DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2026 has been entered.
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 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 06/09/2026, the following has occurred: claims 1 and 20-21 have been amended; claims 2-19 have remained unchanged; claim 22 was canceled; and no new claims have been added.
Claims 1-21 are pending.
Effective Filing Date: 11/30/2022
Response to Arguments
35 U.S.C. 101 Rejections:
I. The specification describes a technological improvement over conventional data storage systems and methods
Applicant argues that data standardization in the manner claimed is a technical improvement. Mapping one format to another format is to standardize the format is not necessarily a technical improvement as that standardization is defined by mapping one format to another format, where mappings are created between formats. The concept of mapping data already exist in the context of standardization, and therefore it is difficult to appreciate that the improvement to standardizing data is to create mappings for formats where no mappings already exist. People already determine mappings between formats for pre-existing mappings, thus using a computer to add new mappings between formats that have not already been mapped is taking an abstract idea and “applying it” using a computer.
II. The claims recite the technological improvement described in the specification and integrate any abstract idea into a practical application
Applicant argues with respect to the amended claim limitations and states that the claims provide an improved data standardization over conventional systems. Applicant states that the system is more robust by extracting data from different formats and storing the extracted data in appropriate fields of a database in a proper data format. The mapping operation enables mapping of new an unknown data elements. The claims however do not reflect this statement as there is no determination of mapping for unknown elements. Furthermore, the mapping of values to determine a standardized version of an unknown format. The application of a mapping step is the technical improvement? The process of mapping elements from an unknown format to a known format is something that always occurs at some point in time when the standardization process occurs for various formats of data which have standardized versions.
35 U.S.C. 103 Rejections:
Applicant argues with respect to the amended claims. The claim rejections have been updated to account for these amendments. The data elements are taught in the Clayton reference, and the display of a GUI is taught in the Ramanujam et al. reference.
Applicant argues that the mapping steps are not taught as the mapping is performed based on data elements in the medical records themselves in the present invention rather than external or other contextual information as in Ramanujam and Clayton. Examiner however respectfully disagrees that there is a restriction based on the present claim language. The extraction of data element from multiple testing records can be located externally or internally. The claim language is not limiting.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-19 are drawn to a system, claim 20 is drawn to a method, and claim 21 is drawn to a medium, each of which is within the four statutory categories. Claims 1-21 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 system for standardizing medical testing data from multiple sources for unified storage in a database, the system comprising:
a) at least one processor programmed to:
1) access multiple medical testing records from the multiple sources, the multiple medical testing records storing results of a medical test as data elements in multiple different data formats, the multiple medical testing records including:
1a) a first medical testing record including a first data element stored in a first data format;
1b) a second medical testing record including a second data element stored in a second data format, the second data format being different from the first data format;
2) extract data elements from the multiple medical testing records, the extracting comprising extracting the first data element from the first medical testing record and the second data element from the second medical testing record, the extracting comprising:
2a) map each of at least some of the extracted data elements to one of multiple value classifiers associated with respective fields of the database, the mapping comprising:
2a1) mapping the first data element in the first data format to a first one of the multiple value classifiers by processing the first data element, the first value classifier associated with a first database field; and
2a2) mapping the second data element in the second data format to the first value classifier by processing the second data element;
3) store the extracted data elements in the database based on results of mapping the at least some extracted data elements to respective value classifiers, the storing comprising:
3a) responsive to the first data element and the second data element being commonly mapped to the first value classifier, storing both the first data element and the second data element in the first database field associated with the first value classifier in a standardized format by:
3a1) converting the first data element from the first format into the standardized format designated for the first database field;
3a2) converting the second data element from the second format into the standardized format designated for the first database field; and
3a3) storing, in the first database field associated with the first value classifier, in the standardized format, the first converted data element and the second converted data element; and
4) generate b) a graphical user interface (GUI) displaying a unified record of the results of the medical test from the medical testing records in the standardized format by:
4a) reading, from the first database field, a set of data elements stored in the standardized format, the set of data elements including the first data and second data elements converted into the standardized format; and
4b) generating a display of the set of data elements stored in the standardized format as the unified record of the results of the medical test from the medical testing records.
