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 .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/26/2026 has been entered.
Notice to Applicant
3. This communication is in response to the communication filed 1/26/2025. Claims 2-14 are cancelled. Claims 1, and 15-17 are currently amended. Claims 18-33 are new. Claims 1 and 15-33 are currently pending.
Claim Rejections - 35 USC § 101
4. 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.
4.1. Claims 1 and 15-33 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regards to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1 and 15, and their respective dependent claims are directed, in part, to computing devices for human metabolic condition management.
In regards to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, independent claims 1 and 15, as a whole, are directed to computing devices for human metabolic condition management by, inter alia, generating at least one goal and outputs for achieving the goal, wherein the outputs are provided as instructions for a treatment, and wherein the treatment is administered by a person which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, assuming arguendo, the claims are not directed to certain methods of organizing human activities, the claims, nevertheless, are directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper.
CLAIM 1:
A computing device comprising:
a processor;
a memory communicatively coupled to the processor;
a display including an interface for providing inputs to the computing device, the inputs including at least one goal for a metabolic response:
a model stored in the memory configured to generate, based on the at least one goal, outputs for achieving the at least one goal; and
the interface at the display also including the outputs from the model to achieve the at least one goal, the outputs including at least one of:
a quantity of food, drug, and/or activity; or
a composition of food, drug, and/or activity; or
a time to ingest food, administer the drug, and/or start the activity;
wherein the outputs are provided as instructions for a treatment and wherein the treatment is administered by a person or by a metabolic-management device.
CLAIM 15:
A computing device comprising:
a processor;
a memory communicatively coupled to the processor;
a display including an interface for providing inputs to the computing device, the inputs including at least one goal for a metabolic response:
a model stored in the memory configured to generate, based on the at least one goal, outputs for achieving the at least one goal; and
the interface at the display also including the outputs from the model to achieve the at least one goal, the outputs including at least one of:
one or more food specifications, each food specification including a composition, a quantity, and/or a time to consume food; or
one or more drug specifications, each drug specification including a composition, a quantity, and/or a time to administer the drug;
wherein the outputs are provided as instructions for a treatment and wherein the treatment is administered by a person or by a metabolic-management device.
CLAIM 16:
The computing device of claim 15, wherein the model adapts in response to new inputs over time such that outputs from the model represent an expected glycemic response of an individual.
CLAIM 17:
The computing device of claim 1, wherein the model adapts in response to new inputs over time such that outputs from the model represent an expected glycemic response of an individual.
CLAIM 18:
The computing device of claim 15, wherein the outputs include the one or more food specifications and the one or more drug specifications.
CLAIM 19:
The computing device of claim 18, wherein the outputs further include at least one activity specification, each activity specification including:
a quantity of activity;
a composition of activity;
a start time for the activity; and/or
a duration of activity.
CLAIM 20:
The computing device of claim 15, wherein the at least one goal for the metabolic response is a time representing a percentage complete of 50% for an effect of at least one of the outputs.
CLAIM 21:
The computing device of claim 15, wherein the at least one goal for the metabolic response is a desired temporal glycemic response.
CLAIM 22:
The computing device of claim 15, wherein the at least one goal includes at least one of:
a rate;
a rate limit;
a sensitivity;
a sensitivity limit; or
a composition for achieving a desired time-to-percent-completion of a metabolic
response.
CLAIM 23:
The computing device of claim 15, wherein the model is further configured to generate one or more response maps, wherein the at least one goal for a metabolic response is a response map selected from the one or more generated response maps.
CLAIM 24:
The computing device of claim 15, wherein the outputs from the model are updated in response to a new goal.
CLAIM 25:
The computing device of claim 15, wherein the model is dynamic to compensate for at least one new characteristic of a user, the at least one new characteristic including:
a new disease state;
a hormonal change;
a change in medication; or
a change in medicating method.
CLAIM 26:
The computing device of claim 1, wherein the outputs include:
the quantity of food, the composition of food, and the time to ingest food; and
the quantity of drug, the composition of drug, and the time to administer the drug.
CLAIM 27:
The computing device of claim 1, wherein the outputs include:
the quantity of food, the composition of food, and the time to ingest food;
the quantity of drug, the composition of drug, and the time to administer the drug; and
the quantity of activity, the composition of activity, and the time to start the activity.
CLAIM 28:
The computing device of claim 1, wherein the at least one goal for the metabolic response is a time representing a percentage complete of 50% for an effect of at least one of the outputs.
