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 .
Drawings
The drawings were submitted on 05/08/2024. The drawings are objected to because the text and features of the claimed invention are unclear due to the low image quality/resolution. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: Abbreviations should be preceded by the entire phrase. For example, “accessing patient health record data from an Electronic Health Record (EHR) system.” Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) accessing health records, interpreting data, abstracting data elements, and transmitting data to a registry. This judicial exception is not integrated into a practical application because the claims are directed to an abstract idea with computer elements. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional 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.
Claim 1 recites, in part, accessing health records, interpreting data, abstracting data elements, and transmitting data to a registry. These steps can be performed in the human mind. For example, a person can look at an electronic health record, interpret the data, and abstract certain data elements. The computer and registry are recited at a high level of generality and are recited as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. Therefore, the claim as a whole does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 2-11 are rejected under the same rationale.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krasnoslobodtsev et al. (US 20220188659 A1).
Regarding claim 1, Krasnoslobodtsev teaches:
A method for data abstraction carried out under the control of computer processing control, comprising:
“accessing patient health record data from an EHR system” (par. 0091; ‘Patient data may be collected from various sources such as, for example, electronic health records (EHRs) and clinical trial information.’);
“processing and interpreting the data with a computer controlled natural language tool” (par. 0092; ‘After the data curation platform 210 ingests and anonymizes an EHR it may be sent to a natural language processing pipeline 1812 which scrapes an EHR for information that pertains to custom fields of a standard EHR data model.’)
“abstracting structured data elements from the data” (par. 0092; ‘After the data curation platform 210 ingests and anonymizes an EHR it may be sent to a natural language processing pipeline 1812 which scrapes an EHR for information that pertains to custom fields of a standard EHR data model.’ Scraping information pertaining to specific fields reads on abstracting structured data elements from the data.); and
“transmitting the data to a data registry” (par. 0092; ‘Once an EHR has been fully scraped, the standard data model may be persisted to database 1815 and the information contained within the standard data model is added to the knowledge graph 111.’).
Regarding claim 2 (dep. on claim 1), Krasnoslobodtsev further teaches:
“where the natural language tool extracts from the data medical terms and associated medical codes along with additional contextual information” (par. 0121; ‘The data platform contains over thirty million medical research papers which pass through a natural language processing (NLP) pipeline which extracts relevant information including, but not limited to, proteins, genetic information, diseases, molecules, biomarkers, clinical trials, assays, and biomarkers.’).
Regarding claim 3 (dep. on claim 1), Krasnoslobodtsev further teaches:
“the step of applying optical character recognition technology to the data to create a text file for processing by the natural language tool” (par. 0069; ‘For example, the data extraction engine 212 may first determine a format of each of the materials received (e.g., text, PDFs, images), and perform conversions of materials not in a machine-readable or extractable format (e.g., performing optical character recognition (OCR) on PDFs and images to extract any text contained therein).’).
Regarding claim 9 (dep. on claim 1), Krasnoslobodtsev further teaches:
“where the data include medical coding data” (par. 0069; ‘The data extraction engine 212 feeds the extracted data to a knowledge graph constructor 213, which constructs a knowledge graph 215 based on the information in the data, representing informational entities (e.g., proteins, molecules, diseases, study results, people) as vertices of a graph and relationships between the entities as edges of the graph.’).
Regarding claim 10 (dep. on claim 1), Krasnoslobodtsev further teaches:
“where the data include injury diagnosis data” (par. 0013; ‘The focus on clinical trial participant matching does not take advantage of the wealth of medical data contained in electronic health records. Information such as diagnosis, prescriptions, surgeries, prescription schedules, and demographic information could be used to find deeper insights hidden within patient health data.’).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Krasnoslobodtsev in view of Walker et al. (US 20150294088 A1).
Regarding claim 4 (dep. on claim 1), Krasnoslobodtsev does not expressly teach:
“a pre-abstraction step screening the data to determine what data is abstracted.”