Claim 1 recites, in part, performing the steps of 1) access multiple medical testing records from the multiple sources, the multiple medical testing records storing results of a medical test as data elements in multiple different data formats, the multiple medical testing records including: 1a) a first medical testing record including a first data element stored in a first data format, 1b) a second medical testing record including a second data element stored in a second data format, the second data format being different from the first data format, 2) extract data elements from the multiple medical testing records, the extracting comprising extracting the first data element from the first medical testing record and the second data element from the second medical testing record, the extracting comprising, 2a) map each of at least some of the extracted data elements to one of multiple value classifiers associated with respective fields of the database (if mental storage of a piece of paper), the mapping comprising: 2a1) mapping the first data element in the first data format to a first one of the multiple value classifiers by processing the first data element, the first value classifier associated with a first database field and 2a2) mapping the second data element in the second data format to the first value classifier by processing the second data element, 3) store the extracted data elements in the database based on results of mapping the at least some extracted data elements to respective value classifiers, the storing comprising: 3a) responsive to the first data element and the second data element being commonly mapped to the first value classifier, storing both the first data element and the second data element in the first database field associated with the first value classifier in a standardized format by: 3a1) converting the first data element from the first format into the standardized format designated for the first database field, 3a2) converting the second data element from the second format into the standardized format designated for the first database field, and 3a3) storing, in the first database field associated with the first value classifier, in the standardized format, the first converted data element and the second converted data element, 4) generate an interface displaying a unified record of the results of the medical test from the medical testing records in the standardized format by: 4a) reading, from the first database field, a set of data elements stored in the standardized format, the set of data elements including the first data and second data elements converted into the standardized format and 4b) generating a display of the set of data elements stored in the standardized format as the unified record of the results of the medical test from the medical testing records. 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 associate different formats of data with each other. Independent claims 20 and 21 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-19 include all of the limitations of claim 1, and therefore likewise incorporate the above described abstract idea. Depending claim 3 adds the additional steps of “applying a trained machine learning model to at least one of the first medical testing record or the second medical testing record, the trained machine learning model being configured to receive one or more medical testing records as an input” and “to generate as an output an indication of a mapping between data elements represented in the one or more medical testing records and one or more predefined value classifiers”; claim 9 adds the additional step of “store the first medical testing record and the second medical testing record in the database”; claim 10 adds the additional step of “store data linking the first data element to the first medical testing record”; claims 12 adds the additional step of “access a data structure storing a plurality of value classifiers and wherein determining that the first data element is associated with the common value classifier includes determining, for each of the plurality of value classifiers, a degree of confidence that the first data element corresponds to the common value classifier”; claim 14 adds the additional steps of “access a third medical testing record including a third data element represented in a third data format, the third data format being different from the first data format”, “determine that the third data element is associated with an additional value classifier, the additional value classifier being different from the common value classifier”, and “store the third data element in the database in association with the additional value classifier”; claim 15 adds the additional step of “determine that the first medical testing record and the third medical testing record are associated with a particular patient”; claim 16 adds the additional step of “cause display of a graphical user interface associated with the particular patient, the graphical user interface including at least a representation of the first data element and a representation of the third data element”; and claim 17 adds the additional step of “cause, based on an interaction with the representation of the first data element, display of a detail region within graphical user interface, the detail region including information associated with the first data element extracted from the first medical testing record”. Additionally, the limitations of depending claims 2, 4-8, 11, 13, and 18-19 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-19 are nonetheless directed towards fundamentally the same abstract idea as independent claim 1 (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) at least one processor, b) a database, c) a graphical user interface (GUI), and d) a non-transitory computer readable medium (from claim 21) to perform the claimed steps.
The a) at least one processor, b) database, c) graphical user interface (GUI), and d) non-transitory computer readable medium 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, paragraph [0017] for a description of a medium and paragraph [0020] for a description of the processor, 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) at least one processor, b) a database, c) a graphical user interface (GUI), and d) a non-transitory computer readable medium to perform the claimed steps amounts to no more than mere instructions to apply the exception using a generic computer component that does 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. 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 relates and stores data utilizing a) at least one processor, b) a database, c) a graphical user interface (GUI), and d) a non-transitory computer readable medium, 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 1-21 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.
Claim 1-2, 7-10, 14-15, and 20-21 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0005573 to Ramanujam in view of U.S. 2013/0238642 to Clayton et al.