CLAIM 29:
The computing device of claim 1, wherein the at least one goal for the metabolic response is a desired temporal glycemic response.
CLAIM 30:
The computing device of claim 1, wherein the at least one goal includes at least one of:
a rate;
a rate limit;
a sensitivity;
a sensitivity limit; or
a composition for achieving a desired time-to-percent-completion of a metabolic response.
CLAIM 31:
The computing device of claim 1, wherein the model is further configured to generate one or more response maps, wherein the at least one goal for a metabolic response is a response map selected from the one or more generated response maps.
CLAIM 32:
The computing device of claim 1, wherein the outputs from the model are updated in response to a new goal.
CLAIM 33:
The computing device of claim 1, wherein the model is dynamic to compensate for one or more new characteristics of a user, the one or more new characteristics including:
a new disease state;
a hormonal change;
a change in medication; or
a change in medicating method.
* The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper. The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., computing device, processor, memory, display, interface, model, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, additional elements are devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the 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.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite 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—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0164]-[0170] of applicant's specification (US 2024/0428953) recites that the system/method may be implemented using a personal computer, a network computer, a mainframe, a handheld device, a personal digital assistant, a smartphone, glucose monitors, insulin pumps, or any other similar microcomputer-based workstation which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (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.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
5.1. Claims 1, 15-19, 21, 24-27, 29, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Hall (US 2013/0198214), in view of Douglas et al. (US 2008/0306353).
CLAIM 1
Hall teaches a computing device (Hall: abstract) comprising:
a processor (Hall: abstract; ¶¶ [0040] “system having at least one processor”; FIGS. 1-6);
a memory communicatively coupled to the processor (Hall: abstract; ¶¶ [0040] “computer 404A includes one or more processors and memory and is configured to receive data from and/or transmit data to the UI”; FIGS. 1-6);
a display including an interface for providing inputs to the computing device, the inputs including at least one goal for a metabolic response (Hall: abstract; ¶¶ [0040] “computer 404A includes one or more processors and memory and is configured to receive data from and/or transmit data to the UI”, [0041] “UI 410A includes a display 413A, such as a monitor, for displaying one or more input forms, and an input device 414A, such as a keyboard or a pointing device (e.g., a mouse, trackball, pen, or touch screen), for entering data for a particular user 112 into one or more data input forms (not shown). For example, the user 412A interacts with data input forms via the user interface 410A to enter subject identification data, body weight data, and/or energy intake data and to generate a weight management request”, [0042]-[0043] “user may decide to modify a body weight goal or the time allotted to achieve the goal, or combinations thereof”; FIGS. 1-6):
a model stored in the memory configured to generate, based on the at least one goal, outputs for achieving the at least one goal (Hall: abstract; ¶¶ [0027] “weight metabolism model”, [0033], [0037], [0039] “PWMS uses a baseline mathematical model of the metabolism of a subject or individual participating in a weight management intervention to prescribe dietary, physical activity guidelines, medication, surgery, and or other interventions for the subject to achieve a desired body weight or to be within a desired weight range over a period time”; FIGS. 1-6); and
the interface at the display also including the outputs from the model to achieve the at least one goal, the outputs including at least one of (Hall: abstract; ¶¶ [0027] “weight metabolism model”, [0033], [0037], [0039] “PWMS uses a baseline mathematical model of the metabolism of a subject or individual participating in a weight management intervention to prescribe dietary, physical activity guidelines, medication, surgery, and or other interventions for the subject to achieve a desired body weight or to be within a desired weight range over a period time”; FIGS. 1-6): and
wherein the outputs are provided as instructions for a treatment (Hall: abstract; ¶¶ [0014] “a prescribed intervention, wherein the intervention is selected from the group consisting of dietary selection, physical activity, exercise, psychological intervention, surgery, medication administration, alteration of sleep or circadian rhythmicity, or a combination thereof. One or more embodiments may be configured to monitor obesity therapy or adherence to a weight loss/intervention program”; FIGS. 1-6).
Hall does not appear to explicitly teach the following:
a quantity of food, drug, and/or activity; or a composition of food, drug, and/or activity; or a time to ingest food, administer the drug, and/or start the activity; and
wherein the treatment is administered by a person or by a metabolic management device.
