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 are pending in the present application with claims 33, 50, and 52 being independent, as set forth in the Preliminary Amendment dated February 12, 2025.
Claim Objections
Claims 33 and 35 are objected to because of the following informalities:
In claim 33, the second to last line, "generating" should be changed to
--generate--.
In claim 35, line 5, "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 33-52 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 33-52 are disclosed in the specification of the '025 Application, the '216 Application, or the '489 Application.
Regarding claims 33, 50, and 52, support for at least the following limitations cannot be identified:
wherein each of the validations include dynamic valuesets specifically tailored to match a sequencing performed, a diagnostic performed or a collection of documents and each respective dynamic valueset configured to encompass structured data specific to the at least one disease state;
extract, via the one or more processors, one or more data products from (1) the sequencing performed, (2) the diagnostic performed or (3) the collection of documents using the test set;
validate, via the one or more processors, the data products by applying the validations wherein applying the validations includes evaluating each of the data products for adherence to the dynamic valuesets and a respective heuristic; and
For instance, while [0213]-[0227] of the '216 Application generally discusses use of "valuesets" to extract structured data from clinical records and [0273]-[0362] of the '216 Application generally discusses use of "test suites" to perform accuracy, coverage, validation, etc. of patient clinical data in relation to assessing suitability for one or more clinical trials including how validation rules can be associated with certain types of cancers, the Examiner cannot identify all of the above limitations.
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 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 data products 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 43, support cannot be found at least for associating structured patient data fields of a template with valuesets based on a type of sequencing performed, diagnostics performed, or collection of documents, each valueset comprising a subset of values and corresponding subset of codes, together with the limitations of claim 33.
Regarding claim 44, support cannot be found at least for receiving respective valuesets based on a type of sequencing performed, diagnostics performed, or collection of documents, together with the limitations of claim 33.
Regarding claim 45, support cannot be found at least for selecting a combination of documents for each subject 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 33-52 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 how each of the validations includes "dynamic" valuesets which the Examiner is interpreting to mean sets of values that change or otherwise adapt. However, these claims also recite that such dynamic valuesets are each "specifically tailored to match a sequencing performed, a diagnostic performed or a collection of documents" and "configured to encompass structured data specific to the at least one disease state" which appears at odds with valuesets that change or otherwise adapt. It is therefore unclear what it means for valuesets that are specifically tailored to match a sequencing performed, a diagnostic performed or a collection of documents and configured to encompass structured data specific to the at least one disease state to be "dynamic."
Each of independent claims 33, 50, and 52 calls for, inter alia, initiating a test set in the plurality of test sets and applying the test set to at least one of the plurality of documents for at least one clinical trial. However, these claims then call for extracting one or more data products from (1) the sequencing performed, (2) the diagnostic performed or (3) the collection of documents using the test set (i.e., as opposed to from the "plurality of documents for at least one clinical trial" in the preceding steps); validating the data products by applying the validations wherein applying the validations includes evaluating each of the data products for adherence to the dynamic valuesets and a respective heuristic; and generating, based on the validations, a match indication of one or more subjects to the at least one of the clinical trial sites. It is therefore unclear i) whether or not or how the initiating/applying of the test set to the "at least one of the plurality of documents for at least one clinical trial" is related to the extracting/validating/generating steps, ii) whether or not or how the "collection of documents" is related to the "at least one of the plurality of documents for at least one clinical trial," and iii) whether or not or how the "one or more subjects" are related to the "collection of documents" and/or the "at least one of the plurality of documents for at least one clinical trial."
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 42, it is unclear whether or not or how the "plurality 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 claims 43-44, it is unclear whether or not or how the "valuesets" are related to the "dynamic valuesets" from independent claim 33.
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.
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 33-52 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 33-49 are directed to a system (i.e., a machine), claims 50 and 51 are directed to a method (i.e., a process), and claim 52 is directed to a non-transitory computer-readable medium (i.e., a manufacture). Accordingly, claims 33-52 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 33 includes limitations that recite at least one abstract idea. Specifically, independent claim 33 recites:
An electronic medical record ingestion and abstraction system for identifying and populating subjects to a plurality of clinical trials conducted at one or more clinical trial sites, comprising:
one or more processors, and
one or more memories, having stored thereon computer-executable instructions that, when executed, cause the electronic medical record ingestion and abstraction system to:
receive, via the one or more processors, a plurality of test sets,
wherein each test set is associated with at least one clinical trial and at least one disease state, and
wherein each test set is configured with validations configured to assess one or more attributes including criteria of a clinical trial, and
wherein each of the validations include dynamic valuesets specifically tailored to match a sequencing performed, a diagnostic performed or a collection of documents and each respective dynamic valueset configured to encompass structured data specific to the at least one disease state;
receive, via the one or more processors, a plurality of documents from a plurality of different sources or streams of data;
initiate, based on a triggering event, a test set in the plurality of test sets;
apply, via the one or more processors, the test set to at least one of the plurality of documents for at least one clinical trial;
extract, via the one or more processors, one or more data products from (1) the sequencing performed, (2) the diagnostic performed or (3) the collection of documents using the test set;
validate, via the one or more processors, the data products by applying the validations wherein applying the validations includes evaluating each of the data products for adherence to the dynamic valuesets and a respective heuristic; and
generating, based on the validations, a match indication of one or more subjects to the at least one of the clinical trial sites.