As per claim 1, Ramanujam teaches a system for standardizing medical testing data from multiple sources for unified storage in a database, (see: paragraph [0038] where there is such a database server) the system comprising:
--at least one processor (see: paragraph [0006] where there is a processor) programmed to:
--access multiple medical testing records from the multiple sources, the multiple testing records storing results of a medical rest as data elements in multiple different data formats (see: paragraph [0003] where sources are disparate systems and formats. Also see: paragraph [0006] where multiple datasets are being accessed)
--extract data elements from the multiple medical testing records, (see: paragraph [0006] where there is extraction of multiple raw datasets automatically. Also see: paragraph [0001] where there are medical records) the extracting comprising extracting the first data element from the first medical testing record and the second data element from the second medical testing record, (see: paragraph [0006] where there is extraction of multiple raw datasets automatically. Also see: paragraph [0001] where there are medical records. This would apply to all data elements with each raw dataset) the extracting comprising:
--map each of at least some of the extracted data elements to one of multiple value classifiers associated with respective fields of the database, (see: paragraph [0023] where there is mapping of raw datasets to a target study data (multiple value classifier associate with respective fields of the database) using the extracted metadata) the mapping comprising:
--mapping the first data element in the first data format to a first one of the multiple value classifiers by the first data element, the first value classifier associated with a first database field; (see: paragraph [0007] where one or more raw datasets are being mapped to a target study based on the extracted metadata. There is a mapping of a first data element of a first format/dataset to a multiple value classifier (information within the target study)) and
--mapping the second data element in the second data format to the first value classifier by processing the second data element; (see: paragraph [0007] where one or more raw datasets are being mapped to a target study based on the extracted metadata. There is a mapping of a second data element of a second format/dataset to a multiple value classifier (information within the target study))
--store the extracted data elements in the database based on results of mapping the at least some extracted data elements to respective value classifiers, (see: paragraph [0022] where there is storing of the extracted datasets in a structured format (mapping of the extracted data elements)) the storing comprising:
--responsive to the first data element and the second data element being commonly mapped to the first value classifier, storing both the first data element and the second data element in the first database field associated with the first value classifier in a standardized format (see: paragraph [0022] where there is storing of the extracted datasets in a structured/standardized format (mapping of the extracted data elements). Also see: paragraph [0021] where new leanings are being recorded. There are new mappings being stored for data where the mappings for one raw dataset and another raw dataset against a standard are recorded for future use) by:
--converting the first data element from the first format into the standardized format designated for the first database field; (see: paragraph [0020] where there is conversion of a first raw dataset to a standardized format)
--converting the second data element from the second format into the standardized format designated for the first database field; (see: paragraph [0020] where there is conversion of a second raw dataset to a standardized format) and
--storing, in the first database field associated with the first value classifier, in the standardized format, the first converted data element and the second converted data element (see: paragraph [0022] where there is storing of the extracted datasets in a structured format (mapping of the extracted data elements). Also see: paragraph [0021] where new leanings are being recorded. There are new mappings being stored for data where the mappings for one raw dataset and another raw dataset against a standard are recorded for future use) and
--generate a graphical user interface (GUI) displaying a unified record of the results of the medical test from the medical testing records in the standardized format (see: paragraphs [0034] and [0038] where there is generation of a graphical user interface and it displays a unified record (eCRF) with annotations. The eCRF here includes displaying score and user information. The user here can access results on a display) by:
--reading, from the first database field, a set of data elements stored in the standardized format, the set of data elements converted into the standardized format; (see: paragraphs [0034] and [0038] where there is generation of a graphical user interface and it displays a unified record (eCRF) with annotations. Also see: paragraph [0022] where there is storing of data. Results of the standardized database are being accessed and displayed. The data here includes elements) and
--generating a display of the set of data elements stored in the standardized format as the unified record of the results of the medical test from the medical testing records (see: paragraphs [0034] and [0038] where there is generation of a display of standardized elements of data in the form of a unified record (eCRF) with annotations. The eCRF here includes displaying score and user information).
Ramanujam may not further, specifically teach:
1) --multiple medical testing records including:
1a) --a first medical testing record including a first data element stored in a first data format;
1b) --a second medical testing record including a second data element stored in a second data format, the second data format being different from the first data format; and
2) --data elements as data elements including the first data and second data elements.