Douglas, however, teaches the following:
a quantity of food, drug, and/or activity; or a composition of food, drug, and/or activity; or a time to ingest food, administer the drug, and/or start the activity (Douglas: abstract; ¶¶ [0014]-[0017] “pump infuses a small amount (0.1 to 10 mL/hr) continuously in order to keep the vein open. Feeding schedules vary, but one common regimen ramps up the nutrition over a few hours, levels off the rate for a few hours, and then ramps it down over a few more hours, in order to simulate a normal set of meal times. The technician, nurse, or other caregiver has complete control over the medical infusion pump and can program the infusion pump to deliver a customized nutrition profile”, [[019], [0109] “digital computational devices are generally software based devices that are used for determining patient specific nutrition and insulin dosages from inputs”, [0112]; FIGS. 1-30); and
wherein the treatment is administered by a person or by a metabolic management device (Douglas: abstract; ¶¶ [0014]-[0017] “pump infuses a small amount (0.1 to 10 mL/hr) continuously in order to keep the vein open. Feeding schedules vary, but one common regimen ramps up the nutrition over a few hours, levels off the rate for a few hours, and then ramps it down over a few more hours, in order to simulate a normal set of meal times. The technician, nurse, or other caregiver has complete control over the medical infusion pump and can program the infusion pump to deliver a customized nutrition profile”; FIGS. 1-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of improving metabolic condition (Douglas: ¶¶ [0002]-[0003], [0086]-[0108]).
CLAIM 15
Hall teaches a computing device (Hall: abstract) comprising:
a processor (Hall: abstract; ¶¶ [0040] “system having at least one processor”; FIGS. 1-6);
a memory communicatively coupled to the processor (Hall: abstract; ¶¶ [0040] “computer 404A includes one or more processors and memory and is configured to receive data from and/or transmit data to the UI”; FIGS. 1-6);
a display including an interface for providing inputs to the computing device, the inputs including at least one goal for a metabolic response (Hall: abstract; ¶¶ [0040] “computer 404A includes one or more processors and memory and is configured to receive data from and/or transmit data to the UI”, [0041] “UI 410A includes a display 413A, such as a monitor, for displaying one or more input forms, and an input device 414A, such as a keyboard or a pointing device (e.g., a mouse, trackball, pen, or touch screen), for entering data for a particular user 112 into one or more data input forms (not shown). For example, the user 412A interacts with data input forms via the user interface 410A to enter subject identification data, body weight data, and/or energy intake data and to generate a weight management request”, [0042]-[0043] “user may decide to modify a body weight goal or the time allotted to achieve the goal, or combinations thereof”; FIGS. 1-6):
a model stored in the memory configured to generate, based on the at least one goal, outputs for achieving the at least one goal (Hall: abstract; ¶¶ [0027] “weight metabolism model”, [0033], [0037], [0039] “PWMS uses a baseline mathematical model of the metabolism of a subject or individual participating in a weight management intervention to prescribe dietary, physical activity guidelines, medication, surgery, and or other interventions for the subject to achieve a desired body weight or to be within a desired weight range over a period time”; FIGS. 1-6); and
the interface at the display also including the outputs from the model to achieve the at least one goal, the outputs including at least one of (Hall: abstract; ¶¶ [0027] “weight metabolism model”, [0033], [0037], [0039] “PWMS uses a baseline mathematical model of the metabolism of a subject or individual participating in a weight management intervention to prescribe dietary, physical activity guidelines, medication, surgery, and or other interventions for the subject to achieve a desired body weight or to be within a desired weight range over a period time”; FIGS. 1-6): and
wherein the outputs are provided as instructions for a treatment (Hall: abstract; ¶¶ [0014] “a prescribed intervention, wherein the intervention is selected from the group consisting of dietary selection, physical activity, exercise, psychological intervention, surgery, medication administration, alteration of sleep or circadian rhythmicity, or a combination thereof. One or more embodiments may be configured to monitor obesity therapy or adherence to a weight loss/intervention program”; FIGS. 1-6).
Hall does not appear to explicitly teach the following:
one or more food specifications, each food specification including a composition, a quantity, and/or a time to consume food; or one or more drug specifications, each drug specification including a composition, a quantity, and/or a time to administer the drug; and
wherein the treatment is administered by a person or by a metabolic management device.
