DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on September 16, 2025. Claims 1, 9, and 16 have been amended. Claims 1-2, 5-10, and 12-19 have been examined and are currently pending.
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 .
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-2, 5-10, and 12-19 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 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: How are the plurality of possible interventions at specific time horizons generated? How are the plurality of possible interventions at specific time horizons based on a propensity score?
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, 5-10, and 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
ALICE/ MAYO: TWO-PART ANALYSIS
2A. First, a determination whether the claim is directed to a judicial exception (i.e., abstract idea).
Prong 1: A determination whether the claim recites a judicial exception (i.e., abstract idea).
Groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Mathematical concepts- mathematical relationships, mathematical formulas or equations, mathematical calculations.
Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Mental processes- concepts performed in the human mind (including an observation, evaluation, judgement, opinion).
Prong 2: A determination whether the judicial exception (i.e., abstract idea) is integrated into a practical application.
Considerations indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Considerations that are not indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
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.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
2B. Second, a determination whether the claim provides an inventive concept (i.e., Whether the claim(s) include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
Considerations indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception NOTE: The only consideration that does not overlap with the considerations indicative of integration into a practical application associated with step 2A: Prong 2.
Considerations that are not indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
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.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. NOTE: The only consideration that does not overlap with the considerations that are not indicative of integration into a practical application associated with step 2A: Prong 2.
See also, 2019 Revised Patent Subject Matter Eligibility Guidance; Federal Register; Vol. 84, No. 4; Monday, January 7, 2019
Claims 1-2, 5-10, and 12-19 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.
1: Statutory Category
Applicant’s claimed invention, as described in independent claim 1 is directed to a method, independent claim 9 is directed to a system, and independent claim 16 is directed to a non-transitory computer readable medium.
2(A): The claim(s) are directed to a judicial exception (i.e., an abstract idea).
PRONG 1: The claim(s) recite a judicial exception (i.e., an abstract idea).
Mathematical Concepts
Independent claims 1, 9, and 16 recite the limitation, “determining a plurality of patient profiles appropriate for a plurality of possible interventions at a specific time horizons based on a propensity score, wherein weighing of intervention effectiveness for the plurality of possible interventions a patient profile of the plurality of patient profiles is determined as a function of the propensity score;”. The limitation recited above for independent claims 1, 9, and 16 is directed to the abstract idea of mathematical concepts (under mathematical relationships, mathematical calculations, and mathematical formulas). Specifically, the limitation is directed to using mathematical concepts (e.g., mathematical relationships, mathematical calculations, and mathematical formulas) to identify patient profiles with a corresponding one or more interventions with specific time periods/ranges based on computed a propensity score and determining effectiveness of intervention based on propensity score.
Mental Processes
Independent claims 1, 9, and 16 recite the limitations, “determining a plurality of patient profiles appropriate for a plurality of possible interventions at a specific time horizons based on a propensity score, wherein weighing of intervention effectiveness for the plurality of possible interventions a patient profile of the plurality of patient profiles is determined as a function of the propensity score; filtering the plurality of possible interventions based on the plurality of patient profiles to select a most effective intervention of the plurality of possible intervention as the intervention recommendation.” The limitations recited above associated with independent claims 1, 9, and 16 are directed to the abstract idea of mental processes. The limitations can be performed by a human through observation, evaluation, and judgment. In particular, a user/human can determine a plurality of patient profiles for possible interventions at specific time periods/ranges based on a propensity scores, identify intervention effectiveness based on propensity score, and filter possible interventions based on patient profiles to select the most effective intervention. These steps can be performed by a human through evaluation and judgment of information (e.g., readmission risks, patient profiles, and interventions) to determine or select the best outcome (e.g., intervention for a patient).
Additionally, under step 2A of “integration into a practical application” requires:
• Improvement to the functioning of a computer, or an improvement to any other technology or technical field
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
• Applying the judicial exception with, or by use of a particular machine.
• Effecting a transformation or reduction of a particular article to a different state or thing
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
The applicant has not shown or demonstrated any of the requirements described above under "integration into a practical application" under step 2A. Specifically, the applicant's limitations are not "integrated into a practical application" because they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). Additionally, improvements to the functioning of a computer or any other technology or technical field has not been shown or disclosed (see MPEP 2106.05(a)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the applicant’s limitations are not “significantly more” because they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). The current application does not amount to 'significantly more' than the abstract idea as described above. The claim does not include additional elements or limitations individually or in combination that are sufficient to amount to significantly more than the judicial exception. Specifically, the individual elements of a readmission risk analysis system, processor, user interface, one or more processors, and non-transitory computer readable medium add no more than implementing an idea with a computerized system and they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea and adding insignificant extra solution activity to the judicial exception. The additional elements taken in combination add nothing more than what is present when the elements are considered individually. Therefore, based on the two-part Alice Corp. analysis, there are no meaningful limitations in the claims that transform the exception (i.e., abstract idea) into a patent eligible application.