Clayton et al. teaches:
1) --multiple medical testing records including:
1a) --a first medical testing record including a first data element stored in a first data format; (see: paragraph [0007] where data of a first format from a first data store is being accessed/received) and
1b) --a second medical testing record including a second data element stored in a second data format, (see: paragraph [0007] where data of a second format from a second data store is being accessed/received) the second data format being different from the first data format; (see: paragraph [0007] where the first and second formats are different) and
2) --data elements as data elements including the first data and second data elements (see: paragraph [0007] where there are different formats for data, e ).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to use 1) multiple medical testing records including: 1a) a first medical testing record including a first data element stored in a first data format and 1b) a second medical testing record including a second data element stored in a second data format, the second data format being different from the first data format as taught by Clayton et al. in the system as taught by Ramanujam with the motivation(s) of being selective when ingesting large amounts of data (see: paragraph [0006] of Clayton et al.).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 2) data elements including the first data and second data elements as taught by Clayton et al. for the data elements as disclosed by Ramanujam et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Ramanujam et al. teaches data with data elements therefore one could substitute these elements for more specific elements and obtain predictable results of using data. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 2, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. Clayton et al. further teaches wherein the first medical testing record is associated with a first entity and the second medical testing record is associated with a second entity, the first entity being different from the second entity (see: paragraph [0023] where there are a plurality of medical records from a plurality of entities).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 7, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. Clayton et al. further teaches wherein storing the first data element and the second data element in the database includes converting the first data element and the second data element to a standardized format (see: claim 7 where at least some of the first and second data records are being converted into the integrated data format. Also see: paragraph [0028] where there is data conversion to a standardized format).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 8, Ramanujam and Clayton et al. in combination teaches the system of claim 7, see discussion of claim 7. Clayton et al. further teaches wherein the standardized format includes predefined term representing a type of data associated with the first data element and the second data element (see: paragraph [0028] where there is a standardized format which includes predefined terms which represent a type of data associated with elements in the form of a standardized CDISC ODM format).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 9, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. Clayton et al. further teaches wherein the at least one processor is further programmed to store the first medical testing record and the second medical testing record in the database (see: paragraph [0007] where data from a first format is being received from a data store and data from a second format is being received from a second data store. The reception of this information is a storing of this information as this information is received and then manipulated in memory).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 10, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. Clayton et al. further teaches wherein the at least one processor is further programmed to store data linking the first data element to the first medical testing record (see: paragraph [0052] where a mapping schema is generated and stored. The schema here contains the data linking the first data element to the first record).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 14, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. Clayton et al. further teaches wherein the at least one processor is further programmed to:
--access a third medical testing record including a third data element represented in a third data format, the third data format being different from the first data format; (this limitation is met using the citations that were used for the accessing a second medical testing record of claim 1)
--determine that the third data element is associated with an additional value classifier, the additional value classifier being different from the common value classifier; (this limitation is met using the citations that were used for the determine a value classifier limitation of claim 1) and
--store the third data element in the database in association with the additional value classifier (this limitation is met using the citations that were used for the storing limitation of claim 1).
Claim limitations of claim 14 are similar to claim limitations already stated within claim 1 without adding any other functionalities. Repeating steps that do not add a new and unexpected result has no patentable significance (see: MPEP 2144.04 (VI)(B), Duplication of Parts). Simply repeating steps that were applied to one medical testing record and applying those steps to another medical testing record produces expected results, and as such, amounts to a mere duplication of parts conferring to no additional patentable weight. This can be extrapolated out to any number of testing records.
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 15, Ramanujam and Clayton et al. in combination teaches the system of claim 14, see discussion of claim 14. Clayton et al. further teaches wherein the at least one processor is further programmed to determine that the first medical testing record and the third medical testing record are associated with a particular patient (see: paragraphs [0038] and [0042] where there is a determination of a subject’s records based on the key data fields).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 20, claim 1 is similar to claim 20 and is therefore rejected in a similar manner using the Ramanujam and Clayton et al. references in combination.
As per claim 21, claim 1 is similar to claim 21 and is therefore rejected in a similar manner using the Ramanujam and Clayton et al. references in combination.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0005573 to Ramanujam in view of U.S. 2013/0238642 to Clayton et al. as applied to claim 1, and further in view of U.S. 2023/0153280 to Rout et al.
As per claim 3, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein determining that the first data element and the second data element are associated with a common value classifier includes applying a trained machine learning model to at least one of the first medical testing record or the second medical testing record, the trained machine learning model being configured to receive one or more medical testing records as an input and to generate as an output an indication of a mapping between data elements represented in the one or more medical testing records and one or more predefined value classifiers.