Douglas, however, teaches the following:
one or more food specifications, each food specification including a composition, a quantity, and/or a time to consume food; or one or more drug specifications, each drug specification including a composition, a quantity, and/or a time to administer the drug (Douglas: abstract; ¶¶ [0014]-[0017] “pump infuses a small amount (0.1 to 10 mL/hr) continuously in order to keep the vein open. Feeding schedules vary, but one common regimen ramps up the nutrition over a few hours, levels off the rate for a few hours, and then ramps it down over a few more hours, in order to simulate a normal set of meal times. The technician, nurse, or other caregiver has complete control over the medical infusion pump and can program the infusion pump to deliver a customized nutrition profile”, [[019], [0109] “digital computational devices are generally software based devices that are used for determining patient specific nutrition and insulin dosages from inputs”, [0112]; FIGS. 1-30); and
wherein the treatment is administered by a person or by a metabolic management device (Douglas: abstract; ¶¶ [0014]-[0017] “pump infuses a small amount (0.1 to 10 mL/hr) continuously in order to keep the vein open. Feeding schedules vary, but one common regimen ramps up the nutrition over a few hours, levels off the rate for a few hours, and then ramps it down over a few more hours, in order to simulate a normal set of meal times. The technician, nurse, or other caregiver has complete control over the medical infusion pump and can program the infusion pump to deliver a customized nutrition profile”; FIGS. 1-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of improving metabolic condition (Douglas: ¶¶ [0002]-[0003], [0086]-[0108]).
CLAIM 16
Hall teaches the computing device of claim 15, wherein the model adapts in response to new inputs over time such that outputs from the model represent an expected glycemic response of an individual (Hall: abstract; ¶¶ [0012] “a mathematical model of metabolism and weight change and providing repeated monitoring of the parameter, iterative recalculation of model parameters and predicted weight change”, [0016]-[0017]: FIGS. 1-6; See also Douglas ¶¶ [0056]).
CLAIM 17
Hall teaches the computing device of claim 1, wherein the model adapts in response to new inputs over time such that outputs from the model represent an expected glycemic response of an individual (Hall: abstract; ¶¶ [0012] “a mathematical model of metabolism and weight change and providing repeated monitoring of the parameter, iterative recalculation of model parameters and predicted weight change”, [0016]-[0017]: FIGS. 1-6; See also Douglas ¶¶ [0056]).
CLAIM 18
Hall does not appear to explicitly teach the computing device of claim 15, wherein the outputs include the one or more food specifications and the one or more drug specifications.
Douglas, however, teaches wherein the outputs include the one or more food specifications and the one or more drug specifications (Douglas: abstract; ¶¶ [0014]-[0017] “pump infuses a small amount (0.1 to 10 mL/hr) continuously in order to keep the vein open. Feeding schedules vary, but one common regimen ramps up the nutrition over a few hours, levels off the rate for a few hours, and then ramps it down over a few more hours, in order to simulate a normal set of meal times. The technician, nurse, or other caregiver has complete control over the medical infusion pump and can program the infusion pump to deliver a customized nutrition profile”, [[019], [0109] “digital computational devices are generally software based devices that are used for determining patient specific nutrition and insulin dosages from inputs”, [0112]; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 15 above and is incorporated herein.
CLAIM 19
Hall does not appear to explicitly teach the computing device of claim 18, wherein the outputs further include at least one activity specification, each activity specification including: a quantity of activity; a composition of activity; a start time for the activity; and/or a duration of activity.
Douglass, however, teaches wherein the outputs further include at least one activity specification, each activity specification including: a quantity of activity; a composition of activity; a start time for the activity; and/or a duration of activity (Douglass: abstract; ¶¶ [0112]-[0117]; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 15 above and is incorporated herein.
CLAIM 21
Hall does not appear to explicitly teach the computing device of claim 15, wherein the at least one goal for the metabolic response is a desired temporal glycemic response.
Douglas, however, teaches wherein the at least one goal for the metabolic response is a desired temporal glycemic response (Douglas: abstract; ¶¶ [0212]-[0214]; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 15 above and is incorporated herein.
CLAIM 24
Hall teaches the computing device of claim 15, wherein the outputs from the model are updated in response to a new goal (Hall: abstract; ¶¶ [0012] “a mathematical model of metabolism and weight change and providing repeated monitoring of the parameter, iterative recalculation of model parameters and predicted weight change”, [0016]-[0017], [0043]; FIGS. 1-6).
CLAIM 25
Hall does not appear to explicitly teach the computing device of claim 15, wherein the model is dynamic to compensate for at least one new characteristic of a user, the at least one new characteristic including: a new disease state; a hormonal change; a change in medication; or a change in medicating method.
Douglas, however, teaches wherein the model is dynamic to compensate for at least one new characteristic of a user, the at least one new characteristic including: a new disease state; a hormonal change; a change in medication; or a change in medicating method (Douglas: abstract; ¶¶ [0316]-[0317] The model is adjusted according to various parameters, such as, change in kind, dose, and means of administration of medication, etc.; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 15 above and is incorporated herein.
