DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 16 June 2026, the status of the claims is as follows:
Claims 1-3 and 9-13 are currently amended;
Claims 4-8 and 14-18 are as originally filed; and
Claims 19 and 20 are withdrawn.
3. In the Amendment, filed 16 June 2026, the claims have been amended to avoid claim limitations being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
4. The rejection of claims 1-18 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, are withdrawn in view of the Amendment, filed 16 June 2026.
5. The rejection of claims 1-18 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a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, are withdrawn in view of the Amendment, filed 16 June 2026.
Response to Arguments
6. Applicant’s arguments, see Remarks, p. 6, filed 16 June 2026, with respect to the rejection of claims 1-18 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more, have been fully considered, but they are not persuasive.
Applicant contends, see Remarks, p. 6, the following:
Claims 1-18 stand rejected under 35 U.S.C. § 101 because the claimed invention is allegedly directed to an abstract idea without significantly more. Independent claims 1 and 10 have been amended to further recite specific processing of patient-specific glucose and risk information to identify suitable therapies, exclude therapies predicted to result in adverse health events, and select a cost-effective therapy from the remaining therapies. Applicant respectfully submits that the claims, at least as amended herein, recite patent-eligible subject matter. In view of the amendments, withdrawal of the § 101 rejection is respectfully requested.
However, respectfully, this argument is not persuasive. Based on broadest reasonable interpretation, claims 1-18 are directed to an abstract idea, i.e. mental process. The amended recitation of “receiving patient data for a patient, the patient data including glucose data of the patient collected by a glucose monitor and a risk metric indicating a relative level of risk of the patient experiencing an adverse health event based on the glucose data of the patient” add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. Gathering data for the mental process is necessary to perform that mental process in order to analyze the data and provide a result. Furthermore, the additional limitations of “A computer-implemented method” and “one or more processors executing instructions” in claim 1, and “a therapy recommendation module comprising one or more processors configured to:” in claim 10, are merely parts of a computer to be used as a tool to perform the mental process. The claim does not recite additional limitations to the mental process that integrates the abstract idea into a practical application.
7. Applicant’s arguments, see Remarks, pp. 7-9, filed 19 June 2026, with respect to the rejection of claims 1-18 under 35 U.S.C. 102(a)(1) as being anticipated by Testa et al., U.S. Patent Application Publication No. 2018/0005332 A1 (“Testa”), have been fully considered, and are persuasive in view of the Amendment, filed 19 June 2026. Therefore, the rejection has been withdrawn.
Claim Rejections - 35 USC § 101
8. 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.
9. Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 1-9 are directed to a “computer-implemented method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Claims 10-18 are directed to a “system”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 1-9 recite the following mental process:
determining … suitable therapies which are suitable to control glucose of the patient based on the patient data and at least in part on the risk metric in order to ensure that the suitable therapies minimize the likelihood of the adverse health event occurring for the patient and do not result in a dangerous health condition for the patient, wherein the suitable therapies are suitable to maintain the patient's glucose within a target range, and wherein determining the suitable therapies excludes therapies that are determined, based at least in part on the risk metric, to result in adverse health events for the patient;
filtering … the suitable therapies to select a cost-effective therapy for the patient based at least in part on therapy cost data, the therapy cost data including costs of the suitable therapies; and…
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitation of “receiving patient data for a patient, the patient data including glucose data of the patient collected by a glucose monitor and a risk metric indicating a relative level of risk of the patient experiencing an adverse health event based on the glucose data of the patient” in claim 1 add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. In addition, the additional limitations of “A computer-implemented method” and “one or more processors executing instructions” in claim 1 are merely parts of a computer to be used as a tool to perform the mental process. Furthermore, the additional limitation of “outputting a therapy recommendation to control glucose for the patient that includes the cost-effective therapy” in claim 1 add insignificant post-solution activity to the mental process as it merely presents the result of the mental process of collecting and analyzing information, without more, and thus, is an ancillary part of such collection and analysis.