In a similar field of endeavor (data extraction), Walker teaches:
“a pre-abstraction step screening the data to determine what data is abstracted” (par. 0048; ‘In some circumstances, only some of the data of an element is considered summary data for a determined category. For example, specific fields, values, or sections of an element in an EMR may be summary data for an element as related to the determined condition.’; par. 0050; ‘In an embodiment, identified elements may be presented to a user for a selection of elements from which to determine data indicative of summary 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 modify Krasnoslobodtsev’s EHR data scraping by incorporating Walker’s determination of appropriate summary data categories in order to determine what data to summarize. The summarized information may be needed for communication purposes internally at medical facilities as well as externally with other medical care providers. (Walker: par. 0005)
Regarding claim 5 (dep. on claim 4), the combination of Krasnoslobodtsev in view of Walker further teaches:
“where a rules engine performs the pre-abstraction step resulting in a status assigned to the data to indicate whether the data is to be abstracted” (Walker: par. 0058; ‘Further, compiling the summary data may involve compiling the summary data into a summary report conforming to rules established for a report type.’).
Regarding claim 6 (dep. on claim 5), the combination of Krasnoslobodtsev in view of Walker further teaches:
“where the status determination is reviewed by a human” (Walker: par. 0050; ‘For example, a user may be presented with all identified elements, and a user may select the elements desired for the summary report data. These selected elements may then be analyzed to determine summary data, whereas the unselected elements may not be analyzed.’).
Regarding claim 7 (dep. on claim 5), the combination of Krasnoslobodtsev in view of Walker further teaches:
“creating from the data a list of patients records ready for abstracting” (Krasnoslobodtsev: par. 0096; ‘System 1800 can use the large plurality of EHR data in conjunction with sample size estimator 1403 to generate lists of patients who might be eligible for research, such as by pre-screening of patients by age, gender, and diagnosis, particularly for exclusion of ineligible patients, and reduce the overall screening burden in clinical trials.’).
Regarding claim 8 (dep. on claim 1), the combination of Krasnoslobodtsev in view of Walker further teaches:
“where the abstracting step requires structuring the data from the EHR system to align with the structure of the data registry” (Walker: par. 0025; ‘The creation of relevant sections (e.g. key results, specific problems) may also include natural language processing to understand, extract, summarize, normalize and codify information present in different systems and different formats. Further, the generation of summaries may also include generation of natural language from keywords and structured information present in tables, forms, or other data structures of an EMR.’).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Krasnoslobodtsev in view of Walker as applied to claim 5 above, and further in view of Kahn et al. (US 20240105289 A1).
Regarding claim 11 (dep. on claim 5), the combination of Krasnoslobodtsev in view of Walker further teaches:
“where the rules engine includes categories of rules for patient inclusion, data derivation, registry specific rules, and [[resolution of data anomalies]]” (Walker: par. 0021; ‘Discharge summaries may involve rules for formatting, inclusion, and presentation of data. These rules may include standard sections or collections of sections in templates.’; par .0058; ‘In an embodiment, rules may be associated with report types. For example, a discharge report may have a rule indicating that only one internal temperature value per day is provided for a patient, whereas a shift report may list every temperature value recorded for a patient during the time period. Further, compiling the summary data may involve compiling the summary data into a summary report conforming to rules established for a report type. The report type may be used to guide the identification and mining so that desired summary data is obtained.’).
However, Krasnoslobodtsev in view of Walker do not expressly teach “resolution of data anomalies.”
Kahn teaches:
“resolution of data anomalies” (par. 0154; ‘In the event that a potential healthcare event and/or data anomaly is determined, a set of rules/actions are then applied at step 2407. These rules may comprise providing an indication or notification to the user to ask them if there is a healthcare event and to ensure that they are correctly obtaining their data (e.g. correctly using the scales) in the correct manner.’).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rules for formatting, inclusion, and presentation of data taught by Krasnoslobodtsev in view of Walker by incorporating Kahn’s data anomaly detection in order to determine whether a healthcare event has occurred. (Kahn: par. 0129)
Conclusion
Other pertinent prior art are cited in the PTO-892 for the applicant's consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK VILLENA whose telephone number is (571)270-3191. The examiner can normally be reached 10 am - 6pm EST Monday through Friday.
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MARK . VILLENA
Examiner
Art Unit 2658
/MARK VILLENA/Examiner, Art Unit 2658