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.
Response to Amendment
In the Amendment dated 6/22/2026, the following has occurred: Claims 1 – 14 and 16 – 22 have been amended.
Claims 23 and 24 have been previously canceled.
Claims 1 – 22 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 1 – 22 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 claims, as a whole, recites subject matter within a statutory category as a process (claims 1 – 17 and 22 – 24), machine (claims 18 – 21) which recite abstract idea steps of
receiving a record comprising associated with an individual, the record comprising a plurality of fields including
prescription-based data, claims-based data, a diagnosis of Type 2 diabetes, an identification of the prescribed diabetes medication associated with the individual that treats Type 2 diabetes, and a current dosage amount or dosage frequency of the prescribed diabetes medication;
receiving historical data associated with the individual, the historical data including one or more of a plurality of blood-glucose measurements and a plurality of hemoglobin Ale measurements recorded over time for the individual;
generating, based on at least a portion of the record and at least a portion of the historical data, a feature associated with the individual;
determining, based on the plurality of blood-glucose measurements, hemoglobin Alc measurements, or both, that the Type 2 diabetes is controlled according to a predetermined glycemic-control criterion;
processing, using an algorithm, at least the feature associated with the individual to generate a diabetes medication titration instruction, wherein the diabetes medication titration instruction reduces the current dosage amount or dosage frequency of the prescribed diabetes medication while maintaining treatment of the Type 2 diabetes according to the predetermined glycemic-control criterion;
updating the record to store the diabetes medication titration instruction as an updated dosage regimen for the prescribed diabetes medication;
generating a message comprising the updated dosage regimen and an instruction to administer the prescribed diabetes medication according to the updated dosage regime; and
outputting the message.
These steps of claims 1 – 22, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. It should be understood that the Examiner is following the guidance of 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People
The term “certain” qualifies the “certain methods of organizing human activity” grouping as a reminder of several important points. First, not all methods of organizing human activity are abstract ideas (e.g., “a defined set of steps for combining particular ingredients to create a drug formulation” is not a certain "method of organizing human activity”), In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). Second, this grouping is limited to activity that falls within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people, and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances as explained in MPEP § 2106.04(a)(3). Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings.
The claims as a whole are understood in light of the Specification. The Specification describes the claimed invention.
FIELD OF THE DISCLOSURE
[0002] The disclosure relates to systems and methods for monitoring and treatment of chronic diseases (e.g., Type 2 diabetes) of a patient using nutritional therapy, healthcare provider and artificial intelligence (Al) based coaching, patient self-management, lifestyle management, and medication alteration (e.g., deprescription).
BACKGROUND
[0003] In healthcare, people with chronic conditions are hospitalized more frequently than those without. Techniques for treating patients having a chronic disease (e.g., Type 2 diabetes) are desired.
The Specification describes “improvement” only in the context of medical care. For example, this is the second paragraph of the Detailed Description.
[0038] While various examples of treating a medical condition (e.g., reversing the medical condition, reversing the progression of the medical condition) of a member will be described in connection with a member having diabetes (e.g., Type 1 diabetes, Type 2 diabetes, diabetes in pregnancy, etc.), it should be appreciated that the disclosure is not so limited. For instance, it is contemplated that examples of the present disclosure can be applied to treating (e.g., reversing) medical conditions of many different types. In other words, the framework described herein for reversing a medical condition can be leveraged to support management opportunities for any type or number of different medical conditions. Examples of such medical conditions that can be addressed or improved (e.g., reversed) with the framework described herein include, without limitation, prediabetes, cardiac conditions, heightened cholesterol, heightened blood pressure, hypertension, post-operative conditions, pre-operative conditions, cancer and other chronic conditions, infertility, chronic pain, broken bones, torn ligaments, torn muscles, etc. The terms "member", "patient", "user", and "individual" may be used interchangeably herein.
The invention is understood to be directed toward providing user instructions.