Claim(s) 10-18 recite the following mental process:
determine suitable therapies which are suitable to control glucose of the patient based on the patient data and at least in part on the risk metric, wherein the determination of suitable therapies includes applying a supervised learning model trained on historical patient data to predict therapy outcomes, and excludes therapies that are determined, based at least in part on the risk metric, to result in adverse health events for the patient, and wherein the determination further includes ranking therapies based on cost and efficacy; and
filter the suitable therapies to select a cost-effective therapy for the patient from the available suitable therapies based on the glucose data of the patient and the therapy cost data, wherein the filtering of suitable therapies includes evaluating each therapy based on cost and efficacy, and selecting the therapy that minimizes cost while maximizing efficacy; and …
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “receive patient data for a patient, the patient data including glucose data of the patient collected by a glucose monitor and a risk metric indicating a relative level of risk of the patient experiencing an adverse health event based on the glucose data of the patient” in claim 10 add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. In addition, the additional limitations of “a therapy recommendation module comprising one or more processors configured to:” in claim 10 are merely parts of a computer to be used as a tool to perform the mental process. Furthermore, the additional limitation of “an output module to output the cost-effective therapy via a user interface” in claim 10 add insignificant post-solution activity to the mental process as it merely presents the result of the mental process of collecting and analyzing information, without more, and thus, is an ancillary part of such collection and analysis.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “receiving patient data for a patient, the patient data including glucose data of the patient collected by a glucose monitor and a risk metric indicating a relative level of risk of the patient experiencing an adverse health event based on the glucose data of the patient” in claim 1, and “receive patient data for a patient, the patient data including glucose data of the patient collected by a glucose monitor and a risk metric indicating a relative level of risk of the patient experiencing an adverse health event based on the glucose data of the patient” in claim 10. Such limitations add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process.
In addition, the additional limitations of “A computer-implemented method” and “one or more processors executing instructions” in claim 1, and “a therapy recommendation module comprising one or more processors configured to:” in claim 10, are merely parts of a computer to be used as a tool to perform the mental process.
Furthermore, the additional limitations of “outputting a therapy recommendation to control glucose for the patient that includes the cost-effective therapy” in claim 1, and “an output module to output the cost-effective therapy via a user interface” in claim 10, add insignificant post-solution activity to the mental process as it merely presents the result of the mental process of collecting and analyzing information, without more, and thus, is an ancillary part of such collection and analysis.
The additional limitations of dependent claims 2-9 and 11-18 are merely directed to and further narrow the scope of the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process 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 mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Allowable Subject Matter
10. Claims 1-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
11. The following is a statement of reasons for the indication of allowable subject matter:
The closes prior art reference to the subject matter of the claims is Tesla.
