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 .
DETAILED ACTION
Response to Amendment
The present Office Action is in response to the Request for Continued Examination dated 09/24/2025.
In the amendment dates 07/23/2024, the following occurred: Claims 1, 2, 5-16 and 18-61 have been amended.
Claims 1-61 are pending.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/24/2025 has been entered.
Claim Objections
Claims 16, 28 and 29 are objected to because they recite multiple abbreviations such as CHF, MI, ESRD, SPSL, HbA1c, SBP, LDL, CVD, HbAIc, BMI without their full form. The first occurrence of all acronyms or abbreviations should be written out for clarity, whether or not they may be considered well known. Appropriate corrections/clarification is required.
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 1-61 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.
Claims 1, 15 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a methods to provide predictions for a diabetic patient and a diabetes complications progression risk engine system, which are within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A1
Regarding claims 1, the limitation of receiving the target diabetic population dataset, the target diabetic population dataset comprising a series of baseline biological characteristics of a target diabetic population over a first time span; assigning parameter values based upon a user defined distribution of the baseline biological characteristics; receiving the diabetic patient’s medical information and values comprising clinical, biomedical, and demographic factor information; analyzing the target diabetic population dataset to generate a diabetes complications progression risk […], wherein: said diabetes complications progression risk […] uses diabetes duration as a time index to reflect a time dependency of a risk of complication events and mortality outcomes on diabetes and thereby predict the risk of complication events and mortality outcomes over a second time span that is greater than the first time span; said diabetes complications progression risk […] operates one or more inter-correlated risk equations used as predictors of one or more diabetes complications-related events or mortality of the diabetic patient; said diabetes complications progression risk […] receives new data collected based upon a new set of annual updated medical information and values collected from the diabetic patient; said diabetes complications progression risk […] adjusts the diabetes complication progression risk […] based upon new data collected using the new set of annual updated medical information and values collected from the diabetic patient; and said diabetes complications progression risk […] compares the diabetic patient’s medical information and values to the diabetic population database and predicts a risk of an occurrence of the one or more diabetes complications-related events based upon said parameter values and the comparison; and displaying the predicted risk of the occurrence of the one or more diabetes complications-related events and mortality, wherein the mortality is predicted using a mortality module and wherein the mortality module comprises two mortality equations comprising an all-cause mortality risk equation and a CVD Death risk equation to predict the occurrence of said mortality of the diabetic patient and regarding claim 15, the limitation of the diabetes complications progression risk […] comprises a diabetes complications-related events […], a risk factor […], and a mortality […]; each of the diabetes complications-related events […], the risk factor […], and the mortality […] predicts the risk of the occurrence of the one or more diabetes complications-related events, a progression of one or more risk factors, and an occurrence of mortality of the diabetic patient, respectively; the risk of the occurrence of the one or more diabetes complications-related events is predicted using at least eight risk equations through an iterative process by the diabetes complications-related events […]; the progression of the one or more risk factors is predicted through the iterative process by the risk factors […] comprising one or more risk factor equations; and the occurrence of the mortality of the diabetic patient is predicted through the iterative process by the mortality […] comprising two risk equations; and displaying the predicted risk of the occurrence of the one or more diabetes complications-related events and the predicted occurrence of the mortality, and regarding claim 16, the limitation of comprising eight risk equations comprising a stroke risk equation, a CHF risk equation, an MI risk equation, an angina risk equation, a revascularization surgery risk equation, an ESRD risk equation, a blindness risk equation and an SPSL risk equation to predict an occurrence of one or more diabetes-related events through an iterative process; comprising seven risk equations comprising an HbAlc risk equation, an SBP risk equation, an LDL risk equation, a weight risk equation, a severe hypoglycemia risk equation, a symptomatic hypoglycemia risk equation and a smoking risk equation to predict a progression of one or more risk factors through the iterative process; two mortality risk equations comprising an All-cause Mortality risk equation and a CVD Death risk equation to predict an occurrence of mortality of a patient through the iterative process; and wherein said diabetes complications progression risk […] calculates the predicted risk of the occurrence of the one or more diabetes complications-related events and the predicted occurrence of the mortality of the diabetic patient; as drafted, is a process that, under the broadest reasonable interpretation, covers a method organizing human activity as detailed below.