Rout et al. teaches:
--wherein determining that the first data element and the second data element are associated with a common value classifier includes applying a trained machine learning model to at least one of the first medical testing record or the second medical testing record, (see: paragraph [0076] where there is a machine learning model which can be used for determining a format is associated with a standardized format) the trained machine learning model being configured to receive one or more medical testing records as an input and to generate as an output an indication of a mapping between data elements represented in the one or more medical testing records and one or more predefined value classifiers (see: paragraph [0076] where the model can input the records (an inbound file) and determine which column the column of data should go to (mapping input file data using a scheme to a predefined value classifier of a column)).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein determining that the first data element and the second data element are associated with a common value classifier includes applying a trained machine learning model to at least one of the first medical testing record or the second medical testing record, the trained machine learning model being configured to receive one or more medical testing records as an input and to generate as an output an indication of a mapping between data elements represented in the one or more medical testing records and one or more predefined value classifiers as taught by Rout et al. in the system as taught by Ramanujam and Clayton et al. in combination with the motivation(s) of improving the quality of data ingestion (see: paragraph [0023] of Rout et al.).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0005573 to Ramanujam in view of U.S. 2013/0238642 to Clayton et al. as applied to claim 1, and further in view of U.S. 2018/0336286 to Shah.
As per claim 4, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein at least one of the first data format and the second data format include unstructured text.
Shah teaches:
--wherein at least one of the first data format and the second data format include unstructured text (see: paragraph [0045] where there is unstructured data which is being used as the UGED. At least one data here has unstructured data).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute wherein at least one of the first data format and the second data format include unstructured text as taught by Shah for the data as disclosed by Ramanujam and Clayton et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Ramanujam and Clayton et al. in combination already teaches of a data thus it would have been obvious to replace the data with a more specific data as predictable results of converting formats using a type of data would have been obtained. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 5, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein at least one of the first data format and the second data format include structured data.
Shah teaches:
--wherein at least one of the first data format and the second data format include structured data (see: paragraph [0045] where there is structured data which is being used as the UGED. At least one data here has structured data).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute wherein at least one of the first data format and the second data format include unstructured text as taught by Shah for the data as disclosed by Ramanujam and Clayton et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Ramanujam and Clayton et al. in combination already teaches of a data thus it would have been obvious to replace the data with a more specific data as predictable results of converting formats using a type of data would have been obtained. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0005573 to Ramanujam in view of U.S. 2013/0238642 to Clayton et al. as applied to claim 1, and further in view of U.S. 2023/0409742 to Hasni et al.
As per claim 6, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein the first data element and the second data element are accessible from the database using an application programming interface (API).
Hasni et al. teaches:
--wherein the first data element and the second data element are accessible from the database using an application programming interface (API) (see: paragraph [0032] where data is being accessed from a database using an API).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the first data element and the second data element are accessible from the database using an application programming interface (API) as taught by Hasni et al. in the system as taught by Ramanujam and Clayton et al. in combination with the motivation(s) of preserving privacy of a patient’s medical record (see: paragraph [0007] of Hasni et al.).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0005573 to Ramanujam in view of U.S. 2013/0238642 to Clayton et al. as applied to claim 1, and further in view of U.S. 2007/0255704 to Baek et al.
As per claim 11, Ramanujam and Clayton et al. in combination teaches the system of claim 10, see discussion of claim 10. The combination may not further, specifically teach wherein the data linking the first data element to the first medical testing record includes an indication of a location within the first medical testing record that the first data element appears.
Baek et al. teaches:
--wherein the data linking the first data element to the first medical testing record includes an indication of a location within the first medical testing record that the first data element appears (see: paragraph [0083] where there is an exact location of an attribute. Also there is a path to specific fields. Data linking an element to a record is present and it indicates a location of an element in the record (which includes the first)).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the data linking the first data element to the first medical testing record includes an indication of a location within the first medical testing record that the first data element appears as taught by Baek et al. in the system as taught by Ramanujam and Clayton et al. in combination with the motivation(s) of extracting information from data (see: paragraph [0001] of Baek et al.).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0005573 to Ramanujam in view of U.S. 2013/0238642 to Clayton et al. as applied to claim 1, and further in view of U.S. 2019/0117074 to Chen et al.
