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 .
Status of Claims
Claims 33-52 were previously pending and subject to a non-final Office Action having a notification date of February 10, 2026 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on May 7, 2026 (the “Amendment”), amending claims 33-36, 38, 39, 41-45, and 49-52 and canceling claim 37.
The present Final Office Action addresses pending claims 33-36 and 38-52 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
While some of these rejections are withdrawn in view of the Amendment, many of the rejections are not addressed in the Amendment and thus are maintained below. Furthermore, new rejections are presented below as necessitated by the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
In relation to the claim rejections under 35 USC 101 set forth in the non-final Office Action, these rejections are now withdrawn when currently pending claims 33-36 and 38-52 are considered in view of the 2019 Revised Patent Subject Matter Eligibility Guidance (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 update issued by the USPTO as now incorporated into the MPEP, and as supported by relevant case law) and Applicant' s remarks in the Amendment.
Specifically, the “additional limitations” of the claims (including, inter alia, the limitations directed to generating a user interface displayed on an electronic display device, the user interface comprising (i) a first portion displaying at least one of the plurality of source documents, and (ii) a second portion concurrently displaying the structured patient data fields for entering structured patient data derived from the at least one of the plurality of source documents displayed in the first portion, the user interface permitting a user to switch between the plurality of source documents without changing the second portion; and propagating a received modification to one of the valuesets associated with the structured patient data fields to all of the templates that use the valueset) together with the limitations directed to the at least one abstract idea (e.g., receiving the test sets and documents from a plurality of sources/streams of data, initiating a test set based on a triggering event, applying the initiated test set for a clinical trial, extracting structured patient data from at least one of the source documents, validating the structured patient data by applying validation rules, generating a match indication, etc.), when viewed as a whole, integrate the at least one abstract idea into a practical application of the at least one abstract idea by improving the functioning of a computer and other technology.
For instance, [0184]-[0185] of the present application discuss how allowing the second portion to remain unchanged while a user view different ones of the source documents of the first portion advantageously improves technology by allowing a user to generate a more comprehensive report from multiple source documents. Furthermore, receiving and automatically propagating valueset modifications to all templates that use the valueset advantageously improves interrogation efficiency by helping abstractors find appropriate values more efficiently thereby facilitating report generation ([0216], [0218], [0227] of the present application). One of ordinary skill in the art would recognize the above-discussed improvements to computers or other technology as disclosed in the present specification and reflected in the present claims. MPEP 2106.05(a).
Claim Objections
Claims 35 is objected to because of the following informalities:
In claim 35, line 7, "known" should be changed to --a known--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 34, 35, 38-40, 45, 46, 49, and 51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The present application is a continuation of U.S. App. No. 17/837,025 ("the '025 Application"), filed June 10, 2022, which is a continuation of U.S. App. No. 16/852,216 ("the '216 Application"), filed April 17, 2020, which claims priority from U.S. App. No. 62/835,489 ("the '489 Application"), filed April 17, 2019.
However, it does not appear that many of the limitations of claims 34, 35, 38-40, 45, 46, 49, and 51 are disclosed in the specification of the '025 Application, the '216 Application, or the '489 Application.
Regarding claims 34 and 51, support cannot be found at least for extracting a subject ID from the documents, identifying unstructured/structured data associated with the subject ID, and notifying the clinical site, together with the limitations of claim 33.
Regarding claim 35, support cannot be found at least for building a cohort of subjects with known, qualifying diagnosis for the clinical site and provisioning a list of subjects satisfying the test set to the clinical site, together with the limitations of claim 33.
Regarding claim 37, support cannot be found at least for wherein receiving the site includes data indicative of establishment of a new site, together with the limitations of claim 33.
Regarding claim 38, support cannot be found at least for a microservice for dynamically building nested test sets specific to each clinical trial and clinical trial site, the microservice utilizing a configurable interface for selecting attributes or inclusion/exclusion criteria of the clinical trial, together with the limitations of claim 33.
Regarding claim 39, support cannot be found at least for a data product integration microservice configured to ingest the extracted structured patient data into downstream applications or databases for further analysis or reporting, together with the limitations of claim 33.
Regarding claim 40, support cannot be found at least for a microservice for real-time alerting of site qualifications based on test set satisfaction, together with the limitations of claim 33.
Regarding claim 45, support cannot be found at least for selecting a combination of documents for each of the subjects to meet a quality metric; and building a collection of documents based on sufficiency and data quality, together with the limitations of claim 33.
Regarding claim 46, support cannot be found at least for a quality assurance (QA) Manager Console user interface configured to allow users to construct and group validations for inclusion or exclusion criteria specific to cohorts for research or clinical trials, together with the limitations of claim 33.
Regarding claim 49, support cannot be found at least for displaying a data section for genetic testing and labs, wherein a user interface includes a plurality of data entry fields corresponding to genetic testing parameters including testing method, results, testing provider, date of testing results, and date of specimen collection; and wherein the system is configured to support validations that switch between different genetic testing methods including Next Generation Sequencing (NGS), Immunohistochemistry (IHC), Fluorescence in situ Hybridization (FISH) via a drop-down menu for the testing method field populated with a plurality of testing method options.