The Examiner submits that the foregoing underlined limitations recite “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). As an example, a medical professional (e.g., principal investigator, etc.) may develop one or more "test sets" that are each associated with a particular clinical trial (e.g., for a particular pharmaceutical or drug regimen) and disease state (e.g., prostate cancer, etc.) and include "validations" for assessing attributes including criteria of the clinical trial (e.g., that patients have prostate cancer, are of a particular age range, etc.) and include various disease state structured data specific "valuesets" (collections/lists of data/attributes) to match a particular sequencing/diagnostic/document collection. Thereafter, the medical professional can receive/obtain a plurality of patient clinical records, initiate/apply a test set to the patient clinical records (e.g. performing an evaluation of the patient clinical records based on the test set) based on a "triggering event" (e.g., manually, in response to receipt of new data, etc.), extract/obtain "data products" from the document collection, validate the data products by applying the validations including evaluating/reviewing the data products for adherence to/compliance with the valuesets and a respective heuristic, and generate a "match indication" of one or more subjects to at least one clinical trial sites
These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III). Claims “directed to collection of information, comprehending the meaning of that collected information, and indication of the results, all on a generic computer network operating in its normal, expected manner,” fail step one of the Alice framework. In re Killian, 45 F.4th 1373, 1380 (Fed. Cir. 2022). Claims directed to “collecting, analyzing, manipulating, and displaying data’’ are abstract. Univ. of Fla. Research Found., Inc. v. General Elec. Co., 916 F.3d 1363, 1368 (Fed. Cir. 2019). Claims directed to organizing, storing, and transmitting information determined to be directed to an abstract idea. Cyberfone Sys., L.L.C. v. CNN Interactive Grp., Inc., 558 F. App’x 988, 992 (Fed. Cir. 2014).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 34-40, 42-48, and 51 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claims 34 and 51 call for receiving a trigger notification associated with one or more documents; extracting (e.g., gleaning, writing down) a subject ID from the one or more documents; identifying (e.g., via visual/mental review) a plurality of unstructured documents or structured data associated with the subject ID; executing a test set on the documents (e.g., evaluating the documents in view of the testing criteria/rules in the test set); and notifying the clinical site of subject qualification based on the test set (e.g., via writing it down), all of which can be performed in the human mind with pen and paper ("mental processes"). Furthermore, such notification recites "certain methods of organizing human activity" because it relates to managing relations between people.
-Claim 35 calls for receiving a test set associated with the site (e.g., via visually/mentally reviewing it); building a cohort of subjects with known, qualifying diagnosis for the clinical site (e.g., writing down a list of subjects on paper); gathering a collection of documents including unstructured documents associated with subjects of the cohort; executing the test set on each gathered collection of documents (e.g., performing one or more evaluations from the test set on the documents); and provisioning a list of subjects satisfying the test set to the clinical site (e.g., via writing it down), all of which can be performed in the human mind with pen and paper ("mental processes"). Furthermore, such provisioning recites "certain methods of organizing" because it relates to managing relations between people.
-Claim 36 recites how the triggering event is at least one of: receiving data related to a patient; receiving data related to a clinical site; or receiving data related to a clinical trial, which just further defines the at least one abstract idea.
-Claim 37 recites how receiving the site includes data indicative of establishment of a new site which just further defines the at least one abstract idea.
-Claim 38 calls for building "nested" test sets (e.g., with sub-groupings, etc.) specific to each clinical trial and site and selecting attributes or inclusion/exclusion criteria of the trial which can be performed in the human mind with pen and paper ("mental processes").
-Claim 39 calls for ingesting the extracted data products for further analysis/reporting which can be performed in the human mind with pen and paper ("mental processes").
-Claim 40 calls for alerting of site qualifications based on test set satisfaction which recites "certain methods of organizing" because it relates to managing relations between people.
-Claim 42 calls for receiving a plurality of documents from multiple, disparate sources or streams of data (at least two of a pathology report, a progress note, testing data, or an electronic medical record) which is which can be performed in the human mind with pen and paper ("mental processes").
-Claim 43 calls for associating structured patient data fields of a template with valuesets based on a type of sequencing performed, diagnostics performed, or collection of documents, each valueset comprising a subset of values and corresponding subset of codes. A person can practically perform these limitations in the human mind with pen and paper ("mental processes").