As per claim 12, Ramanujam and Clayton et al. in combination teaches the system of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein the at least one processor is further programmed to access a data structure storing a plurality of value classifiers and wherein determining that the first data element is associated with the common value classifier includes determining, for each of the plurality of value classifiers, a degree of confidence that the first data element corresponds to the common value classifier.
Chen et al. teaches:
--wherein the at least one processor is further programmed to access a data structure storing a plurality of value classifiers and wherein determining that the first data element is associated with the common value classifier includes determining, for each of the plurality of value classifiers, a degree of confidence that the first data element corresponds to the common value classifier (see: paragraph [0045] where there is access to a data structure storing a plurality of classifiers where data elements are associated with classifiers. A degree of confidence for the data corresponding to the classifier is being determined).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the at least one processor is further programmed to access a data structure storing a plurality of value classifiers and wherein determining that the first data element is associated with the common value classifier includes determining, for each of the plurality of value classifiers, a degree of confidence that the first data element corresponds to the common value classifier as taught by Chen et al. in the system as taught by Ramanujam and Clayton et al. in combination with the motivation(s) of improving a rate of accuracy (see: paragraph [0017] of Chen et al.).
As per claim 13, Ramanujam, Clayton et al, and Chen et al. in combination teaches the system of claim 12, see discussion of claim 12. Chen et al. further teaches wherein determining that the first data element is associated with the common value classifier includes comparing a degree of confidence associated with the common value classifier to a threshold value (see: paragraphs [0044] – [0045] where there is a comparison with a threshold degree of confidence for the classifier (the quality of the match is being compared with the threshold)).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 12, and incorporated herein.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0005573 to Ramanujam in view of U.S. 2013/0238642 to Clayton et al. as applied to claim 1, and further in view of U.S. Patent No. 11, 232,855 to Lancelot.
As per claim 16, Ramanujam and Clayton et al. in combination teaches the system of claim 15, see discussion of claim 15. The combination may not further, specifically teach wherein the at least one processor is further programmed to cause display of a graphical user interface associated with the particular patient, the graphical user interface including at least a representation of the first data element and a representation of the third data element.
Lancelot teaches:
--wherein the at least one processor is further programmed to cause display of a graphical user interface associated with the particular patient, (see: column 15, lines 32-52 where there is display of patient data on a display/GUI) the graphical user interface including at least a representation of the first data element and a representation of the third data element (see: column 18, lines 3-15 where there are multiple EMRs being used to provide data for display. Also see: column 22, lines 27-43 where there is a source ID which is part of a tuple. The displaying of the tuple data is a display of at least a representation of data elements).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the at least one processor is further programmed to cause display of a graphical user interface associated with the particular patient, the graphical user interface including at least a representation of the first data element and a representation of the third data element as taught by Lancelot in the system as taught by Ramanujam and Clayton et al. in combination with the motivation(s) of better tracking of quality metrics for healthcare systems (see: column 3, lines 8-13 of Lancelot).
As per claim 17, Ramanujam, Clayton et al., and Lancelot in combination teaches the system of claim 16, see discussion of claim 16. Lancelot further teaches wherein the at least one processor is further programmed to cause, based on an interaction with the representation of the first data element, display of a detail region within graphical user interface, the detail region including information associated with the first data element extracted from the first medical testing record (see: column 5, lines 40-52 where there is display of patient information, thus there is a region on a display displaying this information).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 16, and incorporated herein.
As per claim 18, Ramanujam, Clayton et al., and Lancelot in combination teaches the system of claim 17, see discussion of claim 17. Lancelot further teaches wherein the detail region further includes an element for causing display of the first medical testing record (see: column 20, lines 44-58 where there is a display of information such as information included in the first record via a filter).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 16, and incorporated herein.
As per claim 19, Ramanujam, Clayton et al., and Lancelot in combination teaches the system of claim 16, see discussion of claim 16. Lancelot further teaches wherein the graphical user interface includes an interactive element for filtering data associated with either the first medical testing record or the third medical testing record (see: column 20, lines 44-58 where there is a display of information such as information included in the first record via a filter).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 16, and incorporated herein.
Additional Relevant Reference
Examiner would also like to cite U.S. 2024/0266037 to Hong as being a relevant reference.
Conclusion
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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