Detailed Notice
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 1-5, 7-14, 16-19, and 22-25 are currently pending.
Claims are amended.
Claims 6, 15, and 20-21 are canceled.
Claims 22-25 are new.
Claims 1-5, 7-14, 16-19, and 22-25 are rejected.
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 1-5, 7-14, 16-19, and 22-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
In the instant case, claims 1-5, 7-11, and 22-25 are directed toward a non-transitory media (i.e., manufacture), claims 12-14 and 16-17 are directed toward a system (i.e., machine), and claims 18-19 are directed toward a computer-implemented method (i.e., process). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claims 1, 12, and 18 recites steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity and/or mental process but for the recitation of generic computer components.
Claim 1 recites: “One or more non-transitory media having computer-readable instructions that, when executed by one or more hardware processors, cause the one or more hardware processors to perform a plurality of operations, the operations comprising: accessing reference information about a reference population of patients treated for pneumonia; utilizing a first machine-learning electronic model (MLEM) and the reference information to select a first plurality of features for inclusion in a potential feature pool, wherein the utilizing of the first MLEM and the reference information comprises:(a) determining reference features within the reference information;(b) determining permuted versions of the reference features;(c) training the first MLEM on the reference features, and on the permuted versions of the reference features, to produce a trained first MLEM; and(d) identifying from the reference features a subset of features having a predictive contribution, to the trained first MLEM, that exceeds a threshold contribution, the subset of features being identified as the first plurality of features; utilizing a second MLEM, different from the first MLEM, to select a second plurality of features from the potential feature pool for predicting pneumonia readmission; receiving pre-discharge information for a patient during a clinical encounter of the patient for a patient condition associated with pneumonia; determining a particular set of features of the pre-discharge information for the patient based on the second plurality of features selected for predicting pneumonia readmission; applying one or more machine learning models to the particular set of features to generate a prediction of the patient being readmitted for pneumonia; and based on the prediction, indicative of whether the patient will be readmitted for pneumonia, and based further on a predicted probability of readmission associated with the prediction satisfying a threshold probability, initiating via the one or more hardware processors a set of intervening actions prior to discharge to reduce a likelihood of readmission, the set of intervening actions performed by automatically modifying computer code or data used at an executing healthcare software program for treating th e patient and/or discharging planning, thereby transforming the software program at runtime”.
The limitations of accessing reference information about a reference population of patients treated for pneumonia; select a first plurality of features for inclusion in a potential feature pool, wherein the utilizing of the first MLEM and the reference information comprises: (a) determining reference features within the reference information; (b) determining permuted versions of the reference features; and (d) identifying from the reference features a subset of features having a predictive contribution, that exceeds a threshold contribution, the subset of features being identified as the first plurality of features; select a second plurality of features from the potential feature pool for predicting pneumonia readmission; receiving pre-discharge information for a patient during a clinical encounter of the patient for a patient condition associated with pneumonia; determining a particular set of features of the pre-discharge information for the patient based on the second plurality of features selected for predicting pneumonia readmission; generate a prediction of the patient being readmitted for pneumonia; and based on the prediction, indicative of whether the patient will be readmitted for pneumonia, and based further on a predicted probability of readmission associated with the prediction satisfying a threshold probability, initiating a set of intervening actions prior to discharge to reduce a likelihood of readmission, the set of intervening actions performed for treating the patient and/or discharging planning, , given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of accessing, select, determining, identifying, predicting, receiving, generating, initiating, and treating, which is properly interpreted as a “personal behavior”), and/or cover the performance of a mental process that a doctor/nurse/physician/person would perform mentally or via pen and paper, but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Further, the abstract idea of claims 12 and 18 are identical as the abstract idea of claim 1. This limitation, given the broadest reasonable interpretation, also falls under the abstract idea of a certain method of organizing human activity because it recites managing personal behavior or relationships or interactions between people.
Step 2A—Prong 2:
Independent claims 1, 12, and 18 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) do not meet the criteria of MPEP 2106.04(d) (improvement to the function of a computer or technical field, particular treatment or prophylaxis, particular machine, etc.), and amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “non-transitory media”, “hardware processors”, “first machine learning model (MLEM)”, “second MLEM”, “machine learning models”, “computer code”, and “software program”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see FIG. 1, [0014]-[0015], and [0023], of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “One or more non-transitory media having computer-readable instructions that, when executed by one or more hardware processors, cause the one or more hardware processors to perform a plurality of operations, the operations comprising”, “utilizing a first machine-learning electronic model (MLEM) and the reference information to”, “(c) training the first MLEM on the reference features, and on the permuted versions of the reference features, to produce a trained first MLEM”, “to the trained first MLEM”, “ utilizing a second MLEM, different from the first MLEM, to”, “applying one or more machine learning models to the particular set of features to”, “via the one or more hardware processors”, “by automatically modifying computer code or data used at an executing healthcare software program”, and “thereby transforming the software program at runtime”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “accessing reference information about a reference population of patients treated for pneumonia” and “receiving pre-discharge information for a patient during a clinical encounter of the patient for a patient condition associated with pneumonia”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Step 2B:
The claims do not include additional elements (i.e., “non-transitory media”, “hardware processors”, “first machine learning model (MLEM)”, “second MLEM”, “machine learning models”, “computer code”, and “software program”) that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “accessing reference information about a reference population of patients treated for pneumonia” and “receiving pre-discharge information for a patient during a clinical encounter of the patient for a patient condition associated with pneumonia”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Dependent Claims Analysis:
Dependent claims 2-5, 7-11, 13-14, 16-17, 19, and 22-25 include other limitations, as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 12, and 18. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Additionally, dependent claims 2-5, 7-11, 13-14, 16-17, 19, and 22-25 include other limitations (for example claim 22 recites the additional elements of “linear models”), the limitations recited by these claims do not meet the criteria of MPEP 2106.04(d), which is similar to what is recited in independent claims 1, 12, and 18, and hence also do not integrate the aforementioned abstract idea into a practical application.
