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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Notice to Applicant
The Examiner is not making a priority determination per MPEP 211. However, the Examiner notes that the instant Specification is 34 pages and the provisional specification, application 63/008,982, is 15 pages.
Response to Amendment
In the Amendment dated 10/3/2025, the following has occurred: Claims 1, 3, 4, 8, 9, 11 – 14, 18, and 19 have been amended
Claims 1 – 20 are pending.
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 11 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims include “a memory storing instructions that…” Paragraph 121 includes, “electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory.” This description includes transitory memory including carrier waves.
Claims 1 – 20 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.
The claim(s) recite(s) subject matter within a statutory category as a process (claims 1 – 10), machine (claims 11 – 20) which recite steps of
receiving, from one or more different data sources, data related to a large plurality of patients;
performing, for each patient of the large plurality of patients, linkage of patient health record across the one or more data sources in a privacy preserving manner to generate patient information for the patient; and
for at least a selected patient of the large plurality of patients:
generating, based on patient information for the selected patient using one or more statistical models, a high-cost status, a phenotype, and a persistence property of the selected patient, wherein the persistence property is one or both of a persistently high cost or a persistently high utilization; and
applying, to an algorithm, the high-cost status, the phenotype, and the persistence property to determine at least one risk score for the selected patient;
mapping the phenotype to at least one action category for the selected patient;
outputting the at least one action category and one or more of the high-cost status, the phenotype, the persistence property, or the at least one risk score for the selected patient to a physician, a nurse, one or more care providers, one or more care managers, or a combination thereof; and
treating, by the physician, the nurse, the one or more care providers, the one or more care managers, or a combination thereof, a medical condition of the selected patient based on at least one intervention selected from the at least one action category for the selected patient.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the computer implemented language, extracting in the context of this claim encompasses a mental process of the user. Similarly, the limitation of generating, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the machine learning language, determine at least one risk in the context of this claim encompasses a mental process of the user. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
It should be emphasized here that the invention is a mental process applied to technology. Therefore, the invention achieves all the benefits of applying the abstract idea to technology.
The Applicant has amended the claims to include “treating, by the physician…” however, the Specification does not limit what “treating” must be. Therefore, the Examiner understands that treating includes writing a prescription. That prescription allows for a mental process with the aide of a pencil and paper.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The Examiner understands the claimed invention in light of the Specification. That is, the Applicant describes what they believe that they have invented by the disclosure. The Specification states:
TECHNICAL FIELD
[0002] The subject matter described herein relates to a devices, methods, and systems for identifying and classifying patient populations into actionable phenotypes. This patient classification system has particular but not exclusive utility for improving the quality and reducing the costs of medical care.
It is the Specification that describes the invention as concepts of or methods of organizing human activity. The Specification does not disclose a technological improvement. The result of the invention is better data. There is no practical application of that data.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 2 – 10 and 12 – 20, reciting particular aspects of how determining a risk score may be performed in the mind but for recitation of generic computer components).
This 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 recitation of a computer implemented method amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of extracting from one or more data structures amounts to mere data gathering, the recitation outputting or treating are considered extra-solution activity; see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10 and 12 – 20, additional limitations which amount to invoking computers as a tool to perform the abstract idea). 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.
The claim(s) does/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, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 20; performing for each of the large plurality of patients… applying, to a machine learning model… to determine, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)))
Additional elements:
data structures/ memory – paragraph 119 – 121
(EHR) – paragraph 98
a machine learning model – paragraph 112
training – paragraphs 112 and 113
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10 and 12 – 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)). 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.
Response to Arguments
Applicant’s arguments, see Objections to Claims 2 and 12, filed 10/3/2025, with respect to the objections(s) of claim(s) 2 and 12 have been fully considered and are persuasive. Therefore, the objections to claims 2 and 12 has been withdrawn.
Applicant’s arguments, see Rejections of Claim 1-20 Under 35 U.S.C. § 112, filed 10/3/2025, with respect to the rejection(s) of claim(s) 1 – 20 have been fully considered and are persuasive. Therefore, the rejection of claims 1 – 20 under 35 U.S.C. § 112 has been withdrawn.
Applicant's arguments filed 10/3/2025 have been fully considered but they are not persuasive.
Rejections of Claims 1-20 Under 35 U.S.C. § 101
The Applicant states, “Without agreeing with the Office's assertion and assuming, arguendo, that the amended claims recite the abstract ideas of mental processes (Step 2A, Prong I), the amended claims integrate the alleged abstract ideas into a practical application that improves electronic health record (EHR) technology and the technical fields of healthcare informatics and predictive modeling for patient classification.” The closets the Specification describes this is in paragraph 46 where the paragraph ends with,
This improved classification system transforms an EHR containing discrete medical information into one that also contains an actionable classification of the patient and their care needs, without the normally routine need to question the patient. In some cases, this may involve analyzing or processing large amounts of data from diverse sources in real time or near real time. This unconventional approach improves the functioning of the EHR system, by improving its information content without adding undue burden to care providers.
Here the Specification here states that it “improves the functioning of the EHR system, by improving its information content…” Therefore, the Examiner understands that better information content has a special definition of improving the functioning of the EHR. On a more generic level, this is similar to stating that a database operates better because it stores better data. That is different from stating the EHR / database perform better because the EHR/ database are reprogrammed to overcome a technical or technological problem.
The Applicant further states, “According to the present invention, generating a phenotype and at least one risk score for a patient and mapping the phenotype to one or more clinically meaningful action categories having one or more interventions provides healthcare providers with means for identifying and targeting appropriate interventions, thereby improving treatment and patient health outcomes. This is the same as by applying the abstract idea to technology, that abstract idea produces better results because the abstract idea is applied to technology. Further, the Applicant’s statements shows how the invention organizes the care providers activities.
The Applicant states, “Associated advantages and benefits described in the Specification include, for example, "supplying this information to care providers and/or care coordinators may reduce unnecessary or preventable utilization of care services, and thus reduce costs " and "categorizing patients into actionable, non-exclusive groups will help to understand their characteristics and align appropriate interventions that fit patients' needs to reduce unnecessary health care spending. "” Therefore, the invention’s purpose is to improve the process of organizing human activity.
The Applicant states, “Thus, the generation and subsequent provision of the phenotype and the action categories, and interventions thereof, enable treatment of the patient in a manner that is more aligned with the patient's needs and that reduces health care spending.” However, it is not clear that improving the organization of data (i.e. Alice), is a technological improvement.
The Applicant states, “Accordingly, amended claim 1 recites additional elements that amount to a practical application of the alleged abstract ideas under Step 2A, Prong II of the 2-step inquiry as per MPEP 2106.04(d)(l).” The Examiner disagrees with the Applicant’s opinion. No practical application exists. Only a potential application occurs. Users are instructed (treatments) to perform actions that may or may not be completed.
The Office Action is Incomplete
The Applicant states, “Further, per MPEP 2106, "Regardless of whether a rejection under 35 U.S.C. 101 is made, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101."” The Examiner repeats, “a complete examination should be made…” First, the Applicant argues that a complete examination was not made without evidence. Second, the Applicant argues that “should” is best interpreted as “must” or “shall.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Narayan et al. Pub. No.: US 2021/0236053 A system and method for identifying and treating a disease in a patient collects one or more data streams from sensors configured to detect biological signals generated within a patient's tissue over time.
Boucher et al Pub. No.: US 2013/0074842 The present invention concerns methods, compositions and apparatus for administering active agents to the lungs of a subject.
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 Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626