It should be understood that the invention result of the invention is data that has a potential application. The potential data application represents information presented to a user, stored in a database, or outputted to printed matter that may never be acted upon. Further, the invention is performed by applying the abstract idea to technology to achieve all the benefits of applying the abstract idea to technology. The invention is not described as a technical or technological improvement to overcome a technological problem.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 17, and 19 – 21, reciting particular aspects of how changing a plan may be performed but for recitation of generic computer components).
The claims also include generalized treatments such as titration. This is different from MPEP 2106.04(d)(2) Particular Treatment and Prophylaxis in Step 2A Prong Two
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.
The Applicant could claim a specific “disease or medical condition” that the treatment is designed for although this is currently not done. Regardless, the treatments described are generic and at a high level. For example, claim 12 recites:
comprises a drug titration of the prescribed drug, wherein the drug titration includes reducing an altered dosage amount to zero when the individual is not dependent on a minimum dosage of the prescribed drug
In this claim, the claimed treatment is “a drug” and not a specific (particular) drug. Therefore, there is no particular treatment for a disease or medical condition.
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 enable the processor to 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 receive data amounts to mere data gathering, recitation of update the electronic record amounts to insignificant application, 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 – 17, and 19 – 21, 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.
There are several important points regarding the dependent claims and the “machine learning.” The specification describes machine learning at a high level. This is explicitly stated in paragraphs 87 or 91
[0087] Non-limiting examples of the machine learning model(s) 184 include Decision Trees, gradient-boosted decision tree approaches (GBMs), Support Vector Machines (SVMs), Nearest Neighbor, and/or Bayesian classifiers, and neural-network-based approaches.
[0091] In some aspects, the machine learning model(s) 184 may include ensemble classification models (also referred to herein as ensemble methods) such as random forests. Random forest techniques may include independent training of each decision tree within a model, using a random sample of data. Random forest techniques may support, for example, medical diagnosis techniques described herein using weighting techniques with respect to different data sources.
The non-limiting nature of this list shows the high level of process. Further, the models themselves are used as a tool
[0041] Machine learning and deep learning-based approaches have built upon the abilities of clinicians to assess current complications and predict the future health conditions of a member. However, while some machine learning approaches may yield relatively high accuracy with respect to assessing and predicting the future health conditions of a member, clinical applications of these approaches have been scarce due to an inability of some systems to translate model findings to actionable treatment (e.g., for reversing a medical condition).
[0045] Approaches capable of offering tangible implementations to actionable member guidance and treatment (e.g., nutritional therapy, lifestyle adjustments, medication deprescription, etc.) are desired. For example, other approaches do not describe techniques inclusive of tapering of dosages to wean a patient off of medication (e.g., medication deprescription, decreasing dosage, etc.). Further, other approaches fail to consider claims data in evaluating a treatment plan. In addition, other approaches do not evaluate macronutrients and granular diet data.
The invention is not directed toward an improved machine learning model. But rather as a computer algorithm.
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 – 22; receiving…updating, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i))
The claimed invention, as a whole, is directed to providing information. That information has a potential application if a user acts upon the message. Even if that message is stored in a file, is displayed upon a screen, is printed upon paper, or is delivered through an alert, the contents of the message may never be interpreted by a user. Therefore, the invention provides a potential application and not a practical application.
The invention takes the abstract idea of patient care and applies it to technology to obtain all the benefits of applying the abstract idea to technology.
Additional Elements
electronic record – paragraph 65 electronic medical record (EMR) paragraph 66 device data
communications device – figure 1, #105 paragraphs 52 and 53 including communications interface, processor coupled with the communications interface and a memory coupled with the processor
machine learning model – paragraph 80 neural network paragraph 86 – 92 any number of formats or forms
training – paragraphs 18, 82, 83 dataset includes (generic data set) and figure 8 and paragraph 189 – 199 where the actual training process is not disclosed
network – paragraph 51 –The Internet is an example of the communication network
feature vector – paragraph 99 to filter or reduce the number of electronic records (e.g., feature vectors) –feature vectors are only described within the Specification as an electronic record
It should be emphasized at this point, the disclosure’s machine learning description and training description. The disclosure does not describe the required data set and the required training process. Examples are provided however, if the data set does not include required information then the relationship between the condition and the result may be missing. If the training is performed in a way that eliminates useful information than that training process results in an incomplete data. The entire machine learning process is described at a high level using functional terms. The current claim language matches the level of disclosure. It is the Examiner’s position that the invention uses the machine learning and training as an additional element applied to the abstract idea. The invention is not directed toward an improved machine learning model.