CLAIM 26
Hall does not appear to explicitly teach the computing device of claim 1, wherein the outputs include: the quantity of food, the composition of food, and the time to ingest food; and the quantity of drug, the composition of drug, and the time to administer the drug.
Douglas, however, teaches wherein the outputs include: the quantity of food, the composition of food, and the time to ingest food; and the quantity of drug, the composition of drug, and the time to administer the drug (Douglas: abstract; ¶¶ [0014]-[0017] “pump infuses a small amount (0.1 to 10 mL/hr) continuously in order to keep the vein open. Feeding schedules vary, but one common regimen ramps up the nutrition over a few hours, levels off the rate for a few hours, and then ramps it down over a few more hours, in order to simulate a normal set of meal times. The technician, nurse, or other caregiver has complete control over the medical infusion pump and can program the infusion pump to deliver a customized nutrition profile”, [[019], [0109] “digital computational devices are generally software based devices that are used for determining patient specific nutrition and insulin dosages from inputs”, [0112]; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 1 above and is incorporated herein.
CLAIM 27
Hall does not appear to explicitly teach the computing device of claim 1, wherein the outputs include: the quantity of food, the composition of food, and the time to ingest food; the quantity of drug, the composition of drug, and the time to administer the drug; and the quantity of activity, the composition of activity, and the time to start the activity.
Douglas, however, teaches wherein the outputs include: the quantity of food, the composition of food, and the time to ingest food; the quantity of drug, the composition of drug, and the time to administer the drug; and the quantity of activity, the composition of activity, and the time to start the activity (Douglass: abstract; ¶¶ [0112]-[0117]; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 1 above and is incorporated herein.
CLAIM 29
Hall does not appear to explicitly teach the computing device of claim 1, wherein the at least one goal for the metabolic response is a desired temporal glycemic response.
Douglas, however, teaches wherein the at least one goal for the metabolic response is a desired temporal glycemic response (Douglas: abstract; ¶¶ [0212]-[0214]; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 1 above and is incorporated herein.
CLAIM 32
Hall teaches the computing device of claim 1, wherein the outputs from the model are updated in response to a new goal (Hall: abstract; ¶¶ [0012] “a mathematical model of metabolism and weight change and providing repeated monitoring of the parameter, iterative recalculation of model parameters and predicted weight change”, [0016]-[0017], [0043]; FIGS. 1-6).
CLAIM 33
Hall does not appear to explicitly teach the computing device of claim 1, wherein the model is dynamic to compensate for one or more new characteristics of a user, the one or more new characteristics including: a new disease state; a hormonal change; a change in medication; or a change in medicating method.
Douglas, however, teaches (Douglas: abstract; ¶¶ [0316]-[0317] The model is adjusted according to various parameters, such as, change in kind, dose, and means of administration of medication, etc.; FIGS. 1-30).
The motivation to include the teachings of Douglas with the teachings of Hall is the same as that of claim 1 above and is incorporated herein.
5.2. Claims 20, 22, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hall (US 2013/0198214), in view of Douglas et al. (US 2008/0306353), and further in view of Schwarzberg et al. (US 2009/0076842).
CLAIM 20
Hall and Douglas may not teach the computing device of claim 15, wherein the at least one goal for the metabolic response is a time representing a percentage complete of 50% for an effect of at least one of the outputs.
Schwarzberg, however, teaches wherein the at least one goal for the metabolic response is a time representing a percentage complete of 50% for an effect of at least one of the outputs (Schwarzberg: abstract; ¶¶ [0023]-[0024], [0045]; FIGS. 1-6B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the health system, as taught by Schwarzberg, with the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of facilitating health (Schwarzberg: ¶¶ [0001]-[0008]).
CLAIM 22
Hall and Douglas may not teach the computing device of claim 15, wherein the at least one goal includes at least one of: a rate; a rate limit; a sensitivity; a sensitivity limit; or a composition for achieving a desired time-to-percent-completion of a metabolic response.
Schwarzberg, however, teaches wherein the at least one goal includes at least one of: a rate; a rate limit; a sensitivity; a sensitivity limit; or a composition for achieving a desired time-to-percent-completion of a metabolic response (Schwarzberg: abstract; ¶¶ [0031]; FIGS. 1-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the health system, as taught by Schwarzberg, with the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of facilitating health (Schwarzberg: ¶¶ [0001]-[0008]).