As drafted, these processes, under the broadest reasonable interpretation, covers a method organizing human activity but for the recitation of generic computer components. That is other than reciting (in claim 1) one or more processors, (in claim 15) one or more processors and a network (and in claim 16) at least one processor, at least one memory and a diabetes complications progression risk engine system, the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the one or more processors, a network, at least one processor, at least one memory and a diabetes complications progression risk engine system, the claims encompass a person or persons following a series of rules or instructions for predicting diabetes progression and mortality. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Note that the broadest reasonable interpretation of “a diabetes complications progression risk engine”, “a mortality module”, “a diabetes complications-related events module” and “a risk factor module” and in light of the disclosure, represent the creation of mathematical interrelationships between data. See Spec. Para. [0027], [0090], [0096]-[0161] and Fig. 2 describing the diabetes complications progression risk engine, the mortality module, the diabetes complications-related events module and the risk factor module as a mathematical concept that uses equations to provide predictions for a diabetic patient. Thus given the broadest reasonable interpretation, the Examiner interprets the diabetes complications progression risk engine, the mortality module, the diabetes complications-related events module and the risk factor module to be implemented using existing, known mathematical techniques. As such, the diabetes complications progression risk engine, the mortality module, the diabetes complications-related events module and the risk factor module are interpreted to be part of the identified abstract idea, supra. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional element of one or more processors. Claim 15 recites the additional elements of one or more processors and a network. Claim 16 recites the additional element of at least one processor, at least one memory and a diabetes complications progression risk engine system. These additional elements are not exclusively defined by the Applicant and are recited at a high-level of generality (i.e., generic computer components for performing generic computer functions. See Spec at para. [0058] and [0086]) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 15 and 16 further recite the additional element of a display interface. This additional element is recited at a high level of generality (i.e. a general means to output/ display data) and amounts to extra solution activity. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Claims 1, 15 and 16 further recite the additional elements of the diabetes complications progression risk engine, the mortality module, the diabetes complications-related events module and the risk factor module, that represent a mathematical concept as described in the specification. This mathematical concept is applied to (“apply it’) the abstract idea. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of one or more processors, network, at least one processor, at least one memory and diabetes complications progression risk engine system to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of the display interface was considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional activity in the field. Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of the diabetes complications progression risk engine, the mortality module, the diabetes complications-related events module and the risk factor module were determined to be the application of mathematical formulas to the identified abstract idea. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(1)(A) indicates that merely saying “apply it’ or equivalent to the abstract idea cannot provide an inventive concept (“significantly more’). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-14 and 17-61 are similarly rejected because they either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Dependent claims 2 and 17 further define risk factors. Dependent claim 3 further defines risk equations. Dependent claim 4 further defines individual’s medical information. Dependent claims 5-14 and 18-27 further define diabetes complication-related events. Dependent claims 28-61 further define the risk equations.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-61, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Applicant respectfully submits that the independent claims, at least as amended, do not recite methods of "organizing human activity," much less the "certain" methods of organizing human activity that can properly be characterized as abstract ideas.
Regarding 1, the Examiner respectfully disagrees. The claims limitation follow rules or instructions for predicting and displaying data to diabetes prediction. The claim recites the abstract idea of receiving target diabetes population dataset, assigning parameters, receiving medical information and values, analyzing the target diabetes population dataset and displaying a predicted risk. Under the broadest reasonable interpretation, this covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. The Examiner submits that performing something by hand and specific recitation of human interaction is not required for a claim to be properly characterized as a Method of Organizing Human Activity. For example, neither identified abstract idea in Electric Power Group, LLC. v. Alstom, S.A. nor TLI Communications LLC. v. AV Automotive, L.L.C., both of which were indicated by the USPTO to be Methods of Organizing Human Activity, described steps/actions that were performed by a human.
… Even if the amended independent claims recite an abstract idea (which Applicant does not concede), the amended claims would be patent-eligible at least by virtue of integrating the alleged abstract idea into a practical application. As stated in section 2106.04(d) of the MPEP, a claim integrates a judicial exception into a practical application if the claims "appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception."… As amended, each of the independent claims improves the technical field of population dataset-based modeling at least by reciting that the "diabetes complications progression risk engine uses diabetes duration as a time index to estimate a time dependency of diabetes on events and mortality'… this feature enables the recited invention to more efficiently leverage a target diabetic population dataset to provide accurate predictions for a diabetic patient over an extended time window. Applicant's specification states that an object of the disclosed invention "is to provide a novel approach to using clinical trials with a limited length of follow-up time", with a goal being to "provide[] more accurate predictions over a range of long-term outcomes as opposed to other current models." For example, existing models that index parameters according to length of participation in a particular clinical trial can suffer poor accuracy if the trial was not conducted over a very long window of time (e.g., decades). The alternative for such models (i.e., simply extending the clinical trial to cover the longer time window), of course, has the severe drawback of requiring many years to generate the models… Because the independent claims recite an invention that improves the technical field of population dataset-based modeling, the claims at a minimum integrate any alleged abstract idea into a practical application.
Regarding 2, the Examiner respectfully disagrees. The invention aims to provide accurate predictions over an extended time window. Predicting data is an abstract idea and providing a more accurate prediction is an improvement to the abstract idea. There is no technical problem/solution in the claims. Moreover, the problem/solution the Applicant addresses are administrative/healthcare problems and are not routed in computer technology. The additional elements recited in the claims are not exclusively defined by the Applicant and are recited at a high-level of generality. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Martin (US 2004/0023947) discloses azepinoindole and pyridoindole derivatives as pharmaceutical agents. Melker (US 2008/0045825) discloses condensate glucose analyzer. Urdea (US 2007/0218519) discloses diabetes-associated markers and methods of use thereof. Rosman (US 2007/0128682) discloses predictive treatment of dysglycemic excursions associated with diabetes mellitus. Theophilos (US 2008/0300923) discloses method, system and interface for setting health insurance premiums. Wahren (US 2011/0098220) discloses methods and kits for preventing hypoglycemia. McKenna (US 2012/0328594) discloses protein and lipid biomarkers providing consistent improvements to the reduction of type 2 diabetes. Wennberg (US 20120078656) discloses systems and methods for predicting healthcare risk related events. Soto (US 2013/0132323) discloses systems and methods for risk stratification of patients populations. Kocis (US 2013/0197924) discloses methods, systems and computer readable media for evaluating a hospital patient risk of mortality. Johnston (US 20150065421) discloses basal insulin therapy. Barhak (US 2014/0297241) discloses reference model for disease progression. Clube (US 2016/0017056) discloses methods of treating anemia. Dong (US 2016/0357934) discloses diabetes onset and progression prediction using a computerized model.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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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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/LIZA TONY KANAAN/Examiner, Art Unit 3683 /ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683