-Claim 44 calls for receiving respective valuesets based on a type of sequencing performed, diagnostics performed, or collection of documents which can be performed in the human mind with pen and paper ("mental processes").
-Claim 45 calls for selecting a combination of documents for each subject to meet a quality metric and building a collection of documents based on sufficiency and data quality which can be performed in the human mind with pen and paper ("mental processes").
Claim 46 calls for constructing/grouping validations for inclusion/exclusion criteria specific to cohorts for research or clinical trials which can be performed in the human mind with pen and paper ("mental processes").
-Claim 47 calls for generating one or more test suites configured to target one or more specific clinical attributes and/or content types which can be performed in the human mind with pen and paper ("mental processes").
-Claim 48 calls for applying validations to one or more attributes including gender and primary diagnosis and designing/building new queries by selecting attributes and associating rules which can be performed in the human mind with pen and paper ("mental processes").
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
An electronic medical record ingestion and abstraction system for identifying and populating subjects to a plurality of clinical trials conducted at one or more clinical trial sites, comprising:
one or more processors (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), and
one or more memories, having stored thereon computer-executable instructions that, when executed, cause the electronic medical record ingestion and abstraction system to (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)):
receive, via the one or more processors (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), a plurality of test sets,
wherein each test set is associated with at least one clinical trial and at least one disease state, and
wherein each test set is configured with validations configured to assess one or more attributes including criteria of a clinical trial, and
wherein each of the validations include dynamic (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)) valuesets specifically tailored to match a sequencing performed, a diagnostic performed or a collection of documents and each respective dynamic (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)) valueset configured to encompass structured data specific to the at least one disease state;
receive, via the one or more processors (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), a plurality of documents from a plurality of different sources or streams of data;
initiate, based on a triggering event, a test set in the plurality of test sets;
apply, via the one or more processors (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), the test set to at least one of the plurality of documents for at least one clinical trial;
extract, via the one or more processors (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), one or more data products from (1) the sequencing performed, (2) the diagnostic performed or (3) the collection of documents using the test set;
validate, via the one or more processors (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), the data products by applying the validations wherein applying the validations includes evaluating each of the data products for adherence to the dynamic (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)) valuesets and a respective heuristic; and
generating, based on the validations, a match indication of one or more subjects to the at least one of the clinical trial sites.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the system including processor(s), memory(ies) with instructions, and the "dynamic" nature of the valuesets, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)). Furthermore, the "dynamic" nature of the valuesets amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” because it amounts to a result-oriented solution without details as to what makes the valuesets "dynamic."
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 33 and analogous independent claims 50 and 52 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 33 and analogous independent claims 50 and 52 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claim 38 recites a "microservice" that uses a configurable interface for performing the selecting which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 39 calls for a "data product integration microservice" for performing the ingesting which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 40 calls for a microservice for performing the alerting which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 41 recites how each test set is managed/updated through a "test set management microservice" which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 42 calls for displaying the documents on a GUI displayed on an electronic display device and including a first portion for displaying the documents and a second portion for entering structured data derived from the displayed documents which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 46 recites a quality assurance manager console UI that allows users to perform the construction/grouping of validations which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 48 recites a dynamic UI that enables user to design/build new the queries which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 49 calls for displaying a data section for genetic testing/labs, wherein a UI 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) which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)). This claim also recites how the system can 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 which again amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 33 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the system including processor(s), memory(ies) with instructions, and the "dynamic" nature of the valuesets, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)). Furthermore, the "dynamic" nature of the valuesets amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” because it amounts to a result-oriented solution without details as to what makes the valuesets "dynamic."
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claim 38 recites a "microservice" that uses a configurable interface for performing the selecting which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 39 calls for a "data product integration microservice" for performing the ingesting which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 40 calls for a microservice for performing the alerting which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 41 recites how each test set is managed/updated through a "test set management microservice" which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 42 calls for displaying the documents on a GUI displayed on an electronic display device and including a first portion for displaying the documents and a second portion for entering structured data derived from the displayed documents which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 46 recites a quality assurance manager console UI that allows users to perform the construction/grouping of validations which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 48 recites a dynamic UI that enables user to design/build new the queries which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 49 calls for displaying a data section for genetic testing/labs, wherein a UI 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) which amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)). This claim also recites how the system can 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 which again amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Therefore, claims 33-52 are ineligible under 35 USC §101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892. For reference, NPL "Trial Prospector: Matching Patients with Cancer Research Studies Using an Automated and Scalable Approach" to Sahoo et al. discloses a trial prospector tool that supports end-to-end management of cancer clinical trial recruitment workflow with (a) structured entry of trial eligibility criteria, (b) automated extraction of patient data from multiple sources, (c) a scalable matching algorithm, and (d) interactive user interface (UI) for physicians with both matching results and a detailed explanation of causes for ineligibility of available trials.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686