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 .
Status of Claims
This action is in reply to the claims filed on 08 September 2025. Claims 1, 7, 9, 15, and 17 were amended. Claims 5, 8, 13, and 16 were previously canceled. Claims 1-4, 6-7, 9-12, 14-15, and 17-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
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 1-4, 6-7, 9-12, 14-15, and 17-20 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.
Claims 1, 9, and 17 recites the limitation “the subset of the individuals” in line 9 of claim 1 (and similar locations in claims 9 and 17). There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, this element will be considered to state “a subset of the individuals.” Appropriate correction is required. Dependent claims 2-4, 6-7, 10-12, 14-15, and 18-20 inherit this deficiency.
Subject Matter Free of Prior Art
Claim 1-4, 6-7, 9-12, 14-15, and 17-20 are considered to be free of prior art. The following is a statement of reasons for the indication of subject matter free of prior art:
Applicant’s claims are directed to a particular system and method for predicting patient outcomes, including the use machine learning, trained with logistic regression and missingness as an offset term, to predict a patient’s 180-day mortality from patient reported outcomes. The closest prior art is understood to be the prior art of record. Krishnapuram discloses a system and method for predicting patient mortality using patient reported outcome data and multiple machine learning models. Zhao teaches the use of missingness and offset terms in analyzing patient-reported outcomes (see Zhao abstract). Fornwalt teaches the prediction of 6-month mortality (i.e. 180-day mortality) using machine learning. However, the prior art does not teach or fairly suggest a combination which results in the specific combination of elements described in the claim language. Accordingly, the claims are considered to be free of prior art.
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 1-4, 6-7, 9-12, 14-15, and 17-20 are rejected under 35 USC § 101
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 1-4, 6-7, 9-12, 14-15, and 17-20 fall within one or more statutory categories. Claims 1-4 and 6-7 fall within the category of a process. Claims 9-12 and 14-15 fall within the category of a machine. Claims 17-20 fall within the category of a manufacture.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-4, 6-7, 9-12, 14-15, and 17-20 recite an abstract idea. Representative claim 1 recites:
… using only electronic health record (EHR) data for a plurality of individuals [as part of a patient outcome prediction], wherein the EHR data is available for all of the individuals and patient reported outcome (PRO) data is only available for a subset of individuals, the subset being less than all of the individuals, and … generating predicted probabilities of 180 day mortality for all of the individuals …; and
… [predicting] 180-day mortality as an outcome, the PRO data as predictors for the subset of individuals for which the PRO data is available…;
supplying at least EHR data for a patient …; and
… predict at least one patient outcome for the patient, wherein the patient comprises an oncology patient and at least one patient outcome includes a predicted probability of 180-day mortality for the oncology patient;
using the predicted probability to inform a decision as to whether to administer palliative care to the oncology patient.
Therefore, the claim as a whole is directed to “predicting patient outcomes,” which is an abstract idea because it is a method of organizing human activity. “Predicting patient outcomes” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the claims include the interaction between a patient and a healthcare provider during treatment.
Representative claim 1 also recites:
training, using … at least one machine learning algorithm, a predictive model by:
fitting … a first model … , wherein fitting the first model includes fitting a preliminary model and missingness models to the EHR data for all of the individuals, including the individuals for which the PRO data is not available;
fitting … a second model using the PRO data for the subset of the plurality of individuals and a logit of the predicted probabilities of 180 day mortality for all of the individuals generated using the first model …, wherein fitting the second model includes fitting a logistic regression model with 180-day mortality as an outcome, the PRO data as predictors for the subset of individuals for which the PRO data is available, and the missingness models as an offset term.
Under the broadest reasonable interpretation, these elements are directed to “training an algorithm,” which is an abstract idea because it is a mathematical concept. “Training an algorithm” is considered to be a mathematical concept because it is an example of mathematical calculation, with the specific recitation of at least the missingness model, the logit, and the logistic regression model.
5. The limitations that recite a method of organizing human activity and the limitations that recite mathematical concepts are considered together as a single abstract idea for further analysis.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the following additional element(s):
at least one processor;
a predictive trainer;
outputting the predicted probability via a computer display device.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional element merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). 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. Claim 1 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements, considered individually or in combination, 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 element(s), individually and in combination, merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, claim 1 is ineligible.
Dependent claim 2 recites the method of claim 1, wherein:
training the predictive model comprises obtaining a summary score for a plurality of electronic health record covariates.
The additional elements present in this claim element merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)), These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 2 is ineligible.
Dependent claim 3 recites the method of claim 1, wherein:
fitting the first model comprises applying the least absolute shrinkage and selection operator (LASSO) logistic regression model.
The additional elements present in this claim element merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)), These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 3 is ineligible.
Dependent claim 4 recites the method of claim 1, wherein:
fitting the first model comprises applying the least absolute shrinkage and selection operator (LASSO) logistic regression model
The additional elements present in this claim element merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)), These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 4 is ineligible.
Dependent claim 6 recites the method of claim 1, wherein:
the electronic health record data includes one or more of: demographic variables, comorbidities, and laboratory data.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 6 is considered to be ineligible.
Dependent claim 7 recites the method of claim 1, wherein:
patient reported outcome data includes patient responses to questions about one or more of: symptoms, quality of life, and functional status.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 7 is considered to be ineligible.
Claims 9-12, 14-15 and 17-20 are parallel in nature to claims 1-4 and 6-7. Accordingly claims 9-12, 14-15 and 17-20 are rejected as being directed towards ineligible subject matter based upon the same analysis above.
Response to Arguments
Applicant's arguments filed 08 September 2025, with respect to the 35 U.S.C. §101 rejection of the claims, have been fully considered but they are not persuasive. Applicant argues that the claims do not recite an abstract idea but instead an advancement in predictive healthcare science for oncology patients (see Applicant Remarks pages 6-7). This is not persuasive. Applicant appears to be arguing that the claims are integrated into a practical application under Step 2A because they recite a practical application in the form of an improvement to technology or other technical field. However, the claims do not recite an improvement to any technology as discussed in MPEP 2106.04(d)(1) because they currently recite the use of general purpose computer functions and components as additional elements. This amounts to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). This is not enough to integrate the abstract idea into a practical application. Accordingly, the claims remain rejected as being directed to ineligible subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gorman et al. (U.S. 2024/0112807) teaches a system that addresses missingness in patient outcome data that is used to predict patient treatment efficacy.
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 BENJAMIN L HANKS whose telephone number is (571)270-5080. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Shahid Merchant can be reached at (571) 270-1360. 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.
/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684