Dependent claims 2, 5-8, 10, 12-15, and 17-19 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
determining a plurality of patient profiles appropriate for a plurality of possible interventions at specific time horizons based on a propensity score, wherein weighing of intervention effectiveness for a patient profile of the plurality of patient profiles is determined as a function of the propensity score,
Response to Arguments
Applicant's arguments filed September 16, 2025 have been fully considered but they are not persuasive.
A. According to applicant’s arguments on pages 11-12 of the remarks disclose, “Under the first prong of step 2A, the Office Action asserts that the limitations related to the generation of the intervention recommendation in claim 1 constitute (3) a mental process. As explained in the MPEP, “claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind.” MPEP § 2106.04(a)(2)(III). Emphasis added… Claim 1 recites “generating, by the trained readmission risk model, an intervention recommendation based on either the initial readmission risk or on the updated readmission risk for one or more of the plurality of different future time periods” (emphasis added). Similar to SRI Int’l, Inc., the human mind is not equipped to generate an intervention recommendation using a readmission risk model trained on historical patient data. Applicant also respectfully points to the recent USPTO Memorandum “Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101” dated August 4, 2025 (accessible at: https://www.uspto.gov/sites/default/files/documents/memo-101-20250804.pdf), Section IT A. As indicated in this section of the recent USPTO Memorandum: The mental process grouping is not without limits. Examiners are reminded not to expand this grouping in a manner that encompasses claim limitations that cannot practically be performed in the human mind. The MPEP and the AI-SME Update provide examples of claim limitations that cannot be practically performed in the human mind.[] Claim limitations that encompass Al in a way that cannot be practically performed in the human mind do not fall within this grouping” (emphasis added). In further view of this recent USPTO Memorandum. Applicant respectfully requests that the Office reconsider their assertion that claim 1 falls with the mental process grouping.” The examiner respectfully disagrees.
Independent claims 1, 9, and 16 recite the limitations, “determining a plurality of patient profiles appropriate for a plurality of possible interventions at a specific time horizons based on a propensity score, wherein weighing of intervention effectiveness for the plurality of possible interventions a patient profile of the plurality of patient profiles is determined as a function of the propensity score; filtering the plurality of possible interventions based on the plurality of patient profiles to select a most effective intervention of the plurality of possible intervention as the intervention recommendation.” The limitations recited above associated with independent claims 1, 9, and 16 are directed to the abstract idea of mental processes. The limitations can be performed by a human through observation, evaluation, and judgment. In particular, a user/human can determine a plurality of patient profiles for possible interventions at specific time periods/ranges based on a propensity scores, identify intervention effectiveness based on propensity score, and filter possible interventions based on patient profiles to select the most effective intervention. These steps can be performed by a human through evaluation and judgment of information (e.g., readmission risks, patient profiles, and interventions) to determine or select the best outcome (e.g., intervention for a patient).
The examiner notes the independent claims recite a trained readmission risk model to perform initial steps of the invention with regards to generating an initial readmission risk or updating readmission risk. However, the claim limitations associated with determining a plurality of patient profiles for a plurality of possible interventions at specific periods of time/ranges based on a propensity score and filtering the corresponding interventions based on the patient profiles are limitations that can be performed by a human through observation, evaluation, and judgment of data. Specifically, a human can analyze the data with respect to patient profiles, interventions with specific times periods, and propensity scores to select effective intervention options/recommendations.
B. According to applicant’s arguments on page 13 of the remarks discloses, “Similarly, claim 1 does not recite a mathematical concept, but rather is only based on or involves a mathematical concept. That is, claim 1 does not merely recite “determining a plurality of patient profiles appropriate for a plurality of possible interventions at specific time horizons based on a propensity score” but rather uses such determination of the propensity score in a particular method for determining an intervention recommendation (most effective intervention) for a patient.” The examiner respectfully disagrees.
Independent claims 1, 9, and 16 recite the limitation, “determining a plurality of patient profiles appropriate for a plurality of possible interventions at a specific time horizons based on a propensity score, wherein weighing of intervention effectiveness for the plurality of possible interventions a patient profile of the plurality of patient profiles is determined as a function of the propensity score;”. The limitation recited above for independent claims 1, 9, and 16 is directed to the abstract idea of mathematical concepts (under mathematical relationships, mathematical calculations, and mathematical formulas). Specifically, the limitation is directed to using mathematical concepts (e.g., mathematical relationships, mathematical calculations, and mathematical formulas) to identify patient profiles with a corresponding one or more interventions with specific time periods/ranges based on computed a propensity score and determining effectiveness of intervention based on propensity score.
