bowers et al. further teaches wherein determining a load plan comprises optimizing for at least one of reduced turn-around-time (TAT), load balancing, efficient reagent usage, lower quality assurance costs, and improved system robustness (see: paragraph [0123] where there is load balancing).
As per claim 8, Bowers et al. and Barrett et al. in combination teaches the method of claim 1, see discussion of claim 1. Bowers et al. further teaches wherein the menu of selected tests further comprises a set of tests that are enabled on an instrument and provided with a quantity of reagent for performing each test of the set of tests (see: FIG. 13 and paragraph [0121] where there is a menu of tests that are enabled on an instrument and provided with quality of reagent).
As per claim 9, Bowers et al. and Barrett et al. in combination teaches the method of claim 8, see discussion of claim 8. Bowers et al. further teaches wherein the computer executable instructions of the load plan is further configured to indicate an assignment of all requested tests to at least some of the plurality of instruments such that each instrument has sufficient reagent to perform all requested tests assigned thereto (see: FIG. 13 and paragraph [0121] where the load plan comprises instructions indicating an assignment of all requested tests such that each instrument has sufficient reagent to perform the tests).
As per claim 10, claim 10 is similar to claim 1 and is therefore rejected in a similar manner. Bowers et al. further teaches a system for patient-centric load planning for a diagnostic laboratory, (see: FIG. 10 and paragraph [0102] where there is such planning) comprising:
--a system controller; (see: paragraph [0069] where there is a controller device)
--a plurality of instruments controlled by the system controller to perform one or more requested tests on one or more patient samples; (see: paragraph [0009] where there are a plurality of instruments) and
--a computer server coupled to the system controller, the computer server comprising a load planning module for determining a load plan for the plurality of instruments, (see: paragraph [0169] where there is a server) the load plan comprising computer executable instructions.
As per claim 11, Bowers et al. and Barrett et al. in combination teaches the system of claim 10, see discussion of claim 10. Bowers et al. further teaches wherein determining a load plan comprises minimizing the number of the plurality of instruments that are needed to perform the requested tests for a patient sample (see: FIG. 11 and paragraph [0112] where there are different run times for order of performances. A performance metric may be maximized is a rush instruction includes assay 1. The steps of the assays require resource B may be batched to minimize the total running time while performing the rush instruction first).
As per claim 12, Bowers et al. and Barrett et al. in combination teaches the system of claim 11, see discussion of claim 11. Bowers et al. further teaches wherein minimizing the number of the plurality of instruments is performed for all patient samples of the one or more patient samples according to the priority score for each patient sample (see: FIGS. 10-11 and paragraph [0112] where assays 1, 2, and 3 require the use of the three resources in the order A, B, and C, A, C, and B, and B, A, and C. To maximize performance, assay steps for different assays require the same resources may be batched together).
As per claim 16, claim 16 is similar to claim 1 and is therefore rejected in a similar manner. Bowers et al. further teaches a teaches a non-transitory computer readable storage medium comprising a load planning module having computer executable instructions configured to cause a computer server to perform patient-centric load planning (see: paragraphs [0072] and paragraph [0102] where there is such a non-transitory medium).
As per claim 17, Bowers et al. and Barrett et al. in combination teaches the medium of claim 16, see discussion of claim 16. Bowers et al. further teaches wherein determining a load plan comprises minimizing the number of the plurality of instruments that are needed to perform the requested tests for a patient sample (see: FIG. 11 and paragraph [0112] where there are different run times for order of performances. A performance metric may be maximized is a rush instruction includes assay 1. The steps of the assays require resource B may be batched to minimize the total running time while performing the rush instruction first).
As per claim 18, Bowers et al. and Barrett et al. in combination teaches the medium of claim 16, see discussion of claim 16. Bowers et al. further teaches wherein minimizing the number of the plurality of instruments is performed for all patient samples in the list of patient samples according to the priority score for each patient sample (see: FIGS. 10-11 and paragraph [0112] where assays 1, 2, and 3 require the use of the three resources in the order A, B, and C, A, C, and B, and B, A, and C. To maximize performance, assay steps for different assays require the same resources may be batched together).
Claims 5-6, 14-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2020/0303066 to Bowers et al. in view of U.S. 2022/0254499 to Barrett et al. as applied to claims 1, 10, and 16, and further in view of U.S. 2021/0145404 to Fornwalt et al.
As per claim 5, Bowers et al. and Barrett et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein generating a priority score for the respective patient sample based on the vector-based fingerprint comprises processing the vector-based fingerprint using a multi-layer perceptron (MLP) to output the priority score for the respective patient sample.
Fornwalt et al. teaches:
--wherein generating a priority score for the respective patient sample based on the vector-based fingerprint comprises processing the vector-based fingerprint using a multi-layer perceptron (MLP) to output the priority score for the respective patient sample (see: paragraph [0089] where there is an incorporation of EHR data into a prediction using a MLP).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein generating a priority score for the respective patient sample based on the vector-based fingerprint comprises processing the vector-based fingerprint using a multi-layer perceptron (MLP) to output the priority score for the respective patient sample as taught by Fornwalt et al. in the method as taught by Bowers et al. and Barrett et al. in combination with the motivation(s) of preprocessing the data (see: paragraph [0077] of Fornwalt et al.).
As per claim 6, Bowers et al. and Barrett et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach:
--accessing a database using the vector-based fingerprint to determine a predicted set of tests for the particular patient;
--providing results of the requested tests and the predicted set of tests to a medical professional; and
--predicting a future test demand for the diagnostic laboratory using the predicted set of tests.
Fornwalt et al. teaches:
--accessing a database using the vector-based fingerprint to determine a predicted set of tests for the particular patient; (see: paragraph [0077] where there is accessing of a database using this fingerprint)
--providing results of the requested tests and the predicted set of tests to a medical professional; (see: paragraph [0104] where there is providing of test results and predicted set of tests) and
--predicting a future test demand for the diagnostic laboratory using the predicted set of tests (see: paragraph [0066] where there is predicting of a future test demand/healthcare utilization).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to access a database using the vector-based fingerprint to determine a predicted set of tests for the particular patient, provide results of the requested tests and the predicted set of tests to a medical professional, and predict a future test demand for the diagnostic laboratory using the predicted set of tests as taught by Fornwalt et al. in the method as taught by Bowers et al. and Barrett et al. in combination with the motivation(s) of preprocessing the data (see: paragraph [0077] of Fornwalt et al.).
As per claim 14, claim 14 is similar to claim 5 and is therefore rejected in a similar manner.
As per claim 15, claim 15 is similar to claim 6 and is therefore rejected in a similar manner.
As per claim 19, claim 19 is similar to claim 5 and is therefore rejected in a similar manner.
As per claim 20, claim 20 is similar to claim 6 and is therefore rejected in a similar manner.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684