Dependent claims 2-5, 7-11, 13-14, 16-17, 19, and 22-25 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 12, and 18, and hence do not amount to “significantly more” than the abstract idea.
Therefore, whether taken individually or as an ordered combination, claims 1-5, 7-14, 16-19, and 22-25 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 08/10/2026 have been fully considered but they are not persuasive. Regarding the 35 U.S.C. 112(a) Rejection, Applicant’s amendments have overcome the new matter rejection and, therefore, the rejection is withdrawn.
Regarding the 35 U.S.C. 101 Rejection, Applicant argues the amendments include limitations that were granted in the parent application. Examiner respectfully disagrees. To qualify as eligible under a particular treatment or prophylaxis, MPEP 2106.04(d)(2), states “Examiners should keep in mind that in order to qualify as a “treatment” or “prophylaxis” limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of “administering amazonic acid to a patient” or a step of “administering a course of plasmapheresis to a patient.” If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration. For example, a step of “prescribing a topical steroid to a patient with eczema” is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a “pharmaceutical composition” or that a “feed dispenser is operable to dispense a mineral supplement” are not affirmative limitations because they are merely indicating how the claimed invention might be used”.
Applicant argues the claims do not recite an abstract idea because the claims do not recite a human or recite limitations that are not performed by a human. Examiner respectfully disagrees. The highlighted limitations in Applicant’s arguments (Remarks, page 13), are identified as additional elements (i.e., machine learning models, processors, computer code, etc.), which is being applied to the abstract idea (see MPEP 2106.05(f) states “The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015)”, “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer” does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015)” and “TLI Communications provides an example of a claim invoking computers and other machinery merely as a tool to perform an existing process. The court stated that the claims describe steps of recording, administration and archiving of digital images, and found them to be directed to the abstract idea of classifying and storing digital images in an organized manner. 823 F.3d at 612, 118 USPQ2d at 1747”). The claims do not have recite actively recite a human, however a person is capable of performing the steps (i.e., determining, selecting, modifying, identifying, generating, initiating, etc.) shown above. Therefore, the claims still recite an abstract idea of a certain method of organizing human activity.
Applicant argues the claims recite an improvement in the technology, more specifically a “machine specific sequence” that improves the operation of the predictive system, restricting the prediction to pre-discharge information, and automatically upon threshold satisfaction, modify computer code or data used at an executing healthcare software program, thereby transforming the software program at runtime”. Examiner respectfully disagrees. The improvement identified in Applicant’s arguments are an improvement to the abstract idea, which is then applied to model or system (e.g., the additional elements). MPEP 2106.05(f) states “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer” does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015)”. Furthermore, even if it wasn’t part of the abstract idea, the claims do not reflect a transformation, see MPEP 2106.05(c) states “An “article” includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. “Transformation” of an article means that the “article” has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Purely mental processes in which thoughts or human based actions are “changed” are not considered an eligible transformation. For data, mere “manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’” has not been deemed a transformation. CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360, 31 USPQ2d 1754, 1755, 1759 (Fed. Cir. 1994))” and provides five relevant factors to analyze when “transformation” is recited in a claim .
Applicant argues under Berkheimer that any assertion that the claimed combination is well-understood, routine, and conventional requires evidentiary support. While evidentiary support is necessary under Berkheimer, Examiner respectfully disagrees that the claimed combination is not well-understood, routine, and conventional and has included evidentiary support within the Office Action. The mailed Office Action contains citations under Step 2B to the MPEP and other court cases to show support as to why the claims are well-understood, routine, and conventional. Furthermore, MPEP 2106.05 states “Specifically, lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101) and patentability over the art (under 35 U.S.C. 102 and/or 103) is further discussed in MPEP § 2106.05(d)”. Additionally, the “severity metrics” are only recited in dependent claims 4, 10, 16, and 22 and a part of the abstract idea. Claim 4 recites “the second plurality of features comprises… a severity metric”, claims 10 and 16 recite “combining the potential categorical features, the potential continuous features, and one or more severity metrics to create”, claim 22 recites “determining one or more severity metrics for the patient using at least some of the pre-discharge information” and “applying… to the pre-discharge information and the one or more severity metrics… wherein applying the ensemble facilitates generation of the prediction”. Therefore, the severity metric is not a part of the additional elements that would be analyzed in Step 2B, which evaluates additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. Therefore, the 35 U.S.C. 101 Rejection is maintained.
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.
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/R.S.S./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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