C. According to applicant’s arguments on page 14 of the remarks discloses, “Indeed, the claimed invention improves the technical field of clinical operations. In particular, the claimed invention provides a patient readmission risk analysis system that provided a particular solution for an improved determination of a patient’s readmission risk As described in the in paragraph [0082] of the Specification: According to an embodiment, the patient readmission risk analysis system is configured to process many thousands or millions of datapoints in the input data used to train the classifier, as well as to process and analyze the received plurality of patient features. For example, generating a functional and skilled trained classifier using an automated process such as feature identification and extraction and subsequent training requires processing of millions of datapoints from input data and the generated features. This can require millions or billions of calculations to generate a novel trained classifier from those millions of datapoints and millions or billions of calculations. As a result, each trained classifier is novel and distinct based on the input data and parameters of the machine learning algorithm, and thus improves the functioning of the patient readmission risk analysis system. Thus, generating a functional and skilled trained classifier comprises a process with a volume of calculation and analysis that a human brain cannot accomplish in a lifetime, or multiple lifetimes. Further, as described another embodiment in paragraph [0083] of the Specification: By providing an improved patient readmission risk analysis, this novel patient readmission risk analysis system has an enormous positive effect on patient readmission risk analysis compared to prior art systems. As just one example in a clinical setting, by providing a system that can improve patient readmission risk analysis with confidence intervals, the system can facilitate treatment decisions and improve survival outcomes, thereby leading to saved lives.” The examiner respectfully disagrees.
Under the 2019 Revised Patent Subject Matter Eligibility Guidance, determining whether a claim integrates a judicial exception into a practical application, examiners should consider whether the claimed invention pertains to an improvement in the functioning of the computer itself or any other technology or technical field. Additionally, making this determination, examiners should determine whether there is a technical explanation as to how to implement the invention in the specification and the claim itself reflects the improvement in technology. The recited claims do not recite and reflect an improvement in the technology or technical field as required in the 2019 Revised Patent Subject Matter Eligibility. Specifically, the applicant cites improvements such as clinical operations, determination of a patient’s readmission risk and functioning of the patient’s readmission risk analysis system. These features are not recited within the body of independent claims 1, 9, and 16. The examiner notes the specification and claims do not provide a technical explanation as to how the invention/computer, technical field, or other technology is improved with regards to improving clinical operations, determination of a patient’s readmission risk and functioning of the patient’s readmission risk analysis system. Additionally, the applicant’s arguments are geared towards to intended end result of the readmission risk invention, but not how the improvement is performed or implemented. The examiner notes the implementation or use of machine learning or a classifier does not automatically describe an improvement in the computer itself, technology, or technical field.
D. According to applicant’s arguments on page 15 of the remarks discloses, “In step 2B, even if a claim is directed to an abstract idea under step 2A, the claim is still subject matter eligibility if it amount to “significantly more” than the abstract idea. As explained in MPEP §2106.05, a claim constitutes “significantly more” if the additional limitations of the claim contribute an inventive concept. For example, if the additional limitations recite a specific limitation other than what is well-understood, routine, conventional activity in the technical field The additional limitations of claim 1 indeed contributes an inventive concept that improves the field of clinical operations. As described above, the claimed invention includes patient readmission risk analysis system of claim 9 that applies a particular method for determination of a patient’s readmission risk, which includes use of a trained machine-learning classifier, that is not well-understood, routine, conventional activity in the technical field.” The examiner respectfully disagrees.
2(B): The claims do not provide an inventive concept (i.e., The claim(s) do not include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)). As discussed with respect to Step 2A Prong Two, the additional element(s) in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Objections to claims 1 and 16 have been withdrawn.
Claims 1-2, 5-10, and 12-19 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 have been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Erdmann et al. US Publication 20160188834 A1 Determination of Patient-Appropriate Post-Acute Care Settings
Erdmann discloses “Turning now to FIG. 5, a continuation of the method 400 is depicted as the method 500. When the patient's propensity score falls between the maximum and minimum propensity scores for the first PAC setting, then, at a step 510, a readmission risk score is generated for the patient. This may be carried out by a readmission risk component such as the readmission risk component 222 of FIG. 2. In aspects, known algorithms are utilized to determine the patient's readmission risk score. The score reflects the likelihood that the patient will be readmitted to an acute care facility within, for instance, 30 days of discharge and is based on an evaluation of the patient's current medical status.” (paragraph 0053) and “At a step 310, a set of propensity scores is determined for the patient by, for instance, a propensity score generator such as the propensity score generator 220 of FIG. 2. Each propensity score in the set corresponds to a particular PAC setting such as, for example, home, home health, skilled nursing facility, inpatient rehabilitation facility, long-term acute care facility, and the like. The scores are generated by performing logistic regression on a defined set of healthcare variables associated with the patient and stored in the patient's EMR. The healthcare variables include current variables as well as historical healthcare variables and comprise demographic information, social factors, medications, labs results, procedure results, medical conditions, information from physical exams and assessments, and the like. Depending on the PAC setting, variables within the set are assigned a weight reflecting their importance to the particular PAC setting.” (paragraph 0049).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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, Marc Jimenez can be reached at (571)272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3681