If Applicant believes support for the above limitations is provided by the '216 Application, then Applicant is respectfully requested to provide detailed specific citations from the '216 Application for the limitations.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33-36 and 38-52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of independent claims 33, 50, and 52 recites, inter alia, "initiate…a test set in the plurality of test sets…," "apply…the test set…," "validate…the structured patient data by applying the validations…". However, it is unclear which of the validations is being applied in the "validate" step because each of these claims recites how each of the test sets is configured with validations. Therefore, it is recommended that each of these claims is amended to recite
--initiate … a first test set in the plurality of test sets…,-- --apply…the first test set…,-- and
--validate … the structured patient data by applying the validations of the first test set…-- or similar language.
Regarding claims 34 and 51, it is unclear whether or not or how the "one or more documents" are related to the "collection of documents" and/or the "at least one of the plurality of documents for at least one clinical trial" from independent claims 33 and 50.
Regarding claim 35, it is unclear whether or not or how the "collection of documents" is related to the "collection of documents" and/or the "at least one of the plurality of documents for at least one clinical trial" from independent claim 33.
Regarding claim 43, it is unclear to which valueset "the valueset" is referring because claim 33 recites "valuesets."
Regarding claim 44, it is unclear whether or not or how the "collection of documents" is related to the "collection of documents" and/or the "at least one of the plurality of documents for at least one clinical trial" from independent claim 33.
Regarding claim 45, it is unclear whether or not or how the "combination of documents" and "collection of documents" are related to the "collection of documents" and/or the "at least one of the plurality of documents for at least one clinical trial" from independent claim 33.
Regarding claim 47, it is unclear whether or not or how the "one or more test suites" are related to the "plurality of test sets" from independent claim 33.
Regarding claim 48, it is unclear whether or not or how the "validations" are related to the "validations" from independent claim 33.
Regarding claim 49, it is unclear whether the displayed data section is on the recited "user interface."
The remaining claims are rejected as depending from the above rejected claims.
Allowable Subject Matter
Claims 33, 50, and 52 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 36, 41-44, 47, and 48 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
U.S. Patent App. Pub. No. 2016/0196411 to Zhang et al. discloses systems and methods for matching of patients with clinical trials in an automated fashion and integrated with an existing clinical workflow. Patient data can be retrieved from an existing clinical data management system. The patient data can be evaluated against eligibility criteria for a plurality of clinical trials to determine an eligibility of the patient for each of the plurality of clinical trials. The eligibility criteria can be stored in a structured format to facilitate matching with the patient data. For example, the eligibility criteria can be structured as an eligibility checklist. The eligibility checklist can include the same categories for different clinical trials, with appropriate values listed for the different categories (including an empty or zero value when the clinical trial does not set forth an eligibility criterion for the certain category). A library stored within a database can define variables and other parameters that can be used to put the eligibility criteria into the structured format. The variables can represent various types of values used in defining the eligibility criteria including, for example, a variable identifier, a set of valid values, a minimum value, a maximum value, a unit of measurement, a description about the subject of the eligibility criterion, and a variable type (e.g., Boolean, categorical, dynamic categorical, continuous, and the like).
A data entry module, in some instances, can aid the user in defining the eligibility criteria (and, in some instances, the eligibility checklist) in the structured format. As an example, the data entry module can allow the user to perform a keyword search to view and select variables from the library. In some examples, the variables can be linked to different widgets that allow the user to define the clinical trial eligibility criteria and group different parts of the eligibility criteria (e.g., creating a criteria that includes if statements, then statements, else statements, etc.). In some instances, the eligibility criteria can be entered in the structured format using the data entry module. In some instances, a user associated with the clinical trial can enter the eligibility criteria in the structured format using the data entry module.
A matcher can output a set of possible clinical trials identified for the patient to a eligibility determination unit that determines an eligibility (or ineligibility) of the patient for each of the set of possible clinical trials. In some instances, the eligibility can be determined based on the plurality of recent laboratory test results being within the respective eligibility criteria for the clinical trial. In other instances, the eligibility can be determined based on three or more recent laboratory test results being within the respective eligibility criteria for the clinical trial.
However, this document does not appear to disclose the eligibility criteria for each clinical trial to include valuesets associated with structured patient data fields organized according to templates and configured to encompass structured data specific to a disease state of the clinical trial; generating a user interface displayed on an electronic display device, the user interface comprising (i) a first portion displaying at least one of a plurality of source documents, and (ii) a second portion concurrently displaying structured patient data fields for entering structured patient data derived from the at least one of the plurality of source documents displayed in the first portion, the user interface permitting a user to switch between the plurality of source documents without changing the second portion; and propagating a received modification to one of the valuesets associated with the structured patient data fields to all of the templates that use the valueset; as recited in independent claims 33, 50, and 52.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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