As to Claim 1, Testa teaches the following:
A computer-implemented method (see “The present invention relates generally to managing diabetes treatment for cost and effectiveness.” in para. [0005]) comprising:
receiving patient data for a patient, the patient data including glucose data of the patient collected by a glucose monitor (see “User interface 102 includes an input device 105 (e.g. touchscreen buttons or mouse) to receive patient data from user …” in para. [0034]; see “The left side of the sample UI is titled PATIENT INFORMATION, and is designed to obtain data about the patient's medical history including A1C LEVEL, COST SENSITIVITY, ADHERENCE, ALREADY TAKING, SOLUTION MUST CONTAIN, ALLERGY, DRUG INTOLERANCE, FORGOT TO TAKE, INSURER, HAS COUPON FOR, COMORBID, PHYSICAL INTOLERANCE, SEX, INSULIN RESISTANCE, INSULIN PRODUCTION, BODY MASS INDEX, MAX # OF INTERVENTIONS, AND DISPLAY SOLUTIONS.” in para. [0035]; and see “A1C LEVEL asks for the patient's current blood glucose level expressed as a percent. This is also commonly referred to in the literature as the “hemoglobin a1c”, “HbA1c” or “glycohemoglobin” level. It is also most commonly referred to as a percent.” in para. [0036]) and a risk metric indicating a relative level of risk of the patient experiencing an adverse health event based on the glucose data of the patient (see “In the example illustrated by FIG. 2, the solution's side effect score was increased because of the beneficial side effect that Jardiance and MetforminXR have in treating CAD (Coronary Artery Disease), and MetforminXR's positive effect on beta cells. Other examples of notes displayed along side recommended therapies in the OUTPUT section of the UI include why a particular drug was disqualified from solutions, such as allergy, conflicts with other drugs, or cost.” in para. [0058]);
determining, by one or more processors (“solution generator module 120” and “solution scoring model 122”) 120/122 executing instructions, suitable therapies which are suitable to control glucose of the patient based on the patient data (see “Referring to FIGS. 3-6, a solution generator module 120 is configured to determine a list of solutions as a function of the patient data and the therapy data. Determining the list of solutions includes eliminating solutions as a function of the patient data to generate a list of compatible solutions and returning list of compatible solutions as the list of solutions.” in para. [0080]; and see “SOLUTION GENERATOR MODULE—The SOLUTION GENERATOR MODULE generates unique combinations of therapies from the THERAPY TABLE 104. This unique combination of therapies is called a solution or therapy. The mechanism by which the unique combination of therapies is generated may be deterministic or random.” in para. [0081]), and … ;
…
outputting (via “reporter 112”) a therapy recommendation (“rank ordered lists of solutions and provides the aggregated table”) to control glucose for the patient that includes the cost-effective therapy (see “The reporter 112 aggregates on a patient by patient basis the rank ordered lists of solution received from the decision engine 106 and provides the aggregated rank ordered lists of solutions to the data source, each rank ordered list of solutions indicated as corresponding to one of the patients of the plurality of patients. That is, the reporter 112 aggregates the table of patient data and rank ordered lists of solutions and provides the aggregated table has an output from the system 100.” in para. [0065]).
As to Claim 10, Testa teaches the following:
A system (see “The present invention relates generally to managing diabetes treatment for cost and effectiveness.” in para. [0005]) comprising:
a therapy recommendation module comprising one or more processors (“solution generator module 120” and “solution scoring model 122”) 120/122 configured to:
receiving patient data for a patient, the patient data including glucose data of the patient collected by a glucose monitor (see “User interface 102 includes an input device 105 (e.g. touchscreen buttons or mouse) to receive patient data from user …” in para. [0034]; see “The left side of the sample UI is titled PATIENT INFORMATION, and is designed to obtain data about the patient's medical history including A1C LEVEL, COST SENSITIVITY, ADHERENCE, ALREADY TAKING, SOLUTION MUST CONTAIN, ALLERGY, DRUG INTOLERANCE, FORGOT TO TAKE, INSURER, HAS COUPON FOR, COMORBID, PHYSICAL INTOLERANCE, SEX, INSULIN RESISTANCE, INSULIN PRODUCTION, BODY MASS INDEX, MAX # OF INTERVENTIONS, AND DISPLAY SOLUTIONS.” in para. [0035]; and see “A1C LEVEL asks for the patient's current blood glucose level expressed as a percent. This is also commonly referred to in the literature as the “hemoglobin a1c”, “HbA1c” or “glycohemoglobin” level. It is also most commonly referred to as a percent.” in para. [0036]) and a risk metric indicating a relative level of risk of the patient experiencing an adverse health event based on the glucose data of the patient (see “In the example illustrated by FIG. 2, the solution's side effect score was increased because of the beneficial side effect that Jardiance and MetforminXR have in treating CAD (Coronary Artery Disease), and MetforminXR's positive effect on beta cells. Other examples of notes displayed along side recommended therapies in the OUTPUT section of the UI include why a particular drug was disqualified from solutions, such as allergy, conflicts with other drugs, or cost.” in para. [0058]);
