DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Claim Objections
Applicant's arguments filed 11/12/2025 have been fully considered. In response the Applicant’s arguments and amendments, the claims objections of claims 5-7 has been withdrawn.
Rejections Under 101
Applicant's arguments filed 11/12/2025 have been fully considered.
Applicant argues that the claims do not recite an abstract idea such as certain methods of organizing human activity. The amended claim recites a detailed process for automatically performing preliminary matching of a subject with a clinical trial based on a valued imputed using a trained artificial intelligence engine operating on health observations selected using a pre/post-diagnostic window.
In response to Applicant’s argument, the argument appears to be directed toward the amendment and is therefore moot. See the updated rejection for further clarification. However, the use of the artificial intelligence amounts to invoking the use of computers to carry out the abstract idea.
The amended claims integrate the abstract idea into a practical application and constitutes significantly more than the alleged exception. The use of the temporal windows increases relevance of health observations and decreases the amount of data to impute using the artificial intelligence. Additionally, performing the matching based on the imputed value improves identification of a clinical trial that the subject may be eligible.
In response to Applicant’s argument, the limitation at issue regarding the temporal windows is considered part of the abstract idea and is not an additional element. The additional elements considered in steps 2A prong 2 and 2B do not amount to a practical application or significantly more than the abstract idea. See the updated rejection below for further clarification.
The amended claims recite a specific technological solution that improves performance of the machine learning engine for imputing a value by using a pre-diagnostic window and a post-diagnostic window and using the imputed value to automatically perform the preliminary matching of a subject with a clinical trial.
In response to Applicant’s argument, while the claims recite “providing the input values to a trained artificial intelligence engine, wherein the trained artificial intelligence engine has been trained to perform actions…” the use of the artificial intelligence is recited at high level of generality and is merely invoking the use of the computer tool to carry out the actions of the abstract idea. Any improvement is an improvement to the abstract idea, not the performance of the machine learning engine.
The combination of additional elements in the amended claims provide an inventive solution that improves the artificial intelligence engine, improves EHR data missingness, and enables automatic preliminary matching of a subject.
In response to Applicant’s argument, the additional elements considered individually or in combination do not amount to anything more than mere instructions to apply an exception in a computer environment. See “c” above for further explanation and the rejection below for the updated rejection.
The additional elements were found to amount to “amount to elements that have been recognized as well understood, routine, and conventional” without considering the improvements to technology in the claim. Therefore, this is overbroad reasoning and improperly discounts the practical application and inventive aspects embodied in the claim without explanation.
In response to Applicant’s argument, while that statement was made in the rejection in analysis step 2B, reading just beyond, Applicant is provided with an explanation in the form of the Berkeimer evidence as to why the additional elements are well understood, routine, and conventional. See the rejection below for further explanation.
It is more likely than not that the amended claims are eligible for the reasons discussed above. Based on the August, 4, 2025 Memo for evaluating subject matter eligibility under 101, if it is a close call the Examiner should only make the rejection when it is more likely than not that the claim is ineligible.
In response to Applicant’s argument, when looking at the claim as a whole and considering the additional elements, the additional elements do not amount to a practical application as discussed above. Therefore, the claims are ineligible.
Rejections Under 103
Applicant's arguments filed 11/12/2025 have been fully considered. Applicant argues that the cited references fail to disclose or suggest all of the features of the pending claims. Xu does not discuss selecting health observations based on pre-diagnostic or post-diagnostic windows as claimed. Xu also does not disclose the amended features of the claims, such as, the deep learning-based imputation method being related to eligibility criterion of a clinical trial and performing matching of a subject with a clinical trial based on the imputed value. In response to Applicant’s arguments, the argument is persuasive and therefore the rejection is withdrawn. See below.