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 – 17, and 19 – 21, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). 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 filed 6/22/2026 have been fully considered but they are not persuasive.
Rejections Under 35 U.S.C. § 101
The Applicant states, “As amended, the independent claims are directed to treating Type 2 diabetes in an individual by controlling titration of a prescribed diabetes medication.” The Examiner, in view of the claim language, disagrees. The claim ends with,
transmitting the message to a communication device over a communication network in real time,
wherein the message includes the updated dosage regimen and an instruction to decrease a dosage amount or dosage frequency of the prescribed diabetes medication for treating the Type 2 diabetes.
The functional step of the limitation is “transmitting the message…” The wherein clause describes the intent of the message. However, the instant claim does not further claim the positively claimed step of controlling the device with the message. Therefore, the limitation does not perform the “controlling titration of a prescribed diabetes medication” but rather intends to control the titration. Any further arguments to the positively claimed step of “controlling” are considered moot.
The Applicant states, “The Office Action further asserts that the claimed invention is directed to an abstract idea without significantly more. Applicant respectfully disagrees, particularly in view of the amendments submitted herewith.” However, the Applicant later states within the same response, “For example, the application describes accessing data records of a patient, retrieving current medications, respective dosages, and historical biomarker data, analyzing current medications, respective dosages, and historical biomarker data, generating a recommendation including medication alteration based on the analysis, and transmitting a message including the recommendation to a communication device associated with a medical provider. See, e.g., Specification-as-filed at, for example, paragraphs [0155]-[0163].” Here, as noted above, the Applicant both confirms that the instant claims ends with “transmitting.” The Applicant further shows that the invention is directed towards a method of organizing human behavior related to “managing personal behavior or relationships or interactions between people.” 2106.04(a)(2)(II)(C)
The Applicant has applied the abstract idea to technology to obtain all the benefits of applying that abstract idea to technology.
Part 1: All pending claims are directed to one of the statutory categories of invention
Part 2A Prong One: The claims recite no judicial exceptions
The Applicant states, “The features of claim 1 do not recite a method of organizing human activity. They do not recite a fundamental economic practice, commercial or legal interaction, or managing personal behavior or relationships.” Please see above.
Part 2A Prong Two: The alleged "judicial exceptions" are integrated into a practical application
The Applicant states, “The claim recites a computer-implemented method for treating Type 2 diabetes in an individual by controlling titration of a prescribed diabetes medication.” As noted above, the claimed invention does not show this “controlling” feature.
The Applicant states, “Thus, the claim does not merely recite receiving information and displaying information. The claim applies the trained machine learning model to the feature vector associated with the individual to generate the diabetes medication titration … and the instruction to administer the prescribed diabetes medication according to the updated dosage regimen, and transmits the message to the communication device over the communication network in real time.” The Examiner agrees that the invention performs the abstract steps of reading in data, processing the read in data, and outputting the results of read in and processed data. Notice again here how the non-claimed “controlling” step is omitted within the argument.
The Applicant states, “The claim is also analogous to USPTO Example 42, in which the USPTO …” Example 42 describes a technological improvement that is absent from the instant disclosure. All further arguments towards a technological improvement are moot. The Specification does not provide proof of its existence.
Part 2B: The claims recite significantly more than any alleged abstract idea
The Applicant states, “The amended claims recite an ordered combination of features directed to a specific treatment-control workflow for Type 2 diabetes.” The “ordered combination” argument is related towards whether the invention shows a technological improvement within the ordered combination. As noted above, the Specification discloses no technological improvement.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wexler et al Pub. No.: US 2021/0383925 biomonitoring and personalized healthcare are disclosed herein
Pauley et al Pub. No.: US 2021/0104173 comprehensive and personalized approach to health and lifestyle coaching are described
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 at (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
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