receive therapy selection data comprising available therapies and therapy cost data (see “Referring to FIGS. 3-6, a solution generator module 120 is configured to determine a list of solutions as a function of the patient data and the therapy data. Determining the list of solutions includes eliminating solutions as a function of the patient data to generate a list of compatible solutions and returning list of compatible solutions as the list of solutions.” in para. [0080]; and see “SOLUTION GENERATOR MODULE—The SOLUTION GENERATOR MODULE generates unique combinations of therapies from the THERAPY TABLE 104. This unique combination of therapies is called a solution or therapy. The mechanism by which the unique combination of therapies is generated may be deterministic or random.” in para. [0081]), the therapy cost data including costs of the available therapies (see “COST SENSITIVITY asks the patient to rate how much money they can afford to pay for treatment of this disease. The sample UI implementation uses an integer 0-to-10 Likert scale, but other implementations (such as asking the user to enter a maximum dollar amount) are easily adapted. In this sample UI implementation, a value of 0 means the patient is able to afford any treatment that may be suggested. A value of 10 indicates the patient strongly prefers the lowest cost treatments that are possible.” in para. [0037]; and see “The display of each individual component scores is meant to explain the reasoning behind the therapy recommendation to the medical professional and patient. For example, a high score in the area of cost sensitivity means that this therapy recommendation is particularly good at addressing the patient's cost concerns. The calculation of these scores is dependent on the implementation goals and many different methods can be used.” in para. [00]; and see figs. 10 and 11);
…
an output module (“reporter”) 112 to output the cost-effective therapy via a user interface (“user interface”) 102 (see “In another embodiment, the user interface 102 is a batch interface including a parser 110 and a reporter 112. … The reporter 112 aggregates on a patient by patient basis the rank ordered lists of solution received from the decision engine 106 and provides the aggregated rank ordered lists of solutions to the data source, each rank ordered list of solutions indicated as corresponding to one of the patients of the plurality of patients. That is, the reporter 112 aggregates the table of patient data and rank ordered lists of solutions and provides the aggregated table has an output from the system 100.” in para. [0065]).
As to Claims 1-9, neither Tesla nor the prior art of record teaches the computer-implemented method of base claim 1, including the following, in combination with all other limitations of the base claim:
determining, by a therapy selection model one or more processors executing instructions, suitable therapies which are suitable to control glucose of the patient based on the patient data and at least in part on the risk metric in order to ensure that the suitable therapies minimize the likelihood of the adverse health event occurring for the patient and do not result in a dangerous health condition for the patient, wherein the suitable therapies are suitable to maintain the patient's glucose within a target range, and wherein determining the suitable therapies excludes therapies that are determined, based at least in part on the risk metric, to result in adverse health events for the patient;
filtering, by the one or more processors executing the instructions, the suitable therapies to select a cost-effective therapy for the patient based at least in part on therapy cost data, the therapy cost data including costs of the suitable therapies; and …
As to Claims 10-18, neither Tesla nor the prior art of record teaches the computer-implemented method of base claim 10, including the following, in combination with all other limitations of the base claim:
determine suitable therapies which are suitable to control glucose of the patient based on the patient data and at least in part on the risk metric, wherein the determination of suitable therapies includes applying a supervised learning model trained on historical patient data to predict therapy outcomes, and excludes therapies that are determined, based at least in part on the risk metric, to result in adverse health events for the patient, and wherein the determination further includes ranking therapies based on cost and efficacy; and
filter the suitable therapies to select a cost-effective therapy for the patient from the available suitable therapies based on the glucose data of the patient and the therapy cost data, wherein the filtering of suitable therapies includes evaluating each therapy based on cost and efficacy, and selecting the therapy that minimizes cost while maximizing efficacy; and …
Conclusion
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 08/01/2026
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