CLAIM 28
Hall and Douglas may not teach the computing device of claim 1, wherein the at least one goal for the metabolic response is a time representing a percentage complete of 50% for an effect of at least one of the outputs.
Schwarzberg, however, teaches wherein the at least one goal for the metabolic response is a time representing a percentage complete of 50% for an effect of at least one of the outputs (Schwarzberg: abstract; ¶¶ [0023]-[0024], [0045]; FIGS. 1-6B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the health system, as taught by Schwarzberg, with the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of facilitating health (Schwarzberg: ¶¶ [0001]-[0008]).
CLAIM 30
Hall and Douglas may not teach the computing device of claim 1, wherein the at least one goal includes at least one of: a rate; a rate limit; a sensitivity; a sensitivity limit; or a composition for achieving a desired time-to-percent-completion of a metabolic response.
Schwarzberg, however, teaches wherein the at least one goal includes at least one of: a rate; a rate limit; a sensitivity; a sensitivity limit; or a composition for achieving a desired time-to-percent-completion of a metabolic response (Schwarzberg: abstract; ¶¶ [0031]; FIGS. 1-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the health system, as taught by Schwarzberg, with the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of facilitating health (Schwarzberg: ¶¶ [0001]-[0008]).
5.4. Claims 23 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Hall (US 2013/0198214), in view of Douglas et al. (US 2008/0306353), and further in view of Ramasubramanian et al. (US 2005/0267356).
CLAIM 23
Hall and Douglas may not teach the computing device of claim 15, wherein the model is further configured to generate one or more response maps, wherein the at least one goal for a metabolic response is a response map selected from the one or more generated response maps.
Ramasubramanian, however, teaches wherein the model is further configured to generate one or more response maps, wherein the at least one goal for a metabolic response is a response map selected from the one or more generated response maps (Ramasubramanian: abstract; ¶¶ [0056]; FIGS. 1-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the patient health system including response maps, as taught by Ramasubramanian, with the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of assisting and facilitating health regimes (Ramasubramanian: ¶¶ [0004]-[0010]).
CLAIM 31
Hall and Douglas may not teach the computing device of claim 1, wherein the model is further configured to generate one or more response maps, wherein the at least one goal for a metabolic response is a response map selected from the one or more generated response maps.
Ramasubramanian, however, teaches wherein the model is further configured to generate one or more response maps, wherein the at least one goal for a metabolic response is a response map selected from the one or more generated response maps (Ramasubramanian: abstract; ¶¶ [0056]; FIGS. 1-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the patient health system including response maps, as taught by Ramasubramanian, with the metabolic condition control system, as taught by Douglas, with the personalized dynamic feedback control of body weight, as taught by Hall, with the motivation of assisting and facilitating health regimes (Ramasubramanian: ¶¶ [0004]-[0010]).
Response to Arguments
6. Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 12/22/2025.
6.1. Applicant argues, on pages 8-14 of the response, that the claims do not recite certain methods of organizing human activity or a mental process; even if the claims recite an abstract idea, the abstract idea is integrated into a practical application because the claims improve a technical field, recite a particular solution and improve the performance of the model.
Examiner respectfully disagrees and reiterates that the pending claims are directed to computing devices for human metabolic condition management by, inter alia, generating at least one goal and outputs for achieving the goal, wherein the outputs are provided as instructions for a treatment, and wherein the treatment is administered by a person which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. As such, whether or not the claims also recite and directed to a mental process is moot. Nevertheless, it is submitted that nothing in the claims precludes a person from performing the steps of obtaining inputs to generate and provide outputs to achieve goals in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion.
Examiner also respectfully reiterates that the alleged improvement pertains to the abstract idea itself, rather than improvements to any technology. For example, the claims recite a general-purpose computer technology (i.e., processor, model, etc.) without any limitations evidencing the technology has been improved, such as, by making the general-purpose computer operate faster, improving the general-purpose computer’s data storage capabilities, or improving the accuracy of the model, etc. It is further submitted that the claims are not directed to solving a technological problem per se, rather the claims are attempting to solve a problem rooted in a medical process (i.e., managing a person’s health) by using well-known general purpose computer technologies to automate what otherwise could be performed by a human. In other words, the focus of Applicant’s claims is not on an improvement in computers as tools, but on certain abstract ideas that use computers as tools.
As such, it is respectfully submitted that the claims are directed to and recite an abstract idea, the abstract idea is not integrated into a practical application, the additional elements do not amount to significantly more than the abstract idea itself, and therefore, the claims are not patent-eligible subject matter under 35 U.S.C. § 101.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681