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 1-2, 5-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1-2, 5-18 are drawn to a method, which is within the four statutory categories (i.e. process). Claim 19 is drawn to a computer system, which is within the four statutory categories (i.e. apparatus). Claims 20-22 are drawn to a non-transitory processor-readable storage medium, which is within the four statutory categories (i.e. manufacture).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, claim 1 (and substantially similar with independent claim 19, 20) recites:
A method for imputing a value associated with a subject within an electronic health record (EHR) system, the method comprising:
receiving a request to impute a value related to an eligibility criterion of a clinical trial, wherein the value is associated with the subject at a diagnostic temporal instance;
retrieving a subset of data associated with the subject from the EHR system, the subset of data organized into specific fields as part of a schema and including a plurality of health observations, wherein each health observation is associated with a temporal instance;
determining, for each health observation, a pre-diagnostic temporal window and a post-diagnostic temporal window, the pre-diagnostic temporal window comprising a specified first duration immediately preceding the diagnostic temporal instance, and the post-diagnostic temporal window comprising a specified second duration immediately following the diagnostic temporal instance;
selecting health observations having a temporal instance within the pre-diagnostic temporal window or the post-diagnostic temporal window;
retrieving, for each of the selected health observations, a value corresponding to the selected health observation, as input values;
providing the input values to a trained artificial intelligence engine, wherein the trained artificial intelligence engine has been trained to perform actions, comprising:
processing the input values to generate the imputed value;
receiving the imputed value from the trained artificial intelligence engine;
automatically performing a preliminary matching of the subject with the clinical trial based on the imputed value; and
providing an indication of the preliminary matching in response to the request.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the EHR system, trained artificial intelligence engine, processors, and non-transitory computer readable media storing instructions, the limitations in the context of this claim encompass following steps or instructions to process health data and generating an imputed value for that clinical trial eligibility data to then output the requested imputed value in order to provide clinical trial matches for the subject. If a claim limitation, under its broadest reasonable interpretation, covers personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2, 5-18, 21-22 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 1 (and substantially similar with independent claim 19, 20) recites:
A method for imputing a value associated with a subject within an electronic health record (EHR) system (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), the method comprising:
receiving a request to impute a value related to an eligibility criterion of a clinical trial, wherein the value is associated with the subject at a diagnostic temporal instance;
retrieving a subset of data associated with the subject from the EHR system (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), the subset of data organized into specific fields as part of a schema and including a plurality of health observations, wherein each health observation is associated with a temporal instance;
determining, for each health observation, a pre-diagnostic temporal window and a post-diagnostic temporal window, the pre-diagnostic temporal window comprising a specified first duration immediately preceding the diagnostic temporal instance, and the post-diagnostic temporal window comprising a specified second duration immediately following the diagnostic temporal instance;
selecting health observations having a temporal instance within the pre-diagnostic temporal window or the post-diagnostic temporal window;
retrieving, for each of the selected health observations, a value corresponding to the selected health observation, as input values;
providing the input values to a trained artificial intelligence engine, wherein the trained artificial intelligence engine has been trained to perform actions, comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
processing the input values to generate the imputed value;
receiving the imputed value from the trained artificial intelligence engine; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
automatically performing a preliminary matching of the subject with the clinical trial based on the imputed value; and
providing an indication of the preliminary matching in response to the request.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the EHR system, trained artificial intelligence engine, processors, and non-transitory computer readable media storing instructions, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0049], [0113]-[0114], see MPEP 2106.05(f))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2, 5-18, 21-22, which further define the abstract idea; 2, 5-12 and 17-20 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea; and claims 2, 5-18, 21-22 recite additional limitations which generally link the abstract idea to a particular technological environment or field of use). 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.
Step 2B of the Alice/Mayo Test for Claims
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 discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the EHR system, trained artificial intelligence engine, processors, and non-transitory computer readable media storing instructions, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0049], [0113]-[0114]); using an EHR system, trained artificial intelligence engine, processor, and non-transitory computer readable media storing instructions, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to furthering the abstract idea, invoking computers as a tool to perform the abstract idea, and are generally linking the abstract idea to a particular field of environment. 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. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 1-2, 5-22 are free of prior art over Xu et al. (“A deep learning-based, unsupervised method to impute missing values in electronic health records for improved patient management,” Oct. 1, 2020) and Schaeffer et al. (US 2022/0044826). The prior art references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest NPL reference is Xu et al. (Oct. 1, 2020) teaches a deep learning-based method to impute missing values in health records while considering temporal patterns in patient data. The closest prior art is Schaeffer et al. (US 2022/0044826), which teaches a system and method for analyzing patient data to predict treatment responses for large datasets relating to patient populations and imputing medical records to have complete responses. The references do not teach or suggest all of the features of the claims, such as, receiving a request to impute a value related to an eligibility criterion of clinical trial, determining the pre-diagnostic and post-diagnostic window, performing matching of the subject with the clinical trial based on the imputed value. The references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible hindsight and not provide any advantages over their present application. The dependent claims are also free of prior art due to their corresponding dependency of the independent claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason B. Dunham can be reached at (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686